42 U.S.C. § 1396u-2 — Provisions relating to managed care

Page 4366 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 (d) Waivers In the case of a waiver of a provision of part A of subchapter IV in effect with respect to a State as of July 16, 1996, or which is submitted to the Secretary before August 22, 1996, and ap- proved by the Secretary on or before July 1, 1997, if the waiver affects eligibility of individ- uals for medical assistance under this sub- chapter, such waiver may (but need not) con- tinue to be applied, at the option of the State, in relation to this subchapter after the date the waiver would otherwise expire. (e) State option to use 1 application form Nothing in this section, or part A of sub- chapter IV, shall be construed as preventing a State from providing for the same application form for assistance under a State program fund- ed under part A of subchapter IV (on or after the welfare reform effective date) and for medical assistance under this subchapter. (f) Additional rules of construction (1) With respect to the reference in section 1396a(a)(5) of this title to a State plan approved under part A of subchapter IV, a State may treat such reference as a reference either to a State program funded under such part (as in ef- fect on and after the welfare reform effective date) or to the State plan under this subchapter. (2) Any reference in section 1396a(a)(55) of this title to a State plan approved under part A of subchapter IV shall be deemed a reference to a State program funded under such part. (3) In applying section 1396b(f) of this title, the applicable income limitation otherwise deter- mined shall be subject to increase in the same manner as income or resource standards of a State may be increased under subsection (b)(2)(B). (g) Relation to other provisions The provisions of this section shall apply not- withstanding any other provision of this chap- ter. (h) Transitional increased Federal matching rate for increased administrative costs (1) In general Subject to the succeeding provisions of this subsection, the Secretary shall provide that with respect to administrative expenditures described in paragraph (2) the per centum specified in section 1396b(a)(7) of this title shall be increased to such percentage as the Secretary specifies. (2) Administrative expenditures described The administrative expenditures described in this paragraph are expenditures described in section 1396b(a)(7) of this title that a State demonstrates to the satisfaction of the Sec- retary are attributable to administrative costs of eligibility determinations that (but for the enactment of this section) would not be in- curred. (3) Limitation The total amount of additional Federal funds that are expended as a result of the ap- plication of this subsection for the period be- ginning with fiscal year 1997 shall not exceed $500,000,000. In applying this paragraph, the Secretary shall ensure the equitable distribu- tion of additional funds among the States. (i) Welfare reform effective date In this section, the term ‘‘welfare reform ef- fective date’’ means the effective date, with re- spect to a State, of title I of the Personal Re- sponsibility and Work Opportunity Reconcili- ation Act of 1996 (as specified in section 116 of such Act). (Aug. 14, 1935, ch. 531, title XIX, § 1931, as added Pub. L. 104–193, title I, § 114(a)(2), Aug. 22, 1996, 110 Stat. 2177; amended Pub. L. 106–113, div. B, § 1000(a)(6) [title VI, § 602(a)], Nov. 29, 1999, 113 Stat. 1536, 1501A–394.) Editorial Notes REFERENCES IN TEXT For effective date, with respect to a State, of title I of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (as specified in section 116 of such Act), referred to in subsec. (i), see section 116 of Pub. L. 104–193, set out as an Effective Date note under section 601 of this title. PRIOR PROVISIONS A prior section 1931 of act Aug. 14, 1935, was renum- bered section 1939 and is classified to section 1396v of this title. AMENDMENTS 1999—Subsec. (h)(3). Pub. L. 106–113, § 1000(a)(6) [title VI, § 602(a)(1)], struck out ‘‘and ending with fiscal year 2000’’ after ‘‘fiscal year 1997’’. Subsec. (h)(4). Pub. L. 106–113, § 1000(a)(6) [title VI, § 602(a)(2)], struck out heading and text of par. (4). Prior to amendment, text read as follows: ‘‘This subsection shall only apply with respect to a State for expendi- tures incurred during the first 12 calendar quarters in which the State program funded under part A of sub- chapter IV of this chapter (as in effect on and after the welfare reform effective date) is in effect.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1999 AMENDMENT Pub. L. 106–113, div. B, § 1000(a)(6) [title VI, § 602(b)], Nov. 29, 1999, 113 Stat. 1536, 1501A–394, provided that: ‘‘The amendments made by this section [amending this section] shall take effect as if included in the enact- ment of section 114 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (Public Law 104–193; 110 Stat. 2177).’’ EFFECTIVE DATE Section effective July 1, 1997, with transition rules relating to State options to accelerate such date, rules relating to claims, actions, and proceedings com- menced before such date, rules relating to closing out of accounts for terminated or substantially modified programs and continuance in office of Assistant Sec- retary for Family Support, and provisions relating to termination of entitlement under AFDC program, see section 116 of Pub. L. 104–193, as amended, set out as a note under section 601 of this title. § 1396u–2. Provisions relating to managed care (a) State option to use managed care (1) Use of medicaid managed care organiza- tions and primary care case managers (A) In general Subject to the succeeding provisions of this section, and notwithstanding paragraph Page 4367 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 1 See References in Text note below. (1), (10)(B), or (23)(A) of section 1396a(a) of this title, a State— (i) may require an individual who is eli- gible for medical assistance under the State plan under this subchapter to enroll with a managed care entity as a condition of receiving such assistance (and, with re- spect to assistance furnished by or under arrangements with such entity, to receive such assistance through the entity), if— (I) the entity and the contract with the State meet the applicable requirements of this section and section 1396b(m) of this title or section 1396d(t) of this title, and (II) the requirements described in the succeeding paragraphs of this subsection are met; and (ii) may restrict the number of provider agreements with managed care entities under the State plan if such restriction does not substantially impair access to services. (B) ‘‘Managed care entity’’ defined In this section, the term ‘‘managed care entity’’ means— (i) a medicaid managed care organiza- tion, as defined in section 1396b(m)(1)(A) of this title, that provides or arranges for services for enrollees under a contract pur- suant to section 1396b(m) of this title; and (ii) a primary care case manager, as de- fined in section 1396d(t)(2) of this title. (2) Special rules (A) Exemption of certain children with spe- cial needs A State may not require under paragraph (1) the enrollment in a managed care entity of an individual under 19 years of age who— (i) is eligible for supplemental security income under subchapter XVI; (ii) is described in section 701(a)(1)(D) of this title; (iii) is described in section 1396a(e)(3) of this title; (iv) is receiving foster care or adoption assistance under part E of subchapter IV; or (v) is in foster care or otherwise in an out-of-home placement. (B) Exemption of medicare beneficiaries A State may not require under paragraph (1) the enrollment in a managed care entity of an individual who is a qualified medicare beneficiary (as defined in section 1396d(p)(1) of this title) or an individual otherwise eligi- ble for benefits under subchapter XVIII. (C) Indian enrollment A State may not require under paragraph (1) the enrollment in a managed care entity of an individual who is an Indian (as defined in section 4(c) 1 of the Indian Health Care Improvement Act of 1976 (25 U.S.C. 1603(c)) unless the entity is one of the following (and only if such entity is participating under the plan): (i) The Indian Health Service. (ii) An Indian health program operated by an Indian tribe or tribal organization pursuant to a contract, grant, cooperative agreement, or compact with the Indian Health Service pursuant to the Indian Self-Determination Act [25 U.S.C. 5321 et seq.]