Lankford, Colleagues Call for Improved Access to Brain Scans to Diagnose Alzheimer’s Disease

WASHINGTON, DC – Senator James Lankford (R-OK) along with Senators Kevin Cramer (R-ND) and Edward Markey (D-MA) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure requesting reconsideration of the 2013 national coverage determination (NCD) brain imaging procedures used for diagnosing Alzheimer’s disease. Specifically, the NCD restricts brain imaging for Medicare recipients to a single scan during a person’s lifetime, contingent on a patient’s enrollment in a clinical trial. New evidence suggests that ‘amyloid PET’ imaging of the brain is effective in detecting Alzheimer’s disease, although scans cost thousands of dollars out of pocket. 

“Since CMS issued the NCD, there has been significant progress in Alzheimer’s and related dementias research,” wrote the Senators. “In light of new research showing the effectiveness of this imaging technology, we support reconsideration of the NCD and urge CMS to update it to improve access to this evidence-based diagnostic tool.”

“Alzheimer’s disease and related dementias are difficult to manage without facing financial and clinical trial barriers,” continued the Senators. “We must make every effort to grant equitable access to tools that can help individuals and their loved ones treat and manage this disease. We ask that CMS update its NCD to improve equitable access to amyloid PET imaging for people managing Alzheimer’s disease and other dementias.”

Joining Senators Lankford, Cramer, and Markey are Senators Shelley Moore Capito (R-WV), Martin Heinrich (D-NM), Sherrod Brown (D-OH), Cory Booker (D-NJ), Jon Tester (D-MT), Mark Warner (D-VA), Marsha Blackburn (R-TN), Mike Braun (R-IN), Susan Collins (R-ME), Rick Scott (R-FL), and Thom Tillis (R-NC).

Click here to read the letter or read below.

Dear Secretary Becerra and Administrator Brooks-LaSure,

In September 2013, the Center for Medicare and Medicaid Services (CMS) issued a national coverage determination (NCD) that limits Medicare coverage of certain brain imaging in connection with diagnosing Alzheimer’s disease. That decision limits the imaging to a single scan during a person’s lifetime, under Medicare coverage that requires enrollment in a clinical trial. In light of new research showing the effectiveness of this imaging technology, we support reconsideration of the NCD and urge CMS to update it to improve access to this evidence-based diagnostic tool.

CMS’s 2013 NCD limited imaging known as “positron emission tomography beta amyloid” (“amyloid PET” or “PET Aβ”) imaging to one lifetime scan, through “coverage with evidence development” in clinical studies that meet CMS criteria. The PET Aβ scan is a “minimally-invasive diagnostic imaging procedure used to distinguish normal from diseased tissue” that can “detect levels of amyloid [a protein associated with Alzheimer’s disease] in the human brain.” When CMS issued the 2013 NCD, it noted that amyloid PET imaging was a promising technology that could “exclude Alzheimer’s disease in narrowly defined and clinically difficult differential diagnoses.” But due to limited findings regarding the relationship between amyloid disposition and Alzheimer’s disease, CMS decided to limit Medicare coverage of amyloid PET imaging to once per lifetime and only while enrolled in a clinical trial.

Since CMS issued the NCD, there has been significant progress in Alzheimer’s and related dementia research. Specifically, studies conducted on the use of amyloid PET scans for patients with dementia have demonstrated the benefits of this diagnostic tool, including improved diagnosis accuracy and better clinical management. Reviews of research on diagnostic management related to PET found consistent “increase[s] in diagnostic confidence or diagnostic certainty after [amyloid PET].” Studies have also found that, although some variation across demographics may exist, PET Aβ imaging can exclude Alzheimer’s disease, prevent potential misdiagnosis, and monitor the impact of therapeutic interventions for patients presenting with symptoms of dementia. The research has also demonstrated other amyloid PET Aβ benefits, including “changes in clinical management” such as adjusting medication and “counseling about safety and future planning.” And the science shows that amyloid PET imaging may provide a needed tool in emerging treatments to combat amyloid plaques.

Despite the new evidence that amyloid PET imaging is effective, current Medicare coverage restrictions create access barriers for patients and providers may be discouraged from including amyloid PET scans “as part of standard clinical practice.” Amyloid PET scans cost thousands of dollars out of pocket, so even if a health care provider who specializes in dementia determines that a patient’s accurate diagnosis requires a scan, only those who can afford it or can enroll in a clinical trial will get one.

Requiring access to clinical trials also disproportionately and negatively impacts populations that are less likely to enroll in those trials because of barriers including cost, stigma, travel, discrimination, and lack of awareness. Indeed, the clinical-trial requirement runs contrary to both the National Institutes of Health and Food and Drug Administration established goals for increasing representative populations in clinical trials. Those who have studied the issue have concluded that, in the context of amyloid PET imaging, lack of diversity in clinical trials “may exacerbate existing racial and ethnic disparities in dementia care,” demonstrating ongoing and significant barriers to amyloid PET imaging. While we are grateful for CMS support for the New IDEAS study that aims to further demonstrate the value of amyloid PET scans across race, gender, and age, the out-of-pocket cost for PET Aβ imaging and other barriers to participation in clinical trials under the current NCD unfairly limit patient access to this diagnostic tool. Patients who need it based on their provider’s clinical judgment should be able to get it. 

Alzheimer’s disease and related dementia are difficult to manage without facing financial and clinical trial barriers. As one caregiver described, amyloid PET imaging can be a helpful tool to address the “gnawing uncertainty of not knowing” why people with Alzheimer’s and related dementia are experiencing memory loss or what the best medical options might be to treat their disease or “develop coping strategies to better manage [the] disease.” We must make every effort to grant equitable access to tools that can help individuals and their loved ones treat and manage this disease.

We ask that CMS update its NCD to improve equitable access to amyloid PET imaging for people managing Alzheimer’s disease and other dementias.