IB 

Union Calendar No. 561 

115TH CONGRESS 

2D SESSION H. R. 5808 

[Report No. 115–726] 

To amend title XIX of the Social Security Act to require States to operate 

drug management programs for at-risk beneficiaries, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 15, 2018 

Mr. BILIRAKIS (for himself and Mr. BEN RAY LUJA ́N of New Mexico) introduced the following bill; which was referred to the Committee on Energy 

and Commerce 

JUNE 12, 2018 

Additional sponsors: Mrs. BLACKBURN and Mr. WALDEN

JUNE 12, 2018 

Committed to the Committee of the Whole House on the State of the Union 

and ordered to be printed 


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A BILL 

To amend title XIX of the Social Security Act to require 

States to operate drug management programs for atrisk beneficiaries, and for other purposes. 


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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicaid Pharma5 ceutical Home Act of 2018’’. 

6 SEC. 2. DRUG MANAGEMENT PROGRAM FOR AT-RISK BENE7 FICIARIES. 

8 (a) IN GENERAL.—Title XIX of the Social Security 

9 Act is amended by inserting after section 1927 (42 U.S.C. 

10 1396r–8) the following new section: 

11 ‘‘SEC. 1927A. DRUG MANAGEMENT PROGRAM FOR AT-RISK 

12 BENEFICIARIES. 

13 ‘‘(a) IN GENERAL.—Beginning January 1, 2020, a 

14 State shall operate a qualified drug management program 

15 under which a State may enroll certain at-risk bene16 ficiaries identified by the State under the program. 

17 ‘‘(b) QUALIFIED DRUG MANAGEMENT PROGRAM.— 

18 For purposes of this section, the term ‘qualified drug man19 agement program’ means, with respect to a State, a pro20 gram carried out by the State (including through a con21 tract with a pharmacy benefit manager) that provides at 

22 least for the following: 

23 ‘‘(1) IDENTIFICATION OF AT-RISK INDIVID24 UALS.—Under the program, the State identifies, in 

25 accordance with subsection (c), individuals enrolled 


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1 under the State plan (or waiver of the State plan) 

2 who are at-risk beneficiaries. 

3 ‘‘(2) ELEMENTS OF PROGRAM.— 

4 ‘‘(A) IN GENERAL.—Under the program, 

5 the State, with respect to each individual identi6 fied under paragraph (1) and enrolled under 

7 the program under paragraph (5)— 

8 ‘‘(i) subject to subparagraphs (B) and 

9 (C), selects at least one, but not more than 

10 three, health care providers and at least 

11 one, but not more than three, pharmacies 

12 for each such individual for purposes of 

13 clause (ii), in accordance with a selection 

14 process that takes into account reasonable 

15 factors such as the individual’s previous 

16 utilization of items and services from 

17 health care providers and pharmacies, geo18 graphic proximity of the individual to such 

19 health care providers and pharmacies, ac20 cess of the individual to health care, rea21 sonable travel time, information regarding 

22 housing status, and any known preference 

23 of the individual for a certain health care 

24 provider or pharmacy; and 


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1 ‘‘(ii) requires that any controlled sub2 stance furnished to such individual during 

3 the period for which such individual is en4 rolled under the program be prescribed by 

5 a health care provider selected under 

6 clause (i) for such individual and dispensed 

7 by a pharmacy selected under clause (i) for 

8 such individual in order for such controlled 

9 substance to be covered under the State 

10 plan (or waiver). 

