S.F. 17 Section 1. MEDICAID PROGRAM COVERAGE —— DIRECT-ACTING 1 ANTIVIRAL DRUGS —— HEPATITIS C VIRUS (HCV) INFECTION. 2 1. The department of human services shall adopt rules 3 pursuant to chapter 17A, shall amend all Medicaid managed care 4 contracts, and shall submit any Medicaid state plan amendments 5 to the centers for Medicare and Medicaid services of the United 6 States department of health and human services (CMS) for 7 approval, as necessary, to require that direct-acting antiviral 8 drugs that are approved by the United States food and drug 9 administration (FDA) for the treatment of chronic HCV-infected 10 patients as a medically accepted indication as defined in 42 11 U.S.C. §1396r-8(k)(6), are a covered outpatient drug under 12 the Medicaid program, and shall be covered consistently for 13 Medicaid beneficiaries under both the fee-for-service and 14 managed care methodologies in accordance with the Medicaid 15 state plan. The rules adopted, Medicaid managed care contracts 16 amended, and state plan amendment submitted shall comply with 17 all of the following requirements: 18 a. Coverage for the outpatient drugs shall be provided 19 in accordance with 42 U.S.C. §1396r-8 and with Medicaid drug 20 rebate program notice release No. 172 issued by CMS on November 21 5, 2015. 22 b. Any limitation on coverage of such drugs, including 23 utilization controls such as prior authorization and placement 24 on the preferred drug list, shall not unreasonably restrict 25 access to these drugs for a medically accepted indication as 26 defined in 42 U.S.C. §1396r-8(k)(6), including that provision 27 of the drugs shall not be based on a beneficiary’s Metavir 28 fibrosis score or disease severity, shall not require a period 29 of abstinence from drug and alcohol abuse, and shall not 30 require prescribing by a specific provider type. 31 c. Coverage shall be consistent with the guidelines 32 published by the American association for the study of liver 33 diseases (AASLD), the infectious diseases society of America 34 (IDSA), and the international antiviral society-USA (IAS-USA) 35 -1- LSB 1054XS (2) 88 pf/rh 1/ 4

S.F. 17 to the extent consistent with federal law and regulation. 1 d. If utilization controls are provided, such utilization 2 controls shall ensure that appropriate access to the covered 3 drugs is consistent with 42 C.F.R. §438.210, and specifically 4 must ensure that the drugs are provided in a manner that is 5 sufficient in amount, duration, and scope to reasonably achieve 6 the purpose for which the drugs are furnished and are not 7 arbitrarily denied or reduced in amount, duration, or scope 8 solely because of the diagnosis, type of illness, or condition 9 of the beneficiary. 10 2. Additionally, the department of human services shall do 11 all of the following: 12 a. Implement programming to provide patients who are 13 undergoing and who have completed direct-acting antiviral HCV 14 drug treatment with supportive care and surveillance to enhance 15 their adherence to regimens and increase success rates. 16 b. Collaborate with the department of public health, 17 bureau of HIV, STD, and hepatitis to provide surveillance and 18 determine the return on investment, benefits, and outcomes 19 resulting from the provision of treatment to all chronic 20 HCV-infected Medicaid beneficiaries, including due to averting 21 new infections. 22 EXPLANATION 23 The inclusion of this explanation does not constitute agreement with 24 the explanation’s substance by the members of the general assembly. 25 This bill relates to coverage of direct-acting antivrial 26 drugs for a chronic hepatitis C virus (HCV) infection under the 27 Medicaid programs. 28 The bill requires the department of human services (DHS) to 29 adopt rules pursuant to Code chapter 17A, amend all Medicaid 30 managed care contracts, and submit any Medicaid state plan 31 amendments to the centers for Medicare and Medicaid services 32 of the United States department of health and human services 33 (CMS) for approval, as necessary, to require that direct-acting 34 antiviral drugs that are approved by the United States food 35 -2- LSB 1054XS (2) 88 pf/rh 2/ 4

S.F. 17 and drug administration (FDA) for the treatment of chronic 1 HCV-infected patients as a medically accepted indication are 2 a covered outpatient drug under the Medicaid program, and 3 shall be covered consistently for Medicaid beneficiaries under 4 both the fee-for-service and managed care methodologies in 5 accordance with the Medicaid state plan. 6 The bill requires that the rules adopted, and state plan 7 amendment submitted, shall comply with all of the following 8 requirements: 9 1. Coverage for the outpatient drugs shall be provided 10 in accordance with 42 U.S.C. §1396r-8 and with Medicaid drug 11 rebate program notice release No. 172 issued by CMS on November 12 5, 2015. 13 2. Any limitation on coverage of such drugs, including 14 utilization controls such as prior authorization and placement 15 on the preferred drug list, shall not unreasonably restrict 16 access to these drugs for a medically accepted indication, 17 including that provision of the drugs shall not be based on a 18 beneficiary’s Metavir fibrosis score or disease severity, shall 19 not require a period of abstinence from drug and alcohol abuse, 20 and shall not require prescribing by a specific provider type. 21 3. Coverage shall be consistent with the guidelines 22 published by the American association for the study of liver 23 diseases (AASLD), the infectious diseases society of America 24 (IDSA), and the international antiviral society-USA (IAS-USA)to 25 the extent consistent with federal law and regulation. 26 4. If utilization controls are provided, such utilization 27 controls shall ensure that appropriate access to the covered 28 drugs is consistent with federal regulations, and specifically 29 must ensure that the drugs are provided in a manner that is 30 sufficient in amount, duration, and scope to reasonably achieve 31 the purpose for which the drugs are furnished and are not 32 arbitrarily denied or reduced in amount, duration, or scope 33 solely because of the diagnosis, type of illness, or condition 34 of the beneficiary. 35 -3- LSB 1054XS (2) 88 pf/rh 3/ 4

S.F. 17 The bill also requires DHS to implement programming to 1 provide patients who are undergoing and who have completed 2 direct-acting antiviral HCV drug treatment with supportive care 3 and surveillance to enhance their adherence to regimens and 4 increase success rates, and to collaborate with the department 5 of public health, bureau of HIV, STD, and hepatitis, to provide 6 surveillance and determine the return on investment, benefits, 7 and outcomes resulting from the provision of treatment to all 8 chronic HCV-infected Medicaid beneficiaries, including due to 9 averting new infections. 10 -4- LSB 1054XS (2) 88 pf/rh 4/ 4