Medicare Coverage of Colony Stimulating Factors

on Monday, 10 July 2017. All News Items | Medicare Coverage

Fighting the War against Disease

You may have noticed a phrase on some of our recent articles – “the right care, at the right time, at the right cost, and in the right setting.” This is more than just a catchy slogan – it has real meaning in the world of healthcare.  Imagine yourself or a loved one is the patient – wouldn’t you want the right care at the right time and so on?  Of course you would.  A lot of the bureaucracy of Medicare that can be so frustrating for providers is simply an attempt to ensure the goal of effective medical care in a timely manner and for a reasonable cost.

Effective medical care and maintaining a healthy body can be a war.  For example, sometimes cancer may attack our bodies and medical treatments may attack the cancer back with the use of chemotherapy drugs or radiation therapy. But the very drugs and treatments we use to help our health may also have negative side effects. The cytotoxic properties of certain chemotherapy drugs or radiation treatments often cause neutropenia which compromises a person’s ability to fight infection.  This requires another line of defense with colony stimulating factors (CSFs) that enhance the recovery of blood related functions in neutropenia. The researchers, who study and plan the battles to preserve our health, develop treatment protocols so that the right drugs are given at the right time for the right conditions.  Medicare and their administrative contractors (MACs) have coverage policies to enforce the correct and appropriate use of CSFs, both to ensure optimal outcomes for Medicare beneficiaries and to protect the Medicare trust fund from unnecessary spending for ineffective treatments.

This month Palmetto GBA released a new LCD for White Cell Colony Stimulating Factors.  This policy replaces a previous Palmetto LCD that was retired in 2016.  A number of other MACs also have policies for all or some of the CSFs – see the table below.

Policy #Policy TitleMAC
L34254 Drugs and Biologicals: Colony Stimulating Factors Cahaba Government Benefit Administrators®, LLC
A54826 Neulasta® (pegfilgrastim) CGS Administrators, LLC
L34002 G-CSF ( Neupogen®, Granix™,Zarxio™ ) First Coast Service Options, Inc.
L33747 Pegfilgrastim (Neulasta®) First Coast Service Options, Inc.
L33394 Drugs and Biologicals, Coverage of, for Label and Off-Label Uses National Government Services, Inc.
A52408 Filgrastim, Pegfilgrastim, Tbo-filgrastim, Filgrastim-sndz (e.g., Neupogen®, Neulasta ™, Granix ™ Zarxio™) - Related to LCD L33394 National Government Services, Inc.
A54682 Neulasta® (pegfilgrastim) Onpro® Kit (On-body Injector) Palmetto GBA
L37176 White Cell Colony Stimulating Factors Palmetto GBA
L34699 Human Granulocyte/Macrophage Colony Stimulating Factors Wisconsin Physicians Service Insurance Corporation

These policies should be read carefully as there are several different drugs, the coverage indications are not the same for all these drugs, and the indications can be quite detailed.  The drugs and their primary FDA indications are:

G-CSF Pegfilgrastim (Neulasta®)

  • Chemotherapy or radiation myelosuppression

G-CSF tob-filgrastim (Granix®)

  • Myelosuppresive chemotherapy

G-CSF filgrastim (Neupogen®) and biosimilar G-CSF filgrastim-sndz (Zarxio®)

  • Chemotherapy or radiation myelosuppression
  • Acute myeloid leukemia (AML) with induction/consolidation chemo
  • Bone marrow transplant for cancer
  • Autologous blood progenitor cell collection and therapy
  • Severe chronic neutropenia

GM-CSF sargramostim (Leukine®)

  • AML induction chemo
  • Autologous blood progenitor cell mobilization and transplant
  • Myeloid reconstitution after allogeneic bone marrow transplant
  • Bone marrow transplant failure or engraftment delay

The policy also lists a number of off-label indications that are covered such as certain circumstances involving some acute leukemias, hairy cell leukemia, myelodysplastic syndromes, dose dense chemotherapy, other causes of neutropenia, and post stem cell transplants.

Palmetto and National Government Services JK MAC have both conducted pre-pay reviews of the Pegfilgrastim Injection, HCPCS code J2505.  These reviews have resulted in denials due to the following reasons:

  • Lack of medication administration record with drug name, dosage, frequency of injection, site, route and date/time of administration;
  • Lack of documentation to support medical necessity of services such as medical history, physician progress notes, pertinent diagnostic tests/procedures, or treatment plan/plan of care;
  • Missing physician/practitioner’s signed order; and
  • The recommended protocol was not ordered and/or followed.

Providers need to follow Medicare’s coverage policy requirements and include the necessary documentation in order to receive appropriate Medicare payments for the services they provide to fight the war against cancer, other diseases, and the complications of treatments.

Other MAC coverage policies that are new, retired or drafts since last month are listed below:

Cahaba JJ

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
ID Title Comment Start Date Comment End Date Final   Status
DL37328  Medicine: Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depressive Disorder  7/1/2017 8/14/2017 No   Draft
DL37334  Medicine: Somatosensory Testing  7/1/2017 8/14/2017 No   Draft
DL37332  Medicine: Visual Electrophysiology Testing  7/1/2017 8/14/2017 No   Draft



IDTitleComment Start DateComment End DateFinalStatus
DL37366  MolDX: Guardant360® Plasma-Based Comprehensive Genomic Profiling in Non-Small Cell Lung Cancer (NSCLC)  6/21/2017 8/4/2017 No Draft


First Coast JN

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L34001  Vinorelbine Tartrate (Navelbine®)  10/1/201510/1/2016 6/13/2017 6/13/2017 Retired 
L33705   Ocular Photodynamic Therapy (OPT) with Verteporfin  10/1/201510/1/2016 6/13/2017 6/13/2017 Retired 
A55582  Eclipse system for the treatment of fecal incontinence in adult women clarification regarding the device technology and correct billing  6/22/2017N/A N/A 6/2/2017 New


NGS J6 and JK

No updates this month


Noridian JE

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
A55548  Sleep Lab Credentialing: Polysomnography and Other Sleep Studies  6/5/2017 N/A N/A 6/12/2017 New


Noridian JF

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
A55549  Sleep Lab Credentialing: Polysomnography and Other Sleep Studies  6/5/2017 N/A N/A 6/12/2017  


Novitas JH and JL

No updates this month


Palmetto JM

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37176  White Cell Colony Stimulating Factors  6/12/2017 N/A  N/A  4/19/2017 New


WPS J5 and J8

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
A55532  MolDX: CYP2C9 and/or VKORC1 Gene Testing for Warfarin Response Coding and Billing Guidelines  7/17/2017 N/A N/A 5/15/2017 New

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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