How Medicare perpetuates privilege – not equity

By Pamela Price

Thanks to Medicare’s top official dodging questions by members of Congress, the fight for equity in American healthcare just suffered a further setback. 

In late April, the Centers for Medicare and Medicaid Services (CMS) Administrator, Chiquita Brooks-LaSure, appeared before the Health Subcommittee of the House Energy and Commerce Committee to answer questions about why the  Medicare program declined a request to fully cover a newly-approved Alzheimer’s therapy that was shown to delay the progression of the disease. Not surprisingly, the decision has been met with fierce opposition from Alzheimer’s advocates — as well it should. That Medicare would deliberately deny patients access to Food and Drug Administration (FDA)-approved treatments is reprehensible. 

The regulatory maneuver employed by Medicare disproportionately harms older people living with early Alzheimer’s in rural areas and communities of color. What is worse, however, is that the CMS administrator rebuffed inquiries about how Medicare intends to provide access and reimbursement for this therapy and denied accountability for rationing care. 

At the center of the Alzheimer’s ruling is a little-known regulatory tool known as “coverage with evidence development,” or CED. Under CED, Medicare denies coverage for an FDA-approved item or service, except for treatments provided through a very narrowly constructed clinical study. Medicare beneficiaries who are ineligible under the strict CED study requirements, or who cannot access the clinical study sites, are denied coverage. 

Ironically, the CED designation was created by CMS, not Congress, in 2005 to help patients get some of the latest medical device treatments more quickly. Lately, however, CMS has abused CED by applying it to ration care for seniors. 

Before CMS’s decision to limit access to new treatments for early Alzheimer’s under CED, the agency had never declined to cover a drug for its FDA-approved, medically accepted use. Importantly, this was also the first time CMS denied coverage for an entire class of drugs based on clinical trial data for a single drug before any data on other drugs in the class were available. 

Right now, there are 22 different therapies requiring CED, including treatments for colorectal cancer, procedures for sickle cell disease, and even cochlear implants for hearing-impaired patients. 

But what’s most disturbing about the agency’s abuse of the CED paradigm is that it puts people of color and other underserved communities at a unique disadvantage. 

Consider, first, that many of the therapies that land in CED limbo treat conditions that disproportionately affect minority populations. Sickle cell anemia, for example, is a genetic condition found among Black Americans. Meanwhile, Black people are anywhere from 1.5 to 2 times more likely to develop Alzheimer’s disease compared to white individuals. 

Black persons are also more likely to be diagnosed with colorectal cancer. For instance, Virginia counties where Black residents make up a greater proportion of the population have higher rates of new colorectal cancer diagnoses than other regions of the state.

Regulatory maneuvers such as CED inequitably restrict access to treatments for persons of color. Importantly, these treatment delays not only impact individuals living with conditions like Alzheimer’s disease and sickle cell anemia but also the caregivers, families and communities disproportionately burdened by these illnesses. 

Patients of color also tend to be vastly underrepresented in clinical studies for CED-designated treatments and procedures. This has certainly been true of the Transcatheter Aortic Valve Replacement (TAVR) procedure for treating severe aortic stenosis, which was granted CED status over a decade ago.

To this day, only patients who find their way into the CMS-approved clinical registry can benefit from TAVR – a group that recent medical research found skews white by a significant margin. In its 2019 reconsideration, Medicare officials claimed that the evidence collected in the CED registry was “insufficient for minority populations,” and had the audacity to use this as a justification to continue the restrictive coverage policy. 

Geographical and racial inequality often intersect. The studies in which CED-designated treatments and procedures are available often take place at major research universities in wealthier, urban areas. This creates access barriers for patients who have trouble traveling long distances for care, like my husband’s 68-year-old aunt with Alzheimer’s disease who lives in rural Mississippi. The nearest clinical study site is more than 2 hours away from her.

In February 2023, the Centers for Medicare & Medicaid Services released its Framework for Health Equity. This framework outlined several key health equity priorities, including assessing the causes of disparities within CMS’s existing programs and “making concrete, actionable decisions about our policies, investments, and resource allocations.”

If the CMS Administrator is serious about addressing health inequities, she should start by abandoning the agency’s discriminatory and unjust use of the CED program. CMS’ sister agency, the Veterans Health Administration – which announced in March that it will widely cover Alzheimer’s medications – imposes no such restrictions.

Medicare’s chief purpose has always been to provide high-quality care to all of its patients without favoring any one group. But by abusing the CED program, CMS has warped a procedure meant to give patients access to treatments sooner into a tool for neglecting some patients, privileging others, and deepening the racial, socio-economic and ethnic inequities in our healthcare system.

Pamela Price, RN, is deputy director of The Balm in Gilead, a non-profit whose mission is to improve the health of Black people in the United States and Africa. She lives in Richmond, Virginia.