I 

114TH CONGRESS 

2D SESSION H. R. 5189 

To address the opioid abuse crisis. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 11, 2016 

Ms. KUSTER introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on 

the Judiciary, Veterans’ Affairs, Education and the Workforce, Ways and 

Means, Armed Services, and Natural Resources, 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 address the opioid abuse crisis. 

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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Opioid Abuse Crisis Act of 2016’’. 

6 (b) TABLE OF CONTENTS.—The table of contents is 

7 as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—PUBLIC HEALTH PROVISIONS 

Sec. 101. Funding for opioid and heroin abuse prevention and treatment. 

Sec. 102. Opioid overdose reversal drugs prescribing grant program. 


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Sec. 103. Partial fills of schedule II controlled substances. 

Sec. 104. Opioid use disorder treatment modernization. 

Sec. 105. Nurturing and supporting healthy babies. 

Sec. 106. Improving treatment for pregnant and postpartum women. 

Sec. 107. Assisting veterans with military emergency medical training to meet 

requirements for becoming civilian emergency medical technicians. 

Sec. 108. Information materials and resources to prevent addiction related to 

youth sports injuries. 

Sec. 109. Lali’s Law. 

Sec. 110. Opioid review modernization. 

Sec. 111. Study on treatment infrastructure. 

Sec. 112. National youth recovery initiative. 

Sec. 113. Building communities of recovery. 

TITLE II—COMPREHENSIVE OPIOID ABUSE REDUCTION 

Sec. 201. Comprehensive opioid abuse grant program. 

Sec. 202. Audit and accountability of grantees. 

Sec. 203. Veterans treatment courts. 

Sec. 204. Emergency Federal law enforcement assistance. 

Sec. 205. Opioid Program Evaluation Act. 

Sec. 206. Good Samaritan Assessment Act. 

TITLE III—PROMOTING RESPONSIBLE OPIOID MANAGEMENT AND 

INCORPORATING SCIENTIFIC EXPERTISE 

Sec. 301. Short title. 

Subtitle A—Opioid Therapy and Pain Management 

Sec. 311. Guidelines on management of opioid therapy by Department of Veterans Affairs and Department of Defense and implementation 

of such guidelines by Department of Veterans Affairs. 

Sec. 312. Improvement of opioid safety measures by Department of Veterans 

Affairs. 

Sec. 313. Strengthening of joint working group on pain management of the Department of Veterans Affairs and the Department of Defense. 

Sec. 314. Review, investigation, and report on use of opioids in treatment by 

Department of Veterans Affairs. 

Subtitle B—Patient Advocacy 

Sec. 321. Community meetings on improving care furnished by Department of 

Veterans Affairs. 

Sec. 322. Improvement of awareness of patient advocacy program and patient 

bill of rights of Department of Veterans Affairs. 

Sec. 323. Comptroller general report on patient advocacy program of Department of Veterans Affairs. 

Subtitle C—Complementary and Integrative Health 

Sec. 331. Expansion of research and education on and delivery of complementary and integrative health to veterans. 

Sec. 332. Pilot program on integration of complementary alternative medicines 

and related issues for veterans and family members of veterans. 


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Subtitle D—Fitness of Health Care Providers 

Sec. 341. Additional requirements for hiring of health care providers by Department of Veterans Affairs. 

Sec. 342. Provision of information on health care providers of Department of 

Veterans Affairs to State Medical Boards. 

Sec. 343. Report on compliance by Department of Veterans Affairs with reviews of health care providers leaving the Department or transferring to other facilities. 

Subtitle E—Other Veterans Matters 

Sec. 351. Audit of Veterans Health Administration programs of Department of 

Veterans Affairs. 

TITLE IV—IMPROVING SAFE CARE FOR PREVENTING INFANT 

ABUSE AND NEGLECT 

Sec. 401. Short title. 

Sec. 402. Best practices for development of plans of safe care. 

Sec. 403. State plans. 

Sec. 404. Data reports. 

Sec. 405. Monitoring and oversight. 

Sec. 406. Rule of construction. 

TITLE V—OTHER PROVISIONS 

Sec. 501. Programs to prevent prescription drug abuse under Medicare parts 

C and D. 

Sec. 502. Exclusion of authorized generic drugs from calculation of average 

manufacturer price for brand name drugs. 

1 TITLE I—PUBLIC HEALTH 

2 PROVISIONS 

3 SEC. 101. FUNDING FOR OPIOID AND HEROIN ABUSE PRE4 VENTION AND TREATMENT. 

5 (a) FUNDING.—There are authorized to be appro6 priated, and are appropriated, out of monies in the Treas7 ury not otherwise obligated, $600,000,000 for fiscal year 

8 2017, to improve opioid prescribing practices and expand 

9 access to substance use treatments to reduce opioid use 

10 disorders and overdose, to be made available in accordance 

11 with this Act. 


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1 (b) STATE TARGETED RESPONSE COOPERATIVE

2 AGREEMENTS.—Subpart 1 of part B of title V of the Pub3 lic Health Service Act (42 U.S.C. 290bb et seq.) is amend4 ed by inserting after section 509 the following: 

5 ‘‘SEC. 510. STATE TARGETED RESPONSE COOPERATIVE 

6 AGREEMENTS. 

7 ‘‘(a) IN GENERAL.—The Secretary shall enter into 

8 additional targeted response cooperative agreements with 

9 States under this title to expand opioid treatment capacity 

10 and make services more affordable to those who cannot 

11 afford such services. 

12 ‘‘(b) AWARDING OF FUNDING.—The Secretary shall 

13 allocate funding to States under this section based on— 

14 ‘‘(1) the severity of the opioid epidemic in the 

15 State; and 

16 ‘‘(2) the strength of the strategy of the State 

17 to respond to such epidemic. 

18 ‘‘(c) USE OF FUNDS.—Amounts received by a State 

19 under this section shall be used to expand treatment ca20 pacity and make services more affordable to those who 

21 cannot afford such services and to help individuals seek 

22 treatment, successfully complete treatment, and sustain 

23 recovery. 

24 ‘‘(d) FUNDING.—Of the amounts appropriated under 

25 section 101(a) of the Opioid Use Disorder Treatment ExVerDate Sep 11 2014 20:51 May 13, 2016 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5189.IH H5189

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1 pansion and Modernization Act for fiscal year 2017, 

2 $460,000,000 shall be made available to carry out this 

3 section, to remain available until expended.’’. 

4 (c) TREATMENT FOR PRESCRIPTION DRUG ABUSE

5 AND HEROIN USE.—Section 331(b) of the Public Health 

6 Service Act (42 U.S.C. 254d(b)) is amended by adding 

7 at the end the following: 

8 ‘‘(3)(A) The Secretary shall use amounts made 

9 available under subparagraph (B) to support en10 hanced loan repayment awards to increase the num11 ber of clinicians in the Corps with medication as12 sisted treatment training to treat individuals with 

13 opioid use disorders through loan repayments to cli14 nicians. 

15 ‘‘(B) Of the amounts appropriated under sec16 tion 101(a) of the Opioid Use Disorder Treatment 

17 Expansion and Modernization Act for fiscal year 

18 2017, $25,000,000 shall be made available to carry 

19 out this section, to remain available until ex20 pended.’’. 

21 (d) EVALUATION OF MEDICATION-ASSISTED TREAT22 MENT.—Subpart 1 of part B of title V of the Public 

23 Health Service Act (42 U.S.C. 290bb et seq.) is amended 

24 by inserting after section 510, as added by subsection (b), 

25 the following: 


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1 ‘‘SEC. 511. EVALUATION OF MEDICATION-ASSISTED TREAT2 MENT. 

3 ‘‘(a) IN GENERAL.—In order to assess the treatment 

4 outcomes of patients with opioid addiction receiving medi5 cation-assisted treatment, the Secretary shall evaluate the 

6 short, medium, and long-term outcomes of such substance 

7 abuse treatment programs in order to increase effective8 ness in reducing opioid use disorders, overdose, and death. 

9 ‘‘(b) FUNDING.—Of the amounts appropriated under 

10 section 101(a) of the Opioid Use Disorder Treatment Ex11 pansion and Modernization Act for fiscal year 2017, 

12 $15,000,000 shall be made available to carry out this sec13 tion, to remain available until expended.’’. 

14 SEC. 102. OPIOID OVERDOSE REVERSAL DRUGS PRE15 SCRIBING GRANT PROGRAM. 

16 (a) ESTABLISHMENT.— 

17 (1) IN GENERAL.—Not later than six months 

18 after the date of the enactment of this Act, the Sec19 retary of Health and Human Services may establish, 

20 in accordance with this section, a five-year opioid 

21 overdose reversal drugs prescribing grant program 

22 (in this section referred to as the ‘‘grant program’’). 

23 (2) MAXIMUM GRANT AMOUNT.—A grant made 

24 under this section may not be for more than 

25 $200,000 per grant year. 


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1 (3) ELIGIBLE ENTITY.—For purposes of this 

2 section, the term ‘‘eligible entity’’ means a federally 

3 qualified health center (as defined in section 

4 1861(aa) of the Social Security Act (42 U.S.C. 

5 1395x(aa))), an opioid treatment program under 

6 part 8 of title 42, Code of Federal Regulations, any 

7 practitioner dispensing narcotic drugs pursuant to 

8 section 303(g) of the Controlled Substances Act (21 

9 U.S.C. 823(g)), or any other entity that the Sec10 retary deems appropriate. 

11 (4) PRESCRIBING.—For purposes of this sec12 tion, the term ‘‘prescribing’’ means, with respect to 

13 an opioid overdose reversal drug, such as naloxone, 

14 the practice of prescribing such drug— 

15 (A) in conjunction with an opioid prescrip16 tion for patients at an elevated risk of overdose; 

17 (B) in conjunction with an opioid agonist 

18 approved under section 505 of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

20 for the treatment of opioid abuse disorder; 

21 (C) to the caregiver or a close relative of 

22 patients at an elevated risk of overdose from 

23 opioids; or 

24 (D) in other circumstances, as identified 

25 by the Secretary, in which a provider identifies 


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1 a patient is at an elevated risk for an inten2 tional or unintentional drug overdose from her3 oin or prescription opioid therapies. 

4 (b) APPLICATION.—To be eligible to receive a grant 

5 under this section, an eligible entity shall submit to the 

6 Secretary of Health and Human Services, in such form 

7 and manner as specified by the Secretary, an application 

8 that describes— 

9 (1) the extent to which the area to which the 

10 entity will furnish services through use of the grant 

11 is experiencing significant morbidity and mortality 

12 caused by opioid abuse; 

13 (2) the criteria that will be used to identify eli14 gible patients to participate in such program; and 

15 (3) how such program will work to try to iden16 tify State, local, or private funding to continue the 

17 program after expiration of the grant. 

18 (c) USE OF FUNDS.—An eligible entity receiving a 

19 grant under this section may use the grant for any of the 

20 following activities, but may use not more than 20 percent 

21 of the grant funds for activities described in paragraphs 

22 (4) and (5): 

23 (1) To establish a program for prescribing 

24 opioid overdose reversal drugs, such as naloxone. 


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1 (2) To train and provide resources for health 

2 care providers and pharmacists on the prescribing of 

3 opioid overdose reversal drugs, such as naloxone. 

4 (3) To establish mechanisms and processes for 

5 tracking patients participating in the program de6 scribed in paragraph (1) and the health outcomes of 

7 such patients. 

8 (4) To purchase opioid overdose reversal drugs, 

9 such as naloxone, for distribution under the program 

10 described in paragraph (1). 

11 (5) To offset the co-pays and other cost sharing 

12 associated with opioid overdose reversal drugs, such 

13 as naloxone, to ensure that cost is not a limiting fac14 tor for eligible patients. 

15 (6) To conduct community outreach, in con16 junction with community-based organizations, de17 signed to raise awareness of prescribing practices, 

18 and the availability of opioid overdose reversal 

19 drugs, such as naloxone. 

20 (7) To establish protocols to connect patients 

21 who have experienced a drug overdose with appro22 priate treatment, including medication assisted 

23 treatment and appropriate counseling and behavioral 

24 therapies. 


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1 (d) EVALUATIONS BY RECIPIENTS.—As a condition 

2 of receipt of a grant under this section, an eligible entity 

3 shall, for each year for which the grant is received, submit 

4 to the Secretary of Health and Human Services informa5 tion on appropriate outcome measures specified by the 

6 Secretary to assess the outcomes of the program funded 

7 by the grant, including— 

8 (1) the number of prescribers trained; 

9 (2) the number of prescribers who have co-pre10 scribed an opioid overdose reversal drug, such as 

11 naloxone, to at least one patient; 

12 (3) the total number of prescriptions written for 

13 opioid overdose reversal drugs, such as naloxone; 

14 (4) the percentage of patients at elevated risk 

15 who received a prescription for an opioid overdose 

16 reversal drug, such as naloxone; 

17 (5) the number of patients reporting use of an 

18 opioid overdose reversal drug, such as naloxone; and 

19 (6) any other outcome measures that the Sec20 retary deems appropriate. 

21 (e) REPORTS BY SECRETARY.—For each year of the 

22 grant program under this section, the Secretary of Health 

23 and Human Services shall submit to the appropriate com24 mittees of the House of Representatives and the Senate 

25 a report aggregating the information received from the 


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1 grant recipients for such year under subsection (d) and 

2 evaluating the outcomes achieved by the programs funded 

3 by grants made under this section. 

4 (f) PROVIDING INFORMATION TO PRESCRIBERS IN

5 CERTAIN FEDERAL HEALTH CARE AND MEDICAL FACILI6 TIES ON BEST PRACTICES FOR PRESCRIBING OPIOID

7 OVERDOSE REVERSAL DRUGS.— 

8 (1) IN GENERAL.—Not later than 180 days 

9 after the date of enactment of this Act, the Sec10 retary of Health and Human Services (in this sub11 section referred to as the ‘‘Secretary’’) may, as ap12 propriate, provide information to prescribers within 

13 Federally qualified health centers (as defined in 

14 paragraph (4) of section 1861(aa) of the Social Se15 curity Act (42 U.S.C. 1395x(aa))), and the health 

16 care facilities of the Indian Health Service, on best 

17 practices for prescribing opioid overdose reversal 

18 drugs, such as naloxone, for patients receiving 

19 chronic opioid therapy, patients being treated for 

20 opioid use disorders, and other patients that a pro21 vider identifies as having an elevated risk of over22 dose from heroin or prescription opioid therapies. 

23 (2) NOT ESTABLISHING A MEDICAL STANDARD

24 OF CARE.—The information on best practices pro25 vided under this section shall not be construed as 


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1 constituting or establishing a medical standard of 

2 care for prescribing opioid overdose reversal drugs, 

3 such as naloxone, for patients described in para4 graph (1). 

5 (3) NO AUTHORIZATION OF ANY ADDITIONAL

6 APPROPRIATIONS.—The Secretary shall carry out 

7 this subsection through funds otherwise appro8 priated and nothing in this subsection shall be con9 strued as authorizing the appropriations of addi10 tional funds to carry out this subsection. 

11 (4) ELEVATED RISK OF OVERDOSE DEFINED.— 

12 In this subsection, the term ‘‘elevated risk of over13 dose’’ has the meaning given such term by the Sec14 retary, which— 

15 (A) may be based on the criteria provided 

16 in the Opioid Overdose Toolkit published by the 

17 Substance Abuse and Mental Health Services 

18 Administration (SAMHSA); and 

19 (B) may include patients on a first course 

20 opioid treatment, patients using extended-re21 lease and long-acting opioid analgesics, and pa22 tients with a respiratory disease or other co23 morbidities. 

24 (g) FUNDING.—There is authorized to be appro25 priated $5,000,000 to carry out this section (other than 


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1 subsection (f)) for the period of fiscal years 2017 through 

2 2021, of which $5,000,000 shall be made available from 

3 amounts appropriated under section 101(a) of the Opioid 

4 Use Disorder Treatment Expansion and Modernization 

5 Act for fiscal year 2017, to remain available until ex6 pended. 

7 SEC. 103. PARTIAL FILLS OF SCHEDULE II CONTROLLED 

8 SUBSTANCES. 

9 (a) IN GENERAL.—Section 309 of the Controlled 

10 Substances Act (21 U.S.C. 829) is amended by adding at 

11 the end the following: 

12 ‘‘(f) PARTIAL FILLS OF SCHEDULE II CONTROLLED

13 SUBSTANCES.— 

14 ‘‘(1) PARTIAL FILLS.— 

15 ‘‘(A) IN GENERAL.—A prescription for a 

16 controlled substance in schedule II may be par17 tially filled if— 

18 ‘‘(i) it is not prohibited by State law; 

19 ‘‘(ii) the prescription is written and 

20 filled in accordance with this Act, regula21 tions prescribed by the Attorney General, 

22 and State law; 

23 ‘‘(iii) the partial fill is requested by 

24 the patient or the practitioner that wrote 

25 the prescription; and 


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1 ‘‘(iv) the total quantity dispensed in 

2 all partial fillings does not exceed the total 

3 quantity prescribed. 

4 ‘‘(B) OTHER CIRCUMSTANCES.—A pre5 scription for a controlled substance in schedule 

6 II may be partially filled in accordance with 

7 section 1306.13 of title 21, Code of Federal 

8 Regulations (as in effect on the date of enact9 ment of the Opioid Abuse Crisis Act of 2016). 

10 ‘‘(2) REMAINING PORTIONS.— 

11 ‘‘(A) IN GENERAL.—Except as provided in 

12 subparagraph (B), remaining portions of a par13 tially filled prescription for a controlled sub14 stance in schedule II— 

15 ‘‘(i) may be filled; and 

16 ‘‘(ii) shall be filled not later than 30 

17 days after the date on which the prescrip18 tion is written. 

19 ‘‘(B) EMERGENCY SITUATIONS.—In emer20 gency situations, as described in subsection (a), 

21 the remaining portions of a partially filled pre22 scription for a controlled substance in schedule 

23 II— 

24 ‘‘(i) may be filled; and 


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1 ‘‘(ii) shall be filled not later than 72 

2 hours after the prescription is issued.’’. 

3 (b) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to affect the authority of the Attor5 ney General to allow a prescription for a controlled sub6 stance in schedule III, IV, or V of section 202(c) of the 

7 Controlled Substances Act (21 U.S.C. 812(c)) to be par8 tially filled. 

9 SEC. 104. OPIOID USE DISORDER TREATMENT MODERNIZA10 TION. 

11 (a) IN GENERAL.—Section 303(g)(2) of the Con12 trolled Substances Act (21 U.S.C. 823(g)(2)) is amend13 ed— 

14 (1) in subparagraph (B), by striking clauses (i), 

15 (ii), and (iii) and inserting the following: 

16 ‘‘(i) The practitioner is a qualifying practitioner 

17 (as defined in subparagraph (G)). 

18 ‘‘(ii) With respect to patients to whom the prac19 titioner will provide such drugs or combinations of 

20 drugs, the practitioner has the capacity to provide 

21 directly, by referral, or in such other manner as de22 termined by the Secretary— 

23 ‘‘(I) all schedule III, IV, and V drugs, as 

24 well as unscheduled medications approved by 

25 the Food and Drug Administration, for the 


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1 treatment of opioid use disorder, including such 

2 drugs and medications for maintenance, detoxi3 fication, overdose reversal, and relapse preven4 tion, as available; and 

5 ‘‘(II) appropriate counseling and other ap6 propriate ancillary services. 

7 ‘‘(iii)(I) The total number of such patients of 

8 the practitioner at any one time will not exceed the 

9 applicable number. Except as provided in subclauses 

10 (II) and (III), the applicable number is 30. 

11 ‘‘(II) The applicable number is 100 if, not soon12 er than 1 year after the date on which the practi13 tioner submitted the initial notification, the practi14 tioner submits a second notification to the Secretary 

15 of the need and intent of the practitioner to treat up 

16 to 100 patients. 

17 ‘‘(III) The applicable number is 300 if the prac18 titioner is a qualifying physician meeting the re19 quirement of subclause (VI) and, not sooner than 1 

20 year after the date on which the physician submitted 

21 a second notification under subclause (II), the prac22 titioner submits a third notification to the Secretary 

23 of the need and intent of the physician to treat up 

24 to 300 patients. 


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1 ‘‘(IV) The Secretary may by regulation change 

2 such total number. 

3 ‘‘(V) The Secretary may exclude from the appli4 cable number patients to whom such drugs or com5 binations of drugs are directly administered by the 

6 qualifying practitioner in the office setting. 

7 ‘‘(VI) For purposes of subclause (III), a quali8 fying physician meets the requirement of this sub9 clause if the physician— 

10 ‘‘(aa) holds a special certification in addic11 tion psychiatry or addiction medicine as de12 scribed in clause (ii) from the American Board 

13 of Medical Specialties, the American Board of 

14 Addiction Medicine, the American Osteopathic 

15 Association, the American Society of Addiction 

16 Medicine, or such other organization as the Sec17 retary determines to be appropriate for pur18 poses of this subclause; or 

19 ‘‘(bb) has completed not fewer than 24 

20 hours of training, with respect to the treatment 

21 and management of opiate-dependent patients, 

22 addressing the topics listed in subparagraph 

23 (G)(ii)(IV). 

24 The Secretary may review and update the require25 ments of this subclause. 


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1 ‘‘(iv) In the case of a third notification under 

2 clause (iii)(III), the qualifying physician maintains 

3 and implements a diversion control plan that con4 tains specific measures to reduce the likelihood of 

5 the diversion of controlled substances prescribed by 

6 the physician for the treatment of opioid use dis7 order. 

8 ‘‘(v) In the case of a third notification under 

9 clause (iii)(III), the qualifying physician obtains a 

10 written agreement from each patient, including the 

11 patient’s signature, that the patient— 

12 ‘‘(I) will receive an initial assessment and 

13 treatment plan and periodic assessments and 

14 treatment plans thereafter; 

15 ‘‘(II) will be subject to medication adher16 ence and substance use monitoring; 

17 ‘‘(III) understands available treatment op18 tions, including all drugs approved by the Food 

19 and Drug Administration for the treatment of 

20 opioid use disorder, including their potential 

21 risks and benefits; and 

22 ‘‘(IV) understands that receiving regular 

23 counseling services is critical to recovery. 

