I 115th CONGRESS 2d Session H. R. 5807 IN THE HOUSE OF REPRESENTATIVES May 15, 2018 Mr. Mullin (for himself and Mr. Blumenauer ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on the Judiciary , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Controlled Substances Act to allow for more flexibility with respect to medication-assisted treatment for opioid use disorders and to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records.

1. Short title This Act may be cited as the Substance Use Disorder Coordination, Access, Recovery Enhancement Act of 2018 or the SUD CARE Act . 2. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders (a) Conforming applicable number Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(B)(iii) ) is amended to read as follows: (II) The applicable number is— (aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients; (bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations); or (cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)). . (b) Extending the time limitation for nurse practitioners and physician assistants To become qualifying practitioners Section 303(g)(2)(G)(iii)(II) of the Controlled Substances Act ( 21 U.S.C. 823(g)(2)(G)(iii)(II) ) is amended by striking 2021 and inserting 2028 . 3. Confidentiality and disclosure of records relating to substance use disorder (a) Conforming changes relating to substance use disorder Subsections (a) and (h) of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) are each amended by striking substance abuse and inserting substance use disorder . (b) Disclosures to covered entities consistent with HIPAA Paragraph (2) of section 543(b) of the Public Health Service Act ( 42 U.S.C. 290dd–2(b) ) is amended by adding at the end the following: (D) To a covered entity or to a program or activity described in subsection (a), for the purposes of treatment, payment, and health care operations, so long as such disclosure is made in accordance with HIPAA privacy regulation. Any redisclosure of information so disclosed may only be made in accordance with this section. . (c) Disclosures of de-Identified health information to public health authorities Paragraph (2) of section 543(b) of the Public Health Service Act ( 42 U.S.C. 290dd–2(b) ), as amended by subsection (b), is further amended by adding at the end the following: (E) To a public health authority, so long as such content does not include any individually identifiable health information and meets the standards established in section 164.514 of title 45, Code of Federal Regulations (or successor regulations) for creating de-identified information. . (d) Definitions Subsection (b) of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) is amended by adding at the end the following: (3) Definitions For purposes of this subsection: (A) Covered entity The term covered entity has the meaning given such term for purposes of HIPAA privacy regulation. (B) Health care operations The term health care operations has the meaning given such term for purposes of HIPAA privacy regulation. (C) HIPAA privacy regulation The term HIPAA privacy regulation has the meaning given such term under section 1180(b)(3) of the Social Security Act. (D) Individually identifiable health information The term individually identifiable health information has the meaning given such term for purposes of HIPAA privacy regulation. (E) Payment The term payment has the meaning given such term for purposes of HIPAA privacy regulation. (F) Public health authority The term public health authority has the meaning given such term for purposes of HIPAA privacy regulation. (G) Treatment The term treatment has the meaning given such term for purposes of HIPAA privacy regulation. . (e) Use of records in criminal, civil, or administrative investigations, actions, or proceedings Subsection (c) of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) is amended to read as follows: (c) Use of records in criminal, civil, or administrative contexts Except as otherwise authorized by a court order under subsection (b)(2)(C) or by the consent of the patient, a record referred to in subsection (a) may not— (1) be entered into evidence in any criminal prosecution or civil action before a Federal or State court; (2) form part of the record for decision or otherwise be taken into account in any proceeding before a Federal agency; (3) be used by any Federal, State, or local agency for a law enforcement purpose or to conduct any law enforcement investigation of a patient; or (4) be used in any application for a warrant. . (f) Penalties Subsection (f) of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) is amended to read as follows: (f) Penalties The provisions of section 1176 of the Social Security Act shall apply to a violation of this section to the extent and in the same manner as such provisions apply to a violation of part C of title XI of such Act. In applying the previous sentence— (1) the reference to this subsection in subsection (a)(2) of such section 1176 shall be treated as a reference to this subsection (including as applied pursuant to section 543(f) of the Public Health Service Act) ; and (2) in subsection (b) of such section 1176— (A) each reference to a penalty imposed under subsection (a) shall be treated as a reference to a penalty imposed under subsection (a) (including as applied pursuant to section 543(f) of the Public Health Service Act) ; and (B) each reference to no damages obtained under subsection (d) shall be treated as a reference to no damages obtained under subsection (d) (including as applied pursuant to section 543(f) of the Public Health Service Act) . . (g) Antidiscrimination Section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) is amended by adding at the end the following: (i) Antidiscrimination (1) In general No entity shall discriminate against an individual on the basis of information received by such entity pursuant to a disclosure made under subsection (b) in— (A) admission or treatment for health care; (B) hiring or terms of employment; (C) the sale or rental of housing; or (D) access to Federal, State, or local courts. (2) Recipients of Federal funds No recipient of Federal funds shall discriminate against an individual on the basis of information received by such recipient pursuant to a disclosure made under subsection (b) in affording access to the services provided with such funds. . (h) Notification in case of breach Section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ), as amended by subsection (g), is further amended by adding at the end the following: (j) Notification in case of breach (1) Application of HITECH notification of breach provisions The provisions of section 13402 of the HITECH Act ( 42 U.S.C. 17932 ) shall apply to a program or activity described in subsection (a), in case of a breach of records described in subsection (a), to the same extent and in the same manner as such provisions apply to a covered entity in the case of a breach of unsecured protected health information. (2) Definitions In this subsection, the terms covered entity and unsecured protected health information have the meanings given to such terms for purposes of such section 13402. . (i) Sense of Congress It is the sense of the Congress that any person treating a patient through a program or activity with respect to which the confidentiality requirements of section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ) apply should access the applicable State-based prescription drug monitoring program as a precaution against substance use disorder. (j) Regulations The Secretary of Health and Human Services, in consultation with appropriate Federal agencies, shall make such revisions to regulations as may be necessary for implementing and enforcing the amendments made by this section, such that such amendments shall apply with respect to uses and disclosures of information occurring on or after the date that is 12 months after the date of enactment of this Act. (k) Development and dissemination of model training programs for substance use disorder patient records (1) Initial programs and materials Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the Secretary ), in consultation with appropriate experts, shall identify the following model programs and materials (or if no such programs or materials exist, recognize private or public entities to develop and disseminate such programs and materials): (A) Model programs and materials for training health care providers (including physicians, emergency medical personnel, psychiatrists, psychologists, counselors, therapists, nurse practitioners, physician assistants, behavioral health facilities and clinics, care managers, and hospitals, including individuals such as general counsels or regulatory compliance staff who are responsible for establishing provider privacy policies) concerning the permitted uses and disclosures, consistent with the standards and regulations governing the privacy and security of substance use disorder patient records promulgated by the Secretary under section 543 of the Public Health Service Act ( 42 U.S.C. 290dd–2 ), as amended by this section, for the confidentiality of patient records. (B) Model programs and materials for training patients and their families regarding their rights to protect and obtain information under the standards and regulations described in subparagraph (A). (2) Requirements The model programs and materials described in subparagraphs (A) and (B) of paragraph (1) shall address circumstances under which disclosure of substance use disorder patient records is needed to— (A) facilitate communication between substance use disorder treatment providers and other health care providers to promote and provide the best possible integrated care; (B) avoid inappropriate prescribing that can lead to dangerous drug interactions, overdose, or relapse; and (C) notify and involve families and caregivers when individuals experience an overdose. (3) Periodic updates The Secretary shall— (A) periodically review and update the model programs and materials identified or developed under paragraph (1); and (B) disseminate such updated programs and materials to the individuals described in paragraph (1)(A). (4) Input of certain entities In identifying, reviewing, or updating the model programs and materials under this subsection, the Secretary shall solicit the input of relevant stakeholders.