§ 1396u-2. Provisions relating to managed care
(a)
State option to use managed care
(1)
Use of medicaid managed care organizations and primary care case managers
(A)
In general
Subject to the succeeding provisions of this section, and notwithstanding paragraph (1), (10)(B), or (23)(A) of section
1396a
(a) of this title, a State—
(i)
may require an individual who is eligible 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 respect to assistance furnished by or under arrangements with such entity, to receive such assistance through the entity), if—
(B)
“Managed care entity” defined
In this section, the term “managed care entity” means—
(2)
Special rules
(A)
Exemption of certain children with special 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—
(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) 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):
(3)
Choice of coverage
(B)
State option
At the option of the State, a State shall be considered to meet the requirements of subparagraph (A) in the case of an individual residing in a rural area, if the State requires the individual to enroll with a managed care entity if 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 individual eligible for medical assistance under the State plan under this subchapter who is enrolled with the entity under this subchapter to terminate (or change) such enrollment—
(B)
Notice of termination rights
The State shall provide for notice to each such individual of the opportunity to terminate (or change) enrollment under such conditions. 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 enrollment priorities in the case of a managed care entity that does not have sufficient capacity 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 process—
(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
(5)
Provision of information
(A)
Information in easily understood form
Each State, enrollment broker, or managed 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 eligible for medical assistance under the State plan under this subchapter.
(B)
Information to enrollees and potential enrollees
Each managed care entity that is a medicaid managed care organization shall, upon request, make available to enrollees and potential enrollees in the organization’s service area information concerning the following:
(i)
Providers
The identity, locations, qualifications, and availability of health care providers that participate with the organization.
(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 services
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 method of referral and prior authorization. Each managed care entity that is a primary care case manager shall, upon request, make available to enrollees and potential 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) provide, 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:
(D)
Information on benefits not covered under managed care arrangement
A State, directly or through managed care entities, shall, on or before an individual enrolls with such an entity under this subchapter, 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 information shall include information on where and how such enrollees may access benefits not made available to the enrollee through the entity.
(b)
Beneficiary protections
(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 manager, and
(ii)
to comply with guidelines established under section
1395w–22
(d)(2) of this title (respecting coordination of post-stabilization care) in the same manner as such guidelines apply to Medicare+Choice plans offered under part C of subchapter XVIII of this chapter.
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 “emergency services” means, with respect to an individual enrolled with an organization, covered inpatient and outpatient services that—
(C)
“Emergency medical condition” defined
In subparagraph (B)(ii), the term “emergency medical condition” means a medical condition manifesting itself by acute symptoms 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—
(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 establishes payment amounts for services furnished to a beneficiary enrolled in the entity’s Medicaid managed care plan must accept 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 communications
(A)
In general
Subject to subparagraphs (B) and (C), under a contract under section
1396b
(m) of this title a medicaid managed care organization (in relation to an individual enrolled under the contract) shall not prohibit or otherwise restrict a covered health care professional (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 organization to provide, reimburse for, or provide coverage of, a counseling or referral service if the organization—
(ii)
in the manner and through the written instrumentalities such organization deems appropriate, makes available information on its policies regarding such service to prospective enrollees before or during 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.
(C)
“Health care professional” defined
For purposes of this paragraph, the term “health care professional” means a physician (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 professional. Such term includes a podiatrist, optometrist, chiropractor, psychologist, dentist, physician assistant, physical or occupational therapist and therapy assistant, speech-language pathologist, audiologist, registered or licensed practical nurse (including nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, and certified nurse-midwife), licensed certified social worker, registered respiratory therapist, and certified respiratory 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 determined by the Secretary) that the organization, with respect to a service area, has the capacity to serve the expected enrollment in such service area, including assurances that the organization—
(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 organization may not be held liable—
(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 applicable State law, solely on the basis of such license 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 organization’s enrollees or from establishing any measure 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 [42 U.S.C. 300gg–4 et seq.] insofar as such requirements apply and are effective with respect to a health insurance issuer that offers group health insurance coverage.
(c)
Quality assurance standards
(1)
Quality assessment and improvement strategy
(A)
In general
If a State provides for contracts with medicaid managed care organizations under section
1396b
(m) of this title, the State shall develop 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 covered services are available within reasonable timeframes and in a manner that ensures continuity of care and adequate primary care and specialized services capacity.