24 ‘‘(vi) The practitioner will comply with the re25 porting requirements of subparagraph (D)(i)(IV).’’; 


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1 (2) in subparagraph (D)— 

2 (A) in clause (i), by adding at the end the 

3 following: 

4 ‘‘(IV) The practitioner reports to the Secretary, 

5 at such times and in such manner as specified by 

6 the Secretary, such information and assurances as 

7 the Secretary determines necessary to assess wheth8 er the practitioner continues to meet the require9 ments for a waiver under this paragraph.’’; 

10 (B) in clause (ii), by striking ‘‘Upon re11 ceiving a notification under subparagraph (B)’’ 

12 and inserting ‘‘Upon receiving a determination 

13 from the Secretary under clause (iii) finding 

14 that a practitioner meets all requirements for a 

15 waiver under subparagraph (B)’’; and 

16 (C) in clause (iii)— 

17 (i) by inserting ‘‘and shall forward 

18 such determination to the Attorney Gen19 eral’’ before the period at the end of the 

20 first sentence; and 

21 (ii) by striking ‘‘physician’’ and in22 serting ‘‘practitioner’’; 

23 (3) in subparagraph (G)— 

24 (A) by amending clause (ii)(IV) to read as 

25 follows: 


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1 ‘‘(IV) The physician has, with respect to 

2 the treatment and management of opiate-de3 pendent patients, completed not less than eight 

4 hours of training (through classroom situations, 

5 seminars at professional society meetings, elec6 tronic communications, or otherwise) that is 

7 provided by the American Society of Addiction 

8 Medicine, the American Academy of Addiction 

9 Psychiatry, the American Medical Association, 

10 the American Osteopathic Association, the 

11 American Psychiatric Association, or any other 

12 organization that the Secretary determines is 

13 appropriate for purposes of this subclause. Such 

14 training shall address— 

15 ‘‘(aa) opioid maintenance and detoxi16 fication; 

17 ‘‘(bb) appropriate clinical use of all 

18 drugs approved by the Food and Drug Ad19 ministration for the treatment of opioid 

20 use disorder; 

21 ‘‘(cc) initial and periodic patient as22 sessments (including substance use moni23 toring); 

24 ‘‘(dd) individualized treatment plan25 ning; overdose reversal; relapse prevention; 


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1 ‘‘(ee) counseling and recovery support 

2 services; 

3 ‘‘(ff) staffing roles and considerations; 

4 ‘‘(gg) diversion control; and 

5 ‘‘(hh) other best practices, as identi6 fied by the Secretary.’’; and 

7 (B) by adding at the end the following: 

8 ‘‘(iii) The term ‘qualifying practitioner’ 

9 means— 

10 ‘‘(I) a qualifying physician, as defined in 

11 clause (ii); or 

12 ‘‘(II) a qualifying other practitioner, as de13 fined in clause (iv). 

14 ‘‘(iv) The term ‘qualifying other practitioner’ 

15 means a nurse practitioner or physician assistant 

16 who satisfies each of the following: 

17 ‘‘(I) The nurse practitioner or physician 

18 assistant is licensed under State law to pre19 scribe schedule III, IV, or V medications for the 

20 treatment of pain. 

21 ‘‘(II) The nurse practitioner or physician 

22 assistant satisfies 1 or more of the following: 

23 ‘‘(aa) Has completed not fewer than 

24 24 hours of initial training addressing each 

25 of the topics listed in clause (ii)(IV) 


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1 (through classroom situations, seminars at 

2 professional society meetings, electronic 

3 communications, or otherwise) provided by 

4 the American Society of Addiction Medi5 cine, the American Academy of Addiction 

6 Psychiatry, the American Medical Associa7 tion, the American Osteopathic Associa8 tion, the American Nurses Credentialing 

9 Center, the American Psychiatric Associa10 tion, the American Association of Nurse 

11 Practitioners, the American Academy of 

12 Physician Assistants, or any other organi13 zation that the Secretary determines is ap14 propriate for purposes of this subclause. 

15 ‘‘(bb) Has such other training or ex16 perience as the Secretary determines will 

17 demonstrate the ability of the nurse practi18 tioner or physician assistant to treat and 

19 manage opiate-dependent patients. 

20 ‘‘(III) The nurse practitioner or physician 

21 assistant is supervised by or works in collabora22 tion with a qualifying physician, if the nurse 

23 practitioner or physician assistant is required 

24 by State law to prescribe medications for the 


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1 treatment of opioid use disorder in collaboration 

2 with or under the supervision of a physician. 

3 The Secretary may review and update the require4 ments for being a qualifying other practitioner under 

5 this clause.’’; and 

6 (4) in subparagraph (H)— 

7 (A) in clause (i), by inserting after sub8 clause (II) the following: 

9 ‘‘(III) Such other elements of the requirements 

10 under this paragraph as the Secretary determines 

11 necessary for purposes of implementing such re12 quirements.’’; and 

13 (B) by amending clause (ii) to read as fol14 lows: 

15 ‘‘(ii) Not later than one year after the date of enact16 ment of the Opioid Use Disorder Treatment Expansion 

17 and Modernization Act, the Secretary shall update the 

18 treatment improvement protocol containing best practice 

19 guidelines for the treatment of opioid-dependent patients 

20 in office-based settings. The Secretary shall update such 

21 protocol in consultation with experts in opioid use disorder 

22 research and treatment.’’. 

23 (b) RECOMMENDATION OF REVOCATION OR SUSPEN24 SION OF REGISTRATION IN CASE OF SUBSTANTIAL NON25 COMPLIANCE.—The Secretary of Health and Human 


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1 Services may recommend to the Attorney General that the 

2 registration of a practitioner be revoked or suspended if 

3 the Secretary determines, according to such criteria as the 

4 Secretary establishes by regulation, that a practitioner 

5 who is registered under section 303(g)(2) of the Controlled 

6 Substances Act (21 U.S.C. 823(g)(2)) is not in substantial 

7 compliance with the requirements of such section, as 

8 amended by this Act. 

9 (c) OPIOID DEFINED.—Section 102(18) of the Con10 trolled Substances Act (21 U.S.C. 802(18)) is amended 

11 by inserting ‘‘or ‘opioid’ ’’ after ‘‘The term ‘opiate’ ’’. 

12 (d) REPORTS TO CONGRESS.— 

13 (1) IN GENERAL.—Not later than 2 years after 

14 the date of enactment of this Act and not less than 

15 over every 5 years thereafter, the Secretary of 

16 Health and Human Services, in consultation with 

17 the Drug Enforcement Administration and experts 

18 in opioid use disorder research and treatment, 

19 shall— 

20 (A) perform a thorough review of the pro21 vision of opioid use disorder treatment services 

22 in the United States, including services pro23 vided in opioid treatment programs and other 

24 specialty and nonspecialty settings; and 


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1 (B) submit a report to the Congress on the 

2 findings and conclusions of such review. 

3 (2) CONTENTS.—Each report under paragraph 

4 (1) shall include an assessment of— 

5 (A) compliance with the requirements of 

6 section 303(g)(2) of the Controlled Substances 

7 Act (21 U.S.C. 823(g)(2)), as amended by this 

8 Act; 

9 (B) the measures taken by the Secretary of 

10 Health and Human Services to ensure such 

11 compliance; 

12 (C) whether there is further need to in13 crease or decrease the number of patients a 

14 waivered practitioner is permitted to treat, as 

15 provided for by the amendment made by sub16 section (a)(1); 

17 (D) the extent to which, and proportions 

18 with which, the full range of Food and Drug 

19 Administration-approved treatments for opioid 

20 use disorder are used in routine health care set21 tings and specialty substance use disorder treat22 ment settings; 

23 (E) access to, and use of, counseling and 

24 recovery support services, including the percent25 age of patients receiving such services; 


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1 (F) changes in State or local policies and 

2 legislation relating to opioid use disorder treat3 ment; 

4 (G) the use of prescription drug moni5 toring programs by practitioners who are per6 mitted to dispense narcotic drugs to individuals 

7 pursuant to a waiver under section 303(g)(2) of 

8 the Controlled Substances Act (21 U.S.C. 

9 823(g)(2)); 

10 (H) the findings resulting from inspections 

11 by the Drug Enforcement Administration of 

12 practitioners described in subparagraph (G); 

13 and 

14 (I) the effectiveness of cross-agency col15 laboration between the Department of Health 

16 and Human Services and the Drug Enforce17 ment Administration for expanding effective 

18 opioid use disorder treatment. 

19 SEC. 105. NURTURING AND SUPPORTING HEALTHY BABIES. 

20 (a) GAO REPORT ON NEONATAL ABSTINENCE SYN21 DROME (NAS).— 

22 (1) IN GENERAL.—Not later than one year 

23 after the date of the enactment of this Act, the 

24 Comptroller General of the United States shall sub25 mit to the Committee on Energy and Commerce of 


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1 the House of Representatives and the Committee on 

2 Finance and the Committee on Health, Education, 

3 Labor, and Pensions of the Senate a report on neo4 natal abstinence syndrome (in this section referred 

5 to as ‘‘NAS’’) in the United States. 

6 (2) INFORMATION TO BE INCLUDED IN RE7 PORT.—Such report shall include information on the 

8 following: 

9 (A) The prevalence of NAS in the United 

10 States, including the proportion of children 

11 born in the United States with NAS who are el12 igible for medical assistance under State Med13 icaid programs under title XIX of the Social 

14 Security Act at birth and the costs associated 

15 with NAS through such programs. 

16 (B) The services for which coverage is 

17 available under State Medicaid programs for 

18 treatment of infants with NAS. 

19 (C) The settings (including inpatient, out20 patient, hospital-based, and other settings) for 

21 the treatment of infants with NAS and the re22 imbursement methodologies and costs associ23 ated with such treatment in such settings. 

24 (D) The prevalence of utilization of various 

25 care settings under State Medicaid programs 


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1 for treatment of infants with NAS and any 

2 Federal barriers to treating such infants under 

3 such programs, particularly in non-hospital4 based settings. 

5 (3) RECOMMENDATIONS.—Such report also 

6 shall include such recommendations as the Comp7 troller General determines appropriate for improve8 ments that will ensure access to treatment for in9 fants with NAS under State Medicaid programs. 

10 (b) EXCLUDING ABUSE-DETERRENT FORMULATIONS

11 OF PRESCRIPTION DRUGS FROM THE MEDICAID ADDI12 TIONAL REBATE REQUIREMENT FOR NEW FORMULA13 TIONS OF PRESCRIPTION DRUGS.— 

14 (1) IN GENERAL.—The last sentence of section 

15 1927(c)(2)(C) of the Social Security Act (42 U.S.C. 

16 1396r–8(c)(2)(C)) is amended by inserting before 

17 the period at the end the following: ‘‘, but does not 

18 include an abuse-deterrent formulation of the drug 

19 (as determined by the Secretary), regardless of 

20 whether such abuse-deterrent formulation is an ex21 tended release formulation’’. 

22 (2) EFFECTIVE DATE.—The amendment made 

23 by paragraph (1) shall apply to drugs that are paid 

24 for by a State in calendar quarters beginning on or 

25 after the date of the enactment of this Act. 


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1 (c) LIMITING DISCLOSURE OF PREDICTIVE MOD2 ELING AND OTHER ANALYTICS TECHNOLOGIES TO IDEN3 TIFY AND PREVENT WASTE, FRAUD, AND ABUSE.— 

4 (1) IN GENERAL.—Title XI of the Social Secu5 rity Act is amended by inserting after section 1128J 

6 (42 U.S.C. 1320a–7k) the following new section: 

7 ‘‘SEC. 1128K. DISCLOSURE OF PREDICTIVE MODELING AND 

8 OTHER ANALYTICS TECHNOLOGIES TO IDEN9 TIFY AND PREVENT WASTE, FRAUD, AND 

10 ABUSE. 

11 ‘‘(a) REFERENCE TO PREDICTIVE MODELING TECH12 NOLOGIES REQUIREMENTS.—For provisions relating to 

13 the use of predictive modeling and other analytics tech14 nologies to identify and prevent waste, fraud, and abuse 

15 with respect to the Medicare program under title XVIII, 

16 the Medicaid program under title XIX, and the Children’s 

17 Health Insurance Program under title XXI, see section 

18 4241 of the Small Business Jobs Act of 2010 (42 U.S.C. 

19 1320a–7m). 

20 ‘‘(b) LIMITING DISCLOSURE OF PREDICTIVE MOD21 ELING TECHNOLOGIES.—In implementing such provisions 

22 under such section 4241 with respect to covered algo23 rithms (as defined in subsection (c)), the following shall 

24 apply: 


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1 ‘‘(1) NONAPPLICATION OF FOIA.—The covered 

2 algorithms used or developed for purposes of such 

3 section (including by the Secretary or a State (or an 

4 entity operating under a contract with a State)) 

5 shall be exempt from disclosure under section 

6 552(b)(3) of title 5, United States Code. 

7 ‘‘(2) LIMITATION WITH RESPECT TO USE AND

8 DISCLOSURE OF INFORMATION BY STATE AGEN9 CIES.— 

10 ‘‘(A) IN GENERAL.—A State agency may 

11 not use or disclose covered algorithms used or 

12 developed for purposes of such section except 

13 for purposes of administering the State plan (or 

14 a waiver of the plan) under the Medicaid pro15 gram under title XIX or the State child health 

16 plan (or a waiver of the plan) under the Chil17 dren’s Health Insurance Program under title 

18 XXI, including by enabling an entity operating 

19 under a contract with a State to assist the 

20 State to identify or prevent waste, fraud and 

21 abuse with respect to such programs. 

22 ‘‘(B) INFORMATION SECURITY.—A State 

23 agency shall have in effect data security and 

24 control policies that the Secretary finds ade25 quate to ensure the security of covered algoVerDate Sep 11 2014 20:51 May 13, 2016 Jkt 059200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\H5189.IH H5189

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1 rithms used or developed for purposes of such 

2 section 4241 and to ensure that access to such 

3 information is restricted to authorized persons 

4 for purposes of authorized uses and disclosures 

5 described in subparagraph (A). 

6 ‘‘(C) PROCEDURAL REQUIREMENTS.— 

7 State agencies to which information is disclosed 

8 pursuant to such section 4241 shall adhere to 

9 uniform procedures established by the Sec10 retary. 

11 ‘‘(c) COVERED ALGORITHM DEFINED.—In this sec12 tion, the term ‘covered algorithm’— 

13 ‘‘(1) means a predictive modeling or other ana14 lytics technology, as used for purposes of section 

15 4241(a) of the Small Business Jobs Act of 2010 (42 

16 U.S.C. 1320a–7m(a)) to identify and prevent waste, 

17 fraud, and abuse with respect to the Medicare pro18 gram under title XVIII, the Medicaid program 

19 under title XIX, and the Children’s Health Insur20 ance Program under title XXI; and 

21 ‘‘(2) includes the mathematical expressions uti22 lized in the application of such technology and the 

23 means by which such technology is developed.’’. 

24 (2) CONFORMING AMENDMENTS.— 


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1 (A) MEDICAID STATE PLAN REQUIRE2 MENT.—Section 1902(a) of the Social Security 

3 Act (42 U.S.C. 1396a(a)) is amended— 

4 (i) in paragraph (80), by striking 

5 ‘‘and’’ at the end; 

6 (ii) in paragraph (81), by striking the 

7 period at the end and inserting ‘‘; and’’; 

8 and 

9 (iii) by inserting after paragraph (81) 

10 the following new paragraph: 

11 ‘‘(82) provide that the State agency responsible 

12 for administering the State plan under this title pro13 vides assurances to the Secretary that the State 

14 agency is in compliance with subparagraphs (A), 

15 (B), and (C) of section 1128K(b)(2).’’. 

16 (B) STATE CHILD HEALTH PLAN REQUIRE17 MENT.—Section 2102(a)(7) of the Social Secu18 rity Act (42 U.S.C. 1397bb(a)(7)) is amend19 ed— 

20 (i) in subparagraph (A), by striking ‘‘, 

21 and’’ at the end and inserting a semicolon; 

22 (ii) in subparagraph (B), by striking 

23 the period at the end and inserting ‘‘; 

24 and’’; and 


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1 (iii) by adding at the end the fol2 lowing new subparagraph: 

3 ‘‘(C) to ensure that the State agency in4 volved is in compliance with subparagraphs (A), 

5 (B), and (C) of section 1128K(b)(2).’’. 

6 (d) MEDICAID IMPROVEMENT FUND.—Section 

7 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w– 

8 1(b)(1)) is amended to read as follows: 

9 ‘‘(1) IN GENERAL.—There shall be available to 

10 the Fund, for expenditures from the Fund for fiscal 

11 year 2021 and thereafter, $5,000,000.’’. 

12 SEC. 106. IMPROVING TREATMENT FOR PREGNANT AND 

13 POSTPARTUM WOMEN. 

14 (a) REAUTHORIZATION OF RESIDENTIAL TREAT15 MENT PROGRAMS FOR PREGNANT AND POSTPARTUM

16 WOMEN.—Section 508 of the Public Health Service Act 

17 (42 U.S.C. 290bb–1) is amended— 

18 (1) in subsection (p), in the first sentence, by 

19 inserting ‘‘(other than subsection (r))’’ after ‘‘sec20 tion’’; and 

21 (2) in subsection (r), by striking ‘‘such sums’’ 

22 and all that follows through ‘‘2003’’ and inserting 

23 ‘‘$16,900,000 for each of fiscal years 2017 through 

24 2021’’. 


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1 (b) PILOT PROGRAM GRANTS FOR STATE SUB2 STANCE ABUSE AGENCIES.— 

3 (1) IN GENERAL.—Section 508 of the Public 

4 Health Service Act (42 U.S.C. 290bb–1) is amend5 ed— 

6 (A) by redesignating subsection (r), as 

7 amended by subsection (a), as subsection (s); 

8 and 

9 (B) by inserting after subsection (q) the 

10 following new subsection: 

11 ‘‘(r) PILOT PROGRAM FOR STATE SUBSTANCE

12 ABUSE AGENCIES.— 

13 ‘‘(1) IN GENERAL.—From amounts made avail14 able under subsection (s), the Director of the Center 

15 for Substance Abuse Treatment shall carry out a 

16 pilot program under which competitive grants are 

17 made by the Director to State substance abuse agen18 cies to— 

19 ‘‘(A) enhance flexibility in the use of funds 

20 designed to support family-based services for 

21 pregnant and postpartum women with a pri22 mary diagnosis of a substance use disorder, in23 cluding opioid use disorders; 

24 ‘‘(B) help State substance abuse agencies 

25 address identified gaps in services furnished to 


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1 such women along the continuum of care, in2 cluding services provided to women in nonresi3 dential based settings; and 

4 ‘‘(C) promote a coordinated, effective, and 

5 efficient State system managed by State sub6 stance abuse agencies by encouraging new ap7 proaches and models of service delivery. 

8 ‘‘(2) REQUIREMENTS.—In carrying out the 

9 pilot program under this subsection, the Director 

10 shall— 

11 ‘‘(A) require State substance abuse agen12 cies to submit to the Director applications, in 

13 such form and manner and containing such in14 formation as specified by the Director, to be eli15 gible to receive a grant under the program; 

16 ‘‘(B) identify, based on such submitted ap17 plications, State substance abuse agencies that 

18 are eligible for such grants; 

19 ‘‘(C) require services proposed to be fur20 nished through such a grant to support family21 based treatment and other services for pregnant 

22 and postpartum women with a primary diag23 nosis of a substance use disorder, including 

24 opioid use disorders; 


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1 ‘‘(D) not require that services furnished 

2 through such a grant be provided solely to 

3 women that reside in facilities; 

4 ‘‘(E) not require that grant recipients 

5 under the program make available through use 

6 of the grant all services described in subsection 

7 (d); and 

8 ‘‘(F) consider not applying requirements 

9 described in paragraphs (1) and (2) of sub10 section (f) to applicants, depending on the cir11 cumstances of the applicant. 

12 ‘‘(3) REQUIRED SERVICES.— 

13 ‘‘(A) IN GENERAL.—The Director shall 

14 specify a minimum set of services required to be 

15 made available to eligible women through a 

16 grant awarded under the pilot program under 

17 this subsection. Such minimum set— 

18 ‘‘(i) shall include requirements de19 scribed in subsection (c) and be based on 

20 the recommendations submitted under sub21 paragraph (B); and 

22 ‘‘(ii) may be selected from among the 

23 services described in subsection (d) and in24 clude other services as appropriate. 


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1 ‘‘(B) STAKEHOLDER INPUT.—The Director 

2 shall convene and solicit recommendations from 

3 stakeholders, including State substance abuse 

4 agencies, health care providers, persons in re5 covery from substance abuse, and other appro6 priate individuals, for the minimum set of serv7 ices described in subparagraph (A). 

8 ‘‘(4) DURATION.—The pilot program under this 

9 subsection shall not exceed 5 years. 

10 ‘‘(5) EVALUATION AND REPORT TO CON11 GRESS.—The Director of the Center for Behavioral 

12 Health Statistics and Quality shall fund an evalua13 tion of the pilot program at the conclusion of the 

14 first grant cycle funded by the pilot program. The 

15 Director of the Center for Behavioral Health Statis16 tics and Quality, in coordination with the Director of 

17 the Center for Substance Abuse Treatment shall 

18 submit to the relevant committees of jurisdiction of 

19 the House of Representatives and the Senate a re20 port on such evaluation. The report shall include at 

21 a minimum outcomes information from the pilot pro22 gram, including any resulting reductions in the use 

23 of alcohol and other drugs; engagement in treatment 

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1 cations approved by the Food and Drug Administra2 tion for the treatment of substance use disorders in 

3 combination with counseling; and other appropriate 

4 measures. 

