Code of Maine Rules
02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION
031 - BUREAU OF INSURANCE
Chapter 210 - STANDARDS FOR PHARMACY BENEFITS MANAGERS
Section 031-210-4 - Licensing Requirements
Universal Citation: 02 ME Code Rules ยง 031-210-4
Current through 2024-38, September 18, 2024
1. Initial Licensing
On or after January 1, 2020, any person acting or purporting to act as a PBM shall apply for a license on a form prescribed by the Superintendent. The application must contain the following:
A.
Applicant Information
(1) The name, principal business address, and
telephone number of the applicant;
(2) The name, address, and telephone number
of the applicant's agent for service of process located in Maine;
(3) The name, address, telephone number of
each officer and director of the applicant;
(4) The name, address and telephone number of
each person who owns 10% or more of the voting securities or equivalent
ownership rights of the applicant; and
(5) The state in which the applicant is
domiciled;
B.
Applicant Qualifications
The applicant must provide information by which the Superintendent can determine whether the applicant has the necessary organizational capability to supply the services sought to be offered. This information includes, but is not limited to:
(1) Copies of the basic organizational
documents of the applicant, such as the articles of incorporation, articles of
association, partnership agreement, trust agreement or other applicable
documents, including all amendments, bylaws, rules, regulations, and/or
procedures regulating the internal conduct of the applicant;
(2) Biographical information for each officer
and director of the applicant, including:
(a)
His or her principal occupation and all offices and positions held during the
past five years;
(b) Whether any
such occupation, position, office, or employment required licensing by or
registration with any federal, state, or municipal governmental agency, and if
so, the current status of each such license or registration and an explanation
of any surrender, revocation, suspension, or disciplinary proceedings in
connection therewith; and
(c) Any
conviction of crimes other than minor traffic violations.
(3) Whether the applicant has ever been
refused a registration, license or certification to act as a provider of
pharmacy benefits management services in any jurisdiction, or had such license,
registration or certification suspended, revoked, or subject to disciplinary
action in any jurisdiction. Disciplinary action includes, but is not limited
to, the imposition of any fines or civil penalties and any reprimand,
probation, or deferred prosecution agreement.
(4) Whether the applicant has ever had a
business relationship with a carrier or other health benefit payer terminated
due to alleged fraudulent, illegal, or dishonest activities in connection with
the administration of pharmacy benefits management services. If the applicant
has had such a relationship terminated, it must explain the circumstances
surrounding the termination.
(5)
Whether the applicant has ever been found liable in any lawsuit or arbitration
proceeding involving allegations of fraudulent, illegal, or dishonest
activities in connection with the administration of pharmacy benefits
management services;
(6) Whether
the applicant, or any company or organization controlling the operation of the
applicant, has experienced any events resulting in unauthorized access to,
disruption of, or misuse of its information system or stored
information.
C. The
applicant must provide information by which the Superintendent can determine
whether the applicant has the necessary expertise to supply the services sought
to be offered. This information includes, but is not limited to:
(1) A copy of the applicant's standard
contract template used in this State for contracts with pharmacies or pharmacy
services administrative organizations in the administration of pharmacy
services.
(2) A current client list
and a template copy of the client contract.
(3) The number of projected enrollees or
beneficiaries in this State to be serviced by the applicant during the upcoming
year for all contracted entities. If applicable, provide the actual number of
enrollees or beneficiaries serviced by the applicant for each entity during the
previous calendar year.
(4) The
applicant's network service areas or proposed network service areas for each
contracted carrier in Maine and the applicant's pharmacy network directory. All
pharmacies that provide pharmaceuticals exclusively through the mail must be
listed separately. The applicant must file with the Superintendent:
(a) A list of all pharmacies in the network,
and indicate which dispense specialty drugs;
(b) The projected ratio of retail pharmacies
to plan enrollees by county;
(c)
Written standards for providing a retail pharmacy network that is sufficient in
numbers and types of pharmacies to assure that prescriptions to covered
persons, including specialty prescriptions, will be reasonably accessible
without unreasonable delay. Standards must be reasonable for the community, the
delivery system, and clinical safety; and
(d) A description of the applicant's plan for
providing prescription drugs for rural and underserved populations.
D. The applicant shall
state whether it intends to provide PBM services for carriers offering health
plans or benefits in Maine within the scope of this rule. Before providing
services for carriers, the applicant must demonstrate to the satisfaction of
the Superintendent its ability to comply with the requirements of
24-A
M.R.S. §§4349 through
4350-D by providing the
following information:
(1) A description,
including any relevant written procedures, of how the applicant intends to
comply with the prohibition against requiring a covered person to make a
payment at the point of sale that exceeds either: the applicable cost-sharing
amount for the prescription drug; the amount the covered person would pay
without using the health plan or any other source of prescription drug benefits
or discounts; or the total amount the pharmacy will be reimbursed for the
prescription, including the cost-sharing amount paid by the covered
person.
(2) A description of how
the applicant intends to comply with the requirements of
24-A
M.R.S. §4350, including: procedures for
changes to the maximum allowable cost list; disclosure of allowable cost
information; the applicant's appeals process; payment for drugs that are not on
the maximum allowable cost list; ensuring that pharmacy providers' payments are
not retroactively denied or reduced except for error or fraud; and standards
and procedures for determination and payment of ingredient costs and dispensing
fees.
(3) If applicable, a
description of how the applicant intends to comply with the requirement to use
all rebates for the benefit of covered persons.
(4) Documentation verifying that the
applicant has established a pharmacy and therapeutics committee and implemented
appropriate procedures to address conflicts of interest and prohibited
compensation arrangements for committee members.
E. The applicant must provide information by
which the Superintendent can determine the financial integrity of the applicant
to supply the services sought to be offered. This information includes, but is
not limited to:
(1) A copy of the applicant's
most recent annual audited financial statement.
(2) Information demonstrating that either:
(a) the applicant is currently licensed in
good standing as a Third-Party Administrator;
(b) the applicant has a pending application
for licensure as a Third-Party Administrator;
(c) the applicant does not handle claims or
collect premium; or
(d) the
applicant is exempt from licensure as a Third-Party Administrator.
(3) A description of the
applicant's business plan.
2. Renewal
A PBM must renew its licenseevery three years to continue to act as a PBM in this state. An applicant for renewal shall provide the same information as an applicant for initial licensing. To the extent that the information is already on file from a previous application, the applicant may incorporate that information by reference if it attests that there have been no changes since it was originally submitted.
Disclaimer: These regulations may not be the most recent version. Maine may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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