Currently, payments for diagnostic positron emission tomography (PET) scans of the brain or other parts of the body when offered in the hospital outpatient department (HOPD) are bundled together to cover all associated costs with administering the scans, including the radiopharmaceuticals used to distinguish problem areas from normally functioning tissues. More advanced radiopharmaceuticals provide greater precision in diagnostic imaging, but cost more than those used in calculating the bundled reimbursement Medicare provides. The way reimbursement is set makes offering these services cost prohibitive for many hospitals and doctors to offer, particularly hospitals in rural and other underserved communities, where people already face significant delays in obtaining timely diagnosis and treatment. Critically, approximately 50% of the US PET scan capacity sits in the HOPD setting.
The Centers for Medicare & Medicaid (CMS) recently provided stakeholders an opportunity to weigh in within the agency’s annual Hospital Outpatient Prospective Payment System (OPPS) proposed rule. For the first time, one of the major issues CMS solicited feedback on is the current bundling policy for diagnostic radiopharmaceuticals that severely impacts patient access to a number of important diagnostic tests, including those critical to detecting Alzheimer’s disease and many cancers. Disappointingly, despite the significant feedback from stakeholders calling for a change (see below), CMS declined to change their policy at this time.
CMS’ current payment policy impacts access to not just advanced imaging for Alzheimer’s disease, but also PET scans for other neurological diseases, heart disease, and certain cancers. The disparities in access are so severe that Congress has introduced legislation that would resolve the issue by unbundling payment for a number of advanced radiotracers.
In addition, the U.S. Senate Committee on Appropriations for the second year in a row included appropriations report language that calls on CMS to “review these rate-setting policies and the impacts these payment rules have on utilization of AD diagnostics among racial and ethnic minority groups… and to consider potential modifications that could make access to advanced imaging for AD more equitable.”
Despite expressing a desire to reduce access barriers and ensure more equitable access to advanced radiopharmaceutical diagnostics, CMS maintains its current payment policy that negatively impacts diagnostics tests in a range of disease states.
More than 70 stakeholders submitted comments to CMS to express concerns with the current bundling policy and share suggested solutions to help improve patient access. Highlights of those comments include:
Partnership to Fight Chronic Disease Led Sign on Letter:
- Alliance for Aging Research
- American College of Neurology
- National Consumers League
- RetireSafe
- Voices of Alzheimer’s
“…we recommend that CMS consider policies that facilitate access by addressing barriers in reimbursement by classifying radiopharmaceuticals as drugs rather than as supplies in the HOPPS fee schedule and reimbursing radiopharmaceuticals used in the diagnosis of Alzheimer’s separately. We also recommend that these changes take effect for the plan year beginning on January 1, 2024.”
American Association of Physicists in Medicine (AAPM)
“We believe separate payments for diagnostic radiopharmaceuticals is the best policy approach to ensure beneficiary access to diagnostic radiopharmaceuticals and equitable payment for innovative and effective technologies.”
American College of Radiology
Council on Radionuclides and Radiopharmaceuticals
Medical Imaging & Technology Alliance
Society of Nuclear Medicine and Molecular Imaging
“To ensure that patients have access to the best diagnostic radiopharmaceuticals in readily accessible healthcare settings, we strongly urge CMS to separately pay for diagnostic radiopharmaceuticals which exceed a specified threshold. This will ensure that patients have access to the most sophisticated diagnostic radiopharmaceuticals and receive the most medically appropriate treatment plan.”
American Society for Radiation Oncology
“ASTRO recommends CMS use its statutory authority to always pay separately for diagnostic radiopharmaceuticals, not just when the products have pass-through payment status…We believe separate payments for diagnostic radiopharmaceuticals (ASP+6%) is the best policy approach to ensure beneficiary access to diagnostic radiopharmaceuticals and equitable payment for innovative and effective technologies.”
American Society of Radiologic Technologists (ASRT)
“To ensure that patients have access to the best diagnostic radiopharmaceuticals in readily accessible health care settings, we strongly urge CMS to separately pay for diagnostic radiopharmaceuticals. This will ensure that patients have access to the most sophisticated diagnostic radiopharmaceuticals and receive the most medically appropriate treatment plan.”
Answer2Cancer
“We are concerned with the inequities and inefficiencies occurring with CMS’s current outpatient payment model regarding diagnostic imaging and the administration of radiopharmaceuticals…traditionally underserved and under-diagnosed patients - such as those in rural and/or minority populations – will continue to fight access issues…Updating this reimbursement model will go a long way toward fulfilling key goals of our current Administration of promoting health equity, improving transparency, and promoting patient-centered care.”
Association for Medical Imaging Management
“AHRA endorses CMS unpackaging diagnostic radiopharmaceuticals that exceed a $500 threshold if CMS chooses to pursue a policy targeting the most expensive diagnostic radiopharmaceuticals.”
