2018 -- S 2406

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LC004711

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2018

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A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS - PHARMACIES - INSURANCE -

PRESCRIPTION DRUG BENEFITS

     

     Introduced By: Senators Sosnowski, Crowley, Miller, and Nesselbush

     Date Introduced: February 15, 2018

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

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     SECTION 1. Section 5-19.1-2 of the General Laws in Chapter 5-19.1 entitled

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"Pharmacies" is hereby amended to read as follows:

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     5-19.1-2. Definitions.

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     (a) "Biological product" means a "biological product" as defined in the "Public Health

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Service Act", 42 U.S.C. § 262.

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     (b) "Board" means the Rhode Island board of pharmacy.

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     (c) "Change of ownership" means:

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     (1) In the case of a pharmacy, manufacturer, or wholesaler that is a partnership, any

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change that results in a new partner acquiring a controlling interest in the partnership;

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     (2) In the case of a pharmacy, manufacturer, or wholesaler that is a sole proprietorship,

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the transfer of the title and property to another person;

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     (3) In the case of a pharmacy, manufacturer, or wholesaler that is a corporation:

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     (i) A sale, lease exchange, or other disposition of all, or substantially all, of the property

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and assets of the corporation; or

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     (ii) A merger of the corporation into another corporation; or

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     (iii) The consolidation of two (2) or more corporations resulting in the creation of a new

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corporation; or

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     (iv) In the case of a pharmacy, manufacturer, or wholesaler that is a business corporation,

 

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any transfer of corporate stock that results in a new person acquiring a controlling interest in the

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corporation; or

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     (v) In the case of a pharmacy, manufacturer, or wholesaler that is a non-business

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corporation, any change in membership that results in a new person acquiring a controlling vote

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in the corporation.

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     (d) "Compounding" means the act of combining two (2) or more ingredients as a result of

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a practitioner's prescription or medication order occurring in the course of professional practice

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based upon the individual needs of a patient and a relationship between the practitioner, patient,

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and pharmacist. Compounding does not mean the routine preparation, mixing, or assembling of

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drug products that are essentially copies of a commercially available product. Compounding shall

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only occur in the pharmacy where the drug or device is dispensed to the patient or caregiver and

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includes the preparation of drugs or devices in anticipation of prescription orders based upon

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routine, regularly observed prescribing patterns.

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     (e) "Controlled substance" means a drug or substance, or an immediate precursor of such

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drug or substance, so designated under, or pursuant to, the provisions of chapter 28 of title 21.

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     (f) "Deliver" or "delivery" means the actual, constructive, or attempted transfer from one

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person to another of a drug or device, whether or not there is an agency relationship.

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     (g) "Device" means instruments, apparatus, and contrivances, including their

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components, parts, and accessories, intended:

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     (1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man

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or other animals; or

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     (2) To affect the structure or any function of the body of man or other animals.

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     (h) "Director" means the director of the Rhode Island state department of health.

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     (i) "Dispense" means the interpretation of a prescription or order for a drug, biological, or

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device and, pursuant to that prescription or order, the proper selection, measuring, compounding,

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labeling, or packaging necessary to prepare that prescription or order for delivery or

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administration.

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     (j) "Distribute" means the delivery of a drug or device other than by administering or

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dispensing.

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     (k) "Drug" means:

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     (1) Articles recognized in the official United States Pharmacopoeia or the Official

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Homeopathic Pharmacopoeia of the U.S.;

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     (2) Substances intended for use in the diagnosis, cure, mitigation, treatment, or

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prevention of disease in man, woman, or other animals;

 

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     (3) Substances (other than food) intended to affect the structure, or any function of the

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body, of man, woman, or other animals; or

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     (4) Substances intended for use as a component of any substances specified in

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subdivision (1), (2), or (3) of this subsection, but not including devices or their component parts

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or accessories.

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     (l) "Equivalent and interchangeable" means a drug, excluding a biological product,

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having the same generic name, dosage form, and labeled potency, meeting standards of the

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United States Pharmacopoeia or National Formulary, or their successors, if applicable, and not

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found in violation of the requirements of the United States Food and Drug Administration, or its

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successor agency, or the Rhode Island department of health.

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     (m) "Insured" means an individual covered by a health plan, including covered

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dependents.

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     (m)(n) "Interchangeable biological product" means a biological product that the United

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States Food and Drug Administration has:

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     (1) Licensed and determined meets the standards for interchangeability pursuant to 42

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U.S.C. § 262(k)(4) or lists of licensed, biological products with reference product exclusivity and

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biosimilarity or interchangeability evaluations; or

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     (2) Determined is therapeutically equivalent as set forth in the latest edition of or

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supplement to, the United States Food and Drug Administration's Approved Drug Products with

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Therapeutic Equivalence Evaluations.

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     (n)(o) "Intern" means:

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     (1) A graduate of an American Council on Pharmaceutical Education (ACPE)-accredited

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program of pharmacy;

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     (2) A student who is enrolled in at least the first year of a professional ACPE-accredited

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program of pharmacy; or

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     (3) A graduate of a foreign college of pharmacy who has obtained full certification from

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the FPGEC (Foreign Pharmacy Graduate Equivalency Commission) administered by the National

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Association of Boards of Pharmacy.

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     (o)(p) "Legend drugs" means any drugs that are required by any applicable federal or

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state law or regulation to be dispensed on prescription only or are restricted to use by practitioners

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only.

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     (p)(q) "Limited-function test" means those tests listed in the federal register under the

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Clinical Laboratory Improvement Amendments of 1988 (CLIA) as waived tests. For the purposes

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of this chapter, limited-function test shall include only the following: blood glucose, hemoglobin

 

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Alc, cholesterol tests, and/or other tests that are classified as waived under CLIA and are

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approved by the United States Food and Drug Administration for sale to the public without a

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prescription in the form of an over-the-counter test kit.

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     (q)(r) "Manufacture" means the production, preparation, propagation, compounding, or

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processing of a drug or other substance or device or the packaging or repackaging.

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     (r)(s) "Non-legend" or "non-prescription drugs" means any drugs that may be lawfully

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sold without a prescription.

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     (s)(t) "Person" means an individual, corporation, government, subdivision, or agency,

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business trust, estate, trust, partnership or association, or any other legal entity.

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     (t)(u) "Pharmaceutical care" is the provision of drugs and other pharmaceutical services

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intended to achieve outcomes related to cure or prevention of a disease elimination or reduction

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of a patient's symptoms or arresting or slowing of a disease process. "Pharmaceutical care"

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includes the judgment of a pharmacist in dispensing an equivalent and interchangeable drug or

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device in response to a prescription after appropriate communication with the prescriber and the

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patient.

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     (v) "Pharmacist" means a person licensed to practice pharmacy in the state.

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     (u)(w) "Pharmacist in charge" means a pharmacist licensed in this state as designated by

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the owner as the person responsible for the operation of a pharmacy in conformance with all laws

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and regulations pertinent to the practice of pharmacy and who is personally in full and actual

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charge of such pharmacy and personnel.

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     (v)(x) "Pharmacy" means that portion or part of a premise where prescriptions are

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compounded and dispensed, including that portion utilized for the storage of prescription or

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legend drugs.

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     (y) "Pharmacy benefit manager" means a person or entity who contracts with a pharmacy

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on behalf of an insurer, health plan, or third party administrator to administer or manage

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prescription drug benefits.

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     (w)(z) "Pharmacy technician" means an individual who meets minimum qualifications

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established by the board, that are less than those established by this chapter as necessary for

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licensing as a pharmacist, and who works under the direction and supervision of a licensed

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pharmacist.

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     (x)(aa) "Practice of pharmacy" means the interpretation, evaluation, and implementation

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of medical orders; the dispensing of prescription drug orders; participation in drug and device

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selection; the compounding of prescription drugs; drug regimen reviews and drug or drug-related

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research; the administration of adult immunizations pursuant to a valid prescription or physician-

 

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approved protocol and in accordance with regulations, to include training requirements as

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promulgated by the department of health; the administration of all forms of influenza

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immunizations to individuals between the ages of nine (9) years and eighteen (18) years,

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inclusive, pursuant to a valid prescription or prescriber-approved protocol, in accordance with the

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provisions of § 5-19.1-31 and in accordance with regulations, to include necessary training

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requirements specific to the administration of influenza immunizations to individuals between the

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ages of nine (9) years and eighteen (18) years, inclusive, as promulgated by the department of

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health; provision of patient counseling and the provision of those acts or services necessary to

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provide pharmaceutical care; and/or the responsibility for the supervision for compounding and

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labeling of drugs and devices (except labeling by a manufacturer, repackager, or distributor of

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non-prescription drugs and commercially packaged legend drugs and devices), proper and safe

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storage of drugs and devices, and maintenance of proper records for them; and the performance of

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clinical laboratory tests, provided such testing is limited to limited-function tests as defined

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herein. Nothing in this definition shall be construed to limit or otherwise affect the scope of

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practice of any other profession.

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     (y)(bb) "Practitioner" means a physician, dentist, veterinarian, nurse, or other person duly

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authorized by law in the state in which they practice to prescribe drugs.

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     (z)(cc) "Preceptor" means a pharmacist registered to engage in the practice of pharmacy

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in this state who has the responsibility for training interns.

