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.
The regulatory maneuver employed by Medicare disproportionately harms older people living with early Alzheimer’s in rural areas and communities of color.
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.
Ironically, the CED designation was created by CMS, not Congress, in 2005 to help get some of the latest medical device treatments to patients more quickly. Lately, however, CMS has abused CED by applying it to ration care for seniors.
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 persons are anywhere from 1.5 to 2 times more likely to develop Alzheimer’s disease compared to white individuals.
Regulatory maneuvers such as CED inequitably restrict access to treatments for persons of color across the nation. 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.
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.
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 get treatments to patients 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. This op-ed originally ran in the Virginia Mercury.