CPIC Urges CMS to Restore Full and Fair Reimbursement for Cardiac PET in CY 2024 OPPS Proposed Rule

The Honorable Chiquita Brooks-LaSure, MPP
Administrator, Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1751-P, Mail Stop C4-26-05
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: CMS-1786-P—Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems.

Dear Administrator Brooks-LaSure:

The Cardiac PET Community & Industry Coalition (CPCIC) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (“CMS”) calendar year (CY) 2024 Hospital Outpatient Prospective Payment System (“OPPS”) proposed rule (“Proposed Rule”) published in the Federal Register on July 31, 2023. CPCIC is an alliance of providers, medical equipment and supply manufacturers and medical imaging companies who are committed to delivering optimal patient care and promoting policies that improve patient outcomes. CPCIC members are dedicated to ensuring patient access to cardiac PET (Positron Emission Tomography), the premier modality of non-invasive molecular imaging for diagnosing, treating, and preventing cardiovascular diseases. Together, we strive to ensure equitable availability of innovative and life-saving technologies for healthcare providers and patients.

To that end, CPCIC offers the following comments:

• CPCIC strongly urges CMS to keep CPT code 78431 in the current APC 1523 to prevent disruption in access to this relatively new technology. The variation in APC from year to year will be destabilizing as hospitals continue to adapt to this new technology and will discourage its uptake. CPCIC requests that CMS withhold this policy until the agency and stakeholders have more robust and longitudinal data.

• CPCIC supports the agency’s proposal to use its authority to pay separately for diagnostic radiopharmaceuticals, but respectfully requests that CMS release more information, and engage with stakeholders, on the threshold and the payment methodology before finalizing it.

I. CPCIC strongly opposes the proposal to shift CPT code 78431 to APC 1522. Instead, CMS should maintain 78431 in its current APC until multiple years of hospital cost data are available in order to maintain stability, prevent disruption in access to nuclear cardiology services, and verify that hospitals have adjusted to billing for this new procedure.

In January 2020, the agency assigned three new codes for cardiac PET/CT -- 78431, 78432, and 78433 -- to New Technology APCs and kept these codes as assigned in subsequent final rules because it was lacking claims data in 2021 and 2022. In 2023, CMS reassigned 78431 [(Myocardial imaging, positron emission tomography (PET), perfusion study; multiple studies at rest and stress (exercise or pharmacologic), with concurrently acquired computed tomography transmission scan)] to the higher APC 1523 based on claims data from 2021. CMS is now proposing to reassign 78431 back to APC 1522 at a proposed payment rate of $2,250.50 in CY 2024. This would reflect a greater than 18% cut and fall below the geometric mean cost of $2,300.26 recorded within CY 2022 claims data.

A cut of this magnitude has the potential to slow and stagnate the adoption of cardiac PET/CT, particularly in rural or underserved areas where hospitals and clinics are often operating at a financial deficit. The uncertainty in Medicare payments created by annual payment swings leads to instability in a market that is already strained and provides a disincentive for hospitals to adopt these essential diagnostic services. Limited access in these areas may exacerbate health inequities and result in decreased detection of coronary artery disease (CAD) and poorer outcomes for cardiac patients and/or use of lesser quality diagnostics, which has been shown to lead to further downstream and costly testing. Additionally, the emergence of coronary flow reserve as a key clinical assessment – now made available through cardiac PET – enables cardiology to take the next step into management of cardiovascular disease to realize true health care savings.¹

CMS should avoid policy changes that will discourage the use of these new codes. PET has demonstrated higher accuracy in diagnosing a number of cardiac diseases, including myocardial ischemia and coronary artery disease (CAD) in women, when compared to other modalities. In addition, cardiac PET exposes patients to much lower levels of radiation than other testing procedures, which has become paramount in diagnostic, non-invasive imaging due to long-term radiation exposure in medical imaging.

We encourage CMS to allow time for hospitals to adjust to this new technology and to reporting the costs associated with it, and for CMS to understand the trends in the data before moving forward with yet another payment change. For instance, CPT code 78431 only registered a 13% increase in single frequency claims, as reflected in rate setting data from CY 2021 (19,632 single frequency claims) and CY 2022 (22,196 single frequency claims). CPCIC respectfully argues that the 110 providers billing 78431 do not constitute a sufficient data set upon which to base such a drastic cut, particularly for a new technology that may be experiencing wide variations in minimum, maximum, and median costs recorded for the CY 2023 OPPS NFRM and CY 2024 NPRM:

Costs for Hospital Outpatient Services, by HCPCS code for CY 2023
(NFRM: Notice of Final Rulemaking)

HCPCS: 78431
APC: 1523
Payment Rate: $2,750.50
Single Frequency: 19632
Total Frequency: 25597
Minimum Cost: $837.40
Maximum Cost: $6,110.88
Median Cost: $2,621.55
Geometric Mean Cost: $2,532.47

Source: 2023 NFRM OPPS Cost Statistics Files

Costs for Hospital Outpatient Services, by HCPCS code for CY 2024
(NPRM: Notice of Proposed Rulemaking)

HCPCS: 78431
APC: 1523
Payment Rate: $2,750.50
Single Frequency: 22196
Total Frequency: 27199
Minimum Cost: $742.80
Maximum Cost: $7,024.10
Median Cost: $2,471.98
Geometric Mean Cost: $2,300.26

Source: 2024 NPRM OPPS Cost Statistics Files

II. CPCIC supports the agency’s proposal to pay separately for diagnostic radiopharmaceuticals, but respectfully requests that CMS release more analysis and justification on a proposed per-day threshold and payment methodology for the unpackaged radiopharmaceuticals before moving forward. CPCIC also encourages CMS to engage with stakeholders for additional input if it elects to finalize this policy.

For many years, CMS has “packaged” certain non-passthrough drugs, biologics and radiopharmaceuticals into an aggregate payment for the associated service rather than pay for them separately. Our industry has long raised concerns and objections to this payment structure because it fails to take into account the price of the drug, biologic, or radiopharmaceutical but instead treats them as supplies. This has been especially problematic for high-cost, low-volume radiopharmaceuticals.

CMS is now soliciting comment on potential alternative payment approaches for diagnostic radiopharmaceuticals. Specifically, the agency is seeking input on whether a separate payment is appropriate based on per-day costs above the OPPS drug packaging threshold of $140; whether a per-day cost threshold should be above or below the OPPS drug packaging amount; whether there should be additional nuclear medicine APCs for services that utilize high-cost diagnostic radiopharmaceuticals; and whether there should be specific policies for use of diagnostic radiopharmaceuticals used in clinical trials or for specific disease states.

CPCIC generally supports a reimbursement model that would unpackage radiopharmaceuticals and pay for them separately. However, understanding both the rationale for the per-day OPPS threshold amount and the payment amount for the unpackaged radiopharmaceutical is critical to determining the viability of any proposal and its impact on patient access. It additionally is imperative for CPCIC members to be able to evaluate the impact of potential unpackaging on existing nuclear cardiology APCs and the basis on which radiopharmaceuticals would be paid, as well as consequences for payments under the Physician Fee Schedule (PFS).

CMS suggests basing the payment for radiopharmaceuticals on “available average sales price (ASP), wholesale acquisition cost (WAC), or average wholesale price (AWP) data with the applicable add-on.” Absent specifics about which payment methodology or the amount of the add-on, it is impossible to weigh in on the impact this proposal will have on patient access. Should CMS move forward with this proposal, we encourage as much transparency and clarity as possible to permit stakeholders to understand fully how these radiopharmaceuticals will be paid.

This change could result in a reduction in the APC to account for the removal of the radiopharmaceuticals, and CMS and stakeholders must completely recognize the magnitude of an associated decrease in nuclear medicine APCs if unpackaging drugs. This analysis should account for drugs at all cost levels, including those that are significantly higher than the determined threshold and those that are lower or at the threshold amount. CMS also should consider situations where the dosing and number of doses of the radiopharmaceutical is variable.

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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 country2. CPCIC 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 at phil.cranmer@cdlnuclear.com should you have any questions or need additional information.

Sincerely,

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

¹ The impact of revascularization on myocardial blood flow as assessed by positron emission tomography. Bober, Robert M., et al. 2019, European Journal of Nuclear Medicine and Molecular Imaging.

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