. (iii) An urban Indian health program op- erated by an urban Indian organization pursuant to a grant or contract with the Indian Health Service pursuant to title V of the Indian Health Care Improvement Act [25 U.S.C. 1651 et seq.]. (3) Choice of coverage (A) In general A State must permit an individual to choose a managed care entity from not less than two such entities that meet the appli- cable requirements of this section, and of section 1396b(m) of this title or section 1396d(t) of this title. (B) State option At the option of the State, a State shall be considered to meet the requirements of sub- paragraph (A) in the case of an individual re- siding in a rural area, if the State requires the individual to enroll with a managed care entity if such entity— (i) permits the individual to receive such assistance through not less than two phy- sicians or case managers (to the extent that at least two physicians or case man- agers are available to provide such assist- ance in the area), and (ii) permits the individual to obtain such assistance from any other provider in ap- propriate circumstances (as established by the State under regulations of the Sec- retary). (C) Treatment of certain county-operated health insuring organizations A State shall be considered to meet the re- quirement of subparagraph (A) if— (i) the managed care entity in which the individual is enrolled is a health-insuring organization which— (I) first became operational prior to January 1, 1986, or (II) is described in section 9517(c)(3) of the Omnibus Budget Reconciliation Act of 1985 (as added by section 4734(2) of the Omnibus Budget Reconciliation Act of 1990), and (ii) the individual is given a choice be- tween at least two providers within such entity. (4) Process for enrollment and termination and change of enrollment As conditions under paragraph (1)(A)— (A) In general The State, enrollment broker (if any), and managed care entity shall permit an indi- vidual eligible for medical assistance under the State plan under this subchapter who is enrolled with the entity under this sub- chapter to terminate (or change) such en- rollment— Page 4368 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 (i) for cause at any time (consistent with section 1396b(m)(2)(A)(vi) of this title), and (ii) without cause— (I) during the 90-day period beginning on the date the individual receives no- tice of such enrollment, and (II) at least every 12 months there- after. (B) Notice of termination rights The State shall provide for notice to each such individual of the opportunity to termi- nate (or change) enrollment under such con- ditions. Such notice shall be provided at least 60 days before each annual enrollment opportunity described in subparagraph (A)(ii)(II). (C) Enrollment priorities In carrying out paragraph (1)(A), the State shall establish a method for establishing en- rollment priorities in the case of a managed care entity that does not have sufficient ca- pacity to enroll all such individuals seeking enrollment under which individuals already enrolled with the entity are given priority in continuing enrollment with the entity. (D) Default enrollment process In carrying out paragraph (1)(A), the State shall establish a default enrollment proc- ess— (i) under which any such individual who does not enroll with a managed care entity during the enrollment period specified by the State shall be enrolled by the State with such an entity which has not been found to be out of substantial compliance with the applicable requirements of this section and of section 1396b(m) of this title or section 1396d(t) of this title; and (ii) that takes into consideration— (I) maintaining existing provider-indi- vidual relationships or relationships with providers that have traditionally served beneficiaries under this sub- chapter; and (II) if maintaining such provider rela- tionships is not possible, the equitable distribution of such individuals among qualified managed care entities available to enroll such individuals, consistent with the enrollment capacities of the en- tities. (5) Provision of information (A) Information in easily understood form Each State, enrollment broker, or man- aged care entity shall provide all enrollment notices and informational and instructional materials relating to such an entity under this subchapter in a manner and form which may be easily understood by enrollees and potential enrollees of the entity who are eli- gible for medical assistance under the State plan under this subchapter. (B) Information to enrollees and potential enrollees Each managed care entity that is a med- icaid managed care organization shall, upon request, make available to enrollees and po- tential enrollees in the organization’s serv- ice area information concerning the fol- lowing: (i) Providers The identity, locations, qualifications, and availability of health care providers that participate with the organization. (ii) Enrollee rights and responsibilities The rights and responsibilities of enroll- ees. (iii) Grievance and appeal procedures The procedures available to an enrollee and a health care provider to challenge or appeal the failure of the organization to cover a service. (iv) Information on covered items and serv- ices All items and services that are available to enrollees under the contract between the State and the organization that are covered either directly or through a meth- od of referral and prior authorization. Each managed care entity that is a pri- mary care case manager shall, upon re- quest, make available to enrollees and po- tential enrollees in the organization’s service area the information described in clause (iii). (C) Comparative information A State that requires individuals to enroll with managed care entities under paragraph (1)(A) shall annually (and upon request) pro- vide, directly or through the managed care entity, to such individuals a list identifying the managed care entities that are (or will be) available and information (presented in a comparative, chart-like form) relating to the following for each such entity offered: (i) Benefits and cost-sharing The benefits covered and cost-sharing imposed by the entity. (ii) Service area The service area of the entity. (iii) Quality and performance To the extent available, quality and per- formance indicators for the benefits under the entity. (D) Information on benefits not covered under managed care arrangement A State, directly or through managed care entities, shall, on or before an individual en- rolls with such an entity under this sub- chapter, inform the enrollee in a written and prominent manner of any benefits to which the enrollee may be entitled to under this subchapter but which are not made available to the enrollee through the entity. Such in- formation shall include information on where and how such enrollees may access benefits not made available to the enrollee through the entity. (b) Beneficiary protections (1) Specification of benefits Each contract with a managed care entity under section 1396b(m) of this title or under Page 4369 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 section 1396d(t)(3) of this title shall specify the benefits the provision (or arrangement) for which the entity is responsible. (2) Assuring coverage to emergency services (A) In general Each contract with a medicaid managed care organization under section 1396b(m) of this title and each contract with a primary care case manager under section 1396d(t)(3) of this title shall require the organization or manager— (i) to provide coverage for emergency services (as defined in subparagraph (B)) without regard to prior authorization or the emergency care provider’s contractual relationship with the organization or