Community Health Network
“Separate payments for advanced innovative diagnostic radiopharmaceuticals in the Hospital Outpatient setting will help improve patient access and diagnoses, and provide fair reimbursement to healthcare providers. This will ultimately improve patient outcomes and quality of care for Medicare beneficiaries…If provided a fair reimbursement healthcare systems would be able to provide these relevant services to cancer patients. As a result, better treatment strategies could be made by providers.”
Community Liver Alliance
“It is time to right-size the CMS payment model for imaging technologies. Separating payment for diagnostic pharmaceuticals will enhance patient access and treatment and will ensure a fairer reimbursement process.”
Council on Radionuclides and Radiopharmaceuticals
“CORAR strongly agrees that the diagnostic RP packaging policy should be reformed for CY 2024, with separate payment for diagnostic RPs that have a cost-per-day exceeding a monetary threshold at either the OPPS drug packaging threshold of $140 (proposed for CY 2024) or a higher OPPS drug packaging threshold with a cost-per-day threshold of $500....”
Johns Hopkins Medicine
“We recommend that CMS … ensure that Medicare beneficiaries who currently suffer from mild cognitive impairment or mild Alzheimer’s Disease have access to the newly FDA approved therapeutics. We believe that the rapid finalization of this approach is administratively feasible for both CMS and providers since it is identical to the claims workflow for other drugs.”
Medical University of South Carolina Candidate, Robert Peacock
“I firmly believe Medicare should expand its coverage to include more modern forms of
radiopharmaceuticals. This crucial step is essential to improve patient care, enhance diagnostic accuracy, and ultimately reduce the burden of urological diseases on individuals and the healthcare system as a whole.”
National Minority Quality Forum (NMQF)
“NMQF encourages CMS to adjust the reimbursement policy for radiopharmaceuticals to support separate payment for the radiopharmaceuticals would ensure access to a key intervention in the diagnosis of Alzheimer’s disease and will expand access to Amyloid PET Scans in the treatment of Alzheimer’s Disease and have a profound impact on minoritized and underserved patients and communities by helping assure access to high quality, beneficial health services.”
To view all submitted comments, visit the CMS website here. PFCD urges CMS to unbundle payment for the 2024 plan year so that Medicare beneficiaries have equitable access to advanced imaging services in the HOPD setting, especially given how critical these diagnostics are to the emerging field of FDA-approved anti-amyloid targeted therapies.
Nevada State Medical Association
“An alternative approach that separates the reimbursement for radiopharmaceuticals from other services could better reflect their unique value in patient care, promote innovation, and ensure equitable access for all Medicare beneficiaries.”
New Hampshire Healthcare Association
“…we are all too familiar with advanced age and infirmity necessitating medical interventions, and very commonly see diseases such as Alzheimer’s and Parkinson’s. Improving the reimbursement methodology you use would meet your aims of ‘ensuring beneficiary access to diagnostic radiopharmaceuticals while also ensuring the availability of new and innovative diagnostic tools for Medicare beneficiaries’ because the current ‘packaging’ payment methodology – while laudably intended to encourage ‘hospital efficiencies’ – can defeat those twin aims.”
Patients Rising
“Removing radiopharmaceuticals from the packaging system would partially correct overpayment for high-volume, lower-cost products while ensuring patient access to appropriate diagnostic care, offering the promise of improved outcomes.”
CEO of Veterans Prostate Cancer Awareness
“To ensure that patients have access to the best diagnostic radiopharmaceuticals in readily accessible healthcare settings, we strongly urge CMS to separately pay for diagnostic radiopharmaceuticals. This will ensure that patients have access to the most sophisticated diagnostic radiopharmaceuticals and receive the most medically appropriate treatment plan…These radiopharmaceuticals are changing how we more accurately diagnose a host of cancers which allow for appropriate precision solutions thus saving lives, time lost, and the almighty dollars spent on late stage diagnosis.”
Women’s Diversity Network
“We believe creating separate payment for radiopharmaceuticals will address this inequity by removing a barrier that is restricting access for vulnerable populations negatively impacting women and communities of color.”
Yale School of Medicine, Robert E. Hunter Professor of Therapeutic Radiology, Peter M. Glazer, M.D., Ph.D., Chair, Department of Therapeutic Radiology
“Simply put, CMS’ packaging policy does not come close to covering our costs for newer diagnostic radiopharmaceuticals where there may be no alternative for a patient’s specific condition. Therefore, we strongly recommend that CMS align diagnostic radiopharmaceutical payment with the methodology for separately payable outpatient drugs that are approved by the FDA. Paying separately for all radiopharmaceuticals using the $140 drug threshold CMS has proposed would be the most consistent approach, aligning with the existing drug packaging policy.”
Young Survival Coalition (YSC)
“Removing higher-cost radiopharmaceuticals from the packaging system would partially correct overpayment for high-volume, lower-cost radiopharmaceuticals while also ensuring patients have access to appropriate diagnostic care. In addition, we would see reduced wasteful spending on flawed treatment plans resulting from less precise imaging products.”
October 2023