115TH CONGRESS 

2D SESSION H. R. 5605 

AN ACT 

To amend title XVIII of the Social Security Act to provide 

for an opioid use disorder treatment demonstration program, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Advancing High Qual3 ity Treatment for Opioid Use Disorders in Medicare Act’’. 

4 SEC. 2. OPIOID USE DISORDER TREATMENT DEMONSTRA5 TION PROGRAM. 

6 Title XVIII of the Social Security Act (42 U.S.C. 

7 1395 et seq.) is amended by inserting after section 1866E 

8 (42 U.S.C. 1395cc–5) the following new section: 

9 ‘‘SEC. 1866F. OPIOID USE DISORDER TREATMENT DEM10 ONSTRATION PROGRAM. 

11 ‘‘(a) IMPLEMENTATION OF 4-YEAR DEMONSTRATION

12 PROGRAM.— 

13 ‘‘(1) IN GENERAL.—Not later than January 1, 

14 2021, the Secretary shall implement a 4-year dem15 onstration program under this title (in this section 

16 referred to as the ‘Program’) to increase access of 

17 applicable beneficiaries to opioid use disorder treat18 ment services, improve physical and mental health 

19 outcomes for such beneficiaries, and to the extent 

20 possible, reduce expenditures under this title. Under 

21 the Program, the Secretary shall make payments 

22 under subsection (e) to participants (as defined in 

23 subsection (c)(1)(A)) for furnishing opioid use dis24 order treatment services delivered through opioid use 

25 disorder care teams, or arranging for such service to 
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1 be furnished, to applicable beneficiaries participating 

2 in the Program. 

3 ‘‘(2) OPIOID USE DISORDER TREATMENT SERV4 ICES.—For purposes of this section, the term ‘opioid 

5 use disorder treatment services’— 

6 ‘‘(A) means, with respect to an applicable 

7 beneficiary, services that are furnished for the 

8 treatment of opioid use disorders and that uti9 lize drugs approved under section 505 of the 

10 Federal Food, Drug, and Cosmetic Act for the 

11 treatment of opioid use disorders in an out12 patient setting; and 

13 ‘‘(B) includes— 

14 ‘‘(i) medication assisted treatment; 

15 ‘‘(ii) treatment planning; 

16 ‘‘(iii) psychiatric, psychological, or 

17 counseling services (or any combination of 

18 such services), as appropriate; 

19 ‘‘(iv) social support services, as appro20 priate; and 

21 ‘‘(v) care management and care co22 ordination services, including coordination 

23 with other providers of services and sup24 pliers not on an opioid use disorder care 

25 team. 
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1 ‘‘(b) PROGRAM DESIGN.— 

2 ‘‘(1) IN GENERAL.—The Secretary shall design 

3 the Program in such a manner to allow for the eval4 uation of the extent to which the Program accom5 plishes the following purposes: 

6 ‘‘(A) Reduces hospitalizations and emer7 gency department visits. 

8 ‘‘(B) Increases use of medication-assisted 

9 treatment for opioid use disorders. 

10 ‘‘(C) Improves health outcomes of individ11 uals with opioid use disorders, including by re12 ducing the incidence of infectious diseases (such 

13 as hepatitis C and HIV). 

14 ‘‘(D) Does not increase the total spending 

15 on items and services under this title. 

16 ‘‘(E) Reduces deaths from opioid overdose. 

17 ‘‘(F) Reduces the utilization of inpatient 

18 residential treatment. 

19 ‘‘(2) CONSULTATION.—In designing the Pro20 gram, including the criteria under subsection 

21 (e)(2)(A), the Secretary shall, not later than 3 

22 months after the date of the enactment of this sec23 tion, consult with specialists in the field of addiction, 

24 clinicians in the primary care community, and bene25 ficiary groups. 
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1 ‘‘(c) PARTICIPANTS; OPIOID USE DISORDER CARE

2 TEAMS.— 

3 ‘‘(1) PARTICIPANTS.— 

4 ‘‘(A) DEFINITION.—In this section, the 

5 term ‘participant’ means an entity or indi6 vidual— 

7 ‘‘(i) that is otherwise enrolled under 

8 this title and that is— 

9 ‘‘(I) a physician (as defined in 

10 section 1861(r)(1)); 

11 ‘‘(II) a group practice comprised 

12 of at least one physician described in 

13 subclause (I); 

14 ‘‘(III) a hospital outpatient de15 partment; 

16 ‘‘(IV) a federally qualified health 

17 center (as defined in section 

18 1861(aa)(4)); 

