FUTURE LCD Reference Article Response To Comments Article

Response to Comments: Erythropoiesis Stimulating Agents

A60417

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
National Government Services, Inc.	MAC - Part A	06101 - MAC A	J - 06	Illinois
National Government Services, Inc.	MAC - Part B	06102 - MAC B	J - 06	Illinois
National Government Services, Inc.	MAC - Part A	06201 - MAC A	J - 06	Minnesota
National Government Services, Inc.	MAC - Part B	06202 - MAC B	J - 06	Minnesota
National Government Services, Inc.	MAC - Part A	06301 - MAC A	J - 06	Wisconsin
National Government Services, Inc.	MAC - Part B	06302 - MAC B	J - 06	Wisconsin
National Government Services, Inc.	A and B and HHH MAC	13101 - MAC A	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13102 - MAC B	J - K	Connecticut
National Government Services, Inc.	A and B and HHH MAC	13201 - MAC A	J - K	New York - Entire State
National Government Services, Inc.	A and B and HHH MAC	13202 - MAC B	J - K	New York - Downstate
National Government Services, Inc.	A and B and HHH MAC	13282 - MAC B	J - K	New York - Upstate
National Government Services, Inc.	A and B and HHH MAC	13292 - MAC B	J - K	New York - Queens
National Government Services, Inc.	A and B and HHH MAC	14111 - MAC A	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14112 - MAC B	J - K	Maine
National Government Services, Inc.	A and B and HHH MAC	14211 - MAC A	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14212 - MAC B	J - K	Massachusetts
National Government Services, Inc.	A and B and HHH MAC	14311 - MAC A	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14312 - MAC B	J - K	New Hampshire
National Government Services, Inc.	A and B and HHH MAC	14412 - MAC B	J - K	Rhode Island
National Government Services, Inc.	A and B and HHH MAC	14511 - MAC A	J - K	Vermont
National Government Services, Inc.	A and B and HHH MAC	14512 - MAC B	J - K	Vermont

Article Information

General Information

Article ID
A60417

Article Title
Response to Comments: Erythropoiesis Stimulating Agents

Article Type
Response to Comments

Original Effective Date
07/15/2026

Retirement Date
N/A

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Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Erythropoiesis Stimulating Agents LCD. The official notice period for the final LCD begins on May 28, 2026, and the final determination will become effective on July 15, 2026.

