J0485 Medicare coverage

Local coverage indication

Parenteral belatacept (J0485), antithymocyte globulin (J7504, J7511), cyclosporine (J7516), and tacrolimus (J7525) are not proven to be safe when administered in the home setting and therefore will be denied as not medically necessary when provided in that setting. Drugs may be covered only if dispensed and billed to Medicare by the entity that actually dispenses the drug to the Medicare beneficiary, and that entity must be permitted under all applicable federal, state, and local laws and regulations to dispense drugs. Only entities licensed in the state where they are physically located may bill the DME MAC for immunosuppressive drugs (bp102c15, §110.3). Treating p ractitioners may bill the DME MAC for drugs if all of the following conditions are met: the t reating p ractitioner is 1) enrolled as a DMEPOS supplier with the National Supplier Clearinghouse, and 2) dispensing the drug(s) to the Medicare beneficiary, and 3) authorized by the State to dispense drugs as part of the treating practitioner’s license. Claims submitted by entities not licensed to dispense drugs will be denied for lack of medical necessity.

Excerpt from LCD L33824 version 60, effective 10/01/2026. CMS LCD L33824.

From A52474

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. CONTINUED MEDICAL NEED For all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered, therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. Ongoing immunosuppressive medication need is assumed to be established by the performance of the transplant and the successful maintenance of its function. There is no requirement for further documentation of continued need for the life of the transplant. CONTINUED USE Continued use describes the ongoing utilization of immunosuppressive medications by a beneficiary. Ongoing immunosuppressive medication use is assumed to be established by the performance of the transplant and the successful maintenance of its function.

CMS source A52474

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