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 finalized changes to Medicare Advantage and Part D to enhance coverage and increase access for Medicare beneficiaries. Read more about the final rule and other news below.
I. Regulations, Notices, & Guidance
- On May 19, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma. This guidance recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 2.1 dated May 2020, prepared by the Plasma Protein Therapeutics Association (PPTA). This guidance also advises Source Plasma manufacturers on how to report implementation of the acceptable PPTA Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12).
- On May 21, 2020, FDA issued guidance entitled, Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of the Department of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
- On May 22, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program. This final rule will revise regulations for the Medicare Advantage (MA or Part C) program, Medicare Prescription Drug Benefit (Part D) program, and Medicare Cost Plan program to implement certain sections of the Bipartisan Budget Act of 2018 and the 21st Century Cures Act. In addition, it will enhance the Part C and D programs, codify several existing CMS policies, and implement other technical changes.
- June 1-2, 2020: CMS announced a public meeting entitled, New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding for Durable Medical Equipment and Accessories, Orthotics and Prosthetics, Supplies and Other Non-Drug and Non-Biological Items. The purpose of this meeting is to discuss CMS’s preliminary coding recommendations for new public requests for revisions to the HCPCS Level II code set for Durable Medical Equipment (DME) and Accessories, Orthotics and Prosthetics (O&P), Supplies, and other non-drug and non-biological items.
- June 1-2, 2020: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on HIV/AIDS. Agenda items will include discussing COVID-19 and the impact on people living with, or at risk of, HIV and implementing the Ending the HIV Epidemic initiative post COVID-19.
- June 4-5, 2020: FDA announced a public meeting entitled, Stakeholder Engagement on ICH E6: Guideline for Good Clinical Practice. The purpose of the web conference is to capture stakeholder experiences with current ICH E6 guidelines for good clinical practice (GCP) and to gather stakeholder input to further inform the development of an updated guideline, ICH E6(R3)
- June 8, 2020: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the Muscular Dystrophy Coordinating Committee. The purpose of this meeting is to bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.
- June 9, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee. The meeting will focus on coronavirus vaccine development, reimbursement, and changes in billing and coverage with updates from members.
- June 22, 2020: CMS announced a public meeting entitled, Public Meeting Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2021. The purpose of this meeting is to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for calendar year 2021.
- June 24, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices. The meeting agenda will include discussions on SARS-CoV-2(COVID-19) Vaccines, influenza vaccines, and meningococcal vaccines. A recommendation vote is scheduled for influenza vaccines and a VFC vote is schedule for meningococcal vaccines.
- June 26, 2020: HHS announced a public meeting entitled, Meeting of the National Clinical Care Commission. The Commission will evaluate and make recommendations to the HHS Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.
- June 29-30, 2020: CMS announced a public meeting entitled, Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The Panel will provide input and recommendations on the establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use “crosswalking” or “gapfilling” processes to determine payment for a specific new test; the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests; and other aspects of the new payment system under section 1834A of the Act.
- June 30, 2020: FDA announced a public meeting entitled, Modernizing the Food and Drug Administration's Data Strategy. The purpose of the meeting is to provide an opportunity to hear from FDA staff and outside experts on topics directly related to modernizing FDA's data strategy, including data quality, data stewardship, data exchange, and data analytics.
II. Congressional Hearings
- On May 21, 2020, the Senate Special Committee on Aging held a hearing entitled, Caring for Seniors Amid the COVID-19 Crisis. Witnesses present included: Mark Mulligan, Director, Division of Infectious Diseases and Immunology, Langone Vaccine Center; Director, Thomas S. Murphy Sr. Professor, Department of Medicine, New York University (NYU) Grossman School of Medicine; Dr. R. Tamara Konetzka, Professor of Health Services Research, Department of Public Health Sciences, University of Chicago; and Dr. Steven Landers, President And CEO, Visiting Nurse Association Health Group (VNAHG).
