The Centers for Medicare & Medicaid Services (CMS) recently published two proposed rules that could affect Medicare reimbursement for cardiology services. On July 22, 2024, CMS published the Calendar Year (CY) 2025 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (Proposed OPPS/ASC Rule), which includes changes in payment rates and covered procedures for ASCs. CMS also published on July 31, 2024, the CY 2025 Medicare Physician Fee Schedule Proposed Rule (Proposed PFS Rule), which proposes a new payment model that couples payments for cardiovascular risk assessments and care management.

Comment periods for the Proposed OPPS/ASC Rule and Proposed PFS Rule will close on Sept. 9, 2024. Both rules will likely be finalized in early November.

The two proposed rules could impact Medicare reimbursement to cardiologists by incentivizing earlier cardiovascular interventions, promoting the lower acuity settings and providing more potential opportunities for reimbursement through newly covered services. Due to an older patient population and greater expense for acute cardiology procedures, cardiologists disproportionately rely on Medicare reimbursement compared to other specialties, so these changes could have a large impact on the cardiology specialty and market.

ASC Rate Increase With Push for Health Equity

For 2025, CMS has proposed a 2.6% increase in payment rates for ASCs that meet the quality reporting requirements under the ASC Quality Reporting (ASCQR) Program. After the proposed rate increase, CMS expects that total ASC payments including beneficiary cost-sharing and estimated changes in enrollment, utilization and case-mix for 2025 will be approximately $7.4 billion, an increase of approximately $202 million over the 2024 Medicare payment.

The ASC rate will have a growing impact on cardiologists and cardiology investors in the coming years. Medicare has been adding cardiac surgeries to its list of covered ASC procedures over the past decade, acknowledging the appropriateness of these procedures in lower-cost, outpatient settings. Bain & Co. reported in 2019 that by the mid-2020s, 30-35% of cardiology procedures will be performed in ASCs. As payors continue to emphasize moving appropriate cases to outpatient sites of service, which are historically lower cost compared to inpatient settings, ASC reimbursement, as well as reimbursement for interventional suites in a physician office, known as an office-based lab (OBL), will impact care decisions.

These payments will also be subject to quality reporting requirements under the ASCQR Program, and ASCs that do not meet the requirements would be subject to a 2% penalty to the annual rate update. The ASCQR Program requires ASCs to report data on quality measures specified by CMS. CMS proposes changing the ASCQR Program to add the following measures that focus on health equity considerations:

1. The Facility Commitment to Health Equity measure beginning with the CY 2025 reporting period/CY 2027 program determination,
2. The Screening for Social Drivers of Health measure beginning with voluntary reporting in the CY 2025 reporting period followed by mandatory reporting beginning with the CY 2026 reporting period/CY 2028 payment determination, and
3. The Screen Positive Rate for Social Drivers of Health measure beginning with voluntary reporting in the CY 2025 reporting period followed by mandatory reporting beginning with the CY 2026 reporting period/CY 2028 payment determination.

These new measures continue to underscore the government’s push for healthcare equity efforts generally, which McGuireWoods previously discussed with respect to a language access report and nondiscrimination rulemaking.

New Covered Procedures and Services in the ASC Setting

In the Proposed OPPS/ASC Rule, CMS has proposed to add 20 medical and dental surgical procedures to the ASC Covered Procedures List for CY 2025, including pacemaker insertion and removal/replacement codes:

1. CPT code 0795T (transcatheter insertion of permanent dual-chamber leadless pacemaker, including imaging guidance and device evaluation, when performed; complete system), and
2. CPT code 0801T (transcatheter removal and replacement of permanent dual-chamber leadless pacemaker, including imaging guidance and device evaluation, when performed; dual-chamber system).

The additional list of covered procedures does not indicate whether the procedures may be furnished in an ASC setting. Such determinations are subject to state laws, certificate of need approvals and other billing requirements. This has been true for past CMS additions to the ASC Covered Procedures List. While CMS may approve these services for reimbursement, state law may still implicate whether an ASC or OBL can be utilized, or if cardiologists need to provide the service in a hospital.

New G-Codes for Atherosclerotic Cardiovascular Disease Assessment and Management

In the Proposed PFS Rule, CMS proposes new G-codes and payments for atherosclerotic cardiovascular disease (ASCVD) risk assessment and management services:

1. HCPCS code GCDRA (administration of a standardized, evidence-based ASCVD risk assessment for patients with ASCVD risk factors on the same date as an evaluation and management (E/M) visit, 5–15 minutes, not more often than every 12 months), with a proposed work relative value unit (RVU) of 0.18, and
2. HCPCS code GCDRM (ASCVD risk management services for patient without a current ASCVD diagnosis but with a medium or high risk for CVD as previously determined by the ASCVD risk assessment, ASCVD-specific care plan, clinical staff time, per calendar month), with a proposed work RVU of 0.18.

The ASCVD risk assessment would be performed on the same date as an E/M visit for patients who have at least one predisposing condition to cardiovascular disease (CVD) (e.g., a family history of CVD, a history of high blood pressure, a history of high cholesterol) that may put them at increased risk for future ASCVD diagnosis. The ASCVD risk assessment would not, however, be separately billable for patients who already have a CVD diagnosis or a history of heart attack or stroke.

The risk assessment will include demographic data, modifiable risk factors for CVD, potential risk enhancers and laboratory data. Risk management includes the development, implementation and monitoring of individualized care plans for reducing cardiovascular risk, including shared decision-making and the use of the ABCs of cardiovascular risk reduction, as well as counseling and monitoring to improve diet and exercise.

This proposal to add ASCVD risk assessment and risk management G-codes is a result of the CMS Innovation Center’s Million Hearts Cardiovascular Disease Risk Reduction model, which was tested from 2017 through 2022 and concluded that payments for cardiovascular risk assessment with cardiovascular care management reduces the rate of death.

If finalized, these proposals could have a significant impact on cardiologists, cardiology investors and other stakeholders in the cardiology space. The Proposed OPPS/ASC Rule would increase ASC rates, add new covered ASC procedures and incentivize certain health equity measures. The Proposed PFS Rule introduces ASCVD risk assessment and risk management codes, incentivizing the provision of cardiovascular services in lower acuity settings such as ASCs and promoting earlier cardiovascular interventions.