19 ‘‘(V) a rural health clinic (as de20 fined in section 1861(aa)(2)); 

21 ‘‘(VI) a community mental health 

22 center (as defined in section 

23 1861(ff)(3)(B)); 

24 ‘‘(VII) a clinic certified as a cer25 tified community behavioral health 
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1 clinic pursuant to section 223 of the 

2 Protecting Access to Medicare Act of 

3 2014; or 

4 ‘‘(VIII) any other individual or 

5 entity specified by the Secretary; 

6 ‘‘(ii) that applied for and was selected 

7 to participate in the Program pursuant to 

8 an application and selection process estab9 lished by the Secretary; and 

10 ‘‘(iii) that establishes an opioid use 

11 disorder care team (as defined in para12 graph (2)) through employing or con13 tracting with health care practitioners de14 scribed in paragraph (2)(A), and uses such 

15 team to furnish or arrange for opioid use 

16 disorder treatment services in the out17 patient setting under the Program. 

18 ‘‘(B) PREFERENCE.—In selecting partici19 pants for the Program, the Secretary shall give 

20 preference to individuals and entities that are 

21 located in areas with a prevalence of opioid use 

22 disorders that is higher than the national aver23 age prevalence. 

24 ‘‘(2) OPIOID USE DISORDER CARE TEAMS.— 
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1 ‘‘(A) IN GENERAL.—For purposes of this 

2 section, the term ‘opioid use disorder care team’ 

3 means a team of health care practitioners es4 tablished by a participant described in para5 graph (1)(A) that— 

6 ‘‘(i) shall include— 

7 ‘‘(I) at least one physician (as 

8 defined in section 1861(r)(1)) fur9 nishing primary care services or ad10 diction treatment services to an appli11 cable beneficiary; and 

12 ‘‘(II) at least one eligible practi13 tioner (as defined in paragraph 

14 (3)(A)), who may be a physician who 

15 meets the criterion in subclause (I); 

16 and 

17 ‘‘(ii) may include other practitioners 

18 licensed under State law to furnish psy19 chiatric, psychological, counseling, and so20 cial services to applicable beneficiaries. 

21 ‘‘(B) REQUIREMENTS FOR RECEIPT OF

22 PAYMENT UNDER PROGRAM.—In order to re23 ceive payments under subsection (e), each par24 ticipant in the Program shall— 
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1 ‘‘(i) furnish opioid use disorder treat2 ment services through opioid use disorder 

3 care teams to applicable beneficiaries who 

4 agree to receive the services; 

5 ‘‘(ii) meet minimum criteria, as estab6 lished by the Secretary; and 

7 ‘‘(iii) submit to the Secretary, in such 

8 form, manner, and frequency as specified 

9 by the Secretary, with respect to each ap10 plicable beneficiary for whom opioid use 

11 disorder treatment services are furnished 

12 by the opioid use disorder care team, data 

13 and such other information as the Sec14 retary determines appropriate to— 

15 ‘‘(I) monitor and evaluate the 

16 Program; 

17 ‘‘(II) determine if minimum cri18 teria are met under clause (ii); and 

19 ‘‘(III) determine the incentive 

20 payment under subsection (e). 

21 ‘‘(3) ELIGIBLE PRACTITIONERS; OTHER PRO22 VIDER-RELATED DEFINITIONS AND APPLICATION

23 PROVISIONS.— 

24 ‘‘(A) ELIGIBLE PRACTITIONERS.—For pur25 poses of this section, the term ‘eligible practi-
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1 tioner’ means a physician or other health care 

2 practitioner, such as a nurse practitioner, 

3 that— 

4 ‘‘(i) is enrolled under section 

5 1866(j)(1); 

6 ‘‘(ii) is authorized to prescribe or dis7 pense narcotic drugs to individuals for 

8 maintenance treatment or detoxification 

9 treatment; and 

10 ‘‘(iii) has in effect a waiver in accord11 ance with section 303(g) of the Controlled 

12 Substances Act for such purpose and is 

13 otherwise in compliance with regulations 

14 promulgated by the Substance Abuse and 

15 Mental Health Services Administration to 

16 carry out such section. 

17 ‘‘(B) ADDICTION SPECIALISTS.—For pur18 poses of subsection (e)(1)(B)(iv), the term ‘ad19 diction specialist’ means a physician that pos20 sesses expert knowledge and skills in addiction 

21 medicine, as evidenced by appropriate certifi22 cation from a specialty body, a certificate of ad23 vanced qualification in addiction medicine, or 

24 completion of an accredited residency or fellow-
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1 ship in addiction medicine or addiction psychi2 atry, as determined by the Secretary. 

