Current through Register Vol. 49, No. 27, December 30, 2024
Subpart 1.
Acting without a license.
If a pharmacy benefit manager acts without a license, the
pharmacy benefit manager may be subject to a fine of up to $5,000 per day for
the period the pharmacy benefit manager is found to be in violation. The
commissioner must consider timeliness of responses, content of responses, and
progress toward licensure when assessing fines.
Subp. 2.
Basis for suspension,
revocation, or probation.
The commissioner may consider the following when suspending,
revoking, or placing a pharmacy benefit manager license on probation:
A. failure to comply with relevant state and
federal law, as determined by the relevant regulatory body:
(1) Minnesota Statutes, chapter 62W;
and
(2) state health care and
pharmacy laws:
(a) insurance laws codified in
Minnesota Statutes, chapters 60A, 62A to 62W, and related rules;
(b) health laws codified in Minnesota
Statutes, chapter 151, and related rules;
(c) the electronic health record technology
requirements under Minnesota Statutes, section
62J.495,
the electronic prescription drug program requirements under Minnesota Statutes,
section
62J.497,
the uniform electronic transactions standards under Minnesota Statutes, section
62J.536,
the implementation of electronic data interchange standards under Minnesota
Statutes, section
62J.56,
and the Minnesota uniform health care identification card requirements under
Minnesota Statutes, section
62J.60;
and
(d) for pharmacy benefit
managers providing benefits to a person covered by workers' compensation, the
pharmacy benefit manager must comply with the processes, cost sharing, and
treatment access described in Minnesota Statutes, section
176.135,
in relation to compensable prescriptions, including the requirement that a
pharmacy or network of pharmacies may be required only if a designated pharmacy
is located within 15 miles of the employee's place of residence;
B. fraudulent activity
that constitutes a violation of state or federal law;
C. consumer, plan sponsor, or health care
provider complaints that have led to a civil or criminal action to protect the
safety and interests of consumers;
D. failure to pay any fees and penalties;
and
E. compliance with federal
pharmacy laws, including but not limited to the following laws, regulations,
and guidance, as applicable to the plan sponsor or product that the pharmacy
benefit manager serves.
Subp.
3.
Notice.
The commissioner must provide a 30-day notice before
suspending, revoking, or placing a pharmacy benefit manager license on
probation. If the pharmacy benefit manager demonstrates remedy or good faith
progress toward remediation before the 30-day notice period expires, the
commissioner may approve the license, reduce the enforcement action to
probation, or provide an extended timeline for probation and
remediation.