42 C.F.R. Subpart B—General Administrative Requirements
Title 42 - Public Health
Source: 56 FR 8847, Mar. 1, 1991, unless otherwise noted.
(a) This subpart sets forth State plan requirements and exceptions that pertain to the following administrative requirements and provisions of the Act: (1) Statewideness—section 1902(a)(1); (2) Proper and efficient administration—section 1902(a)(4); (3) Comparability of services—section 1902(a)(10) (B)–(E); (4) Payment for services furnished outside the State—section 1902(a)(16); (5) Free choice of providers—section 1902(a)(23); (6) Special waiver provisions applicable to American Samoa and the Northern Mariana Islands—section 1902(j); and (7) Exceptions to, and waiver of, State plan requirements—sections 1915 (a)–(c) and 1916 (a)(3) and (b)(3). (b) Other applicable regulations include the following: (1) Section 430.25 Waivers of State plan requirements. (2) Section 440.250 Limits on comparability of services. (a) Statutory basis. Section 1902(a)(1) of the Act requires a State plan to be in effect throughout the State, and section 1915 permits certain exceptions. (b) State plan requirements. A State plan must provide that the following requirements are met: (1) The plan will be in operation statewide through a system of local offices, under equitable standards for assistance and administration that are mandatory throughout the State. (2) If administered by political subdivisions of the State, the plan will be mandatory on those subdivisions. (3) The agency will ensure that the plan is continuously in operation in all local offices or agencies through— (i) Methods for informing staff of State policies, standards, procedures, and instructions; (ii) Systematic planned examination and evaluation of operations in local offices by regularly assigned State staff who make regular visits; and (iii) Reports, controls, or other methods. (c) Exceptions. (1) “Statewide operation” does not mean, for example, that every source of service must furnish the service State-wide. The requirement does not preclude the agency from contracting with a comprehensive health care organization (such as an HMO or a rural health clinic) that serves a specific area of the State, to furnish services to Medicaid recipients who live in that area and chose to receive services from that HMO or rural health clinic. Recipients who live in other parts of the State may receive their services from other sources. (2) Other allowable exceptions and waivers are set forth in §§431.54 and 431.55. [56 FR 8847, Mar. 1, 1991; 56 FR 23022, May 20, 1991] (a) Statutory basis. This section is based on sections 1902(a)(23), 1902(e)(2), and 1915(a) and (b) and 1932(a)(3) of the Act. (1) Section 1902(a)(23) of the Act provides that recipients may obtain services from any qualified Medicaid provider that undertakes to provide the services to them. (2) Section 1915(a) of the Act provides that a State shall not be found out of compliance with section 1902(a)(23) solely because it imposes certain specified allowable restrictions on freedom of choice. (3) Section 1915(b) of the Act authorizes waiver of the section 1902(a)(23) freedom of choice of providers requirement in certain specified circumstances, but not with respect to providers of family planning services. (4) Section 1902(a)(23) of the Act provides that a recipient enrolled in a primary care case management system or Medicaid managed care organization (MCO) may not be denied freedom of choice of qualified providers of family planning services. (5) Section 1902(e)(2) of the Act provides that an enrollee who, while completing a minimum enrollment period, is deemed eligible only for services furnished by or through the MCO or PCCM, may, as an exception to the deemed limitation, seek family planning services from any qualified provider. (6) Section 1932(a) of the Act permits a State to restrict the freedom of choice required by section 1902(a)(23), under specified circumstances, for all services except family planning services. (b) State plan requirements. A State plan, except the plan for Puerto Rico, the Virgin Islands, or Guam, must provide as follows: (1) Except as provided under paragraph (c) of this section and part 438 of this chapter, a recipient may obtain Medicaid services from any institution, agency, pharmacy, person, or organization that is— (i) Qualified to furnish the services; and (ii) Willing to furnish them to that particular recipient. This includes an organization that furnishes, or arranges for the furnishing of, Medicaid services on a prepayment basis. (2) A recipient enrolled in a primary care case-management system, a Medicaid MCO, or other similar entity will not be restricted in freedom of choice of providers of family planning services. (c) Exceptions. Paragraph (b) of this section does not prohibit the agency from— (1) Establishing the fees it will pay providers for Medicaid services; (2) Setting reasonable standards relating to the qualifications of providers: or (3) Subject to paragraph (b)(2) of this section, restricting recipients' free choice of providers in accordance with one or more of the exceptions set forth in §431.54, or under a waiver as provided in §431.55. (d) Certification requirement—(1) Content of certification. If a State implements a project under one of the exceptions allowed under §431.54 (d), (e) or (f), it must certify to CMS that the statutory safeguards and requirements for an exception under section 1915(a) of the Act are met. (2) Timing of certification. (i) For