Chapter 603: PRESCRIPTION DRUG ACCESS HEADING: PL 1999, C. 786, PT. A, §3 (NEW)
Subchapter 4: PRESCRIPTION DRUG PRACTICES HEADING: PL 2003, C. 456, §1 (NEW)
§2699. Prescription drug practices
Pharmacy benefits managers shall and contracts for pharmacy benefits management must comply with the requirements of this
section. [2003, c. 456, §1 (NEW).]
1.Definitions. As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings.
A. "Covered entity" means a nonprofit hospital or medical service organization, insurer, health coverage plan or health maintenance
organization licensed pursuant to Title 24 or 24-A; a health program administered by the department or the State in the capacity
of provider of health coverage; or an employer, labor union or other group of persons organized in the State that provides
health coverage to covered individuals who are employed or reside in the State. "Covered entity" does not include a health
plan that provides coverage only for accidental injury, specified disease, hospital indemnity, Medicare supplement, disability
income, long-term care or other limited benefit health insurance policies and contracts. [2003, c. 456, §1 (NEW).]
B. "Covered individual" means a member, participant, enrollee, contract holder or policy holder or beneficiary of a covered
entity who is provided health coverage by the covered entity. "Covered individual" includes a dependent or other person provided
health coverage through a policy, contract or plan for a covered individual. [2003, c. 456, §1 (NEW).]
C. "Generic drug" means a chemically equivalent copy of a brand-name drug with an expired patent. [2003, c. 456, §1 (NEW).]
D. "Labeler" means an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those
drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 Code of Federal
Regulations, 270.20 (1999). [2003, c. 456, §1 (NEW).]
E. "Pharmacy benefits management" means the procurement of prescription drugs at a negotiated rate for dispensation within
this State to covered individuals, the administration or management of prescription drug benefits provided by a covered entity
for the benefit of covered individuals or any of the following services provided with regard to the administration of pharmacy
benefits:
(1) Mail service pharmacy;
(2) Claims processing, retail network management and payment of claims to pharmacies for prescription drugs dispensed to
covered individuals;
(3) Clinical formulary development and management services;
(4) Rebate contracting and administration;
(5) Certain patient compliance, therapeutic intervention and generic substitution programs; and
(6) Disease management programs. [2003, c. 456, §1 (NEW).]
F. "Pharmacy benefits manager" means an entity that performs pharmacy benefits management. "Pharmacy benefits manager" includes
a person or entity acting for a pharmacy benefits manager in a contractual or employment relationship in the performance of
pharmacy benefits management for a covered entity and includes mail service pharmacy. [2003, c. 456, §1 (NEW).]
[
2003, c. 456, §1 (NEW)
.]
2.Required practices. A pharmacy benefits manager owes a fiduciary duty to a covered entity and shall discharge that duty in accordance with the
provisions of state and federal law.
A. A pharmacy benefits manager shall perform its duties with care, skill, prudence and diligence and in accordance with the
standards of conduct applicable to a fiduciary in an enterprise of a like character and with like aims. [2003, c. 456, §1 (NEW).]
B. [2003, c. 673, Pt. FFF, §1 (RP).]
C. A pharmacy benefits manager shall notify the covered entity in writing of any activity, policy or practice of the pharmacy
benefits manager that directly or indirectly presents any conflict of interest with the duties imposed by this subsection. [2003, c. 456, §1 (NEW).]
D. A pharmacy benefits manager shall provide to a covered entity all financial and utilization information requested by the
covered entity relating to the provision of benefits to covered individuals through that covered entity and all financial
and utilization information relating to services to that covered entity. A pharmacy benefits manager providing information
under this paragraph may designate that material as confidential. Information designated as confidential by a pharmacy benefits
manager and provided to a covered entity under this paragraph may not be disclosed by the covered entity to any person without
the consent of the pharmacy benefits manager, except that disclosure may be ordered by a court of this State for good cause
shown or made in a court filing under seal unless or until otherwise ordered by a court. Nothing in this paragraph limits
the Attorney General's use of civil investigative demand authority under the Maine Unfair Trade Practices Act to investigate
violations of this section. [2003, c. 688, Pt. C, §9 (AMD); 2003, c. 688, Pt. C, §11 (AFF).]
