Despite opposition by the Minnesota Board of Pharmacy, the Minnesota legislature passed HF 2402, which one section requires drug manufacturers to report payments to physician assistants, APRNs, and dental therapists. These entities are excluded from the Federal Physician Payments Sunshine reporting obligations. This follows a trend we recently reported about in Connecticut of states broadening their reporting laws from the already burdensome requirements of the Sunshine Act.
Notably, the law only applies to payments from pharmaceutical and biologic manufacturers, medical device manufacturers—many of which are located in Minnesota—are excluded from the reporting requirements.
Minnesota Disclosure Law
Minnesota Statute 151.252 states that drug manufacturers must file an annual report identifying all payments, honoraria, reimbursement, or other compensation paid to practitioners in Minnesota during the preceding calendar year. The report must identify the nature and value of any payments totaling $100 or more to a particular practitioner during the year, and must identify the practitioner.
According to a new law in Minnesota (page 189 of the PDF; 9535 of the bill), “Practitioner” means a licensed doctor of medicine, licensed doctor of osteopathy duly licensed to practice medicine, licensed doctor of dentistry, licensed doctor of optometry, licensed podiatrist, or licensed veterinarian. The statute now states that for purposes of the disclosure law, “practitioner” redefined to include a physician assistant authorized to prescribe, dispense, and administer under chapter 147A, or an advanced practice nurse authorized to prescribe, dispense, and administer under section 148.235, and dental therapist authorized to dispense and administer under chapter 150A.
Furthermore, the definition of “dispense,” which appears several times in the new definition of practitioner has been changed:
Dispense or dispensing. “Dispense or dispensing” means the preparation or delivery of a drug pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the drug. interpretation, evaluation, and processing of a prescription drug order and includes those processes specified by the board in rule that are necessary for the preparation and provision of a drug to a patient or patient’s agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.
Minnesota currently has a gift ban. This expansion of the definintion of prescriber applies to that ban as well.
“It is unlawful for any manufacturer or wholesale drug distributor, or any agent thereof, to offer or give any gift of value to a practitioner. A medical device manufacturer that distributes drugs as an incidental part of its device business shall not be considered a manufacturer, a wholesale drug distributor, or agent under this section.”
They specify that a “gift” does NOT include:
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Professional samples of a drug provided to a prescriber for free distribution to patients;
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Items with a total combined retail value, in any calendar year, of not more than $50;
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A payment to the sponsor of a medical conference, professional meeting, or other educational program, provided the payment is not made directly to a practitioner and is used solely for bona fide educational purposes;
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Reasonable honoraria and payment of the reasonable expenses of a practitioner who serves on the faculty at a professional or educational conference or meeting;
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Compensation for the substantial professional or consulting services of a practitioner in connection with a genuine research project;
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Publications and educational materials; or
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Salaries or other benefits paid to employees.
In last year’s coverage of Minnesota’s disclosure law, we noted that Minnesota’s Board of Pharmacy had announced that they would “not require wholesalers and manufacturers to report any data for calendar year 2012” because the “vast majority of data that is reported under Minnesota law is information covered by the Sunshine Act.”
In a memo issued last summer from the Minnesota board of pharmacy, they stated:
“Given that the clear legislative intent this session was for the Board to continue collecting data concerning payments made to practitioners other than “physicians”, the Board will seek clarifying language during the 2014 session. That language is very likely to pass, so manufacturers are advised to make arrangements to track data for calendar year 2014 concerning payments made to nurse practitioners, physician assistants and dental therapists. That data will most likely have to be reported to the Board in 2015.”
It is unclear if this new law will be retroactive to 2014 or begin in 2015. We believe that despite the memo from the board of pharmacy it may be unworkable and out of jurisdictional bounds to make the program retroactive.
However, we now know that Minnesota reports will be expected to include Physician Assistants, APRNs, and Dental Therapists. As previously covered states such as Massachusetts and Vermont that have had reporting on NP’s and APRN’s their payments represent less than 1% each of the HCP spend by companies. Laws like these become significantly more expensive to track the payments than the payments themselves.
Thanks to G&M Health, LLC for alerting us to this new law.