House Energy and Commerce Holds Medicaid Policy Hearing: On Tuesday, the House Energy and Commerce Subcommittee on Health held a hearing regarding Medicaid reimbursement and improper payments. The featured panelist was CMS Director of the Center for Medicaid and CHIP Services Daniel Tsai, who voiced support for President Biden’s proposed $150 billion investment in home and community-based services. Republican legislators repeatedly voiced support for HR 8114, which would overturn the recently finalized rule on nursing home staffing requirements.  

Senate Finance and House Energy and Commerce Hold Hearings on Change Healthcare Cyberattack: On Wednesday, both the Senate Finance and House Energy and Commerce Subcommittee on Oversight held hearings on the cause and fallout of the Change Healthcare cyberattack. Legislators from both sides of the aisle voiced harsh criticisms to UnitedHealth CEO Andrew Witty and the company’s failure to institute multifactor authentication across all servers and provide potentially affected patients with HIPAA breach notices. There was also some bipartisan discussion over consolidation and its cost and privacy implications.

Senate Finance Chairman and Ranking Member Release Drug Shortage Legislation. Today, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released draft legislation on drug shortages. The Drug Shortage Prevention and Mitigation Act would update Medicare policy and focuses on group purchasing organizations, providers such as hospitals and physician offices, and generic drug manufacturers of injectable/infusible drugs. Policies will reward hospitals for business practices that ensure an adequate supply of drugs, including buffer stock incentives and minimum volume and duration contracting for applicable generics. The Committee welcomes comments, sent by email to DrugShortages@finance.senate.gov, by June 6. A one-page summary of the discussion draft can be found here.  A section-by-section summary can be found here. The legislative text can be found here.

FTC Finalizes Noncompete Rule: On April 23, the Federal Trade Commission finalized a rule banning noncompetes nationwide. The FTC said in their ruling they hope to raise average wages and kickstart new business ventures, yet nonprofit health centers, which make up 60% of all hospitals, are now waiting for further exemption guidance. Hospital trade groups also oppose the rule, believing they make it harder for for-profit hospitals to retain employees and compete against nonprofits in their markets.

FTC Sends Orange Book Patent Dispute Letters: On Tuesday, the Federal Trade Commission sent letters to 10 drugmakers warning them that hundreds of patent listings for 20 drugs are invalid. The agency said such listings keep drug prices high by stalling generic competition.  The FDA will now contact the drugmakers regarding the disputes. The companies will then have 30 days to withdraw or amend the listings.

HHS Finalizes Non-Discrimination Rules: On April 26 and 30, HHS finalized two rules strengthening section 1557 of the Affordable Care Act, banning all gender- and sex-based discrimination in healthcare organizations or in any HHS grant program. The first finalized rule codifies protections for LGBTQ+ populations, while the second extends 1557 non-discrimination requirements to HHS grant programs.

Hospitals No Longer Required to Report COVID Data: April 30 marked the official end for hospital data reporting requirements that have been in place since the early days of the COVID-19 pandemic. Hospitals are no longer required to report their COVID-19 data to the CDC’s National Healthcare Safety Network.

HHS Finalizes HIPAA Protections for Reproductive Care: On April 22, the HHS released a final rule to assure patient privacy under HIPAA for those seeking and administering lawful reproductive healthcare. In their statement, HHS Secretary Xavier Becerra said this rule provides “stronger protections to people seeking lawful reproductive health care regardless of whether the care is in their home state or if they must cross state lines to get it.”

FDA Finalizes Laboratory Developed Tests Oversight Rules: On Monday, the FDA finalized a rule explicitly stating its oversight authority of laboratory-developed tests. In the proposed process, all lab tests will be required to register with FDA and report problems or errors. Based on this information, FDA will be able to target problematic tests. Importantly, however, the FDA decided that the thousands of tests currently on the market will not have to undergo federal review.