CPIC Supports Separate Payments For Diagnostic Radiopharmaceuticals

The Honorable Chiquita Brooks-LaSure, MPP
Administrator, Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1809-P, Mail Stop C4-26-05
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: CMS-1809-P—Medicare Program: CY 2025 Hospital Outpatient Prospective Payment Systems Proposed Rule: Separate Payment for Diagnostic Radiopharmaceuticals

Dear Administrator Brooks-LaSure:

The Cardiac PET Industry Coalition (CPIC) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (“CMS”) calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (“OPPS”) proposed rule (“Proposed Rule”) published in the Federal Register on July 22, 2024. CPIC is an alliance of providers, diagnostic medical equipment and supply manufacturers and medical imaging companies who are committed to delivering optimal patient care and promoting policies that improve patient outcomes. CPIC members are dedicated to ensuring patient access to cardiac PET (Positron Emission Tomography), the premier modality of non-invasive molecular imaging which has become essential in the practice of modern cardiovascular medicine, not only in diagnosis, but also in the management of various cardiovascular disease states as well as in the guidance of invasive procedures. Together, we strive to ensure equitable availability of innovative and life-saving technologies for healthcare providers and the patients they serve.

Our comments primarily address the unpackaging proposal concerning diagnostic radiopharmaceuticals—a policy that holds significant importance to our members. The CPIC commends the agency for its proposal and values CMS’ ongoing collaboration with stakeholders on this matter. Below, we offer feedback on specific aspects of the proposal, as well as input on the proposed new technology Ambulatory Payment Classification (APC) assignments.

1. Proposed Payment for Diagnostic Radiopharmaceuticals

We commend CMS for its recognition and proposal to provide separate payments for certain diagnostic radiopharmaceuticals, ensuring equitable reimbursement and sustained beneficiary access. We strongly encourage CMS to finalize a policy, effective CY 2025, that unpacks specific diagnostic radiopharmaceuticals at a newly established diagnostic radiopharmaceutical threshold. This threshold would account for significantly higher costs and lower utilization compared to other diagnostic radiopharmaceuticals within an APC group. We believe this updated policy represents a substantial improvement, balancing the need to acknowledge innovation and maintain access for Medicare beneficiaries while preserving the integrity of an averaging prospective payment system.

A. CPIC Recommends that CMS Adopt a Packaging Threshold of $395

The CPIC appreciates CMS's proposal to offer separate payments for diagnostic radiopharmaceuticals that exceed a per-day cost threshold, in a manner akin to other drugs. We also value CMS's thoughtful approach, which acknowledges the unique contributions of diagnostic radiopharmaceuticals by calculating a volume-weighted average of the offset dollar amount for each nuclear medicine APC group. While we understand that the $314.28 threshold was derived from early CMS claims data, we support CMS's use of the full claims dataset to establish a final rule threshold. Although we agree with starting with the weighted average per-day dollar amount, we believe that applying the "two times rule" is an overestimate and may exclude some critical diagnostic radiopharmaceuticals.

For consideration, a more effective policy could involve using the 1.75 outlier rule, setting the threshold at $550 based on early claims data. This alternative approach would allow for the inclusion of four additional low-volume diagnostic radiopharmaceuticals (A9551, A9508, A9509, and A9571) in the separate payment category. This policy, already employed by CMS, would better represent these outlier costs.

Furthermore, CMS could consider establishing a new multiplier specific to diagnostic radiopharmaceuticals for setting this initial threshold, as it will serve as the basis for all future proposed and final rules beyond CY 2025. Since CMS aims to identify significant outliers, CMS should consider a threshold multiplier of 1.50 or 1.51, which would still exceed half the weighted average. We believe CMS is not constrained by existing multipliers, as this policy is newly specific to diagnostic radiopharmaceuticals. CMS should explore all options, in conjunction with claims data, to determine the most appropriate cutoff.

Alternatively, CMS could analyze drug file claims to identify the diagnostic radiopharmaceuticals driving payment rates due to volume, such as FDG, sestamibi, and tetrofosmin, and then set a threshold above those high-volume costs. One could argue that even 1.25 times the average is significant, provided the volumes are low compared to the drivers of APC payment rates. Reducing the threshold to 1.25 times the weighted average would set the initial diagnostic radiopharmaceutical threshold at $395 and allow four more diagnostic radiopharmaceuticals (A4642, A9526, A9554, and A9555)—including two PET cardiac tracers and two oncologic tracers—to be separately reimbursed. These are lower-volume, higher-cost diagnostic radiopharmaceuticals that merit separate payment consideration.

In conclusion, we strongly urge CMS to reconsider the proposed $630 threshold for CY 2025. We support CMS considering all available options to ensure that low-volume, higher-cost services are appropriately captured when setting the CY 2025 threshold. We respectfully recommend setting a starting threshold at 1.25 times the weighted average, amounting to $395.00.

B. CPIC Supports the Proposed Payment Methodology Using Mean Unit Cost (MUC), but Recommends CMS Average Sales Price (ASP) Data in Unique Circumstances in CY 2025 and More Broadly in Future Years

For drugs, CMS intends to use the Average Sales Price (ASP) methodology for payment. However, diagnostic radiopharmaceuticals are not required to submit ASP data, and CMS has noted that the data currently available is limited, does not align with expected costs based on hospital-submitted data, and is not suitable for payment purposes. Therefore, CMS believes that manufacturers should have the opportunity to submit, certify, or restate the ASPs of their products and is proposing to use mean unit cost as an alternative for 2025.

CMS also addresses the submission of ASP data at the patient-ready level. We are open to discussions with CMS and want to assure the agency that we are willing to collaborate on a submission that accurately represents the average patient-ready diagnostic radiopharmaceuticals. We greatly appreciate CMS’s willingness to allow manufacturers time to understand how the ASP drug methodology can be adapted for diagnostic radiopharmaceuticals.

CPIC supports using mean unit cost as a reasonable alternative methodology for the payment of radiopharmaceuticals that exceed the threshold for CY2025. However, CPIC agrees that ASP should be accepted by CMS in future years and strongly supports CMS’s ongoing dialogue with manufacturers to address the unique challenges associated with meeting ASP reporting requirements. CPIC believes that accurately submitted ASP data will provide a better proxy for the average sales of diagnostic radiopharmaceuticals than hospital claims data based on mean unit cost (MUC).

2. New Technology APC Placements for Cardiac Positron Emission Tomography (PET)/ Computed Tomography (CT) Studies (APCs 1520 and 1522)

For CY 2025, CMS proposes to use CY 2023 claims data to determine OPPS payment rates for PET-CT services (CPT codes 78431, 78432, and 78433).7 CMS proposes to assign CPT code 78431 to APC 1522 (New Technology–Level 22 ($2,001-$2,500)) with a payment rate of $2,250.50 for CY 2025. CMS proposes for CY 2025 to reassign CPT code 78432 to APC 1521 (New Technology–Level 21($1,901-$2,000)) with a payment rate of $1950.50. And for CPT code 78433, CMS proposes to reassign to APC 1522, with a payment rate of $2,250.50. The CPIC supports these proposed assignments and recommends that CMS finalize as proposed.

Thank you for the opportunity to weigh in on these important issues that impact our ability to prevent and diagnose cardiac diseases, the leading cause of death in our country1. CPIC again urges CMS to preserve access to cardiac PET/CT services and stands ready to assist you as you consider new approaches to payment for diagnostic radiopharmaceuticals. Please do not hesitate to reach out to Phil Cranmer, Executive Director, at cpicquestsions@polsinelli.com you have any questions or need additional information.

Sincerely,

Lon Wilson, CPIC Board of Directors
Kim McDaniel, CPIC Board of Directors
Walter Stenborg, CPIC Board of Directors

Source: ¹ National Center for Health Statistics. Multiple Cause of Death 2018–2021 on CDC WONDER Database. Accessed February 2, 2023.