ENROLLED Page 1 of 4 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. 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 case management services to Medicaid recipients pursuant to a contract with the21 department.22 ENROLLEDHB NO. 393 Page 2 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. (3) "Medicaid" and "medical assistance program" mean the medical1 assistance program provided for in Title XIX of the Social Security Act.2 (4) "Prepaid coordinated care network" means a private entity that contracts3 with the department to provide Medicaid benefits and services to enrollees of the4 Medicaid coordinated care program known as "Bayou Health" in exchange for a5 monthly prepaid capitated amount per member.6 (5) "Primary care case management" means a system in which an entity7 contracts with the state to furnish case management services, which include but are8 not limited to the location, coordination, and monitoring of primary health care9 service to Medicaid beneficiaries.10 (6) "Secretary" means the secretary of the Department of Health and11 Hospitals.12 §460.32. Prepaid coordinated care networks; pharmaceutical and therapeutics13 committees14 On or before January 1, 2014, each prepaid coordinated care network shall15 form a body to be designated as a "Pharmaceutical and Therapeutics Committee"16 which shall develop a drug formulary and preferred drug list for the prepaid17 coordinated care network. Each Pharmaceutical and Therapeutics Committee18 created pursuant to the provisions of this Section shall meet no less frequently than19 semiannually in Baton Rouge, Louisiana. Such meetings shall be open to the public20 and shall allow for public comment prior to voting by the committee on any change21 in the preferred drug list or formulary.22 §460.33. Prior authorization form; requirements23 A. All managed care organizations shall accept, in addition to any currently24 accepted facsimile and electronic prior authorization forms, a standard prior25 authorization form, not to exceed two pages, excluding guidelines or instructions,26 that has been duly promulgated by the department in accordance with the27 Administrative Procedure Act. A health care provider may submit the prior28 authorization form electronically if the managed care organization allows for29 submission of the form in this manner.30 ENROLLEDHB NO. 393 Page 3 of 4 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 will be expected to be ineffective based20 on the known relevant physical or mental characteristics and medical history of the21 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 than the duration of action for the medication as described in the pharmacokinetics28 section of the package insert approved by the United States Food and Drug29 ENROLLEDHB NO. 393 Page 4 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. Administration when such treatment is demonstrated by the prescribing physician1 to be clinically ineffective.2 §460.35. Exemptions3 The provisions of this Part shall not apply to any entity that contracts with the4 department to provide fiscal intermediary services in processing claims of health care5 providers.6 Section 2. This Act shall become effective on January 1, 2014.7 SPEAKER OF THE HOUSE OF REPRESENTATI VES PRESIDENT OF THE SENATE GOVERNOR OF THE STATE OF LOUISIANA APPROVED: