Strengthening Behavioral Health Parity Act

Bill: 116-hr-7539
Sponsor: full_name: Rep. Kennedy, Joseph P., III [D-MA-4]
Introduced: 2020-07-09
Policy area: Health
Subjects: Accounting and auditing

Administrative law and regulatory procedures

Congressional oversight

Consumer affairs

Department of Health and Human Services

Department of Labor

Department of the Treasury

Drug, alcohol, tobacco use

Employee benefits and pensions

Government information and archives

Health care costs and insurance

Health care coverage and access

Health information and medical records

Health programs administration and funding

Intergovernmental relations

Mental health

Prescription drugs

Surgery and anesthesia
Latest action: action_date: 2020-12-24
text: Placed on the Union Calendar, Calendar No. 575.

Summaries:
action_date: 2020-07-09
action_desc: Introduced in House
text: <p><b>Strengthening Behavioral Health Parity Act<br> </b><br> This bill establishes compliance mechanisms related to the requirements for health insurance plans that cover mental health or substance use disorder services to provide such coverage in a manner consistent with the coverage of other medical and surgical services under their plans.</p>

action_date: 2020-12-24
action_desc: Reported to House, Part I
text: <p><b>Strengthening Behavioral Health Parity Act<br> </b><br> This bill establishes compliance mechanisms related to the requirements for health insurance plans that cover mental health or substance use disorder services to provide such coverage in a manner consistent with the coverage of other medical and surgical services under their plans.</p>

tv_txt: I 116th CONGRESS 2d Session H. R. 7539 IN THE HOUSE OF REPRESENTATIVES July 9, 2020 Mr. Kennedy (for himself, Ms. Porter , Mr. Bilirakis , and Mr. Upton ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committees on Ways and Means , and Education and Labor , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To strengthen parity in mental health and substance use disorder benefits.

