Medicare Program Integrity Manual, Chapter 13

=== Page 1 === # Medicare Program Integrity Manual ## Chapter 13 – Local Coverage Determinations Table of Contents (Rev. 863, 02-12-19) ## Transmittals for Chapter 13 13.1 - Glossary of Acronyms 13.1.1 – LCD Definition & Statutory Authority for LCDs 13.2 - LCD Process 13.2.1 – General LCD Process Overview 13.2.2 – Requests 13.2.2.1 – Informal Meetings 13.2.2.2 – New LCD Requests 13.2.2.3 – New LCD Request Requirements 13.2.3 – Clinical Guidelines, Consensus Documents & Consultation 13.2.4 – Proposed LCD 13.2.4.1 – Proposed Decision and Posting of LCD Summary Sheet 13.2.4.2 – Public Comment 13.2.4.3 – Contractor Advisory Committee (CAC) 13.2.4.4 – Open Meeting 13.2.5 – Final Determination 13.2.5.1 – Response to Public Comment 13.2.6 – Notice Period 13.3 - LCD Reconsideration Request 13.3.1 – Web site Requirements for the LCD Reconsideration Process 13.3.2 – Valid LCD Reconsideration Request Requirements 13.3.3 – Process Requirements 13.4 - Challenge of an LCD 13.5 - LCD Content 13.5.1 – General Requirements 13.5.2 – Consultation 13.5.2.1 – Consultation Summary 13.5.2.2 – CAC Recommendations 13.5.3 - Evidentiary Content 13.5.4 - Reasonable and Necessary Provision in an LCD 13.5.5 - Public Comment 13.5.6 – Final Decision 13.6 - LCD Record === Page 2 === 13.1 - Glossary of Acronyms (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) ALJ: Administrative Law Judge BFL: Business Function Lead BIPA: Benefits Improvement and Protection Act CAC: Contractor Advisory Committee CFR: Code of Federal Regulation COR: Contracting Officer Representative CMS: Centers for Medicare & Medicaid Services DAB: Department of Appeals Board FR: Federal Register LCD: Local Coverage Determination LCBE: Local Coverage Backend Database MAC: Medicare Administrative Contractor MCD: Medicare Coverage Database PFS: Physician Fee Schedule RTC: Response to Comments SSA: Social Security Act 13.1.1 - Local Coverage Determinations (LCD) Definition & Statutory Authority for LCDs (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) An LCD, as defined in §1869(f)(2)(B) of the Social Security Act (SSA), is a determination by a Medicare Administrative Contractor (MAC) respecting whether or not a particular item or service is covered on a contractor-wide basis in accordance with section 1862(a)(1)(A) of the Act. 1869(f)(2)(A) of the SSA outlines the process for Administrative Law Judge (ALJ) and Department of Appeals Board (DAB) review of LCDs. This process is known as the LCD Challenge Process. Procedures related to this challenge process are described in 42 Code of Federal Regulation (CFR) part426. === Page 3 === §1862(1)(5)(B) of the SSA requires the MACs providing services within the same jurisdiction to consult on all new local coverage determinations within the jurisdiction. The 2016 21st Century Cures Act included changes to the LCD process, adding language to 1862(1)(5)(D) of the SSA to describe the LCD process. Section 1862(1)(5)(D), of the SSA requires each MAC that develops an LCD to make available on the Internet website of such contractor and on the Medicare Internet website, at least 45 days before the effective date of such determination, the following information: (i) Such determination in its entirety. (ii) Where and when the proposed determination was first made public. (iii) Hyperlinks to the proposed determination and a response to comments submitted to the contractor with respect to such proposed determination. (iv) A summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence. (v) An explanation of the rationale that supports such determination. ## 13.2 - LCD Process (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) ## 13.2.1 - General LCD Process Overview (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) This section outlines the processes used for informal meetings prior to the development of an LCD, external requests to develop an LCD, consultations, the proposed determination, public comment, the Contractor Advisory Committee, final determination, and the notice period. ## 13.2.2 - Requests (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) ## 13.2.2.1 - Informal Meetings (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) The LCD process may begin with informal meetings in which interested parties in the MAC's jurisdiction can informally discuss potential LCD requests. These meetings are for educational purposes only and are not pre-decisional negotiations. MACs should publish on their contractor websites how an interested party can contact them to set up an informal meeting. These meetings are permitted but are not required and the process allows requestors to communicate via conference call or in-person meeting before submitting a formal request. These meetings will assure that all relevant evidence needed for review for coverage is submitted with the request for a formal review. === Page 4 === 13.2.2.2 - New LCD Requests (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) The New LCD Request Process is a mechanism by which interested parties within a contractor's jurisdiction can request a new LCD. Contractors consider all new LCD requests from: - Beneficiaries residing or receiving care in a contractor's jurisdiction; - Health care professionals doing business in a contractor's jurisdiction; and - Any interested party doing business in a contractor's jurisdiction. 13.2.2.3 - New LCD Request Requirements (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) Contractors shall consider New LCD Requests to be a complete, formal request if the following are met: - The request is in writing and can be sent to the MAC via e-mail, facsimile or written letter; - The request clearly identifies the statutorily-defined Medicare benefit category to which the requestor believes the item or service falls under and provides a rationale justifying the assignment; - The request shall identify the language that the requestor wants in an LCD; - The request shall include a justification supported by peer-reviewed evidence. Full copies of published evidence to be considered shall be included and failure to include same invalidates the request; - The request shall include information that addresses the relevance, usefulness, clinical health outcomes, or the medical benefits of the item or service; and - The request shall include information that fully explains the design, purpose, and/or method, as appropriate, of using the item or service for which the request is made. The MAC will review materials received within 60 calendar days upon receipt and determine whether the request is complete or incomplete. If the request is incomplete, the contractor shall respond, in writing, to the requestor explaining why the request was incomplete. If the request is complete, the MAC shall follow the process outlined in chapter 13 of Pub.100-08. A valid request response does not convey that a determination has been made whether or not the item or service will be covered or non-covered under 1862 (a)(1)(A) of the Act. The response to the requestor that the request is valid is simply an acknowledgement by the MAC of the receipt of a complete, valid request. If the MAC requires an extension to the timeframes noted above, the MAC shall inform their COR and BFL in writing. The MAC shall also provide their rationale for the extension request. === Page 5 === 13.2.3 - Clinical Guidelines, Consensus Documents and Consultation (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) Prior to drafting and during the development of an LCD, if available the MACs shall supplement their research (see section 13.5.3) 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, when applicable. When a MAC consults with an expert, they shall inform and obtain consent from the expert that their opinion may be used, disclosed publicly, and clearly identified as such within the proposed or final LCD. 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. 13.2.4 - Proposed LCD (Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) All proposed LCDs, with limited exceptions noted below, must follow the LCD process outlined in 13.2 of this manual, consisting of consultation, publication of proposed LCD, open meeting concerning the proposed policy, opportunity for public comment in writing, publication of a final LCD that includes a response to public comments received and notice to public of new policy 45 days in advance of the effective date. 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 Statutes, Federal regulations, CMS Rulings, NCDs, HCPCS code changes for DME, coverage provisions in interpretive manuals, and payment policies. - Revise LCD to effectuate an Administrative Law Judge’s decision to nullify an existing LCD due to an LCD Challenge. Contractors must obtain explicit approval from the CMS Contracting Officer Representative (COR) and Business Function Lead (BFL) in all other situations (e.g. there is compelling new evidence that a procedure/device is highly unsafe and coverage must be removed

