Medicare Coverage of Colony Stimulating Factors
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 Title||MAC|
|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:
Article by Debbie Rubio
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.