March 13, 2012 — Proposed federal regulations that would put physicians' financial relationships with drug and device makers on the Web could unfairly jeopardize their careers in the process, according to organized medicine.
Medical societies have asked the Centers for Medicare and Medicaid Services (CMS) to revise the proposed regulations to give physicians more time to contest erroneous information about consulting and speaking fees, travel and lodging, and other "transfers of value" from industry before they are published. The societies also want these "sunshine" regulations rewritten so that physicians need not worry whether a drug representative's pizza lunch or a continuing medical education (CME) course will put them in a bad light.
The regulations in question, first proposed last December, would implement a section of the Affordable Care Act that attempts to discourage inappropriate relationships between manufacturers and physicians that might unduly influence the latter's professional judgment. Later this year, after the final regulations are issued, manufacturers must begin to inform CMS about their financial relationships with physicians, beginning at the $10 level or with smaller transactions that add up to more than $100 a year. CMS must begin publishing the dollar value of industry payments or ownership stakes online in a searchable format by September 30, 2013.
Product samples, educational materials intended for patients, and short-term loans of medical devices are excluded from the reporting requirements.
"Destruction of Professional Reputation and Livelihood"
The public, including medical societies and drug and device makers, had until February 17 to tell CMS what it thought about the proposed sunshine rules. The American Medical Association (AMA) and 92 other medical societies urged CMS in a letter to ensure that published reports on physician–industry financial relationships are accurate.
The proposed regulations give physicians 45 days to review a calendar year's worth of financial data that manufacturers submit about them before it is published online. During that period, they can ask manufacturers to correct any information they deem inaccurate. If the parties cannot agree, CMS would publish the data, but flag it as disputed and also include the physician's contradictory data. The information would remain unchanged until the next annual 45-day review period, which would cover the latest calendar year as well as the previous one. CMS stated that constantly refreshing the Web site with financial data would be "operationally difficult."
The AMA and the other medical societies stated that CMS should junk the annual 45-day review period and allow physicians and manufacturers to correct published data on a rolling basis. "The current state of technology," they said, gives CMS and manufacturers the capability of "real-time updates."
"The proposed rule," they stated, "opens the door to the real possibility that a large number of physicians could become the victims of false, inaccurate, or misleading reporting and suffer significant damages including investigation by government and private entities, potential disciplinary actions, public censure, ridicule, and destruction of professional reputation and livelihood."
Organized medicine also has a bone to pick about how CMS would regulate food and beverages served to physicians by manufacturers. The Medical Group Management Association (MGMA), for example, takes issue with the methodology of apportioning the cost of industry chow. When a drug representative treats a solo practice to $25 worth of bagels and coffee, the solo physician is credited with a $25 payment, even if his or her staff consumes most of the treats, according to the proposed regulation. If the practice consists of 5 physicians, the $25 is split 5 ways.
In its letter to CMS, the MGMA complained that each physician in a group is assigned a share of the meal, even if he or she never touched it. A problem, the MGMA wrote, could easily arise in a multispecialty practice in which 1 physician arranges an industry-supported educational event of little or no interest to colleagues outside his or her specialty. The association asked CMS to develop a more equitable approach.
Drug maker Merck recommended to CMS that manufacturers such as itself be obliged to report only on the physicians who actually put fork to mouth, as opposed to every physician in the practice. Furthermore, the reported cost should be the value of the individual meal. Bagels consumed by medical assistants, for example, would not enter the equation.
On a similar note, the American College of Cardiology (ACC) asked CMS to explicitly exclude food and beverages served at industry-funded programs (think buffet lines at medical conferences) from the reporting requirements. Physicians who do not load their plates with turkey sandwiches and 3-bean salad should not have that cost put on their accounts, according to the ACC. CMS also gives credence to this notion of food fair play in the commentary portion of its proposed regulations, but the ACC noted that this good intention does not appear in the proposed regulatory text.
Exclude CME From Reporting Requirements, Say Societies
CMS proposes requiring drug and device makers to report not only direct transfers of value to physicians but also indirect transfers through a third party when the manufacturer knows whom the ultimate recipients are. An example would be a grant given to CME faculty by an industry-funded CME provider. Organized medicine has cried foul about this, saying that CMS is going beyond the intent of Congress.
In their letter to CMS, the AMA and its allies contended that accredited CME does not need to be policed for influence peddling, as it is structured to prevent industry funders from controlling its content, speakers, or attendees. According to organized medicine, following these dollars would further burden CME providers, manufacturers, and physicians, who would have to track "any activity that could conceivably have any indirect transfer of value." That task contributes greatly to the 80 hours of annual paperwork that the regulation would impose on physicians, stated the medical societies. Accordingly, they urged CMS to exclude CME from the reporting requirements.
The ACC also asked CMS to exempt CME. Otherwise, drug and device makers would be less likely to fund CME events, and physicians would be less likely to attend.
"Better educated physicians furnish higher quality care," the ACC stated. "Reducing available CME activities certainly does not assist in achieving that goal."
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Cite this: Physicians Say 'Sunshine' Regs Could Unjustly Harm Careers - Medscape - Mar 13, 2012.