evekhm/cms_iom_500 huggingface dataset:
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13.2.5 - Final Determination  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  After the close of the comment period and the required meetings and consultation, the final LCD and the Response to Comment (RTC) Article shall be published on the MCD.    A.  Response to Public Comments   MACs respond to all comments received during the comment period of the proposed LCD by using the Response to Comment (RTC) article associated with the LCD.  The RTC Article is published on the start date of the notice peri od.  The RTC Article will remain publicly  available indefinitely on the MCD or the MCD Archive.   13.2.6 - Notice Period  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The date the final 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.  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 aft er the notice period began.    13.3 - LCD Reconsideration Process (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The LCD reconsideration process is a mechanism by which a beneficiary or stakeholder (including a medical professional society or physician) in the MACs jurisdiction can request a revision to an LCD.  The LCD reconsideration process differs from an initial request for an LCD in that it is available only for final effective LCDs.  The whole LCD or any provisio n of the LCD may be reconsidered.  In addition, MACs have the discretion to revise or retire th eir LCDs at any time on their own initiative.   13.3.1 - Web site Requirements for the LCD Reconsideration Process  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)
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13.3.1 - Web site Requirements for the LCD Reconsideration Process  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs shall add to their MAC Web sites information on the LCD Reconsideration Process.  This information should be 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, i ncluding postal, e -mail, and fax addresses where requests may be submitted.   13.3.2 - Valid LCD Reconsideration Request Requirements  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs shall consider all LCD reconsideration requests from:    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.   MACs should only accept reconsideration requests for LCDs published as an effective final.  Requests shall not be accepted for other documents including:    National Coverage Determinations (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.
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 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.   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 reco nsideration process.  Requestors can be referred to http://www.cms.gov/DeterminationProcess/01_overview.asp#regs . Requests shall be submitted in writing and shall identify the language that the requestor wants added to or deleted from an LCD.  Requests shall include a justification supported by new evidence, which may materially affect the LCD's content or basis.  Copies of published evidence shall be included.  Any request for LCD reconsideration that, after MAC review, is determined to not meet these criteria is invalid.  MACs have the discretion to consolidate va lid requests if similar requests are received.   13.3.3 - Process Requirements  (Rev:  854; Issued:  01-11-19; Effective:  09-26-18; Implementation: 01 -08-19)  The requestor shall submit a valid LCD reconsideration request to the appropriate MAC, following instructions on the MAC's Web site.   Within 60 calendar days of the day the request is received, the MAC shall determine whether the request is valid or invalid.  If the request is invalid, the contractor shall respond, in writing, to the requestor explaining why the request was invalid.  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.  The MAC shall respond, in writing, to the requestor notifying the requestor of the acceptance, and if applicabl e, wait -listing, of the reconsideration request.    Contractors shall keep an internal list of the LCD Reconsideration Requests received and the dates, subject, and disposition of each one.  13.4 - Challenge of an LCD  (Rev:  854; Issued:  01-11-19; Effective : 09-26-18; Implementation: 01 -08-19)
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13.4 - Challenge of an LCD  (Rev:  854; Issued:  01-11-19; Effective : 09-26-18; Implementation: 01 -08-19)  In addition to creating the term Local Coverage Determination (LCD), section 1869(f) of the Social Security Act creates an appeals process for an aggrieved party to challenge LCDs/LCD provisions that are in effect  at the time of the challenge. Aggrieved party is defined in regulation as a Medicare beneficiary, or the estate of a Medicare beneficiary, who is entitled to benefits under Part A, enrolled under Part B, or both (including an individual enrolled in fee -for-service Medicare, in a Medicare Advantage  plan (MA), or in another Medicare managed care plan), and is in need of coverage for an item or service that would be denied by an LCD, as documented by the beneficiarys treating physician, regardless of whether the service has been received.  An aggrieved party has obtained documentation of the need by the beneficiarys treating physician.   Contractors shall follow all LCD Challenge requirements outlined in 42 CFR part 426.  As indicated in 42 CFR  426.415 if  appropriate, CMS may choose to participate as a party in the LCD Challenge process.   13.5  LCD Content  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  13.5.1 - General Requirements  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The Medicare Coverage Database (MCD) is the central repository that houses proposed, and final LCDs, and LCD related articles.
