SLS 16RS-265 ENGROSSED 2016 Regular Session SENATE BILL NO. 117 BY SENATOR MILLS MEDICAID. Provides for the Medicaid Pharmaceutical and Therapeutics Committee. (gov sig) 1 AN ACT 2 To amend and reenact R.S. 46:153.3(B)(2)(a)(iv), the introductory paragraph of (D)(2), 3 (D)(2)(c), (d), (e), (f), (g), (h), (k), and (p), and (D)(5)(b) and (c) and to repeal R.S. 4 46:153.3(B)(1)(b), (c), (d), and (e), (B)(2)(d), (B)(3) and (4), (C)(2) and (3), and 5 (D)(5)(d) and (e), relative to the Medicaid Pharmaceutical and Therapeutics 6 Committee; to remove legislative intent and expired implementation restrictions; to 7 remove references to committees that no longer exist; to remove provisions that have 8 been sunset by subsequent legislation; to change the Pharmaceutical and 9 Therapeutics Committee membership selection criteria; to change terminology; to 10 provide for an effective date; and to provide for related matters. 11 Be it enacted by the Legislature of Louisiana: 12 Section 1. R.S. 46:153.3(B)(2)(a)(iv), the introductory paragraph of (D)(2), (D)(2)(c), 13 (d), (e), (f), (g), (h), (k), and (p), and (D)(5)(b) and (c) are hereby amended and reenacted to 14 read as follows: 15 ยง153.3. Medical vendor reimbursements; allowable restrictions; peer-based 16 prescribing and dispensing practice patterns; Medicaid 17 Pharmaceutical and Therapeutics Committee Page 1 of 6 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 117 SLS 16RS-265 ENGROSSED 1 * * * 2 B. 3 * * * 4 (2)(a) 5 * * * 6 (iv) Involve medical personnel, including but not limited to pharmacists, 7 pharmacy technicians, nurses, and physicians. 8 * * * 9 D. 10 * * * 11 (2) Each nominating organization shall certify by affidavit that the practice 12 of each nominee involves either the care of or the supervision of the care of no less 13 than one hundred fifty Medicaid recipients. The committee shall be comprised of the 14 following persons: 15 * * * 16 (c) One practicing physician who is participating in the Title XIX program 17 as a family practitioner recommended from a list of three names submitted by the 18 Louisiana State Medical Society. 19 (d) One practicing physician who is participating in the Title XIX program 20 as an internal medicine specialist recommended from a list of three names submitted 21 by the Louisiana State Medical Society. 22 (e) One practicing physician who is participating in the Title XIX program 23 as a pediatrician recommended from a list of three names submitted by the Louisiana 24 State Medical Society. 25 (f) One practicing physician who is participating in the Title XIX program 26 as a surgeon recommended from a list of three names submitted by the Louisiana 27 State Medical Society. 28 (g) One practicing physician who is participating in the Title XIX program 29 as an obstetrics/gynecologist recommended from a list of three names submitted by Page 2 of 6 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 117 SLS 16RS-265 ENGROSSED 1 the Louisiana State Medical Society. 2 (h) Two practicing physicians who are participating in the Title XIX program 3 recommended from a list of six names submitted by the Louisiana Medical 4 Association. 5 * * * 6 (k) Two practicing pharmacists who are participating in the Title XIX drug 7 program recommended from a list of six names submitted by the Louisiana 8 Pharmacists Association. One pharmacist shall be an independent pharmacist 9 recommended by the Louisiana Independent Pharmacies Association and one 10 pharmacist shall be a pharmacist representing a chain pharmacy recommended by 11 the Louisiana Independent Pharmacists Association. 12 * * * 13 (p) One practicing physician who is participating in the Title XIX program 14 as a psychiatrist recommended from a list of three names submitted by the Louisiana 15 Psychiatric Medical Association. 16 * * * 17 (5) 18 * * * 19 (b) The committee shall be responsible for developing and maintaining a 20 pharmacopoeia preferred drug list established in conjunction with a prior approval 21 process as provided in Subparagraph (B)(2)(a) of this Section. The pharmacopoeia 22 preferred drug list shall comply with all applicable state and federal laws, rules, 23 and regulations. The committee may recommend additions and deletions to the 24 pharmacopoeia preferred drug list and the pharmacopoeia preferred drug list may 25 change in accordance with those recommendations. The committee shall also advise 26 the secretary of the department on policy recommendations related to the prudent 27 administration of the Medicaid drug program. The secretary shall assure that all 28 actions of the committee comply with applicable state and federal laws, rules, and 29 regulations prior to implementation or modification of the pharmacopoeia preferred Page 3 of 6 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 117 SLS 16RS-265 ENGROSSED 1 drug list. The clinical decisions regarding the preferred drug list shall be made 2 transparent through a written report that is publicly available. If the decision of the 3 Medicaid Pharmaceutical and Therapeutics Committee is contrary to the clinical 4 evidence found in labeling, drug compendia, or peer review literature, such decisions 5 shall be justified in writing. 