Quiero saber acerca de...

khammond on DSKJM1Z7X2PROD with RULES

Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations Response: We appreciate the comments and agree. We proposed provider and facility requirements in the proposed reasonable and necessary definition please say what they were and where they are addressed in other comments and finalize these requirements to maximize positive health outcomes for the Medicare population. We will look to the appropriate sources for provider and facility requirements for implementation purposes.
Comment: Commenters noted that new FDA approved indications should be included.
Response: We appreciate the comments and agree. We recognize that new FDA approved indications for a breakthrough device could be added during the MCIT period. We believe the new FDA required indication would also meet the MCIT definition and would be eligible for the duration of the breakthrough device MCIT period.
In 405.603d and e, we additionally proposed limitations to what is coverable under the Act. In 405.603e, we proposed that if CMS
has issued an NCD on a particular breakthrough device, that breakthrough device is not eligible for MCIT. We proposed this because, once the device has been reviewed by CMS for the FDA
required approved or cleared indication for use; CMS has made a coverage determination based on the available evidence for that technology. We believe this would happen rarely because breakthrough devices are new technologies that are not likely to have been previously reviewed through the NCD process. In 405.603f, we acknowledge that devices in the MCIT
pathway may be excluded due to statute or regulation for example, 42 CFR
411.15, Particular services excluded from coverage and, like other items and services coverable by Medicare, the device must fall within the scope of a Medicare benefit category under section 1861 of the Act and the implementing regulations. If the device does not fall within a Medicare benefit category as outlined in the statute and implementing regulations, the device is not eligible for Medicare coverage;
therefore, the device would not be eligible for the MCIT pathway.
Comment: CMS proposed that the breakthrough device must fall into an existing benefit category to be included under MCIT. Commenters supported the benefit category designation. Several comments recommended the inclusion of breakthrough devices that do not fall within an existing benefit category, for example, digital health technologies, or
VerDate Sep<11>2014

18:22 Jan 13, 2021

Jkt 253001

to modify existing benefit categories to include these devices.
Response: We appreciate the comments. However, in general, for Medicare coverage, an item or service must fall within an existing benefit category. Benefit categories are generally established by statute. CMS is unable to create a new benefit category or alter the language of existing benefit categories in this rule.
After consideration of the public comments we received, we are finalizing the rule as proposed with slight modification, as we indicated with a placeholder in the proposed, to update 405.603b with the latest date for the lookback to be the date two years prior to the effective date of the rule.
3. General Coverage of Items and Services Under the MCIT Pathway We proposed in 405.605 that devices covered under the MCIT pathway are covered no differently from devices that are covered outside of MCIT. In other words, provided the items and services are otherwise coverable that is, not specifically excluded and not found by CMS to be outside the scope of a Medicare benefit category, covered items and services could include the device, reasonable and necessary surgery to implant the device, if implantable, related care and services of the device for example, replacing reasonable and necessary parts of the device such as a battery, and coverage of any reasonable and necessary treatments due to complications arising from use of the device. What the MCIT
pathway offers compared to other pathways is predictable national coverage simultaneous with FDA market authorization that will generally last for a set time period.
The proposed MCIT pathway would support and accelerate beneficiary access to certain innovative devices.
CMS encourages manufacturers that have breakthrough devices covered under MCIT to develop additional data for the healthcare community.
Comment: Commenters questioned for clarification of whether breakthrough diagnostic medical tests are eligible for MCIT.
Response: Diagnostic medical tests are considered FDA medical devices and fall within an existing benefit category.
Based on this categorization, breakthrough designated diagnostic medical tests would be eligible to be included under MCIT.
Comment: Commenters questioned whether breakthrough medical devices that are approved for screening indications, for example cancer
PO 00000

Frm 00049

Fmt 4700

Sfmt 4700

3001

screening tests, would be eligible under MCIT.
Response: We appreciate the comments. MCIT is based on a specific Medicare authority. Since screening tests and preventive services have separate and distinct statutory authorities, items and services used for screening and preventive services are outside the scope of the MCIT rule.
Comment: Commenters suggested the inclusion of medical devices approved under different FDA designations, such as IDE, Humanitarian Device Exemption HDE and devices that have not received the breakthrough device designation.
Response: We appreciate the comments. Medical devices that receive breakthrough designation from the FDA
and meet the definition and inclusion criteria in the final rule will be eligible for MCIT. By the definition, nonbreakthrough devices will not be eligible for MCIT but in general other coverage mechanisms such as the claim review process, NCDs, or LCDs may be available. We note that for certain other medical devices that have received FDA
IDE there are existing coverage regulations 42 CFR 405 Subpart B. The IDE regulation generally applies to devices that have not yet received formal FDA approval. Some breakthrough devices may also have IDE
status and may be eligible for coverage under the IDE regulation and also may be subsequently eligible for coverage under MCIT once the breakthrough device receives FDA market authorization.
Comment: Commenters requested clarification of what is covered under MCITthe device only or the device and the implantation of the device if required.
Response: MCIT would cover both the breakthrough device and the implantation of the device. Other items and services for the diagnosis and treatment of the patients illness would be recoverable as usual through existing coverage regulations and policies or when determined to be reasonable of the local Medicare Administrative Contractors MACs in the claims appeals process. There are existing Medicare coverage and payment policies that also may apply to other items and services that may be used for treatment during hospitalizations and complications that may arise from the device treatment in subsequent hospitalizations. MCIT rule does not supersede existing coverage and payment policies on routine and related items and services for the diagnosis and treatment of the patients illness.

E:FRFM14JAR1.SGM

14JAR1