[Code of Federal Regulations] [Title 42, Volume 3] [Revised as of October 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR438.1] [Page 193-195] TITLE 42--PUBLIC HEALTH CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 438_MANAGED CARE--Table of Contents Subpart A_General Provisions Sec. 438.1 Basis and scope. Subpart A_General Provisions Sec. 438.1 Basis and scope. 438.2 Definitions. 438.6 Contract requirements. 438.8 Provisions that apply to PIHPs and PAHPs. 438.10 Information requirements. 438.12 Provider discrimination prohibited. Subpart B_State Responsibilities 438.50 State Plan requirements. 438.52 Choice of MCOs, PIHPs, PAHPs, and PCCMs. 438.56 Disenrollment: Requirements and limitations. 438.58 Conflict of interest safeguards. 438.60 Limit on payment to other providers. 438.62 Continued services to recipients. 438.66 Monitoring procedures. Subpart C_Enrollee Rights and Protections 438.100 Enrollee rights. 438.102 Provider-enrollee communications. 438.104 Marketing activities. 438.106 Liability for payment. 438.108 Cost sharing. 438.114 Emergency and poststabilization services. [[Page 194]] 438.116 Solvency standards. Subpart D_Quality Assessment and Performance Improvement 438.200 Scope. 438.202 State responsibilities. 438.204 Elements of State quality strategies. Access Standards 438.206 Availability of services. 438.207 Assurances of adequate capacity and services. 438.208 Coordination and continuity of care. 438.210 Coverage and authorization of services. Structure and Operation Standards 438.214 Provider selection. 438.218 Enrollee information. 438.224 Confidentiality. 438.226 Enrollment and disenrollment. 438.228 Grievance systems. 438.230 Subcontractual relationships and delegation. Measurement and Improvement Standards 438.236 Practice guidelines. 438.240 Quality assessment and performance improvement program. 438.242 Health information systems. Subpart E_External Quality Review 438.310 Basis, scope, and applicability. 438.320 Definitions. 438.350 State responsibilities. 438.352 External quality review protocols. 438.354 Qualifications of external quality review organizations. 438.356 State contract options. 438.358 Activities related to external quality review. 438.360 Nonduplication of mandatory activities. 438.362 Exemption from external quality review. 438.364 External quality review results. 438.370 Federal financial participation. Subpart F_Grievance System 438.400 Statutory basis and definitions. 438.402 General requirements. 438.404 Notice of action. 438.406 Handling of grievances and appeals. 438.408 Resolution and notification: Grievances and appeals. 438.410 Expedited resolution of appeals. 438.414 Information about the grievance system to providers and subcontractors. 438.416 Recordkeeping and reporting requirements. 438.420 Continuation of benefits while the MCO or PIHP appeal and the State fair hearing are pending. 438.424 Effectuation of reversed appeal resolutions. Subpart G [Reserved] 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. Subpart I_Sanctions 438.700 Basis for imposition of sanctions. 438.702 Types of intermediate sanctions. 438.704 Amounts of civil money penalties. 438.706 Special rules for temporary management. 438.708 Termination of an MCO or PCCM contract. 438.710 Due process: Notice of sanction and pre-termination hearing. 438.722 Disenrollment during termination hearing process. 438.724 Notice to CMS. 438.726 State plan requirement. 438.730 Sanction by CMS: Special rules for MCOs. Subpart J_Conditions for Federal Financial Participation 438.802 Basic requirements. 438.806 Prior approval. 438.808 Exclusion of entities. 438.810 Expenditures for enrollment broker services. 438.812 Costs under risk and nonrisk contracts. Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). Source: 67 FR 41095, June 14, 2002, unless otherwise noted. (a) Statutory basis. This part is based on sections 1902(a)(4), 1903(m), 1905(t), and 1932 of the Act. (1) Section 1902(a)(4) requires that States provide for methods of administration that the Secretary finds necessary for proper and efficient operation of the State plan. The application of the requirements of this part to PIHPs and PAHPs that do not meet the statutory definition of an MCO or a [[Page 195]] PCCM is under the authority in section 1902(a)(4). (2) Section 1903(m) contains requirements that apply to comprehensive risk contracts. (3) Section 1903(m)(2)(H) provides that an enrollee who loses Medicaid eligibility for not more than 2 months may be enrolled in the succeeding month in the same MCO or PCCM if that MCO or PCCM still has a contract with the State. (4) Section 1905(t) contains requirements that apply to PCCMs. (5) Section 1932-- (i) Provides that, with specified exceptions, a State may require Medicaid recipients to enroll in MCOs or PCCMs; (ii) Establishes the rules that MCOs, PCCMs, the State, and the contracts between the State and those entities must meet, including compliance with requirements in sections 1903(m) and 1905(t) of the Act that are implemented in this part; (iii) Establishes protections for enrollees of MCOs and PCCMs; (iv) Requires States to develop a quality assessment and performance improvement strategy; (v) Specifies certain prohibitions aimed at the prevention of fraud and abuse; (vi) Provides that a State may not enter into contracts with MCOs unless it has established intermediate sanctions that it may impose on an MCO that fails to comply with specified requirements; and (vii) Makes other minor changes in the Medicaid program. (b) Scope. This part sets forth requirements, prohibitions, and procedures for the provision of Medicaid services through MCOs, PIHPs, PAHPs, and PCCMs. Requirements vary depending on the type of entity and on the authority under which the State contracts with the entity. Provisions that apply only when the contract is under a mandatory managed care program authorized by section 1932(a)(1)(A) of the Act are identified as such.