Last week, Texas Attorney General Ken Paxton filed a complaint in federal district court against HHS and the Office for Civil Rights (OCR) challenging a recently issued rule strengthening protection of protected health information (PHI) related to reproductive health. As summarized in a previous post, the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (Final Rule), generally prohibits disclosure or use of PHI by a covered entity or their business associate for purposes of criminal, civil, or administrative investigations into persons for seeking, obtaining, providing, or facilitating reproductive health care under lawful circumstances. In its complaint, Texas argues that the Final Rule is unlawful and seeks to have it vacated.

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program (MPN or Program). In all, reactions to the MPN results varied: Reuters reported that executives from four of the manufacturers selected in the first round of negotiations stated that they do not expect the negotiated prices to significantly impact their businesses; meanwhile, in its press release announcing the maximum fair prices (MFPs), CMS touted an estimated $1.5 billion in Medicare prescription drug out-of-pocket cost savings for Medicare beneficiaries when the negotiated prices go into effect in 2026. 

On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil Monetary Penalties Law (CMPL) with clarifications regarding waiving patients’ cost-sharing amounts pursuant to health care providers’ financial assistance policies. The new FAQs (FAQs #13-16) reiterate the OIG’s longstanding position that hospitals and other health care providers may provide financial assistance to Medicare and Medicaid beneficiaries on the basis of financial need. Of note, the OIG also provides some guidance on the distinction between marketing and advertising to patients as opposed to making patients aware about the availability of financial assistance, and this guidance may be useful in a variety of contexts beyond cost-sharing waivers. 

In the Proposed Medicare Advantage and Part D Rules for 2025, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to how Medicare Advantage organizations (MAOs) are allowed to contract with and compensate entities that provide agent/broker and enrollment services.  The proposed rules were heavily disfavored by entities that provide such services, but were not widely commented on by MAOs or Part D sponsors (PDP Sponsors), which are the entities to which the rules actually apply.

A recent court split about whether awards granted through arbitration under the No Surprises Act (NSA) are enforceable through litigation has created uncertainty around an already complicated process.  A Texas judge recently held that the NSA does not grant parties a right to bring suit to enforce arbitration awards, while last year a New Jersey court granted enforcement of a similar award.  The resulting split raises questions about the enforceability and utility of the NSA and its Independent Dispute Resolution (IDR) process.