• District of Columbia: Officials from HHS, CMS, and the Office for Civil Rights on Monday sent a letter to teaching hospitals and medical schools saying that they must obtain written informed consent before administering sensitive examinations, including pelvis and prostate exams, on patients. In 2020, an investigation from the New York Times found that hospitals, doctors, and doctors in training sometimes performed pelvic exams on women who were under anesthesia, even if they had not authorized the exams and they were not medically necessary. In the letter, the officials said that "[i]t is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent." HHS also issued guidelines that clarified a longstanding requirement that hospitals obtain written informed consent from patients if they want to participate in Medicare and Medicaid programs. (Goldberg, New York Times, 4/1)
• Maryland: CMS last week issued several proposed rules that would increase payments for skilled nursing facilities (SNFs), hospices, and inpatient psychiatric facilities (IPFs) for fiscal year (FY) 2025. For FY 2025, CMS proposed a 4.1% payment increase for SNFs, which is estimated to total $196.5 million. The proposed rule would also increase CMS oversight of SNFs and strengthen the agency's ability to issue financial penalties to ensure the immediate correction of any health and safety problems. Mark Parkinson, CEO of the American Healthcare Association, said the nursing home industry appreciates the payment rate increase, but that it would not be enough to cover the overall costs of the upcoming federal staffing mandate. In a separate rule, CMS proposed a 2.6% Medicare reimbursement increase for hospice operators in FY 2025. The rule also includes a 2.6% increase in the statutory aggregate cap. Finally, CMS proposed a 2.7% payment increase for IPFs in FY 2025, roughly equal to $70 million. (Eastabrook, Modern Healthcare, 3/28; CMS SNF proposed rule fact sheet, 3/28; CMS hospice proposed rule fact sheet, 3/28; CMS IPF proposed rule fact sheet, 3/28)
• New Jersey: Last week, CMS announced that Medicare will cover Novo Nordisk's weight-loss drug Wegovy for some patients with a history of heart disease. Now, several major health insurers, including Aetna, Elevance Health, and Kaiser Permanente, also plan to cover the drug for certain Medicare beneficiaries who have heart-related conditions. Elevance also noted that it would extend Wegovy coverage to individuals with commercial plans. While the coverage change will be effective immediately for some plans, others are planning to make the change over the next few weeks. According to a Novo spokesperson, the company is encouraged by recent changes to Wegovy's label and coverage, "[b]ut there's more work to be done because Part D coverage is still not available for obesity medicines when used for chronic weight management." (Rutherford et al., Bloomberg, 3/28; Loftus/Mathews, Wall Street Journal, 3/28)

The pharmaceutical market is experiencing significant shifts, and you need to be prepared. Explore the major trends shaping the industry, including the rise of high-cost drugs and the impact of changing policies, and find out what they mean for your organization.