(ii)
Other measures
Examination of other aspects of care and service directly related to the improvement of quality of care (including grievance procedures and marketing and information standards).
(iii)
Monitoring procedures
Procedures for monitoring and evaluating the quality and appropriateness of care and services to enrollees that reflect the full spectrum of populations enrolled under the contract and that includes requirements for provision of quality assurance data to the State using the data and information set that the Secretary has specified for use under part C of subchapter XVIII of this chapter or such alternative data as the Secretary approves, in consultation with the State.
(B)
Standards
The strategy developed under subparagraph (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 quality assurance established under this subparagraph.
(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 review conducted by a qualified independent entity of the quality outcomes and timeliness of, and access to, the items and services for which the organization is responsible under the contract. The requirement for such a review shall not apply until after the date that the Secretary establishes 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 review organization (such as the National Committee for Quality Assurance) to develop 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 enrollees 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 external review conducted under section
1395w–22
(e)(3) of this title, the external review activities conducted under subparagraph (A) with respect to the organization shall not be duplicative of review activities conducted as part of the accreditation process or the external review conducted under such section.
(C)
Deemed compliance for medicare managed care organizations
At the option of a State, the requirements of subparagraph (A) shall not apply with respect to a medicaid managed care organization if the organization is an eligible organization with a contract in effect under section
1395mm of this title or a Medicare+Choice organization with a contract in effect under part C of subchapter XVIII of this chapter and the organization 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 knowingly—
(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—
(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 consultation with the Inspector General of the Department of Health and Human Services) provides to the State and to Congress a written statement describing compelling reasons that exist for renewing or extending the agreement.
(C)
Persons described
A person is described in this subparagraph if such person—
(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 materials within any State—
The requirement of subclause (I) shall not apply with respect to a State until such date as the Secretary specifies in consultation with such State.
(C)
Prohibition of tie-ins
A managed care entity, or any agency of such entity, may not seek to influence an individual’s enrollment with the entity in conjunction with the sale of any other insurance.
(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 entity, the individual is provided accurate oral and written information sufficient to make an informed decision whether or not to enroll.
(3)
State conflict-of-interest safeguards in medicaid 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 contracts with such organizations or to the default enrollment process described in subsection (a)(4)(C)(ii) of this section that are at least as effective as the Federal safeguards provided under section
423 of title
41, against conflicts of interest that apply with respect to Federal procurement officials with comparable responsibilities with respect to such contracts.
(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 contract under section
1396b
(m) of this title unless 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 medicaid managed care organization, which the State may impose against a medicaid managed care organization with such a contract, if the organization—
(i)
fails substantially to provide medically necessary items and services that are required (under law or under such organization’s contract with the State) to be provided to an enrollee covered under the contract;
(ii)
imposes premiums or charges on enrollees in excess of the premiums or charges permitted under this subchapter;
(iii)
acts to discriminate among enrollees on the basis of their health status or requirements for health care services, including 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 enrollment with the organization by eligible individuals whose medical condition or history indicates a need for substantial future medical services;
The State may also impose such intermediate sanction against a managed care entity 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) of this section.
(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 services if the organization does not provide such services as provided for under the contract.
(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 determination 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.
(B)
The appointment of temporary management—
(i)
to oversee the operation of the medicaid managed care organization upon a finding by the State that there is continued egregious behavior by the organization or there is a substantial risk to the health of enrollees; or
(C)
Permitting individuals enrolled with the managed care entity to terminate enrollment without cause, and notifying such individuals of such right to terminate enrollment.
(3)
Treatment of chronic substandard entities
In the case of a medicaid managed care organization which has repeatedly failed to meet the requirements of section
1396b
(m) of this title and this section, the State shall (regardless of what other sanctions are provided) impose 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 medical assistance under the State plan under this subchapter other than through a managed care entity).
(B)
Availability of hearing prior to termination of contract
A State may not terminate a contract with a managed care entity under subparagraph (A) unless the entity is provided with a hearing prior to the termination.
(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 provide the entity with notice and such other due process protections as the State may provide, except that a State may not provide a managed care entity with a pre-termination hearing before imposing the sanction described in paragraph (2)(B).
(f)
Timeliness of payment
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 organization 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 sc