STS News, Winter 2021 — In a major win for cardiothoracic surgeons and their patients, significant Medicare reimbursement cuts set to take effect on January 1 were halted.

Congress approved a massive omnibus spending bill in late December that prevented the Centers for Medicare & Medicaid Services (CMS) from implementing cuts that were part of the 2021 Final Rule for the Medicare Physician Fee Schedule.

The legislation included language that delays an add-on billing code for office Evaluation and Management (E/M) services and increases Medicare payments for all of medicine by 3.75%. Combined, these two actions negated nearly the entire 8% in cuts that were expected for cardiothoracic surgeons.

The Society, in collaboration with the Surgical Care Coalition, has been involved in comprehensive advocacy efforts to stop the reduction in Medicare reimbursement payments. In addition, the hard work and steadfast efforts of STS members, especially those who reached out to their Congressional representatives and shared their stories, helped lawmakers realize that cutting physician pay in the middle of a public health emergency was absurd.

The 2021 spending package also included “wins” that buoyed other important STS advocacy priorities: the arbitrary cap on Medicare funding for graduate medical education (GME) was removed and 1,000 new Medicare-supported GME positions at rural and urban teaching hospitals were added (ending a 25-year freeze); current levels of funding for the Agency for Healthcare Research and Quality were sustained; and funding for the National Institutes of Health and the Centers for Disease Control and Prevention was increased.

STS will continue working to fully understand the impact of this legislation and help ensure appropriate implementation, while also pushing forward to resolve underlying issues in physician Medicare reimbursement.

21st Century Cures 2.0

Work continues on the next iteration of the landmark 21st Century Cures Act.

Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released a concept paper this past spring that includes COVID-19 surveillance and testing capabilities, educational programs for at-home caregivers, patient health literacy and access to health information, and diversity in clinical trials.

Cures 2.0 also will explore ways to safely and efficiently modernize CMS coverage and care delivery and better utilize real-world data and evidence in the US Food and Drug Administration (FDA)-approval processes.

The Society has urged Reps. DeGette and Upton to include guaranteed registry access to Medicare claims data in Cures 2.0. This would allow registries such as the STS National Database to facilitate medical research and quality improvement initiatives, as well as support patients and their families as they choose the right treatment options. Similar discussions have been under way with Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA), who are leading the Cures revamp in the Senate.
 

Legislator of the Year

Last fall, Rep. DeGette was named Legislator of the Year by STS in recognition of her strong leadership and support of health care policies that impact cardiothoracic surgeons and their patients.

Rep. DeGette, who has served in the US House of Representatives since 1997, consistently has been a champion of STS advocacy priorities such as the Patient-Centered Outcomes Research Institute and e-cigarette and vaping regulations. She also supported the repeal of the Sustainable Growth Rate and voted in favor of the Medicare Access and CHIP Reauthorization Act of 2015.

“We’re facing one of the worst public health crises in our nation’s history, and it’s made the work that our cardiothoracic surgeons and all of our frontline health care workers do that much more important. So, thank you to them and everyone at STS for your tireless efforts to help us improve our nation’s health care system and modernize the way we care for patients” she said.

The STS Legislator of the Year Award acknowledges a member of Congress who has made sustained and/or extraordinary efforts in promoting issues of importance to cardiothoracic surgeons and their patients through legislation, funding, or other outreach to policymakers.

Coverage with Evidence Development

In addition to fighting Medicare cuts and advancing Cures 2.0, a key priority for the Society in 2021 is preserving coverage with evidence development (CED) as a Medicare pathway.

CMS policy allows Medicare coverage of an innovative treatment or technology while simultaneously collecting data through a clinical trial or registry on the efficacy and safety of the intervention in real-world populations; however, the agency recently started stripping CED from national coverage decisions (NCDs).

For example, CMS proposed to change the NCD for mitral valve transcatheter edge-to-edge repair (TEER), previously known as transcatheter mitral valve repair (TMVR). While the proposed NCD offers expanded coverage for patients with functional mitral regurgitation (FMR), it does not include a CED requirement for TEER in patients with degenerative mitral regurgitation (DMR) and FMR. This means that participation in a registry such as the STS/ACC TVT Registry would not be required as a condition of coverage.

In addition, both the FDA and CMS would be deprived of data on how TEER performs in real-world populations, which could have serious implications for patient safety and cause the FDA to revert back to more rigorous pre-market requirements for manufacturers, thereby delaying beneficiary access to innovative technology.

Medicare Coverage of Innovative Technology

The Society also will focus in 2021 on a CMS proposal to streamline the coverage pathway for FDA-approved “breakthrough medical devices.” Under the proposed rule—Medicare Coverage of Innovative Technology (MCIT)—devices that the FDA deems as high-impact would be covered immediately for the first 4 years, rather than waiting for a coverage decision.

The 4-year window is intended for device manufacturers to generate clinical and real-world evidence on health outcomes among the Medicare population.

STS supports bringing innovative technologies to market faster, but in submitted comments to CMS, the Society stated that a less-rigorous evidence-based coverage process could result in premature coverage of unproven devices. Other concerns included the need for careful monitoring and the possibility that patients’ access to competitive innovations would be limited.