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WHY IT MATTERS Researchers worked with primary care doctors who use EHRs regularly for documentation purposes to understand their views on future AI documentation assistants. They identified three major themes that viagra cost emerged from the discussions. Professional autonomy, human-AI collaboration and new models of care.

First, the doctors emphasized the importance of their ability to care for patients in their own way with the viagra cost abilities AI technology provided."If they [patients] think that we're just getting suggestions from a computer, then maybe they can just get suggestions from a computer. I think it becomes more difficult to convince them that our recommendations are more valuable than what they can pick up on the internet," said one physician. They noted the need for a bottom-up approach to technology development, with a focus on delivering clear benefits to practice and workflow, and expressed fears around potential legal complications that could stem from viagra cost working with an AI assistant.With regard to human-AI collaboration, doctors expressed a variety of viewpoints about what tasks could be delegated to AI.

Many believed that an AI system could assist with tasks such as documentation, referrals and other paperwork. Most said viagra cost that AI systems would lack empathy. "GPs voiced several concerns, including some potential biases in patient data and system design, the time needed to fix the errors and train the system, challenges of dealing with complex cases, and the auditing of AI," wrote the researchers.

However, doctors also discussed how AI could help with emerging models of primary care, including viagra cost preconsultation, mobile health and telehealth. THE LARGER TREND The question of reducing EHR-related clinician burnout has loomed large, with vendors and researchers trying to pinpoint major causes – and, in turn, potential solutions. AI has viagra cost been raised as one such solution, with several major EHR vendors offering plans for incorporating the technology into their workflows.

But human input remains vital, as the new JAMIA study and other research has noted. AI could "bring back meaning and purpose in the practice of medicine while providing new levels viagra cost of efficiency and accuracy," wrote Stanford researchers in a 2017 Journal of the American Medical Association study. But, they continued, physicians must "proactively guide, oversee, and monitor the adoption of artificial intelligence as a partner in patient care."ON THE RECORD"AI documentation assistants will likely ...

Be integral to the future primary care consultations viagra cost. However, these technologies will still need to be supervised by a human until strong evidence for reliable autonomous performance is available. Therefore, different human-AI collaboration models will need to be designed and evaluated to ensure patient safety, quality of care, doctor safety, and viagra cost doctor autonomy," wrote the Australian Institute for Health Innovation researchers.

Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication.Konica Minolta Healthcare Americas will pay $500,000 to settle a whistleblower viagra cost case that alleged its Viztek electronic health record subsidiary had falsified data for certification tests.WHY IT MATTERSIn the qui tam complaint, filed in 2017 in U.S. District Court in New Jersey – where Konica Minolta is based – was filed by whistleblower Leighsa Wilson, who worked for two years at Viztek, best known for its PACS and imaging technologies, as a project manager for its EXA EHR product.In mid-2015, the complaint alleges, Viztek, which was in negotiations to be acquired by Konica Minolta, worked together with InfoGard Laboratories (which was then an ONC-authorized certification and testing body) to make false representations that the EHR software complied with requirements for certification – and qualified for receipt of incentive payments under the federal meaningful use program."To ensure that their product was certified and that their customers received incentive payments, Viztek and Konica Minolta.

(a) falsely attested to viagra cost InfoGard that their software met the certification criteria. (b) hard-coded their software to pass certification testing requirements temporarily without ensuring that the software released to customers met certification criteria. And (c) caused their users to falsely attest to viagra cost using a certified EHR technology, when their software could not support the applicable certification criteria in the field," according to the complaint, which also alleges that InfoGard "facilitated and participated in" these false attestations, "knowingly or with reckless disregard," certifying the EHR software despite its inability to meet ONC's certification criteria.The flaws in Viztek's software "not only rendered the system unreliable and unable to meet meaningful use standards, but the flaws also created a risk to patient health and safety.

Rather than spend the time and resources necessary to correct the flaws in its EHR software, the EHR defendants opted to do nothing."THE LARGER TRENDThis is only the most recent settlement of this type from health IT vendors accused of False Claims Act violations, of course.Most notable, was the case of eClinicalWorks, which was alleged by the Department of Justice to have falsely claimed meaningful use certification, to have neglected to have safety addressed issues in its software and to have paid kickbacks to clients. That case was settled in viagra cost 2017 for $155 million.More recently, similar complaints were lodged against companies such as Practice Fusion and Greenway Health. They settled with DOJ for $145 million and $57 million, respectively."We will be unflagging in our efforts to preserve the accuracy and reliability of Americans’ health records and guard the public against corporate greed," said U.S.

Attorney for the District of Vermont Christina Nolan after the Greenway case this past year viagra cost. "EHR companies should consider themselves on notice."ON THE RECORD"The lives of patients depend upon the information processed by electronic health records," said Wilson – who, as a qui tam whistleblower will receive 20% of the financial settlement – in a statement. "Functionality testing and subsequent certification must be performed and obtained through a reliable, measurable process.""Filing a qui tam lawsuit is a powerful and effective way to report problems with EHR software purchased with federal funds and get the problems fixed when they are ignored," viagra cost said Luke Diamond, an associate at Phillips &.

Cohen. "The False Claims Act protects whistleblowers from job retaliation and offers rewards if the government recovers funds as a result of the qui tam case.""Our client was concerned about possible patient harm that can occur if EHR software isn't properly certified, so she stepped forward to inform the government viagra cost about what she had witnessed," said Colette Matzzie, a partner and whistleblower attorney with Phillips &. Cohen, which brought the case.

"Ensuring that EHR viagra cost software meets all governmental requirements is important to safeguard both patient care and federal funds."The Arc Madison Cortland in Oneida, New York, knows that there is a lack of providers that specialize in the intellectual/developmental disability field. Making the problem worse, not so many that understand dual diagnosis.THE PROBLEMWith COVID-19 minimizing the ability for individuals to receive face-to-face services with their viagra cost providers, many patients are resorting to emergency department visits.Additionally, The Arc is in a rural area requiring travel to see a provider, and there is a lack of providers in the field. The population itself is underserved, with a lack of transportation to get to appointments.

Without the ability to institute telemedicine as a solution to these problems, the population supported by The Arc would have seen a lengthy (permanent? viagra cost. ) pause for needed medical services.PROPOSALThe Arc this year received funding from the FCC to help provide telehealth services.“With this funding we can further treat patients, reduce crisis and allow for social distancing, which is imperative to our vulnerable population,” said Jackie Fahey, director of clinic services at The Arc Madison Cortland. €œWe could provide ongoing services to the individuals we serve to viagra cost ensure there are no unnecessary emergency department visits.

This places less of a strain on our local emergency departments and unneeded additional costs.”With the purchase of tablets and headsets and telehealth services from vendor Doxy.me, The Arc was able to still provide medical care to its population of people with an I/DD. Additionally, eliminating emergency department visits also eliminates their viagra cost exposure to COVID-19 and eases the burden of the ED providers who are overburdened right now.MARKETPLACEThere are many vendors of telemedicine technology and services on the health IT market today. Healthcare IT News recently compiled a comprehensive list of these vendors with detailed descriptions.

To read this special report, click here.MEETING THE CHALLENGE“When all of our locations were closed abruptly in the middle of March due to the COVID-19 pandemic, we needed to determine a way to quickly and easily implement a telehealth solution so that we were able to still support the individuals that we serve during the crisis, especially when many were under strict quarantine protocols viagra cost for a variety of reasons,” Fahey explained.“We signed up immediately for the Doxy.me telehealth platform as it was a user-friendly platform that is HIPAA-compliant. The feature we liked about Doxy.me was that it is web-based, so nothing had to be downloaded and it could easily be used on a laptop, tablet or smartphone.”The Arc rolled out the technology initially with its mental health providers, who offer psychiatry/medication monitoring services, social work counseling and mental health counseling. More than half the organization’s enrollment is enrolled in one or all of these three services, so it was able to continue providing services to a large number of enrolled individuals.“We then began to roll the telehealth services out to nutrition, speech therapy, physical therapy and occupational viagra cost therapy caseloads if individuals were appropriate to receive the service through telehealth,” Fahey said.RESULTSThe first success metric The Arc has been able to achieve with the technology is maintaining its utilization for mental health services.

When everything was running normal prior to COVID-19, The Arc’s mental health services made up about 25% of the services it provided on a monthly basis. With the implementation of telehealth services during the COVID-19 pandemic, the organization was able to achieve 20% of the services provided on a monthly basis.This has shown to staff that they have been able to still serve viagra cost and respond to the needs of their psychiatry, social work and mental health counseling patients with minimal issues by implementing the telehealth technology.“The second success metric we have been able to achieve with the technology is we have been able to continue to receive referrals for our services and enroll new individuals into the services they need if the services are able to be completed via telehealth,” she said. €œBetween April, May and June, we have enrolled 16 new individuals into ongoing clinic services, which is right on par for our normal enrollment average per month.”USING FCC AWARD FUNDSThe Arc Madison Cortland was awarded $49,455 by the FCC earlier this year for laptop computers and headsets to provide remote consultations and treatment during the COVID-19 pandemic for psychological services, counseling, and occupational and physical therapy for people with developmental and other disabilities.“With the funds, we purchased headsets and tablets to allow the people we support to have access to medical appointments, along with physical therapy, occupational therapy and psychology appointments remotely,” Fahey explained.

€œThe technology enables us to continue to provide these services at a time when the people we support are unable to leave for traditional in-person appointments.“Because these are such uncertain times, and a time frame for when we may return to ‘normalcy’ is unknown, the technology allows us to continue delivering medical support without the viagra cost concern of a pause in those services.”Twitter. @SiwickiHealthITEmail the writer. Bill.siwicki@himss.orgHealthcare IT News is a HIMSS Media publication.HIMSSCast host Jonah Comstock convenes a panel of HIMSS Media editors – HITN Senior Editor Kat Jercich, MobiHealthNews Associate Editor Dave Muoio viagra cost and HFN Associate Editor Jeff Lagasse – to discuss recent delivery slowdowns at the Post Office and how they have and haven't affected healthcare stakeholders, including startups and patients.

The team also looks into the broader trend of the politicization of traditionally apolitical government agencies and how that could affect public faith in COVID-19 treatments or vaccines.More about this episode:USPS service delays are hitting some mail-order pharmacies and telehealth platforms harder than othersMail delays may affect medication supply for nearly 1 in 4 Americans over 50Postmaster General Louis DeJoy's full testimony (C-SPAN)The Package Coalition homepageThe Trump administration this week asked the U.S. Supreme Court to reverse a lower court ruling that allowed for mail-order and telemedicine abortion viagra cost during the COVID-19 crisis. U.S.

Food and Drug Administration regulations require mifepristone, which is viagra cost used in medication abortion, to be dispensed at a clinic, hospital or medical office. In June, U.S. District Judge for the District of Maryland Theodore Chuang blocked the requirements during the pandemic, finding them to be a "substantial obstacle." Mifepristone, in combination with misoprostol, is FDA-approved for abortions up viagra cost to ten weeks' gestation.

In 2017, a New England Journal of Medicine article argued against the FDA regulations for mifepristone given the drug's safety record. WHY viagra cost IT MATTERS Acting Solicitor General Jeffrey B. Wall applied for a stay of Chuang's injunction on Wednesday as the case makes its way through the lower courts, arguing that the regulations do not represent an undue burden.

"The safety requirements here concern only viagra cost medication abortions using Mifeprex, which is approved for use only during the first ten weeks of pregnancy. They have no effect on the availability of surgical abortions, a method that this Court has treated as safe for women," wrote Wall. Reproductive rights groups spoke out against the move, noting that people of color are viagra cost disproportionately affected both by abortion restrictions and by the COVID-19 pandemic.

"Black, Brown, Indigenous people and people of color are already dying/getting sick at disproportionate rates from COVID-19," said All Above All* on Twitter. "The Trump-Pence admin is trying to make this viagra cost worse by asking SCOTUS to require people face unnecessary risk just to get abortion care." "The FDA’s in-person requirements on mifepristone subject patients to unnecessary exposure to a deadly virus, and two federal courts have already rejected the Trump administration’s argument. Forcing patients to travel to a health center to access the safe, effective medication they need especially hurts people of color and people with low-incomes, who already face more barriers to care," said Planned Parenthood Federation of America President and CEO Alexis McGill-Johnson in a statement.THE LARGER TREND The COVID-19 pandemic has exacerbated many existing barriers to care, including for reproductive health services.

"We’ve seen the undue burden and hardship these restrictions create during COVID-19, especially in communities hit hardest by the pandemic," said Skye Perryman, viagra cost chief legal officer at the American College of Obstetricians and Gynecologists, a co-plaintiff in the telemedicine case, to Healthcare IT News. In response to the July ruling, some abortion providers reportedly moved to delivering mifepristone by mail. Still, others faced state laws that restricted the provision of abortion via telemedicine.And as Dr viagra cost.

Jacquelyn Yeh from Physicians from Reproductive Health pointed out in July, telemedicine itself involves hurdles such as broadband access and privacy concerns. It remains to be seen whether viagra cost the Supreme Court will grant the Trump administration's request. ON THE RECORD "As COVID-19 ravages Black, Latino, Indigenous, and other communities of color across the country, the Trump administration should be aiming to keep us healthy – not moving forward with an agenda to endanger people who seek abortion," said McGill-Johnson.

Kat Jercich viagra cost is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication..

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Start Preamble pfizer viagra online Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures. This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August pfizer viagra online 24, 2020. Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, pfizer viagra online 200 Independence Avenue SW, Washington, DC 20201.

Telephone. 202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant. The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2.

It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act.

On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020. On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration).

On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. 15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Description of This Amendment by Section Section V.

Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed. Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S.

Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed. Most practices had reduced office hours for in-person visits. When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here.

If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations. Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms. Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks.

The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates. We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience.

What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination. In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible.

Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements. The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children.

That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule. All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures.

Section VIII. Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19. Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below.

All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr. 15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States. In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency.

(b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act. (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met. The vaccine must be FDA-authorized or FDA-approved.

The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine. The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program.

Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures. 2.

Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C.

247d-6d. End Authority Start Signature Dated. August 19, 2020. Alex M. Azar II, Secretary of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-18542 Filed 8-20-20. 4:15 pm]BILLING CODE 4150-03-PToday, the U.S. Department of Health and Human Services released Healthy People 2030, the nation's 10-year plan for addressing our most critical public health priorities and challenges. Since 1980, HHS's Office of Disease Prevention and Health Promotion has set measurable objectives and targets to improve the health and well-being of the nation.This decade, Healthy People 2030 features 355 core – or measurable – objectives with 10-year targets, new objectives related to opioid use disorder and youth e-cigarette use, and resources for adapting Healthy People 2030 to emerging public health threats like COVID-19.

For the first time, Healthy People 2030 also sets 10-year targets for objectives related to social determinants of health."Healthy People was the first national effort to lay out a set of data-driven priorities for health improvement," said HHS Secretary Alex Azar. "Healthy People 2030 adopts a more focused set of objectives and more rigorous data standards to help the federal government and all of our partners deliver results on these important goals over the next decade."Healthy People has led the nation with its focus on social determinants of health, and continues to prioritize economic stability, education access and quality, health care access and quality, neighborhood and built environment, and social and community context as factors that influence health. Healthy People 2030 also continues to prioritize health disparities, health equity, and health literacy."Now more than ever, we need programs like Healthy People that set a shared vision for a healthier nation, where all people can achieve their full potential for health and well-being across the lifespan," said ADM Brett P. Giroir, MD, Assistant Secretary for Health. "COVID-19 has brought the importance of public health to the forefront of our national dialogue.

Achieving Healthy People 2030's vision would help the United States become more resilient to public health threats like COVID-19."Healthy People 2030 emphasizes collaboration, with objectives and targets that span multiple sectors. A federal advisory committee of 13 external thought leaders and a workgroup of subject matter experts from more than 20 federal agencies contributed to Healthy People 2030, along with public comments received throughout the development process.The HHS Office of Disease Prevention and Health Promotion leads Healthy People in partnership with the National Center for Health Statistics at the Centers for Disease Control and Prevention, which oversees data in support of the initiative.HHS Secretary Alex M. Azar II, ADM Brett P. Giroir, MD, Assistant Secretary for Health, and U.S. Surgeon General Jerome M.

Adams, MD, MPH, and others from HHS and CDC will launch Healthy People 2030 during a webcast on August 18 at 1 pm (EDT) at https://www.hhs.gov/live. No registration is necessary. For more information about Healthy People 2030, visit https://healthypeople.gov..

Start Preamble viagra cost Notice of amendment. The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures. This amendment to the Declaration published on March 17, 2020 (85 FR 15198) is effective as of August 24, 2020 viagra cost.

Start Further Info Robert P. Kadlec, MD, MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, viagra cost DC 20201. Telephone.

202-205-2882. End Further Info End Preamble Start Supplemental Information The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, § 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified at 42 U.S.C.

247d-6d and 42 U.S.C. 247d-6e, respectively. Section 319F-3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136, enacted on March 27, Start Printed Page 521372020, to expand Covered Countermeasures under the PREP Act.

On January 31, 2020, the Secretary declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration on April 26, 2020, and July 25, 2020.

On March 10, 2020, the Secretary issued a Declaration under the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, Mar. 17, 2020) (the Declaration). On April 10, the Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr.

15, 2020). On June 4, the Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID-19 might otherwise cause. The Secretary now amends section V of the Declaration to identify as qualified persons covered under the PREP Act, and thus authorizes, certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule (ACIP-recommended vaccines).[] The Secretary also amends section VIII of the Declaration to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures includes not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.

Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a “qualified person” is a “covered person.” Subject to certain limitations, a covered person is immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure. €œQualified person” includes (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

Or (B) “a person within a category of persons so identified in a declaration by the Secretary” under subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8).[] By this amendment to the Declaration, the Secretary identifies an additional category of persons who are qualified persons under section 247d-6d(i)(8)(B).[] On May 8, 2020, CDC reported, “The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S.

Children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” and suggested that a decrease in rates of routine childhood vaccinations were due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies.[] The report also stated that “[p]arental concerns about potentially exposing their children to COVID-19 during well child visits might contribute to the declines observed.” [] On July 10, 2020, CDC reported its findings of a May survey it conducted to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19 pandemic. The survey, which was limited to practices participating in the Vaccines for Children program, found that, as of mid-May, 15 percent of Northeast pediatric practices were closed, 12.5 percent of Midwest practices were closed, 6.2 percent of practices in the South were closed, and 10 percent of practices in the West were closed. Most practices had reduced office hours for in-person visits.

When asked whether their practices would likely be able to accommodate new patients for immunization services through August, 418 practices (21.3 percent) either responded that this was not likely or the practice was permanently closed or not resuming immunization services for all patients, and 380 (19.6 percent) responded that they were unsure. Urban practices and those in the Northeast were less likely to be able to accommodate new patients compared with rural practices and those in the South, Midwest, or West.[] In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed, “Well-child visits and vaccinations are essential services and help make sure children are protected.” [] The Secretary re-emphasizes that important recommendation to parents and legal guardians here. If your child is due for a well-child visit, contact your pediatrician's or other primary-care provider's office and ask about ways that the office safely offers well-child visits and vaccinations.

Many medical offices are taking extra steps to make sure that well-child visits can occur safely during the COVID-19 pandemic, including. Scheduling sick visits and well-child visits during different times of the Start Printed Page 52138day or days of the week, or at different locations. Asking patients to remain outside until it is time for their appointments to reduce the number of people in waiting rooms.

Adhering to recommended social (physical) distancing and other infection-control practices, such as the use of masks. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19. Together, the United States must turn to available medical professionals to limit the harm and public health threats that may result from decreased immunization rates.

We must quickly do so to avoid preventable infections in children, additional strains on our healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with additional resurgence of COVID-19. Together with pediatricians and other healthcare professionals, pharmacists are positioned to expand access to childhood vaccinations. Many States already allow pharmacists to administer vaccines to children of any age.[] Other States permit pharmacists to administer vaccines to children depending on the age—for example, 2, 3, 5, 6, 7, 9, 10, 11, or 12 years of age and older.[] Few States restrict pharmacist-administered vaccinations to only adults.[] Many States also allow properly trained individuals under the supervision of a trained pharmacist to administer those vaccines.[] Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.[] As of 2018, nearly 90 percent of Americans lived within five miles of a community pharmacy.[] Pharmacies often offer extended hours and added convenience.

What is more, pharmacists are trusted healthcare professionals with established relationships with their patients. Pharmacists also have strong relationships with local medical providers and hospitals to refer patients as appropriate. For example, pharmacists already play a significant role in annual influenza vaccination.

In the early 2018-19 season, they administered the influenza vaccine to nearly a third of all adults who received the vaccine.[] Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations. Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible. Therefore, the Secretary amends the Declaration to identify State-licensed pharmacists (and pharmacy interns acting under their supervision if the pharmacy intern is licensed or registered by his or her State board of pharmacy) as qualified persons under section 247d-6d(i)(8)(B) when the pharmacist orders and either the pharmacist or the supervised pharmacy intern administers vaccines to individuals ages three through 18 pursuant to the following requirements.

The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule.[] The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training Start Printed Page 52139program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE.

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.[] The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.[] The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.[] The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.[] The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.[] These requirements are consistent with those in many States that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.[] Administering vaccinations to children age three and older is less complicated and requires less training and resources than administering vaccinations to younger children. That is because ACIP generally recommends administering intramuscular injections in the deltoid muscle for individuals age three and older.[] For individuals less than three years of age, ACIP generally recommends administering intramuscular injections in the anterolateral aspect of the thigh muscle.[] Administering injections in the thigh muscle often presents additional complexities and requires additional training and resources including additional personnel to safely position the child while another healthcare professional injects the vaccine.[] Moreover, as of 2018, 40% of three-year-olds were enrolled in preprimary programs (i.e. Preschool or kindergarten programs).[] Preprimary programs are beginning in the coming weeks or months, so the Secretary has concluded that it is particularly important for individuals ages three through 18 to receive ACIP-recommended vaccines according to ACIP's standard immunization schedule.

All States require children to be vaccinated against certain communicable diseases as a condition of school attendance. These laws often apply to both public and private schools with identical immunization and exemption provisions.[] As nurseries, preschools, kindergartens, and schools reopen, increased access to childhood vaccinations is essential to ensuring children can return. Notwithstanding any State or local scope-of-practice legal requirements, (1) qualified licensed pharmacists are identified as qualified persons to order and administer ACIP-recommended vaccines and (2) qualified State-licensed or registered pharmacy interns are identified as qualified persons to administer the ACIP-recommended vaccines ordered by their supervising qualified licensed pharmacist.[] Both the PREP Act and the June 4, 2020 Second Amendment to the Declaration define “covered countermeasures” to include qualified pandemic and epidemic products that “limit the harm such pandemic or epidemic might otherwise cause.” [] The troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by Start Printed Page 52140COVID-19 as set forth in Sections VI and VIII of this Declaration.[] Hence, such vaccinations are “covered countermeasures” under the PREP Act and the June 4, 2020 Second Amendment to the Declaration.

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C. 300aa-10 et seq.

Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other terms and conditions of the Declaration apply to such covered countermeasures. Section VIII.

Category of Disease, Health Condition, or Threat As discussed, the troubling decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. The Secretary therefore amends section VIII, which describes the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures, to clarify that the category of disease, health condition, or threat for which he recommends the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Amendments to Declaration Amended Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19.

Sections V and VIII of the March 10, 2020 Declaration under the PREP Act for medical countermeasures against COVID-19, as amended April 10, 2020 and June 4, 2020, are further amended pursuant to section 319F-3(b)(4) of the PHS Act as described below. All other sections of the Declaration remain in effect as published at 85 FR 15198 (Mar. 17, 2020) and amended at 85 FR 21012 (Apr.

15, 2020) and 85 FR 35100 (June 8, 2020). 1. Covered Persons, section V, delete in full and replace with.

V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B) Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

In addition, I have determined that the following additional persons are qualified persons. (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency. (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act.

(c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act. And (d) a State-licensed pharmacist who orders and administers, and pharmacy interns who administer (if the pharmacy intern acts under the supervision of such pharmacist and the pharmacy intern is licensed or registered by his or her State board of pharmacy), vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule. Such State-licensed pharmacists and the State-licensed or registered interns under their supervision are qualified persons only if the following requirements are met.

The vaccine must be FDA-authorized or FDA-approved. The vaccination must be ordered and administered according to ACIP's standard immunization schedule. The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE).

This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation. The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period. The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient's primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.

The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregiver accompanying the child of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate. Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party's ability to obtain compensation under that program. Covered countermeasures that are subject to the National Vaccine Injury Compensation Program authorized under 42 U.S.C.

300aa-10 et seq. Are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program. All other Start Printed Page 52141terms and conditions of the Declaration apply to such covered countermeasures.

2. Category of Disease, Health Condition, or Threat, section VIII, delete in full and replace with. VIII.

Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases. Start Authority 42 U.S.C.

247d-6d. End Authority Start Signature Dated. August 19, 2020.

Alex M. Azar II, Secretary of Health and Human Services. End Signature End Supplemental Information [FR Doc.

2020-18542 Filed 8-20-20. 4:15 pm]BILLING CODE 4150-03-PToday, the U.S. Department of Health and Human Services released Healthy People 2030, the nation's 10-year plan for addressing our most critical public health priorities and challenges.

Since 1980, HHS's Office of Disease Prevention and Health Promotion has set measurable objectives and targets to improve the health and well-being of the nation.This decade, Healthy People 2030 features 355 core – or measurable – objectives with 10-year targets, new objectives related to opioid use disorder and youth e-cigarette use, and resources for adapting Healthy People 2030 to emerging public health threats like COVID-19. For the first time, Healthy People 2030 also sets 10-year targets for objectives related to social determinants of health."Healthy People was the first national effort to lay out a set of data-driven priorities for health improvement," said HHS Secretary Alex Azar. "Healthy People 2030 adopts a more focused set of objectives and more rigorous data standards to help the federal government and all of our partners deliver results on these important goals over the next decade."Healthy People has led the nation with its focus on social determinants of health, and continues to prioritize economic stability, education access and quality, health care access and quality, neighborhood and built environment, and social and community context as factors that influence health.

Healthy People 2030 also continues to prioritize health disparities, health equity, and health literacy."Now more than ever, we need programs like Healthy People that set a shared vision for a healthier nation, where all people can achieve their full potential for health and well-being across the lifespan," said ADM Brett P. Giroir, MD, Assistant Secretary for Health. "COVID-19 has brought the importance of public health to the forefront of our national dialogue.

Achieving Healthy People 2030's vision would help the United States become more resilient to public health threats like COVID-19."Healthy People 2030 emphasizes collaboration, with objectives and targets that span multiple sectors. A federal advisory committee of 13 external thought leaders and a workgroup of subject matter experts from more than 20 federal agencies contributed to Healthy People 2030, along with public comments received throughout the development process.The HHS Office of Disease Prevention and Health Promotion leads Healthy People in partnership with the National Center for Health Statistics at the Centers for Disease Control and Prevention, which oversees data in support of the initiative.HHS Secretary Alex M. Azar II, ADM Brett P.

Giroir, MD, Assistant Secretary for Health, and U.S. Surgeon General Jerome M. Adams, MD, MPH, and others from HHS and CDC will launch Healthy People 2030 during a webcast on August 18 at 1 pm (EDT) at https://www.hhs.gov/live.

No registration is necessary. For more information about Healthy People 2030, visit https://healthypeople.gov..

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If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Call your health care provider right away if you have any change in vision. Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking Viagra, you should refrain from further activity and call your doctor or health care professional as soon as possible. Using Viagra does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

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Latest Sleep donde venden viagra News By Dennis site here ThompsonHealthDay ReporterTHURSDAY, Aug. 27, 2020A frequent need to donde venden viagra nap could be a red flag for future heart problems and a higher risk of early death, a new analysis concludes.Long naps lasting more than an hour are associated with a 34% elevated risk of heart disease and a 30% greater risk of death, according to the combined results of 20 previous studies.Overall, naps of any length were associated with a 19% increased risk of premature death, a Chinese research team found. The study results were released Wednesday for presentation at the virtual annual meeting of the European Society of Cardiology."If you want to take a siesta, our study indicates it's safest to keep it under an hour," lead researcher Zhe Pan of Guangzhou Medical University said in a society news release.

"For those of us not in the habit of a daytime slumber, there is no convincing evidence to donde venden viagra start."For their study, the researchers analyzed data from 20 studies involving more than 313,000 participants. About two in five people in the studies said they nap.The investigators found that the connection was more pronounced in people aged 65 and older. These older folks had a 27% higher risk of death associated with napping and donde venden viagra a 36% greater risk of heart disease.

Women also had a stronger association between napping and poor health, with a 22% greater risk of death and a 31% greater risk of heart problems.Interestingly, long naps were linked with an increased risk of donde venden viagra death in people who sleep more than six hours a night. That would seem to rule out poor sleep as an explanation for the increased risk of death and heart health issues.Adults who get less than seven hours of sleep each night are more likely to say they've had a heart attack, according to the U.S. Centers for Disease donde venden viagra Control and Prevention.

Poor sleep also has been linked to high blood pressure, type 2 diabetes and obesity, all of which increase the risk of heart disease, heart attack and stroke.Pan speculated that long naps might affect the body because they are associated with higher levels of inflammation.But heart health experts said that just because you're sleeping through the night doesn't mean you've gotten a good night's sleep -- something for which this study doesn't account.Regarding how well you're resting at night, napping "might be a sign that there's something else going on," said Dr. Nieca Goldberg, a cardiologist and director of the NYU Langone Center for Women's Health, in New York City."What kind of sleep were these individuals getting? donde venden viagra. " Goldberg said of the study donde venden viagra participants.

"Were they waking up at night?. Did they have donde venden viagra sleep apnea?. "Dr.

Matthew Tomey, donde venden viagra a cardiologist with Mount Sinai Morningside in New York City, agreed that these folks might be suffering from poor sleep."Some people take naps as a matter of habit, or they take a power nap," Tomey said. "For others, they're taking potentially longer naps during the daytime because of too little or too poor quality sleep at night."People should take a nap when they feel like it, but if they regularly need naps that could be a sign of trouble, Tomey said."If they notice that they feel excessively sleepy during the daytime, needing multiple or long naps, that's a wake-up call to pay attention to the quality and quantity of their nighttime sleep," he added.People who frequently nap should talk with their doctor about their sleep issues, since they might be suffering from sleep apnea or some other issue that disrupts quality sleep, Tomey and Goldberg said.Good sleep habits, according to the CDC, include:Sticking to a regular sleep schedule.Getting enough natural light during the day, to positively influence brain chemicals related to sleep.Exercising regularly, but not within a few hours of bedtime.Avoiding artificial light near bedtime.Keeping your bedroom cool, dark and quiet.Copyright © 2020 HealthDay. All rights donde venden viagra reserved.

SLIDESHOW donde venden viagra Sleep Disorders. Foods That Help Sleep or Keep You Awake See Slideshow References SOURCES. Nieca Goldberg, MD, cardiologist and director, NYU Langone Center for donde venden viagra Women's Health, New York City.

Matthew Tomey, MD, cardiologist, Mount Sinai Morningside, New York City. European Society donde venden viagra of Cardiology, annual meeting.Latest Heart News By Serena McNiffHealthDay ReporterWEDNESDAY, Aug. 26, 2020 (HealthDay News)Most strokes strike when an artery in the brain suddenly becomes blocked, but new research shows a rarer cause of strokes is becoming more common.It's called cerebral venous thrombosis (CVT), and it happens when a vein in the brain is clogged.

While CVT is estimated to cause less than 1% of all strokes, scientists discovered it is now more prevalent donde venden viagra and affecting a different demographic than previously thought.Study author Dr. Fadar Otite and his donde venden viagra colleagues pored over years of hospital records from New York and Florida to find out how many cases of CVT occurred in these states between 2006 and 2016. Otite is an assistant professor of neurology at SUNY Upstate Medical University in Syracuse, N.Y.Based on the data they analyzed, the researchers estimated that the number of CVT cases in the United States rose from around 14 cases per million in 2006 to 20 cases per million in 2014."We still find that the incidence of CVT is less than 1% of all strokes, even across our study period, but the incidence increased by 70% over time," Otite said.

"In 2006, the proportion of all strokes donde venden viagra that were CVT was 0.47%. At the end of our study, which was in 2016, that proportion increased to 0.80%."CVT causes blood clots to form in the veins of the brain. These veins drain blood that has already been used by brain cells, sending it back to donde venden viagra the heart to be replenished with oxygen.

If a clot forms in one of these veins, it may leak into donde venden viagra the surrounding brain tissue and could cause a stroke, the researchers explained.While CVT is still most common in young women -- about two-thirds of all CVT hospitalizations included in the study were in females -- the researchers found that the number of cases among this demographic did not increase over the 10-year study period. Instead, they saw increases in CVT among men and older women."Part of the message is that we agree that CVT is still more common in women, but because of the diverse clinical presentation of CVT, when other symptoms that may be attributable to CVT are present in other demographics, we should take them with more seriousness," Otite said.Another major finding was that CVT incidence in Black people was significantly higher than in other races. But why that donde venden viagra is the case remains unknown.

"We have no clear explanation, because this is truly the first study to ever relate the incidence of CVT between races," he added.Several factors may put one at a higher risk of developing CVT, including pregnancy and taking hormonal birth control pills, which may be why it is more common in younger women, the researchers noted.And many of the risk factors for CVT -- like blood clotting disorders or medications that cause clotting, severe dehydration, infections of the ear, face or neck, head trauma, obesity and cancer -- are somewhat different from the triggers typically associated with stroke.It is important for clinicians to be aware of this rise in CVT incidence because the condition can easily be confused as something else, Otite said. Patients with donde venden viagra CVT may have unspecific complaints such as headaches, blurry vision or seizures.Around 3% of patients in a prior study who had CVT and went to the hospital were diagnosed with something else and sent home, according to Otite. "So, it's important to recognize this from the start, because by the next time the clinical condition may be worse," he said.CVT can be treated with medication to thin the blood and help prevent further clotting, which may not be prescribed if the condition isn't properly diagnosed, he added.Dr.

Jose Biller, chair of the neurology department at Loyola University Medical Center in Hines, Ill., said the takeaway from this study is that more attention should is viagra prescribed be paid to CVT."I think that there should be an increased awareness of cerebral venous thrombosis because, donde venden viagra by and large, when people think about stroke, they don't think about it," Biller said. "There should be an increasing level of awareness because donde venden viagra this is a condition that has a specific treatment."The study was published online Aug. 26 in the journal Neurology.Copyright © 2020 HealthDay.

All rights donde venden viagra reserved. SLIDESHOW Stroke Causes, Symptoms, and Recovery See Slideshow References SOURCES. Fadar Oliver Otite, MD, assistant professor, neurology, State University of New York (SUNY) Upstate Medical University, Syracuse, N.Y. donde venden viagra.

Jose Biller, MD, chair, department of neurology, Loyola University Medical donde venden viagra Center, Hines, Ill.. Neurology, Aug. 26, 2020, onlineLatest Hearing News donde venden viagra WEDNESDAY, Aug.

26, 2020 (HealthDay News)Even if they appear unresponsive, dying people may still be able to hear.That's the takeaway from a Canadian analysis of hospice patients in Vancouver.Researchers compared electroencephalography (EEG) data -- a measure of electrical activity in the brain -- collected when patients were conscious and when they became unresponsive at the end of life. Those patients were compared to a healthy control group.The study looked at brain response to various patterns of common and rare sounds that changed frequency, and found that responses of some of the dying patients were similar to those of healthy people -- even hours before death."In the donde venden viagra last hours before an expected natural death, many people enter a period of unresponsiveness," said lead author Elizabeth Blundon, a doctoral student in psychology at the University of British Columbia at the time of the study."Our data shows that a dying brain can respond to sound, even in an unconscious state, up to the last hours of life," she said in a university news release.Co-author Lawrence Ward, a professor of psychology, said researchers were able to identify specific mental processes in both groups of participants."We had to look very carefully at the individual control participants' data, to see if each one of them showed a particular type of brain response before we felt confident that the unresponsive patient's brain reacted similarly," he said in the release.The findings were recently published in the journal Scientific Reports."This research gives credence to the fact that hospice nurses and physicians noticed that the sounds of loved ones helped comfort people when they were dying," said study co-author Dr. Romayne Gallagher, a now-retired palliative care physician at St.

John Hospice in donde venden viagra Vancouver."And to me, it adds significant meaning to the last days and hours of life and shows that being present, in person or by phone, is meaningful," she said. "It is a comfort to be able to say goodbye and express love."While the evidence of brain activity supports the idea that dying people might hear, it's not known if they're aware of what donde venden viagra they're hearing, Blundon noted."Their brains responded to the auditory stimuli, but we can't possibly know if they're remembering, identifying voices, or understanding language," she said. "There are all these other questions that have yet to be answered.

This first glimpse supports the idea that we have to keep talking to people when donde venden viagra they are dying because something is happening in their brain."-- Robert PreidtCopyright © 2020 HealthDay. All rights reserved. QUESTION What is donde venden viagra hearing loss?.

See donde venden viagra Answer References SOURCE. University of British Columbia, news release, July 8, 2020Latest Pregnancy News THURSDAY, Aug. 27, 2020 (HealthDay News)A new case study adds to growing evidence that the new coronavirus can be transmitted from a pregnant woman donde venden viagra to her fetus."It's very important to bring to the forefront this finding that mothers and infants can be affected by COVID-19, transmission can occur during pregnancy, and pregnant mothers need to protect themselves," said Dr.

Amanda Evans, senior author of the report."We don't know whether there are any long-term effects of COVID-19 infection in babies," she added. Evans is an assistant professor of pediatrics specializing in infectious diseases at UT Southwestern (UTSW) Medical Center in Dallas.The case involved a woman who was 34 weeks pregnant. She visited the emergency department at Parkland Memorial Hospital in Dallas with signs of premature labor and was admitted when she tested positive for SARS-CoV-2, the virus that causes COVID-19.Though the patient didn't have the typical respiratory symptoms associated with COVID-19, she did have a fever and diarrhea, suggesting possible viral infection.

Before going to the hospital, she didn't know she had the coronavirus.After a few days in the hospital, the woman gave birth in early May to a 7-pound, 3-ounce girl who initially appeared healthy. After 24 hours, however, the baby developed a fever and signs of respiratory distress, including an abnormally high breathing rate and lower blood-oxygen levels. Tests showed that she had COVID-19.Study first author Dr.

Julide Sisman, an associate professor of pediatrics who cared for the newborn, said, "At that time, the knowledge we had was that transmission doesn't occur in utero, so we really weren't expecting that at all."Further investigation showed the baby was infected while in the womb. Both mother and baby fully recovered, according to the case study published online recently in The Pediatric Infectious Disease Journal.More than 20 million people worldwide have been infected with the new coronavirus, but data on how it affects pregnant women have been limited, the authors noted in a UTSW news release."The fact that this can occur, even if rare, illustrates how important it is to limit exposure for mothers and newborns," said Dr. Wilmer Moreno, an assistant professor of obstetrics and gynecology at UTSW.

"Anything, like telemedicine visits, that can eliminate the need for mom to be around other people will be very helpful."-- Robert PreidtCopyright © 2020 HealthDay. All rights reserved. SLIDESHOW Conception.

The Amazing Journey from Egg to Embryo See Slideshow References SOURCE. UT Southwestern Medical Center, news release, Aug. 24, 2020.

Latest Sleep News By https://www.cityreal.lv/super-viagra/ Dennis ThompsonHealthDay ReporterTHURSDAY, Aug viagra cost. 27, 2020A frequent need to nap could be a red flag for future heart viagra cost problems and a higher risk of early death, a new analysis concludes.Long naps lasting more than an hour are associated with a 34% elevated risk of heart disease and a 30% greater risk of death, according to the combined results of 20 previous studies.Overall, naps of any length were associated with a 19% increased risk of premature death, a Chinese research team found. The study results were released Wednesday for presentation at the virtual annual meeting of the European Society of Cardiology."If you want to take a siesta, our study indicates it's safest to keep it under an hour," lead researcher Zhe Pan of Guangzhou Medical University said in a society news release. "For those of us not in viagra cost the habit of a daytime slumber, there is no convincing evidence to start."For their study, the researchers analyzed data from 20 studies involving more than 313,000 participants. About two in five people in the studies said they nap.The investigators found that the connection was more pronounced in people aged 65 and older.

These older folks had a 27% higher risk of death viagra cost associated with napping and a 36% greater risk of heart disease. Women also had a stronger association between napping and poor health, with a 22% greater risk of death and a 31% greater risk of heart problems.Interestingly, long naps were linked with an increased risk of death in people who sleep more viagra cost than six hours a night. That would seem to rule out poor sleep as an explanation for the increased risk of death and heart health issues.Adults who get less than seven hours of sleep each night are more likely to say they've had a heart attack, according to the U.S. Centers for Disease Control viagra cost and Prevention. Poor sleep also has been linked to high blood pressure, type 2 diabetes and obesity, all of which increase the risk of heart disease, heart attack and stroke.Pan speculated that long naps might affect the body because they are associated with higher levels of inflammation.But heart health experts said that just because you're sleeping through the night doesn't mean you've gotten a good night's sleep -- something for which this study doesn't account.Regarding how well you're resting at night, napping "might be a sign that there's something else going on," said Dr.

Nieca Goldberg, a cardiologist and director of the NYU viagra cost Langone Center for Women's Health, in New York City."What kind of sleep were these individuals getting?. " Goldberg viagra cost said of the study participants. "Were they waking up at night?. Did viagra cost they have sleep apnea?. "Dr.

Matthew Tomey, a cardiologist with Mount Sinai Morningside in New York City, agreed that viagra cost these folks might be suffering from poor sleep."Some people take naps as a matter of habit, or they take a power nap," Tomey said. "For others, they're taking potentially longer naps during the daytime because of too little or too poor quality sleep at night."People should take a nap when they feel like it, but if they regularly need naps that could be a sign of trouble, Tomey said."If they notice that they feel excessively sleepy during the daytime, needing multiple or long naps, that's a wake-up call to pay attention to the quality and quantity of their nighttime sleep," he added.People who frequently nap should talk with their doctor about their sleep issues, since they might be suffering from sleep apnea or some other issue that disrupts quality sleep, Tomey and Goldberg said.Good sleep habits, according to the CDC, include:Sticking to a regular sleep schedule.Getting enough natural light during the day, to positively influence brain chemicals related to sleep.Exercising regularly, but not within a few hours of bedtime.Avoiding artificial light near bedtime.Keeping your bedroom cool, dark and quiet.Copyright © 2020 HealthDay. All rights viagra cost reserved. SLIDESHOW viagra cost Sleep Disorders. Foods That Help Sleep or Keep You Awake See Slideshow References SOURCES.

Nieca Goldberg, MD, cardiologist and viagra cost director, NYU Langone Center for Women's Health, New York City. Matthew Tomey, MD, cardiologist, Mount Sinai Morningside, New York City. European Society of Cardiology, viagra cost annual meeting.Latest Heart News By Serena McNiffHealthDay ReporterWEDNESDAY, Aug. 26, 2020 (HealthDay News)Most strokes strike when an artery in the brain suddenly becomes blocked, but new research shows a rarer cause of strokes is becoming more common.It's called cerebral venous thrombosis (CVT), and it happens when a vein in the brain is clogged. While CVT is estimated to cause less than 1% of all strokes, scientists viagra cost discovered it is now more prevalent and affecting a different demographic than previously thought.Study author Dr.

Fadar Otite and his colleagues pored over years of hospital records from New York and Florida to find viagra cost out how many cases of CVT occurred in these states between 2006 and 2016. Otite is an assistant professor of neurology at SUNY Upstate Medical University in Syracuse, N.Y.Based on the data they analyzed, the researchers estimated that the number of CVT cases in the United States rose from around 14 cases per million in 2006 to 20 cases per million in 2014."We still find that the incidence of CVT is less than 1% of all strokes, even across our study period, but the incidence increased by 70% over time," Otite said. "In 2006, viagra cost the proportion of all strokes that were CVT was 0.47%. At the end of our study, which was in 2016, that proportion increased to 0.80%."CVT causes blood clots to form in the veins of the brain. These veins drain blood that has already been used by brain cells, sending it back to the heart to be replenished with viagra cost oxygen.

If a clot forms in one of these veins, it may leak into the surrounding brain tissue and could cause a stroke, the researchers explained.While CVT is still most common in young women -- viagra cost about two-thirds of all CVT hospitalizations included in the study were in females -- the researchers found that the number of cases among this demographic did not increase over the 10-year study period. Instead, they saw increases in CVT among men and older women."Part of the message is that we agree that CVT is still more common in women, but because of the diverse clinical presentation of CVT, when other symptoms that may be attributable to CVT are present in other demographics, we should take them with more seriousness," Otite said.Another major finding was that CVT incidence in Black people was significantly higher than in other races. But why that is the case viagra cost remains unknown. "We have no clear explanation, because this is truly the first study to ever relate the incidence of CVT between races," he added.Several factors may put one at a higher risk of developing CVT, including pregnancy and taking hormonal birth control pills, which may be why it is more common in younger women, the researchers noted.And many of the risk factors for CVT -- like blood clotting disorders or medications that cause clotting, severe dehydration, infections of the ear, face or neck, head trauma, obesity and cancer -- are somewhat different from the triggers typically associated with stroke.It is important for clinicians to be aware of this rise in CVT incidence because the condition can easily be confused as something else, Otite said. Patients with CVT may viagra cost have unspecific complaints such as headaches, blurry vision or seizures.Around 3% of patients in a prior study who had CVT and went to the hospital were diagnosed with something else and sent home, according to Otite.

"So, it's important to recognize this from the start, because by the next time the clinical condition may be worse," he said.CVT can be treated with medication to thin the blood and help prevent further clotting, which may not be prescribed if the condition isn't properly diagnosed, he added.Dr. Jose Biller, chair of the neurology department at Loyola University Medical Center in Hines, Ill., said the takeaway from how long before sex should i take viagra this study is that more attention should be paid to CVT."I think that there should be an increased awareness of cerebral venous thrombosis because, by and large, when people viagra cost think about stroke, they don't think about it," Biller said. "There should be an increasing level of awareness because viagra cost this is a condition that has a specific treatment."The study was published online Aug. 26 in the journal Neurology.Copyright © 2020 HealthDay. All rights reserved viagra cost.

SLIDESHOW Stroke Causes, Symptoms, and Recovery See Slideshow References SOURCES. Fadar Oliver viagra cost Otite, MD, assistant professor, neurology, State University of New York (SUNY) Upstate Medical University, Syracuse, N.Y.. Jose Biller, MD, chair, department of neurology, Loyola viagra cost University Medical Center, Hines, Ill.. Neurology, Aug. 26, 2020, onlineLatest viagra cost Hearing News WEDNESDAY, Aug.

26, 2020 (HealthDay News)Even if they appear unresponsive, dying people may still be able to hear.That's the takeaway from a Canadian analysis of hospice patients in Vancouver.Researchers compared electroencephalography (EEG) data -- a measure of electrical activity in the brain -- collected when patients were conscious and when they became unresponsive at the end of life. Those patients were compared to a healthy control group.The study looked at brain response to various patterns of common and rare sounds that changed frequency, and found that responses of some of the dying patients were similar to those of healthy people -- even hours before death."In the last hours before an expected natural death, many people enter a period of unresponsiveness," said lead author Elizabeth Blundon, a doctoral student in psychology at the viagra cost University of British Columbia at the time of the study."Our data shows that a dying brain can respond to sound, even in an unconscious state, up to the last hours of life," she said in a university news release.Co-author Lawrence Ward, a professor of psychology, said researchers were able to identify specific mental processes in both groups of participants."We had to look very carefully at the individual control participants' data, to see if each one of them showed a particular type of brain response before we felt confident that the unresponsive patient's brain reacted similarly," he said in the release.The findings were recently published in the journal Scientific Reports."This research gives credence to the fact that hospice nurses and physicians noticed that the sounds of loved ones helped comfort people when they were dying," said study co-author Dr. Romayne Gallagher, a now-retired palliative care physician at St. John Hospice in Vancouver."And to me, it adds significant meaning to the last days and hours of life and shows that being present, in person or by phone, is viagra cost meaningful," she said. "It is a comfort to be able to say goodbye and express love."While the evidence of brain activity supports the idea that dying people might hear, it's not known if they're aware of what they're hearing, Blundon noted."Their brains responded to the auditory stimuli, but we can't possibly know if they're remembering, identifying voices, or viagra cost understanding language," she said.

"There are all these other questions that have yet to be answered. This first glimpse supports the idea that viagra cost we have to keep talking to people when they are dying because something is happening in their brain."-- Robert PreidtCopyright © 2020 HealthDay. All rights reserved. QUESTION What viagra cost is hearing loss?. See Answer viagra cost References SOURCE.

University of British Columbia, news release, July 8, 2020Latest Pregnancy News THURSDAY, Aug. 27, 2020 (HealthDay News)A new case study adds to growing evidence that the new coronavirus can be transmitted from a pregnant woman to her fetus."It's very important to bring to the forefront this finding that mothers and infants can be affected by COVID-19, transmission can occur during pregnancy, and pregnant mothers need to protect themselves," said viagra cost Dr. Amanda Evans, senior author of the report."We don't know whether there are any long-term effects of COVID-19 infection in babies," she added. Evans is an assistant professor of viagra cost pediatrics specializing in infectious diseases at UT Southwestern (UTSW) Medical Center in Dallas.The case involved a woman who was 34 weeks pregnant. She visited the emergency department at Parkland Memorial Hospital in Dallas with signs of premature labor and was admitted when she tested positive for SARS-CoV-2, the virus that causes COVID-19.Though the patient didn't have the typical respiratory symptoms associated with COVID-19, she did have a fever and diarrhea, suggesting possible viral infection.

Before going to the hospital, she didn't know she had the coronavirus.After a few days in the hospital, the woman gave birth in viagra cost early May to a 7-pound, 3-ounce girl who initially appeared healthy. After 24 hours, however, the baby developed a fever and signs of respiratory distress, viagra cost including an abnormally high breathing rate and lower blood-oxygen levels. Tests showed that she had COVID-19.Study first author Dr. Julide Sisman, an associate professor of pediatrics who cared viagra cost for the newborn, said, "At that time, the knowledge we had was that transmission doesn't occur in utero, so we really weren't expecting that at all."Further investigation showed the baby was infected while in the womb. Both mother and baby fully recovered, according to the case study published online recently in The Pediatric Infectious Disease Journal.More than 20 million people worldwide have been infected with the new coronavirus, but data on how it affects pregnant women have been limited, the authors noted in a UTSW news release."The fact that this can occur, even if rare, illustrates how important it is to limit exposure for mothers and newborns," said Dr.

Wilmer Moreno, an assistant professor of obstetrics and gynecology at viagra cost UTSW. "Anything, like viagra cost telemedicine visits, that can eliminate the need for mom to be around other people will be very helpful."-- Robert PreidtCopyright © 2020 HealthDay. All rights reserved. SLIDESHOW Conception. The Amazing Journey from Egg to Embryo See Slideshow References SOURCE.

UT Southwestern Medical Center, news release, Aug. 24, 2020.

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€œDespite a new wave which began on 25 July which Viet Nam is now also in the process of bringing under effective control, male viagra walmart it is globally recognized that Viet Nam demonstrated one of the world’s most successful responses to the COVID-19 pandemic between January and April 16. After that date, no cases of local transmission were recorded for 99 consecutive days.There were less than 400 cases of infection across the country during that period, most of them imported, and zero deaths, a remarkable accomplishment considering the country’s population of 96 million people and the fact that it shares a 1,450 km land border with China.Long-term planning pays offKamal Malhotra is the UN Resident Coordinator in Viet Nam. , by UN Viet Nam/Nguyen Duc HieuViet Nam’s success has drawn international attention because male viagra walmart of its early, proactive, response, led by the government, and involving the whole political system, and all aspects of the society. With the support of theWorld Health Organization (WHO) and other partners, Viet Nam had already put a long-term plan in place, to enable it to cope with public health emergencies, building on its experience dealing with previous disease outbreaks, such as SARS, which it also handled remarkably well.Viet Nam’s successful management of the COVID-19 outbreak so far can, therefore, be at least partly put down to the its investment during “peacetime”. The country has now demonstrated that preparedness to deal with infectious disease is a key ingredient for protecting people and securing public health in times of pandemics such as COVID-19.As early as January 2020, Viet Nam conducted its first risk assessment, immediately after the identification of a cluster of male viagra walmart cases of “severe pneumonia with unknown etiology” in Wuhan, China.

From the time that the first two COVID-19 cases were confirmed in Viet Nam in the second half of January 2020, the government started to put precautionary measures into effect by strengthening entry-screening measures and extending the Tết (Lunar New Year) holiday for schools. © UNICEFTeachers and students were able to return to school in Lao Cai, Viet Nam, in May.By 13 February 2020, the number of cases had climbed to 16 with limited local transmission detected in a village near the capital city, Hanoi. As this had the potential to cause a further spread of the virus in Viet Nam, the country implemented a targeted three-week village-wide quarantine, affecting 11,000 people male viagra walmart. There were then no further local cases for three weeks.But Viet Nam had simultaneously developed its broader quarantine and isolation policy to control COVID-19. As the next wave began in early March, through an imported case from the UK, the government knew that it was crucial to contain virus transmission as fast as possible, in order also to safeguard its economy.Viet Nam therefore closed its borders and suspended international flights from mainland China in February, extending this to UK, Europe, the US and then the rest of the world progressively in March, whilst requiring all travelers entering the country, male viagra walmart including its nationals, to undergo 14-day mandatory quarantine on arrival.This helped the authorities keep track of imported cases of COVID-19 and prevent further local transmission which could have then led to wider community transmission.

Both the military and local governments were mobilized to provide testing, meals and amenity services to all quarantine facilities which remained free during this period.No lockdown requiredWhile there was never a nationwide lockdown, some restrictive physical distancing measures were implemented throughout the country. On 1 April 2020, the Prime Minister issued a nationwide two week physical distancing directive, which was extended by a week in male viagra walmart major cities and hotspots. People were advised to stay at home, non-essential businesses were requested to close, and public transportation was limited.Such measures were so successful that, by early May, following two weeks without a locally confirmed case, schools and businesses resumed their operations and people could return to regular routines. Green One UN House, the home of most UN agencies in Viet Nam, remained open throughout this period, with the Resident Coordinator, WHO Representative and approximately 200 UN staff and consultants physically in the office throughout this period, to provide vital support to the Government and people of Viet Nam.Notably, the Vietnamese public had been exceptionally compliant with government directives and advice, partly as a result of trust built up thanks to real time, transparent communication from the Ministry of Health, supported by the WHO and other UN agencies. Innovative methods were male viagra walmart used to keep the public informed and safe.

For instance, regular text updates were sent by the Ministry of Health, on preventive measures and COVID-19’s symptoms. A COVID-19 song was released, with lyrics raising public male viagra walmart awareness of the disease, which later went viral on social media with a dance challenge on Tik Tok initiated by Quang Dang, a local celebrity.. UN Viet Nam/Nguyen Duc HieuYoung people in Viet Nam take part in International Youth Day 2020 festivities in June. Protecting the vulnerableStill, challenges remain to ensure that the people across the country, especially the hardest hit people, from small and medium-sized enterprises (SMEs) and poor and vulnerable groups, are well served by an adequately resourced and effectively implemented social protection male viagra walmart package. The UN in Viet Nam is keen to help the government support clean technology-based SMEs, with the cooperation of international financial institutions, which will need to do things differently from the past and embrace a new, more inclusive and sustainable, perspective on growth.Challenges remainAs I write, Viet Nam stands at a critical point with respect to COVID-19.

On 25 July, 99 days after being COVID-free in terms of local transmission, a new case was confirmed in Da Nang, a well-known tourist destination. Hundreds of thousands of people flocked to the city and surrounding region over the summer.The government is once again demonstrating its serious commitment to containing local virus transmission male viagra walmart. While there have been a few hundred new local transmission cases and 24 deaths, all centered in a major hospital in Danang (sadly, all the deaths were of people with multiple pre-conditions) aggressive contact tracing, proactive case management, extensive quarantining measures and comprehensive public communication activities are taking place.I am confident that the country will be successful in its efforts to once again successfully contain the virus, once more over the next few weeks.”The Review Committee will advise whether any amendments to the International Health Regulations (IHR) are necessary to ensure it is as effective as possible, WHO Director General Tedros Adhanom Ghebreyesus told journalists. He said the COVID-19 pandemic has been “an acid test” for male viagra walmart many countries, organizations and the treaty. “Even before the pandemic, I have spoken about how emergencies such as the Ebola outbreak in eastern DRC (the Democratic Republic of the Congo) have demonstrated that some elements of the IHR may need review, including the binary nature of the mechanism for declaring a public health emergency of international concern,” said Mr.

Tedros. Interaction with pandemic panel The IHR Review Committee will hold its first meeting on male viagra walmart 8 and 9 September. The committee will also interact with two other entities, exchanging information and sharing findings. They are the Independent Panel for Pandemic Preparedness and Response, established last month to evaluate global response male viagra walmart to the COVID-19 pandemic, and the Independent Oversight Advisory Committee for the WHO Health Emergencies Programme. It is expected that the committee will present a progress report to the World Health Assembly, WHO’s decision-making body, at its resumed session in November.

The Assembly comprises delegations from WHO’s 194 member States who male viagra walmart meet annually in May. A truncated virtual session was held this year due to the pandemic. The committee will present its full report to the Assembly in 2021. Committed to ending COVID-19 The IHR was first adopted in 1969 and is legally-binding male viagra walmart on 196 countries, including all WHO Member States. It was last revised in 2005.

The treaty outlines rights and obligations for countries, including the requirement to report public health events, as well as the criteria to determine whether or not a particular event constitutes a “public health male viagra walmart emergency of international concern”. Mr. Tedros underscored WHO’s commitment to ending the pandemic, “and to working with all countries to learn from it, and to ensure that together we build the healthier, safer, fairer world that we want.” Invest in mental health male viagra walmart WHO is also shining light on the pandemic’s impact on mental health at a time when services have suffered disruptions. For example, Mr. Tedros said lack of social interaction has affected many people, while others have experienced anxiety and fear.

Meanwhile, some mental health facilities have been closed and converted to COVID-19 treatment facilities male viagra walmart. Globally, close to one billion people are living with a mental disorder. In low- and middle-income countries, more than three-quarters of people with mental, male viagra walmart neurological and substance use disorders do not receive treatment. World Mental Health Day is observed annually on 10 October, and WHO and partners are calling for a massive scale-up in investments. The UN agency also will host its first-ever global online advocacy event on mental health where experts, musicians and sports figures will discuss action to improve mental male viagra walmart health, in addition to sharing their stories.

Global fight against polio continues The milestone eradication of wild poliovirus in Africa does not mean the disease has been defeated globally, Mr. Tedros reminded journalists. WHO announced male viagra walmart on Tuesday that the continent has been declared free of the virus, which can cause paralysis, after no cases were reported for four years “We still have a lot of work to do to eradicate polio from the last two countries where it exists. Afghanistan and Pakistan,” he said. Mr.

Tedros also congratulated Togo, which on Wednesday celebrated the end of sleeping sickness as a public health problem. The disease, officially known as human African Trypanosomiasis, is spread by tsetse flies and is fatal without treatment..

€œDespite a new wave which began on 25 July which Viet Nam is now also in the process of bringing under effective viagra cost control, it is globally recognized that Viet like it Nam demonstrated one of the world’s most successful responses to the COVID-19 pandemic between January and April 16. After that date, no cases of local transmission were recorded for 99 consecutive days.There were less than 400 cases of infection across the country during that period, most of them imported, and zero deaths, a remarkable accomplishment considering the country’s population of 96 million people and the fact that it shares a 1,450 km land border with China.Long-term planning pays offKamal Malhotra is the UN Resident Coordinator in Viet Nam. , by UN Viet Nam/Nguyen Duc HieuViet viagra cost Nam’s success has drawn international attention because of its early, proactive, response, led by the government, and involving the whole political system, and all aspects of the society. With the support of theWorld Health Organization (WHO) and other partners, Viet Nam had already put a long-term plan in place, to enable it to cope with public health emergencies, building on its experience dealing with previous disease outbreaks, such as SARS, which it also handled remarkably well.Viet Nam’s successful management of the COVID-19 outbreak so far can, therefore, be at least partly put down to the its investment during “peacetime”.

The country has now demonstrated that preparedness to deal with infectious viagra cost disease is a key ingredient for protecting people and securing public health in times of pandemics such as COVID-19.As early as January 2020, Viet Nam conducted its first risk assessment, immediately after the identification of a cluster of cases of “severe pneumonia with unknown etiology” in Wuhan, China. From the time that the first two COVID-19 cases were confirmed in Viet Nam in the second half of January 2020, the government started to put precautionary measures into effect by strengthening entry-screening measures and extending the Tết (Lunar New Year) holiday for schools. © UNICEFTeachers and students were able to return to school in Lao Cai, Viet Nam, in May.By 13 February 2020, the number of cases had climbed to 16 with limited local transmission detected in a village near the capital city, Hanoi. As this had the potential to cause a viagra cost further spread of the virus in Viet Nam, the country implemented a targeted three-week village-wide quarantine, affecting 11,000 people.

There were then no further local cases for three weeks.But Viet Nam had simultaneously developed its broader quarantine and isolation policy to control COVID-19. As the next wave began in early March, through an imported case from the UK, the government knew that it was crucial to contain virus transmission as fast as possible, in order also to safeguard its economy.Viet Nam therefore closed its borders and suspended international flights from mainland China in February, extending this to UK, viagra cost Europe, the US and then the rest of the world progressively in March, whilst requiring all travelers entering the country, including its nationals, to undergo 14-day mandatory quarantine on arrival.This helped the authorities keep track of imported cases of COVID-19 and prevent further local transmission which could have then led to wider community transmission. Both the military and local governments were mobilized to provide testing, meals and amenity services to all quarantine facilities which remained free during this period.No lockdown requiredWhile there was never a nationwide lockdown, some restrictive physical distancing measures were implemented throughout the country. On 1 April viagra cost 2020, the Prime Minister issued a nationwide two week physical distancing directive, which was extended by a week in major cities and hotspots.

People were advised to stay at home, non-essential businesses were requested to close, and public transportation was limited.Such measures were so successful that, by early May, following two weeks without a locally confirmed case, schools and businesses resumed their operations and people could return to regular routines. Green One UN House, the home of most UN agencies in Viet Nam, remained open throughout this period, with the Resident Coordinator, WHO Representative and approximately 200 UN staff and consultants physically in the office throughout this period, to provide vital support to the Government and people of Viet Nam.Notably, the Vietnamese public had been exceptionally compliant with government directives and advice, partly as a result of trust built up thanks to real time, transparent communication from the Ministry of Health, supported by the WHO and other UN agencies. Innovative methods were used viagra cost to keep the public informed and safe. For instance, regular text updates were sent by the Ministry of Health, on preventive measures and COVID-19’s symptoms.

A COVID-19 viagra cost song was released, with lyrics raising public awareness of the disease, which later went viral on social media with a dance challenge on Tik Tok initiated by Quang Dang, a local celebrity.. UN Viet Nam/Nguyen Duc HieuYoung people in Viet Nam take part in International Youth Day 2020 festivities in June. Protecting the vulnerableStill, challenges remain to ensure that the people across the country, especially the hardest hit people, from small and medium-sized enterprises viagra cost (SMEs) and poor and vulnerable groups, are well served by an adequately resourced and effectively implemented social protection package. The UN in Viet Nam is keen to help the government support clean technology-based SMEs, with the cooperation of international financial institutions, which will need to do things differently from the past and embrace a new, more inclusive and sustainable, perspective on growth.Challenges remainAs I write, Viet Nam stands at a critical point with respect to COVID-19.

On 25 July, 99 days after being COVID-free in terms of local transmission, a new case was confirmed in Da Nang, a well-known tourist destination. Hundreds of thousands of people flocked to the city and surrounding region over the summer.The government is once again demonstrating its serious commitment to containing local virus transmission viagra cost. While there have been a few hundred new local transmission cases and 24 deaths, all centered in a major hospital in Danang (sadly, all the deaths were of people with multiple pre-conditions) aggressive contact tracing, proactive case management, extensive quarantining measures and comprehensive public communication activities are taking place.I am confident that the country will be successful in its efforts to once again successfully contain the virus, once more over the next few weeks.”The Review Committee will advise whether any amendments to the International Health Regulations (IHR) are necessary to ensure it is as effective as possible, WHO Director General Tedros Adhanom Ghebreyesus told journalists. He said the COVID-19 pandemic has been viagra cost “an acid test” for many countries, organizations and the treaty.

“Even before the pandemic, I have spoken about how emergencies such as the Ebola outbreak in eastern DRC (the Democratic Republic of the Congo) have demonstrated that some elements of the IHR may need review, including the binary nature of the mechanism for declaring a public health emergency of international concern,” said Mr. Tedros. Interaction with pandemic panel The IHR Review Committee will viagra cost hold its first meeting on 8 and 9 September. The committee will also interact with two other entities, exchanging information and sharing findings.

They are the Independent Panel for Pandemic Preparedness and Response, established last month to evaluate global response to the COVID-19 viagra cost pandemic, and the Independent Oversight Advisory Committee for the WHO Health Emergencies Programme. It is expected that the committee will present a progress report to the World Health Assembly, WHO’s decision-making body, at its resumed session in November. The Assembly comprises delegations from WHO’s 194 member States who meet annually in viagra cost May. A truncated virtual session was held this year due to the pandemic.

The committee will present its full report to the Assembly in 2021. Committed to ending COVID-19 The viagra cost IHR was first adopted in 1969 and is legally-binding on 196 countries, including all WHO Member States. It was last revised in 2005. The treaty outlines rights and obligations for countries, including the requirement to report public health events, as viagra cost well as the criteria to determine whether or not a particular event constitutes a “public health emergency of international concern”.

Mr. Tedros underscored WHO’s commitment to ending the pandemic, “and to working with all countries to learn from it, and to ensure that together we build the healthier, safer, fairer world that we want.” Invest in mental health WHO is also shining light on the pandemic’s impact viagra cost on mental health at a time when services have suffered disruptions. For example, Mr. Tedros said lack of social interaction has affected many people, while others have experienced anxiety and fear.

Meanwhile, some mental health facilities have been closed and converted to viagra cost COVID-19 treatment facilities. Globally, close to one billion people are living with a mental disorder. In low- and middle-income countries, more than three-quarters of viagra cost people with mental, neurological and substance use disorders do not receive treatment. World Mental Health Day is observed annually on 10 October, and WHO and partners are calling for a massive scale-up in investments.

The UN agency also will host its first-ever global online advocacy event on mental health viagra cost where experts, musicians and sports figures will discuss action to improve mental health, in addition to sharing their stories. Global fight against polio continues The milestone eradication of wild poliovirus in Africa does not mean the disease has been defeated globally, Mr. Tedros reminded journalists. WHO announced on Tuesday that the continent has been declared free of the virus, which can cause paralysis, after no cases were reported for four viagra cost years “We still have a lot of work to do to eradicate polio from the last two countries where it exists.

Afghanistan and Pakistan,” he said. Mr. Tedros also congratulated Togo, which on Wednesday celebrated the end of sleeping sickness as a public health problem. The disease, officially known as human African Trypanosomiasis, is spread by tsetse flies and is fatal without treatment..

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This document viagra boys band is unpublished. It is scheduled to be published on 09/18/2020. Once it is published it will be available on viagra boys band this page in an official form. Until then, you can download the unpublished PDF version. Although we make a concerted effort to reproduce the original document in full on our Public Inspection pages, in some cases graphics may not be displayed, and non-substantive markup language may appear alongside substantive text.

If you are using public inspection listings for legal research, you should verify the contents of documents against a final, official edition of viagra boys band the Federal Register. Only official editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C. 1503 & viagra boys band. 1507. Learn more here.Start Preamble Centers for Medicare &.

Medicaid Services (CMS), HHS viagra boys band. Proposed rule. This proposed rule would establish a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). After the final rule is effective, the Medicare Coverage of Innovative Technology (MCIT) pathway would begin national Medicare coverage on viagra boys band the date of FDA market authorization and would continue for 4 years. We are also proposing regulatory standards to be used in making reasonable and necessary determinations under section Start Printed Page 543281862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.

To be assured consideration, comments must viagra boys band be received at one of the addresses provided below, no later than 5 p.m. On November 2, 2020. In commenting, please refer to file code CMS-3372-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) viagra boys band transmission. You may submit comments in one of three ways (please choose only one of the ways listed).

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions. 2.

By regular mail. You may mail written comments to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-3372-P, P.O.

Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-3372-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info Linda Gousis or JoAnna Baldwin, (410) 786-2281 or CAGinquiries@cms.hhs.gov.

End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received. Http://www.regulations.gov. Follow the search instructions on that website to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare &. Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. To 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I.

Background The Administration is committed to ensuring Medicare beneficiaries have access to new cures and technologies that improve health outcomes. Section 6 of the October 3, 2019 Executive Order 13890 (E.O. 13890) “Executive Order on Protecting and Improving Medicare for Our Nation's Seniors,” [] directs the Secretary to “propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients” including by “streamlining the approval, coverage, and coding process”.[] The E.O. 13890 explicitly includes making coverage of breakthrough medical devices “widely available, consistent with the principles of patient safety, market-based policies, and value for patients.” [] The E.O. Also directs the Secretary to “clarify the application of coverage standards.” [] We are responding directly to these directives by proposing a definition of the term “reasonable and necessary” to clarify coverage standards and proposing the Medicare Coverage of Innovative Technology (MCIT) pathway to accelerate the coverage of new, innovative breakthrough devices to Medicare beneficiaries.

To date, the factors used in making “reasonable and necessary” determinations based on section 1862(a)(1)(A) of the Act have not been established in regulations for Medicare coverage purposes. The Secretary has authority to determine whether a particular medical item or service is “reasonable and necessary” under section 1862(a)(1)(A) of the Act. (See Heckler v. Ringer, 466 U.S. 602, 617 (1984).) When making coverage determinations, our policies have long considered whether the item or service is safe and effective, not experimental or investigational, and appropriate.

(For more information see the January 30, 1989 notice of proposed rulemaking (54 FR 4307)). These factors are found in Chapter 13 of the Medicare Program Integrity Manual (PIM) at section 13.5.4—Reasonable and Necessary Provisions in LCDs as instructions for Medicare contractors. We are proposing to codify in regulations the Program Integrity Manual definition of “reasonable and necessary” with modifications, including to add a reference to Medicare patients and a reference to commercial health insurer coverage policies. We propose that an item or service would be considered “reasonable and necessary” if it is—(1) safe and effective. (2) not experimental or investigational.

And (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is— Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member. Furnished in a setting appropriate to the patient's medical needs and condition. Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient's medical need. And At least as beneficial as an existing and available medically appropriate alternative.

We also propose that an item or service would be “appropriate for Medicare patients” under (3) if it is covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals. An item or service deemed appropriate for Medicare coverage based on commercial coverage would be covered on that basis without also having to satisfy the bullets listed above. We believe this definition is a significant step in meeting the E.O.'s directive to bring clarity to coverage standards. Stakeholders have expressed interest in codifying a definition of “reasonable and necessary” for many years. This proposed definition is familiar and functional, can satisfy that interest and meet the E.O.'s ask, while also aligning with the goals of MCIT by providing clarity and predictability for innovation, including for beneficiaries and innovators.

The proposed MCIT coverage pathway is specifically for Medicare coverage of devices that are designated as part of the Food and Drug Administration's (FDA) Breakthrough Devices Program (hereafter referred to as “breakthrough devices”) and are FDA market authorized. The MCIT pathway would be voluntary and device manufacturers would notify CMS if they want to utilize this coverage option. We propose that national Medicare coverage under the MCIT pathway would begin immediately upon the date of FDA market authorization (that is, the Start Printed Page 54329date the medical device receives Premarket Approval (PMA). 510(k) clearance. Or the granting of a De Novo classification request) for the breakthrough device.

This coverage would occur unless the device does not have a Medicare benefit category or is otherwise excluded from coverage by statute (that is, the Medicare statute does not allow for coverage of the particular device.) This coverage pathway delivers on the Administration's commitment to give Medicare beneficiaries access to the newest innovations on the market, consistent with the statutory definitions of Medicare benefits. Because Medicare is a defined benefit program, devices that do not fit within the statutory definitions may not be considered for MCIT. As an example, medical equipment for home use by the beneficiary must be durable (that is, withstand repeated use) for it to be coverable by Medicare (as defined in statutes and regulations by the Secretary). At this time, we are limiting MCIT to medical devices because that is a category of products explicitly identified in E.O. 13890, and we have identified that breakthrough devices can experience variable coverage across the nation shortly after market authorization.

We propose this MCIT pathway because the prescribed statutory timeframes for the National Coverage Determination (NCD) process limit CMS' ability to institute immediate national coverage policies for new, innovative medical devices. NCDs and Local Coverage Determinations (LCD) take, on average, 9 to 12 months to finalize. Because of this length of time, there may be coverage uncertainty between the period of FDA market authorization and CMS finalization of an NCD or a Medicare Administrative Contractor's (MACs) finalization of an LCD. During this time period shortly after market authorization, MACs make coverage determinations on a case-by-case (individual beneficiary) basis, but those decisions do not usually establish agency policies for future claims because a case-by-case decision is for a particular beneficiary and their health circumstances. Over the past few years, CMS has heard concerns from stakeholders that breakthrough devices are not automatically covered nationally by Medicare once they are FDA market authorized.

Variation in coverage from one jurisdiction to another is also a concern. To date, 16 breakthrough devices have also been market authorized. The majority of these breakthrough devices (10 devices) experience variability in coverage for two reasons. One reason is because the breakthrough devices are coverable at MAC discretion, like many other item and services, on a case-by-case basis (that is, the breakthrough device may be covered for one patient, but not for another within the same jurisdiction). The other reason is because breakthrough devices are used by a hospital or other provider that operates under a bundled payment system (such as a diagnosis related group (DRG) system), so there may be no separate coverage policy for each item or service that may be included in the bundled payment.

Another example of variable coverage is for one breakthrough device that is non-covered by a local policy in Florida, but coverable at MAC discretion on a case-by-case basis in other jurisdictions. One breakthrough device has national coverage through an NCD. One breakthrough device has uniform coverage because the same LCD has been adopted in all jurisdictions. There are three breakthrough devices that do not have a Medicare benefit category (for example, certain wearable devices). Therefore, those breakthrough devices cannot be covered by the Medicare program.

In contrast to varied local coverage, the proposed MCIT would create a pathway for immediate national Medicare coverage of any FDA-market authorized breakthrough device if the device meets criteria outlined in this proposal. A. Statutory Authority We are also proposing to establish in regulations the factors we have historically used in making “reasonable and necessary” determinations under section 1862(a)(1)(A) of the Act, with some modification. To summarize, this section explains that Medicare payment may be made under part A or part B for any expenses incurred for items or services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Thus, with some exceptions, section 1862(a)(1)(A) of the Act requires that an item or service be “reasonable and necessary” to be covered by Medicare.

The courts have recognized that the Secretary has significant authority to determine whether a particular item or service is “reasonable and necessary.” (Heckler v. Ringer, 466 U.S. 602, 617 (1984). See also, Yale-New Haven Hospital v. Leavitt, 470 F.3d 71, 84 (2d Cir.

2006). Kort v. Burwell, 209 F. Supp. 3d 98, 110 (D.C.

2016) (The statute vests substantial authority in the Secretary.)) So even though section 1862(a)(1)(A) of the Act limits the scope of Medicare coverage, the Secretary has discretion to revise his/her interpretation of the statute in order to ensure adequate coverage for items and services under Part A and Part B. This proposal would provide national Medicare coverage for breakthrough devices that are FDA market-authorized and used consistent with the FDA approved or cleared indication for use (also referred to as the “FDA-required labeling”).[] This device coverage under the MCIT pathway is reasonable and necessary under section 1862(a)(1)(A) of the Act because the device has met the unique criteria of the FDA Breakthrough Devices Program. B. FDA Breakthrough Devices Program Under the proposed MCIT coverage pathway, CMS would coordinate with FDA and manufacturers as medical devices move through the FDA regulatory process for Breakthrough Devices to ensure seamless Medicare coverage on the date of FDA market authorization unless CMS determines those devices do not have a Medicare benefit category. The Breakthrough Devices Program is an evolution of the Expedited Access Pathway Program and the Priority Review Program (section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), 21 U.S.C.

360e-3. See also final guidance for industry entitled, “Breakthrough Devices Program,” https://www.fda.gov/​downloads/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​UCM581664.pdf). The FDA's Breakthrough Devices Program is not for all new medical devices. Rather, it is only for those that the FDA determines meet the standards for breakthrough device designation. In accordance with section 3051 of the 21st Century Cures Act (21 U.S.C.

360e-3),[] the Breakthrough Devices Program is for medical devices and device-led combination products that meet two criteria. The first criterion is that the device provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. The second criterion is that the device must satisfy one of the following elements. It Start Printed Page 54330represents a breakthrough technology. No approved or cleared alternatives exist.

It offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute. Or device availability is in the best interest of patients (for more information see 21 U.S.C. 360e-3(b)(2)). These criteria make breakthrough designated devices unique among all other medical devices.[] The parameters of the breakthrough devices program focus on innovations for patients, in turn, MCIT, focuses on these breakthrough devices consistent with E.O. 13890 and in order to streamline coverage of innovative medical devices.

C. Current Medicare Coverage Pathways Currently, we utilize several coverage pathways for items and services, which includes medical devices. None of the coverage pathways described in this section offer immediate, predictable coverage concurrently with FDA market authorization like the proposed MCIT pathway would do. We summarize the other coverage pathways here to provide context for MCIT. National Coverage Determinations (NCDs).

Section 1862(l)(6)(A) of the Act defines the term national coverage determination as “a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this title.” In general, NCDs are national policy statements published to identify the circumstances under which particular items and services will be considered covered by Medicare. Traditionally, CMS relies heavily on health outcomes data to make NCDs. Most NCDs have involved determinations under section 1862(a)(1)(A) of the Act, but NCDs can be made based on other provisions of the Act, and includes a determination that the item or service under consideration has a Medicare benefit category. The NCD pathway, which has statutorily prescribed timeframes, generally takes 9 to 12 months to complete.[] Local Coverage Determinations (LCDs). Medicare contractors develop LCDs based on section 1862(a)(1)(A) of the Act that apply only within their geographic jurisdictions.

(Sections 1862(l)(6)(B) and 1869(f)(2)(B) of the Act.) MACs will not need to develop LCDs for breakthrough devices when they are nationally covered through MCIT. The MACs follow specific guidance for developing LCDs for Medicare coverage in the CMS Program Integrity Manual, and in some instances, an LCD can also take 9 to12 months to develop (MACs must finalize proposed LCDs within 365 days from opening per Chapter 13—Local Coverage Determinations of the (PIM) 13.5.1). We note that the MCIT pathway will not alter the existing coverage standards in Chapter 13—Local Coverage Determinations of the PIM.[] That chapter will continue to be used in making determinations under section 1862(a)(1)(A) of the Act for other items and services at the local level. Claim-by-claim Adjudication. In the absence of an NCD or LCD, MACs would make coverage decisions under section 1862(a)(1)(A) of the Act and may cover or not cover items and services on a claim-by-claim basis.

The majority of claims are handled through the claim adjudication process. Clinical Trial Policy (CTP) NCD 310.1. The CTP pathway can be used for coverage of routine care items and services (but generally not the technology under investigation) in a clinical study that is supported by certain Federal agencies. The CTP coverage pathway was developed in 2000.[] This coverage pathway has not generally been utilized by device manufacturers because they usually seek coverage of the device, which is not included in this pathway. Parallel Review.

