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 issued the CY 2023 Medicare Advantage and Part D Proposed Rule. Read more about this proposed rule and other news below.
I. Regulations, Notices & Guidance
- On December 28, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2023. This proposed rule includes proposed payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs, as well as proposed 2023 user fee rates for issuers offering qualified health plans (QHPs) through federally-facilitated Exchanges and State-based Exchanges on the Federal platform. This proposed rule also proposes requirements related to prohibiting discrimination based on sexual orientation and gender identity; guaranteed availability; the offering of QHP standardized options through Exchanges on the Federal platform; requirements for agents, brokers, web-brokers, and issuers assisting consumers with enrollment through Exchanges that use the Federal platform; verification standards related to employer sponsored coverage; Exchange eligibility determinations during a benefit year; special enrollment period verification; cost-sharing requirements; Essential Health Benefits (EHBs); Actuarial Value (AV); QHP issuer quality improvement strategies; accounting for quality improvement activity (QIA) expenses and provider incentives for medical loss ratio (MLR) reporting and rebate calculation purposes; reenrollment, and requirements related to a new State Exchange improper payment measurement program.
- On January 6, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Tenth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19. The Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer seasonal influenza vaccines under section VI of this Declaration.
- On January 6, 2022, CMS issued a proposed rule entitled, Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs. This proposed rule would revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, Star Ratings, network adequacy, medical loss ratio reporting, special requirements during disasters or public emergencies, and pharmacy price concessions. This proposed rule would also revise regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans.
- On January 7, 2022, the HHS Office of Inspector General (OIG) issued a final rule entitled, Medicare and State Health Care Programs: Fraud and Abuse; Procedures Regarding the Submission of Advisory Opinion Requests to, and the Issuance of Advisory Opinions by, OIG. In this final rule, OIG is amending the regulations governing the procedures for the submission of advisory opinion requests 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's National Advisory Council for Nursing Research. The meeting agenda includes a discussion of Program Policies and Issues.
- February 11, 2022: NIH announced a public meeting of the National Eye Institute (NEI) National Advisory Eye Council. The meeting agenda will include a presentation of the NEI Director's report, discussion of NEI programs, and concept clearances.
- February 16, 2022: The Food and Drug Administration (FDA) announced a public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues.
- Various Dates: The Department of Health and Human Services (HHS) announced the 2022 public meetings of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). These meetings include deliberation and voting on proposals for physician-focused payment models (PFPMs) submitted by individuals and stakeholder entities and may include discussions on topics related to current or previously submitted PFPMs.
- Various Dates: The Federal Emergency Management Agency (FEMA) announced several meetings under the Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to COVID19, to implement the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic.
II. Congressional Hearings
No Congressional hearings were scheduled for this week.
III. Reports, Studies & Analyses
- On January 4, 2022, HHS OIG published a report entitled, COVID-19 Tests Drove an Increase in Total Medicare Part B Spending on Lab Tests in 2020, While Use of Non-COVID-19 Tests Decreased Significantly. This data brief provides an analysis of Medicare payments for lab tests in 2020. HHS OIG found that Medicare Part B spending on lab tests in 2020 was affected by significant new spending on COVID-19 tests, a type of test that did not exist before the pandemic. Overall spending increased 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 on COVID-19 tests, including $1.0 billion on a rapid COVID-19 test, which was the number 1 test by spending. Aside from COVID-19 tests, spending for all other tests, as a group, decreased by about $1.2 billion in 2020. The decline in spending was driven by a sharp decline in non-COVID-19 tests during the early months of the pandemic, as well as further reductions in payment rates for some of these tests, as required by the Protecting Access to Medicare Act of 2014.
IV. Other Health Policy News
- On January 3, 2022, HHS announced that beginning January 1, 2022, new federal protections championed by the Biden-Harris Administration will shield millions of consumers from surprise medical bills—unexpected bills from an out-of-network provider, out-of-network facility or out-of-network air ambulance provider. The protections, implemented under the No Surprises Act, ban surprise billing in private insurance for most emergency care and many instances of non-emergency care. They also require that uninsured and self-pay patients receive key information, including overviews of anticipated costs and details about their rights. More information on this announcement can be found here and a fact sheet on the Act can be found here.
- On January 3, 2022, 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 individuals 12 through 15 years of age; shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months; and allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age. More information about this action can be found here.
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