evekhm/cms_iom_500 huggingface dataset:
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R 13/13.5/13.5.3/Evidentiary Content  R 13/13.5/13.5.4 /Reasonable and Necessary Provision in an LCD  N 13/13.5/13.5.5/Public Comment  N 13/13.5/13.5.6/Final Decision  R 13/13.6/LCD Record  R/N/D  CHAPTER / SECTION / SUBSECTION / TITLE  R Exhibits/Table of Contents  D Exhibits/3/Description of CAC Members  D Exhibits/3/3.1/Physicians  D Exhibits/3/3.2/Clinical Laboratory Representative  D Exhibits/3/3.3/Beneficiaries  D Exhibits/3/3.4/Other Organizations  D Exhibits/6/LMRP Format  D Exhibits/6/6.1/Local Coverage Determination (LCD) Format
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III. FUNDING:  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. I f 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 notify the Contracting Officer, in writing or by e -mail, and request formal directions regarding continued performance requirements.  IV. ATTACHMENTS:   Business Requirements  Manual Instruction     Attachment - Business Requirements  Pub. 100 -08 Transmittal: 854 Date: January 11, 2019  Change Request: 10901   Transmittal 829, dated October 3, 2018, is being rescinded and replaced by Tr ansmittal 854 , dated January 11, 2019, to update 3 business requirements (BR) and their related chapter 13 manual instructions.  This correction will revise BRs 10901.7 and 10901.7.1, includi ng the related section 13.2.4.3, to add language that indicates that MACs have the discretion to host multi -jurisdictional CACs ; revise BR 10901.24, including the related section 13.5.2.2, to strike the words in their proposed LCD and strike the words " meeting logistics" and replace with "attendance information"; and BR 10901.26, including the related section 13.5.3, to add language that allows MACs the option of providing a hyperlink to the FDA clearance to market.  All other information remains the same.   SUBJECT: Local Coverage Determinations (LCDs)   EFFECTIVE DATE:  September 26, 2018  *Unless otherwise specified, the effective date is the date of service.  IMPLEMENTATION DATE:  January 8, 2019 -  unless otherwise specified.   I. GENERAL INFORMATION
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SUBJECT: Local Coverage Determinations (LCDs)   EFFECTIVE DATE:  September 26, 2018  *Unless otherwise specified, the effective date is the date of service.  IMPLEMENTATION DATE:  January 8, 2019 -  unless otherwise specified.   I. GENERAL INFORMATION    A. Background:   Stakeholders have provided the CMS with valuable insight regarding LCD process modernization through feedback received in the proposed calendar year 2018 Physician Fee Schedule Rule (82 FR 33950) and through various meetings and correspondence with providers and healthcare associations. Most stakeholders acknowledged that local coverage process is an important means to provide decisions on the items and services that benefit Medicares beneficiaries and ensure beneficiary access to life savin g and medically necessary products and procedures. However, concerns have been raised related to the lack of local coverage process transparency including processes for notifying stakeholders of proposed revisions to, and drafting of, new LCDs. Additional stakeholder concerns include: ineffective MAC processes for soliciting and providing feedback to stakeholders on information provided during open public meetings, lack of non- physician representation on Contractor Advisory Committees (CACs), and concerns that CACs are closed meetings and are not open to the public.   The revisions (additions, deletions, corrections) to this manual reflect policy process changes in response to new statutory (21st century Cures Act) requirements and stakeholder comments. These changes will help to increase transparency, clarity, consistency, improve provider burden and public relations while retaining the ability to be responsive to local clinical and coverage policy concerns.   The 2016 21st Century Cures Act included changes t o the LCD process, adding language to section 1862(l)(5)(D) of the Social Security Act (the Act) to describe the LCD process. Section 1862(l)(5)(D) of the Act requires each MAC that develops an LCD to make available on the Internet website of such contract or and on the Medicare Internet website, at least 45 days before the effective date of such determination, the following information:   1.  Such determination in its entirety.  2.  Where and when the proposed determination was first made public.  3.  Hyperlinks to t he proposed determination and a response to comments submitted to the contractor with respect to such proposed determination.  4.  A summary of evidence that was considered by the contractor during the development of such determination and a list of the sourc es of such evidence.  5.  An explanation of the rationale that supports such determination.
