Alston & Bird Health Care Week in Review - June 2021 #2

Alston & Bird

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, HHS released revised reporting requirements for recipients of the Provider Relief Fund. Read more about the updated requirements and other news below.

I. Regulations, Notices & Guidance

  • On June 9, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Core Patient-Reported Outcomes in Cancer Clinical Trials. This draft guidance provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. This guidance focuses on patient-reported outcome (PRO) measures and is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy. The draft guidance recommendations supplement previous guidance on use of PRO measures in clinical trials by providing additional considerations specific to the cancer clinical trial setting. The draft guidance is intended to facilitate generation of high-quality data on a core set of patient-reported symptom and functional impacts that are important contributors to a patient’s health-related quality of life.
  • On June 10, 2021, The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) submitted to the Federal Register a final rule entitled, COVID-19 Emergency Temporary Standard. This rule, which is pending publication in the Federal Register, issues an emergency temporary standard to protect health care workers from the coronavirus. The emergency temporary standard establishes new requirements for settings where employees provide healthcare or health care support services, including skilled nursing homes and home healthcare, with some exemptions for healthcare providers who screen out patients who may have COVID-19. OSHA will update the standard, if necessary, to align with the Centers for Disease Control and Prevention (CDC) guidelines and changes in the pandemic.

Event Notices

  • June 16-17, 2021: The Department of Health and Human Services (HHS) announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During this meeting, NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
  • June 18, 2021: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccine safety and booster doses.
  • June 23, 2021: FDA announced a public workshop entitled, Fiscal Year 2021 Generic Drug Science and Research Initiatives Workshop. The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.
  • June 24, 2021: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting regarding new and reconsidered clinical diagnostic laboratory test codes for the Clinical Laboratory Fee Schedule for calendar year (CY) 2022. This notice announces a public meeting 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 CY 2022. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
  • June 25, 2021: HHS announced a public meeting entitled, Meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to consider interim recommendations addressing the inequities and the impact of long-COVID or Post-Acute Sequelae of SARS-CoV-2 infection (PASC), and access to personal protection equipment, testing, and therapeutics that are related to this pandemic.
  • July 7-9, 2021: CMS announced a public meeting entitled, New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set. The purpose of the meeting is to discuss preliminary coding recommendations for new revisions to the HCPCS Level II code set.
  • June 29-30, 2021: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This meeting will be dedicated to the council’s deliberation and vote on two reports to transmit to the HHS Secretary, the first from the Disparities in Antibiotics Access and Use Working Group, and the second from the Working Group on Antimicrobial Resistance (AMR) in Inter-Professional Education. The remainder of the two-day public meeting will include an update on the status of the antibiotic development pipeline and an open council discussion on provocative questions in AMR (no recommendations will be made), in addition to presentations from subject matter experts on Operationalizing One Health and the Environmental Dimensions of AMR.
  • July 28-29, 2021: CMS announced a public meeting entitled, Meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The purpose of the Panel is to advise the HHS Secretary and CMS Administrator on issues related to clinical diagnostic laboratory tests.

II. Congressional Hearings

U.S. Senate

  • On June 8, 2021, the Senate Committee on Health, Education, Labor, and Pensions held a hearing to consider the nominations of Dawn O’Connell to be Assistant Secretary for Preparedness and Response and Miriam Delphin-Rittmon to be Assistant Secretary for Mental Health and Substance Use.
  • On June 9, 2021, the Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, The President’s Fiscal Year 2022 Budget Request for the United States Department of Health and Human Services. HHS Secretary Xavier Becerra served as the sole witness.
  • On June 10, 2021, the Senate Committee on Finance held a hearing entitled, The President’s FY 2022 HHS Budget. HHS Secretary Xavier Becerra served as the sole witness.

U.S. House of Representatives

III. Reports, Studies & Analyses

  • On June 8, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Key Facts About Medicare Part D Enrollment, Premiums, and Cost Sharing in 2021. This analysis provides the latest data about Medicare Part D enrollment, premiums, and cost sharing in 2021 and trends over time, based on data from the CMS Part D Enrollment, Benefit, Landscape, and Low Income Subsidy files.
  • On June 9, 2021, KFF published an issue brief entitled, Utilization and Spending Trends in Medicaid Outpatient Prescription Drugs, 2015-2019. Prescription drug spending in Medicaid and other health programs has returned to the national policy debate. This analysis examines Medicaid outpatient prescription drug utilization and spending before rebates over the 2015 to 2019 period, which is helpful for understanding recent cost drivers and areas for targeted policy action.
  • On June 9, 2021, KFF published an issue brief entitled, Implications of COVID-19 for Social Determinants of Health. This brief provides an overview of social determinants of health and a look at how American adults are faring across an array of measures over a year into the pandemic.

IV. Other Health Policy News

  • On June 8, 2021, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and FDA released a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains. Led by FDA and ASPR, the White House report and recommendations center on four main pillars: (1) boosting local production and fostering international cooperation; (2) promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience; (3) creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance; and (4) leveraging data to improve supply chain resilience. More information about the policy recommendations can be found here.
  • On June 9, 2021, CMS announced an additional payment amount for administering in-home COVID-19 vaccinations to Medicare beneficiaries who have difficulty leaving their homes or are otherwise hard to reach. To better serve this group, Medicare is incentivizing providers and will pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home, increasing the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose. More information about this announcement can be found here.
  • On June 11, 2021, HHS, through the Health Resources and Services Administration (HRSA), announced that it is providing $424.7 million in funding to over 4,200 Rural Health Clinics (RHCs) for COVID-19 testing and mitigation. Later this summer, HRSA will issue up to $35.3 million in additional funding to RHCs that meet eligibility requirements. More information about this funding can be found here.
  • On June 11, 2021, HHS released revised reporting requirements for recipients of Provider Relief Fund (PRF) payments. This announcement includes expanding the amount of time providers will have to report information, aims to reduce burdens on smaller providers, and extends key deadlines for expending PRF payments for recipients who received payments after June 30, 2020. The revised reporting requirements will be applicable to providers who received one or more payments exceeding, in the aggregate, $10,000 during a single Payment Received Period from the PRF General Distributions, Targeted Distributions, and/or Skilled Nursing Facility and Nursing Home Infection Control Distributions. More information on the revised reporting requirements can be found here.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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