H.R. 7666 — what changed

added “(c) Plan

added “(1) In general—For purposes of maintaining the suicide prevention hotline under subsection (b)(2), the Secretary shall develop and implement a plan to ensure the provision of high-quality service.

added “(2) Contents—The plan required by paragraph (1) shall include the following:

added “(A) Quality assurance provisions, including—

added “(i) clearly defined and measurable performance indicators and objectives to improve the responsiveness and performance of the hotline, including at backup call centers; and

added “(ii) quantifiable timeframes to track the progress of the hotline in meeting such performance indicators and objectives.

added “(B) Standards that crisis centers and backup centers must meet—

added “(i) to participate in the network under subsection (b)(1); and

added “(ii) to ensure that each telephone call, online chat message, and other communication received by the hotline, including at backup call centers, is answered in a timely manner by a person, consistent with the guidance established by the American Association of Suicidology or other guidance determined by the Secretary to be appropriate.

added “(C) Guidelines for crisis centers and backup centers to implement evidence-based practices including with respect to followup and referral to other health and social services resources.

added “(D) Guidelines to ensure that resources are available and distributed to individuals using the hotline who are not personally in a time of crisis but know of someone who is.

added “(E) Guidelines to carry out periodic testing of the hotline, including at crisis centers and backup centers, during each fiscal year to identify and correct any problems in a timely manner.

added “(F) Guidelines to operate in consultation with the State department of health, local governments, Indian tribes, and tribal organizations.

added “(3) Initial plan; updates—The Secretary shall—

added “(A) not later than 6 months after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, complete development of the initial version of the plan required by paragraph (1), begin implementation of such plan, and make such plan publicly available; and

added “(B) periodically thereafter, update such plan and make the updated plan publicly available.”

added “(d) Transmission of data to CDC—The Secretary shall formalize and strengthen agreements between the National Suicide Prevention Lifeline program and the Centers for Disease Control and Prevention to transmit any necessary epidemiological data from the program to the Centers, including local call center data, to assist the Centers in suicide prevention efforts.”

added “(e) Authorization of appropriations

added “(1) In general—To carry out this section, there are authorized to be appropriated $101,621,000 for each of fiscal years 2023 through 2027.

added “(2) Allocation—Of the amount authorized to be appropriated by paragraph (1) for each of fiscal years 2023 through 2027—

added “(A) at least 80 percent shall be made available to crisis centers; and

added “(B) not more than 10 percent may be used for carrying out the pilot program in section 103(b)(1) of the Restoring Hope for Mental Health and Well-Being Act of 2022.”

added Section 309A(a)(5) of the Controlled Substances Act (21 U.S.C. 829a(a)(5)) is amended by striking “14 days” and inserting “60 days”.

added “(3) upon discovering a suspicious order or series of orders, and in a manner consistent with the other requirements of this section—

added “(A) exercise due diligence as appropriate;

added “(B) establish and maintain (for not less than a period to be determined by the Administrator of the Drug Enforcement Administration) a record of the due diligence that was performed;

added “(C) decline to fill the order or series of orders if the due diligence fails to dispel all of the indicators that give rise to the suspicion that, if the order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted; and

added “(D) notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business of—

added “(i) each suspicious order or series of orders discovered by the registrant; and

added “(ii) the indicators giving rise to the suspicion that, if the order or series of orders is filled, the drugs that are the subject of the order or series of orders are likely to be diverted.”

added “(b) Resolution of suspicious indicators—If a registrant resolves all of the indicators giving rise to suspicion about an order or series of orders under subsection (a)(3)—

added “(1) notwithstanding subsection (a)(3)(C), the registrant may choose to fill the order or series of orders; and

added “(2) notwithstanding subsection (a)(3)(D), the registrant may choose not to make the notification otherwise required by such subsection.”

added “(1) pharmacists on how to verify the identity of the patient;”

added “(d) Materials for training on verification of identity—Not later than 1 year after the date of enactment of this subsection, the Secretary of Health and Human Services, after seeking stakeholder input in accordance with subsection (c), shall—

added “(1) update the materials developed under subsection (a) to include information for pharmacists on how to verify the identity the patient; and

added “(2) disseminate, as appropriate, the updated materials.”

added “(c) Preference—In determining the amounts of grants awarded to States under subsections (a) and (b), the Director of the Centers for Disease Control and Prevention may give preference to States in accordance with such criteria as the Director may specify and may choose to give preference to States that—

added “(1) maintain a prescription drug monitoring program;

added “(2) require prescribers of controlled substances in schedule II, III, or IV to issue such prescriptions electronically, and make such requirement subject to exceptions in the cases listed in section 1860D–4(e)(7)(B) of the Social Security Act; and

added “(3) require dispensers of such controlled substances to enter certain information about the purchase of such controlled substances into the respective State’s prescription drug monitoring program, including—

added “(A) the National Drug Code or, in the case of compounded medications, compound identifier;

added “(B) the quantity dispensed;

added “(C) the patient identifier; and

added “(D) the date filled.”

added “(d) Definitions—In this section:

added “(1) Controlled substance—The term controlled substance has the meaning given that term in section 102 of the Controlled Substances Act.

added “(2) Dispenser—The term dispenser means a physician, pharmacist, or other person that dispenses a controlled substance to an ultimate user.

added “(3) Indian Tribe—The term Indian Tribe has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act.”

added “317V. Synthetic Opioids Public Awareness Campaign

added “(a) In general—Not later than one year after the date of the enactment of this section, the Secretary shall provide for the planning and implementation of a public education campaign to raise public awareness of synthetic opioids (including fentanyl and its analogues). Such campaign shall include the dissemination of information that—

added “(1) promotes awareness about the potency and dangers of fentanyl and its analogues and other synthetic opioids;

added “(2) explains services provided by the Substance Abuse and Mental Health Services Administration and the Centers for Disease Control and Prevention (and any entity providing such services under a contract entered into with such agencies) with respect to the misuse of opioids, particularly as such services relate to the provision of alternative, non-opioid pain management treatments; and

added “(3) relates generally to opioid use and pain management.

added “(b) Use of media—The campaign under subsection (a) may be implemented through the use of television, radio, internet, in-person public communications, and other commercial marketing venues and may be targeted to specific age groups.

added “(c) Consideration of report findings—In planning and implementing the public education campaign under subsection (a), the Secretary shall take into consideration the findings of the report required under section 7001 of the SUPPORT for Patients and Communities Act (Public Law 115–271).

added “(d) Consultation—In coordinating the campaign under subsection (a), the Secretary shall consult with the Assistant Secretary for Mental Health and Substance Use to provide ongoing advice on the effectiveness of information disseminated through the campaign.

added “(e) Requirement of Campaign—The campaign implemented under subsection (a) shall not be duplicative of any other Federal efforts relating to eliminating the misuse of opioids.

added “(f) Evaluation

added “(1) In general—The Secretary shall ensure that the campaign implemented under subsection (a) is subject to an independent evaluation, beginning 2 years after the date of the enactment of this section, and every 2 years thereafter.

added “(2) Measures and benchmarks—For purposes of an evaluation conducted pursuant to paragraph (1), the Secretary shall—

added “(A) establish baseline measures and bench­marks to quantitatively evaluate the impact of the campaign under this section; and

added “(B) conduct qualitative assessments regarding the effectiveness of strategies employed under this section.