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We are revising our instructions to contractors in Pub. 100- 08, Chapter 13 of the Medicare Program Integrity Manual in order to reflect these policy changes. 42 CFR 426 outlines all the requirements regarding the LCD Challenge process; therefore, we believe sections 13.13.1- 13.13.15 in Chapter 13 of Pub. 100- 08 are duplicative and will be deleted.   B. Policy:   The 2016 21st Century Cures Act and Section 1862(1)(5)(D ) of the Act   II. BUSINESS REQUIREMENTS TABLE    "Shall" denotes a mandatory requirement, and "should" denotes an optional requirement.   Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF 10901.1  MACs may allow for informal meetings with interested parties in the MAC's jurisdiction to discuss potential LCD requests.   X X X X      10901.1.1 MACs shall publish on their contractor website how an interested party can contact them to set up an informal meeting.   X X X X      10901.2  The New LCD Request Process is a mechanism by which interested parties within a contractors jurisdiction can request a new LCD. Contractors shall 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.   X X X X      10901.3  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 whic h 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;  X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF
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A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF     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.    10901.3.1 The MAC will review materials received within 60 calendar days upon receipt and determine whether the request is complete or incomplete.  X X X X      10901.3.2 If the request is incomplete, the contractor shall respond, in writing, to the requestor explaining why the request was incomplete.   X X X X      10901.3.3 If the request is complete, the MAC shall follow the process outlined in section 13.2 in chapter 13 of Pub.100- 08.  X X X X      10901.3.4 If the MAC requires an extension to the timeframes noted above, the MAC shall inform their COR and Business Function Lead (BFL) in writing. The MAC shall also provide their rationale for the extension request.   X X X X      10901.4  When a MAC consults with an expert, they shall inform and obtain consent from the expert that their opinion may be used and clearly identified within the proposed or final LCD.   X X X X      10901.5  For all proposed LCDs, with limited exceptions noted below, MACs shall follow the LCD process, consisting of consultation, X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF 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 the  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 e xample, typographical or grammatical errors that do not substantially change the LCD.
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 Revised LCD Being Issued for Compelling Reasons   Revised LCD that Makes a Non -Substantive Correction - For e xample, 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, National Coverage Determinations (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.   10901.5.1 Contractors shall obtain explicit approval from the CMS contracting officer and BFL in all other situations.   X X X X      10901.6  Once the proposed LCD is published, MACs shall provide a minimum of 45 calendar days for public comment.  X X X X      10901.6.1 MACs shall contact the CMS BFL if they determine an extension to the comment period is needed.  X X X X      10901.7  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.   X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF 10901.7.1 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 the evidence used to make a determination.   X X X X      10901.7.2 The MAC shall endeavor to ensure each specialty that serves on the CAC shall have only at least one member and a designated alternate approved  by the MAC.   X X X       10901.7.3 MACs shall work with CAC members to select a meeting location that will optimize participation. Contractors have the option of hosting in -person or telephonic/video/on- line conference/etc. meetings.   X X X X      10901.7.4 MACs shall ensure all CAC meetings will be open to the public to attend and observe.