3 ‘‘(d) PARTICIPATION OF APPLICABLE BENE4 FICIARIES.— 

5 ‘‘(1) APPLICABLE BENEFICIARY DEFINED.—In 

6 this section, the term ‘applicable beneficiary’ means 

7 an individual who— 

8 ‘‘(A) is entitled to, or enrolled for, benefits 

9 under part A and enrolled for benefits under 

10 part B; 

11 ‘‘(B) is not enrolled in a Medicare Advan12 tage plan under part C; 

13 ‘‘(C) has a current diagnosis for an opioid 

14 use disorder; and 

15 ‘‘(D) meets such other criteria as the Sec16 retary determines appropriate. 

17 Such term shall include an individual who is dually 

18 eligible for benefits under this title and title XIX if 

19 such individual satisfies the criteria described in 

20 subparagraphs (A) through (D). 

21 ‘‘(2) VOLUNTARY PARTICIPATION; LIMITATION

22 ON NUMBER OF PARTICIPANTS.—An applicable bene23 ficiary may participate in the Program on a vol24 untary basis and may terminate participation in the 

25 Program at any time. Not more than 20,000 appli-
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1 cable beneficiaries may participate in the Program 

2 at any time. 

3 ‘‘(3) SERVICES.—In order to participate in the 

4 Program, an applicable beneficiary shall agree to re5 ceive opioid use disorder treatment services from a 

6 participant. Participation under the Program shall 

7 not affect coverage of or payment for any other item 

8 or service under this title for the applicable bene9 ficiary. 

10 ‘‘(4) BENEFICIARY ACCESS TO SERVICES.— 

11 Nothing in this section shall be construed as encour12 aging providers to limit applicable beneficiary access 

13 to services covered under this title and applicable 

14 beneficiaries shall not be required to relinquish ac15 cess to any benefit under this title as a condition of 

16 receiving services from a participant in the Program. 

17 ‘‘(e) PAYMENTS.— 

18 ‘‘(1) PER APPLICABLE BENEFICIARY PER

19 MONTH CARE MANAGEMENT FEE.— 

20 ‘‘(A) IN GENERAL.—The Secretary shall 

21 establish a schedule of per applicable bene22 ficiary per month care management fees. Such 

23 a per applicable beneficiary per month care 

24 management fee shall be paid to a participant 

25 in addition to any other amount otherwise pay-
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1 able under this title to the health care practi2 tioners in the participant’s opioid use disorder 

3 care team or, if applicable, to the participant. 

4 A participant may use such per applicable bene5 ficiary per month care management fee to de6 liver additional services to applicable bene7 ficiaries, including services not otherwise eligi8 ble for payment under this title. 

9 ‘‘(B) PAYMENT AMOUNTS.—In carrying 

10 out subparagraph (A), the Secretary shall— 

11 ‘‘(i) consider payments otherwise pay12 able under this title for opioid use disorder 

13 treatment services and the needs of appli14 cable beneficiaries; 

15 ‘‘(ii) pay a higher per applicable bene16 ficiary per month care management fee for 

17 an applicable beneficiary who receives more 

18 intensive treatment services from a partici19 pant and for whom those services are ap20 propriate based on clinical guidelines for 

21 opioid use disorder care; 

22 ‘‘(iii) pay a higher per applicable ben23 eficiary per month care management fee 

24 for the month in which the applicable ben25 eficiary begins treatment with a partici-
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1 pant than in subsequent months, to reflect 

2 the greater time and costs required for the 

3 planning and initiation of treatment, as 

4 compared to maintenance of treatment; 

5 ‘‘(iv) pay higher per applicable bene6 ficiary per month care management fees 

7 for participants that have established 

8 opioid use disorder care teams that include 

9 an addiction specialist (as defined in sub10 section (c)(3)(B)); and 

11 ‘‘(v) take into account whether a par12 ticipant’s opioid use disorder care team re13 fers applicable beneficiaries to other sup14 pliers or providers for any opioid use dis15 order treatment services. 

16 ‘‘(C) NO DUPLICATE PAYMENT.—The Sec17 retary shall make payments under this para18 graph to only one participant for services fur19 nished to an applicable beneficiary during a cal20 endar month. 

