Alston & Bird Health Care Week in Review, June 12, 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 Tuesday, HHS announced the allotment of an additional $25 billion in CARES Act Provider Relief Funds for safety net hospitals, Medicaid, and CHIP providers. Read more about this funding and other news below.

I. Regulations, Notices, & Guidance

• On June 8, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency. FDA is issuing this guidance to address questions FDA has received asking for clarification regarding FDA’s enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency (PHE). PDMA is part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the relevant implementing regulations regarding drug samples are in 21 CFR part 203 (part 203), subpart D.
• On June 8, 2020, the Internal Revenue Service (IRS) issued a proposed rule entitled, Certain Medical Care Arrangements. This document contains proposed regulations relating to section 213 of the Internal Revenue Code regarding the treatment of amounts paid for certain medical care arrangements, including direct primary care arrangements, health care sharing ministries, and certain government-sponsored health care programs. The proposed regulations affect individuals who pay for these arrangements or programs and want to deduct the amounts paid as medical expenses under section 213.
• On June 12, 2020, the Drug Enforcement Administration (DEA) issued a rule entitled, Schedules of Controlled Substances: Exempt Anabolic Steroid Products. The DEA is designating two pharmaceutical preparations containing esterified estrogens and methyltestosterone as exempt anabolic steroid products under the Controlled Substances Act.
• On June 12, 2020, the Department of Health and Human Services (HHS) issued a rule entitled, Nondiscrimination in Health and Health Education Programs or Activities: Delegation of Authority. HHS is committed to ensuring the civil rights of all individuals who access or seek to access health programs or activities of covered entities under Section 1557 of the Patient Protection and Affordable Care Act (“ACA”). After considering public comments, in this final rule, HHS revises its Section 1557 regulations, Title IX regulations, and specific regulations of the Centers for Medicare & Medicaid Services (CMS) as proposed, with minor and primarily technical corrections. This will better comply with the mandates of Congress, address legal concerns, relieve billions of dollars in undue regulatory burdens, further substantive compliance, reduce confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights statutes and regulations prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability.

Event Notices 

• June 17-18: FDA announced a public meeting entitled, Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committe Information will be presented regarding pediatric development plans for four products that are in development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate.
• 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.
• July 16, 2020: 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 22, 2020: 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).

II. Congressional Hearings

U.S. House of Representatives

• On June 9, 2020, the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy held a briefing entitled, COVID-19 Antibody Testing: Uses, Abuses, Limitations, and the Federal Response. Witnesses present included: Jesse Ehrenfeld, Chair, Board of Trustees, American Medical Association (AMA); Dr. Jesse Goodman, Director, Center on Medical Product Access, Safety and Stewardship (COMPASS), Georgetown University, former Chief Scientist, FDA; Dr. Jennifer Rakeman, Assistant Commissioner, New York City Department of Health and Mental Hygiene; and Dr. Gigi Gronvall, Senior Scholar & Associate Professor, Johns Hopkins Bloomberg School of Public Health, Center for Health Security.
• On June 10, 2020, the House Committee on Oversight and Reform held a hearing entitled, No Worker Left Behind: Supporting Essential Workers. Witnesses present included: Eneida Becote, Wife of Edward Becote (essential worker who died from coronavirus); John A. Costa, International President, Amalgamated Transit Union; Anthony “Marc” Perrone, International President, United Food and Commercial Workers International Union; Bonnie Castillo, Executive Director, National Nurses United, California Nurses Association, and National Nurses Organizing Committee; Clint Odom, Senior Vice President for Policy and Advocacy, Executive Director, Washington Bureau, National Urban League; and Avik S. A. Roy, President, The Foundation for Research on Equal Opportunity.

U.S. Senate

• On June 9, 2020, the Senate Committee on Homeland Security and Governmental Affairs held a hearing entitled, Evaluating the Federal Government’s Procurement and Distribution Strategies in Response to the COVID-19 Pandemic. Witnesses present included: The Honorable Brett Giroir, M.D., Assistant Secretary for Health, HHS; The Honorable Peter T. Gaynor, Administrator, Federal Emergency Management Agency (FEMA), U.S. Department of Homeland Security; and Rear Admiral John Polowczyk, Vice Director of Logistics, Joint Chiefs of Staff, U.S. Department of Defense (DOD).
• On June 10, 2020, the Senate HELP Committee held a hearing entitled, COVID-19: Going Back to School Safely. Witnesses present included: Dr. Penny Schwinn, Commissioner of Education, Tennessee Department of Education; Dr. Matthew Blomstedt, Commissioner of Education, Nebraska Department of Education; Ms. Susana Cordova, Superintendent, Denver Public Schools; and The Honorable John B. King, Jr., President and CEO, The Education Trust.
• On June 11, 2020, the Senate Aging Committee held a hearing entitled, Combatting Social Isolation and Loneliness During the COVID-19 Pandemic. Witnesses present included: Carla Perissinotto, Associate Chief for Geriatrics Clinical Programs, Associate Professor, School of Medicine, The University of California; Dr. Peter Reed, Director, Sanford Center for Aging, Professor, Community Health Sciences, School of Medicine, University of Nevada; Betsy Sawyer-Manter, President and CEO, SeniorsPlus; and Najja Orr, President and CEO, Philadelphia Corporation for Aging.

