Bipartisan legislation would ensure fair Medicare coverage consideration for new drugs
FOR IMMEDIATE RELEASE
April 7, 2023
(202)-538-2836
WASHINGTON, D.C. – Today, Reps. Nanette Barragán (CA-44) and John Joyce, M.D. (PA-13) reintroduced legislation that would require the Centers for Medicare & Medicaid Services (CMS) to consider covering new, innovative treatments when enough data is collected on the drug’s effectiveness. The legislation will ensure that as new treatments become available CMS considers each drug individually to determine whether it should be covered by Medicare.
“I know the impact of Alzheimer’s firsthand — I’ve watched my mom struggle with Alzheimer’s over the last several years. Her disease is so advanced that she is no longer able to benefit from scientific, breakthrough therapies that could improve her condition. However, there are still other people out there who can benefit. Last year’s decision by CMS to apply its coverage decision to an entire class of drugs continues to be detrimental to the millions of families and individuals suffering from this heartbreaking disease” said Congresswoman Barragán. “We must work to ensure these breakthrough therapies are accessible. This legislation is a crucial step forward for ensuring that Medicare beneficiaries have access to new drugs when enough data is collected on the product.”
“Ensuring that patients affected by Alzheimer’s disease have access to life-altering treatments must remain one of our top priorities in Congress,” said Rep. Joyce. “The Access to Innovative Treatments Act would support the more than 280,000 Pennsylvanians who have been diagnosed with Alzheimer’s by offering the ability to potentially obtain medications that could slow or halt the progression of this disease.”
On January 6, 2023, the U.S. Food and Drug Administration (FDA) granted the accelerated approval of Lecanemab, the second of an innovative and new category of monoclonal antibodies (mAbs) therapy for the treatment of early-stage Alzheimer’s disease. Following this, the Veterans Health Administration (VHA) announced they will provide coverage of Lecanemab. In sharp contrast, CMS’ policy continues to tightly restrict access to FDA-approved treatments for people living with Alzheimer’s disease. Despite new data demonstrating the clinical effectiveness of new mAB therapies for the treatment of Alzheimer’s disease since the release of its decision last year, CMS denied the Member of Congress’ request and stakeholder’s request to change its coverage policy.
On April 7, 2022, CMS finalized a National Coverage Determination (NCD) that monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease be covered for Medicare beneficiaries only under CMS’ Coverage with Evidence Development (CED) pathway. This decision restricts coverage for these products to randomized controlled trials approved by the CMS and severely limits access to this entire class of drugs. As a result, less than 1% of Medicare beneficiaries can access currently available treatments and new FDA-approved treatments will be subject to the same coverage restrictions regardless of the drug’s effectiveness.
“Last year’s decision by CMS to effectively deny coverage to the entire first class of Alzheimer’s treatments, without even seeing each drug’s data, was a devastating blow to people living with Alzheimer’s,” said George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s. “As the data are now becoming available on new treatments, we are seeing clearly that each drug is different, which confirms that each should be evaluated on its own merits. That’s how science works, and this bill would ensure that is how CMS would approach future decisions regarding Medicare coverage.”
“We are grateful to Reps. Barragán and Joyce for their leadership to ensure Medicare coverage of FDA-approved treatments. Their bipartisan Access to Innovative Treatments Act would ensure CMS determines coverage on a treatment-by-treatment basis, rather than by class of drug,” said Robert Egge, Alzheimer’s Association Chief public policy officer and Alzheimer’s Impact Movement (AIM) executive director. “People living with Alzheimer’s are currently being denied access to FDA-approved treatments because CMS made a blanket decision about a class of treatments. We appreciate congressional champions like Barragán and Joyce for supporting people living with Alzheimer’s and all other dementia.”
“The Access to Innovation Treatments Act is a critical piece of legislation that will improve the lives of many patients and families impacted by Alzheimer’s disease. It is imperative that CMS choose to cover the new, innovative treatments being developed to treat Alzheimer’s when clinical evidence indicates its effectiveness. We urge Congress to act now on this critical issue. Families deserve the chance to see their loved one’s age happily, safely, and in the best possible health; CMS must give them that chance” said Dr. Yanira Cruz, President & CEO, National Hispanic Council on Aging.
The Access to Alzheimer’s Treatments Act, creates a fair and transparent process for ensuring that CMS responds and reconsiders drugs for Medicare coverage when enough data is collected on the drug’s effectiveness:
- CMS must open reconsideration of applications within 30 days of notification that a drug under CMS’ coverage with evidence development (CED) program is effective & complete reconsideration with 90 days of this notification
- CMS may not implement limited coverage policies (i.e., CEDs) for an entire class of drugs.
The following organizations have endorsed the bill: UsAgainstAlzheimer’s, Alzheimer’s Association, Alzheimer’s Impact Movement (AIM), National Hispanic Council on Aging, and Alliance for Aging Research.
A fact sheet on the Access to Innovative Treatments Act can be found here.
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Nanette Diaz Barragán is proud to represent California’s 44th Congressional District, which includes the communities of Bellflower, Carson, Harbor City, Harbor Gateway, Lakewood, Long Beach, Lynwood, Paramount, Rancho Dominguez, San Pedro, South Gate, West Carson, and Wilmington. She serves as Chair of the Congressional Hispanic Caucus, and on the House Energy and Commerce Committee and Health, Environment, Manufacturing, and Critical Minerals Subcommittees.