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Medicare Coverage ~ Glossary



Coverage Analysis for Laboratories (CALs): CALs is an abbreviated process, similar to the NCD process, for making changes to the coding component of the negotiated laboratory NCDs. The process is used for adjusting the list of covered (or non-covered) ICD-9-CM diagnosis codes and coding guidance in the NCDs when there is a question regarding whether the code flows from the narrative indications in the NCD. A tracking sheet is posted opening a CAL and a 30-day public comment period follows. A decision memorandum announcing and explaining the decision is posted following the comment period. Changes are implemented in the next available quarterly update of the laboratory edit module. More details regarding the process can be found in 68 FR 74607.

Coverage Issues Manual (CIM): The CIM has been replaced by the Medicare National Coverage Determinations Manual.

Local Coverage Determination (LCD): An LCD, as established by Section 522 of the Benefits Improvement and Protection Act, is a decision by a fiscal intermediary or carrier whether to cover a particular service on an intermediary-wide or carrier-wide basis in accordance with Section 1862(a)(1)(A) of the Social Security Act (i.e., a determination as to whether the service is reasonable and necessary). The difference between LMRPs and LCDs is that LCDs consist only of "reasonable and necessary" information, while LMRPs may also contain category or statutory provisions.

The final rule establishing LCDs was published November 11, 2003. Effective December 7, 2003, CMS's contractors will begin issuing LCDs instead of LMRPs. Over the next 2 years (until December 31, 2005) contractors will convert all existing LMRPs into LCDs and articles. Until the conversion is complete, for purposes of a 522 challenge, the term LCD will refer to both 1.) Reasonable and necessary provisions of an LMRP and, 2.) an LCD that contains only reasonable and necessary language. Any non-reasonable and necessary language a contractor wishes to communicate to providers must be done through an article.

Local Medical Review Policy (LMRP): LMRP is an administrative and educational tool to assist providers, physicians and suppliers in submitting correct claims for payment. Local policies outline how contractors will review claims to ensure that they meet Medicare coverage requirements. CMS requires that LMRPs be consistent with national guidance (although they can be more detailed or specific), developed with scientific evidence and clinical practice, and are developed through certain specified federal guidelines. Contractor Medical Directors develop these policies. Reviewing Local Medical Review Policies assists in understanding why Medicare claims may be paid or denied. For a full description of the process and criteria used in developing LMRPs, refer to Chapter 13 of the Medicare Program Integrity Manual. For information about how to request that the authoring contractor conduct a reconsideration of an LMRP, refer to Chapter 13, Section 11.

LMRP Articles: Articles and Frequently Asked Questions (FAQs) that appear on contractor websites address local coverage, coding and medical review related billing issues.

Manual Transmittals: Manual transmittals announce policy revisions. National coverage determinations are announced in transmittals for the Medicare National Coverage Determinations Manual. Changes to Local Medical Review Policy are announced in transmittals for the Medicare Program Integrity Manual.

Medicare Coverage Advisory Committee (MCAC): The MCAC advises CMS on whether specific medical items and services are reasonable and necessary under Medicare law. They perform this task via a careful review and discussion of specific clinical and scientific issues in an open and public forum. The MCAC is advisory in nature, with the final decision on all issues resting with CMS. Accordingly, the advice rendered by the MCAC is most useful when it results from a process of full scientific inquiry and thoughtful discussion, in an open forum, with careful framing of recommendations and clear identification of the basis of those recommendations.

The MCAC is used to supplement CMS's internal expertise and to ensure an unbiased and contemporary consideration of "state of the art" technology and science. Accordingly, MCAC members are valued for their background, education, and expertise in a wide variety of scientific, clinical, and other related fields. In composing the MCAC, CMS was diligent in pursuing ethnic, gender, geographic, and other diverse views, and to carefully screen each member to determine potential conflicts of interest.

Medicare National Coverage Determinations Manual: (Formerly the Coverage Issues Manual) The National Coverage Determinations Manual contains implementing instructions for National Coverage Determinations. The manual includes information whether specific medical items, services, treatment procedures, or technologies are paid for under the Medicare program on a national level.

National Coverage Analyses (NCA): Numerous documents support the national coverage determination process. They include tracking sheets to inform the public of the issues under consideration and the status (i.e., Pending, Closed) of the review, information about and results of MCAC meetings, Technology Assessments, and Decision Memoranda that announce CMS's intention to issue an NCD. These documents, along with the compilation of medical and scientific information currently available, any FDA safety and efficacy data, clinical trial information, etc., provide the rationale behind the evidence-based NCDs.

NCA Closed: When the Decision Memorandum is issued, the NCA is considered closed. However, the policy change is not effective until the NCD is issued.

NCA Decision Memoranda: The decision memorandum provides the reasons supporting an NCD and announces CMS's intent to issue an NCD. Prior to any new or modified policy taking effect, CMS must first issue a Manual Transmittal, CMS ruling or Federal Register Notice, giving specific directions to our claims-processing contractors. That manual transmittal, or other issuance, which includes the effective date, is the actual NCD. If appropriate, the Agency must also change billing and claims processing systems and issue related instructions to allow for payment. The NCD will be published in the Medicare National Coverage Determinations Manual. Policy changes become effective as of the date listed in the Manual Transmittal that announces the National Coverage Determinations Manual revision.

NCA New: An NCA is considered new if CMS has received a coverage request or a current NCD is being edited. The "N" at the end of the tracking number (e.g., CAG-0000N) indicates a new NCA.

NCA Pending: A pending NCA is one currently under review. The Decision Memorandum has not yet been issued. The subject may or may not be an existing NCD.

NCA Reconsideration: A formal reconsideration can be requested if the requestor presents documentation that meets either of the following criteria: additional medical material or scientific information that was not considered during the initial review; or arguments that our conclusion materially misinterpreted the existing evidence at the time the NCD was made. The “R” at the end of the tracking number (e.g, CAG-0000R) indicates a reconsideration. Further reconsiderations are annotated with a number after the “R”, e.g., R2, R3, etc.

National Coverage Determinations (NCDs): An NCD sets forth the extent to which Medicare will cover specific services, procedures, or technologies on a national basis. Medicare contractors are required to follow NCDs. If an NCD does not specifically exclude/limit an indication or circumstance, or if the item or service is not mentioned at all in an NCD or in a Medicare manual, it is up to the Medicare contractor to make the coverage decision (see LMRP). Prior to an NCD taking effect, CMS must first issue a Manual Transmittal, CMS ruling, or Federal Register Notice giving specific directions to our claims-processing contractors. That issuance, which includes an effective date and implementation date, is the NCD. If appropriate, the Agency must also change billing and claims processing systems and issue related instructions to allow for payment. The NCD will be published in the Medicare National Coverage Determinations Manual. An NCD becomes effective as of the date listed in the transmittal that announces the manual revision.

Technology Assessment (TA): Health care TA is a multidisciplinary field of policy analysis. It studies the medical, social, ethical and economic implications of the development, diffusion and use of technologies. In support of NCDs, TA often focuses on the safety and efficacy of technologies.

Each NCD includes a comprehensive TA process. For some NCDs, external TAs are requested through the Agency for Health Research and Quality (AHRQ). For a description of the TA process and guiding principles for selecting which topics are refereed for external TA assistance see http://www.cms.hhs.gov/mcac/guidelines.asp