Hospitals that sued CMS over cuts to reimbursement for 340B drugs are asking the court to make CMS recalculate payments to make up for those cuts, but the government says that would require all hospital outpatient payments be recalculated in order to keep the pay system budget neutral and tells the court to let CMS figure out how to fix the situation.

Hospitals are asking a federal court to give CMS 30 days to scrap its plans to continue lower reimbursement for 340B drugs in 2019, as the court already found the 2018 pay cuts beyond the scope of the agency’s authority.

CMS will require hospitals that administer the expensive new CAR-T gene therapy to participate in a clinical registry or study aimed at determining whether real-world results mirror those from clinical trials used to get the treatments approved, according to a national coverage determination published Friday (Feb. 15) for chimeric antigen receptor (CAR) T-cells therapy.

House Ways & Means Chairman Rep. Richard Neal (D-MA) said Tuesday (Feb. 12) that he asked HHS Secretary Alex Azar to consider making prescription drug makers pay rebates to Medicare if they hike Part B drug prices faster than the rate of inflation.

FDA on Friday (Feb. 15) finalized a compounding rule that, for the first time, places six bulk drug substances on the list of bulk substances that can be used by compounders not registered as outsourcing facilities -- also known as the 503A bulks list.

Rep. Lloyd Doggett (D-TX) reintroduced his bill requiring hospitals notify patients if the care they are receiving is out of their insurance network, joining efforts by several other Capitol Hill lawmakers to cut back on surprise billing practices.

The federal judge overseeing two lawsuits challenging Medicaid work requirements scheduled back-to-back hearings in the cases for March 14.

FDA took another step toward encouraging more generic drug development by unveiling draft guidance on Friday (Feb. 15) that explains how drug developers can apply for the competitive generic therapy pathway, which is intended for generic versions of drugs that have little-to-no competition on the market.