man- ager, and (ii) to comply with guidelines estab- lished under section 1395w–22(d)(2) of this title (respecting coordination of post-sta- bilization care) in the same manner as such guidelines apply to Medicare+Choice plans offered under part C of subchapter XVIII. The requirement under clause (ii) shall first apply 30 days after the date of promulgation of the guidelines referred to in such clause. (B) ‘‘Emergency services’’ defined In subparagraph (A)(i), the term ‘‘emer- gency services’’ means, with respect to an individual enrolled with an organization, covered inpatient and outpatient services that— (i) are furnished by a provider that is qualified to furnish such services under this subchapter, and (ii) are needed to evaluate or stabilize an emergency medical condition (as defined in subparagraph (C)). (C) ‘‘Emergency medical condition’’ defined In subparagraph (B)(ii), the term ‘‘emer- gency medical condition’’ means a medical condition manifesting itself by acute symp- toms of sufficient severity (including severe pain) such that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in— (i) placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, (ii) serious impairment to bodily func- tions, or (iii) serious dysfunction of any bodily organ or part. (D) Emergency services furnished by non- contract providers Any provider of emergency services that does not have in effect a contract with a Medicaid managed care entity that estab- lishes payment amounts for services fur- nished to a beneficiary enrolled in the enti- ty’s Medicaid managed care plan must ac- cept as payment in full no more than the amounts (less any payments for indirect costs of medical education and direct costs of graduate medical education) that it could collect if the beneficiary received medical assistance under this subchapter other than through enrollment in such an entity. In a State where rates paid to hospitals under the State plan are negotiated by contract and not publicly released, the payment amount applicable under this subparagraph shall be the average contract rate that would apply under the State plan for general acute care hospitals or the average contract rate that would apply under such plan for tertiary hospitals. (3) Protection of enrollee-provider communica- tions (A) In general Subject to subparagraphs (B) and (C), under a contract under section 1396b(m) of this title a medicaid managed care organiza- tion (in relation to an individual enrolled under the contract) shall not prohibit or otherwise restrict a covered health care pro- fessional (as defined in subparagraph (D)) from advising such an individual who is a patient of the professional about the health status of the individual or medical care or treatment for the individual’s condition or disease, regardless of whether benefits for such care or treatment are provided under the contract, if the professional is acting within the lawful scope of practice. (B) Construction Subparagraph (A) shall not be construed as requiring a medicaid managed care organiza- tion to provide, reimburse for, or provide coverage of, a counseling or referral service if the organization— (i) objects to the provision of such serv- ice on moral or religious grounds; and (ii) in the manner and through the writ- ten instrumentalities such organization deems appropriate, makes available infor- mation on its policies regarding such serv- ice to prospective enrollees before or dur- ing enrollment and to enrollees within 90 days after the date that the organization adopts a change in policy regarding such a counseling or referral service. Nothing in this subparagraph shall be con- strued to affect disclosure requirements under State law or under the Employee Re- tirement Income Security Act of 1974 [29 U.S.C. 1001 et seq.]. (C) ‘‘Health care professional’’ defined For purposes of this paragraph, the term ‘‘health care professional’’ means a physi- cian (as defined in section 1395x(r) of this title) or other health care professional if coverage for the professional’s services is provided under the contract referred to in subparagraph (A) for the services of the pro- fessional. Such term includes a podiatrist, optometrist, chiropractor, psychologist, den- tist, physician assistant, physical or occupa- tional therapist and therapy assistant, speech-language pathologist, audiologist, registered or licensed practical nurse (in- cluding nurse practitioner, clinical nurse Page 4370 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 specialist, certified registered nurse anes- thetist, and certified nurse-midwife), li- censed certified social worker, registered respiratory therapist, and certified res- piratory therapy technician. (4) Grievance procedures Each medicaid managed care organization shall establish an internal grievance procedure under which an enrollee who is eligible for medical assistance under the State plan under this subchapter, or a provider on behalf of such an enrollee, may challenge the denial of coverage of or payment for such assistance. (5) Demonstration of adequate capacity and services Each medicaid managed care organization shall provide the State and the Secretary with adequate assurances (in a time and manner de- termined by the Secretary) that the organiza- tion, with respect to a service area, has the ca- pacity to serve the expected enrollment in such service area, including assurances that the organization— (A) offers an appropriate range of services and access to preventive and primary care services for the population expected to be enrolled in such service area, and (B) maintains a sufficient number, mix, and geographic distribution of providers of services. (6) Protecting enrollees against liability for payment Each medicaid managed care organization shall provide that an individual eligible for medical assistance under the State plan under this subchapter who is enrolled with the orga- nization may not be held liable— (A) for the debts of the organization, in the event of the organization’s insolvency, (B) for services provided to the indi- vidual— (i) in the event of the organization fail- ing to receive payment from the State for such services; or (ii) in the event of a health care provider with a contractual, referral, or other ar- rangement with the organization failing to receive payment from the State or the or- ganization for such services, or (C) for payments to a provider that fur- nishes covered services under a contractual, referral, or other arrangement with the or- ganization in excess of the amount that would be owed by the individual if the orga- nization had directly provided the services. (7) Antidiscrimination A medicaid managed care organization shall not discriminate with respect to participation, reimbursement, or indemnification as to any provider who is acting within the scope of the provider’s license or certification under appli- cable State law, solely on the basis of such li- cense or certification. This paragraph shall not be construed to prohibit an organization from including providers only to the extent necessary to meet the needs of the organiza- tion’s enrollees or from establishing any meas- ure designed to maintain quality and control costs consistent with the responsibilities of the organization. (8) Compliance with certain maternity and mental health requirements Each medicaid managed care organization shall comply with the requirements of subpart 2 of part A of title XXVII of the Public Health Service Act 1 insofar as such requirements apply and are effective with respect to a health insurance issuer that offers group health insurance coverage. In applying the previous sentence with respect to require- ments under paragraph (8) of section 300gg–26(a) of this title, a Medicaid managed care organization (or a prepaid inpatient health plan (as defined by the Secretary) or prepaid ambulatory health plan (as defined by the Secretary) that offers services to enrollees of a Medicaid managed care organization) shall be treated as in compliance with such re- quirements if the Medicaid managed care or- ganization (or prepaid inpatient health plan or prepaid