1. Short title This Act may be cited as the Strengthening Behavioral Health Parity Act . 2. Strengthening parity in mental health and substance use disorder benefits (a) PHSA (1) In general Title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg–11 et seq.) is amended by adding at the end the following new part: D Additional Coverage Provisions 2799A–1. Parity in mental health and substance use disorder benefits (a) In General (1) Aggregate lifetime limits In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits— (A) No lifetime limit If the plan or coverage does not include an aggregate lifetime limit on substantially all medical and surgical benefits, the plan or coverage may not impose any aggregate lifetime limit on mental health or substance use disorder benefits. (B) Lifetime limit If the plan or coverage includes an aggregate lifetime limit on substantially all medical and surgical benefits (in this paragraph referred to as the applicable lifetime limit ), the plan or coverage 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 In the case of a plan or coverage that is not described in subparagraph (A) or (B) and that includes no or different aggregate lifetime limits on different categories of medical and surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or coverage with respect to mental health and substance use disorder benefits by substituting for the applicable lifetime limit an average aggregate lifetime limit that is computed taking into account the weighted average of the aggregate lifetime limits applicable to such categories. (2) Annual limits In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits— (A) No annual limit If the plan or coverage does not include an annual limit on substantially all medical and surgical benefits, the plan or coverage may not impose any annual limit on mental health or substance use disorder benefits. (B) Annual limit If the plan or coverage includes an annual limit on substantially all medical and surgical benefits (in this paragraph referred to as the applicable annual limit ), the plan or coverage 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 In the case of a plan or coverage that is not described in subparagraph (A) or (B) and that includes no or different annual limits on different categories of medical and surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or coverage with respect to mental health and substance use disorder benefits by substituting for the applicable annual limit an average annual limit that is computed taking into account the weighted average of the annual limits applicable to such categories. (3) Financial requirements and treatment limitations (A) In general In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits, such plan or coverage 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 (or coverage), 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 (or coverage) 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 The term financial requirement includes deductibles, copayments, coinsurance, and out-of-pocket expenses, but excludes an aggregate lifetime limit and an annual limit subject to paragraphs (1) and (2). (ii) Predominant A financial requirement or treatment limit is considered to be predominant if it is the most common or frequent of such type of limit or requirement. (iii) Treatment limitation The term treatment limitation includes limits on the frequency of treatment, number of visits, days of coverage, or other similar limits on the scope or duration of treatment. (4) Availability of plan information The criteria for medical necessity determinations made under the plan with respect to mental health or substance use disorder benefits (or the health insurance coverage offered in connection with the plan with respect to such benefits) shall be made available by the plan administrator (or the health insurance issuer offering such coverage) in accordance with regulations to any current or potential participant, beneficiary, or contracting provider upon request. The reason for any denial under the plan (or coverage) of reimbursement or payment for services with respect to mental health or substance use disorder benefits in the case of any participant or beneficiary shall, on request or as otherwise required, be made available by the plan administrator (or the health insurance issuer offering such coverage) to the participant or beneficiary in accordance with regulations. (5) Out-of-network providers In the case of a plan or coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits, if the plan or coverage provides coverage for medical or surgical benefits provided by out-of-network providers, the plan or coverage shall provide coverage for mental health or substance use disorder benefits provided by out-of-network providers in a manner that is consistent with the requirements of this section. (6) Compliance program guidance document (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Labor, and the Secretary of the Treasury, in consultation 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, shall issue a compliance program guidance document to help improve compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, and section 9812 of the Internal Revenue Code of 1986, as applicable. In carrying out this paragraph, the Secretaries may take into consideration the 2016 publication of the Department of Health and Human Services and the Department of Labor, entitled Warning Signs - Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance . (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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, 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 To the extent that any example described in clause (i) involves a finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment limitations, the example shall provide sufficient detail to fully explain such finding, including a full description of the criteria involved for approving medical and surgical benefits and the criteria involved for approving mental health and substance use disorder benefits. (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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, 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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable. (C) Recommendations The compliance program guidance document shall include recommendations to advance compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, and encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements. Such internal controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance use disorder benefits, which may fail to comply with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, in relation to nonquantitative treatment limitations on medical and surgical benefits. (D) Updating the compliance program guidance document The Secretary, the Secretary of Labor, and the Secretary of the Treasury, in consultation 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, shall update the compliance program guidance document every 2 years to include 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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable. (7) Additional guidance (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Labor, and the Secretary of the Treasury shall issue guidance to group health plans and health insurance issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the requirements of this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable. (B) Disclosure (i) Guidance for plans and issuers The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use for disclosing information to ensure compliance with the requirements under this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable (and any regulations promulgated pursuant to such sections, as applicable). (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 and health insurance issuers offering group or individual health insurance coverage may use to provide any participant, beneficiary, contracting provider, or authorized representative, as applicable, with documents containing information that the health plans or issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, 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 and health insurance issuers offering group or individual health insurance coverage may use regarding the development and application of nonquantitative treatment limitations to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, 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 or issuers 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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable. (D) Public comment Prior to issuing any final guidance under this paragraph, the Secretary shall provide a public comment period of not less than 60 days during which any member of the public may provide comments on a draft of the guidance. (8) Compliance requirements (A) Nonquantitative treatment limitation (NQTL) requirements Beginning 45 days after the date of enactment of this paragraph, in the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage 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 NQTL ) on mental health or substance use disorder benefits, the plan or issuer offering health insurance coverage shall perform comparative analyses of the design and application of NQTLs in accordance with subparagraph (B), and make available to the applicable State authority (or, as applicable, the Secretary), upon request, the following information: (i) The specific plan or coverage terms regarding the NQTL, that applies to such plan or coverage, and a description of all mental health or substance use disorder and medical or surgical benefits to which it applies in each respective benefits classification. (ii) The factors used to determine that the NQTL 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 NQTL 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 design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL for mental health or substance use disorder benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used to design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL to medical or surgical benefits. (v) A disclosure of the specific findings and conclusions reached by the plan or coverage that the results of the analyses described in this subparagraph indicate that the plan or coverage is in compliance with this section. (B) Secretary request process (i) Submission upon request The Secretary shall request that a group health plan or a health insurance issuer offering group or individual health insurance coverage submit the comparative analyses described in subparagraph (A) for plans that involve potential violations of this section or complaints regarding noncompliance with this section that concern NQTLs and any other instances in which the Secretary determines appropriate. The Secretary shall request not fewer than 20 such analyses per year. (ii) Additional information In instances in which the Secretary has concluded that the plan or coverage has not submitted sufficient information for the Secretary to review the comparative analyses described in subparagraph (A), as requested under clause (i), the Secretary shall specify to the plan or coverage the information the plan or coverage must submit to be responsive to the request under clause (i) for the Secretary to review the comparative analyses described in subparagraph (A) for compliance with this section. Nothing in this paragraph shall require the Secretary to conclude that a plan is in compliance with this section solely based upon the inspection of the comparative analyses described in subparagraph (A), as requested under clause (i). (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 plan or coverage is not in compliance with this section, the plan or coverage— (aa) shall specify to the Secretary the actions the plan or coverage will take to be in compliance with this section and provide to the Secretary 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 or coverage is not in compliance; and (bb) following the 45-day corrective action period under item (aa), if the Secretary determines that the plan or coverage still is not in compliance with this section, not later than 7 days after such determination, shall notify all individuals enrolled in the plan or coverage that the plan or coverage has been determined to be not in compliance with this section. (II) Exemption from disclosure Documents or communications produced in connection with the Secretary’s recommendations to the plan or coverage shall not be subject to disclosure pursuant to section 552 of title 5, United States Code. (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 plan or coverage 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 plan or coverage submitted sufficient information for the Secretary to review the comparative analyses requested under clause (i) for compliance with this section; (III) for each plan or coverage 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 or coverage is in compliance with the requirements under this section; (IV) the Secretary’s specifications described in clause (ii) for each plan or coverage 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 plan or coverage 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 or coverage is not in compliance. (C) Compliance program guidance document update process (i) In general The Secretary shall include instances of noncompliance that the Secretary discovers upon reviewing the comparative analyses requested under subparagraph (B)(i) in the compliance program guidance document described in paragraph (6), as it is updated every 2 years, except that such instances shall not disclose any protected health information or individually identifiable information. (ii) Guidance and regulations Not later than 18 months after the date of enactment of this paragraph, the Secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section. Such draft guidance shall include guidance to clarify the process and