Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care 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 released a 2022 Strategic Framework White Paper detailing CMS’s strategic pillars and initiatives and issued a Year in Review report highlighting CMS’s accomplishments over the past year. Read more about this report and other news below.
I. Regulations, Notices & Guidance
- On June 7, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Common Formats for Patient Safety Data Collection. AHRQ coordinates the development of common definitions and reporting formats (Common Formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for Event Reporting – Diagnostic Safety (CFER-DS) Version 1.0.
- On June 7, 2022, the Food and Drug Administration (FDA) issued a final rule entitled, Medical Devices; Cardiovascular Devices; Classification of the Intravascular Bleed Monitor. FDA is classifying the intravascular bleed monitor into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intravascular bleed monitor’s classification. FDA is taking this action because FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices.
- On June 7, 2022, FDA issued a notice entitled, Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications. FDA is publishing a list of premarket approval applications (PMAs) that have been approved from January 1, 2021, through February 14, 2022. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency’s Dockets Management Staff.
- On June 8, 2022, the Government Accountability Office (GAO) issued a notice entitled, Request for Nominations for the Physician-Focused Payment Model Technical Advisory Committee. The Physician-Focused Payment Model Technical Advisory Committee (PTAC) provides comments and recommendations to the Secretary of Health and Human Services (HHS) on physician payment models and gave the Comptroller General responsibility for appointing its members. GAO is now accepting nominations of individuals for this committee. Letters of nomination and resumes should be submitted no later than July 11, 2022. Appointments will be made in October 2022.
- On June 10, 2022, FDA issued a notice entitled, Antimicrobial Drug Use in Companion Animals; Extension of Comment Period. FDA is extending the comment period for the notice that appeared in the Federal Register of February 16, 2022. In that notice, FDA requested comments on antimicrobial drug use practices in companion animals and the potential impacts of such uses on antimicrobial resistance in both humans and animals. FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. Comments are due by September 14, 2022.
- On June 10, 2022, FDA issued a notice of correction to draft guidance entitled, Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry; Correction. FDA is correcting a notice that appeared in the Federal Register of Tuesday, May 24, 2022. The document announced the availability of a draft guidance entitled, Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry. The draft guidance document was published with incorrect information of a comment period due date. This document corrects that error to state that comments should be submitted by July 25, 2022.
- On June 10, 2022, GAO issued a notice entitled, Request for Health Information Technology Advisory Committee (HITAC) Nominations. HITAC provides recommendations to the National Coordinator for Health Information Technology on policies, standards, implementation specifications, and certification criteria relating to the implementation of a health information technology infrastructure that advances the electronic access, exchange, and use of health information. GAO is now accepting nominations for HITAC appointments that will be effective January 1, 2023. From these nominations, GAO expects to appoint at least 4 new HITAC members, focusing especially on patients or consumers, health care providers, ancillary health care workers, and individuals with technical expertise on health care quality, system functions, privacy, security, and on the electronic exchange and use of health information. Letters of nomination and resumes should be submitted no later than July 22, 2022.
- On June 10, 2022, the National Institutes of Health (NIH) issued a notice entitled, Notice of Listing of Members of the National Institutes of Health’s Senior Executive Service 2022 Performance Review Board (PRB). In this notice, NIH announces the persons who will serve on the National Institutes of Health’s Senior Executive Service 2022 Performance Review Board.
- June 17, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on the use of COVID-19 pediatric vaccines. A recommendation vote(s) is scheduled. Agenda items are subject to change as priorities dictate.
- October 13-14, 2022: NIH announced a public meeting of the Board of Scientific Counselors of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The agenda will include introductions and overview of the Board.
II. Congressional Hearings
- On June 7, 2022, the Senate Committee on Finance held a hearing entitled, The President’s Fiscal Year 2023 Budget. Witnesses present included: The Honorable Janet L. Yellen, Secretary, United States Department of the Treasury.