ambulatory health plan) is in compli- ance with subpart K of part 438 of title 42, Code of Federal Regulations, and section 438.3(n) of such title, or any successor regula- tion. (c) Quality assurance standards (1) Quality assessment and improvement strat- egy (A) In general If a State provides for contracts with med- icaid managed care organizations under sec- tion 1396b(m) of this title, the State shall de- velop and implement a quality assessment and improvement strategy consistent with this paragraph. Such strategy shall include the following: (i) Access standards Standards for access to care so that cov- ered services are available within reason- able timeframes and in a manner that en- sures continuity of care and adequate pri- mary care and specialized services capac- ity. (ii) Other measures Examination of other aspects of care and service directly related to the improve- ment of quality of care (including griev- ance procedures and marketing and infor- mation standards). (iii) Monitoring procedures Procedures for monitoring and evalu- ating the quality and appropriateness of care and services to enrollees that reflect the full spectrum of populations enrolled under the contract and that includes re- quirements for provision of quality assur- ance data to the State using the data and information set that the Secretary has specified for use under part C of sub- chapter XVIII or such alternative data as the Secretary approves, in consultation with the State. (iv) Periodic review Regular, periodic examinations of the scope and content of the strategy. Page 4371 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 (B) Standards The strategy developed under subpara- graph (A) shall be consistent with standards that the Secretary first establishes within 1 year after August 5, 1997. Such standards shall not preempt any State standards that are more stringent than such standards. Guidelines relating to quality assurance that are applied under section 1396n(b)(1) of this title shall apply under this subsection until the effective date of standards for qual- ity assurance established under this sub- paragraph. (C) Monitoring The Secretary shall monitor the develop- ment and implementation of strategies under subparagraph (A). (D) Consultation The Secretary shall conduct activities under subparagraphs (B) and (C) in consulta- tion with the States. (2) External independent review of managed care activities (A) Review of contracts (i) In general Each contract under section 1396b(m) of this title with a medicaid managed care organization shall provide for an annual (as appropriate) external independent re- view conducted by a qualified independent entity of the quality outcomes and timeli- ness of, and access to, the items and serv- ices for which the organization is respon- sible under the contract. The requirement for such a review shall not apply until after the date that the Secretary estab- lishes the identification method described in clause (ii). (ii) Qualifications of reviewer The Secretary, in consultation with the States, shall establish a method for the identification of entities that are qualified to conduct reviews under clause (i). (iii) Use of protocols The Secretary, in coordination with the National Governors’ Association, shall contract with an independent quality re- view organization (such as the National Committee for Quality Assurance) to de- velop the protocols to be used in external independent reviews conducted under this paragraph on and after January 1, 1999. (iv) Availability of results The results of each external independent review conducted under this subparagraph shall be available to participating health care providers, enrollees, and potential en- rollees of the organization, except that the results may not be made available in a manner that discloses the identity of any individual patient. (B) Nonduplication of accreditation A State may provide that, in the case of a medicaid managed care organization that is accredited by a private independent entity (such as those described in section 1395w–22(e)(4) of this title) or that has an ex- ternal review conducted under section 1395w–22(e)(3) of this title, the external re- view activities conducted under subpara- graph (A) with respect to the organization shall not be duplicative of review activities conducted as part of the accreditation proc- ess or the external review conducted under such section. (C) Deemed compliance for medicare man- aged care organizations At the option of a State, the requirements of subparagraph (A) shall not apply with re- spect to a medicaid managed care organiza- tion if the organization is an eligible organi- zation with a contract in effect under sec- tion 1395mm of this title or a Medicare+ Choice organization with a contract in effect under part C of subchapter XVIII and the or- ganization has had a contract in effect under section 1396b(m) of this title at least during the previous 2-year period. (d) Protections against fraud and abuse (1) Prohibiting affiliations with individuals debarred by Federal agencies (A) In general A managed care entity may not know- ingly— (i) have a person described in subpara- graph (C) as a director, officer, partner, or person with beneficial ownership of more than 5 percent of the entity’s equity, or (ii) have an employment, consulting, or other agreement with a person described in such subparagraph for the provision of items and services that are significant and material to the entity’s obligations under its contract with the State. (B) Effect of noncompliance If a State finds that a managed care entity is not in compliance with clause (i) or (ii) of subparagraph (A), the State— (i) shall notify the Secretary of such noncompliance; (ii) may continue an existing agreement with the entity unless the Secretary (in consultation with the Inspector General of the Department of Health and Human Services) directs otherwise; and (iii) may not renew or otherwise extend the duration of an existing agreement with the entity unless the Secretary (in con- sultation with the Inspector General of the Department of Health and Human Serv- ices) provides to the State and to Congress a written statement describing compelling reasons that exist for renewing or extend- ing the agreement. (C) Persons described A person is described in this subparagraph if such person— (i) is debarred, suspended, or otherwise excluded from participating in procure- ment activities under the Federal Acquisi- tion Regulation or from participating in nonprocurement activities under regula- tions issued pursuant to Executive Order Page 4372 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 No. 12549 or under guidelines implementing such order; or (ii) is an affiliate (as defined in such Reg- ulation) of a person described in clause (i). (2) Restrictions on marketing (A) Distribution of materials (i) In general A managed care entity, with respect to activities under this subchapter, may not distribute directly or through any agent or independent contractor marketing mate- rials within any State— (I) without the prior approval of the State, and (II) that contain false or materially misleading information. The requirement of subclause (I) shall not apply with respect to a State until such date as the Secretary specifies in consulta- tion with such State. (ii) Consultation in review of market mate- rials In the process of reviewing and approv- ing such materials, the State shall provide for consultation with a medical care advi- sory committee. (B) Service market A managed care entity shall distribute marketing materials to the entire service area of such entity covered under the con- tract under section 1396b(m) of this title or section 1396d(t)(3) of this title. (C) Prohibition of tie-ins A managed care entity, or any agency of such entity, may not seek to influence an in- dividual’s enrollment with the entity in con- junction with the sale of any other insur- ance. (D) Prohibiting marketing fraud Each managed care entity shall comply with such procedures and conditions as the Secretary prescribes in order to ensure that, before an individual