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July 17, 2009

Physician Payment Sunshine Act: Payment Disclosure Laws -- History and Challenges in Minnesota

Physician Payment Sunshine provisions are now part of the healthcare reform bills working their way through the house and senate. 

One Minnesota physician who has seen the effects of payment disclosure first hand , sent an open letter this week to the Minnesota Board of Pharmacy asking for an explanation as to why, though not required by the law, the payments to physicians are listed on the Board’s website.    

In this article we will explore the history of the Minnesota law and the problems that the payment disclosure law has created for physicians, patients and economically for the state.

History

The Minnesota Board of Pharmacy has collected reports on physician industry disclosure since 1997, according to Dr. Cory Wiberg, who became Executive Director in 2005. According to Dr. Wiberg’s Office Manager—who has been with the Board for about 30 years—the reports were filed away and were never publicized because “nobody ever requested to view the reports.”

In 2004, Ralph Nader’s Group “Public Citizen” sent a “researcher” to look at and make copies of the reports. A couple of months after, Gardiner Harris of the New York Times contacted Dr. Wiberg to obtain copies of the reports. Then Tom Sheck of Minnesota Public Radio, and another researcher from California also asked for copies in the spring of 2006.  

Less than one week after he took over as Executive Director, he received a question from a Washington, DC law firm that represents several pharmaceutical manufacturers. They had a question about an interpretation of the law that establishes the gift limitation. After giving his response, Dr. Wiberg learned his answer “differed from the answer his predecessor had given the firm.” He also began receiving other questions that he then decided to list on the Board’s website under Frequently Asked Questions (FAQ).

Since his answer differed from his predecessor’s, Dr. Wiberg submitted all of the questions he received to the Minnesota Attorney General's Office (AGO) and requested a formal legal opinion. Specifically, “The request for a legal opinion was sent to Assistant Attorney General Tiernee Murphy who, at the time, was the AAG assigned to the Board, and her supervisor, Steve Gunn, reviewed the opinion.” Accordingly, the full Minnesota Board of Pharmacy unanimously adopted the Minnesota AGO legal opinion at its January 2006 meeting. The AGO opinion became the basis of the FAQ document posted on the Minnesota Board of Pharmacy’s website. In fact, according to Dr. Wiberg, the FAQ is in most places taken verbatim from that opinion including:

· Considering nominal meals and luncheons to doctors gifts;

 

· Counting these meals towards the state's limit of no more than $50 in gifts by a drugmaker to a doctor per year; and

 

· Preventing physicians from getting paid to complete marketing surveys.

Board of Pharmacy: Accountability

In early 2007, the researchers from Public Citizen published an article in the Journal of the American Medical Association (JAMA) which focused on the payments to physicians reported to the Minnesota Board of Pharmacy, causing numerous requests for copies of the reports. That is when Dr. Wiberg decided to place the reports on the Board's website as a matter of efficiency.

In choosing to do so, the Board sparked a new fight with physicians, who are pointing out the problems with the Minnesota disclosure law: J. Michael Gonzalez-Campoy, MD, PhD, FACE Medical Director and CEO, Minnesota Center for Obesity, Metabolism and Endocrinology, PA (MNCOME), Past President, of the Minnesota Medical Association(MMA), and current member of the Board of Directors of the American Association of Clinical Endocrinologists (AACE) is representing his colleagues in Minnesota, and in the specialty of endocrinology.

Dr. Michael Gonzalez-Campoy: Call to Action

Dr. Gonzalez-Campoy wrote to the Minnesota Board of Pharmacy after realizing the harm to medicine and patient care from anti-industry campaigns in Minnesota .  In his first letter, “The catalyst” for his inquiry was that several of his patients began to question the use of prescribed medications because of news reports claiming that doctors are getting paid by pharmaceutical companies.  As a result, patients expressed concern that doctors could not be trusted to provide unbiased care to their patients, and physicians were getting paid by industry for self gain—according to information on the Board’s website.

In response, he asserted that nothing could be further from the truth, even though Dr. Wiberg disagreed. Standing firm, Dr. Gonzalez-Campoy emphasized that physician industry relationships deploy newer, better treatments. Although these advances require the involvement of specialists to teach their colleagues, distinguishing the roles that specialists have as researchers and as physician educators from their primary role as health care professionals is unnecessary

Dr. Gonzalez-Campoy acknowledged the role of the Board to collect data on industry payments to physicians, under Minnesota statutes. He also clarified however, that the Board does not have a mandate to interpret the law—which the website attempts to do--and actually interferes with the practice of medicine, leading to patient harm.  Specifically, there is no accountability when the Board issued its opinion regarding the gifts because there is no authorship of the opinions the board posts. As a result, he firmly states that his letter, on behalf of his colleagues and patients,serves:

“as a request to make the public aware that all income which by law must be declared to the Minnesota Board of Pharmacy, is ethical, moral and legal, and represents the standard of care,” and that the working relationship between physicians and industry is not suspect. 

He notes that current treatments and technologies were made through the physician-industry relationships to treat patients, and any implication that this is not so, needs to be removed from the Board’s website. Specifically:

“The income reported to the Minnesota Board of Pharmacy represents part of the legal work product of physicians, and it is entirely for the good of medicine and our patients” and that  “This income should not be distinguished from the income physicians derive from patient care.”

The actions of the Minnesota Board of Pharmacy have unintended consequences and will continue to have a very negative impact on the doctor-patient relationship, research and development, and medical education. This negative impact has resulted in a decrease in support from industry that many physicians, patients, and students benefitted from.

Ultimately, efforts to control costs with the implementation of “transparency laws” are misguided because media coverage leads people to distrust their doctors, and some to stop taking their medications.  Dr. Gonzalez-Campoy believes, and demographics back him up, that:

“the real cost driver is an aging population that does not have access to timely medications as prescribed by their physicians,” which causes us to  “spend more on office visits, lab testing, ER visits, and long-term complications, when we don’t consider the global cost of care.”

MN Board of Pharmacy Response

Dr. Wiberg disagreed with Dr. Gonzalez-Campoy, that the postings on the Board's website implied that the working relationship between physicians and industry is suspect. In response to the first letter Gonzalez-Campoy wrote to the Minnesota Board of Pharmacy on behalf of his colleagues and patients, Dr. Wiberg noted the following corrections he would make to the Board’s website:

 

· Edit the FAQ to acknowledge that the Board adopted a formal legal opinion issued by the AGO during a public meeting in January of 2006;

 

· Edit the FAQ document to add information that indicates that the reported payments are legal under Minnesota law; and

 

· List Minnesota Board of Pharmacy members and staff who authored the FAQ and opinion

 

 

In addition, Dr. Wiberg recognized that acknowledging all of the payments reported by manufacturers as "entirely for the good of medicine and . . . patients," would be something more appropriate for the legislature. Ironically, the Director noted that even though “there is a considerable amount of disagreement in this country concerning the value of certain payments that manufacturers make to practitioners,” his website still maintains ‘their interpretation.’

Some specific changes and factors with the Board's adoption of the legal opinion it received from the Attorney General's Office included:

 

· Some pharmaceutical manufacturers directed their sales representatives to restrict providing food on their sales calls;

 

· Manufacturers of educational materials such as brochures, journal articles and patient teachings aids are NOT considered gifts or have to be reported; 

 

· FDA 2003 guidance to the industry allows manufacturers to provide grants to support medical education, if they do not control the programs;

 

· Pressures from advocacy groups such as The Prescription Project and Public Citizen.

 

Gonzalez-Campoy Fires Back

In reaction to the Board of Pharmacy’s response to his initial letter, Dr. Gonzalez-Campoy did not hesitate to press the Director for more answers and transparency. In particular, he declared that the Boards published interpretation caused harm to patients by:

 

· Eroding the patient-doctor relationship by the innuendo of impropriety;

 

· Hurting medical education by mandating students to take anti-industry classes, and deeming industry sponsorship of medical education suspect, which is creating a generation of physicians who lack fair balance;

 

· Hurting the physician-industry relationship because anti-industry messages cause “leadership” of medical groups to shut down their institutions to industry colleagues and their sales are discredited;

 

· Threatening the steady scientific work force Minnesota enjoyed by anti-industry messages in medical and graduate schools, making it difficult to recruit talented scientists and physicians to work in Minnesota when they learn of the negative practice environment;

 

· Stagnating medical research/development because investors are unsure;

 

· Causing the tax base provided by medical industry and the employment opportunities it had brought to Minnesotans to dwindle, such as pharmaceutical companies choosing not to work in Minnesota (even though they continue to do business in Minnesota);

· Depriving dollars previously spent in Minnesota, which helped the economy, including dinner programs for physician education and travel to Minnesota by physician educators, are now being spent elsewhere;

 

· Wasting Minnesota taxpayer dollars to collect and process data from the by the Minnesota Board of Pharmacy staff; and

 

· Not reaching optimal patient care because efforts to cut pill costs do not consider global cost of care for individuals or what optimal treatment is.

 

The harm done to patients, medical education and medical research “has its roots in Minnesota.” The opinions regarding the Minnesota gift laws were a direct catalyst for a major withdrawal by industry in Minnesota, and subsequently in other states, negatively impacting patient welfare and medicine nationally.

 

Other physicians, companies, state and federal institutions should support Dr. Gonzalez-Campoy and his colleagues before patients lose their voice and are forced to make health choices based on politically funded propaganda.

 

The research and dedication Dr. Gonzalez-Campoy and his colleagues employ regarding these issues makes them champions for the overwhelming percentage of physicians who practice individualized, patient-centered care, and consider using industry support essential to improving health outcomes for their patients. 

 

Minnesota

 

Minnesota: Board of Pharmacy Q&A

 

Disclosure Reports (1997-2008)

 

(Part 1 of 2) in our next article we will be discussing recent activities around the Minnesota Law.

 

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