Quiero saber acerca de...

jbell on DSKJLSW7X2PROD with RULES

26852

Federal Register / Vol. 86, No. 94 / Tuesday, May 18, 2021 / Rules and Regulations
Response: There is not a substantive discussion on how the MCIT pathway would affect MA plans in the MCIT/
R&N final rule. Under current law, MA
plans are required to offer coverage of reasonable and necessary items and services covered under part A and part B on terms at least as favorable as those adopted by fee for service Medicare.
CMS did not fully consider the MA
effects in the MCIT/R&N final rule.
Specifically, the cost implications for MA plans of blanket national coverage and all of the associated costs to the breakthrough device was not fully explored. For example, if a breakthrough device was implanted, Medicare would pay not just for the device, but also for the reasonable and necessary procedures and related care and services such as the surgery, and related visits to prepare for surgery and follow up. These non-device costs were not considered in the regulatory impact analysis RIA.
Comment: Some commenters noted that the MCIT/R&N final rule could potentially lead to increased fraud, waste and abuse. A commenter noted that, under the final rule, the current MCIT construct offering guaranteed Medicare payment for 3 to 4 years with broad-based coverage criteria and minimal limitations for a massive patient population is a strong scenario for fraud.
Response: We believe the commenters are suggesting that the expanded coverage may encourage greater use of these devices than they believe is warranted. Because these determinations would depend on specific facts, CMS would follow its normal process in the event there was a concern of fraud or abuse.
Comment: Another stakeholder raised concerns that the MCIT/R&N final rule as currently constructed only considers industrys perspective and does not take into account physician and patient perspectives. They further noted that for MCIT there is no established mechanism in place for those stakeholders to provide comments regarding their concerns about using these technologies on the Medicare population. To that end, they claim that the current MCIT/R&N final rule lacks the transparency and accountability found in the existing NCD and LCD
processes.
Response: We appreciate these comments. We acknowledge that the MCIT/R&N final rule as currently designed does not provide the same level of opportunities for public participation as stakeholders have become accustomed to with the established NCD and LCD processes
VerDate Sep<11>2014

15:42 May 17, 2021

Jkt 253001

where, for each item or service considered for coverage, stakeholders have an opportunity to comment.
Comment: Regarding operational issues for MCIT, manufacturers commented that the existing processes in place for BCD, coding, and payment should work for MCIT, and that early coordination with CMS shortly after breakthrough designation should allow for time for these processes to play out.
Commenters, including several manufacturers, recommended that CMS
establish provisional codes and payment for breakthrough devices as part of the MCIT pathway to ensure availability of codes and payment at the time of FDA approval. They also recommended that CMS formalize an operational framework with a predictable timeline to conduct evidence reviews, develop benefit category determinations, codes, and payment.
Response: We will take these suggestions under consideration for future rulemaking.
Comment: Commenters indicated that the newly public information about the volume increase in the Breakthrough Device volume 2 was not a concern and that it should not impede implementation of the MCIT/R&N final rule. Others stated that the RIA was sufficient because not all devices designated as breakthrough would ultimately achieve market authorization after the 4-year period. Still others believed the RIA was insufficient because they believe there would be more breakthrough devices market authorized than included in the estimate. In light of the increase in volume, a commenter suggested considering mechanisms, such as establishing user fees, to increase resources through dedicated appropriation or other mechanisms.
Response: We must take into consideration the number of possible devices that will be approved through the MCIT pathway. Further, under the MCIT/R&N final rule any breakthrough device that receives FDA marketauthorization is potentially covered for any Medicare patient without evidence of its benefit generated in the Medicare population. Beyond limits in the indications for use for which FDA
approves or clears a device, CMS does not have the authority under the finalized MCIT policy to further define 2 U.S. Department of Health and Human Services, Food and Drug Administration, Reflections on a Record Year for Novel Device Innovation Despite COVID19 Challenges Feb. 16, 2021, available at https www.fda.gov/news-events/fda-voices/
reflections-record-year-novel-device-innovationdespite-covid-19-challenges.

PO 00000

Frm 00028

Fmt 4700

Sfmt 4700

clinical parameters to narrow or expand national coverage. In addition, all related care and services associated with the device are covered which could include additional visits and maintenance of the device. CMS did not factor these costs in the RIA. This analysis has an impact on ensuring there are sufficient resources for the program to run efficiently. As with any program, sufficient resources are key to efficient and timely operations.
Comment: Most manufacturers commented that the patient protections in place in the final rule, specifically the reliance on FDA safety and efficacy requirements to grant coverage to breakthrough devices under MCIT, were sufficient to prevent beneficiary harm.
Response: As finalized in the MCIT/
R&N final rule, devices could be used on Medicare patients without any evidence of the devices clinical utility in the Medicare population. To remove a device from Medicare coverage under MCIT, FDA must issue a safety communication, warning letter, or remove the device from the market.
Under the MCIT/R&N final rule, if CMS
observes a trend of higher risk, specifically in the Medicare population, CMS authority to deny coverage is limited. For example, if a CMS
contractor for example, a Medicare Administrative Contractor MAC
identifies a pattern or trend of significant patient harm or death related to an MCIT device, there is no procedure to quickly remove coverage for the device until and unless the FDA
acts. We believe that the public should have an additional opportunity to comment on this policy.
Comment: A commenter recommends that MCIT coverage could be offered to the class of the breakthrough device including device iterations and followon competitive devices. The commenter suggested that CMS direct an evidence review at the end of the 4 years of MCIT
coverage for a particular device determine which coverage pathway would be most appropriate to ensure the most benefit to Medicare patients.
Response: Clinical evidence development that includes Medicare beneficiaries is central to ensuring that Medicare patients are receiving optimal clinical care and minimizing risk when possible. While examining data on a group of similar breakthrough devices and identifying gaps in the evidence base may be a greater effort initially than the evidence review for one device, it could result in efficiencies across several components within CMS and inform coverage in a more comprehensive manner than MCIT, which is one device at a time. We will
E:FRFM18MYR1.SGM

18MYR1