Medical imaging manufacturers and professional societies joined Eli Lilly & Co. in criticizing CMS’ proposed national coverage determination (NCD) for beta-amyloid positron emission tomography (PET) in dementia and neurodegenerative disease as too restrictive and not compatible with the current appropriate-use criteria developed by professional societies.

In the July 3 draft NCD, CMS proposes to permit Medicare payment for a single beta-amyloid PET scan per Medicare beneficiary only if the patient is enrolled in a clinical trial consistent with coverage-with-evidence-development (CED) policies. Beta-amyloid PET imaging is intended to help physicians diagnose cognitive disorders such as Alzheimer’s disease. PET imaging equipment manufacturers include Siemens Medical Solutions USA Inc. andGE Healthcare. Lilly manufactures the only beta-amyloid imaging agent approved for use in PET, Amyvid (florbetapir F-18 injection).

An NCD now in place bars coverage of beta-amyloid PET. CMS initiated a national coverage analysis Oct. 9 after Lilly requested the re-evaluation of the NCD in June 2012 and advocated in favor of unrestricted coverage. (See Also see "Reimbursement In Brief" - Medtech Insight, 15 October, 2012..) CMS expects to issue a final decision memo by Oct. 1.

Lilly and other radiopharmaceutical industry representatives’ argue that CMS’ review of beta-amyloid PET inappropriately applies the Medicare statute’s criteria that items and services must be “reasonable and necessary” in order to be reimbursed. (See Also see "Lilly Says CMS Review Of Beta-Amyloid PET Goes Beyond Medicare Statutory Criteria" - Pink Sheet, 5 August, 2013..)

Other commenters who support unrestricted coverage of beta-amyloid PET, including representatives of the imaging industry, shared this opinion, and also argue that the proposed decision should follow the consensus of experts as expressed in the Appropriate Use Criteria developed by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) through an Amyloid Imaging Taskforce. The AUC are designed to guide physicians on determining which patients are the best candidates for the procedure based on individual patient attributes.

The AUC conclude that “beta-amyloid PET imaging demonstrates more than adequate evidence exists for Medicare to cover Medicare beneficiaries without additional onerous CED,” SNMMI wrote in Aug. 1 comments, adding later that it “recommends CMS reverse its proposed decision memo and cover the three indications of the appropriate use criteria without inappropriate coverage with evidence development.”

According to the AUC, Medicare coverage should be established for Medicare beneficiaries who complain of persistent or progressive unexplained memory problems or confusion and who demonstrate impairments using standard tests of cognition and memory; patients meeting tests for possible Alzheimer’s, but who are unusual in their clinical presentation; and individuals with progressive dementia and atypically early age of onset (before age 65). It also specifies situations in which use of beta-amyloid PET would be inappropriate, such as in patients with core clinical criteria for probable Alzheimer’s disease with typical age of onset.

“For appropriate clinical use, there is no diversity of views; these recommendations, which specifically exclude use in screening, are not opposed by any of the relevant professional societies,” Siemens wrote in its July 30 comments.

Support For Use Of Appropriate Use Criteria, Questions Around CED

Comments on the proposal, of which the agency received 202, were due Aug. 2.

As in the earlier round of comments submitted when the agency first announced it was undertaking the NCD process, those who support coverage also oppose confining coverage to specific trials as part of a CED policy until CMS finalizes a new guidance on CED. The agency released a draft guidance on CED in November, replacing a 2006 guidance. (See Also see "CMS Redefines Coverage-With-Evidence-Development In Draft Guidance" - Medtech Insight, 3 December, 2012..)

These stakeholders claim that restricting coverage under a CED protocol would be contrary to the goals of the National Alzheimer’s Project Act of 2010 and the resulting National Plan to Address Alzheimer’s Disease released by HHS in 2012. (See Also see "CMS Urged To Cover Beta Amyloid PET Scans For Alzheimer's, But Cautiously" - Medtech Insight, 12 November, 2012..)

