Response to NPRM comments

Summary of Comments – CMS-855B

Comment: Several commenters expressed concern that CMS will not accept Medicare enrollment applications from home infusion therapy suppliers until after this final rule is issued. They stated that this will give these suppliers only 2 months to complete the enrollment process before the home infusion therapy supplier benefit commences on January 1, 2021, thus delaying the provision of these services to beneficiaries.

Response: We recognize the limited timeframe between the issuance of this rule and January 1, 2021. However, we cannot accept applications from a new Medicare supplier type before any final regulatory provisions pertaining thereto have been made public. To permit suppliers to submit applications based on proposed regulatory provisions could lead to confusion for stakeholders, especially if the final rule’s provisions ultimately differ from those that we proposed. Nevertheless, and as with all incoming provider and supplier enrollment applications, Form CMS-855B submissions from home infusion therapy suppliers will be processed as expeditiously as feasible. We also note that our previously mentioned proposals to revise §§ 424.520(d) and 424.521(a) would permit home infusion therapy suppliers to backbill for certain services furnished prior to the date on which the MAC approved the supplier’s enrollment application.

Comment: Several commenters asked CMS to clarify the specific supplier type that the enrolling home infusion therapy supplier should indicate on the Form CMS-855B.

Response: Until the Form CMS-855B is revised to include a specific supplier type category for home infusion therapy suppliers, such suppliers should, in the appropriate section of the current Form CMS-855B: (1) indicate a supplier type of “Other”; and (2) list “home infusion therapy supplier” in the space next thereto.

Comment: A number of commenters requested that CMS outline the enrollment and licensure requirements for home infusion therapy suppliers that-- (1) operate in multiple jurisdictions; and/or (2) perform certain services through subcontractors. Regarding the first issue, several commenters contended that home infusion therapy suppliers should not be required to enroll in each MAC jurisdiction in which it performs services; besides being overly burdensome, they believed this would require the supplier to have a physical presence in each such jurisdiction (and perhaps even in each state that the MAC covers). These commenters requested that home infusion therapy suppliers be permitted to bill all MACs from a single location: (1) without having to maintain fixed sites in every applicable MAC jurisdiction or state; and (2) with a single National Provider Identifier (NPI).

Response: It has long been general provider enrollment policy that Medicare providers and suppliers must be enrolled in each MAC jurisdiction (and, as applicable, licensed or certified in each state) in which it performs services, even if the provider or supplier does not have a physical practice location in that MAC and/or state. To illustrate, suppose a supplier has a single practice location in State X. The supplier sends its personnel out from this site to perform services in States X, Y, and Z; each of these states falls within a different MAC jurisdiction. The supplier must separately enroll with all three MACs if it wishes to receive Medicare payments for services provided in States X, Y, and Z. The purpose of this policy is to ensure that the applicable MAC can: (1) verify the provider’s or supplier’s compliance with the state’s requirements; and (2) make accurate payments. For this important reason, we believe home infusion therapy suppliers should be subject to this requirement as well.

Concerning the maintenance of fixed practice locations in each MAC jurisdiction in which services are performed, we recognize that home infusion therapy suppliers will often operate out of only one central location, with services occasionally furnished in homes located in various MAC jurisdictions and/or states. We will issue sub-regulatory guidance to address this issue for home infusion therapy suppliers in more detail.

Comment: Several commenters stated that some pharmacies are enrolled in Medicare as suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) via the Form CMS-855S (OMB Control No. 0938-1056) in order to furnish external infusion pump items. (The National Supplier Clearinghouse (NSC) is the Medicare contractor that processes Form CMS-855S applications. Durable Medicare Equipment Medicare Administrative Contractors (DME MACs) process DMEPOS claims.) The commenters requested that such pharmacies also enrolling via the Form CMS-855B as home infusion therapy suppliers be able to use their existing NPI (that is, the same NPI utilized for their DMEPOS enrollment) when doing so. A commenter further requested that pharmacies enrolled as DMEPOS suppliers be permitted to have a single enrollment as a qualified home infusion therapy supplier; the commenter believed this would enable pharmacies to submit all claims for items (for example, drugs and durable medical equipment) and services to the Part A/B MAC alone rather than to the DME MAC and the Part A/B MAC.

Response: Similar to our response to a previous NPI-related comment, we encourage these commenters to review the NPI Final Rule, NPI regulations, and Medicare Expectations Subpart Paper for guidance concerning the acquisition and use of NPIs. We do note (and subject to the provisions of the NPI Final Rule, NPI regulations, and the Medicare Expectations Subpart Paper) that there is no express prohibition against using the same NPI for enrollment with the NSC as a DMEPOS supplier and enrollment with the Part A/B MAC as another provider or supplier type (such as a home infusion therapy supplier). On the other hand, this does not mean that such dually-enrolled providers and suppliers can use a single Form CMS-855 to encompass both their NSC enrollment and their Part A/B MAC enrollment. The Forms CMS-855S and CMS-855B are separate applications specifically tailored to capture certain information unique to the different provider and supplier types they pertain to; as an illustration, allowing an entity to enroll as a DMEPOS supplier via the Form CMS-855B (as opposed to the DMEPOS-specific Form CMS-855S) would deprive the NSC of important data needed to verify the entity’s compliance with all DMEPOS enrollment standards and requirements. Accordingly, we must respectfully decline the commenter’s request for joint enrollment with the NSC and the Part A/B MAC via a single application.