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X X X X      10901.7.4 MACs shall ensure all CAC meetings will be open to the public to attend and observe.   X X X X      10901.7.5 MACs shall keep a copy of the number of CAC attendees and make a copy available to CMS BFL and COR upon request.   X X X X      10901.7.6 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.   X X X X      10901.7.7 Participation in the CAC is considered voluntary. MACs shall not provide an honorarium or other forms of compensation to members.   X X X X      10901.8  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.   X X X X      10901.8.1 MACs should endeavor to accommodate some in -person attendance, subject to limitations based on venue.  X X X X      10901.8.2 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 X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF discussed.   10901.8.2.1 MACs shall provide an email address on their contractor website where all interested parties shall submit their presentation materials.   X X X X      10901.8.3 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. MACs shall ensure the presentation time shall be equally divided amongst the LCDs discussed at the meeting.   X X X X      10901.8.4 MACs shall keep a copy of the number of attendees and make a copy available to CMS BFL and COR upon request.   X X X X      10901.8.5 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.
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X X X X      10901.8.5 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.   X X X X      10901.8.6 MACs shall notify the public about the dates, times, and location for the open meeting. MACs have the option of setting up email listservs to announce this information or may use other education methods to adequately inform the public.   X X X X      10901.8.6.1 The MACs shall ensure that the listserv or other method clearly identifies 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.   X X X X      10901.8.7 MACs shall post the planned agenda for the open meeting a minimum of two weeks prior to the event on their contractor website and shall inform the public that the agenda has been posted.   X X X X      10901.9  After the close of the comment period and the required meetings and consultation, the MACs shall publish the final LCD and the Response to Comment (RTC) Article on the X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF Medicare Coverage Database (MCD).   10901.9.1 MACs shall 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 publically available indefinitely on t he MCD or the MCD Archive.   X X X X      10901.10 The MACs shall publish the final LCD on the MCD. The date the LCD is published on the MCD marks the beginning of the required notice period of a minimum 45 calendar days before the LCD can take effect.   X X X X      10901.10.1 If the MAC would like to extend the notice period, they shall seek approval from CMS BFL. If the notice period is not extended by the contractor, the effective date of the LCD is the 46th calendar day after the notice period began
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X X X X      10901.11 MACs shall add to their MAC Web sites information on the LCD Reconsideration Process.   X X X X      10901.11.1 The MACs shall ensure that this information is listed on the LCD home page of the MACs Web site.   It shall be labeled "LCD Reconsideration Process" and shall include:    A description of the LCD Reconsideration Process; and    Instructions for submitting LCD reconsideration requests, including postal, e -mail, and fax addresses where requests may be submitted.  X X X X      10901.12 MACs shall consider all LCD reconsideration requests from:   X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF  Beneficiaries residing or receiving care in a contractor's jurisdiction; and    Providers doing business in a contractor's jurisdiction    Any interested party doing business in a contractor's jurisdiction   10901.13 MACs should only accept reconsideration requests for LCDs published as an effective final.  Requests shall not  be accepted for other documents including:    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   X X X X      10901.14 If modification of the LCD would conflict with an NCD, the request would not be valid. The MAC should refer the requestor to the NCD reconsideration process. Requestors can be referred to http://www.cms.gov/DeterminationProcess/01_overview.asp#regs.   X X X X      10901.15 Any request for LCD reconsideration that, after MAC review, is determined to not meet these criteria is invalid. MACs shall have the discretion to consolidate valid requests, if similar requests are received.   X X X X      10901.15.1 Within 60 calendar days of the day the request is received, the MAC shall determine X X X X      Number  Requirement  Responsibility     A/B MAC  DME
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X X X X      10901.15.1 Within 60 calendar days of the day the request is received, the MAC shall determine X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF whether the request is valid or invalid.   10901.15.1.1 If the request is invalid, the MAC shall respond in writing, to the requestor explaining why the request was invalid.   X X X X      10901.15.2 If the request is valid, the contractor shall follow the requirements below.  The MAC shall open the LCD and follow the LCD process as outlined  in section 13.2 of this manual or include the LCD on the MACs waiting list.   X X X X      10901.15.3 The MAC shall respond, in writing, to the requestor notifying the requestor of the acceptance, and if applicable, wait -listing, of the reconsideration request.   X X X X      10901.15.4 Contractors shall keep an internal list of the LCD Reconsideration Requests received and the dates, subject, and disposition of each one.  X X X X      10901.16 Contractors shall follow all LCD Challenge requirements outlined in 42 CFR part 426.  X X X X      10901.17 The MACs shall publish all proposed and final LCDs and LCD related articles on the MCD. The public may access the MCD at http://www.cms.gov/medicare -coverage -database.     MACs shall ensure the accuracy of the information entered into the MCD.    If a MAC decides to have LCDs and related articles on their MAC web sites, then the MAC shall link from their MAC website to the MCD.    X X X X      10901.18 MACs shall finalize or retire all proposed LCDs within a rolling year of publication date of the proposed LCD on the MCD (365 days). If an unusual circumstance occurs and the MAC wishes to request an exception to this requirement, they shall notify their C OR and LCD BFLs at least 21 business days X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF before the one year expiration date.
