• District of Columbia: The Federal Trade Commission (FTC) on Friday finalized a rule aimed at restricting the data that digital health apps share with tech companies. Under the Health Breach Notification Rule, vendors managing digital health records — including health apps — that aren't covered by HIPAA will be required to notify individuals, FTC, and, in some cases, the media, of any breach of unsecured personally identifiable health data. FTC defined this data as traditional health information like diagnoses and medications, as well as data collected from fitness trackers and "emergent health data," or health information inferred from location data or health-related purchases. (Landi, Fierce Healthcare, 4/26)
• District of Columbia: The U.S. District Court for the District of Columbia on Friday dismissed a lawsuit brought by the National Association for Home Care and Hospice (NAHCH) against HHS and CMS over Medicare home healthcare payment calculations. In 2020, CMS introduced the Patient-Driven Groupings Model as a new way to calculate Medicare home health pay rates by tying reimbursements to patient characteristics. In 2023, NAHCH sued the Biden administration challenging the method CMS used to reduce payments by 3.9% in fiscal year 2023. The court ruled that NAHCH didn't exhaust all possible administrative fixes before they filed a lawsuit since it skipped an agency process aimed at seeking expedited review of a new reimbursement method. (Eastabrook, Modern Healthcare, 4/29)
• New Jersey: Judge Zahid Quraishi of the U.S. District Court for the District of New Jersey on Monday ruled that Medicare's drug price negotiations program is constitutional and said drugmakers failed to show they're legally compelled to sell drugs to Medicare patients. "The program neither requires nor forces plaintiffs to give or sell their drugs to defendants," Quraishi wrote, citing other opinions from district judges in Ohio and Delaware who similarly found that drugmakers aren't legally required to participate in the Medicare program. Drugmakers have argued that the Medicare program is large enough that it would be financially ruinous for them to not participate in the program. In his opinion, Quraishi wrote that "manufacturers selected to participate in the program will not face any fee, tax, or fine if they initially choose not to participate in the program," and since drugmakers aren't forced to participate in Medicare, they couldn't be compelled to violate their First Amendment right to free speech by agreeing to a "fair market price" as they alleged. (Zhang, STAT+ [subscription required], 4/29)

CMS announced a list of the first 10 drugs that will be eligible for price negotiations under the Inflation Reduction Act (IRA). What does this tell us about the future of Medicare drug price negotiation? Advisory Board's Lindsey Paul and Chloe Bakst share six things the selected drugs reveal about HHS' strategy.