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This part establishes State plan requirements for the designation, organization, and general administrative activities of a State agency responsible for operating the State Medicaid program, directly or through supervision of local administering agencies.
(a) Basis, purpose, and definitions. (1) This section implements section 1902(a)(4) and (5) of the Act.
(2) For purposes of this part—
Appeals decision means a decision made by a hearing officer adjudicating a fair hearing under subpart E of this part.
Exchange has the meaning given to the term in 45 CFR 155.20.
Exchange appeals entity has the meaning given to the term “appeals entity,” as defined in 45 CFR 155.500.
Medicaid agency is the single State agency for the Medicaid program.
(b) Designation and certification. A State plan must—
(1) Specify a single State agency established or designated to administer or supervise the administration of the plan; and
(2) Include a certification by the State Attorney General, citing the legal authority for the single State agency to—
(i) Administer or supervise the administration of the plan; and
(ii) Make rules and regulations that it follows in administering the plan or that are binding upon local agencies that administer the plan.
(3) The single State agency is responsible for determining eligibility for all individuals applying for or receiving benefits in accordance with regulations in part 435 of this chapter and for fair hearings filed in accordance with subpart E of this part.
(c) Delegations. (1) Subject to the requirement in paragraph (c)(2) of this section, the Medicaid agency—
(i)(A) May, in the approved state plan, delegate authority to determine eligibility for all or a defined subset of individuals to—
( 1 ) The single State agency for the financial assistance program under title IV-A (in the 50 States or the District of Columbia), or under title I or XVI (AABD), in Guam, Puerto Rico, or the Virgin Islands;
( 2 ) The separate Children's Health Insurance Program agency;
( 3 ) The Basic Health Program agency;
( 4 ) The Federal agency administering the supplemental security income program under title XVI of the Act; or
( 5 ) The Exchange.
(B) Must in the approved state plan specify to which agency, and the individuals for which, authority to determine eligibility is delegated.
(ii) Delegate authority to conduct fair hearings under subpart E of this part for denials of eligibility for individuals whose income eligibility is determined based on the applicable modified adjusted gross income standard described in § 435.911(c) of this chapter, to an Exchange or Exchange appeals entity, provided that individuals who have requested a fair hearing of such a denial are given a choice to have their fair hearing instead conducted by the Medicaid agency.
(2) The Medicaid agency may delegate authority to make eligibility determinations or to conduct fair hearings under this section only to a government agency which maintains personnel standards on a merit basis.
(3) The Medicaid agency—
(i) Must ensure that any agency to which eligibility determinations or appeals decisions are delegated—
(A) Complies with all relevant Federal and State law, regulations and policies, including, but not limited to, those related to the eligibility criteria applied by the agency under part 435 of this chapter; prohibitions against conflicts of interest and improper incentives; and safeguarding confidentiality, including regulations set forth at subpart F of this part.
(B) Informs applicants and beneficiaries how they can directly contact and obtain information from the agency; and
(ii) Must exercise appropriate oversight over the eligibility determinations and appeals decisions made by such agencies to ensure compliance with paragraphs (c)(2) and (c)(3)(i) of this section and institute corrective action as needed, including, but not limited to, rescission of the authority delegated under this section.
(iii) If authority to conduct fair hearings is delegated to the Exchange or Exchange appeals entity under paragraph (c)(1)(ii) of this section, the agency may establish a review process whereby the agency may review fair hearing decisions made under that delegation, but that review will be limited to the proper application of federal and state Medicaid law and regulations, including sub-regulatory guidance and written interpretive policies, and must be conducted by an impartial official not directly involved in the initial determination.
(d) Agreement with Federal, State or local entities making eligibility determinations or appeals decisions. The plan must provide for written agreements between the Medicaid agency and the Exchange or any other State or local agency that has been delegated authority under paragraph (c)(1)(i) of this section to determine Medicaid eligibility and for written agreements between the agency and the Exchange or Exchange appeals entity that has been delegated authority to conduct Medicaid fair hearings under paragraph (c)(1)(ii) of this section. Such agreements must be available to the Secretary upon request and must include provisions for:
(1) The relationships and respective responsibilities of the parties, including but not limited to the respective responsibilities to effectuate the fair hearing rules in subpart E of this part;
(2) Quality control and oversight by the Medicaid agency, including any reporting requirements needed to facilitate such control and oversight;
(3) Assurances that the entity to which authority to determine eligibility or conduct fair hearings will comply with the provisions set forth in paragraph (c)(3) of this section.
(4) For appeals, procedures to ensure that individuals have notice and a full opportunity to have their fair hearing conducted by either the Exchange or Exchange appeals entity or the Medicaid agency.
(e) Authority of the single State agency. The Medicaid agency may not delegate, to other than its own officials, the authority to supervise the plan or to develop or issue policies, rules, and regulations on program matters.
(a) Basis and purpose. This section, based on section 1902(a)(4) of the Act, prescribes the general organization and staffing requirements for the Medicaid agency and the State plan.
(b) Description of organization. (1) The plan must include a description of the organization and functions of the Medicaid agency.
(2) When submitting a state plan amendment related to the designation, authority, organization or functions of the Medicaid agency, the Medicaid agency must provide an organizational chart reflecting the key components of the Medicaid agency and the functions each performs.
(c) Eligibility determined or fair hearings decided by other entities. If eligibility is determined or fair hearings decided by Federal or State entities other than the Medicaid agency or by local agencies under the supervision of other State agencies, the plan must include a description of the staff designated by those other entities and the functions they perform in carrying out their responsibilities.
(a) Basis and purpose. This section, based on section 1902(a)(4) of the Act, prescribes State Plan requirements for establishment and ongoing operation of a public Medicaid Advisory Committee (MAC) with a dedicated Beneficiary Advisory Council (BAC) comprised of current and former Medicaid beneficiaries, their family members, and caregivers, to advise the State Medicaid agency on matters of concern related to policy development, and matters related to the effective administration of the Medicaid program.
(b) State plan requirement. The State plan must provide for a MAC and a BAC that will advise the director of the single State Agency for the Medicaid program on matters of concern related to policy development and matters related to the effective administration of the Medicaid program.
(c) Selection of members. The Director of the single State Agency for the Medicaid program must select members for the MAC and BAC for a term of length determined by the State, which may not be followed immediately by a consecutive term for the same member, on a rotating and continuous basis. The State must create a process for recruitment and selection of members and publish this information on the State's website as specified in paragraph (f).
(d) MAC membership and composition. The membership of the MAC must be composed of the following percentage and representative categories of interested parties in the State:
(1) For the period from July 9, 2025 through July 9, 2026, 10 percent of the MAC members must come from the BAC; for the period from July 10, 2026 through July 9, 2027, 20 percent of MAC members must come from the BAC; and thereafter, 25 percent of MAC members must come from the BAC.
(2) The remaining committee members must include representation of at least one from each of the following categories:
(A) State or local consumer advocacy groups or other community-based organizations that represent the interests of, or provide direct service, to Medicaid beneficiaries.
(B) Clinical providers or administrators who are familiar with the health and social needs of Medicaid beneficiaries and with the resources available and required for their care. This includes providers or administrators of primary care, specialty care, and long-term care.
(C) As applicable, participating Medicaid MCOs, PIHPs, PAHPs, PCCM entities or PCCMs as defined in § 438.2, or a health plan association representing more than one such plans; and
(D) Other State agencies that serve Medicaid beneficiaries (for example, foster care agency, mental health agency, health department, State agencies delegated to conduct eligibility determinations for Medicaid, State Unit on Aging), as ex-officio, non-voting members.
(e) Beneficiary Advisory Council. The State must form and support a BAC, which can be an existing beneficiary group, that is comprised of: individuals who are currently or have been Medicaid beneficiaries and individuals with direct experience supporting Medicaid beneficiaries (family members and paid or unpaid caregivers of those enrolled in Medicaid), to advise the State regarding their experience with the Medicaid program, on matters of concern related to policy development and matters related to the effective administration of the Medicaid program.
(1) The MAC members described in paragraph (d)(1) of this section must also be members of the BAC.
(2) The BAC must meet separately from the MAC, on a regular basis, and in advance of each MAC meeting to ensure BAC member preparation for each MAC meeting.
(f) MAC and BAC administration. The State agency must create standardized processes and practices for the administration of the MAC and the BAC that are available for public review on the State website. The State agency must—
(1) Develop and publish, by posting publicly on its website, bylaws for governance of the MAC and BAC along with a current list of members. States will also post publicly the past meeting minutes of the MAC and BAC meetings, including a list of meeting attendees. States will give BAC members the option to include their names in the membership list and meeting minutes that will be posted publicly.
(2) Develop and publish by posting publicly on its website a process for MAC and BAC member recruitment and selection along with a process for selection of MAC and BAC leadership;
(3) Develop, publish by posting publicly on its website, and implement a regular meeting schedule for the MAC and BAC; the MAC and BAC must each meet at least once per quarter and hold off-cycle meetings as needed. Each MAC and BAC meeting agenda must include a time for members and the public (if applicable) to disclose conflicts of interest.
