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Saturday, November 23, 2024

States Take Steps to Allow Cardiac Procedures in ASCs

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Ambulatory Surgery Center Association Pac (ASCAPAC) recently issued the following announcement.

State laws and regulations governing the performance of percutaneous coronary intervention (PCI) procedures—a type of cardiac catheterization service—still pose a major obstacle in ASCs performing the procedures despite the addition of three PCI procedures—CPT codes 92920 and 92928 and HCPCS code C9600—along with three associated add-on procedures—CPT codes 92921 and 92929 and HCPCS code C9601—to the ASC Covered Procedures List (ASC-CPL). As part of its final 2020 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) Payment System Rule, the Centers for Medicare & Medicaid Services (CMS) shifted a number of procedures to the ASC-CPL back in November 2019, including the PCI procedures.

Certain states, such as California, very clearly exclude ASCs from performing the procedures, while others, such as Connecticut, require the issuance of a certificate of need (CON) for the performance of inpatient and outpatient cardiac catheterizations, suggesting ASCs could perform the procedures. However, a Connecticut ASC professional says that the state refuses to issue ASCs a CON for PCI procedures, resulting in a de facto prohibition on ASCs performing the procedure.

Michigan was the first state to introduce legislation on the matter, with SB 675 referred to committee on December 4, 2019, and an identical measure, HB 6325, introduced in the Michigan House in November of 2020. The measures would have removed the need to obtain a CON to perform PCI procedures, but ultimately died upon the adjournment of the legislative session due to a combination of two factors: strong opposition from the state hospital association and the arrival of the COVID-19 pandemic, with the response to the latter dominating state legislative agendas across the country to the detriment of other issues.

California took aim at the issue next. Assembly member Joaquin Arambula introduced AB 3083 in February of 2020; the measure would have authorized the Department of Public Health, within its existing PCI program, to certify ASCs to provide elective PCIs. After passing its first committee, the measure stalled in the Appropriations Committee. While it had received support from the California Medical Association, the California chapter of the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions, the Service Employees International Union in California (SEIU CA), one of the single most powerful groups in California politics, opposed the bill. Despite the level of support the measure had garnered, the union’s level of influence in the legislature resulted in the death of the measure upon adjournment of the 2019-2020 session.

While Michigan and California both attempted legislative fixes, Mississippi succeeded in changing its requirements first. At the start of 2020, Mississippi was one of the states that had a clearly articulated prohibition against ASCs performing PCI procedures. The FY 2018 Mississippi State Health Plan stated, “MSDH shall not approve CON applications for the establishment of therapeutic cardiac catheterization services at any facility that does not have open-heart surgery capability ...” According to the Mississippi Ambulatory Surgery Center Association (MASCA), the Hattiesburg Clinic—a large and powerful clinic in the state with more than 60 satellite locations and more than 350 providers—was a first mover on the issue, cutting out other organizations like MASCA and working directly with hospitals.

The heavy involvement of hospitals was evident in the final product, which granted hospitals an extensive amount of power over ASCs seeking to perform PCI procedures. When the state issued its FY 2020 Mississippi State Health Plan, it contained two new licensing categories of ASCs that would be allowed to perform PCI procedures: Cardiac Ambulatory Surgical Facilities (CASF) and Joint Venture Cardiac Ambulatory Surgical Facilities (JV-CASF), the latter of which required joint ownership by an acute care hospital offering cardiac catheterization and PCI services and one or more cardiologists. The new regulations provided that cardiac catheterizations may only be performed by an acute care hospital, a hospital-owned CASF or a JV-CASF. The state provided one exception to this: the state department of health could consider an application for a CASF without hospital ownership if the applicant obtained a letter of written support for the project from all acute care hospitals offering cardiac catheterization and/or PCI services located within a 25-mile radius of the proposed project.

A perfect storm of cardiologist and hospital support for the issue following a previous relaxation of requirements surrounding PCIs, and increased oversight of the state Certificate of Need Commission by the legislature due to a dispute over an unrelated CON issue, resulted in a standing advisory committee recommending to the Certificate of Need Commission that all billable codes for cardiac catheterization be allowed on an outpatient basis. The new CON Review Standards for Cardiac Catheterization Services adopted by the CON Commission in June of 2021 allowed freestanding surgical outpatient facilities—FSOFs, Michigan’s term for ASCs—to apply for a CON to perform PCI procedures.

Michigan facilities will still need to jump through a few hoops. The new standards require an ASC to, among other things, identify at least one interventional cardiologist to perform the procedures who has performed at least 50 PCI sessions annually during the most recent 24-month period, identify trained nursing and technical catheterization laboratory staff experienced in handling acutely ill patients, have a laboratory equipped with optimal imaging systems and obtain a written agreement with an open heart surgery hospital that is within 30 minutes travel time. Still, a handful of centers are pursuing CONs for these services, meaning ASCs could be performing the procedures in Michigan as soon as 2022.

Despite the differences between Michigan and Mississippi, the experiences in both point to the fact that the support of hospitals and large health systems is likely a necessary condition for the issue of PCI procedures in ASCs to gain traction with lawmakers and regulators. Those attempting to push the issue elsewhere would do well to study how the issue played out in Michigan and Mississippi, and to be aware of the double-edged sword of hospital support for the issue.

Original source can be found here.

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