In a largely partisan vote the Iowa State Senate passed (30-18) Senate Bill 389, a comprehensive healthcare reform bill which includes the most restrictive pharmaceutical marketing provisions passed by a legislative body to date. The bill includes a “Gift” ban on all payments for services related to marketing, “Gift” registry on all payments for services related to research and certified education, and a prescription data mining ban.
All payments for services directed by marketing includes all services a physician or healthcare provider may perform other than research, Continuing Medical Education (CME) education conference, or a policy conference. All other services will be banned, which includes market research, marketing consulting, promotional speaking, attendance at a promotional event – even out of state, international speaking expenses, single speaker grand rounds at rural institutions, non-branded disease management programs, investigator initiated clinical trials, etc.… we are just scratching the surface.
This will include payments not banned and will only include Continuing Education (CE)/CME and Clinical Research.
Grants to sponsors of significant educational, scientific, or policy making seminar or Conference (SESPMCS).
- The definition for SESPMCS:
o Accredited by the Accreditation Council for Continuing Medical Education or a comparable organization;
o Offers continuing education credit;
o Features multiple presenters or scientific research; and/or
o Is authorized by the sponsoring organization to recommend or make policy.
- Reasonable Honorarium and Payment of Expenses
- Only at a SESPMCS session;
- Restricted to scientific issues and not marketing; and
- Slides and written materials are determined by the healthcare practitioners.
- Compensation for Consulting in a bona fide clinical trial
- Explicit contract; and
- Specific deliverables (This eliminates investigator initiated trials).
- Reporting to the State on December 1st or each year with all the typical information, name, address, the value, nature, and purpose of these “gifts.”
- Information on “gifts” (research and education work) required to be disclosed shall be presented in aggregate form and by selected types of healthcare practitioners or individual healthcare practitioners and analyzed to determine whether prescribing patterns by these healthcare professionals (criminals) reimbursed by the state healthcare programs may reflect manufacturers’ or wholesalers’ influence.
Of course, they are going to put all this information on a searchable website and charge a fee to manufacturers and distributors to defray the cost to the Department.
The fine for violation of the “Gift Restrictions” is $10,000 per violation.
Ban on use of prescription information for marketing of prescribed products.
Of course, the State would like access to the data for other purposes, including law enforcement, research on prescribing patterns for government use, product safety evaluations, product recalls, and pharmacy reimbursement…the list goes on.
What they do not keep in mind is that without resale for marketing, those databases would be prohibitively expensive to maintain and the data would more than likely no longer be available at a reduced rate to governments (no savings here).
The fine for violations in the data mining restrictions is $50,000 per violation.
Establishes an evidence-based prescription drug education program.
Promoting the therapeutic and cost-effective utilization of prescription drugs.
The Department will seek funding from non-governmental health foundations and other non-profit foundations to administer the program (good luck finding those non-profit monies for these state activities).
If this fails, they will establish and collect fees (taxes) from private payors (health plans, self-employed and small businesses) for the purpose of administering the program.
Summary
First, let me address the gift ban, by defining every payment made by a pharmaceutical company to a healthcare provider as a “gift,” the State Senate is doing the medical community in Iowa a huge disservice.
Since when is conducting a clinical trial, or some poor doctor giving a medical talk at some remote “hole in the wall” town in Iowa and getting paid for taking a day off their practice and driving themselves across the geographically diverse state of Iowa perceived as a gift?. I believe that the State should be reporting that the doctor gave them a gift.
These types of bills criminalize the medical community. Doctors, nurses, physician assistants, nurse practitioners, and pharmacists across Iowa should be outraged at the arrogance of their legislators (Iowa has gift restrictions on elected officials, but not for services provided, and allows pens and meals one friend of mine who just came from the capitol says there are meals galore during the legislative session).
The use of the data registry for “gifts” payments on research and CME to track its effect on changes in prescription practices, is counterintuitive and potentially misapplied, so if a series of education were done around the State on lipid management that reduced hospitalizations, you would see the number of prescriptions increase, but the overall healthcare burden go down, the information captured would only show that the prescriptions went up and no corresponding benefit to hospitalizations, and this is yet another way of labeling healthcare providers as criminals.
I have discussed these types of bills with leaders at several pharmaceutical and device companies, and many feel they will have no choice but to pull research and education grants from institutions in states that enact such undermining bills.
The data mining restrictions are equally foolish especially with the addition of the wish list of how the government will use the data.
Perhaps there is still time for the State House to stop this witch hunt against our manufacturing industries and health-care practitioners before it is too late.
Bill Track: Senate Bill 389
Text of Full Bill with Amendments: Senate Bill 389
Evidence Based Prescribing Section
De Moines Register: Senate Approves Health Care Bill
Owen Arenas
I cannot thank you enough for the article post.Really looking forward to read more. Much obliged.
Chaz Brigman
Thanks a lot for the blog article.Much thanks again. Cool.