11 ‘‘(B) BENEFICIARY PREFERENCE.—In the 

12 case of an individual receiving a notice under 

13 paragraph (3)(A) of being identified as poten14 tially being an at-risk beneficiary described in 

15 such paragraph, such individual may submit, 

16 during the 30-day period following receipt of 

17 such notice, preferences for which health care 

18 providers and pharmacies the individual would 

19 prefer the State to select under subparagraph 

20 (A). The State shall select or change the selec21 tion of health care providers and pharmacies 

22 under subparagraph (A) for the individuals 

23 based on such preferences, except that in the 

24 case that State determines that such selection 

25 (or change of selection) of a health care proVerDate Sep 11 2014 02:05 Jun 13, 2018 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5808.RH H5808

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1 vider or pharmacy under subparagraph (A) is 

2 contributing or would contribute to prescription 

3 drug abuse or drug diversion by the individual, 

4 the State may select or change the selection of 

5 health care provider or pharmacy for the indi6 vidual without regard to the preferences of the 

7 individual described in this subparagraph. If the 

8 State selects or changes the selection pursuant 

9 to the preceding sentence without regard to the 

10 preferences of the individual, the State shall 

11 provide the individual with at least 30 days 

12 written notice of the selection or change of se13 lection and a rationale for the selection or 

14 change. 

15 ‘‘(C) TREATMENT OF PHARMACY WITH

16 MULTIPLE LOCATIONS.—For purposes of sub17 paragraph (A)(i), in the case of a pharmacy 

18 that has multiple locations that share real-time 

19 electronic prescription data and the same chain 

20 identification number, all such locations of the 

21 pharmacy shall collectively be treated as one 

22 pharmacy. 

23 ‘‘(D) TREATMENT OF EXISTING FFS DRUG

24 MANAGEMENT PROGRAMS.—In the case of a pa25 tient review and restriction program (as identiVerDate Sep 11 2014 02:05 Jun 13, 2018 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5808.RH H5808

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1 fied in the annual report submitted to the Sec2 retary under section 1927(g)(3)(D)) operated 

3 by a State pursuant to section 1915(a)(2) be4 fore the date of the enactment of this section, 

5 such program shall be treated as a qualified 

6 drug management program. 

7 ‘‘(E) REASONABLE ACCESS.—The program 

8 shall ensure, including through waiver of ele9 ments of the program (including under sub10 paragraph (A)(ii)), reasonable access to health 

11 care (including access to health care providers 

12 and pharmacies with respect to prescription 

13 drugs described in subparagraph (A)) in the 

14 case of individuals with multiple residences, in 

15 the case of natural disasters and similar situa16 tions, and in the case of the provision of emer17 gency services (as defined for purposes of sec18 tion 1860D–4(c)(5)(D)(ii)(II)). 

19 ‘‘(3) NOTIFICATION TO IDENTIFIED INDIVID20 UALS.—Under the program, the State provides each 

21 individual who is identified under paragraph (1), 

22 prior to enrolling such individual under the program, 

23 at least one notification of each of the following: 

24 ‘‘(A) Notice that the State has identified 

25 the individual as potentially being an at-risk 


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1 beneficiary for abuse or misuse of a controlled 

2 substance. 

3 ‘‘(B) The name, address, and contact in4 formation of each health care provider and 

5 pharmacy that may be selected for the indi6 vidual under paragraph (2)(A). 

7 ‘‘(C) Information describing all State and 

8 Federal public health resources that are de9 signed to address such abuse or misuse to 

10 which the individual has access, including men11 tal health services and other counseling serv12 ices. 

13 ‘‘(D) Notice of, and information about, the 

14 right of the individual to— 

15 ‘‘(i) submit preferences of the indi16 vidual for health care providers and phar17 macies to be selected under paragraph 

18 (2)(A), including as described in paragraph 

19 (2)(B); 

20 ‘‘(ii) appeal under paragraph (4)— 

21 ‘‘(I) such identification described 

22 in subparagraph (A); and 

23 ‘‘(II) the selection of health care 

24 providers and pharmacies under para25 graph (2)(A). 


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1 ‘‘(E) An explanation of the meaning and 

2 consequences of the identification of the indi3 vidual as potentially being an at-risk beneficiary 

4 for abuse or misuse of a controlled substance, 

5 including an explanation of the program. 

6 ‘‘(F) Information, including a contact list 

7 and clear instructions, that explain how the in8 dividual can contact the appropriate entities ad9 ministering the program in order to submit 

10 preferences described in paragraph (2)(B) and 

11 any other communications relating to the pro12 gram. 

