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Senate File 17 - IntroducedA Bill ForAn Act 1relating to the coverage of direct-acting antiviral
2drugs for Medicaid beneficiaries living with a chronic
3hepatitis C virus infection.
4BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. MEDICAID PROGRAM COVERAGE — DIRECT-ACTING
2ANTIVIRAL DRUGS — HEPATITIS C VIRUS (HCV) INFECTION.
31. The department of human services shall adopt rules
4pursuant to chapter 17A, shall amend all Medicaid managed care
5contracts, and shall submit any Medicaid state plan amendments
6to the centers for Medicare and Medicaid services of the United
7States department of health and human services (CMS) for
8approval, as necessary, to require that direct-acting antiviral
9drugs that are approved by the United States food and drug
10administration (FDA) for the treatment of chronic HCV-infected
11patients as a medically accepted indication as defined in 42
12U.S.C. §1396r-8(k)(6), are a covered outpatient drug under
13the Medicaid program, and shall be covered consistently for
14Medicaid beneficiaries under both the fee-for-service and
15managed care methodologies in accordance with the Medicaid
16state plan. The rules adopted, Medicaid managed care contracts
17amended, and state plan amendment submitted shall comply with
18all of the following requirements:
19a. Coverage for the outpatient drugs shall be provided
20in accordance with 42 U.S.C. §1396r-8 and with Medicaid drug
21rebate program notice release No.172 issued by CMS on November
225, 2015.
23b. Any limitation on coverage of such drugs, including
24utilization controls such as prior authorization and placement
25on the preferred drug list, shall not unreasonably restrict
26access to these drugs for a medically accepted indication as
27defined in 42 U.S.C. §1396r-8(k)(6), including that provision
28of the drugs shall not be based on a beneficiary’s Metavir
29fibrosis score or disease severity, shall not require a period
30of abstinence from drug and alcohol abuse, and shall not
31require prescribing by a specific provider type.
32c. Coverage shall be consistent with the guidelines
33published by the American association for the study of liver
34diseases (AASLD), the infectious diseases society of America
35(IDSA), and the international antiviral society-USA (IAS-USA)
-1-1to the extent consistent with federal law and regulation.
2d. If utilization controls are provided, such utilization
3controls shall ensure that appropriate access to the covered
4drugs is consistent with 42 C.F.R. §438.210, and specifically
5must ensure that the drugs are provided in a manner that is
6sufficient in amount, duration, and scope to reasonably achieve
7the purpose for which the drugs are furnished and are not
8arbitrarily denied or reduced in amount, duration, or scope
9solely because of the diagnosis, type of illness, or condition
10of the beneficiary.
112. Additionally, the department of human services shall do
12all of the following:
13a. Implement programming to provide patients who are
14undergoing and who have completed direct-acting antiviral HCV
15drug treatment with supportive care and surveillance to enhance
16their adherence to regimens and increase success rates.
17b. Collaborate with the department of public health,
18bureau of HIV, STD, and hepatitis to provide surveillance and
19determine the return on investment, benefits, and outcomes
20resulting from the provision of treatment to all chronic
21HCV-infected Medicaid beneficiaries, including due to averting
22new infections.
23EXPLANATION
24The inclusion of this explanation does not constitute agreement with
25the explanation’s substance by the members of the general assembly.
26This bill relates to coverage of direct-acting antivrial
27drugs for a chronic hepatitis C virus (HCV) infection under the
28Medicaid programs.
29The bill requires the department of human services (DHS) to
30adopt rules pursuant to Code chapter 17A, amend all Medicaid
31managed care contracts, and submit any Medicaid state plan
32amendments to the centers for Medicare and Medicaid services
33of the United States department of health and human services
34(CMS) for approval, as necessary, to require that direct-acting
35antiviral drugs that are approved by the United States food
-2-1and drug administration (FDA) for the treatment of chronic
2HCV-infected patients as a medically accepted indication are
3a covered outpatient drug under the Medicaid program, and
4shall be covered consistently for Medicaid beneficiaries under
5both the fee-for-service and managed care methodologies in
6accordance with the Medicaid state plan.
