Bill Text: IA SF2102 | 2017-2018 | 87th General Assembly | Introduced
Bill Title: A bill for an act relating to the coverage of direct-acting antiviral drugs for Medicaid beneficiaries living with a chronic hepatitis C virus infection.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2018-01-25 - Subcommittee: Chelgren, Quirmbach, and Segebart. S.J. 166. [SF2102 Detail]
Download: Iowa-2017-SF2102-Introduced.html
Senate File 2102 - Introduced SENATE FILE BY BOLKCOM A BILL FOR 1 An Act relating to the coverage of direct=acting antiviral 2 drugs for Medicaid beneficiaries living with a chronic 3 hepatitis C virus infection. 4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: TLSB 5753XS (4) 87 pf/rh PAG LIN 1 1 Section 1. MEDICAID PROGRAM COVERAGE == DIRECT=ACTING 1 2 ANTIVIRAL DRUGS == HEPATITIS C VIRUS (HCV) INFECTION. 1 3 1. The department of human services shall adopt rules 1 4 pursuant to chapter 17A, shall amend all Medicaid managed care 1 5 contracts, and shall submit any Medicaid state plan amendments 1 6 to the centers for Medicare and Medicaid services of the United 1 7 States department of health and human services (CMS) for 1 8 approval, as necessary, to require that direct=acting antiviral 1 9 drugs that are approved by the United States food and drug 1 10 administration (FDA) for the treatment of chronic HCV=infected 1 11 patients as a medically accepted indication as defined in 42 1 12 U.S.C. {1396r=8(k)(6), are a covered outpatient drug under 1 13 the Medicaid program, and shall be covered consistently for 1 14 Medicaid beneficiaries under both the fee=for=service and 1 15 managed care methodologies in accordance with the Medicaid 1 16 state plan. The rules adopted, Medicaid managed care contracts 1 17 amended, and state plan amendment submitted shall comply with 1 18 all of the following requirements: 1 19 a. Coverage for the outpatient drugs shall be provided 1 20 in accordance with 42 U.S.C. {1396r=8 and with Medicaid drug 1 21 rebate program notice release No. 172 issued by CMS on November 1 22 5, 2015. 1 23 b. Any limitation on coverage of such drugs, including 1 24 utilization controls such as prior authorization and placement 1 25 on the preferred drug list, shall not unreasonably restrict 1 26 access to these drugs for a medically accepted indication as 1 27 defined in 42 U.S.C. {1396r=8(k)(6), including that provision 1 28 of the drugs shall not be based on a beneficiary's Metavir 1 29 fibrosis score or disease severity, shall not require a period 1 30 of abstinence from drug and alcohol abuse, and shall not 1 31 require prescribing by a specific provider type. 1 32 c. Coverage shall be consistent with the guidelines 1 33 published by the American association for the study of liver 1 34 diseases (AASLD), the infectious diseases society of America 1 35 (IDSA), and the international antiviral society=USA (IAS=USA) 2 1 to the extent consistent with federal law and regulation. 2 2 d. If utilization controls are provided, such utilization 2 3 controls shall ensure that appropriate access to the covered 2 4 drugs is consistent with 42 C.F.R. {438.210 and specifically 2 5 must ensure that the drugs are provided in a manner that is 2 6 sufficient in amount, duration, and scope to reasonably achieve 2 7 the purpose for which the drugs are furnished and are not 2 8 arbitrarily denied or reduced in amount, duration, or scope 2 9 solely because of the diagnosis, type of illness, or condition 2 10 of the beneficiary. 2 11 2. Additionally, the department of human services shall do 2 12 all of the following: 2 13 a. Implement programming to provide patients who are 2 14 undergoing and who have completed direct=acting antiviral HCV 2 15 drug treatment with supportive care and surveillance to enhance 2 16 their adherence to regimens and increase success rates. 2 17 b. Collaborate with the department of public health, 2 18 bureau of HIV, STD, and hepatitis to provide surveillance and 2 19 determine the return on investment, benefits, and outcomes 2 20 resulting from the provision of treatment to all chronic 2 21 HCV=infected Medicaid beneficiaries, including due to averting 2 22 new infections. 2 23 EXPLANATION 2 24 The inclusion of this explanation does not constitute agreement with 2 25 the explanation's substance by the members of the general assembly. 2 26 This bill relates to coverage of direct=acting antivrial 2 27 drugs for a chronic hepatitis C virus (HCV) infection under the 2 28 Medicaid programs. 2 29 The bill requires the department of human services to adopt 2 30 rules pursuant to Code chapter 17A, amend all Medicaid managed 2 31 care contracts, and submit any Medicaid state plan amendments 2 32 to the centers for Medicare and Medicaid services of the United 2 33 States department of health and human services (CMS) for 2 34 approval, as necessary, to require that direct=acting antiviral 2 35 drugs that are approved by the United States food and drug 3 1 administration (FDA) for the treatment of chronic HCV=infected 3 2 patients as a medically accepted indication are a covered 3 3 outpatient drug under the Medicaid program, and shall be 3 4 covered consistently for Medicaid beneficiaries under both the 3 5 fee=for=service and managed care methodologies in accordance 3 6 with the Medicaid state plan. 3 7 The bill requires that the rules adopted, and state plan 3 8 amendment submitted, shall comply with all of the following 3 9 requirements: 3 10 1. Coverage for the outpatient drugs shall be provided 3 11 in accordance with 42 U.S.C. {1396r=8 and with Medicaid drug 3 12 rebate program notice release No. 172 issued by CMS on November 3 13 5, 2015. 3 14 2. Any limitation on coverage of such drugs, including 3 15 utilization controls such as prior authorization and placement 3 16 on the preferred drug list, shall not unreasonably restrict 3 17 access to these drugs for a medically accepted indication, 3 18 including that provision of the drugs shall not be based on a 3 19 beneficiary's Metavir fibrosis score or disease severity, shall 3 20 not require a period of abstinence from drug and alcohol abuse, 3 21 and shall not require prescribing by a specific provider type. 3 22 3. Coverage shall be consistent with the guidelines 3 23 published by the American association for the study of liver 3 24 diseases (AASLD), the infectious diseases society of America 3 25 (IDSA), and the international antiviral society=USA (IAS=USA)to 3 26 the extent consistent with federal law and regulation. 3 27 4. If utilization controls are provided, such utilization 3 28 controls shall ensure that appropriate access to the covered 3 29 drugs is consistent with federal regulations and specifically 3 30 must ensure that the drugs are provided in a manner that is 3 31 sufficient in amount, duration, and scope to reasonably achieve 3 32 the purpose for which the drugs are furnished and are not 3 33 arbitrarily denied or reduced in amount, duration, or scope 3 34 solely because of the diagnosis, type of illness, or condition 3 35 of the beneficiary. 4 1 The bill also requires DHS to implement programming to 4 2 provide patients who are undergoing and who have completed 4 3 direct=acting antiviral HCV drug treatment with supportive care 4 4 and surveillance to enhance their adherence to regimens and 4 5 increase success rates, and to collaborate with the department 4 6 of public health, bureau of HIV, STD, and hepatitis, to provide 4 7 surveillance and determine the return on investment, benefits, 4 8 and outcomes resulting from the provision of treatment to all 4 9 chronic HCV=infected Medicaid beneficiaries, including due to 4 10 averting new infections. LSB 5753XS (4) 87 pf/rh
