The HHS Office of Inspector General released a report highlighting concerns that nursing home residents with endangering behaviors, many of whom are diagnosed with mental health disorders and are long-term residents, may be especially vulnerable to facility-initiated discharges. OIG says CMS and state long-term care ombudsman have been flagging concerns about the extent to which nursing homes are following the federal protocol for discharging patients. Facility-initiated discharges that don’t follow federal regulations can be unsafe and traumatic, OIG says, which...

Regulation of nicotine products was a popular topic at a Thursday (April 11) House Committee on Oversight & Accountability hearing as lawmakers grilled FDA Commissioner Robert Califf about why the agency has failed to swiftly assess product applications for e-cigarettes while illicit products from China flood store shelves, but Califf defended FDA's approach by saying the agency is not resourced to deal with the flood of millions of applications for vaping products. Multiple lawmakers blamed FDA’s failure to quickly approve...

FDA Commissioner Robert Califf told lawmakers removing frivolous patents from the FDA-administered Orange Book is the responsibility of the Federal Trade Commission (FTC), but he also offered to work with Congress to tighten up patent oversight. The issue came up at a Thursday (April 11) hearing by the House Committee on Oversight and Accountability, where Califf was grilled on numerous topics, including Orange Book enforcement. Rep. Ro Khanna (D-CA) raised the concern of frivolous patents and pointed to Teva Pharmaceuticals...

The transition from fee-for-service to value-based care needs to move at a faster clip to meet the federal government’s goals for 2030, and policymakers could help accelerate the pace by strengthening incentives for provider participation, improving data integration and interoperability, and shaping models in a way that meets patients where they are, according to consensus recommendations from more than 70 health care executives who attended a January roundtable convened by the Healthcare Leadership Council, along with member companies AdventHealth and...

CMS is proposing a policy to boost the New Technology Add-on Payment (NTAP) to hospitals for gene therapies intended to treat sickle cell disease, a move Bloomberg health analyst Duane Wright says could benefit drug makers and hospitals in addition to patients and would be consistent with a separate administration proposal to improve access and utilization to expensive cell and gene therapies in Medicaid. CMS’ proposed inpatient hospital payment rule for fiscal 2025 includes a proposal to increase the NTAP...