Last week CMS complied with the requirements of the 21st Century Cures Act by issuing its revised instruction manual to the Medicare Administrative Contractors (MACs). You will find it described on the CMS website as: CMS Accelerates Innovation and Promotes Patient Access to Medical Technology.
I’ve talked a lot about the impact these often capricious Local Coverage Determinations (LCDs) have on the availability of wound care services. While clinicians and manufacturers are held to high evidentiary standards for clinical decision making, LCDs often craft coverage policy out of thin air. Many of us spend hours late at night crafting thoughtful, multi-page responses to these draft policies (complete with references), only to have our comments ignored in the final version of the LCD.
Chapter 13 of the new manual addresses LCDs. According to the press release, “the updated manual responds to Congress’ requirement in the 21st Century Cures Act for more transparency in the LCD process and aims to ensure an open LCD process that meets patients’ needs. The changes will clarify and simplify the process, helping to ensure that companies can get therapies and devices to patients more efficiently.” I hope so. The manual is intended to be used as a road map for the LCD process to help stakeholders more effectively engage in the process.
Here are a few of the key points:

  • The Manual includes a step-by-step description of the LCD process, and offer an option for stakeholders to request an informal meeting with Medicare Administrative Contractors that determine local coverage decisions. The reforms also include a new process for stakeholders within a MAC’s jurisdiction to request a new LCD.
  • CMS will also require a standardized summary of clinical evidence supporting LCD decisions and MAC coverage determination rationale.
  • Proposed coverage decisions that are not finalized within a year of when they are posted will be retired.
  • MACs will notify the public when they publish a final decision and provide a web link to it.
  • MAC responses to public comments will be linked to in a final LCD and remain in the Medicare Coverage Database archives indefinitely.
  • The manual revisions make the LCD reconsideration process consistent with the NCD reconsideration process, and MACs must follow the full process for valid requests
  • The Contractor Advisory Committee, which includes members that review the quality of evidence used in the development of an LCD, now can include other health care professionals like nurses and social workers in addition to physicians. CMS also says the committee must include beneficiary representatives.
  • LCD Meetings will be open to the public, and MACs will determine how frequently they occur, CMS says.
  • Patients will be allowed to request a new LCD.
  • Meetings will be held virtually (e.g., by webinar) instead of in-person to allow for broader participation.

CMS wants stakeholders to submit feedback on their experiences with the revised LCD process via submissions to [email protected] and will consider additional revisions based on the feedback.
Also last month the House passed the Local Coverage Determination Clarification Act, key  provisions of which include:

  • Disclosure of the rationale the MACs rely on in order to deny coverage.
  • Additional options for challenging an LCD.
  • Annual reports to Congress on the number of LCD appeals and actions taken in lieu of the creation of an ombudsman.

This is a great move forward by CMS to increase transparency to this process, and is the first changes to this process in a very long time.
For additional information, here’s a link to a Med Learn matters:   https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10901.pdf