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 
 
  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 contractorwide 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.    
  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 
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 MACs 
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.   
 
 
  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 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. 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. 
  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 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. 863; Issued: 02-12-19; Effective: 10-03-18; 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. 863; Issued: 02-12-19; Effective: 10-03-18; 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. 863; Issued: 02-12-19; Effective: 10-03-18; 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 
informed 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 discussion with careful framing of 
recommendations and clear identification of the basis of those recommendations.  
 
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 scientific, 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 related 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. 863; Issued: 02-12-19; Effective: 10-03-18; 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 attendance, 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 of 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 announce this information or may use other 
education methods to inform the public.  The listserv or other method should 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. 
 
13.2.5 - Final Determination 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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.   
 
13.2.5.1 - Response to Public Comments 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) 
 
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 period.  The RTC Article will remain publicly available 
indefinitely on the MCD or the MCD Archive. 
 
   
 
 
13.2.6 - Notice Period 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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 after the notice 
period began.   
 
 
13.3 - LCD Reconsideration Process 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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 provision of the LCD 
may be reconsidered.  In addition, MACs have the discretion to revise or retire their LCDs at 
any time on their own initiative. 
 
13.3.1 - Web site Requirements for the LCD Reconsideration Process 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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, including postal, e-mail, and 
fax addresses where requests may be submitted. 
 
13.3.2 - Valid LCD Reconsideration Request Requirements 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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. 
 
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. 
 
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 valid requests if 
similar requests are received. 
 
13.3.3 - Process Requirements 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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 applicable, 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. 863; Issued: 02-12-19; Effective: 10-03-18; 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. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) 
 
13.5.1 - General Requirements 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) 
 
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, 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) 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 instructions on the date upon which this change will be 
effective.  
 
13.5.2 - Consultation 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19) 
 
13.5.2.1 - Consultation Summary 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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. 863; Issued: 02-12-19; Effective: 10-03-18; 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 consultation as part of the LCD process. 
 
13.5.3 - Evidentiary Content 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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.   
  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, 
systematic 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 led to the LCD in the Bibliography.  The citations 
shall be consistent with the American Medical Association (AMA) Manual of Style.  
  
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. 
 
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 the 
proposed LCD.   
 
13.5.4  Reasonable and Necessary Provisions in LCDs 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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;  
 
  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 considered appropriate for the 
item or service, in terms of whether it is:  
 
  Furnished in accordance with accepted standards of medical practice for the 
o
diagnosis or treatment of the patient's condition or to improve the function of a 
malformed body member;  
 
  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 
o
alternative.  
 
13.5.5 - Public Comment 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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. 863; Issued: 02-12-19; Effective: 10-03-18; 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.  
 
13.6 - LCD Record 
(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; 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 
investigation 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 litigation interests.   
 
Transmittals Issued for this Chapter 
 
Impl Date  CR# 
Rev #  Issue Date  Subject 
R863PI  02/12/2019  Local Coverage Determinations (LCDs)  01/08/2019  10901 
R857PI  01/30/2019  Local Coverage Determinations (LCDs)  01/08/2019  10901 
R854PI  01/11/2019  Local Coverage Determinations (LCDs)  01/08/2019  10901 
R829PI  10/03/2018  Local Coverage Determinations (LCDs)  01/08/2019  10901 
R608PI  08/14/2015  Update to Pub. 100-08 to Provide Language-Only 09/14/2015  8747 
Changes for Updating ICD-10 and ASC X12 
R510PI  04/11/2014  Clarification to Pub. 100-02, Medicare Benefit  05/12/2014  8665 
Policy Manual Regarding Antigens and Deletion 
of Section 13.14 from Chapter 13 of Pub. 100-08, 
Medicare Program Integrity Manual 
R473PI  06/21/2013  Update to Pub. 100-08, Program Integrity  01/15/2013  7829 
Manual, Chapter 13 
R443PI  12/14/2012  Update to Pub. 100-08, Program Integrity  01/15/2013  7829 
Manual, Chapter 13  Rescinded and replaced by 
Transmittal 473 
R253PI  04/25/2008  Local Coverage Determinations (LCDs)  05/27/2008  5953 
Responsibility Transition From Durable Medical 
Equipment (DME) Program Safeguard Contractor 
(PSC) to DME Medicare Administrative 
Contractors (MAC) 
R186PI  01/26/2007  Durable Medical Equipment Medicare  02/26/2007  5410 
Administrative Contractors (DME MACs) 
Adoption or Rejection of Local Coverage 
Determinations (LCDs) Recommended by 
Durable Medical Equipment Program Safeguard 
Contractors (DME PSCs) 
R174PI  11/17/2006  Transition of Medical Review Educational  10/06/2006  5275 
Activities 
R170PI  11/03/2006  Transition of Medical Review Educational  10/06/2006  5275 
Activities  Replaced by Transmittal 174 
R165PI  10/06/2006  Durable Medical Equipment Medicare  10/26/2006  5301 
Administrative Contractors (DME MACs) 
Adoption or Rejection of Local Coverage 
Determinations (LCDs) Recommended by 
Durable Medical Equipment Program Safeguard 
Contractors (DME PSCs) 
R163PI  09/29/2006  Transition of Medical Review Educational  10/06/2006  5275 
Activities  Replaced by Transmittal 170  Impl Date  CR# 
Rev #  Issue Date  Subject 
R147PI  05/19/2006  Evaluation of LCD Topics for NCD  06/19/2006  4233 
Consideration 
R099PI  01/21/2005  Waivers Approved by the Regional Office (RO)  02/22/2005  3646 
by Replacing Regional Office with Central office 
(CO) 
R071PI  04/09/2004  Rewrite of Program Integrity Manual (except  05/10/2004  3030 
Chapter 10) to Apply to PSCs 
R063PI  01/23/2004  Conversion from LMRP to LCD  02/23/2004  3010 
R044PI  07/25/2003  Replacing Contractor MR Web Sites with  10/01/2003  2592 
Medicare Coverage Database 
R038PI  02/03/2003  Articles is deleted  02/14/2003  2120 
R034PI  11/22/2002  LMRP Reconsideration  N/A  2435 
R028PIM 07/10/2002  LMRP Reconsideration  10/01/2002  2196 
R027PIM 07/02/2002  Contractor Review of LMRPs  10/01/2002  2141 
R024PIM 04/05/2002  Moves the LMRP and related sections from Chap  10/01/2002  2061 
1 and to Chap 13 
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