5 ‘‘(6) STATE SUBSTANCE ABUSE AGENCIES DE6 FINED.—For purposes of this subsection, the term 

7 ‘State substance abuse agency’ means, with respect 

8 to a State, the agency in such State that manages 

9 the Substance Abuse Prevention and Treatment 

10 Block Grant under part B of title XIX.’’. 

11 (2) FUNDING.—Subsection (s) of section 508 of 

12 the Public Health Service Act (42 U.S.C. 290bb–1), 

13 as amended by subsection (a) and redesignated by 

14 paragraph (1), is further amended by adding at the 

15 end the following new sentence: ‘‘Of the amounts 

16 made available for a year pursuant to the previous 

17 sentence to carry out this section, not more than 25 

18 percent of such amounts shall be made available for 

19 such year to carry out subsection (r), other than 

20 paragraph (5) of such subsection. Notwithstanding 

21 the preceding sentence, no funds shall be made 

22 available to carry out subsection (r) for a fiscal year 

23 unless the amount made available to carry out this 

24 section for such fiscal year is more than the amount 


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1 made available to carry out this section for fiscal 

2 year 2016.’’. 

3 (c) CUT-GO COMPLIANCE.—Subsection (f) of section 

4 319D of the Public Health Service Act (42 U.S.C. 247d– 

5 4) is amended by striking ‘‘through 2018’’ and inserting 

6 ‘‘through 2016, $133,300,000 for fiscal year 2017, and 

7 $138,300,000 for fiscal year 2018’’. 

8 SEC. 107. ASSISTING VETERANS WITH MILITARY EMER9 GENCY MEDICAL TRAINING TO MEET RE10 QUIREMENTS FOR BECOMING CIVILIAN 

11 EMERGENCY MEDICAL TECHNICIANS. 

12 Part B of title III of the Public Health Service Act 

13 (42 U.S.C. 243 et seq.) is amended by inserting after sec14 tion 314 the following: 

15 ‘‘SEC. 315. ASSISTING VETERANS WITH MILITARY EMER16 GENCY MEDICAL TRAINING TO MEET RE17 QUIREMENTS FOR BECOMING CIVILIAN 

18 EMERGENCY MEDICAL TECHNICIANS. 

19 ‘‘(a) PROGRAM.—The Secretary shall establish a pro20 gram consisting of awarding demonstration grants to 

21 States to streamline State requirements and procedures 

22 in order to assist veterans who completed military emer23 gency medical technician training while serving in the 

24 Armed Forces of the United States to meet certification, 


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1 licensure, and other requirements applicable to becoming 

2 an emergency medical technician in the State. 

3 ‘‘(b) USE OF FUNDS.—Amounts received as a dem4 onstration grant under this section shall be used to pre5 pare and implement a plan to streamline State require6 ments and procedures as described in subsection (a), in7 cluding by— 

8 ‘‘(1) determining the extent to which the re9 quirements for the education, training, and skill level 

10 of emergency medical technicians in the State are 

11 equivalent to requirements for the education, train12 ing, and skill level of military emergency medical 

13 technicians; and 

14 ‘‘(2) identifying methods, such as waivers, for 

15 military emergency medical technicians to forgo or 

16 meet any such equivalent State requirements. 

17 ‘‘(c) ELIGIBILITY.—To be eligible for a grant under 

18 this section, a State shall demonstrate that the State has 

19 a shortage of emergency medical technicians. 

20 ‘‘(d) REPORT.—The Secretary shall submit to the 

21 Congress an annual report on the program under this sec22 tion. 

23 ‘‘(e) FUNDING.—No additional funds are authorized 

24 to be appropriated for the purpose of carrying out this 


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1 section. This section shall be carried out using amounts 

2 otherwise available for such purpose.’’. 

3 SEC. 108. INFORMATION MATERIALS AND RESOURCES TO 

4 PREVENT ADDICTION RELATED TO YOUTH 

5 SPORTS INJURIES. 

6 (a) TECHNICAL CLARIFICATION.—Effective as if in7 cluded in the enactment of the Children’s Health Act of 

8 2000 (Public Law 106–310), section 3405(a) of such Act 

9 (114 Stat. 1221) is amended by striking ‘‘Part E of title 

10 III’’ and inserting ‘‘Part E of title III of the Public Health 

11 Service Act’’. 

12 (b) AMENDMENT.—Title III of the Public Health 

13 Service Act is amended by inserting after part D of such 

14 title (42 U.S.C. 254b et seq.) the following new part E: 

15 ‘‘PART E—OPIOID USE DISORDER 

16 ‘‘SEC. 341. INFORMATION MATERIALS AND RESOURCES TO 

17 PREVENT ADDICTION RELATED TO YOUTH 

18 SPORTS INJURIES. 

19 ‘‘(a) REPORT.—The Secretary shall— 

20 ‘‘(1) not later than 24 months after the date of 

21 the enactment of this section, make publicly avail22 able a report determining the extent to which infor23 mational materials and resources described in sub24 section (b) are available to teenagers and adolescents 

25 who play youth sports, families of such teenagers 


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1 and adolescents, nurses, youth sports groups, and 

2 relevant health care provider groups; and 

3 ‘‘(2) for purposes of educating and preventing 

4 addiction in teenagers and adolescents who are in5 jured playing youth sports and are subsequently pre6 scribed an opioid, not later than 12 months after 

7 such report is made publicly available and taking 

8 into consideration the findings of such report, de9 velop and, in coordination with youth sports groups, 

10 disseminate informational materials and resources 

11 described in subsection (b) for teenagers and adoles12 cents who play youth sports, families of such teen13 agers and adolescents, nurses, youth sports groups, 

14 and relevant health care provider groups. 

15 ‘‘(b) MATERIALS AND RESOURCES DESCRIBED.—For 

16 purposes of this section, the informational materials and 

17 resources described in this subsection are informational 

18 materials and resources with respect to youth sports inju19 ries for which opioids are potentially prescribed and subse20 quently potentially lead to addiction, including materials 

21 and resources focused on the dangers of opioid use and 

22 misuse, treatment options for such injuries that do not 

23 involve the use of opioids, and how to seek treatment for 

24 addiction. 


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1 ‘‘(c) NO ADDITIONAL FUNDS.—No additional funds 

2 are authorized to be appropriated for the purpose of car3 rying out this section. This section shall be carried out 

4 using amounts otherwise available for such purpose.’’. 

5 SEC. 109. LALI’S LAW. 

6 (a) OPIOID OVERDOSE REVERSAL MEDICATION AC7 CESS AND EDUCATION GRANT PROGRAM.—Part E of title 

8 III of the Public Health Service Act, as added by section 

9 109, is amended by adding at the end the following 

10 ‘‘SEC. 342. OPIOID OVERDOSE REVERSAL MEDICATION AC11 CESS AND EDUCATION GRANT PROGRAMS. 

12 ‘‘(a) GRANTS TO STATES.—The Secretary may make 

13 grants to States for— 

14 ‘‘(1) developing standing orders for pharmacies 

15 regarding opioid overdose reversal medication; 

16 ‘‘(2) encouraging pharmacies to dispense opioid 

17 overdose reversal medication pursuant to a standing 

18 order; 

19 ‘‘(3) implementing best practices for persons 

20 authorized to prescribe medication regarding— 

21 ‘‘(A) prescribing opioids for the treatment 

22 of chronic pain; 

23 ‘‘(B) co-prescribing opioid overdose rever24 sal medication with opioids; and 


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1 ‘‘(C) discussing the purpose and adminis2 tration of opioid overdose reversal medication 

3 with patients; 

4 ‘‘(4) developing or adapting training materials 

5 and methods for persons authorized to prescribe or 

6 dispense medication to use in educating the public 

7 regarding— 

8 ‘‘(A) when and how to administer opioid 

9 overdose reversal medication; and 

10 ‘‘(B) steps to be taken after administering 

11 opioid overdose reversal medication; and 

12 ‘‘(5) educating the public regarding— 

13 ‘‘(A) the public health benefits of opioid 

14 overdose reversal medication; and 

15 ‘‘(B) the availability of opioid overdose re16 versal medication without a person-specific pre17 scription. 

18 ‘‘(b) CERTAIN REQUIREMENT.—A grant may be 

19 made under this section only if the State involved has au20 thorized standing orders regarding opioid overdose rever21 sal medication. 

22 ‘‘(c) PREFERENCE IN MAKING GRANTS.—In making 

23 grants under this section, the Secretary shall give pref24 erence to States that— 


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1 ‘‘(1) have not issued standing orders regarding 

2 opioid overdose reversal medication; 

3 ‘‘(2) authorize standing orders that permit com4 munity-based organizations, substance abuse pro5 grams, or other nonprofit entities to acquire, dis6 pense, or administer opioid overdose reversal medica7 tion; 

8 ‘‘(3) authorize standing orders that permit po9 lice, fire, or emergency medical services agencies to 

10 acquire and administer opioid overdose reversal 

11 medication; 

12 ‘‘(4) have a higher per capita rate of opioid 

13 overdoses than other applicant States; or 

14 ‘‘(5) meet any other criteria deemed appro15 priate by the Secretary. 

16 ‘‘(d) GRANT TERMS.— 

17 ‘‘(1) NUMBER.—A State may not receive more 

18 than 1 grant under this section. 

19 ‘‘(2) PERIOD.—A grant under this section shall 

20 be for a period of 3 years. 

21 ‘‘(3) AMOUNT.—A grant under this section may 

22 not exceed $500,000. 

23 ‘‘(4) LIMITATION.—A State may use not more 

24 than 20 percent of a grant under this section for 

25 educating the public pursuant to subsection (a)(5). 


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1 ‘‘(e) APPLICATIONS.—To be eligible to receive a grant 

2 under this section, a State shall submit an application to 

3 the Secretary in such form and manner and containing 

4 such information as the Secretary may require, including 

5 detailed proposed expenditures of grant funds. 

6 ‘‘(f) REPORTING.—Not later than 3 months after the 

7 Secretary disburses the first grant payment to any State 

8 under this section and every 6 months thereafter for 3 

9 years, such State shall submit a report to the Secretary 

10 that includes the following: 

11 ‘‘(1) The name and ZIP Code of each pharmacy 

12 in the State that dispenses opioid overdose reversal 

13 medication under a standing order. 

14 ‘‘(2) The total number of opioid overdose rever15 sal medication doses dispensed by each such phar16 macy, specifying how many were dispensed with or 

17 without a person-specific prescription. 

18 ‘‘(3) The number of pharmacists in the State 

19 who have participated in training pursuant to sub20 section (a)(4). 

21 ‘‘(g) DEFINITIONS.—In this section: 

22 ‘‘(1) OPIOID OVERDOSE REVERSAL MEDICA23 TION.—The term ‘opioid overdose reversal medica24 tion’ means any drug, including naloxone, that— 


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1 ‘‘(A) blocks opioids from attaching to, but 

2 does not itself activate, opioid receptors; or 

3 ‘‘(B) inhibits the effects of opioids on 

4 opioid receptors. 

5 ‘‘(2) STANDING ORDER.—The term ‘standing 

6 order’ means a document prepared by a person au7 thorized to prescribe medication that permits an8 other person to acquire, dispense, or administer 

9 medication without a person-specific prescription. 

10 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.— 

11 ‘‘(1) IN GENERAL.—To carry out this section, 

12 there is authorized to be appropriated $5,000,000 

13 for the period of fiscal years 2017 through 2019. 

14 ‘‘(2) ADMINISTRATIVE COSTS.—Not more than 

15 3 percent of the amounts made available to carry 

16 out this section may be used by the Secretary for 

17 administrative expenses of carrying out this sec18 tion.’’. 

19 (b) CUT-GO COMPLIANCE.—Subsection (f) of section 

20 319D of the Public Health Service Act (42 U.S.C. 247d– 

21 4) is amended by inserting before the period at the end 

22 the following: ‘‘(except such dollar amount shall be re23 duced by $5,000,000 for fiscal year 2017)’’. 


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1 SEC. 110. OPIOID REVIEW MODERNIZATION. 

2 (a) FDA OPIOID ACTION PLAN.—Chapter V of the 

3 Federal Food, Drug, and Cosmetic Act is amended by in4 serting after section 569 of such Act (21 U.S.C. 350bbb– 

5 8) the following: 

6 ‘‘SEC. 569–1. OPIOID ACTION PLAN. 

7 ‘‘(a) NEW DRUG APPLICATION.— 

8 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

9 prior to the approval pursuant to an application 

10 under section 505(b) of a new drug that is an opioid 

11 and does not have abuse-deterrent properties, the 

12 Secretary shall refer the application to an advisory 

13 committee of the Food and Drug Administration to 

14 seek recommendations from such advisory com15 mittee. 

16 ‘‘(2) PUBLIC HEALTH EXEMPTION.—A referral 

17 to an advisory committee under paragraph (1) is not 

18 required with respect to a new drug if the Sec19 retary— 

20 ‘‘(A) finds that such a referral is not in 

21 the interest of protecting and promoting public 

22 health; 

23 ‘‘(B) finds that such a referral is not nec24 essary based on a review of the relevant sci25 entific information; and 


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1 ‘‘(C) submits a notice containing the ra2 tionale for such findings to the Committee on 

3 Health, Education, Labor, and Pensions of the 

4 Senate and the Committee on Energy and Com5 merce of the House of Representatives. 

6 ‘‘(b) PEDIATRIC OPIOID LABELING.—The Secretary 

7 shall convene the Pediatric Advisory Committee of the 

8 Food and Drug Administration to seek recommendations 

9 from such Committee regarding a framework for the inclu10 sion of information in the labeling of drugs that are 

11 opioids relating to the use of such drugs in pediatric popu12 lations before the Secretary approves any labeling or 

13 change to labeling for any drug that is an opioid intended 

14 for use in a pediatric population. 

15 ‘‘(c) SUNSET.—The requirements of subsections (a) 

16 and (b) shall cease to be effective on October 1, 2022.’’. 

17 (b) PRESCRIBER EDUCATION.—Not later than 1 year 

18 after the date of the enactment of this Act, the Secretary 

19 of Health and Human Services, acting through the Com20 missioner of Food and Drugs, as part of the Food and 

21 Drug Administration’s evaluation of the Extended-Re22 lease/Long-Acting Opioid Analgesics Risk Evaluation and 

23 Mitigation Strategy, and in consultation with relevant 

24 stakeholders, shall develop recommendations regarding 

25 education programs for prescribers of opioids pursuant to 


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1 section 505–1 of the Federal Food, Drug, and Cosmetic 

2 Act (21 U.S.C. 355–1), including recommendations on— 

3 (1) which prescribers should participate in such 

4 programs; and 

5 (2) how often participation in such programs is 

6 necessary. 

7 (c) GUIDANCE ON EVALUATING THE ABUSE DETER8 RENCE OF GENERIC SOLID ORAL OPIOID DRUG PROD9 UCTS.—Not later than 2 years after the end of the period 

10 for public comment on the draft guidance entitled ‘‘Gen11 eral Principals for Evaluating the Abuse Deterrence of Ge12 neric Solid Oral Opioid Drug Products’’ issued by the 

13 Center for Drug Evaluation and Research of the Food and 

14 Drug Administration in March 2016, the Commissioner 

15 of Food and Drugs shall publish in the Federal Register 

16 a final version of such guidance. 

17 SEC. 111. STUDY ON TREATMENT INFRASTRUCTURE. 

18 Not later than 24 months after the date of enactment 

19 of this Act, the Comptroller General of the United States 

20 shall initiate an evaluation, and submit to Congress a re21 port, of the inpatient and outpatient treatment capacity, 

22 availability, and needs of the United States, which shall 

23 include, to the extent data are available— 

24 (1) the capacity of acute residential or inpatient 

25 detoxification programs; 


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1 (2) the capacity of inpatient clinical stabiliza2 tion programs, transitional residential support serv3 ices, and residential rehabilitation programs; 

4 (3) the capacity of demographic specific resi5 dential or inpatient treatment programs, such as 

6 those designed for pregnant women or adolescents; 

7 (4) geographical differences of the availability 

8 of residential and outpatient treatment and recovery 

9 options for substance use disorders across the con10 tinuum of care; 

11 (5) the availability of residential and outpatient 

12 treatment programs that offer treatment options 

13 based on reliable scientific evidence of efficacy for 

14 the treatment of substance use disorders, including 

15 the use of Food and Drug Administration-approved 

16 medicines and evidence-based nonpharmacological 

17 therapies; 

18 (6) the number of patients in residential and 

19 specialty outpatient treatment services for substance 

20 use disorders; 

21 (7) an assessment of the need for residential 

22 and outpatient treatment for substance use disorders 

23 across the continuum of care; 

24 (8) the availability of residential and outpatient 

25 treatment programs to American Indians and Alaska 


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1 Natives through an Indian health program (as de2 fined by section 4 of the Indian Health Care Im3 provement Act (25 U.S.C. 1603)); and 

4 (9) the barriers (including technological bar5 riers) at the Federal, State, and local levels to real6 time reporting of de-identified information on drug 

7 overdoses and ways to overcome such barriers. 

8 SEC. 112. NATIONAL YOUTH RECOVERY INITIATIVE. 

9 Part II of title I of the Omnibus Crime Control and 

10 Safe Streets Act of 1968 (42 U.S.C. 3797cc et seq.) is 

11 amended by adding at the end the following: 

12 ‘‘SEC. 2999A. NATIONAL YOUTH RECOVERY INITIATIVE. 

13 ‘‘(a) DEFINITIONS.—In this section: 

14 ‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible en15 tity’ means— 

16 ‘‘(A) a high school that has been accred17 ited as a recovery high school by the Associa18 tion of Recovery Schools; 

19 ‘‘(B) an accredited high school that is 

20 seeking to establish or expand recovery support 

21 services; 

22 ‘‘(C) an institution of higher education; 

23 ‘‘(D) a recovery program at a nonprofit 

24 collegiate institution; or 

25 ‘‘(E) a nonprofit organization. 


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1 ‘‘(2) INSTITUTION OF HIGHER EDUCATION.— 

2 The term ‘institution of higher education’ has the 

3 meaning given the term in section 101 of the Higher 

4 Education Act of 1965 (20 U.S.C. 1001). 

5 ‘‘(3) RECOVERY PROGRAM.—The term ‘recovery 

6 program’— 

7 ‘‘(A) means a program to help individuals 

8 who are recovering from substance use dis9 orders to initiate, stabilize, and maintain 

10 healthy and productive lives in the community; 

11 and 

12 ‘‘(B) includes peer-to-peer support and 

13 communal activities to build recovery skills and 

14 supportive social networks. 

15 ‘‘(b) GRANTS AUTHORIZED.—The Secretary of 

16 Health and Human Services, in coordination with the Sec17 retary of Education, may award grants to eligible entities 

18 to enable the entities to— 

19 ‘‘(1) provide substance use disorder recovery 

20 support services to young people in high school and 

21 enrolled in institutions of higher education; 

22 ‘‘(2) help build communities of support for 

23 young people in recovery through a spectrum of ac24 tivities such as counseling and health- and wellness25 oriented social activities; and 


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1 ‘‘(3) encourage initiatives designed to help 

2 young people achieve and sustain recovery from sub3 stance use disorders. 

4 ‘‘(c) USE OF FUNDS.—Grants awarded under sub5 section (b) may be used for activities to develop, support, 

6 and maintain youth recovery support services, including— 

7 ‘‘(1) the development and maintenance of a 

8 dedicated physical space for recovery programs; 

9 ‘‘(2) dedicated staff for the provision of recov10 ery programs; 

11 ‘‘(3) health- and wellness-oriented social activi12 ties and community engagement; 

13 ‘‘(4) establishment of recovery high schools; 

14 ‘‘(5) coordination of recovery programs with— 

15 ‘‘(A) substance use disorder treatment pro16 grams and systems; 

17 ‘‘(B) providers of mental health services; 

18 ‘‘(C) primary care providers and physi19 cians; 

20 ‘‘(D) the criminal justice system, including 

21 the juvenile justice system; 

22 ‘‘(E) employers; 

23 ‘‘(F) housing services; 

24 ‘‘(G) child welfare services; 


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1 ‘‘(H) high schools and institutions of high2 er education; and 

3 ‘‘(I) other programs or services related to 

4 the welfare of an individual in recovery from a 

5 substance use disorder; 

6 ‘‘(6) the development of peer-to-peer support 

7 programs or services; and 

8 ‘‘(7) additional activities that help youths and 

9 young adults to achieve recovery from substance use 

10 disorders. 

11 ‘‘(d) FUNDING.—There is authorized to be appro12 priated $5,000,000 to carry out this section for each of 

13 fiscal years 2017 through 2021, of which $5,000,000 shall 

14 be made available from amounts appropriated under sec15 tion 101(a) of the Opioid Use Disorder Treatment Expan16 sion and Modernization Act for fiscal year 2017, to remain 

17 available until expended.’’. 

18 SEC. 113. BUILDING COMMUNITIES OF RECOVERY. 

19 Part II of title I of the Omnibus Crime Control and 

20 Safe Streets Act of 1968 (42 U.S.C. 3797cc et seq.), as 

21 amended by section 113, is amended by adding at the end 

22 the following: 


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1 ‘‘SEC. 2999B. BUILDING COMMUNITIES OF RECOVERY. 

2 ‘‘(a) DEFINITION.—In this section, the term ‘recov3 ery community organization’ means an independent non4 profit organization that— 

5 ‘‘(1) mobilizes resources within and outside of 

6 the recovery community to increase the prevalence 

7 and quality of long-term recovery from substance 

8 use disorders; and 

9 ‘‘(2) is wholly or principally governed by people 

10 in recovery for substance use disorders who reflect 

11 the community served. 

12 ‘‘(b) GRANTS AUTHORIZED.—The Secretary of 

13 Health and Human Services may award grants to recovery 

14 community organizations to enable such organizations to 

15 develop, expand, and enhance recovery services. 

16 ‘‘(c) FEDERAL SHARE.—The Federal share of the 

17 costs of a program funded by a grant under this section 

18 may not exceed 50 percent. 

