H.R. 4531 — what changed

changed Section 317N 317L(d) of the Public Health Service Act (42 U.S.C. 247b–15) 247b–13(d)) is amended—amended by striking “such sums as may be necessary for each of the fiscal years 2019 through 2023” and inserting “$4,250,000 for each of fiscal years 2024 through 2028”.

added Section 317N of the Public Health Service Act (42 U.S.C. 247b–15) is amended—

removed Section 508(s) of the Public Health Service Act (42 U.S.C. 290bb–1(s)) is amended by striking “$29,931,000 for each of fiscal years 2019 through 2023” and inserting “$38,931,000 for each of fiscal years 2024 through 2028”.

changed Section 546(h) 508(s) of the Public Health Service Act (42 U.S.C. 290ee–1(h)) 290bb–1(s)) is amending amended by striking “$36,000,000 “$29,931,000 for each of fiscal years 2019 through 2023” and inserting “$56,000,000 “$38,931,000 for each of fiscal years 2024 through 2028”.

changed Section 547(f) 7102(c)(9) of the Public Health Service SUPPORT for Patients and Communities Act (42 U.S.C. 290ee–2(f)) 290bb–7a(c)(9)) is amended by striking “$5,000,000 for each of fiscal “fiscal years 2019 through 2023” and inserting “$16,000,000 for each of fiscal “fiscal years 2024 through 2028”.

changed Section 547A(e) 546(h) of the Public Health Service Act (42 U.S.C. 290ee–2a(e)) 290ee–1(h)) is amended amending by striking “$1,000,000 “$36,000,000 for each of fiscal years 2019 through 2023” and inserting “$2,000,000 “$56,000,000 for each of fiscal years 2024 through 2028”.

added Section 547(f) of the Public Health Service Act (42 U.S.C. 290ee–2(f)) is amended by striking “$5,000,000 for each of fiscal years 2019 through 2023” and inserting “$16,000,000 for each of fiscal years 2024 through 2028”.

removed “(3) Documentation

removed “(A) In general—Evidence required to be provided under paragraph (1) may be provided through a letter of intent from partner agencies or other relevant documentation (as defined by the Secretary).

removed “(B) Partner agency defined—In this paragraph, the term partner agency means a non-governmental organization or other public or private entity—

removed “(i) the primary purpose of which is the delivery of mental health or substance use disorder treatment services; and

removed “(ii) with which the applicant coordinates to provide the full continuum of treatment services (as specified in subsection (g)(1)(B)) that the applicant is unable to offer on site.”

changed Section 582(j) 547A(e) of the Public Health Service Act (42 U.S.C. 290hh–1(j)) 290ee–2a(e)) is amended by striking “$63,887,000 “$1,000,000 for each of fiscal years 2019 through 2023” and inserting “$93,887,000 “$2,000,000 for each of fiscal years 2024 through 2028”.

added “(3) Documentation

added “(A) In general—Evidence required to be provided under paragraph (1) may be provided through a letter of intent from partner agencies or other relevant documentation (as defined by the Secretary).

added “(B) Partner agency defined—In this paragraph, the term partner agency means a non-governmental organization or other public or private entity—

added “(i) the primary purpose of which is the delivery of mental health or substance use disorder treatment services; and

added “(ii) with which the applicant coordinates to provide the full continuum of treatment services (as specified in subsection (g)(1)(B)) that the applicant is unable to offer on site.”

removed Section 756(f) of the Public Health Service Act (42 U.S.C. 294e–1(f)) is amended by striking “fiscal years 2023 through 2027” and inserting “fiscal years 2024 through 2028”.

changed Section 781(j) 582(j) of the Public Health Service Act (42 U.S.C. 295h(j)) 290hh–1(j)) is amended by striking “$25,000,000 “$63,887,000 for each of fiscal years 2019 through 2023” and inserting “$40,000,000 “$93,887,000 for each of fiscal years 2024 through 2028”.

changed Section 7011(d) 756(f) of the SUPPORT for Patients and Communities Public Health Service Act (42 U.S.C. 247d–10(d)) 294e–1(f)) is amended by striking “fiscal years 2019 2023 through 2023” 2027” and inserting “fiscal years 2024 through 2028”.

changed Section 7131(e) 781(j) of the SUPPORT for Patients and Communities Public Health Service Act (42 U.S.C. 242t(e)) 295h(j)) is amended by striking “$2,000,000 “$25,000,000 for each of fiscal years 2019 through 2023” and inserting “$9,000,000 “$40,000,000 for each of fiscal years 2024 through 2028”.

removed Section 7132 of the SUPPORT for Patients and Communities Act (Public Law 115–271) is amended—

added “(4) public, private, and academic entities with expertise in detection and testing activities, such as wastewater surveillance, with respect to synthetic opioids, including fentanyl and its analogues.”

removed “(3) additional reports and updates to existing reports, as necessary.”

changed Section 7183 7131(e) of the SUPPORT for Patients and Communities Act (42 U.S.C. 290ee–8) 242t(e)) is amended—amended by striking “$2,000,000 for each of fiscal years 2019 through 2023” and inserting “$9,000,000 for each of fiscal years 2024 through 2028”.

removed “(2) Rates—The rates described in this paragraph are the following:

removed “(A) The amount by which the average rate of drug overdose deaths in the State, adjusted for age, for the period of 5 calendar years for which there is available data, including if necessary provisional data, immediately preceding the grant cycle (which shall be the period of calendar years 2018 through 2022 for the first grant cycle following the enactment of the Support for Patients and Communities Reauthorization Act) is above the average national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention, for the same period.

removed “(B) The amount by which the average rate of unemployment for the State, based on data provided by the Bureau of Labor Statistics, for the period of 5 calendar years for which there is available data, including if necessary provisional data, immediately preceding the grant cycle (which shall be the period of calendar years 2018 through 2022 for the first grant cycle following the enactment of the Support for Patients and Communities Reauthorization Act) is above the national average for the same period.

removed “(C) The amount by which the average rate of labor force participation in the State, based on data provided by the Bureau of Labor Statistics, for the period of 5 calendar years for which there is available data, including if necessary provisional data, immediately preceding the grant cycle (which shall be the period of calendar years 2018 through 2022 for the first grant cycle following the enactment of the Support for Patients and Communities Reauthorization Act) is below the national average for the same period.”

removed “(1) In general—An entity”

removed “(2) Transportation services—An entity receiving a grant under this section may use the funds for providing transportation for individuals to participate in an activity supported by a grant under this section, which transportation shall be to or from a place of work or a place where the individual is receiving vocational education or job training services or receiving services directly linked to treatment of or recovery from a substance use disorder.”

changed Section 1003(b)(4)(A) 7132 of the 21st Century Cures SUPPORT for Patients and Communities Act (42 U.S.C. 290ee–3a(b)(4)(A)) (Public Law 115–271) is amended after “which may include drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act” by inserting “or fentanyl or xylazine test strips”.amended—

added “(3) additional reports and updates to existing reports, as necessary.”

added “(i) Sunset—The task force shall sunset on September 30, 2026.”

added Section 7183 of the SUPPORT for Patients and Communities Act (42 U.S.C. 290ee–8) is amended—

added “(2) Rates—The rates described in this paragraph are the following:

added “(A) The amount by which the average rate of drug overdose deaths in the State, adjusted for age, for the period of 5 calendar years for which there is available data, including if necessary provisional data, immediately preceding the grant cycle (which shall be the period of calendar years 2018 through 2022 for the first grant cycle following the enactment of the Support for Patients and Communities Reauthorization Act) is above the average national overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention, for the same period.

added “(B) The amount by which the average rate of unemployment for the State, based on data provided by the Bureau of Labor Statistics, for the period of 5 calendar years for which there is available data, including if necessary provisional data, immediately preceding the grant cycle (which shall be the period of calendar years 2018 through 2022 for the first grant cycle following the enactment of the Support for Patients and Communities Reauthorization Act) is above the national average for the same period.

added “(C) The amount by which the average rate of labor force participation in the State, based on data provided by the Bureau of Labor Statistics, for the period of 5 calendar years for which there is available data, including if necessary provisional data, immediately preceding the grant cycle (which shall be the period of calendar years 2018 through 2022 for the first grant cycle following the enactment of the Support for Patients and Communities Reauthorization Act) is below the national average for the same period.”

added “(1) In general—An entity”

added “(2) Transportation services—An entity receiving a grant under this section may use not more than 5 percent of the funds for providing transportation for individuals to participate in an activity supported by a grant under this section, which transportation shall be to or from a place of work or a place where the individual is receiving vocational education or job training services or receiving services directly linked to treatment of or recovery from a substance use disorder.

added “(3) No other authorized uses—An entity receiving a grant under this section may not use the funds for any activity other than the activities listed in paragraphs (1) and (2).”

added Section 1003(b)(4)(A) of the 21st Century Cures Act (42 U.S.C. 290ee–3a(b)(4)(A)) is amended after “which may include drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act” by inserting “or fentanyl or xylazine test strips”.

removed “(5) Other concurrent substance use disorders—The Secretary may authorize the recipient of a grant under this subsection, in addition to using the grant for activities described in paragraph (4) with respect to opioid misuse and use disorders and stimulant misuse and use disorders, to use the grant to for similar activities with respect to other concurrent substance use disorders.”

removed “(4) the amount of funds each State that receiving a grant under subsection (b) received for the 12-month grant cycle covered by the report;

removed “(5) the amount of grant funds each such State spent for such grant cycle, disaggregated by the uses for which such funds were spent, including each allowable use under paragraphs (4) and (5) of subsection (b);

removed “(6) how many such States for such grant cycle did not spend the all of the grant funds before such grant cycle expired;

removed “(7) how many such States for such grant cycle requested waivers to extend the grant cycle; and

removed “(8) challenges for such States to spend all of the funds allocated and the reason for such challenges, including to what extent reporting requirements or other requirements placed an increased burden on the ability of such States to spend all of the funds.”

removed “(2) Other concurrent substance use disorders—The term other substance use disorders includes alcohol use disorders co-occurring with opioid misuse and use disorders and alcohol use disorders co-occurring with stimulant misuse and use disorders, including polydrug use and alcohol use disorder.”

Paragraph (2) of section 309A(a) of the Controlled Substances Act (21 U.S.C. 829a(a)) is amended to read as follows:

changed “(2) the controlled substance is a drug in schedule III, IV, or V that is, pursuant to the approval or licensure of such drug under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, to be administered by, or under the supervision of, the prescribing practitioner;”

“(60)

“(A) The term “xylazine” means the substance xylazine as well as its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible.

“(B) Except as provided in subparagraph (E), such term does not include a substance described in subparagraph (A) to the extent—

changed “(i) such substance is used or intended for use in animals other than humans and is an animal drug that has been approved by the Secretary of Health and Human Services under section 512 of the Federal Food, Drug, and Cosmetic Act, conditionally approved under section 571 of such Act, index listed under section 573 of such Act, or subject to an exemption for investigational use under section 512(j) of such Act, Act and such substance’s use or intended use conforms to the approved application or index listing, application, including the manufacturing, importation, holding, or distribution for such use;use; or

changed “(ii) such substance is used or intended for use in animals other than humans as permitted under section 512(a)(4) of the Federal Food, Drug, and Cosmetic Act;Act.

changed “(iii) “(C) If any person prescribes, dispenses, distributes, manufactures, or imports xylazine for human use, such substance is manufactured, imported, held, person shall be considered to have prescribed, dispensed, distributed, manufactured, or used—imported xylazine not subject to an exclusion under subparagraph (B).”

removed “(I) as an active pharmaceutical ingredient for manufacturing an animal drug approved under section 512 of the Federal Food, Drug, and Cosmetic Act, conditionally approved under section 571 of such Act, index listed under section 573 of the such Act, or subject to an exemption for investigational use under section 512(j) of such Act; or

removed “(II) as a bulk chemical for pharmaceutical compounding of a new animal drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) by or under the direct supervision of a licensed pharmacist or by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client-patient relationship, as defined by the Secretary of Health and Human Services;

removed “(iv) such substance is held or used as a compounded new animal drug described in clause (iii)(II);

removed “(v) such substance is otherwise used or intended for use in animals other than humans, and such use is approved or otherwise authorized under the Federal Food, Drug, and Cosmetic Act provided any such use conforms to such approval or authorization;

removed “(vi) such substance is subject to an exemption for investigational use under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act;

removed “(vii) such substance is imported, held, distributed, or used for the development, manufacturing, or performance of tests for detection of xylazine (including xylazine used as a control or calibration standard) by persons who are professionally, regularly, and lawfully engaged in such activities; or

removed “(viii) such substance is held, distributed, or used in a commercially manufactured test for the detection of xylazine, provided such test does not contain xylazine in a form that can be extracted.

removed “(C) Notwithstanding subparagraph (B), the Attorney General may place any substance listed in such subparagraph on a schedule under section 202 in accordance with subsections (a) through (c) of section 201.

removed “(D) Nothing in this paragraph shall be construed as a basis for inferring that a compounded animal drug is not a new animal drug subject to the requirements of section 512(a) of the Federal Food, Drug, and Cosmetic Act.

removed “(E) If any person prescribes, dispenses, distributes, manufactures, or imports xylazine for human use, such person shall be considered to have prescribed, dispensed, distributed, manufactured, or imported xylazine not subject to an exclusion under subparagraph (B).”

“(f) Xylazine.”

changed Section 1902(oo) 1902(oo)(1)(B) of the Social Security Act (42 U.S.C. 1396a(oo)) 1396a(oo)(1)(B)) is amended—

removed “(C) Application in case of program to monitor antipsychotic medications—Subparagraph (A)(ii) shall not apply to the drug review and utilization requirement described in paragraph (1)(B) with respect to an individual to whom such subparagraph applies by reason of the amendments made by section 303(1) of the Support for Patients and Communities Reauthorization Act.”