CMS Proposes Expanded Definition of External Infusion Pump to Support Beneficiary Access to Home Infusion Therapy
As part of the 21st Century Cures Act, Congress added a permanent home infusion therapy benefit to Medicare, beginning in 2021. A transitional benefit, covering 2019 and 2020, was further provided, and CMS had previously used authorities under the Public Health Emergency declaration for COVID to expand access to home infusion through the end of 2020. Medicare Advantage plans have had the flexibility to offer home infusion therapy as an added benefit, though the cost of that benefit must be covered by beneficiary premiums.
The home infusion therapy benefit only covers drugs that are infused using an external infusion pump that is classified as an item of durable medical equipment (DME) and covered under the Medicare DME benefit. Historically, external infusion pumps have only been considered DME when they could be operated by a patient or a patient’s caregiver. Yesterday, the Centers for Medicare and Medicaid Services (CMS) released a proposed expanded definition of “external infusion pump” as part of the proposed Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) payment rule. Under the new definition, external infusion pumps would be covered as durable medical equipment (DME) as long as the following conditions are met:
The drug’s Food and Drug Administration (FDA) labeling requires preparation immediately before administration or requires a health care professional to administer the drug;
The drug is administered in a safe and effective manner in the patient’s home by a qualified home infusion therapy supplier;
The drug’s FDA labeling specifies infusion via an external infusion pump as a possible route of administration; and
The drug requires administration at least once every 30 days.
Beneficiaries must also have a documented plan of care signed by a physician that describes the type, amount, and duration of home infusion therapy services, and that plan must be coordinated by the physician with the DME supplier and home infusion therapy provider. Payment for the drugs would be made at current Medicare rates (e.g. 106% of average sales price), but drugs may only be billed by the entity responsible for administering the drug to the beneficiary. In other words, a physician practice could not bill for a drug that was administered by a home infusion therapy supplier, unless the supplier was owned by the physician practice.
Manufacturers Would be Responsible for Filing Redetermination Requests for Drugs
CMS is clear that the intent of this proposal is to broaden access to home infusion therapy services and the types of drugs eligible for the benefit, with the goal of moving Medicare towards delivering more value-based care. However, it looks as if the agency will rely on manufacturers to file redetermination requests with the DME Medicare Administrative Contractors (MACs) for inclusion in the home infusion therapy local coverage determination (LCD):
We note that this proposal, if finalized, would necessitate updates to the local coverage determinations for external infusion pumps by the DME MACs. The DME MACs update local coverage determinations upon receipt and review of an LCD reconsideration request. The DME MACs have instructions about LCD reconsideration requests on their websites, and we anticipate that manufacturers, suppliers, and others would approach the DME MACs in this manner requesting that drugs or biologicals be included in the LCDs for external infusion pumps. This proposal, if finalized, should not be construed as CMS staff and Medical Officers taking on the responsibility for evaluating requests and making determinations on which drugs or biologicals satisfy the “appropriate for use in the home” criteria in addition to or in lieu of DME MAC process for updates to LCDs. Consistent with long standing practice, the DME MACs are responsible for maintaining the list of eligible drugs that can be infused using an external infusion pump.
The current LCD governing Medicare coverage of home infusion therapy was last updated September 5, 2020 and lists the drugs currently eligible for service.
Comments on the proposal are due in 60 days, and a final rule could be released as early as 60 days after the closing of the comment period.
