§ 9812.
(a)
In general
(1)
Aggregate lifetime limits
In the case of a group health plan that provides both medical and surgical benefits and mental health or substance use disorder benefits—
(B)
Lifetime limit
If the plan includes an aggregate lifetime limit on substantially all medical and surgical benefits (in this paragraph referred to as the “applicable lifetime limit”), the plan shall either—
(i)
apply the applicable lifetime limit both to the medical and surgical benefits to which it otherwise would apply and to mental health and substance use disorder benefits and not distinguish in the application of such limit between such medical and surgical benefits and mental health and substance use disorder benefits; or
(ii)
not include any aggregate lifetime limit on mental health or substance use disorder benefits that is less than the applicable lifetime limit.
(C)
Rule in case of different limits
(2)
Annual limits
In the case of a group health plan that provides both medical and surgical benefits and mental health or substance use disorder benefits—
(B)
Annual limit
If the plan includes an annual limit on substantially all medical and surgical benefits (in this paragraph referred to as the “applicable annual limit”), the plan shall either—
(i)
apply the applicable annual limit both to medical and surgical benefits to which it otherwise would apply and to mental health and substance use disorder benefits and not distinguish in the application of such limit between such medical and surgical benefits and mental health and substance use disorder benefits; or
(ii)
not include any annual limit on mental health or substance use disorder benefits that is less than the applicable annual limit.
(C)
Rule in case of different limits
(3)
Financial requirements and treatment limitations
(A)
In general
In the case of a group health plan that provides both medical and surgical benefits and mental health or substance use disorder benefits, such plan shall ensure that—
(i)
the financial requirements applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant financial requirements applied to substantially all medical and surgical benefits covered by the plan, and there are no separate cost sharing requirements that are applicable only with respect to mental health or substance use disorder benefits; and
(ii)
the treatment limitations applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant treatment limitations applied to substantially all medical and surgical benefits covered by the plan and there are no separate treatment limitations that are applicable only with respect to mental health or substance use disorder benefits.
(B)
Definitions
In this paragraph:
(i)
Financial requirement
(iii)
Treatment limitation
(4)
Availability of plan information
(5)
Out-of-network providers
(6)
Compliance program guidance document
(B)
Examples illustrating compliance and noncompliance
(i)
In general
The compliance program guidance document required under this paragraph shall provide illustrative, de-identified examples (that do not disclose any protected health information or individually identifiable information) of previous findings of compliance and noncompliance with this section, section 2726 of the Public Health Service Act, or section 712 of the Employee Retirement Income Security Act of 1974, as applicable, based on investigations of violations of such sections, including—
(I)
examples illustrating requirements for information disclosures and nonquantitative treatment limitations; and
(II)
descriptions of the violations uncovered during the course of such investigations.
(ii)
Nonquantitative treatment limitations
(iii)
Access to additional information regarding compliance
In developing and issuing the compliance program guidance document required under this paragraph, the Secretaries specified in subparagraph (A)—
(I)
shall enter into interagency agreements with the Inspector General of the Department of Health and Human Services, the Inspector General of the Department of Labor, and the Inspector General of the Department of the Treasury to share findings of compliance and noncompliance with this section, section 2726 of the Public Health Service Act, or section 712 of the Employee Retirement Income Security Act of 1974, as applicable; and
(II)
shall seek to enter into an agreement with a State to share information on findings of compliance and noncompliance with this section, section 2726 of the Public Health Service Act, or section 712 of the Employee Retirement Income Security Act of 1974, as applicable.
(D)
Updating the compliance program guidance document
(7)
Additional guidance
(B)
Disclosure
(ii)
Documents for participants, beneficiaries, contracting providers, or authorized representatives
The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans may use to provide any participant, beneficiary, contracting provider, or authorized representative, as applicable, with documents containing information that the health plans are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section, section 2726 of the Public Health Service Act, or section 712 of the Employee Retirement Income Security Act of 1974, as applicable, compliance with any regulation issued pursuant to such respective section, or compliance with any other applicable law or regulation. Such guidance shall include information that is comparative in nature with respect to—
(I)
nonquantitative treatment limitations for both medical and surgical benefits and mental health and substance use disorder benefits;
(II)
the processes, strategies, evidentiary standards, and other factors used to apply the limitations described in subclause (I); and
(III)
the application of the limitations described in subclause (I) to ensure that such limitations are applied in parity with respect to both medical and surgical benefits and mental health and substance use disorder benefits.
(C)
Nonquantitative treatment limitations
The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods, processes, strategies, evidentiary standards, and other factors that group health plans may use regarding the development and application of nonquantitative treatment limitations to ensure compliance with this section, section 2726 of the Public Health Service Act, or section 712 of the Employee Retirement Income Security Act of 1974, as applicable, (and any regulations promulgated pursuant to such respective section), including—
(i)
examples of methods of determining appropriate types of nonquantitative treatment limitations with respect to both medical and surgical benefits and mental health and substance use disorder benefits, including nonquantitative treatment limitations pertaining to—
(I)
medical management standards based on medical necessity or appropriateness, or whether a treatment is experimental or investigative;
(II)
limitations with respect to prescription drug formulary design; and
(III)
use of fail-first or step therapy protocols;
(ii)
examples of methods of determining—
(I)
network admission standards (such as credentialing); and
(II)
factors used in provider reimbursement methodologies (such as service type, geographic market, demand for services, and provider supply, practice size, training, experience, and licensure) as such factors apply to network adequacy;
(iii)
examples of sources of information that may serve as evidentiary standards for the purposes of making determinations regarding the development and application of nonquantitative treatment limitations;
(iv)
examples of specific factors, and the evidentiary standards used to evaluate such factors, used by such plans in performing a nonquantitative treatment limitation analysis;
(v)
examples of how specific evidentiary standards may be used to determine whether treatments are considered experimental or investigative;
(vi)
examples of how specific evidentiary standards may be applied to each service category or classification of benefits;
(vii)
examples of methods of reaching appropriate coverage determinations for new mental health or substance use disorder treatments, such as evidence-based early intervention programs for individuals with a serious mental illness and types of medical management techniques;
(viii)
examples of methods of reaching appropriate coverage determinations for which there is an indirect relationship between the covered mental health or substance use disorder benefit and a traditional covered medical and surgical benefit, such as residential treatment or hospitalizations involving voluntary or involuntary commitment; and
(ix)
additional illustrative examples of methods, processes, strategies, evidentiary standards, and other factors for which the Secretary determines that additional guidance is necessary to improve compliance with this section, section 2726 of the Public Health Service Act, or section 712 of the Employee Retirement Income Security Act of 1974, as applicable.