an exception under §431.54(d), the State may not institute the project until after it has submitted the certification and CMS has made the findings required under the Act, and so notified the State. (ii) For exceptions under §431.54 (e) or (f), the State must submit the certificate by the end of the quarter in which it implements the project. [56 FR 8847, Mar. 1, 1991, as amended at 67 FR 41094, June 14, 2002] (a) Statutory basis. Section 1902(a)(16) of the Act authorizes the Secretary to prescribe State plan requirements for furnishing Medicaid to State residents who are absent from the State. (b) Payment for services. A State plan must provide that the State will pay for services furnished in another State to the same extent that it would pay for services furnished within its boundaries if the services are furnished to a recipient who is a resident of the State, and any of the following conditions is met: (1) Medical services are needed because of a medical emergency; (2) Medical services are needed and the recipient's health would be endangered if he were required to travel to his State of residence; (3) The State determines, on the basis of medical advice, that the needed medical services, or necessary supplementary resources, are more readily available in the other State; (4) It is general practice for recipients in a particular locality to use medical resources in another State. (c) Cooperation among States. The plan must provide that the State will establish procedures to facilitate the furnishing of medical services to individuals who are present in the State and are eligible for Medicaid under another State's plan. A State plan must— (a) Specify that the Medicaid agency will ensure necessary transportation for recipients to and from providers; and (b) Describe the methods that the agency will use to meet this requirement. (Sec. 1902(a)(4) of the Act) (a) Statutory basis. Section 1915(a) of the Act provides that a State shall not be deemed to be out of compliance with the requirements of sections 1902(a) (1), (10), or (23) of the Act solely because it has elected any of the exceptions set forth in paragraphs (b) and (d) through (f) of this section. (b) Additional services under a prepayment system. If the Medicaid agency contracts on a prepayment basis with an organization that provides services additional to those offered under the State plan, the agency may restrict the provision of the additional services to recipients who live in the area served by the organization and wish to obtain services from it. (c) [Reserved] (d) Special procedures for purchase of medical devices and laboratory and X-ray tests. The Medicaid agency may establish special procedures for the purchase of medical devices or laboratory and X-ray tests (as defined in §440.30 of this chapter) through a competitive bidding process or otherwise, if the State assures, in the certification required under §431.51(d), and CMS finds, as follows: (1) Adequate services or devices are available to recipients under the special procedures. (2) Laboratory services are furnished through laboratories that meet the following requirements: (i) They are independent laboratories, or inpatient or outpatient hospital laboratories that provide services for individuals who are not hospital patients, or physician laboratories that process at least 100 specimens for other physicians during any calendar year. (ii) They meet the requirements of subpart M of part 405 or part 482 of this chapter. (iii) Laboratories that require an interstate license under 42 CFR part 74 are licensed by CMS or receive an exemption from the licensing requirement by the College of American Pathologists. (Hospital and physician laboratories may participate in competitive bidding only with regard to services to non-hospital patients and other physicians' patients, respectively.) (3) Any laboratory from which a State purchases services under this section has no more than 75 percent of its charges based on services to Medicare beneficiaries and Medicaid recipients. (e) Lock-in of recipients who over-utilize Medicaid services. If a Medicaid agency finds that a recipient has utilized Medicaid services at a frequency or amount that is not medically necessary, as determined in accordance with utilization guidelines established by the State, the agency may restrict that recipient for a reasonable period of time to obtain Medicaid services from designated providers only. The agency may impose these restrictions only if the following conditions are met: (1) The agency gives the recipient notice and opportunity for a hearing (in accordance with procedures established by the agency) before imposing the restrictions. (2) The agency ensures that the recipient has reasonable access (taking into account geographic location and reasonable travel time) to Medicaid services of adequate quality. (3) The restrictions do not apply to emergency services furnished to the recipient. (f) Lock-out of providers. If a Medicaid agency finds that a Medicaid provider has abused the Medicaid program, the agency may restrict the provider, through suspension or otherwise, from participating in the program for a reasonable period of time. Before imposing any restriction, the agency must meet the following conditions: (1) Give the provider notice and opportunity for a hearing, in accordance with procedures established by the agency. (2) Find that in a significant number or proportion of cases, the provider has: (i) Furnished Medicaid services at a