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, President Biden signed an Executive Order intended to promote competition across the American economy, including the health care industry. Read more about the order and other news below.
I. Regulations, Notices & Guidance
- On July 6, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Unique Device Identification System: Form and Content of the Unique Device Identifier. This document describes the requirements for, and FDA's recommendations regarding, the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule.
- On July 9, 2021, FDA issued a delay of effective date for the final rule entitled, Tobacco Products; Required Warnings for Cigarette Packages and Advertisements. As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule until July 13, 2022.
- On July 9, 2021, FDA issued revised guidance entitled, Submission of Plans for Cigarette Packages and Cigarette Advertisements. This is a revision to the third edition of this final guidance, which is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. FDA is revising this guidance to reflect the May 21, 2021, court order that postponed the effective date of the final rule entitled Tobacco Products; Required Warnings for Cigarette Packages and Advertisements to July 13, 2022. Pursuant to the court order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by the recommended submission date, which is currently September 13, 2021.
- July 14, 2021: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting entitled, Meeting of the National Advisory Council for Healthcare Research and Quality. The meeting will begin with an update on AHRQ's recent accomplishments in Health Systems Research, Practice Improvement, and Data and Analytics. The agenda will also include discussions on Strategic Opportunities for FY 2022, Opportunities to Advance Telehealth, and Advancing Patient Safety.
- July 14, 2021: The Department of Health and Human Services (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.
- July 19, 2021: HHS announced a public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council will discuss the implications of and opportunities presented by the approval of aducanumab. The Council will also hear updates from federal workgroups on efforts undertaken in the last quarter. The risk reduction subcommittee will present a summary of their work and recommendations. The research, clinical care, and long-term services and supports subcommittees will present recommendations and the Council will vote on adopting them.
- July 28-29, 2021: The Centers for Medicare & Medicaid Services (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: 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.
- 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
There were no health-related Congressional hearings this week.
III. Reports, Studies & Analyses
- On July 8, 2021, RAND Corporation published a research brief entitled, Key Findings from RAND Health Care Research on Telehealth Policy. RAND Health Care researchers have been using public and private data, such as data from health care claims, to understand telehealth's effect on health care delivery and how it affects care quality, access, equity, and costs. Researchers have also been working with an array of partners, including the National Institutes of Health, private payers, and telehealth services and app companies that work directly with patients to conduct studies to assess the impacts and effectiveness of particular services. Researchers have conducted randomized controlled trials and interviews and surveys of the general public, telehealth patients, and health care providers. This document synthesizes key findings from recent RAND research on telehealth.
III. Other Health Policy News
- On July 8, 2021, the Centers for Disease Control (CDC) and FDA released a joint statement on COVD-19 vaccine boosters, announcing that Americans who have been fully vaccinated do not need a booster shot at this time. The full statement can be found here.
- On July 9, 2021, the HHS Office of the National Coordinator for Health Information Technology (ONC) released the United States Core Data for Interoperabilityversion 2 (USCDI v2), a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange. The update supports the standardized, electronic exchange of social determinants of health (SDOH), sexual orientation, and gender identity (SO/GI) among several other updated data elements. While encouraged, this update does not require health professionals, such as doctors and nurses, to record this data or individuals to share such data. More information about the update can be found here.
- On July 9, 2021, President Biden signed an Executive Order (EO) intended to promote competition in the American economy. Among other things, the wide-ranging EO addresses four areas of the health care industry where the Biden Administration has identified a lack of competition: (1) prescription drug manufacturers, (2) hearing aids, (3) hospitals, and (4) the health insurance industry. The EO proposes solutions to address anti-competitive practices among prescription drug manufacturers; directs HHS to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter; and calls on the Federal Trade Commission (FTC) and HHS to take steps to address hospital and insurance company consolidation. More information on the EO can be found here.
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