III. Reports, Studies, & Analyses
- On May 20, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Impact of Coronavirus on Community Health Centers. Community health centers are a national network of safety net primary care providers that fill an important role in national, state, and local responses to the coronavirus pandemic. This brief presents findings from new data collected by the Health Resources and Services Administration (HRSA) to provide insights into how health centers are adapting their services in response to the pandemic and how coronavirus is affecting their operations and long-term financial outlook with patient visits and revenue from those visits dropping precipitously.
- On May 19, 2020, KFF published an issue brief entitled, How Have Healthcare Utilization and Spending Changed so Far During the Coronavirus Pandemic? This brief summarizes what is known so far about how health costs and utilization have changed during the pandemic. This builds on other work KFF has done looking at the potential cost of treating coronavirus hospitalizations and a brief explaining the factors driving costs higher or lower and particular considerations for private insurers, Medicare, and Medicaid. Taken together, these data show there has been an abrupt and sizable decrease in healthcare utilization, at least in the early months of the pandemic. The exception has been telehealth, which has experienced an increase; however, the increase so far in telehealth was not enough to offset the decrease in in-person office visits. Some of the most recently available data suggest some healthcare utilization began picking back up in late April or early May.
- On May 20, 2020, the Government Accountability Office (GAO) published a report entitled, Infection Control Deficiencies Were Widespread and Persistent in Nursing Homes Prior to COVID-19 Pandemic. In light of the COVID-19 pandemic, GAO was asked to examine CMS's oversight of infection prevention and control protocols and the adequacy of emergency preparedness standards for emerging infectious diseases in nursing homes, as well as CMS's response to the pandemic. In this report, GAO describes the prevalence of infection prevention and control deficiencies in nursing homes prior to the COVID-19 pandemic. Future GAO reports will examine more broadly infection prevention and control and emergency preparedness in nursing homes, and CMS's response to the COVID-19 pandemic.
IV. Other Health Policy News
- On May 18, 2020, CMS announced new guidance for state and local officials to ensure the safe reopening of nursing homes across the country. The guidance is part of President Trump’s Guidelines for Opening Up America Again. It details critical steps nursing homes and communities should take prior to relaxing restrictions implemented to prevent the spread of COVID-19, including rigorous infection prevention and control, adequate testing, and surveillance. More information about this guidance can be found here.
- On May 18, 2020, HHS announced that it is delivering $11 billion in new funding to support testing for COVID-19. The Centers for Disease Control and Prevention (CDC) will provide $10.25 billion to states, territories, and local jurisdictions through CDC’s existing Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) cooperative agreement. The Indian Health Service (IHS) will provide $750 million to IHS, tribal, and urban Indian Health programs to expand testing capacity and testing-related activities. More information on this funding can be found here.
- On May 19, 2020, HHS announced that it will work with a team of private industry partners led by Phlow Corporation of Richmond, Virginia, to expand pharmaceutical manufacturing in the United States for use in producing medicines needed during the COVID-19 response and future public health emergencies. The Phlow-led team will provide immediate, U.S.-based capacity to produce the active pharmaceutical ingredients (APIs) and the chemical compounds for those ingredients to make critical medicines to help alleviate or prevent drug shortages, particularly during the COVID-19 pandemic. More information about this announcement can be found here.
- On May 20, 2020, HHS announced $225 million in funding to Rural Health Clinics (RHCs) for COVID-19 testing. These investments will support over 4,500 RHCs across the country to support COVID-19 testing efforts and expand access to testing in rural communities. More information on this announcement can be found here.
- On May 22, 2020, HHS announced it has begun distributing billions in additional relief funds to skilled nursing facilities (SNFs) to help them combat the devastating effects of the COVID-19 pandemic. This funding, which supplements previously announced provider relief funds, will be used to support nursing homes suffering from significant expenses or lost revenue attributable to COVID-19. More information about this funding can be found here.
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