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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
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B. FDA Breakthrough Devices Program Under the MCIT coverage pathway, CMS will coordinate with FDA and manufacturers as medical devices move through the FDA regulatory processes for breakthrough device designation and market authorization to ensure seamless Medicare coverage after market authorization unless CMS determines those devices do not have a Medicare benefit category. The Breakthrough Devices Program is an evolution of the Expedited Access Pathway Program and the Priority Review Program section 515B of the Federal Food, Drug, and Cosmetic Act FD&C Act, 21 U.S.C.
360e3; see also final guidance for industry entitled, Breakthrough Devices Program, https www.fda.gov/
downloads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM581664.pdf.
The FDAs Breakthrough Devices Program is not for all new medical devices; rather, it is only for those that the FDA determines meet the standards for breakthrough device designation. In accordance with section 3051 of the 21st Century Cures Act 21 U.S.C. 360e3,8
the Breakthrough Devices Program is for medical devices and device-led combination products that meet two criteria. The first criterion is that the device provide for more effective treatment or diagnosis of lifethreatening or irreversibly debilitating human disease or conditions. The second criterion is that the device must satisfy one of the following elements: It represents a breakthrough technology;
no approved or cleared alternatives exist; it offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute; or device availability is in the best interest of patients for more information see 21
U.S.C. 360e3b2. These criteria make breakthrough designated devices unique among all other medical devices.9 The parameters of the breakthrough devices program focus on innovations for patients, in turn, MCIT, 8 21st Century Cures Act, available at https
www.congress.gov/114/plaws/publ255/PLAW114publ255.pdf; see FDA Guidance for Industry and Food and Drug Administration Staff, Breakthrough Devices Program available at https
www.fda.gov/medical-devices/how-study-andmarket-your-device/breakthrough-devices-program.
9 FDA does not publish a list of breakthrough designated or breakthrough designated and subsequently market authorized devices. However if a breakthrough device gains market authorization through a PMA only, then the summary of safety and effectiveness data SSED will contain a reference for the breakthrough designation. This is not true for De Novos which have been granted or cleared 510ks. In consideration of that approach, this notice of public rulemaking does not contain such lists.

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focuses on these breakthrough devices consistent with E.O. 13890 and in order to streamline coverage of innovative medical devices. We note that the FDAs guidance stresses the need for breakthrough devices to still meet the statutory standard of reasonable assurance of safety and effectiveness at the time of approval, meaning that a device which receives FDA
breakthrough designation automatically satisfies factor 1 of our reasonable and necessary definition.
C. Current Medicare Coverage Pathways Currently, we utilize several coverage pathways for items and services, which includes medical devices. None of the coverage pathways described in this section offer immediate, predictable coverage concurrently with FDA market authorization like the proposed MCIT
pathway would do. We summarize the other coverage pathways here to provide context for MCIT.
National Coverage Determinations NCDs: Section 1862l6A of the Act defines the term national coverage determination as a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this title. In general, NCDs are national policy statements published to identify the circumstances under which particular items and services will be considered covered by Medicare. Traditionally, CMS relies heavily on health outcomes data to make NCDs. Most NCDs have involved determinations under section 1862a1A of the Act, but NCDs can be made based on other provisions of the Act, and includes a determination that the item or service under consideration has a Medicare benefit category. The NCD pathway, which has statutorily prescribed timeframes, generally takes 9 to 12 months to complete.10
Local Coverage Determinations LCDs: Medicare contractors develop LCDs based on section 1862a1A of the Act that apply only within their geographic jurisdictions. Sections 1862l6B and 1869f2B of the Act. MACs will not need to develop LCDs for breakthrough devices when they are nationally covered through MCIT. Manufacturers declining to participate in the MCIT pathway may still seek LCDs from the MACs during and after the four year eligibility period, using the current process.
The MACs follow specific guidance for developing LCDs for Medicare coverage in the CMS Program Integrity Manual, and in some instances, an LCD
10 Section
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1869f4 of the Act.

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can also take 9 to 12 months to develop MACs must finalize proposed LCDs within 365 days from opening per Chapter 13Local Coverage Determinations of the PIM 13.5.1. We note that the MCIT pathway does not alter the existing coverage standards in Chapter 13Local Coverage Determinations of the PIM.11 That chapter will continue to be used, to the extent consistent with other parts of this final rule, in making determinations under section 1862a1A of the Act.
Claim-by-claim Adjudication: In the absence of an NCD or LCD, MACs would make coverage decisions under section 1862a1A of the Act and may cover or not cover items and services on a claim-by-claim basis. The majority of claims are handled through the claim adjudication process.
Clinical Trial Policy CTP NCD
310.1: The CTP pathway can be used for coverage of routine care items and services but generally not the technology under investigation in a clinical study that is supported by certain Federal agencies. The CTP
coverage pathway was developed in 2000.12 This coverage pathway has not generally been utilized by device manufacturers because they usually seek coverage of the device, which is not included in the CTP pathway.
Parallel Review: Parallel Review is a mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDAs approval of a premarket application or granting of a de novo classification and the subsequent CMS
NCD. Parallel Review has two stages: 1
FDA and CMS meet with the manufacturer to provide feedback on the proposed pivotal clinical trial within the FDA pre-submission process; and 2
FDA and CMS concurrently review in parallel the clinical trial results submitted in the PMA, or De Novo request. FDA and CMS independently review the data to determine whether it meets their respective Agencys standards and communicate with the manufacturer during their respective reviews. This program is most successful for devices that have a significant amount of clinical evidence.
Candidates for parallel review are not be appropriate for simultaneous MCIT
consideration.
11 CMS Program Integrity Manual, Chapter 13
Local Coverage Determinations, available at https
www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/downloads/pim83c13.pdf.
12 CMS, National Coverage Determination for Routine Costs in Clinical Trials available at https
www.cms.gov/medicare-coverage-database/details/
ncd-details.aspx?NCDId=1&fromdb=true.

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