As Interventions Dip During COVID-19, CMS Offers Leniency on Volumes

Due to disruptions related to COVID-19, the Centers for Medicare & Medicaid Services (CMS) will not hold hospitals and physicians responsible for meeting volume requirements mandated for reimbursement for various procedures.

Confirmed in an interim final rule published at the beginning of this month, the volume requirements found in national coverage determinations (NCDs) for TAVR, transcatheter mitral valve repair, percutaneous left atrial appendage closure, and ventricular assist devices will not be enforced as long as the standards were being met prior to the pandemic. The rule applies only during the official public health emergency; that declaration was reaffirmed in July and will expire near the end of October without another renewal.

All requirements for coverage in the NCDs other than those related to procedural volume remain in effect.

“This enforcement discretion . . . ensures that beneficiaries will continue to have access to the services that are covered under the NCD,” CMS writes.

John Carroll, MD (University of Colorado, Aurora), chair of the steering committee for the Society of Thoracic Surgeons/American College of Cardiology TVT Registry, said of the move, “I think they’re being quite reasonable.” The move by CMS echoes the flexibility seen in other areas of medicine and health policy, Carroll said, noting that the US Food and Drug Administration has provided guidance on how to adapt clinical trials so that they can continue during the COVID-19 era.

Now that they’ve demonstrated flexibility and, more importantly, an understanding about what is happening in clinical practice from COVID, I would expect them to consider further modifications . . . as we move to the next stage. John Carroll

COVID-19 has had a rapid and substantial impact on the delivery of healthcare in the United States. On March 18, 2020, CMS recommended that hospitals and physicians delay certain nonessential procedures during the pandemic. Carroll said a lot valve programs saw their procedure volumes plummet or dry up completely. Indeed, a May survey of US catheterization laboratories in 48 states showed that median monthly TAVR volumes had dropped by 64% compared with last year. Celina M. Yong, MD, MBA, MSc (Stanford University and VA Palo Alto Healthcare System, CA), who led that survey, told TCTMD at the time that it would be in the best interests of the CMS to allow for some leniency on procedure volumes, saying: “If our first priority is to our patients, then we need to be careful that we not shut down their access to high quality TAVR centers just because of a metric that was designed for pre-COVID times."

 In June, CMS said these services could resume. “Even so, as a result of the public health emergency for COVID-19, hospitals and practitioners have performed fewer nonessential procedures for several months and as a result may not be able to meet certain procedural volume requirements that are set forth in these NCDs,” the interim final rule states.

The relaxed enforcement from CMS provides relief to hospitals and physicians running these types of programs. “Now that they’ve demonstrated flexibility and, more importantly, an understanding about what is happening in clinical practice from COVID, I would expect them to consider further modifications of a variety of requirements as we move to the next stage,” Carroll said, acknowledging that it’s not clear what it will take to bring an end to the public health emergency.

There is some question about how the pandemic will impact outcomes of various procedures, as centers prioritized the highest-risk patients during periods of high COVID-19 activity. “It’s possible that we’ll see a decrement in outcomes in the TVT Registry,” Carroll said. Data for the first half of 2020 are being gathered currently, and they’ll provide insights into the effect COVID-19 has had on procedural volumes and outcomes. Researchers will also gain some understanding about whether there has been a shift to sicker patients and whether the risk adjustment performed as part of the registry is adequate to tackle this issue, Carroll said. These analyses, he added, are complicated by how COVID-19 is waxing and waning around the country and by the reduction in related mortality over time.