19 ‘‘(d) USE OF FUNDS.—Grants awarded under sub20 section (b)— 

21 ‘‘(1) shall be used to develop, expand, and en22 hance community and statewide recovery support 

23 services; and 

24 ‘‘(2) may be used to— 

25 ‘‘(A) advocate for individuals in recovery 

26 from substance use disorders; 


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1 ‘‘(B) build connections between recovery 

2 networks, between recovery community organi3 zations, and with other recovery support serv4 ices, including— 

5 ‘‘(i) substance use disorder treatment 

6 programs and systems; 

7 ‘‘(ii) providers of mental health serv8 ices; 

9 ‘‘(iii) primary care providers and phy10 sicians; 

11 ‘‘(iv) the criminal justice system; 

12 ‘‘(v) employers; 

13 ‘‘(vi) housing services; 

14 ‘‘(vii) child welfare agencies; and 

15 ‘‘(viii) other recovery support services 

16 that facilitate recovery from substance use 

17 disorders; 

18 ‘‘(C) reduce the stigma associated with 

19 substance use disorders; 

20 ‘‘(D) conduct public education and out21 reach on issues relating to substance use dis22 orders and recovery, including— 

23 ‘‘(i) how to identify the signs of addic24 tion; 


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1 ‘‘(ii) the resources that are available 

2 to individuals struggling with addiction 

3 and families who have a family member 

4 struggling with or being treated for addic5 tion, including programs that mentor and 

6 provide support services to children; 

7 ‘‘(iii) the resources that are available 

8 to help support individuals in recovery; and 

9 ‘‘(iv) information on the medical con10 sequences of substance use disorders, in11 cluding neonatal abstinence syndrome and 

12 potential infection with human immuno13 deficiency virus and viral hepatitis; and 

14 ‘‘(E) carry out other activities that 

15 strengthen the network of community support 

16 for individuals in recovery. 

17 ‘‘(e) FUNDING.—Of the amounts appropriated under 

18 section 101(a) of the Opioid Use Disorder Treatment Ex19 pansion and Modernization Act for fiscal year 2017, 

20 $25,000,000 shall be made available to carry out this sec21 tion, to remain available until expended’’. 


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1 TITLE II—COMPREHENSIVE 

2 OPIOID ABUSE REDUCTION 

3 SEC. 201. COMPREHENSIVE OPIOID ABUSE GRANT PRO4 GRAM. 

5 (a) IN GENERAL.—Title I of the Omnibus Crime 

6 Control and Safe Streets Act of 1968 (42 U.S.C. 3711 

7 et seq.) is amended by adding at the end the following: 

8 ‘‘PART LL—COMPREHENSIVE OPIOID ABUSE 

9 GRANT PROGRAM 

10 ‘‘SEC. 3021. DESCRIPTION. 

11 ‘‘(a) GRANTS AUTHORIZED.—From amounts made 

12 available to carry out this part, the Attorney General may 

13 make grants to States, units of local government, and In14 dian tribes, for use by the State, unit of local government, 

15 or Indian tribe to provide services primarily relating to 

16 opioid abuse, including for any one or more of the fol17 lowing: 

18 ‘‘(1) Developing, implementing, or expanding a 

19 treatment alternative to incarceration program, 

20 which may include— 

21 ‘‘(A) pre-booking or post-booking compo22 nents, which may include the activities de23 scribed in part HH of this title; 

24 ‘‘(B) training for criminal justice agency 

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1 curring mental illness and substance use dis2 orders; 

3 ‘‘(C) a mental health court, including the 

4 activities described in part V of this title; 

5 ‘‘(D) a drug court, including the activities 

6 described in part EE of this title; and 

7 ‘‘(E) a veterans treatment court program, 

8 including the activities described in subsection 

9 (i) of section 2991 of this title. 

10 ‘‘(2) In the case of a State, facilitating or en11 hancing planning and collaboration between State 

12 criminal justice agencies and State substance abuse 

13 systems in order to more efficiently and effectively 

14 carry out programs described in paragraph (1) that 

15 address problems related to opioid abuse. 

16 ‘‘(3) Providing training and resources for first 

17 responders on carrying and administering an opioid 

18 overdose reversal drug or device approved by the 

19 Food and Drug Administration, and purchasing 

20 such a drug or device for first responders who have 

21 received such training to carry and administer. 

22 ‘‘(4) Investigative purposes to locate or inves23 tigate illicit activities related to the unlawful dis24 tribution of opioids. 


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1 ‘‘(5) Developing, implementing, or expanding a 

2 medication-assisted treatment program used or oper3 ated by a criminal justice agency, which may include 

4 training criminal justice agency personnel on medi5 cation-assisted treatment, and carrying out the ac6 tivities described in part S of this title. 

7 ‘‘(6) In the case of a State, developing, imple8 menting, or expanding a prescription drug moni9 toring program to collect and analyze data related to 

10 the prescribing of schedule II, III, and IV controlled 

11 substances through a centralized database adminis12 tered by an authorized State agency, which includes 

13 tracking the dispensation of such substances, and 

14 providing for data sharing with other States. 

15 ‘‘(7) Developing, implementing, or expanding a 

16 program to prevent and address opioid abuse by ju17 veniles. 

18 ‘‘(8) Developing, implementing, or expanding an 

19 integrated and comprehensive opioid abuse response 

20 program. 

21 ‘‘(b) CONTRACTS AND SUBAWARDS.—A State, unit of 

22 local government, or Indian tribe may, in using a grant 

23 under this subpart for purposes authorized by subsection 

24 (a), use all or a portion of that grant to contract with 

25 or make one or more subawards to one or more— 


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1 ‘‘(1) local or regional organizations that are pri2 vate and nonprofit, including faith-based organiza3 tions; 

4 ‘‘(2) units of local government; or 

5 ‘‘(3) tribal organizations. 

6 ‘‘(c) PROGRAM ASSESSMENT COMPONENT; WAIV7 ER.— 

8 ‘‘(1) PROGRAM ASSESSMENT COMPONENT.— 

9 Each program funded under this subpart shall con10 tain a program assessment component, developed 

11 pursuant to guidelines established by the Attorney 

12 General, in coordination with the National Institute 

13 of Justice. 

14 ‘‘(2) WAIVER.—The Attorney General may 

15 waive the requirement of paragraph (1) with respect 

16 to a program if, in the opinion of the Attorney Gen17 eral, the program is not of sufficient size to justify 

18 a full program assessment. 

19 ‘‘(d) ADMINISTRATIVE COSTS.—Not more than 10 

20 percent of a grant made under this subpart may be used 

21 for costs incurred to administer such grant. 

22 ‘‘(e) PERIOD.—The period of a grant made under 

23 this part may not be longer than 4 years, except that re24 newals and extensions beyond that period may be granted 

25 at the discretion of the Attorney General. 


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1 ‘‘SEC. 3022. APPLICATIONS. 

2 ‘‘To request a grant under this part, the chief execu3 tive officer of a State, unit of local government, or Indian 

4 tribe shall submit an application to the Attorney General 

5 at such time and in such form as the Attorney General 

6 may require. Such application shall include the following: 

7 ‘‘(1) A certification that Federal funds made 

8 available under this subpart will not be used to sup9 plant State, local, or tribal funds, but will be used 

10 to increase the amounts of such funds that would, 

11 in the absence of Federal funds, be made available 

12 for the activities described in section 3021(a). 

13 ‘‘(2) An assurance that, for each fiscal year 

14 covered by an application, the applicant shall main15 tain and report such data, records, and information 

16 (programmatic and financial) as the Attorney Gen17 eral may reasonably require. 

18 ‘‘(3) A certification, made in a form acceptable 

19 to the Attorney General and executed by the chief 

20 executive officer of the applicant (or by another offi21 cer of the applicant, if qualified under regulations 

22 promulgated by the Attorney General), that— 

23 ‘‘(A) the programs to be funded by the 

24 grant meet all the requirements of this part; 

25 ‘‘(B) all the information contained in the 

26 application is correct; 


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1 ‘‘(C) there has been appropriate coordina2 tion with affected agencies; and 

3 ‘‘(D) the applicant will comply with all 

4 provisions of this part and all other applicable 

5 Federal laws. 

6 ‘‘(4) An assurance that the applicant will work 

7 with the Drug Enforcement Administration to de8 velop an integrated and comprehensive strategy to 

9 address opioid abuse. 

10 ‘‘SEC. 3023. REVIEW OF APPLICATIONS. 

11 ‘‘The Attorney General shall not finally disapprove 

12 any application (or any amendment to that application) 

13 submitted under this part without first affording the ap14 plicant reasonable notice of any deficiencies in the applica15 tion and opportunity for correction and reconsideration. 

16 ‘‘SEC. 3024. GEOGRAPHIC DIVERSITY. 

17 ‘‘The Attorney General shall ensure equitable geo18 graphic distribution of grants under this part and take 

19 into consideration the needs of underserved populations, 

20 including rural and tribal communities. 

21 ‘‘SEC. 3025. DEFINITIONS. 

22 ‘‘In this part: 

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1 ing an employee of a legally organized and recog2 nized volunteer organization, whether compensated 

3 or not), who, in the course of professional duties, re4 sponds to fire, medical, hazardous material, or other 

5 similar emergencies. 

6 ‘‘(2) The term ‘medication-assisted treatment’ 

7 means the use of medications approved by the Food 

8 and Drug Administration for the treatment of opioid 

9 abuse. 

10 ‘‘(3) The term ‘opioid’ means any drug, includ11 ing heroin, having an addiction-forming or addiction12 sustaining liability similar to morphine or being ca13 pable of conversion into a drug having such addic14 tion-forming or addiction-sustaining liability. 

15 ‘‘(4) The term ‘schedule II, III, or IV controlled 

16 substance’ means a controlled substance that is list17 ed on schedule II, schedule III, or schedule IV of 

18 section 202(c) of the Controlled Substances Act (21 

19 U.S.C. 812(c)). 

20 ‘‘(5) The terms ‘drug’ and ‘device’ have the 

21 meanings given those terms in section 201 of the 

22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

23 321). 

24 ‘‘(6) The term ‘criminal justice agency’ means 

25 a State, local, or tribal— 


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1 ‘‘(A) court; 

2 ‘‘(B) prison; 

3 ‘‘(C) jail; 

4 ‘‘(D) law enforcement agency; or 

5 ‘‘(E) other agency that performs the ad6 ministration of criminal justice, including pros7 ecution, pretrial services, and community super8 vision. 

9 ‘‘(7) The term ‘tribal organization’ has the 

10 meaning given that term in section 4 of the Indian 

11 Self-Determination and Education Assistance Act 

12 (25 U.S.C. 450b).’’. 

13 (b) FUNDING.—There is authorized to be appro14 priated $65,000,000 to carry out this section, section 203, 

15 and section 204 (including the amendments made by such 

16 sections) for the period of fiscal years 2017 through 2021, 

17 of which $65,000,000 shall be made available from 

18 amounts appropriated under section 101(a) of the Opioid 

19 Use Disorder Treatment Expansion and Modernization 

20 Act for fiscal year 2017, to remain available until ex21 pended. 

22 SEC. 202. AUDIT AND ACCOUNTABILITY OF GRANTEES. 

23 (a) DEFINITIONS.—In this section— 


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1 (1) the term ‘‘covered grant program’’ means a 

2 grant program operated by the Department of Jus3 tice; 

4 (2) the term ‘‘covered grantee’’ means a recipi5 ent of a grant from a covered grant program; 

6 (3) the term ‘‘nonprofit’’, when used with re7 spect to an organization, means an organization that 

8 is described in section 501(c)(3) of the Internal Rev9 enue Code of 1986, and is exempt from taxation 

10 under section 501(a) of such Code; and 

11 (4) the term ‘‘unresolved audit finding’’ means 

12 an audit report finding in a final audit report of the 

13 Inspector General of the Department of Justice that 

14 a covered grantee has used grant funds awarded to 

15 that grantee under a covered grant program for an 

16 unauthorized expenditure or otherwise unallowable 

17 cost that is not closed or resolved during a 12-month 

18 period prior to the date on which the final audit re19 port is issued. 

20 (b) AUDIT REQUIREMENT.—Beginning in fiscal year 

21 2016, and annually thereafter, the Inspector General of 

22 the Department of Justice shall conduct audits of covered 

23 grantees to prevent waste, fraud, and abuse of funds 

24 awarded under covered grant programs. The Inspector 


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1 General shall determine the appropriate number of cov2 ered grantees to be audited each year. 

3 (c) MANDATORY EXCLUSION.—A grantee that is 

4 found to have an unresolved audit finding under an audit 

5 conducted under subsection (b) may not receive grant 

6 funds under a covered grant program in the fiscal year 

7 following the fiscal year to which the finding relates. 

8 (d) REIMBURSEMENT.—If a covered grantee is 

9 awarded funds under the covered grant program from 

10 which it received a grant award during the 1-fiscal-year 

11 period during which the covered grantee is ineligible for 

12 an allocation of grant funds under subsection (c), the At13 torney General shall— 

14 (1) deposit into the General Fund of the Treas15 ury an amount that is equal to the amount of the 

16 grant funds that were improperly awarded to the 

17 covered grantee; and 

18 (2) seek to recoup the costs of the repayment 

19 to the Fund from the covered grantee that was im20 properly awarded the grant funds. 

21 (e) PRIORITY OF GRANT AWARDS.—The Attorney 

22 General, in awarding grants under a covered grant pro23 gram shall give priority to eligible entities that during the 

24 2-year period preceding the application for a grant have 

25 not been found to have an unresolved audit finding. 


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1 (f) NONPROFIT REQUIREMENTS.— 

2 (1) PROHIBITION.—A nonprofit organization 

3 that holds money in offshore accounts for the pur4 pose of avoiding the tax described in section 511(a) 

5 of the Internal Revenue Code of 1986, shall not be 

6 eligible to receive, directly or indirectly, any funds 

7 from a covered grant program. 

8 (2) DISCLOSURE.—Each nonprofit organization 

9 that is a covered grantee shall disclose in its applica10 tion for such a grant, as a condition of receipt of 

11 such a grant, the compensation of its officers, direc12 tors, and trustees. Such disclosure shall include a 

13 description of the criteria relied on to determine 

14 such compensation. 

15 SEC. 203. VETERANS TREATMENT COURTS. 

16 Section 2991 of the Omnibus Crime Control and Safe 

17 Streets Act of 1968 (42 U.S.C. 3797aa) is amended— 

18 (1) by redesignating subsection (i) as subsection 

19 (j); and 

20 (2) by inserting after subsection (h) the fol21 lowing: 

22 ‘‘(i) ASSISTING VETERANS.— 

23 ‘‘(1) DEFINITIONS.—In this subsection: 

24 ‘‘(A) PEER TO PEER SERVICES OR PRO25 GRAMS.—The term ‘peer to peer services or 


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1 programs’ means services or programs that con2 nect qualified veterans with other veterans for 

3 the purpose of providing support and 

4 mentorship to assist qualified veterans in ob5 taining treatment, recovery, stabilization, or re6 habilitation. 

7 ‘‘(B) QUALIFIED VETERAN.—The term 

8 ‘qualified veteran’ means a preliminarily quali9 fied offender who— 

10 ‘‘(i) served on active duty in any 

11 branch of the Armed Forces, including the 

12 National Guard or Reserves; and 

13 ‘‘(ii) was discharged or released from 

14 such service under conditions other than 

15 dishonorable. 

16 ‘‘(C) VETERANS TREATMENT COURT PRO17 GRAM.—The term ‘veterans treatment court 

18 program’ means a court program involving col19 laboration among criminal justice, veterans, and 

20 mental health and substance abuse agencies 

21 that provides qualified veterans with— 

22 ‘‘(i) intensive judicial supervision and 

23 case management, which may include ran24 dom and frequent drug testing where ap25 propriate; 


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1 ‘‘(ii) a full continuum of treatment 

2 services, including mental health services, 

3 substance abuse services, medical services, 

4 and services to address trauma; 

5 ‘‘(iii) alternatives to incarceration; or 

6 ‘‘(iv) other appropriate services, in7 cluding housing, transportation, mentoring, 

8 employment, job training, education, or as9 sistance in applying for and obtaining 

10 available benefits. 

11 ‘‘(2) VETERANS ASSISTANCE PROGRAM.— 

12 ‘‘(A) IN GENERAL.—The Attorney General, 

13 in consultation with the Secretary of Veterans 

14 Affairs, may award grants under this sub15 section to applicants to establish or expand— 

16 ‘‘(i) veterans treatment court pro17 grams; 

18 ‘‘(ii) peer to peer services or programs 

19 for qualified veterans; 

20 ‘‘(iii) practices that identify and pro21 vide treatment, rehabilitation, legal, transi22 tional, and other appropriate services to 

23 qualified veterans who have been incarcer24 ated; or 


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1 ‘‘(iv) training programs to teach 

2 criminal justice, law enforcement, correc3 tions, mental health, and substance abuse 

4 personnel how to identify and appro5 priately respond to incidents involving 

6 qualified veterans. 

7 ‘‘(B) PRIORITY.—In awarding grants 

8 under this subsection, the Attorney General 

9 shall give priority to applications that— 

10 ‘‘(i) demonstrate collaboration be11 tween and joint investments by criminal 

12 justice, mental health, substance abuse, 

13 and veterans service agencies; 

14 ‘‘(ii) promote effective strategies to 

15 identify and reduce the risk of harm to 

16 qualified veterans and public safety; and 

17 ‘‘(iii) propose interventions with em18 pirical support to improve outcomes for 

19 qualified veterans.’’. 

20 SEC. 204. EMERGENCY FEDERAL LAW ENFORCEMENT AS21 SISTANCE. 

22 Section 609Y(a) of the Justice Assistance Act of 

23 1984 (42 U.S.C. 10513(a)) is amended by striking ‘‘Sep24 tember 30, 1984’’ and inserting ‘‘September 30, 2021’’. 


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1 SEC. 205. OPIOID PROGRAM EVALUATION ACT. 

2 (a) SHORT TITLE.—This section may be cited as the 

3 ‘‘Opioid Program Evaluation Act’’ or the ‘‘OPEN Act’’. 

4 (b) EVALUATION OF PERFORMANCE OF DEPART5 MENT OF JUSTICE PROGRAM.— 

6 (1) EVALUATION OF JUSTICE DEPARTMENT

7 COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM.— 

8 Not later than 5 years after the date of enactment 

9 of this Act, the Attorney General shall complete an 

10 evaluation of the effectiveness of the Comprehensive 

11 Opioid Abuse Grant Program under part LL of the 

12 Omnibus Crime Control and Safe Streets Act of 

13 1968 administered by the Department of Justice 

14 based upon the information reported under para15 graph (4) of this subsection. 

16 (2) INTERIM EVALUATION.—Not later than 3 

17 years after the date of enactment of this Act, the 

18 Attorney General shall complete an interim evalua19 tion assessing the nature and extent of the incidence 

20 of opioid abuse and illegal opioid distribution in the 

21 United States. 

22 (3) METRICS AND OUTCOMES FOR EVALUA23 TION.—Not later than 180 days after the date of en24 actment of this Act, the Attorney General shall iden25 tify outcomes that are to be achieved by activities 

26 funded by the Comprehensive Opioid Grant Abuse 


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1 Program and the metrics by which the achievement 

2 of such outcomes shall be determined. 

3 (4) METRICS DATA COLLECTION.—The Attor4 ney General shall require grantees under the Com5 prehensive Opioid Abuse Grant Program (and those 

6 receiving subawards under section 3021(b) of part 

7 LL of the Omnibus Crime Control and Safe Streets 

8 Act of 1968) to collect and annually report to the 

9 Department of Justice data based upon the metrics 

10 identified under paragraph (3). 

11 (5) PUBLICATION OF DATA AND FINDINGS.— 

12 (A) PUBLICATION OF OUTCOMES AND

13 METRICS.—The Attorney General shall, not 

14 later than 30 days after completion of the re15 quirement under paragraph (3), publish the 

16 outcomes and metrics identified under that 

17 paragraph. 

18 (B) PUBLICATION OF EVALUATION.—In 

19 the case of the interim evaluation under para20 graph (2), and the final evaluation under para21 graph (1), the Secretary shall arrange for an 

22 independent, external evaluator to, not later 

23 than 90 days after such an evaluation is com24 pleted, publish the results of such evaluation 

25 and issue a report on such evaluation to the 


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1 Committee on the Judiciary of the House of 

2 Representatives and the Committee on the Ju3 diciary of the Senate. Such report shall also be 

4 published along with the data used to make 

5 such evaluation. 

6 (6) ARRANGEMENT WITH THE NATIONAL ACAD7 EMY OF SCIENCES.—For purposes of paragraphs 

8 (1), (2), and (3), the Attorney General shall enter 

9 into an arrangement with the National Academy of 

10 Sciences. 

11 (c) EVALUATION OF PERFORMANCE OF DEPART12 MENT OF HEALTH AND HUMAN SERVICES PROGRAM.— 

13 (1) EVALUATION OF JUSTICE DEPARTMENT

14 COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM.— 

15 Not later than 5 years after the date of enactment 

16 of this Act, the Secretary of Health and Human 

17 Services shall complete an evaluation of any pro18 gram administered by the Secretary that provides 

19 grants for the primary purpose of providing assist20 ance in addressing problems pertaining to opioid 

21 abuse based upon the information reported under 

22 paragraph (4) of this subsection. 

23 (2) INTERIM EVALUATION.—Not later than 3 

24 years after the date of enactment of this Act, the 

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1 sessing the nature and extent of the incidence of 

2 opioid abuse and illegal opioid distribution in the 

3 United States. 

4 (3) METRICS AND OUTCOMES FOR EVALUA5 TION.—Not later than 180 days after the date of en6 actment of this Act, the Secretary shall identify out7 comes that are to be achieved by activities funded by 

8 the programs described in paragraph (1) and the 

9 metrics by which the achievement of such outcomes 

10 shall be determined. 

