42 C.F.R. Subpart H—Certifications and Program Integrity
Title 42 - Public Health
This subpart is based on sections 1902(a)(4), 1902(a)(19), 1903(m), and 1932(d)(1) of the Act. (a) Section 1902(a)(4) requires that the State plan provide for methods of administration that the Secretary finds necessary for the proper and efficient operation of the plan. (b) Section 1902(a)(19) requires that the State plan provide the safeguards necessary to ensure that eligibility is determined and services are provided in a manner consistent with simplicity of administration and the best interests of the recipients. (c) Section 1903(m) establishes conditions for payments to the State with respect to contracts with MCOs. (d) Section 1932(d)(1) prohibits MCOs and PCCMs from knowingly having certain types of relationships with individuals excluded under Federal regulations from participating in specified activities, or with affiliates of those individuals. As a condition for receiving payment under the Medicaid managed care program, an MCO, PCCM, PIHP, or PAHP must comply with the applicable certification, program integrity and prohibited affiliation requirements of this subpart. (a) Data certifications. When State payments to an MCO or PIHP are based on data submitted by the MCO or PIHP, the State must require certification of the data as provided in §438.606. The data that must be certified include, but are not limited to, enrollment information, encounter data, and other information required by the State and contained in contracts, proposals, and related documents. (b) Additional certifications. Certification is required, as provided in §438.606, for all documents specified by the State. (a) Source of certification. For the data specified in §438.604, the data the MCO or PIHP submits to the State must be certified by one of the following: (1) The MCO's or PIHP's Chief Executive Officer. (2) The MCO's or PIHP's Chief Financial Officer. (3) An individual who has delegated authority to sign for, and who reports directly to, the MCO's or PIHP's Chief Executive Officer or Chief Financial Officer. (b) Content of certification. The certification must attest, based on best knowledge, information, and belief, as follows: (1) To the accuracy, completeness and truthfulness of the data. (2) To the accuracy, completeness and truthfulness of the documents specified by the State. (c) Timing of certification. The MCO or PIHP must submit the certification concurrently with the certified data. (a) General requirement. The MCO or PIHP must have administrative and management arrangements or procedures, including a mandatory compliance plan, that are designed to guard against fraud and abuse. (b) Specific requirements. The arrangements or procedures must include the following: (1) Written policies, procedures, and standards of conduct that articulate the organization's commitment to comply with all applicable Federal and State standards. (2) The designation of a compliance officer and a compliance committee that are accountable to senior management. (3) Effective training and education for the compliance officer and the organization's employees. (4) Effective lines of communication between the compliance officer and the organization's employees. (5) Enforcement of standards through well-publicized disciplinary guidelines. (6) Provision for internal monitoring and auditing. (7) Provision for prompt response to detected offenses, and for development of corrective action initiatives relating to the MCO's or PIHP's contract. (a) General requirement. An MCO, PCCM, PIHP, or PAHP may not knowingly have a relationship of the type described in paragraph (b) of this section with the following: (1) An individual who is debarred, suspended, or otherwise excluded from participating in procurement activities under the Federal Acquisition Regulation or from participating in nonprocurement activities under regulations issued under Executive Order No. 12549 or under guidelines implementing Executive Order No. 12549. (2) An individual who is an affiliate, as defined in the Federal Acquisition Regulation, of a person described in paragraph (a)(1) of this section. (b) Specific requirements. The relationships described in this paragraph are as follow: (1) A director, officer, or partner of the MCO, PCCM, PIHP, or PAHP. (2) A person with beneficial ownership of five percent or more of the MCO's, PCCM's, PIHP's, or PAHP's equity. (3) A person with an employment, consulting or other arrangement with the MCO, PCCM, PIHP, or PAHP for the provision of items and services that are significant and material to the MCO's, PCCM's, PIHP's, or PAHP's obligations under its contract with the State. (c) Effect of Noncompliance. If a State finds that an MCO, PCCM, PIHP, or PAHP is not in compliance with paragraphs (a) and (b) of this section, the State: (1) Must notify the Secretary of the noncompliance. (2) May continue an existing agreement with the MCO, PCCM, PIHP, or PAHP unless the Secretary directs otherwise. (3) May not renew or otherwise extend the duration of an existing agreement with the MCO, PCCM, PIHP, or PAHP unless the Secretary provides to the State and to Congress a written statement describing compelling reasons that exist for renewing or extending the agreement. (d) Consultation with the Inspector General. Any action by the Secretary described in paragraphs (c)(2) or (c)(3) of this section is taken in consultation with the Inspector General.
Title 42: Public Health
PART 438—MANAGED CARE
Subpart H—Certifications and Program Integrity
§ 438.600 Statutory basis.
§ 438.602 Basic rule.
§ 438.604 Data that must be certified.
§ 438.606 Source, content, and timing of certification.
§ 438.608 Program integrity requirements.
§ 438.610 Prohibited affiliations with individuals debarred by Federal agencies.
