Below is Alston & Bird’s Health Week in Review, which provides a summary of the latest health regulations, notices and guidelines; federal legislation and congressional committee action; reports, analyzes and analyzes; and other health policy news.
Week in Review Weekly mention:
This week, CMS released the 2022 Strategic Framework White Paper outlining CMS’s strategic pillars and initiatives, and published a Year Review Report highlighting CMS’s achievements over the past year. Read more about this report and other news below.
I. Regulations, notices and guidelines
- On June 7, 2022, the Agency for Health Research and Quality (AHRQ) issued a statement: Common formats for collecting patient safety data. The AHRQ coordinates the development of common definitions and reports (Common Formats) for reports on the quality of health care and patient safety. The purpose of this announcement is to inform you that common event reporting formats are available – Diagnostic Safety (CFER-DS) Version 1.0.
- On June 7, 2022, the Food and Drug Administration (FDA) issued its final rule: Medical devices; Cardiovascular devices; Classification of Internal Bleeding Monitor. The FDA is classifying an internal bleeding monitor as Class II (special controls). Special controls for the device type are identified in this order and will be part of the coded language for the classification of the internal bleeding monitor. The FDA is taking this measure because the FDA has determined that the classification of the device in Class II (special controls) will provide a reasonable assurance of the safety and efficacy of the device. The FDA believes that this action will also improve access to beneficial innovative patient devices.
- On June 7, 2022, the FDA released a release. Medical devices; Availability of security and effectiveness summaries for pre-market approval applications. The FDA publishes a list of pre-market approval applications (MAPs) approved between January 1, 2021 and February 14, 2022. The purpose of this list is to provide information on the availability of safety and efficacy summaries of accepted PMAs over the Internet. and Agency File Management Staff.
- On June 8, 2022, the Office of Government Accountability (GAO) issued a statement entitled: Application for appointment to the Technical Advisory Committee of the Physician-in-Charge Payment Model. The Medical Payroll Technical Advisory Committee (PTAC) provides comments and recommendations to the Secretary of Health and Human Services (HHS) on payment models for physicians and has assigned the Director General to the appointment of its members. The GAO is now approving nominations for this committee. Selection letters and resumes must be submitted by July 11, 2022. Appointments will be made in October 2022.
- On June 10, 2022, the FDA released a release. The use of antimicrobial drugs in animal friends; Extension of comment period. The FDA is extending the deadline for comments on the February 16, 2022 Federal Register notice. In that announcement, the FDA requested comments on practices for the use of antimicrobial drugs in animal friends and their potential effects on antimicrobial resistance in humans and humans. animals. The FDA is taking this action in response to a request for an extension to give interested parties more time to submit comments. Comments must be submitted by September 14, 2022.
- On June 10, 2022, the FDA issued a corrective notice, entitled Draft Guidelines: Blood pressure and pulse donor eligibility requirements: compliance policy; Draft Industry Guide; Correction. The FDA is correcting the release that appeared in the Federal Register on May 24, 2022, on Tuesday, May 24, 2022. Blood pressure and pulse donor eligibility requirements: compliance policy; Draft Industry Guide. The draft guide document was published with incorrect information within the comment deadline. This document corrects this error by stating that comments must be submitted by July 25, 2022.
- On June 10, 2022, the GAO issued the following notice. Application for Health Information Technology Advisory Committee (HITAC) Candidates. HITAC provides recommendations on the National Health Information Technology Coordinator’s policy, standards, implementation specifications and certification criteria for the implementation of a health information technology infrastructure that promotes access to, exchange and use of health information. The GAO now approves nominations for HITAC appointments, which will take effect on January 1, 2023. From these selections, the GAO expects to appoint at least 4 new HITAC members, focusing on patients or consumers, health care providers, health care providers, and individuals. with technical experience with the quality of healthcare, system functions, privacy, security, and the exchange and use of health information. Letters of appointment and resumes must be submitted by July 22, 2022.
- On June 10, 2022, the National Institutes of Health (NIH) issued a statement entitled: Release of the list of members of the 2022 Performance Review Board (PRB) Senior Executive Service of the National Institutes of Health. In this announcement, the NIH announces the 2022 Senior Executive Service of the National Institutes of Health of the 2022 Performance Review Committee.