“We believe that the evidence is sufficient to conclude that PET beta-amyloid imaging improves health outcomes by helping physicians manage beneficiaries’ medical conditions,” the Medical Imaging & Technology Alliance wrote in July 26 comments. “We urge CMS to cover PET beta-amyloid imaging, without CED, when used in accordance with the Appropriate Use Criteria developed by the Alzheimer’s Association in partnership with the Society of Nuclear Medicine and Molecular Imaging. We are also troubled by CMS’ proposed requirements for studies under CED described in the proposed decision, which are highly inconsistent with the AUC, and we urge the agency not to move forward with any application of CED using the proposed criteria for studies.”

Industry representatives, the World Molecular Imaging Society, SNMMI and the American College of Radiology all presented comments similar to MITA’s on the proposal.

GE wrote that it is “disappointed in the conclusions of the proposed decision, and especially with the proposed requirement of coverage with evidence development,” in July 31 comments, and the company suggests that CMS “consider broader coverage of beta-amyloid imaging in order to be consistent with the National Alzheimer’s Plan’s strategy of ensuring timely and accurate diagnosis.” GE argues that the “CED as outlined in the proposed decision, is not only unduly burdensome, but also inconsistent with previous CMS coverage decisions and does not appropriately address the questions of reasonable and necessary.”

The World Molecular Imaging Society wrote in Aug. 2 comments that it “is concerned that researchers who wish to develop CED clinical studies of beta-amyloid PET will find it exceptionally difficult and challenging to meet the proposed approval thresholds articulated in the proposed decision.” However, should CMS decide to proceed with using CED for certain uses of beta-amyloid PET, WMIS and other stakeholders “can provide technical assistance in developing registries or other similar approaches to collect evidence that would inform the eventual coverage of beta-amyloid PET,” the society wrote.

MITA recommends that CMS consider an alternative to the proposed CED, following the approach it used to evaluate fluorodeoxyglucose PET and “consider whether beta-amyloid PET imaging improves health outcomes by supporting the physician and patient’s treatment decisions without specifically identified and explicitly tied patient health outcomes.”

The American College of Radiology urges CMS in its Aug. 2 comments to consider “more appropriate short-term criteria for patients with dementia, such as actual management change and quality of life change as achievable end points under a CED framework,” should the agency decide to use CED.

Some Support CMS

Patient advocacy groups and Alzheimer’s researchers sided with industry in opposing restricted coverage; some stakeholders from the Alzheimer’s community met in a special session at the Alzheimer’s International Conference July 15 to begin forging a unified response to the proposed decision memo. (See [A#01130722014].)

However, the trade association America’s Health Insurance Plans supports CMS’ approach. In Aug. 2 comments, AHIP writes “the evidence is insufficient to conclude that the use of positron emission tomography amyloid-beta imaging improves health outcomes for Medicare beneficiaries with dementia or neurodegenerative disease.” The insurance group also said that the safety and effectiveness of the radiopharmaceuticals used in PETs for predicting the development of dementia and other neurologic conditions or monitoring responses to therapies have not been established, and that there is a need for definitive criteria for use in the interpretation of these scans to determine “what constitutes a positive study,” and for specialized training related to interpretation of these scans.

In January, panelists at a Medicare Evidence Development and Coverage Advisory Committee meeting said there was not enough evidence to 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..)

Consumer watchdog Public Citizen also supports CMS’ proposal.

Beta-amyloid PET scans to help diagnose and manage patients with dementia and other neurodegenerative diseases, such as Alzheimer’s, were among the imaging services identified by CMS in November for possible coverage policy changes this year. (See Also see "CMS Issues List Of Potential National Coverage Determination Topics" - Medtech Insight, 3 December, 2012..)

Imaging Groups Oppose CMS Coverage Proposal For Beta-Amyloid PET

More from Archive

More from Medtech Insight