- HHS has scrapped plans to issue sweeping regulations clarifying the federal 340B drug pricing program in light of a court ruling against another 340B rule. Drug manufacturers, hospitals and pharmacies have been waiting since last spring for what they call a “mega-reg,” a regulation that may narrow the reach of the drug discount program. The change in direction stems from a lawsuit filed last year by the Pharmaceutical Research and Manufacturers of America, which sued HHS over a rule that required drugmakers to offer reduced prices for orphan drugs if they were used for non-orphan conditions. Orphan drugs are some of the most expensive drugs sold in the U.S. A judge struck down that rule but the HHS agency that oversees the 340B program eventually re-issued the policy as an interpretative rule.
- A federal appeals court last week upheld a path devised by the Obama administration allowing religious not-for-profits to avoid paying for contraception under the Affordable Care Act. In a 3-0 decision, the U.S. Court of Appeals for the District of Columbia Circuit rejected a challenge by the groups, which claimed the accommodation still imposes a substantial burden on their expression of religion. The ACA requires that women covered by group health plans be able to acquire FDA-approved contraceptive methods at no additional cost. In response to religious groups, the government devised the work-around, but the groups continued to oppose the regulations.
- The Joint Commission last week recognized 620 hospitals as top performers, up 53% from 405 hospitals last year. The designation is based on hospitals' performance during 2011 across 45 accountability measures in areas such as pneumonia care, heart-failure care and inpatient psychiatric services. To make the list, hospitals had to receive a composite score of 95% or above on all of the accountability measures they reported to the organization. Top-performing hospitals also needed to meet or exceed the 95% performance mark on each of the individual accountability measures they reported.
HHS scraps plans to clarify 340B drug pricing program regs, and other briefs
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