6 (c) Any new drug approved by the United States Food and Drug 7 Administration shall may be added to the formulary preferred drug list as soon as 8 when it becomes commercially available and the manufacturer enters into a 9 Federal Medicaid Drug Rebate program if the department determines it is in 10 the best interest of the medical assistance program. The Medicaid Pharmaceutical 11 and Therapeutics Committee shall conduct an evidence-based analysis of the drug 12 to determine if the drug shall be maintained on the formulary preferred drug list. 13 The analysis shall include but not be limited to the medical evidence of the clinical 14 effectiveness of the drug as well as evidence of the cost-effectiveness of the drug in 15 treating illness and disease. The determination by the committee on any new drug 16 approval by the United States Food and Drug Administration shall be made no later 17 than ninety days after the drug becomes commercially available. Prior to a drug 18 being prior authorized, it must have been reviewed by the Medicaid Pharmaceutical 19 and Therapeutics Committee. When a new drug that is included in the Medicaid 20 Pharmaceutical and Therapeutics Committee process is approved by the United 21 States Food and Drug Administration, the drug shall be reviewed at the next 22 Medicaid Pharmaceutical and Therapeutics Committee meeting. 23 Section 2. R.S. 46:153.3(B)(1)(b), (c), (d), and (e), (B)(2)(d), (B)(3) and (4), (C)(2) 24 and (3), and (D)(5)(d) and (e) are hereby repealed in their entirety. 25 Section 3. This Act shall become effective upon signature by the governor or, if not 26 signed by the governor, upon expiration of the time for bills to become law without signature 27 by the governor, as provided by Article III, Section 18 of the Constitution of Louisiana. If 28 vetoed by the governor and subsequently approved by the legislature, this Act shall become 29 effective on the day following such approval. Page 4 of 6 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 117 SLS 16RS-265 ENGROSSED The original instrument and the following digest, which constitutes no part of the legislative instrument, were prepared by Christine Arbo Peck. DIGEST SB 117 Engrossed 2016 Regular Session Mills Present law includes legislative intent that was added in 2006 after implementation of Medicare Part D and post-Hurricane Katrina. Proposed law removes present law. Present law includes a restriction on implementation of provisions of present law for a period of six months after June 13, 2001. Proposed law removes present law. Present law includes provisions that were sunset by subsequent law. Proposed law removes the provisions that were sunset. Present law requires membership of the committee to be selected from a list of three names submitted by each represented organization. Proposed law allows each represented organization to submit one name as their representative. Present law provides that two practicing pharmacists shall be selected from a list of names submitted by the Louisiana Pharmacists Association. Proposed law changes the committee appointment members for the two practicing pharmacist positions to require that one member shall be an independent pharmacist recommended by the Louisiana Independent Pharmacies Association and one members shall be a pharmacist representing a chain pharmacy recommended by the Louisiana Pharmacists Association. Present law refers to the Medicaid pharmacy drug list as a pharmacopia. Proposed law changes the reference to preferred drug list. Present law provides that new drugs are available on the pharmacopia as soon as they are approved by the USDA and commercially available. Proposed law states that new drugs may be added when approved by the USDA and the manufacturer enters into a Federal Medicaid Drug Rebate program if the department determines it is in the best interest of the medical assistance program. Proposed law clarifies that when a new drug reviewed by the committee is approved by the FDA, it shall be reviewed at the next committee meeting. Effective upon signature of the governor or lapse of time for gubernatorial action. (Amends R.S. 46:153.3(B)(2)(a)(iv), (D)(2)(intro para), (D)(2)(c), (d), (e), (f), (g), (h), (k), and (p), and (D)(5)(b) and (c); repeals R.S. 46:153.3(B)(1)(b), (c), (d), and (e), (B)(2)(d), (B)(3) and (4), (C)(2) and (3), and (D)(5)(d) and (e)) Summary of Amendments Adopted by Senate Committee Amendments Proposed by Senate Committee on Health and Welfare to the original bill 1. Changes the committee appointment members for the two practicing pharmacist positions to require that one member shall be an independent pharmacist recommended by the Louisiana Independent Pharmacies Association and one member shall be a pharmacist representing a chain pharmacy recommended by the Louisiana Pharmacists Association. Page 5 of 6 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 117 SLS 16RS-265 ENGROSSED 2. Clarifies that when a new drug is approved by the FDA, it shall be reviewed for consideration by the committee at their next scheduled meeting for consideration of inclusion on the preferred drug list. 3. Makes technical changes. Page 6 of 6 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions.