Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
On Thursday, CMS announced new repayment terms for Medicare loans made to health care providers during the COVID-19 pandemic. Read more about the amended terms and other news below.
I. Regulations, Notices & Guidance
- On October 6, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Emergency Use Authorization for Vaccines to Prevent COVID-19. FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
- On October 7, 2020, FDA issued guidance entitled, Premenopausal Women with Breast Cancer: Developing Drugs for Treatment. This draft guidance provides recommendations regarding the inclusion of premenopausal women in breast cancer clinical trials. The guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials for breast cancer drugs.
Event Notices
- October 16, 2020: The Public Health Service (PHS) announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee. The committee will discuss responses to a charge on COVID-19 vaccination and may vote on sending these responses forward to the Director of the National Vaccine Program.
- October 26, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Board of Scientific Counselors, Center for Preparedness and Response (CPR). The agenda will include discussions on updates from the CPR Director and Division Directors, CPR Strategic Planning and Science Agenda, and CPR BSC Polio Containment Workgroup (PCWG) Updates.
- October 27, 2020: FDA announced a public meeting entitled, Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027 (MDUFA V).
- October 28-29, 2020: CDC announced a public meeting entitled, Meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, the Centers for Medicare & Medicaid Services (CMS), and FDA. The focus of the meeting is Clinical Laboratory Medicine in the Age of COVID-19 and will include presentations and discussions on preparedness and response: the partnership between clinical laboratories and public health; laboratory data exchanges during COVID-19; and the clinical laboratory’s role in identifying health inequities during the COVID-19 response.
- October 30, 2020: FDA announced a public workshop entitled, New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation. The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization.
- October 30, 2020: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the Diabetes Mellitus Interagency Coordinating Committee. The topic for this meeting will be “Health Literacy and Numeracy: Considerations for Equity Approaches.”
- November 5, 2020: CDC announced a public meeting entitled, Meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following HICPAC workgroups: The Healthcare Personnel Guideline Workgroup; the Long-term Care/Post-acute Care Workgroup; and the Neonatal Intensive Care Unit Workgroup.
- November 6, 2020: FDA announced a public meeting entitled, Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease.
- November 9, 2020: FDA announced a public meeting entitled, Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The committee will discuss, make recommendations and vote on information regarding the PMA for the VisAbility Micro Insert sponsored by Refocus Group, Inc.
- November 16, 2020: FDA announced a public meeting entitled, Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs. The purpose of the meeting is to obtain early input from the public on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with the use of antimicrobial drugs in animals. FDA is seeking public input on a potential revised process for ranking antimicrobials according to their relative importance in human medicine, on the potential criteria for their ranking, and on the resulting ranked list of antimicrobial drugs.
- November 20, 2020: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Breast Cancer in Young Women (ACBCYW). The agenda will include discussions on current topics related to breast cancer in young women. These will include Mental/Behavioral Health, Sexual Health, Genetics and Genomics, and Provider Engagement.
II. Congressional Hearings
There were no health-related hearings this week.
III. Reports, Studies & Analyses
- On October 6, 2020, RAND Corporation published a report entitled, Comparing Insulin Prices in the United States to Other Countries. In this report, the authors compare international prices for insulins using a price index approach. They describe the shares of volume and sales for all insulins and different categories of insulin (including insulin type and timing characteristics) in the U.S. and 32 comparison Organisation for Economic Co-operation and Development (OECD) countries in 2018. For the market basket of insulins sold in both the U.S. and comparison countries, the authors report ratios of U.S. insulin prices to insulin prices in other countries. They found that manufacturer prices in the U.S. were considerably higher (often five to ten times higher) than those in other OECD countries for all insulins combined and for different types of insulin. Although the authors focused their analysis on manufacturer prices rather than on net prices after potential rebates, the analysis suggests that U.S. insulin prices would still have been considerably higher—about four times higher—than those in other countries even when accounting for potential rebates.
- On October 8, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, 10 FAQs on Prescription Drug Importation. These FAQs provide information about recent efforts to import prescription drugs from abroad. In addition, they provide background on the history of drug importation in the U.S., explain why previous efforts to carry out importation proposals have faced challenges, and describe how current proposals, including recent ones from the Trump Administration, seek to address those concerns.
- On October 8, 2020, KFF published a report entitled, 2020 Employer Health Benefits Survey. This annual survey of employers provides a detailed look at trends in employer-sponsored health coverage, including premiums, employee contributions, cost-sharing provisions, offer rates, wellness programs, and employer practices. The 2020 survey included 1,765 interviews with non-federal public and private firms.
- On October 8, 2020, KFF published an issue brief entitled, Medicare Accelerated and Advance Payments for COVID-19 Revenue Loss: More Time to Repay. In March 2020, the Centers for Medicare & Medicaid Services (CMS) accelerated Medicare payments to hospitals and advanced payments to physicians and other providers to minimize the effects of revenue shortfalls due to COVID-19, and Congress passed the CARES Act, which provided grants to providers to help offset losses due to the pandemic. This brief provides an overview and status update of payments made to providers in response to the pandemic through Medicare’s accelerated and advance payments programs, as well other sources of funding.
IV. Other Health Policy News
- On October 5, 2020, the White House issued an Executive Order entitled, Saving Lives Through Increased Support For Mental- and Behavioral-Health Needs. The order calls for the creation of a Coronavirus Mental Health Working Group, co-chaired by Department of Health and Human Services (HHS) Secretary Alex Azar and Brooke Rollins, Acting Director of the Domestic Policy Council (or their designees), the submission of a plan by the working group for addressing the mental health impacts of COVID-19, and calls for agencies to maximize support, including safe in-person services, for Americans in need of behavioral health treatment.
- On October 8, 2020, CMS announced that Medicare beneficiaries will continue to have access to high-quality Medicare Advantage (MA) and Part D prescription drug plans in 2021. According to the latest data, quality ratings of MA and Medicare Part D drug plans remain strong. Most Medicare beneficiaries—about 77 percent—who enroll in MA plans with drug coverage will be in plans with four or more stars in 2021. That compares with 69 percent of beneficiaries enrolled in such plans in 2017. More information about this announcement can be found here.
- On October 8, 2020, CMS announced amended terms for payments issued under the Accelerated and Advance Payment (AAP) Program as required by recent action by President Trump and Congress. This Medicare loan program allows CMS to make advance payments to providers and are typically used in emergency situations. Under the Continuing Appropriations Act, 2021 and Other Extensions Act repayment will now begin one year from the issuance date of each provider or supplier’s accelerated or advance payment. CMS issued $106 billion in payments to providers and suppliers in order to alleviate the financial burden healthcare providers faced while experiencing cash flow issues in the early stages of combating the COVID-19 Public Health Emergency. More information about the amended repayment terms can be found here.
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