added “(g) Report—The Secretary shall, beginning 2 years after the date of the enactment of this section, and every 2 years thereafter, submit to Congress a report on the effectiveness of the campaign implemented under subsection (a) towards meeting the measures and benchmarks established under subsection (e)(2).

added “(h) Dissemination of Information Through Providers—The Secretary shall develop and implement a plan for the dissemination of information related to synthetic opioids, to health care providers who participate in Federal programs, including programs administered by the Department of Health and Human Services, the Indian Health Service, the Department of Veterans Affairs, the Department of Defense, and the Health Resources and Services Administration, the Medicare program under title XVIII of the Social Security Act, and the Medicaid program under title XIX of such Act.”

added Section 1003 of the 21st Century Cures Act (42 U.S.C. 290ee–3 note) is amended to read as follows:

added “1003. Grant program for State and Tribal response to opioid and stimulant use and misuse

added “(a) In general—The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall carry out the grant program described in subsection (b) for purposes of addressing opioid and stimulant use and misuse, within States, Indian Tribes, and populations served by Tribal organizations and Urban Indian organizations.

added “(b) Grants program

added “(1) In general—Subject to the availability of appropriations, the Secretary shall award grants to States, Indian Tribes, Tribal organizations, and Urban Indian organizations for the purpose of addressing opioid and stimulant use and misuse, within such States, such Indian Tribes, and populations served by such Tribal organizations and Urban Indian organizations, in accordance with paragraph (2).

added “(2) Minimum allocations; preference—In determining grant amounts for each recipient of a grant under paragraph (1), the Secretary shall—

added “(A) ensure that each State receives not less than $4,000,000; and

added “(B) give preference to States, Indian Tribes, Tribal organizations, and Urban Indian organizations whose populations have an incidence or prevalence of opioid use disorders or stimulant use or misuse that is substantially higher relative to the populations of other States, other Indian Tribes, Tribal organizations, or Urban Indian organizations, as applicable.

added “(3) Formula methodology

added “(A) In general—Before publishing a funding opportunity announcement with respect to grants under this section, the Secretary shall—

added “(i) develop a formula methodology to be followed in allocating grant funds awarded under this section among grantees, which includes performance assessments for continuation awards; and

added “(ii) not later than 30 days after developing the formula methodology under clause (i), submit the formula methodology to—

added “(I) the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives; and

added “(II) the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate.

added “(B) Report—Not later than two years after the date of the enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that—

added “(i) assesses how grant funding is allocated to States under this section and how such allocations have changed over time;

added “(ii) assesses how any changes in funding under this section have affected the efforts of States to address opioid or stimulant use or misuse; and

added “(iii) assesses the use of funding provided through the grant program under this section and other similar grant programs administered by the Substance Abuse and Mental Health Services Administration.

added “(4) Use of funds—Grants awarded under this subsection shall be used for carrying out activities that supplement activities pertaining to opioid and stimulant use and misuse, undertaken by the State agency responsible for administering the substance abuse prevention and treatment block grant under subpart II of part B of title XIX of the Public Health Service Act (42 U.S.C. 300x–21 et seq.), which may include public health-related activities such as the following:

added “(A) Implementing prevention activities, and evaluating such activities to identify effective strategies to prevent substance use disorders.

added “(B) Establishing or improving prescription drug monitoring programs.

added “(C) Training for health care practitioners, such as best practices for prescribing opioids, pain management, recognizing potential cases of substance use disorders, referral of patients to treatment programs, preventing diversion of controlled substances, and overdose prevention.

added “(D) Supporting access to health care services, including—

added “(i) services provided by federally certified opioid treatment programs;

added “(ii) outpatient and residential substance use disorder treatment services that utilize medication-assisted treatment, as appropriate; or

added “(iii) other appropriate health care providers to treat substance use disorders.

added “(E) Recovery support services, including—

added “(i) community-based services that include peer supports;

added “(ii) mutual aid recovery programs that support medication-assisted treatment; or

added “(iii) services to address housing needs and family issues.

added “(F) Other public health-related activities, as the State, Indian Tribe, Tribal organization, or Urban Indian organization determines appropriate, related to addressing substance use disorders within the State, Indian Tribe, Tribal organization, or Urban Indian organization, including directing resources in accordance with local needs related to substance use disorders.

added “(c) Accountability and oversight—A State receiving a grant under subsection (b) shall include in reporting related to substance use disorders submitted to the Secretary pursuant to section 1942 of the Public Health Service Act (42 U.S.C. 300x–52), a description of—

added “(1) the purposes for which the grant funds received by the State under such subsection for the preceding fiscal year were expended and a description of the activities of the State under the grant;

added “(2) the ultimate recipients of amounts provided to the State; and

added “(3) the number of individuals served through the grant.

added “(d) Limitations—Any funds made available pursuant to subsection (i)—

added “(1) shall not be used for any purpose other than the grant program under subsection (b); and

added “(2) shall be subject to the same requirements as substance use disorders prevention and treatment programs under titles V and XIX of the Public Health Service Act (42 U.S.C. 290aa et seq., 300w et seq.).

added “(e) Indian Tribes, Tribal organizations, and Urban Indian organizations—The Secretary, in consultation with Indian Tribes, Tribal organizations, and Urban Indian organizations, shall identify and establish appropriate mechanisms for Indian Tribes, Tribal organizations, and Urban Indian organizations to demonstrate or report the information as required under subsections (b), (c), and (d).

added “(f) Report to Congress—Not later than September 30, 2024, and biennially thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and the Committees on Appropriations of the House of Representatives and the Senate, a report that includes a summary of the information provided to the Secretary in reports made pursuant to subsections (c) and (e), including—

added “(1) the purposes for which grant funds are awarded under this section;

added “(2) the activities of the grant recipients; and

added “(3) for each State, Indian Tribe, Tribal organization, and Urban Indian organization that receives a grant under this section, the funding level provided to such recipient.

added “(g) Technical assistance—The Secretary, including through the Tribal Training and Technical Assistance Center of the Substance Abuse and Mental Health Services Administration, shall provide States, Indian Tribes, Tribal organizations, and Urban Indian organizations, as applicable, with technical assistance concerning grant application and submission procedures under this section, award management activities, and enhancing outreach and direct support to rural and underserved communities and providers in addressing substance use disorders.

added “(h) Definitions—In this section:

added “(1) Indian Tribe—The term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304).

added “(2) Tribal organization—The term Tribal organization has the meaning given the term tribal organization in such section 4.

added “(3) State—The term State has the meaning given such term in section 1954(b) of the Public Health Service Act (42 U.S.C. 300x–64(b)).

added “(4) Urban Indian organization—The term Urban Indian organization has the meaning given such term in section 4 of the Indian Health Care Improvement Act.

added “(i) Authorization of appropriations

added “(1) In general—For purposes of carrying out the grant program under subsection (b), there is authorized to be appropriated $1,750,000,000 for each of fiscal years 2023 through 2027, to remain available until expended.

added “(2) Federal administrative expenses—Of the amounts made available for each fiscal year to award grants under subsection (b), the Secretary shall not use more than 20 percent for Federal administrative expenses, training, technical assistance, and evaluation.