(8)
Compliance requirements
(A)
Nonquantitative treatment limitation (NQTL) requirements
In the case of a group health plan that provides both medical and surgical benefits and mental health or substance use disorder benefits and that imposes nonquantitative treatment limitations (referred to in this section as “NQTLs”) on mental health or substance use disorder benefits, such plan shall perform and document comparative analyses of the design and application of NQTLs and, beginning 45 days after the date of enactment of the Consolidated Appropriations Act, 2021, make available to the Secretary, upon request, the comparative analyses and the following information:
(i)
The specific plan terms or other relevant terms regarding the NQTLs and a description of all mental health or substance use disorder and medical or surgical benefits to which each such term applies in each respective benefits classification.
(ii)
The factors used to determine that the NQTLs will apply to mental health or substance use disorder benefits and medical or surgical benefits.
(iii)
The evidentiary standards used for the factors identified in clause (ii), when applicable, provided that every factor shall be defined, and any other source or evidence relied upon to design and apply the NQTLs to mental health or substance use disorder benefits and medical or surgical benefits.
(iv)
The comparative analyses demonstrating that the processes, strategies, evidentiary standards, and other factors used to apply the NQTLs to mental health or substance use disorder benefits, as written and in operation, are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used to apply the NQTLs to medical or surgical benefits in the benefits classification.
(v)
A disclosure of the specific findings and conclusions reached by the group health plan, including any results of the analyses described in this subparagraph that indicate that the plan is or is not in compliance with this section.
(B)
Secretary request process
(i)
Submission upon request
(ii)
Additional information
(iii)
Required action
(I)
In general
In instances in which the Secretary has reviewed the comparative analyses described in subparagraph (A), as requested under clause (i), and determined that the group health plan is not in compliance with this section, the plan—
(aa)
shall specify to the Secretary the actions the plan will take to be in compliance with this section and provide to the Secretary additional comparative analyses described in subparagraph (A) that demonstrate compliance with this section not later than 45 days after the initial determination by the Secretary that the plan is not in compliance; and
(bb)
following the 45-day corrective action period under item (aa), if the Secretary makes a final determination that the plan still is not in compliance with this section, not later than 7 days after such determination, shall notify all individuals enrolled in the plan that the plan has been determined to be not in compliance with this section.
(II)
Exemption from disclosure
(iv)
Report
Not later than 1 year after the date of enactment of this paragraph, and not later than October 1 of each year thereafter, the Secretary shall submit to Congress, and make publicly available, a report that contains—
(I)
a summary of the comparative analyses requested under clause (i), including the identity of each group plan that is determined to be not in compliance after the final determination by the Secretary described in clause (iii)(I)(bb);
(II)
the Secretary’s conclusions as to whether each group health plan submitted sufficient information for the Secretary to review the comparative analyses requested under clause (i) for compliance with this section;
(III)
for each group health plan that did submit sufficient information for the Secretary to review the comparative analyses requested under clause (i), the Secretary’s conclusions as to whether and why the plan is in compliance with the disclosure requirements under this section;
(IV)
the Secretary’s specifications described in clause (ii) for each group health plan that the Secretary determined did not submit sufficient information for the Secretary to review the comparative analyses requested under clause (i) for compliance with this section; and
(V)
the Secretary’s specifications described in clause (iii) of the actions each group health plan that the Secretary determined is not in compliance with this section must take to be in compliance with this section, including the reason why the Secretary determined the plan is not in compliance.
(C)
Compliance program guidance document update process
(ii)
Guidance and regulations
(Added [Pub. L. 105–34, title XV, § 1531(a)(4)], Aug. 5, 1997, [111 Stat. 1083]; amended [Pub. L. 107–116, title VII, § 701(c)], Jan. 10, 2002, [115 Stat. 2228]; [Pub. L. 107–147, title VI, § 610(a)], Mar. 9, 2002, [116 Stat. 60]; [Pub. L. 108–311, title III, § 302(a)], Oct. 4, 2004, [118 Stat. 1178]; [Pub. L. 109–151, § 1(c)], Dec. 30, 2005, [119 Stat. 2886]; [Pub. L. 109–432, div. A, title I, § 115(a)], Dec. 20, 2006, [120 Stat. 2941]; [Pub. L. 110–245, title IV, § 401(a)], June 17, 2008, [122 Stat. 1649]; [Pub. L. 110–343, div. C, title V, § 512(c)], (g)(3)(A), Oct. 3, 2008, [122 Stat. 3888], 3892; [Pub. L. 115–141, div. U, title IV, § 401(a)(349)], Mar. 23, 2018, [132 Stat. 1201]; [Pub. L. 116–260, div. BB, title II, § 203(a)(3)], Dec. 27, 2020, [134 Stat. 2910].)