1. (a) Definition. For purposes of this section, a home infusion therapy supplier means a supplier of home infusion therapy that meets all of the following requirements:

   1. (1) Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs.
   2. (2) Ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis.
   3. (3) Is accredited by an organization designated by the Secretary in accordance with section 1834(u)(5) of the Act.
   4. (4) Is enrolled in Medicare as a home infusion therapy supplier consistent with the provisions of this section and subpart P of this part.
2. (b) General requirement. For a supplier to receive Medicare payment for the provision of home infusion therapy supplier services, the supplier must qualify as a home infusion therapy supplier (as defined in this section) and be in compliance with all applicable provisions of this section and of subpart P of this part.

3. (c) Specific requirements for enrollment. To enroll in the Medicare program as a home infusion therapy supplier, a home infusion therapy supplier must meet all of the following requirements:

   1. (1)

      1. (i) Fully complete and submit the Form CMS-855B application (or its electronic or successor application) to its applicable Medicare contractor.
      2. (ii) Certify via the Form CMS-855B that the home infusion therapy supplier meets and will continue to meet the specific requirements and standards for enrollment described in this section and in subpart P of this part.
   2. (2) Comply with the application fee requirements in § 424.514.
   3. (3) Be currently and validly accredited as a home infusion therapy supplier by a CMS-recognized home infusion therapy supplier accreditation organization.
   4. (4) Comply with § 414.1515 of this chapter and all provisions of part 486, subpart I of this chapter.
   5. (5) Successfully complete the limited categorical risk level of screening under § 424.518.

4. (d) Denial of enrollment.

   1. (1) Enrollment denial by CMS. CMS may deny a supplier's enrollment application as a home infusion therapy supplier on either of the following grounds:

      1. (i) The supplier does not meet all of the requirements for enrollment outlined in § 424.68 and in subpart P of this part.
      2. (ii) Any of the applicable denial reasons in § 424.530.
   2. (2) Appeal of an enrollment denial. A supplier may appeal the denial of its enrollment application as a home infusion therapy supplier under part 498 of this chapter.

5. (e) Continued compliance, standards, and reasons for revocation.

   1. (1) Upon and after enrollment, a home infusion therapy supplier—

      1. (i) Must remain currently and validly accredited as described in paragraph (c)(3) of this section.

      2. (ii) Remains subject to, and must remain in full compliance with, all of the provisions of—

         1. (A) This section;
         2. (B) Subpart P of this part;
         3. (C) Section 414.1515 of this chapter; and
         4. (D) Part 486, subpart I of this chapter.

   2. (2) CMS may revoke a home infusion therapy supplier's enrollment on any of the following grounds:

      1. (i) The supplier does not meet the accreditation requirements as described in paragraph (c)(3) of this section.

      2. (ii) The supplier does not comply with all of the provisions of—

         1. (A) This section;
         2. (B) Subpart P of this part;
         3. (C) Section 414.1515 of this chapter; and
         4. (D) Part 486, subpart I of this chapter; or
      3. (iii) Any of the revocation reasons in § 424.535 applies.
   3. (3) A home infusion therapy supplier may appeal the revocation of its enrollment under part 498 of this chapter.

[85 FR 70355, Nov. 4, 2020]