The Centers for Medicare and Medicaid Services released extensive updates to the Medicare Program Integrity Manual (Pub 100-08) related to the local coverage determination (LCD) process. These changes are effective Oct. 3 and will be implemented Jan. 8, 2019.
CMS collected feedback through comments on the calendar year 2018 physician fee schedule rule as well as through meetings and correspondence with stakeholders. While most acknowledged that the LCD process is an important way to provide decisions regarding coverage and access to medical products and procedures, the lack of transparency in the LCD process was of concern.
The changes to the Medicare Program Integrity Manual, Chapter 13, provide instructions to the Medicare Administrative Contractors (MACs) that reflect the requirements of the 21st Century Cures Act and stakeholder concerns.
CMS has revamped the format of the manual so it can be used as a “roadmap” for the LCD process. The manual now helps stakeholders engage in the process and lays out CMS’s expectations for MACs.
Important changes to the manual include:
- Requiring a consistent, standardized summary of the clinical evidence supporting LCD decisions
- Including a beneficiary representative and other healthcare professionals in addition to physicians (e.g. nurses, social workers) on Contactor Advisory Committees that inform LCDs, and
- Ensuring that Contractor Advisory Committee meetings are open to the public.
The new process takes further steps to be responsive to patient needs by allowing patients to request a new LCD, and by holding open meetings virtually, including by webinar, instead of in-person to allow for broader participation.
CMS has invited stakeholders to submit feedback on their experiences with the revised LCD process by emailing LCDmanual@cms.hhs.gov.
The Novitas Contractor Advisory Committee will meet Oct. 17 to review and discuss the changes to the process.
For a full list of changes to the manual, refer to the CMS fact sheet.