CMS Revises LCD Process

on Tuesday, 09 October 2018. All News Items | Medicare Coverage

Your Turn for Action

The second week of each month the Wednesday@One newsletter provides updates on new, retired, and draft Local Coverage Determinations (LCDs) from the Medicare Administrative Contractors (MACs). LCDs are determinations by a MAC as to whether or not a particular item or service is covered (reasonable and necessary) on a contractor-wide basis. Medicare contractors develop LCDs when there is no National Coverage Determination (NCD) or when there is a need to further define an NCD. LCDs contain only reasonable and necessary conditions of coverage. MACs publish other information such as coding and payment guidelines in a related complementary article.

Local coverage policies, currently known as LCDs and their predecessor LMRPs (local medical review policies) have been around for years and CMS provided guidelines for LCD development in Chapter 13 of the Medicare Program Integrity Manual. However, stakeholders expressed to CMS concerns about lack of local coverage process transparency, specifically

  • Notification to stakeholders of proposed revisions to, and drafting of, new LCDs;
  • Ineffective MAC processes for soliciting from, and providing to, stakeholders feedback on information provided during open public meetings;
  • A lack of non-physician representation on Contractor Advisory Committees (CACs); and
  • CAC meetings not being open to the public.

In response to these concerns, CMS is revising the LCD process and updating the Medicare Program Integrity Manual instructions. Per the MLN Matters Article MM10901 that details these revisions, “these changes will help to increase transparency, clarity, consistency, reduce provider burden and enhance public relations while retaining the ability to be responsive to local clinical and coverage policy concerns.” The revised manual instructions provide a roadmap to the steps of the LCD process and enable stakeholders to effectively engage in the process.

The LCD process can begin with informal meetings to discuss potential LCD requests although this is not required. LCDs may start with a formal request through the New LCD Request Process. Requests may be made by beneficiaries, healthcare providers/professionals, or other interested parties receiving care or doing business in the MAC jurisdiction. The LCD request must:

  • Be in writing and sent via email, fax, or letter;
  • Identify the Medicare benefit category;
  • State the language the requestor wants in the LCD;
  • Include a justification supported by peer-reviewed evidence;
  • Address relevance, usefulness, and medical benefits/outcomes of the item/service; and
  • Explain the design, purpose, and/or method of using the item/service.

MACs have 60 days to determine if the request is complete or not. If it is, they proceed with the LCD process; if not, they will notify the requestor in writing as to why the request was incomplete.

MACs will consider the information provided in the request along with clinical guidelines, consensus documents, and opinions of healthcare experts, medical associations, and healthcare professionals to form their proposed determination. A summary of the information considered will be included in the draft LCD. Once a draft LCD is published, the MAC will hold meetings to discuss the LCD and accept public comments for at least 45 days.

One meeting is with the Contractor Advisory Committee (CAC) – a group of healthcare professionals, beneficiary representatives, and representatives of medical organizations that supplements the MAC’s internal expertise. Each state in a jurisdiction will be represented and CAC meetings will be open to the public. Per the MLN article, “The CAC’s purpose 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 MACs and the healthcare community. The CAC is advisory in nature, with the final decision on all issues resting with MACs.”

There will also be Open Meetings to discuss the evidence and rationale of the proposed LCDs. MACs must notify the public about the dates and location for the open meetings. Interested stakeholders, such as providers, physicians, vendors, manufacturers, beneficiaries, caregivers, etc. can present information at these meetings. After the required meetings and the end of the comment period, the MAC will publish a final LCD. An accompanying “Response to Comment” article that addresses the MAC’s response to all comments received will be published on the same day as the final LCD and will remain publicly available indefinitely.  There will be at least a 45-day Notice Period beginning when the LCD is published. The LCD will not become active until the end of the Notice Period.

There is also a Reconsideration Process available where beneficiaries, providers, or interested parties may request revisions to final effective LCDs. Two other significant changes to the LCD process are:

  • MACs must finalize or retire draft LCDs within one calendar year of their publication on the Medicare coverage database (MCD).
  • CPT procedure and ICD-10 diagnosis codes will no longer appear in LCDs. They will be included in billing and coding articles that are linked to the LCD.

Those are the facts but here are some of my thoughts. I appreciate that CMS has taken steps to make this process more transparent and inclusive of all stakeholders. However, that now puts the onus on the stakeholders to actually do something! Request an LCD if you know of a service that needs one, look for and read draft LCDs, provide comments, attend the open meetings and give input, etc. Many years ago, when I worked in hospital compliance, my area contractor held meetings to discuss proposed Part A LCDs. A few topics (rehabilitative therapy for example) garnered a large engaged audience, but most meetings were attended by only a sparse few with even fewer, if any, comments. CMS has done their part to make the process better, now it is time for providers to step up, take action, and be involved.

LCD updates since last month are listed in the table below:

 

Palmetto JJ and JM Coverage Updates

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37761  Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor  9/24/2018 N/A  N/A  7/31/2018 New
L37779  Intraoperative Radiation Therapy  9/24/2018 9/24/2018 N/A  8/17/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL34454  Colonoscopy/Sigmoidoscopy/Proctosigmoidoscopy  10/1/2018 11/15/2018 No  Draft
DL37826  Lumbar Artificial Disc Replacement  10/1/2018 11/15/2018 No  Draft
DL37848  Lumbar Spinal Fusion  10/1/2018 11/15/2018 No  Draft
DL37857  MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test  10/1/2018 11/15/2018 No  Draft
DL37870  MolDX: Inivata, InVisionFirst, Liquid Biopsy for Patients with Lung Cancer  10/1/2018 11/15/2018 No  Draft
DL37859  MolDX: myPath Melanoma Assay  10/1/2018 11/15/2018 No  Draft
DL37865  MolDX: NeuroIDgenetix® Test for Depression  10/1/2018 11/15/2018 No  Draft
DL37853  Non-Invasive Peripheral Venous Vascular and Hemodialysis Access Studies  10/1/2018 11/15/2018 No  Draft
DL37873  Topical Oxygen Therapy  10/1/2018 11/15/2018 No  Draft
DL37863  Voretigene Neparvovec-rzyl (Luxturna™)  10/1/2018 11/15/2018 No  Draft