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The Medicare Coverage Database (MCD) is the central repository that houses proposed, and final LCDs, and LCD related articles.     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 must 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 must link from their MAC website to the MCD.   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 COR and LCD BFLs at least 21 business days before the one year expiration date.     The MAC shall ensure that all LCDs do not conflict with all statutes, rulings, regulations, and national coverage, payment, and coding policies.   For all new and revised LCDs MACs shall no longer include national policy language found in statute, regulati ons, 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. public ation number, Medicare title of manual, section of manual) without reiterating the text from the policy .    It is no longer appropriate to include Current Procedure Terminology (CPT) codes or International Classification of Diseases- Tenth Revision- Clinical Modification (ICD -10-CM) codes in the LCDs.  All CPT and ICD -10-CM codes shall be removed from LCDs and placed in billing & coding articles or Policy Articles that are to be published to the MCD and related to the LCD.  CMS will provide additional instruc tions on the date upon which this change will be effective.   13.5.2 - Consultation  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)
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13.5.2 - Consultation  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  13.5.2.1 - Consultation Summary  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  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.     13.5.2.2 - CAC Recommendations  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  When a MAC determines that a CAC consultation should be sought for a proposed LCD, the summary of recommendations from the CAC regarding the policy shall be included in the Final LCD.    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.  The MAC shall also make available a means to accommodate reasonable requests for assistance from stakeholders who are hearing or visually impaired.  The frequency of the CAC meetings are at the discretion of the MAC and will be based on the appropriateness and on the volume of LCDs that require CAC consultat ion as part of the LCD process.   13.5.3 - Evidentiary Content  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  In every proposed and final LCD, the MAC must 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 or service;   the target Medicare population; and   whether  the item or service is intended for use by health care providers or beneficiaries.
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If the item or service is regulated by the FDA, and determined by the MAC to be reasonable and necessary, information regarding the use of the item or service subject to the FDA indication, as applicable, shall be included. MACs have the option of providing a hyperlink to the FDA clearance to market to meet this requirement.    In conducting a review, MACs shall use the available evidence of general acceptance by the medical community , such as published original research in peer -reviewed medical journals, sy stematic reviews and meta -analyses, evidence -based consensus statements and clinical guidelines.  Proprietary information, submitted by a requestor, not available to the public shall not be considered. Medicare data considered as part of the evidence review for an LCD shall be reported in the evidence summary. The reported data shall comply with Medicare Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule data disclosure requirements by using aggregate level information, such as aggregated statistics on Medicare beneficiary or provider utilization.  The review shall include a summary of all the evidence used to support the determination, which may be grouped by type of evidence evaluated.   MACs shall list all articles and sources that l ed to the LCD in the Bibliography.  The citations shall be consistent with the American Medical Association (AMA) Manual of Style.     MACs sh all 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.  If it is appropriate for a MAC to provide coding/billing information to help implement the coverage policy, MAC shall publish the coding/billing article at the same time they publish t he proposed LCD.    13.5.4  Reasonable and Necessary Provisions in LCDs  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  An item or service may be covered by a contractor LCD if:    It is reasonable and necessary under 1862(a)( 1)(A) of The Act. Only reasonable and necessary provisions are considered part of the LCD.   Reasonable and Necessary   Contractors shall determine and describe in the LCD the circumstances under which the item or service is reasonable and necessary under 1862(a)(1)(A). Contractors shall determine if evidence exist to consider an item or service to be reasonable and necessary if the contractor determines that the service is:    Safe and effective;
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 Safe and effective;    Not experimental or investigational (exception: routine cos ts 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 c onsidered 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;    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.   13.5.5 - Public Comment  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs are required to provide a minimum of  45 calendar days for public comment on all proposed LCDs.  MACs shall respond to all timely received public comments, and may group similar comments and responses in logical categories in the RTC article .    13.5.6 - Final Decision  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  MACs shall finalize or retire all proposed LCDs within a rolling year of publication date of the proposed LCD on the MCD (365 days). After the close of the comment period and the required meetings,  the MACs shall publish a final LCD to the MCD.  MACs shall link from their contractor website to the final LCD on the MCD.  As stated earlier, the MAC shall also respond to all comments received, via the RTC article which shall be published on the MCD and be related to the LCD.  The RTC article shall be displayed at the same time as the final LCD.    MACs shall notify the public that a final decision has been published and provide the Web link to the final decision.  MACs may use several tools at their disposal to educate providers, including the Whats New Report on the Medicare Coverage Database, setting up email listservs, or other 508 compliant and accessible means to inform stakeholders.
