Minn. R. agency 120, ch. 2737, pt. 2737.0700

Current through Register Vol. 49, No. 24, December 9, 2024
Part 2737.0700 - ENFORCEMENT BY COMMISSIONER
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.

Minn. R. agency 120, ch. 2737, pt. 2737.0700

46 SR 175
46 SR 731
46 SR 809