is enrolled with the en- tity, the individual is provided accurate oral and written information sufficient to make an informed decision whether or not to en- roll. (E) Prohibition of ‘‘cold-call’’ marketing Each managed care entity shall not, di- rectly or indirectly, conduct door-to-door, telephonic, or other ‘‘cold-call’’ marketing of enrollment under this subchapter. (3) State conflict-of-interest safeguards in med- icaid risk contracting A medicaid managed care organization may not enter into a contract with any State under section 1396b(m) of this title unless the State has in effect conflict-of-interest safeguards with respect to officers and employees of the State with responsibilities relating to con- tracts with such organizations or to the de- fault enrollment process described in sub- section (a)(4)(C)(ii) that are at least as effec- tive as the Federal safeguards provided under chapter 21 of title 41, against conflicts of in- terest that apply with respect to Federal pro- curement officials with comparable respon- sibilities with respect to such contracts. (4) Use of unique physician identifier for par- ticipating physicians Each medicaid managed care organization shall require each physician providing services to enrollees eligible for medical assistance under the State plan under this subchapter to have a unique identifier in accordance with the system established under section 1320d–2(b) of this title. (5) Contract requirement for managed care en- tities With respect to any contract with a man- aged care entity under section 1396b(m) or 1396d(t)(3) of this title (as applicable), no later than July 1, 2018, such contract shall include a provision that providers of services or persons terminated (as described in section 1396a(kk)(8) of this title) from participation under this subchapter, subchapter XVIII, or subchapter XXI shall be terminated from par- ticipating under this subchapter as a provider in any network of such entity that serves indi- viduals eligible to receive medical assistance under this subchapter. (6) Enrollment of participating providers (A) In general Beginning not later than January 1, 2018, a State shall require that, in order to partici- pate as a provider in the network of a man- aged care entity that provides services to, or orders, prescribes, refers, or certifies eligi- bility for services for, individuals who are el- igible for medical assistance under the State plan under this subchapter (or under a waiv- er of the plan) and who are enrolled with the entity, the provider is enrolled consistent with section 1396a(kk) of this title with the State agency administering the State plan under this subchapter. Such enrollment shall include providing to the State agency the provider’s identifying information, in- cluding the name, specialty, date of birth, Social Security number, national provider identifier, Federal taxpayer identification number, and the State license or certifi- cation number of the provider. (B) Rule of construction Nothing in subparagraph (A) shall be con- strued as requiring a provider described in such subparagraph to provide services to in- dividuals who are not enrolled with a man- aged care entity under this subchapter. (e) Sanctions for noncompliance (1) Use of intermediate sanctions by the State to enforce requirements (A) In general A State may not enter into or renew a con- tract under section 1396b(m) of this title un- less the State has established intermediate sanctions, which may include any of the types described in paragraph (2), other than the termination of a contract with a med- icaid managed care organization, which the State may impose against a medicaid man- Page 4373 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 aged care organization with such a contract, if the organization— (i) fails substantially to provide medi- cally necessary items and services that are required (under law or under such organi- zation’s contract with the State) to be pro- vided to an enrollee covered under the con- tract; (ii) imposes premiums or charges on en- rollees in excess of the premiums or charges permitted under this subchapter; (iii) acts to discriminate among enroll- ees on the basis of their health status or requirements for health care services, in- cluding expulsion or refusal to reenroll an individual, except as permitted by this subchapter, or engaging in any practice that would reasonably be expected to have the effect of denying or discouraging en- rollment with the organization by eligible individuals whose medical condition or history indicates a need for substantial fu- ture medical services; (iv) misrepresents or falsifies informa- tion that is furnished— (I) to the Secretary or the State under this subchapter; or (II) to an enrollee, potential enrollee, or a health care provider under such sub- chapter; or (v) fails to comply with the applicable requirements of section 1396b(m)(2)(A)(x) of this title. The State may also impose such inter- mediate sanction against a managed care en- tity if the State determines that the entity distributed directly or through any agent or independent contractor marketing materials in violation of subsection (d)(2)(A)(i)(II). (B) Rule of construction Clause (i) of subparagraph (A) shall not apply to the provision of abortion services, except that a State may impose a sanction on any medicaid managed care organization that has a contract to provide abortion serv- ices if the organization does not provide such services as provided for under the con- tract. (2) Intermediate sanctions The sanctions described in this paragraph are as follows: (A) Civil money penalties as follows: (i) Except as provided in clause (ii), (iii), or (iv), not more than $25,000 for each de- termination under paragraph (1)(A). (ii) With respect to a determination under clause (iii) or (iv)(I) of paragraph (1)(A), not more than $100,000 for each such determination. (iii) With respect to a determination under paragraph (1)(A)(ii), double the ex- cess amount charged in violation of such subsection (and the excess amount charged shall be deducted from the penalty and re- turned to the individual concerned). (iv) Subject to clause (ii), with respect to a determination under paragraph (1)(A)(iii), $15,000 for each individual not enrolled as a result of a practice described in such subsection. (B) The appointment of temporary man- agement— (i) to oversee the operation of the med- icaid managed care organization upon a finding by the State that there is contin- ued egregious behavior by the organization or there is a substantial risk to the health of enrollees; or (ii) to assure the health of the organiza- tion’s enrollees, if there is a need for tem- porary management while— (I) there is an orderly termination or reorganization of the organization; or (II) improvements are made to remedy the violations found under paragraph (1), except that temporary management under this subparagraph may not be terminated until the State has determined that the medicaid managed care organization has the capability to ensure that the viola- tions shall not recur. (C) Permitting individuals enrolled with the managed care entity to terminate en- rollment without cause, and notifying such individuals of such right to terminate en- rollment. (D) Suspension or default of all enrollment of individuals under this subchapter after the date the Secretary or the State notifies the entity of a determination of a violation of any requirement of section 1396b(m) of this title or this section. (E) Suspension of payment to the entity under this subchapter for individuals en- rolled after the date the Secretary or State notifies the entity of such a determination and until the Secretary or State is satisfied that the basis for such determination has been corrected and is not likely to recur. (3) Treatment of chronic substandard entities In the case of a medicaid managed care orga- nization which has repeatedly failed to meet the requirements of section 1396b(m) of this title and this section, the State shall (regard- less of what other sanctions are provided) im- pose the sanctions described in