Brent Vaughan, CEO of Cognito Therapeutics

As a healthcare executive in the industry for over 25 years, I recently submitted comments to Centers for Medicare Services (CMS) urging the agency to implement without further delay a regulation that would offer Medicare beneficiaries automatic access to cutting edge medical technologies authorized under FDA's breakthrough device program. CMS finalized this proposed regulation on Jan 12 and planned to make it effective on March 15 before altering course and postponing its implementation for 60 days to consider additional public comments.

The Medicare Coverage of Innovative Technology (MCIT) rule will be an important step towards reducing healthcare disparities in the Medicare population by providing national Medicare coverage of breakthrough devices for four years, starting at the time of FDA marketing authorization. At the end of the period, CMS will re-evaluate the technology based on clinical and real-world evidence of improved health outcomes and determine whether to grant permanent coverage.

President Lyndon Johnson said on July 30, 1965, at the signing of the law that created Medicare and Medicaid, that, “No longer will older Americans be denied the healing miracle of modern medicine. No longer will illness crush and destroy the savings that they have so carefully put away over a lifetime so that they might enjoy dignity in their later years.” Since its inception in 1965, Medicare has been instrumental in helping address age related healthcare disparities as well as healthcare disparities driven by socioeconomic (SES) and ethnic factors within the Medicare population.

As the nation’s largest purchaser and regulator of healthcare, Medicare plays a critical role in expanding coverage, improving the affordability of health care for elderly patients, and reducing racial and ethnic disparities in health coverage and access to care. MCIT has the opportunity to continue to help Medicare achieve its goal of ensuring access to and use of needed health care among all persons aged 65 years or older by facilitating patient access and Medicare reimbursement on day one, following FDA market authorization.

Once the MCIT rule is in place, it will ensure that Medicare beneficiaries have access to the improved health outcomes from breakthrough devices which treat life-threatening or irreversibly debilitating diseases or conditions. Advamed, the American medical device trade association, voiced similar conclusions regarding the negative impact to patients, as additional delays in policy implementation could compromise patient access to breakthrough technologies.

Innovative and breakthrough medical devices are often not covered by insurers, including Medicare, upon FDA authorization and thus many providers are unwilling to prescribe or order these breakthrough medical devices for their patients in order to avoid surprise costs for their patients. This lack of coverage represents a significant barrier to patient access, especially for patients with low income or socioeconomic status.

MCIT addresses this challenge and increases access to care for Medicare patients by enabling reimbursement on day one of FDA authorization, which removes policy-based barriers between physicians and patients, allowing for improved access, uptake and utilization to be determined by clinical appropriateness and clinical need. Importantly, MCIT’s solution also enables innovators to use the 4-year coverage period to develop critical real-world evidence in the Medicare population, translating clinical evidence in the Medicare population into real-world effectiveness data and evidence that the Agency can use at the end of the initial coverage period to determine longer-term impact and the real-world value of the breakthrough technology to Medicare beneficiaries.  

Manufacturers will be able to use the initial four-year coverage period provided under MCIT to further justify coverage levels through real world evidence (RWE) of long-term health and economic impact of their breakthrough products and patients will simultaneously benefit from immediate access to these breakthrough devices that support their health and independence.

I urge CMS to move forward with enacting the MCIT rule, including the four-year Medicare coverage upon FDA authorization, as part of furthering Medicare’s mission and to ensure more patients have timely access to the most innovative therapies targeting unmet medical needs.

In my opinion, CMS is appropriately defining the scope of MCIT to apply to breakthrough devices that are cleared or approved by the FDA as medically reasonable and necessary, in conformation with their approved labels, as long as they are: (1) safe and effective, (2) not experimental or investigational, and (3) appropriate for the Medicare patients. I believe that requiring evidence of efficacy in a Medicare population is an appropriate threshold for covering and paying for breakthrough technologies and is aligned with existing Medicare authority and long-recognized criteria of Medicare programmatic need.

Suggestions for Improving MCIT Rule

I support the Agency’s requirement that to qualify for MCIT coverage, the breakthrough device must fit within an existing benefit category. However, to mitigate unnecessary delays and to ensure timely patient access to these vital treatments, I would recommend the following operational guidance be promulgated as part of rule implementation:

Allow for manufacturers to initiate benefit category determinations with CMS following FDA breakthrough designation and in parallel to FDA review. By advancing benefit category determination in parallel to FDA review, CMS will both advance the spirit of the current parallel review program, which has long aided innovators via health plan guidance while falling short of concretely resolving the patient access challenges solved by MCIT.

Use a temporary code for all MCIT products during the 4-year coverage period to be placed in the Healthcare Common procedure Coding System (HCPCS) coding field for claims processing forms, enabling insurers to rapidly systemize the verification of coverage and reimbursement for any MCIT-coded product. Manufacturers can also include the unique device identifier as part of claims to enable tracking of program utilization and benefit during the 4-year period.  

Minority and low-income/SES populations stand to benefit the most from an expansion of health insurance coverage through the MCIT ruling, as they are more likely to be currently uninsured or under-insured. Systematic and efficient coverage and reimbursement of breakthrough devices for areasofunmet medical need stands to significantly improve quality of care and life for Medicare beneficiaries and the financial state of the Medicare program. I hope the Agency considers the suggested improvements from industry members on the current proposed rule, and strongly support timely finalization and promulgation to increase access for all patients.