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:
This week, CMS published its Medicaid and Children’s Health Insurance Program (CHIP) Managed Care final rule. Read more about the rule and other news below.
I. Regulations, Notices & Guidance
- On November 9, 2020, the Food & Drug Administration (FDA) issued guidance entitled, Assessing User Fees under the Prescription Drug User Fee Amendments of 2017. This revised final guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017. In particular, this revised final guidance removes section VI.B. contained in the May 2018 guidance, regarding the "same product as another product" prescription drug program fee exception for certain prescription drug products under the Federal Food, Drug, and Cosmetic Act.
- On November 9, 2020, FDA issued guidance entitled, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs. This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials. This guidance is being issued, in part, to satisfy the mandates of the FDA Reauthorization Act of 2017 (FDARA). This guidance finalizes the draft guidance of the same title issued on June 7, 2019.
- On November 9, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicaid and Children’s Health Insurance Program (CHIP) Managed Care. This final rule advances CMS’ efforts to streamline the Medicaid and Children’s Health Insurance Program (CHIP) managed care regulatory framework and reflects a broader strategy to relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and innovation in the delivery of care. These revisions of the Medicaid and CHIP managed care regulations are intended to ensure that the regulatory framework is efficient and feasible for states to implement in a cost-effective manner and ensure that states can implement and operate Medicaid and CHIP managed care programs without undue administrative burdens.
- On November 12, 2020, the Department of Health and Human Services (HHS) announced a public hearing for their proposed rule entitled, Securing Updated and Necessary Statutory Evaluations Timely. The hearing will be held on November 23, 2020 and is intended to provide an open forum for the presentation of information and views concerning all aspects of the Notice of Proposed Rulemaking (NPRM) by interested persons.
- On November 13, 2020, HHS issued a final rule entitled, Regulatory Clean Up Initiative. HHS is amending its regulations to make miscellaneous corrections, including correcting references to other regulations, misspellings and other typographical errors. This document is necessary to inform the public of these non-substantive changes to HHS’s regulations.
- On November 13, 2020, FDA issued guidance entitled, Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff. This guidance is intended to explain FDA implementation of the revised statutory provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) amended the statutory provisions relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom sensitive and identifiable information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding to disclose identifiable sensitive information about the research participant, created or compiled for the research. As amended, a CoC prohibits a researcher from disclosing such information unless a specified exception applies.
Event Notices
- 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 19, 2020: FDA announced a public meeting entitled, Reauthorization of the Biosimilar User Fee Act. The purpose of this public meeting is to hear stakeholder views on the Biosimilar User Fee Act (BsUFA) as the FDA considers elements to propose, update, or discontinue in the next BsUFA.
- November 20, 2020: The Centers for Disease Control and Prevention (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.
- November 20, 2020: HHS announced a public meeting entitled, Meeting of the Advisory Committee on Minority Health. The purpose of this meeting is to finalize recommendations for improving access to and utilization of clinical preventive services among racial and ethnic minority populations. The recommendations will be given to the Deputy Assistant Secretary for Minority Health to inform efforts for removing barriers to achieving health equity.
- December 8-9, 2020: FDA announced a public meeting entitled, The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security. The purpose of the public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA and provide input on strategies and issues related to the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) and the results of FDA’s DSCSA Pilot Project Program.
- December 11, 2020: FDA announced a public workshop entitled, Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes—Exploring the Path Forward for Assessment. The purpose of the public workshop is to obtain scientific input on methods to evaluate the Opioid Analgesics Risk Evaluation and Mitigation Strategy (OA REMS) education program. To assist in the workshop discussion, FDA is making available an issues paper that provides a brief overview of the REMS background and challenges with evaluating the REMS education intervention.
- December 15, 2020: FDA announced a public meeting entitled, Meeting of the Cardiovascular and Renal Drugs Advisory Committee. The committee will discuss supplemental new drug application (sNDA) 207620-S18, for the angiotensin receptor-neprilysin inhibitor, ENTRESTO (sacubitril and valsartan) tablets, submitted by Novartis Pharmaceuticals Corp., for the proposed indication of heart failure with preserved ejection fraction (HFpEF)
- December 15-16, 2020: CMS announced a town hall entitled, Meeting on the FY 2022 Applications for New Medical Services and Technologies Add-On Payments. The purpose of the meeting is to discuss FY 2022 applications for add-on payments for new medical services and technologies under the IPPS.
- December 16, 2020: FDA announced a public meeting entitled, Meeting of the Cardiovascular and Renal Drugs Advisory Committee. The committee will discuss spironolactone for the proposed treatment of heart failure with preserved ejection fraction, a serious and often fatal condition for which no drug is approved to improve outcomes.
II. Congressional Hearings
There were no health-related Congressional hearings this week.
III. Reports, Studies & Analyses
- On November 10, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, Racial Disparities in Maternal and Infant Health: An Overview. Stark racial disparities in maternal and infant health in the U.S. have persisted for decades despite continued advancements in medical care. Growing calls for racial justice and the disparate impact of the COVID-19 pandemic for people of color have brought a new focus to health disparities, including the longstanding inequities in maternal and infant health. This brief provides an overview of racial disparities for selected key measures of maternal and infant health.
- On November 10, 2020, KFF published an issue brief entitled, Medicaid Initiatives to Improve Maternal and Infant Health and Address Racial Disparities. As a primary source of coverage for pregnant women and children, particularly among people of color, Medicaid can play a key role in helping to improve maternal and infant health and reducing racial disparities. This brief provides a summary of Medicaid’s role for pregnant women and infants and current Medicaid initiatives to improve maternal and infant health.
- On November 11, 2020, KFF published an issue brief entitled, COVID-19 Risks and Impacts Among Health Care Workers by Race/Ethnicity. Health care workers face potential COVID-19 exposure through their job. Data suggest that at least 200,000 health care workers have been infected with coronavirus as of November 2020, but this estimate likely vastly underestimates the number affected due to major gaps in data collection. Data further show that people of color account for the majority of COVID-19 cases and deaths known among health care workers, and that they are more likely to be in health care worker roles and settings that have particularly high risks of workplace exposure. This analysis provides greater insight into COVID-19 risks and impacts among health care workers and how they vary by race and ethnicity.
IV. Other Health Policy News
- On November 10, 2020, CMS announced that Medicare beneficiaries can receive coverage of monoclonal antibodies to treat COVID-19 with no cost-sharing during the public health emergency (PHE). CMS’ coverage of monoclonal antibody infusions applies to bamlanivimab, which received an emergency use authorization (EUA) from the FDA on Monday, November 9. More information about this coverage decision can be found here.
- On November 12, 2020, HHS announced that as part of its efforts to maximize access to COVID-19 vaccines for all Americans, it is partnering with large chain pharmacies and networks that represent independent pharmacies and regional chains. Through the partnership with pharmacy chains, this program covers approximately 60 percent of pharmacies throughout the 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Through the partnerships with network administrators, independent pharmacies and regional chains will also be part of the federal pharmacy program, further increasing access to vaccine across the country—particularly in traditionally underserved areas. More information about this partnership can be found here.
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