With the future of medical exploration chilled by unelected bureaucrats, Ways and Means Health Subcommittee Republican Leader Rep. Vern Buchanan (R-FL) introduced bipartisan legislation to help ensure coverage of potentially life-saving drugs and new treatments for Medicare beneficiaries.

Rep. Buchanan said:

“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. Unfortunately, the Biden administration and Democrats in Washington have continuously pursued policies that will stifle innovation, halt progress toward revolutionary cures and move manufacturing overseas – particularly to China.”

Background:

Earlier this year, bureaucrats at the Centers for Medicare and Medicaid Services (CMS) took the unprecedented move to unilaterally restrict coverage for the first new treatment for Alzheimer’s disease (Aduhelm) in nearly two decades, despite the drug receiving approval from the Food and Drug Administration’s (FDA) rigorous gold-standard process. In doing so, CMS cast a very wide net by restricting coverage of any similar drugs in its class.

Following CMS’s decision, one medical company slowed its timeline of its experimental Alzheimer’s drug, which experts warned is just one example of how CMS’s overreach will “affect the exploration for new treatments” for years to come. 

To protect similar drugs from future bureaucratic overreach, the Mandating Exclusive Review of Individual Treatments (MERIT) Act requires the CMS to evaluate treatments and cures individually and based on their own merits, rather than as a broad class of drugs.

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. With additional drugs to treat Alzheimer’s preparing to come to market soon, this bill will ensure those drugs receive fair and accurate consideration for coverage, rather than requiring onerous additional steps before CMS will make them available to Medicare beneficiaries. For example, just this week, preliminary data for a second drug to treat Alzheimer’s in the same way as Aduhelm was released and showed promise in slowing the progression of this horrible disease.

What Leading Alzheimer’s Groups Are Saying About the MERIT Act:

The MERIT Act is supported by the Alzheimer’s Association, UsAgainstAlzheimer’s and the Global Alzheimer’s Platform Foundation.

Robert Egge, Alzheimer’s Association chief public policy officer and Alzheimer’s Impact Movement (AIM) executive director said:

“No two treatments are the same, even if they are in the same class of drug, and CMS should not determine coverage based on type of treatment. Thank you to Representatives Buchanan and Barragan for introducing this critical, bipartisan legislation and supporting people living with Alzheimer’s and all other dementia.”

George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s, said:

“This bill corrects a massive injustice by CMS against people with Alzheimer’s. 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. Further, for the first time in history, CMS refused to cover an FDA-approved drug, discriminating against millions of people living with this disease. This bill will help ensure CMS reviews each drug based on its own merits and prevent the agency from making uninformed blanket coverage decisions in the future.”

John Dwyer, president of the Global Alzheimer’s Platform Foundation said:

“We strongly support Congressman Buchanan’s proposed changes to Medicare’s NCD process. The changes are needed to avoid unwarranted bureaucratic delays and ensure access to new therapies for patients with Alzheimer’s or other life-threatening diseases.”

Similarly, the FDA just approved a new drug to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, the third drug available to treat ALS symptoms available in the United States. Without legislation like the MERIT Act requiring consideration of each drug on its own merits, CMS could implement another overly restrictive decision for any new ALS drugs based on just this one, which would inhibit access to new treatments for the nearly 30,000 ALS patients across America.