III. Reports, Studies, & Analyses

• On June 9, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Trends in Workplace Wellness Programs and Evolving Federal Standards. In 2019, 84 percent of large employers (200 or more workers) offering health benefits offered a workplace wellness program, such as those to help people lose weight, stop smoking, or provide lifestyle and behavioral coaching; in addition 4 percent of large offering firms have programs that exclusively do health screening, meaning in total almost 9 in 10 firms have some sort of workplace wellness program (88 percent). An estimated 63 million covered employees, including 59 million at large employers work for firms which offer health benefits and one of these workplace wellness programs. The Employer Health Benefit Survey (EHBS) has tracked the growth in workplace wellness programs from 2008 when about 70 percent of large employers (with 41 million covered employees) offered them. Over time, EHBS has changed the way it asks employers about their wellness and health screening offerings.
• On June 10, 2020, KFF published an issue brief entitled, How Could the Price of Remdesivir Impact Medicare Spending for COVID-19 Patients? On May 1, 2020, the FDA issued an Emergency Use Authorization for Remdesivir, a direct acting antiviral drug, for the treatment of COVID-19. Remdesivir is not a cure for COVID-19, but preliminary evidence suggests that it may shorten the recovery time among patients with COVID-19. Gilead has donated the first 1.5 million doses of Remdesivir at no cost, but the company has yet to set a price for the drug or make it commercially available. Because a relatively large share of COVID-19 cases and hospitalizations are among older adults, there is both optimism about the drug’s potential benefits for Medicare beneficiaries and concern about its potential cost to Medicare. If Remdesivir has a high price tag, it could have implications for the fiscal health of hospitals and the Medicare program. The vast majority of Medicare spending for prescription drugs occurs under the Medicare Part D program, which covers retail prescription drugs filled at a pharmacy, typically in pill form but sometimes injected by patients themselves. Remdesivir is expected to be covered under Part A, which pays for inpatient care, because the drug was administered on an inpatient basis in clinical trials. In this brief, the authors discuss how drugs provided in inpatient hospital settings are covered and reimbursed for beneficiaries in traditional Medicare under current law.
• On June 12, 2020, KFF published an issue brief entitled, Understanding the Intersection of Medicaid, Work, and COVID-19. This brief highlights data related to the work status and financial security of Medicaid adults prior to the COVID-19 pandemic as well as findings from focus groups conducted with Medicaid enrollees in January 2020. Data and enrollee experiences can inform understanding of the implications of the pandemic for Medicaid adults and the availability of health coverage for these adults living at or near poverty.

IV. Other Health Policy News

• On June 9, 2020, HHS announced additional distributions from the CARES Act Provider Relief Fund to eligible Medicaid and Children's Health Insurance Program (CHIP) providers that participate in state Medicaid and CHIP programs. HHS expects to distribute approximately $15 billion to eligible providers that participate in state Medicaid and CHIP programs and have not received a payment from the Provider Relief Fund General Allocation. HHS is also announcing the distribution of $10 billion in Provider Relief Funds to safety net hospitals that serve America’s most vulnerable citizens. More information about this announcement can be found here.
• On June 9, 2020, CMS released a guide for patients and beneficiaries as they consider their in-person care options. During the height of the pandemic, many healthcare systems and patients postponed non-emergency, in-person care in order to keep patients and providers safe and to ensure capacity to care for COVID-19 patients. As states and regions across the United States see a decline in cases of COVID-19, CMS is providing these recommendations to ensure that non-emergency healthcare resumes safely and that patients are receiving needed in-person treatment that may have been postponed due to the public health emergency. More information about this guidance can be found here.
• On June 11, 2020, CMS issued a warning to nursing homes against seizing residents economic impact payments (or “Stimulus Checks”) authorized under the CARES Act. CMS noted that this practice is prohibited, and nursing homes that seize these payments from residents could be subject to federal enforcement actions, including potential termination from participation in the Medicare and Medicaid programs. More information about the warning can be found here.
• On June 11, 2020, HHS awarded $8 million to 73 organizations that provide training and technical assistance (T/TA) to HRSA-funded health centers nationwide. These organizations will provide critical COVID-19 resources to health centers, including support and expertise to advance health centers’ ability to prevent, prepare, and respond to the COVID-19 pandemic. More information about this funding can be found here.

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