Health Care Week in Review July 23, 2021

Alston & Bird Health Care Week in Review, July 23, 2021

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 calendar year 2022 hospital outpatient prospective payment system proposed rule. Read more about the regulation and other news below.

I. Regulations, Notices & Guidance

  • On July 19, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model; Request for Information on Rural Emergency Hospitals. This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2022 based on CMS’s continuing experience with these systems. In this proposed rule, CMS describes the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program, update Hospital Price Transparency requirements, and update and refine the design of the Radiation Oncology Model. Finally, this proposed rule includes a Request for Information (RFI) focusing on the health and safety standards, quality measures and reporting requirements, and payment policies for Rural Emergency Hospitals (REHs), a new Medicare provider type. The RFI will be used to inform future rulemaking for REHs.
  • On July 21, 2021, CMS issued a payment advisory entitled, Medicare Program; Calendar Year 2021 Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians – Request for Current Billing Information for Qualifying APM Participants. This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment.
  • On July 22, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Field Alert Report Submission: Questions and Answers; Guidance for Industry. This guidance provides FDA's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA's recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions about FARs.

Event Notices

  • July 28, 2021: CMS announced a public meeting entitled, Meeting of the Advisory Panel on Outreach and Education (APOE). The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the CMS Administrator on 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 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.
  • July 30, 2021: The Department of Health and Human Services (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 future pandemic preparedness, mitigation, and resilience needed to ensure equitable response and recovery in communities of color and other underserved populations.
  • August 12, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) announced a public meeting. The meeting is open to the public and will include consideration of minutes from the SAMHSA CSAT NAC meeting of March 31, 2021; an update on CSAT activities; a discussion with SAMHSA leadership; and discussion of recovery and recovery support. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council.
  • August 12-13, 2021: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. During the meeting, the Advisory Committee will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening.
  • August 23, 2021: CMS announced a public meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for Calendar Year 2021. The purpose of the Panel is to advise the HHS Secretary and the CMS Administrator concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as CMS prepares the annual updates for the hospital outpatient prospective payment system.
  • September 8, 2021: HHS announced a public meeting of the National Clinical Care Commission. The Commission is charged to evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications. During the meeting, the Commission will vote to approve the final report to be submitted to Congress.
  • September 9, 2021: NIH announced a meeting entitled, Meeting of the National Institute on Minority Health and Health Disparities. The purpose of the meeting it to review and evaluate grant applications.
  • September 21, 2021: The Food and Drug Administration (FDA) announced a public workshop entitled, Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs. The purpose of the public workshop is to discuss the challenges and clinical trial design considerations for developing therapeutic products for the treatment of progressive multifocal leukoencephalopathy (PML).

II. Congressional Hearings

U.S. House of Representatives

  • On July 20, 2021, the House Committee on Education and Labor Subcommittee on Health, Employment, Labor, and Pensions and Subcommittee on Higher Education and Workforce Investment held a hearing entitled, Care for Our Communities: Investing in the Direct Care Workforce. Witnesses present included: Robert Espinoza, Vice President of Policy, PHI; Zulma Torres, Home Health Aid, Cooperative Home Care Associates; Paul Burani, Head of Business Development, North America, Udacity, Inc.; and The Honorable Jessica Fay, State Representative, Maine House of Representatives.

U.S. Senate

  • On July 20, 2021, Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, The Path Forward: A Federal Perspective on the COVID-19 Response. Witnesses present included: Rochelle Walensky, MD, MPH, Director, United States Centers for Disease Control and Prevention (CDC); Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH); Janet Woodcock, MD, Acting Commissioner, United States Food and Drug Administration (FDA); and Dawn O’Connell, Assistant Secretary for Preparedness and Response (ASPR), United States De-partment of Health and Human Services (HHS).

III. Reports, Studies & Analyses

  • On July 19, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Insurer Filings Suggest COVID-19 Pandemic Will Not Drive Health Spending In 2022. This brief reviews initial 2022 premium rate filings for Marketplace-participating individual market insurers in 13 states and the District of Columbia. Although the ACA individual market represents a small share of the privately insured population, the rate filings for this market are detailed and publicly accessible, making them a useful source of information on how health insurers are thinking about their likely costs for the next year. The brief finds most of these insurers expect health utilization patterns to return to pre-pandemic levels and therefore most are factoring in no additional costs or savings related to COVID-19 into their 2022 premiums. These insurers also tended to make similar assumptions about how COVID-19 would affect their group market costs.
  • On July 23, 2021, KFF published an issue brief entitled, Millions of Medicare Part D Enrollees Have Had Out-of-Pocket Drug Spending Above the Catastrophic Threshold Over Time. To inform discussions about proposals to add a hard cap on out-of-pocket spending under Part D, KFF analyzed the number of Part D enrollees without low-income subsidies who have exceeded the catastrophic coverage threshold annually, and over multiple years, based on 2007-2019 Part D claims data for Part D enrollees without low-income subsidies from the Centers for Medicare & Medicaid Services Chronic Conditions Data Warehouse.

IV. Other Health Policy News

  • On July 19, 2021, HHS Secretary Alex Azar renewed the COVID-19 public health emergency (PHE determination. The PHE renewal went into effect July 20, 2021. The renewal can be found here.
  • On July 22, 2021, HHS provided nearly $100 million in American Rescue Plan Act funds to rural health clinics across the country to support outreach efforts to increase vaccinations in rural communities. The funds will go to more than 1,980 Rural Health Clinics (RHCs) who will use these resources to develop and implement additional vaccine confidence and outreach efforts as many communities face the Delta variant and work to get more people vaccinated and protected from COVID-19 in medically underserved rural communities. More information about the funding decision can be found here.
  • On July 22, 2021, HHS announced that it will invest more than $1.6 billion from the American Rescue Plan Act to support testing and mitigation measures in high-risk congregate settings to prevent the spread of COVID-19 and detect and stem potential outbreaks. More information about this funding can be found here.

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