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Radar On Market Access: PBM Regulation, Rebate Rule Are High on Legislative Agenda

Posted by Peter Johnson on Apr 1, 2021


As a new bill introduced by Sen. Bernie Sanders (I-VT) indicates, Congress is once again looking seriously at tackling drug pricing reform. D.C. insiders say that Democrats could pursue big changes to PBM regulation and Medicare's ability to negotiate drug prices, AIS Health reported.

Also, Congress could repeal the Trump administration’s so-called "rebate rule," which would have removed safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs and Medicare Part D plans.

Each of H.R. 3 , the new bill from Sanders, and a Senate bill sponsored by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) would implement out-of-pocket spending caps for Part D beneficiaries and considerably change how costs are divided up in the catastrophic phase of coverage. In each bill, Medicare would pay less, enrollees would pay nothing, and manufacturers and plan sponsors would pay more in the catastrophic coverage phase. H.R. 3 also would mandate more drug price transparency from manufacturers, allow HHS to negotiate prices for covered drugs, and set the maximum price for a drug at 120% of the average of prices in Australia, Canada, France, Germany, Japan and the United Kingdom.

Dan Mendelson, founder of Avalere Health, says that lowering drug prices is a popular policy.

"They need to pass something if they do it at all, because next year it's going to be the run-up to the [2022 midterm] election," Mendelson observes. "What sits on the other side of that is that these laws are exceedingly difficult to pass. I think there's…an intensified support for the pharmaceutical industry given their incredible performance in getting these COVID vaccines to market so quickly. And they are a force of nature when it comes to lobbying, so…it's likely that this stuff will get tempered a lot."

Further complicating matters is Democrats' narrow majority in the Senate. A standalone drug reform bill is unlikely to garner support from enough members of the upper chamber.

As the American Rescue Plan was passed through the budget reconciliation process, eliminating the rebate rule is likely to be part of the next package. The rebate rule would be costly but hasn't actually been implemented, so eliminating it would create a massive savings on paper without the political cost that would come from cutting a real program of similar scale.

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Topics: Industry Trends, Market Access, Payer