21 ‘‘(2) INCENTIVE PAYMENTS.— 

22 ‘‘(A) IN GENERAL.—Under the Program, 

23 the Secretary shall establish a performance24 based incentive payment, which shall be paid 

25 (using a methodology established and at a time 
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1 determined appropriate by the Secretary) to 

2 participants based on the performance of par3 ticipants with respect to criteria, as determined 

4 appropriate by the Secretary, in accordance 

5 with subparagraph (B). 

6 ‘‘(B) CRITERIA.— 

7 ‘‘(i) IN GENERAL.—Criteria described 

8 in subparagraph (A) may include consider9 ation of the following: 

10 ‘‘(I) Patient engagement and re11 tention in treatment. 

12 ‘‘(II) Evidence-based medication13 assisted treatment. 

14 ‘‘(III) Other criteria established 

15 by the Secretary. 

16 ‘‘(ii) REQUIRED CONSULTATION AND

17 CONSIDERATION.—In determining criteria 

18 described in subparagraph (A), the Sec19 retary shall— 

20 ‘‘(I) consult with stakeholders, 

21 including clinicians in the primary 

22 care community and in the field of ad23 diction medicine; and 
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1 ‘‘(II) consider existing clinical 

2 guidelines for the treatment of opioid 

3 use disorders. 

4 ‘‘(C) NO DUPLICATE PAYMENT.—The Sec5 retary shall ensure that no duplicate payments 

6 under this paragraph are made with respect to 

7 an applicable beneficiary. 

8 ‘‘(f) MULTIPAYER STRATEGY.—In carrying out the 

9 Program, the Secretary shall encourage other payers to 

10 provide similar payments and to use similar criteria as ap11 plied under the Program under subsection (e)(2)(C). The 

12 Secretary may enter into a memorandum of understanding 

13 with other payers to align the methodology for payment 

14 provided by such a payer related to opioid use disorder 

15 treatment services with such methodology for payment 

16 under the Program. 

17 ‘‘(g) EVALUATION.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall con19 duct an intermediate and final evaluation of the pro20 gram. Each such evaluation shall determine the ex21 tent to which each of the purposes described in sub22 section (b) have been accomplished under the Pro23 gram. 

24 ‘‘(2) REPORTS.—The Secretary shall submit to 

25 the Secretary and Congress— 
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1 ‘‘(A) a report with respect to the inter2 mediate evaluation under paragraph (1) not 

3 later than 3 years after the date of the imple4 mentation of the Program; and 

5 ‘‘(B) a report with respect to the final 

6 evaluation under paragraph (1) not later than 

7 6 years after such date. 

8 ‘‘(h) FUNDING.— 

9 ‘‘(1) ADMINISTRATIVE FUNDING.—For the pur10 poses of implementing, administering, and carrying 

11 out the Program (other than for purposes described 

12 in paragraph (2)), $5 million shall be available from 

13 the Federal Supplementary Medical Insurance Trust 

14 Fund under section 1841. 

15 ‘‘(2) CARE MANAGEMENT FEES AND INCEN16 TIVES.—For the purposes of making payments 

17 under subsection (e), $10 million shall be available 

18 from the Federal Supplementary Medical Insurance 

19 Trust Fund under section 1841 for each of fiscal 

20 years 2021 through 2024. 

21 ‘‘(3) AVAILABILITY.—Amounts transferred 

22 under this subsection for a fiscal year shall be avail23 able until expended. 
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1 ‘‘(i) WAIVERS.—The Secretary may waive any provi2 sion of this title as may be necessary to carry out the Pro3 gram under this section.’’. 

4 SEC. 3. REQUIRING E-PRESCRIBING FOR COVERAGE OF 

5 COVERED PART D CONTROLLED SUB6 STANCES. 

7 (a) IN GENERAL.—Section 1860D–4(e) of the Social 

8 Security Act (42 U.S.C. 1395w–104(e)) is amended by 

9 adding at the end the following: 

10 ‘‘(7) REQUIREMENT OF E-PRESCRIBING FOR

11 CONTROLLED SUBSTANCES.— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graph (B), a prescription for a covered part D 

14 drug under a prescription drug plan (or under 

15 an MA–PD plan) for a schedule II, III, IV, or 

16 V controlled substance shall be transmitted by 

17 a health care practitioner electronically in ac18 cordance with an electronic prescription drug 

19 program that meets the requirements of para20 graph (2). 

