HLS 13RS-973 REENGROSSED Page 1 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. Regular Session, 2013 HOUSE BILL NO. 393 BY REPRESENTATIVES ANDERS AND STUART BISHOP Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana. MEDICAID: Provides relative to prescription drug benefits of certain managed care organizations participating in the La. Medicaid coordinated care network program AN ACT1 To enact Part XI of Chapter 3 of Title 46 of the Louisiana Revised Statutes of 1950, to be2 comprised of R.S. 46:460.31 through 460.35, relative to the medical assistance3 program; to provide relative to managed care organizations which provide health4 care services to medical assistance program enrollees; to provide relative to5 prescription drugs; to provide for prepaid coordinated care network pharmaceutical6 and therapeutics committees; to provide for a standard form for the prior7 authorization of prescription drugs; to provide for certain procedures relative to step8 therapy and fail first protocols; to provide for promulgation of rules; to provide for9 exemptions; and to provide for related matters.10 Be it enacted by the Legislature of Louisiana:11 Section 1. Part XI of Chapter 3 of Title 46 of the Louisiana Revised Statutes of 1950,12 comprised of R.S. 46:460.31 through 460.35, is hereby enacted to read as follows:13 PART XI. MEDICAID MANAGED CARE PRESCRIPTION DRUG BENEFITS14 §460.31. Definitions15 As used in this Part, the following terms shall have the meaning ascribed to16 them in this Section unless the context clearly indicates otherwise:17 (1) "Department" means the Department of Health and Hospitals.18 (2) "Managed care organization" shall have the same meaning as provided19 for that term in 42 CFR 438.2 and shall also mean any entity providing primary care20 HLS 13RS-973 REENGROSSED HB NO. 393 Page 2 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. case management services to Medicaid recipients pursuant to a contract with the1 department.2 (3) "Medicaid" and "medical assistance program" mean the medical3 assistance program provided for in Title XIX of the Social Security Act.4 (4) "Prepaid coordinated care network" means a private entity that contracts5 with the department to provide Medicaid benefits and services to enrollees of the6 Medicaid coordinated care program known as "Bayou Health" in exchange for a7 monthly prepaid capitated amount per member.8 (5) "Primary care case management" means a system in which an entity9 contracts with the state to furnish case management services, which include but are10 not limited to the location, coordination, and monitoring of primary health care11 service to Medicaid beneficiaries.12 (6) "Secretary" means the secretary of the Department of Health and13 Hospitals.14 §460.32. Prepaid coordinated care networks; pharmaceutical and therapeutics15 committees16 On or before January 1, 2014, each prepaid coordinated care network shall17 form a body to be designated as a "Pharmaceutical and Therapeutics Committee"18 which shall develop a drug formulary and preferred drug list for the prepaid19 coordinated care network. Each Pharmaceutical and Therapeutics Committee20 created pursuant to the provisions of this Section shall meet no less frequently than21 semiannually in Baton Rouge, Louisiana. Such meetings shall be open to the public22 and shall allow for public comment prior to voting by the committee on any change23 in the preferred drug list or formulary.24 §460.33. Prior authorization form; requirements25 A. Beginning January 1, 2014, all managed care organizations shall utilize26 a two-page prior authorization form, excluding guidelines or information, duly27 promulgated by the department in accordance with the Administrative Procedure28 Act.29 HLS 13RS-973 REENGROSSED HB NO. 393 Page 3 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. B. The department shall promulgate rules and regulations prior to January1 1, 2014, that establish the form which shall be utilized by all managed care2 organizations. The department may consult with the managed care organizations as3 necessary in development of the prior authorization form.4 §460.34. Step therapy; fail first protocols; requirements5 A. Each managed care organization that utilizes step therapy or fail first6 protocols shall comply with the provisions of this Section.7 B. When medications for the treatment of any medical condition are8 restricted for use by a managed care organization by a step therapy or fail first9 protocol, the prescribing physician shall be provided with and have access to a clear10 and convenient process to expeditiously request an override of such restriction from11 the managed care organization. The managed care organization shall expeditiously12 grant an override of such restriction under any of the following circumstances:13 (1) The prescribing physician can demonstrate to the managed care14 organization, based on sound clinical evidence, that the preferred treatment required15 under step therapy or fail first protocol has been ineffective in the treatment of the16 Medicaid enrollee's disease or medical condition.17 (2) The prescribing physician can demonstrate to the managed care18 organization, based on sound clinical evidence, that the preferred treatment required19 under the step therapy or fail first protocol is reasonably expected to be ineffective20 based on the known relevant physical or mental characteristics and medical history21 of the Medicaid enrollee and known characteristics of the drug regimen.22 (3) The prescribing physician can demonstrate to the managed care23 organization, based on sound clinical evidence, that the preferred treatment required24 under the step therapy or fail first protocol will cause or will likely cause an adverse25 reaction or other physical harm to the Medicaid enrollee.26 C. The duration of any step therapy or fail first protocol shall not be longer27 in duration than the customary period for the medication when such treatment is28 demonstrated by the prescribing physician to be clinically ineffective. When the29 managed care organization can demonstrate, through sound clinical evidence, that30 HLS 13RS-973 REENGROSSED HB NO. 393 Page 4 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. the originally prescribed medication is likely to require more than the customary1 period for such medication to provide any relief or an amelioration to the Medicaid2 enrollee, the