March 19, 2024

Physician Payments Sunshine Act

Consumers have more information about the products they use than ever before, but health care is still behind the curve.  A lot of smart people believe health care costs would go down and quality would improve if we pulled back the curtain on where the money goes.

For my part, I know transparency improves just about every situation in the public interest.  Members of Congress are held accountable through financial disclosure forms. The Freedom of Information Act opens federal agencies to scrutiny. Tax-exempt organizations have to disclose their basic financial information as part of their special tax treatment.

Several years ago, it started to become clear how little public information exists on the financial relationships between doctors and pharmaceutical and medical device companies.

A doctor would not tell The New York Times how much money she received from the maker of the antipsychotic drug Seroquel. The doctor was behind a study recommending the drug for bipolar disorder in teenagers, even though only eight teens completed the study. She later disclosed receiving income from eight drug companies, including all five makers of drugs like Seroquel.

Baylor College of Medicine didn’t tell the National Institutes of Health that a researcher who was studying cholesterol-lowering drugs for NIH also received payments from a drug company to consult on a cholesterol-lowering drug. That drug appeared to be no more effective than less expensive drugs.

At Stanford University, the chairman of psychiatry received an NIH grant to study a drug while partially owning as much as $6 million in stock in a company that was seeking U.S. Food and Drug Administration approval of that drug. After exposure, the NIH removed the individual from the grant.

At Harvard University, three professors failed to report almost $1 million each in outside income while heading up several federal research grants. In response to my oversight, Harvard revised its conflict of interest policies and conducted an internal investigation of these professors.

No one knows exactly how much money flows from drug and device companies to doctors. The  media organization ProPublica and the website Pharmashine mined payment information from court cases and other disclosures. In their latest update, they concluded drug companies paid more than $4 billion to doctors from 2009 to 2013. That’s just a snapshot. The total number is likely much higher.

Doctors say they maintain their integrity and receive payments to research new medicines and medical devices for patient benefit or receive compensation for their time in educating other doctors about products they consider effective.

The doctors rightly point out that such payments are perfectly legal, unlike kickbacks to steer prescribers toward certain drugs. But studies have shown that exposure to a prescription drug on the lecture circuit or in the lab leads to more prescriptions for that drug, whether the doctor feels influenced or not.

Purists advocate an all-out ban on any payments or other items of value, such as trips and meals, from drug and medical device companies to doctors. Some medical schools and health care providers voluntarily have adopted restrictions.

What about the doctors who receive the outside money and want to continue that way?  Rather than interfere with the practice of medicine, Congress arrived at transparency as the solution.
Drug companies and device makers are free to continue giving payments for lectures and scientific research and picking up the tab for meals and trips to conferences, but the companies have to disclose each payment to each doctor by name. The data will be in a publicly available database for consumer, think tank and reporter use.

This is the idea of the Physician Payments Sunshine Act, developed by then-Sen. Herb Kohl and me, and enacted in 2010. After years of data reporting, database mechanical work, and review of accuracy from doctors, the data became public for the first time Tuesday.

My staff sought and received regular briefings from the Centers for Medicare and Medicaid Services (CMS), which is handling the project.

The roll-out won’t be perfect. We’re told some of the data made public initially will be presented without the doctors’ names. This is because a small percentage of data submitted by the drug and device companies had blatant errors, and CMS made the decision to de-identify a large portion of the data in an overabundance of caution to protect doctors.

The system also is dependent on doctors’ taking the opportunity to confirm the accuracy of payments reported with their names prior to the public launch. Some doctors experienced challenges accessing the database. Others remain unaware of the Sunshine Act. Overall, the review rate among doctors was very low. All of the shortcomings will need to improve considerably in the future.

As the problems are fixed, the database will improve.  It will become more precise and more complete as doctors, drug and device companies and CMS work to update and refine the information.

From day one, the Physician Payments Sunshine Act database will be helpful in shining light on a part of medicine most people haven’t had the time or opportunity to consider.  Eventually, the database will become a valuable resource for all of us with a stake in our country’s health care system – individual consumers, insurance companies, and taxpayers who pay for Medicare and Medicaid.

Transparency shouldn’t stop doctors from receiving a payment if they want to.  It should empower consumers to learn whether their doctors take payments and if so, why, and whether that matters to them.  The parent of a teenager who is prescribed a drug that might be beneficial yet risky will be able to learn whether the prescribing doctor accepted drug company money to study the risks.  The information might not change the outcome, but it’s something a parent might like to know.

Grassley, an Iowa Republican, is co-author of the Physician Payments Sunshine Act.