The Massachusetts State House, for the third year in a row, voted to repeal the controversial Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct(PCOC). As reported by Pharmalot, the latest effort goes beyond the previous two tries: “the House also agreed to repeal a disclosure rule that requires all financial arrangements between drug and device makers with prescribers is posted on a website maintained by the state Department of Public Health.”
Dr. Charles Birbara, a Worcester rheumatologist, is in favor of lifting the ban, because it is better for his patients and gives them more options.” Dr. Birbara told GoLocalWorcester, “The insurance company often times controls what we prescribe by virtue of what’s on their formula. There are many people that don’t take prescribed medicine, because they can’t afford it. These co-pays can get very pricey. The coupons really help out the patient.”
According to MA Rep. Jason Lewis, who is working to stop the amendment from passing, those on the other side of the issue have their reasons. “We want to make sure they have the best interest of patients. There are opponents who say that that argument is well and good, but it’s hurting the pharmaceutical industry in Massachusetts,” he said.
Speaker of the Massachusetts State House, Robert A. DeLeo is also opposed to the ban.
Background
In 2010, Massachusetts Governor Deval Patrick made a point during his reelection campaign that the PCOC “was never intended to extend to the state’s medical device industry,” and “goes beyond” the code that the pharmaceutical industry uses to police itself,” “and thus should be narrowed.”
“I think that was not its intent,” he said during an October 2010 forum in front of an audience of biotech advocates. “Aligning it with Pharma is a priority of mine.”
Patrick added that the PCOC was “ripe for repeal or modification, since the Obama administration’s federal health care overhaul included superseding language.” As a result, a spokesman from the Department of Public Health, which oversees these regulations, said the agency was currently reviewing the ways in which Massachusetts regulations are impacted by federal law in order to determine whether there are any additional steps that need to be take.
Additionally, the Massachusetts State Assembly voted overwhelmingly 128-22 to repeal the PCOC in late April, 2011 during its annual budget debate, but the proposal was dropped during negotiations with the Senate.
Despite strong signals that Gov. Deval Patrick, the House and the Senate would support peeling back parts of a three-year-old ban on gifts from pharmaceutical companies to doctors – a policy that critics say is strangling the restaurant business and killing jobs – 2011 came to a close without action.
However, the article noted that “efforts to dismantle components of the ban are poised to reemerge in 2012 and received the fresh backing of a panel of lawmakers” at the end of December, potentially teeing up the issue for consideration during debate on a major health care system overhaul eyed for next year.
Specifically, a move by the Committee on Public Health to give a favorable recommendation to the proposal came at a time when most lawmakers had cleared out of the capitol for an extended holiday recess. The pre-Christmas activity angered consumer advocates who argue that any attempt to weaken the so-called gift ban would encourage doctors to prescribe costlier medications, drive up health care costs, and infringe upon safeguards intended to ensure that patient interests prevail over business relationships.
Most recently, House leaders have been calling for a repeal of the gift ban according to a recent article from the Boston Herald, mostly because lawmakers believe that the federal law—Physician Payment Sunshine Act—will preempt majority of Massachusetts law. Until CMS proposes the final regulations and the Supreme Court decides whether the entire Affordable Care Act stays or goes, it is unlikely that Massachusetts will repeal the gift ban. The proposed House bill would keep the state reporting requirements, some of which exceed those required under the Sunshine Act.
Enacted in 2009, the PCOC or “gift ban” has been a controversial piece of legislation that has had significant impacts on the pharmaceutical and medical device industry in Massachusetts. The ban prohibits pharmaceutical companies and medical device manufacturers from providing “entertainment or recreational items of any value,” such as sports tickets; cash payments; “complimentary items” such as pens, mugs or gift cards; grants and scholarships in exchange for a promise to prescribe certain drugs or use certain devices; or any other prohibited “kickback.”
In addition, drug and device companies may only provide meals to doctors inside the hospitals or offices where they work, a fact that proponents say prevents lavish spending on expensive dinners and alcohol as a means to peddle influence. The policy also requires drug and medical device companies to annually disclose “any fee, payment, subsidy or other economic benefit with a value of at least $50” provided to doctors, hospitals, nursing home workers, insurers or other “health care practitioners.”
Payments for 2009 were then published on the states website in late November, 2010. The payments for 2010 were published just this week.
The legislation also requires manufacturers to adopt a set marketing code of conduct to help ensure that health care providers were making choices about prescription drugs for their patients based on therapeutic benefits and cost-effectiveness. This code had a number of provisions governing the types and nature of interactions industry could have with physicians. The Code of was subsequently adopted by the Massachusetts Department of Public Health (DPH).
Discussion
Those who support repealing the PCOC maintain that the regulation has severely affected medical innovation and collaboration, and thus decreased the quality of training and education health professionals receive, also decreasing the quality of patient care. In fact, a study done by MIT showed that the Code of Conduct is having significantly negative effects on patient care and medical innovation. And one article noted how the gift ban is having a negative effect on primary care physicians in Massachusetts because it is cutting off opportunities for clinicians to gather new scientific information and exchange real-world clinical information. Additionally, the gift ban has resulted in companies withdrawing funding for fellowships, professorships, and other faculty positions and departments in Massachusetts.
Moreover, medical device companies noted the significant burden the legislation placed on them considering the fact that many physicians needed to work directly with industry to learn how to use certain medical devices.
As noted by the Boston Herald, The bill backed by the Public Health Committee (H 1507) would eliminate the disclosure requirement. The proposal also repeals a prohibition on pharmaceutical companies providing meals to doctors outside of a “hospital setting,” so long as the meals are part of an event that is “primarily educational in nature.”
Backers of eliminating restrictions on meals say they have harmed the restaurant and convention industries, particularly in Boston, which has a high concentration of hospitals and pharmaceutical companies that surround the North End, a popular restaurant district. For example, pharmaceutical and device companies have been “curtailing sales, marketing and training activities in Massachusetts” in order to comply with the new rules, and “some outside companies are avoiding Massachusetts altogether.”
State Rep. John Mahoney told GoLocalWorcester the restaurant ban is hurting business in the Bay State. “We are the only state that doesn’t allow doctors to have dinner with pharma companies. I don’t think doctors are being swayed by a free meal. People who own restaurants are getting hurt by this. Companies are going to other states to work around this law. They are holding events and dinners in neighboring states.”
In fact, an article in the Boston Globe noted how the new laws have resulted in “fewer jobs related to training, medical device sales and clinical trials.” They also argue that doctors would not be improperly influenced by a meal and could gain valuable insight into advancements in medical devices or cutting-edge drugs.
“I think we should be looking at ways of modifying this. It’s, in my opinion, way too restrictive. I think it’s negatively impacting our convention industry,” said Rep. Vincent Pedone (D-Worcester), lead sponsor of the legislation. “This is what some of the proponents of modest change wanted to see. I’m trying to find a compromise between repealing the whole gift ban and making it more workable.”
Pedone said he’s supportive of the pharmaceutical industry’s own code of conduct. “The pharmaceutical industry has come a long way in a short time with this. If we can adopt just what their code is, which I think is the standard across the country for states, we would be in much better shape,” he said.
Efforts to relax the gift ban have gained popularity in the House, which has passed complete repeals for two straight sessions. But they’ve stalled in the Senate, where Senate President Therese Murray led the drive to implement the gift ban in 2008 legislation. Last year, however, senators nearly deadlocked on a plan to permit pharmaceutical and medical device companies to buy dinners for doctors, voting 19-18 to preserve the ban.
The Boston Herald noted that, “it is unclear how eight freshmen in the Senate will affect the outcome, although four of five new senators who served in the House voted to repeal the gift ban law as state representatives.”
Sen. Susan Fargo (D-Lincoln), co-chair of the committee, said she is opposed to efforts to weaken the gift ban, describing even an incremental change as “the nose of the camel getting under the tent.” Fargo said she hopes the proposal is “fully debated” on the floors of the House and Senate. “At the time that the gift ban was passed – and the Senate strongly endorsed it – pharmaceutical companies were spending far more on marketing and advertising than they were on research and development,” she said.
Asked about the House’s repeated votes to repeal the gift ban altogether, Fargo said, “Sometimes the House and the Senate simply have philosophical differences about legislation.” She added that she has no reason to believe the Senate has changed its attitude about the ban. Fargo also said she hoped efforts to whittle down the ban are debated apart from omnibus health care reform legislation planned for next year.
“The core issue of payment reform is big enough and important enough that it should stand alone,” she said.
Deirdre Cummings, legislative director of the consumer group MassPIRG, said she hopes the House waits until its members return from a seven-week recess before considering efforts to weaken the gift ban. “The concern from the consumer end is that the pharmaceutical industry are setting up these meetings and they’re really only marketing the most expensive, brand name prescription drugs,” said Cummings. “The impact of that marketing is also significant. It leads to higher prescribing. That’s the concern from the consumer end.”
Restaurant industry officials, however, say amending the gift ban to permit educational meals at local restaurants would provide an immediate economic jolt to the hospitality industry and lure drug conventions to Massachusetts. Dave Andelman, CEO of Phantom Gourmet, said the ban failed to prevent deep-pocketed drug companies from flooding consumers with advertisements but has created an impediment for smaller companies hoping to break into the market.
“Pfizer can wrap the whole T in advertising but these generic companies can’t take a doctor to dinner. It’s silly. It should be changed, and it should be changed now,” he said. “I have every reason to believe that it can change. We’ve been approaching every senator and making our case, and without naming names, even some senators that I thought really wouldn’t give us the time of day had to admit that all the arguments I’m making to you now make a lot of sense.”
Conclusion
As one recent article from the Boston Business Journal noted, it is “insulting to our physicians, some of the best minds in the country, to think they can be bought for a mug or a yogurt.” The author correctly recognized that “Much of the money flowing to our health care institutions [from industry] goes toward things like fellowships in the orthopedics department at Massachusetts General Hospital or a diabetes clinical trial at Beth Israel Deaconess Medical Center. It also goes towards training for heart surgeons on the newest stent procedures and to safety studies on rare disease drugs developed by Genzyme Corp.
Ultimately, with more and more companies picking up and leaving Massachusetts, and new businesses and other industries deciding to set up their offices in other states, it is becoming clearer to some that the Code of Conduct must go. With 8 new Senators in the Massachussetts Senators, this may provide the needed difference to repeal the PCOC, especially given that the Sunshine Act regulations are now out, making the reporting requirements under the code unnecessary and duplicative. Accordingly, Governor Patrick would be doing a service to the patients, health care practitioners, and entrepreneurs of Massachusetts by urging his legislature to repeal the Code of Conduct.
It is unlikely that Massachusetts will repeal this law until the U.S. Supreme Court decides whether the Affordable Care Act is constitutional, and whether the Sunshine Act will stand or be stricken. But the effort to repeal the current law in Massachusetts is sincere and it is important for states to note, that despite the “claims” of cost savings there is no evidence of that for the bay state, thus the repeal effort.