In an effort to “modernize the Medicare program and bring the latest technologies and innovations to Medicare beneficiaries,” CMS has announced revisions to the local coverage determination (LCD) process. Specifically, under authority provided in the 21st Century Cures Act and taking into account stakeholder feedback, CMS has issued Program Integrity Manual (PIM) changes intended to promote transparency, clarity, and consistency in the development of LCDs. As provided in the 21st Century Cures Act, CMS is requiring Medicare administrative contractors (MACs) to post information about LCDs under development on their websites at least 45 days before the effective date of such a determination. The information must include (1) the determination in its entirety, (2) when and where the proposed LCD was first made public, (3) hyperlinks to the proposed LCD and a response to public comments, (4) a summary of evidence that was considered in the development of the LCD, and (5) an explanation of the rationale that supports the determination. Beyond this statutory mandate, the PIM changes include numerous other policies intended to help “ensure that companies can get therapies and devices to patients more efficiently.” For instance, CMS is:
- Establishing a “New LCD Request Process” to allow interested parties within a contractor’s jurisdiction to request a new LCD.
- Allowing interested parties to request an informal meeting with the MAC to discuss potential LCD requests.
- Directing MACs to consider clinical guidelines, consensus documents, and consultation by experts, medical associations or other health care professionals, when available, in developing LCDs. CMS notes, however that “[a]cceptance by individual health care providers, or even a limited group of health care providers, does not indicate general acceptance of the item or service by the medical community.”
- Requiring Contractor Advisory Committee (CAC) meetings to be open to the public and broadening CAC membership to include beneficiary representation and healthcare professionals beyond physicians.
- Conforming the LCD reconsideration process to the National Coverage Determination reconsideration process.
The implementation date for the new provisions is January 8, 2019. CMS invites interested stakeholders to submit feedback on their experiences with the revised LCD process to LCDmanual@cms.hhs.gov; the agency will consider making additional revisions based on the feedback it receives.
Looking ahead, the Trump Administration’s fall 2018 regulatory agenda indicates that the CMS intends to issue a proposed rule early in 2019 on Medicare coverage of innovative technologies. Specifically, the proposed rule would modify the Medicare coverage process in order “to streamline coverage of breakthrough technologies [that] have the potential to improve patient health outcomes and quality of care.” CMS currently anticipates releasing the rule in March 2019.