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CMS Manual System  Department of Health & Human Services (DHHS)  Pub 100 -08 Medicare Program Integrity  Centers for Medicare & Medicaid Services (CMS)  Transmittal  854 Date: January 11, 2019   Change Request 10901   Transmittal 829, dated October 3, 2018, is being rescinded and replaced by Tr ansmittal 854 , dated January 11, 2019, to update 3 business requirements (BR) and their related chapter 13 manual instructions.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, including 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 repl ace 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)   I. SUMMARY OF CHANGES: The purpose of this Change Request (CR) is to notify the Medicare Administrative Contractors (MACs) that, in accordance with section 4009 of H.R. 34- 21st Century Cures Act (Public Law 114- 255), this manual is being updated with detailed changes to the LCD process.  EFFECTIVE DATE: September 26, 2018  *Unless otherwise specified, the effective date is the date of service.  IMPLEMENTATION DATE: January 8, 2019 -  unless otherwise specified.   Disclaimer for manual ch anges only: The revision date and transmittal number apply only to red italicized material. Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised informat ion only, and not the entire table of contents.   II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is not updated)  R=REVISED, N=NEW, D=DELETED- Only One Per Row.   R/N/D  CHAPTER / SECTION / SUBSECTION / TITLE  R Chapter 13/Table of Contents  R 13/13.1/Glossary of Acronyyms  R 13/13.1/13.1.2/LCD Definition and Statutory Authority for LCDs  N 13/13.2/LCD Process  N 13/13.2/13.2.1/General LCD Process Overview  N 13/13.2/13.2.2/Requests  N 13/13.2/13.2.2.1/Informal Meetings  N 13/13.2/13.2.2.2/New LCD Requests  N 13/13.2/13.2.2.3/New LCD Request Requirements  N 13/13.2/13.2.4/Proposed LCD  N 13/13.2/13.2.4.1/Proposed Decision and Posting of LCD Summary Sheet  N 13/13.2/13.2.4.2/Public Comment  N 13/13.2/13.2.4.3/Contractor Advisory Committee (CAC)  N 13/13.2/13.2.4.4/Open Meeting  N 13/13.2/13.2.5/Final Determination  N 13/13.2/13.2.5.1/Response to Public Comment  N 13/13.2/13.2.6/Notice Period  R 13/13.3 /LCD Reconsideration Request  N 13/13.3/13.3.1/Web site Requirements for the LCD Reconsideration  Process  N 13/13.3/13.3.2/Valid LCD Reconsideration Request Requirements  N 13/13.3/13.3.3/Process Requirements  R 13/13.4/Challenge of an LCD  R 13/13.5 /LCD Content  R 13/13.5/13.5.1 /General Requirements  R 13/13.5/13.5.2/Consultation  N 13/13.5/13.5.2.1/Consultation Summary  N 13/13.5/13.5.2.2/CAC Recommendations  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   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    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.   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     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.