June 27 -- The Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), provides information to the public on the process we will use to provide transitional coverage for emerging technologies (TCET) through the national coverage determination (NCD) process under the Social Security Act (the Act). It also solicits public comment on the proposed TCET pathway. To be assured consideration, comments must be received by 5 p.m. on August 28, 2023.
The TCET pathway is designed to deliver transparent, predictable, and expedited national coverage for certain eligible Breakthrough Devices that are Food and Drug Administration (FDA) market authorized. It builds upon the Centers for Medicare & Medicaid Services' (CMS') experience with the Parallel Review program and the Coverage with Evidence Development (CED) pathway. Additionally, the TCET pathway reflects the feedback received from multiple stakeholder groups, including beneficiaries, patient groups, medical professionals and societies, medical device manufacturers, other Federal partners, and others involved in developing innovative medical devices. This feedback was obtained from informal and formal meetings, the comments we received as we conducted rulemaking for the Medicare Coverage of Innovative Technologies (MCIT) pathway (referenced later in this section) as well as during the listening sessions that were held following the repeal of the MCIT/Reasonable and Necessary (R&N) final rule (86 FR 62944, November 15, 2021). The TCET pathway described in this notice is intended to balance multiple considerations when making coverage determinations: (1) facilitating early, predictable and safe beneficiary access to new technologies; (2) reducing uncertainty about coverage by evaluating early the potential benefits and harms of technologies with innovators; and (3) encouraging evidence development if notable evidence gaps exist for coverage purposes. Further, the TCET pathway aims to coordinate benefit category determination, coding, and payment reviews and to allow any evidence gaps to be addressed through fit-for-purpose studies.
The Medicare program serves over 62 million beneficiaries and is the largest single health care purchaser in the U.S. Currently, approximately 60 percent of the total Medicare beneficiary population, or 36 million Medicare beneficiaries, receive coverage through Medicare fee-for-service (FFS). More than 1.1 billion Medicare FFS claims were processed in fiscal year (FY) 2021, comprised of approximately 221 million Part A claims (such as inpatient care in hospitals, skilled nursing facility care, hospice care, and home health care) and 956 million Part B claims (such as doctor and other health care services and outpatient care, durable medical equipment, and some preventive services), providing approximately $424 billion in Medicare FFS benefits.
Medicare covers a wide range of items and services. In general, in order for an item or service to be covered under Medicare, it must meet the standard described in section 1862(a)(1)(A) of the Social Security Act (the Act)—that is, it must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. CMS makes reasonable and necessary coverage decisions through various pathways in order to facilitate expeditious beneficiary access to items and services that meet the statutory standard for coverage. We recognize that new approaches are needed to make decisions on certain new items and services, such as medical devices, more quickly to provide expedited access to new and innovative medical technologies. On November 15, 2021 (86 FR 62944), CMS published a final rule that repealed an earlier rule that never became legally effective and thus was not implemented. As promised in the repeal, CMS has conducted additional opportunities to engage with the public and stakeholders. We have incorporated that input, along with input gathered in MCIT rulemaking, into our plans to improve the Medicare coverage process when making decisions on certain emerging technologies at the national level.
One of the issues identified in the prior rulemaking was that the agency did not adequately address how certain steps, which are necessary to implement national coverage determinations for a new item or service, would be accomplished in a timely manner. Specifically, under the Medicare program an item or service must fall within the parameters of a benefit category that is within the scope of Part A or Part B. Commenters have requested that CMS explain how benefit category determinations (BCDs) will be made in connection with emerging technology. CMS was also encouraged to align coding and payment processes to facilitate coverage and payment for new or emerging technologies.
Over the last several years, stakeholders have expressed support for coverage process improvements and a new pathway that is more flexible, transparent, predictable, and collaborative. Additionally, stakeholders expressed that that they would like for CMS to develop a more agile, iterative evidence review process that considers real world evidence and fit-for-purpose evidence study designs. Further, we have heard concerns from stakeholders that device coverage lags further behind that of drugs and biologics and, devices are more in need of a program like TCET. In light of the unique FDA criteria for Breakthrough designation status (described later in this document), we are limiting the TCET pathway to certain eligible FDA-designated Breakthrough Devices, since we believe that this is the area with the most immediate need.