13 ‘‘(4) APPEALS PROCESS.—Under the program, 

14 the State provides for an appeals process under 

15 which, with respect to an individual identified under 

16 paragraph (1)— 

17 ‘‘(A) such individual may appeal— 

18 ‘‘(i) such identification; and 

19 ‘‘(ii) the selection of a health care pro20 vider or pharmacy under paragraph (2)(A); 

21 ‘‘(B) in the case of an appeal described in 

22 subparagraph (A)(ii), the State shall accommo23 date the health care provider or pharmacy pre24 ferred by the individual for selection for pur25 poses of paragraph (2)(A), unless the State deVerDate Sep 11 2014 02:05 Jun 13, 2018 Jkt 079200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5808.RH H5808

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1 termines that a change to the selection of 

2 health care provider or pharmacy under such 

3 paragraph is contributing or would contribute 

4 to prescription drug abuse or drug diversion by 

5 the individual; 

6 ‘‘(C) such individual is provided a period of 

7 not less than 30 days following the date of re8 ceipt of the notice described in paragraph (3) to 

9 submit such appeal; and 

10 ‘‘(D) the State must make a determination 

11 with respect to an appeal described in subpara12 graph (A), and notify the individual of such de13 termination, prior to enrollment of such indi14 vidual in the program. 

15 ‘‘(5) ENROLLMENT.—Under the program, the 

16 State initially enrolls individuals who are identified 

17 under paragraph (1) in the program for a 12-month 

18 period— 

19 ‘‘(A) in the case of such an individual who 

20 does not submit an appeal under paragraph (4) 

21 within the period applied by the State pursuant 

22 to subparagraph (C) of such paragraph, begin23 ning on the day after the last day of such pe24 riod; and 


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1 ‘‘(B) in the case of such an individual who 

2 does submit an appeal under paragraph (4) 

3 within the period applied by the State pursuant 

4 to subparagraph (C) of such paragraph but 

5 such appeal is denied, beginning not later than 

6 30 days after the date of such denial. 

7 ‘‘(6) NOTIFICATION OF HEALTH CARE PRO8 VIDERS AND PHARMACIES.—Under the program, the 

9 State provides to each health care provider and 

10 pharmacy selected for an individual under paragraph 

11 (2)— 

12 ‘‘(A) notification that the individual is an 

13 at-risk beneficiary enrolled under the program 

14 and that the provider or pharmacy has been se15 lected for the individual under paragraph (2); 

16 ‘‘(B) information on such program and the 

17 role of being so selected; and 

18 ‘‘(C) a process through which the provider 

19 or pharmacy can submit a concern or complaint 

20 with respect to being so selected and refuse to 

21 be a provider or pharmacy so selected. 

22 ‘‘(7) CONTINUATION OF ENROLLMENT.—Under 

23 the program, the State, with respect to an individual 

24 enrolled under the program, provides for a process 

25 to— 


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1 ‘‘(A) not later than 30 days before the end 

2 of the 12-month period for which the individual 

3 is so enrolled pursuant to paragraph (5)— 

4 ‘‘(i) assess, in accordance with pub5 licly available evidence-based guidelines, 

6 whether or not such individual should con7 tinue to be enrolled under the program; 

8 and 

9 ‘‘(ii) notify such individual of the re10 sults of the assessment under clause (i); 

11 ‘‘(B) continue, subject to subparagraph 

12 (C), enrollment of such individual if such as13 sessment recommends such continuation; and 

14 ‘‘(C) appeal the continuation of enrollment 

15 in accordance with the appeals process de16 scribed in paragraph (4). 