subparagraphs (B) and (C) of paragraph (2). (4) Authority to terminate contract (A) In general In the case of a managed care entity which has failed to meet the requirements of this part or a contract under section 1396b(m) or 1396d(t)(3) of this title, the State shall have the authority to terminate such contract with the entity and to enroll such entity’s enrollees with other managed care entities (or to permit such enrollees to receive med- ical assistance under the State plan under this subchapter other than through a man- aged care entity). (B) Availability of hearing prior to termi- nation of contract A State may not terminate a contract with a managed care entity under subpara- graph (A) unless the entity is provided with a hearing prior to the termination. (C) Notice and right to disenroll in cases of termination hearing A State may— Page 4374 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 (i) notify individuals enrolled with a managed care entity which is the subject of a hearing to terminate the entity’s con- tract with the State of the hearing, and (ii) in the case of such an entity, permit such enrollees to disenroll immediately with the entity without cause. (5) Other protections for managed care entities against sanctions imposed by State Before imposing any sanction against a managed care entity other than termination of the entity’s contract, the State shall pro- vide the entity with notice and such other due process protections as the State may provide, except that a State may not provide a man- aged care entity with a pre-termination hear- ing before imposing the sanction described in paragraph (2)(B). (f) Timeliness of payment; adequacy of payment for primary care services A contract under section 1396b(m) of this title with a medicaid managed care organization shall provide that the organization shall make payment to health care providers for items and services which are subject to the contract and that are furnished to individuals eligible for medical assistance under the State plan under this subchapter who are enrolled with the orga- nization on a timely basis consistent with the claims payment procedures described in section 1396a(a)(37)(A) of this title, unless the health care provider and the organization agree to an alternate payment schedule and, in the case of primary care services described in section 1396a(a)(13)(C) of this title, consistent with the minimum payment rates specified in such sec- tion (regardless of the manner in which such payments are made, including in the form of capitation or partial capitation). (g) Identification of patients for purposes of making DSH payments Each contract with a managed care entity under section 1396b(m) of this title or under sec- tion 1396d(t)(3) of this title shall require the en- tity either— (1) to report to the State information nec- essary to determine the hospital services pro- vided under the contract (and the identity of hospitals providing such services) for purposes of applying sections 1395ww(d)(5)(F) and 1396r–4 of this title; or (2) to include a sponsorship code in the iden- tification card issued to individuals covered under this subchapter in order that a hospital may identify a patient as being entitled to benefits under this subchapter. (h) Special rules with respect to Indian enroll- ees, Indian health care providers, and Indian managed care entities (1) Enrollee option to select an Indian health care provider as primary care provider In the case of a non-Indian Medicaid man- aged care entity that— (A) has an Indian enrolled with the entity; and (B) has an Indian health care provider that is participating as a primary care provider within the network of the entity, insofar as the Indian is otherwise eligible to receive services from such Indian health care provider and the Indian health care provider has the capacity to provide primary care serv- ices to such Indian, the contract with the enti- ty under section 1396b(m) of this title or under section 1396d(t)(3) of this title shall require, as a condition of receiving payment under such contract, that the Indian shall be allowed to choose such Indian health care provider as the Indian’s primary care provider under the enti- ty. (2) Assurance of payment to Indian health care providers for provision of covered services Each contract with a managed care entity under section 1396b(m) of this title or under section 1396d(t)(3) of this title shall require any such entity, as a condition of receiving payment under such contract, to satisfy the following requirements: (A) Demonstration of access to Indian health care providers and application of alter- native payment arrangements Subject to subparagraph (C), to— (i) demonstrate that the number of In- dian health care providers that are partici- pating providers with respect to such enti- ty are sufficient to ensure timely access to covered Medicaid managed care services for those Indian enrollees who are eligible to receive services from such providers; and (ii) agree to pay Indian health care pro- viders, whether such providers are partici- pating or nonparticipating providers with respect to the entity, for covered Medicaid managed care services provided to those Indian enrollees who are eligible to receive services from such providers at a rate equal to the rate negotiated between such entity and the provider involved or, if such a rate has not been negotiated, at a rate that is not less than the level and amount of payment which the entity would make for the services if the services were fur- nished by a participating provider which is not an Indian health care provider. The Secretary shall establish procedures for applying the requirements of clause (i) in States where there are no or few Indian health providers. (B) Prompt payment To agree to make prompt payment (con- sistent with rule for prompt payment of pro- viders under section 1396u–2(f) of this title) to Indian health care providers that are par- ticipating providers with respect to such en- tity or, in the case of an entity to which sub- paragraph (A)(ii) or (C) applies, that the en- tity is required to pay in accordance with that subparagraph. Page 4375 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 2 So in original. Probably should be section ‘‘438.3(s)(4)’’ and second parenthesis probably should not appear. 3 So in original. Probably should be section ‘‘438.3(s)(5)’’. (C) Application of special payment require- ments for federally-qualified health cen- ters and for services provided by certain Indian health care providers (i) Federally-qualified health centers (I) Managed care entity payment require- ment To agree to pay any Indian health care provider that is a federally-qualified health center under this subchapter but not a participating provider with respect to the entity, for the provision of cov- ered Medicaid managed care services by such provider to an Indian enrollee of the entity at a rate equal to the amount of payment that the entity would pay a federally-qualified health center that is a participating provider with respect to the entity but is not an Indian health care provider for such services. (II) Continued application of State re- quirement to make supplemental payment Nothing in subclause (I) or subpara- graph (A) or (B) shall be construed as waiving the application of section 1396a(bb)(5) of this title regarding the State plan requirement to make any sup- plemental payment due under such sec- tion to a federally-qualified health cen- ter for services furnished by such center to an enrollee of a managed care entity (regardless of whether the federally- qualified health center is or is not a par- ticipating provider with the entity). (ii) Payment rate for services provided by certain Indian health care providers If the amount paid by a managed care entity to an Indian health care provider that is not a federally-qualified health center for services provided by the pro- vider to an Indian enrollee with the man- aged care entity is less than the rate that applies to the provision of such services by the provider under the State plan, the plan shall provide for