We are pleased to provide our most recent installment of the bi-weekly regulatory reports intended to keep PHA members informed on regulatory changes of interest to our industry. McGuireWoods, PHA’s legal counsel, produced the report.

1.         CMS Announces Updates to Medicare Advantage and Part D Rates. On April 4, the Centers for Medicare and Medicaid Services (CMS) announced Medicare Advantage (MA) Capitation Rates and Part C and D Payment Policies for Calendar Year (CY) 2023. The announced rates and policies are reflective of comments submitted to CMS in response to the Advance Notice of Methodological Changes for CY 2023 MA Capitation Rates and Part C and D Payment policies published on February 2. The announcement can be found here, and CMS’s fact sheet can be found here.

2.         CMS Releases Proposed Rule with Updates for the Inpatient Psychiatric Facilities Prospective Payment System. On March 31, CMS released a proposed rule titled “Medicare Program: Fiscal Year 2023 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update and Quality Reporting.” The proposed rule would make updates to prospective payment rates, the outlier threshold and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF). The proposed rule would also establish a mitigation policy to facilitate the yearly changes in IPF payments. The changes are summarized in this CMS fact sheet. The proposed changes would be in effect from October 1, 2022, to September 30, 2023.

Public comments will be accepted until May 31, 2022.

3.         COVID-19 Vaccine and Treatment Updates. On April 5, the Food and Drug Administration (FDA) revoked its emergency use authorization (EUA) for GlaxoSmithKline’s COVID-19 monoclonal antibody sotrovimab. Sotrovimab is likely ineffective against the COVID-19 BA.2 subvariant, which is estimated to account for a majority of COVID-19 cases in all regions of the United States.

On March 29, the Centers for Disease Control and Prevention (CDC) recommended that all adults over 50 years of age and immunocompromised children 12 and older receive an additional COVID-19 booster shot.

4.         Cybersecurity Bills Introduced in the Senate. On March 24, Senators Jacky Rosen (D-NV) and Bill Cassidy (R-LA) introduced the Healthcare Cybersecurity Act. The bill would direct the Cybersecurity and Infrastructure Security Agency (CISA) to work with the Department of Health and Human Services (HHS) to improve healthcare and public health cybersecurity.

On April 1, Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduced the Protecting and Transforming Cyber Health Care (PATCH) Act. The bill would require manufacturers seeking premarket approval from the Food and Drug Administration (FDA) to meet cybersecurity requirements. The bill would also require that a plan be developed to monitor and address threats to postmarket cybersecurity.