added “(3) Set aside—Of the amounts made available for each fiscal year to award grants under subsection (b) for a fiscal year, the Secretary shall—

added “(A) award 5 percent to Indian Tribes, Tribal organizations, and Urban Indian organizations; and

added “(B) of the amount remaining after application of subparagraph (A), set aside up to 15 percent for awards to States with the highest age-adjusted rate of drug overdose death based on the ordinal ranking of States according to the Director of the Centers for Disease Control and Prevention.”

added Section 597(c) of the Public Health Service Act (42 U.S.C. 290ll(c)) is amended by striking “$12,669,000 for each of fiscal years 2018 through 2022” and inserting “$25,000,000 for each of fiscal years 2023 through 2027”.

added “317V. Data system to capture national public safety officer suicide incidence

added “(a) In general—The Secretary, in coordination with the Director of the Centers for Disease Control and Prevention and other agencies as the Secretary determines appropriate, may—

added “(1) develop and maintain a data system, to be known as the Public Safety Officer Suicide Reporting System, for the purposes of—

added “(A) collecting data on the suicide incidence among public safety officers; and

added “(B) facilitating the study of successful interventions to reduce suicide among public safety officers; and

added “(2) integrate such system into the National Violent Death Reporting System, so long as the Secretary determines such integration to be consistent with the purposes described in paragraph (1).

added “(b) Data collection—In collecting data for the Public Safety Officer Suicide Reporting System, the Secretary shall, at a minimum, collect the following information:

added “(1) The total number of suicides in the United States among all public safety officers in a given calendar year.

added “(2) Suicide rates for public safety officers in a given calendar year, disaggregated by—

added “(A) age and gender of the public safety officer;

added “(B) State;

added “(C) occupation; including both the individual’s role in their public safety agency and their primary occupation in the case of volunteer public safety officers;

added “(D) where available, the status of the public safety officer as volunteer, paid-on-call, or career; and

added “(E) status of the public safety officer as active or retired.

added “(c) Consultation during development—In developing the Public Safety Officer Suicide Reporting System, the Secretary shall consult with non-Federal experts to determine the best means to collect data regarding suicide incidence in a safe, sensitive, anonymous, and effective manner. Such non-Federal experts shall include, as appropriate, the following:

added “(1) Public health experts with experience in developing and maintaining suicide registries.

added “(2) Organizations that track suicide among public safety officers.

added “(3) Mental health experts with experience in studying suicide and other profession-related traumatic stress.

added “(4) Clinicians with experience in diagnosing and treating mental health issues.

added “(5) Active and retired volunteer, paid-on-call, and career public safety officers.

added “(6) Relevant national police, and fire and emergency medical services, organizations.

added “(d) Data privacy and security—In developing and maintaining the Public Safety Officer Suicide Reporting System, the Secretary shall ensure that all applicable Federal privacy and security protections are followed to ensure that—

added “(1) the confidentiality and anonymity of suicide victims and their families are protected, including so as to ensure that data cannot be used to deny benefits; and

added “(2) data is sufficiently secure to prevent unauthorized access.

added “(e) Reporting

added “(1) Annual report—Not later than 2 years after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022, and biannually thereafter, the Secretary shall submit a report to the Congress on the suicide incidence among public safety officers. Each such report shall—

added “(A) include the number and rate of such suicide incidence, disaggregated by age, gender, and State of employment;

added “(B) identify characteristics and contributing circumstances for suicide among public safety officers;

added “(C) disaggregate rates of suicide by—

added “(i) occupation;

added “(ii) status as volunteer, paid-on-call, or career; and

added “(iii) status as active or retired;

added “(D) include recommendations for further study regarding the suicide incidence among public safety officers;

added “(E) specify in detail, if found, any obstacles in collecting suicide rates for volunteers and include recommended improvements to overcome such obstacles;

added “(F) identify options for interventions to reduce suicide among public safety officers; and

added “(G) describe procedures to ensure the confidentiality and anonymity of suicide victims and their families, as described in subsection (d)(1).

added “(2) Public availability—Upon the submission of each report to the Congress under paragraph (1), the Secretary shall make the full report publicly available on the website of the Centers for Disease Control and Prevention.

added “(f) Definition—In this section, the term public safety officer means—

added “(1) a public safety officer as defined in section 1204 of the Omnibus Crime Control and Safe Streets Act of 1968; or

added “(2) a public safety telecommunicator as described in detailed occupation 43–5031 in the Standard Occupational Classification Manual of the Office of Management and Budget (2018).

added “(g) Prohibited use of information—Notwithstanding any other provision of law, if an individual is identified as deceased based on information contained in the Public Safety Officer Suicide Reporting System, such information may not be used to deny or rescind life insurance payments or other benefits to a survivor of the deceased individual.”

added “320C. Peer-support behavioral health and wellness programs within fire departments and emergency medical service agencies

added “(a) In general—The Secretary may award grants to eligible entities for the purpose of establishing or enhancing peer-support behavioral health and wellness programs within fire departments and emergency medical services agencies.

added “(b) Program description—A peer-support behavioral health and wellness program funded under this section shall—

added “(1) use career and volunteer members of fire departments or emergency medical services agencies to serve as peer counselors;

added “(2) provide training to members of career, volunteer, and combination fire departments or emergency medical service agencies to serve as such peer counselors;

added “(3) purchase materials to be used exclusively to provide such training; and

added “(4) disseminate such information and materials as are necessary to conduct the program.

added “(c) Definition—In this section:

added “(1) The term eligible entity means a nonprofit organization with expertise and experience with respect to the health and life safety of members of fire and emergency medical services agencies.

added “(2) The term member—

added “(A) with respect to an emergency medical services agency, means an employee, regardless of rank or whether the employee receives compensation (as defined in section 1204(7) of the Omnibus Crime Control and Safe Streets Act of 1968); and

added “(B) with respect to a fire department, means any employee, regardless of rank or whether the employee receives compensation, of a Federal, State, Tribal, or local fire department who is responsible for responding to calls for emergency service.”

added “320D. Health care provider behavioral health and wellness programs

added “(a) In general—The Secretary may award grants to eligible entities for the purpose of establishing or enhancing behavioral health and wellness programs for health care providers.

added “(b) Program description—A behavioral health and wellness program funded under this section shall—

added “(1) provide confidential support services for health care providers to help handle stressful or traumatic patient-related events, including counseling services and wellness seminars;

added “(2) provide training to health care providers to serve as peer counselors to other health care providers;

added “(3) purchase materials to be used exclusively to provide such training; and

added “(4) disseminate such information and materials as are necessary to conduct such training and provide such peer counseling.

added “(c) Definitions—In this section, the term eligible entity means a hospital, including a critical access hospital (as defined in section 1861(mm)(1) of the Social Security Act) or a disproportionate share hospital (as defined under section 1923(a)(1)(A) of such Act), a Federally-qualified health center (as defined in section 1905(1)(2)(B) of such Act), or any other health care facility.”

added “581. School-based mental health; children and adolescents

added “(a) In general—The Secretary, in consultation with the Secretary of Education, shall, through grants, contracts, or cooperative agreements awarded to eligible entities described in subsection (c), provide comprehensive school-based mental health services and supports to assist children in local communities and schools (including schools funded by the Bureau of Indian Education) dealing with traumatic experiences, grief, bereavement, risk of suicide, and violence. Such services and supports shall be—

added “(1) developmentally, linguistically, and culturally appropriate;

added “(2) trauma-informed; and

added “(3) incorporate positive behavioral interventions and supports.