step therapy or fail first protocol may be extended for an additional3 period of time no longer than the original customary period for the medication.4 §460.35. Exemptions5 The provisions of this Part shall not apply to any entity that contracts with the6 department to provide fiscal intermediary services in processing claims of health care7 providers.8 Section 2. This Act shall become effective on January 1, 2014.9 DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] Anders HB No. 393 Abstract: Provides relative to prescription drug benefits of managed care organizations participating in the La. Medicaid coordinated care network program. Proposed law defines "prepaid coordinated care network" as a private entity that contracts with the department to provide Medicaid benefits and services to enrollees of the Medicaid coordinated care program known as "Bayou Health" in exchange for a monthly prepaid capitated amount per member. Proposed law requires each prepaid coordinated care network to form a pharmaceutical and therapeutics committee which shall develop a drug formulary and preferred drug list for the prepaid coordinated care network. Provides that such committees shall: (1)Meet no less frequently than semiannually in Baton Rouge. (2)Make such meetings open to the public. (3)Allow for public comment at such meetings prior to voting by the committee on any change in the preferred drug list or formulary. Proposed law requires, beginning Jan. 1, 2014, that all managed care organizations participating in the La. Medicaid program utilize a two-page prior authorization form to be issued by DHH. Requires DHH to promulgate rules and regulations that establish the form, and authorizes DHH to consult with the managed care organizations as necessary in development of the form. Proposed law requires that each managed care organization which utilizes step therapy or fail first protocols comply with the provisions of proposed law. Proposed law provides that when medications are restricted for use by a managed care organization by a step therapy or fail first protocol, the prescribing physician shall be provided with and have access to a clear and convenient process to expeditiously request an HLS 13RS-973 REENGROSSED HB NO. 393 Page 5 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. override of such restriction from the managed care organization. Requires the managed care organization to expeditiously grant an override of such restriction under any of the following circumstances: (1)The prescribing physician can demonstrate to the managed care organization, based on sound clinical evidence, that the preferred treatment required under step therapy or fail first protocol has been ineffective in the treatment of the Medicaid enrollee's disease or medical condition. (2)The prescribing physician can demonstrate to the managed care organization, based on sound clinical evidence, that the preferred treatment required under the step therapy or fail first protocol is reasonably expected to be ineffective based on the known relevant physical or mental characteristics and medical history of the Medicaid enrollee and known characteristics of the drug regimen. (3)The prescribing physician can demonstrate to the managed care organization, based on sound clinical evidence, that the preferred treatment required under the step therapy or fail first protocol will cause or will likely cause an adverse reaction or other physical harm to the Medicaid enrollee. Proposed law provides that the duration of any step therapy or fail first protocol shall not be longer in duration than the customary period for the medication when such treatment is demonstrated by the prescribing physician to be clinically ineffective. Provides that when the managed care organization can demonstrate, through sound clinical evidence, that the originally prescribed medication is likely to require more than the customary period for such medication to provide any relief or an amelioration to the Medicaid enrollee, the step therapy or fail first protocol may be extended for an additional period of time no longer than the original customary period for the medication. Proposed law provides that provisions of proposed law shall not apply to any entity that contracts with DHH to provide fiscal intermediary services in processing claims of health care providers. Effective Jan. 1, 2014. (Adds R.S. 46:460.31-460.35) Summary of Amendments Adopted by House Committee Amendments Proposed by House Committee on Health and Welfare to the original bill. 1. Deleted provisions creating and specifying functions of a Medicaid Managed Care Pharmaceutical and Therapeutics Committee. 2. Deleted requirement that all managed care organizations provide as a pharmacy benefit the minimum drug pharmacopoeia in conjunction with a prior approval process developed and maintained by the Medicaid Managed Care Pharmaceutical and Therapeutics Committee. 3. Added "prepaid coordinated care network" as a defined term, defining such term as a private entity that contracts with the department to provide Medicaid benefits and services to enrollees of the Medicaid coordinated care program known as "Bayou Health" in exchange for a monthly prepaid capitated amount per member. 4. Added provisions requiring each prepaid coordinated care network to form a pharmaceutical and therapeutics committee which shall develop a drug formulary HLS 13RS-973 REENGROSSED HB NO. 393 Page 6 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. and preferred drug list for the prepaid coordinated care network. Provided that such committees are subject to the following requirements: (a)Meet no less frequently than semiannually in Baton Rouge. (b)Make such meetings open to the public. (c)Allow for public comment at such meetings prior to voting by the committee on any change in the preferred drug list or formulary. 5. Changed prescribed page length for the prior authorization form provided for in proposed law from one page to two pages. 6. Added an exemption from provisions of proposed law for any entity that contracts with DHH to provide fiscal intermediary services in processing claims of health care providers. 7. Changed effective date of proposed law from date of signature by the governor or lapse of time for gubernatorial action to Jan. 1, 2014. 8. Made technical changes. House Floor Amendments to the engrossed bill. 1. Made technical change.