III. Reports, Studies & Analyses
- On June 6, 2022, HHS Office of the Inspector General (OIG) published a report entitled, Semiannual Report to Congress: October 1, 2021 to March 31, 2022. This report summarizes the activities of HHS OIG for the 6-month period ending on March 31, 2022.
- On June 6, 2022, the Congressional Budget Office (CBO) published a cost estimate entitled, Estimated Budgetary Effects of S. 1435, the Affordable Prescriptions for Patients Act of 2021. S. 1435 would establish a statutory framework for the Federal Trade Commission (FTC) to undertake litigation against manufacturers that engage in “product hopping” and limit the number of patents that could be included in infringement claims for biological products.
- On June 6, 2022, CBO published a cost estimate entitled, Estimated Budgetary Effects of S. 1428, the Preserve Access to Affordable Generics and Biosimilars Act. Under S. 1428, certain agreements that are used to settle claims of patent infringement between sponsors of brand-name, generic, or biosimilar drugs and relating to the sale of a drug or biological product would presumptively be considered illegal under antitrust law.
- On June 6, 2022, CBO published a cost estimate entitled, Estimated Budgetary Effects of S. 1425, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act. S. 1425 would authorize FTC to take civil action against individuals or entities involved in submitting certain petitions to the Food and Drug Administration.
- On June 6, 2022, CBO published a cost estimate entitled, Estimated Budgetary Effects of H.R. 7667, the Food and Drug Amendments of 2022 Act. H.R. 7667 would reauthorize the collection and spending of user fees by FDA for activities related to the approval and marketing of prescription drugs and medical devices. The bill also would amend the Federal Food, Drug, and Cosmetic Act in part to change processes and procedures for regulating, manufacturing, and marketing certain prescription drugs, medical devices, and other medical products.
- On June 8, 2022, the Centers for Medicare & Medicaid Services (CMS) published a white paper entitled, 2022 CMS Strategic Framework. The white paper discusses CMS’s strategic vision based on its six strategic pillars and highlights CMS’s cross-cutting initiatives intended to drive the goals highlighted by the strategic pillars and enhance focus on critical components of CMS’s work.
- On June 8, 2022, CMS published a report entitled, A Year in Review: June 2021 – May 2022. The report highlights CMS’s key accomplishments over the last year across each of its six strategic pillars, which uphold CMS’s vision to deliver meaningful, person-centered, and equitable care to the people CMS serves.
- On June 8, 2022, the Congressional Research Service (CRS) published a report entitled, Finding Medicare Fee-For-Service (FFS) Payment System Rules: Schedules and Resources. This report contains information on Medicare FFS payment system rules in a quick reference table. Specifically, the table compiles the payment systems, their main portals on the CMS website, the typical rulemaking schedule, statutory and regulatory requirements, and the most recently issued proposed rules, public comments, final rules, and subsequent corrections. The table also includes embedded links to the applicable resources.
IV. Other Health Policy News
- On June 8, 2022, HHS, through the Health Resources and Services Administration (HRSA), announced nearly $15 million in funding for rural communities to address psychostimulant misuse and related overdose deaths. Psychostimulants include methamphetamine and other illegal drugs, such as cocaine and ecstasy, as well as prescription stimulants for conditions such as attention deficit hyperactivity disorder or depression. This funding helps support the National Drug Control Strategy and address the overdose epidemic. More information on this funding can be found here.
- On June 9, 2022, HHS, through HRSA, announced the launch of the Building Bridges to Better Health: A Primary Health Care Challenge, a national competition with a total of $1 million in cash prizes to encourage innovation through technical assistance to health centers. Competition participants will accelerate the development of low-cost, scalable solutions to help HRSA-supported community health centers improve patient access to primary care and strengthen the link between health care and social services. It is part of an ongoing effort by the Biden-Harris Administration to address social determinants of health and advance health equity. More information on this announcement can be found here.
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