added “(b) Activities—Grants, contracts, or cooperative agreements awarded under subsection (a), shall, as appropriate, be used for—

added “(1) implementation of school and community-based mental health programs that—

added “(A) build awareness of individual trauma and the intergenerational, continuum of impacts of trauma on populations;

added “(B) train appropriate staff to identify, and screen for, signs of trauma exposure, mental health disorders, or risk of suicide; and

added “(C) incorporate positive behavioral interventions, family engagement, student treatment, and multigenerational supports to foster the health and development of children, prevent mental health disorders, and ameliorate the impact of trauma;

added “(2) technical assistance to local communities with respect to the development of programs described in paragraph (1);

added “(3) facilitating community partnerships among families, students, law enforcement agencies, education agencies, mental health and substance use disorder service systems, family-based mental health service systems, child welfare agencies, health care providers (including primary care physicians, mental health professionals, and other professionals who specialize in children’s mental health such as child and adolescent psychiatrists), institutions of higher education, faith-based programs, trauma networks, and other community-based systems to address child and adolescent trauma, mental health issues, and violence; and

added “(4) establishing mechanisms for children and adolescents to report incidents of violence or plans by other children, adolescents, or adults to commit violence.

added “(c) Requirements

added “(1) In general—To be eligible for a grant, contract, or cooperative agreement under subsection (a), an entity shall be a partnership that includes—

added “(A) a State educational agency, as defined in section 8101 of the Elementary and Secondary Education Act of 1965, in coordination with one or more local educational agencies, as defined in section 8101 of the Elementary and Secondary Education Act of 1965, or a consortium of any entities described in subparagraph (B), (C), (D), or (E) of section 8101(30) of such Act; and

added “(B) at least 1 community-based mental health provider, including a public or private mental health entity, health care entity, family-based mental health entity, trauma network, or other community-based entity, as determined by the Secretary (and which may include additional entities such as a human services agency, law enforcement or juvenile justice entity, child welfare agency, agency, an institution of higher education, or another entity, as determined by the Secretary).

added “(2) Compliance with HIPAA—Any patient records developed by covered entities through activities under the grant shall meet the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996.

added “(3) Compliance with FERPA—Section 444 of the General Education Provisions Act (commonly known as the “Family Educational Rights and Privacy Act of 1974”) shall apply to any entity that is a member of the partnership in the same manner that such section applies to an educational agency or institution (as that term is defined in such section).

added “(d) Geographical distribution—The Secretary shall ensure that grants, contracts, or cooperative agreements under subsection (a) will be distributed equitably among the regions of the country and among urban and rural areas.

added “(e) Duration of awards—With respect to a grant, contract, or cooperative agreement under subsection (a), the period during which payments under such an award will be made to the recipient shall be 5 years, with options for renewal.

added “(f) Evaluation and measures of outcomes

added “(1) Development of process—The Assistant Secretary shall develop a fiscally appropriate process for evaluating activities carried out under this section. Such process shall include—

added “(A) the development of guidelines for the submission of program data by grant, contract, or cooperative agreement recipients;

added “(B) the development of measures of outcomes (in accordance with paragraph (2)) to be applied by such recipients in evaluating programs carried out under this section; and

added “(C) the submission of annual reports by such recipients concerning the effectiveness of programs carried out under this section.

added “(2) Measures of outcomes—The Assistant Secretary shall develop measures of outcomes to be applied by recipients of assistance under this section to evaluate the effectiveness of programs carried out under this section, including outcomes related to the student, family, and local educational systems supported by this Act.

added “(3) Submission of annual data—An eligible entity described in subsection (c) that receives a grant, contract, or cooperative agreement under this section shall annually submit to the Assistant Secretary a report that includes data to evaluate the success of the program carried out by the entity based on whether such program is achieving the purposes of the program. Such reports shall utilize the measures of outcomes under paragraph (2) in a reasonable manner to demonstrate the progress of the program in achieving such purposes.

added “(4) Evaluation by assistant secretary—Based on the data submitted under paragraph (3), the Assistant Secretary shall annually submit to Congress a report concerning the results and effectiveness of the programs carried out with assistance received under this section.

added “(5) Limitation—An eligible entity shall use not more than 20 percent of amounts received under a grant under this section to carry out evaluation activities under this subsection.

added “(g) Information and education—The Secretary shall disseminate best practices based on the findings of the knowledge development and application under this section.

added “(h) Amount of grants and authorization of appropriations

added “(1) Amount of grants—A grant under this section shall be in an amount that is not more than $2,000,000 for each of the first 5 fiscal years following the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022. The Secretary shall determine the amount of each such grant based on the population of children up to age 21 of the area to be served under the grant.

added “(2) Authorization of appropriations—There is authorized to be appropriated to carry out this section, $130,000,000 for each of fiscal years 2023 through 2027.”

added “G School-based mental health”

added Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall—

added The Public Health Service Act is amended by inserting after section 520H of such Act, as added by section 151, the following new section:

added “520I. Best practices for behavioral intervention teams

added “(a) In general—The Secretary shall identify and facilitate the development of best practices to assist elementary schools, secondary schools, and institutions of higher education in establishing and using behavioral intervention teams.

added “(b) Elements—The best practices under subsection (a)(1) shall include guidance on the following:

added “(1) How behavioral intervention teams can operate effectively from an evidence-based, objective perspective while protecting the constitutional and civil rights of individuals.

added “(2) The use of behavioral intervention teams to identify concerning behaviors, implement interventions, and manage risk through the framework of the school’s or institution’s rules or code of conduct, as applicable.

added “(3) How behavioral intervention teams can, when assessing an individual—

added “(A) access training on evidence-based, threat-assessment rubrics;

added “(B) ensure that such teams—

added “(i) have trained, diverse stakeholders with varied expertise; and

added “(ii) use cross validation by a wide-range of individual perspectives on the team; and

added “(C) use violence risk assessment.

added “(4) How behavioral intervention teams can help mitigate—

added “(A) inappropriate use of a mental health assessment;

added “(B) inappropriate limitations or restrictions on law enforcement’s jurisdiction over criminal matters;

added “(C) attempts to substitute the behavioral intervention process in place of a criminal process, or impede a criminal process, when an individual’s behavior has potential criminal implications;

added “(D) endangerment of an individual’s privacy by failing to ensure that all applicable Federal and State privacy laws are fully complied with; or

added “(E) inappropriate referrals to, or involvement of, law enforcement when an individual’s behavior does not warrant a criminal response.

added “(c) Consultation—In carrying out subsection (a)(1), the Secretary shall consult with—

added “(1) the Secretary of Education;

added “(2) the Director of the National Threat Assessment Center of the United States Secretary Service;

added “(3) the Attorney General and the Director of the Bureau of Justice Assistance;

added “(4) teachers and other educators, principals, school administrators, school board members, school psychologists, mental health professionals, and parents of students;

added “(5) local law enforcement agencies and campus law enforcement administrators;

added “(6) privacy experts; and

added “(7) other education and mental health professionals as the Secretary deems appropriate.

added “(d) Publication—Not later than 2 years after the date of enactment of this section, the Secretary shall publish the best practices under subsection (a)(1) on the internet website of the Department of Health and Human Services.

added “(e) Technical assistance—The Secretary shall provide technical assistance to institutions of higher education, elementary schools, and secondary schools to assist such institutions and schools in implementing the best practices under subsection (a).

added “(f) Definitions—In this section:

added “(1) The term behavioral intervention team means a team of qualified individuals who—

added “(A) are responsible for identifying and assessing individuals exhibiting concerning behaviors, experiencing distress, or who are at risk of harm to self or others;

added “(B) develop and facilitate implementation of evidence-based interventions to mitigate the threat of harm to self or others posed by an individual and address the mental and behavioral health needs of individuals to reduce risk; and

added “(C) provide information to students, parents, and school employees on recognizing behavior described in this subsection.

added “(2) The terms elementary school, parent, and secondary school have the meanings given to such terms in section 8101 of the Elementary and Secondary Education Act of 1965.

added “(3) The term institution of higher education has the meaning given to such term in section 102 of the Higher Education Act of 1965.

added “(4) The term mental health assessment means an evaluation, primarily focused on diagnosis, determining the need for involuntary commitment, medication management, and on-going treatment recommendations.

added “(5) The term violence risk assessment means a broad determination of the potential risk of violence based on evidence-based literature.”

added Subpart 7 of part C of title IV of the Public Health Service Act (42 U.S.C. 285g et seq.) is amended by adding at the end the following:

added “452H. Research on the health and development effects of media on infants, children, and adolescents

added “(a) In general—The Director of the National Institutes of Health, in coordination with or acting through the Director of the Institute, shall conduct and support research and related activities concerning the health and developmental effects of media on infants, children, and adolescents, which may include the positive and negative effects of exposure to and use of media, such as social media, applications, websites, television, motion pictures, artificial intelligence, mobile devices, computers, video games, virtual and augmented reality, and other media formats as they become available. Such research shall attempt to better understand the relationships between media and technology use and individual differences and characteristics of children and shall include longitudinally designed studies to assess the impact of media on youth over time. Such research shall include consideration of core areas of child and adolescent health and development including the following:

added “(1) Cognitive—The role and impact of media use and exposure in the development of children and adolescents within such cognitive areas as language development, executive functioning, attention, creative problem solving skills, visual and spatial skills, literacy, critical thinking, and other learning abilities, and the impact of early technology use on developmental trajectories.

added “(2) Physical—The role and impact of media use and exposure on children’s and adolescent’s physical development and health behaviors, including diet, exercise, sleeping and eating routines, and other areas of physical development.

added “(3) Socio-emotional—The role and impact of media use and exposure on children’s and adolescents’ social-emotional competencies, including self-awareness, self-regulation, social awareness, relationship skills, empathy, distress tolerance, perception of social cues, awareness of one’s relationship with the media, and decision-making, as well as outcomes such as violations of privacy, perpetration of or exposure to violence, bullying or other forms of aggression, depression, anxiety, substance use, misuse or disorder, and suicidal ideation/behavior and self-harm.

added “(b) Developing research agenda—The Director of the National Institutes of Health, in consultation with the Director of the Institute, other appropriate national research institutes, academies, and centers, the Trans-NIH Pediatric Research Consortium, and non-Federal experts as needed, shall develop a research agenda on the health and developmental effects of media on infants, children, and adolescents to inform research activities under subsection (a). In developing such research agenda, the Director may use whatever means necessary (such as scientific workshops and literature reviews) to assess current knowledge and research gaps in this area.

added “(c) Research program—In coordination with the Institute and other national research institutes and centers, and utilizing the National Institutes of Health’s process of scientific peer review, the Director of the National Institutes of Health shall fund an expanded research program on the health and developmental effects of media on infants, children, and adolescents.

added “(d) Report to congress—Not later than 1 year after the date of enactment of this Act, the Director of the National Institutes of Health shall submit a report to Congress on the progress made in gathering data and expanding research on the health and developmental effects of media on infants, children, and adolescents in accordance with this section. Such report shall summarize the grants and research funded, by year, under this section.”

added “(D) beginning on the first day of the first calendar quarter that begins two years after the date of enactment of this subparagraph, in the case of individuals who are eligible juveniles described in subsection (nn)(2), are within 30 days of the date on which such eligible juvenile is scheduled to be released from a public institution following adjudication, the State shall have in place a plan to ensure, and in accordance with such plan, provide—

added “(i) for, in the 30 days prior to the release of such an eligible juvenile from such public institution (or not later than one week after release from the public institution), and in coordination with such institution—

added “(I) any screening or diagnostic service which meets reasonable standards of medical and dental practice, as determined by the State, or as indicated as medically necessary, in accordance with paragraphs (1)(A) and (5) of section 1905(r); and

added “(II) a mental health or other behavioral health screening that is a screening service described under section 1905(r)(1), or a diagnostic service described under paragraph (5) of such section, if such screening or diagnostic service was not otherwise conducted pursuant to this clause;

added “(ii) for, not later than one week after release from the public institution, referrals for such eligible juvenile to the appropriate care and services available under the State plan (or waiver of such plan) in the geographic region of the home or residence of such eligible juvenile, based on such screenings; and

added “(iii) for, following the release of such eligible juvenile from such institution, not less than 30 days of targeted case management services furnished by a provider in the geographic region of the home or residence of such eligible juvenile.”

added “(12) Required coverage of screenings, diagnostic services, referrals, and case management for certain inmates pre-release—With respect to individuals described in section 2110(b)(7), the State shall provide screenings, diagnostic services, referrals, and case management otherwise covered under the State child health plan (or waiver of such plan) during the period described in such section with respect to such screenings, services, referrals, and case management.”

added “(7) Exception to exclusion of children who are inmates of a public institution—A child shall not be considered to be described in paragraph (2)(A) if such child is an eligible juvenile (as described in section 1902(a)(84)(D)) with respect to the screenings, diagnostic services, referrals, and case management otherwise covered under the State child health plan (or waiver of such plan) during the period with respect to which such screenings, services, referrals, and case management is respectively required under such section.”

added Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance to States on how to expand the provision of, and access to, behavioral health services, including mental health services, for children covered under State plans (or waivers of such plans) under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or State child health plans (or waivers of such plans) under title XXI of such Act (42 U.S.C. 1397aa et seq.), including a description of best practices for—

added Not later than 1 year after the date of the enactment of this Act, and in the event updates are available, once every five years thereafter, the Secretary of Health and Human Services shall update guidance issued by the Centers for Medicare & Medicaid Services to States, the State Medicaid & CHIP Telehealth Toolkit, or any successor guidance, to describe strategies States may use to overcome existing barriers and increase access to telehealth services under the Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) and the Children’s Health Insurance Program under title XXI of such Act (42 U.S.C. 1397aa et seq.). Such updated guidance shall include examples of and promising practices regarding—

added The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled “Budgetary Effects of PAYGO Legislation” for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.

added “2799A–11. Oversight of pharmacy benefit manager services

added “(a) In general—For plan years beginning on or after January 1, 2024, a group health plan or health insurance issuer offering group health insurance coverage or an entity or subsidiary providing pharmacy benefits management services on behalf of such a plan or issuer shall not enter into a contract with a drug manufacturer, distributor, wholesaler, subcontractor, rebate aggregator, or any associated third party that limits the disclosure of information to plan sponsors in such a manner that prevents the plan or issuer, or an entity or subsidiary providing pharmacy benefits management services on behalf of a plan or issuer, from making the reports described in subsection (b).