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A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF before the one year expiration date.   10901.19 The MAC shall ensure that all LCDs do not conflict with all statutes, rulings, regulations, and national coverage, payment, and coding policies.   X X X X      10901.20 For all new and revised LCDs, MACs shall no longer include national policy language found in statute, regulations, rulings, interpretive manual instructions, etc. in the coverage and indications section of their LCDs. If contractors need to  reference a national policy in the coverage and indications section of their LCD, they shall cite the reference (e.g., publication number, Medicare title of manual, section of manual).   X X X X      10901.21 MACs shall remove all codes from LCDs and plac e them in billing & coding articles that are linked to the LCD. CMS will provide additional instructions on the date upon which this change will be effective.   X X X X      10901.22 The MAC shall summarize the opinions received as a result of consultation  with healthcare professional expert(s), professional societies, etc. prior to the drafting of a proposed LCD, and include this information in the proposed LCD.   X X X X      10901.23 When a MAC determines that a CAC consultation should be sought for a proposed LCD, the MAC shall include the summary of recommendations from the CAC regarding the policy in the Final LCD.   X X X X      10901.24 Contractors shall clearly identify attendance information consisting of location, time and date for the CAC meeting(s) and ensure that these are clearly distinguished from the information for the Open meeting(s), even if they occur on the same day at the same location.   X X X X      10901.24.1 The MAC shall also make available a means to accommodate reasonable requests for assistance from stakeholders who are hearing X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF or visually impaired.
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A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF or visually impaired.   10901.24.2 The MAC shall have the discretion to determine the frequency of the CAC meetings and shall base the meetings on the appropriateness and on the volume of LCDs that require CAC consultation as part of the LCD process.   X X X       10901.25 In every proposed and final LCD, the MAC shall summarize the evidence that supports coverage, limited coverage, maintenance of existing coverage in cases of LCD reconsideration or non- coverage. At a minimum, the summary should include the following:    a complete description of the item or service under review;    a narrative that describes the scientific evidence supporting the clinical indications for the item o r service;    the target Medicare population; and    whether the item or service is intended for use by health care providers or beneficiaries.   X X X X      10901.26 If the item or service is regulated by the Food and Drug Administration (FDA), and determined by the MAC to be reasonable and necessary, information regarding the use of the item or service subject to the FDA labeling requirements shall be included. MACs have the option of providing a hyperlink to the FDA clearance to market to meet this  requirement.   X X X       10901.27 In conducting a review, MACs shall use the available evidence, such as published original research, systematic reviews and meta -analyses, and evidence- based consensus statements and guidelines. Proprietary information, submitted by the requestor, not avail able to the public shall not be considered. The review shall include a summary of all the evidence used to support the determination and may be grouped by X X X X      Number  Requirement  Responsibility     A/B MAC  DME  MAC Shared -System Maintainers  Other A B HHH FISS MCS VMS CWF type of evidence evaluated.   10901.28 MACs shall list all articles and sources that led to the LCD in the Bibliography. The citations shall be consistent with the American Medical Association Manual of Style.   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.