21 ‘‘(B) EXCEPTION FOR CERTAIN CIR22 CUMSTANCES.—The Secretary shall, pursuant 

23 to rulemaking, specify circumstances with re24 spect to which the Secretary may waive the re25 quirement under subparagraph (A), with re-
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1 spect to a covered part D drug, including in the 

2 case of— 

3 ‘‘(i) a prescription issued when the 

4 practitioner and dispenser are the same 

5 entity; 

6 ‘‘(ii) a prescription issued that cannot 

7 be transmitted electronically under the 

8 most recently implemented version of the 

9 National Council for Prescription Drug 

10 Programs SCRIPT Standard; 

11 ‘‘(iii) a prescription issued by a practi12 tioner who has received a waiver or a re13 newal thereof for a specified period deter14 mined by the Secretary, not to exceed 1 

15 year, from the requirement to use elec16 tronic prescribing, pursuant to a process 

17 established by regulation by the Secretary, 

18 due to demonstrated economic hardship, 

19 technological limitations that are not rea20 sonably within the control of the practi21 tioner, or other exceptional circumstance 

22 demonstrated by the practitioner; 

23 ‘‘(iv) a prescription issued by a practi24 tioner under circumstances in which, not25 withstanding the practitioner’s ability to 
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1 submit a prescription electronically as re2 quired by this subsection, such practitioner 

3 reasonably determines that it would be im4 practical for the individual involved to ob5 tain substances prescribed by electronic 

6 prescription in a timely manner, and such 

7 delay would adversely impact the individ8 ual’s medical condition involved; 

9 ‘‘(v) a prescription issued by a practi10 tioner allowing for the dispensing of a non11 patient specific prescription pursuant to a 

12 standing order, approved protocol for drug 

13 therapy, collaborative drug management, 

14 or comprehensive medication management, 

15 in response to a public health emergency, 

16 or other circumstances where the practi17 tioner may issue a non-patient specific pre18 scription; 

19 ‘‘(vi) a prescription issued by a practi20 tioner prescribing a drug under a research 

21 protocol; 

22 ‘‘(vii) a prescription issued by a prac23 titioner for a drug for which the Food and 

24 Drug Administration requires a prescrip25 tion to contain elements that are not able 
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1 to be included in electronic prescribing, 

2 such as a drug with risk evaluation and 

3 mitigation strategies that include elements 

4 to assure safe use; and 

5 ‘‘(viii) a prescription issued by a prac6 titioner for an individual who— 

7 ‘‘(I) receives hospice care under 

8 this title; or 

9 ‘‘(II) is a resident of a skilled 

10 nursing facility (as defined in section 

11 1819(a)), or a medical institution or 

12 nursing facility for which payment is 

13 made for an institutionalized indi14 vidual under section 1902(q)(1)(B), 

15 for which frequently abused drugs are 

16 dispensed for residents through a con17 tract with a single pharmacy, as de18 termined by the Secretary in accord19 ance with this paragraph. 

20 ‘‘(C) DISPENSING.—Nothing in this para21 graph shall be construed as requiring a sponsor 

22 of a prescription drug plan under this part, MA 

23 organization offering an MA–PD plan under 

24 part C, or a pharmacist to verify that a practi25 tioner, with respect to a prescription for a cov-
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1 ered part D drug, has a waiver (or is otherwise 

2 exempt) under subparagraph (B) from the re3 quirement under subparagraph (A). Nothing in 

4 this paragraph shall be construed as affecting 

5 the ability of the plan to cover or the phar6 macists’ ability to continue to dispense covered 

7 part D drugs from otherwise valid written, oral 

8 or fax prescriptions that are consistent with 

9 laws and regulations. Nothing in this paragraph 

10 shall be construed as affecting the ability of the 

11 beneficiary involved to designate a particular 

12 pharmacy to dispense a prescribed drug to the 

13 extent consistent with the requirements under 

14 subsection (b)(1) and under this paragraph. 

15 ‘‘(D) ENFORCEMENT.—The Secretary 

16 shall, pursuant to rulemaking, have authority to 

17 enforce and specify appropriate penalties for 

18 non-compliance with the requirement under 

19 subparagraph (A).’’. 
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1 (b) EFFECTIVE DATE.—The amendment made by 

2 subsection (a) shall apply to coverage of drugs prescribed 

3 on or after January 1, 2021. 

Passed the House of Representatives June 19, 2018. 

Attest: 

Clerk. 

115TH CONGRESS 

2D SESSION H. R. 5605 

AN ACT 

To amend title XVIII of the Social Security Act to 

demonstration program, and for other purposes. provide for an opioid use disorder treatment