CMS Advises on New Local Coverage Determination Rules
January 2019 ~
CMS used recent Medicare Physician Fee Schedule (MPFS) feedback to revise the Local Coverage Determination (LCD) process. The LCD process revamp includes new timelines, more consultation options, a different request mechanism, and more.
As seen in the revision announcement, the key parts of the New LCD Process are summarized as follows:
THE NEW LCD PROCESS
The New LCD Process may begin with informal meetings in which interested parties within the MAC’s jurisdiction can discuss potential LCD requests. These educational meetings, which are not required, can be held either in person, using web-based technologies, or via teleconference, which allow discussions before requestors submit a formal request.
New LCD Requests
The New LCD Request Process is a mechanism through which interested parties within a MAC’s jurisdiction can request a new LCD. In this process, MACs will consider all new LCD requests from:
- Beneficiaries residing or receiving care in the MAC’s jurisdiction
- Health care professionals doing business in the MAC’s jurisdiction
- Any interested party doing business in the MAC’s jurisdiction
MACs will consider a New LCD Request to be a complete, formal request if the following requirements are met. The request:
- Is in writing and is sent to the MAC via e-mail, facsimile or written letter
- Clearly identifies the statutorily-defined Medicare benefit category to which the requestor believes the item or service applies
- Identifies the language that the requestor wants in an LCD
- Includes a justification supported by peer-reviewed evidence (full copies of published evidence must be included or the request is not valid)
- Addresses relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service
- Fully explains the design, purpose, and/or method, as appropriate, of using the item or service for which the request is made.
Within 60 calendar days of the day they receive the request; MACs will review the materials and determine whether the request is complete or incomplete. If the request is complete, the MAC will follow the New LCD Process, as described in the revised manual. If, however, the process is incomplete, they will respond, in writing, to the requestor explaining why the request was incomplete.
Clinical Guidelines, Consensus Documents and Consultation
During an LCD’s development, MACs should (when applicable and available) supplement their research with clinical guidelines, consensus documents, or consultation by experts (recognized authorities in the field), medical associations or other health care professionals for an advisory opinion. They will summarize the opinions they receive as a result of this consultation with healthcare professional expert(s), professional societies, and others prior to the drafting of a proposed or final LCD, and include this information in the proposed or final LCD. Note that acceptance 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.
Publication of the Proposed LCD
The public announcement of a MAC’s proposed determination begins with the date the proposed LCD is published on the Medicare Coverage Database (MCD). Once the proposed LCD is published, MACs will provide a minimum of 45 calendar days for public comment, and will contact the CMS if they determine an extension to the comment period is needed.
These processes shall be used for all LCDs except in the following situations:
- Revised LCD Being Issued for Compelling Reasons.
- Revised LCD that Makes a Non-Substantive Correction – For example, typographical or grammatical errors that do not substantially change the LCD.
- Revised LCD that Makes a Non-discretionary Coverage Update – Contractors shall update LCDs to reflect changes in NCDs or when a conflict with national policy occurs, coverage provisions in interpretive manuals, and payment systems.
- Revise LCD to effectuate an Administrative Law Judge’s decision to nullify an existing LCD due to an LCD Challenge.
Contractor Advisory Committee (CAC)
The CAC is to be composed of healthcare professionals, beneficiary representatives, and representatives of medical organizations; and is used to supplement the MAC’s internal expertise, and to ensure an unbiased and contemporary consideration of “state of the art” technology and science. Additionally, all CAC meetings will be open to the public to attend and observe.
MACs will establish one CAC per state or have the option of establishing one CAC per jurisdiction or multi-jurisdictional CAC with representation from each state. If a MAC chooses to have one CAC per jurisdiction or multi-jurisdictional CAC, the MAC must endeavor to ensure that each state has a full committee and the opportunity to discuss the quality of the evidence used to make a determination.
The CAC’s purpose is to provide a formal mechanism for healthcare professionals to be informed of the evidence used in developing the LCD and promote communications between the MACs and the healthcare community. The CAC is advisory in nature, with the final decision on all issues resting with MACs.
After the proposed LCD is made public, MACs will hold open meetings to discuss the review of the evidence and the rationale for the proposed LCD(s) with stakeholders in their jurisdiction. Interested parties (generally those that would be affected by the LCD, including providers, physicians, vendors, manufacturers, beneficiaries, caregivers, etc.) can make presentations of information related to the proposed LCDs. Members of the CAC may also attend these open meetings. MACs must notify the public about the dates and location for the open meeting. MACs have the option of setting up email list serve to announce this information or may use other education methods to adequately inform the public. The listserv or other method should clearly identify the location, dates and telephone/video/online conference information for the open meeting to ensure that this information is clearly distinguished from the information for the CAC meetings.
Publication of the Final Determination
After the close of the comment period and the required meetings and consultation, the final LCD and the Response to Comment (RTC) Article will be published on the MCD.
Response to Public Comments
MACs will respond to all comments received during the comment period of the proposed LCD by using the RTC article associated with the LCD. The RTC Article is published on the start date of the notice period. The RTC Article will remain publicly available indefinitely on the MCD or the MCD Archive.
The date the final LCD is published on the MCD, marks the beginning of the required notice period of at least 45 calendar days before the LCD can take effect. If the notice period is not extended by the MAC, the effective date of the LCD is the 46th calendar day after the notice period began.
LCD RECONSIDERATION PROCESS
The LCD reconsideration process is a mechanism by which a beneficiary or stakeholder (including a medical professional society or physician) in the MAC’s jurisdiction can request a revision to an LCD. The LCD reconsideration process differs from an initial request for an LCD in that it is available only for final effective LCDs. The whole LCD or any provision of the LCD may be reconsidered. In addition, MACs have the discretion to revise or retire their LCDs at any time on their own initiative. This process is summarized as follows:
1. MACs shall consider all LCD reconsideration requests from:
- Beneficiaries residing or receiving care in a contractor’s jurisdiction
- Providers doing business in a contractor’s jurisdiction
- Any interested party doing business in a contractor’s jurisdiction
2. MACs should only accept reconsideration requests for LCDs published as an effective final. Requests shall not be accepted for other documents including:
- National Coverage Determinations (NCDs);
- Coverage provisions in interpretive manuals;
- Proposed LCDs;
- Template LCDs, unless or until they are adopted and in effect by the contractor;
- Retired LCDs;
- Individual claim determinations
- Bulletins, articles, training materials; and
- Any instance in which no LCD exists, i.e., requests for development of an LCD.
3. Process Requirements – The requestor shall submit a valid LCD reconsideration request to the appropriate MAC, following instructions on the MAC’s Web site. Within 60 calendar days of the day the request is received, the MAC shall determine whether the request is valid or invalid. If the request is invalid, the MAC will respond, in writing, to the requestor explaining why the request was invalid. If the request is valid, the MAC will open the LCD and follow the LCD process as outlined in the above for new LCDs or include the LCD on the MAC’s waiting list. The MAC shall respond, in writing, to the requestor notifying the requestor of the acceptance, and if applicable, wait-listing, of the reconsideration request.
OTHER IMPORTANT CHANGES
Other key changes to the manual include:
- MACs shall finalize or retire all proposed LCDs within one calendar year of publication date on the MCD.
- Upon further notice from CMS, it will no longer be appropriate to routinely include Current Procedure Terminology (CPT) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All codes will be removed from LCDs and placed in billing & coding articles that are linked to the LCD.
Full details of this new process are in the updated manual which is an attachment to CR10901.
Source(s): CMS MLN Matters 10901; Super Coder;