Requests for new LCDs can be submitted by beneficiaries, healthcare professionals, or any interested parties within the contractor's jurisdiction. Requests must be from beneficiaries, providers, or any interested party within the contractor's jurisdiction. Only reconsideration requests for published effective final LCDs are accepted. Requests for LCD reconsideration must include justification supported by new evidence. Medicare beneficiaries in need of coverage for a service denied by an LCD can challenge the decision. Coverage is supported by scientific evidence demonstrating the clinical usefulness of the item or service. Indicated for the target Medicare population as defined in the policy. Items or services regulated by the FDA that are determined to be reasonable and necessary by the MAC. An item or service may be covered if it is reasonable and necessary under Section 1862(a)(1)(A) of The Act. Services are covered if they are safe and effective. Services must not be experimental or investigational. Medically necessary services must be furnished in accordance with accepted medical standards for diagnosis or treatment. Services must be delivered in an appropriate setting based on the patient's medical needs.

No specific limitations outlined in the provided document excerpt. Participation in the CAC is considered voluntary. MACs do not provide compensation to members. Requests for other documents apart from final LCDs will not be accepted. Requests that conflict with an NCD are not valid. Referrals to NCD reconsideration process must be made for conflicting requests. Any request for LCD reconsideration that does not meet the specified criteria is invalid. Not covered unless you provide scientific evidence supporting the clinical indication. Exclusions may apply based on the service's intended use by health care providers or beneficiaries. Only reasonable and necessary provisions are considered part of the LCD. Routine costs of qualifying clinical trial services are only considered reasonable and necessary if they meet the requirements of the Clinical Trials NCD. Services should not exceed the patient's medical need. Items must be ordered and furnished by qualified personnel. LCD records must be maintained for a minimum of 6 years and 3 months post-retirement. Records related to current investigations or litigation must not be destroyed.

Relevant evidence needed for coverage must be submitted with the request for formal review. Validation of complete and formal request requirements must be met. Request must clearly identify the Medicare benefit category and provide justification. Full copies of peer-reviewed evidence must be included with the request. Information on the relevance, usefulness, clinical health outcomes, or medical benefits must be provided. The request must explain the design, purpose, and/or method of using the item or service. Explicit approval from CMS Contracting Officer Representative (COR) and Business Function Lead (BFL) needed for coverage removal. Formal comments must be submitted in writing to the MAC. Presentation materials should be submitted via email to the MAC. Submit reconsideration requests via postal mail, email, or fax to designated addresses. Published evidence must be included with the request. Documentation of the need for coverage by the beneficiary’s treating physician. Complete description of the item or service under review. Narrative detailing the scientific evidence supporting clinical indications. Information regarding the use of the item or service subject to the FDA indication. Evidence from peer-reviewed medical journals, systematic reviews, and clinical guidelines. Aggregate level information complying with HIPAA Privacy Rule. Mechanism must be in place for archiving retired LCDs. Must allow response to requests for LCD records.