I 

115TH CONGRESS 

2D SESSION H. R. 5807 

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. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Substance Use Dis5 order Coordination, Access, Recovery Enhancement Act of 

6 2018’’ or the ‘‘ ‘SUD CARE Act’ ’’. 


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1 SEC. 2. ALLOWING FOR MORE FLEXIBILITY WITH RESPECT 

2 TO MEDICATION-ASSISTED TREATMENT FOR 

3 OPIOID USE DISORDERS. 

4 (a) CONFORMING APPLICABLE NUMBER.—Subclause 

5 (II) of section 303(g)(2)(B)(iii) of the Controlled Sub6 stances Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to 

7 read as follows: 

8 ‘‘(II) The applicable number is— 

9 ‘‘(aa) 100 if, not sooner than 1 year after 

10 the date on which the practitioner submitted 

11 the initial notification, the practitioner submits 

12 a second notification to the Secretary of the 

13 need and intent of the practitioner to treat up 

14 to 100 patients; 

15 ‘‘(bb) 100 if the practitioner holds addi16 tional credentialing, as defined in section 8.2 of 

17 title 42, Code of Federal Regulations (or suc18 cessor regulations); or 

19 ‘‘(cc) 100 if the practitioner provides medi20 cation-assisted treatment (MAT) using covered 

21 medications (as defined in section 8.2 of title 

22 42, Code of Federal Regulations (or successor 

23 regulations)) in a qualified practice setting (as 

24 described in section 8.615 of title 42, Code of 

25 Federal Regulations (or successor regula26 tions)).’’. 


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1 (b) EXTENDING THE TIME LIMITATION FOR NURSE

2 PRACTITIONERS AND PHYSICIAN ASSISTANTS TO BE3 COME QUALIFYING PRACTITIONERS.—Section 

4 303(g)(2)(G)(iii)(II) of the Controlled Substances Act (21 

5 U.S.C. 823(g)(2)(G)(iii)(II)) is amended by striking 

6 ‘‘2021’’ and inserting ‘‘2028’’. 

7 SEC. 3. CONFIDENTIALITY AND DISCLOSURE OF RECORDS 

8 RELATING TO SUBSTANCE USE DISORDER. 

9 (a) CONFORMING CHANGES RELATING TO SUB10 STANCE USE DISORDER.—Subsections (a) and (h) of sec11 tion 543 of the Public Health Service Act (42 U.S.C. 

12 290dd–2) are each amended by striking ‘‘substance 

13 abuse’’ and inserting ‘‘substance use disorder’’. 

14 (b) DISCLOSURES TO COVERED ENTITIES CON15 SISTENT WITH HIPAA.—Paragraph (2) of section 543(b) 

16 of the Public Health Service Act (42 U.S.C. 290dd–2(b)) 

17 is amended by adding at the end the following: 

18 ‘‘(D) To a covered entity or to a program 

19 or activity described in subsection (a), for the 

20 purposes of treatment, payment, and health 

21 care operations, so long as such disclosure is 

22 made in accordance with HIPAA privacy regu23 lation. Any redisclosure of information so dis24 closed may only be made in accordance with 

25 this section.’’. 


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1 (c) DISCLOSURES OF DE-IDENTIFIED HEALTH IN2 FORMATION TO PUBLIC HEALTH AUTHORITIES.—Para3 graph (2) of section 543(b) of the Public Health Service 

4 Act (42 U.S.C. 290dd–2(b)), as amended by subsection 

5 (b), is further amended by adding at the end the following: 

6 ‘‘(E) To a public health authority, so long 

7 as such content does not include any individ8 ually identifiable health information and meets 

9 the standards established in section 164.514 of 

10 title 45, Code of Federal Regulations (or suc11 cessor regulations) for creating de-identified in12 formation.’’. 

13 (d) DEFINITIONS.—Subsection (b) of section 543 of 

14 the Public Health Service Act (42 U.S.C. 290dd–2) is 

15 amended by adding at the end the following: 

16 ‘‘(3) DEFINITIONS.—For purposes of this sub17 section: 

18 ‘‘(A) COVERED ENTITY.—The term ‘cov19 ered entity’ has the meaning given such term 

20 for purposes of HIPAA privacy regulation. 

21 ‘‘(B) HEALTH CARE OPERATIONS.—The 

22 term ‘health care operations’ has the meaning 

23 given such term for purposes of HIPAA privacy 

24 regulation. 