added “(b) Reports

added “(1) In general—For plan years beginning on or after January 1, 2024, not less frequently than once every 6 months, a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan or an issuer providing group health insurance coverage shall submit to the plan sponsor (as defined in section 3(16)(B) of the Employee Retirement Income Security Act of 1974) of such group health plan or health insurance coverage a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format. Each such report shall include, with respect to the applicable group health plan or health insurance coverage—

added “(A) as applicable, information collected from drug manufacturers by such issuer or entity on the total amount of copayment assistance dollars paid, or copayment cards applied, that were funded by the drug manufacturer with respect to the participants and beneficiaries in such plan or coverage;

added “(B) a list of each drug covered by such plan, issuer, or entity providing pharmacy benefit management services that was dispensed during the reporting period, including, with respect to each such drug during the reporting period—

added “(i) the brand name, chemical entity, and National Drug Code;

added “(ii) the number of participants and beneficiaries for whom the drug was filled during the plan year, the total number of prescription fills for the drug (including original prescriptions and refills), and the total number of dosage units of the drug dispensed across the plan year, including whether the dispensing channel was by retail, mail order, or specialty pharmacy;

added “(iii) the wholesale acquisition cost, listed as cost per days supply and cost per pill, or in the case of a drug in another form, per dose;

added “(iv) the total out-of-pocket spending by participants and beneficiaries on such drug, including participant and beneficiary spending through copayments, coinsurance, and deductibles; and

added “(v) for any drug for which gross spending of the group health plan or health insurance coverage exceeded $10,000 during the reporting period—

added “(I) a list of all other drugs in the same therapeutic category or class, including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic category or class as such drug; and

added “(II) the rationale for preferred formulary placement of such drug in that therapeutic category or class, if applicable;

added “(C) a list of each therapeutic category or class of drugs that were dispensed under the health plan or health insurance coverage during the reporting period, and, with respect to each such therapeutic category or class of drugs, during the reporting period—

added “(i) total gross spending by the plan, before manufacturer rebates, fees, or other manufacturer remuneration;

added “(ii) the number of participants and beneficiaries who filled a prescription for a drug in that category or class;

added “(iii) if applicable to that category or class, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that category or class;

added “(iv) the total out-of-pocket spending by participants and beneficiaries, including participant and beneficiary spending through copayments, coinsurance, and deductibles; and

added “(v) for each therapeutic category or class under which 3 or more drugs are included on the formulary of such plan or coverage—

added “(I) the amount received, or expected to be received, from drug manufacturers in rebates, fees, alternative discounts, or other remuneration—

added “(aa) that has been paid, or is to be paid, by drug manufacturers for claims incurred during the reporting period; or

added “(bb) that is related to utilization of drugs, in such therapeutic category or class;

added “(II) the total net spending, after deducting rebates, price concessions, alternative discounts or other remuneration from drug manufacturers, by the health plan or health insurance coverage on that category or class of drugs; and

added “(III) the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply, incurred by the health plan or health insurance coverage and its participants and beneficiaries, after manufacturer rebates, fees, and other remuneration for drugs dispensed within such therapeutic category or class during the reporting period;

added “(D) total gross spending on prescription drugs by the plan or coverage during the reporting period, before rebates and other manufacturer fees or remuneration;

added “(E) total amount received, or expected to be received, by the health plan or health insurance coverage in drug manufacturer rebates, fees, alternative discounts, and all other remuneration received from the manufacturer or any third party, other than the plan sponsor, related to utilization of drug or drug spending under that health plan or health insurance coverage during the reporting period;

added “(F) the total net spending on prescription drugs by the health plan or health insurance coverage during the reporting period; and

added “(G) amounts paid directly or indirectly in rebates, fees, or any other type of remuneration to brokers, consultants, advisors, or any other individual or firm who referred the group health plan's or health insurance issuer's business to the pharmacy benefit manager.

added “(2) Privacy requirements—Health insurance issuers offering group health insurance coverage and entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph (1) in a manner consistent with the privacy, security, and breach notification regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, and shall restrict the use and disclosure of such information according to such privacy regulations.

added “(3) Disclosure and redisclosure

added “(A) Limitation to business associates—A group health plan receiving a report under paragraph (1) may disclose such information only to business associates of such plan as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations).

added “(B) Clarification regarding public disclosure of information—Nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such issuer or entity may not restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, or applicable State agencies.

added “(C) Limited form of report—The Secretary shall define through rulemaking a limited form of the report under paragraph (1) required of plan sponsors who are drug manufacturers, drug wholesalers, or other direct participants in the drug supply chain, in order to prevent anti-competitive behavior.

added “(4) Report to GAO—A health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan shall submit to the Comptroller General of the United States each of the first 4 reports submitted to a plan sponsor under paragraph (1) with respect to such coverage or plan, and other such reports as requested, in accordance with the privacy requirements under paragraph (2), the disclosure and redisclosure standards under paragraph (3), the standards specified pursuant to paragraph (5), and such other information that the Comptroller General determines necessary to carry out the study under section 602(d) of the Restoring Hope for Mental Health and Well-Being Act of 2022.

added “(5) Standard format—Not later than June 1, 2023, the Secretary shall specify through rulemaking standards for health insurance issuers and entities required to submit reports under paragraph (4) to submit such reports in a standard format.

added “(c) Enforcement

added “(1) In general—The Secretary, in consultation with the Secretary of Labor and the Secretary of the Treasury, shall enforce this section.

added “(2) Failure to provide timely information—A health insurance issuer or an entity providing pharmacy benefit management services that violates subsection (a) or fails to provide information required under subsection (b), or a drug manufacturer that fails to provide information under subsection (b)(1)(A) in a timely manner, shall be subject to a civil monetary penalty in the amount of $10,000 for each day during which such violation continues or such information is not disclosed or reported.

added “(3) False information—A health insurance issuer, entity providing pharmacy benefit management services, or drug manufacturer that knowingly provides false information under this section shall be subject to a civil money penalty in an amount not to exceed $100,000 for each item of false information. Such civil money penalty shall be in addition to other penalties as may be prescribed by law.

added “(4) Procedure—The provisions of section 1128A of the Social Security Act, other than subsection (a) and (b) and the first sentence of subsection (c)(1) of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A of the Social Security Act.

added “(5) Waivers—The Secretary may waive penalties under paragraph (2), or extend the period of time for compliance with a requirement of this section, for an entity in violation of this section that has made a good-faith effort to comply with this section.

added “(d) Rule of construction—Nothing in this section shall be construed to permit a health insurance issuer, group health plan, or other entity to restrict disclosure to, or otherwise limit the access of, the Department of Health and Human Services to a report described in subsection (b)(1) or information related to compliance with subsection (a) by such issuer, plan, or entity.

added “(e) Definition—In this section, the term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act.”

