Alston & Bird Health Care Week in Review - June 2021 #4

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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 announced $20 million in aid to state Marketplaces and OSHA issued an ETS requiring covered healthcare employers to develop COVID-19 safety plans. Read more about these actions and other news below.


I. Regulations, Notices & Guidance

  • On June 21, 2021, the Department of Health and Human Services (HHS) issued a request for information (RFI) entitled, Request for Information Regarding Reporting on Pharmacy Benefits and Prescription Drug Costs. HHS is issuing this RFI to gather input from the public regarding implementation considerations for the data collection required under section 204 of Title II of Division BB of the CAA, and the associated impact on group health plans and health insurance issuers. As part of this request for information, the Office of Personnel Management (OPM) is also seeking input from the public regarding implementation considerations for the data collection required under section 204 of Title II of Division BB of the CAA as it pertains to Federal Employees Health Benefits (FEHB) carriers (whether or not they are also health insurance issuers). The Departments and OPM also seek input on specific data elements, including the level of detail that is feasible to report for entities subject to the data collection requirements and the associated burdens and potential compliance costs. Public comments will inform the Departments’ and OPM’s implementation of section 204 through rulemaking and the establishment of processes to receive the required information.
  • On June 21, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. FDA is providing guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA) as specified in Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12) (i.e., post-approval changes) (Refs. 1 and 2).  The guidance describes general and administrative information on evaluating and reporting changes and recommendations for reporting categories based on a tiered-reporting system for specific changes under 21 CFR 601.12.
  • On June 23, 2021, FDA issued guidance entitled, COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention. FDA is issuing this guidance to assist sponsors developing master protocols for trials evaluating drugs and biological products for the treatment or prevention of COVID-19. This guidance primarily focuses on trial design and conduct as well as statistical considerations for master protocols intended to generate substantial evidence of effectiveness and adequate characterization of safety for COVID-19. Additionally, this guidance provides administrative and procedural recommendations to sponsors of master protocols for COVID-19. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency’s good guidance practices.
  • On June 24, 2021, FDA issued guidance entitled, Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings. This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred to as existing treatment options) for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative setting. For the purpose of this guidance, non-curative is generally defined as 1) unresectable, locally advanced, or metastatic disease in solid tumors or 2) hematologic malignancies with unfavorable long-term overall survival.
  • On June 25, 2021, FDA issued guidance entitled, Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies. This draft guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies. In doing so, the guidance provides recommendations related to the two IND safety reporting provisions that require assessment of aggregate data to facilitate appropriate IND safety reporting practices.

Event Notices

  • July 7-9, 2021: The Centers for Medicare & Medicaid Services (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.
  • July 14, 2021: HHS announced a public meeting entitled, Meeting of the National Committee on Vital and Health Statistics, Subcommittee on Privacy, Confidentiality and Security. At the hearing, the Subcommittee will hear from invited experts on the range of security challenges affecting the health care industry and business partners. The Subcommittee will also hear about the range of policy options that may be available to the Department of Health and Human Services (HHS) and data stewards to improve the security posture of those organizations holding individually identifiable information (III), including federal, state, local, and tribal organizations.
  • 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.
  • September 21, 2021: 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. Senate

  • On June 22, 2021, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Vaccines: America’s Shot at Ending the COVID-19 Pandemic. Witnesses present included: Dr. Susan Bailey, Immediate Past President, American Medical Association; Dr. Jeanette Betancourt, Senior Vice President for U.S. Social Impact, Sesame Workshop; Curtis Chang, Consulting Professor, Duke Divinity School; and Dr. Michelle Nichols, Associate Dean of Clinical Affairs, Morehouse School of Medicine.

U.S. House of Representatives

  • On June 24, 2021, the House Committee on Energy and Commerce Subcommittee on Health held a legislative hearing entitled, Empowered by Data: Legislation to Advance Equity and Public Health. Witnesses present included: Karen DeSalvo, Chief Health Officer, Google Health; Dr. Romilla Batra, Chief Medical Officer, SCAN Health Plan; Beth Blauer, Executive Director, Johns Hopkins University Centers for Civic Impact; Dr. Faisel Syed, National Director of Primary Care, ChenMed; and Dr. Kara Odom Walker, Executive Vice President and Chief Population Health Officer, Nemours Children’s Health System.

III. Reports, Studies & Analyses

  • On June 21, 2021, the Government Accountability Office (GAO) published a report entitled, Physician Workforce: Caps on Medicare-Funded Graduate Medical Education at Teaching Hospitals. GAO was asked to review Medicare Graduate Medical Education (GME) funding. This report, among other issues, describes the extent to which hospitals were over or under their Medicare GME caps and stakeholders' views on extending the time window before new caps are established. GAO analyzed 2018 Medicare data (the most recent available at the time of GAO's analysis), reviewed agency documentation, and interviewed eight selected stakeholder groups—including a GME accreditor and groups representing health care providers—identified through past GAO work.
  • On June 22, 2021, Kaiser Family Foundation (KFF) published an issue brief entitled, Costs and Savings under Federal Policy Approaches to Address Medicaid Prescription Drug Spending. This brief analyzes leading federal approaches to address Medicaid prescription drug spending, discusses (where available) a range of cost estimates for each policy, and assesses what drives those estimates or where there is uncertainty in them.
  • On June 24, 2021, KFF published an issue brief entitled, Ground Ambulance Rides and Potential for Surprise Billing. This analysis finds that half of emergency ground ambulance rides result in an out-of-network charge for people with private health insurance, potentially leaving patients at risk of getting a surprise bill. Overall ambulances transport about 3 million privately insured patients to emergency rooms each year. Local fire and rescue departments and other government agencies account for nearly two thirds of those rides. The analysis also examines several existing state and local laws that seek to protect consumers from unexpected or excessive bills for ground ambulance services, generally by limiting when and how much ambulance providers can bill patients for their services.

IV. Other Health Policy News

  • On June 21, 2021, CMS announced $20 million in American Rescue Plan (ARP) funding to support State-based Marketplaces (SBMs) to improve access to affordable, comprehensive health insurance coverage for consumers in their states. States can apply for funding to help modernize or update their systems, programs, or technology to comply with federal Marketplace requirements, including the recent provisions of the ARP that increased the financial assistance available to certain consumers. More information about this funding is available here.
  • On June 21, 2021, the Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) requiring covered healthcare employers to develop and implement a COVID-19 plan to identify and control COVID-19 hazards in the workplace. The ETS was issued pursuant to the directives of President Biden’s Executive Order on Protecting Worker Health and Safety, January 21, 2021. Most provisions of the ETS (except for physical barriers, ventilation, and employee training) must be implemented by July 6, and all provisions must be implemented by July 21.
  • On June 22, 2021, Senate Finance Committee Chair Ron Wyden (D-OR) published a framework for legislation to bring down the cost of prescription drugs. The document includes several ideas for addressing prescription drug prices, including the proposal to give the federal government the power to negotiate prices directly with drug manufacturers. Other key principles include creating an inducement for drug manufacturers to negotiate, rebates to mitigate year-to-year price hikes and, most important, an extension of the negotiated prices beyond Medicare recipients to private insurers and their beneficiaries.

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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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