CMS’ final Medicare national coverage determination on beta amyloid positron emission tomography for brain imaging may offer a little more flexibility in the types of outcomes studied in clinical trials, the only setting where Medicare will pay for the test. (See [A#14131002001].)

Nevertheless, the final decision was a disappointment to medical imaging manufacturers and drug makers.

Like the draft NCD, the Sept. 27 final coverage determination concludes that beta amyloid PET is not “reasonable and necessary” as a diagnostic for dementia and neurodegenerative disease, such as Alzheimer’s disease, and therefore will not be a covered service under Medicare Part B. (See Also see "Trial-Only Medicare Coverage Proposed For PET Alzheimer’s Scans" - Medtech Insight, 15 July, 2013..)

Drawing on its coverage-with-evidence-development (CED) policy, the agency will pay for the scan in the limited context of a clinical trial that meets CMS criteria. (See Also see "The Value of Knowing: CMS Rejects Coverage of Lilly’s Amyvid – Except As Tool For Further Research" - Pink Sheet, 24 July, 2013..) CMS says there is sufficient evidence that the scan could help exclude Alzheimer’s disease in certain difficult cases and aid in the selection of subjects for Alzheimer’s treatment or prevention clinical trials. The agency will therefore pay for scans to develop outcomes data on these uses. Only one scan per patient will be reimbursed.

The decision affects PET imaging manufacturers such as Siemens Medical Solutions USA Inc. and GE Healthcareas well as Eli Lilly & Co., which manufactures the only beta amyloid imaging agent approved for use in PET, Amyvid (florbetapir F18 injection). Lilly initiated the NCD process through a request submitted in October 2012 and had sought unrestricted coverage under Medicare.

The wording of the final NCD is very similar to the draft version, with one notable exception – a new sentence clarifying the outcomes goals of the CED trials. “These may include short-term outcomes related to changes in management as well as longer-term dementia outcomes,” the document says. The additional language could provide some flexibility in designing CED trials, since the earlier proposal seemed to suggest that only improved health outcomes would be the main goal of trials. (See Also see "Lilly Says CMS Review Of Beta-Amyloid PET Goes Beyond Medicare Statutory Criteria" - Pink Sheet, 5 August, 2013..)

In a Sept. 27 press release, Eli Lilly again voiced its concern that CMS’ review of beta amyloid PET inappropriately applied the Medicare statute’s criteria that items and services must be “reasonable and necessary” in order to be reimbursed.

The final decision “contradicts the statutory authority CMS has over coverage determinations for diagnostics,” the company said.

“Reasonable and necessary of course has always been a very tough thing for folks to understand. What constitutes reasonable? What constitutes necessary?” said Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance, in an interview with “The Gray Sheet.”

“And it leaves CMS with some wiggle room of course when they make their decisions,” she added.

Criteria For Clinical Trials

The key questions CMS says should be addressed in the CED studies are:

“Do the results of PET Aβ imaging lead to improved health outcomes? Meaningful health outcomes of interest include: avoidance of futile treatment or tests; improving, or slowing the decline of, quality of life; and survival.”
“Are there specific subpopulations, patient characteristics or differential diagnoses that are predictive of improved health outcomes in patients whose management is guided by the PET Aβ imaging?”
“Does using PET Aβ imaging in guiding patient management, to enrich clinical trials seeking better treatments or prevention strategies for AD, by selecting patients on the basis of biological as well as clinical and epidemiological factors, lead to improved health outcomes?”

While expressing gratitude for the CED pathway that will make beta amyloid PET imaging available to some Medicare beneficiaries, MITA said in a Sept. 30 press release that it was disappointed that coverage will not be provided without CED to Medicare beneficiaries with suspected dementia or Alzheimer’s disease who meet specific appropriate use criteria. (See Also see "Imaging Groups Oppose CMS Coverage Proposal For Beta-Amyloid PET" - Medtech Insight, 26 August, 2013..)

The decision “stops short of extending broad coverage for this scan in accordance with the appropriate use criteria developed by the Alzheimer’s Association and the Society for Nuclear Medicine and Molecular Imaging (SNMMI),” MITA said.

The groups’ appropriate use criteria were designed to help physicians determine which patients are the best candidates for the procedure, based on individual patient attributes.

“We’re very disappointed that CMS has again ignored all the work that went into [the appropriate use criteria],” Rodriguez said in an interview. “Those are peer-reviewed, published standards and I think [they] gave CMS the throttle that they wanted to ensure that not every patient on the street would get this scan,” she added.

She also reiterated MITA’s concern about CMS’ CED reimbursement of just one scan. “If this drug is going to be used to help develop new therapy, one scan won’t do it,” Rodriguez said.

GE Healthcare, the Alzheimer’s Association and SNMMI also expressed disappointment about the final NCD. “The CED process will further delay access to the scans and impose administrative burdens on referring physicians,” GE Healthcare said in an emailed statement Oct. 2.

Nevertheless, CMS’ approach has some supporters. In January, panelists at a Medicare Evidence Development and Coverage Advisory Committee meeting said there was not enough evidence on patient health outcomes to establish the benefit of beta amyloid imaging, and a number of MedCAC members suggested that CED might be the best approach to coverage, given the circumstances. (See Also see "Medicare Panel Finds Little Support For Amyloid PET Imaging Changes" - Medtech Insight, 4 February, 2013..)

While the trade association America’s Health Insurance Plans does not plan to issue a statement on the final decision, it supported CMS’ proposal.

Michael Carome, director of consumer watchdog Public Citizen’s Health Research Group told “The Gray Sheet” the group was “pleased” with CMS’ final decision.

Imaging Groups Disappointed By CMS’ Final Beta Amyloid PET NCD

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