Dive Brief:

• A draft CMS rule on payments device makers receive for products used in outpatient settings drew hundreds of comments from physicians and medtech companies including Wright Medical, CVRx and Lantheus by this week's deadline.
• The Medical Alley Association, the Minnesota-based trade group for Medtronic, Boston Scientific, Abbott as well as some payers and providers, recommended Medicare Administrative Contractors not be allowed to make regional coverage decisions obstructing so-called transitional pass-through payments. CMS uses the payments to back adoption of products that may otherwise be too costly for providers.
• Other areas of the wide-reaching rule that drew comments included heart and lung rehab via telemedicine, vertebral implants and a number of imaging modalities.

Dive Insight:

Transitional pass-through payments are a benefit companies can apply for from CMS intended for FDA-approved or cleared devices used in outpatient settings like ASCs and where the cost may preclude patients from receiving them.

The Medical Alley Association argued in its comments that all products designated by FDA as breakthrough devices ought to satisfy all non-cost criteria necessary for TPT eligibility.

The group also said that despite the program's aims, "All too often, Medicare patients are still restricted from accessing these technologies due to coverage determinations made by Medicare Administrative Contractors ... when determining the coverage needs of Medicare beneficiaries within their regional jurisdiction, refusal to cover the technologies that are eligible for TPT payments is in opposition with the intent of the program."

The Medical Alley Association offered a recommendation: "To that end, we believe that CMS should confer a presumption of coverage for all technologies that receive TPT status for the length of their eligibility. This enables the purpose of these programs to be fulfilled, while preserving the ability of the MACs to evaluate them individually for coverage after the guaranteed add-on payment period expires."

Also making recommendations for the program was a trio of gastroenterology societies concerned about how COVID-19 may affect the generation of clinical evidence supporting continued reimbursement for certain devices.

"We believe CMS should use its authority to provide separate payment for an additional one year after pass-through status of pass-through devices ends for devices whose data collection was impacted by the COVID-19 PHE pause on elective procedures," they wrote.

Many respondents focused on much more specific impacts of the rule.

One area drawing attention was heart and lung rehab via telemedicine. The American Association of Cardiovascular and Pulmonary Rehabilitation said many hospitals closed cardiac and pulmonary rehabilitation programs during the pandemic to create additional space, reduce outpatient traffic and reassign staff, leaving patients without ongoing services. Telehealth codes were delineated through the physician fee schedule, but there was no clear path for cardiac or pulmonary rehab services. 

The group said it appears programs are being given the option to conduct real-time virtual sessions with patients when they re-open. The group requested specific verification that the expanded virtual delivery option for cardiac and pulmonary rehab services is on a permanent basis beyond the public health emergency. 

Another area of concern was coronary CT angiogram, which can be leveraged in a procedure to quickly image the entire structure of the heart and coronary arteries. The vice chairman for clinical affairs at the University of Maryland Medical Center said proposed payment changes in the 2021 rule underestimate the true cost of imaging via the method preventing hospitals from adopting the technology.

Meanwhile, dozens of physicians urged CMS to revise the proposed facility fee reimbursement for High-Intensity Focused Ultrasound treatment for prostate cancer, saying the current code does not reimburse hospitals or surgery centers enough to offer the treatment. Several said the treatment provides good cancer cure rates with lower complications than commonly seen with other forms of prostate cancer treatment.

Many others wrote to ask that CMS approve the transitional pass-through code for Stryker's SpineJack device to treat vertebral compression fractures. Some pointed to the SAKOS study, published last year, that showed favorable results for SpineJack versus balloon kyphoplasty, once the gold standard.