CMS Announcements Hold Big Surprises for PET Scans

July 19, 2021

Last week brought two big announcements from the Centers for Medicare and Medicaid Services (CMS) in the form of a national coverage analysis notice on Alzheimer's Disease treatment and the Medicare Physician Fee Schedule (MPFS).

1. CMS offers opportunity to comment on beta amyloid PET

First, CMS is initiating a national coverage determination (NCD) analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. For the next 30 days, the agency will accept comments about Alzheimer’s Disease therapy using monoclonal antibodies directed against brain amyloid. They are particularly interested in comments that include scientific evidence and address the following questions:

  1. Which health outcomes are important, and what degree of improvement in them is meaningful for patients receiving treatment?
  2. What characteristics of patients with Alzheimer’s disease are important to optimizing the likelihood of positive health outcomes from treatment?
  3. What issues of equity and inclusion must be accounted for in the diagnosis and treatment of Alzheimer’s disease?
  4. What health care providers should be included as part of the patient’s treatment team? Should medical specialists be included in the care team of patients receiving treatment? If so, which specialists should be included in the care?
  5. In what setting(s) should treatment and care be given?

SNMMI is working with its Brain Imaging Council to provide comments, including the importance of covering beta amyloid PET scans. At this point in time, beta amyloid PET is the only FDA-approved diagnostic to identify amyloid plaque. 

2. CMS removes exclusion for non-oncologic PET

Second, on July 13, 2021, CMS published its CY 2022 MPFS Proposed Rule—including a significant change for nuclear medicine.

CMS proposes to remove the "exclusionary language" from NCD 220.6 Positron Emission Tomography (PET) Scans. This will leave non-oncologic PET indications (unless noted by NCD 220.6.1-220.6.20) to the discretion of local Medicare Administrative Contractors (MACs). CMS stated, "We believe that extending local contractor discretion for non-oncologic indications of PET provides an immediate avenue to potential coverage in appropriate candidates and provides a framework that better serves the needs of the Medicare program and its beneficiaries." New FDA-approved non-oncologic radiopharmaceuticals will be covered under MAC discretion.

We applaud CMS’s coverage decision, which results from years of work by SNMMI and our industry partners.

Unfortunately, in this proposal, the national non-coverage determination for beta amyloid PET (NCD 220.6.20) remains. SNMMI and our partners are working to resolve this coverage discrepancy.

Also, to our dismay, the proposed rule proposes to cut the conversion factor to $33.58 in CY 2022, as compared to $34.89 in CY 2021; this follows the expiration of the 3.75% payment increase, a 0.00% conversion factor update, and a budget neutrality adjustment. SNMMI will work with the medical community to prevent cuts to physician reimbursement. Our most recent letter to Congress may be found here.

More news: CMS proposes to delay implementation of the payment penalty phase of the Appropriate Use Criteria program to the later of Jan. 1, 2023, or the Jan. 1 that follows the end of the public health emergency. Currently, the penalty phase is set to begin Jan. 1, 2022. This is great news for referring physicians who needed the extra time to implement because of COVID-19.

The CY 2022 proposed Medicare Physician Fee Schedule Chart may be found here.