CMS Posts Final Rule on Faster Pathway for Seeking Medicare Coverage of Devices

On Wednesday, the Centers for Medicare and Medicaid Services (CMS) posted the final rule and amendments to the Code of Federal Regulations regarding the new Medicare Coverage of Innovative Technology (MCIT) pathway. The final rule becomes effective March 15 and establishes an optional pathway that medical device manufacturers and medical facilities can use to seek payment coverage of new and cutting-edge devices more quickly than the current processes allow.

Under the current division of responsibilities, the Food and Drug Administration (FDA) reviews new medical devices for efficacy and safety for use by all patients. These determinations include any restrictions on use, both for safety purposes and intended use. However, a determination from the FDA that a product is safe and effective to use for a person who qualifies for Medicare coverage does not mean that the device automatically is approved for Medicare coverage and payment. Devices have to be separately certified by CMS.

Under the current system, Medicare Approved Contractors (MACs), pay for items that have obtained approval from one of three major possible routes: a national coverage determination (NCD), a local coverage determination (LCD), or parallel review. NCDs are the traditional route, but the process typically takes nine to 18 months after the certification by the FDA, which means that Medicare patients, even though they are typically the intended audience, are unable to receive coverage for these devices for an extended period. LCDs typically process faster than NCDs, because they do not require a nationwide review, but this process results in a device being covered in one jurisdiction and not in another. Finally, parallel review decisions, while resulting in nationwide coverage, typically require a higher standard of clinical testing due to the fact that the review is conducted prior to the FDA completing the review, which also can lead to delays in certification.

The proposed MCIT pathway is being established as an opt-in alternative to the above pathways. The process is limited only to breakthrough medical devices that already have been certified by the FDA. The new pathway allows the use of evidence as to medical necessity including the information already provided for certification by the FDA but also extending to evidence based on commercial use of the device in both trial and actual treatment settings and would look to a turnaround time of nationwide coverage within one to two months instead of the longer periods in the other determinations. However, the MCIT pathway must be selected within four years of receiving FDA approval and can be superseded at any time by removal of FDA approval or by a later NCD determination.