(4) Make at least two MAC meetings per year open to the public and those meetings must include a dedicated time during the meeting for the public to make comments. BAC meetings are not required to be open to the public, unless the State's BAC members decide otherwise. The public must be adequately notified of the date, location, and time of each public MAC meeting and any public BAC meeting at least 30 calendar days in advance of the date of the meeting.
(5) Offer a rotating, variety of meeting attendance options. These meeting options are: all in-person attendance, all virtual attendance, and hybrid (in person and virtual) attendance options. Regardless of which attendance type of meeting it is, States are required to always have, at a minimum, telephone dial-in option at the MAC and BAC meetings for its members. If the MAC or BAC meeting is deemed open to the public, the State must offer at a minimum a telephone dial-in option for members of the public;
(6) Ensure that the meeting times and locations for MAC and BAC meetings are selected to maximize member attendance and may vary by meeting; and
(7) Facilitate participation of beneficiaries by ensuring that that meetings are accessible to people with disabilities, that reasonable modifications are provided when necessary to ensure access and enable meaningful participation, and communications with individuals with disabilities are as effective as with others, that reasonable steps are taken to provide meaningful access to individuals with Limited English Proficiency, and that meetings comply with the requirements at § 435.905(b) of this chapter and applicable regulations implementing the ADA, Title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act, and section 1557 of the Affordable Care Act at 28 CFR part 35 and 45 CFR parts 80, 84 and 92, respectively.
(g) MAC and BAC participation and scope. The MAC and BAC participants must have the opportunity to advise the director of the single State Agency for the Medicaid program on matters related to policy development and matters related to the effective administration of the Medicaid program. At a minimum, the MAC and BAC must determine, in collaboration with the State, which topics to provide advice on related to—
(1) Additions and changes to services;
(2) Coordination of care;
(3) Quality of services;
(4) Eligibility, enrollment, and renewal processes;
(5) Beneficiary and provider communications by State Medicaid agency and Medicaid MCOs, PIHPs, PAHPs, PCCM entities or PCCMs as defined in § 438.2;
(6) Cultural competency, language access, health equity, and disparities and biases in the Medicaid program;
(7) Access to services; and
(8) Other issues that impact the provision or outcomes of health and medical care services in the Medicaid program as determined by the MAC, BAC, or State.
(h) State agency staff assistance, participation, and financial help. The single State Agency for the Medicaid program must provide staff to support planning and execution of the MAC and the BAC to include—
(1) Recruitment of MAC and BAC members;
(2) Planning and execution of all MAC and BAC meetings and the production of meeting minutes that include actions taken or anticipated actions by the State in response to interested parties' feedback provided during the meeting. The minutes are to be posted on the State's website within 30 calendar days following each meeting. Additionally, the State must produce and post on its website an annual report as specified in paragraph (i) of this section; and
(3) The provision of appropriate support and preparation (providing research or other information needed) to the MAC and BAC members who are Medicaid beneficiaries to ensure meaningful participation. These tasks include—
(i) Providing staff whose responsibilities are to facilitate MAC and BAC member engagement;
(ii) Providing financial support, if necessary, to facilitate Medicaid beneficiary engagement in the MAC and the BAC; and
(iii) Attendance by at least one staff member from the single State Agency for the Medicaid program's executive staff at all MAC and BAC meetings.
(i) Annual report. The MAC, with support from the State, must submit an annual report describing its activities, topics discussed, and recommendations. The State must review the report and include responses to the recommended actions. The State agency must then—
(1) Provide MAC members with final review of the report;
(2) Ensure that the annual report of the MAC includes a section describing the activities, topics discussed, and recommendations of the BAC, as well as the State's responses to the recommendations; and
(3) Post the report to the State's website. States have 2 years from July 9, 2024 to finalize the first annual MAC report. After the report has been finalized, States will have 30 days to post the annual report.
(j) Federal financial participation. FFP is available at 50 percent of expenditures for the MAC and BAC activities.
(k) Applicability dates. Except as noted in paragraphs (d)(1) and (i)(3) of this section, the requirements in paragraphs (a) through (j) of this section are applicable July 9, 2025.
A State plan must provide for methods of administration that are found by the Secretary to be necessary for the proper and efficient operation of the plan.
A State plan must provide that the Medicaid agency will—
(a) Submit all reports required by the Secretary;
(b) Follow the Secretary's instructions with regard to the form and content of those reports; and
(c) Comply with any provisions that the Secretary finds necessary to verify and assure the correctness of the reports.
(a) Basis and purpose. This section, based on section 1902(a)(4) of the Act, prescribes the kinds of records a Medicaid agency must maintain, the minimum retention period for such records, and the conditions under which those records must be provided or made available.
(b) Content of records. A State plan must provide that the Medicaid agency will maintain or supervise the maintenance of the records necessary for the proper and efficient operation of the plan. The records must include all of the following:
(1) Individual records on each applicant and beneficiary that contain all of the following:
(i) All information provided on the initial application submitted through any modality described in § 435.907 of this chapter by, or on behalf of, the applicant or beneficiary, including the signature on and date of application.
(ii) The electronic account and any information or other documentation received from another insurance affordability program in accordance with § 435.1200(c) and (d) of this chapter.
(iii) The date of, basis for, and all documents or other evidence to support any determination, denial, or other adverse action, including decisions made at application, renewal, and as a result of a change in circumstance, taken with respect to the applicant or beneficiary, including all information provided by, or on behalf of, the applicant or beneficiary, and all information obtained electronically or otherwise by the agency from third-party sources.
(iv) The provision of, and payment for, services, items and other medical assistance, including the service or item provided, relevant diagnoses, the date that the service or item was provided, the practitioner or provider rendering, providing or prescribing the service or item, including their National Provider Identifier, and the full amount paid or reimbursed for the service or item, and any third-party liabilities.
(v) Any changes in circumstances reported by the individual and any actions taken by the agency in response to such reports.
(vi) All renewal forms and documentation returned by, or on behalf of, a beneficiary, to the Medicaid agency in accordance with § 435.916 of this chapter, regardless of the modality through which such forms are submitted, including the signature on the form and date received.
(vii) All notices provided to the applicant or beneficiary in accordance with § 431.206 and §§ 435.917 and 435.918 of this chapter.
(viii) All records pertaining to any fair hearings requested by, or on behalf of, the applicant or beneficiary, including each request submitted and the date of such request, the complete record of the hearing decision, as described in § 431.244(b), and the final administrative action taken by the agency following the hearing decision and date of such action.
(ix) The disposition of income and eligibility verification information received under §§ 435.940 through 435.960 of this chapter, including evidence that no information was returned from an electronic data source.
(2) Statistical, fiscal, and other records necessary for reporting and accountability as required by the Secretary.
(c) Retention of records. The State plan must—
(1) Except as provided in paragraph (c)(2) of this section, provide that the records required under paragraph (b) of this section will be retained for the period when the applicant or beneficiary's case is active, plus a minimum of 3 years thereafter.
(2) For beneficiaries described in section 1917(a)(1)(B), (b)(1)(B) and (b)(1)(C) of the Act, provide that the records required under paragraph (b) of this section will be retained until the State has satisfied the requirements of section 1917(b) of the Act (relating to estate recovery).
(d) Accessibility and availability of records. The agency must—
(1) Maintain the records described in paragraph (b) of this section in an electronic format; and
(2) Consistent with paragraph (e) of this section, and to the extent permitted under Federal law, make the records available to the Secretary, Federal and State auditors and other parties who request and are authorized to review such records within 30 calendar days of the request (or longer period specified in the request), except when there is an administrative or other emergency beyond the agency's control.
(e) Release and safeguarding information. The agency must provide safeguards that restrict the use or disclosure of information contained in the records described in paragraph (b) of this section in accordance with the requirements set forth in subpart F of this part.
(a) Basis and purpose. This section, based on section 1902(a)(4) of the Act, prescribes State plan requirements for facilitating access to Medicaid rules and policies by individuals outside the State Medicaid agency.
(b) State plan requirements. A State plan must provide that the Medicaid agency meets the requirements of paragraphs (c) through (g) of this section.
(c) Availability in agency offices. (1) The agency must maintain, in all its offices, copies of its current rules and policies that affect the public, including those that govern eligibility, provision of medical assistance, covered services, and beneficiary rights and responsibilities.
(2) These documents must be available upon request for review, study, and reproduction by individuals during regular working hours of the agency.
(d) Availability through other entities. The agency must provide copies of its current rules and policies to—
(1) Public and university libraries;
(2) The local or district offices of the Bureau of Indian Affairs;
(3) Welfare and legal services offices; and
(4) Other entities that—
(i) Request the material in order to make it accessible to the public;
(ii) Are centrally located and accessible to a substantial number of the beneficiary population they serve; and
(iii) Agree to accept responsibility for filing all amendments or changes forwarded by the agency.
(e) Availability in relation to fair hearings. The agency must make available to an applicant or beneficiary, or his representative, a copy of the specific policy materials necessary—
(1) To determine whether to request a fair hearing; or
(2) To prepare for a fair hearing.
(f) Availability for other purposes. The agency must establish rules for making program policy materials available to individuals who request them for other purposes.