frequency or amount not medically necessary, as determined in accordance with utilization guidelines established by the agency; or (ii) Furnished Medicaid services of a quality that does not meet professionally recognized standards of health care. (3) Notify CMS and the general public of the restriction and its duration. (4) Ensure that the restrictions do not result in denying recipients reasonable access (taking into account geographic location: and reasonable travel time) to Medicaid services of adequate quality, including emergency services. (a) Statutory basis. Section 1915(b) of the Act authorizes the Secretary to waive most requirements of section 1902 of the Act to the extent he or she finds proposed improvements or specified practices in the provision of services under Medicaid to be cost effective, efficient, and consistent with the objectives of the Medicaid program. Sections 1915 (f) and (h) prescribe how such waivers are to be approved, continued, monitored, and terminated. Section 1902(p)(2) of the Act conditions FFP in payments to an entity under a section 1915(b)(1) waiver on the State's provision for exclusion of certain entities from participation. (b) General requirements. (1) General requirements for submittal of waiver requests, and the procedures that CMS follows for review and action on those requests are set forth in §430.25 of this chapter. (2) In applying for a waiver to implement an approvable project under paragraph (c), (d), (e), or (f) of this section, a Medicaid agency must document in the waiver request and maintain data regarding: (i) The cost-effectiveness of the project; (ii) The effect of the project on the accessibility and quality of services; (iii) The anticipated impact of the project on the State's Medicaid program and; (iv) Assurances that the restrictions on free choice of providers do not apply to family planning services. (3) No waiver under this section may be granted for a period longer than 2 years, unless the agency requests a continuation of the waiver. (4) CMS monitors the implementation of waivers granted under this section to ensure that requirements for such waivers are being met. (i) If monitoring demonstrates that the agency is not in compliance with the requirements for a waiver under this section, CMS gives the agency notice and opportunity for a hearing. (ii) If, after a hearing, CMS finds an agency to be out of compliance with the requirements of a waiver, CMS terminates the waiver and gives the agency a specified date by which it must demonstrate that it meets the applicable requirements of section 1902 of the Act. (5) The requirements of section 1902(s) of the Act, with regard to adjustments in payments for inpatient hospital services furnished to infants who have not attained age 1 and to children who have not attained age 6 and who receive these services in disproportionate share hospitals, may not be waived under a section 1915(b) waiver. (c) Case-management system. (1) Waivers of appropriate requirements of section 1902 of the Act may be authorized for a State to implement a primary care case-management system or specialty physician services system. (i) Under a primary care case-management system the agency assures that a specific person or persons or agency will be responsible for locating, coordinating, and monitoring all primary care or primary care and other medical care and rehabilitative services on behalf of a recipient. The person or agency must comply with the requirements set forth in part 438 of this chapter for primary care case management contracts and systems. (ii) A specialty physician services system allows States to restrict recipients of specialty services to designated providers of such services, even in the absence of a primary care case-management system. (2) A waiver under this paragraph (c) may not be approved unless the State's request assures that the restrictions— (i) Do not apply in emergency situations; and (ii) Do not substantially impair access to medically necessary services of adequate quality. (d) Locality as central broker. Waivers of appropriate requirements of section 1902 of the Act may be authorized for a State to allow a locality to act as a central broker to assist recipients in selecting among competing health care plans. States must ensure that access to medically necessary services of adequate quality is not substantially impaired. (1) A locality is any defined jurisdiction, e.g., district, town, city, borough, county, parish, or State. (2) A locality may use any agency or agent, public or private, profit or nonprofit, to act on its behalf in carrying out its central broker function. (e) Sharing of cost savings. (1) Waivers of appropriate requirements of section 1902 of the Act may be authorized for a State to share with recipients the cost savings resulting from the recipients' use of more cost-effective medical care. (2) Sharing is through the provision of additional services, including— (i) Services furnished by a plan selected by the recipient; and (ii) Services expressly offered by the State as an inducement for recipients to participate in a primary care case-management system, a competing health care plan or other system that furnishes health care services in a more cost-effective manner. (f) Restriction of freedom of choice—(1) Waiver of appropriate requirements of section 1902 of the Act may be authorized for States to restrict recipients to obtaining services from (or through) qualified providers or practitioners that