Bipartisan legislation would ensure fair Medicare coverage consideration for new drugs
FOR IMMEDIATE RELEASE
November 29, 2022
WASHINGTON, D.C. – Today, Reps. Nanette Diaz Barragán (CA-44) and John Joyce, M.D. (PA-13) introduced 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 create a review process within CMS to ensure that as new treatments become available, CMS considers each drug and its effectiveness individually to determine whether it should be covered by Medicare, instead of applying a broad or outdated coverage decision to an entire class of drugs.
“I know the impact of Alzheimer’s firsthand — I’ve watched my mom struggle with Alzheimer’s over the last several years. While her disease is too far advanced to benefit from scientific breakthrough therapies that could improve her condition, there are hundreds of thousands of people out there who can benefit. CMS’ current policy of applying its coverage decision to an entire class of drugs is detrimental to the families and individuals suffering from this heartbreaking disease” said Congresswoman Barragán. “And the problem exists beyond treatment of Alzheimer’s – a similar determination for any disease would restrict access to breakthrough drugs regardless of their effectiveness. 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.”
On April 7, 2022, CMS finalized a National Coverage Determination 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 pathway. This decision restricts coverage to the only known class of drugs that is reasonably likely to affect the course of the disease to randomized controlled trials approved by 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.
Currently, there is no mandatory review process for CMS National Coverage Determinations. This means that if a new drug in this class is produced, even if the FDA approves it and deems it effective, it will be subject to the same coverage restrictions.
“With over 6 million Americans and 280,000 Pennsylvanians affected by Alzheimer’s disease, we must ensure that as many patients as possible are able to access groundbreaking, innovative treatments to slow or stop the progression of this devastating disorder. The Access to Innovative Treatments Act would ensure that seniors can access potentially lifesaving therapies, and I urge my colleagues to join me in passing this legislation that supports patients and their caregivers” said Congressman Joyce.
“Scientists, former regulators, and bipartisan members of Congress have been loud and clear: CMS got it wrong, and people are suffering because of it,” said George Vradenburg, Chair and Co-Founder of UsAgainstAlzheimer’s. “We hope that between this bill and the recently introduced Mandating Exclusive Review of Individual Treatments (MERIT) Act patients will get the transparency they deserve and access they need to promising, new treatments just on the horizon.”
“Thank you to Representatives Barragán and Joyce for introducing the bipartisan ‘‘Access to Innovative Treatments Act of 2022,’’ which will help ensure greater Medicare access to FDA-approved treatments for people living with Alzheimer’s disease and other dementia,” said Robert Egge, Alzheimer’s Association Chief Public Policy Officer and Alzheimer’s Impact Movement (AIM) Executive Director. “CMS should not determine coverage based on type of treatment, as no two treatments are the same, even if they are in the same class of drug. The Alzheimer’s community recently experienced the potential harm this practice can bring, and we appreciate congressional champions like Barragán and Joyce for supporting people living with Alzheimer’s and all other dementia.”
“The Access to Innovative 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 chooses 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 and CEO of the National Hispanic Council on Aging.
“Before its decision on Alzheimer’s disease, CMS had historically covered most FDA-approved drugs for their on-label use, and the agency had never denied coverage of an entire class of drugs based on the safety and efficacy profile of one FDA-approved drug,” said Sue Peschin, President and CEO of the Alliance for Aging Research, “That is for two good reasons. First, the scientific expertise lies within FDA, and respectfully, not within CMS. Second, each FDA-approved drug has a unique molecular structure, different mechanism of action, and different side effect profile, making it wholly inappropriate for CMS to issue class-wide coverage determinations. The Access to Innovative Treatments Act would help fix some of the problems CMS created by departing from its past practice.”
The Access to Innovative Treatments Act creates a fair and transparent process to ensure that CMS reconsiders Medicare coverage decisions for drugs and therapies when enough data is collected on an individual drug’s effectiveness by mandating:
- 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 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.
Nanette Diaz Barragán is proud to represent California’s 44th Congressional District, which includes the communities of Carson, Compton, Florence-Firestone, Lynwood, North Long Beach, Rancho Dominguez, San Pedro, South Gate, Walnut Park, Watts, Willowbrook and Wilmington. She serves as chairwoman of the House Homeland Security Committee’s Subcommittee on Border Security, and on the House Energy and Commerce Health, Energy, and Environment & Climate Change Subcommittees.