CGS J15

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37790  Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor  10/1/2018 N/A  N/A  8/9/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL37832  MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test  11/15/2018 12/29/2018 No  Draft
DL37834  MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease  11/15/2018 12/29/2018 No  Draft
DL37905  MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test  11/15/2018 12/29/2018 No  Draft
DL37903  MolDX: Inivata, InVisionFirst, Liquid Biopsy for Patients with Lung Cancer  11/15/2018 12/29/2018 No  Draft
DL37907  MolDX: myPath Melanoma Assay  11/15/2018 12/29/2018 No  Draft
DL37909  MolDX: NeuroIDgenetix® Test for Depression  11/15/2018 12/29/2018 No  Draft
DL37836  MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC)  11/15/2018 12/29/2018 No  Draft

First Coast JN

IDTitleComment Start DateComment End DateFinalStatus
DL37943  Anorectal Manometry and Electromyography (EMG) of the Urinary and Anal Sphincters  9/27/2018 11/11/2018 No Draft

National Government Services J6 and JK

IDTitleComment Start DateComment End DateFinalStatus
DL37851  Biomarker Testing for Neuroendocrine Tumors/Neoplasms  10/17/2018 11/30/2018 No Draft
DL37810  Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasm  10/17/2018 11/30/2018 No Draft
DL37929  Transvenous Phrenic Nerve Stimulation in the Treatment of Central Sleep Apnea  10/17/2018 11/30/2018 No Draft

Noridian JE

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37628  In Vitro Chemosensitivity & Chemoresistance Assays  10/1/2018 N/A  N/A  8/10/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL37822  MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test  10/4/2018 12/14/2018 No  Draft
DL37818  MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease  10/4/2018 12/14/2018 No  Draft
DL37887  MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test  10/4/2018 12/14/2018 No  Draft
DL36370  MolDX: Genetic Testing for Lynch Syndrome  10/4/2018 12/14/2018 No  Draft
DL37897  MolDX: Inivata, InVisionFirst, Liquid Biopsy for Patients with Lung Cancer  10/4/2018 12/14/2018 No  Draft
DL37879  MolDX: myPath Melanoma Assay  10/4/2018 12/14/2018 No  Draft
DL37875  MolDX: NeuroIDgenetix® Test for Depression  10/4/2018 12/14/2018 No  Draft

Noridian JF

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37630  In Vitro Chemosensitivity & Chemoresistance Assays  10/1/2018 N/A  N/A  8/10/2018 Active
IDTitleComment Start DateComment End DateFinal Status
DL37824  MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test  10/4/2018 12/14/2018 No  Draft
DL37820  MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease  10/4/2018 12/14/2018 No  Draft
DL37891  MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test  10/4/2018 12/14/2018 No  Draft
DL36374  MolDX: Genetic Testing for Lynch Syndrome  10/4/2018 12/14/2018 No  Draft
DL37899  MolDX: Inivata, InVisionFirst, Liquid Biopsy for Patients with Lung Cancer  10/4/2018 12/14/2018 No  Draft
DL37881  MolDX: myPath Melanoma Assay  10/4/2018 12/14/2018 No  Draft
DL37877  MolDX: NeuroIDgenetix® Test for Depression  10/4/2018 12/14/2018 No  Draft

Novitas JH and JL

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37682  Nusinersen (Spinraza)  9/14/2018 N/A  N/A  7/20/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL37893  Endovenous Stenting  9/20/2018 11/8/2018 No  Draft
DL35427  Hyaluronan Acid Therapies for Osteoarthritis of the Knee  9/20/2018 11/8/2018 No  Draft

WPS J5 and J8

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37665 MolDX: AlloSure Donor-Derived Cell-Free DNA Test 8/16/2018 N/A N/A 6/18/2018 New
L37663 MolDX: EndoPredict® Breast Cancer Gene Expression Test 8/16/2018 N/A N/A 6/18/2018 New
L37667 MolDX: Oncotype DX® Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer 8/16/2018 9/1/2018 N/A 8/21/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL37913  MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test  10/8/2018 11/23/2018 No  Draft
DL37917  MolDX: clonoSEQ® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies  10/8/2018 11/23/2018 No  Draft
DL37911  MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease  10/8/2018 11/23/2018 No  Draft
DL37919  MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test  10/8/2018 11/23/2018 No  Draft
DL37921  MolDX: Inivata, InVisionFirst, Liquid Biopsy for Patients with Lung Cancer  10/8/2018 11/23/2018 No  Draft
DL37923  MolDX: myPath Melanoma Assay  10/8/2018 11/23/2018 No  Draft
DL37915  MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC)  10/8/2018 11/23/2018 No  Draft

 

Article by Debbie Rubio

Debbie Rubio, BS, MT (ASCP), is the Manager of Regulatory Affairs and Compliance at Medical Management Plus, Inc. Debbie has over twenty-seven years of experience in healthcare including nine years as the Clinical Compliance Coordinator at a large multi-facility health system. In her current position, Debbie monitors, interprets and communicates current and upcoming regulatory and compliance issues as they relate to specific entities concerning Medicare and other payers. You may contact Debbie at This email address is being protected from spambots. You need JavaScript enabled to view it..

This material was compiled to share information. MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.

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