7The bill requires that the rules adopted, and state plan
8amendment submitted, shall comply with all of the following
9requirements:
101. Coverage for the outpatient drugs shall be provided
11in accordance with 42 U.S.C. §1396r-8 and with Medicaid drug
12rebate program notice release No.172 issued by CMS on November
135, 2015.
142. Any limitation on coverage of such drugs, including
15utilization controls such as prior authorization and placement
16on the preferred drug list, shall not unreasonably restrict
17access to these drugs for a medically accepted indication,
18including that provision of the drugs shall not be based on a
19beneficiary’s Metavir fibrosis score or disease severity, shall
20not require a period of abstinence from drug and alcohol abuse,
21and shall not require prescribing by a specific provider type.
223. Coverage shall be consistent with the guidelines
23published by the American association for the study of liver
24diseases (AASLD), the infectious diseases society of America
25(IDSA), and the international antiviral society-USA (IAS-USA)to
26the extent consistent with federal law and regulation.
274. If utilization controls are provided, such utilization
28controls shall ensure that appropriate access to the covered
29drugs is consistent with federal regulations, and specifically
30must ensure that the drugs are provided in a manner that is
31sufficient in amount, duration, and scope to reasonably achieve
32the purpose for which the drugs are furnished and are not
33arbitrarily denied or reduced in amount, duration, or scope
34solely because of the diagnosis, type of illness, or condition
35of the beneficiary.
-3- 1The bill also requires DHS to implement programming to
2provide patients who are undergoing and who have completed
3direct-acting antiviral HCV drug treatment with supportive care
4and surveillance to enhance their adherence to regimens and
5increase success rates, and to collaborate with the department
6of public health, bureau of HIV, STD, and hepatitis, to provide
7surveillance and determine the return on investment, benefits,
8and outcomes resulting from the provision of treatment to all
9chronic HCV-infected Medicaid beneficiaries, including due to
10averting new infections.
-4-pf/rh
2drugs for Medicaid beneficiaries living with a chronic
3hepatitis C virus infection.
4BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. MEDICAID PROGRAM COVERAGE — DIRECT-ACTING
2ANTIVIRAL DRUGS — HEPATITIS C VIRUS (HCV) INFECTION.
31. The department of human services shall adopt rules
4pursuant to chapter 17A, shall amend all Medicaid managed care
5contracts, and shall submit any Medicaid state plan amendments
6to the centers for Medicare and Medicaid services of the United
7States department of health and human services (CMS) for
8approval, as necessary, to require that direct-acting antiviral
9drugs that are approved by the United States food and drug
10administration (FDA) for the treatment of chronic HCV-infected
11patients as a medically accepted indication as defined in 42
12U.S.C. §1396r-8(k)(6), are a covered outpatient drug under
13the Medicaid program, and shall be covered consistently for
14Medicaid beneficiaries under both the fee-for-service and
15managed care methodologies in accordance with the Medicaid
16state plan. The rules adopted, Medicaid managed care contracts
17amended, and state plan amendment submitted shall comply with
18all of the following requirements:
19a. Coverage for the outpatient drugs shall be provided
20in accordance with 42 U.S.C. §1396r-8 and with Medicaid drug
21rebate program notice release No.172 issued by CMS on November
225, 2015.
23b. Any limitation on coverage of such drugs, including
24utilization controls such as prior authorization and placement
25on the preferred drug list, shall not unreasonably restrict
26access to these drugs for a medically accepted indication as
27defined in 42 U.S.C. §1396r-8(k)(6), including that provision
28of the drugs shall not be based on a beneficiary’s Metavir
29fibrosis score or disease severity, shall not require a period
30of abstinence from drug and alcohol abuse, and shall not
31require prescribing by a specific provider type.
32c. Coverage shall be consistent with the guidelines
33published by the American association for the study of liver
34diseases (AASLD), the infectious diseases society of America
35(IDSA), and the international antiviral society-USA (IAS-USA)
-1-1to the extent consistent with federal law and regulation.
