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Sunshine Act – another reminder

I’ve written about the Physician Payment Sunshine Act several times since it became law in 2013. My basic opinion – that it is a tempest in a teapot – has not changed. Nonetheless, now is the time to review the 2014 data reported under your name – and if necessary, initiate a dispute – before the information is posted publicly on June 30.

A quick review: The Sunshine Act, known officially as the “Open Payments Program,” requires all manufacturers of drugs, devices, and medical supplies covered by federal health care programs to report to the Centers for Medicare & Medicaid Services any financial interactions with physicians and teaching hospitals.

Reportable interactions include consulting, food, ownership or investment interest, direct compensation for speakers at education programs, and research. Compensation for clinical trials must be reported but is not made public until the product receives FDA approval, or until 4 years after the payment, whichever is earlier. Payments for trials involving a new indication for an approved drug are posted the following year.

Exemptions include CME activities funded by manufacturers and product samples for patient use. Medical students and residents are exempted entirely.

You are allowed to review your data and request corrections before information is posted publicly. You will have an additional 2 years to pursue corrections after the content goes live at the end of June, but any erroneous information will remain online until the next scheduled update, so you should find and fix errors as promptly as possible.

If you don’t see drug reps, accept sponsored lunches, or give sponsored talks, don’t assume that you won’t be on the website. Check anyway: You might be indirectly involved in a compensation that you were not aware of, or you might have been reported in error.

To review your data, register at the CMS Enterprise Portal (https://portal.cms.gov/wps/portal/unauthportal/home/) and request access to the Open Payments system.

The question remains as to what effect the law might be having on research, continuing education, or physicians’ relationships with the pharmaceutical industry. The short answer is that no one knows. The first data posting this past September came and went with little fanfare, and no repercussions directly attributable to the program have been reported as of this writing.

Sunshine laws have been in effect for several years in six states: California, Colorado, Massachusetts, Minnesota, Vermont, and West Virginia, plus the District of Columbia. (Maine repealed its law in 2011.) Observers disagree on their impact. Studies in Maine and West Virginia showed no significant public reaction or changes in prescribing patterns, according to a 2012 article in the Archives of Internal Medicine (now JAMA Internal Medicine).

Reactions from the public are equally inscrutable. Do citizens think less of doctors who accept the occasional industry-sponsored lunch for their employees? Do they think more of doctors who speak at meetings, or conduct industry-sponsored clinical research? There are no objective data. Anecdotally, I haven’t heard a peep – positive, negative, or indifferent – from any of my patients, nor have any other physicians that I’ve asked.

As of now, I stand by my initial prediction that attorneys, activists, and the occasional reporter will data-mine the information for various purposes, but few patients will bother to visit. Of course, that doesn’t mean you should ignore it as well. As always, I suggest you review the accuracy of anything posted about you, in any form or context, on any venue. This year’s data (reflecting all 2014 reports) have been available for review since April 6. You can initiate a dispute at any time over the next 2 years, before or after public release on June 30, but the sooner the better. Corrections are made each time CMS updates the system.

Maintaining accurate financial records has always been important, but it will be even more important now to support your disputes. CMS won’t simply take your word for it. A free app is available to help you track payments and other reportable industry interactions; search for “Open Payments” at your favorite app store.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News.

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I’ve written about the Physician Payment Sunshine Act several times since it became law in 2013. My basic opinion – that it is a tempest in a teapot – has not changed. Nonetheless, now is the time to review the 2014 data reported under your name – and if necessary, initiate a dispute – before the information is posted publicly on June 30.

A quick review: The Sunshine Act, known officially as the “Open Payments Program,” requires all manufacturers of drugs, devices, and medical supplies covered by federal health care programs to report to the Centers for Medicare & Medicaid Services any financial interactions with physicians and teaching hospitals.

Reportable interactions include consulting, food, ownership or investment interest, direct compensation for speakers at education programs, and research. Compensation for clinical trials must be reported but is not made public until the product receives FDA approval, or until 4 years after the payment, whichever is earlier. Payments for trials involving a new indication for an approved drug are posted the following year.

Exemptions include CME activities funded by manufacturers and product samples for patient use. Medical students and residents are exempted entirely.

You are allowed to review your data and request corrections before information is posted publicly. You will have an additional 2 years to pursue corrections after the content goes live at the end of June, but any erroneous information will remain online until the next scheduled update, so you should find and fix errors as promptly as possible.

If you don’t see drug reps, accept sponsored lunches, or give sponsored talks, don’t assume that you won’t be on the website. Check anyway: You might be indirectly involved in a compensation that you were not aware of, or you might have been reported in error.

To review your data, register at the CMS Enterprise Portal (https://portal.cms.gov/wps/portal/unauthportal/home/) and request access to the Open Payments system.

The question remains as to what effect the law might be having on research, continuing education, or physicians’ relationships with the pharmaceutical industry. The short answer is that no one knows. The first data posting this past September came and went with little fanfare, and no repercussions directly attributable to the program have been reported as of this writing.

Sunshine laws have been in effect for several years in six states: California, Colorado, Massachusetts, Minnesota, Vermont, and West Virginia, plus the District of Columbia. (Maine repealed its law in 2011.) Observers disagree on their impact. Studies in Maine and West Virginia showed no significant public reaction or changes in prescribing patterns, according to a 2012 article in the Archives of Internal Medicine (now JAMA Internal Medicine).

Reactions from the public are equally inscrutable. Do citizens think less of doctors who accept the occasional industry-sponsored lunch for their employees? Do they think more of doctors who speak at meetings, or conduct industry-sponsored clinical research? There are no objective data. Anecdotally, I haven’t heard a peep – positive, negative, or indifferent – from any of my patients, nor have any other physicians that I’ve asked.

As of now, I stand by my initial prediction that attorneys, activists, and the occasional reporter will data-mine the information for various purposes, but few patients will bother to visit. Of course, that doesn’t mean you should ignore it as well. As always, I suggest you review the accuracy of anything posted about you, in any form or context, on any venue. This year’s data (reflecting all 2014 reports) have been available for review since April 6. You can initiate a dispute at any time over the next 2 years, before or after public release on June 30, but the sooner the better. Corrections are made each time CMS updates the system.

Maintaining accurate financial records has always been important, but it will be even more important now to support your disputes. CMS won’t simply take your word for it. A free app is available to help you track payments and other reportable industry interactions; search for “Open Payments” at your favorite app store.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News.

I’ve written about the Physician Payment Sunshine Act several times since it became law in 2013. My basic opinion – that it is a tempest in a teapot – has not changed. Nonetheless, now is the time to review the 2014 data reported under your name – and if necessary, initiate a dispute – before the information is posted publicly on June 30.

A quick review: The Sunshine Act, known officially as the “Open Payments Program,” requires all manufacturers of drugs, devices, and medical supplies covered by federal health care programs to report to the Centers for Medicare & Medicaid Services any financial interactions with physicians and teaching hospitals.

Reportable interactions include consulting, food, ownership or investment interest, direct compensation for speakers at education programs, and research. Compensation for clinical trials must be reported but is not made public until the product receives FDA approval, or until 4 years after the payment, whichever is earlier. Payments for trials involving a new indication for an approved drug are posted the following year.

Exemptions include CME activities funded by manufacturers and product samples for patient use. Medical students and residents are exempted entirely.

You are allowed to review your data and request corrections before information is posted publicly. You will have an additional 2 years to pursue corrections after the content goes live at the end of June, but any erroneous information will remain online until the next scheduled update, so you should find and fix errors as promptly as possible.

If you don’t see drug reps, accept sponsored lunches, or give sponsored talks, don’t assume that you won’t be on the website. Check anyway: You might be indirectly involved in a compensation that you were not aware of, or you might have been reported in error.

To review your data, register at the CMS Enterprise Portal (https://portal.cms.gov/wps/portal/unauthportal/home/) and request access to the Open Payments system.

The question remains as to what effect the law might be having on research, continuing education, or physicians’ relationships with the pharmaceutical industry. The short answer is that no one knows. The first data posting this past September came and went with little fanfare, and no repercussions directly attributable to the program have been reported as of this writing.

Sunshine laws have been in effect for several years in six states: California, Colorado, Massachusetts, Minnesota, Vermont, and West Virginia, plus the District of Columbia. (Maine repealed its law in 2011.) Observers disagree on their impact. Studies in Maine and West Virginia showed no significant public reaction or changes in prescribing patterns, according to a 2012 article in the Archives of Internal Medicine (now JAMA Internal Medicine).

Reactions from the public are equally inscrutable. Do citizens think less of doctors who accept the occasional industry-sponsored lunch for their employees? Do they think more of doctors who speak at meetings, or conduct industry-sponsored clinical research? There are no objective data. Anecdotally, I haven’t heard a peep – positive, negative, or indifferent – from any of my patients, nor have any other physicians that I’ve asked.

As of now, I stand by my initial prediction that attorneys, activists, and the occasional reporter will data-mine the information for various purposes, but few patients will bother to visit. Of course, that doesn’t mean you should ignore it as well. As always, I suggest you review the accuracy of anything posted about you, in any form or context, on any venue. This year’s data (reflecting all 2014 reports) have been available for review since April 6. You can initiate a dispute at any time over the next 2 years, before or after public release on June 30, but the sooner the better. Corrections are made each time CMS updates the system.

Maintaining accurate financial records has always been important, but it will be even more important now to support your disputes. CMS won’t simply take your word for it. A free app is available to help you track payments and other reportable industry interactions; search for “Open Payments” at your favorite app store.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News.

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