evekhm/cms_iom_500 huggingface dataset:
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X X X X      10901.29 MACs shall explain the rationale that supports their coverage determination of covered, non- covered, or limited coverage. The rationale is the reasoning leading to the coverage determination.   X X X X      10901.30 If it is appropriate for a MAC to provide coding/billing information to help implement the coverage policy, the MAC shall publish the coding/billing article at the same time they publish the proposed LCD.   X X X X      10901.31 Contractors shall determine and describe in the LCD the circumstances under which the item or service is reasonable and necessary under section 1862(a)(1)(A) of the Act. Contractors shall determine if evidence exists to consider an item or service to be reasonable and necessary if the contractor determines that the service is:    Safe and effective;    Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary); and    Appropriate, including the duration and frequency that is con sidered appropriate for the item or service, in terms of whether it is:   o Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;   X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF o Furnished in a setting appropriate to the patient's medical needs and condition;   o Ordered and furnished by qualified personnel;   o One that meets, but does not exceed, the patient's medical need; and   o At least as beneficial as an existing and available medically appropriate alternative   10901.32 MACs shall provide a minimum of 45 calendar days for public comment on all proposed LCDs.   X X X X      10901.32.1 MACs shall respond to all timely received public comments, and may group similar comments and responses in logical categories in the RTC article.   X X X X      10901.33 After the close of the comment period and the required meetings, the MACs shall publish a final LCD to the MCD.   X X X X      10901.33.1 MACs shall link from their contractor website to the final LCD on the MCD.
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X X X X      10901.33.1 MACs shall link from their contractor website to the final LCD on the MCD.   X X X X      10901.33.2 The MAC shall respond to all comments received, via the RTC article which shall be published on the MCD at the same time as the publication of the final LCD.  MACs shall ensure the final LCD and RTC article are related on the MCD.    X X X X      10901.33.3 MACs shall notify the public that a final decision has been published and provide the Web link to the final decision. MACs shall use several tools at their disposal to educate providers, including the Whats New Report on the MCD, setting up email listservs, or other 508 compliant and accessible means to adequately inform stakeholders.   X X X X      10901.33.4 MACs shall notify the public that a final determination has been published and provide the Web link to the final decision. MACs may use several tools at their disposal X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF to notify the public, including the "What's New Report" on the MCD, setting up listservs, or other 508 compliant and accessible means to inform stakeholders.   10901.34 The contractors shall maintain the LCD record for a minimum of 6 years and 3 months from the date the LCD is retired.   X X X X      10901.34.1 Contractors shall have a mechanism for archiving retired LCDs. This mechanism shall also allow the contractor to respond to requests and retrieve the LCD record.   X X X X      10901.35 After 6 years and 3 months from the date the LCD is retired, the contractors shall destr oy the LCD record. However, contractors shall not destroy the LCD record if it relates to a current investigation of litigation/negotiation; ongoing Workers Compensation set aside arrangements; or documents which prompt suspicions of fraud and abuse of it ems or services.   X X X X       III. PROVIDER EDUCATION TABLE   Number  Requirement  Responsibility     A/B MAC  DME
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X X X X       III. PROVIDER EDUCATION TABLE   Number  Requirement  Responsibility     A/B MAC  DME   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
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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
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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.