17 ‘‘(c) AT-RISK BENEFICIARY.— 

18 ‘‘(1) IDENTIFICATION.—For purposes of this 

19 section, a State shall identify an individual enrolled 

20 under the State plan (or waiver of the State plan) 

21 as an at-risk beneficiary if the individual is not an 

22 exempted individual described in paragraph (2) 

23 and— 

24 ‘‘(A) is identified as such an at-risk bene25 ficiary through the use of publicly available eviVerDate Sep 11 2014 02:05 Jun 13, 2018 Jkt 079200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H5808.RH H5808

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1 dence-based guidelines that indicate misuse or 

2 abuse of a controlled substance; or 

3 ‘‘(B) the State received notification from a 

4 PDP sponsor or Medicare Advantage organiza5 tion that such individual was identified as being 

6 an at-risk beneficiary for prescription drug 

7 abuse for enrollment in a drug management 

8 program established by the sponsor or organiza9 tion pursuant to section 1860D–4(c)(5) and 

10 such identification has not been terminated 

11 under subparagraph (F) of such section. 

12 ‘‘(2) EXEMPTED INDIVIDUAL DESCRIBED.—For 

13 purposes of paragraph (1), an exempted individual 

14 described in this paragraph is an individual who— 

15 ‘‘(A) is receiving— 

16 ‘‘(i) hospice or palliative care; or 

17 ‘‘(ii) treatment for cancer; 

18 ‘‘(B) is a resident of a long-term care facil19 ity, of a facility described in section 1905(d), or 

20 of another facility for which frequently abused 

21 drugs are dispensed for residents through a 

22 contract with a single pharmacy; or 

23 ‘‘(C) the State elects to treat as an ex24 empted individual for purposes of paragraph 

25 (1). 


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1 ‘‘(d) APPLICATION OF PRIVACY RULES CLARIFICA2 TION.—The Secretary shall clarify privacy requirements, 

3 including requirements under the regulations promulgated 

4 pursuant to section 264(c) of the Health Insurance Port5 ability and Accountability Act of 1996 (42 U.S.C. 1320d– 

6 2 note), related to the sharing of data under subsection 

7 (b)(6) in the same manner as the Secretary is required 

8 under subparagraph (J) of section 1860D–4(c)(5) to clar9 ify privacy requirements related to the sharing of data de10 scribed in such subparagraph. 

11 ‘‘(e) REPORTS.— 

12 ‘‘(1) ANNUAL REPORTS.—A State operating a 

13 qualified drug management program shall include in 

14 the annual report submitted to the Secretary under 

15 section 1927(g)(3)(D), beginning with such reports 

16 submitted for 2021, the following information: 

17 ‘‘(A) The number of individuals enrolled 

18 under the State plan (or waiver of the State 

19 plan) who are enrolled under the program and 

20 the percentage of individuals enrolled under the 

21 State plan (or waiver) who are enrolled under 

22 such program. 

23 ‘‘(B) The number of prescriptions for con24 trolled substances that were dispensed per 

25 month during each such year per individual enVerDate Sep 11 2014 02:05 Jun 13, 2018 Jkt 079200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H5808.RH H5808

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1 rolled under the program, including the dosage 

2 and pill count for each such prescription. 

3 ‘‘(C) The number of pharmacies filling pre4 scriptions for controlled substances for individ5 uals enrolled under such program. 

6 ‘‘(D) The number of health care providers 

7 writing prescriptions for controlled substances 

8 (other than prescriptions for a refill) for indi9 viduals enrolled under such program. 

10 ‘‘(E) Any other data that the Secretary 

11 may require. 

12 ‘‘(F) Any report submitted by a managed 

13 care entity under subsection (e)(2) with respect 

14 to years. 

15 For each such report for a year after 2021, the in16 formation described in this paragraph shall be pro17 vided in a manner that compares such information 

18 with respect to the prior calendar year to such infor19 mation with respect to the second prior calendar 

20 year. 

