Rx Drugs

The House Energy & Commerce Committee approved 32 opioid-related bills on Thursday (May 17), including a bill that would weaken privacy protections for medical records containing information about substance use disorders and a watered-down version of a bill that would allow Medicaid to cover treatment for opioid use disorder in large inpatient treatment centers.

The House will vote next week on the Right to Try bill passed out of the Senate last August, House leadership said Thursday.

CMS' Medicare Evidence Development & Coverage Advisory Committee will meet in August to consider a National Coverage Determination for chimeric antigen receptor (CAR)-T cell therapies after UnitedHealthcare requested such a determination to make sure there is a level playing field across Medicare for coverage of the expensive therapies.

Specialists with a big stake in Part B warn HHS that following through with the administration’s proposal to let Part D plans negotiate Part B drug prices would cause patients to face access restrictions in Part D that they don’t have to deal with in Part B.

House appropriators added to their FDA spending bill Wednesday (May 16) a measure calling for FDA to analyze MedWatch data to see whether certain television advertisements -- specifically those from legal firms or marketing firms that warn consumers of dangers associated with specific medicines -- affect medication adherence.

HHS Secretary Alex Azar on Wednesday (May 16) hit back at the drug industry for criticizing the administration’s proposal to move Medicare Part B drugs into Part D, and he said the announcement on how HHS will execute that policy is coming soon.

A Pharmaceutical Research and Manufacturers of America executive on Tuesday (May 15) criticized several policies that HHS is considering to lower drug costs: moving Medicare Part B drugs to Part D, replacing the Part B doctor-reimbursement system with the Competitive Acquisition Program, encouraging plans to restrict the use of drugs in protected classes, removing the two-drug per-class rule in Part D, basing Medicaid’s average manufacturer price calculation on commercial-market net prices and removing the cap on price-inflation penalty in Medicaid.

Facing a White House mandate to study whether FDA can require disclosure of drug list prices in direct-to-consumer ads, FDA Commissioner Scott Gottlieb insinuated it was an open question whether list prices are the best way to inform consumers of a drug’s potential out-of-pocket cost.

FDA Commissioner Scott Gottlieb has fulfilled his promise to contact supply chain intermediaries and discourage them from entering into so-called voluntary restricted distribution systems that block generic companies from buying samples needed for FDA-required testing, however his pressure to date has not been successful.