(g) Charges for reproduction. The agency must make copies of its program policy materials available without charge or at a charge related to the cost of reproduction.
(a) Basis and purpose. This section, based on section 1902(a) (57) and (58) of the Act, prescribes State plan requirements for the development and distribution of a written description of State law concerning advance directives.
(b) A State Plan must provide that the State, acting through a State agency, association, or other private nonprofit entity, develop a written description of the State law (whether statutory or as recognized by the courts of the State) concerning advance directives, as defined in § 489.100 of this chapter, to be distributed by Medicaid providers and health maintenance organizations (as specified in section 1903(m)(1)(A) of the Act) in accordance with the requirements under part 489, subpart I of this chapter. Revisions to the written descriptions as a result of changes in State law must be incorporated in such descriptions and distributed as soon as possible, but no later than 60 days from the effective date of the change in State law, to Medicaid providers and health maintenance organizations.
(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 beneficiaries who live in that area and chose to receive services from that HMO or rural health clinic. beneficiaries 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.
(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 beneficiaries 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 beneficiary 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 beneficiary 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 beneficiary.
This includes an organization that furnishes, or arranges for the furnishing of, Medicaid services on a prepayment basis.
(2) A beneficiary 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 beneficiaries' 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; or
(4) Limiting the providers who are available to furnish targeted case management services defined in § 440.169 of this chapter to target groups that consist solely of individuals with developmental disabilities or with chronic mental illness. This limitation may only be permitted so that the providers of case management services for eligible individuals with developmental disabilities or with chronic mental illness are capable of ensuring that those individuals receive needed services.
(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.
(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 beneficiary 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 beneficiary'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 beneficiaries 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 beneficiaries to and from providers; and
(b) Describe the methods that the agency will use to meet this requirement.
(a) Statutory basis —(1) 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.
(2) Section 1915(g) of the Act provides that a State may provide, as medical assistance, targeted case management services under the plan without regard to the requirements of sections 1902(a)(1) and 1902(a)(10)(B) of the Act.
(3) Section 1915(i) of the Act provides that a State may provide, as medical assistance, home and community-based services under an approved State plan amendment that meets certain requirements, without regard to the requirements of sections 1902(a)(10)(B) and 1902(a)(10)(C)(i)(III) of the Act, with respect to such services.
(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 beneficiaries 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 beneficiaries 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 beneficiaries.
(e) Lock-in of beneficiaries who over-utilize Medicaid services. If a Medicaid agency finds that a beneficiary 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 beneficiary 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 beneficiary notice and opportunity for a hearing (in accordance with procedures established by the agency) before imposing the restrictions.
(2) The agency ensures that the beneficiary 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 beneficiary.
(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 beneficiaries reasonable access (taking into account geographic location: and reasonable travel time) to Medicaid services of adequate quality, including emergency services.
(g) Targeted case management services. The requirements of § 431.50(b) relating to the statewide operation of a State plan and § 440.240 of this chapter related to comparability of services do not apply with respect to targeted case management services defined in § 440.169 of this chapter.
(h) State plan home and community-based services. The requirements of § 440.240 of this chapter related to comparability of services do not apply with respect to State plan home and community-based services defined in § 440.182 of this chapter.
(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 beneficiary. 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 beneficiaries 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 beneficiaries 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 beneficiaries the cost savings resulting from the beneficiaries' 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 beneficiary; and
(ii) Services expressly offered by the State as an inducement for beneficiaries 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 beneficiaries 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 beneficiaries residing at a long-term care facility when a restriction is imposed unless the State arranges for reasonable and adequate beneficiary 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.
(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) Application Programming Interface to support Medicaid beneficiaries. A State must implement and maintain a standards-based Application Programming Interface (API) that permits third-party applications to retrieve, with the approval and at the direction of a current beneficiary or the beneficiary's personal representative, data specified in paragraph (b) of this section through the use of common technologies and without special effort from the beneficiary.
(b) Accessible content. A State must make the following information accessible to its current beneficiaries or the beneficiary's personal representative through the API described in paragraph (a) of this section:
(1) Data concerning adjudicated claims, including claims data for payment decisions that may be appealed, were appealed, or are in the process of appeal, and provider remittances and beneficiary cost-sharing pertaining to such claims, no later than one (1) business day after a claim is processed;
(2) Encounter data no later than one (1) business day after receiving the data from providers, other than MCOs, PIHPs, and PAHPs, compensated on the basis of capitation payments;
(3) All data classes and data elements included in a content standard in 45 CFR 170.213 that are maintained by the State no later than 1 business day after the State receives the data; and
(4) Information about covered outpatient drugs and updates to such information, including, where applicable, preferred drug list information, no later than one (1) business day after the effective date of any such information or updates to such information.
(5) Beginning January 1, 2027, the information in paragraph (b)(5)(i) of this section about prior authorizations for items and services (excluding drugs as defined in paragraph (b)(6) of this section), according to the timelines in paragraph (b)(5)(ii) of this section.
(i) The prior authorization request and decision, including all of the following, as applicable:
(A) The prior authorization status.
(B) The date the prior authorization was approved or denied.
(C) The date or circumstance under which the prior authorization ends.
(D) The items and services approved.
(E) If denied, a specific reason why the request was denied.
(F) Related structured administrative and clinical documentation submitted by a provider.
(ii) The information in paragraph (b)(5)(i) of this section must—
(A) Be accessible no later than 1 business day after the State receives a prior authorization request;
(B) Be updated no later than 1 business day after any status change; and
(C) Continue to be accessible for the duration that the authorization is active and at least 1 year after the prior authorization's last status change.
(6) Drugs are defined for the purposes of paragraph (b)(5) of this section as any and all drugs covered by the State.
(c) Technical requirements. A State implementing an API under paragraph (a) of this section:
(1) Must implement and maintain API technology conformant with 45 CFR 170.215(a)(1), (b)(1)(i), (c)(1), and (e)(1);
(2) Must conduct routine testing and monitoring, and update as appropriate, to ensure the API functions properly, including assessments to verify that the API is fully and successfully implementing privacy and security features such as, but not limited to, those required to comply with HIPAA privacy and security requirements in 45 CFR parts 160 and 164, 42 CFR parts 2 and 3, and other applicable law protecting the privacy and security of individually identifiable data;
(3) Must comply with the content and vocabulary standards requirements in paragraphs (c)(3)(i) and (ii) of this section, as applicable to the data type or data element, unless alternate standards are required by other applicable law:
(i) Content and vocabulary standards at 45 CFR 170.213 where such standards are applicable to the data type or element, as appropriate; and
(ii) Content and vocabulary standards at 45 CFR part 162 and § 423.160 of this chapter where required by law, or where such standards are applicable to the data type or element, as appropriate.
(4) May use an updated version of any standard or all standards required under paragraph (c)(1) or (3) of this section, where:
(i) Use of the updated version of the standard is required by other applicable law, or
(ii) Use of the updated version of the standard is not prohibited under other applicable law, provided that:
(A) For content and vocabulary standards other than those at 45 CFR 170.213, the Secretary has not prohibited use of the updated version of a standard for purposes of this section or 45 CFR part 170;
(B) For standards at 45 CFR 170.213 and 45 CFR 170.215, the National Coordinator has approved the updated version for use in the ONC Health IT Certification Program; and
(C) Using the updated version of the standard, implementation guide, or specification does not disrupt an end user's ability to access the data specified in paragraph (b) of this section or §§ 431.61, 431.70, and 431.80, through the required APIs.
(d) Documentation requirements for APIs. For each API implemented in accordance with paragraph (a) of this section, a State must make publicly accessible, by posting directly on its website or via publicly accessible hyperlink(s), complete accompanying documentation that contains, at a minimum the information listed in this paragraph. For the purposes of this section, “publicly accessible” means that any person using commonly available technology to browse the internet could access the information without any preconditions or additional steps, such as a fee for access to the documentation; a requirement to receive a copy of the material via email; a requirement to register or create an account to receive the documentation; or a requirement to read promotional material or agree to receive future communications from the organization making the documentation available;
(1) API syntax, function names, required and optional parameters supported and their data types, return variables and their types/structures, exceptions and exception handling methods and their returns;
(2) The software components and configurations an application must use in order to successfully interact with the API and process its response(s); and
(3) All applicable technical requirements and attributes necessary for an application to be registered with any authorization server(s) deployed in conjunction with the API.
(e) Denial or discontinuation of access to the API. A State may deny or discontinue any third-party application's connection to the API required under paragraph (a) of this section if the State:
(1) Reasonably determines, consistent with its security risk analysis under 45 CFR part 164 subpart C, that allowing an application to connect or remain connected to the API would present an unacceptable level of risk to the security of protected health information on the State's systems; and
(2) Makes this determination using objective, verifiable criteria that are applied fairly and consistently across all apps and developers through which parties seek to access electronic health information, as defined in 45 CFR 171.102, including but not limited to criteria that rely on automated monitoring and risk mitigation tools.