2d. If utilization controls are provided, such utilization
3controls shall ensure that appropriate access to the covered
4drugs is consistent with 42 C.F.R. §438.210, and specifically
5must ensure that the drugs are provided in a manner that is
6sufficient in amount, duration, and scope to reasonably achieve
7the purpose for which the drugs are furnished and are not
8arbitrarily denied or reduced in amount, duration, or scope
9solely because of the diagnosis, type of illness, or condition
10of the beneficiary.
112. Additionally, the department of human services shall do
12all of the following:
13a. Implement programming to provide patients who are
14undergoing and who have completed direct-acting antiviral HCV
15drug treatment with supportive care and surveillance to enhance
16their adherence to regimens and increase success rates.
17b. Collaborate with the department of public health,
18bureau of HIV, STD, and hepatitis to provide surveillance and
19determine the return on investment, benefits, and outcomes
20resulting from the provision of treatment to all chronic
21HCV-infected Medicaid beneficiaries, including due to averting
22new infections.
23EXPLANATION
24The inclusion of this explanation does not constitute agreement with
25the explanation’s substance by the members of the general assembly.
26This bill relates to coverage of direct-acting antivrial
27drugs for a chronic hepatitis C virus (HCV) infection under the
28Medicaid programs.
29The bill requires the department of human services (DHS) to
30adopt rules pursuant to Code chapter 17A, amend all Medicaid
31managed care contracts, and submit any Medicaid state plan
32amendments to the centers for Medicare and Medicaid services
33of the United States department of health and human services
34(CMS) for approval, as necessary, to require that direct-acting
35antiviral drugs that are approved by the United States food
-2-1and drug administration (FDA) for the treatment of chronic
2HCV-infected patients as a medically accepted indication are
3a covered outpatient drug under the Medicaid program, and
4shall be covered consistently for Medicaid beneficiaries under
5both the fee-for-service and managed care methodologies in
6accordance with the Medicaid state plan.
7The bill requires that the rules adopted, and state plan
8amendment submitted, shall comply with all of the following
9requirements:
101. Coverage for the outpatient drugs shall be provided
11in accordance with 42 U.S.C. §1396r-8 and with Medicaid drug
12rebate program notice release No.172 issued by CMS on November
135, 2015.
142. Any limitation on coverage of such drugs, including
15utilization controls such as prior authorization and placement
16on the preferred drug list, shall not unreasonably restrict
17access to these drugs for a medically accepted indication,
18including that provision of the drugs shall not be based on a
19beneficiary’s Metavir fibrosis score or disease severity, shall
20not require a period of abstinence from drug and alcohol abuse,
21and shall not require prescribing by a specific provider type.
223. Coverage shall be consistent with the guidelines
23published by the American association for the study of liver
24diseases (AASLD), the infectious diseases society of America
25(IDSA), and the international antiviral society-USA (IAS-USA)to
26the extent consistent with federal law and regulation.
274. If utilization controls are provided, such utilization
28controls shall ensure that appropriate access to the covered
29drugs is consistent with federal regulations, and specifically
30must ensure that the drugs are provided in a manner that is
31sufficient in amount, duration, and scope to reasonably achieve
32the purpose for which the drugs are furnished and are not
33arbitrarily denied or reduced in amount, duration, or scope
34solely because of the diagnosis, type of illness, or condition
35of the beneficiary.
-3- 1The bill also requires DHS to implement programming to
2provide patients who are undergoing and who have completed
3direct-acting antiviral HCV drug treatment with supportive care
4and surveillance to enhance their adherence to regimens and
5increase success rates, and to collaborate with the department
6of public health, bureau of HIV, STD, and hepatitis, to provide
7surveillance and determine the return on investment, benefits,
8and outcomes resulting from the provision of treatment to all
9chronic HCV-infected Medicaid beneficiaries, including due to
10averting new infections.
-4-pf/rh