We are committed to establishing an alternative coverage pathway that better balances the needs of beneficiaries, patient groups, medical professionals and societies, medical device manufacturers, and others involved in developing innovative medical devices. . . .
This notice proposes to create the TCET pathway. Since the TCET pathway relies on our existing authorities, we believe that establishing TCET through a procedural notice rather than rulemaking has the advantages that it is faster to implement and can be more easily modified as we gain experience with the approach. We also describe the procedures for how stakeholders and the public at large may engage with CMS to facilitate the TCET pathway. The topics addressed in the notice include the following: (1) TCET general principles; (2) appropriate candidates for the TCET pathway; (3) procedures for the TCET pathway; and (4) general roles.
We continue to pursue our efforts to work with various sectors of the scientific and medical community to develop and publish guidance documents on our website that describe our approach when analyzing scientific and clinical evidence to develop an NCD. In response to stakeholder feedback, our proposed CED and Evidence Review guidance documents propose to incorporate robust fit-for-purpose evidence development where manufacturers may use fit-for-purpose studies to close any evidence gaps. Fit-for-purpose studies are those where the study design, analysis plan, and study data can credibly answer the research question. Additionally, CMS intends to publish a series of guidance documents that review health outcomes and their clinically meaningful differences within priority therapeutic areas. The public will have an opportunity to provide comments on these guidance documents which will be available on the CMS coverage website which can be accessed at
https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/index.html. . . .
We believe that the TCET pathway can support manufacturers that are interested in working with CMS to generate additional evidence that is appropriate for Medicare beneficiaries and that may demonstrate improved health outcomes in the Medicare population to support more expeditious national Medicare coverage. While we believe that leveraging the statutorily established NCD process will allow us to responsibly cover new, innovative technologies with limited or developing evidence, it is important that we provide an evidence generation framework that, when appropriate, not only develops reliable evidence for patients and their physicians but also provides safeguards to ensure that Medicare beneficiaries are protected and continue to receive high quality care. . . .
CMS is committed to ensuring Medicare beneficiaries have access to emerging technologies. CMS' goal is to finalize an NCD for technologies accepted into and continuing in the TCET pathway, within 6 months after FDA market authorization. The TCET pathway builds off of prior initiatives, including CED. The TCET pathway will meet the following 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. We note that many Breakthrough Devices are currently coverable without the TCET pathway because they are not separately payable (that is, the device may be furnished under a bundled payment, such as payment for a hospital stay) or they are addressed by an existing NCD. Others are not indicated for use in a population that includes Medicare beneficiaries (for example, those devices that are targeted toward a pediatric population).
• CMS may conduct an early evidence review (Evidence Preview, more details in section II.D.1.g. of this notice with comment period) 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.
• Prior to FDA marketing authorization, CMS may initiate discussions with manufacturers to discuss any evidence gaps for coverage purposes and the types of studies that may need to be completed to address the gaps, which could include the manufacturer developing an evidence development plan and confirming that there are appropriate safeguards for Medicare beneficiaries.
• If CMS determines that further evidence development (that is, CED) is the best coverage pathway, CMS will work with the manufacturers to reduce the burden on manufacturers, clinicians and patients while maintaining rigorous evidence requirements. CMS will work to ensure we are not requiring duplicative or conflicting evidence development with any FDA post-market requirements for the device.
• 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 under section 1862(a)(1)(A) of the Act.
• Manufacturers and CMS have the option to withdraw from the pathway up until CMS opens the NCD by posting a tracking sheet. CMS will not publicly disclose participation of a manufacturer in the TCET pathway prior to CMS' posting of an NCD tracking sheet, unless the manufacturer consents or has already made this information public or disclosure is required by law. If a manufacturer does not wish the information that would be revealed by the posting of the NCD tracking sheet to become public, it should withdraw from the TCET pathway prior to this point. CMS requests that a manufacturer who wishes to withdraw from the TCET pathway notify CMS by email at TCET@cms.hhs.gov.
FRN:
https://www.federalregister.gov/d/2023-13544 [12 pages]
