NHIA submitted comments on a CMS PFS proposed rule (CMS-1784-P) that would affect Medicare classification and coverage of self-administered drugs, payment for administration of non-chemotherapeutic complex biologics, as well as coding and billing requirements related to the use of single dose containers and drug waste.

NHIA recommends that CMS specify that all intravenous (IV) and subcutaneous (SC) drugs administered through an access device (catheter) or via the use of an infusion pump be disqualified from being placed on the SAD list to ensure that Medicare beneficiaries have access to HIT services. NHIA also encouraged CMS institute a transparent process for MACs to evaluate the appropriateness of drugs for the SAD list, including a well-publicized opportunity for public comment.

NHIA appreciates CMS examining issues related to the “self-administered drug (SAD)” list and requesting input on the process and definitions used to determine whether a drug should be included on the SAD list—which are excluded from coverage under Medicare Part B. NHIA recommends that CMS specify that all intravenous (IV) and subcutaneous (SC) drugs administered through an access device (catheter) or via the use of an infusion pump be disqualified from being placed on the SAD list to ensure that Medicare beneficiaries have access to HIT services. NHIA also encouraged CMS institute a transparent process for MACs to evaluate the appropriateness of drugs for the SAD list, including a well-publicized opportunity for public comment.

NHIA also asks that CMS recognize that the administration of complex non-chemotherapeutic biologic agents requires special expertise from physicians, nurses, and pharmacists to ensure proper preparation and prevention of adverse reactions during and post-infusion and allow for billing using CPT codes 96401-96549. Medicare does not currently pay for the administration of these agents outside of a physician office or hospital outpatient department despite existing coverage under Medicare Part D for the drugs, however these agents are routinely administered at home and in pharmacy-based infusion suites for patients with other plans, including commercial insurance, Medicare Advantage, and TRICARE. The association recommends CMS address the lack of coverage for home administration of complex non-chemotherapeutic biologic agents for Medicare beneficiaries.

The association also noted that CMS’ proposal to require a separate modifier to be included on all claims for drugs with no discarded amounts would be administratively burdensome, cause confusion when a drug has more than one manufacturer (generic drugs), and may require substantial investments to update billing software systems. NHIA recommends that CMS not require use of the JZ modifier for drugs provided under the Part B DMEPOS benefit, as the administrative burden far outweighs any benefit that CMS would obtain by mandating use of the modifier. Instead of creating an entirely new, unnecessarily burdensome system, NHIA recommends that the Medicare Administrative Contractors (MACs) provide education regarding use of the JW modifier or limit its use to drugs identified for the rebate program.