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1 ‘‘(C) HIPAA PRIVACY REGULATION.—The 

2 term ‘HIPAA privacy regulation’ has the mean3 ing given such term under section 1180(b)(3) of 

4 the Social Security Act. 

5 ‘‘(D) INDIVIDUALLY IDENTIFIABLE

6 HEALTH INFORMATION.—The term ‘individually 

7 identifiable health information’ has the meaning 

8 given such term for purposes of HIPAA privacy 

9 regulation. 

10 ‘‘(E) PAYMENT.—The term ‘payment’ has 

11 the meaning given such term for purposes of 

12 HIPAA privacy regulation. 

13 ‘‘(F) PUBLIC HEALTH AUTHORITY.—The 

14 term ‘public health authority’ has the meaning 

15 given such term for purposes of HIPAA privacy 

16 regulation. 

17 ‘‘(G) TREATMENT.—The term ‘treatment’ 

18 has the meaning given such term for purposes 

19 of HIPAA privacy regulation.’’. 

20 (e) USE OF RECORDS IN CRIMINAL, CIVIL, OR AD21 MINISTRATIVE INVESTIGATIONS, ACTIONS, OR PRO22 CEEDINGS.—Subsection (c) of section 543 of the Public 

23 Health Service Act (42 U.S.C. 290dd–2) is amended to 

24 read as follows: 


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1 ‘‘(c) USE OF RECORDS IN CRIMINAL, CIVIL, OR AD2 MINISTRATIVE CONTEXTS.—Except as otherwise author3 ized by a court order under subsection (b)(2)(C) or by the 

4 consent of the patient, a record referred to in subsection 

5 (a) may not— 

6 ‘‘(1) be entered into evidence in any criminal 

7 prosecution or civil action before a Federal or State 

8 court; 

9 ‘‘(2) form part of the record for decision or oth10 erwise be taken into account in any proceeding be11 fore a Federal agency; 

12 ‘‘(3) be used by any Federal, State, or local 

13 agency for a law enforcement purpose or to conduct 

14 any law enforcement investigation of a patient; or 

15 ‘‘(4) be used in any application for a warrant.’’. 

16 (f) PENALTIES.—Subsection (f) of section 543 of the 

17 Public Health Service Act (42 U.S.C. 290dd–2) is amend18 ed to read as follows: 

19 ‘‘(f) PENALTIES.—The provisions of section 1176 of 

20 the Social Security Act shall apply to a violation of this 

21 section to the extent and in the same manner as such pro22 visions apply to a violation of part C of title XI of such 

23 Act. In applying the previous sentence— 

24 ‘‘(1) the reference to ‘this subsection’ in sub25 section (a)(2) of such section 1176 shall be treated 


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1 as a reference to ‘this subsection (including as ap2 plied pursuant to section 543(f) of the Public Health 

3 Service Act)’; and 

4 ‘‘(2) in subsection (b) of such section 1176— 

5 ‘‘(A) each reference to ‘a penalty imposed 

6 under subsection (a)’ shall be treated as a ref7 erence to ‘a penalty imposed under subsection 

8 (a) (including as applied pursuant to section 

9 543(f) of the Public Health Service Act)’; and 

10 ‘‘(B) each reference to ‘no damages ob11 tained under subsection (d)’ shall be treated as 

12 a reference to ‘no damages obtained under sub13 section (d) (including as applied pursuant to 

14 section 543(f) of the Public Health Service 

15 Act)’.’’. 

16 (g) ANTIDISCRIMINATION.—Section 543 of the Public 

17 Health Service Act (42 U.S.C. 290dd–2) is amended by 

18 adding at the end the following: 

19 ‘‘(i) ANTIDISCRIMINATION.— 

20 ‘‘(1) IN GENERAL.—No entity shall discrimi21 nate against an individual on the basis of informa22 tion received by such entity pursuant to a disclosure 

23 made under subsection (b) in— 

24 ‘‘(A) admission or treatment for health 

25 care; 


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1 ‘‘(B) hiring or terms of employment; 

2 ‘‘(C) the sale or rental of housing; or 

3 ‘‘(D) access to Federal, State, or local 

4 courts. 

5 ‘‘(2) RECIPIENTS OF FEDERAL FUNDS.—No re6 cipient of Federal funds shall discriminate against 

7 an individual on the basis of information received by 

8 such recipient pursuant to a disclosure made under 

9 subsection (b) in affording access to the services 

10 provided with such funds.’’. 

