SB45,1404,21 (a) “Exchange” has the meaning given in 45 CFR 155.20.

SB45,1405,2 (b) “State-based exchange on the federal platform” means an exchange that is described in and meets the requirements of 45 CFR 155.200 (f) and is approved by the federal secretary of health and human services under 45 CFR 155.106.

SB45,1405,6 (c) “State-based exchange without the federal platform” means an exchange, other than one described in 45 CFR 155.200 (f), that performs all the functions described in 45 CFR 155.200 (a) and is approved by the federal secretary of health and human services under 45 CFR 155.106.

SB45,1405,13 (2) Establishment and operation of state-based exchange. The commissioner shall establish and operate an exchange that at first is a state-based exchange on the federal platform and then subsequently transitions to a state- based exchange without the federal platform. The commissioner shall develop procedures to address the transition from the state-based exchange on the federal platform to the state-based exchange without the federal platform, including the circumstances that shall be met in order for the transition to occur.

SB45,1405,16 (3) Agreement with federal government. The commissioner may enter into any agreement with the federal government necessary to facilitate the implementation of this section.

SB45,1405,22 (4) User fees. The commissioner shall impose a user fee, as authorized under 45 CFR 155.160 (b) (1), on each insurer that offers a health plan through the state-based exchange on the federal platform or the state-based exchange without the federal platform. The user fee shall be applied at one of the following rates on the total monthly premiums charged by an insurer for each policy under the plan for which enrollment is through the exchange:

SB45,1406,2 (a) For any plan year for which the commissioner operates a state-based exchange on the federal platform, the rate is 0.5 percent.

SB45,1406,6 (b) For the first 2 plan years for which the commissioner operates a state- based exchange without the federal platform, the rate is equal to the user fee rate the federal department of health and human services specifies under 45 CFR 156.50 (c) (1) for the federally facilitated exchanges for the applicable plan year.

SB45,1406,9 (c) Beginning with the 3rd plan year for which the commissioner operates a state-based exchange without the federal platform and for each plan year thereafter, the rate shall be set by the commissioner by rule.

SB45,1406,11 (5) Rules. The commissioner may promulgate rules necessary to implement this section.

SB45,2890 Section 2890. Subchapter VI (title) of chapter 601 [precedes 601.78] of the statutes is created to read:

SB45,1406,14 CHAPTER 601

SB45,1406,15 SUBCHAPTER VI

SB45,1406,16 PRESCRIPTION DRUG

SB45,1406,17 AFFORDABILITY REVIEW BOARD

SB45,2891 Section 2891. 601.78 of the statutes is created to read:

SB45,1406,19 601.78 Definitions. In this subchapter:

SB45,1406,21 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

SB45,1406,23 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

SB45,1407,2 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

SB45,1407,5 (4) “Brand name drug” means a drug that is produced or distributed in accordance with an original new drug application approved under 21 USC 355 (c), other than an authorized generic drug, as defined in 42 CFR 447.502.

SB45,1407,9 (5) “Financial benefit” includes an honorarium, fee, stock, the value of the stock holdings of a member of the board or any immediate family member of the member of the board, and any direct financial benefit deriving from the finding of a review conducted under s. 601.79.

SB45,1407,10 (6) “Generic drug” means any of the following:

SB45,1407,12 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

SB45,1407,13 (b) An authorized generic drug, as defined in 42 CFR 447.502.

SB45,1407,15 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

SB45,1407,18 (7) “Immediate family member” means a spouse, grandparent, parent, sibling, child, stepchild, or grandchild or the spouse of a grandparent, parent, sibling, child, stepchild, or grandchild.

SB45,1407,19 (8) “Manufacturer” means an entity that does all of the following:

SB45,1407,22 (a) Engages in the manufacture of a prescription drug product or enters into a lease with another entity to market and distribute a prescription drug product under the entity’s own name.