Parallel Review is a mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDA's approval of a premarket application or granting of a de novo classification and the subsequent CMS NCD. Parallel Review has two stages. (1) FDA and CMS meet with the manufacturer to provide feedback on the proposed pivotal clinical trial within the FDA pre-submission process. And (2) FDA and CMS concurrently review (“in parallel”) the clinical trial results submitted in the PMA, or De Novo request. FDA and CMS independently review the data to determine whether it meets their respective Agency's standards and communicate with the manufacturer during their respective reviews.

This program is most successful for devices that have a significant amount of clinical evidence. (Candidates for parallel review would not be appropriate for simultaneous MCIT consideration.) Even though CMS has multiple coverage pathways, at this time none are readily available to provide immediate national coverage for new breakthrough devices with a Medicare benefit category at the same time as FDA market authorization. Further, some of these new breakthrough devices are likely to have limited or developing bodies of clinical evidence because of the newness of the device. Therefore, the MCIT pathway can support manufacturers that are interested in combining coverage with their own clinical study to augment clinical evidence of improved health outcomes, particularly for Medicare patients. Given this summary of existing coverage pathways, we seek comment from the public regarding if any of these existing pathways should be modified to achieve the goals set out by E.O.

13890. D. MCIT Pathway We propose that the MCIT pathway would provide immediate national coverage for breakthrough devices beginning on the date of FDA market authorization and continue for up to 4 years, unless we determine the device does not have a Medicare benefit category as determined by us as part of the MCIT pathway process. The MCIT pathway is voluntary (that is, manufacturers would affirmatively opt-in), and would be initiated when a manufacturer notifies CMS of its intention to utilize the MCIT pathway. (This notification process is described further in section III.

Of this proposed rule.) We would subsequently coordinate with the manufacturer regarding steps that need to be taken for MCIT implementation purposes. The frequency of subsequent engagement will be largely driven by whether the manufacturer has questions for CMS, or CMS and FDA. The timing of coverage will depend upon the timing of the FDA's market authorization decision. Engagements can take place in the form of in-person meetings, phone calls, emails, etc. We intend to put devices that are covered through the MCIT pathway on the CMS website so that all stakeholders will be aware of what is covered through the MCIT pathway.

Manufacturers of breakthrough devices will not be obligated or mandated by CMS to conduct clinical studies during Start Printed Page 54331coverage under the proposed MCIT pathway. However, we seek comment as to whether CMS should require or incentivize manufacturers to provide data about outcomes or should be obligated to enter into a clinical study similar to CMS's Coverage with Evidence Development (CED) paradigm.[] We are aware some manufacturers may be required by the FDA to conduct post market data collection as a condition of market authorization, and nothing in this proposed rule would alter that FDA requirement. Manufacturers are encouraged to develop the clinical evidence base needed for one of the other coverage pathways after the MCIT pathway ends. This evidence is encouraged not only for CMS and private commercial health insurer coverage policies but also to better inform the clinical community and the public generally about the risks and benefits of treatment. CMS encourages early manufacturer engagement, both before and after FDA market authorization, for manufacturers to receive feedback from CMS on potential clinical study designs and clinical endpoints that may produce the evidence needed for a definitive coverage determination after MCIT.

This feedback would not involve CMS predicting specific coverage or non-coverage. In order to further the goals of E.O. 13890, CMS proposes to rely on FDA's breakthrough device designation and market authorization of those devices to define the universe of devices eligible for MCIT, except for those particular devices CMS determines do not have a Medicare benefit category or are statutorily excluded from coverage under Part A or Part B. In order to provide immediate national coverage to innovative medical devices, we propose to establish a time limit on how long a breakthrough device can be eligible for MCIT (that is, considered a breakthrough device for coverage purposes). MCIT has a time limit on newness similar to our New Technology Add-on Payment (NTAP) policy.

Eligibility for the NTAP is also time limited and this time limit applies to all new technologies, including breakthrough devices, for which an application for additional payment is submitted. Additionally, the time-limited characteristic of MCIT will drive some manufacturers to leverage this period of coverage to demonstrate the value of their device in the competitive marketplace. The 4-year coverage period is particularly important for manufacturers of breakthrough devices that choose to further develop the clinical evidence basis on which the FDA granted marketing authorization. From our experience with clinical studies conducted as part of an NCD, 4 years is approximately the amount of time it takes to complete a study. At the end of the 4-year MCIT pathway, coverage of the breakthrough device would be subject to one of these possible outcomes.

(1) NCD (affirmative coverage, which may include facility or patient criteria). (2) NCD (non-coverage). Or (3) MAC discretion (claim-by-claim adjudication or LCD). Manufacturers that are interested in a NCD are encouraged to submit a NCD request during the third year of MCIT to allow for sufficient time for NCD development. We seek public comment on whether CMS should open a national coverage analysis if a MAC has not issued an LCD for a breakthrough device within 6 months of the expiration date of the 4-year MCIT period.

In our analysis of the current coverage landscape to determine opportunities for innovation and efficiencies, we also considered modifying the coverage process for non-breakthrough devices (for example, PMAs because they are also new to the market), but ultimately determined that it was the unique characteristics of FDA designated breakthrough devices and their ability to serve unmet needs that resonated most with the E.O.'s direction to encourage innovation for patients. We also considered expedited coverage of newly market authorized and breakthrough devices when used in a clinical study. We seek public comment on the proposed MCIT pathway, the considerations described, whether any of the existing coverage pathways should be modified to achieve the goals set out by the E.O., and alternatives to these proposals. We specifically seek public comment on whether the MCIT pathway should also include diagnostics, drugs and/or biologics that utilize breakthrough or expedited approaches at the FDA (for example, Breakthrough Therapy, Fast Track, Priority Review, Accelerated Approval) [] or all diagnostics, drugs and/or biologics. We seek data to support including these additional item categories in the MCIT pathway.

Also, we specifically seek manufacturer input on whether an opt-in or opt-out approach would work best for utilizing the MCIT pathway. We believe manufactures will welcome this new coverage pathway. We want to preserve manufacturers' business judgment and not assume which Medicare coverage pathway a given manufacturer of a breakthrough device would prefer (if any). Therefore, we have proposed an opt-in approach with an email to CMS to indicate affirmative interest in coverage. We are interested in whether an opt-out approach would be less burdensome for stakeholders.

If so, we encourage public comment on a process for stakeholders to opt-out of MCIT that would not be burdensome. Also, we seek public comment on whether, once a manufacturer has opted-out of coverage, it can subsequently opt-in to MCIT. II. Provision of Proposed Regulations A. Defining “Reasonable and Necessary” As described in section I.

Of this proposed rule, the Secretary has authority to determine the meaning of “reasonable and necessary” under section 1862(a)(1)(A) of the Act. We are proposing to codify the longstanding Program Integrity Manual definition of “reasonable and necessary” into our regulations at 42 CFR 405.201(b), with modification. Under the current definition, an item or service is considered “reasonable and necessary” if it is (1) safe and effective. (2) not experimental or investigational. And (3) appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is— Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.

Furnished in a setting appropriate to the patient's medical needs and condition. Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient's medical need. And At least as beneficial as an existing and available medically appropriate alternative. In addition to codifying the above criteria, we propose to include a separate basis under which an item or service would be appropriate under (3) above that is based on commercial health insurers' coverage policies (that is, non-governmental entities that sponsor health insurance plans).

The Start Printed Page 54332commercial market analysis would be initiated if an item/service fails to fulfill the existing factor (3) criteria defining appropriate for Medicare patients but fulfills (1) safe and effective and (2) not experimental or investigational. By considering commercial health insurer coverage policies, CMS would bring together the expertise of private payers and CMS. For example, in a recent NCD on acupuncture for chronic low back pain, CMS considered the technology assessments and coverage criteria among commercial health insurer coverage policies.[] We believe that this approach would be in line with E.O. 13890 that directs us to make technologies “widely available, consistent with the principles of patient safety, market-based policies, and value for patients.” Under this separate basis, we propose that an item or service would satisfy factor (3) if it is covered under a plan(s) coverage policy if offered in the commercial insurance market, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant. Under our proposal, we would exclude Medicaid managed care, Medicare Advantage, and other government administered healthcare coverage programs from the types of coverage CMS would consider, as these enrollees are not in the commercial market.

In the following paragraphs, we seek comment on this proposal and on how best to implement this mechanism. We solicit comments on sources of data that could be used to implement this policy, and whether CMS should make this information public and transparent. We seek public comment on the most appropriate source(s) for these coverage policies and the best way to determine which commercial plan(s) we would rely on for Medicare coverage. We seek comment on whether beneficiaries, providers, innovators, or others wishing to gain coverage for an item or service demonstrate that the item or service is covered by at least one commercial insurance plan policy. If they can provide CMS with evidence of commercial coverage or if CMS or its MACs identify such coverage from its review of compilations of health insurance offerings or data from other sources, CMS would consider factor (3) to be satisfied.

We solicit comment on whether we should limit our consideration of commercial plan offerings or covered lives to a subset of the commercial market in the interest of simplicity, including looking at geographic subsets, subsets based on number of enrollees, subsets based on plan type (HMO, PPO, etc.), or other subsets of plans—including utilizing a singular plan. We also seek comment on whether, given considerations such the variation and distribution of coverage policies and access to innovations, we should only cover an item or service if it is covered for a majority, or a different proportion such as a plurality, of covered lives amongst plans or a majority, plurality, or some other proportion of plan offerings in the commercial market. (A plan offering is a contract an insurer offers to its enrollees, and a single insurance company may provide many different offerings.) We also recognize that plan offerings may impose certain coverage restrictions on an item or service, e.g. Related to clinical criteria, disease stage, or number and frequency of treatment. As greater access to innovative treatments provides beneficiaries with more opportunity to improve health and drive decisions, we would, when coverage is afforded on the basis of commercial coverage, adopt the least restrictive coverage policy for the item or service amongst the offerings we examine.

However, given potential unreasonable or unnecessary utilization, we also solicit comment on whether we should instead adopt the most restrictive coverage policy. We are further considering, as another variation, that if coverage restrictions are largely similar and present across the majority of offerings, CMS would adopt these in its coverage policies. We note that such coverage restrictions include the basic requirement for medical necessity at the level of individual patients. Medicare will still only pay for an item or service received by a beneficiary if it is medically necessary for the beneficiary. We seek comment on whether, if we were to take this approach, we should instead use a proportion other than a majority, as low as any offering and as high as all offerings, as a sufficient threshold.

As a final variation, we could defer, in the absence of an NCD or national policy, to the MACs to tailor the restrictions on coverage based on what they observe in the commercial market, just as we rely on MACs with regards to the current definition. We further solicit comment on whether to grant coverage for an item or service to the extent it meets the first and second factors and the commercial coverage basis for the third factor. Under this approach, we would only use the current definition of “appropriate” from the current PIM when the exception for clinically relevant differences between Medicare beneficiaries and commercially insured individuals applies (or if the commercial coverage basis is determined by a proportion like a majority and there is insufficient commercial coverage information available). We note that referring to commercial coverage in this way may expand or narrow the circumstances under which we will cover a particular item or service and therefore solicit comment on whether, under such an approach, we should grandfather our current coverage policies for items and services. We also emphasize that the MACs will continue to make judgements in evaluating individual claims for reimbursement, such that a decision by CMS that an item or service is reasonable and necessary in general does not mean that it is reasonable and necessary in all circumstances with respect to individual claims for reimbursement.

We seek public comment on the most appropriate source(s) for these coverage policies. Further, under our proposal, each MAC would be responsible for reviewing commercial offerings to inform their LCDs or claim by claim decisions, which would include individual medical necessity decisions. We may also allow the MACs to develop approaches to address any or all of the considerations outlined above, parallel to their current practice of making coverage decisions in the absence of an NCD or national policy. We solicit comment on the best role of the MACs, along these lines or otherwise. We also solicit comment on whether the discretion to use the current criteria in the PIM when there is evidence to believe Medicare beneficiaries have different clinical needs should be exercised through the NCD process or in other ways, as well as what quantum of evidence should be sufficient.

In sum, we are proposing to define the term “reasonable and necessary” based on the factors currently found in the PIM, plus an alternative basis for meeting factor (3) based on any coverage in the commercial market. We are also soliciting comment on an alternative under whether an item or service satisfies the commercial coverage basis for factor (3) is determined by how it is treated across a majority of covered lives amongst commercial plan offerings, as well as an alternative whereby an item or service would be appropriate for Medicare patients to the extent it is covered in the commercial market. Start Printed Page 54333When evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant, we would rely on the criteria in the current PIM. We would continue relying on local administration of the program by MACs (including coverage on a claim by claim basis and LCDs) and maintain our discretion to issue NCDs based on the final rule. We solicit comment on this proposed definition of reasonable and necessary, and alternatives outlined above, as well as other mechanisms or definitions we could establish for the term “reasonable and necessary”, and the merits and drawbacks associated with each, including the potential impact on Medicare program expenses or complexity.

We may finalize any variation or outgrowth of the policies described in this proposal, or some combination of these options in lieu of or in conjunction with our proposed definition. B. Application of the “Reasonable and Necessary” Standard to the MCIT Pathway We are proposing that, under the proposed MCIT pathway, an item or service that receives a breakthrough device designation from the FDA would be considered “reasonable and necessary” under section 1862(a)(1)(A) of the Act because breakthrough devices have met the FDA's unique breakthrough devices criteria, and they are innovations that serve unmet needs. While other devices are still considered new to the market, for example, PMAs and even some 510(k)s, the devices designated by the FDA as breakthrough are representative of true innovations in the marketplace. This application of the “reasonable and necessary” standard in this way would ensure that the MCIT pathway can provide a fast-track to Medicare coverage of innovative devices that may more effectively treat or diagnose life-threatening or irreversibly debilitating human disease or conditions.

MCIT would improve healthcare for Medicare beneficiaries by providing national Medicare coverage for devices receiving the FDA breakthrough device designation, which are FDA market-authorized and used consistent with the FDA approved or cleared indication for use (also referred to as the “FDA required labeling”),[] so long as the breakthrough device is described in an appropriate Medicare benefit category under Part A or Part B and is not specifically excluded by statute. We believe the criteria for qualification as a breakthrough device, as defined in section 515B(b) of the Food, Drug and Cosmetic Act (21 U.S.C. 360e-3(b)) is sufficient to satisfy the elements of the “reasonable and necessary” standard. The first breakthrough device designation criterion is that a device must “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” (21 U.S.C. 360e-3(b)(1)).

The second criterion is that the device must satisfy one of the following elements. It represents a breakthrough technology. There are no approved or cleared alternatives. It offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute. Or availability of the device is in the best interest of patients (21 U.S.C.

360e-3(b)(2)). Thus, breakthrough devices are those that HHS has determined may provide better health outcomes for patients facing life-threatening or irreversibly debilitating human disease or conditions. We believe that a device meeting these criteria, once also FDA market authorized, is “reasonable and necessary” for purposes of Medicare coverage. This proposed rule recognizes that the FDA market authorization of breakthrough devices warrants immediate coverage under the “reasonable and necessary” clause in section 1862(a)(1)(A) of the Act. We previously stated that FDA determinations were not controlling determinations for Medicare coverage purposes under section 1862(a)(1)(A) of the Act.

(For more information see the January 30, 1989 Federal Register (54 FR 4307) (“FDA approval for the marketing of a medical device will not necessarily lead to a favorable coverage recommendation. . . €) and the August 7, 2013 Federal Register (78 FR 48165) (“However, FDA approval or clearance alone does not entitle that technology to Medicare coverage.”) Under the Secretary's broad authority to interpret section 1862(a)(1)(A) of the Act (supra section I.A.), we are revising our interpretation of the statute because of the practical concerns that our current standards have delayed access to a unique set of innovative devices that FDA has found to be safe and effective, and we believe are “reasonable and necessary” for purposes of Medicare coverage. In light of E.O.

13890, the Secretary has determined that application of the current standards for making “reasonable and necessary” determinations may take too long following FDA market authorization of breakthrough devices. More importantly, the existing standard has not always provided Medicare beneficiaries adequate access to certain breakthrough medical devices when needed to improve health outcomes. We are proposing that breakthrough devices per se meet the reasonable and necessary standard in order to increase access and to reduce the delay from FDA market authorization to Medicare coverage. C. MCIT Pathway We are proposing the MCIT pathway to deliver on the Administration's commitment to provide access to breakthrough devices to Medicare beneficiaries.

The MCIT pathway provides up to 4 years of national coverage to newly FDA market authorized breakthrough devices. We are aware that this coverage may also facilitate evidence development on devices for the Medicare population because manufacturers can gather additional data on utilization of the device during the MCIT coverage period. 1. Definitions In § 405.601(a) we are proposing that the MCIT pathway is voluntary. Operationally, we propose that manufacturers of breakthrough devices notify CMS of their intention to elect MCIT shortly after receiving notice from the FDA of being granted the breakthrough device designation.

Ideally, this notification would be sent to CMS within 2 weeks of receiving breakthrough designation. However, entities would not be penalized for notifying CMS after that time. Alternatively, submitting a notification to CMS shortly before or concurrently with the date of the FDA marketing submission should also afford CMS sufficient time to operationalize MCIT for the device. The CMS Coverage and Analysis Group would establish an email box for these inquires. This notification alerts CMS to offer guidance to manufacturers about the MCIT pathway and point to resources for coding and payment, which are key conversations to effectuate coverage upon FDA market authorization.

We intend to utilize the existing coverage implementation processes to be prepared to offer coverage immediately upon the FDA market authorization. In § 405.601(b), we propose the following definitions for the purposes of 42 CFR part 405. We propose to define Start Printed Page 54334“breakthrough device” as a medical device that receives such designation by the FDA (section 515B(d)(1) of the FD&C Act (21 U.S.C. 360e-3(d)(1))). We also propose to define, for the sake of clarity in the rule, that the acronym MCIT stands for Medicare Coverage of Innovative Technology.

2. MCIT Pathway Device Eligibility In § 405.603(a) we propose that the pathway is available to devices that meet the definitions proposed in § 405.601. Based on the explicit mention of devices in E.O. 13890 and our interaction and feedback from stakeholders who expressed their concern that there is more uncertainty of coverage for devices than for other items and services (for example, diagnostics, drugs and biologics), this proposed policy is for devices only. We propose in § 405.603(b) that the breakthrough devices that received FDA market authorization no more than 2 calendar years prior to the effective date of this subpart (the date the final rule is finalized) and thereafter will be eligible for coverage for claims submitted on or after the effective date of this rule.

Claims for breakthrough devices with dates of service that occurred before the effective date of this rule would not be covered through MCIT. For example, a hypothetical breakthrough device that was FDA market authorized on October 1, 2018, and utilized on January 1, 2020 would not be eligible for coverage under MCIT because on January 1, 2020, the date of service, the final MCIT rule was not yet legally in effect. In contrast, a claim for utilization of the same hypothetical breakthrough device with a date of service on January 1, 2021 might be eligible for coverage if the claim occurred after the effective date of the rule (assuming that the effective date of the rule was prior to January 1, 2021). Breakthrough devices market authorized prior to the effective date of this rule will not be eligible for all 4 years of coverage. The 4-year period starts on the date of FDA market authorization.

For example, a breakthrough device market authorized on October 1, 2018 would have claims covered through MCIT from the effective date of the final rule until October 1, 2022. If a manufacturer initially chooses to not utilize the MCIT pathway, and then chooses to do so some time after the breakthrough device's market authorization, coverage still only lasts 4 years from the date of FDA market authorization. We seek comment on this eligibility criterion for devices and specifically the 2 year lookback. We propose in § 405.603(c) that to be part of the MCIT pathway, the device must be used according to its FDA approved or cleared indication for use. We propose that the device is only covered for use consistent with its FDA approved or cleared indication for use because that is the indication and conditions for use that were reviewed by the FDA and authorized for marketing.

Data are unlikely to be available to support extending beyond the FDA required labeling for breakthrough devices on the date of marketing authorization. Use of the device for a condition or population that is not labeled (“off-label”) will not be covered as that use would not be FDA authorized. We specifically seek comment on whether off-label use of breakthrough devices should be covered and, if so, under what specific circumstances and/or evidentiary support. In § 405.603(d) and (e), we additionally propose limitations to what is coverable under the Act. In § 405.603(e), we are proposing that if CMS has issued an NCD on a particular breakthrough device, that breakthrough device is not eligible for MCIT.

We are proposing this because, once the device has been reviewed by CMS for the FDA required approved or cleared indication for use. CMS has made a coverage determination based on the available evidence for that technology. We believe this would happen rarely because breakthrough devices are new technologies that are not likely to have been previously reviewed through the NCD process. In § 405.603(f), we acknowledge that devices in the MCIT pathway may be excluded due to statute or regulation (for example, 42 CFR 411.15, Particular services excluded from coverage) and, like other items and services coverable by Medicare, the device must fall within the scope of a Medicare benefit category under section 1861 of the Act and the implementing regulations. If the device does not fall within a Medicare benefit category as outlined in the statute and implementing regulations, the device is not eligible for Medicare coverage.

Therefore, the device would not be eligible for the MCIT pathway. 3. General Coverage of Items and Services under the MCIT Pathway We propose in § 405.605 that devices covered under the MCIT pathway are covered no differently from devices that are covered outside of MCIT. In other words, provided the items and services are otherwise coverable (that is, not specifically excluded and not found by CMS to be outside the scope of a Medicare benefit category), covered items and services could include the device, reasonable and necessary surgery to implant the device, if implantable, related care and services costs of the device (for example, replacing reasonable and necessary parts of the device such as a battery), and coverage of any reasonable and necessary treatments due to complications arising from use of the device. What the MCIT pathway offers compared to other pathways is predictable national coverage simultaneous with FDA market authorization that will generally last for a set time period.

The proposed MCIT pathway would support and accelerate beneficiary access to certain innovative devices. CMS encourages manufacturers that have breakthrough devices covered under MCIT to develop additional data for the healthcare community. 4. MCIT Pathway for Breakthrough Devices. 4 Years of Coverage In § 405.607(a), we propose that the MCIT pathway for coverage would begin on the same date the device receives FDA market authorization.

We propose this point in time to ensure there is no gap between Medicare coverage and FDA market authorization. This supports the MCIT pathway's focus of ensuring beneficiaries have a predictable access to new devices. We propose in § 405.607(b)(1) that the MCIT pathway for breakthrough devices ends 4 years from the date the device received FDA market authorization. We propose this 4 year time period because it could allow manufacturers to develop clinical evidence and data regarding the benefit of the use of their device in a real world setting. For example, we believe 4 years would allow most manufacturers sufficient time to complete FDA required post-approval or other real-world data collection studies that may have been a condition of FDA market authorization.

This assumption is based upon our historical experience with studies conducted through coverage with evidence development (CED). Further, this time period allows Medicare to support manufacturers that, whether required by the FDA or not, have an interest in better understanding the health outcomes of their device in the Medicare population, including impacts on patient-reported and longer-term outcomes. Further, § 405.607(b) proposes reasons that the MCIT pathway may end prior to 4 years. This includes circumstances whereby the device becomes subject to an NCD, regulation, statute, or if the device can no longer be lawfully marketed.Start Printed Page 54335 D. Summary In summary, the MCIT pathway would provide immediate Medicare coverage of newly FDA market authorized breakthrough devices for 4 years.

We seek public comment on all of our proposals. In particular, we seek feedback on whether the proposed 4 year coverage period is sufficient. We also look to stakeholders and the public to determine the level of interest and expected use of the proposed MCIT pathway so the agency can begin to estimate the level of needed resources to support successful implementation. We are also seeking public comments on our proposal to codify in regulations the standards we have historically used in making reasonable and necessary decisions under Part A and Part B under section 1862(a)(1)(A) of the Act. After considering public comments we would prepare a final rule that we expect would be effective 60 days after publication of the final rule.

III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden.

The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of the section 3506(c)(2)(A)-required issues for the following sections of this document that contain information collection requirements (ICRs). To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2018 National Occupational Employment and Wage Estimates for all salary estimates (https://www.bls.gov/​oes/​current/​oes131041.htm, released May 2019).

In this regard, the table that follows presents the mean hourly wage, the cost of fringe benefits (calculated at 100 percent of salary), and the adjusted hourly wage. Table 1—National Occupational Employment and Wage Estimates for MCITOccupation titleOccupation codeMean hourly wage ($/hr)Fringe benefit ($/hr)Adjusted hourly wage ($/hr)Compliance Officer13-104134.8634.8669.72 As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. This proposed coverage pathway allows for a voluntary participation and therefore necessitates that manufacturers of breakthrough devices notify CMS of their intent to enter the MCIT pathway.

Therefore, the burden associated with notifying CMS is the time and effort it would take for each of the organizations to send CMS an email or letter. We anticipate two MCIT pathway participants in the first year based upon the number of medical devices that received FY2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles. We estimate notifying CMS of intent to participate in MCIT would involve 15 minutes at $69.72 per hour by a compliance officer. In this regard, we estimate 15 mins per notification at a cost of $17.43 per organization (0.25 hours × $69.72). In aggregate, we estimate 0.5 hours (0.25 hours × 2 submissions) at $34.86 ($17.43 × 2 submissions).

After the anticipated initial 2 submitters, over the next 3 years we expect 3 submitters in year 2, 4 submitters in year 3, and 5 submitters in year 4 to notify CMS of interested in the MCIT pathway. We expect this increase in submitters each year to level off at this point. In this regard, we estimate the same 0.25 hours per submission at a cost of $17.43 per organization. Similarly, in aggregate, we estimate, for year 2 (0.75 hours at $52.29 an hour), for year 3 (1.0 hour at $69.72 an hour), and for year 4 (1.25 hours at $87.15 an hour). The proposed requirements and burden will be submitted to OMB under control number 0938-NEW.

We are requesting public comments on these information collection and recordkeeping requirements. If you comment on these information collection and recordkeeping requirements, please do either of the following. 1. Submit your comments electronically as specified in the ADDRESSES section of this proposed rule. Or 2.

Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention. CMS Desk Officer, CMS-3372-P, Fax. (202) 395-6974. Or Email. OIRA_submission@omb.eop.gov.

Comments must be received on/by November 2, 2020. IV. Regulatory Impact Statement This proposed rule makes Medicare coverage policy updates pursuant to the authority at section 1862(a)(1)(A) of the Act. We are using regulatory action per the October 3, 2019 “Executive Order on Protecting and Improving Medicare for Our Nation's Seniors” to address the increasing need for a swift Medicare coverage mechanism to allow beneficiaries across the nation to access breakthrough devices faster after FDA market authorization. This proposed rule addresses that need by establishing a coverage pathway that will allow immediate beneficiary access to FDA market authorized breakthrough devices.

We have examined the impact of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub. L.

104-4), Start Printed Page 54336Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This proposed rule does reach the economic threshold and thus is considered a major rule.

Regulatory alternatives to this proposed rule were to combine Medicare coverage with clinical evidence development under section 1862(a)(1)(E) of the Act, to take no regulatory action at this time, or to adjust the duration of the MCIT pathway. Combining coverage with clinical evidence development would have met the E.O. 13890 overarching goal of beneficiary access to breakthrough devices. However, this alternative did not meet the other E.O. 13890 aims of minimizing time between FDA market authorization and Medicare coverage and wide availability.

The timing of coverage would depend upon the manufacturer being able to initiate a clinical study and the wide availability of coverage could be an issue if providers did not have the infrastructure necessary to participate in the clinical study. CMS chose to not to pursue combining coverage with evidence development for breakthrough devices because we wanted to meet the timing and wide availability aims of E.O. 13890. CMS also considered taking no regulatory action and trying to leverage the existing Medicare coverage pathways or proposing sub-regulatory policies to achieve the streamlined coverage process described in E.O. 13890.

Taking no action would not have resulted in the desired national coverage and access envisioned in E.O. 13890 because, as described in this preamble, the existing coverage pathways do not consistently provide swift, national beneficiary access to innovative devices. As discussed elsewhere in the preamble, the nature of the problem being addressed by this proposed regulation is a potential delay between a milestone such as FDA market authorization and CMS coverage. As such, we request comment on a policy option of shortening of the duration of the MCIT pathway from the proposed 4 years to 1 year. In addition to the alternatives just discussed, there are various possibilities regarding how to change the definition of “reasonable and necessary”—for example, whether to include a new aspect of the proposed definition that focuses on commercial insurance coverage practices.

As noted earlier in the preamble, the goal of this revision is to expand coverage. However, the nuances of the definition would affect the magnitude of the impact and we request comment that would facilitate quantification of effects and comparison of alternatives at the final rule stage. The impact of implementing the MCIT pathway is difficult to determine without knowing the specific technologies that would be covered. In addition, many of these technologies would be eligible for coverage in the absence of this rule, such as through a local or national coverage determination, so the impact for certain items may be the acceleration of coverage or adoption by just a few months. Furthermore, some of these devices would be covered immediately if the MACs decide to pay for them, which would result in no impact on Medicare spending for devices approved under this pathway.

However, it is possible that some of these innovative technologies would not otherwise be eligible for coverage in the absence of this rule. Because it is not known how these new technologies would otherwise come to market and be reimbursed, it is not possible to develop a point estimate of the impact. In general, we believe the MCIT coverage pathway would range in impact from having no impact on Medicare spending, to a temporary cost for innovations that are adopted under an accelerated basis. The decision to enter the MCIT pathway is voluntary for the manufacturer. Because manufacturers typically join the Medicare coverage pathway that is most beneficial to them, this would result in selection against the existing program coverage pathways (to what degree is unknown at this point).

In addition, the past trend of new technology costing more than existing technology could lead to a higher cost for Medicare if this trend continued for technologies enrolling in the MCIT pathway. Nevertheless, new technology may also mitigate ongoing chronic health issues or improve efficiency of services thereby reducing some costs for Medicare. In order to demonstrate the potential impact on Medicare spending, the CMS Office of the Actuary (OACT) developed three hypothetical scenarios that illustrate the impact of implementing the proposed MCIT pathway. Scenarios two and three assume that the device would not have been eligible for coverage in the absence of this proposed rule. (See Table 2) The illustration used the new devices that applied for a NTAP in FY 2020 as a proxy for the new devices that would utilize the MCIT pathway.

The submitted cost and anticipated utilization for these devices was published in the Federal Register.[] In addition, we assumed that two manufacturers would elect to utilize the MCIT pathway in the first year, three manufacturers in the second year, four manufacturers in the third year, and five manufacturers in the fourth year each year for all three scenarios. This assumption is based on the number of medical devices that received FY 2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles and our impression from the FDA that the number of devices granted breakthrough status is increasing. For the first scenario, the no-cost scenario, we assumed that all the devices would be eligible for coverage in the absence of the proposed rule. If the devices received payment nationally and at the same time then there would be no additional cost under this pathway. For the second scenario, the low-cost scenario, we assumed that the new technologies would have the average costs ($2,044) and utilization (2,322 patients) of similar technologies included in the FY 2020 NTAP application cycle.

Therefore, to estimate the first year of MCIT, we multiplied the add-on payment for a new device by the anticipated utilization for a new device by the number of anticipated devices in the pathway ($2,044 × 2,322 × 2 = $ 9.5 million). For the third scenario, the high-cost scenario, we assumed the new technologies would receive the maximum add-on payment from the FY 2020 NTAP application cycle ($22,425) and the highest utilization of a device (6,500 patients). Therefore, to estimate for the first year of MCIT, we estimated similarly ($22,425 × 6,500 patients × 2 = $ 291.5 million). For subsequent years, we increased the number of anticipated devices in the pathway by three, four, and five in the last two scenarios until 2024.[] In addition to Start Printed Page 54337not taking into account inflation, the illustration does not reflect any offsets for the costs of these technologies that would be utilized through existing authorities nor the cost of other treatments (except as noted). It is not possible to explicitly quantify these offsetting costs but they could substantially reduce or eliminate the net program cost.

However, by assuming that only two to five manufacturers will elect MCIT coverage, we have implicitly assumed that, while more manufacturers could potentially elect coverage under MCIT, the majority of devices would have been covered under a different coverage pathway. Therefore, a substantial portion of the offsetting costs are implicitly reflected. Based on this analysis, there is a range of potential impacts of the proposed MCIT coverage pathway as shown in Table 2. The difference between the three estimates demonstrates how sensitive the impact is to the cost and utilization of these unknown devices. Table 2—Illustrated Impact on the Medicare Program by Proposed MCIT Coverage Pathway Costs (in millions)FY 2021FY 2022FY 2023FY 2024No-cost Scenario$0$0$0$0Low-cost Scenario9.523.742.766.4High-cost Scenario291.5728.81,311.92,040.7 We believe the assumptions used in the three scenarios are reasonable to show the possible wide range of impacts for implementing this proposed pathway, in particular for a technology that would not have otherwise been eligible for coverage.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Some hospitals and other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. We reviewed the Small Business Administration's Table of Small Business Size Standards Matched to North American Industry Classification System (NAICS) Codes to determine the NAICS U.S.

Industry titles and size standards in millions of dollars and/or number of employees that apply to small businesses that could be impacted by this rule.[] We determined that small businesses potentially impacted may include surgical and medical instrument manufacturers (NAICS code 339112, dollars not provided/1,000 employees), Offices of Physicians (except Mental Health Specialists) (NAICS code 621111, $12 million/employees not provided), and Freestanding Ambulatory Surgical and Emergency Centers (NAICS code 621493, $16.5 million/employees not provided). During the first 4 years of MCIT, we anticipate approximately 14 surgical and medical instrument manufacturers may participate, and based off of U.S. Census data, the majority of this businesses type are small businesses with less than 1,000 employees (968 out of 1,093 businesses have less than 500 employees).[] As such, this proposed rule would impact less than 5 percent of these businesses, and the revenue impact, if any, would not be negative. Rather, it would be a positive impact because MCIT would provide Medicare coverage (and subsequent payment) to providers who purchase the devices from these manufacturers. For Offices of Physicians (except Mental Health Specialists) and Freestanding Ambulatory Surgical and Emergency Centers that may be providing the breakthrough devices, the majority are small businesses with less than 1,000 employees (4,060 out of 4,385 and 160, 367 out of 161, 286 have less than 500 employees, respectively).[] Given that we estimate, at most in the high-cost scenario, that 6,500 beneficiaries would utilize breakthrough devices through MCIT per year, and even if each beneficiary were to access services at only one of these small businesses (that is, no two beneficiaries used the same office or center), still less than 5 percent of these small businesses would be impacted by MCIT.

As such, the revenue impact, if any, would not be negative, rather, it would be a positive impact because MCIT would provide Medicare coverage (and subsequent payment) to providers. Overall, this proposed rule results in a payment, not a reduction in revenue. We are not preparing a further analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule will not have a significant negative economic impact on a substantial number of small entities because small entities are not being asked to undertake additional effort or take on additional costs outside of the ordinary course of business through this proposed rule. Rather, for small entities that develop or provide breakthrough devices to patients, this proposed rule is a means for the device to be covered through the Medicare program, which does not detract from revenue and could be viewed as a positive economic impact. With the limited information we had to base this estimate, we solicit public comment on improvements to this estimate for the final rule.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital Start Printed Page 54338as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals because small rural hospitals are not being asked to undertake additional effort or take on additional costs outside of the ordinary course of business through this proposed rule. Obtaining breakthrough devices for patients is at the discretion of providers.

We are not requiring the purchase and use of breakthrough devices. Providers should continue to work with their patients to choose the best treatment. For small rural hospitals that provide breakthrough devices to their patients, this proposed rule is a means for the device to be covered through the Medicare program. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2020, that threshold was approximately $156 million.

This proposed rule would have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable. Executive Order 13771 (E.O. 13771), titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017.

This proposed rule, if finalized as proposed, is expected to impose no more than de minimis costs and thus be neither an E.O. 13771 regulatory action nor an E.O. 13771 deregulatory action. In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget. V.

Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Start List of Subjects Administrative practice and procedureDiseasesHealth facilitiesHealth professionsMedical devicesMedicareReporting and recordkeeping requirementsRural areasX-rays End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services proposes to amend 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1.

The authority for part 405 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k). End Authority Start Amendment Part2. Section 405.201 is amended in paragraph (b) by adding the definition of “Reasonable and necessary” in alphabetical order to read as follows.

End Amendment Part Scope of subpart and definitions. * * * * * (b) * * * Reasonable and necessary means that an item or service is considered— (1) Safe and effective. (2) Except as set forth in § 411.15(o)) of this chapter, not experimental or investigational. And (3) Appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it (i) Meets all of the following criteria. (A) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.

(B) Furnished in a setting appropriate to the patient's medical needs and condition. (C) Ordered and furnished by qualified personnel. (D) One that meets, but does not exceed, the patient's medical need. And (E) At least as beneficial as an existing and available medically appropriate alternative. Or (ii) Is covered by commercial insurers, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant.

* * * * * Start Amendment Part3. Subpart F, consisting of §§ 405.601-405.607, is added to read as follows. End Amendment Part 405.601 Medicare coverage of innovative technology. 405.603 Medical device eligibility. 405.605 Coverage of items and services.

405.607 Coverage period. Medicare coverage of innovative technology. (a) Basis and scope. Medicare coverage of innovative technology (MCIT) is a program that provides national, time-limited coverage under section 1862(a)(1)(A) of the Act for certain breakthrough medical devices. Manufacturer participation in the pathway for breakthrough device coverage is voluntary.

(b) Definitions. For the purposes of this subpart, the following definitions are applicable. Breakthrough device means a device that receives such designation by the Food and Drug Administration (FDA) (section 515B(d)(1) of the FD&C Act (21 U.S.C. 360e-3(d)(1)). MCIT stands for Medicare coverage of innovative technology.

Medical device eligibility. The MCIT pathway is available only to medical devices that meet all of the following. (a) That are FDA-designated breakthrough devices. (b) That are FDA market authorized at most [date 2 years prior to effective date of final rule] and thereafter. (c) That are used according to their FDA approved or cleared indication for use.

(d) That are within a Medicare benefit category. (e) That are not the subject of a Medicare national coverage determination. (f) That are not otherwise excluded from coverage through law or regulation. Coverage of items and services. Covered items and services furnished within the MCIT pathway may include any of the following, if not otherwise excluded from coverage.

(a) The breakthrough device. (b) Any reasonable and necessary procedures to implant the breakthrough device.Start Printed Page 54339 (c) Reasonable and necessary costs to maintain the breakthrough device. (d) Related care and services for the breakthrough device. (e) Reasonable and necessary services to treat complications arising from use of the breakthrough device. Coverage period.

(a) Start of the period. The MCIT pathway begins on the date the breakthrough device receives FDA market authorization. (b) End of the period. The MCIT pathway for a breakthrough device ends as follows. (1) No later than 4 years from the date the breakthrough device received FDA market authorization.

(2) Prior to 4 years if a manufacturer withdraws the breakthrough device from the MCIT pathway. (3) Prior to 4 years if the breakthrough device becomes the subject of a national coverage determination or otherwise becomes noncovered through law or regulation. Start Signature Dated. May 4, 2020. Seema Verma, Administrator, Centers for Medicare &.

Medicaid Services. Dated. June 11, 2020. Alex M. Azar II, Secretary, Department of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-19289 Filed 8-31-20. 8:45 am]BILLING CODE 4120-01-P.

This document viagra results is unpublished viagra cost. It is scheduled to be published on 09/18/2020. Once it is published it will be available on this viagra cost page in an official form. Until then, you can download the unpublished PDF version. Although we make a concerted effort to reproduce the original document in full on our Public Inspection pages, in some cases graphics may not be displayed, and non-substantive markup language may appear alongside substantive text.

If you are using public inspection listings for legal viagra cost research, you should verify the contents of documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice to the public and judicial notice to the courts under 44 U.S.C. 1503 & viagra cost. 1507. Learn more here.Start Preamble Centers for Medicare &.

Medicaid Services viagra cost (CMS), HHS. Proposed rule. This proposed rule would establish a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). After the final rule is effective, the Medicare Coverage of Innovative Technology (MCIT) pathway would begin national Medicare coverage on the date of FDA market authorization and would viagra cost continue for 4 years. We are also proposing regulatory standards to be used in making reasonable and necessary determinations under section Start Printed Page 543281862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.

To be assured consideration, comments must be received at one viagra cost of the addresses provided below, no later than 5 p.m. On November 2, 2020. In commenting, please refer to file code CMS-3372-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission viagra cost. You may submit comments in one of three ways (please choose only one of the ways listed).

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions. 2.

By regular mail. You may mail written comments to the following address ONLY. Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-3372-P, P.O.

Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, Department of Health and Human Services, Attention. CMS-3372-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info Linda Gousis or JoAnna Baldwin, (410) 786-2281 or CAGinquiries@cms.hhs.gov.

End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received. Http://www.regulations.gov. Follow the search instructions on that website to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare &. Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. To 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I.

Background The Administration is committed to ensuring Medicare beneficiaries have access to new cures and technologies that improve health outcomes. Section 6 of the October 3, 2019 Executive Order 13890 (E.O. 13890) “Executive Order on Protecting and Improving Medicare for Our Nation's Seniors,” [] directs the Secretary to “propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients” including by “streamlining the approval, coverage, and coding process”.[] The E.O. 13890 explicitly includes making coverage of breakthrough medical devices “widely available, consistent with the principles of patient safety, market-based policies, and value for patients.” [] The E.O. Also directs the Secretary to “clarify the application of coverage standards.” [] We are responding directly to these directives by proposing a definition of the term “reasonable and necessary” to clarify coverage standards and proposing the Medicare Coverage of Innovative Technology (MCIT) pathway to accelerate the coverage of new, innovative breakthrough devices to Medicare beneficiaries.

To date, the factors used in making “reasonable and necessary” determinations based on section 1862(a)(1)(A) of the Act have not been established in regulations for Medicare coverage purposes. The Secretary has authority to determine whether a particular medical item or service is “reasonable and necessary” under section 1862(a)(1)(A) of the Act. (See Heckler v. Ringer, 466 U.S. 602, 617 (1984).) When making coverage determinations, our policies have long considered whether the item or service is safe and effective, not experimental or investigational, and appropriate.

(For more information see the January 30, 1989 notice of proposed rulemaking (54 FR 4307)). These factors are found in Chapter 13 of the Medicare Program Integrity Manual (PIM) at section 13.5.4—Reasonable and Necessary Provisions in LCDs as instructions for Medicare contractors. We are proposing to codify in regulations the Program Integrity Manual definition of “reasonable and necessary” with modifications, including to add a reference to Medicare patients and a reference to commercial health insurer coverage policies. We propose that an item or service would be considered “reasonable and necessary” if it is—(1) safe and effective. (2) not experimental or investigational.

And (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is— Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member. Furnished in a setting appropriate to the patient's medical needs and condition. Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient's medical need. And At least as beneficial as an existing and available medically appropriate alternative.

We also propose that an item or service would be “appropriate for Medicare patients” under (3) if it is covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals. An item or service deemed appropriate for Medicare coverage based on commercial coverage would be covered on that basis without also having to satisfy the bullets listed above. We believe this definition is a significant step in meeting the E.O.'s directive to bring clarity to coverage standards. Stakeholders have expressed interest in codifying a definition of “reasonable and necessary” for many years. This proposed definition is familiar and functional, can satisfy that interest and meet the E.O.'s ask, while also aligning with the goals of MCIT by providing clarity and predictability for innovation, including for beneficiaries and innovators.

The proposed MCIT coverage pathway is specifically for Medicare coverage of devices that are designated as part of the Food and Drug Administration's (FDA) Breakthrough Devices Program (hereafter referred to as “breakthrough devices”) and are FDA market authorized. The MCIT pathway would be voluntary and device manufacturers would notify CMS if they want to utilize this coverage option. We propose that national Medicare coverage under the MCIT pathway would begin immediately upon the date of FDA market authorization (that is, the Start Printed Page 54329date the medical device receives Premarket Approval (PMA). 510(k) clearance. Or the granting of a De Novo classification request) for the breakthrough device.

This coverage would occur unless the device does not have a Medicare benefit category or is otherwise excluded from coverage by statute (that is, the Medicare statute does not allow for coverage of the particular device.) This coverage pathway delivers on the Administration's commitment to give Medicare beneficiaries access to the newest innovations on the market, consistent with the statutory definitions of Medicare benefits. Because Medicare is a defined benefit program, devices that do not fit within the statutory definitions may not be considered for MCIT. As an example, medical equipment for home use by the beneficiary must be durable (that is, withstand repeated use) for it to be coverable by Medicare (as defined in statutes and regulations by the Secretary). At this time, we are limiting MCIT to medical devices because that is a category of products explicitly identified in E.O. 13890, and we have identified that breakthrough devices can experience variable coverage across the nation shortly after market authorization.

We propose this MCIT pathway because the prescribed statutory timeframes for the National Coverage Determination (NCD) process limit CMS' ability to institute immediate national coverage policies for new, innovative medical devices. NCDs and Local Coverage Determinations (LCD) take, on average, 9 to 12 months to finalize. Because of this length of time, there may be coverage uncertainty between the period of FDA market authorization and CMS finalization of an NCD or a Medicare Administrative Contractor's (MACs) finalization of an LCD. During this time period shortly after market authorization, MACs make coverage determinations on a case-by-case (individual beneficiary) basis, but those decisions do not usually establish agency policies for future claims because a case-by-case decision is for a particular beneficiary and their health circumstances. Over the past few years, CMS has heard concerns from stakeholders that breakthrough devices are not automatically covered nationally by Medicare once they are FDA market authorized.

Variation in coverage from one jurisdiction to another is also a concern. To date, 16 breakthrough devices have also been market authorized. The majority of these breakthrough devices (10 devices) experience variability in coverage for two reasons. One reason is because the breakthrough devices are coverable at MAC discretion, like many other item and services, on a case-by-case basis (that is, the breakthrough device may be covered for one patient, but not for another within the same jurisdiction). The other reason is because breakthrough devices are used by a hospital or other provider that operates under a bundled payment system (such as a diagnosis related group (DRG) system), so there may be no separate coverage policy for each item or service that may be included in the bundled payment.

Another example of variable coverage is for one breakthrough device that is non-covered by a local policy in Florida, but coverable at MAC discretion on a case-by-case basis in other jurisdictions. One breakthrough device has national coverage through an NCD. One breakthrough device has uniform coverage because the same LCD has been adopted in all jurisdictions. There are three breakthrough devices that do not have a Medicare benefit category (for example, certain wearable devices). Therefore, those breakthrough devices cannot be covered by the Medicare program.

In contrast to varied local coverage, the proposed MCIT would create a pathway for immediate national Medicare coverage of any FDA-market authorized breakthrough device if the device meets criteria outlined in this proposal. A. Statutory Authority We are also proposing to establish in regulations the factors we have historically used in making “reasonable and necessary” determinations under section 1862(a)(1)(A) of the Act, with some modification. To summarize, this section explains that Medicare payment may be made under part A or part B for any expenses incurred for items or services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Thus, with some exceptions, section 1862(a)(1)(A) of the Act requires that an item or service be “reasonable and necessary” to be covered by Medicare.

The courts have recognized that the Secretary has significant authority to determine whether a particular item or service is “reasonable and necessary.” (Heckler v. Ringer, 466 U.S. 602, 617 (1984). See also, Yale-New Haven Hospital v. Leavitt, 470 F.3d 71, 84 (2d Cir.

2006). Kort v. Burwell, 209 F. Supp. 3d 98, 110 (D.C.

2016) (The statute vests substantial authority in the Secretary.)) So even though section 1862(a)(1)(A) of the Act limits the scope of Medicare coverage, the Secretary has discretion to revise his/her interpretation of the statute in order to ensure adequate coverage for items and services under Part A and Part B. This proposal would provide national Medicare coverage for breakthrough devices that are FDA market-authorized and used consistent with the FDA approved or cleared indication for use (also referred to as the “FDA-required labeling”).[] This device coverage under the MCIT pathway is reasonable and necessary under section 1862(a)(1)(A) of the Act because the device has met the unique criteria of the FDA Breakthrough Devices Program. B. FDA Breakthrough Devices Program Under the proposed MCIT coverage pathway, CMS would coordinate with FDA and manufacturers as medical devices move through the FDA regulatory process for Breakthrough Devices to ensure seamless Medicare coverage on the date of FDA market authorization unless CMS determines those devices do not have a Medicare benefit category. The Breakthrough Devices Program is an evolution of the Expedited Access Pathway Program and the Priority Review Program (section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), 21 U.S.C.

360e-3. See also final guidance for industry entitled, “Breakthrough Devices Program,” https://www.fda.gov/​downloads/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​UCM581664.pdf). The FDA's Breakthrough Devices Program is not for all new medical devices. Rather, it is only for those that the FDA determines meet the standards for breakthrough device designation. In accordance with section 3051 of the 21st Century Cures Act (21 U.S.C.

360e-3),[] the Breakthrough Devices Program is for medical devices and device-led combination products that meet two criteria. The first criterion is that the device provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. The second criterion is that the device must satisfy one of the following elements. It Start Printed Page 54330represents a breakthrough technology. No approved or cleared alternatives exist.

It offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute. Or device availability is in the best interest of patients (for more information see 21 U.S.C. 360e-3(b)(2)). These criteria make breakthrough designated devices unique among all other medical devices.[] The parameters of the breakthrough devices program focus on innovations for patients, in turn, MCIT, focuses on these breakthrough devices consistent with E.O. 13890 and in order to streamline coverage of innovative medical devices.

C. Current Medicare Coverage Pathways Currently, we utilize several coverage pathways for items and services, which includes medical devices. None of the coverage pathways described in this section offer immediate, predictable coverage concurrently with FDA market authorization like the proposed MCIT pathway would do. We summarize the other coverage pathways here to provide context for MCIT. National Coverage Determinations (NCDs).

Section 1862(l)(6)(A) of the Act defines the term national coverage determination as “a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this title.” In general, NCDs are national policy statements published to identify the circumstances under which particular items and services will be considered covered by Medicare. Traditionally, CMS relies heavily on health outcomes data to make NCDs. Most NCDs have involved determinations under section 1862(a)(1)(A) of the Act, but NCDs can be made based on other provisions of the Act, and includes a determination that the item or service under consideration has a Medicare benefit category. The NCD pathway, which has statutorily prescribed timeframes, generally takes 9 to 12 months to complete.[] Local Coverage Determinations (LCDs). Medicare contractors develop LCDs based on section 1862(a)(1)(A) of the Act that apply only within their geographic jurisdictions.

(Sections 1862(l)(6)(B) and 1869(f)(2)(B) of the Act.) MACs will not need to develop LCDs for breakthrough devices when they are nationally covered through MCIT. The MACs follow specific guidance for developing LCDs for Medicare coverage in the CMS Program Integrity Manual, and in some instances, an LCD can also take 9 to12 months to develop (MACs must finalize proposed LCDs within 365 days from opening per Chapter 13—Local Coverage Determinations of the (PIM) 13.5.1). We note that the MCIT pathway will not alter the existing coverage standards in Chapter 13—Local Coverage Determinations of the PIM.[] That chapter will continue to be used in making determinations under section 1862(a)(1)(A) of the Act for other items and services at the local level. Claim-by-claim Adjudication. In the absence of an NCD or LCD, MACs would make coverage decisions under section 1862(a)(1)(A) of the Act and may cover or not cover items and services on a claim-by-claim basis.

The majority of claims are handled through the claim adjudication process. Clinical Trial Policy (CTP) NCD 310.1. The CTP pathway can be used for coverage of routine care items and services (but generally not the technology under investigation) in a clinical study that is supported by certain Federal agencies. The CTP coverage pathway was developed in 2000.[] This coverage pathway has not generally been utilized by device manufacturers because they usually seek coverage of the device, which is not included in this pathway. Parallel Review.

Parallel Review is a mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDA's approval of a premarket application or granting of a de novo classification and the subsequent CMS NCD. Parallel Review has two stages. (1) FDA and CMS meet with the manufacturer to provide feedback on the proposed pivotal clinical trial within the FDA pre-submission process. And (2) FDA and CMS concurrently review (“in parallel”) the clinical trial results submitted in the PMA, or De Novo request. FDA and CMS independently review the data to determine whether it meets their respective Agency's standards and communicate with the manufacturer during their respective reviews.

This program is most successful for devices that have a significant amount of clinical evidence. (Candidates for parallel review would not be appropriate for simultaneous MCIT consideration.) Even though CMS has multiple coverage pathways, at this time none are readily available to provide immediate national coverage for new breakthrough devices with a Medicare benefit category at the same time as FDA market authorization. Further, some of these new breakthrough devices are likely to have limited or developing bodies of clinical evidence because of the newness of the device. Therefore, the MCIT pathway can support manufacturers that are interested in combining coverage with their own clinical study to augment clinical evidence of improved health outcomes, particularly for Medicare patients. Given this summary of existing coverage pathways, we seek comment from the public regarding if any of these existing pathways should be modified to achieve the goals set out by E.O.

13890. D. MCIT Pathway We propose that the MCIT pathway would provide immediate national coverage for breakthrough devices beginning on the date of FDA market authorization and continue for up to 4 years, unless we determine the device does not have a Medicare benefit category as determined by us as part of the MCIT pathway process. The MCIT pathway is voluntary (that is, manufacturers would affirmatively opt-in), and would be initiated when a manufacturer notifies CMS of its intention to utilize the MCIT pathway. (This notification process is described further in section III.

Of this proposed rule.) We would subsequently coordinate with the manufacturer regarding steps that need to be taken for MCIT implementation purposes. The frequency of subsequent engagement will be largely driven by whether the manufacturer has questions for CMS, or CMS and FDA. The timing of coverage will depend upon the timing of the FDA's market authorization decision. Engagements can take place in the form of in-person meetings, phone calls, emails, etc. We intend to put devices that are covered through the MCIT pathway on the CMS website so that all stakeholders will be aware of what is covered through the MCIT pathway.

Manufacturers of breakthrough devices will not be obligated or mandated by CMS to conduct clinical studies during Start Printed Page 54331coverage under the proposed MCIT pathway. However, we seek comment as to whether CMS should require or incentivize manufacturers to provide data about outcomes or should be obligated to enter into a clinical study similar to CMS's Coverage with Evidence Development (CED) paradigm.[] We are aware some manufacturers may be required by the FDA to conduct post market data collection as a condition of market authorization, and nothing in this proposed rule would alter that FDA requirement. Manufacturers are encouraged to develop the clinical evidence base needed for one of the other coverage pathways after the MCIT pathway ends. This evidence is encouraged not only for CMS and private commercial health insurer coverage policies but also to better inform the clinical community and the public generally about the risks and benefits of treatment. CMS encourages early manufacturer engagement, both before and after FDA market authorization, for manufacturers to receive feedback from CMS on potential clinical study designs and clinical endpoints that may produce the evidence needed for a definitive coverage determination after MCIT.

This feedback would not involve CMS predicting specific coverage or non-coverage. In order to further the goals of E.O. 13890, CMS proposes to rely on FDA's breakthrough device designation and market authorization of those devices to define the universe of devices eligible for MCIT, except for those particular devices CMS determines do not have a Medicare benefit category or are statutorily excluded from coverage under Part A or Part B. In order to provide immediate national coverage to innovative medical devices, we propose to establish a time limit on how long a breakthrough device can be eligible for MCIT (that is, considered a breakthrough device for coverage purposes). MCIT has a time limit on newness similar to our New Technology Add-on Payment (NTAP) policy.

Eligibility for the NTAP is also time limited and this time limit applies to all new technologies, including breakthrough devices, for which an application for additional payment is submitted. Additionally, the time-limited characteristic of MCIT will drive some manufacturers to leverage this period of coverage to demonstrate the value of their device in the competitive marketplace. The 4-year coverage period is particularly important for manufacturers of breakthrough devices that choose to further develop the clinical evidence basis on which the FDA granted marketing authorization. From our experience with clinical studies conducted as part of an NCD, 4 years is approximately the amount of time it takes to complete a study. At the end of the 4-year MCIT pathway, coverage of the breakthrough device would be subject to one of these possible outcomes.

(1) NCD (affirmative coverage, which may include facility or patient criteria). (2) NCD (non-coverage). Or (3) MAC discretion (claim-by-claim adjudication or LCD). Manufacturers that are interested in a NCD are encouraged to submit a NCD request during the third year of MCIT to allow for sufficient time for NCD development. We seek public comment on whether CMS should open a national coverage analysis if a MAC has not issued an LCD for a breakthrough device within 6 months of the expiration date of the 4-year MCIT period.

In our analysis of the current coverage landscape to determine opportunities for innovation and efficiencies, we also considered modifying the coverage process for non-breakthrough devices (for example, PMAs because they are also new to the market), but ultimately determined that it was the unique characteristics of FDA designated breakthrough devices and their ability to serve unmet needs that resonated most with the E.O.'s direction to encourage innovation for patients. We also considered expedited coverage of newly market authorized and breakthrough devices when used in a clinical study. We seek public comment on the proposed MCIT pathway, the considerations described, whether any of the existing coverage pathways should be modified to achieve the goals set out by the E.O., and alternatives to these proposals. We specifically seek public comment on whether the MCIT pathway should also include diagnostics, drugs and/or biologics that utilize breakthrough or expedited approaches at the FDA (for example, Breakthrough Therapy, Fast Track, Priority Review, Accelerated Approval) [] or all diagnostics, drugs and/or biologics. We seek data to support including these additional item categories in the MCIT pathway.

Also, we specifically seek manufacturer input on whether an opt-in or opt-out approach would work best for utilizing the MCIT pathway. We believe manufactures will welcome this new coverage pathway. We want to preserve manufacturers' business judgment and not assume which Medicare coverage pathway a given manufacturer of a breakthrough device would prefer (if any). Therefore, we have proposed an opt-in approach with an email to CMS to indicate affirmative interest in coverage. We are interested in whether an opt-out approach would be less burdensome for stakeholders.

If so, we encourage public comment on a process for stakeholders to opt-out of MCIT that would not be burdensome. Also, we seek public comment on whether, once a manufacturer has opted-out of coverage, it can subsequently opt-in to MCIT. II. Provision of Proposed Regulations A. Defining “Reasonable and Necessary” As described in section I.

Of this proposed rule, the Secretary has authority to determine the meaning of “reasonable and necessary” under section 1862(a)(1)(A) of the Act. We are proposing to codify the longstanding Program Integrity Manual definition of “reasonable and necessary” into our regulations at 42 CFR 405.201(b), with modification. Under the current definition, an item or service is considered “reasonable and necessary” if it is (1) safe and effective. (2) not experimental or investigational. And (3) appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is— Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.

Furnished in a setting appropriate to the patient's medical needs and condition. Ordered and furnished by qualified personnel. One that meets, but does not exceed, the patient's medical need. And At least as beneficial as an existing and available medically appropriate alternative. In addition to codifying the above criteria, we propose to include a separate basis under which an item or service would be appropriate under (3) above that is based on commercial health insurers' coverage policies (that is, non-governmental entities that sponsor health insurance plans).

The Start Printed Page 54332commercial market analysis would be initiated if an item/service fails to fulfill the existing factor (3) criteria defining appropriate for Medicare patients but fulfills (1) safe and effective and (2) not experimental or investigational. By considering commercial health insurer coverage policies, CMS would bring together the expertise of private payers and CMS. For example, in a recent NCD on acupuncture for chronic low back pain, CMS considered the technology assessments and coverage criteria among commercial health insurer coverage policies.[] We believe that this approach would be in line with E.O. 13890 that directs us to make technologies “widely available, consistent with the principles of patient safety, market-based policies, and value for patients.” Under this separate basis, we propose that an item or service would satisfy factor (3) if it is covered under a plan(s) coverage policy if offered in the commercial insurance market, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant. Under our proposal, we would exclude Medicaid managed care, Medicare Advantage, and other government administered healthcare coverage programs from the types of coverage CMS would consider, as these enrollees are not in the commercial market.

In the following paragraphs, we seek comment on this proposal and on how best to implement this mechanism. We solicit comments on sources of data that could be used to implement this policy, and whether CMS should make this information public and transparent. We seek public comment on the most appropriate source(s) for these coverage policies and the best way to determine which commercial plan(s) we would rely on for Medicare coverage. We seek comment on whether beneficiaries, providers, innovators, or others wishing to gain coverage for an item or service demonstrate that the item or service is covered by at least one commercial insurance plan policy. If they can provide CMS with evidence of commercial coverage or if CMS or its MACs identify such coverage from its review of compilations of health insurance offerings or data from other sources, CMS would consider factor (3) to be satisfied.

We solicit comment on whether we should limit our consideration of commercial plan offerings or covered lives to a subset of the commercial market in the interest of simplicity, including looking at geographic subsets, subsets based on number of enrollees, subsets based on plan type (HMO, PPO, etc.), or other subsets of plans—including utilizing a singular plan. We also seek comment on whether, given considerations such the variation and distribution of coverage policies and access to innovations, we should only cover an item or service if it is covered for a majority, or a different proportion such as a plurality, of covered lives amongst plans or a majority, plurality, or some other proportion of plan offerings in the commercial market. (A plan offering is a contract an insurer offers to its enrollees, and a single insurance company may provide many different offerings.) We also recognize that plan offerings may impose certain coverage restrictions on an item or service, e.g. Related to clinical criteria, disease stage, or number and frequency of treatment. As greater access to innovative treatments provides beneficiaries with more opportunity to improve health and drive decisions, we would, when coverage is afforded on the basis of commercial coverage, adopt the least restrictive coverage policy for the item or service amongst the offerings we examine.

However, given potential unreasonable or unnecessary utilization, we also solicit comment on whether we should instead adopt the most restrictive coverage policy. We are further considering, as another variation, that if coverage restrictions are largely similar and present across the majority of offerings, CMS would adopt these in its coverage policies. We note that such coverage restrictions include the basic requirement for medical necessity at the level of individual patients. Medicare will still only pay for an item or service received by a beneficiary if it is medically necessary for the beneficiary. We seek comment on whether, if we were to take this approach, we should instead use a proportion other than a majority, as low as any offering and as high as all offerings, as a sufficient threshold.

As a final variation, we could defer, in the absence of an NCD or national policy, to the MACs to tailor the restrictions on coverage based on what they observe in the commercial market, just as we rely on MACs with regards to the current definition. We further solicit comment on whether to grant coverage for an item or service to the extent it meets the first and second factors and the commercial coverage basis for the third factor. Under this approach, we would only use the current definition of “appropriate” from the current PIM when the exception for clinically relevant differences between Medicare beneficiaries and commercially insured individuals applies (or if the commercial coverage basis is determined by a proportion like a majority and there is insufficient commercial coverage information available). We note that referring to commercial coverage in this way may expand or narrow the circumstances under which we will cover a particular item or service and therefore solicit comment on whether, under such an approach, we should grandfather our current coverage policies for items and services. We also emphasize that the MACs will continue to make judgements in evaluating individual claims for reimbursement, such that a decision by CMS that an item or service is reasonable and necessary in general does not mean that it is reasonable and necessary in all circumstances with respect to individual claims for reimbursement.

We seek public comment on the most appropriate source(s) for these coverage policies. Further, under our proposal, each MAC would be responsible for reviewing commercial offerings to inform their LCDs or claim by claim decisions, which would include individual medical necessity decisions. We may also allow the MACs to develop approaches to address any or all of the considerations outlined above, parallel to their current practice of making coverage decisions in the absence of an NCD or national policy. We solicit comment on the best role of the MACs, along these lines or otherwise. We also solicit comment on whether the discretion to use the current criteria in the PIM when there is evidence to believe Medicare beneficiaries have different clinical needs should be exercised through the NCD process or in other ways, as well as what quantum of evidence should be sufficient.

In sum, we are proposing to define the term “reasonable and necessary” based on the factors currently found in the PIM, plus an alternative basis for meeting factor (3) based on any coverage in the commercial market. We are also soliciting comment on an alternative under whether an item or service satisfies the commercial coverage basis for factor (3) is determined by how it is treated across a majority of covered lives amongst commercial plan offerings, as well as an alternative whereby an item or service would be appropriate for Medicare patients to the extent it is covered in the commercial market. Start Printed Page 54333When evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant, we would rely on the criteria in the current PIM. We would continue relying on local administration of the program by MACs (including coverage on a claim by claim basis and LCDs) and maintain our discretion to issue NCDs based on the final rule. We solicit comment on this proposed definition of reasonable and necessary, and alternatives outlined above, as well as other mechanisms or definitions we could establish for the term “reasonable and necessary”, and the merits and drawbacks associated with each, including the potential impact on Medicare program expenses or complexity.

We may finalize any variation or outgrowth of the policies described in this proposal, or some combination of these options in lieu of or in conjunction with our proposed definition. B. Application of the “Reasonable and Necessary” Standard to the MCIT Pathway We are proposing that, under the proposed MCIT pathway, an item or service that receives a breakthrough device designation from the FDA would be considered “reasonable and necessary” under section 1862(a)(1)(A) of the Act because breakthrough devices have met the FDA's unique breakthrough devices criteria, and they are innovations that serve unmet needs. While other devices are still considered new to the market, for example, PMAs and even some 510(k)s, the devices designated by the FDA as breakthrough are representative of true innovations in the marketplace. This application of the “reasonable and necessary” standard in this way would ensure that the MCIT pathway can provide a fast-track to Medicare coverage of innovative devices that may more effectively treat or diagnose life-threatening or irreversibly debilitating human disease or conditions.

MCIT would improve healthcare for Medicare beneficiaries by providing national Medicare coverage for devices receiving the FDA breakthrough device designation, which are FDA market-authorized and used consistent with the FDA approved or cleared indication for use (also referred to as the “FDA required labeling”),[] so long as the breakthrough device is described in an appropriate Medicare benefit category under Part A or Part B and is not specifically excluded by statute. We believe the criteria for qualification as a breakthrough device, as defined in section 515B(b) of the Food, Drug and Cosmetic Act (21 U.S.C. 360e-3(b)) is sufficient to satisfy the elements of the “reasonable and necessary” standard. The first breakthrough device designation criterion is that a device must “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” (21 U.S.C. 360e-3(b)(1)).

The second criterion is that the device must satisfy one of the following elements. It represents a breakthrough technology. There are no approved or cleared alternatives. It offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute. Or availability of the device is in the best interest of patients (21 U.S.C.

360e-3(b)(2)). Thus, breakthrough devices are those that HHS has determined may provide better health outcomes for patients facing life-threatening or irreversibly debilitating human disease or conditions. We believe that a device meeting these criteria, once also FDA market authorized, is “reasonable and necessary” for purposes of Medicare coverage. This proposed rule recognizes that the FDA market authorization of breakthrough devices warrants immediate coverage under the “reasonable and necessary” clause in section 1862(a)(1)(A) of the Act. We previously stated that FDA determinations were not controlling determinations for Medicare coverage purposes under section 1862(a)(1)(A) of the Act.

(For more information see the January 30, 1989 Federal Register (54 FR 4307) (“FDA approval for the marketing of a medical device will not necessarily lead to a favorable coverage recommendation. . . €) and the August 7, 2013 Federal Register (78 FR 48165) (“However, FDA approval or clearance alone does not entitle that technology to Medicare coverage.”) Under the Secretary's broad authority to interpret section 1862(a)(1)(A) of the Act (supra section I.A.), we are revising our interpretation of the statute because of the practical concerns that our current standards have delayed access to a unique set of innovative devices that FDA has found to be safe and effective, and we believe are “reasonable and necessary” for purposes of Medicare coverage. In light of E.O.

13890, the Secretary has determined that application of the current standards for making “reasonable and necessary” determinations may take too long following FDA market authorization of breakthrough devices. More importantly, the existing standard has not always provided Medicare beneficiaries adequate access to certain breakthrough medical devices when needed to improve health outcomes. We are proposing that breakthrough devices per se meet the reasonable and necessary standard in order to increase access and to reduce the delay from FDA market authorization to Medicare coverage. C. MCIT Pathway We are proposing the MCIT pathway to deliver on the Administration's commitment to provide access to breakthrough devices to Medicare beneficiaries.

The MCIT pathway provides up to 4 years of national coverage to newly FDA market authorized breakthrough devices. We are aware that this coverage may also facilitate evidence development on devices for the Medicare population because manufacturers can gather additional data on utilization of the device during the MCIT coverage period. 1. Definitions In § 405.601(a) we are proposing that the MCIT pathway is voluntary. Operationally, we propose that manufacturers of breakthrough devices notify CMS of their intention to elect MCIT shortly after receiving notice from the FDA of being granted the breakthrough device designation.

Ideally, this notification would be sent to CMS within 2 weeks of receiving breakthrough designation. However, entities would not be penalized for notifying CMS after that time. Alternatively, submitting a notification to CMS shortly before or concurrently with the date of the FDA marketing submission should also afford CMS sufficient time to operationalize MCIT for the device. The CMS Coverage and Analysis Group would establish an email box for these inquires. This notification alerts CMS to offer guidance to manufacturers about the MCIT pathway and point to resources for coding and payment, which are key conversations to effectuate coverage upon FDA market authorization.

We intend to utilize the existing coverage implementation processes to be prepared to offer coverage immediately upon the FDA market authorization. In § 405.601(b), we propose the following definitions for the purposes of 42 CFR part 405. We propose to define Start Printed Page 54334“breakthrough device” as a medical device that receives such designation by the FDA (section 515B(d)(1) of the FD&C Act (21 U.S.C. 360e-3(d)(1))). We also propose to define, for the sake of clarity in the rule, that the acronym MCIT stands for Medicare Coverage of Innovative Technology.

2. MCIT Pathway Device Eligibility In § 405.603(a) we propose that the pathway is available to devices that meet the definitions proposed in § 405.601. Based on the explicit mention of devices in E.O. 13890 and our interaction and feedback from stakeholders who expressed their concern that there is more uncertainty of coverage for devices than for other items and services (for example, diagnostics, drugs and biologics), this proposed policy is for devices only. We propose in § 405.603(b) that the breakthrough devices that received FDA market authorization no more than 2 calendar years prior to the effective date of this subpart (the date the final rule is finalized) and thereafter will be eligible for coverage for claims submitted on or after the effective date of this rule.

Claims for breakthrough devices with dates of service that occurred before the effective date of this rule would not be covered through MCIT. For example, a hypothetical breakthrough device that was FDA market authorized on October 1, 2018, and utilized on January 1, 2020 would not be eligible for coverage under MCIT because on January 1, 2020, the date of service, the final MCIT rule was not yet legally in effect. In contrast, a claim for utilization of the same hypothetical breakthrough device with a date of service on January 1, 2021 might be eligible for coverage if the claim occurred after the effective date of the rule (assuming that the effective date of the rule was prior to January 1, 2021). Breakthrough devices market authorized prior to the effective date of this rule will not be eligible for all 4 years of coverage. The 4-year period starts on the date of FDA market authorization.

For example, a breakthrough device market authorized on October 1, 2018 would have claims covered through MCIT from the effective date of the final rule until October 1, 2022. If a manufacturer initially chooses to not utilize the MCIT pathway, and then chooses to do so some time after the breakthrough device's market authorization, coverage still only lasts 4 years from the date of FDA market authorization. We seek comment on this eligibility criterion for devices and specifically the 2 year lookback. We propose in § 405.603(c) that to be part of the MCIT pathway, the device must be used according to its FDA approved or cleared indication for use. We propose that the device is only covered for use consistent with its FDA approved or cleared indication for use because that is the indication and conditions for use that were reviewed by the FDA and authorized for marketing.

Data are unlikely to be available to support extending beyond the FDA required labeling for breakthrough devices on the date of marketing authorization. Use of the device for a condition or population that is not labeled (“off-label”) will not be covered as that use would not be FDA authorized. We specifically seek comment on whether off-label use of breakthrough devices should be covered and, if so, under what specific circumstances and/or evidentiary support. In § 405.603(d) and (e), we additionally propose limitations to what is coverable under the Act. In § 405.603(e), we are proposing that if CMS has issued an NCD on a particular breakthrough device, that breakthrough device is not eligible for MCIT.

We are proposing this because, once the device has been reviewed by CMS for the FDA required approved or cleared indication for use. CMS has made a coverage determination based on the available evidence for that technology. We believe this would happen rarely because breakthrough devices are new technologies that are not likely to have been previously reviewed through the NCD process. In § 405.603(f), we acknowledge that devices in the MCIT pathway may be excluded due to statute or regulation (for example, 42 CFR 411.15, Particular services excluded from coverage) and, like other items and services coverable by Medicare, the device must fall within the scope of a Medicare benefit category under section 1861 of the Act and the implementing regulations. If the device does not fall within a Medicare benefit category as outlined in the statute and implementing regulations, the device is not eligible for Medicare coverage.

Therefore, the device would not be eligible for the MCIT pathway. 3. General Coverage of Items and Services under the MCIT Pathway We propose in § 405.605 that devices covered under the MCIT pathway are covered no differently from devices that are covered outside of MCIT. In other words, provided the items and services are otherwise coverable (that is, not specifically excluded and not found by CMS to be outside the scope of a Medicare benefit category), covered items and services could include the device, reasonable and necessary surgery to implant the device, if implantable, related care and services costs of the device (for example, replacing reasonable and necessary parts of the device such as a battery), and coverage of any reasonable and necessary treatments due to complications arising from use of the device. What the MCIT pathway offers compared to other pathways is predictable national coverage simultaneous with FDA market authorization that will generally last for a set time period.

The proposed MCIT pathway would support and accelerate beneficiary access to certain innovative devices. CMS encourages manufacturers that have breakthrough devices covered under MCIT to develop additional data for the healthcare community. 4. MCIT Pathway for Breakthrough Devices. 4 Years of Coverage In § 405.607(a), we propose that the MCIT pathway for coverage would begin on the same date the device receives FDA market authorization.

We propose this point in time to ensure there is no gap between Medicare coverage and FDA market authorization. This supports the MCIT pathway's focus of ensuring beneficiaries have a predictable access to new devices. We propose in § 405.607(b)(1) that the MCIT pathway for breakthrough devices ends 4 years from the date the device received FDA market authorization. We propose this 4 year time period because it could allow manufacturers to develop clinical evidence and data regarding the benefit of the use of their device in a real world setting. For example, we believe 4 years would allow most manufacturers sufficient time to complete FDA required post-approval or other real-world data collection studies that may have been a condition of FDA market authorization.

This assumption is based upon our historical experience with studies conducted through coverage with evidence development (CED). Further, this time period allows Medicare to support manufacturers that, whether required by the FDA or not, have an interest in better understanding the health outcomes of their device in the Medicare population, including impacts on patient-reported and longer-term outcomes. Further, § 405.607(b) proposes reasons that the MCIT pathway may end prior to 4 years. This includes circumstances whereby the device becomes subject to an NCD, regulation, statute, or if the device can no longer be lawfully marketed.Start Printed Page 54335 D. Summary In summary, the MCIT pathway would provide immediate Medicare coverage of newly FDA market authorized breakthrough devices for 4 years.

We seek public comment on all of our proposals. In particular, we seek feedback on whether the proposed 4 year coverage period is sufficient. We also look to stakeholders and the public to determine the level of interest and expected use of the proposed MCIT pathway so the agency can begin to estimate the level of needed resources to support successful implementation. We are also seeking public comments on our proposal to codify in regulations the standards we have historically used in making reasonable and necessary decisions under Part A and Part B under section 1862(a)(1)(A) of the Act. After considering public comments we would prepare a final rule that we expect would be effective 60 days after publication of the final rule.

III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden.

The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of the section 3506(c)(2)(A)-required issues for the following sections of this document that contain information collection requirements (ICRs). To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2018 National Occupational Employment and Wage Estimates for all salary estimates (https://www.bls.gov/​oes/​current/​oes131041.htm, released May 2019).

In this regard, the table that follows presents the mean hourly wage, the cost of fringe benefits (calculated at 100 percent of salary), and the adjusted hourly wage. Table 1—National Occupational Employment and Wage Estimates for MCITOccupation titleOccupation codeMean hourly wage ($/hr)Fringe benefit ($/hr)Adjusted hourly wage ($/hr)Compliance Officer13-104134.8634.8669.72 As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. This proposed coverage pathway allows for a voluntary participation and therefore necessitates that manufacturers of breakthrough devices notify CMS of their intent to enter the MCIT pathway.

Therefore, the burden associated with notifying CMS is the time and effort it would take for each of the organizations to send CMS an email or letter. We anticipate two MCIT pathway participants in the first year based upon the number of medical devices that received FY2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles. We estimate notifying CMS of intent to participate in MCIT would involve 15 minutes at $69.72 per hour by a compliance officer. In this regard, we estimate 15 mins per notification at a cost of $17.43 per organization (0.25 hours × $69.72). In aggregate, we estimate 0.5 hours (0.25 hours × 2 submissions) at $34.86 ($17.43 × 2 submissions).

After the anticipated initial 2 submitters, over the next 3 years we expect 3 submitters in year 2, 4 submitters in year 3, and 5 submitters in year 4 to notify CMS of interested in the MCIT pathway. We expect this increase in submitters each year to level off at this point. In this regard, we estimate the same 0.25 hours per submission at a cost of $17.43 per organization. Similarly, in aggregate, we estimate, for year 2 (0.75 hours at $52.29 an hour), for year 3 (1.0 hour at $69.72 an hour), and for year 4 (1.25 hours at $87.15 an hour). The proposed requirements and burden will be submitted to OMB under control number 0938-NEW.

We are requesting public comments on these information collection and recordkeeping requirements. If you comment on these information collection and recordkeeping requirements, please do either of the following. 1. Submit your comments electronically as specified in the ADDRESSES section of this proposed rule. Or 2.

Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention. CMS Desk Officer, CMS-3372-P, Fax. (202) 395-6974. Or Email. OIRA_submission@omb.eop.gov.

Comments must be received on/by November 2, 2020. IV. Regulatory Impact Statement This proposed rule makes Medicare coverage policy updates pursuant to the authority at section 1862(a)(1)(A) of the Act. We are using regulatory action per the October 3, 2019 “Executive Order on Protecting and Improving Medicare for Our Nation's Seniors” to address the increasing need for a swift Medicare coverage mechanism to allow beneficiaries across the nation to access breakthrough devices faster after FDA market authorization. This proposed rule addresses that need by establishing a coverage pathway that will allow immediate beneficiary access to FDA market authorized breakthrough devices.

We have examined the impact of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub. L.

104-4), Start Printed Page 54336Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This proposed rule does reach the economic threshold and thus is considered a major rule.

Regulatory alternatives to this proposed rule were to combine Medicare coverage with clinical evidence development under section 1862(a)(1)(E) of the Act, to take no regulatory action at this time, or to adjust the duration of the MCIT pathway. Combining coverage with clinical evidence development would have met the E.O. 13890 overarching goal of beneficiary access to breakthrough devices. However, this alternative did not meet the other E.O. 13890 aims of minimizing time between FDA market authorization and Medicare coverage and wide availability.

The timing of coverage would depend upon the manufacturer being able to initiate a clinical study and the wide availability of coverage could be an issue if providers did not have the infrastructure necessary to participate in the clinical study. CMS chose to not to pursue combining coverage with evidence development for breakthrough devices because we wanted to meet the timing and wide availability aims of E.O. 13890. CMS also considered taking no regulatory action and trying to leverage the existing Medicare coverage pathways or proposing sub-regulatory policies to achieve the streamlined coverage process described in E.O. 13890.

Taking no action would not have resulted in the desired national coverage and access envisioned in E.O. 13890 because, as described in this preamble, the existing coverage pathways do not consistently provide swift, national beneficiary access to innovative devices. As discussed elsewhere in the preamble, the nature of the problem being addressed by this proposed regulation is a potential delay between a milestone such as FDA market authorization and CMS coverage. As such, we request comment on a policy option of shortening of the duration of the MCIT pathway from the proposed 4 years to 1 year. In addition to the alternatives just discussed, there are various possibilities regarding how to change the definition of “reasonable and necessary”—for example, whether to include a new aspect of the proposed definition that focuses on commercial insurance coverage practices.

As noted earlier in the preamble, the goal of this revision is to expand coverage. However, the nuances of the definition would affect the magnitude of the impact and we request comment that would facilitate quantification of effects and comparison of alternatives at the final rule stage. The impact of implementing the MCIT pathway is difficult to determine without knowing the specific technologies that would be covered. In addition, many of these technologies would be eligible for coverage in the absence of this rule, such as through a local or national coverage determination, so the impact for certain items may be the acceleration of coverage or adoption by just a few months. Furthermore, some of these devices would be covered immediately if the MACs decide to pay for them, which would result in no impact on Medicare spending for devices approved under this pathway.

However, it is possible that some of these innovative technologies would not otherwise be eligible for coverage in the absence of this rule. Because it is not known how these new technologies would otherwise come to market and be reimbursed, it is not possible to develop a point estimate of the impact. In general, we believe the MCIT coverage pathway would range in impact from having no impact on Medicare spending, to a temporary cost for innovations that are adopted under an accelerated basis. The decision to enter the MCIT pathway is voluntary for the manufacturer. Because manufacturers typically join the Medicare coverage pathway that is most beneficial to them, this would result in selection against the existing program coverage pathways (to what degree is unknown at this point).

In addition, the past trend of new technology costing more than existing technology could lead to a higher cost for Medicare if this trend continued for technologies enrolling in the MCIT pathway. Nevertheless, new technology may also mitigate ongoing chronic health issues or improve efficiency of services thereby reducing some costs for Medicare. In order to demonstrate the potential impact on Medicare spending, the CMS Office of the Actuary (OACT) developed three hypothetical scenarios that illustrate the impact of implementing the proposed MCIT pathway. Scenarios two and three assume that the device would not have been eligible for coverage in the absence of this proposed rule. (See Table 2) The illustration used the new devices that applied for a NTAP in FY 2020 as a proxy for the new devices that would utilize the MCIT pathway.

The submitted cost and anticipated utilization for these devices was published in the Federal Register.[] In addition, we assumed that two manufacturers would elect to utilize the MCIT pathway in the first year, three manufacturers in the second year, four manufacturers in the third year, and five manufacturers in the fourth year each year for all three scenarios. This assumption is based on the number of medical devices that received FY 2020 NTAP and were non-covered in at least one MAC jurisdiction by LCDs and related articles and our impression from the FDA that the number of devices granted breakthrough status is increasing. For the first scenario, the no-cost scenario, we assumed that all the devices would be eligible for coverage in the absence of the proposed rule. If the devices received payment nationally and at the same time then there would be no additional cost under this pathway. For the second scenario, the low-cost scenario, we assumed that the new technologies would have the average costs ($2,044) and utilization (2,322 patients) of similar technologies included in the FY 2020 NTAP application cycle.

Therefore, to estimate the first year of MCIT, we multiplied the add-on payment for a new device by the anticipated utilization for a new device by the number of anticipated devices in the pathway ($2,044 × 2,322 × 2 = $ 9.5 million). For the third scenario, the high-cost scenario, we assumed the new technologies would receive the maximum add-on payment from the FY 2020 NTAP application cycle ($22,425) and the highest utilization of a device (6,500 patients). Therefore, to estimate for the first year of MCIT, we estimated similarly ($22,425 × 6,500 patients × 2 = $ 291.5 million). For subsequent years, we increased the number of anticipated devices in the pathway by three, four, and five in the last two scenarios until 2024.[] In addition to Start Printed Page 54337not taking into account inflation, the illustration does not reflect any offsets for the costs of these technologies that would be utilized through existing authorities nor the cost of other treatments (except as noted). It is not possible to explicitly quantify these offsetting costs but they could substantially reduce or eliminate the net program cost.

However, by assuming that only two to five manufacturers will elect MCIT coverage, we have implicitly assumed that, while more manufacturers could potentially elect coverage under MCIT, the majority of devices would have been covered under a different coverage pathway. Therefore, a substantial portion of the offsetting costs are implicitly reflected. Based on this analysis, there is a range of potential impacts of the proposed MCIT coverage pathway as shown in Table 2. The difference between the three estimates demonstrates how sensitive the impact is to the cost and utilization of these unknown devices. Table 2—Illustrated Impact on the Medicare Program by Proposed MCIT Coverage Pathway Costs (in millions)FY 2021FY 2022FY 2023FY 2024No-cost Scenario$0$0$0$0Low-cost Scenario9.523.742.766.4High-cost Scenario291.5728.81,311.92,040.7 We believe the assumptions used in the three scenarios are reasonable to show the possible wide range of impacts for implementing this proposed pathway, in particular for a technology that would not have otherwise been eligible for coverage.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Some hospitals and other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. We reviewed the Small Business Administration's Table of Small Business Size Standards Matched to North American Industry Classification System (NAICS) Codes to determine the NAICS U.S.

Industry titles and size standards in millions of dollars and/or number of employees that apply to small businesses that could be impacted by this rule.[] We determined that small businesses potentially impacted may include surgical and medical instrument manufacturers (NAICS code 339112, dollars not provided/1,000 employees), Offices of Physicians (except Mental Health Specialists) (NAICS code 621111, $12 million/employees not provided), and Freestanding Ambulatory Surgical and Emergency Centers (NAICS code 621493, $16.5 million/employees not provided). During the first 4 years of MCIT, we anticipate approximately 14 surgical and medical instrument manufacturers may participate, and based off of U.S. Census data, the majority of this businesses type are small businesses with less than 1,000 employees (968 out of 1,093 businesses have less than 500 employees).[] As such, this proposed rule would impact less than 5 percent of these businesses, and the revenue impact, if any, would not be negative. Rather, it would be a positive impact because MCIT would provide Medicare coverage (and subsequent payment) to providers who purchase the devices from these manufacturers. For Offices of Physicians (except Mental Health Specialists) and Freestanding Ambulatory Surgical and Emergency Centers that may be providing the breakthrough devices, the majority are small businesses with less than 1,000 employees (4,060 out of 4,385 and 160, 367 out of 161, 286 have less than 500 employees, respectively).[] Given that we estimate, at most in the high-cost scenario, that 6,500 beneficiaries would utilize breakthrough devices through MCIT per year, and even if each beneficiary were to access services at only one of these small businesses (that is, no two beneficiaries used the same office or center), still less than 5 percent of these small businesses would be impacted by MCIT.

As such, the revenue impact, if any, would not be negative, rather, it would be a positive impact because MCIT would provide Medicare coverage (and subsequent payment) to providers. Overall, this proposed rule results in a payment, not a reduction in revenue. We are not preparing a further analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule will not have a significant negative economic impact on a substantial number of small entities because small entities are not being asked to undertake additional effort or take on additional costs outside of the ordinary course of business through this proposed rule. Rather, for small entities that develop or provide breakthrough devices to patients, this proposed rule is a means for the device to be covered through the Medicare program, which does not detract from revenue and could be viewed as a positive economic impact. With the limited information we had to base this estimate, we solicit public comment on improvements to this estimate for the final rule.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital Start Printed Page 54338as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals because small rural hospitals are not being asked to undertake additional effort or take on additional costs outside of the ordinary course of business through this proposed rule. Obtaining breakthrough devices for patients is at the discretion of providers.

We are not requiring the purchase and use of breakthrough devices. Providers should continue to work with their patients to choose the best treatment. For small rural hospitals that provide breakthrough devices to their patients, this proposed rule is a means for the device to be covered through the Medicare program. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2020, that threshold was approximately $156 million.

This proposed rule would have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable. Executive Order 13771 (E.O. 13771), titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017.

This proposed rule, if finalized as proposed, is expected to impose no more than de minimis costs and thus be neither an E.O. 13771 regulatory action nor an E.O. 13771 deregulatory action. In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget. V.

Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Start List of Subjects Administrative practice and procedureDiseasesHealth facilitiesHealth professionsMedical devicesMedicareReporting and recordkeeping requirementsRural areasX-rays End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services proposes to amend 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1.

The authority for part 405 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k). End Authority Start Amendment Part2. Section 405.201 is amended in paragraph (b) by adding the definition of “Reasonable and necessary” in alphabetical order to read as follows.

End Amendment Part Scope of subpart and definitions. * * * * * (b) * * * Reasonable and necessary means that an item or service is considered— (1) Safe and effective. (2) Except as set forth in § 411.15(o)) of this chapter, not experimental or investigational. And (3) Appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it (i) Meets all of the following criteria. (A) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.

(B) Furnished in a setting appropriate to the patient's medical needs and condition. (C) Ordered and furnished by qualified personnel. (D) One that meets, but does not exceed, the patient's medical need. And (E) At least as beneficial as an existing and available medically appropriate alternative. Or (ii) Is covered by commercial insurers, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant.

* * * * * Start Amendment Part3. Subpart F, consisting of §§ 405.601-405.607, is added to read as follows. End Amendment Part 405.601 Medicare coverage of innovative technology. 405.603 Medical device eligibility. 405.605 Coverage of items and services.

405.607 Coverage period. Medicare coverage of innovative technology. (a) Basis and scope. Medicare coverage of innovative technology (MCIT) is a program that provides national, time-limited coverage under section 1862(a)(1)(A) of the Act for certain breakthrough medical devices. Manufacturer participation in the pathway for breakthrough device coverage is voluntary.

(b) Definitions. For the purposes of this subpart, the following definitions are applicable. Breakthrough device means a device that receives such designation by the Food and Drug Administration (FDA) (section 515B(d)(1) of the FD&C Act (21 U.S.C. 360e-3(d)(1)). MCIT stands for Medicare coverage of innovative technology.

Medical device eligibility. The MCIT pathway is available only to medical devices that meet all of the following. (a) That are FDA-designated breakthrough devices. (b) That are FDA market authorized at most [date 2 years prior to effective date of final rule] and thereafter. (c) That are used according to their FDA approved or cleared indication for use.

(d) That are within a Medicare benefit category. (e) That are not the subject of a Medicare national coverage determination. (f) That are not otherwise excluded from coverage through law or regulation. Coverage of items and services. Covered items and services furnished within the MCIT pathway may include any of the following, if not otherwise excluded from coverage.

(a) The breakthrough device. (b) Any reasonable and necessary procedures to implant the breakthrough device.Start Printed Page 54339 (c) Reasonable and necessary costs to maintain the breakthrough device. (d) Related care and services for the breakthrough device. (e) Reasonable and necessary services to treat complications arising from use of the breakthrough device. Coverage period.

(a) Start of the period. The MCIT pathway begins on the date the breakthrough device receives FDA market authorization. (b) End of the period. The MCIT pathway for a breakthrough device ends as follows. (1) No later than 4 years from the date the breakthrough device received FDA market authorization.

(2) Prior to 4 years if a manufacturer withdraws the breakthrough device from the MCIT pathway. (3) Prior to 4 years if the breakthrough device becomes the subject of a national coverage determination or otherwise becomes noncovered through law or regulation. Start Signature Dated. May 4, 2020. Seema Verma, Administrator, Centers for Medicare &.

Medicaid Services. Dated. June 11, 2020. Alex M. Azar II, Secretary, Department of Health and Human Services.

End Signature End Supplemental Information [FR Doc. 2020-19289 Filed 8-31-20. 8:45 am]BILLING CODE 4120-01-P.

Viagra risks

As the wind howled and the rain slammed down, a team of nurses, respiratory https://www.cityreal.lv/viagra-samples/ therapists and a doctor worked through the night to care for 19 viagra risks tiny babies as Hurricane Laura slammed southwestern Louisiana.The babies, some on ventilators or eating through a feeding tube, seemed to weather the storm just fine, said Dr. Juan Bossano, the medical director of the neonatal intensive care unit at Lake Charles Memorial Hospital for Women. "They did viagra risks very well.

They tolerated it very well. We had a very good day," he said.Laura made landfall early Thursday morning as a Category 4 storm, packing top winds of 150 mph (241 kph), and pushing a storm surge as high as 15 feet in some areas.Hours before it made landfall, officials had to move viagra risks the babies from the women's hospital to the main hospital in the system after it became clear that storm surge could inundate the women's hospital, located on the southern end of Lake Charles. The hospital has its own generator and hospital administrator Alesha Alford said it was built to withstand hurricane force winds.

But in the single story facility, there's viagra risks no room to move up and storm surge in that area was expected to hit nine feet. In a roughly two-hour operation the babies in the intensive care unit were transferred by ambulance to Lake Charles Memorial Hospital, a ten-story facility on the northern side of the city. Trucks carried needed equipment such as incubators.Alford said the storm hadn't yet hit but "the skies looked very ominous." She viagra risks said everyone pitched in to get supplies moved to the other hospital."It went as smooth as could be because we had everyone helping," she said.Alford said three mothers who couldn't be discharged from the women's hospital were also transferred.

Two of them had their newborns with them while the child of the third mom was in the intensive care unit. Parents of the other children in the neonatal intensive care unit couldn't stay with them during the storm because there wasn't enough room so Bossano said one nurse was tasked with calling parents to keep them informed of how their children were doing. Bossano occasionally posted updates on Facebook.Once they got viagra risks situated at the larger hospital and the winds picked up, Alford said the patients were moved into the hallways.

To "protect our babies," mattresses were pushed up against the windows to prevent flying glass although none of the windows ended up breaking.She said as huge gusts of wind started coming in, they could feel the building vibrate. In addition to Bossano, viagra risks the medical staff consisted of two neonatal nurse practitioners, 14 nurses and three respiratory therapists who worked on 12-hour shifts. Some of the staff slept on air mattresses in the hallway, Alford said.

After making it through viagra risks the hurricane, the plan was to have the babies stay in Lake Charles. While electricity was out in the city, the hospital has its own generator. But Alford said the city's water system has been so heavily damaged that it ultimately forced them to transfer the babies as well as other patients to other hospitals around the state Friday.Both Alford and Bossano repeatedly viagra risks praised the nursing staff for their work in caring for the babies that in some cases were born weighing only a pound or two.

Some of the nursing staff lost their houses in the storm, and they were worried about their own families, but they put those concerns aside to care for their tiny patients."Really the nurses and the respiratory therapists are the heroes here," Bosanno said. "They showed this link that very clearly the way they performed."When Dr. George Wanna viagra risks saw how devastated St.

George Hospital University Medical Center was by an explosion that shook Beirut, he felt a need to help his hometown. The Aug viagra risks. 4 blast in the city’s harbor ravaged St.

George’s, so Wanna viagra risks launched a GoFundMe page to help the hospital, where a good friend of his, Dr. Alexander Nehme, is chief medical officer.At deadline, more than $86,600 had been raised, with a goal of $100,000. €œThis is viagra risks the first time in their 140-year history when St.

George’s Hospital was damaged so severely that it is unable to function,” said Wanna, chair of the otolaryngology department at New York Eye and Ear Infirmary of Mount Sinai and Mount Sinai Beth Israel in New York. €¨St. George Hospital even remained open during Lebanon’s 15-year civil war, a conflict that wracked Beirut and forced viagra risks Wanna to spend much of his childhood in bomb shelters.

Wanna is also working with Mount Sinai to send medical supplies. €œSt. George Hospital is in need of everything needed to run a hospital—beds, ventilators, protective equipment.” The tragedy also affected Wanna’s family.

His parents weren’t home when the blast struck and were unharmed. But “my parents’ home was severely damaged by the blast. Sadly, we lost the lives of several of my dad’s relatives,” he said via email.

Wanna, who spent his residency at Mount Sinai, is grateful to the system. €œThey have given me a chance to have the kind of life I could never have hoped for—they helped me build a home and a life in this great country.”.

As the wind howled and the rain slammed down, a team of nurses, respiratory therapists and viagra cost a doctor worked through the night to care for 19 tiny babies as Hurricane Laura slammed southwestern Louisiana.The babies, some on ventilators or eating through a feeding tube, seemed to weather the storm just fine, said Dr. Juan Bossano, the medical director of the neonatal intensive care unit at Lake Charles Memorial Hospital for Women. "They did very viagra cost well.

They tolerated it very well. We had a very good day," he said.Laura made landfall early Thursday morning as a Category 4 storm, packing top winds of 150 mph (241 kph), and pushing a storm surge as high as 15 feet in some areas.Hours before it made landfall, officials had to move the babies from the women's hospital to the main hospital in the system after it became clear that storm surge viagra cost could inundate the women's hospital, located on the southern end of Lake Charles. The hospital has its own generator and hospital administrator Alesha Alford said it was built to withstand hurricane force winds.

But in the single viagra cost story facility, there's no room to move up and storm surge in that area was expected to hit nine feet. In a roughly two-hour operation the babies in the intensive care unit were transferred by ambulance to Lake Charles Memorial Hospital, a ten-story facility on the northern side of the city. Trucks carried needed equipment such as incubators.Alford said the storm hadn't yet hit but "the skies looked very ominous." She said everyone pitched in to get viagra cost supplies moved to the other hospital."It went as smooth as could be because we had everyone helping," she said.Alford said three mothers who couldn't be discharged from the women's hospital were also transferred.

Two of them had their newborns with them while the child of the third mom was in the intensive care unit. Parents of the other children in the neonatal intensive care unit couldn't stay with them during the storm because there wasn't enough room so Bossano said one nurse was tasked with calling parents to keep them informed of how their children were doing. Bossano occasionally posted updates on Facebook.Once they got situated at the larger hospital and the winds picked up, Alford said the patients were moved into the hallways viagra cost.

To "protect our babies," mattresses were pushed up against the windows to prevent flying glass although none of the windows ended up breaking.She said as huge gusts of wind started coming in, they could feel the building vibrate. In addition to Bossano, the medical staff consisted of two neonatal nurse practitioners, 14 nurses and three respiratory therapists viagra cost who worked on 12-hour shifts. Some of the staff slept on air mattresses in the hallway, Alford said.

After making it through the hurricane, the plan was to have the babies viagra cost stay in Lake Charles. While electricity was out in the city, the hospital has its own generator. But Alford said the city's water system has been so heavily damaged that it ultimately forced them to transfer the babies as well as other patients to other hospitals around the state Friday.Both Alford and Bossano repeatedly praised the nursing staff for their work viagra cost in caring for the babies that in some cases were born weighing only a pound or two.

Some of the nursing staff lost their houses in the storm, and they were worried about their own families, but they put those concerns aside to care for their tiny patients."Really the nurses and the respiratory therapists are the heroes here," Bosanno said. "They showed that very clearly the way they performed."When Dr. George Wanna viagra cost saw how devastated St.

George Hospital University Medical Center was by an explosion that shook Beirut, he felt a need to help his hometown. The Aug viagra cost. 4 blast in the city’s harbor ravaged St.

George’s, so Wanna launched a GoFundMe page to help the hospital, where a good viagra cost friend of his, Dr. Alexander Nehme, is chief medical officer.At deadline, more than $86,600 had been raised, with a goal of $100,000. €œThis is the first time in their 140-year history when viagra cost St.

George’s Hospital was damaged so severely that it is unable to function,” said Wanna, chair of the otolaryngology department at New York Eye and Ear Infirmary of Mount Sinai and Mount Sinai Beth Israel in New York. €¨St. George Hospital even remained open during Lebanon’s viagra cost 15-year civil war, a conflict that wracked Beirut and forced Wanna to spend much of his childhood in bomb shelters.

Wanna is also working with Mount Sinai to send medical supplies. €œSt. George Hospital is in need of everything needed to run a hospital—beds, ventilators, protective equipment.” The tragedy also affected Wanna’s family.

His parents weren’t home when the blast struck and were unharmed. But “my parents’ home was severely damaged by the blast. Sadly, we lost the lives of several of my dad’s relatives,” he said via email.

Wanna, who spent his residency at Mount Sinai, is grateful to the system. €œThey have given me a chance to have the kind of life I could never have hoped for—they helped me build a home and a life in this great country.”.

When was viagra invented

The items below are highlights from the free newsletter, “Smart, useful, science stuff about COVID-19.” To when was viagra invented receive https://www.cityreal.lv/best-place-to-buy-viagra-online-2020/ newsletter issues daily in your inbox, sign up here. Please consider a monthly contribution to support this newsletter. Women’s immune response to SARS-CoV-2 is stronger than men’s immune response to the virus, according to a study published 8/26/20 in when was viagra invented Nature and covered the same day by Apoorva Mandavilli at The New York Times. The finding could explain why men “are twice as likely to become severely sick and to die [from COVID-19] as women of the same age,” Mandavilli writes. The study also suggests that older men might need multiple shots of a coronavirus vaccine compared perhaps with young women, who might need just one shot, according to an immunologist quoted in the story.

He's at the Heinrich Pette Institute and the University Medical when was viagra invented Center Hamburg-Eppendorf in Germany. The study leader, a Yale University immunologist, is quoted in the story as saying, “Women who are older — even very old, like 90 years — the women are still making pretty good, decent immune response” to SARS-CoV-2. The U.S. Food and Drug Administration (FDA) on 8/26/20 gave emergency-use authorization to Abbott Laboratories' $5, portable nasal-swab SARS-CoV-2 test that returns results in 15 minutes, reports Sheila Kaplan at The New York Times (8/26/20) when was viagra invented. The test detects viral fragments called antigens.

Such tests miss more infections than widely used, slower tests that rely on a technology called polymerase chain reaction (PCR). But the speed of antigen when was viagra invented tests, three others of which previously received FDA emergency-use approval, could prove useful in relieving test backlogs. Abbott says its new antigen test will become available in September, the story states. Autopsies of 11 people who died of COVID-19 revealed that their spleens and lymph nodes lacked sites called germinal centers where B cells (immune cells) gather to “mature and refine their antibody response to the virus,” when was viagra invented writes Jon Cohen at Science (8/25/20). The researchers compared tissue from the people who died of COVID-19 with tissue from 6 people who died of other causes, the story states.

The finding, which confirms an earlier study’s findings in a smaller group, could provide insights into the progression of severe cases of COVID-19, the story states. The studies “establish a profound lack of [antibody] responses in the deceased population of COVID-19 patients,” says a Huazhong University of Science and Technology (HUST) researcher who co-authored the smaller study and when was viagra invented is quoted in the story. The missing germinal centers in severe COVID-19 patients could be linked to the biochemical “cytokine storms” that often occur in the dangerous, second phase of the disease, the HUST researcher is quoted as saying. Meanwhile, a MGH, MIT and Harvard immunologist who is a co-author of the newer study, published earlier this month in the journal Cell, says it won’t be difficult to stop SARS-CoV-2 with a vaccine. He is quoted as saying, “This is a piece of cake.” The United States, UK, Japan, and the European Union nations when was viagra invented all have pre-ordered in bulk doses of vaccines under development to protect against SARS-CoV-2, reports Ewen Callaway at Nature (8/24/20).

Some of these candidate vaccines could be approved in late 2020 or early 2021 at the earliest, the story states. But only "1 billion doses will be available by the fourth quarter of 2021,” according to a life-sciences market analytics firm, the story states. A different organization estimates 2 billion to 4 billion doses will be available by the when was viagra invented end of 2021, the story where can i buy viagra states. A chart near the top of the piece illustrates pre-order details by vaccine manufacturer, nation and number of doses. Meanwhile, an international effort to secure vaccine doses for people when was viagra invented living in a total of 92 low- and middle-income, as well as some wealthier countries, is “far short of raising the roughly $18 billion that it estimates” will be needed to meet its target number of doses, Callaway reports.

Lower in the piece, a chart illustrates pre-orders made by several countries and regions worldwide. Callaway writes that “patents and intellectual property are not what’s standing in the way of fair distribution of COVID-19 vaccines…rather, equitable access and affordable prices require collaboration between governments and vaccine makers,” according to the head of the International AIDS Vaccine Initiative in New York City, which reportedly is co-developing a COVID-19 vaccine. In an 8/22/20 essay for The Washington when was viagra invented Post, Elizabeth Svoboda writes that many people in the U.S. Have become desensitized to the risks of SARS-CoV-2, which has led to some behavioral backsliding, especially in crowded places. €œThis habituation stems from a principle well-known in psychological therapy,” Svoboda writes.

€œThe more we’re exposed to a given threat, the less intimidating it when was viagra invented seems.” Some researchers recommend a return to stricter distancing, outdoor masking and stay-at-home orders, the essay suggests. But we also need authorities to “supply in-your-face reminders of those mandates, especially visual cues, so people won’t draw their own erroneous conclusions about what’s safe,” she writes. In any case, we should cultivate an awareness of the diminishing effectiveness of our “snap judgments about COVID-19’s dangers,” and make more careful decisions, a la Nobel laureate Daniel Kahneman's “slow thinking,” she advises. Ventilation discussions when was viagra invented in public-health circles predate the current pandemic. Infection control theories born of the U.S.

Experience with the Spanish flu pandemic of 1918-1919 inspired engineers of the early 20th century to design steam-heating when was viagra invented systems for buildings that could be effective in cold weather even with apartment windows open, reports Patrick Sisson for Bloomberg CityLab. That’s right. Steam-heat radiators were designed to be used with the open windows, allowing fresh air to gush in, which “health officials thought (correctly)…would ward off airborne diseases,” Sisson writes. The piece draws from a 1992 book “The Lost Art of when was viagra invented Steam Heating,” by heating-systems researcher Dan Holohan. Radiators were designed, according to Holohan the story states, in response to a New York City Board of Health order that windows should remain open for ventilation in the winter.

€œAnybody who’s thrown their windows open in January, when their apartment is stifling, is in an odd way, replicating what engineers hoped would happen a century ago,” Sisson writes (8/5/20). You might when was viagra invented enjoy. €œJerry Seinfeld. So You Think New York Is ‘Dead’ (It’s not.)” (8/24/20)..

The items below are highlights from the free newsletter, “Smart, useful, science stuff about https://www.cityreal.lv/best-place-to-buy-viagra-online-2020/ COVID-19.” To receive newsletter issues daily in your inbox, sign up viagra cost here. Please consider a monthly contribution to support this newsletter. Women’s immune response to SARS-CoV-2 is stronger than men’s immune response to the virus, according to a study published 8/26/20 in Nature and covered the same day by Apoorva Mandavilli at The New York Times viagra cost. The finding could explain why men “are twice as likely to become severely sick and to die [from COVID-19] as women of the same age,” Mandavilli writes. The study also suggests that older men might need multiple shots of a coronavirus vaccine compared perhaps with young women, who might need just one shot, according to an immunologist quoted in the story.