11 (4) METRICS DATA COLLECTION.—The Sec12 retary shall require grantees under the programs de13 scribed in paragraph (1) to collect and annually re14 port to the Department of Health and Human Serv15 ices data based upon the metrics identified under 

16 paragraph (3). 

17 (5) PUBLICATION OF DATA AND FINDINGS.— 

18 (A) PUBLICATION OF OUTCOMES AND

19 METRICS.—The Secretary shall, not later than 

20 30 days after completion of the requirement 

21 under paragraph (3), publish the outcomes and 

22 metrics identified under that paragraph. 

23 (B) PUBLICATION OF EVALUATION.—In 

24 the case of the interim evaluation under sub25 paragraph (B), and each final evaluation under 


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1 paragraph (1), the Secretary shall arrange for 

2 an independent, external evaluator to, not later 

3 than 90 days after such an evaluation is com4 pleted, publish the results of such evaluation 

5 and issue a report on such evaluation to the 

6 Committee on Energy and Commerce of the 

7 House of Representatives and the Committee 

8 on Health, Education, Labor, and Pensions of 

9 the Senate. Such report shall also be published 

10 along with the data used to make such evalua11 tion. 

12 (6) ARRANGEMENT WITH AN INDEPENDENT, 

13 EXTERNAL EVALUATOR.—For purposes of para14 graphs (1), (2), (3), and (5), the Secretary shall 

15 enter into an arrangement with an independent, ex16 ternal evaluator. 

17 (d) DEFINITION.—In this section, the term ‘‘opioid’’ 

18 has the meaning given the term ‘‘opiate’’ in section 102 

19 of the Controlled Substances Act (21 U.S.C. 802). 

20 (e) NO ADDITIONAL FUNDS AUTHORIZED.—No addi21 tional funds are authorized to be appropriated to carry 

22 out this Act. 

23 SEC. 206. GOOD SAMARITAN ASSESSMENT ACT. 

24 (a) GAO STUDY ON GOOD SAMARITAN LAWS PER25 TAINING TO TREATMENT OF OPIOID OVERDOSES.—The 


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1 Comptroller General of the United States shall submit to 

2 the Committee on the Judiciary of the House of Rep3 resentatives, the Committee on Oversight and Government 

4 Reform of the House of Representatives, the Committee 

5 on the Judiciary of the Senate, and the Committee on 

6 Homeland Security and Governmental Affairs of the Sen7 ate a report on— 

8 (1) the extent to which the Director of National 

9 Drug Control Policy has reviewed Good Samaritan 

10 laws, and any findings from such a review, including 

11 findings related to the potential effects of such laws, 

12 if available; 

13 (2) efforts by the Director to encourage the en14 actment of Good Samaritan laws; and 

15 (3) a compilation of Good Samaritan laws in ef16 fect in the States, the territories, and the District of 

17 Columbia. 

18 (b) DEFINITIONS.—In this section— 

19 (1) the term ‘‘Good Samaritan law’’ means a 

20 law of a State or unit of local government that ex21 empts from criminal or civil liability any individual 

22 who administers an opioid overdose reversal drug or 

23 device, or who contacts emergency services providers 

24 in response to an overdose; and 


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1 (2) the term ‘‘opioid’’ means any drug, includ2 ing heroin, having an addiction-forming or addiction3 sustaining liability similar to morphine or being ca4 pable of conversion into a drug having such addic5 tion-forming or addiction-sustaining liability. 

6 TITLE III—PROMOTING RESPON7 SIBLE OPIOID MANAGEMENT 

8 AND INCORPORATING SCI9 ENTIFIC EXPERTISE 

10 SEC. 301. SHORT TITLE. 

11 This title may be cited as the ‘‘Promoting Respon12 sible Opioid Management and Incorporating Scientific Ex13 pertise Act’’ or the ‘‘Jason Simcakoski PROMISE Act’’. 

14 Subtitle A—Opioid Therapy and 

15 Pain Management 

16 SEC. 311. GUIDELINES ON MANAGEMENT OF OPIOID THER17 APY BY DEPARTMENT OF VETERANS AFFAIRS 

18 AND DEPARTMENT OF DEFENSE AND IMPLE19 MENTATION OF SUCH GUIDELINES BY DE20 PARTMENT OF VETERANS AFFAIRS. 

21 (a) IN GENERAL.—Not later than one year after the 

22 date of the enactment of this Act, the Secretary of Vet23 erans Affairs and the Secretary of Defense shall jointly 

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1 agement of Opioid Therapy for Chronic Pain to include 

2 the following: 

3 (1) In accordance with subsection (b), common 

4 recommended guidelines for safely prescribing 

5 opioids for the treatment of chronic, non-cancer pain 

6 in outpatient settings as compiled by the Director of 

7 the Centers for Disease Control and Prevention. 

8 (2) Enhanced guidance with respect to— 

9 (A) the administration of two or more 

10 drugs that may result in a life-limiting drug-to11 drug interaction, including benzodiazepines; 

12 (B) the treatment of patients with current 

13 acute psychiatric instability or substance use 

14 disorder or patients at risk of suicide; and 

15 (C) the use of opioid therapy to treat men16 tal health disorders other than opioid use dis17 order. 

18 (3) Enhanced guidance with respect to the 

19 treatment of patients with behaviors or 

20 comorbidities, such as post-traumatic stress dis21 order, psychiatric disorders, or a history of sub22 stance abuse or addiction, that requires a consulta23 tion or comanagement of opioid therapy with one or 

24 more specialists in pain management, mental health, 

25 or addictions. 


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1 (4) Enhanced guidance with respect to the con2 duct by health care providers of an effective assess3 ment for patients receiving opioid therapy, including 

4 patients on long-term opioid therapy, to determine— 

5 (A) whether opioid therapy is meeting the 

6 expected goals of the patient and health care 

7 provider of relieving pain, improving function, 

8 and providing patient satisfaction; and 

9 (B) whether opioid therapy should be con10 tinued. 

11 (5) Guidance that each health care provider of 

12 the Department of Veterans Affairs and the Depart13 ment of Defense, before initiating opioid therapy to 

14 treat a patient as part of the comprehensive assess15 ment conducted by the health care provider, use the 

16 Opioid Therapy Risk Report tool of the Department 

17 of Veterans Affairs (or successor tool), which shall 

18 include the ability to access the most recent patient 

19 information from the prescription drug monitoring 

20 program of each State that has such a program to 

21 assess the risk for adverse outcomes of opioid ther22 apy for the patient, including with respect to the 

23 concurrent use of controlled substances, including 

24 benzodiazepines. 


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1 (6) Guidelines to govern the methodologies used 

2 by health care providers of the Department of Vet3 erans Affairs and the Department of Defense to 

4 safely titrate and taper opioid therapy when adjust5 ing or discriminating the use of opioid therapy, in6 cluding with respect to— 

7 (A) prescription of the lowest effective dose 

8 based on patient need; 

9 (B) use of opioid only for a limited period 

10 of time; and 

11 (C) augmentation of opioid therapy with 

12 other pain management therapies and modali13 ties. 

14 (7) Guidelines with respect to appropriate case 

15 management for patients receiving opioid therapy 

16 who transition between inpatient and outpatient 

17 health care settings, which may include the use of 

18 care transition plans. 

19 (8) Guidelines with respect to appropriate 

20 transfer of case management responsibility for pa21 tients receiving opioid therapy who transition from 

22 receiving care furnished by the Secretary of Defense 

23 to receiving care furnished by other health care pro24 viders after the patient has been discharged or sepa25 rated from the Armed Forces. 


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1 (9) Enhanced standards with respect to the use 

2 of routine and random urine drug tests for all pa3 tients before and during opioid therapy to help pre4 vent substance abuse, dependence, and diversion, in5 cluding— 

6 (A) that such tests occur not less fre7 quently than once each year; and 

8 (B) that health care providers appro9 priately interpret and respond to the results 

10 from such tests to tailor pain therapy, safe11 guards, and risk management strategies to each 

12 patient. 

13 (10) Guidance that health care providers dis14 cuss with patients, before initiating opioid therapy, 

15 options for pain management therapies without the 

16 use of opioids and options to augment opioid therapy 

17 with other clinical and complementary and integra18 tive health services to minimize opioid dependence. 

19 (b) TREATMENT OF CERTAIN GUIDELINES DEVEL20 OPED AFTER DEADLINE.—If the Director of the Centers 

21 for Disease Control and Prevention issues the guidelines 

22 described in paragraph (1) of subsection (a) after the date 

23 on which the Secretary of Veterans Affairs and the Sec24 retary of Defense jointly update the VA/DOD Clinical 

25 Practice Guideline for Management of Opioid Therapy for 


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1 Chronic Pain pursuant to such subsection, the Secretaries 

2 shall jointly modify the VA/DOD Clinical Practice Guide3 line for Management of Opioid Therapy for Chronic Pain 

4 to incorporate such guidelines of the Director. 

5 (c) CONSULTATION BEFORE UPDATE.—Before up6 dating the guideline under subsection (a), the Secretary 

7 of Veterans Affairs and the Secretary of Defense shall 

8 jointly consult with the Pain Management Working Group 

9 of the Department of Veterans Affairs–Department of De10 fense Joint Executive Committee established by section 

11 320 of title 38, United States Code. 

12 (d) DEFINITIONS.—In this section: 

13 (1) The term ‘‘controlled substance’’ has the 

14 meaning given that term in section 102 of the Con15 trolled Substances Act (21 U.S.C. 802). 

16 (2) The term ‘‘State’’ means each of the several 

17 States, territories, and possessions of the United 

18 States, the District of Columbia, and the Common19 wealth of Puerto Rico. 

20 SEC. 312. IMPROVEMENT OF OPIOID SAFETY MEASURES BY 

21 DEPARTMENT OF VETERANS AFFAIRS. 

22 (a) EXPANSION OF OPIOID SAFETY INITIATIVE.— 

23 Not later than 180 days after the date of the enactment 

24 of this Act, the Secretary of Veterans Affairs shall expand 


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1 the Opioid Safety Initiative of the Department of Veterans 

2 Affairs to include all medical facilities of the Department. 

3 (b) PAIN MANAGEMENT EDUCATION AND TRAIN4 ING.— 

5 (1) IN GENERAL.—In carrying out the Opioid 

6 Safety Initiative of the Department, the Secretary 

7 shall require all employees of the Department re8 sponsible for prescribing opioids to receive education 

9 and training described in paragraph (2). 

10 (2) EDUCATION AND TRAINING.—Education 

11 and training described in this paragraph is edu12 cation and training on pain management and safe 

13 opioid prescribing practices for purposes of safely 

14 and effectively managing patients with chronic pain, 

15 including education and training on the following: 

16 (A) The implementation of and full compli17 ance with the VA/DOD Clinical Practice Guide18 line for Management of Opioid Therapy for 

19 Chronic Pain, including any update to such 

20 guideline. 

21 (B) The use of evidence-based pain man22 agement therapies, including cognitive-behav23 ioral therapy, non-opioid alternatives, and non24 drug methods and procedures to managing pain 


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1 and related health conditions including com2 plementary alternative medicines. 

3 (C) Screening and identification of patients 

4 with substance use disorder, including drug5 seeking behavior, before prescribing opioids, as6 sessment of risk potential for patients devel7 oping an addiction, and referral of patients to 

8 appropriate addiction treatment professionals if 

9 addiction is identified or strongly suspected. 

10 (D) Communication with patients on the 

11 potential harm associated with the use of 

12 opioids and other controlled substances, includ13 ing the need to safely store and dispose of sup14 plies relating to the use of opioids and other 

15 controlled substances. 

16 (E) Such other education and training as 

17 the Secretary considers appropriate to ensure 

18 that veterans receive safe and high-quality pain 

19 management care from the Department. 

20 (3) USE OF EXISTING PROGRAM.—In providing 

21 education and training described in paragraph (2), 

22 the Secretary shall use the Interdisciplinary Chronic 

23 Pain Management Training Team Program of the 

24 Department (or success program). 

25 (c) PAIN MANAGEMENT TEAMS.— 


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1 (1) IN GENERAL.—In carrying out the Opioid 

2 Safety Initiative of the Department, the director of 

3 each medical facility of the Department shall iden4 tify and designate a pain management team of 

5 health care professionals, which may include board 

6 certified pain medicine specialists, responsible for co7 ordinating and overseeing pain management therapy 

8 at such facility for patients experiencing acute and 

9 chronic pain that is non-cancer related. 

10 (2) ESTABLISHMENT OF PROTOCOLS.— 

11 (A) IN GENERAL.—In consultation with 

12 the Directors of each Veterans Integrated Serv13 ice Network, the Secretary shall establish 

14 standard protocols for the designation of pain 

15 management teams at each medical facility 

16 within the Department. 

17 (B) CONSULTATION ON PRESCRIPTION OF

18 OPIOIDS.—Each protocol established under sub19 paragraph (A) shall ensure that any health care 

20 provider without expertise in prescribing anal21 gesics or who has not completed the education 

22 and training under subsection (b), including a 

23 mental health care provider, does not prescribe 

24 opioids to a patient unless that health care pro25 vider— 


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1 (i) consults with a health care pro2 vider with pain management expertise or 

3 who is on the pain management team of 

4 the medical facility; and 

5 (ii) refers the patient to the pain man6 agement team for any subsequent prescrip7 tions and related therapy. 

8 (3) REPORT.— 

9 (A) IN GENERAL.—Not later than one year 

10 after the date of enactment of this Act, the di11 rector of each medical facility of the Depart12 ment shall submit to the Under Secretary for 

13 Health and the director of the Veterans Inte14 grated Service Network in which the medical fa15 cility is located a report identifying the health 

16 care professionals that have been designated as 

17 members of the pain management team at the 

18 medical facility pursuant to paragraph (1). 

19 (B) ELEMENTS.—Each report submitted 

20 under subparagraph (A) with respect to a med21 ical facility of the Department shall include— 

22 (i) a certification as to whether all 

23 members of the pain management team at 

24 the medical facility have completed the 


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1 education and training required under sub2 section (b); and 

3 (ii) a plan for the management and 

4 referral of patients to such pain manage5 ment team if health care providers without 

6 expertise in prescribing analgesics pre7 scribe opioid medications to treat acute 

8 and chronic pain that is non-cancer re9 lated. 

10 (d) TRACKING AND MONITORING OF OPIOID USE.— 

11 (1) PRESCRIPTION DRUG MONITORING PRO12 GRAMS OF STATES.—In carrying out the Opioid 

13 Safety Initiative and the Opioid Therapy Risk Re14 port tool of the Department, the Secretary shall— 

15 (A) ensure access by health care providers 

16 of the Department to information on controlled 

17 substances, including opioids and 

18 benzodiazepines, prescribed to veterans who re19 ceive care outside the Department through the 

20 prescription drug monitoring program of each 

21 State with such a program, including by seek22 ing to enter into memoranda of understanding 

23 with States to allow shared access of such infor24 mation between States and the Department; 


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1 (B) include such information in the Opioid 

2 Therapy Risk Report; and 

3 (C) require health care providers of the 

4 Department to submit to the prescription drug 

5 monitoring program of each State information 

6 on prescriptions of controlled substances re7 ceived by veterans in that State under the laws 

8 administered by the Secretary. 

9 (2) REPORT ON TRACKING OF DATA ON OPIOID

10 USE.—Not later than 18 months after the date of 

11 the enactment of this Act, the Secretary shall submit 

12 to the Committee on Veterans’ Affairs of the Senate 

13 and the Committee on Veterans’ Affairs of the 

14 House of Representatives a report on the feasibility 

15 and advisability of improving the Opioid Therapy 

16 Risk Report tool of the Department to allow for 

17 more advanced real-time tracking of and access to 

18 data on— 

19 (A) the key clinical indicators with respect 

20 to the totality of opioid use by veterans; 

21 (B) concurrent prescribing by health care 

22 providers of the Department of opioids in dif23 ferent health care settings, including data on 

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1 tal health disorders other than opioid use dis2 order; and 

3 (C) mail-order prescriptions of opioid pre4 scribed to veterans under the laws administered 

5 by the Secretary. 

6 (e) AVAILABILITY OF OPIOID RECEPTOR ANTAGO7 NISTS.— 

8 (1) INCREASED AVAILABILITY AND USE.— 

9 (A) IN GENERAL.—The Secretary shall 

10 maximize the availability of opioid receptor an11 tagonists approved by the Food and Drug Ad12 ministration, including naloxone, to veterans. 

13 (B) AVAILABILITY, TRAINING, AND DIS14 TRIBUTING.—In carrying out subparagraph 

15 (A), not later than 90 days after the date of the 

16 enactment of this Act, the Secretary shall— 

17 (i) equip each pharmacy of the De18 partment with opioid receptor antagonists 

19 approved by the Food and Drug Adminis20 tration to be dispensed to outpatients as 

21 needed; and 

22 (ii) expand the Overdose Education 

23 and Naloxone Distribution program of the 

24 Department to ensure that all veterans in 

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1 tered by the Secretary who are at risk of 

2 opioid overdose may access such opioid re3 ceptor antagonists and training on the 

4 proper administration of such opioid recep5 tor antagonists. 

6 (C) VETERANS WHO ARE AT RISK.—For 

7 purposes of subparagraph (B), veterans who are 

8 at risk of opioid overdose include— 

9 (i) veterans receiving long-term opioid 

10 therapy; 

11 (ii) veterans receiving opioid therapy 

12 who have a history of substance use dis13 order or prior instances of overdose; and 

14 (iii) veterans who are at risk as deter15 mined by a health care provider who is 

16 treating the veteran. 

17 (2) REPORT.—Not later than 120 days after 

18 the date of the enactment of this Act, the Secretary 

19 shall submit to the Committee on Veterans’ Affairs 

20 of the Senate and the Committee on Veterans’ Af21 fairs of the House of Representatives a report on 

22 carrying out paragraph (1), including an assessment 

23 of any remaining steps to be carried out by the Sec24 retary to carry out such paragraph. 


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1 (f) INCLUSION OF CERTAIN INFORMATION AND CA2 PABILITIES IN OPIOID THERAPY RISK REPORT TOOL OF

3 THE DEPARTMENT.— 

4 (1) INFORMATION.—The Secretary shall include 

5 in the Opioid Therapy Risk Report tool of the De6 partment— 

7 (A) information on the most recent time 

8 the tool was accessed by a health care provider 

9 of the Department with respect to each veteran; 

10 and 

11 (B) information on the results of the most 

12 recent urine drug test for each veteran. 

13 (2) CAPABILITIES.—The Secretary shall include 

14 in the Opioid Therapy Risk Report tool the ability 

15 of the health care providers of the Department to 

16 determine whether a health care provider of the De17 partment prescribed opioids to a veteran without 

18 checking the information in the tool with respect to 

19 the veteran. 

20 (g) NOTIFICATIONS OF RISK IN COMPUTERIZED

21 HEALTH RECORD.—The Secretary shall modify the com22 puterized patient record system of the Department to en23 sure that any health care provider that accesses the record 

24 of a veteran, regardless of the reason the veteran seeks 


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1 care from the health care provider, will be immediately no2 tified whether the veteran— 

3 (1) is receiving opioid therapy and has a history 

4 of substance use disorder or prior instances of over5 dose; 

6 (2) has a history of opioid abuse; or 

7 (3) is at risk of becoming an opioid abuser as 

8 determined by a health care provider who is treating 

9 the veteran. 

10 (h) DEFINITIONS.—In this section: 

11 (1) The term ‘‘controlled substance’’ has the 

12 meaning given that term in section 102 of the Con13 trolled Substances Act (21 U.S.C. 802). 

14 (2) The term ‘‘State’’ means each of the several 

15 States, territories, and possessions of the United 

16 States, the District of Columbia, and the Common17 wealth of Puerto Rico. 

18 SEC. 313. STRENGTHENING OF JOINT WORKING GROUP ON 

19 PAIN MANAGEMENT OF THE DEPARTMENT 

20 OF VETERANS AFFAIRS AND THE DEPART21 MENT OF DEFENSE. 

22 (a) IN GENERAL.—Not later than 90 days after the 

23 date of enactment of this Act, the Secretary of Veterans 

24 Affairs and the Secretary of Defense shall ensure that the 

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1 tive Committee of the Department of Veterans Affairs– 

2 Department of Defense Joint Executive Committee estab3 lished under section 320 of title 38, United States Code, 

4 includes a focus on the following: 

5 (1) The opioid prescribing practices of health 

6 care providers of each Department. 

7 (2) The ability of each Department to manage 

8 acute and chronic pain among individuals receiving 

9 health care from the Department, including training 

10 health care providers with respect to pain manage11 ment. 

12 (3) The use by each Department of complemen13 tary and integrative health and complementary alter14 native medicines in treating such individuals. 

15 (4) The concurrent use by health care providers 

16 of each Department of opioids and prescription 

17 drugs to treat mental health disorders, including 

18 benzodiazepines. 

19 (5) The practice by health care providers of 

20 each Department of prescribing opioids to treat 

21 mental health disorders. 

22 (6) The coordination in coverage of and con23 sistent access to medications prescribed for patients 

24 transitioning from receiving health care from the 


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1 Department of Defense to receiving health care from 

2 the Department of Veterans Affairs. 

3 (7) The ability of each Department to identify 

4 and treat substance use disorders among individuals 

5 receiving health care from that Department. 

6 (b) COORDINATION AND CONSULTATION.—The Sec7 retary of Veterans Affairs and the Secretary of Defense 

8 shall ensure that the working group described in sub9 section (a)— 

10 (1) coordinates the activities of the working 

11 group with other relevant working groups estab12 lished under section 320 of title 38, United States 

13 Code, including the working groups on evidence14 based practice, patient safety, pharmacy, psycho15 logical health, and psychological health; 

16 (2) consults with other relevant Federal agen17 cies, including the Centers for Disease Control and 

18 Prevention, with respect to the activities of the 

19 working group; and 

20 (3) consults with the Department of Veterans 

21 Affairs and the Department of Defense with respect 

22 to, reviews, and comments on the VA/DOD Clinical 

23 Practice Guideline for Management of Opioid Ther24 apy for Chronic Pain, or any successor guideline, be25 fore any update to the guideline is released. 


