Have you ever thought … how does my brain work at 4:00 am after working all day; can I concentrate; can I make accurate decisions?
Well, the Massachusetts legislature has become a case study in what not to do at 4:00 am. This is when they settled on their final gift ban disclosure legislation.
CME = Non CME
For instance, in their revisions to Section 14 of the Healthcare Cost Containment bill they define CME as Independent Medical Education that does not meet the Accreditation Council for Continuing Medical Education (ACCME’s) Standards for Commercial Support. This is the exact opposite of the definition of CME.
They also failed to recognize that not all healthcare providers receive CME. CME is for MD’s only. This leaves out all the DO’s, nurses, nurse practitioner, physician assistants, pharmacists, technicians, caseworkers, hospitals administrators, those who have separate accrediting organizations and different rules than the ACCME standards for commercial support.
Financial support for the cost of travel, lodging or other personal expense for non faculty attending a scientific conference except in cases as determined by the department (ACCME rules don’t allow this any way, but the real shot on this one is against advisory boards).
Supervised Office Lunches
For meals, the rule is even more confusing.
Under these circumstances meals are prohibited:
· As part of entertainment or recreational event; (The problem here is what if a pharmaceutical or device company is asked to support the “race for the cure” even national sponsorship would have to be discontinued. “How do you stop a doctor’s wife from participating” as this would be prohibited under this language)
· That are offered without an informational presentation made by a pharmaceutical agent or without a pharmaceutical marketing agent being present (so if you are a device company, you better bring along a Pharma rep!)
· That are offered, consumed or provided outside of the healthcare practitioners office or hospital setting, (so no meals at any restaurants, any outside event – so again "race for the cure" sponsorship is banned)
· The provision of or payment for meals directly (not sure what this is) at any CME event, third-party scientific or educational conferences or professional meetings. (I think this means that companies can pay the meals directly, but who knows since the language is very confusing).
Yes You Can
The code does allow for:
· Distribution and Dissemination of “peer reviewed” academic, scientific or clinical information
· Purchase of Advertising in peer reviewed journals
· Drug Samples for the patients use
· Professional or Consulting Services in connection with a “genunine” research project or clinical trial
· Payment for expenses on technical training for medical devices
Who Knows
What is not disallowed or allowed are:
· Market Research and Consulting
· DTC and Professional Internet Advertising
· Product Brochures – Product Materials
Training Your Children Well
There are also provisions for training employees on the code, annual audits of compliance to the code, policies and procedures for investigating instances of non-compliance with the marketing code of conduct and to take corrective action in response to non compliance, and identification of a compliance officer. (This way the state can use the companies’ own resources to investigate infractions.)
Report Everything
The Value Nature and Purpose of:
Any Fee, Payment Subsidy or other economic benefit with a value of at least $50, which the company provides directly or through its agents to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or other person in authorized to prescribe, dispense, or purchase prescription drugs or medical devices in the commonwealth.
This will have a chilling effect to biotech industry in that every payment for consulting, research or anything else will be reported. A new company operating in the state will have to divulge who is doing their research well in advance of filing a patent.
Big Fines
Oh, by the way if you miss something, there is a $5,000 fine for each transaction, occurrence or event that violates this chapter.