meet, accept, and comply with the State reimbursement, quality and utilization standards specified in the State's waiver request. (2) An agency may qualify for a waiver under this paragraph (f) only if its applicable State standards are consistent with access, quality and efficient and economic provision of covered care and services and the restrictions it imposes— (i) Do not apply to recipients residing at a long-term care facility when a restriction is imposed unless the State arranges for reasonable and adequate recipient transfer. (ii) Do not discriminate among classes of providers on grounds unrelated to their demonstrated effectiveness and efficiency in providing those services; and (iii) Do not apply in emergency circumstances. (3) Demonstrated effectiveness and efficiency refers to reducing costs or slowing the rate of cost increase and maximizing outputs or outcomes per unit of cost. (4) The agency must make payments to providers furnishing services under a freedom of choice waiver under this paragraph (f) in accordance with the timely claims payment standards specified in §447.45 of this chapter for health care practitioners participating in the Medicaid program. (g) [Reserved] (h) Waivers approved under section 1915(b)(1) of the Act—(1) Basic rules. (i) An agency must submit, as part of it's waiver request, assurance that the entities described in paragraph (h)(2) of this section will be excluded from participation under an approved waiver. (ii) FFP is available in payments to an entity that furnishes services under a section 1915(b)(1) waiver only if the agency excludes from participation any entity described in paragraph (h)(2) of this section. (2) Entities that must be excluded. The agency must exclude an entity that meets any of the following conditions: (i) Could be excluded under section 1128(b)(8) of the Act as being controlled by a sanctioned individual. (ii) Has a substantial contractual relationship (direct or indirect) with an individual convicted of certain crimes, as described in section 1128(b)(8)(B) of the Act. (iii) Employs or contracts directly or indirectly with one of the following: (A) Any individual or entity that, under section 1128 or section 1128A of the Act, is precluded from furnishing health care, utilization review, medical social services, or administrative services. (B) Any entity described in paragraph (h)(2)(i) of this section. (3) Definitions. As used in this section, substantial contractual relationship means any contractual relationship that provides for one or more of the following services: (i) The administration, management, or provision of medical services. (ii) The establishment of policies, or the provision of operational support, for the administration, management, or provision of medical services. [56 FR 8847, Mar. 1, 1991, as amended at 59 FR 4599, Feb. 1, 1994; 59 FR 36084, July 15, 1994; 67 FR 41094, June 14, 2002] (a) Statutory basis. Section 1902(j) of the Act provides for waiver of all but three of the title XIX requirements, in the case of American Samoa and the Northern Mariana Islands. (b) Waiver provisions. American Samoa or the Northern Mariana Islands may request, and CMS may approve, a waiver of any of the title XIX requirements except the following: (1) The Federal medical assistance percentage specified in section 1903 of the Act and §433.10(b) of this chapter. (2) The limit imposed by section 1108(c) of the Act on the amount of Federal funds payable to American Samoa or the Northern Mariana Islands for care and services that meet the section 1905(a) definition for Medicaid assistance. (3) The requirement that payment be made only with respect to expenditure made by American Samoa or the Northern Mariana Islands for care and services that meet the section 1905(a) definition of medical assistance. (a) Sections 1916(a)(3) and 1916(b)(3) of the Act specify the circumstances under which the Secretary is authorized to waive the requirement that cost-sharing amounts be nominal. (b) For nonemergency services furnished in a hospital emergency room, the Secretary may by waiver permit a State to impose a copayment of up to double the “nominal” copayment amounts determined under §447.54(a)(3) of this subchapter. (c) Nonemergency services are services that do not meet the definition of emergency services at §447.53(b)(4) of this subchapter. (d) In order for a waiver to be approved under this section, the State must establish to the satisfaction of CMS that alternative sources of nonemergency, outpatient services are available and accessible to recipients. (e) Although, in accordance with §431.55(b)(3) of this part, a waiver will generally be granted for a 2-year duration, CMS will reevaluate waivers approved under this section if the State increases the nominal copayment amounts in effect when the waiver was approved. (f) A waiver approved under this section cannot apply to services furnished before the waiver was granted. [59 FR 4600, Feb. 1, 1994]
Title 42: Public Health
PART 431—STATE ORGANIZATION AND GENERAL ADMINISTRATION
Subpart B—General Administrative Requirements
§ 431.40 Basis and scope.
§ 431.50 Statewide operation.
§ 431.51 Free choice of providers.
§ 431.52 Payments for services furnished out of State.
§ 431.53 Assurance of transportation.
§ 431.54 Exceptions to certain State plan requirements.
§ 431.55 Waiver of other Medicaid requirements.
§ 431.56 Special waiver provisions applicable to American Samoa and the Northern Mariana Islands.
§ 431.57 Waiver of cost-sharing requirements.