(f) Reporting on Patient Access API usage. Beginning in 2026, by March 31 of each year, a State must report to CMS the following metrics, in the form of aggregated, de-identified data, for the previous calendar year at the State level in the form and manner specified by the Secretary:
(1) The total number of unique beneficiaries whose data are transferred via the Patient Access API to a health app designated by the beneficiary; and
(2) The total number of unique beneficiaries whose data are transferred more than once via the Patient Access API to a health app designated by the beneficiary.
(g) Beneficiary resources regarding privacy and security. The State must provide in an easily accessible location on its public website and through other appropriate mechanisms through which it ordinarily communicates with current and former beneficiaries seeking to access their health information held by the State Medicaid agency, educational resources in non-technical, simple and easy-to-understand language explaining at a minimum—
(1) General information on steps the individual may consider taking to help protect the privacy and security of their health information, including factors to consider in selecting an application including secondary uses of data, and the importance of understanding the security and privacy practices of any application to which they will entrust their health information; and
(2) An overview of which types of organizations or individuals are and are not likely to be HIPAA covered entities, the oversight responsibilities of the Office for Civil Rights (OCR) and the Federal Trade Commission (FTC), and how to submit a complaint to—
(i) The HHS Office for Civil Rights (OCR); and
(ii) The Federal Trade Commission (FTC).
(h) Applicability. A State must comply with the requirements in paragraphs (a) through (e) and (g) of this section beginning January 1, 2021, and with the requirements in paragraph (f) of this section beginning in 2026, with regard to data:
(1) With a date of service on or after January 1, 2016; and
(2) That are maintained by the State.
(a) Application programming interface to support data exchange from payers to providers—Provider Access API. Beginning January 1, 2027, unless granted an extension or exemption under paragraph (c) of this section, a State must do the following:
(1) API requirements. Implement and maintain an application programming interface (API) conformant with all of the following:
(i) Section 431.60(c)(2) through (4), (d), and (e).
(ii) The standards in 45 CFR 170.215(a)(1), (b)(1)(i), (c)(1), and (d)(1).
(2) Provider access. Make the data specified in § 431.60(b) with a date of service on or after January 1, 2016, excluding provider remittances and beneficiary cost-sharing information, that are maintained by the State available to enrolled Medicaid providers via the API required in paragraph (a)(1) of this section no later than 1 business day after receiving a request from such a provider, if all the following conditions are met:
(i) The State authenticates the identity of the provider that requests access and attributes the beneficiary to the provider under the attribution process described in paragraph (a)(3) of this section.
(ii) The beneficiary does not opt out as described in paragraph (a)(4) of this section.
(iii) Disclosure of the data is not prohibited by other applicable law.
(3) Attribution. Establish and maintain a process to associate beneficiaries with their enrolled Medicaid providers to enable data exchange via the Provider Access API.
(4) Opt out and patient educational resources. (i) Establish and maintain a process to allow a beneficiary or the beneficiary's personal representative to opt out of the data exchange described in paragraph (a)(2) of this section and to change their permission at any time. That process must be available before the first date on which the State makes beneficiary information available via the Provider Access API and at any time while the beneficiary is enrolled with the State.
(ii) Provide information to beneficiaries in plain language about the benefits of API data exchange with their providers, their opt out rights, and instructions both for opting out of data exchange and for subsequently opting in, as follows:
(A) Before the first date on which the State makes beneficiary information available through the Provider Access API.
(B) No later than 1 week after enrollment.
(C) At least annually.
(D) In an easily accessible location on its public website.
(5) Provider resources. Provide on its website and through other appropriate provider communications, information in plain language explaining the process for requesting beneficiary data using the Provider Access API required in paragraph (a)(1) of this section. The resources must include information about how to use the State's attribution process to associate beneficiaries with their providers.
(b) Application programming interface to support data exchange between payers—Payer-to-Payer API. Beginning January 1, 2027, unless granted an extension or exemption under paragraph (c) of this section, a State must do the following:
(1) API requirements. Implement and maintain an API conformant with all of the following:
(i) Section 431.60(c)(2) through (4), (d), and (e).
(ii) The standards in 45 CFR 170.215(a)(1), (b)(1)(i), and (d)(1).
(2) Opt in. Establish and maintain a process to allow beneficiaries or their personal representatives to opt into the State's payer to payer data exchange with the beneficiary's previous payer(s), described in paragraphs (b)(4) and (5) of this section, and with concurrent payer(s), described in paragraph (b)(6) of this section, and to change their permission at any time.
(i) The opt in process must be offered as follows:
(A) To current beneficiaries, no later than the compliance date.
(B) To new beneficiaries, no later than 1 week after enrollment.
(ii) If a beneficiary has coverage through any Medicaid MCO, prepaid inpatient health plan (PIHP), or prepaid ambulatory health plan (PAHP) within the same State while enrolled in Medicaid, the State must share their opt in permission with those MCO, PIHP, or PAHP to allow the Payer-to-Payer API data exchange described in this section.
(iii) If a beneficiary does not respond or additional information is necessary, the State must make reasonable efforts to engage with the beneficiary to collect this information.
(3) Identify previous and concurrent payers. Establish and maintain a process to identify a new beneficiary's previous and concurrent payer(s) to facilitate the Payer-to-Payer API data exchange. The information request process must start as follows:
(i) For current beneficiaries, no later than the compliance date.
(ii) For new beneficiaries, no later than 1 week after enrollment.
(iii) If a beneficiary does not respond or additional information is necessary, the State must make reasonable efforts to engage with the beneficiary to collect this information.
(4) Exchange request requirements. Exchange beneficiary data with other payers, consistent with the following requirements:
(i) The State must request the data specified in paragraph (b)(4)(ii) of this section through the beneficiary's previous payers' API, if all the following conditions are met:
(A) The beneficiary has opted in, as described in paragraph (b)(2) of this section, except for data exchanges between a State Medicaid agency and its contracted MCOs, PIHPs, or PAHPs, which do not require a beneficiary to opt in.
(B) The exchange is not prohibited by other applicable law.
(ii) The data to be requested are all of the following with a date of service within 5 years before the request:
(A) Data specified in § 431.60(b), excluding the following:
( 1 ) Provider remittances and enrollee cost-sharing information.
( 2 ) Denied prior authorizations.
(B) Unstructured administrative and clinical documentation submitted by a provider related to prior authorizations.
(iii) The State must include an attestation with this request affirming that the beneficiary is enrolled with the State and has opted into the data exchange.
(iv) The State must complete this request as follows:
(A) No later than 1 week after the payer has sufficient identifying information about previous payers and the beneficiary has opted in.
(B) At a beneficiary's request, within 1 week of the request.
(v) The State must receive, through the API required in paragraph (b)(1) of this section, and incorporate into its records about the beneficiary, any data made available by other payers in response to the request.
(5) Exchange response requirements. Make available the data specified in paragraph (b)(4)(ii) of this section that are maintained by the State to other payers via the API required in paragraph (b)(1) of this section within 1 business day of receiving a request, if all the following conditions are met:
(i) The payer that requests access has its identity authenticated and includes an attestation with the request that the patient is enrolled with the payer and has opted into the data exchange.
(ii) Disclosure of the data is not prohibited by other applicable law.
(6) Concurrent coverage data exchange requirements. When a beneficiary has provided sufficient identifying information about concurrent payers and has opted in as described in paragraph (b)(2) of this section, a State must do the following, through the API required in paragraph (b)(1) of this section:
(i) Request the beneficiary's data from all known concurrent payers as described in paragraph (b)(4) of this section, and at least quarterly thereafter while the beneficiary is enrolled with both payers.
(ii) Respond as described in paragraph (b)(5) of this section within 1 business day of a request from any concurrent payers. If agreed upon with the requesting payer, the State may exclude any data that were previously sent to or originally received from the concurrent payer.
(7) Patient educational resources. Provide information to applicants or beneficiaries in plain language, explaining at a minimum: the benefits of Payer-to-Payer API data exchange, their ability to opt in or withdraw that permission, and instructions for doing so. The State must provide the following resources:
(i) When requesting a beneficiary's permission for Payer-to-Payer API data exchange, as described in paragraph (b)(2) of this section.
(ii) At least annually, in appropriate mechanisms through which it ordinarily communicates with current beneficiaries.
(iii) In an easily accessible location on its public website.
(c) Extensions and exemptions —(1) Extension. (i) A State may submit a written application to request a one-time, 1-year extension of the requirements in paragraph (a) or (b) of this section (or paragraphs (a) and (b)) for its Medicaid fee-for-service (FFS) program. The written application must be submitted as part of the State's annual Advance Planning Document (APD) for Medicaid Management Information System (MMIS) operations expenditures described in part 433, subpart C, of this chapter, and approved before the compliance date for the requirements to which the State is seeking an extension. It must include all the following:
(A) A narrative justification describing the specific reasons why the State cannot satisfy the requirement(s) by the compliance date and why those reasons result from circumstances that are unique to the agency operating the Medicaid FFS program.
(B) A report on completed and ongoing State activities that evidence a good faith effort towards compliance.
(C) A comprehensive plan to meet the requirements no later than 1 year after the compliance date.
(ii) CMS grants the State's request if it determines, based on the information provided, that—
(A) The request adequately establishes a need to delay implementation; and
(B) The State has a comprehensive plan to meet the requirements no later than 1 year after the compliance date.