added “726. Oversight of pharmacy benefit manager services

added “(a) In general—For plan years beginning on or after January 1, 2024, a group health plan (or health insurance issuer offering group health insurance coverage in connection with such a plan) or an entity or subsidiary providing pharmacy benefits management services on behalf of such a plan or issuer shall not enter into a contract with a drug manufacturer, distributor, wholesaler, subcontractor, rebate aggregator, or any associated third party that limits the disclosure of information to plan sponsors in such a manner that prevents the plan or issuer, or an entity or subsidiary providing pharmacy benefits management services on behalf of a plan or issuer, from making the reports described in subsection (b).

added “(b) Reports

added “(1) In general—For plan years beginning on or after January 1, 2024, not less frequently than once every 6 months, a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan or an issuer providing group health insurance coverage shall submit to the plan sponsor (as defined in section 3(16)(B)) of such group health plan or group health insurance coverage a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format. Each such report shall include, with respect to the applicable group health plan or health insurance coverage—

added “(A) as applicable, information collected from drug manufacturers by such issuer or entity on the total amount of copayment assistance dollars paid, or copayment cards applied, that were funded by the drug manufacturer with respect to the participants and beneficiaries in such plan or coverage;

added “(B) a list of each drug covered by such plan, issuer, or entity providing pharmacy benefit management services that was dispensed during the reporting period, including, with respect to each such drug during the reporting period—

added “(i) the brand name, chemical entity, and National Drug Code;

added “(ii) the number of participants and beneficiaries for whom the drug was filled during the plan year, the total number of prescription fills for the drug (including original prescriptions and refills), and the total number of dosage units of the drug dispensed across the plan year, including whether the dispensing channel was by retail, mail order, or specialty pharmacy;

added “(iii) the wholesale acquisition cost, listed as cost per days supply and cost per pill, or in the case of a drug in another form, per dose;

added “(iv) the total out-of-pocket spending by participants and beneficiaries on such drug, including participant and beneficiary spending through copayments, coinsurance, and deductibles; and

added “(v) for any drug for which gross spending of the group health plan or health insurance coverage exceeded $10,000 during the reporting period—

added “(I) a list of all other drugs in the same therapeutic category or class, including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic category or class as such drug; and

added “(II) the rationale for preferred formulary placement of such drug in that therapeutic category or class, if applicable;

added “(C) a list of each therapeutic category or class of drugs that were dispensed under the health plan or health insurance coverage during the reporting period, and, with respect to each such therapeutic category or class of drugs, during the reporting period—

added “(i) total gross spending by the plan, before manufacturer rebates, fees, or other manufacturer remuneration;

added “(ii) the number of participants and beneficiaries who filled a prescription for a drug in that category or class;

added “(iii) if applicable to that category or class, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that category or class;

added “(iv) the total out-of-pocket spending by participants and beneficiaries, including participant and beneficiary spending through copayments, coinsurance, and deductibles; and

added “(v) for each therapeutic category or class under which 3 or more drugs are included on the formulary of such plan or coverage—

added “(I) the amount received, or expected to be received, from drug manufacturers in rebates, fees, alternative discounts, or other remuneration—

added “(aa) that has been paid, or is to be paid, by drug manufacturers for claims incurred during the reporting period; or

added “(bb) that is related to utilization of drugs, in such therapeutic category or class;

added “(II) the total net spending, after deducting rebates, price concessions, alternative discounts or other remuneration from drug manufacturers, by the health plan or health insurance coverage on that category or class of drugs; and

added “(III) the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply, incurred by the health plan or health insurance coverage and its participants and beneficiaries, after manufacturer rebates, fees, and other remuneration for drugs dispensed within such therapeutic category or class during the reporting period;

added “(D) total gross spending on prescription drugs by the plan or coverage during the reporting period, before rebates and other manufacturer fees or remuneration;

added “(E) total amount received, or expected to be received, by the health plan or health insurance coverage in drug manufacturer rebates, fees, alternative discounts, and all other remuneration received from the manufacturer or any third party, other than the plan sponsor, related to utilization of drug or drug spending under that health plan or health insurance coverage during the reporting period;

added “(F) the total net spending on prescription drugs by the health plan or health insurance coverage during the reporting period; and

added “(G) amounts paid directly or indirectly in rebates, fees, or any other type of remuneration to brokers, consultants, advisors, or any other individual or firm who referred the group health plan's or health insurance issuer's business to the pharmacy benefit manager.

added “(2) Privacy requirements—Health insurance issuers offering group health insurance coverage and entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph (1) in a manner consistent with the privacy, security, and breach notification regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, and shall restrict the use and disclosure of such information according to such privacy regulations.

added “(3) Disclosure and redisclosure

added “(A) Limitation to business associates—A group health plan receiving a report under paragraph (1) may disclose such information only to business associates of such plan as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations).

added “(B) Clarification regarding public disclosure of information—Nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such issuer or entity may not restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, or applicable State agencies.

added “(C) Limited form of report—The Secretary shall define through rulemaking a limited form of the report under paragraph (1) required of plan sponsors who are drug manufacturers, drug wholesalers, or other direct participants in the drug supply chain, in order to prevent anti-competitive behavior.

added “(4) Report to GAO—A health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan shall submit to the Comptroller General of the United States each of the first 4 reports submitted to a plan sponsor under paragraph (1) with respect to such coverage or plan, and other such reports as requested, in accordance with the privacy requirements under paragraph (2), the disclosure and redisclosure standards under paragraph (3), the standards specified pursuant to paragraph (5), and such other information that the Comptroller General determines necessary to carry out the study under section 602(d) of the Restoring Hope for Mental Health and Well-Being Act of 2022.

added “(5) Standard format—Not later than June 1, 2023, the Secretary shall specify through rulemaking standards for health insurance issuers and entities required to submit reports under paragraph (4) to submit such reports in a standard format.

added “(c) Enforcement

added “(1) In general—The Secretary, in consultation with the Secretary of Health and Human Services and the Secretary of the Treasury, shall enforce this section.

added “(2) Failure to provide timely information—A health insurance issuer or an entity providing pharmacy benefit management services that violates subsection (a) or fails to provide information required under subsection (b), or a drug manufacturer that fails to provide information under subsection (b)(1)(A) in a timely manner, shall be subject to a civil monetary penalty in the amount of $10,000 for each day during which such violation continues or such information is not disclosed or reported.

added “(3) False information—A health insurance issuer, entity providing pharmacy benefit management services, or drug manufacturer that knowingly provides false information under this section shall be subject to a civil money penalty in an amount not to exceed $100,000 for each item of false information. Such civil money penalty shall be in addition to other penalties as may be prescribed by law.

added “(4) Procedure—The provisions of section 1128A of the Social Security Act, other than subsection (a) and (b) and the first sentence of subsection (c)(1) of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A of the Social Security Act.

added “(5) Waivers—The Secretary may waive penalties under paragraph (2), or extend the period of time for compliance with a requirement of this section, for an entity in violation of this section that has made a good-faith effort to comply with this section.

added “(d) Rule of construction—Nothing in this section shall be construed to permit a health insurance issuer, group health plan, or other entity to restrict disclosure to, or otherwise limit the access of, the Department of Labor to a report described in subsection (b)(1) or information related to compliance with subsection (a) by such issuer, plan, or entity.

added “(e) Definition—In this section, the term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act.”

