Alternate CMS Payment Structure for Outpatient Services: A Road to Improving Access to Molecular Imaging in Oncologic Care

HomeRadiology: Imaging CancerVol. 5, No. 6 Next EditorialFree AccessAlternate CMS Payment Structure for Outpatient Services: A Road to Improving Access to Molecular Imaging in Oncologic CareKritika Subramanian , Jana Ivanidze, Manny Paris, Andres Ricaurte Fajardo, Joseph R. OsborneKritika Subramanian , Jana Ivanidze, Manny Paris, Andres Ricaurte Fajardo, Joseph R. OsborneAuthor AffiliationsFrom the Department of Radiology, Division of Molecular Imaging and Therapeutics, Weill Cornell Medicine, 1300 York Ave, New York, NY 10065 (K.S., J.I., A.R.F., J.R.O.); Department of Radiation Oncology, Montefiore Medical Center, Bronx, NY (K.S.); and MI4 LLC, Wayne, NJ (M.P.).Address correspondence to K.S. (email: [email protected]).Kritika Subramanian Jana IvanidzeManny ParisAndres Ricaurte FajardoJoseph R. OsbornePublished Online:Nov 10 2023https://doi.org/10.1148/rycan.230166MoreSectionsPDF ToolsAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinked In In July 2023, the Centers for Medicare & Medicaid Services (CMS) requested feedback on how the Hospital Outpatient Prospective Payment System (HOPPS) affects patients, particularly in response to the bipartisan proposed and nuclear physician supported Facilitating Innovative Nuclear Diagnostics (FIND) Act (S.1544). The FIND Act is an exciting initiative that aims to improve patient access to imaging with diagnostic radiopharmaceuticals (1). One important provision of the act requests the Secretary of Health and Human Services to individually reimburse the costs associated with diagnostic radiopharmaceuticals under the HOPPS system when the mean per day product cost exceeds the set threshold amount, defined as $500 for 2024. This would have a direct benefit to more than 20% of individuals uninsured at some point prior to Medicare eligibility (2), many of whom would benefit from finally having access to cost-effective and life-saving diagnostic molecular imaging.At present, professional and technical charges may be omitted for patients with emergency Medicaid or those who do not have Medicare Part B (approximately 7.5% of more than 60 million Medicare beneficiaries) (3). Unlike Medicare Part A, which covers inpatient care costs, Medicare Part B is voluntary and covers ambulatory care costs. As such, Medicare Part B enrollment requires paying a premium and thereby disproportionately affects lower income individuals. If these individuals opt to enroll at a later time, they must pay a higher premium. In these scenarios, separating the charges may provide a more personalized and affordable alternative pathway to accessing high-quality, targeted molecular imaging. On the other hand, while more convenient for billing purposes, the bundling of charges restricts access for patients in need of newly U.S. Food and Drug Administration–approved radiopharmaceuticals. Therefore, the greatest negative impact will be felt in underserved areas and by individuals without private insurance. The payment and billing mechanism becomes an important driver of unequal access to care, particularly in the context of oncologic imaging. It is paramount for us in the cancer imaging community to understand the impact of these changes, and to do so, we must also understand how and why these rules were created.The Bundled Payments for Care Improvement (BPCI) initiative was created in 2013 as a means to lower overall care costs to Medicare while warranting high-quality, appropriate patient care by grouping multidisciplinary involvement, coordination, and quality assurance costs into a standardized package (4). Of note, the BPCI initiative was established after the Medicare program began bundling reimbursement for hospital outpatient procedures involving diagnostic radiopharmaceuticals in January 2008. These bundled payment systems and charges were derived from models that focused on hospital admissions and inpatient care. The initiative extended until 2020, whereby a total of 21 models were evaluated. Fourteen models demonstrated cost savings in the inpatient and postacute care setting, six demonstrated quality-of-care improvement, and seven demonstrated decline in emergency department visits and hospital readmission. Combined, however, these models revealed only modest reductions in overall costs to the health system.Of particular interest within the BPCI initiative is the Oncology Care Model (OCM) (5), which evaluated an episode-based payment model aiming to provide high-quality, coordinated patient care while decreasing overall costs to the health system. More than 1.5 million individuals are diagnosed with cancer every year, many of whom use CMS services. Therefore, cost-effective, high-quality cancer care is crucial. The OCM consisted of a two-part payment system: (a) per-beneficiary Monthly Enhanced Oncology Services and (b) a performance-based payment system for patients receiving chemotherapy. Although the OCM enhanced the quality of oncologic care at lower costs to the health system, it did not demonstrate any alleviation in utilization differences between racial and ethnic groups in underserved communities. The FIND Act therefore recommends separating the charges to improve patient access to Medicare beneficiaries, particularly when considering the lack of financial benefit to the overall health system with bundled charges.Traditional CMS pass-through status is a temporary increase in associated reimbursement amounts of novel medical pharmaceuticals and technologies that intends to introduce and enhance the use of these products in medical facilities (6). The positive financial reinforcement consequently results in increased access for CMS beneficiaries. Pass-through status lasts for a maximum of 3 years and may provide an avenue for evaluating the benefits of split fees relative to patient access. This status also creates a barrier where newer agents and their sponsors must reap the majority of the financial benefits in the first 3 years. For radiologists, this results in a complex situation where some of the agents, such as the β-amyloid targeting radiotracers, have exhausted pass through, while newly approved prostate-specific membrane antigen–targeting radiotracers are racing against the clock.Radiologists must understand the interplay between policy and practice. Cost-effective analyses are useful for validating clinically meaningful workflows for radiopharmaceutical-based imaging. We recently performed a cost-effective analysis evaluating the overall costs associated with fluorine 18 (18F) DCFPyL (18F-piflufolastat) PET/CT (while pass-through is in effect) in patients with prostate cancer. This analysis demonstrated that while 18F-DCFPyl costs exceeded those of older imaging options, it increased quality-adjusted life-years by detecting disease at earlier stages, thus demonstrating the cost-effectiveness of this technique (7). Our recent cost-effective analyses of 68Ga DOTATATE (NETSPOT; Advanced Accelerator Applications) PET/MRI in patients with intermediate-risk meningioma (8) and 18F-fluorodeoxyglucose cardiac PET/MRI in patients with cardiac sarcoidosis (9) found that compared with conventional diagnostic imaging alone, targeted PET imaging was cost-effective in the respective patient populations, as it was associated with increased quality-adjusted life-years and/or decreased costs. The technical charges associated with a combined imaging modality such as PET/CT or PET/MRI would also be lower compared with multiple diagnostic imaging studies, as the imaging would be completed in a single visit.Equitable access to cutting-edge cancer imaging is a universal goal. Implementing changes in HOPPS is a critical part of realizing these changes, but it involves understanding a series of rules that have been implemented over the last 15 years. Herein, we have described some of the changes, including bundled charges and pass-through status, that are unique to the United States and how CMS has attempted to facilitate use of diagnostic imaging in oncologic care. It is critical for the oncologic imaging community to understand how these changes apply to the July 2023 proposed policy changes and to collectively advocate to CMS to implement the changes proposed by the FIND Act.Disclosures of conflicts of interest: K.S. No relevant relationships. J.I. Investigator-initiated trial grant (funds paid to institution), PI; grant/contract from Novartis Pharmaceuticals; Radiology: Imaging Cancer editorial board member. M.P. No relevant relationships. A.R.F. No relevant relationships. J.R.O. No relevant relationships.Authors declared no funding for this work.References1. S.2609 - Facilitating Innovative Nuclear Diagnostics Act of 2021. Sen. Blackburn M. http://www.congress.gov/bill/117th-congress/senate-bill/2609/text. Published 2021. Accessed July 19, 2023. Google Scholar2. Baker DW, Sudano JJ. Health insurance coverage during the years preceding medicare eligibility. Arch Intern Med 2005;165(7):770–776. Crossref, Medline, Google Scholar3. Medicare Beneficiary Enrollment Trends and Demographic Characteristics. ASPE. https://aspe.hhs.gov/reports/medicare-enrollment. Accessed August 27, 2023. Google Scholar4. Bundled Payments for Care Improvement (BPCI) Initiative. CMS Innovation Center. https://innovation.cms.gov/innovation-models/bundled-payments. Accessed August 27, 2023. Google Scholar5. Oncology Care Model. CMS Innovation Center. https://innovation.cms.gov/innovation-models/oncology-care. Accessed August 27, 2023. Google Scholar6. A Primer on Pass-Through Status. CRSToday. https://crstoday.com/articles/2019-june/a-primer-on-pass-through-status. Accessed August 27, 2023. Google Scholar7. Subramanian K, Martinez J, Huicochea Castellanos S, et al. Complex implementation factors demonstrated when evaluating cost-effectiveness and monitoring racial disparities associated with [18F]DCFPyL PET/CT in prostate cancer men. Sci Rep 2023;13(1):8321. Crossref, Medline, Google Scholar8. Rodriguez J, Martinez G, Mahase S, et al. Cost-Effectiveness Analysis of 68Ga-DOTATATE PET/MRI in Radiotherapy Planning in Patients with Intermediate-Risk Meningioma. AJNR Am J Neuroradiol 2023;44(7):783–791. Crossref, Medline, Google Scholar9. Subramanian K, Martinez J, Osborne JR, et al. Access to cardiac PET/CT by sarcoidosis patients and cost-effectiveness analysis of cardiac PET/MR compared to the standard of care. Clin Imaging 2023;94:50–55. Crossref, Medline, Google ScholarArticle HistoryReceived: Sept 25 2023Revision requested: Oct 5 2023Revision received: Oct 12 2023Accepted: Oct 18 2023Published online: Nov 10 2023 FiguresReferencesRelatedDetailsRecommended Articles RSNA Education Exhibits RSNA Case Collection Vol. 5, No. 6 Metrics Altmetric Score PDF download