21 ‘‘(2) MACPAC REPORTS AND REVIEW.—Not 

22 later than two years after the date of the enactment 

23 of this section, the Medicaid and CHIP Payment 

24 and Access Commission (in this section referred to 

25 as ‘MACPAC’), in consultation with the National 


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1 Association of Medicaid Directors, pharmacy benefit 

2 managers, managed care organizations, health care 

3 providers (including pharmacists), beneficiary advo4 cates, and other stakeholders, shall publish a report 

5 that includes— 

6 ‘‘(A) best practices for operating drug 

7 management programs, based on a review of a 

8 representative sample of States administering 

9 such a program; 

10 ‘‘(B) a summary of the experience of the 

11 appeals process under drug management pro12 grams operated by several States, such as the 

13 frequency at which individuals appealed the 

14 identification of being an at-risk individual, the 

15 frequency at which individuals appealed the se16 lection of a health care provider or pharmacy 

17 under such a program, the timeframes for such 

18 appeals, a summary of the reasons for such ap19 peals, and the design of such appeals processes; 

20 ‘‘(C) a summary of trends and the effec21 tiveness of qualified drug management pro22 grams operated under this section; and 

23 ‘‘(D) recommendations to States on how 

24 improvements can be made with respect to the 

25 operation of such programs. 


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1 In reporting on State practices, the MACPAC shall 

2 consider how such programs have been implemented 

3 in rural areas, under fee-for-service as well as man4 aged care arrangements, and the extent to which 

5 such programs have resulted in increased efficiencies 

6 to such States or to the Federal Government under 

7 this title. 

8 ‘‘(3) REPORT ON PLAN FOR COORDINATED

9 CARE.—Not later than January 1, 2021, each State 

10 operating a qualified drug management program 

11 shall submit to the Administrator of the Centers for 

12 Medicare & Medicaid Services a report on how such 

13 State plans to provide coordinated care for individ14 uals enrolled under the State plan (or waiver of the 

15 State plan) and— 

16 ‘‘(A) who are enrolled under the program; 

17 or 

18 ‘‘(B) who are enrolled with a managed care 

19 entity and enrolled under such a qualified drug 

20 management program operated by such entity. 

21 ‘‘(f) APPLICABILITY TO MANAGED CARE ENTI22 TIES.— 

23 ‘‘(1) IN GENERAL.—With respect to any con24 tract that a State enters into on or after January 

25 1, 2020, with a managed care entity (as defined in 


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1 section 1932(a)(1)(B)) pursuant to section 1903(m), 

2 the State shall, as a condition of the contract, re3 quire the managed care entity— 

4 ‘‘(A) to operate a qualified drug manage5 ment program (as defined in subsection (b)) for 

6 at-risk beneficiaries who are enrolled with such 

7 entity and identified by the managed care entity 

8 by means of application of paragraph (2); 

9 ‘‘(B) to submit to the State an annual re10 port on the matters described in subparagraphs 

11 (A) through (E) of subsection (e)(1); and 

12 ‘‘(C) to submit to the State a list (and as 

13 necessary update such list) of individuals en14 rolled with such entity under the qualified drug 

15 management program operated by such entity 

16 under subparagraph (A) for purposes of allow17 ing State plans for which medical assistance is 

18 paid on a fee-for-service basis to have access to 

19 such information. 

20 ‘‘(2) APPLICATION.—For purposes of applying, 

21 with respect to a managed care entity— 

22 ‘‘(A) under paragraph (1)(A)— 

23 ‘‘(i) the definition of the term ‘quali24 fied drug management program’ under 


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1 subsection (b), other than paragraph 

2 (2)(D) of such subsection; and 

3 ‘‘(ii) the provisions of paragraphs (1) 

4 and (2) of subsection (c); and 

5 ‘‘(B) under paragraph (1)(B), the report 

6 requirements described in subparagraphs (A) 

7 through (E) of subsection (e)(1); 

8 each reference in such subsection (b) and para9 graphs of subsection (c) to ‘a State’ or ‘the State’ 

10 (other than to ‘a State plan’ or ‘the State plan’) 

11 shall be deemed a reference to the managed care en12 tity, each reference under such subsection, para13 graphs, or subparagraphs to individuals enrolled 

14 under the State plan (or waiver of the State plan) 

15 shall be deemed a reference to individuals enrolled 

16 with such entity, and each reference under such sub17 section, paragraphs, or subparagraphs to individuals 

18 enrolled under the qualified drug management pro19 gram operated by the State shall be deemed a ref20 erence to individuals enrolled under the qualified 

21 drug management program operated by the man22 aged care entity. 