timeline for current and potential participants and beneficiaries (and authorized representatives and health care providers of such participants and beneficiaries) with respect to plans to file complaints of such plans or issuers being in violation of this section, including guidance, by plan type, on the relevant State, regional, or national office with which such complaints should be filed. (iii) State The Secretary shall share information on findings of compliance and noncompliance discovered upon reviewing the comparative analyses requested under subparagraph (B)(i) with the State where the group health plan is located or the State where the health insurance issuer is licensed to do business for coverage offered by a health insurance issuer in the group market, in accordance with paragraph (6)(B)(iii)(II). (b) Construction Nothing in this section shall be construed— (1) as requiring a group health plan or a health insurance issuer offering group or individual health insurance coverage to provide any mental health or substance use disorder benefits; or (2) in the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides mental health or substance use disorder benefits, as affecting the terms and conditions of the plan or coverage relating to such benefits under the plan or coverage, except as provided in subsection (a). (c) Exemptions (1) Small employer exemption This section shall not apply to any group health plan and a health insurance issuer offering group or individual health insurance coverage for any plan year of a small employer (as defined in section 2791(e)(4), except that for purposes of this paragraph such term shall include employers with 1 employee in the case of an employer residing in a State that permits small groups to include a single individual). (2) Cost exemption (A) In general With respect to a group health plan or a health insurance issuer offering group or individual health insurance coverage, if the application of this section to such plan (or coverage) results in an increase for the plan year involved of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits under the plan (as determined and certified under subparagraph (C)) by an amount that exceeds the applicable percentage described in subparagraph (B) of the actual total plan costs, the provisions of this section shall not apply to such plan (or coverage) during the following plan year, and such exemption shall apply to the plan (or coverage) for 1 plan year. An employer may elect to continue to apply mental health and substance use disorder parity pursuant to this section with respect to the group health plan (or coverage) involved regardless of any increase in total costs. (B) Applicable percentage With respect to a plan (or coverage), the applicable percentage described in this subparagraph shall be— (i) 2 percent in the case of the first plan year in which this section is applied; and (ii) 1 percent in the case of each subsequent plan year. (C) Determinations by actuaries Determinations as to increases in actual costs under a plan (or coverage) for purposes of this section shall be made and certified by a qualified and licensed actuary who is a member in good standing of the American Academy of Actuaries. All such determinations shall be in a written report prepared by the actuary. The report, and all underlying documentation relied upon by the actuary, shall be maintained by the group health plan or health insurance issuer for a period of 6 years following the notification made under subparagraph (E). (D) 6-month determinations If a group health plan (or a health insurance issuer offering coverage in connection with a group health plan) seeks an exemption under this paragraph, determinations under subparagraph (A) shall be made after such plan (or coverage) has complied with this section for the first 6 months of the plan year involved. (E) Notification (i) In general A group health plan (or a health insurance issuer offering coverage in connection with a group health plan) that, based upon a certification described under subparagraph (C), qualifies for an exemption under this paragraph, and elects to implement the exemption, shall promptly notify the Secretary, the appropriate State agencies, and participants and beneficiaries in the plan of such election. (ii) Requirement A notification to the Secretary under clause (i) shall include— (I) a description of the number of covered lives under the plan (or coverage) involved at the time of the notification, and as applicable, at the time of any prior election of the cost-exemption under this paragraph by such plan (or coverage); (II) for both the plan year upon which a cost exemption is sought and the year prior, a description of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits under the plan; and (III) for both the plan year upon which a cost exemption is sought and the year prior, the actual total costs of coverage with respect to mental health and substance use disorder benefits under the plan. (iii) Confidentiality A notification to the Secretary under clause (i) shall be confidential. The Secretary shall make available, upon request and on not more than an annual basis, an anonymous itemization of such notifications, that includes— (I) a breakdown of States by the size and type of employers submitting such notification; and (II) a summary of the data received under clause (ii). (F) Audits by appropriate agencies To determine compliance with this paragraph, the Secretary may audit the books and records of a group health plan or health insurance issuer relating to an exemption, including any actuarial reports prepared pursuant to subparagraph (C), during the 6 year period following the notification of such exemption under subparagraph (E). A State agency receiving a notification under subparagraph (E) may also conduct such an audit with respect to an exemption covered by such notification. (d) Separate Application to Each Option Offered In the case of a group health plan that offers a participant or beneficiary two or more benefit package options under the plan, the requirements of this section shall be applied separately with respect to each such option. (e) Definitions For purposes of this section— (1) Aggregate lifetime limit The term aggregate lifetime limit means, with respect to benefits under a group health plan or health insurance coverage, a dollar limitation on the total amount that may be paid with respect to such benefits under the plan or health insurance coverage with respect to an individual or other coverage unit. (2) Annual limit The term annual limit means, with respect to benefits under a group health plan or health insurance coverage, a dollar limitation on the total amount of benefits that may be paid with respect to such benefits in a 12-month period under the plan or health insurance coverage with respect to an individual or other coverage unit. (3) Medical or surgical benefits The term medical or surgical benefits means benefits with respect to medical or surgical services, as defined under the terms of the plan or coverage (as the case may be), but does not include mental health or substance use disorder benefits. (4) Mental health benefits The term mental health benefits means benefits with respect to services for mental health conditions, as defined under the terms of the plan and in accordance with applicable Federal and State law. (5) Substance use disorder benefits The term substance use disorder benefits means benefits with respect to services for substance use disorders, as defined under the terms of the plan and in accordance with applicable Federal and State law. . (2) Sunset Section 2726 of the Public Health Service Act ( 42 U.S.C. 300gg–26 ) is amended by adding at the end the following new subsection: (f) Sunset The provisions of this section shall have no force or effect after the date of the enactment of the Strengthening Behavioral Health Parity Act. . (b) ERISA Section 712(a) of the Employee Retirement Income Security Act of 1974 (1185a(a)) is amended by adding at the end the following new paragraphs: (6) Compliance program guidance document (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Health and Human Services, and the Secretary of the Treasury, in consultation 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, shall issue a compliance program guidance document to help improve compliance with this section, section 2799A–1 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986, as applicable. In carrying out this paragraph, the Secretaries may take into consideration the 2016 publication of the Department of Health and Human Services and the Department of Labor, entitled Warning Signs - Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance . (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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, 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 To the extent that any example described in clause (i) involves a finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment limitations, the example shall provide sufficient detail to fully explain such finding, including a full description of the criteria involved for approving medical and surgical benefits and the criteria involved for approving mental health and substance use disorder benefits. (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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, 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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable. (C) Recommendations The compliance program guidance document shall include recommendations to advance compliance with this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable, and encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements. Such internal controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance use disorder benefits, which may fail to comply with this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable, in relation to nonquantitative treatment limitations on medical and surgical benefits. (D) Updating the compliance program guidance document The Secretary, the Secretary of Health and Human Services, and the Secretary of the Treasury, in consultation 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, shall update the compliance program guidance document every 2 years to include 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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable. (7) Additional guidance (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Health and Human Services, and the Secretary of the Treasury shall issue guidance to group health plans and health insurance issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the requirements of this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable. (B) Disclosure (i) Guidance for plans and issuers The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use for disclosing information to ensure compliance with the requirements under this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable (and any regulations promulgated pursuant to such sections, as applicable). (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 and health insurance issuers offering group or individual health insurance coverage may use to provide any participant, beneficiary, contracting provider, or authorized representative, as applicable, with documents containing information that the health plans or issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, 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 and health insurance issuers offering group or individual health insurance coverage may use regarding the development and application of nonquantitative treatment limitations to ensure compliance with this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, 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 or issuers 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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable. (D) Public comment Prior to issuing any final guidance under this paragraph, the Secretary shall provide a public comment period of not less than 60 days during which any member of the public may provide comments on a draft of the guidance. (8) Compliance requirements (A) Nonquantitative treatment limitation (NQTL) requirements Beginning 45 days after the date of enactment of this paragraph, in the case of a group health plan or a health insurance issuer offering group health insurance coverage 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 NQTL ) on mental health or substance use disorder benefits, the plan or issuer offering health insurance coverage shall perform comparative analyses of the design and application of NQTLs in accordance with subparagraph (B), and make available to the applicable State authority (or, as applicable, the Secretary), upon request, the following information: (i) The specific plan or coverage terms regarding the NQTL, that applies to such plan or coverage, and a description of all mental health or substance use disorder and medical or surgical benefits to which it applies in each respective benefits classification. (ii) The factors used to determine that the NQTL 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 NQTL 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 design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL for mental health or substance use disorder benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used to design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL to medical or surgical benefits. (v) A disclosure of the specific findings and conclusions reached by the plan or coverage that the results of the analyses described in this subparagraph indicate that the plan or coverage is in compliance with this section. (B) Secretary request process (i) Submission upon request The Secretary shall request that a group health plan or a health insurance issuer offering group health insurance coverage submit the comparative analyses described in subparagraph (A) for plans that involve