Response To Comments

Number	Comment	Response
1	The commenter emphasizes that clinical decision-making should remain individualized. They note that a single billing policy cannot fully account for the wide range of patient-specific clinical scenarios, particularly in the management of ESRD patients on dialysis.	Thank you for your comments. We appreciate your concerns regarding the coverage guidelines for ESRD patients on dialysis. The guidelines outlined in the Local Coverage Determination (LCD) are based on a comprehensive review of current medical literature and clinical studies related to the treatment of ESRD with Erythropoiesis Stimulating Agents.
2	The commenters raise concerns about a specific bullet related to hemoglobin (Hb) levels and dose reductions, stating that it is inconsistent with subsequent guidance and creates ambiguity about coverage thresholds and required documentation as Hb approaches 12 g/dL. Because of this lack of clarity, they recommend removing the bullet altogether.	Thank you for your comment. The policy has been revised to align with FDA labeling and current guidelines, emphasizing individualized ESA use at the lowest dose necessary to reduce transfusions and avoiding hemoglobin levels above 11 g/dL.
3	The commenters suggest revising guidance that limits ESA dose increases to once per month. They argue that there are legitimate clinical situations where more frequent adjustments may be necessary and recommend adding language to allow exceptions when supported by proper documentation. Finally, they recommend removing the requirement to check iron stores prior to every dose increase, noting that this is unnecessary since iron levels are already routinely monitored during ESA therapy.	Thank you for your comment. The LCD does not impose a strict once-monthly limit on dose increases but instead supports individualized titration based on patient response and safety considerations, including avoiding rapid Hb rises. “Doses must be titrated according to the patient’s response.” Additionally, the LCD supports periodic monitoring not per dose iron monitoring, specifying that at least every three months during maintenance therapy. This aligns with standard practice and ensures ESA effectiveness without unnecessary testing. “For these patients, stores of iron should be regularly monitored.”, “This LCD establishes monitoring of iron stores during ESA maintenance therapy at least every 3 months as a thoughtful reasonable standard.”
4	The commenters key concern with the proposed LCD is the eligibility criteria for chronic kidney disease (CKD) patients not on dialysis. They argue that the proposed glomerular filtration rate (GFR) threshold of <45 mL/min/1.73 m² is too restrictive and inconsistent with established standards. Instead, they recommend aligning the threshold with <60 mL/min/1.73 m² to match FDA labeling, prior LCD policy, most Medicare Administrative Contractors (MACs), and routine clinical practice.	Thank you for your comment. The LCD has been revised to <60 mL/min/1.73 m² to match FDA labeling.
5	Commenters highlight that FDA-approved labeling for ESAs such as Aranesp® and EPOGEN® does not distinguish between CKD Stage 3a and 3b, and that clinical trials and real-world data include patients with GFR values up to 60. They emphasize that a significant proportion of anemic CKD patients (about 43% with Hb <10 g/dL) fall within Stage 3a, meaning the proposed threshold could exclude many clinically appropriate patients from access to ESA therapy.	Thank you for your comment. The policy has been updated to include Stage 3a CKD patients.
6	Commenter raises concerns about operational and administrative requirements. They argue that requiring a creatinine test within 30 days of ESA initiation is unnecessary in ESRD patients and could delay treatment, as it does not align with standard dialysis lab practices. Similarly, they state that mandating weight documentation in kilograms for every claim creates unnecessary system burdens and risk of claim denials without improving clinical care.	For both CKD and ESRD patients, NGS believes it is reasonable to have a reasonably up to date serum creatinine level to inform the payer as to the severity of potential renal failure issues. It is one element, but certainly an applicable one. Clinical circumstances can change, even in ESRD, and a creatinine measure within the prior one month is neither burdensome nor redundant. Lab values help establish a reasonable and necessary foundation for all treatment provided to the beneficiary. No specific serum creatinine value can be expected or predicted and no specific parameters are set. The LCD’s requirement to document patient weight in kilograms is intended to support accurate, safe, and verifiable dosing of ESAs, which are commonly prescribed on a units/kg basis. The policy explicitly states that “the medical record should reference current patient weight in kilograms [and] the ESA units/kg dose,” ensuring that dosing aligns with FDA labeling and can be validated during review. We do not believe this is what the article or LCD implies. While these should be done, they should be documented and available.
7	Commenter highlights multiple patient safety risks. They note that restricting ESA initiation and restart strictly to hemoglobin (Hb) levels below 10 g/dL fails to account for common clinical scenarios, such as restarting therapy after temporary interruptions, and could lead to avoidable complications like severe anemia or transfusions.	Thank you for your comment. The LCD has been updated to clarify support clinical flexibility for re-initiation of therapy. Reinitiation may be appropriate based on factors such as hemoglobin decline, symptoms, or transfusion risk, and must be supported by documentation.
8	Commenter criticizes the requirement to stop therapy after 8 weeks without a specified Hb increase, arguing that many patients benefit from stabilization rather than measurable increases. Additionally, they oppose tying ESA coverage to strict iron thresholds, explaining that this could inappropriately deny treatment during acute situations like blood loss, where ESA therapy remains critical.	Thank you for your comment. The LCD’s expectation to discontinue ESA therapy after 8 weeks without adequate Hb response is aligned with FDA labeling and evidence-based practice, which indicate that lack of response suggests limited clinical benefit and continued use may expose patients to unnecessary risk. The policy specifies that continued use is not reasonable if Hb fails to rise meaningfully after appropriate dose adjustment, reinforcing appropriate utilization and patient safety.

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Revision History Information

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Associated Documents

Related Local Coverage Documents
Articles
A60381 - Billing and Coding: Erythropoiesis Stimulating Agents (Future)
LCDs
L40334 - Erythropoiesis Stimulating Agents (Future)

Related National Coverage Documents
NCDs
110.21 - Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions

Public Versions

Updated On	Effective Dates	Status
05/21/2026	07/15/2026 - N/A	Future Effective	You are here

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Contents

Response to Comments: Erythropoiesis Stimulating Agents

Document Note

Note History

Contractor Information

Article Information

General Information

CMS National Coverage Policy

Article Guidance

Response To Comments

Coding Information

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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ICD-10-PCS Codes

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Additional ICD-10 Information

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