A4221 Medicare coverage

Local coverage indication

Supplies for the maintenance of a parenteral drug infusion catheter (A4221), supplies for the maintenance for an insulin infusion pump (A4224), or supplies for the maintenance of a drug-pump combination (A4228) are covered during the period of covered use of an infusion pump. They are also covered for the weeks in between covered infusion pump use, not to exceed 4 weeks per episode.

Excerpt from LCD L33794 version 176, effective 10/01/2026. CMS LCD L33794.

What NCD 280.14 says the item is

A. General Infusion pumps are medical devices used to deliver solutions containing parenteral drugs under pressure at a regulated flow rate.

National coverage indication, NCD 280.14

B. Nationally Covered Indications The following indications for treatment using infusion pumps are covered under Medicare: 1. External Infusion Pumps a. Iron Poisoning (Effective for Services Performed On or After September 26, 1984) When used in the administration of deferoxamine for the treatment of acute iron poisoning and iron overload, only external infusion pumps are covered. b. Thromboembolic Disease (Effective for Services Performed On or After September 26, 1984) When used in the administration of heparin for the treatment of thromboembolic disease and/or pulmonary embolism, only external infusion pumps used in an institutional setting are covered. c. Chemotherapy for Liver Cancer (Effective for Services Performed On or After January 29, 1985) The external chemotherapy infusion pump is covered when used in the treatment of primary hepatocellular carcinoma or colorectal cancer where this disease is unresectable; OR, where the patient refuses surgical excision of the tumor. d.

Excerpt from NCD 280.14 version 2. CMS NCD 280.14.

From A52507

Coverage of an external infusion pump for the administration of continuous subcutaneous insulin as outlined in the related LCD’s “Coverage Indications, Limitations, and/or Medical” section under criteria IV. C. and D. requires a frequency of glucose self-testing an average of at least 4 times per day. A beneficiary using a continuous glucose monitor (CGM) is inherently testing more than the 4 times per day glucose monitoring requirement. Documentation of the use of a CGM device in the beneficiary’s medical records would meet the testing requirement in the External Infusion Pump LCD. In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD. Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below. For parenteral inotropic drugs, the cardiologist with training in the management of advanced heart failure who performs the initial evaluation does not need to be the prescriber for the parenteral inotropic drug.

CMS source A52507

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426