potential violations of this section or complaints regarding noncompliance with this section that concern NQTLs and any other instances in which the Secretary determines appropriate. The Secretary shall request not fewer than 20 such analyses per year. (ii) Additional information In instances in which the Secretary has concluded that the plan or coverage has not submitted sufficient information for the Secretary to review the comparative analyses described in subparagraph (A), as requested under clause (i), the Secretary shall specify to the plan or coverage the information the plan or coverage must submit to be responsive to the request under clause (i) for the Secretary to review the comparative analyses described in subparagraph (A) for compliance with this section. Nothing in this paragraph shall require the Secretary to conclude that a plan is in compliance with this section solely based upon the inspection of the comparative analyses described in subparagraph (A), as requested under clause (i). (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 plan or coverage is not in compliance with this section, the plan or coverage— (aa) shall specify to the Secretary the actions the plan or coverage will take to be in compliance with this section and provide to the Secretary 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 or coverage is not in compliance; and (bb) following the 45-day corrective action period under item (aa), if the Secretary determines that the plan or coverage still is not in compliance with this section, not later than 7 days after such determination, shall notify all individuals enrolled in the plan or coverage that the plan or coverage has been determined to be not in compliance with this section. (II) Exemption from disclosure Documents or communications produced in connection with the Secretary’s recommendations to the plan or coverage shall not be subject to disclosure pursuant to section 552 of title 5, United States Code. (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 plan or coverage 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 plan or coverage submitted sufficient information for the Secretary to review the comparative analyses requested under clause (i) for compliance with this section; (III) for each plan or coverage 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 or coverage is in compliance with the requirements under this section; (IV) the Secretary’s specifications described in clause (ii) for each plan or coverage 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 plan or coverage 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 or coverage is not in compliance. (C) Compliance program guidance document update process (i) In general The Secretary shall include instances of noncompliance that the Secretary discovers upon reviewing the comparative analyses requested under subparagraph (B)(i) in the compliance program guidance document described in paragraph (6), as it is updated every 2 years, except that such instances shall not disclose any protected health information or individually identifiable information. (ii) Guidance and regulations Not later than 18 months after the date of enactment of this paragraph, the Secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section. Such draft guidance shall include guidance to clarify the process and timeline for current and potential participants and beneficiaries (and authorized representatives and health care providers of such participants and beneficiaries) with respect to plans to file complaints of such plans or issuers being in violation of this section, including guidance, by plan type, on the relevant State, regional, or national office with which such complaints should be filed. (iii) State The Secretary shall share information on findings of compliance and noncompliance discovered upon reviewing the comparative analyses requested under subparagraph (B)(i) with the State where the group health plan is located or the State where the health insurance issuer is licensed to do business for coverage offered by a health insurance issuer in the group market, in accordance with paragraph (6)(B)(iii)(II). . (c) IRC Section 9812 of the Internal Revenue Code of 1986 is amended by adding at the end the following new paragraphs: (6) Compliance program guidance document (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Labor, and the Secretary of Health and Human Services, in consultation 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, shall issue a compliance program guidance document to help improve compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, and section 2799A–1 of the Public Health Service Act, as applicable. In carrying out this paragraph, the Secretaries may take into consideration the 2016 publication of the Department of Health and Human Services and the Department of Labor, entitled Warning Signs - Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance . (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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, 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 To the extent that any example described in clause (i) involves a finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment limitations, the example shall provide sufficient detail to fully explain such finding, including a full description of the criteria involved for approving medical and surgical benefits and the criteria involved for approving mental health and substance use disorder benefits. (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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, 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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable. (C) Recommendations The compliance program guidance document shall include recommendations to advance compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable, and encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements. Such internal controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance use disorder benefits, which may fail to comply with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable, in relation to nonquantitative treatment limitations on medical and surgical benefits. (D) Updating the compliance program guidance document The Secretary, the Secretary of Labor, and the Secretary of Health and Human Services, in consultation 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, shall update the compliance program guidance document every 2 years to include 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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable. (7) Additional guidance (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Labor, and the Secretary of Health and Human Services shall issue guidance to group health plans and health insurance issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the requirements of this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable. (B) Disclosure (i) Guidance for plans and issuers The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use for disclosing information to ensure compliance with the requirements under this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act (and any regulations promulgated pursuant to such sections, as applicable). (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 and health insurance issuers offering group or individual health insurance coverage may use to provide any participant, beneficiary, contracting provider, or authorized representative, as applicable, with documents containing information that the health plans or issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, 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 and health insurance issuers offering group or individual health insurance coverage may use regarding the development and application of nonquantitative treatment limitations to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, 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 or issuers 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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable. (D) Public comment Prior to issuing any final guidance under this paragraph, the Secretary shall provide a public comment period of not less than 60 days during which any member of the public may provide comments on a draft of the guidance. (8) Compliance requirements (A) Nonquantitative treatment limitation (NQTL) requirements Beginning 45 days after the date of enactment of this paragraph, 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 NQTL ) on mental health or substance use disorder benefits, the plan shall perform comparative analyses of the design and application of NQTLs in accordance with subparagraph (B), and make available to the applicable State authority (or, as applicable, the Secretary), upon request, the following information: (i) The specific plan terms regarding the NQTL, that applies to such plan or coverage, and a description of all mental health or substance use disorder and medical or surgical benefits to which it applies in each respective benefits classification. (ii) The factors used to determine that the NQTL 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 NQTL 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 design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL for mental health or substance use disorder benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used to design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL to medical or surgical benefits. (v) A disclosure of the specific findings and conclusions reached by the plan that the results of the analyses described in this subparagraph indicate that the plan is in compliance with this section. (B) Secretary request process (i) Submission upon request The Secretary shall request that a group health plan submit the comparative analyses described in subparagraph (A) for plans that involve potential violations of this section or complaints regarding noncompliance with this section that concern NQTLs and any other instances in which the Secretary determines appropriate. The Secretary shall request not fewer than 20 such analyses per year. (ii) Additional information In instances in which the Secretary has concluded that the plan has not submitted sufficient information for the Secretary to review the comparative analyses described in subparagraph (A), as requested under clause (i), the Secretary shall specify to the plan the information the plan or coverage must submit to be responsive to the request under clause (i) for the Secretary to review the comparative analyses described in subparagraph (A) for compliance with this section. Nothing in this paragraph shall require the Secretary to conclude that a plan is in compliance with this section solely based upon the inspection of the comparative analyses described in subparagraph (A), as requested under clause (i). (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 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 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 determines 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 or coverage that the plan has been determined to be not in compliance with this section. (II) Exemption from disclosure Documents or communications produced in connection with the Secretary’s recommendations to the plan or coverage shall not be subject to disclosure pursuant to section 552 of title 5, United States Code. (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 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 plan submitted sufficient information for the Secretary to review the comparative analyses requested under clause (i) for compliance with this section; (III) for each 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 or coverage is in compliance with the requirements under this section; (IV) the Secretary’s specifications described in clause (ii) for each 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 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 or coverage is not in compliance. (C) Compliance program guidance document update process (i) In general The Secretary shall include instances of noncompliance that the Secretary discovers upon reviewing the comparative analyses requested under subparagraph (B)(i) in the compliance program guidance document described in paragraph (6), as it is updated every 2 years, except that such instances shall not disclose any protected health information or individually identifiable information. (ii) Guidance and regulations Not later than 18 months after the date of enactment of this paragraph, the Secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section. Such draft guidance shall include guidance to clarify the process and timeline for current and potential participants and beneficiaries (and authorized representatives and health care providers of such participants and beneficiaries) with respect to plans to file complaints of such plans or issuers being in violation of this section, including guidance, by plan type, on the relevant State, regional, or national office with which such complaints should be filed. (iii) State The Secretary shall share information on findings of compliance and noncompliance discovered upon reviewing the comparative analyses requested under subparagraph (B)(i) with the State where the group health plan is located or the State where the health insurance issuer is licensed to do business for coverage offered by a health insurance issuer in the group market, in accordance with paragraph (6)(B)(iii)(II). . (d) Implementation The Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury may implement the paragraph (8) of section 2799A–1(a) of the Public Health Service Act, added by subsection (a), the paragraph (8) of section 712(a) of the Employee Retirement Income Security Act of 1974, as added by subsection (b), and the paragraph (8) of section 9812(a) of the Internal Revenue Code of 1986, as added by subsection (c), by program instruction, guidance, or otherwise.