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     (aa)(dd) "Prescription" means an order for drugs or devices issued by the practitioner

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duly authorized by law in the state in which he or she practices to prescribe drugs or devices in

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the course of his or her professional practice for a legitimate medical purpose.

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     (bb)(ee) "Wholesaler" means a person who buys drugs or devices for resale and

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distribution to corporations, individuals, or entities other than consumers.

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     SECTION 2. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby

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amended by adding thereto the following section:

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     5-19.1-33. Pharmacist - Patient relationship.

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     (a) A pharmacy benefits manager shall not prohibit a pharmacist or pharmacy from

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providing an insured information regarding the amount of the insured's cost share for a

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prescription drug and the clinical efficacy of a lower-priced alternative drug, if one is available.

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Neither a pharmacy nor a pharmacist shall be penalized by a pharmacy benefits manager for

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discussing any information described in this section or for selling a lower-priced drug to the

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insured if one is available.

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     (b) A pharmacy or pharmacist shall have the right to provide the insured individual with

 

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any relevant information pertaining to the acquisition of a prescription medication. A pharmacist

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may disclose any and all relevant information pertaining to the clinical efficacy, or the

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availability of any therapeutically equivalent alternative prescription medications, or any

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alternative methods to the purchasing of a prescription medication, including, but not limited to,

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paying a cash price, that is less expensive than the cost of the prescription medication to the

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insured individual.

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     (c) Communication by and between a pharmacist and patient shall be confidential health

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care communication and disclosed only pursuant to the provisions of § 5-37.3-4.

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     SECTION 3. Sections 27-20.8-1 and 27-20.8-2 of the General Laws in Chapter 27-20.8

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entitled "Prescription Drug Benefits" are hereby amended to read as follows:

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     27-20.8-1. Definitions.

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     For the purposes of this chapter, the following terms shall mean:

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     (1) "Director" shall mean the director of the department of business regulation.

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     (2) "Health plan" shall mean an insurance carrier as defined in chapters 18, 19, 20 and 41

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of this title, and any plan by which health benefits are paid by an insurer, the state, or the United

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States.

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     (3) "Insured" shall mean any person who is entitled to have pharmacy services paid by a

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health plan pursuant to a policy, certificate, contract or agreement of insurance or coverage

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including those administered for the health plan under a contract with a third-party administrator

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that manages pharmacy benefits or pharmacy network contracts.

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     27-20.8-2. Pharmacy benefit, limits and co-payments.

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     Any health plan that offers pharmacy benefits shall comply with the following:

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     (a) When a health plan's pharmacy benefit has a dollar limit, the insured's use of such

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benefit shall be determined based on the health plan's contracted rate to purchase the drug minus

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the enrollee's applicable co-payment for covered drugs. The balance will apply towards the

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enrollee's dollars limit.

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     (b) When a health plan charges a co-payment for covered prescription drugs that is based

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on a percent of the drug cost, the health plan shall disclose within the group policy or individual

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policy benefits description statement whether the co-payment is based on the plan's contracted

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rate to purchase the drug or some other cost basis such as retail price.

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     (c) No insured shall be required to make a payment for a prescription drug at point of sale

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in an amount greater than the lesser of the pharmacy's usual and customary price of filling the

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prescription or the contracted copayment.

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     (d) The amount reimbursed to the pharmacy in connection with the claims associated to

 

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the co-payment from the insured shall be retained by the pharmacy. The amount that is credited to

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the insured's account in the pre-coverage gap shall be no more than the amount that the pharmacy

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was reimbursed by the health plan payor from the corresponding co-payment made by the

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insured. The pharmacy benefits manager or health plan may not apply an amount greater than the

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actual amount reimbursed to the pharmacy by the health plan payor per prescription from the

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corresponding co-payment to an insured's account or to determine when an insured falls into a

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coverage gap.

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     (e) A pharmacy benefits manager may not charge a fee, or otherwise hold a pharmacist or

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pharmacy responsible, for costs relating to the adjudication of a claim.

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     (f) No pharmacy benefits manager shall act as a proponent for any pharmacy or pharmacy

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chain nor shall any pharmacy benefits manager prescribe, direct, or cause any pharmacy or

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pharmacy chain name or logo to appear on any employer base health plan card or prescription

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savings card.

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     SECTION 4. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS - PHARMACIES - INSURANCE -

PRESCRIPTION DRUG BENEFITS

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     This act would allow a pharmacist to provide information to patients including less

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expensive prescription alternatives. This act would also limit charges for drugs to the lesser of

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usual price or co-pay, provide restrictions on credit for insurance coverage gaps, and prohibit

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pharmacy benefit managers from placing a pharmacy logo to be placed on an insurance or

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savings cards.

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     This act would take effect upon passage.

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