CBSA Advocates for Medicare Coverage of Emerging Technologies
By: Colorado BioScience Association Date: 06/26/2023
Weekly Policy Blog: CBSA Advocates for Medicare Coverage of Emerging Technologies
CBSA advocates for policies that improve patient access to critical life-saving novel technologies. The bipartisan Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691), which was introduced by Reps. Brad Wenstrup (R-OH) and Suzan DelBene (D-WA) on March 31st, has garnered growing support with 50 co-sponsors. CBSA applauds Colorado U.S. Representative Diana DeGette for signing-on as the most recent co-sponsor of H.R. 1691. This House bill seeks to provide four years of Medicare coverage for medical devices that receive approval from the FDA under the Breakthrough Devices Program. It would also create a roadmap for additional data collection for CMS to make a permanent coverage decision after the initial four years.
This week, CMS also released its notice on the long-awaited proposed Transitional Coverage for Emerging Technologies (TCET) pathway, which is an important opportunity for our industry and CMS to modernize the coverage process, allowing swifter access to innovative, lifesaving technologies and therapies to Medicare beneficiaries.
Background
In January 2021, CMS announced the Medicare Coverage of Innovative Technology (MCIT) rule, that would have provided four years of automatic coverage for FDA-approved breakthrough-designated products. CMS repealed the MCIT rule that November, a month before it was set to go into effect. At the repeal of MCIT, CMS announced it would propose a new rule called Transitional Coverage for Emerging Technologies (TCET).
Just weeks ahead of CMS’ promised timeline to propose TCET in April 2023, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) was introduced to accelerate safe and effective life changing and saving therapies and cures to Medicare patients. This House bill seeks to provide four years of Medicare coverage for medical devices that receive approval from the FDA under the Breakthrough Devices Program. It would also create a roadmap for additional data collection for CMS to make a permanent coverage decision after the initial four years.
H.R. 1691 rapidly gained growing support from bipartisan co-sponsors and national medical technology organizations, Advanced Medical Technology Association (AdvaMed) and Medical Device Manufacturers Organization (MDMA) who expressed the importance of this legislation as a crucial element of the reforms ongoing within CMS.
Then, on June 22, 2023 CMS released its notice on the proposed TCET pathway. CMS plans to establish TCET through a procedural notice rather than rulemaking so that it can be implemented more quickly and modified as needed. A 60-day public comment period is currently open.
CBSA appreciates CMS releasing their draft proposal on TCET. Our Policy & Advocacy team is reviewing this notice, and will consult with our Policy Committee and advocacy partners at the federal level on strategy for engaging on the proposed TCET pathway.
According to their release “CMS’ goal is to finalize a National Coverage Determination (NCD) for technologies accepted into and continuing in the TCET pathway, within 6 months after FDA market authorization.”
According to CMS, the TCET pathway will meet these principles:
- “Medicare coverage under the TCET pathway is limited to certain Breakthrough Devices that receive market authorization for one or more indications for use covered by the Breakthrough Device designation when used according to those indications for use
- Manufacturers of FDA-designated Breakthrough Devices that fall within a Medicare benefit category may self-nominate to participate in the TCET pathway on a voluntary basis
- CMS may conduct an early evidence review before FDA decides on marketing authorization for the device and discuss with the manufacturer the best available coverage pathways depending on the strength of the evidence
- If CMS determines that further evidence development (CED) is the best coverage pathway, CMS will work with the manufacturers, clinicians and patients while maintaining rigorous evidence requirements
- CMS does not believe that an NCD that requires CED as a condition of coverage should last indefinitely, including under the TCET pathway. If the evidence supports a favorable coverage decision under CED, coverage will be time-limited to facilitate the timely generation of sufficient evidence to inform patient and clinician decision making and to support a Medicare coverage determination
- Manufacturers and CMS have the option to withdraw from the pathway up until CMS opens the NCD by posting a tracking sheet”
CBSA and Partner Engagement
CBSA is collaborating with our national partners at AdvaMed and MDMA on outreach regarding H.R. 1691 and TCET.
TCET
In October 2022, CBSA encouraged members of our delegation to join a Senate sign on letter, requesting CMS to release the rule by year end. Additionally, in March 2023, CBSA met with members of the Colorado Congressional Delegation virtually, urging them to reach out to CMS and encourage release of the proposed TCET rule.
We thank CMS for introducing the proposed TCET pathway and look forward to working with them during the comment and implementation period.
H.R. 1691
Following the introduction of H.R. 1691 on March 31st, CBSA urged members of the Colorado Congressional delegation to co-sponsor this bill and to urge other members of Congress to take action to support this legislation as well. Congress must take swift action to advance this legislation as it is vital to ensure that older Americans gain access to critical life-saving novel technologies being developed by our life sciences community.CBSA applauds Colorado U.S. Representative Diana DeGette for signing-on as the 50th co-sponsor of H.R. 1691 the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 and urges additional members of the Colorado Congressional delegation to co-sponsor H.R. 1691.
Learn more visit our national partner AdvaMed’s website with more information on TCET and CMS’s Proposed Rule for Breakthrough Technology Coverage.