tv_txt: IB Union Calendar No. 575 116th CONGRESS 2d Session H. R. 7539 [Report No. 116–692, Part I] IN THE HOUSE OF REPRESENTATIVES July 9, 2020 Mr. Kennedy (for himself, Ms. Porter , Mr. Bilirakis , and Mr. Upton ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committees on Ways and Means , and Education and Labor , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned December 24, 2020 Additional sponsors: Mr. Luján , Mr. Soto , and Mr. Fitzpatrick December 24, 2020 Reported from the Committee on Energy and Commerce with an amendment Strike out all after the enacting clause and insert the part printed in italic December 24, 2020 Committees on Ways and Means and Education and Labor discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed For text of introduced bill, see copy of bill as introduced on July 9, 2020 A BILL To strengthen parity in mental health and substance use disorder benefits.

1. Short title This Act may be cited as the Strengthening Behavioral Health Parity Act . 2. Strengthening parity in mental health and substance use disorder benefits (a) PHSA (1) In general Title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg–11 et seq.) is amended by adding at the end the following new part: D Additional Coverage Provisions 2799A–1. Parity in mental health and substance use disorder benefits (a) In General (1) Aggregate lifetime limits In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits— (A) No lifetime limit If the plan or coverage does not include an aggregate lifetime limit on substantially all medical and surgical benefits, the plan or coverage may not impose any aggregate lifetime limit on mental health or substance use disorder benefits. (B) Lifetime limit If the plan or coverage includes an aggregate lifetime limit on substantially all medical and surgical benefits (in this paragraph referred to as the applicable lifetime limit ), the plan or coverage 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 In the case of a plan or coverage that is not described in subparagraph (A) or (B) and that includes no or different aggregate lifetime limits on different categories of medical and surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or coverage with respect to mental health and substance use disorder benefits by substituting for the applicable lifetime limit an average aggregate lifetime limit that is computed taking into account the weighted average of the aggregate lifetime limits applicable to such categories. (2) Annual limits In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits— (A) No annual limit If the plan or coverage does not include an annual limit on substantially all medical and surgical benefits, the plan or coverage may not impose any annual limit on mental health or substance use disorder benefits. (B) Annual limit If the plan or coverage includes an annual limit on substantially all medical and surgical benefits (in this paragraph referred to as the applicable annual limit ), the plan or coverage 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 In the case of a plan or coverage that is not described in subparagraph (A) or (B) and that includes no or different annual limits on different categories of medical and surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or coverage with respect to mental health and substance use disorder benefits by substituting for the applicable annual limit an average annual limit that is computed taking into account the weighted average of the annual limits applicable to such categories. (3) Financial requirements and treatment limitations (A) In general In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits, such plan or coverage 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 (or coverage), 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 (or coverage) 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 The term financial requirement includes deductibles, copayments, coinsurance, and out-of-pocket expenses, but excludes an aggregate lifetime limit and an annual limit subject to paragraphs (1) and (2). (ii) Predominant A financial requirement or treatment limit is considered to be predominant if it is the most common or frequent of such type of limit or requirement. (iii) Treatment limitation The term treatment limitation includes limits on the frequency of treatment, number of visits, days of coverage, or other similar limits on the scope or duration of treatment. (4) Availability of plan information The criteria for medical necessity determinations made under the plan with respect to mental health or substance use disorder benefits (or the health insurance coverage offered in connection with the plan with respect to such benefits) shall be made available by the plan administrator (or the health insurance issuer offering such coverage) in accordance with regulations to any current or potential participant, beneficiary, or contracting provider upon request. The reason for any denial under the plan (or coverage) of reimbursement or payment for services with respect to mental health or substance use disorder benefits in the case of any participant or beneficiary shall, on request or as otherwise required, be made available by the plan administrator (or the health insurance issuer offering such coverage) to the participant or beneficiary in accordance with regulations. (5) Out-of-network providers In the case of a plan or coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits, if the plan or coverage provides coverage for medical or surgical benefits provided by out-of-network providers, the plan or coverage shall provide coverage for mental health or substance use disorder benefits provided by out-of-network providers in a manner that is consistent with the requirements of this section. (6) Compliance program guidance document (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Labor, and the Secretary of the Treasury, in consultation 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, shall issue a compliance program guidance document to help improve compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, and section 9812 of the Internal Revenue Code of 1986, as applicable. In carrying out this paragraph, the Secretaries may take into consideration the 2016 publication of the Department of Health and Human Services and the Department of Labor, entitled Warning Signs - Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance . (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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, 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 To the extent that any example described in clause (i) involves a finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment limitations, the example shall provide sufficient detail to fully explain such finding, including a full description of the criteria involved for approving medical and surgical benefits and the criteria involved for approving mental health and substance use disorder benefits. (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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, 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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable. (C) Recommendations The compliance program guidance document shall include recommendations to advance compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, and encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements. Such internal controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance use disorder benefits, which may fail to comply with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, in relation to nonquantitative treatment limitations on medical and surgical benefits. (D) Updating the compliance program guidance document The Secretary, the Secretary of Labor, and the Secretary of the Treasury, in consultation 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, shall update the compliance program guidance document every 2 years to include 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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable. (7) Additional guidance (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Labor, and the Secretary of the Treasury shall issue guidance to group health plans and health insurance issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the requirements of this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable. (B) Disclosure (i) Guidance for plans and issuers The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use for disclosing information to ensure compliance with the requirements under this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, (and any regulations promulgated pursuant to such sections, as applicable). (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 and health insurance issuers offering group or individual health insurance coverage may use to provide any participant, beneficiary, contracting provider, or authorized representative, as applicable, with documents containing information that the health plans or issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, 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 and health insurance issuers offering group or individual health insurance coverage may use regarding the development and application of nonquantitative treatment limitations to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, 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 or issuers 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 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable. (D) Public comment Prior to issuing any final guidance under this paragraph, the Secretary shall provide a public comment period of not less than 60 days during which any member of the public may provide comments on a draft of the guidance. (8) Compliance requirements (A) Nonquantitative treatment limitation (NQTL) requirements In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage 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 NQTL ) on mental health or substance use disorder benefits, the plan or issuer offering health insurance coverage shall perform comparative analyses of the design and application of NQTLs in accordance with subparagraph (B), and, beginning 45 days after the date of enactment of this paragraph, make available to the applicable State authority (or, as applicable, the Secretary), upon request, the comparative analyses and the following information: (i) The specific plan or coverage terms regarding the NQTL, that applies to such plan or coverage, and a description of all mental health or substance use disorder and medical or surgical benefits to which it applies in each respective benefits classification. (ii) The factors used to determine that the NQTL 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 NQTL 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 design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL for mental health or substance use disorder benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used to design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL to medical or surgical benefits. (v) A disclosure of the specific findings and conclusions reached by the plan or coverage that the results of the analyses described in this subparagraph indicate that the plan or coverage is in compliance with this section. (B) Secretary request process (i) Submission