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13.6 - LCD Record  (Rev:  854; Issued:  01-11-19; Effective: 09 -26-18; Implementation: 01 -08-19)  The LCD record shall be maintained by contractors for a minimum of 6 years and 3 months from the date the LCD is retired.  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.  After 6 years and 3 months from the date the LCD is retired, the LCD record shall be destroyed.  However, contractors shall not destroy the LCD record if it relates to a current investiga tion of litigation/negotiation; ongoing Workers Compensation set aside arrangements; or documents which prompt suspicions of fraud and abuse of items or services.  This will satisfy evidentiary needs and discovery obligations critical to the agencys liti gation interests.     Medicare Program Integrity Manual  Exhibits  Table of Contents  (Rev.  854, Issued: 01 -11-19)  Transmittals for Exhibits  1 -Definitions  2  Allowed Services for Prior Determinations  4 -Reliable Information  5 -Background Information for Contractor Staff When IRP is Questioned  5.1 -Reward Eligibility Notification Letter  5.2 -Reward Claim Form  5.3 -How to Use the IRP Tracking System  5.4 -Section I: Pending Case List Screen  5.5 -Section II: Pending Case List by Contractor Screen  5.6 -Section III: New Case  5.7 -Section IV: Closed Case List  5.8 -Section V: Closed Case List by Contractor
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5.9 -Section VI: Report Menu  7 -Sample Letter for On -Site Reviews  7.1 -Attachment to Letter for Provider Site Reviews  7.2  Sample Letter  Request for Medical Records  7.3  Part A Sample Letter Notifying the Provider of the Results, and Request Repayment of Overpayments  7.3.1  Attachment to the Part A Letter Notifying the Provider of the Results, and Request Repaymen t of Overpayments  7.4  Part B Sample Letter Notifying the Provider of the Results, and Request Repayment of Overpayments  7.4.1  Attachment to the Part B Letter Notifying the Provider of the Results, and  Request Repayment of Overpayments  8  Reserved for Future Use  9 -Projection Methodologies and Instructions for Reviews of Home Health Agencies for Claims Not Paid Under PPS  10 -Projection Methodologies and Instructions for Reviews of Skilled Nursing Facilities (SNFs) for Claims Not Paid Under PPS  11 -Projection Methodologies and Instructions for Reviews of Comprehensive Outpatient Rehabilitation Facilities (CORFS) for Claims Not Paid Under PPS  12 -Projection Methodologies and Instructions for Reviews of Community Mental Health Centers (CMHCs) for Claims Not Paid Under PPS  13 -Postpayment CMR Summary Report Format Example  13.1  Excluded Providers  14 -Contractor Denials 1862(a)(1) of the Act  14.1 - Section 1879 of the Act Determination - Limitation of Liability  14.2 - Section 1870 of the Act Deter mination - Waiver of Recovery of an Overpayment  14.3 - Section 1842(l) of the Act Determination - Refunds to Beneficiary  14.4  Effect of Sections 1879 and 1870 of the Social Security Act During Postpayment  Reviews  15 -Consent Settlement Documents  16 -Model Payment Suspension Letters   16.1 - OIG/OI Case Referral Fact Sheet Format
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16.1 - OIG/OI Case Referral Fact Sheet Format   16.2 - OIG/OI Case Summary Format  17  Signature Attestation Form (for missing or illegible signatures)  18  Corrective Action Reporting Formats  19  Reserved for Future Use  20  Reserved for Future Use  21 -Regional Home Health Intermediaries/Jurisdictions  22 -Office of Inspector General, Office of Investigations Field Offices  23 -PIM Acronyms  25  Procedures and Forms for Obtaining Protected Health Information  26 -DOJ Report (Excel Spreadsheet)  27 -National Medicare Fraud Alert  28 -Restricted Medicare Fraud Alert  29 -Reserved for Future Use  30 -Treatment Codes  31 -Form CMS -485, Home Health Certification and Plan of Care  32 -Harkin Grantee Winframe Database Access and Operation Instructions  33 -Harkin Grantee Model Form  34  Reserved for Future Use  35  Memorandum of Understanding (MOU) with Law Enforcement  36  Overview of the CERT Process  36.1  CERT Formats for A/B MAC (A) MACS and Shared Systems  36.2  CERT Formats for A/B MACs (B) and DME MACs and Shared Systems  37  Federal Agreement (Office of the Inspector General) for Release of Data with Individual Identifiers  38  Qualified Independent Contractor (QIC) Jurisdictions (as of March 2005)  39 -Carrier Record Requirements  40 -UPIN Carrier Record Layout  40.1 - Trailer Record Data Elements  41 -List of Medical School Codes  41.1 - List of Medical School in the U.S.  41.2 - Directory of Podiatric Medical Colleges  41.3 - American Optometric Association Council on Optometric Education  41.4 - List of Chiropractic Schools in the U.S.  42 -Sanction Codes  43 -Exhibit 5  Exhibit 44   JOA Appendices Exhibit  45  ZPIC Prepayment and Postpayment Notification Letter Exhibit  46 -Unified Postpayment ADR Sample Letters  46.1 - MAC Unified Postpayment ADR Sample Letter  46.2 - DME MAC Unified Postpayment ADR Sample Letter  46.3  Recovery Auditor Unified Postpayment ADR Sample Letter  46.4  CERT Unified Postpayment  ADR Sample Letter   46.5  SMRC Unified Postpayment ADR Sample Letter Exhibit  47  Program Integrity Unit Contacts within the State Medicaid Agency
Article - Billing and Coding: 4Kscore Test Algorithm (A56287)
CMS National Coverage PolicyN/AArticle TextThis First Coast Billing and Coding Article for Local Coverage Determination (LCD) L37798 4Kscore Test Algorithm provides billing and coding guidance for diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in the LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.Refer to the LCD for reasonable and necessary requirements and limitations.The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in the LCD.Coding GuidelinesNotice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.Documentation RequirementsAll documentation must be maintained in the patient's medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.Documentation of shared decision making (SDM)), concerning the 4Kscore testing, between the ordering provider and patient must be present in the medical record and a copy of same shall be provided to the performing laboratory prior tothe test being performed.A simple notation that SDM occurred is insufficient for documentation. The actual process must be documented in the patients record.The document(s) shall be dated and include the orderingproviderand patients names and signatures legibly noted to attest that the SDM occurred.Utilization GuidelinesIn accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.Compliance with the provisions in LCD L37798, 4Kscore Test Algorithm may be monitored and addressed through post payment data analysis and subsequent medical review audits.