As part of a broader effort to modernize the Medicare program and bring the latest technologies and innovations to Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) announced changes to the way Medicare Administrative Contractors (MACs) decide which technologies are covered. CMS revised its Medicare’s Program Integrity Manual for more transparency in the local coverage determination process. Those revisions are effective October 3, 2018 and are scheduled to be implemented by January 8, 2019.
National coverage determinations (NCDs) and local coverage determinations (LCDs) are issued to provide guidance on which healthcare items and services meet requirements for Medicare coverage. When NCDs do not exist or when MACs need to further define a national determination, they publish LCDs. The Medicare Program Integrity Manual includes instructions, policies and procedures that MACs use to administer the Medicare fee-for-service program. Chapter 13 of the manual addresses coverage policies including LCDs. The manual has been revamped to follow Congress’ requirement in the 21st Century Cures Act requirements for more transparency in the LCD process and aims to ensure an open LCD process that meets patients’ needs.
“The redesigned local coverage determination process will pave the way to expanded access to new medical technologies. Coverage decisions will be made more transparently with an explanation of the clinical evidence that supports them, and with input from beneficiaries who are affected. This is just the beginning of our efforts to further accelerate medical innovation, improve the quality of care and lower costs for our beneficiaries.” said CMS Administrator Seema Verma.
CMS has revamped the manual so it can be used as a “roadmap” for the LCD process and better help stakeholders effectively engage in the LCD process. According to CMS, important changes to the revised manual include:
- Clear process “roadmap.” A step-by-step description of the LCD process in language that is accessible to all stakeholders.
- Consistent presentation of evidence. Standardized summary of clinical evidence supporting LCD decisions and a MAC coverage determination rationale.
- Informal meetings with MACs. Option to request an informal meeting with the MAC to discuss potential LCD requests.
- New LCD request process. A novel process by which interested parties in a MAC jurisdiction can request a new LCD.
- Restructured Contractor Advisory Committee (CAC) meetings. Meetings open to the public. CAC members serve in an advisory capacity as representatives of their constituency to review the quality of the evidence used in the development of an LCD. MACs can host CAC meetings in various ways (e.g., in-person, telephone, video, webinar). MACs determine how frequently these meetings occur based on the appropriateness and volume of LCDs requiring CAC input.
- More voices on CAC. In addition to physicians, other healthcare professionals (e.g., nurses, social workers, epidemiologists) can participate in the CAC. The CAC also must include beneficiary representation.
- Repurposed public meetings. Open meetings in the MAC jurisdiction to present proposed coverage, including evidence and rationale of decisions. MACs clearly identify the location, dates and conference information (e.g., telephone, webinar) and distinguish these meetings from CAC meetings.
- No “old” proposed policies. Proposed policies retired if not finalized within 1 year of the original posting date.
- Relocation of codes. International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and Current Procedure Terminology (CPT) codes removed from LCD in the future.
- Better communication. MAC responses to public comments linked to the final LCD and remain in the Medicare Coverage Database indefinitely (archives). MACs notify the public when they publish a final decision and provide a web link to it.
- Consistent reconsideration process. LCD reconsideration process consistent with the National Coverage Determination reconsideration process. MACs must follow the full LCD process for valid requests.
CMS invites interested stakeholders to submit feedback on their experiences with the revised LCD process. CMS will collect feedback via submissions to LCDmanual@cms.hhs.gov and will consider additional revisions based on the feedback.
GIRS will continue to follow the updates in the Medicare LCD process as we incorporate them in our client strategies. Do you have a medical device that needs improvement in coverage? Are your devices facing negative coverage and payment issues and you are not sure where to begin? Have you always dreamed of requesting a new LCD? The GIRS Payer Advocacy Compass® (PAC) team can assist you. We work closely with payers to help inform them of payer desired outcomes/data and the value story for our clients’ products. We help manufacturers to present safety, efficacy data, and outcomes data to keep proving the clinical effectiveness and the value proposition for your product to gain and maintain coverage and payment.
Are you interested in coverage results we are getting for our clients? We invite you to read about how the GIRS PAC® team was successful at gaining positive coverage and greater market access for over 4 million patients HERE.
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Sources:
Medicare Program Integrity Manual (PIM) Chapter 13
Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/summary-significant-changes-medicare-program-integrity-manual-chapter-13-local-coverage
Change Request, CR 10901, Transmittal R829PI: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R829PI.pdf