Alston & Bird Health Care Week in Review, July 10, 2020

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 Monday, CMS issued a proposed rule to revise and update the ESRD prospective payment system for 2021. Read more about this proposal and other news below.

I. Regulations, Notices, & Guidance

• On July 6, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program. This proposed rule would update and make revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2021. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rule proposes to update requirements for the ESRD Quality Incentive Program (QIP).
• On July 10, 2020, Department of the Treasury, Department of Labor, and the Department of Health and Human Services released a notice of proposed rulemaking (NPRM) entitled, Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. This NPRM is related to grandfathered group health plans and grandfathered group health insurance coverage that would, if finalized, amend current rules to provide greater flexibility for certain grandfathered health plans to make changes to certain types of cost-sharing requirements without causing a loss of grandfathered status.

Event Notices

• July 14, 2020: FDA announced a public meeting entitled, Meeting of the Oncologic Drugs Advisory Committee. The committee will discuss biologic license application (BLA) 761158, for belantamab mafodotin, submitted by GlaxoSmithKline Intellectual Property Development Ltd. England. The proposed indication for this product is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
• July 16, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting for the Board of Scientific Counselors, Center for Preparedness and Response. The agenda will include discussions on Center for Preparedness and Response Director Updates and Board of Scientific Counselors members’ perspectives on COVID-19 pandemic preparedness and response.
• July 21, 2020: FDA announced a public meeting entitled, Generic Drug User Fee Amendments (GDUFA) of 2017. At the end of September 2022, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The purpose of this meeting is for the public to present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (i.e., the GDUFA II Commitment Letter).
• July 22, 2020: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting entitled, Meeting of the Medicare Evidence Development and Coverage Advisory Committee. This meeting will focus on the home use of noninvasive positive pressure ventilation in patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). CMS is seeking the MEDCAC’s recommendations regarding the characteristics that define those patient selection and usage criteria, concomitant services, and equipment parameters necessary to best achieve positive patient health outcomes in beneficiaries with CRF consequent to COPD.
• July 23, 2020: FDA announced a public meeting entitled, Reauthorization of the Prescription Drug User Fee Act. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027.
• July 25, 2020: CMS announced a public meeting entitled, Meeting of the Advisory Panel on Outreach and Education (APOE). The purpose of the meeting is to discuss opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
• July 30, 2020: The Health Resources and Services Administration announced a public meeting entitled, Meeting of the National Advisory Committee on Rural Health and Human Services. At this meeting, the National Advisory Committee on Rural Health and Human Services (NACRHHS) will discuss the development of a vision statement that emphasizes rural community transformation, sustainable services, and resiliency

II. Congressional Hearings

U.S. House of Representatives

• On July 7, 2020, the House Committee on Education and Labor Subcommittee on Higher Education and Workforce Investment held a hearing entitled, A Major Test: Examining the Impact of COVID-19 on the Future of Higher Education. Witnesses present included: Ms. Sharon J. Pierce, Ed.D., M.S.N., President, Minneapolis College; Mr. Timothy P. White, Ph.D., Chancellor, The California State University; Mr. Scott Pulsipher, President, Western Governors University; and Mr. Shaun Harper, Ph.D., President, American Educational Research Association.
• On July 7, 2020, the House Committee on Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies held a markup of FY 2021 appropriations legislation.
• On July 8, 2020, the House Committee on Homeland Security held a hearing entitled, Examining the National Response to the Worsening Coronavirus Pandemic. Witnesses present included: Jay Robert Pritzker, Governor, Illinois; Jason Shelton, Mayor, City of Tupelo, Mississippi; Dr. Umair A. Shah, Executive Director and Local Health Authority of Harris County Public Health, Texas; and Brian Hastings, Col (ret) USAF, Director, Alabama Emergency Management Agency.
• On July 10, 2020, the House Committee on Homeland Security Subcommittee on Emergency Preparedness, Response, and Recovery held a hearing entitled, Pandemic Response: Confronting the Unequal Impacts of COVID-19. Witnesses present included: Dr. Leana Web, Visiting Professor of Health Policy and Management, George Washington University Milken Institute School of Public Health; Dr. George C. Benjamin, Executive Director of the American Public Health Association; and Chauncia Willis, Co-Founder and CEO, Institute for Diversity and Inclusion in Emergency Management.

III. Reports, Studies, & Analyses

• On July 9, 2020, the HHS Office of the Inspector General issued a report entitled, Loophole in Drug Payment Rule Continues to Cost Medicare Beneficiaries Hundreds of Millions of Dollars, OEI-BL-20-00100. The report finds that closing a “payment loophole” for self-administered drugs would have saved Medicare half a billion dollars on Orencia and Cimzia in 2017 and 2018. Generally speaking, Medicare had a policy that incentivized physicians to administer these products, which resulted in higher payments and increased spending for Medicare. The report calls on Congress to enact legislation that would resolve the issue.

IV. Other Health Policy News

• On July 9, 2020, Health Affairs published a report entitled, Shelter-in-Place Orders Reduced COVID-19 Mortality and Reduced the Rate of Growth in Hospitalizations. According to the report, projections suggest that as many as 250,000–370,000 deaths were avoided by May 15 in 42 states plus the District of Columbia.

Click here to view the members of our Health Care Legislative & Public Policy team.