(2) Exemption. (i) A State operating a Medicaid program in which at least 90 percent of the State's Medicaid beneficiaries are enrolled in Medicaid managed care organizations, as defined in § 438.2 of this chapter, may request an exemption for its FFS program from either or both of the following requirement(s):
(A) Paragraph (a) of this section.
(B) Paragraphs (b)(1) and (3) through (7) of this section.
(ii) The State's exemption request must:
(A) Be submitted in writing as part of a State's annual APD for MMIS operations expenditures before the compliance date for the requirements to which the State is seeking an exemption.
(B) Include both of the following:
( 1 ) Documentation that the State meets the threshold for the exemption, based on enrollment data from the most recent CMS “Medicaid Managed Care Enrollment and Program Characteristics” (or successor) report.
( 2 ) An alternative plan to ensure that enrolled providers will have efficient electronic access to the same information through other means while the exemption is in effect.
(iii) CMS grants the exemption if the State establishes to CMS's satisfaction that the State—
(A) Meets the threshold for the exemption; and
(B) Has established an alternative plan to ensure that enrolled providers will have efficient electronic access to the same information through other means while the exemption is in effect.
(iv) The State's exemption expires if either—
(A) Based on the 3 previous years of available, finalized Medicaid Transformed Medicaid Statistical Information System (T-MSIS) managed care and FFS enrollment data, the State's managed care enrollment for 2 of the previous 3 years is below 90 percent; or
(B)( 1 ) CMS has approved a State plan amendment, waiver, or waiver amendment that would significantly reduce the percentage of beneficiaries enrolled in managed care; and
( 2 ) The anticipated shift in enrollment is confirmed by the first available, finalized Medicaid T-MSIS managed care and FFS enrollment data.
(v) If a State's exemption expires under paragraph (c)(2)(iv) of this section, the State is required to do both of the following—
(A) Submit written notification to CMS that the State no longer qualifies for the exemption within 90 days of the finalization of annual Medicaid T-MSIS managed care enrollment data that demonstrates that there has been the requisite shift from managed care enrollment to FFS enrollment resulting in the State's managed care enrollment falling below the 90 percent threshold.
(B) Obtain CMS approval of a timeline for compliance with the requirements in paragraph (a) or (b) (or paragraph0s (a) and (b)) of this section within 2 years of the expiration of the exemption.
(a) The State must implement and maintain a publicly accessible, standards-based Application Programming Interface (API) that is conformant with the technical requirements at § 431.60(c), excluding the security protocols related to user authentication and authorization and any other protocols that restrict the availability of this information to particular persons or organizations, the documentation requirements at § 431.60(d), and is accessible via a public-facing digital endpoint on the State's website.
(b) The API must provide a complete and accurate directory of—
(1) The State's provider directory information specified in section 1902(a)(83) of the Act, updated no later than 30 calendar days after the State receives provider directory information or updates to provider directory information.
(2) [Reserved]
(c) This section is applicable beginning January 1, 2021.
(a) Communicating a reason for denial. Beginning January 1, 2026, if the State denies a prior authorization request (excluding a request for coverage of drugs as defined in § 431.60(b)(6)), in accordance with the timeframes established in § 440.230(e)(1) of this chapter, the response to the provider must include a specific reason for the denial, regardless of the method used to communicate that information.
(b) Prior Authorization Application Programming Interface (API). Unless granted an extension or exemption under paragraph (c) of this section, beginning January 1, 2027, a State must implement and maintain an API conformant with § 431.60(c)(2) through (4), (d), and (e), and the standards in 45 CFR 170.215(a)(1), (b)(1)(i), and (c)(1) that—
(1) Is populated with the State's list of covered items and services (excluding drugs, as defined in § 431.60(b)(6)) that require prior authorization;
(2) Can identify all documentation required by the State for approval of any items or services that require prior authorization;
(3) Supports a HIPAA-compliant prior authorization request and response, as described in 45 CFR part 162; and
(4) Communicates the following information about prior authorization requests:
(i) Whether the State—
(A) Approves the prior authorization request (and the date or circumstance under which the authorization ends);
(B) Denies the prior authorization request; or
(C) Requests more information.
(ii) If the State denies the prior authorization request, it must include a specific reason for the denial.
(c) Extensions and exemptions —(1) Extension. (i) A State may submit a written application to request a one-time, 1-year extension of the requirements in paragraph (b) of this section for its Medicaid FFS program. The written application must be submitted as part of the State's annual APD for MMIS operations expenditures described in part 433, subpart C, of this chapter; and approved before the compliance date in paragraph (b) of this section. It must include all the following:
(A) A narrative justification describing the specific reasons why the State cannot satisfy the requirement(s) by the compliance date and why those reasons result from circumstances that are unique to the agency operating the Medicaid FFS program.
(B) A report on completed and ongoing State activities that evidence a good faith effort towards compliance.
(C) A comprehensive plan to meet the requirements no later than 1 year after the compliance date.
(ii) CMS grants the State's request if it determines, based on the information provided, that—
(A) The request adequately establishes a need to delay implementation; and
(B) The State has a comprehensive plan to meet the requirements no later than 1 year after the compliance date.
(2) Exemption. (i) A State operating a Medicaid program in which at least 90 percent of the State's Medicaid beneficiaries are enrolled in Medicaid managed care organizations, as defined in § 438.2 of this chapter, may request an exemption for its FFS program from the requirements in paragraph (b) of this section.
(ii) The State's exemption request must:
(A) Be submitted in writing as part of a State's annual APD for MMIS operations expenditures before the compliance date in paragraph (b) of this section.
(B) The State's request must include both of the following:
( 1 ) Documentation that the State meets the threshold for the exemption, based on enrollment data from the most recent CMS “Medicaid Managed Care Enrollment and Program Characteristics” (or successor) report.
( 2 ) An alternative plan to ensure that enrolled providers will have efficient electronic access to the same information through other means while the exemption is in effect.
(iii) CMS grants the exemption if the State establishes to CMS's satisfaction that the State—
(A) Meets the threshold for the exemption; and
(B) Has established an alternative plan to ensure that enrolled providers will have efficient electronic access to the same information through other means while the exemption is in effect.
(iv) The State's exemption expires if either—
(A) Based on the 3 previous years of available, finalized Medicaid Transformed Medicaid Statistical Information System (T-MSIS) managed care and FFS enrollment data, the State's managed care enrollment for 2 of the previous 3 years is below 90 percent; or
(B)( 1 ) CMS has approved a State plan amendment, waiver, or waiver amendment that would significantly reduce the percentage of beneficiaries enrolled in managed care; and
( 2 ) The anticipated shift in enrollment is confirmed by the first available, finalized Medicaid T-MSIS managed care and FFS enrollment data.
(v) If a State's exemption expires under paragraph (c)(2)(iv) of this section, the State is required to do both of the following—
(A) Submit written notification to CMS that the State no longer qualifies for the exemption within 90 days of the finalization of annual Medicaid T-MSIS managed care enrollment data that demonstrates that there has been the requisite shift from managed care enrollment to FFS enrollment resulting in the State's managed care enrollment falling below the 90 percent threshold.
(B) Obtain CMS approval of a timeline for compliance with the requirements in paragraph (b) of this section within 2 years of the expiration of the exemption.
(a) Basis and purpose. This section implements section 1902(a)(24) of the Act, which requires that the State plan provide for consultative services by State agencies to certain institutions furnishing Medicaid services.
(b) State plan requirements. A State plan must provide that health agencies and other appropriate State agencies furnish consultative services to hospitals, nursing homes, home health agencies, clinics, and laboratories in order to assist these facilities to—
(1) Qualify for payments under the maternal and child health and crippled children's program (title V of the Act), Medicaid or Medicare;
(2) Establish and maintain fiscal records necessary for the proper and efficient administration of the Act; and
(3) Provide information needed to determine payments due under the Act for services furnished to beneficiaries.
(c) State plan option: Consultation to other facilities. The plan may provide that health agencies and other appropriate State agencies furnish consultation to other types of facilities if those facilities are specified in the plan and provide medical care to individuals receiving services under the programs specified in paragraph (b) of this section.
(a) Basis and purpose. This section sets forth State plan requirements, based on sections 1902(a)(4), 1902(a)(27), 1902(a)(57), and 1902(a)(58) of the Act, that relate to the keeping of records and the furnishing of information by all providers of services (including individual practitioners and groups of practitioners).
(b) Agreements. A State plan must provide for an agreement between the Medicaid agency and each provider or organization furnishing services under the plan in which the provider or organization agrees to:
(1) Keep any records necessary to disclose the extent of services the provider furnishes to beneficiaries;
(2) On request, furnish to the Medicaid agency, the Secretary, or the State Medicaid fraud control unit (if such a unit has been approved by the Secretary under § 455.300 of this chapter), any information maintained under paragraph (b)(1) of this section and any information regarding payments claimed by the provider for furnishing services under the plan;
(3) Comply with the disclosure requirements specified in part 455, subpart B of this chapter; and
(4) Comply with the advance directives requirements for hospitals, nursing facilities, providers of home health care and personal care services, hospices, and HMOs specified in part 489, subpart I, and § 417.436(d) of this chapter.
(5)(i) Furnish to the State agency its National Provider Identifier (NPI) (if eligible for an NPI); and
(ii) Include its NPI on all claims submitted under the Medicaid program.
(a) Applicability —(1) General rule. Except as provided in paragraph (a)(2) of this section, this section applies to Medicaid provider agreements with entities that, as a basis for participation in Medicaid—
(i) Are subject to survey and certification by CMS or the State survey agency; or
(ii) Are deemed to meet Federal requirements on the basis of accreditation by an accrediting organization whose program has CMS approval at the time of accreditation survey and accreditation decision.
(2) Exception. A Medicaid provider agreement with a laboratory is effective only while the laboratory has in effect a valid CLIA certificate issued under part 493 of this chapter, and only for the specialty and subspecialty tests it is authorized to perform.
(b) All requirements are met on the date of survey. The agreement is effective on the date the onsite survey (including the Life Safety Code survey if applicable) is completed, if on that date the provider meets—
(1) All applicable Federal requirements as set forth in this chapter; and
(2) Any other requirements imposed by the State for participation in the Medicaid program. (If the provider has a time-limited agreement, the new agreement is effective on the day following expiration of the current agreement.)
(c) All requirements are not met on the date of survey. If on the date the survey is completed the provider fails to meet any of the requirements specified in paragraph (b) of this section, the following rules apply:
(1) An NF provider agreement is effective on the date on which—
(i) The NF is found to be in substantial compliance as defined in § 488.301 of this chapter; and
(ii) CMS or the State survey agency receives from the NF, if applicable, an approvable waiver request.
(2) For an agreement with any other provider, the effective date is the earlier of the following:
(i) The date on which the provider meets all requirements.
(ii) The date on which a provider is found to meet all conditions of participation but has lower level deficiencies, and CMS or the State survey agency receives from the provider an acceptable plan of correction for the lower level deficiencies, or an approvable waiver request, or both. (The date of receipt is the effective date of the agreement, regardless of when CMS approves the plan of correction or waiver request, or both.)
(d) Accredited provider requests participation in the Medicaid program —(1) General rule. If a provider is currently accredited by a national accrediting organization whose program had CMS approval at the time of accreditation survey and accreditation decision, and on the basis of accreditation, CMS has deemed the provider to meet Federal requirements, the effective date depends on whether the provider is subject to requirements in addition to those included in the accrediting organization's approved program.
(i) Provider subject to additional requirements. For a provider that is subject to additional requirements, Federal or State, or both, the effective date is the date on which the provider meets all requirements, including the additional requirements.
(ii) Provider not subject to additional requirements. For a provider that is not subject to additional requirements, the effective date is the date of the provider's initial request for participation if on that date the provider met all Federal requirements.
(2) Special rule: Retroactive effective date. If the provider meets the requirements of paragraphs (d)(1) and (d)(1)(i) or (d)(1)(ii) of this section, the effective date may be retroactive for up to one year, to encompass dates on which the provider furnished, to a Medicaid beneficiary, covered services for which it has not been paid.
(a) Basis. This section is based on section 1902(a)(4) of the Act, proper and efficient administration; 1902(a)(23), free choice of provider; and 1911, reimbursement of Indian Health Service facilities.
(b) State plan requirements. A State plan must provide that an Indian Health Service facility meeting State requirements for Medicaid participation must be accepted as a Medicaid provider on the same basis as any other qualified provider. However, when State licensure is normally required, the facility need not obtain a license but must meet all applicable standards for licensure. In determining whether a facility meets these standards, a Medicaid agency or State licensing authority may not take into account an absence of licensure of any staff member of the facility.
(a) Basis and purpose. This section implements—
(1) Section 1902(a)(36) of the Act, which requires a State plan to provide that the State survey agency will make publicly available the findings from surveys of health care facilities, laboratories, agencies, clinics, or organizations; and
(2) Section 1106(d) of the Act, which places certain restrictions on the Medicaid agency's disclosure of contractor and provider evaluations.
(b) Definition of State survey agency. The State survey agency referred to in this section means the agency specified under section 1902(a)(9) of the Act as responsible for establishing and maintaining health standards for private or public institutions in which Medicaid beneficiaries may receive services.
(c) State plan requirements. A State plan must provide that the requirements of this section and § 488.325 of this chapter are met.
(d) Disclosure procedure. The Medicaid agency must have a procedure for disclosing pertinent findings obtained from surveys made by the State survey agency to determine if a health care facility, laboratory, agency, clinic or health care organization meets the requirements for participation in the Medicaid program.
(e) Documents subject to disclosure. Documents subject to disclosure include—
(1) Survey reports, except for Joint Commission on the Accreditation of Hospitals reports prohibited from disclosure under § 422.426(b)(2) of this chapter;
(2) Official notifications of findings based on survey reports:
(3) Pertinent parts of written documents furnished by the health care provider to the survey agency that relate to the reports and findings; and
(4) Ownership and contract information as specified in § 455.104 of this subchapter.
(f) Availability for inspection and copy of statements listing deficiencies. The disclosure procedure must provide that the State survey agency will—
(1) Make statements of deficiencies based on the survey reports available for inspection and copying in both the public assistance office and the Social Security Administration district office serving the area where the provider is located; and
(2) Submit to the Regional Medicaid Director, through the Medicaid agency, a plan for making those findings available in other public assistance offices in standard metropolitian statistical areas where this information would be helpful to persons likely to use the health care provider's services.
(g) When documents must be made available. The disclosure procedure must provide that the State survey agency will—
(1) Retain in the survey agency office and make available upon request survey reports and current and accurate ownership information; and
(2) Make available survey reports, findings, and deficiency statements immediately upon determining that a health care provider is eligible to begin or continue participation in the Medicaid program, or within 90 days after completion of the survey, whichever occurs first.
(h) Evaluation reports on providers and contractors. (1) If the Secretary sends the following reports to the Medicaid agency, the agency must meet the requirements of paragraphs (h) (2) and (3) of this section in releasing them:
(i) Individual contractor performance reviews and other formal performance evaluations of carriers, intermediaries, and State agencies, including the reports of followup reviews;
(ii) Comparative performance evaluations of those contractors, including comparisons of either overall performance or of any particular aspect of contractor operations; and
(iii) Program validation survey reports and other formal performance evaluations of providers, including the reports of followup reviews.
(2) The agency must not make the reports public until—
(i) The contractor or provider has had a reasonable opportunity, not to exceed 30 days, to comment on them; and
(ii) Those comments have been incorporated in the report.
(3) The agency must ensure that the reports contain no identification of individual patients, individual health care practitioners or other individuals.
(a) State plan requirements. A State plan must—
(1) Provide that the requirements of subpart D of part 483 of this chapter are met; and
(2) Specify the procedures and rules that the State follows in carrying out the specified requirements, including review and approval of State-operated programs.
(3) To an NF or ICF/IID that is dissatisfied with a determination as to the effective date of its provider agreement.
(b) Basis and scope of requirements. The requirements set forth in part 483 of this chapter pertain to the following aspects of nursing facility services and are required by the indicated sections of the Act.
(1) Nurse aide training and competency programs, and evaluation of nurse aide competency (1919(e)(1) of the Act).
(2) Nurse aide registry (1919(e)(2) of the Act).
(a) General rules. This subpart sets forth the appeals procedures that a State must make available as follows:
(1) To a nursing facility (NF) that is dissatisfied with a State's finding of noncompliance that has resulted in one of the following adverse actions:
(i) Denial or termination of its provider agreement.
(ii) Imposition of a civil money penalty or other alternative remedy.
(2) To an intermediate care facility for Individuals with Intellectual Disabilities (ICF/IID) that is dissatisfied with a State's finding of noncompliance that has resulted in the denial, termination, or nonrenewal of its provider agreement.
(3) To an NF or ICF/IID that is dissatisfied with a determination as to the effective date of its provider agreement.
(b) Special rules. This subpart also sets forth the special rules that apply in particular circumstances, the limitations on the grounds for appeal, and the scope of review during a hearing.
The State plan must provide for appeals procedures that, as a minimum, satisfy the requirements of §§ 431.153 and 431.154.
(a) Right to hearing. Except as provided in paragraph (b) of this section, and subject to the provisions of paragraphs (c) through (j) of this section, the State must give the facility a full evidentiary hearing for any of the actions specified in § 431.151.
(b) Limit on grounds for appeal. The following are not subject to appeal:
(1) The choice of sanction or remedy.
(2) The State monitoring remedy.
(3) [Reserved]
(4) The level of noncompliance found by a State except when a favorable final administrative review decision would affect the range of civil money penalty amounts the State could collect.
(5) A State survey agency's decision as to when to conduct an initial survey of a prospective provider.
(c) Notice of deficiencies and impending remedies. The State must give the facility a written notice that includes:
(1) The basis for the decision; and
(2) A statement of the deficiencies on which the decision was based.
(d) Request for hearing. The facility or its legal representative or other authorized official must file written request for hearing within 60 days of receipt of the notice of adverse action.
(e) Special rules: Denial, termination or nonrenewal of provider agreement —(1) Appeal by an ICF/IID. If an ICF/IID requests a hearing on denial, termination, or nonrenewal of its provider agreement—
(i) The evidentiary hearing must be completed either before, or within 120 days after, the effective date of the adverse action; and
(ii) If the hearing is made available only after the effective date of the action, the State must, before that date, offer the ICF/IID an informal reconsideration that meets the requirements of § 431.154.
(2) Appeal by an NF. If an NF requests a hearing on the denial or termination of its provider agreement, the request does not delay the adverse action and the hearing need not be completed before the effective date of the action.
(f) Special rules: Imposition of remedies. If a State imposes a civil money penalty or other remedies on an NF, the following rules apply:
(1) Basic rule. Except as provided in paragraph (f)(2) of this section (and notwithstanding any provision of State law), the State must impose all remedies timely on the NF, even if the NF requests a hearing.
(2) Exception. The State may not collect a civil money penalty until after the 60-day period for request of hearing has elapsed or, if the NF requests a hearing, until issuance of a final administrative decision that supports imposition of the penalty.
(g) Special rules: Dually participating facilities. If an NF is also participating or seeking to participate in Medicare as an SNF, and the basis for the State's denial or termination of participation in Medicaid is also a basis for denial or termination of participation in Medicare, the State must advise the facility that—
(1) The appeals procedures specified for Medicare facilities in part 498 of this chapter apply; and
(2) A final decision entered under the Medicare appeals procedures is binding for both programs.
(h) Special rules: Adverse action by CMS. If CMS finds that an NF is not in substantial compliance and either terminates the NF's Medicaid provider agreement or imposes alternative remedies on the NF (because CMS's findings and proposed remedies prevail over those of the State in accordance with § 488.452 of this chapter), the NF is entitled only to the appeals procedures set forth in part 498 of this chapter, instead of the procedures specified in this subpart.
(i) Required elements of hearing. The hearing must include at least the following:
(1) Opportunity for the facility—
(i) To appear before an impartial decision-maker to refute the finding of noncompliance on which the adverse action was based;
(ii) To be represented by counsel or other representative; and
(iii) To be heard directly or through its representative, to call witnesses, and to present documentary evidence.
(2) A written decision by the impartial decision-maker, setting forth the reasons for the decision and the evidence on which the decision is based.
(j) Limits on scope of review: Civil money penalty cases. In civil money penalty cases—
(1) The State's finding as to a NF's level of noncompliance must be upheld unless it is clearly erroneous; and
(2) The scope of review is as set forth in § 488.438(e) of this chapter.
The informal reconsideration must, at a minimum, include—
(a) Written notice to the facility of the denial, termination or nonrenewal and the findings upon which it was based;
(b) A reasonable opportunity for the facility to refute those findings in writing, and
(c) A written affirmation or reversal of the denial, termination, or nonrenewal.
This subpart—
(a) Implements section 1902(a)(3) of the Act, which requires that a State plan provide an opportunity for a fair hearing to any person whose claim for assistance is denied or not acted upon promptly;
(b) Prescribes procedures for an opportunity for a hearing if the State agency or non-emergency transportation PAHP (as defined in § 438.9(a) of this chapter) takes action, as stated in this subpart, to suspend, terminate, or reduce services, or of an adverse benefit determination by an MCO, PIHP or PAHP under subpart F of part 438 of this chapter; and
(c) Implements sections 1919(f)(3) and 1919(e)(7)(F) of the Act by providing an appeals process for any person who—
(1) Is subject to a proposed transfer or discharge from a nursing facility; or
(2) Is adversely affected by the pre-admission screening or the annual resident review that are required by section 1919(e)(7) of the Act.
(d) Implements section 1943(b)(3) of the Act and section 1413 of the Affordable Care Act to permit coordinated hearings and appeals among insurance affordability programs.
For purposes of this subpart:
Action means one of the following:
(1) A termination, suspension of, or reduction in covered benefits or services, including benefits or services for which there is a current approved prior authorization;
(2) A termination, suspension of, or reduction in Medicaid eligibility, or an increase in beneficiary liability, including a determination that a beneficiary must incur a greater amount of medical expenses to establish income eligibility in accordance with § 435.121(e)(4) or § 435.831 of this chapter;
(3) A determination that a beneficiary is subject to an increase in premiums or cost-sharing charges under subpart A of part 447 of this chapter; or
(4) A determination by a skilled nursing facility or nursing facility to transfer or discharge a resident and an adverse determination by a State regarding the preadmission screening and resident review requirements of section 1919(e)(7) of the Act.
Adverse determination means a determination made in accordance with sections 1919(b)(3)(F) or 1919(e)(7)(B) of the Act that the individual does not require the level of services provided by a nursing facility or that the individual does or does not require specialized services.
Date of action means the intended date on which a termination, suspension, reduction, transfer or discharge becomes effective. It also means the date of the determination made by a State with regard to the preadmission screening and annual resident review requirements of section 1919(e)(7) of the Act.
De novo hearing means a hearing that starts over from the beginning.
Evidentiary hearing means a hearing conducted so that evidence may be presented.
Joint fair hearing request means a request for a Medicaid fair hearing which is included in an appeal request submitted to an Exchange or Exchange appeals entity under 45 CFR 155.520 or other insurance affordability program or appeals entity, in accordance with the signed agreement between the agency and an Exchange or Exchange appeals entity or other program or appeals entity described in § 435.1200(b)(3) of this chapter .
Local evidentiary hearing means a hearing held on the local or county level serving a specified portion of the State.
Notice means a written statement that meets the requirements of § 431.210.
Request for a hearing means a clear expression by the applicant or beneficiary, or his authorized representative, that he wants the opportunity to present his case to a reviewing authority.
Send means deliver by mail or in electronic format consistent with § 435.918 of this chapter.
Service authorization request means a managed care enrollee's request for the provision of a service.
A State plan must provide that the requirements of §§ 431.205 through 431.246 of this subpart are met.
(a) The Medicaid agency must be responsible for maintaining a hearing system that meets the requirements of this subpart.
(b) The State's hearing system must provide for—
(1) A hearing before—
(i) The Medicaid agency; or
(ii) For the denial of eligibility for individuals whose income eligibility is determined based on the applicable modified adjusted gross income standard described in§ 435.911(c) of this chapter, the Exchange or Exchange appeals entity to which authority to conduct fair hearings has been delegated under § 431.10(c)(1)(ii), provided that individuals who have requested a fair hearing are given the choice to have their fair hearing conducted instead by the Medicaid agency; at state option the Exchange or Exchange appeals entity decision may be subject to review by the Medicaid agency in accordance with § 431.10(c)(3)(iii); or
(2) An evidentiary hearing at the local level, with a right of appeal to the Medicaid agency.
(c) The agency may offer local hearings in some political subdivisions and not in others.
(d) The hearing system must meet the due process standards set forth in Goldberg v. Kelly, 397 U.S. 254 (1970), and any additional standards specified in this subpart.
(e) The hearing system must be accessible to persons who are limited English proficient and persons who have disabilities, consistent with § 435.905(b) of this chapter.
(f) The hearing system must comply with the United States Constitution, the Social Security Act, title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act of 1973, the Americans with Disabilities Act of 1990, the Age Discrimination Act of 1975, and section 1557 of the Affordable Care Act and implementing regulations.
(a) The agency must issue and publicize its hearing procedures.
(b) The agency must, at the time specified in paragraph (c) of this section, inform every applicant or beneficiary in writing—
(1) Of his or her right to a fair hearing and right to request an expedited fair hearing;
(2) Of the method by which he may obtain a hearing;
(3) That he may represent himself or use legal counsel, a relative, a friend, or other spokesman; and
(4) Of the time frames in which the agency must take final administrative action, in accordance with § 431.244(f).
(c) The agency must provide the information required in paragraph (b) of this section—(1) At the time that the individual applies for Medicaid;
(2) At the time the agency denies an individual's claim for eligibility, benefits or services; or denies a request for exemption from mandatory enrollment in an Alternative Benefit Plan; or takes other action, as defined at § 431.201; or whenever a hearing is otherwise required in accordance with § 431.220(a);
(3) At the time a skilled nursing facility or a nursing facility notifies a resident in accordance with § 483.15 of this chapter that he or she is to be transferred or discharged; and
(4) At the time an individual receives an adverse determination by the State with regard to the preadmission screening and annual resident review requirements of section 1919(e)(7) of the Act.
(d) If, in accordance with § 431.10(c)(1)(ii), the agency has delegated authority to the Exchange or Exchange appeals entity to conduct the fair hearing, the agency must inform the individual in writing that—
(1) He or she has the right to have his or her hearing before the agency, instead of the Exchange or the Exchange appeals entity; and
(2) The method by which the individual may make such election;
(e) The information required under this subpart must be accessible to individuals who are limited English proficient and to individuals with disabilities, consistent with § 435.905(b) of this chapter, and may be provided in electronic format in accordance with § 435.918 of this chapter.
A notice required under § 431.206 (c)(2), (c)(3), or (c)(4) of this subpart must contain—
(a) A statement of what action the agency, skilled nursing facility, or nursing facility intends to take and the effective date of such action;
(b) A clear statement of the specific reasons supporting the intended action;
(c) The specific regulations that support, or the change in Federal or State law that requires, the action;
(d) An explanation of—
(1) The individual's right to request a local evidentiary hearing if one is available, or a State agency hearing; or
(2) In cases of an action based on a change in law, the circumstances under which a hearing will be granted; and
(e) An explanation of the circumstances under which Medicaid is continued if a hearing is requested.
The State or local agency must send a notice at least 10 days before the date of action, except as permitted under §§ 431.213 and 431.214.
The agency may send a notice not later than the date of action if—
(a) The agency has factual information confirming the death of a beneficiary;
(b) The agency receives a clear written statement signed by a beneficiary that—
(1) He no longer wishes services; or
(2) Gives information that requires termination or reduction of services and indicates that he understands that this must be the result of supplying that information;
(c) The beneficiary has been admitted to an institution where he is ineligible under the plan for further services;
(d) The beneficiary's whereabouts are unknown, and the post office returns mail directed to him indicating no forwarding address (see § 435.919(f)(4) of this chapter for procedures if the beneficiary's whereabouts become known);
(e) The agency establishes the fact that the beneficiary has been accepted for Medicaid services by another local jurisdiction, State, territory, or commonwealth;
(f) A change in the level of medical care is prescribed by the beneficiary's physician;
(g) The notice involves an adverse determination made with regard to the preadmission screening requirements of section 1919(e)(7) of the Act; or
(h) The date of action will occur in less than 10 days, in accordance with § 483.15(b)(4)(ii) and (b)(8), which provides exceptions to the 30 days notice requirements of § 483.15(b)(4)(i) of this chapter.
The agency may shorten the period of advance notice to 5 days before the date of action if—
(a) The agency has facts indicating that action should be taken because of probable fraud by the beneficiary; and
(b) The facts have been verified, if possible, through secondary sources.
(a) The State agency must grant an opportunity for a hearing to the following:
(1) Any individual who requests it because he or she believes the agency has taken an action erroneously, denied his or her claim for eligibility or for covered benefits or services, or issued a determination of an individual's liability, or has not acted upon the claim with reasonable promptness including, if applicable—
(i) An initial or subsequent decision regarding eligibility;
(ii) A determination of the amount of medical expenses that an individual must incur in order to establish eligibility in accordance with § 435.121(e)(4) or § 435.831 of this chapter; or
(iii) A determination of the amount of premiums and cost sharing charges under subpart A of part 447 of this chapter;
(iv) A change in the amount or type of benefits or services;
(v) A request for exemption from mandatory enrollment in an Alternative Benefit Plan; or
(vi) A prior authorization decision.
(2) Any resident who requests it because he or she believes a skilled nursing facility or nursing facility has erroneously determined that he or she must be transferred or discharged.
(3) Any individual who requests it because he or she believes the State has made an erroneous determination with regard to the preadmission and annual resident review requirements of section 1919(e)(7) of the Act.
(4) Any MCO, PIHP, or PAHP enrollee who is entitled to a hearing under subpart F of part 438 of this chapter.
(5) Any enrollee in a non-emergency medical transportation PAHP (as that term is defined in § 438.9 of this chapter) who has an action as stated in this subpart.
(6) Any enrollee who is entitled to a hearing under subpart B of part 438 of this chapter.
(b) The agency need not grant a hearing if the sole issue is a Federal or State law requiring an automatic change adversely affecting some or all beneficiaries.
(a)(1) The agency must establish procedures that permit an individual, or an authorized representative as defined at § 435.923 of this chapter, to—
(i) Submit a hearing request via any of the modalities described in § 435.907(a) of this chapter, except that the requirement to establish procedures for submission of a fair hearing request described in § 435.907(a)(1), (2) and (5) of this chapter (relating to submissions via Internet Web site, telephone and other electronic means) is effective no later than the date described in § 435.1200(i) of this chapter; and
(ii) Include in a hearing request submitted under paragraph (a)(1)(i) of this section, a request for an expedited fair hearing.
(2) [Reserved]
(b) The agency may not limit or interfere with the applicant's or beneficiary's freedom to make a request for a hearing.
(c) The agency may assist the applicant or beneficiary in submitting and processing his request.
(d) The agency must allow the applicant or beneficiary a reasonable time, not to exceed 90 days from the date that notice of action is mailed, to request a hearings.
The agency—
(a) May respond to a series of individual requests for hearing by conducting a single group hearing;
(b) May consolidate hearings only in cases in which the sole issue involved is one of Federal or State law or policy;
(c) Must follow the policies of this subpart and its own policies governing hearings in all group hearings; and
(d) Must permit each person to present his own case or be represented by his authorized representative.
The agency may deny or dismiss a request for a hearing if—
(a) The applicant or beneficiary withdraws the request. The agency must accept withdrawal of a fair hearing request via any of the modalities available per § 431.221(a)(1)(i). For telephonic hearing withdrawals, the agency must record the individual's statement and telephonic signature. For telephonic, online and other electronic withdrawals, the agency must send the affected individual written confirmation, via regular mail or electronic notification in accordance with the individual's election under § 435.918(a) of this chapter.
(b) The applicant or beneficiary fails to appear at a scheduled hearing without good cause.
(a) General rule. (1) The agency must establish and maintain an expedited fair hearing process for individuals to request an expedited fair hearing, if the agency determines that the time otherwise permitted for a hearing under § 431.244(f)(1) could jeopardize the individual's life, health or ability to attain, maintain, or regain maximum function.
(2) The agency must take final administrative action within the period of time permitted under § 431.244(f)(3) if the agency determines that the individual meets the criteria for an expedited fair hearing in paragraph (a)(1) of this section.
(b) Notice. The agency must notify the individual whether the request is granted or denied as expeditiously as possible. Such notice must be provided orally or through electronic means in accordance with § 435.918 of this chapter, if consistent with the individual's election under such section; if oral notice is provided, the agency must follow up with written notice, which may be through electronic means if consistent with the individual's election under § 435.918.
(a) If the agency sends the 10-day or 5-day notice as required under § 431.211 or § 431.214 of this subpart, and the beneficiary requests a hearing before the date of action, the agency may not terminate or reduce services until a decision is rendered after the hearing unless—
(1) It is determined at the hearing that the sole issue is one of Federal or State law or policy; and
(2) The agency promptly informs the beneficiary in writing that services are to be terminated or reduced pending the hearing decision.
(b) If the agency's action is sustained by the hearing decision, the agency may institute recovery procedures against the applicant or beneficiary to recoup the cost of any services furnished the beneficiary, to the extent they were furnished solely by reason of this section.
(a) The agency may reinstate services if a beneficiary requests a hearing not more than 10 days after the date of action.
(b) The reinstated services must continue until a hearing decision unless, at the hearing, it is determined that the sole issue is one of Federal or State law or policy.
(c) The agency must reinstate and continue services until a decision is rendered after a hearing if—
(1) Action is taken without the advance notice required under § 431.211 or § 431.214 of this subpart;
(2) The beneficiary requests a hearing within 10 days from the date that the individual receives the notice of action. The date on which the notice is received is considered to be 5 days after the date on the notice, unless the beneficiary shows that he or she did not receive the notice within the 5-day period; and
(3) The agency determines that the action resulted from other than the application of Federal or State law or policy.
(d) [Reserved]
If the decision of a local evidentiary hearing is adverse to the applicant or beneficiary, the agency must—
(a) Inform the applicant or beneficiary of the decision;
(b) Inform the applicant or beneficiary in writing that he or she has a right to appeal the decision to the State agency within 10 days after the individual receives the notice of the adverse decision. The date on which the notice is received is considered to be 5 days after the date on the notice, unless the individual shows that he or she did not receive the notice within the 5-day period; and
(c) Inform the applicant or beneficiary of his right to request that his appeal be a de novo hearing; and
(d) Discontinue services after the adverse decision.
(a) Unless the applicant or beneficiary specifically requests a de novo hearing, the State agency hearing may consist of a review by the agency hearing officer of the record of the local evidentiary hearing to determine whether the decision of the local hearing officer was supported by substantial evidence in the record.
(b) A person who participates in the local decision being appealed may not participate in the State agency hearing decision.
(a) All hearings must be conducted—
(1) At a reasonable time, date, and place;
(2) Only after adequate written notice of the hearing; and
(3) By one or more impartial officials or other individuals who have not been directly involved in the initial determination of the action in question.
(b) If the hearing involves medical issues such as those concerning a diagnosis, an examining physician's report, or a medical review team's decision, and if the hearing officer considers it necessary to have a medical assessment other than that of the individual involved in making the original decision, such a medical assessment must be obtained at agency expense and made part of the record.
(c) A hearing officer must have access to agency information necessary to issue a proper hearing decision, including information concerning State policies and regulations.
STATE ORGANIZATION AND GENERAL ADMINISTRATION (U.S.C.). Retrieved via LawPlayer, https://lawplayer.com/us/act/cfr-title-42-part-431
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