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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)
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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
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 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)
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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  -   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 sh all 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 Judges 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 immediately) .  13.2.4.1 - Proposed Determination & Posting of LCD Summary Sheet  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The Proposed LCD is the MACs proposed determination regarding coverage, non- coverage or limited coverage for a particular item or service.  The public announcement of the MACs proposed determination begins with the date the proposed LCD is published on the Medicare Coverage Database (MCD) .    The LCD Summary Sheet is a document that summarizes contractor actions related to the LCD and includes open meeting and CAC information, if applicable.  The LCD Summary Sheet will be posted to the MCD.    13.2.4.2 - Public Comment  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)
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13.2.4.2 - Public Comment  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  Once the proposed LCD is published MACs shall provide a minimum of 45 calendar days for public comment.  MACs shall contact CMS Business Function Lead (BFL) if they determine an extension to the comment period is needed.  13.2.4.3  Contractor Advisory Committee (CAC)  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs shall establish one CAC per state or have the option of establishing one CAC per jurisdiction or multi- jurisdictional CAC with  representation from each state. It is expected that if a MAC chooses to have one CAC per jurisdiction  or multi -jurisdictional CAC , the MAC shall endeavor to ensure that each state has a full committee and the opportunity to discuss the quality of evidence used to make a determination.   The purpose of the CAC is to provide a formal mechanism for healthcare professionals to be inform ed of the evidence used in developing the LCD and promote communications between the MAC and the healthcare community.  CAC members should serve in an advisory capacity as representatives of their constituency to review the quality of the evidence used in the development of an LCD.  The CAC is advisory in nature, with the final decision on all issues resting with MACs.  Accordingly, the advice rendered by the CAC is most useful when it results from a process of full scientific inquiry and thoughtful discuss ion with careful framing of recommendations and clear identification of the basis of those recommendations.
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The CAC is to be composed of healthcare professionals, beneficiary representatives, and representatives of medical organizations.  The CAC is used to supplement the MACs internal expertise and to ensure an unbiased and contemporary consideration of "state of the art" technology and science.  CAC members are valued for their background, education, experience and/or expertise in a wide variety of sci entific, clinical, and other related fields.  The MAC shall endeavor to ensure each specialty that serves on the CAC shall have at least one member and a designated alternate approved by the MAC.  If the CAC member or alternate cannot attend the CAC meeting, a substitute may attend if the MAC is notified and approved at least 1 week prior to the meeting.  MACs shall work with CAC members to select a meeting location that will optimize participation. MACs shall keep a copy of the number of CAC attendees and make a copy available to CMS BFL and COR upon request. MACs shall record (video, audio or both) the CAC meetings and as part of the LCD record, assure the recording is maintained on their contractor website. Contractors have the option of hosting in- person  and/or telephonic/video/on- line conference/etc. meetings.  All CAC meetings will be open to the public to attend and observe  Portions of the meeting not discussing evidence for a proposed LCD, such as provider practice trend reporting or discussions relat ed to fraud and abuse, may be closed to the public.   Participation in the CAC is considered voluntary.  MACs do not provide an honorarium or other forms of compensation to members.  Expenses are the responsibility of the individuals or the associations they represent.   13.2.4.4 - Open Meeting  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)
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13.2.4.4 - Open Meeting  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  After the proposed LCD is made public, MACs shall hold open meetings to discuss the review of the evidence and the rationale for the proposed LCD(s) with stakeholders in their jurisdiction. The open meeting should endeavor to accommodate some in- person att endance, subject to limitations based on venue.   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. MACs should provide an email address on their contractor website where all interested parties shall submit their presentation materials.  However, all formal comments must be submitted in writing to the MAC.  Contractors shall remain  sensitive to parties that may have an interest in an issue and endeavor to invite them to participate in meetings at which a related LCD is being discussed.  In recognition that the efficient use of resources may require several proposed LCDs to be discussed during one meeting, time for presentation by interested parties may be limited.  The presentation time shall be equally divided amongst the LCDs discussed at the meeting.  Members of the CAC may also attend these open meetings. MACs shall keep a copy o f the number of attendees and make a copy available to CMS BFL and COR upon request.  MACs shall record (video, audio or both) the Open Meetings and as part of the LCD record, assure the recording is maintained on their contractor website.   MACs are required to notify the public about the dates, times, and location for the open meeting.  MACs have the option of setting up email listservs to announc e this information or may use other education methods to inform the public.  The listserv or other method shoul d clearly identify the location, times, dates and telephone/video/on- line conference information for the open meeting to ensure that this information is clearly distinguished from the information for the CAC meetings.  MACs shall post the planned agenda for the open meeting a minimum of two weeks prior to the event on their contractor website and will inform the public that the agenda has been posted.