The Centers Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) on September 27, 2013, which allows conditional coverage of amyloid PET under Coverage with Evidence Development (CED). On October 13, 2023, CMS issued a public announcement that retired the NCD on amyloid PET and ended CED as a criterion for coverage of amyloid PET scans. As a result of the retirement of the NCD, the CED is no longer applicable to the New IDEAS Study.
Study Title: Imaging Dementia—Evidence for Amyloid Scanning (New IDEAS) Study
Sponsor: American College of Radiology
ClinicalTrials.gov Number: NCT04426539
CMS Approval Date: 04/21/2020
A PET imaging facility may not perform a New IDEAS Study PET scan until the referring physician has submitted a pre-PET clinical assessment form to the New IDEAS Study database. Once the PET scan has been completed and the appropriate data uploaded to the New IDEAS Study database, a system-generated notification is sent from the email address NewIDEAS@acr.org to the PET imaging facility indicating that the case data are complete. These notifications should be maintained as documentation in the event that CMS opts to audit the PET imaging facility.
After receiving the notification, the PET facility (and the interpreting physician, if technical and professional component billing are performed separately) may submit the claim for the service to the local Medicare Administrative Contractor (MAC) or MA plan as appropriate. 2016 PET technical component reimbursement for amyloid PET imaging performed on patients enrolled in the New IDEAS Study will be based on the following:
The National 2024 OPPS payment for CPT code 78811 or 78814 (limited body PET or PET/CT, respectively) is $1,354.34 – $1,492.14, respectively (rates are adjusted by local wage indexes, so the exact payment will vary slightly based on region). Payment for the diagnostic radiopharmaceutical is packaged into the OPPS payment amount. For hospital-based PET facilities, there is a co-payment or co-insurance associated with the procedure.
For physician offices and IDTFs, payment is determined by the Medicare Physician Fee Schedule (MPFS). The technical component payment for the procedure is carrier priced but is often capped at the OPPS technical component rate (For CPT 78811 at $1,354.34 and 78814 at $1,492.14). Payment for the diagnostic radiopharmaceutical is based on the invoice cost (approximately $3,000, depending on the product used).
In the MPFS setting, all rates are subject to co-payment, co-insurance and any deductibles that the patient’s Medicare plan requires. The co-payment policies for the diagnostic radiopharmaceutical differ in the MPFS setting versus the OPPS.
The national payment rates for the professional reading of the New IDEAS Study: 78811-26 ($68.44) and 78814-26 ($97.91).
Please consult your contract with each Medicare Advantage plan for reimbursement rates. Payment will vary based on the contract between you and the Medicare Advantage plan.
Yes. Note that the technical charge for a PET study on a Medicare inpatient is not billed directly, but rather is considered to be covered by the Diagnostic Related Grouping (DRG) payment to the hospital for that patient. Inclusion of a patient in the New IDEAS Study is necessary, however, for professional component reimbursement for the PET study if performed on an inpatient. It is expected that brain amyloid PET imaging in a patient meeting the eligibility criteria for the New IDEAS Study would rarely need to be done while the patient was hospitalized.
The answer depends on the payer, but in general, yes, Medicare supplemental (Medigap) insurance plans (or Medicaid, if applicable) should cover the co-payment, as for any other Medicare-covered service, in patients with traditional Medicare coverage (Part A and Part B). There are some third party payers that deny picking up the co-payments; Tricare, for example, will not cover these costs. We will list more as we become aware of these payers.
However, any coinsurance costs related to the amyloid PET scan that are not covered by the beneficiary's supplemental plan, will be covered by the study sponsor.
Please refer to the New IDEAS Coinsurance Reimbursement Program Policy for additional detail.
Yes, Medicare Advantage (MA) beneficiaries are eligible to be included in the New IDEAS Study. The MA plans will make payments for MA enrollees. New IDEAS Study claims should be billed to the MA plan. This policy is located in Publication 100-16, Chapter 4: Managed Care Manual 10.7.3 – Benefits and Beneficiary Protections – Payment for Clinical Studies Approved Under Coverage with Evidence.
Beneficiaries enrolled in Medicare Advantage (MA) plans are responsible for any unmet deductibles and co-payments associated with their visits to the dementia specialist.
Any coinsurance related to the amyloid PET scan will be covered by the study sponsor. The PET provider MUST NOT bill the MA enrollee for any co-insurance, outside of an unmet deductible.
Please refer to the New IDEAS Coinsurance Reimbursement Program Policy for additional detail.
Publication 100-3 Section 310.1 of the NCD Manual: Routine Costs in a Clinical Trial states that Medicare Advantage (MA) plans may request prior authorization or approval for enrollees participating in clinical trials or for coverage with evidence development in CMS-approved trials. Referring physicians or PET facilities should obtain pre-authorization for patients in MA plans or document (e.g., date, time and person with whom you spoke) the details of the call. In some instances, the MA plans may direct patients to their preferred providers assuming the MA plan preferred providers are qualified and participating in the New IDEAS CED Study.
If you receive a denial on the prior authorization from a MA plan, it is recommended that all levels of appeal be used with Medicare Advantage plans as we are aware from the IDEAS CED Study, of MA plans that denied the first request for prior authorization for a PET scan. A facility should appeal that denial and, if the first appeal is denied, the facility should appeal once again. You will need to state: “ [T]his patient is enrolled in the CMS-approved CED program known as the New IDEAS Study” and be sure to provide additional documentation to support your request.
As a reminder, Medicare Advantage (MA) beneficiaries are eligible to be included in the New IDEAS Study and the MA plans will make payments for MA enrollees. New IDEAS Study claims should be billed to the MA plan. This policy is located in Publication 100-16, Chapter 4: Managed Care Manual 10.7.3. – Benefits and Beneficiary Protections – Payment for Clinical Studies Approved Under Coverage with Evidence.
The last level of appeal should reach an Independent Review Entity (IRE). More information regarding IRE can be found at https://www.cms.gov/medicare/appeals-and-grievances/mmcag/ire.html. Finally, you may submit a completed New IDEAS claim denial form after the first prior authorization or first post imaging denial. We will simultaneously engage our CMS colleagues to identify why you received that denial; however, we request that you continue all appeals while we review with CMS.
The New IDEAS database will generate an e-mail notification to the PET Facility Administrator when all case data required for PET claim submission have been entered (PET report eCRF, PET assessment, and PET scan (image)). At this time, a claim with Medicare can be filed. The PET Center does not need to wait for the 90-day follow up by the dementia specialist.