23 ‘‘(g) CONTROLLED SUBSTANCE DEFINED.—For pur24 poses of this section, the term ‘controlled substance’ 

25 means a drug that is included in schedule II, III, or IV 


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1 of section 202(c) of the Controlled Substances Act, or any 

2 combination thereof, as specified by the State.’’. 

3 (b) GUIDANCE ON AT-RISK POPULATION

4 TRANSITIONING BETWEEN MEDICAID FFS AND MAN5 AGED CARE.—Not later than October 1, 2019, the Sec6 retary of Health and Human Services shall issue guidance 

7 for State Medicaid programs, with respect to individuals 

8 who are enrolled under a State plan (or waiver of such 

9 plan) under title XIX of the Social Security Act and under 

10 a drug management program, for purposes of providing 

11 best practices— 

12 (1) for transitioning, as applicable, such indi13 viduals from fee-for-service Medicaid (and such a 

14 program operated by the State) to receiving medical 

15 assistance under such title through a managed care 

16 entity (as defined in section 1932(a)(1)(B) of the 

17 Social Security Act) with a contract that with the 

18 State pursuant to section 1903(m) of such Act (and 

19 such a program operated by such entity); and 

20 (2) for transitioning, as applicable, such indi21 viduals from receiving medical assistance under such 

22 title through a managed care entity (as defined in 

23 section 1932(a)(1)(B) of the Social Security Act) 

24 with a contract that with the State pursuant to sec25 tion 1903(m) of such Act (and such a program operVerDate Sep 11 2014 02:05 Jun 13, 2018 Jkt 079200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H5808.RH H5808

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1 ated by such entity) to fee-for-service Medicaid (and 

2 such a program operated by the State). 

3 (c) GUIDANCE ON AT-RISK POPULATION

4 TRANSITIONING TO MEDICARE.— 

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

6 2020, the Secretary of Health and Human Services, 

7 after consultation with the Federal Coordinated 

8 Health Care Office established under section 2602 

9 of the Patient Protection and Affordable Care Act 

10 (42 U.S.C. 1315b), shall issue guidance for State 

11 Medicaid programs, with respect to transitioning in12 dividuals, providing for— 

13 (A) notification to be submitted by the 

14 State to the Centers for Medicare & Medicaid 

15 Services and such individuals of the status of 

16 such individuals as transitioning individuals; 

17 (B) notification to such individuals about 

18 enrollment under a prescription drug plan 

19 under part D of such title or under a MA–PD 

20 plan under part C of such title; 

21 (C) best practices for transitioning such in22 dividuals to such a plan; and 

23 (D) best practices for coordination between 

24 the qualified drug management program (as de25 scribed in section 1927A(b) of the Social SecuVerDate Sep 11 2014 02:05 Jun 13, 2018 Jkt 079200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H5808.RH H5808

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1 rity Act, as added by subsection (a)) carried out 

2 by the State and a drug management program 

3 carried out under such a plan pursuant to sec4 tion 1860D–4(c)(5) of the Social Security Act 

5 (42 U.S.C. 1395w–10(c)(5)). 

6 (2) TRANSITIONING INDIVIDUALS.—For pur7 poses of paragraph (1), a transitioning individual is 

8 an individual who, with respect to a month— 

9 (A) is enrolled under the State plan (or 

10 waiver of the State plan) and under the quali11 fied drug management program (as described in 

12 section 1927A(b) of the Social Security Act, as 

13 added by subsection (a)) carried out by the 

14 State; and 

15 (B) is expected to become eligible for the 

16 Medicare program under title XVIII of such 

17 Act during the subsequent 12-month period. 


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Union Calendar No. 561 

115TH CONGRESS 

2D SESSION H. R. 5808 

[Report No. 115–726] 

A BILL 

To amend title XIX of the Social Security Act to 

poses. grams for at-risk beneficiaries, and for other purrequire States to operate drug management proJUNE 12, 2018 

Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 


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