New Medicare Coverage with Evidence Development Decision Memos

on Tuesday, 12 March 2019. All News Items | Medicare Coverage

A Balancing Act

It is important to maintain balance in life, for example, people need to balance their job responsibilities with their family and personal lives. In healthcare, it is important to balance the risks of new innovations against their efficacy and safety. Medicare has detailed processes for evaluating and approving coverage of new items and services through the National Coverage Determination (NCD) process. A final NCD describes the covered indications and any contraindications for a particular item or service. Even using the NCD process, Medicare sometimes determines there is not yet enough evidence available to make a coverage decision. In these situations, Medicare must balance offering the new technology to those in need, while being careful not to cover services that may not be effective or safe enough for the benefits to outweigh the risks. They have another process for these scenarios – coverage with evidence development (CED).

According to a Medicare document, “Coverage with Evidence Development (CED) allows coverage of certain items or services where additional data gathered in the context of clinical care would further clarify the impact of these items and services on the health of Medicare beneficiaries. Medicare coverage may be extended to patients enrolled in a clinical research study. CED allows Medicare to provide coverage for an item or service because it is provided within a research setting where there are added safety, patient protections, monitoring, and clinical expertise. CED projects provide the necessary new evidence to influence clinical practice and help Medicare beneficiaries and providers make more informed diagnostic and therapeutic decisions.”

In mid-February, CMS released one final and one proposed decision memo allowing coverage with evidence development for two services.

Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD):

The final decision memo allows coverage of “FDA approved vagus nerve stimulation (VNS) devices for treatment resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in a CMS approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year with the possibility of extending the study to a prospective longitudinal study when the CMS approved, double-blind, randomized placebo-controlled trial has completed enrollment, and there are positive interim findings.” The studies must be approved by CMS and must address whether VNS improves health outcomes for TRD patients compared to a control group. The policy delineates specific research questions, patient criteria and contraindications for trial participation.

Chimeric Antigen Receptor (CAR) T-cell Therapy:

CMS proposes to cover autologous treatment with T-cells expressing at least one chimeric antigen receptor (CAR) through coverage with evidence development (CED)

  • when prescribed by the treating oncologist,
  • performed in a hospital,
  • for patients who have relapsed or refractory cancer and have not currently been experiencing any comorbidity that would otherwise preclude patient benefit, and
  • when certain hospital and treatment criteria are met.

CAR T-cell therapy is a new form of cancer therapy that uses a patient’s own immune system to fight the disease. It is the first FDA-approved gene therapy. According to the CMS announcement, “The proposed National Coverage Determination would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment. Evidence from the registries and studies would help CMS identify the types of patients that benefit from CAR T-cell therapy, informing a future decision by the agency regarding the types of cases in which Medicare would cover the treatment with no registry or trial requirement.”

Both of these decision memos will improve access to treatment options and maintain patient safety while deepening CMS’s understanding of how patients in Medicare respond. This will allow CMS to ensure that it is paying for treatments in which the benefits outweigh the risks.

Coverage updates over the last month from local Medicare Administrative Contractors are listed below. Notice that 9 of the 12 MACs have released a coverage article on Coding and Billing for Implantable Automatic Defibrillators (ICDs). 

 

Palmetto JJ and JM Coverage Updates

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
A56343  Implantable Automatic Defibrillators – Coding and Billing  3/26/2019 3/26/2019 N/A 2/15/2019 New

CGS J15 Coverage Updates

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
A56159  Coding for Hemodialysis Sessions  4/1/2019 N/A N/A 1/31/2019 New
IDTitleComment Start DateComment End DateFinal Status
DL38016  MolDX: DecisionDx-Melanoma  2/13/2019 3/29/2019 NRTF  N/A    Draft

First Coast JN

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37564  Frequency of Hemodialysis  2/25/2019 N/A  N/A  1/4/2019 New
L33970   Frequency of Hemodialysis Services  10/1/2015 10/1/2017 3/1/2019 3/1/2019 Retired 
A56341  Implantable Automatic Defibrillators – Coding and Billing  3/26/2019 N/A N/A 2/15/2019 New
A56287  Billing and Coding Article: Noncovered Service - 4Kscore Test Algorithm  3/18/2019 N/A N/A 1/24/2019 New
A56262  Coding for Hemodialysis Sessions  2/25/2019 N/A N/A 1/4/2019 New

