House seeks to limit CMS' drug coverage authority after Aduhelm decision

 New bipartisan legislation seeks to limit regulators’ ability to restrict Medicare reimbursement of certain drugs in response to the Biden administration’s controversial Aduhelm decision. 

Reps. Vern Buchanan, R-Florida, and Nanette Barragan, D-California, introduced on Wednesday the Mandating Exclusive Review of Individual Treatments (MERIT) Act. The legislation would reform the Centers for Medicare & Medicaid Services (CMS) process for coverage determinations of new drugs. 

“The federal government should make it easier for seniors to access breakthrough treatments, not unreasonably restrict potentially life-changing drugs for our nation’s most vulnerable patients,” Buchanan said in a statement. 

Buchanan and Barragan’s bill is in response to how CMS handled Medicare coverage of Biogen’s Aduhelm, a controversial Alzheimer’s disease treatment. 

Back in April, CMS finalized a national coverage determination that targets not only Aduhelm but the entire class of treatments. CMS ruled that only Medicare patients in eligible clinical trials would get coverage for the monoclonal antibodies directed against amyloid plaques.

So far, the Food and Drug Administration has only approved Biogen’s Aduhelm in the class. However, more such drugs are in the pipeline, and their clinical efficacy has been disputed.

The legislation would require CMS to evaluate any new drugs or treatments individually instead of an entire class as in the Aduhelm decision. 

“By requiring CMS to review each drug individually, the MERIT Act will undo the actions taken by CMS that would otherwise unnecessarily limit access to drugs like Aduhelm for seniors,” according to a release on the legislation. 

Buchanan noted in a release that preliminary data have shown promising results for a drug similar to Aduhelm. 

The legislation has broad support from Alzheimer’s patient groups that vehemently fought the CMS decision. 

“This bill corrects a massive injustice by CMS against people with Alzheimer’s,” said George Vradenburg, chairman and co-founder of the group UsAgainstAlzheimer’s, in a statement. “The decision by CMS to deny coverage for the first class of disease-modifying Alzheimer’s treatments, including those still in clinical trials, was cruel and unconscionable.”

It remains unclear whether the legislation would get through Congress before the end of this session as lawmakers don’t come back until after the midterm elections next month. However, if Republicans take the House, Buchanan would be in line to lead the health subcommittee on the powerful Ways and Means Committee, which could help passage in the next session. 

CMS said in a statement it does not comment on pending legislation.

https://www.fiercehealthcare.com/payers/house-lawmakers-seek-limit-cms-drug-coverage-authority-after-aduhelm-decision