§ 424.516 Additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program. ( a ) *Certifying compliance.* CMS enrolls and maintains an active enrollment status for a provider or supplier when that provider or supplier certifies that it meets, and continues to meet, and CMS verifies that it meets, and continues to meet, all of the following requirements: ( 1 ) Compliance with title XVIII of the Act and applicable Medicare regulations.
( 2 ) Compliance with Federal and State licensure, certification, and regulatory requirements, as required, based on the type of services or supplies the provider or supplier type will furnish and bill Medicare.
( 3 ) Not employing or contracting with individuals or entities that meet either of the following conditions: ( i ) Excluded from participation in any Federal health care programs, for the provision of items and services covered under the programs, in violation of section 1128A(a)(6) of the Act.
( ii ) Debarred by the General Services Administration (GSA) from any other Executive Branch procurement or nonprocurement programs or activities, in accordance with the Federal Acquisition and Streamlining Act of 1994, and with the HHS Common Rule at 45 CFR part 76.
( b ) *Reporting requirements Independent Diagnostic Testing Facilities (IDTFs).* IDTF reporting requirements are specified in § 410.33(g)(2) of this chapter.
( c ) *Reporting requirements DMEPOS suppliers.* DMEPOS reporting requirements are specified in § 424.57(c)(2).
( d ) *Reporting requirements for physicians, nonphysician practitioners, and physician and nonphysician practitioner organizations.* Physicians, nonphysician practitioners, and physician and nonphysician practitioner organizations must report the following reportable events to their Medicare contractor within the specified timeframes: ( 1 ) Within 30 days— ( i ) A change of ownership;
( ii ) Any adverse legal action; or
( iii ) A change, addition, or deletion of a practice location.
( 2 ) All other changes in enrollment must be reported within 90 days.
( e ) *Reporting requirements for all other providers and suppliers.* Reporting requirements for all other providers and suppliers not identified in paragraphs (a) through (d) of this section, with the exception of MDPP suppliers whose reporting requirements are established at § 424.205(d), must report to CMS the following information within the specified timeframes: ( 1 ) Within 30 days for a change of ownership or control (including changes in authorized official(s) or delegated official(s)) or a change, addition, or deletion of a practice location;
( 2 ) All other changes to enrollment must be reported within 90 days.
( 3 ) Within 30 days of any revocation or suspension of a Federal or State license or certification including Federal Aviation Administration certifications, an air ambulance supplier must report a revocation or suspension of its license or certification to the applicable Medicare contractor. The following FAA certifications must be reported: ( i ) Specific pilot certifications including but not limited to instrument and medical certifications.
( ii ) Airworthiness certification.
( f ) *Maintaining and providing access to documentation.* ( 1 ) ( i ) A provider or a supplier that furnishes covered ordered, certified, referred, or prescribed Part A or B services, items or drugs is required to— ( A ) Maintain documentation (as described in paragraph (f)(1)(ii) of this section) for 7 years from the date of service; and
( B ) Upon the request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(1)(ii) of this section).
( ii ) The documentation includes written and electronic documents (including the NPI of the physician or, when permitted, other eligible professional who ordered, certified, referred, or prescribed the Part A or B service, item, or drug) relating to written orders, certifications, referrals, prescriptions, and requests for payments for Part A or B services, items or drugs.
( 2 ) ( i ) A physician or, when permitted, an eligible professional who orders, certifies, refers, or prescribes Part A or B services, items or drugs is required to— ( A ) Maintain documentation (as described in paragraph (f)(2)(ii) of this section) for 7 years from the date of the service; and
( B ) Upon request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(2)(ii) of this section).
( ii ) The documentation includes written and electronic documents (including the NPI of the physician or, when permitted, other eligible professional who ordered, certified, referred, or prescribed the Part A or B service, item, or drug) relating to written orders, certifications, referrals, prescriptions or requests for payments for Part A or B services, items, or drugs.
( g ) *Skilled nursing facilities.* ( 1 ) In addition to all other applicable reporting requirements in this subpart, a skilled nursing facility (as defined in section 1819(a) of the Act) must disclose upon initial enrollment (which, for purposes of this paragraph (g), also includes a change of ownership under 42 CFR 489.18) and revalidation the following information: ( i ) Each member of the governing body of the facility, including the name, title, and period of service for each such member.
( ii ) Each person or entity who is an officer, director, member, partner, trustee, or managing employee (as defined in § 424.502) of the facility, including the name, title, and period of service of each such person or entity.
( iii ) Each person or entity who is an additional disclosable party of the facility (as defined in § 424.502).
( iv ) The organizational structure (as defined in § 424.502) of each additional disclosable party of the facility and a description of the relationship of each such additional disclosable party to the facility and to one another.
( 2 ) The skilled nursing facility need not disclose the same information described in paragraph (g)(1) of this section more than once on the same enrollment application submission.
( 3 ) The skilled nursing facility must report any change to any of the information described in paragraph (g)(1) of this section consistent with the applicable timeframes in paragraph (e) of this section.
[73 FR 69939, Nov. 19, 2008; 73 FR 80304, Dec. 31, 2008, as amended at 75 FR 24449, May 5, 2010; 75 FR 73628, Nov. 29, 2010; 77 FR 25318, Apr. 27, 2012; 82 FR 53368, Nov. 15, 2017; 84 FR 47852, Sept. 10, 2019; 88 FR 79541, Nov. 16, 2023; 88 FR 80168, Nov. 17, 2023]