He's at the Heinrich Pette Institute and the viagra cost University Medical Center Hamburg-Eppendorf in Germany. The study leader, a Yale University immunologist, is quoted in the story as saying, “Women who are older — even very old, like 90 years — the women are still making pretty good, decent immune response” to SARS-CoV-2. The U.S. Food and Drug Administration (FDA) on 8/26/20 gave emergency-use authorization to Abbott Laboratories' $5, portable nasal-swab SARS-CoV-2 test that returns results in 15 minutes, reports Sheila Kaplan at The New viagra cost York Times (8/26/20). The test detects viral fragments called antigens.

Such tests miss more infections than widely used, slower tests that rely on a technology called polymerase chain reaction (PCR). But the speed of antigen tests, three others of which previously received FDA emergency-use approval, could viagra cost prove useful in relieving test backlogs. Abbott says its new antigen test will become available in September, the story states. Autopsies of 11 people who died of COVID-19 revealed that their spleens and lymph nodes lacked sites called viagra cost germinal centers where B cells (immune cells) gather to “mature and refine their antibody response to the virus,” writes Jon Cohen at Science (8/25/20). The researchers compared tissue from the people who died of COVID-19 with tissue from 6 people who died of other causes, the story states.

The finding, which confirms an earlier study’s findings in a smaller group, could provide insights into the progression of severe cases of COVID-19, the story states. The studies “establish a profound lack of [antibody] responses in viagra cost the deceased population of COVID-19 patients,” says a Huazhong University of Science and Technology (HUST) researcher who co-authored the smaller study and is quoted in the story. The missing germinal centers in severe COVID-19 patients could be linked to the biochemical “cytokine storms” that often occur in the dangerous, second phase of the disease, the HUST researcher is quoted as saying. Meanwhile, a MGH, MIT and Harvard immunologist who is a co-author of the newer study, published earlier this month in the journal Cell, says it won’t be difficult to stop SARS-CoV-2 with a vaccine. He is quoted as saying, “This is a piece of cake.” The United States, UK, Japan, and the European Union nations viagra cost all have pre-ordered in bulk doses of vaccines under development to protect against SARS-CoV-2, reports Ewen Callaway at Nature (8/24/20).

Some of these candidate vaccines could be approved in late 2020 or early 2021 at the earliest, the story states. But only "1 billion doses will be available by the fourth quarter of 2021,” according to a life-sciences market analytics firm, the story states. A different organization estimates 2 viagra cost billion to 4 billion doses will be https://www.cityreal.lv/get-viagra-online/ available by the end of 2021, the story states. A chart near the top of the piece illustrates pre-order details by vaccine manufacturer, nation and number of doses. Meanwhile, an international effort to secure vaccine doses for people living in a total of 92 low- and middle-income, as viagra cost well as some wealthier countries, is “far short of raising the roughly $18 billion that it estimates” will be needed to meet its target number of doses, Callaway reports.

Lower in the piece, a chart illustrates pre-orders made by several countries and regions worldwide. Callaway writes that “patents and intellectual property are not what’s standing in the way of fair distribution of COVID-19 vaccines…rather, equitable access and affordable prices require collaboration between governments and vaccine makers,” according to the head of the International AIDS Vaccine Initiative in New York City, which reportedly is co-developing a COVID-19 vaccine. In an 8/22/20 essay for The Washington Post, Elizabeth Svoboda writes that many people in the viagra cost U.S. Have become desensitized to the risks of SARS-CoV-2, which has led to some behavioral backsliding, especially in crowded places. €œThis habituation stems from a principle well-known in psychological therapy,” Svoboda writes.

€œThe more we’re exposed to a given threat, the less intimidating it seems.” Some researchers recommend a return to stricter distancing, viagra cost outdoor masking and stay-at-home orders, the essay suggests. But we also need authorities to “supply in-your-face reminders of those mandates, especially visual cues, so people won’t draw their own erroneous conclusions about what’s safe,” she writes. In any case, we should cultivate an awareness of the diminishing effectiveness of our “snap judgments about COVID-19’s dangers,” and make more careful decisions, a la Nobel laureate Daniel Kahneman's “slow thinking,” she advises. Ventilation discussions in public-health circles predate the viagra cost current pandemic. Infection control theories born of the U.S.

Experience with the Spanish flu pandemic of 1918-1919 inspired engineers of the early 20th century to design steam-heating systems for buildings that could be effective in cold weather even with apartment windows open, reports Patrick viagra cost Sisson for Bloomberg CityLab. That’s right. Steam-heat radiators were designed to be used with the open windows, allowing fresh air to gush in, which “health officials thought (correctly)…would ward off airborne diseases,” Sisson writes. The piece draws from a 1992 viagra cost book “The Lost Art of Steam Heating,” by heating-systems researcher Dan Holohan. Radiators were designed, according to Holohan the story states, in response to a New York City Board of Health order that windows should remain open for ventilation in the winter.

€œAnybody who’s thrown their windows open in January, when their apartment is stifling, is in an odd way, replicating what engineers hoped would happen a century ago,” Sisson writes (8/5/20). You might enjoy viagra cost. €œJerry Seinfeld. So You Think New York Is ‘Dead’ (It’s not.)” (8/24/20)..

Viagra side effects

There’s a reason for that, viagra side effects too. For the past few weeks I’ve seen Facebook posts daily from former nursing colleagues in metro Detroit, one of the hardest hit areas in the country, as they provide front-line care to patients with COVID-19. It makes me very proud to call these nurses my friends. As a former emergency department nurse, I recall the feeling of satisfaction knowing that I’ve helped someone on the worst day of their life viagra side effects. One of the best parts of being a nurse is knowing you matter to the only person in health care that truly matters.

The patient. Several years ago I made the difficult decision to no viagra side effects longer perform bedside nursing and become a nurse administrator. The biggest loss from my transition is the feeling that what I do matters to the patient. COVID-19 has forced a lot of us to rethink the role we play in health care and what the real priority should be. Things that were top priorities three months ago have been rightfully cast aside to either care for patients in a pandemic or prepare for the unknown future viagra side effects of, “When is our turn?.

€ For me, COVID-19 has reignited the feeling that what I do matters as virtual care has become a powerful tool on the forefront of care during this crisis. It has also shown that many of the powerful rules and regulations that limit virtual care are not needed and should be discarded permanently. When I became the director of virtual care at our organization in 2015 I knew viagra side effects nothing about telehealth. Sure, I had seen a stroke robot in some Emergency Departments, and I had some friends that told me their insurance company lets them FaceTime a doctor for free (spoiler alert. It’s not FaceTime).

I was viagra side effects tech-savvy from a consumer perspective and a tech novice from an IT perspective. Nevertheless, my team and I spent the next few years learning as we built one of the higher volume virtual care networks in the state of Michigan. We discovered a lot of barriers that keep virtual care from actually making the lives of patients and providers better and we also became experts in working around those barriers. But, there viagra side effects were two obstacles that we could not overcome. Government regulation and insurance provider willingness to cover virtual visits.

These two barriers effectively cripple most legitimate attempts to provide value-added direct-to-consumer virtual care, which I define as using virtual care technologies to provide care outside of our brick-and-mortar facilities, most commonly in the patient home. The need to social distance, cancel appointments, close provider offices, keep from overloading emergency departments and urgent cares and shelter in viagra side effects place created instant demand for direct-to-consumer virtual care. In all honesty, I’ve always considered direct-to-consumer virtual care to be the flashy, must-have holiday gift of the year that organizations are convinced will be the way of the future. If a health system wants to provide on-demand access to patients for low-complexity acute conditions, they will easily find plenty of vendors that will sell them their app and their doctors and put the health system’s logo on it. What a health system will struggle with is to find is enough patient demand to viagra side effects cover the high cost.

Remember my friends from earlier that told me about the app their insurance gave them?. Nearly all of them followed that up by telling me they’ve never actually used it. I am fortunate that I work for an organization that understands this and instead focuses on how can we provide care that our patients actually want and need from the doctors they want to viagra side effects see. Ironically, this fiscal year we had a corporate top priority around direct-to-consumer virtual care. We wanted to expand what we thought were some successful pilots and perform 500 direct-to-consumer visits.

This year has been one of the hardest of my leadership career because, frankly, up until a month ago I viagra side effects was about to fail on this top priority. With only four months left, we were only about halfway there. The biggest problem we ran into was that every great idea a physician brought to me was instantly dead in the water because practically no insurance company would pay for it. There are (prior to COVID-19) a plethora of rules around virtual care billing but the viagra side effects simplest way to summarize it is that most virtual care will only be paid if it happens in a rural location and inside of a health care facility. It is extremely limited what will be paid for in the patient home and most of it is so specific that the average patient isn’t eligible to get any in-home virtual care.

Therefore, most good medical uses for direct-to-consumer care would be asking the patient to pay cash or the physician to forgo reimbursement for a visit that would be covered if it happened in office. Add to viagra side effects that the massive capital and operating expenses it takes to build a virtual care network and you can see why these programs don’t exist. A month ago I was skeptical we’d have a robust direct-to-consumer program any time soon and then COVID-19 hit. When COVID-19 started to spread rapidly in the United States, regulations and reimbursement rules were being stripped daily. The first change that had major impact is when the Centers for Medicare and Medicaid Services (CMS) announced that they viagra side effects would temporarily begin reimbursing for virtual visits conducted in the patient’s home for COVID-19 and non-COVID related visits.

We were already frantically designing a virtual program to handle the wave of COVID-19 screening visits that were overloading our emergency departments and urgent cares. We were having plenty of discussions around reimbursement for this clinic. Do we attempt to bill insurances knowing they will likely deny, do we do a cash clinic model or do we do this as a community benefit viagra side effects and eat the cost?. The CMS waiver gave us hope that we would be compensated for diverting patients away from reimbursed visits to a virtual visit that is more convenient for the patient and aligns with the concept of social distancing. Realistically we don’t know if we will be paid for any of this.

We are holding all of the bills for at least 90 days while the industry sorts out the viagra side effects rules. I was excited by the reimbursement announcement because I knew we had eliminated one of the biggest direct-to-consumer virtual care barriers. However, I was quickly brought back to reality when I was reminded that HIPAA (Health Insurance Portability and Accountability Act) still existed. I had this crazy idea that during a pandemic we should make it as easy as possible for people to receive virtual care and that the best way to do that was to meet the patient on the device they are most comfortable with and the application (FaceTime, viagra side effects Facebook, Skype, etc.) that they use every day. The problem is nearly every app the consumer uses on a daily basis is banned by HIPAA because “it’s not secure.” I’m not quite sure what a hacker stands to gain by listening into to my doctor and me talk about how my kids yet again gave me strep throat but apparently the concern is great enough to stifle the entire industry.

Sure, not every health care discussion is as low-key as strep throat and a patient may want to protect certain topics from being discussed over a “non-secure” app but why not let the patient decide through informed consent?. Regulators could also abandon this all-or-nothing approach and lighten viagra side effects regulations surrounding specific health conditions. The idea that regulations change based on medical situation is not new. For example, in my home state of Michigan, adolescents are essentially considered emancipated if it involves sexual health, mental health or substance abuse. Never mind that this same information is freely given over the phone by every office around the country daily without issue, viagra side effects but I digress.

While my job is to innovate new pathways for care, our lawyer’s job is to protect the organization and he, along with IT security, rightfully shot down my consumer applications idea. A few days later I legitimately screamed out loud in joy when the Department of Health and Human Services announced that it would use discretion on enforcing HIPAA compliance rules and specifically allowed for use of consumer applications. The elimination viagra side effects of billing restrictions and HIPAA regulations changed what is possible for health care organizations to offer virtually. Unfortunately both changes are listed as temporary and will likely be removed when the pandemic ends. Six days after the HIPAA changes were announced, we launched a centralized virtual clinic for any patient that wanted a direct-to-consumer video visit to be screened by a provider for COVID-19.

It allows patients viagra side effects to call in without a referral and most patients are on-screen within five minutes of clicking the link we text them. They don’t have to download an app, create an account or even be an established patient of our health system. It saw over 900 patients in the first 12 days it was open. That is 900 real patients that received care from a physician or advanced practice viagra side effects provider without risking personal exposure and without going to an already overwhelmed ED or urgent care. To date, 70 percent of the patients seen by the virtual clinic did not meet CDC testing criteria for COVID-19.

I don’t believe we could have reached even half of these patients had the consumer application restrictions been kept. A program like this almost certainly wouldn’t exist if not for the regulations being lifted and even if it did, it would have taken six to 12 months to navigate barriers and implement viagra side effects in normal times. Sure, the urgency of a pandemic helps but the impact of provider, patients, regulators and payors being on the same page is what fueled this fire. During the virtual clinic’s first two weeks, my team turned its attention to getting over 300 providers across 60+ offices virtual so they could see their patients at home. Imagine being an immunocompromised cancer viagra side effects patient right now and being asked to leave your home and be exposed to other people in order to see your oncologist.

Direct-to-consumer virtual care is the best way to safely care for these patients and without these temporary waivers it wouldn’t be covered by insurance even if you did navigate the clunky apps that are HIPAA compliant. Do we really think the immunocompromised cancer patient feels any more comfortable every normal flu season?. Is it any more appropriate to ask them to risk exposure to viagra side effects the flu than it is to COVID-19?. And yet we deny them this access in normal times and it quite possibly will be stripped away from them when this crisis is over. Now 300 to 400 patients per day in our health system are seen virtually by their own primary care doctor or specialist for non-COVID related visits.

Not a single one of these would have been reimbursed one month ago and I am highly skeptical I would have gotten approval to use viagra side effects the software that connects us to the patient. Lastly, recall that prior to COVID-19, our system had only found 250 total patients that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement. COVID-19 has been a wake-up call to the whole country and health care is no exception. It has put priorities viagra side effects in perspective and shined a light on what is truly value-added. For direct-to-consumer virtual care it has shown us what is possible when we get out of our own way.

If a regulation has to be removed to allow for care during a crisis then we must question why it exists in the first place. HIPAA regulation cannot go back to its antiquated practices if we are truly going to shift the viagra side effects focus to patient wellness. CMS and private payors must embrace value-added direct-to-consumer virtual care and allow patients the access they deserve. COVID-19 has forced this industry forward, we cannot allow it to regress and be forgotten when this is over. Tom Wood is the director of trauma and virtual care for MidMichigan Health, a non-profit health system headquartered in Midland, Michigan, affiliated with Michigan Medicine, the health care division of the University of viagra side effects Michigan.

The views and opinions expressed in this commentary are his own.When dealing with all of the aspects of diabetes, it’s easy to let your feel fall to the bottom of the list. But daily care and evaluation is one of the best ways to prevent foot complications. It’s important to identify your risk factors and take viagra side effects the proper steps in limiting your complications. Two of the biggest complications with diabetes are peripheral neuropathy and ulcer/amputation. Symptoms of peripheral neuropathy include numbness, tingling and/or burning in your feet and legs.

You can slow the progression of developing neuropathy by making it a point to viagra side effects manage your blood sugars and keep them in the normal range. If you are experiencing these symptoms, it is important to establish and maintain a relationship with a podiatrist. Your podiatrist can make sure things are looking healthy and bring things to your attention to monitor and keep a close eye on. Open wounds or ulcers viagra side effects can develop secondary to trauma, pressure, diabetes, neuropathy or poor circulation. If ulcerations do develop, it’s extremely important to identify the cause and address it.

Ulcers can get worse quickly, so it’s necessary to seek immediate medical treatment if you find yourself or a loved one dealing with this complication. Untreated ulcerations often lead to amputation viagra side effects and can be avoided if proper medical attention is sought right away. There are important things to remember when dealing with diabetic foot care. It’s very important to inspect your feet daily, especially if you have peripheral neuropathy. You may have a cut or a sore viagra side effects on your feet that you can’t feel, so your body doesn’t alarm you to check your feet.

Be gentle when bathing your feet. Moisturize your feet, but not between your toes. Do not treat viagra side effects calluses or corns on your own. Wear clean, dry socks. Never walk barefoot, and consider socks and shoes made specifically for patients with diabetes.

Kristin Raleigh, D.P.M., is a podiatrist who sees patients at Foot &.

It makes me very proud to call these nurses my viagra cost friends. As a former emergency department nurse, I recall the feeling of satisfaction knowing that I’ve helped someone on the worst day of their life. One of the best parts of being a nurse is knowing you matter to the only person in health care that truly matters.

The patient viagra cost. Several years ago I made the difficult decision to no longer perform bedside nursing and become a nurse administrator. The biggest loss from my transition is the feeling that what I do matters to the patient.

COVID-19 has forced a lot of us to rethink the role we play in health care and what the real priority should viagra cost be. Things that were top priorities three months ago have been rightfully cast aside to either care for patients in a pandemic or prepare for the unknown future of, “When is our turn?. € For me, COVID-19 has reignited the feeling that what I do matters as virtual care has become a powerful tool on the forefront of care during this crisis.

It has also shown that many of the powerful rules and regulations that limit virtual care are not needed and should be viagra cost discarded permanently. When I became the director of virtual care at our organization in 2015 I knew nothing about telehealth. Sure, I had seen a stroke robot in some Emergency Departments, and I had some friends that told me their insurance company lets them FaceTime a doctor for free (spoiler alert.

It’s not FaceTime) viagra cost. I was tech-savvy from a consumer perspective and a tech novice from an IT perspective. Nevertheless, my team and I spent the next few years learning as we built one of the higher volume virtual care networks in the state of Michigan.

We discovered a lot of barriers that keep viagra cost virtual care from actually making the lives of patients and providers better and we also became experts in working around those barriers. But, there were two obstacles that we could not overcome. Government regulation and insurance provider willingness to cover virtual visits.

These two barriers effectively cripple most legitimate attempts to provide value-added direct-to-consumer virtual care, which I define as using virtual care technologies to provide care outside of our brick-and-mortar facilities, most commonly viagra cost in the patient home. The need to social distance, cancel appointments, close provider offices, keep from overloading emergency departments and urgent cares and shelter in place created instant demand for direct-to-consumer virtual care. In all honesty, I’ve always considered direct-to-consumer virtual care to be the flashy, must-have holiday gift of the year that organizations are convinced will be the way of the future.

If a health system wants to provide on-demand access to patients for low-complexity acute conditions, they will easily find plenty of vendors that will sell them their app and their doctors and put the health system’s logo viagra cost on it. What a health system will struggle with is to find is enough patient demand to cover the high cost. Remember my friends from earlier that told me about the app their insurance gave them?.

Nearly all of them followed that up by telling me they’ve never viagra cost actually used it. I am fortunate that I work for an organization that understands this and instead focuses on how can we provide care that our patients actually want and need from the doctors they want to see. Ironically, this fiscal year we had a corporate top priority around direct-to-consumer virtual care.

We wanted to viagra cost expand what we thought were some successful pilots and perform 500 direct-to-consumer visits. This year has been one of the hardest of my leadership career because, frankly, up until a month ago I was about to fail on this top priority. With only four months left, we were only about halfway there.

The biggest problem we ran into was that every great idea a physician brought to me was viagra cost instantly dead in the water because practically no insurance company would pay for it. There are (prior to COVID-19) a plethora of rules around virtual care billing but the simplest way to summarize it is that most virtual care will only be paid if it happens in a rural location and inside of a health care facility. It is extremely limited what will be paid for in the patient home and most of it is so specific that the average patient isn’t eligible to get any in-home virtual care.

Therefore, most good medical uses for direct-to-consumer care would be asking the patient to pay cash or the physician to forgo reimbursement for viagra cost a visit that would be covered if it happened in office. Add to that the massive capital and operating expenses it takes to build a virtual care network and you can see why these programs don’t exist. A month ago I was skeptical we’d have a robust direct-to-consumer program any time soon and then COVID-19 hit.

When COVID-19 started to spread rapidly in the United States, regulations and reimbursement viagra cost rules were being stripped daily. The first change that had major impact is when the Centers for Medicare and Medicaid Services (CMS) announced that they would temporarily begin reimbursing for virtual visits conducted in the patient’s home for COVID-19 and non-COVID related visits. We were already frantically designing a virtual program to handle the wave of COVID-19 screening visits that were overloading our emergency departments and urgent cares.

We were having plenty of discussions around reimbursement for this clinic viagra cost. Do we attempt to bill insurances knowing they will likely deny, do we do a cash clinic model or do we do this as a community benefit and eat the cost?. The CMS waiver gave us hope that we would be compensated for diverting patients away from reimbursed visits to a virtual visit that is more convenient for the patient and aligns with the concept of social distancing.

Realistically we don’t know if viagra cost we will be paid for any of this. We are holding all of the bills for at least 90 days while the industry sorts out the rules. I was excited by the reimbursement announcement because I knew we had eliminated one of the biggest direct-to-consumer virtual care barriers.

However, I viagra cost was quickly brought back to reality when I was reminded that HIPAA (Health Insurance Portability and Accountability Act) still existed. I had this crazy idea that during a pandemic we should make it as easy as possible for people to receive virtual care and that the best way to do that was to meet the patient on the device they are most comfortable with and the application (FaceTime, Facebook, Skype, etc.) that they use every day. The problem is nearly every app the consumer uses on a daily basis is banned by HIPAA because “it’s not secure.” I’m not quite sure what a hacker stands to gain by listening into to my doctor and me talk about how my kids yet again gave me strep throat but apparently the concern is great enough to stifle the entire industry.

Sure, not every viagra cost health care discussion is as low-key as strep throat and a patient may want to protect certain topics from being discussed over a “non-secure” app but why not let the patient decide through informed consent?. Regulators could also abandon this all-or-nothing approach and lighten regulations surrounding specific health conditions. The idea that regulations change based on medical situation is not new.

For example, in my home viagra cost state of Michigan, adolescents are essentially considered emancipated if it involves sexual health, mental health or substance abuse. Never mind that this same information is freely given over the phone by every office around the country daily without issue, but I digress. While my job is to innovate new pathways for care, our lawyer’s job is to protect the organization and he, along with IT security, rightfully shot down my consumer applications idea.

A few days later I legitimately screamed out loud in joy when the Department of Health and Human Services announced that it would use discretion on enforcing HIPAA compliance rules and specifically allowed for use of consumer viagra cost applications. The elimination of billing restrictions and HIPAA regulations changed what is possible for health care organizations to offer virtually. Unfortunately both changes are listed as temporary and will likely be removed when the pandemic ends.

Six days after the HIPAA changes were announced, we launched a centralized virtual clinic for any patient that wanted a direct-to-consumer video viagra cost visit to be screened by a provider for COVID-19. It allows patients to call in without a referral and most patients are on-screen within five minutes of clicking the link we text them. They don’t have to download an app, create an account or even be an established patient of our health system.

It saw over 900 patients in the first 12 days viagra cost it was open. That is 900 real patients that received care from a physician or advanced practice provider without risking personal exposure and without going to an already overwhelmed ED or urgent care. To date, 70 percent of the patients seen by the virtual clinic did not meet CDC testing criteria for COVID-19.

I don’t believe we could have reached even half of these patients had the viagra cost consumer application restrictions been kept. A program like this almost certainly wouldn’t exist if not for the regulations being lifted and even if it did, it would have taken six to 12 months to navigate barriers and implement in normal times. Sure, the urgency of a pandemic helps but the impact of provider, patients, regulators and payors being on the same page is what fueled this fire.

During the virtual clinic’s first two weeks, viagra cost my team turned its attention to getting over 300 providers across 60+ offices virtual so they could see their patients at home. Imagine being an immunocompromised cancer patient right now and being asked to leave your home and be exposed to other people in order to see your oncologist. Direct-to-consumer virtual care is the best way to safely care for these patients and without these temporary waivers it wouldn’t be covered by insurance even if you did navigate the clunky apps that are HIPAA compliant.

Do we really think the immunocompromised cancer patient feels any more comfortable every normal flu viagra cost season?. Is it any more appropriate to ask them to risk exposure to the flu than it is to COVID-19?. And yet we deny them this access in normal times and it quite possibly will be stripped away from them when this crisis is over.

Now 300 viagra cost to 400 patients per day in our health system are seen virtually by their own primary care doctor or specialist for non-COVID related visits. Not a single one of these would have been reimbursed one month ago and I am highly skeptical I would have gotten approval to use the software that connects us to the patient. Lastly, recall that prior to COVID-19, our system had only found 250 total patients that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement.

COVID-19 has viagra cost been a wake-up call to the whole country and health care is no exception. It has put priorities in perspective and shined a light on what is truly value-added. For direct-to-consumer virtual care it has shown us what is possible when we get out of our own way.

If a regulation has to be removed to allow for care during a crisis then we must question why it exists in the first place viagra cost. HIPAA regulation cannot go back to its antiquated practices if we are truly going to shift the focus to patient wellness. CMS and private payors must embrace value-added direct-to-consumer virtual care and allow patients the access they deserve.

COVID-19 has forced this industry forward, we cannot allow it to regress and be forgotten when this viagra cost is over. Tom Wood is the director of trauma and virtual care for MidMichigan Health, a non-profit health system headquartered in Midland, Michigan, affiliated with Michigan Medicine, the health care division of the University of Michigan. The views and opinions expressed in this commentary are his own.When dealing with all of the aspects of diabetes, it’s easy to let your feel fall to the bottom of the list.

But daily care and evaluation is one of the best ways to viagra cost prevent foot complications. It’s important to identify your risk factors and take the proper steps in limiting your complications. Two of the biggest complications with diabetes are peripheral neuropathy and ulcer/amputation.

Symptoms of peripheral neuropathy include numbness, tingling and/or burning in viagra cost your feet and legs. You can slow the progression of developing neuropathy by making it a point to manage your blood sugars and keep them in the normal range. If you are experiencing these symptoms, it is important to establish and maintain a relationship with a podiatrist.

Your podiatrist can make sure things are looking healthy and bring things to your attention to monitor and keep viagra cost a close eye on. Open wounds or ulcers can develop secondary to trauma, pressure, diabetes, neuropathy or poor circulation. If ulcerations do develop, it’s extremely important to identify the cause and address it.

Ulcers can get worse quickly, so it’s necessary to seek viagra cost immediate medical treatment if you find yourself or a loved one dealing with this complication. Untreated ulcerations often lead to amputation and can be avoided if proper medical attention is sought right away. There are important things to remember when dealing with diabetic foot care.

It’s very important to inspect your feet daily, especially if you viagra cost have peripheral neuropathy. You may have a cut or a sore on your feet that you can’t feel, so your body doesn’t alarm you to check your feet. Be gentle when bathing your feet.

Moisturize your feet, but not viagra cost between your toes. Do not treat calluses or corns on your own. Wear clean, dry socks.

Never walk viagra cost barefoot, and consider socks and shoes made specifically for patients with diabetes. Kristin Raleigh, D.P.M., is a podiatrist who sees patients at Foot &. Ankle Specialists of Mid-Michigan in Midland.

Those who would like to make an appointment may contact her office at (989) 488-6355..


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