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1 (c) CONSULTATIONS.—The Secretary of Veterans Af2 fairs and the Secretary of Defense shall ensure that the 

3 working group described in subsection (a) is able to mean4 ingfully consult with respect to the updated guideline re5 quired under subsection (a) of section 311, as required 

6 by subsection (b) of such section, not later than 1 year 

7 after the date of enactment of this Act. 

8 SEC. 314. REVIEW, INVESTIGATION, AND REPORT ON USE 

9 OF OPIOIDS IN TREATMENT BY DEPARTMENT 

10 OF VETERANS AFFAIRS. 

11 (a) COMPTROLLER GENERAL REPORT.— 

12 (1) IN GENERAL.—Not later than two years 

13 after the date of the enactment of this Act, the 

14 Comptroller General of the United States shall sub15 mit to the Committee on Veterans’ Affairs of the 

16 Senate and the Committee on Veterans’ Affairs of 

17 the House of Representatives a report on the Opioid 

18 Safety Initiative of the Department of Veterans Af19 fairs and the opioid prescribing practices of health 

20 care providers of the Department. 

21 (2) ELEMENTS.—The report submitted under 

22 paragraph (1) shall include the following: 

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1 partment as the Comptroller General considers 

2 appropriate. 

3 (B) Information with respect to— 

4 (i) deaths resulting from sentinel 

5 events involving veterans prescribed opioids 

6 by a health care provider of the Depart7 ment; 

8 (ii) overall prescription rates and pre9 scriptions indications of opioids to treat 

10 non-cancer, non-palliative, and non-hospice 

11 care patients; 

12 (iii) the prescription rates and pre13 scriptions indications of benzodiazepines 

14 and opioids concomitantly by health care 

15 providers of the Department; 

16 (iv) the practice by health care pro17 viders of the Department of prescribing 

18 opioids to treat patients without any pain, 

19 including to treat patients with mental 

20 health disorders other than opioid use dis21 order; and 

22 (v) the effectiveness of opioid therapy 

23 for patients receiving such therapy, includ24 ing the effectiveness of long-term opioid 

25 therapy. 


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1 (C) An evaluation of processes of the De2 partment in place to oversee opioid use among 

3 veterans, including procedures to identify and 

4 remedy potential over-prescribing of opioids by 

5 health care providers of the Department. 

6 (D) An assessment of the implementation 

7 by the Secretary of the VA/DOD Clinical Prac8 tice Guideline for Management of Opioid Ther9 apy for Chronic Pain. 

10 (b) QUARTERLY PROGRESS REPORT ON IMPLEMEN11 TATION OF COMPTROLLER GENERAL RECOMMENDA12 TIONS.—Not later than two years after the date of the 

13 enactment of this Act, and not later than 30 days after 

14 the end of each quarter thereafter, the Secretary of Vet15 erans Affairs shall submit to the Committee on Veterans’ 

16 Affairs of the Senate and the Committee on Veterans’ Af17 fairs of the House of Representatives a progress report 

18 detailing the actions by the Secretary during the period 

19 covered by the report to address any outstanding findings 

20 and recommendations by the Comptroller General of the 

21 United States under subsection (a) with respect to the 

22 Veterans Health Administration. 

23 (c) ANNUAL REVIEW OF PRESCRIPTION RATES.— 

24 Not later than one year after the date of the enactment 

25 of this Act, and not less frequently than annually for the 


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1 following five years, the Secretary shall submit to the 

2 Committee on Veterans’ Affairs of the Senate and the 

3 Committee on Veterans’ Affairs of the House of Rep4 resentatives a report, with respect to each medical facility 

5 of the Department of Veterans Affairs, to collect and re6 view information on opioids prescribed by health care pro7 viders at the facility to treat non-cancer, non-palliative, 

8 and non-hospice care patients that contains, for the one9 year period preceding the submission of the report, the 

10 following: 

11 (1) The number of patients and the percentage 

12 of the patient population of the Department who 

13 were prescribed benzodiazepines and opioids concur14 rently by a health care provider of the Department. 

15 (2) The number of patients and the percentage 

16 of the patient population of the Department without 

17 any pain who were prescribed opioids by a health 

18 care provider of the Department, including those 

19 who were prescribed benzodiazepines and opioids 

20 concurrently. 

21 (3) The number of non-cancer, non-palliative, 

22 and non-hospice care patients and the percentage of 

23 such patients who were treated with opioids by a 

24 health care provider of the Department on an inpa25 tient-basis and who also received prescription opioids 


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1 by mail from the Department while being treated on 

2 an inpatient-basis. 

3 (4) The number of non-cancer, non-palliative, 

4 and non-hospice care patients and the percentage of 

5 such patients who were prescribed opioids concur6 rently by a health care provider of the Department 

7 and a health care provider that is not health care 

8 provider of the Department. 

9 (5) With respect to each medical facility of the 

10 Department, information on opioids prescribed by 

11 health care providers at the facility to treat non-can12 cer, non-palliative, and non-hospice care patients, in13 cluding information on— 

14 (A) the prescription rate at which each 

15 health care provider at the facility prescribed 

16 benzodiazepines and opioids concurrently to 

17 such patients and the aggregate such prescrip18 tion rate for all health care providers at the fa19 cility; 

20 (B) the prescription rate at which each 

21 health care provider at the facility prescribed 

22 benzodiazepines or opioids to such patients to 

23 treat conditions for which benzodiazepines or 

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1 gregate such prescription rate for all health 

2 care providers at the facility; 

3 (C) the prescription rate at which each 

4 health care provider at the facility prescribed or 

5 dispensed mail-order prescriptions of opioids to 

6 such patients while such patients were being 

7 treated with opioids on an inpatient-basis and 

8 the aggregate of such prescription rate for all 

9 health care providers at the facility; and 

10 (D) the prescription rate at which each 

11 health care provider at the facility prescribed 

12 opioids to such patients who were also concur13 rently prescribed opioids by a health care pro14 vider that is not a health care provider of the 

15 Department and the aggregate of such prescrip16 tion rates for all health care providers at the fa17 cility. 

18 (6) With respect to each medical facility of the 

19 Department, the number of times a pharmacist at 

20 the facility overrode a critical drug interaction warn21 ing with respect to an interaction between opioids 

22 and another medication before dispensing such medi23 cation to a veteran. 

24 (d) INVESTIGATION OF PRESCRIPTION RATES.—If 

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1 spect to a health care provider or medical facility of the 

2 Department conflicts with or is otherwise inconsistent 

3 with the standards of appropriate and safe care, the Sec4 retary shall— 

5 (1) immediately notify the Committee on Vet6 erans’ Affairs of the Senate and the Committee on 

7 Veterans’ Affairs of the House of Representatives of 

8 such determination, including information relating to 

9 such determination, prescription rate, and health 

10 care provider or medical facility, as the case may be; 

11 and 

12 (2) through the Office of the Medical Inspector 

13 of the Veterans Health Administration, conduct a 

14 full investigation of the health care provider or med15 ical facility, as the case may be. 

16 (e) PRESCRIPTION RATE DEFINED.—In this section, 

17 the term ‘‘prescription rate’’ means, with respect to a 

18 health care provider or medical facility of the Department, 

19 each of the following: 

20 (1) The number of patients treated with opioids 

21 by the health care provider or at the medical facility, 

22 as the case may be, divided by the total number of 

23 pharmacy users of that health care provider or med24 ical facility. 


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1 (2) The average number of morphine equiva2 lents per day prescribed by the health care provider 

3 or at the medical facility, as the case may be, to pa4 tients being treated with opioids. 

5 (3) Of the patients being treated with opioids 

6 by the health care provider or at the medical facility, 

7 as the case may be, the average number of prescrip8 tions of opioids per patient. 

9 Subtitle B—Patient Advocacy 

10 SEC. 321. COMMUNITY MEETINGS ON IMPROVING CARE 

11 FURNISHED BY DEPARTMENT OF VETERANS 

12 AFFAIRS. 

13 (a) COMMUNITY MEETINGS.— 

14 (1) MEDICAL CENTERS.—Not later than 90 

15 days after the date of the enactment of this Act, and 

16 not less frequently than once every 90 days there17 after, the Secretary shall ensure that each medical 

18 facility of the Department of Veterans Affairs hosts 

19 a community meeting open to the public on improv20 ing health care furnished by the Secretary. 

21 (2) COMMUNITY BASED OUTPATIENT CLIN22 ICS.—Not later than one year after the date of the 

23 enactment of this Act, and not less frequently than 

24 annually thereafter, the Secretary shall ensure that 

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1 partment hosts a community meeting open to the 

2 public on improving health care furnished by the 

3 Secretary. 

4 (b) ATTENDANCE BY DIRECTOR OF VETERANS INTE5 GRATED SERVICE NETWORK OR DESIGNEE.— 

6 (1) IN GENERAL.—Each community meeting 

7 hosted by a medical facility or community based out8 patient clinic under subsection (a) shall be attended 

9 by the Director of the Veterans Integrated Service 

10 Network in which the medical facility or community 

11 based outpatient clinic, as the case may be, is lo12 cated. Subject to paragraph (2), the Director may 

13 delegate such attendance only to an employee who 

14 works in the Office of the Director. 

15 (2) ATTENDANCE BY DIRECTOR.—Each Direc16 tor of a Veterans Integrated Service Network shall 

17 personally attend not less than one community meet18 ing under subsection (a) hosted by each medical fa19 cility located in the Veterans Integrated Service Net20 work each year. 

21 (c) NOTICE.—The Secretary shall notify the Com22 mittee on Veterans’ Affairs of the Senate, the Committee 

23 on Veterans’ Affairs of the House of Representatives, and 

24 each Member of Congress (as defined in section 314) who 

25 represents the area in which the medical facility is located 


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1 of a community meeting under subsection (a) by not later 

2 than 10 days before such community meeting occurs. 

3 SEC. 322. IMPROVEMENT OF AWARENESS OF PATIENT AD4 VOCACY PROGRAM AND PATIENT BILL OF 

5 RIGHTS OF DEPARTMENT OF VETERANS AF6 FAIRS. 

7 Not later than 90 days after the date of the enact8 ment of this Act, the Secretary of Veterans Affairs shall, 

9 in as many prominent locations as the Secretary deter10 mines appropriate to be seen by the largest percentage of 

11 patients and family members of patients at each medical 

12 facility of the Department of Veterans Affairs— 

13 (1) display the purposes of the Patient Advo14 cacy Program of the Department and the contact in15 formation for the patient advocate at such medical 

16 facility; and 

17 (2) display the rights and responsibilities of— 

18 (A) patients and family members and pa19 tients at such medical facility; and 

20 (B) with respect to community living cen21 ters and other residential facilities of the De22 partment, residents and family members of resi23 dents at such medical facility. 


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1 SEC. 323. COMPTROLLER GENERAL REPORT ON PATIENT 

2 ADVOCACY PROGRAM OF DEPARTMENT OF 

3 VETERANS AFFAIRS. 

4 (a) IN GENERAL.—Not later than two years after the 

5 date of the enactment of this Act, the Comptroller General 

6 of the United States shall submit to the Committee on 

7 Veterans’ Affairs of the Senate and the Committee on Vet8 erans’ Affairs of the House of Representatives a report 

9 on the Patient Advocacy Program of the Department of 

10 Veterans Affairs (in this section referred to as the ‘‘Pro11 gram’’). 

12 (b) ELEMENTS.—The report required by subsection 

13 (a) shall include the following: 

14 (1) A description of the Program, including— 

15 (A) the purpose of the Program; 

16 (B) the activities carried out under the 

17 Program; and 

18 (C) the sufficiency of the Program in 

19 achieving the purpose of the Program. 

20 (2) An assessment of the sufficiency of staffing 

21 of employees of the Department responsible for car22 rying out the Program. 

23 (3) An assessment of the sufficiency of the 

24 training of such employees. 

25 (4) An assessment of— 


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1 (A) the awareness of the Program among 

2 veterans and family members of veterans; and 

3 (B) the use of the Program by veterans 

4 and family members of veterans. 

5 (5) Such recommendations and proposals for 

6 improving or modifying the Program as the Comp7 troller General considers appropriate. 

8 (6) Such other information with respect to the 

9 Program as the Comptroller General considers ap10 propriate. 

11 Subtitle C—Complementary and 

12 Integrative Health 

13 SEC. 331. EXPANSION OF RESEARCH AND EDUCATION ON 

14 AND DELIVERY OF COMPLEMENTARY AND IN15 TEGRATIVE HEALTH TO VETERANS. 

16 (a) ESTABLISHMENT.—There is established a com17 mission to be known as the ‘‘Creating Options for Vet18 erans’ Expedited Recovery’’ or the ‘‘COVER Commission’’ 

19 (in this Act referred to as the ‘‘Commission’’). The Com20 mission shall examine the evidence-based therapy treat21 ment model used by the Secretary of Veterans Affairs for 

22 treating mental health conditions of veterans and the po23 tential benefits of incorporating complementary alter24 native treatments available in non-Department facilities 


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1 (as defined in section 1701 of title 38, United States 

2 Code). 

3 (b) DUTIES.—The Commission shall perform the fol4 lowing duties: 

5 (1) Examine the efficacy of the evidence-based 

6 therapy model used by the Secretary for treating 

7 mental health illnesses of veterans and identify areas 

8 to improve wellness-based outcomes. 

9 (2) Conduct a patient-centered survey within 

10 each of the Veterans Integrated Service Networks to 

11 examine— 

12 (A) the experience of veterans with the De13 partment of Veterans Affairs when seeking 

14 medical assistance for mental health issues 

15 through the health care system of the Depart16 ment; 

17 (B) the experience of veterans with non18 Department facilities and health professionals 

19 for treating mental health issues; 

20 (C) the preference of veterans regarding 

21 available treatment for mental health issues and 

22 which methods the veterans believe to be most 

23 effective; 


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1 (D) the experience, if any, of veterans with 

2 respect to the complementary alternative treat3 ment therapies described in paragraph (3); 

4 (E) the prevalence of prescribing prescrip5 tion medication among veterans seeking treat6 ment through the health care system of the De7 partment as remedies for addressing mental 

8 health issues; and 

9 (F) the outreach efforts of the Secretary 

10 regarding the availability of benefits and treat11 ments for veterans for addressing mental health 

12 issues, including by identifying ways to reduce 

13 barriers to gaps in such benefits and treat14 ments. 

15 (3) Examine available research on complemen16 tary alternative treatment therapies for mental 

17 health issues and identify what benefits could be 

18 made with the inclusion of such treatments for vet19 erans, including with respect to— 

20 (A) music therapy; 

21 (B) equine therapy; 

22 (C) training and caring for service dogs; 

23 (D) yoga therapy; 

24 (E) acupuncture therapy; 

25 (F) meditation therapy; 


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1 (G) outdoor sports therapy; 

2 (H) hyperbaric oxygen therapy; 

3 (I) accelerated resolution therapy; 

4 (J) art therapy; 

5 (K) magnetic resonance therapy; and 

6 (L) other therapies the Commission deter7 mines appropriate. 

8 (4) Study the sufficiency of the resources of the 

9 Department to ensure the delivery of quality health 

10 care for mental health issues among veterans seek11 ing treatment within the Department. 

12 (5) Study the current treatments and resources 

13 available within the Department and assess— 

14 (A) the effectiveness of such treatments 

15 and resources in decreasing the number of sui16 cides per day by veterans; 

17 (B) the number of veterans who have been 

18 diagnosed with mental health issues; 

19 (C) the percentage of veterans using the 

20 resources of the Department who have been di21 agnosed with mental health issues; 

22 (D) the percentage of veterans who have 

23 completed counseling sessions offered by the 

24 Department; and 


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1 (E) the efforts of the Department to ex2 pand complementary alternative treatments via3 ble to the recovery of veterans with mental 

4 health issues as determined by the Secretary to 

5 improve the effectiveness of treatments offered 

6 with the Department. 

7 (c) MEMBERSHIP.— 

8 (1) IN GENERAL.—The Commission shall be 

9 composed of 10 members, appointed as follows: 

10 (A) Two members appointed by the Speak11 er of the House of Representatives, at least one 

12 of whom shall be a veteran. 

13 (B) Two members appointed by the Minor14 ity Leader of the House of Representatives, at 

15 least one of whom shall be a veteran. 

16 (C) Two members appointed by the Major17 ity Leader of the Senate, at least one of whom 

18 shall be a veteran. 

19 (D) Two members appointed by the Minor20 ity Leader of the Senate, at least one of whom 

21 shall be a veteran. 

22 (E) Two members appointed by the Presi23 dent, at least one of whom shall be a veteran. 

24 (2) QUALIFICATIONS.—Members of the Com25 mission shall be— 


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1 (A) individuals who are of recognized 

2 standing and distinction within the medical 

3 community with a background in treating men4 tal health; 

5 (B) individuals with experience working 

6 with the military and veteran population; and 

7 (C) individuals who do not have a financial 

8 interest in any of the complementary alternative 

9 treatments reviewed by the Commission. 

10 (3) CHAIRMAN.—The President shall designate 

11 a member of the Commission to be the Chairman. 

12 (4) PERIOD OF APPOINTMENT.—Members of 

13 the Commission shall be appointed for the life of the 

14 Commission. 

15 (5) VACANCY.—A vacancy in the Commission 

16 shall be filled in the manner in which the original 

17 appointment was made. 

18 (6) APPOINTMENT DEADLINE.—The appoint19 ment of members of the Commission in this section 

20 shall be made not later than 90 days after the date 

21 of the enactment of this Act. 

22 (d) POWERS OF COMMISSION.— 

23 (1) MEETINGS.— 

24 (A) INITIAL MEETING.—The Commission 

25 shall hold its first meeting not later than 30 


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1 days after a majority of members are appointed 

2 to the Commission. 

3 (B) MEETING.—The Commission shall reg4 ularly meet at the call of the Chairman. Such 

5 meetings may be carried out through the use of 

6 telephonic or other appropriate telecommuni7 cation technology if the Commission determines 

8 that such technology will allow the members to 

9 communicate simultaneously. 

10 (2) HEARINGS.—The Commission may hold 

11 such hearings, sit and act at such times and places, 

12 take such testimony, and receive evidence as the 

13 Commission considers advisable to carry out the re14 sponsibilities of the Commission. 

15 (3) INFORMATION FROM FEDERAL AGENCIES.— 

16 The Commission may secure directly from any de17 partment or agency of the Federal Government such 

18 information as the Commission considers necessary 

19 to carry out the duties of the Commission. 

20 (4) INFORMATION FROM NONGOVERNMENTAL

21 ORGANIZATIONS.—In carrying out its duties, the 

22 Commission may seek guidance through consultation 

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1 ganizations as the Commission determines appro2 priate. 

3 (5) COMMISSION RECORDS.—The Commission 

4 shall keep an accurate and complete record of the 

5 actions and meeting of the Commission. Such record 

6 shall be made available for public inspection and the 

7 Comptroller General of the United States may audit 

8 and examine such record. 

9 (6) PERSONNEL RECORDS.—The Commission 

10 shall keep an accurate and complete record of the 

11 actions and meetings of the Commission. Such 

12 record shall be made available for public inspection 

13 and the Comptroller General of the United States 

14 may audit and examine such records. 

15 (7) COMPENSATION OF MEMBERS; TRAVEL EX16 PENSES.—Each member shall serve without pay but 

17 shall receive travel expenses to perform the duties of 

18 the Commission, including per diem in lieu of sub19 stances, at rates authorized under subchapter I of 

20 chapter 57 of title 5, United States Code. 

21 (8) STAFF.—The Chairman, in accordance with 

22 rules agreed upon the Commission, may appoint fix 

23 the compensation of a staff director and such other 

24 personnel as may be necessary to enable the Com25 mission to carry out its functions, without regard to 


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1 the provisions of title 5, United States Code, gov2 erning appointments in the competitive service, with3 out regard to the provision of chapter 51 and sub4 chapter III of chapter 53 of such title relating to 

5 classification and General Schedule pay rates, except 

6 that no rate of pay fixed under this paragraph may 

7 exceed the equivalent of that payable for a position 

8 at a level IV of the Executive Schedule under section 

9 5316 of title 5, United States Code. 

10 (9) PERSONNEL AS FEDERAL EMPLOYEES.— 

11 (A) IN GENERAL.—The executive director 

12 and any personnel of the Commission are em13 ployees under section 2105 of title 5, United 

14 States Code, for purpose of chapters 63, 81, 83, 

15 84, 85, 87, 89, and 90 of such title. 

16 (B) MEMBERS OF THE COMMISSION.— 

17 Subparagraph (A) shall not be construed to 

18 apply to members of the Commission. 

19 (10) CONTRACTING.—The Commission may, to 

20 such extent and in such amounts as are provided in 

21 appropriations Acts, enter into contracts to enable 

22 the Commission to discharge the duties of the Com23 mission under this Act. 

24 (11) EXPERT AND CONSULTANT SERVICE.—The 

25 Commission may procure the services of experts and 


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1 consultants in accordance with section 3109 or title 

2 5, United States Code, at rates not to exceed the 

3 daily rate paid to a person occupying a position at 

4 level IV of the Executive Schedule under section 

5 3109 of title 5, United States Code. 

6 (12) POSTAL SERVICE.—The Commission may 

7 use the United States mails in the same manner and 

8 under the same conditions as departments and agen9 cies of the United States. 

10 (13) PHYSICAL FACILITIES AND EQUIPMENT.— 

11 Upon the request of the Commission, the Adminis12 trator of General Services shall provide to the Com13 mission, on a reimbursable basis, the administrative 

14 support services necessary for the Commission to 

15 carry out its responsibilities under this Act. These 

16 administrative services may include human resource 

17 management, budget, leasing accounting, and payroll 

18 services. 

