In a move to eliminate medical conflicts of interest, the Obama Administration is set to require drug, device and supply companies to disclose the payments made to doctors, whether it’s “for research, consulting, speaking, travel and entertainment.” They are really trying to cover the spectrum. The thought is, these disclosures should increase the probability that physicians would make better decisions –more in line with the specific needs of patients—without having to consider their financial interests.
I don’t want to belabor the point. If you trust the research, about 25% of physicians take cash payments from drug and device manufacturers. And that same research says that doctors who take such payments tend to practice medicine differently than those who don’t. Supposedly, they take more risks (i.e. they are quicker to diagnose, order a procedure and/or prescribe medication). Royalty payments, payments made to hospitals for research and yes, “meeting donuts,” must all soon be reported. In addition, any ownership interest a physician may have in covered companies must be disclosed (unless the company is publicly traded) and Physician Owned Distributors (PODs) or Manufacturers must disclose any financial incentives offered to their doctor-customers. Like I said, it really is intended to be comprehensive.
The rules will be implemented and enforced by CMS. Essentially, if you are a company that expects to get paid by Medicare or Medicaid, you must disclose any/all payment data made to physicians other than your own employees. And all of that same payment information will be posted on a web site maintained by the federal government.
The point here isn’t to distinguish between what is or isn’t an improper payment. It’s just about disclosure; appeasing consumer rights advocates; and a belief that the disclosure process itself will save the system money by reducing instances of unnecessary procedures and over-prescribing. “The goal is to let the sun shine in and make information available to foster accountability,” said co sponsors Senator Grassley (R) Iowa and Herb Kohl, (D) Wisconsin.
Adoption of a disclosure practice certainly seems like a step in the right direction. Even Wall Street has jumped on the disclosure bandwagon. But will the Obama Administration extend such disclosure policy to other government employees, including the FDA? For example, should members of an FDA panel responsible for determining a grant be employed by one of the potential recipients? That seems like a classic conflict of interest doesn’t it?
A recent panel of FDA advisers took a vote and approved several controversial birth control medications manufactured and sold by Bayer AG. These same medications had been linked to blood clotting, hence the controversy. Three members of that panel had direct/compensated ties to Bayer. If a pharmaceutical rep is obliged to disclose/file a report on donuts purchased for a meeting, do you think situations like these make the grade?
—Tom Finn
Tagged as:
CMS disclosure enforcement,
disclosure,
FDA,
healthcare,
new fines for failure to disclose,
payments to doctors
New Disclosure Rules Pending: A Step in the Right Direction
by Tom on January 18, 2012
in General News and Commentary, Healthcare Providers, Medical Device Manufacturers
In a move to eliminate medical conflicts of interest, the Obama Administration is set to require drug, device and supply companies to disclose the payments made to doctors, whether it’s “for research, consulting, speaking, travel and entertainment.” They are really trying to cover the spectrum. The thought is, these disclosures should increase the probability that physicians would make better decisions –more in line with the specific needs of patients—without having to consider their financial interests.
I don’t want to belabor the point. If you trust the research, about 25% of physicians take cash payments from drug and device manufacturers. And that same research says that doctors who take such payments tend to practice medicine differently than those who don’t. Supposedly, they take more risks (i.e. they are quicker to diagnose, order a procedure and/or prescribe medication). Royalty payments, payments made to hospitals for research and yes, “meeting donuts,” must all soon be reported. In addition, any ownership interest a physician may have in covered companies must be disclosed (unless the company is publicly traded) and Physician Owned Distributors (PODs) or Manufacturers must disclose any financial incentives offered to their doctor-customers. Like I said, it really is intended to be comprehensive.
The rules will be implemented and enforced by CMS. Essentially, if you are a company that expects to get paid by Medicare or Medicaid, you must disclose any/all payment data made to physicians other than your own employees. And all of that same payment information will be posted on a web site maintained by the federal government.
The point here isn’t to distinguish between what is or isn’t an improper payment. It’s just about disclosure; appeasing consumer rights advocates; and a belief that the disclosure process itself will save the system money by reducing instances of unnecessary procedures and over-prescribing. “The goal is to let the sun shine in and make information available to foster accountability,” said co sponsors Senator Grassley (R) Iowa and Herb Kohl, (D) Wisconsin.
Adoption of a disclosure practice certainly seems like a step in the right direction. Even Wall Street has jumped on the disclosure bandwagon. But will the Obama Administration extend such disclosure policy to other government employees, including the FDA? For example, should members of an FDA panel responsible for determining a grant be employed by one of the potential recipients? That seems like a classic conflict of interest doesn’t it?
A recent panel of FDA advisers took a vote and approved several controversial birth control medications manufactured and sold by Bayer AG. These same medications had been linked to blood clotting, hence the controversy. Three members of that panel had direct/compensated ties to Bayer. If a pharmaceutical rep is obliged to disclose/file a report on donuts purchased for a meeting, do you think situations like these make the grade?
—Tom Finn
Tagged as: CMS disclosure enforcement, disclosure, FDA, healthcare, new fines for failure to disclose, payments to doctors