Late last spring, the FDA approved the first new Alzheimer’s disease therapy since 2003. For the six million plus U.S. citizens living with this fatal disease, approval of a medicine designed to treat the underlying cause of the disease was a breakthrough.
However, it appears very few of those six million Alzheimer’s patients will ever receive this new medicine because of government regulators at the Center for Medicare & Medicaid Services (CMS). This agency oversees health coverage to more than 100 million people through Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace.
The CMS seeks to strengthen and modernize the nation’s health care system to provide access to high quality care and improved health at lower costs. In January, the CMS launched a process called a National Coverage Determination (NCD) to decide whether Medicare would pay for this newly approved Alzheimer’s therapy or not. Their draft decision: Medicare, as the insurer of roughly 62 million Americans, would not cover this medicine.
The proposed NCD applies to an entire class of Alzheimer’s drugs, which could impact the current FDA approved drugs, aducanumab, as well as future drug therapies in this class. Given the regulatory governance granted to the FDA by Congressional order, it is my opinion this element of the NCD is over-reaching and creates a divisive relationship between two of the most critical federal agencies in the country, FDA and CMS.
This decision would also require certain Alzheimer drugs already in development, (which may have different demographic and efficacy profiles) to be subjected to a CED process that lacks its own data and findings with regards to diversity, inclusion, and efficacy.
Furthermore, and most importantly, the proposed NCD betrays the commitment articulated by President Joe Biden in his Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government: “Equal opportunity is the bedrock of American democracy, and our diversity is one of our country’s greatest strengths. But for too many, the American Dream remains out of reach. Entrenched disparities in our laws and public policies, and in our public and private institutions, have often denied that equal opportunity to individuals and communities.
“Our country faces converging economic, health, and climate crises that have exposed and exacerbated inequities, while a historic movement for justice has highlighted the unbearable human costs of systemic racism. Our nation deserves an ambitious whole-of-government equity agenda that matches the scale of the opportunities and challenges that we face.
“It is therefore the policy of my administration that the Federal Government should pursue a comprehensive approach to advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality.
“Affirmatively advancing equity, civil rights, racial justice, and equal opportunity is the responsibility of the whole of our government. Because advancing equity requires a systematic approach to embedding fairness in decision-making processes, executive departments and agencies (agencies) must recognize and work to redress inequities in their policies and programs that serve as barriers to equal opportunity.”
I know that CMS is fully aware that Alzheimer’s disease is a devastating disease that affects more than six million Americans, 80% of who are Medicare beneficiaries – fatally affecting women like my grandmother….. who lost her fight to Alzheimer’s Disease in 2017.
I request that big government (aka CMS) modify their proposed determination to cover all FDA-approved Alzheimer therapies for the treatment of Alzheimer’s disease and allow patients, social workers and physicians the ability to make a collective decision in the best interests of those suffering from Alzheimer’s Disease.
Yes, this is very personal as I watched my grandmother suffer from this horrifying and painful disease.
Isadore Hall represented the 35th District in the California State Senate and the 64th District in the California State Assembly from 2008 to 2016.