- June 17, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Immunization Practice Advisory Committee (ACIP). The agenda will include discussions on the use of COVID-19 pediatric vaccines. Voting (s) is scheduled. Agenda topics may vary depending on your preferences.
- October 13-14, 2022: The NIH announced a public meeting of the Board of Scientific Advisors of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The agenda will include presentations and an overview of the Board.
II. Congress hearings
- On June 7, 2022, the Senate Finance Committee held a hearing: President’s 2023 budget. Witnesses included Janet L. Yellen, Honorary Secretary of the United States Department of the Treasury.
III. Reports, Analyzes and Analyzes
- On June 6, 2022, the HHS Office of the Inspector General (OIG) published a report. Semester Report to Congress: October 1, 2021, March 31, 2022. This report summarizes the activities of HHS OIG for the 6 months ending March 31, 2022.
- On June 6, 2022, the Congressional Budget Office (CBO) released a cost estimate. S. 1435, Estimated Budgetary Consequences of the Cheap Patient Prescription Act 2021. S. 1435 would establish a legal framework for the Federal Trade Commission (FTC) to file lawsuits against manufacturers who make a “jump in products” and limit the number of patents that could be included in infringement claims for organic products.
- On June 6, 2022, the CBO released a cost estimate. S. 1428, Estimated Budgetary Consequences of the Preserve Access to Affordable Generics and Biosimilars Act. According to S. 1428, certain agreements used to resolve patent infringement claims between trademark, generic, or bio-similar drug sponsors and the sale of a drug or biological product would be deemed illegal.
- On June 6, 2022, the CBO released a cost estimate. 1425 S. Estimated Budgetary Implications for Significant Abuse and Loss of Time (Stop STALLING) Limiting the Legitimate Innovation of New Generics. S. 1425 would authorize the FTC to take civil action against the persons or entities involved in submitting certain petitions to the Food and Drug Administration.
- On June 6, 2022, the CBO released a cost estimate. HR 7667, Estimated Budgetary Consequences of the Food and Drug Change Act 2022. For activities related to the approval and marketing of prescription drugs and medical devices HR 7667, the FDA would re-authorize the collection and spending of user fees. The bill would also amend the Food, Drug, and Cosmetic Act to partially change the processes and procedures for regulating, manufacturing, and marketing prescription drugs, medical devices, and other medical products.
- On June 8, 2022, the Centers for Medicare and Medicaid Services (CMS) published a white paper. 2022 CMS Strategic Framework. The White Paper examines the strategic vision of the CMS based on its six strategic pillars and highlights the cross-cutting initiatives of the CMS to promote the goals highlighted by the strategic pillars and to improve attention to the critical components of the CMS work.
- On June 8, 2022, the CMS published a report. Examine one year: June 2021 – May 2022. The report highlights the main achievements of the CMS over the past year in each of its six strategic pillars, which support the CMS’s vision to provide meaningful, person-centered and fair care to the people it serves.
- On June 8, 2022, he published a report called the Congressional Research Service (CRS). Finding Medicare Service Fee (FFS) Payment System Rules: Schedules and Resources. This report contains information about Medicare FFS payment system rules in a quick reference table. Specifically, it includes the payment system of the tables, the main portals of the CMS website, the usual rules for making the rules, the statutory and regulatory requirements and the most recently issued regulations, public comments, final rules and subsequent amendments. The table includes links to applicable resources.
IV. Other Health Policy News
- On June 8, 2022, HHS, through the Health Resources and Services Administration (HRSA), announced a $ 15 million grant to address the misuse of psychostimulants and related overdose deaths in rural communities. 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 contributes to the National Drug Control Strategy and helps tackle the overdose epidemic. More information on this funding can be found here.
- On June 9, 2022, HHS, through the HRSA, announced its launch Building Bridges for Better Health: The Challenge of Primary Health Care, a national competition totaling $ 1 million in cash prizes to encourage innovation in health care through technical support. Participants in the competition will accelerate the development of low-cost scalable solutions to help HRSA-assisted community health centers improve access to primary care for patients and strengthen the link between health care and social services. It is part of the Biden-Harris Administration’s efforts to address social determinants of health and advance health equity. More information about this ad can be found here.