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MAC  CEDI  A B HHH  10901.36  MLN Article: CMS will make available an MLN Matters provider education article that will be marketed through the MLN Connects weekly newsletter shortly after the CR is released. MACs shall follow IOM Pub. No. 100- 09 Chapter 6, Section 50.2.4.1, instructions for distributing MLN Connects information to providers, posting the article or a direct link to the article on your website, and including the article or a direct link to the article in your bulletin or newsletter. You may supplement MLN Matters articles with localized information benefiting your provider community in billing and administering the Medicare program correctly.  Subscribe to the MLN Matters listserv to get article release X X X X  Number  Requirement  Responsibility     A/B MAC  DME   MAC  CEDI  A B HHH  notifications, or review them in the MLN Connects weekly newsletter.   IV. SUPPORTING INFORMATION   Section A:  Recommendations and supporting information associated with listed requirements: N/A     "Should" denotes a recommendation.  X-Ref  Requirement  Number  Recommendations or other supporting information:   Section B:  All other recommendations and supporting information: N/A  V. CONTACTS   Pre-Implementation Contact(s): Wanda Belle, 410- 786-7491 or wanda.belle@cms.hhs.gov (Coverage) , Karen Reinhardt, 410- 786-0189 or karen.reinhardt@cms.hhs.gov , Marie Casey, 410- 786-7861 or marie.casey@cms.hhs.gov   Post-Implementation Contact(s): Contact your Contracting Officer's Representative (COR).   VI. FUNDING   Section A: For Medicare Administrative Contractors (MACs):  The Medicare Administrative Contractor is hereby advised that this constitutes technical direction as defined in your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the Contracting Officer. If the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notif y the Contracting Officer, in writing or by e -mail, and request formal directions regarding continued performance requirements.  ATTACHMENTS: 0    Medicare Program Integrity Manual  Chapter 13  Local Coverage Determinations (LCDs)  Table of Contents  (Rev.  854, Issued: 01- 11-19)  Transmittals for Chapter 13  13.1  Glossary of Acronyms  13.1.2  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  Contract or 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     13.1 - Glossary of Acronyms  (Rev:  854; Issued:  01-11-19; Effective:  09-26-18; 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   13.1.2 - Local Coverage Determinations (LCD) Definition & Statutory Authority for LCDs  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; 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 pr ocess are described in 42 Code of Federal Regulation (CFR) part426.     1862(l)(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(l)(5)(D) of the SSA to describe the LCD process.  Section 1862(l)(5)(D), of the SSA requires each MAC that develops an LCD to make available on the Internet website of such cont ractor 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:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  13.2.1 - General LCD Process Overview  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; 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:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  13.2.2.1 - Informal Meetings  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The LCD process may begin with informal meetings in which interested parties in the MACs jurisdiction can informally discuss potential LCD r equests.  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 a re 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 reques t for a formal review.    13.2.2.2 - New LCD Requests  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The New LCD Request Process is a mechanism by which interested parties within a contractors jurisdiction can request a new LCD.  Contractors consider all new LCD requests from:    Beneficiaries residing or receiving care in a contractors jurisdiction;    Health care professionals doing business in a contractors jurisdiction; and   Any interested party doing business in a contractors jurisdiction.   13.2.2.3 - New LCD Request Requirements  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; 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 i ncomplete.  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.   13.2.3 - Clinical Guidelines, Consensus Documents and Consultation  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; 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:  854; Issued:  01-11-19; Effective: 09 -26-18; 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, publica tion 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  -