---
kind: "section"
citation: "42 C.F.R. § 424.68"
title: "42"
number: "424.68"
heading: "Enrollment requirements for home infusion therapy suppliers."
url: "https://uscodex.org/cfr/42/424.68"
---

# §424.68. Enrollment requirements for home infusion therapy suppliers.

- (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) Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs.
  - (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) Is accredited by an organization designated by the Secretary in accordance with [section 1834(u)(5)](/cfr/42/1834.md?p=u-5) of the Act.
  - (4) Is enrolled in Medicare as a home infusion therapy supplier consistent with the provisions of this section and subpart P of this part.
- (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](/cfr/42/subpartP.md) of this part.
- (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)
    - (i) Fully complete and submit the Form CMS-855B application (or its electronic or successor application) to its applicable Medicare contractor.
    - (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](/cfr/42/subpartP.md) of this part.
  - (2) Comply with the application fee requirements in [§ 424.514](/cfr/42/424.514.md).
  - (3) Be currently and validly accredited as a home infusion therapy supplier by a CMS-recognized home infusion therapy supplier accreditation organization.
  - (4) Comply with [§ 414.1515](/cfr/42/414.1515.md) of this chapter and all provisions of [part 486](/cfr/42/part486.md), [subpart I](/cfr/42/subpartI.md) of this chapter.
  - (5) Successfully complete the limited categorical risk level of screening under [§ 424.518](/cfr/42/424.518.md).
- (d) **Denial of enrollment.**
  - (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:
    - (i) The supplier does not meet all of the requirements for enrollment outlined in § 424.68 and in [subpart P](/cfr/42/subpartP.md) of this part.
    - (ii) Any of the applicable denial reasons in [§ 424.530](/cfr/42/424.530.md).
  - (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](/cfr/42/part498.md) of this chapter.
- (e) **Continued compliance, standards, and reasons for revocation.**
  - (1) **Upon and after enrollment, a home infusion therapy supplier—**
    - (i) **Must remain currently and validly accredited as described in paragraph (c)(3) of this section.**
    - (ii) Remains subject to, and must remain in full compliance with, all of the provisions of—
      - (A) This section;
      - (B) Subpart P of this part;
      - (C) [Section 414.1515](/cfr/42/414.1515.md) of this chapter; and
      - (D) **Part 486, subpart I of this chapter.**
  - (2) CMS may revoke a home infusion therapy supplier's enrollment on any of the following grounds:
    - (i) The supplier does not meet the accreditation requirements as described in [paragraph (c)(3)](#c-3) of this section.
    - (ii) **The supplier does not comply with all of the provisions of—**
      - (A) This section;
      - (B) Subpart P of this part;
      - (C) [Section 414.1515](/cfr/42/414.1515.md) of this chapter; and
      - (D) [Part 486](/cfr/42/part486.md), [subpart I](/cfr/42/subpartI.md) of this chapter; or
    - (iii) Any of the revocation reasons in [§ 424.535](/cfr/42/424.535.md) applies.
  - (3) A home infusion therapy supplier may appeal the revocation of its enrollment under [part 498](/cfr/42/part498.md) of this chapter.

## Notes

### Amendments

[85 FR 70355, Nov. 4, 2020]

### Authority

Authority: 42 U.S.C. 1302 and 1395hh.

### Source

Source: 53 FR 6634, Mar. 2, 1988, unless otherwise noted.

### Amendments

[85 FR 70355, Nov. 4, 2020]