National Government Services J6 and JK

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37475  Frequency of Hemodialysis  3/1/2019 N/A  N/A  12/28/2018 New
A56326  Implantable Automatic Defibrillators – Coding and Billing  3/26/2019 N/A N/A 2/16/2019 New
A55672  Coding for Hemodialysis Sessions  3/1/2019 N/A N/A 12/28/2018 New
IDTitleComment Start DateComment End DateFinal Status
DL38014  Corneal Hysteresis  2/27/2019 4/13/2019 NRTF  N/A   Draft

Noridian JE

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37746  MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC)  3/2/2019 N/A  N/A  1/3/2019 New
L37502  Frequency of Hemodialysis  2/18/2019 3/1/2019 N/A  2/1/2019 New
A56340  Implantable Automatic Defibrillators – Coding and Billing  3/26/2019 N/A N/A 2/14/2019 New
A56322  MolDX: Clonoseq® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies  3/4/2019 N/A N/A 2/21/2019 New
A55675  Coding for Hemodialysis Sessions  2/18/2019 3/1/2019 N/A 2/1/2019 New

Noridian JF

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37744  MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC)  3/2/2019 N/A  N/A  1/3/2019 New
L37504  Frequency of Hemodialysis  2/18/2019 3/1/2019 N/A  2/1/2019 New
A56342  Implantable Automatic Defibrillators – Coding and Billing  3/26/2019 N/A N/A 2/14/2019 New
A56323  MolDX: Clonoseq® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies  3/4/2019 N/A N/A 2/21/2019 New
A55676  Coding for Hemodialysis Sessions  2/18/2019 3/1/2019 N/A 2/1/2019 New

Novitas JH and JL

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
A56355  Billing and Coding Article: Implantable Automatic Defibrillators  3/26/2019 N/A N/A 2/22/2019 New
A56281  Coding for 4Kscore Test Algorithm  3/21/2019 N/A N/A 1/25/2019 New
A56268  Coding Article for Sclerotherapy and Endovenous Non-Thermal Treatment of Varicose Veins  3/21/2019 N/A N/A 1/25/2019 New

WPS J5 and J8

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37537  Frequency of Hemodialysis  3/1/2019 N/A  N/A  12/27/2018 New
L37766  MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs)  2/16/2019 N/A  N/A  12/18/2018 New
L37915  MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC)  2/16/2019 N/A  N/A  12/18/2018 New
L37193  Coenzyme Q10 Testing  10/17/2017 9/1/2018 3/1/2019 3/1/2019 Retired 
L36404  Foot Care  2/16/2016 2/15/2019 2/15/2019 2/15/2019 Retired 
A56334  MolDX: Oncotype DX® Genomic Prostate Score Coding and Billing Article  4/15/2019 N/A N/A 2/19/2019 New
A56335  Coding Article for MolDX: Breast Cancer Index™ (BCI) Gene Expression Test LCD L37913  4/15/2019 N/A N/A 2/19/2019 New
A56333  Coding article for MolDX: Inivata, InVisionFirst, Liquid Biopsy for Patients with Lung Cancer LCD L37921  4/15/2019 N/A N/A 2/19/2019 New
A56332  MolDX: Bladder Tumor Marker FISH Billing and Coding Guidelines Update  4/15/2019 N/A N/A 2/19/2019 New
A56331  Posterior Tibial Nerve Stimulation (PTNS) Billing & Coding Guidelines  4/15/2019 N/A N/A 2/18/2019 New
A56277  MolDX: clonoSEQ® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies  3/19/2019 3/19/2019 N/A 2/19/2019 New
A56274  Human Granulocyte/Macrophage Colony Stimulating Factors Billing and Coding Guidelines  3/19/2019 N/A N/A 1/24/2019 New
A56232  Billing and Coding Guidelines for Foot Care  2/16/2019 2/16/2019 N/A 1/22/2019 New
IDTitleComment Start DateComment End DateFinal Status
DL38018  MolDX: DecisionDX-Melanoma  2/21/2019 4/7/2019 NRTF  N/A   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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