United States: Alston and Birds Health Care Week in Review, January 7, 2022
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Below, Alston & Bird’s Healthcare Week Review, which provides a summary of the latest health care regulatory news, advice and guidance; federal legislation and the work of congressional committees; reports, studies and analyzes; and other health policy news.
Weekly review Highlight of the week:
This week, CMS released the CY 2023 Medicare Advantage and Part D of the proposed rule. Learn more about this proposed rule and other news below.
I. Regulations, notices and guidelines
- On December 28, 2021, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule titled, Patient Protection and Affordable Care Act; HHS Benefit Notice and Payment Parameters for 2023. This proposed rule includes the proposed payment parameters and provisions for risk adjustment and risk adjustment data validation programs, as well as the proposed user fee rates for 2023 for issuers offering risk adjustment plans. health professionals (PSQ) through Federal-facilitated and State-facilitated Exchanges on the Federal Platform. This proposed rule also proposes requirements related to the prohibition of discrimination based on sexual orientation and gender identity; guaranteed availability; offering standardized QHP options via exchanges on the federal platform; requirements for agents, brokers, online brokers, and issuers helping consumers register through exchanges that use the federal platform; auditing standards related to employer-sponsored coverage; Exchange eligibility determinations during a benefit year; verification of the special registration period; cost sharing requirements; Essential health benefits (BSE); Actuarial value (VA); QHP issuers quality improvement strategies; accounting for expenses related to quality improvement activities (AIQ) and supplier incentives for medical claim ratio (MLR) reporting and discount calculation purposes; re-enrollment and requirements for a new State Exchange Inappropriate Payments Measurement Program.
- On January 6, 2022, the Department of Health and Human Services (HHS) issued a notice titled, Tenth Amendment to the Declaration under the Public Preparedness and Emergency Preparedness Act for Medical Countermeasures against COVID-19. The Secretary is issuing this amendment pursuant to Section 319F-3 of the Public Health Service Act to extend the power of certain qualified persons authorized to prescribe, dispense and administer seasonal influenza vaccines under Section VI of the this statement.
- On January 6, 2022, CMS released a proposed rule titled, Health insurance program; Contract year 2023 Changes to the policy and techniques of the Medicare Advantage and Medicare Prescription Drug Benefit programs. This proposed rule would revise the Medicare Advantage (MA) (Part C) and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, star rating. , network adequacy, medical loss rate reporting, special disaster or public emergency requirements, and drugstore price discounts. This proposed rule would also revise the regulations relating to Dual Eligibility for Special Needs (D-SNP) plans, other special needs plans and cost contracting plans.
- On January 7, 2022, the Office of the Inspector General (OIG) of HHS issued a final rule titled: State Medicare and Health Care Programs: Fraud and Abuse; Procedures for submitting requests for advisory opinions to the OIG and issuing advisory opinions by the OIG. In this final rule, OIG amends the regulations governing the procedures for submitting requests for advisory opinions to, and the issuance of advisory opinions by, OIG.
- January 25, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Institute of Nursing Research National Advisory Council for Nursing Research. The meeting agenda includes a discussion of policies and program issues.
- February 11, 2022: The NIH announced a public meeting of the National Eye Institute (NEI) National Advisory Eye Council. The agenda for the meeting will include a presentation of the NEI Director’s report, discussion of NEI programs and concept approvals.
- February 16, 2022: The Food and Drug Administration (FDA) announced a meeting of the Public Advisory Committee of the Anesthetic and Analgesic Pharmaceuticals Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the FDA on regulatory matters.
- Various dates: The Department of Health and Human Services (HHS) announced the 2022 public meetings of the Physician-Centered Payment Model (PTAC) Technical Advisory Committee. These meetings include deliberations and votes on the Physician-Centric Payment Model (PFPM) proposals submitted by individuals and stakeholders and may include discussions on topics related to current or previously submitted PFPMs.
- Various dates: The Federal Emergency Management Agency (FEMA) has announced several meetings as part of the action plan to establish a national strategy for the coordination of national multimodal health care supply chains to respond to COVID19, in order to implement the voluntary agreement for the manufacture and distribution of essential health resources needed to respond to a pandemic.
II. Congressional hearings
No congressional hearing was scheduled this week.
III. Reports, Studies & Analyzes
- On January 4, 2022, HHS OIG released a report titled, COVID-19 testing led to an increase in Medicare Part B’s total spending on lab tests in 2020, while use of non-COVID-19 tests declined significantly. This data sheet provides an analysis of Medicare payments for lab tests in 2020. The HHS OIG found that Medicare Part B spending for lab tests in 2020 was affected by significant new spending for COVID-testing. 19, a type of test that did not exist before the pandemic. Overall spending rose from $ 7.7 billion in 2019 to $ 8.0 billion in 2020. This increase in spending was driven by $ 1.5 billion in new spending for COVID-19 testing, including 1 $ 0 billion for a rapid COVID-19 test, which was the number 1 test by spend. Aside from COVID-19 testing, spending on all other tests, as a group, declined by approximately $ 1.2 billion in 2020. The drop in spending is due to a sharp drop in non-COVID testing -19 in the first few months of the pandemic, as well as further reductions in payment rates for some of these tests, as required by Medicare Access Protection Act, 2014.
IV. Other health policy news
- On January 3, 2022, the HHS announced that effective January 1, 2022, the new federal protections championed by the Biden-Harris administration will protect millions of consumers from surprise medical bills, unexpected bills from an off-grid provider. , outside of network facility or off-network air ambulance supplier. The protections, put in place as part of the Law without surprises, prohibit surprise billing in private insurance for most emergency care and many cases of non-urgent care. They also require uninsured and self-paid patients to receive key information, including overviews of anticipated costs and details of their entitlements. More information on this announcement can be found here and a fact sheet on the Act can be found here.
- On January 3, 2022, the FDA amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand the use of a single booster dose to include use in people aged 12 to 15; shorten the time between the end of the primary series of Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months; and allow a third dose of the primary series for certain immunocompromised children aged 5 to 11 years. You can find more information about this action here.
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