19 (e) REPORT.— 

20 (1) INTERIM REPORTS.— 

21 (A) IN GENERAL.—Not later than 60 days 

22 after the date on which the Commission first 

23 meets, and each 30-day period thereafter end24 ing on the date on which the Commission sub25 mits the final report under paragraph (2), the 


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1 Commission shall submit to the Committees on 

2 Veterans’ Affairs of the House of Representa3 tives and the Senate and the President a report 

4 detailing the level of cooperation the Secretary 

5 of Veterans Affairs (and the heads of other de6 partments or agencies of the Federal Govern7 ment) has provided to the Commission. 

8 (B) OTHER REPORTS.—In carrying out its 

9 duties, at times that the Commission deter10 mines appropriate, the Commission shall submit 

11 to the Committee on Veterans’ Affairs of the 

12 House of Representatives and the Senate and 

13 any other appropriate entities an interim report 

14 with respect to the findings identified by the 

15 Commission. 

16 (2) FINAL REPORT.—Not later than 18 months 

17 after the first meeting of the Commission, the Com18 mission shall submit to the Committee on Veterans’ 

19 Affairs of the House of Representatives and the Sen20 ate, the President, and the Secretary of Veterans Af21 fairs a final report on the findings of the Commis22 sion. Such report shall include the following: 

23 (A) Recommendations to implement in a 

24 feasible, timely, and cost efficient manner the 

25 solutions and remedies identified within the 


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1 findings of the Commission pursuant to sub2 section (b). 

3 (B) An analysis of the evidence-based ther4 apy model used by the Secretary of Veterans 

5 Affairs for treating veterans with mental health 

6 care issues, and an examination of the preva7 lence and efficacy of prescription drugs as a 

8 means for treatment. 

9 (C) The findings of the patient-centered 

10 survey conducted within each of the Veterans 

11 Integrated Service Networks pursuant to sub12 section (b)(2). 

13 (D) An examination of complementary al14 ternative treatments described in subsection 

15 (b)(3) and the potential benefits of incor16 porating such treatments in the therapy models 

17 used by the Secretary for treating veterans with 

18 mental health issues. 

19 (3) PLAN.—Not later than 90 days after the 

20 date on which the Commission submits the final re21 port under paragraph (2), the Secretary of Veterans 

22 Affairs shall submit to the Committee on Veterans’ 

23 Affairs of the House of Representatives and the Sen24 ate a report on the following: 


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1 (A) An action plan for implementing the 

2 recommendations established by the Commis3 sion on such solutions and remedies for improv4 ing wellness-based outcomes for veterans with 

5 mental health care issues. 

6 (B) A feasible timeframe on when the com7 plementary alternative treatments described in 

8 subsection (b)(3) can be implemented Depart9 ment-wide. 

10 (C) With respect to each recommendation 

11 established by the Commission, including any 

12 complementary alternative treatment, that the 

13 Secretary determines is not appropriate or fea14 sible to implement, a justification for such de15 termination and an alternative solution to im16 prove the efficacy of the therapy models used by 

17 the Secretary for treating veterans with mental 

18 health issues. 

19 (f) TERMINATION OF COMMISSION.—The Commis20 sion shall terminate 30 days after the Commission submits 

21 the final report under subsection (e)(2). 


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1 SEC. 332. PILOT PROGRAM ON INTEGRATION OF COM2 PLEMENTARY ALTERNATIVE MEDICINES AND 

3 RELATED ISSUES FOR VETERANS AND FAM4 ILY MEMBERS OF VETERANS. 

5 (a) PILOT PROGRAM.— 

6 (1) IN GENERAL.—Not later than 180 days 

7 after the date on which the Secretary of Veterans 

8 Affairs receives the final report under section 

9 331(e), the Secretary shall commence a pilot pro10 gram to assess the feasibility and advisability of 

11 using wellness-based programs (as defined by the 

12 Secretary) to complement the provision of pain man13 agement and related health care services, including 

14 mental health care services, to veterans. 

15 (2) MATTERS ADDRESSED.—In carrying out the 

16 pilot program, the Secretary shall assess the fol17 lowing: 

18 (A) Means of improving coordination be19 tween Federal, State, local, and community pro20 viders of health care in the provision of pain 

21 management and related health care services to 

22 veterans. 

23 (B) Means of enhancing outreach, and co24 ordination of outreach, by and among providers 

25 of health care referred to in subparagraph (A) 


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1 on the pain management and related health 

2 care services available to veterans. 

3 (C) Means of using wellness-based pro4 grams of providers of health care referred to in 

5 subparagraph (A) as complements to the provi6 sion by the Department of pain management 

7 and related health care services to veterans. 

8 (D) Whether wellness-based programs de9 scribed in subparagraph (C)— 

10 (i) are effective in enhancing the qual11 ity of life and well-being of veterans; 

12 (ii) are effective in increasing the ad13 herence of veterans to the primary pain 

14 management and related health care serv15 ices provided such veterans by the Depart16 ment; 

17 (iii) have an effect on the sense of 

18 well-being of veterans who receive primary 

19 pain management and related health care 

20 services from the Department; and 

21 (iv) are effective in encouraging vet22 erans receiving health care from the De23 partment to adopt a more healthy lifestyle. 


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1 (b) DURATION.—The Secretary shall carry out the 

2 pilot program under subsection (a)(1) for a period of three 

3 years. 

4 (c) LOCATIONS.— 

5 (1) FACILITIES.—The Secretary shall carry out 

6 the pilot program under subsection (a)(1) at facili7 ties of the Department providing pain management 

8 and related health care services, including mental 

9 health care services, to veterans. In selecting such 

10 facilities to carry out the pilot program, the Sec11 retary shall select not fewer than 15 medical centers 

12 of the Department, of which not fewer than two 

13 shall be polytrauma rehabilitation centers of the De14 partment. 

15 (2) MEDICAL CENTERS WITH PRESCRIPTION

16 RATES OF OPIOIDS THAT CONFLICT WITH CARE

17 STANDARDS.—In selecting the medical centers under 

18 paragraph (1), the Secretary shall give priority to 

19 medical centers of the Department at which there is 

20 a prescription rate of opioids that conflicts with or 

21 is otherwise inconsistent with the standards of ap22 propriate and safe care. 

23 (d) PROVISION OF SERVICES.—Under the pilot pro24 gram under subsection (a)(1), the Secretary shall provide 

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1 plementary and alternative medicines and integrative 

2 health services with other services provided by the Depart3 ment at the medical centers selected under subsection (c). 

4 (e) COVERED VETERANS.—For purposes of the pilot 

5 program under subsection (a)(1), a covered veteran is any 

6 veteran who— 

7 (1) has a mental health condition diagnosed by 

8 a clinician of the Department; 

9 (2) experiences chronic pain; 

10 (3) has a chronic condition being treated by a 

11 clinician of the Department; or 

12 (4) is not described in paragraph (1), (2), or 

13 (3) and requests to participate in the pilot program 

14 or is referred by a clinician of the Department who 

15 is treating the veteran. 

16 (f) COVERED SERVICES.— 

17 (1) IN GENERAL.—For purposes of the pilot 

18 program, covered services are services consisting of 

19 complementary and integrative health services as se20 lected by the Secretary. 

21 (2) ADMINISTRATION OF SERVICES.—Covered 

22 services shall be administered under the pilot pro23 gram as follows: 

24 (A) Covered services shall be administered 

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1 propriate training and expertise in complemen2 tary and integrative health services who are em3 ployees of the Department or with whom the 

4 Department enters into an agreement to pro5 vide such services. 

6 (B) Covered services shall be included as 

7 part of the Patient Aligned Care Teams initia8 tive of the Office of Patient Care Services, Pri9 mary Care Program Office, in coordination with 

10 the Office of Patient Centered Care and Cul11 tural Transformation. 

12 (C) Covered services shall be made avail13 able to— 

14 (i) covered veterans who have received 

15 conventional treatments from the Depart16 ment for the conditions for which the cov17 ered veteran seeks complementary and in18 tegrative health services under the pilot 

19 program; and 

20 (ii) covered veterans who have not re21 ceived conventional treatments from the 

22 Department for such conditions. 

23 (g) REPORTS.— 

24 (1) IN GENERAL.—Not later than 30 months 

25 after the date on which the Secretary commences the 


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1 pilot program under subsection (a)(1), the Secretary 

2 shall submit to the Committee on Veterans’ Affairs 

3 of the Senate and the Committee on Veterans’ Af4 fairs of the House of Representatives a report on the 

5 pilot program. 

6 (2) ELEMENTS.—The report under paragraph 

7 (1) shall include the following: 

8 (A) The findings and conclusions of the 

9 Secretary with respect to the pilot program 

10 under subsection (a)(1), including with respect 

11 to— 

12 (i) the use and efficacy of the com13 plementary and integrative health services 

14 established under the pilot program; 

15 (ii) the outreach conducted by the 

16 Secretary to inform veterans and commu17 nity organizations about the pilot program; 

18 and 

19 (iii) an assessment of the benefit of 

20 the pilot program to covered veterans in 

21 mental health diagnoses, pain manage22 ment, and treatment of chronic illness. 

23 (B) Identification of any unresolved bar24 riers that impede the ability of the Secretary to 

25 incorporate complementary and integrative 


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1 health services with other health care services 

2 provided by the Department. 

3 (C) Such recommendations for the continu4 ation or expansion of the pilot program as the 

5 Secretary considers appropriate. 

6 (h) COMPLEMENTARY AND INTEGRATIVE HEALTH

7 DEFINED.—In this section, the term ‘‘complementary and 

8 integrative health’’ shall have the meaning given that term 

9 by the National Institutes of Health. 

10 Subtitle D—Fitness of Health Care 

11 Providers 

12 SEC. 341. ADDITIONAL REQUIREMENTS FOR HIRING OF 

13 HEALTH CARE PROVIDERS BY DEPARTMENT 

14 OF VETERANS AFFAIRS. 

15 As part of the hiring process for each health care pro16 vider considered for a position at the Department of Vet17 erans Affairs after the date of the enactment of the Act, 

18 the Secretary of Veterans Affairs shall require from the 

19 medical board of each State in which the health care pro20 vider has a medical license— 

21 (1) information on any violation of the require22 ments of the medical license of the health care pro23 vider during the 20-year period preceding the con24 sideration of the health care provider by the Depart25 ment; and 


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1 (2) information on whether the health care pro2 vider has entered into any settlement agreement for 

3 the disciplinary charge relating to the practice of 

4 medicine by the health care provider. 

5 SEC. 342. PROVISION OF INFORMATION ON HEALTH CARE 

6 PROVIDERS OF DEPARTMENT OF VETERANS 

7 AFFAIRS TO STATE MEDICAL BOARDS. 

8 Notwithstanding section 552a of title 5, United 

9 States Code, with respect to each health care provider of 

10 the Department of Veterans Affairs who has violated a 

11 requirement of the medical license of the health care pro12 vider, the Secretary of Veterans Affairs shall provide to 

13 the medical board of each State in which the health care 

14 provider is licensed detailed information with respect to 

15 such violation, regardless of whether such board has for16 mally requested such information. 

17 SEC. 343. REPORT ON COMPLIANCE BY DEPARTMENT OF 

18 VETERANS AFFAIRS WITH REVIEWS OF 

19 HEALTH CARE PROVIDERS LEAVING THE DE20 PARTMENT OR TRANSFERRING TO OTHER 

21 FACILITIES. 

22 Not later than two years after the date of the enact23 ment of this Act, the Secretary of Veterans Affairs shall 

24 submit to the Committee on Veterans’ Affairs of the Sen25 ate and the Committee on Veterans’ Affairs of the House 


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1 of Representatives a report on the compliance by the De2 partment of Veterans Affairs with the policy of the De3 partment— 

4 (1) to conduct a review of each health care pro5 vider of the Department who transfers to another 

6 medical facility of the Department, retires, or is ter7 minated to determine whether there are any con8 cerns, complaints, or allegations of violations relat9 ing to the medical practice of the health care pro10 vider; and 

11 (2) to take appropriate action with respect to 

12 any such concern, complaint, or allegation. 

13 Subtitle E—Other Veterans Matters 

14 SEC. 351. AUDIT OF VETERANS HEALTH ADMINISTRATION 

15 PROGRAMS OF DEPARTMENT OF VETERANS 

16 AFFAIRS. 

17 (a) AUDIT.—The Secretary of Veterans Affairs shall 

18 seek to enter into a contract with a nongovernmental enti19 ty under which the entity shall conduct a audits of the 

20 programs of the Veterans Health Administration of the 

21 Department of Veterans Affairs to identify ways to im22 prove the furnishing of benefits and health care adminis23 tered by the Veterans Health Administration to veterans 

24 and families of veterans. 


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1 (b) AUDIT REQUIREMENTS.—In carrying out each 

2 audit under subsection (a), the entity shall perform the 

3 following: 

4 (1) Five-year risk assessments to identify the 

5 functions, staff organizations, and staff offices of the 

6 Veterans Health Administration that would lead to7 wards the greatest improvement in furnishing of 

8 benefits and health care to veterans and families of 

9 veterans. 

10 (2) Development of plans that are informed by 

11 the risk assessment under paragraph (1) to conduct 

12 audits of the functions, staff organizations, and staff 

13 offices identified under paragraph (1). 

14 (3) Conduct audits in accordance with the plans 

15 developed pursuant to paragraph (2). 

16 (c) REPORTS.—Not later than 90 days after the date 

17 on which each audit is completed under subsection (a), 

18 the Secretary shall submit to the Committees on Veterans’ 

19 Affairs of the House of Representatives and the Senate 

20 a report that includes— 

21 (1) a summary of the audit; 

22 (2) the findings of the entity that conducted the 

23 audit with respect to the audit; and 

24 (3) such recommendations as the Secretary de25 termines appropriate for legislative or administrative 


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1 action to improve the furnishing of benefits and 

2 health care to veterans and families of veterans. 

3 TITLE IV—IMPROVING SAFE 

4 CARE FOR PREVENTING IN5 FANT ABUSE AND NEGLECT 

6 SEC. 401. SHORT TITLE. 

7 This title may be cited as the ‘‘Improving Safe Care 

8 for the Prevention of Infant Abuse and Neglect Act’’. 

9 SEC. 402. BEST PRACTICES FOR DEVELOPMENT OF PLANS 

10 OF SAFE CARE. 

11 Section 103(b) of the Child Abuse Prevention and 

12 Treatment Act (42 U.S.C. 5104(b)) is amended— 

13 (1) by redesignating paragraphs (5) through 

14 (8) as paragraphs (6) through (9), respectively; and 

15 (2) by inserting after paragraph (4), the fol16 lowing: 

17 ‘‘(5) maintain and disseminate information 

18 about the best practices relating to the development 

19 of plans of safe care as described in section 

20 106(b)(2)(B)(iii) for infants born and identified as 

21 being affected by illegal substance abuse or with22 drawal symptoms, or a Fetal Alcohol Spectrum Dis23 order;’’. 


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1 SEC. 403. STATE PLANS. 

2 Section 106(b)(2)(B)(iii) of the Child Abuse Preven3 tion and Treatment Act (42 U.S.C. 5106a(b)(2)(B)(iii)) 

4 is amended by inserting before the period at the end the 

5 following: ‘‘to ensure the safety and well-being of such in6 fant following release from the care of healthcare pro7 viders, including through addressing the health of the af8 fected family or caregiver’’. 

9 SEC. 404. DATA REPORTS. 

10 (a) IN GENERAL.—Section 106(d) of the Child Abuse 

11 Prevention and Treatment Act (42 U.S.C. 5106a(d)) is 

12 amended by adding at the end of the following: 

13 ‘‘(17) The total number of infants— 

14 ‘‘(A) identified under subsection 

15 (b)(2)(B)(ii); 

16 ‘‘(B) for whom a plan of safe care was de17 veloped under subsection (b)(2)(B)(iii); and 

18 ‘‘(C) for whom referrals are made for ap19 propriate services, including services for the af20 fected family or caregiver, as may be necessary 

21 under subsection (b)(2)(B)(iii).’’. 

22 (b) REDESIGNATION.—Effective on May 29, 2017, 

23 section 106(d) of the Child Abuse Prevention and Treat24 ment Act (42 U.S.C. 5106a(d)) is amended by redesig25 nating paragraph (17) (as added by subsection (a)) as 

26 paragraph (18). 


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1 SEC. 405. MONITORING AND OVERSIGHT. 

2 (a) AMENDMENT.—Title I of the Child Abuse Preven3 tion and Treatment Act (42 U.S.C. 5101 et seq.) is fur4 ther amended by adding at the end the following: 

5 ‘‘SEC. 114. MONITORING AND OVERSIGHT. 

6 ‘‘The Secretary shall conduct monitoring to ensure 

7 that each State that receives a grant under section 106 

8 is in compliance with the requirements of section 106(b), 

9 which— 

10 ‘‘(1) shall— 

11 ‘‘(A) be in addition to the review of the 

12 State plan upon its submission under section 

13 106(b)(1)(A); and 

14 ‘‘(B) include monitoring of State policies 

15 and procedures required under clauses (ii) and 

16 (iii) of section 106(b)(2)(B); and 

17 ‘‘(2) may include— 

18 ‘‘(A) a comparison of activities carried out 

19 by the State to comply with the requirements of 

20 section 106(b) with the State plan most re21 cently approved under section 432 of the Social 

22 Security Act; 

23 ‘‘(B) information available on the Website 

24 of the State relating to its compliance with the 

25 requirements of section 106(b); 


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1 ‘‘(C) site visits, as may be necessary to 

2 carry out such monitoring; and 

3 ‘‘(D) information available in the State’s 

4 Annual Progress and Services Report most re5 cently submitted under section 1357.16 of title 

6 45, Code of Federal Regulations (or successor 

7 regulations).’’. 

8 (b) TABLE OF CONTENTS.—The table of contents in 

9 section 1(b) of the Child Abuse Prevention and Treatment 

10 Act (42 U.S.C. 5101 note) is amended by inserting after 

11 the item relating to section 113, the following: 

‘‘Sec. 114. Monitoring and oversight.’’. 

12 SEC. 406. RULE OF CONSTRUCTION. 

13 Nothing in this Act shall be construed to authorize 

14 the Secretary of Health and Human Services or any other 

15 officer of the Federal Government to add new require16 ments to section 106(b) of the Child Abuse Prevention and 

17 Treatment Act (42 U.S.C. 5106a(b)), as amended by this 

18 Act. 

19 TITLE V—OTHER PROVISIONS 

20 SEC. 501. PROGRAMS TO PREVENT PRESCRIPTION DRUG 

21 ABUSE UNDER MEDICARE PARTS C AND D. 

22 (a) DRUG MANAGEMENT PROGRAM FOR AT-RISK

23 BENEFICIARIES.— 


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1 (1) IN GENERAL.—Section 1860D–4(c) of the 

2 Social Security Act (42 U.S.C. 1395w–10(c)) is 

3 amended by adding at the end the following: 

4 ‘‘(5) DRUG MANAGEMENT PROGRAM FOR AT5 RISK BENEFICIARIES.— 

6 ‘‘(A) AUTHORITY TO ESTABLISH.—A PDP 

7 sponsor may establish a drug management pro8 gram for at-risk beneficiaries under which, sub9 ject to subparagraph (B), the PDP sponsor 

10 may, in the case of an at-risk beneficiary for 

11 prescription drug abuse who is an enrollee in a 

12 prescription drug plan of such PDP sponsor, 

13 limit such beneficiary’s access to coverage for 

14 frequently abused drugs under such plan to fre15 quently abused drugs that are prescribed for 

16 such beneficiary by one or more prescribers se17 lected under subparagraph (D), and dispensed 

18 for such beneficiary by one or more pharmacies 

19 selected under such subparagraph. 

20 ‘‘(B) REQUIREMENT FOR NOTICES.— 

21 ‘‘(i) IN GENERAL.—A PDP sponsor 

22 may not limit the access of an at-risk ben23 eficiary for prescription drug abuse to cov24 erage for frequently abused drugs under a 


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1 prescription drug plan until such spon2 sor— 

3 ‘‘(I) provides to the beneficiary 

4 an initial notice described in clause 

5 (ii) and a second notice described in 

6 clause (iii); and 

7 ‘‘(II) verifies with the providers 

8 of the beneficiary that the beneficiary 

9 is an at-risk beneficiary for prescrip10 tion drug abuse. 

11 ‘‘(ii) INITIAL NOTICE.—An initial no12 tice described in this clause is a notice that 

13 provides to the beneficiary— 

14 ‘‘(I) notice that the PDP sponsor 

15 has identified the beneficiary as po16 tentially being an at-risk beneficiary 

17 for prescription drug abuse; 

18 ‘‘(II) information describing all 

19 State and Federal public health re20 sources that are designed to address 

21 prescription drug abuse to which the 

22 beneficiary has access, including men23 tal health services and other coun24 seling services; 


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1 ‘‘(III) notice of, and information 

2 about, the right of the beneficiary to 

3 appeal such identification under sub4 section (h) and the option of an auto5 matic escalation to external review; 

6 ‘‘(IV) a request for the bene7 ficiary to submit to the PDP sponsor 

8 preferences for which prescribers and 

9 pharmacies the beneficiary would pre10 fer the PDP sponsor to select under 

11 subparagraph (D) in the case that the 

12 beneficiary is identified as an at-risk 

13 beneficiary for prescription drug 

14 abuse as described in clause (iii)(I); 

15 ‘‘(V) an explanation of the mean16 ing and consequences of the identi17 fication of the beneficiary as poten18 tially being an at-risk beneficiary for 

19 prescription drug abuse, including an 

20 explanation of the drug management 

21 program established by the PDP 

22 sponsor pursuant to subparagraph 

23 (A); 

24 ‘‘(VI) clear instructions that ex25 plain how the beneficiary can contact 


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1 the PDP sponsor in order to submit 

2 to the PDP sponsor the preferences 

3 described in subclause (IV) and any 

4 other communications relating to the 

5 drug management program for at-risk 

6 beneficiaries established by the PDP 

7 sponsor; and 

8 ‘‘(VII) contact information for 

9 other organizations that can provide 

10 the beneficiary with assistance regard11 ing such drug management program 

12 (similar to the information provided 

13 by the Secretary in other standardized 

14 notices provided to part D eligible in15 dividuals enrolled in prescription drug 

16 plans under this part). 

