SLS 14RS-215 REENGROSSED Page 1 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. Regular Session, 2014 SENATE BILL NO. 410 BY SENATOR MILLS HEALTH/ACC INSURANCE. Provides for the transparency of Maximum Allowable Cost Lists for prescription drugs. (8/1/14) AN ACT1 To enact Subpart C-1 of Part II of Chapter 6 of Title 22 of the Louisiana Revised Statutes2 of 1950, to be comprised of R.S. 22:1863 through 1865, relative to Maximum3 Allowable Cost Lists for prescription drugs; to provide with respect to definitions;4 to provide for the regulation of pharmacy benefit manager's maintenance and use of5 Maximum Allowable Cost Lists for prescription drugs; to provide with respect to an6 appeals process; and to provide for related matters.7 Be it enacted by the Legislature of Louisiana:8 Section 1. Subpart C-1 of Part II of Chapter 6 of Title 22 of the Louisiana Revised9 Statutes of 1950, comprised of R.S. 22:1863 through 1865, is hereby enacted to read as10 follows:11 Subpart C-1. PHARMACY BENEFIT MANAGER'S MAINTENANCE AND USE12 OF "MAXIMUM ALLOWABLE COST LISTS" FOR PRESCRIPTION DRUGS13 §1863. Definitions14 As used in this Subpart, the following definitions shall apply:15 (1) "Maximum Allowable Cost List" means a listing of the National Drug16 Code used by a pharmacy benefits manager setting the maximum allowable cost17 SB NO. 410 SLS 14RS-215 REENGROSSED Page 2 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. on which reimbursement to a pharmacy or pharmacist may be based.1 (2) "NDC" means the National Drug Code, a numerical identifier2 assigned to all prescription drugs.3 (3) "Pharmacist" means a licensed pharmacist as defined in R.S.4 22:1852(8).5 (4) "Pharmacist services" means products, goods, or services provided6 as a part of the practice of pharmacy as defined in R.S. 22:1852(9).7 (5) "Pharmacy" means any appropriately licensed place where8 prescription drugs are dispensed as defined in R.S. 22:1852(10).9 (6) "Pharmacy benefits manager" means an entity that administers or10 manages a pharmacy benefits plan or program.11 (7) "Pharmacy benefits plan" or "pharmacy benefits program" means12 a plan or program that pays for, reimburses, covers the cost of, or otherwise13 provides for pharmacist services to individuals who reside in or are employed14 in Louisiana.15 §1864. Requirements for use of the NDC by a pharmacy benefits manager16 A. Before a pharmacy benefits manager places or continues a particular17 NDC or Maximum Allowable Cost List, the following requirements shall be18 met:19 (1) The prescription drug to which the NDC is assigned shall be listed as20 "A" or "B" rated in the most recent version of the FDA's Approved Drug21 Products with Therapeutic Equivalence Evaluations, also known as the Orange22 Book, or have an "NR" or "NA" rating or a similar rating by a nationally23 recognized reference.24 (2) The prescription drug to which the NDC is assigned shall be available25 for purchase by pharmacies in the state from national or regional wholesalers.26 (3) The prescription drug to which the NDC is assigned shall not be27 considered obsolete.28 B. A pharmacy benefits manager shall be required to:29 SB NO. 410 SLS 14RS-215 REENGROSSED Page 3 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. (1) Provide access to its Maximum Allowable Cost List to each pharmacy1 subject to the list.2 (2) Update its Maximum Allowable Cost List on a timely basis, but in no3 event longer than seven calendar days from a change in the methodology on4 which the Maximum Allowable Cost List is based or in the value of a variable5 involved in the methodology.6 (3) Provide a process for each pharmacy subject to the list to review an7 update to the Maximum Allowable Cost List.8 §1865. Appeals9 A. The pharmacy benefits manager shall provide a reasonable10 administrative appeal procedure to allow pharmacies to challenge maximum11 allowable costs for a specific NDC or NDCs as not meeting the requirements of12 this Subpart or being below the cost at which the pharmacy may obtain the13 NDC. Within seven business days after the applicable fill date, a pharmacy may14 file an appeal by following the appeal process as provided for in this Subpart.15 The pharmacy benefits manager shall respond to a challenge within seven16 business days after receipt of the challenge.17 B. If an appeal made pursuant to this Section is upheld, the pharmacy18 benefits manager shall take the following actions:19 (1) Make the change in the Maximum Allowable Cost List.20 (2) Permit the challenging pharmacy or pharmacist to reverse and rebill21 the claim in question.22 (3) Make the change effective for each similarly situated pharmacy as23 defined by the payor subject to the Maximum Allowable Cost List.24 C. If an appeal made pursuant to this Section is denied, the pharmacy25 benefits manager shall provide the challenging pharmacy or pharmacist the26 NDC number from national or regional wholesalers operating in Louisiana.27 D. A violation of this Subpart shall be deemed an unfair or deceptive act28 and practice pursuant to R.S. 22:1961 et seq.29 SB NO. 410 SLS 14RS-215 REENGROSSED Page 4 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. The original instrument was prepared by Cheryl Horne. The following digest, which does not constitute a part of the legislative instrument, was prepared by Linda Nugent. DIGEST Mills (SB 410) Proposed law provides for definitions of: (1)Maximum Allowable Cost List (2)National Drug Code (NDC) (3)Pharmacist (4)Pharmacist services (5)Pharmacy (6)Pharmacy benefits manager (7)Pharmacy benefits plan or program Proposed law allows a pharmacy benefits manager to use the NDC only when the following conditions have been met: (1)The prescription drug to which the NDC is assigned is listed as "A" or "B" rated in the most recent version of the FDA's Orange Book. (2)The prescription drug to which the NDC is assigned is available for purchase by pharmacies in the state from national or regional wholesalers. (3)The prescription drug to which the NDC is assigned is not considered obsolete. Proposed law requires a pharmacy benefits manager to: (1)Provide access to its Maximum Allowable Cost List. (2)Update its Maximum Allowable Cost List on a timely basis. (3)Provide a process for each pharmacy to review an update to the Maximum Allowable Cost List. Proposed law requires a pharmacy benefits manager to provide a reasonable administrative appeal procedure. Permits a pharmacy to file an appeal by following the appeal process in proposed law. Requires the pharmacy benefits manager to respond to a challenge within seven business days after receipt of a challenge. Proposed law requires a pharmacy benefits manager to perform the following if an appeal is upheld: (1)Make the change in the Maximum Allowable Cost List. (2)Permit the challenging pharmacy or pharmacist to reverse and rebill the claim. (3)Make the change effective for each similarly situated pharmacy. SB NO. 410 SLS 14RS-215 REENGROSSED Page 5 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. Proposed law requires a pharmacy benefits manager to provide the challenging pharmacy or pharmacist the NDC number if an appeal is denied. Proposed law deems a violation of proposed law to be an unfair or deceptive act and practice pursuant to R.S. 22:1961 et seq. Effective August 1, 2014. (Adds R.S. 22:1863-1865) Summary of Amendments Adopted by Senate Committee Amendments Proposed by Senate Committee on Insurance to the original bill. 1. Permits a pharmacy to file an appeal within seven business days after the applicable fill date by following the appeal process in proposed law. 2. Provides that a violation of proposed law shall be deemed an unfair or deceptive act and practice pursuant to present law. Senate Floor Amendments to engrossed bill 1. Technical amendments.