§ 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) 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 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 of this part.
( 2 ) Comply with the application fee requirements in § 424.514.
( 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 of this chapter and all provisions of part 486, subpart I of this chapter.
( 5 ) Successfully complete the limited categorical risk level of screening under § 424.518.
( 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 of this part.
( ii ) Any of the applicable denial reasons in § 424.530.
( 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.
( 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 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) 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 of this chapter; and
( D ) Part 486, subpart I of this chapter; or
( iii ) Any of the revocation reasons in § 424.535 applies.
( 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]