added “9826. Oversight of pharmacy benefit manager services

added “(a) In general—For plan years beginning on or after January 1, 2024, a group health plan or an entity or subsidiary providing pharmacy benefits management services on behalf of such a plan shall not enter into a contract with a drug manufacturer, distributor, wholesaler, subcontractor, rebate aggregator, or any associated third party that limits the disclosure of information to plan sponsors in such a manner that prevents the plan, or an entity or subsidiary providing pharmacy benefits management services on behalf of a plan, from making the reports described in subsection (b).

added “(b) Reports

added “(1) In general—For plan years beginning on or after January 1, 2024, not less frequently than once every 6 months, an entity providing pharmacy benefits management services on behalf of a group health plan shall submit to the plan sponsor (as defined in section 3(16)(B) of the Employee Retirement Income Security Act of 1974) of such group health plan a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format. Each such report shall include, with respect to the applicable group health plan—

added “(A) as applicable, information collected from drug manufacturers by such entity on the total amount of copayment assistance dollars paid, or copayment cards applied, that were funded by the drug manufacturer with respect to the participants and beneficiaries in such plan;

added “(B) a list of each drug covered by such plan or entity providing pharmacy benefit management services that was dispensed during the reporting period, including, with respect to each such drug during the reporting period—

added “(i) the brand name, chemical entity, and National Drug Code;

added “(ii) the number of participants and beneficiaries for whom the drug was filled during the plan year, the total number of prescription fills for the drug (including original prescriptions and refills), and the total number of dosage units of the drug dispensed across the plan year, including whether the dispensing channel was by retail, mail order, or specialty pharmacy;

added “(iii) the wholesale acquisition cost, listed as cost per days supply and cost per pill, or in the case of a drug in another form, per dose;

added “(iv) the total out-of-pocket spending by participants and beneficiaries on such drug, including participant and beneficiary spending through copayments, coinsurance, and deductibles; and

added “(v) for any drug for which gross spending of the group health plan exceeded $10,000 during the reporting period—

added “(I) a list of all other drugs in the same therapeutic category or class, including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic category or class as such drug; and

added “(II) the rationale for preferred formulary placement of such drug in that therapeutic category or class, if applicable;

added “(C) a list of each therapeutic category or class of drugs that were dispensed under the health plan during the reporting period, and, with respect to each such therapeutic category or class of drugs, during the reporting period—

added “(i) total gross spending by the plan, before manufacturer rebates, fees, or other manufacturer remuneration;

added “(ii) the number of participants and beneficiaries who filled a prescription for a drug in that category or class;

added “(iii) if applicable to that category or class, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that category or class;

added “(iv) the total out-of-pocket spending by participants and beneficiaries, including participant and beneficiary spending through copayments, coinsurance, and deductibles; and

added “(v) for each therapeutic category or class under which 3 or more drugs are included on the formulary of such plan—

added “(I) the amount received, or expected to be received, from drug manufacturers in rebates, fees, alternative discounts, or other remuneration—

added “(aa) that has been paid, or is to be paid, by drug manufacturers for claims incurred during the reporting period; or

added “(bb) that is related to utilization of drugs, in such therapeutic category or class;

added “(II) the total net spending, after deducting rebates, price concessions, alternative discounts or other remuneration from drug manufacturers, by the health plan on that category or class of drugs; and

added “(III) the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply, incurred by the health plan and its participants and beneficiaries, after manufacturer rebates, fees, and other remuneration for drugs dispensed within such therapeutic category or class during the reporting period;

added “(D) total gross spending on prescription drugs by the plan during the reporting period, before rebates and other manufacturer fees or remuneration;

added “(E) total amount received, or expected to be received, by the health plan in drug manufacturer rebates, fees, alternative discounts, and all other remuneration received from the manufacturer or any third party, other than the plan sponsor, related to utilization of drug or drug spending under that health plan during the reporting period;

added “(F) the total net spending on prescription drugs by the health plan during the reporting period; and

added “(G) amounts paid directly or indirectly in rebates, fees, or any other type of remuneration to brokers, consultants, advisors, or any other individual or firm who referred the group health plan's business to the pharmacy benefit manager.

added “(2) Privacy requirements—Entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph (1) in a manner consistent with the privacy, security, and breach notification regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, and shall restrict the use and disclosure of such information according to such privacy regulations.

added “(3) Disclosure and redisclosure

added “(A) Limitation to business associates—A group health plan receiving a report under paragraph (1) may disclose such information only to business associates of such plan as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations).

added “(B) Clarification regarding public disclosure of information—Nothing in this section prevents an entity providing pharmacy benefits management services on behalf of a group health plan from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such entity may not restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, or applicable State agencies.

added “(C) Limited form of report—The Secretary shall define through rulemaking a limited form of the report under paragraph (1) required of plan sponsors who are drug manufacturers, drug wholesalers, or other direct participants in the drug supply chain, in order to prevent anti-competitive behavior.

added “(4) Report to GAO—An entity providing pharmacy benefits management services on behalf of a group health plan shall submit to the Comptroller General of the United States each of the first 4 reports submitted to a plan sponsor under paragraph (1) with respect to such plan, and other such reports as requested, in accordance with the privacy requirements under paragraph (2), the disclosure and redisclosure standards under paragraph (3), the standards specified pursuant to paragraph (5), and such other information that the Comptroller General determines necessary to carry out the study under section 602(d) of the Restoring Hope for Mental Health and Well-Being Act of 2022.

added “(5) Standard format—Not later than June 1, 2023, the Secretary shall specify through rulemaking standards for entities required to submit reports under paragraph (4) to submit such reports in a standard format.

added “(c) Enforcement

added “(1) In general—The Secretary, in consultation with the Secretary of Labor and the Secretary of Health and Human Services, shall enforce this section.

added “(2) Failure to provide timely information—An entity providing pharmacy benefit management services that violates subsection (a) or fails to provide information required under subsection (b), or a drug manufacturer that fails to provide information under subsection (b)(1)(A) in a timely manner, shall be subject to a civil monetary penalty in the amount of $10,000 for each day during which such violation continues or such information is not disclosed or reported.

added “(3) False information—An entity providing pharmacy benefit management services, or drug manufacturer that knowingly provides false information under this section shall be subject to a civil money penalty in an amount not to exceed $100,000 for each item of false information. Such civil money penalty shall be in addition to other penalties as may be prescribed by law.

added “(4) Procedure—The provisions of section 1128A of the Social Security Act, other than subsection (a) and (b) and the first sentence of subsection (c)(1) of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1128A of the Social Security Act.

added “(5) Waivers—The Secretary may waive penalties under paragraph (2), or extend the period of time for compliance with a requirement of this section, for an entity in violation of this section that has made a good-faith effort to comply with this section.

added “(d) Rule of construction—Nothing in this section shall be construed to permit a group health plan or other entity to restrict disclosure to, or otherwise limit the access of, the Department of the Treasury to a report described in subsection (b)(1) or information related to compliance with subsection (a) by such plan or entity.

added “(e) Definition—In this section, the term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act.”

added Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by striking “$5,000,000” and inserting “$1,029,000,000”.

added In carrying out any program of the Substance Abuse and Mental Health Services Administration whose statutory authorization is enacted or amended by this Act, the Secretary of Health and Human Services shall not allocate funding, or require award recipients to prioritize, dedicate, or allocate funding, without consideration of the incidence, prevalence, or determinants of mental health or substance use issues, unless such allocation or requirement is consistent with statute, regulation, or other Federal law.