Rx Drugs

If HHS waits until November to ban Medicare drug rebates, consistent with the department’s regulatory agenda, it would be too late to implement the new policy in 2020, sources say.

Maryland on Friday (May 24) became the first state to create a board that will study drug costs, and could be given the power to set drug pay rates. Maryland Gov. Larry Hogan (R) allowed the state legislature’s banner drug-pricing bill to become law without his signature.

The Federal Trade Commission said on Thursday (May 23) that while brand and generic drug makers settled patent disputes more often in fiscal year 2016 than prior years, only one of the agreements met the Supreme Court’s criteria of potentially being anticompetitive.

In a quick turn of events, the focus of drug-pricing legislation in the House shifted from Medicare negotiation to Part D reinsurance reform, which also is the approach that is being considered in the Senate.

FDA has once again officially delayed its planned release of a highly anticipated nonprescription drug proposed rule, although an FDA official said this week the agency hopes to get the rule out as soon as possible.

The Senate health committee’s bipartisan draft bill on lowering health care costs does not expand the Trump administration’s point-of-sale rebate proposal to the commercial market, after Chair Lamar Alexander (R-TN) said the proposal was being considered for inclusion.

CMS Administrator Seema Verma on Wednesday (May 22) said the agency is taking its time with a national Medicare coverage policy for new expensive hospital-administered cancer drugs, which was due to be published May 17 but was delayed, because the policy will affect coverage of drugs other than the two chimeric antigen receptor (CAR) T-cell therapies already on the market.

After legislative talks between House Speaker Nancy Pelosi (D-CA) and President Donald Trump ground to a halt Wednesday morning, Senate Finance Chair Chuck Grassley (R-IA), who is helping lead negotiations on health care policy, said the Senate was always in the driver’s seat in the drug-pricing debate.

The Trump administration’s spring regulatory agenda, released Wednesday (May 22), shows that two of HHS’ most disruptive drug-pricing regulatory actions -- its proposal to base Medicare Part B pay rates on foreign drug prices and its overhaul of the rebate system -- are set to be released later than originally anticipated.