upon request The Secretary shall request that a group health plan or a health insurance issuer offering group or individual health insurance coverage submit the comparative analyses described in subparagraph (A) for plans that involve potential violations of this section or complaints regarding noncompliance with this section that concern NQTLs and any other instances in which the Secretary determines appropriate. The Secretary shall request not fewer than 20 such analyses per year. (ii) Additional information In instances in which the Secretary has concluded that the plan or coverage has not submitted sufficient information for the Secretary to review the comparative analyses described in subparagraph (A), as requested under clause (i), the Secretary shall specify to the plan or coverage the information the plan or coverage must submit to be responsive to the request under clause (i) for the Secretary to review the comparative analyses described in subparagraph(A) for compliance with this section. Nothing in this paragraph shall require the Secretary to conclude that a plan is in compliance with this section solely based upon the inspection of the comparative analyses described in subparagraph (A), as requested under clause (i). (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 plan or coverage is not in compliance with this section, the plan or coverage— (aa) shall specify to the Secretary the actions the plan or coverage will take to be in compliance with this section and provide to the Secretary 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 or coverage is not in compliance; and (bb) following the 45-day corrective action period under item (aa), if the Secretary determines that the plan or coverage still is not in compliance with this section, not later than 7 days after such determination, shall notify all individuals enrolled in the plan or coverage that the plan or coverage has been determined to be not in compliance with this section. (II) Exemption from disclosure Documents or communications produced in connection with the Secretary’s recommendations to the plan or coverage shall not be subject to disclosure pursuant to section 552 of title 5, United States Code. (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 plan or coverage 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 plan or coverage submitted sufficient information for the Secretary to review the comparative analyses requested under clause (i) for compliance with this section; (III) for each plan or coverage 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 or coverage is in compliance with the requirements under this section; (IV) the Secretary’s specifications described in clause (ii) for each plan or coverage 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 plan or coverage 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 or coverage is not in compliance. (C) Compliance program guidance document update process (i) In general The Secretary shall include instances of noncompliance that the Secretary discovers upon reviewing the comparative analyses requested under subparagraph (B)(i) in the compliance program guidance document described in paragraph (6), as it is updated every 2 years, except that such instances shall not disclose any protected health information or individually identifiable information. (ii) Guidance and regulations Not later than 18 months after the date of enactment of this paragraph, the Secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section. Such draft guidance shall include guidance to clarify the process and timeline for current and potential participants and beneficiaries (and authorized representatives and health care providers of such participants and beneficiaries) with respect to plans to file complaints of such plans or issuers being in violation of this section, including guidance, by plan type, on the relevant State, regional, or national office with which such complaints should be filed. (iii) State The Secretary shall share information on findings of compliance and noncompliance discovered upon reviewing the comparative analyses requested under subparagraph (B)(i) with the State where the group health plan is located or the State where the health insurance issuer is licensed to do business for coverage offered by a health insurance issuer in the group market, in accordance with paragraph (6)(B)(iii)(II). (b) Construction Nothing in this section shall be construed— (1) as requiring a group health plan or a health insurance issuer offering group or individual health insurance coverage to provide any mental health or substance use disorder benefits; or (2) in the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides mental health or substance use disorder benefits, as affecting the terms and conditions of the plan or coverage relating to such benefits under the plan or coverage, except as provided in subsection (a). (c) Exemptions (1) Small employer exemption This section shall not apply to any group health plan and a health insurance issuer offering group or individual health insurance coverage for any plan year of a small employer (as defined in section 2791(e)(4), except that for purposes of this paragraph such term shall include employers with 1 employee in the case of an employer residing in a State that permits small groups to include a single individual). (2) Cost exemption (A) In general With respect to a group health plan or a health insurance issuer offering group or individual health insurance coverage, if the application of this section to such plan (or coverage) results in an increase for the plan year involved of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits under the plan (as determined and certified under subparagraph (C)) by an amount that exceeds the applicable percentage described in subparagraph (B) of the actual total plan costs, the provisions of this section shall not apply to such plan (or coverage) during the following plan year, and such exemption shall apply to the plan (or coverage) for 1 plan year. An employer may elect to continue to apply mental health and substance use disorder parity pursuant to this section with respect to the group health plan (or coverage) involved regardless of any increase in total costs. (B) Applicable percentage With respect to a plan (or coverage), the applicable percentage described in this subparagraph shall be— (i) 2 percent in the case of the first plan year in which this section is applied; and (ii) 1 percent in the case of each subsequent plan year. (C) Determinations by actuaries Determinations as to increases in actual costs under a plan (or coverage) for purposes of this section shall be made and certified by a qualified and licensed actuary who is a member in good standing of the American Academy of Actuaries. All such determinations shall be in a written report prepared by the actuary. The report, and all underlying documentation relied upon by the actuary, shall be maintained by the group health plan or health insurance issuer for a period of 6 years following the notification made under subparagraph (E). (D) 6-month determinations If a group health plan (or a health insurance issuer offering coverage in connection with a group health plan) seeks an exemption under this paragraph, determinations under subparagraph (A) shall be made after such plan (or coverage) has complied with this section for the first 6 months of the plan year involved. (E) Notification (i) In general A group health plan (or a health insurance issuer offering coverage in connection with a group health plan) that, based upon a certification described under subparagraph (C), qualifies for an exemption under this paragraph, and elects to implement the exemption, shall promptly notify the Secretary, the appropriate State agencies, and participants and beneficiaries in the plan of such election. (ii) Requirement A notification to the Secretary under clause (i) shall include— (I) a description of the number of covered lives under the plan (or coverage) involved at the time of the notification, and as applicable, at the time of any prior election of the cost-exemption under this paragraph by such plan (or coverage); (II) for both the plan year upon which a cost exemption is sought and the year prior, a description of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits under the plan; and (III) for both the plan year upon which a cost exemption is sought and the year prior, the actual total costs of coverage with respect to mental health and substance use disorder benefits under the plan. (iii) Confidentiality A notification to the Secretary under clause (i) shall be confidential. The Secretary shall make available, upon request and on not more than an annual basis, an anonymous itemization of such notifications, that includes— (I) a breakdown of States by the size and type of employers submitting such notification; and (II) a summary of the data received under clause (ii). (F) Audits by appropriate agencies To determine compliance with this paragraph, the Secretary may audit the books and records of a group health plan or health insurance issuer relating to an exemption, including any actuarial reports prepared pursuant to subparagraph (C), during the 6 year period following the notification of such exemption under subparagraph (E). A State agency receiving a notification under subparagraph (E) may also conduct such an audit with respect to an exemption covered by such notification. (d) Separate Application to Each Option Offered In the case of a group health plan that offers a participant or beneficiary two or more benefit package options under the plan, the requirements of this section shall be applied separately with respect to each such option. (e) Definitions For purposes of this section— (1) Aggregate lifetime limit The term aggregate lifetime limit means, with respect to benefits under a group health plan or health insurance coverage, a dollar limitation on the total amount that may be paid with respect to such benefits under the plan or health insurance coverage with respect to an individual or other coverage unit. (2) Annual limit The term annual limit means, with respect to benefits under a group health plan or health insurance coverage, a dollar limitation on the total amount of benefits that may be paid with respect to such benefits in a 12-month period under the plan or health insurance coverage with respect to an individual or other coverage unit. (3) Medical or surgical benefits The term medical or surgical benefits means benefits with respect to medical or surgical services, as defined under the terms of the plan or coverage (as the case may be), but does not include mental health or substance use disorder benefits. (4) Mental health benefits The term mental health benefits means benefits with respect to services for mental health conditions, as defined under the terms of the plan and in accordance with applicable Federal and State law. (5) Substance use disorder benefits The term substance use disorder benefits means benefits with respect to services for substance use disorders, as defined under the terms of the plan and in accordance with applicable Federal and State law. . (2) Sunset Section 2726 of the Public Health Service Act ( 42 U.S.C. 300gg–26 ) is amended by adding at the end the following new subsection (f) Sunset The provisions of this