E. With regard to the dispensation of a substitute prescription drug for a prescribed drug to a covered individual the following
provisions apply.
(2) If a pharmacy benefits manager makes a substitution in which the substitute drug costs more than the prescribed drug,
the pharmacy benefits manager shall disclose to the covered entity the cost of both drugs and any benefit or payment directly
or indirectly accruing to the pharmacy benefits manager as a result of the substitution.
(3) The pharmacy benefits manager shall transfer in full to the covered entity any benefit or payment received in any form
by the pharmacy benefits manager either as a result of a prescription drug substitution under subparagraph (2) or as a result
of the pharmacy benefits manager's substituting a lower-priced generic and therapeutically equivalent drug for a higher-priced
prescribed drug. [2003, c. 673, Pt. FFF, §2 (AMD).]
F. A pharmacy benefits manager that derives any payment or benefit for the dispensation of prescription drugs within the State
based on volume of sales for certain prescription drugs or classes or brands of drugs within the State shall pass that payment
or benefit on in full to the covered entity. [2003, c. 456, §1 (NEW).]
G. A pharmacy benefits manager shall disclose to the covered entity all financial terms and arrangements for remuneration of
any kind that apply between the pharmacy benefits manager and any prescription drug manufacturer or labeler, including, without
limitation, formulary management and drug-switch programs, educational support, claims processing and pharmacy network fees
that are charged from retail pharmacies and data sales fees. A pharmacy benefits manager providing information under this
paragraph may designate that material as confidential. Information designated as confidential by a pharmacy benefits manager
and provided to a covered entity under this paragraph may not be disclosed by the covered entity to any person without the
consent of the pharmacy benefits manager, except that disclosure may be ordered by a court of this State for good cause shown
or made in a court filing under seal unless or until otherwise ordered by a court. Nothing in this paragraph limits the Attorney
General's use of civil investigative demand authority under the Maine Unfair Trade Practices Act to investigate violations
of this section. [2003, c. 688, Pt. C, §9 (AMD); 2003, c. 688, Pt. C, §11 (AFF).]
H. A pharmacy benefits manager or insurer shall require a contracted pharmacy to charge to an enrollee or insured person the
pharmacy's usual and customary price of filling the prescription or the contracted copayment, whichever is less. [2007, c. 431, §1 (NEW); 2007, c. 431, §3 (AFF).]
[
2007, c. 431, §1 (AMD);
2007, c. 431, §3 (AFF)
.]
3.Compliance. Compliance with the requirements of this section is required in all contracts for pharmacy benefits management entered into
in this State or by a covered entity in this State.
[
2003, c. 456, §1 (NEW)
.]
4.Enforcement. A violation of this section is a violation of the Maine Unfair Trade Practices Act, for which a fine of not more than $10,000
may be adjudged.
[
2003, c. 456, §1 (NEW)
.]
5.Application.
§2699. Marketing costs
(As enacted by PL 2003, c. 430, §1 and affected by §3 is REALLOCATED TO TITLE 22, SECTION 2698-A)
[
2007, c. 431, §2 (RP)
.]
SECTION HISTORY
2003, c. 430, §1 (NEW).
2003, c. 456, §1 (NEW).
2003, c. 673, §§FFF1,2 (AMD).
2003, c. 688, §§C9,10 (AMD).
RR 2003, c. 1, §18 (AFF).
2003, c. 430, §3 (AFF).
2003, c. 688, §C11 (AFF).
RR 2003, c. 1, §17 (RAL).
2007, c. 431, §§1, 2 (AMD).
2007, c. 431, §3 (AFF).
Data for this page extracted on 02/09/2010 08:47:18.