CMS Changes Create Uncertainty for ASCs, Orthopedics, and Patients

During President Trump’s term, an executive order (EO)—Protecting and Improving Medicare for Our Nation’s Seniors—was issued (EO 13890 on Oct. 3, 2019) with the intention to improve access to healthcare services. As part of that order, it was announced the Centers for Medicare & Medicaid Services (CMS) would eliminate its Inpatient Only (IPO) list, which contained approximately 1,700 procedures. These procedures were only paid for by Medicare when performed in the hospital as inpatient.

Starting with the elimination of almost 300 primarily musculoskeletal-related services at the start of 2021, the list would be completely eliminated by 2024. This would enable the growing ASC (ambulatory surgical center) community (among other options) to offer services previously exclusive to hospitals. The intent was to encourage competition among healthcare providers, enabling options for patients.

Unfortunately, not everyone was in agreement with the move. In its CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS-1753-P), CMS stated it had “received a large number of stakeholder comments throughout the CY 2021 rulemaking cycle and following issuance of the final rule with comment period that opposed the elimination of the IPO list primarily due to patient safety concerns, stating that the IPO list serves as an important programmatic safeguard.”

As a result, CMS stated it would restore the 298 previously removed services to the IPO list at the start of CY 2022. According to the agency, “This change in policy would ensure that any service removed from the IPO list has been reviewed against Medicare’s longstanding IPO list criteria to determine if it is appropriate for Medicare to pay for the provision of the service in the outpatient setting. Furthermore, CMS is proposing to codify the longstanding criteria for removal of procedures from the IPO list to make clear in regulatory text how we will evaluate future procedures for removal.”

In the same announcement, CMS indicated it was reinstating the criteria (based on patient safety) used to determine additions to the ASC Covered Procedure List (CPL). As a result of the action, 258 of the 267 procedures added to the list in CY 2021 would be removed. The agency is welcoming comments on the 258 procedures.

CMS also announced, in connection with the move, it would implement a program in which anyone could nominate a procedure to be considered for addition to the ASC CPL. If the nominee was accepted, the procedure would be added to the list during the next rulemaking schedule.

In the short term, any company that sells an orthopedic device used in a procedure removed from the ASC CPL should seriously consider the nomination option (once available). Of course, patient safety should be paramount, but with such a large move, it’s certainly possible some procedures are inherently safe to be performed in an ASC setting. It’s also quite possible these procedures are missed or not given priority for review should no one nominate them. You know, squeaky wheel…

In the big picture, this was a completely botched move. This isn’t a matter of enabling a handful of procedures to be performed outside the hospital setting only to be returned to that status a year later. This type of uncertainty is bad for device makers, bad for healthcare professionals, and, most notably, bad for patients.

I’m fully supportive of putting patient safety first. When it comes to healthcare, that must always be the number one priority. So I don’t have an issue with the move specifically; I have more of a problem with a system that allowed it to happen. Executive order or not, healthcare cannot change on the whim of whomever is in power at the time. It needs to be well considered, well planned, and well executed. Unfortunately, political timelines and healthcare timelines don’t always align. Thus, we have “unhealthy” execution of plans, such as this one.

If you’re a company with products “in limbo” between potentially new customers (e.g., ASCs) and more established ones (e.g., hospitals), I would be sure to be active during any CMS comment period. Further, encourage doctors, surgeons, and even patients who are benefiting and/or using your product to comment as well. Again, I’m not advocating circumventing patient safety, but I think it’s safe to assume not all 258 procedures should have been removed from the ASC CPL (just as it is likely not all 258 procedures should have been added to it in the first place).

Hopefully, the right people will ultimately make the best decisions based on what’s best for patients, and not what’s best for device makers, surgeons, or politicians. 

Sean Fenske, Editor-in-Chief
[email protected]