Massachusetts Sen. Mark C. Montigny (D) introduced S.B. 515, which would replace the existing physician gift law (Chapter 111N) with a ban on gifts and a more expansive public reporting requirement than exists in current regulations.
Rep. Steven M. Walsh (D) introduced H.B. 1544 to require physicians to disclose payments from the pharmaceutical industry as part of their licensing.
Details on S.B. 515 and H.B. 1544
S.B. 515 would prohibit any agent of a pharmaceutical or medical device manufacturer from “knowingly and willfully” offering a “a gift of any value” to “a health care practitioner, a member of a health care practitioner's immediate family, a health care practitioner's employee or agent, a health care facility or employee or agent of a health care facility” and any of those entities from “knowingly and willfully” soliciting such gifts. The ban on gifts also forbids offering gifts “through a third party corporation, association or charitable organization.” S.B. 515 would also require public reporting by a pharmaceutical or medical device manufacturer of “any fee, payment, subsidy, or other economic benefit not prohibited... including fees, payments subsidies or other economic benefits related to, which is provided by the company, directly or through its agents, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or any other person in this state authorized to prescribe, dispense, or purchase prescription drugs or medical devices in this state.” That public reporting would expressly include “non-marketing related economic benefits, including, but not limited to, research, education and consulting arrangements”.
H.B. 1544 would amend the laws on physician licensing (Chapter 112, Section 2) so that the Board of Registration in Medicine “shall require as a condition of granting or renewing a physician's certificate of registration, that the physician disclose in writing each gift, benefit, gratuity, blandishment or incentive of any kind received from any agent or manufacture of drugs, pharmaceuticals or other medication, or from any agent or manufacturer of any medical device, treatment or service that the physician has or could provide to patients under his care. For each gift, gratuity, blandishment, or incentive, the disclosure shall include a description, the estimated cash value and the name and company of the donor.”
Impact on marketing research
If it became law, S.B. 515 would obviate Massachusetts’ 2009 regulations on payments to practitioners – including the public reporting requirements, from which MRA ensured marketing research incentives were exempted. Given that S.B. 515 specifically would include “research… and consulting arrangements” in the public reporting structure, marketing research incentives would most likely be included as well.
The reporting requirements for physicians in H.B. 1544 would presumably also include incentives for marketing research.
Conclusion: Much of the medical community, pharmaceutical and medical device manufacturers, the broader business community and Governor Deval Patrick (D) have all proposed scaling back or repealing the Department of Public Health’s regulations. As a result of such political pressure, any legislation making the law and regulations stricter, such as S.B. 515 and H.B. 1544, do not appear likely to become law. Nonetheless, MRA has contacted the sponsors to urge that they exclude research incentives from these bills. Absent such amendments, MRA will seek to defeat S.B. 515 and H.B. 1544.