payment to the Indian health care provider, whether the provider is a participating or nonparticipating pro- vider with respect to the entity, of the dif- ference between such applicable rate and the amount paid by the managed care enti- ty to the provider for such services. (D) Construction Nothing in this paragraph shall be con- strued as waiving the application of section 1396a(a)(30)(A) of this title (relating to appli- cation of standards to assure that payments are consistent with efficiency, economy, and quality of care). (3) Special rule for enrollment for Indian man- aged care entities Regarding the application of a Medicaid managed care program to Indian Medicaid managed care entities, an Indian Medicaid managed care entity may restrict enrollment under such program to Indians in the same manner as Indian Health Programs may re- strict the delivery of services to Indians. (4) Definitions For purposes of this subsection: (A) Indian health care provider The term ‘‘Indian health care provider’’ means an Indian Health Program or an Urban Indian Organization. (B) Indian Medicaid managed care entity The term ‘‘Indian Medicaid managed care entity’’ means a managed care entity that is controlled (within the meaning of the last sentence of section 1396b(m)(1)(C) of this title) by the Indian Health Service, a Tribe, Tribal Organization, or Urban Indian Organi- zation, or a consortium, which may be com- posed of 1 or more Tribes, Tribal Organiza- tions, or Urban Indian Organizations, and which also may include the Service. (C) Non-Indian Medicaid managed care enti- ty The term ‘‘non-Indian Medicaid managed care entity’’ means a managed care entity that is not an Indian Medicaid managed care entity. (D) Covered Medicaid managed care services The term ‘‘covered Medicaid managed care services’’ means, with respect to an indi- vidual enrolled with a managed care entity, items and services for which benefits are available with respect to the individual under the contract between the entity and the State involved. (E) Medicaid managed care program The term ‘‘Medicaid managed care pro- gram’’ means a program under sections 1396b(m), 1396d(t), and 1396u–2 of this title and includes a managed care program oper- ating under a waiver under section 1396n(b) or 1315 of this title or otherwise. (i) Drug utilization review activities and require- ments Beginning not later than October 1, 2019, each contract under a State plan with a managed care entity (other than a primary care case manager) under section 1396b(m) of this title shall provide that the entity is in compliance with the applicable provisions of section 438.3(s)(2) of title 42, Code of Federal Regula- tions, section 483.3(s)(4)) 2 of such title, and sec- tion 483.3(s)(5) 3 of such title, as such provisions were in effect on March 31, 2018. (Aug. 14, 1935, ch. 531, title XIX, § 1932, as added and amended Pub. L. 105–33, title IV, §§ 4701(a), 4704(a), 4705(a), 4707(a), 4708(c), Aug. 5, 1997, 111 Stat. 489, 495, 498, 501, 506; Pub. L. 106–113, div. B, § 1000(a)(6) [title VI, § 608(w)], Nov. 29, 1999, 113 Stat. 1536, 1501A–398; Pub. L. 106–554, § 1(a)(6) [title VII, § 701(b)(1)], Dec. 21, 2000, 114 Stat. 2763, 2763A–570; Pub. L. 109–171, title VI, § 6085(a), Feb. 8, 2006, 120 Stat. 121; Pub. L. 111–5, div. B, title V, § 5006(d)(1), Feb. 17, 2009, 123 Stat. 507; Pub. L. 111–152, title I, § 1202(a)(2), Mar. 30, 2010, 124 Stat. 1053; Pub. L. 114–255, div. A, title V, § 5005(a)(2), Page 4376 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–2 (b)(2), Dec. 13, 2016, 130 Stat. 1192, 1193; Pub. L. 115–271, title I, § 1004(a)(3), Oct. 24, 2018, 132 Stat. 3911; Pub. L. 116–260, div. BB, title II, § 203(a)(4)(A), Dec. 27, 2020, 134 Stat. 2917; Pub. L. 117–328, div. FF, title V, § 5123(a), Dec. 29, 2022, 136 Stat. 5944.) AMENDMENT OF SUBSECTION (a)(5) Pub. L. 117–328, div. FF, title V, § 5123(a), (d), Dec. 29, 2022, 136 Stat. 5944, 5946, provided that, effective July 1, 2025, subsection (a)(5) of this section is amended as follows: (1) in subparagraph (B)(i), by inserting ‘‘, including as required by subparagraph (E)’’ before the period at the end; and (2) by adding at the end the following new subparagraph: (E) Provider directories (i) In general Each managed care organization, prepaid inpatient health plan (as defined by the Sec- retary), prepaid ambulatory health plan (as defined by the Secretary), and, when appro- priate, primary care case management entity (as defined by the Secretary) with a contract with a State to enroll individuals who are eli- gible for medical assistance under the State plan under this subchapter or under a waiver of such plan, shall publish (and update on at least a quarterly basis or more frequently as required by the Secretary) on a public website, a searchable directory of network providers, which shall include physicians, hospitals, pharmacies, providers of mental health services, providers of substance use disorder services, providers of long term serv- ices and supports as appropriate, and such other providers as required by the Secretary, and that includes with respect to each such provider— (I) the name of the provider; (II) the specialty of the provider; (III) the address at which the provider provides services; (IV) the telephone number of the pro- vider; and (V) information regarding— (aa) the provider’s cultural and lin- guistic capabilities, including languages (including American Sign Language) of- fered by the provider or by a skilled med- ical interpreter who provides interpreta- tion services at the provider’s office; (bb) whether the provider is accepting as new patients, individuals who receive medical assistance under this subchapter; (cc) whether the provider’s office or fa- cility has accommodations for individuals with physical disabilities, including of- fices, exam rooms, and equipment; (dd) the Internet website of such pro- vider, if applicable; and (ee) whether the provider offers covered services via telehealth; and (VI) other relevant information, as re- quired by the Secretary. (ii) Network provider defined In this subparagraph, the term ‘‘network provider’’ includes any provider, group of providers, or entity that has a network pro- vider agreement with a managed care organi- zation, a prepaid inpatient health plan (as defined by the Secretary), a prepaid ambula- tory health plan (as defined by the Sec- retary), or a primary care case management entity (as defined by the Secretary) or a sub- contractor of any such entity or plan, and re- ceives payment under this subchapter directly or indirectly to order, refer, or render covered services as a result of the State’s contract with the entity or plan. For purposes of this subparagraph, a network provider shall not be considered to be a subcontractor by virtue of the network provider agreement. See 2022 Amendment notes below. Editorial Notes REFERENCES IN TEXT Section 4(c) of the Indian Health Care Improvement Act of 1976, referred to in subsec. (a)(2)(C), probably means section 4(c) of the Indian Health Care Improve- ment Act, which was redesignated section 4(13) of the Act by Pub. L. 111–148, title X, § 10221(a), Mar. 23, 2010, 124 Stat. 935, and is classified to section 1603(13) of Title 25, Indians. The Indian Self-Determination Act, referred to in subsec. (a)(2)(C)(ii), is title I of Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2206, which is classified principally to sub- chapter I (§ 5321 et seq.) of chapter 46 of Title 25, Indi- ans. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables. The Indian Health Care Improvement Act, referred to in subsec. (a)(2)(C)(iii), is Pub. L. 94–437, Sept. 30, 1976, 90 Stat. 1400. Title V of the Act is classified generally to subchapter IV (§ 1651 et seq.) of chapter 18 of Title 25. For complete classification of this Act to the Code, see Short Title note set out under section 1601 of Title 25 and Tables. Section 9517(c)(3) of the Omnibus Budget Reconcili- ation Act of 1985, referred to in subsec. (a)(3)(C)(i)(II), is section 9517(c)(3) of Pub. L. 99–272, which is set out as a note under section 1396b of this title. The Employee Retirement Income Security Act of 1974, referred to in subsec. (b)(3)(B), is Pub. L. 93–406, Sept. 2, 1974, 88 Stat. 832, which is classified principally to chapter 18 (§ 1001 et seq.) of Title 29, Labor. For com- plete classification of this Act to the Code, see Short Title note set out under section 1001 of Title 29 and Ta- bles. The Public Health Service Act, referred to in subsec. (b)(8), is act July 1, 1944, ch. 373, 58 Stat. 682. Subpart 2 of part A of title XXVII of the Act may refer to sub- part II of part A of subchapter XXV of chapter 6A of this title. Pub. L. 111–148, title I, §§ 1001(5), 1563(c)(2), (11), formerly § 1562(c)(2), (11), title X, § 10107(b)(1), Mar. 23, 2010, 124 Stat. 130, 265, 268, 911, amended part A by inserting ‘‘SUBPART II—IMPROVING COVERAGE’’ (pre- ceding section 300gg–11 of this title), by striking out ‘‘SUBPART 2—OTHER REQUIREMENTS’’ (preceding section 300gg–4 of this title), and by redesignating subpart 4 as subpart 2 ‘‘EXCLUSION OF PLANS; ENFORCEMENT; PREEMP- TION’’ (preceding section 300gg–21 of this title). For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables. Executive Order No. 12549, referred to in subsec. (d)(1)(C)(i), is set out as a note under section 6101 of Title 31, Money and Finance. CODIFICATION In subsec. (d)(3), ‘‘chapter 21 of title 41’’ substituted for ‘‘section 27 of the Office of Federal Procurement Policy Act (41 U.S.C. 423)’’ on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act en- acted Title 41, Public Contracts. Page 4377 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396u–3 PRIOR PROVISIONS A prior section 1932 of act Aug. 14, 1935, was renum- bered section 1939 and is classified to section 1396v of this title. AMENDMENTS 2022—Subsec. (a)(5)(B)(i). Pub. L. 117–328, § 5123(a)(1), inserted ‘‘, including as required by subparagraph (E)’’ before period at end. Subsec. (a)(5)(E). Pub. L. 117–328, § 5123(a)(2), added subpar. (E). 2020—Subsec. (b)(8). Pub. L. 116–260 inserted at end ‘‘In applying the previous sentence with respect to re- quirements under paragraph (8) of section 300gg–26(a) of this title, a Medicaid managed care organization (or a prepaid inpatient health plan (as defined by the Sec- retary) or prepaid ambulatory health plan (as defined by the Secretary) that offers services to enrollees of a Medicaid managed care organization) shall be treated as in compliance with such requirements if the Med- icaid managed care organization (or prepaid inpatient health plan or prepaid ambulatory health plan) is in compliance with subpart K of part 438 of title 42, Code of Federal Regulations, and section 438.3(n) of such title, or any successor regulation.’’ 2018—Subsec. (i). Pub. L. 115–271 added subsec. (i). 2016—Subsec. (d)(5). Pub. L. 114–255, § 5005(a)(2), added par. (5). Subsec. (d)(6). Pub. L. 114–255, § 5005(b)(2), added par. (6). 2010—Subsec. (f). Pub. L. 111–152 inserted ‘‘; adequacy of payment for primary care services’’ after ‘‘payment’’ in heading and ‘‘and, in the case of primary care serv- ices described in section 1396a(a)(13)(C) of this title, consistent with the minimum payment rates specified in such section (regardless of the manner in which such payments are made, including in the form of capitation or partial capitation)’’ before period at end of text. 2009—Subsec. (h). Pub. L. 111–5 added subsec. (h). 2006—Subsec. (b)(2)(D). Pub. L. 109–171 added subpar. (D). 2000—Subsec. (g). Pub. L. 106–554 added subsec. (g). 1999—Subsec. (c)(2)(C). Pub. L. 106–113, § 1000(a)(6) [title VI, § 608(w)(1)], inserted ‘‘part’’ before ‘‘C of sub- chapter XVIII’’. Subsec. (d)(1)(C)(ii). Pub. L. 106–113, § 1000(a)(6) [title VI, § 608(w)(2)(A)], substituted ‘‘Regulation’’ for ‘‘Act’’. Subsec. (d)(2)(B). Pub. L. 106–113, § 1000(a)(6) [title VI, § 608(w)(2)(B)], substituted ‘‘1396d(t)(3) of this title’’ for ‘‘1396b(t)(3) of this title’’. 1997—Subsec. (b). Pub. L. 105–33, § 4704(a), added sub- sec. (b). Subsec. (c). Pub. L. 105–33, § 4705(a), added subsec. (c). Subsecs. (d), (e). Pub. L. 105–33, § 4707(a), added sub- secs. (d) and (e). Subsec. (f). Pub. L. 105–33, § 4708(c), added subsec. (f). Statutory Notes and Related Subsidiaries CHANGE OF NAME References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of Pub. L. 108–173, set out as a note under section 1395w–21 of this title. EFFECTIVE DATE OF 2022 AMENDMENT Amendment by Pub. L. 117–328 effective July 1, 2025, see section 5123(d) of Pub. L. 117–328, set out as a note under section 1396a of this title. EFFECTIVE DATE OF 2009 AMENDMENT Amendment by Pub. L. 111–5 effective July 1, 2009, see section 5006(f) of Pub. L. 111–5, set out as a note under section 1396a of this title. EFFECTIVE DATE OF 2006 AMENDMENT Pub. L. 109–171, title VI, § 6085(b), Feb. 8, 2006, 120 Stat. 121, provided that: ‘‘The amendment made by sub- section (a) [amending this section] shall take effect on January 1, 2007.’’ EFFECTIVE DATE OF 2000 AMENDMENT Pub. L. 106–554, § 1(a)(6) [title VII, § 701(b)(3)(A)], Dec. 21, 2000, 114 Stat. 2763, 2763A–570, provided that: ‘‘The amendment made by paragraph (1) [amending this sec- tion] shall apply to contracts as of January 1, 2001.’’ EFFECTIVE DATE Section effective Aug. 5, 1997, and applicable to con- tracts entered into or renewed on or after Oct. 1, 1997, except that, subject to provisions relating to extension of effective date for State law amendments, and to non- application to waivers, subsec. (c)(1) effective Jan. 1, 1999, and subsec. (e) applicable to contracts entered into or renewed on or after Apr. 1, 1998, see section 4710(a), (b)(3), (5) of Pub. L. 105–33, set out as an Effec- tive Date of 1997 Amendment note under section 1396b of this title. CONSTRUCTION OF 2016 AMENDMENT Nothing in amendment by Pub. L. 114–255 to be con- strued as changing or limiting the appeal rights of pro- viders or the process for appeals of States under the So- cial Security Act, see section 5005(d) of Pub. L. 114–255, set out as a note under section 1396a of this title. STUDIES AND REPORTS Pub. L. 105–33, title IV, § 4705(c), Aug. 5, 1997, 111 Stat. 500, provided that: ‘‘(1) GAO STUDY AND REPORT ON QUALITY ASSURANCE AND ACCREDITATION STANDARDS.— ‘‘(A) STUDY.—The Comptroller General of the United States shall conduct a study and analysis of the quality assurance programs and accreditation standards applicable to managed care entities oper- ating in the private sector, or to such entities that operate under contracts under the medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.). Such study shall determine— ‘‘(i) if such programs and standards include con- sideration of the accessibility and quality of the health care items and services delivered under such contracts to low-income individuals; and ‘‘(ii) the appropriateness of applying such pro- grams and standards to medicaid managed care or- ganizations under section 1932(c) of such Act [42 U.S.C. 1396u–2(c)]. ‘‘(B) REPORT.—The Comptroller General shall sub- mit a report to the Committee on Commerce [now Committee on Energy and Commerce] of the House of Representatives and the Committee on Finance of the Senate on the study conducted under subparagraph (A). ‘‘(2) STUDY AND REPORT ON SERVICES PROVIDED TO INDI- VIDUALS WITH SPECIAL HEALTH CARE NEEDS.— ‘‘(A) STUDY.—The Secretary of Health and Human Services, in consultation with States, managed care organizations, the National Academy of State Health Policy, representatives of beneficiaries with special health care needs, experts in specialized health care, and others, shall conduct a study concerning safe- guards (if any) that may be needed to ensure that the health care needs of individuals with special health care needs and chronic conditions who are enrolled with medicaid managed care organizations are ade- quately met. ‘‘(B) REPORT.—Not later than 2 years after the date of the enactment of this Act [Aug. 5, 1997], the Sec- retary shall submit to Committees described in para- graph (1)(B) a report on such study.’’ § 1396u–3. State coverage of medicare cost-shar- ing for additional low-income medicare bene- ficiaries (a) In general A State plan under this subchapter shall pro- vide, under section 1396a(a)(10)(E)(iv) of this