17 ‘‘(iii) SECOND NOTICE.—A second no18 tice described in this clause is a notice that 

19 provides to the beneficiary notice— 

20 ‘‘(I) that the PDP sponsor has 

21 identified the beneficiary as an at-risk 

22 beneficiary for prescription drug 

23 abuse; 

24 ‘‘(II) that such beneficiary is 

25 subject to the requirements of the 


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1 drug management program for at-risk 

2 beneficiaries established by such PDP 

3 sponsor for such plan; 

4 ‘‘(III) of the prescriber (or pre5 scribers) and pharmacy (or phar6 macies) selected for such individual 

7 under subparagraph (D); 

8 ‘‘(IV) of, and information about, 

9 the beneficiary’s right to appeal such 

10 identification under subsection (h) 

11 and the option of an automatic esca12 lation to external review; 

13 ‘‘(V) that the beneficiary can, in 

14 the case that the beneficiary has not 

15 previously submitted to the PDP 

16 sponsor preferences for which pre17 scribers and pharmacies the bene18 ficiary would prefer the PDP sponsor 

19 select under subparagraph (D), sub20 mit such preferences to the PDP 

21 sponsor; and 

22 ‘‘(VI) that includes clear instruc23 tions that explain how the beneficiary 

24 can contact the PDP sponsor. 

25 ‘‘(iv) TIMING OF NOTICES.— 


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1 ‘‘(I) IN GENERAL.—Subject to 

2 subclause (II), a second notice de3 scribed in clause (iii) shall be provided 

4 to the beneficiary on a date that is 

5 not less than 60 days after an initial 

6 notice described in clause (ii) is pro7 vided to the beneficiary. 

8 ‘‘(II) EXCEPTION.—In the case 

9 that the PDP sponsor, in conjunction 

10 with the Secretary, determines that 

11 concerns identified through rule12 making by the Secretary regarding 

13 the health or safety of the beneficiary 

14 or regarding significant drug diversion 

15 activities require the PDP sponsor to 

16 provide a second notice described in 

17 clause (iii) to the beneficiary on a 

18 date that is earlier than the date de19 scribed in subclause (I), the PDP 

20 sponsor may provide such second no21 tice on such earlier date. 

22 ‘‘(C) AT-RISK BENEFICIARY FOR PRE23 SCRIPTION DRUG ABUSE.— 

24 ‘‘(i) IN GENERAL.—For purposes of 

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1 ficiary for prescription drug abuse’ means 

2 a part D eligible individual who is not an 

3 exempted individual described in clause (ii) 

4 and— 

5 ‘‘(I) who is identified as such an 

6 at-risk beneficiary through the use of 

7 clinical guidelines developed by the 

8 Secretary in consultation with PDP 

9 sponsors and other stakeholders de10 scribed in section 3141(f)(2)(A) of the 

11 21st Century Cures Act; or 

12 ‘‘(II) with respect to whom the 

13 PDP sponsor of a prescription drug 

14 plan, upon enrolling such individual in 

15 such plan, received notice from the 

16 Secretary that such individual was 

17 identified under this paragraph to be 

18 an at-risk beneficiary for prescription 

19 drug abuse under the prescription 

20 drug plan in which such individual 

21 was most recently previously enrolled 

22 and such identification has not been 

23 terminated under subparagraph (F). 

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1 scribed in this clause is an individual 

2 who— 

3 ‘‘(I) receives hospice care under 

4 this title; 

5 ‘‘(II) is a resident of a long-term 

6 care facility, of an intermediate care 

7 facility for the mentally retarded, or 

8 of another facility for which fre9 quently abused drugs are dispensed 

10 for residents through a contract with 

11 a single pharmacy; or 

12 ‘‘(III) the Secretary elects to 

13 treat as an exempted individual for 

14 purposes of clause (i). 

15 ‘‘(D) SELECTION OF PRESCRIBERS AND

16 PHARMACIES.— 

17 ‘‘(i) IN GENERAL.—With respect to 

18 each at-risk beneficiary for prescription 

19 drug abuse enrolled in a prescription drug 

20 plan offered by such sponsor, a PDP spon21 sor shall, based on the preferences sub22 mitted to the PDP sponsor by the bene23 ficiary pursuant to clauses (ii)(IV) and 

24 (iii)(V) of subparagraph (B) (except as 


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1 otherwise provided in this subparagraph), 

2 select— 

3 ‘‘(I) one or more individuals who 

4 are authorized to prescribe frequently 

5 abused drugs (referred to in this 

6 paragraph as ‘prescribers’) who may 

7 write prescriptions for such drugs for 

8 such beneficiary; and 

9 ‘‘(II) one or more pharmacies 

10 that may dispense such drugs to such 

11 beneficiary. 

12 ‘‘(ii) REASONABLE ACCESS.—In mak13 ing the selections under this subpara14 graph— 

15 ‘‘(I) a PDP sponsor shall ensure 

16 that the beneficiary continues to have 

17 reasonable access to frequently abused 

18 drugs (as defined in subparagraph 

19 (G)), taking into account geographic 

20 location, beneficiary preference, im21 pact on cost-sharing, and reasonable 

22 travel time; and 

23 ‘‘(II) a PDP sponsor shall ensure 

24 such access (including access to pre25 scribers and pharmacies with respect 


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1 to frequently abused drugs) in the 

2 case of individuals with multiple resi3 dences and in the case of natural dis4 asters and similar emergency situa5 tions. 

6 ‘‘(iii) BENEFICIARY PREFERENCES.— 

7 If an at-risk beneficiary for prescription 

8 drug abuse submits preferences for which 

9 in-network prescribers and pharmacies the 

10 beneficiary would prefer the PDP sponsor 

11 select in response to a notice under sub12 paragraph (B), the PDP sponsor shall— 

13 ‘‘(I) review such preferences; 

14 ‘‘(II) select or change the selec15 tion of prescribers and pharmacies for 

16 the beneficiary based on such pref17 erences; and 

18 ‘‘(III) inform the beneficiary of 

19 such selection or change of selection. 

20 ‘‘(iv) EXCEPTION REGARDING BENE21 FICIARY PREFERENCES.—In the case that 

22 the PDP sponsor determines that a change 

23 to the selection of prescriber or pharmacy 

24 under clause (iii)(II) by the PDP sponsor 

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1 scription drug abuse or drug diversion by 

2 the beneficiary, the PDP sponsor may 

3 change the selection of prescriber or phar4 macy for the beneficiary without regard to 

5 the preferences of the beneficiary described 

6 in clause (iii). 

7 ‘‘(v) CONFIRMATION.—Before select8 ing a prescriber (or prescribers) or phar9 macy (or pharmacies) under this subpara10 graph, a PDP sponsor must request and 

11 receive confirmation from such a prescriber 

12 or pharmacy acknowledging and accepting 

13 that the beneficiary involved is in the drug 

14 management program for at-risk bene15 ficiaries. 

16 ‘‘(E) TERMINATIONS AND APPEALS.—The 

17 identification of an individual as an at-risk ben18 eficiary for prescription drug abuse under this 

19 paragraph, a coverage determination made 

20 under a drug management program for at-risk 

21 beneficiaries, and the selection of prescriber or 

22 pharmacy under subparagraph (D) with respect 

23 to such individual shall be subject to reconsider24 ation and appeal under subsection (h) and the 


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1 option of an automatic escalation to external re2 view to the extent provided by the Secretary. 

3 ‘‘(F) TERMINATION OF IDENTIFICATION.— 

4 ‘‘(i) IN GENERAL.—The Secretary 

5 shall develop standards for the termination 

6 of identification of an individual as an at7 risk beneficiary for prescription drug abuse 

8 under this paragraph. Under such stand9 ards such identification shall terminate as 

10 of the earlier of— 

11 ‘‘(I) the date the individual dem12 onstrates that the individual is no 

13 longer likely, in the absence of the re14 strictions under this paragraph, to be 

15 an at-risk beneficiary for prescription 

16 drug abuse described in subparagraph 

17 (C)(i); and 

18 ‘‘(II) the end of such maximum 

19 period of identification as the Sec20 retary may specify. 

21 ‘‘(ii) RULE OF CONSTRUCTION.— 

22 Nothing in clause (i) shall be construed as 

23 preventing a plan from identifying an indi24 vidual as an at-risk beneficiary for pre25 scription drug abuse under subparagraph 


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1 (C)(i) after such termination on the basis 

2 of additional information on drug use oc3 curring after the date of notice of such ter4 mination. 

5 ‘‘(G) FREQUENTLY ABUSED DRUG.—For 

6 purposes of this subsection, the term ‘frequently 

7 abused drug’ means a drug that is a controlled 

8 substance that the Secretary determines to be 

9 frequently abused or diverted. 

10 ‘‘(H) DATA DISCLOSURE.—In the case of 

11 an at-risk beneficiary for prescription drug 

12 abuse whose access to coverage for frequently 

13 abused drugs under a prescription drug plan 

14 has been limited by a PDP sponsor under this 

15 paragraph, such PDP sponsor shall disclose 

16 data, including any necessary individually iden17 tifiable health information, in a form and man18 ner specified by the Secretary, about the deci19 sion to impose such limitations and the limita20 tions imposed by the sponsor under this part to 

21 other PDP sponsors that request such data. 

22 ‘‘(I) EDUCATION.—The Secretary shall 

23 provide education to enrollees in prescription 

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1 risk beneficiaries described in this paragraph, 

2 including education— 

3 ‘‘(i) provided by Medicare administra4 tive contractors through the improper pay5 ment outreach and education program de6 scribed in section 1874A(h); and 

7 ‘‘(ii) through current education efforts 

8 (such as State health insurance assistance 

9 programs described in subsection (a)(1)(A) 

10 of section 119 of the Medicare Improve11 ments for Patients and Providers Act of 

12 2008 (42 U.S.C. 1395b–3 note)) and ma13 terials directed toward such enrollees. 

14 ‘‘(J) APPLICATION UNDER MA–PD

15 PLANS.—Pursuant to section 1860D–21(c)(1), 

16 the provisions of this paragraph apply under 

17 part D to MA organizations offering MA–PD 

18 plans to MA eligible individuals in the same 

19 manner as such provisions apply under this 

20 part to a PDP sponsor offering a prescription 

21 drug plan to a part D eligible individual.’’. 

22 (2) INFORMATION FOR CONSUMERS.—Section 

23 1860D–4(a)(1)(B) of the Social Security Act (42 

24 U.S.C. 1395w–104(a)(1)(B)) is amended by adding 

25 at the end the following: 


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1 ‘‘(v) The drug management program 

2 for at-risk beneficiaries under subsection 

3 (c)(5).’’. 

4 (b) UTILIZATION MANAGEMENT PROGRAMS.—Sec5 tion 1860D–4(c) of the Social Security Act (42 U.S.C. 

6 1395w–104(c)), as amended by subsection (a)(1), is fur7 ther amended— 

8 (1) in paragraph (1), by inserting after sub9 paragraph (D) the following new subparagraph: 

10 ‘‘(E) A utilization management tool to pre11 vent drug abuse (as described in paragraph 

12 (6)(A)).’’; and 

13 (2) by adding at the end the following new 

14 paragraph: 

15 ‘‘(6) UTILIZATION MANAGEMENT TOOL TO PRE16 VENT DRUG ABUSE.— 

17 ‘‘(A) IN GENERAL.—A tool described in 

18 this paragraph is any of the following: 

19 ‘‘(i) A utilization tool designed to pre20 vent the abuse of frequently abused drugs 

21 by individuals and to prevent the diversion 

22 of such drugs at pharmacies. 

23 ‘‘(ii) Retrospective utilization review 

24 to identify— 


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1 ‘‘(I) individuals that receive fre2 quently abused drugs at a frequency 

3 or in amounts that are not clinically 

4 appropriate; and 

5 ‘‘(II) providers of services or sup6 pliers that may facilitate the abuse or 

7 diversion of frequently abused drugs 

8 by beneficiaries. 

9 ‘‘(iii) Consultation with the contractor 

10 described in subparagraph (B) to verify if 

11 an individual enrolling in a prescription 

12 drug plan offered by a PDP sponsor has 

13 been previously identified by another PDP 

14 sponsor as an individual described in 

15 clause (ii)(I). 

16 ‘‘(B) REPORTING.—A PDP sponsor offer17 ing a prescription drug plan (and an MA orga18 nization offering an MA–PD plan) in a State 

19 shall submit to the Secretary and the Medicare 

20 drug integrity contractor with which the Sec21 retary has entered into a contract under section 

22 1893 with respect to such State a report, on a 

23 monthly basis, containing information on— 

24 ‘‘(i) any provider of services or sup25 plier described in subparagraph (A)(ii)(II) 


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1 that is identified by such plan sponsor (or 

2 organization) during the 30-day period be3 fore such report is submitted; and 

4 ‘‘(ii) the name and prescription 

5 records of individuals described in para6 graph (5)(C).’’. 

7 (c) EXPANDING ACTIVITIES OF MEDICARE DRUG IN8 TEGRITY CONTRACTORS (MEDICS).— 

9 (1) IN GENERAL.—Section 1893 of the Social 

10 Security Act (42 U.S.C. 1395ddd) is amended by 

11 adding at the end the following new subsection: 

12 ‘‘(j) EXPANDING ACTIVITIES OF MEDICARE DRUG

13 INTEGRITY CONTRACTORS (MEDICS).— 

14 ‘‘(1) ACCESS TO INFORMATION.—Under con15 tracts entered into under this section with Medicare 

16 drug integrity contractors (including any successor 

17 entity to a Medicare drug integrity contractor), the 

18 Secretary shall authorize such contractors to directly 

19 accept prescription and necessary medical records 

20 from entities such as pharmacies, prescription drug 

21 plans, MA–PD plans, and physicians with respect to 

22 an individual in order for such contractors to pro23 vide information relevant to the determination of 

24 whether such individual is an at-risk beneficiary for 


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1 prescription drug abuse, as defined in section 

2 1860D–4(c)(5)(C). 

3 ‘‘(2) REQUIREMENT FOR ACKNOWLEDGMENT

4 OF REFERRALS.—If a PDP sponsor or MA organiza5 tion refers information to a contractor described in 

6 paragraph (1) in order for such contractor to assist 

7 in the determination described in such paragraph, 

8 the contractor shall— 

9 ‘‘(A) acknowledge to the sponsor or organi10 zation receipt of the referral; and 

11 ‘‘(B) in the case that any PDP sponsor or 

12 MA organization contacts the contractor re13 questing to know the determination by the con14 tractor of whether or not an individual has been 

15 determined to be an individual described such 

16 paragraph, shall inform such sponsor or organi17 zation of such determination on a date that is 

18 not later than 15 days after the date on which 

19 the sponsor or organization contacts the con20 tractor. 

21 ‘‘(3) MAKING DATA AVAILABLE TO OTHER EN22 TITIES.— 

23 ‘‘(A) IN GENERAL.—For purposes of car24 rying out this subsection, subject to subpara25 graph (B), the Secretary shall authorize MEDVerDate Sep 11 2014 20:51 May 13, 2016 Jkt 059200 PO 00000 Frm 00152 Fmt 6652 Sfmt 6201 E:\BILLS\H5189.IH H5189

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1 ICs to respond to requests for information from 

2 PDP sponsors and MA organizations, State 

3 prescription drug monitoring programs, and 

4 other entities delegated by such sponsors or or5 ganizations using available programs and sys6 tems in the effort to prevent fraud, waste, and 

7 abuse. 

8 ‘‘(B) HIPAA COMPLIANT INFORMATION

9 ONLY.—Information may only be disclosed by a 

10 MEDIC under subparagraph (A) if the disclo11 sure of such information is permitted under the 

12 Federal regulations (concerning the privacy of 

13 individually identifiable health information) pro14 mulgated under section 264(c) of the Health 

15 Insurance Portability and Accountability Act of 

16 1996 (42 U.S.C. 1320d–2 note).’’. 

17 (2) OIG STUDY AND REPORT ON EFFECTIVE18 NESS OF MEDICS.— 

19 (A) STUDY.—The Inspector General of the 

20 Department of Health and Human Services 

21 shall conduct a study on the effectiveness of 

22 Medicare drug integrity contractors with which 

23 the Secretary of Health and Human Services 

24 has entered into a contract under section 1893 

25 of the Social Security Act (42 U.S.C. 1395ddd) 


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1 in identifying, combating, and preventing fraud 

2 under the Medicare Program, including under 

3 the authority provided under section 1893(j) of 

4 the Social Security Act, added by paragraph 

5 (1). 

6 (B) REPORT.—Not later than 1 year after 

7 the date of the enactment of this Act, the In8 spector General shall submit to Congress a re9 port on the study conducted under subpara10 graph (A). Such report shall include such rec11 ommendations for improvements in the effec12 tiveness of such contractors as the Inspector 

13 General determines appropriate. 

14 (d) TREATMENT OF CERTAIN COMPLAINTS FOR PUR15 POSES OF QUALITY OR PERFORMANCE ASSESSMENT.— 

16 Section 1860D–42 of the Social Security Act (42 U.S.C. 

17 1395w–152) is amended by adding at the end the fol18 lowing new subsection: 

19 ‘‘(d) TREATMENT OF CERTAIN COMPLAINTS FOR

20 PURPOSES OF QUALITY OR PERFORMANCE ASSESS21 MENT.—In conducting a quality or performance assess22 ment of a PDP sponsor, the Secretary shall develop or 

23 utilize existing screening methods for reviewing and con24 sidering complaints that are received from enrollees in a 

25 prescription drug plan offered by such PDP sponsor and 


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1 that are complaints regarding the lack of access by the 

2 individual to prescription drugs due to a drug manage3 ment program for at-risk beneficiaries.’’. 

4 (e) SENSE OF CONGRESS REGARDING USE OF TECH5 NOLOGY TOOLS TO COMBAT FRAUD.—It is the sense of 

6 Congress that MA organizations and PDP sponsors 

7 should consider using e-prescribing and other health infor8 mation technology tools to support combating fraud under 

9 MA–PD plans and prescription drug plans under parts C 

10 and D of the Medicare Program. 

11 (f) EFFECTIVE DATE.— 

12 (1) IN GENERAL.—The amendments made by 

13 this section shall apply to prescription drug plans 

14 (and MA–PD plans) for plan years beginning more 

15 than 1 year after the date of the enactment of this 

16 Act. 

17 (2) STAKEHOLDER MEETINGS PRIOR TO EFFEC18 TIVE DATE.— 

19 (A) IN GENERAL.—Not later than January 

20 1, 2016, the Secretary of Health and Human 

21 Services shall convene stakeholders, including 

22 individuals entitled to benefits under part A of 

23 title XVIII of the Social Security Act or en24 rolled under part B of such title of such Act, 

25 advocacy groups representing such individuals, 


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1 physicians, pharmacists, and other clinicians, 

2 retail pharmacies, plan sponsors, entities dele3 gated by plan sponsors, and biopharmaceutical 

4 manufacturers for input regarding the topics 

5 described in subparagraph (B). 

6 (B) TOPICS DESCRIBED.—The topics de7 scribed in this subparagraph are the topics of— 

8 (i) the anticipated impact of drug 

9 management programs for at-risk bene10 ficiaries under paragraph (5) of section 

11 1860D–4(c) of the Social Security Act (42 

12 U.S.C. 1395w–104(c)) on cost-sharing and 

13 ensuring accessibility to prescription drugs 

14 for enrollees in prescription drug plans of 

15 PDP sponsors, and enrollees in MA–PD 

16 plans, who are at-risk beneficiaries for pre17 scription drug abuse (as defined in sub18 paragraph (C) of such paragraph); 

19 (ii) the use of an expedited appeals 

20 process under which such an enrollee may 

21 appeal an identification of such enrollee as 

22 an at-risk beneficiary for prescription drug 

23 abuse under such paragraph (similar to the 

24 processes established under the Medicare 

25 Advantage program under part C of title 


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1 XVIII of the Social Security Act that allow 

2 an automatic escalation to external review 

3 of claims submitted under such part); 

4 (iii) the types of enrollees that should 

5 be treated as exempted individuals, as de6 scribed in subparagraph (C)(ii) of such 

7 paragraph; 

8 (iv) the manner in which terms and 

9 definitions in such paragraph should be ap10 plied, such as the use of clinical appro11 priateness in determining whether an en12 rollee is an at-risk beneficiary for prescrip13 tion drug abuse as defined in subpara14 graph (C) of such paragraph; 

15 (v) the information to be included in 

16 the notices described in subparagraph (B) 

17 of such paragraph and the standardization 

18 of such notices; and 

19 (vi) with respect to a PDP sponsor 

20 (or Medicare Advantage organization) that 

21 establishes a drug management program 

22 for at-risk beneficiaries under such para23 graph, the responsibilities of such PDP 

24 sponsor (or organization) with respect to 

25 the implementation of such program. 


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1 (g) RULEMAKING.—The Secretary of Health and 

2 Human Services shall promulgate regulations based on the 

3 input gathered pursuant to subsection (f)(2)(A). 

4 SEC. 502. EXCLUSION OF AUTHORIZED GENERIC DRUGS 

5 FROM CALCULATION OF AVERAGE MANUFAC6 TURER PRICE FOR BRAND NAME DRUGS. 

7 (a) IN GENERAL.—Section 1927(k)(1)(C) of the So8 cial Security Act (42 U.S.C. 1396r–8(k)(1)(C)) is amend9 ed— 

10 (1) in the subparagraph heading, by striking 

11 ‘‘INCLUSION’’ and inserting ‘‘EXCLUSION’’; 

12 (2) by striking ‘‘a new drug application’’ and 

13 inserting ‘‘the manufacturer’s new drug applica14 tion’’; and 

15 (3) by striking ‘‘inclusive’’ and inserting ‘‘exclu16 sive’’. 

17 (b) EFFECTIVE DATE.—The amendments made by 

18 subsection (a) shall take effect one year after the date of 

19 the enactment of this section. 

Æ 


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