Physician-legislation is already on the books in California, the District of Columbia, Maine, Minnesota, New Hampshire, and Vermont. And now physician-marketing legislation has been proposed in Arkansas, Illinois, Iowa, Maryland, Massachusetts, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Washington, and Wisconsin. Here’s a roundup of the most relevant proposals.
The Massachusetts Senate recently approved legislation that would make it illegal for pharma reps to give gifts of any value to physicians, other healthcare providers, or their family members, and would require reps to be licensed. If passed into law, it would create criminal and civil penalties of up to $5,000 and/or two years in prison for providing “anything of value…unless consideration of equal or greater value is received.” This includes any payment, travel, honorarum, entertainment, advance, subscription, or service. Drug samples given for free to patients would be exempt, but only those given to a physician (not a health care facility or other type of prescriber). While it is unclear whether or not CME grants would be affected, this is one to keep an eye on. The two proposals, one House, one Senate, were approved in May as amendments to the state budget for fiscal year 2007.
While it doesn’t relate specifically to CME, a New Hampshire Senate vote for a proposal to prohibit third parties from selling, transferring, and using prescription information for commercial reasons, including as sales tools for pharma companies, has stirred up a ruckus. Pharma companies use prescription info to track the effectiveness of their marketing programs, including meetings. Also, there has been controversy about allowing prescription tracking to be a type of CME outcome to be measured. The proposal, which also passed the New Hampshire House earlier in the spring, could be the first of its kind in the nation, should it be passed into law. Similar bills have been introduced in Arizona and West Virginia. Starting in July, the American Medical Association will let individual physicians opt out of making their prescription records available to drug reps, in an effort to self-police before New Hampshire and other states begin to institute legislative bans on the practice. In an Associate Press report, the New Hampshire bill sponsor, Rep Cindy Rosenwald (D-Nashua), objected that the AMA move “does not keep physicians prescription data out of the hands of drug companies. It only says they are not supposed to share them with the sales forces.”
While pharma gift disclosure laws died or are stalled in Connecticut and Mississippi, there still are plenty more bills hanging fire in a number of state legislatures. For example, Alaska’s HB 454 and 457, which would require pharma companies to report marketing costs and disclose marketing practices, were referred to House Committees on Labor and Commerce, Health, Education and Social Services, and Finance in February. Hawaii’s HB 32, which would have similar requirements to Maine’s law, is being held in the Senate Committee on Commerce. New Jersey’s AB 2930, which would restrict drug companies from providing gifts to healthcare professionals and prohibit healthcare professionals with financial ties to drug companies from serving on healthcare facility formulary committees, has been referred to the Assembly Committee on Health and Senior Services. Vermont, in the vanguard again, has two bills pending that would prohibit the advertising of prescription drugs on broadcast media.
But, says Karmen Hanson, MA, senior policy specialist with the National Conference of State Legislatures, Denver, CME providers -shouldn’t worry too much about all this legislation. “By and large, the legislators realize how important medical education is. If it’s an up-and-up conference or medical event, that’s not what they’re looking to regulate. They’re looking to regulate the free dinners, the items for their office, the golfing trips, the things that are purely entertainment, not educational.” However, these bills do affect exhibitors at medicaland pharma meetings for healthcare professionals, including those held in conjunction with association meetings.
States Get Into the FCA Act
The recently passed Deficit Reduction Act includes provisions to the False Claims Act that encourage state governments to enact qui tam (whistleblower) laws, according to the May 24 edition of Rx Compliance Report. Fifteen states and Washington, D.C., had already enacted qui tam provisions prior to the DRA’s passing, in which someone with knowledge of financial fraud against the government can file suit against the alleged wrongdoer on behalf of the government. The whistleblower then is entitled to a share of the proceeds. These are often used in actions against pharma companies related to illegal marketing practices involving Medicaid and Medicare. The DRA, which goes into effect January 1, 2007, gives states incentives in this area by allowing states that have a qualifying qui tam false claims statute to keep an extra 10 percent of the federal share in any Medicaid settlement. This could encourage state attorney generals to initiate even more investigations into pharma marketing practices. As of press time, 10 additional states are pursuing instituting their own False Claims Acts, most of which contain qui tem provisions.
Don’t Forget the Feds
The states aren’t the only government entities looking to tighten up on pharma gift disclosures. Rep. Peter DeFazio of Oregon introduced House Bill 4718, entitled the “Drug Company Gift Disclosure Act,” in February. This bill proposes amending the Food, Drug, and Cosmetics Act to require prescription drug manufacturers, packers, and distributors to report annually to the Commissioner of Food and Drugs any gifts provided to covered healthcare entities in connection with detailing or other marketing activities.
The bill broadly defines a “gift” as any fee, payment, subsidy, or other economic benefit with a value of $50 or more, with the following exemptions: drug samples intended for free distribution to patients; the payment of reasonable compensation and reimbursement in connection with clinical trials; and scholarships or other support for medical students, residents, or fellow selected by the conference provider. It does not specifically provide an exemption for CME grants.
As of press time, the bill is pending before the House Subcommittee on Health.
For More Information
For more information on current legislation, go to the National Conference of State Legislature’s Marketing and Direct-to-Consumer Advertising (DTCA) of Pharmaceuticals page: www.ncsl.org/programs/health/rxads.htm#lastyears
For updates on legislation in the 2006 session, go to NCSL’s 2006 Prescription Drug State Legislation Web page: www.ncsl.org/programs/health/drugbill06.htm