11 (h) NOTIFICATION IN CASE OF BREACH.—Section 

12 543 of the Public Health Service Act (42 U.S.C. 290dd– 

13 2), as amended by subsection (g), is further amended by 

14 adding at the end the following: 

15 ‘‘(j) NOTIFICATION IN CASE OF BREACH.— 

16 ‘‘(1) APPLICATION OF HITECH NOTIFICATION

17 OF BREACH PROVISIONS.—The provisions of section 

18 13402 of the HITECH Act (42 U.S.C. 17932) shall 

19 apply to a program or activity described in sub20 section (a), in case of a breach of records described 

21 in subsection (a), to the same extent and in the 

22 same manner as such provisions apply to a covered 

23 entity in the case of a breach of unsecured protected 

24 health information. 


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1 ‘‘(2) DEFINITIONS.—In this subsection, the 

2 terms ‘covered entity’ and ‘unsecured protected 

3 health information’ have the meanings given to such 

4 terms for purposes of such section 13402.’’. 

5 (i) SENSE OF CONGRESS.—It is the sense of the Con6 gress that any person treating a patient through a pro7 gram or activity with respect to which the confidentiality 

8 requirements of section 543 of the Public Health Service 

9 Act (42 U.S.C. 290dd–2) apply should access the applica10 ble State-based prescription drug monitoring program as 

11 a precaution against substance use disorder. 

12 (j) REGULATIONS.—The Secretary of Health and 

13 Human Services, in consultation with appropriate Federal 

14 agencies, shall make such revisions to regulations as may 

15 be necessary for implementing and enforcing the amend16 ments made by this section, such that such amendments 

17 shall apply with respect to uses and disclosures of informa18 tion occurring on or after the date that is 12 months after 

19 the date of enactment of this Act. 

20 (k) DEVELOPMENT AND DISSEMINATION OF MODEL

21 TRAINING PROGRAMS FOR SUBSTANCE USE DISORDER

22 PATIENT RECORDS.— 

23 (1) INITIAL PROGRAMS AND MATERIALS.—Not 

24 later than 1 year after the date of the enactment of 

25 this Act, the Secretary of Health and Human ServVerDate Sep 11 2014 23:26 May 30, 2018 Jkt 079200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5807.IH H5807

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1 ices (referred to in this subsection as the ‘‘Sec2 retary’’), in consultation with appropriate experts, 

3 shall identify the following model programs and ma4 terials (or if no such programs or materials exist, 

5 recognize private or public entities to develop and 

6 disseminate such programs and materials): 

7 (A) Model programs and materials for 

8 training health care providers (including physi9 cians, emergency medical personnel, psychia10 trists, psychologists, counselors, therapists, 

11 nurse practitioners, physician assistants, behav12 ioral health facilities and clinics, care managers, 

13 and hospitals, including individuals such as gen14 eral counsels or regulatory compliance staff who 

15 are responsible for establishing provider privacy 

16 policies) concerning the permitted uses and dis17 closures, consistent with the standards and reg18 ulations governing the privacy and security of 

19 substance use disorder patient records promul20 gated by the Secretary under section 543 of the 

21 Public Health Service Act (42 U.S.C. 290dd– 

22 2), as amended by this section, for the con23 fidentiality of patient records. 

24 (B) Model programs and materials for 

25 training patients and their families regarding 


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1 their rights to protect and obtain information 

2 under the standards and regulations described 

3 in subparagraph (A). 

4 (2) REQUIREMENTS.—The model programs and 

5 materials described in subparagraphs (A) and (B) of 

6 paragraph (1) shall address circumstances under 

7 which disclosure of substance use disorder patient 

8 records is needed to— 

9 (A) facilitate communication between sub10 stance use disorder treatment providers and 

11 other health care providers to promote and pro12 vide the best possible integrated care; 

13 (B) avoid inappropriate prescribing that 

14 can lead to dangerous drug interactions, over15 dose, or relapse; and 

16 (C) notify and involve families and care17 givers when individuals experience an overdose. 

18 (3) PERIODIC UPDATES.—The Secretary 

19 shall— 

20 (A) periodically review and update the 

21 model programs and materials identified or de22 veloped under paragraph (1); and 

23 (B) disseminate such updated programs 

24 and materials to the individuals described in 

25 paragraph (1)(A). 


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1 (4) INPUT OF CERTAIN ENTITIES.—In identi2 fying, reviewing, or updating the model programs 

3 and materials under this subsection, the Secretary 

4 shall solicit the input of relevant stakeholders. 

Æ 


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