section shall have no force or effect after the date of the enactment of the Strengthening Behavioral Health Parity Act. . (3) Administration; conforming amendments (A) Application of implementation regulations The provisions of sections 146.136 and 147.160 of title 45, Code of Federal Regulations shall apply to section 2799A–1 of the Public Health Service Act, as added by paragraph (1), in the same manner as such provisions applied to section 2726 of the Public Health Service Act ( 42 U.S.C. 300gg–26 ) before the date of the enactment of this Act. (B) Conforming amendments (i) Section 2722 of the Public Health Service Act ( 42 U.S.C. 300gg–21 ) is amended— (I) in subsection (a)(1), by inserting and part D after subparts 1 and 2 ; (II) in subsection (b), by inserting and part D after subparts 1 and 2 ; (III) in subsection (c)(1), by inserting and part D after subparts 1 and 2 ; (IV) in subsection (c)(2), by inserting and part D after subparts 1 and 2 ; (V) in subsection (c)(3), by inserting and part D after this part ; and (VI) in subsection (d), in the matter preceding paragraph (1), by inserting and part D after this part . (ii) Section 2723 of the Public Health Service Act ( 42 U.S.C. 300gg–22 ) is amended— (I) in subsection (a)(1), by inserting and part D after this part ; (II) in subsection (a)(2), by inserting or part D after this part ; (III) in subsection (b)(1), by inserting or part D after this part ; (IV) in subsection (b)(2)(A), by inserting or part D after this part ; and (V) in subsection (b)(2)(C)(ii), by inserting and part D after this part . (iii) Section 2724 of the Public Health Service Act ( 42 U.S.C. 300gg–23 ) is amended— (I) in subsection (a)(1)— (aa) by striking this part and part C insofar as it relates to this part and inserting this part, part D, and part C insofar as it relates to this part or part D ; and (bb) by inserting or part D after requirement of this part ; (II) in subsection (a)(2), by inserting or part D after this part ; and (III) in subsection (c), by inserting or part D after this part (other than section 2704) . (b) ERISA Section 712(a) of the Employee Retirement Income Security Act of 1974 (1185a(a)) is amended by adding at the end the following new paragraphs: (6) Compliance program guidance document (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Health and Human Services, and the Secretary of the Treasury, in consultation 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, shall issue a compliance program guidance document to help improve compliance with this section, section 2799A–1 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986, as applicable. In carrying out this paragraph, the Secretaries may take into consideration the 2016 publication of the Department of Health and Human Services and the Department of Labor, entitled Warning Signs - Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance . (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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, 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 To the extent that any example described in clause (i) involves a finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment limitations, the example shall provide sufficient detail to fully explain such finding, including a full description of the criteria involved for approving medical and surgical benefits and the criteria involved for approving mental health and substance use disorder benefits. (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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, 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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable. (C) Recommendations The compliance program guidance document shall include recommendations to advance compliance with this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable, and encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements. Such internal controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance use disorder benefits, which may fail to comply with this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable, in relation to nonquantitative treatment limitations on medical and surgical benefits. (D) Updating the compliance program guidance document The Secretary, the Secretary of Health and Human Services, and the Secretary of the Treasury, in consultation 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, shall update the compliance program guidance document every 2 years to include 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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable. (7) Additional guidance (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Health and Human Services, and the Secretary of the Treasury shall issue guidance to group health plans and health insurance issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the requirements of this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable. (B) Disclosure (i) Guidance for plans and issuers The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use for disclosing information to ensure compliance with the requirements under this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable, (and any regulations promulgated pursuant to such sections, as applicable). (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 and health insurance issuers offering group or individual health insurance coverage may use to provide any participant, beneficiary, contracting provider, or authorized representative, as applicable, with documents containing information that the health plans or issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, 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 and health insurance issuers offering group or individual health insurance coverage may use regarding the development and application of nonquantitative treatment limitations to ensure compliance with this section, section 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, 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 or issuers 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 2799A–1 of the Public Health Service Act, or section 9812 of the Internal Revenue Code of 1986, as applicable. (D) Public comment Prior to issuing any final guidance under this paragraph, the Secretary shall provide a public comment period of not less than 60 days during which any member of the public may provide comments on a draft of the guidance. (8) Compliance requirements (A) Nonquantitative treatment limitation (NQTL) requirements Beginning 45 days after the date of enactment of this paragraph, in the case of a group health plan or a health insurance issuer offering group health insurance coverage 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 NQTL ) on mental health or substance use disorder benefits, the plan or issuer offering health insurance coverage shall perform comparative analyses of the design and application of NQTLs in accordance with subparagraph (B), and make available to the applicable State authority (or, as applicable, the Secretary), upon request, the following information: (i) The specific plan or coverage terms regarding the NQTL, that applies to such plan or coverage, and a description of all mental health or substance use disorder and medical or surgical benefits to which it applies in each respective benefits classification. (ii) The factors used to determine that the NQTL 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 NQTL 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 design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL for mental health or substance use disorder benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used to design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL to medical or surgical benefits. (v) A disclosure of the specific findings and conclusions reached by the plan or coverage that the results of the analyses described in this subparagraph indicate that the plan or coverage is in compliance with this section. (B) Secretary request process (i) Submission upon request The Secretary shall request that a group health plan or a health insurance issuer offering group health insurance coverage submit the comparative analyses described in subparagraph (A) for plans that involve potential violations of this section or complaints regarding noncompliance with this section that concern NQTLs and any other instances in which the Secretary determines appropriate. The Secretary shall request not fewer than 20 such analyses per year. (ii) Additional information In instances in which the Secretary has concluded that the plan or coverage has not submitted sufficient information for the Secretary to review the comparative analyses described in subparagraph (A), as requested under clause (i), the Secretary shall specify to the plan or coverage the information the plan or coverage must submit to be responsive to the request under clause (i) for the Secretary to review the comparative analyses described in subparagraph(A) for compliance with this section. Nothing in this paragraph shall require the Secretary to conclude that a plan is in compliance with this section solely based upon the inspection of the comparative analyses described in subparagraph (A), as requested under clause (i). (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 plan or coverage is not in compliance with this section, the plan or coverage— (aa) shall specify to the Secretary the actions the plan or coverage will take to be in compliance with this section and provide to the Secretary 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 or coverage is not in compliance; and (bb) following the 45-day corrective action period under item (aa), if the Secretary determines that the plan or coverage still is not in compliance with this section, not later than 7 days after such determination, shall notify all individuals enrolled in the plan or coverage that the plan or coverage has been determined to be not in compliance with this section. (II) Exemption from disclosure Documents or communications produced in connection with the Secretary’s recommendations to the plan or coverage shall not be subject to disclosure pursuant to section 552 of title 5, United States Code. (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 plan or coverage 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 plan or coverage submitted sufficient information for the Secretary to review the comparative analyses requested under clause (i) for compliance with this section; (III) for each plan or coverage 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 or coverage is in compliance with the requirements under this section; (IV) the Secretary’s specifications described in clause (ii) for each plan or coverage 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 plan or coverage 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 or coverage is not in compliance. (C) Compliance program guidance document update process (i) In general The Secretary shall include instances of noncompliance that the Secretary discovers upon reviewing the comparative analyses requested under subparagraph (B)(i) in the compliance program guidance document described in paragraph (6), as it is updated every 2 years, except that such instances shall not disclose any protected health information or individually identifiable information. (ii) Guidance and regulations Not later than 18 months after the date of enactment of this paragraph, the Secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section. Such draft guidance shall include guidance to clarify the process and timeline for current and potential participants and beneficiaries (and authorized representatives and health care providers of such participants and beneficiaries) with respect to plans to file complaints of such plans or issuers being in violation of this section, including guidance, by plan type, on the relevant State, regional, or national office with which such complaints should be filed. (iii) State The Secretary shall share information on findings of compliance and noncompliance discovered upon reviewing the comparative analyses requested under subparagraph (B)(i) with the State where the group health plan is located or the State where the health insurance issuer is licensed to do business for coverage offered by a health insurance issuer in the group market, in accordance with paragraph (6)(B)(iii)(II). . (c) IRC Section 9812 of the Internal Revenue Code of 1986 is amended by adding at the end the following new paragraphs: (6) Compliance program guidance document (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Labor, and the Secretary of Health and Human Services, in consultation 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, shall issue a compliance program guidance document to help improve compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, and section 2799A–1 of the Public Health Service Act, as applicable. In carrying out this paragraph, the Secretaries may take into consideration the 2016 publication of the Department of Health and Human Services and the Department of Labor, entitled Warning Signs - Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance . (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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, 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 To the extent that any example described in clause (i) involves a finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment limitations, the example shall provide sufficient detail to fully explain such finding, including a full description of the criteria involved for approving medical and surgical benefits and the criteria involved for approving mental health and substance use disorder benefits. (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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, 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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable. (C) Recommendations The compliance program guidance document shall include recommendations to advance compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable, and encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements. Such internal controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance use disorder benefits, which may fail to comply with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable, in relation to nonquantitative treatment limitations on medical and surgical benefits. (D) Updating the compliance program guidance document The Secretary, the Secretary of Labor, and the Secretary of Health and Human Services, in consultation 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, shall update the compliance program guidance document every 2 years to include 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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable. (7) Additional guidance (A) In general Not later than 12 months after the date of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016 , the Secretary, the Secretary of Labor, and the Secretary of Health and Human Services shall issue guidance to group health plans and health insurance issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the requirements of this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable. (B) Disclosure (i) Guidance for plans and issuers The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use for disclosing information to ensure compliance with the requirements under this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, (and any regulations promulgated pursuant to such sections, as applicable). (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 and health insurance issuers offering group or individual health insurance coverage may use to provide any participant, beneficiary, contracting provider, or authorized representative, as applicable, with documents containing information that the health plans or issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, 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 and health insurance issuers offering group or individual health insurance coverage may use regarding the development and application of nonquantitative treatment limitations to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, 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 or issuers 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 712 of the Employee Retirement Income Security Act of 1974, or section 2799A–1 of the Public Health Service Act, as applicable. (D) Public comment Prior to issuing any final guidance under this paragraph, the Secretary shall provide a public comment period of not less than 60 days during which any member of the public may provide comments on a draft of the guidance. (8) Compliance requirements (A) Nonquantitative treatment limitation (NQTL) requirements Beginning 45 days after the date of enactment of this paragraph, 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 NQTL ) on mental health or substance use disorder benefits, the plan shall perform comparative analyses of the design and application of NQTLs in accordance with subparagraph (B), and make available to the applicable State authority (or, as applicable, the Secretary), upon request, the following information: (i) The specific plan terms regarding the NQTL, that applies to such plan or coverage, and a description of all mental health or substance use disorder and medical or surgical benefits to which it applies in each respective benefits classification. (ii) The factors used to determine that the NQTL 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 NQTL 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 design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL for mental health or substance use disorder benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, and other factors used to design the NQTL, as written, and the operation processes and strategies as written and in operation that are used to apply the NQTL to medical or surgical benefits. (v) A disclosure of the specific findings and conclusions reached by the plan that the results of the analyses described in this subparagraph indicate that the plan is in compliance with this section. (B) Secretary request process (i) Submission upon request The Secretary shall request that a group health plan submit the comparative analyses described in subparagraph (A) for plans that involve potential violations of this section or complaints regarding noncompliance with this section that concern NQTLs and any other instances in which the Secretary determines appropriate. The Secretary shall request not fewer than 20 such analyses per year. (ii) Additional information In instances in which the Secretary has concluded that the plan has not submitted sufficient information for the Secretary to review the comparative analyses described in subparagraph (A), as requested under clause (i), the Secretary shall specify to the plan the information the plan or coverage must submit to be responsive to the request under clause (i) for the Secretary to review the comparative analyses described in subparagraph(A) for compliance with this section. Nothing in this paragraph shall require the Secretary to conclude that a plan is in compliance with this section solely based upon the inspection of the comparative analyses described in subparagraph (A), as requested under clause (i). (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 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 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 determines 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 or coverage that the plan has been determined to be not in compliance with this section. (II) Exemption from disclosure Documents or communications produced in connection with the Secretary’s recommendations to the plan or coverage shall not be subject to disclosure pursuant to section 552 of title 5, United States Code. (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 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 plan submitted sufficient information for the Secretary to review the comparative analyses requested under clause (i) for compliance with this section; (III) for each 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 or coverage is in compliance with the requirements under this section; (IV) the Secretary’s specifications described in clause (ii) for each 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 plan hat 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 or coverage is not in compliance. (C) Compliance program guidance document update process (i) In general The Secretary shall include instances of noncompliance that the Secretary discovers upon reviewing the comparative analyses requested under subparagraph (B)(i) in the compliance program guidance document described in paragraph (6), as it is updated every 2 years, except that such instances shall not disclose any protected health information or individually identifiable information. (ii) Guidance and regulations Not later than 18 months after the date of enactment of this paragraph, the Secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section. Such draft guidance shall include guidance to clarify the process and timeline for current and potential participants and beneficiaries (and authorized representatives and health care providers of such participants and beneficiaries) with respect to plans to file complaints of such plans or issuers being in violation of this section, including guidance, by plan type, on the relevant State, regional, or national office with which such complaints should be filed. (iii) State The Secretary shall share information on findings of compliance and noncompliance discovered upon reviewing the comparative analyses requested under subparagraph (B)(i) with the State where the group health plan is located or the State where the health insurance issuer is licensed to do business for coverage offered by a health insurance issuer in the group market, in accordance with paragraph (6)(B)(iii)(II). . (d) Implementation The Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury may implement the paragraph (8) of section 2799A–1(a) of the Public Health Service Act, added by subsection (a), the paragraph (8) of section 712(a) of the Employee Retirement Income Security Act of 1974, as addedby subsection (b), and the paragraph (8) of section 9812(a) of the Internal Revenue Code of 1986, as added by subsection (c), by program instruction, guidance, or otherwise.

December 24, 2020 Reported from the Committee on Energy and Commerce with an amendment December 24, 2020 Committees on Ways and Means and Education and Labor discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed