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September 19, 2012

Physician Payment Sunshine Act: Recent Survey Shows Physicians Still Unaware and Hospitals Concerned about Impending Regulation

Physician Unaware
A recent follow-up survey shows that 47% of physicians are still unaware of the requirements of the physician payment sunshine act.  This is the same percentage as in January 2010, and other data shows hospitals are concerned by the lack of context for payments in the proposed rule.

In response to last week’s Senate Roundtable discussion on the Physician Payment Sunshine Act, MMIS, Inc. submitted comments to the Senate Special Committee on Aging.  The comments were authored by Timothy Robinson, MMIS General Counsel and President of the Regulatory Law Group, PLLC, and Michaeline Daboul, President & CEO of MMIS, Inc.   

The response highlights multiple surveys conducted between MMIS, and the Regulatory Law Group in conjunction with the American Medical Association (AMA) in order to understand the attitudes, awareness, and concerns of physicians as they relate to the Physician Payment Sunshine Act.  “Results prove the lack of awareness among physicians regarding this Act and their expressed concerns.” 

Over the last 3 years, the Regulatory Law Group, PLLC and MMIS, Inc. have conducted multiple surveys to understand the attitudes, awareness and concerns of physicians as they relate to the Physician Payment Sunshine Act. B ased upon the results of the surveys as outlined below, as well as research conducted by 3rd parties, there is a significant need for physician education, prior to the implementation of the Physician Payment Sunshine Act, and a platform to encourage industry to share disclosure data with physicians prior submission to CMS. 

In January, 2011, the Regulatory Law Group, PLLC conducted a cross-specialty survey of physicians designed to gather information on physicians’ attitudes, opinions and awareness as they relate to various issues surrounding physician/industry relationships. The survey announcement was distributed to 3,300 physicians via e-mail that contained a link to the online survey.  The survey was completed by 250 physicians, the majority of which (52%) have been in practice for greater than 15 years.  According to the survey results: 

  • 47% of the respondents were not aware that pharmaceutical and medical device manufacturers will be required to track and report to the federal government certain expenditures made to or on behalf of physicians greater than $10.00.
  • 53% of the respondents were not aware that the information disclosed to the federal government will be made available to the public in a searchable database.
  • 63% of the respondents expressed a desire to review and correct, if necessary, all disclosures prior to industry submission to the federal government. 

Approximately one year later in December 2011, MMIS, Inc., in conjunction with the American Medical Association, replicated the survey previously conducted by the Regulatory Law Group, PLLC. Survey invitations were distributed to 50,000 physicians contained within the AMA Masterfile. The survey was completed by 1,057 physicians, the majority of which were specialists (64%) with greater than 20 years of experience (58%). Similar to the results obtained in the Regulatory Law Group, PLLC survey, the results to the AMA/MMIS, Inc. survey showed a continued lack of awareness on the part of physicians. 

  • 47% of the respondents were not aware of the requirements of the Physician Payment Sunshine Act.
  • 67% of the respondents were not aware that the information collected would be reported to HHS and made available in the public domain.
  • 56% of the respondents are concerned about the implications of the Physician Payment Sunshine Act. 

54% of respondents are “somewhat” or “very” concerned about the public availability of the information disclosed in the public domain. 

“As the survey results demonstrate, there is a significant lack of awareness on the party of physicians with regard to the Physician Payment Sunshine Act. When made aware of the requirements, physicians have expressed concern over the implications on their relationships with both patients and industry alike.”  

According to a survey recently conducted by Kyruus, Inc., 87% of physician respondents would be “concerned” or “very concerned” if the information publicly disclosed was false or incorrect.  Moreover, respondents indicated that the disclosure of false information would negatively impact their relationships with industry (66% would reduce interactions and 45% would reduce utilization). 

As the Special Committee on Aging monitors the implementation of the Physician Payment Sunshine Act, “it is important to recognize the need for significant physician education with regard to the requirements of the Act,” the comments stated.  In addition, considering the implications as they relate to the erroneous disclosure of information in the public domain, “it is recommended that industry be encouraged to share disclosure data with physician’s prior submission to CMS.” 

Ultimately, the authors urged the Committee to educate physicians and consumers alike to “fully understand the benefits achieved through physician/industry relationships and interactions.” 

Sunshine Concerns and Hospitals 

Another recent survey of 50,000 specialists and primary care physicians found that 56 percent are concerned about the pending Sunshine Act.  Additionally, according to a recent story from Becker Hospital Review, “Hospitals are taking note too, uncertain how CMS will implement the Sunshine Act.”  Michaeline Daboul further explained the effect the Sunshine Act will have on hospitals and physicians.

Daboul first noted that the primary concern of all affected stakeholders is that once the information is available in the public domain, it could “unfairly distort the positive nature of the collaborative relationships that physicians maintain with the industry.”  CMS is required to provide context and background information, posted on a public website, in order to educate consumers about the relationships that exist between physicians and the industry.  However, there was much discussion at the Roundtable about whether context would be sufficient.  One member suggested putting payments for research on a separate page completely, so that the public would understand that research is a unique arrangement, particularly for medical devices, because the industry relies on physicians for numerous aspects in the R&D stages.   

She maintained that “significant improvements to enhanced patient care — new drugs and new medical devices to diagnose and treat diseases — have occurred because of these close, ethical relationships; a physician’s financial relationship with the industry does not mean the physician's judgment is compromised or that the relationship with the manufacturer or drug maker is unethical.”  Other areas of concern she pointed to, which were addressed at the Roundatble as well, included:  

  • Correct identification of a physician,
  • Reporting of a physician's specialty as listed in the NPI database (which could inadvertently create issues for off-label marketing),
  • The manner in which research payments are reported and
  • Listing food and beverage dispersal to physicians who may not have participated in a meal. 

Daboul explained that the primary issue hospitals face with the Sunshine Act “involves the reporting of indirect payments for independent continuing medical education. Specifically, the question is: Does the industry have to report payments to teaching hospitals, in support of independent continuing medical education (CME), over which the industry has no control?”

Additional hospital concerns involve:  

  • Research related payments to institutions reported as such and not attributed to the physician investigator;  
  • Timely review and resolution of disputes,
  • The accuracy of payments made to physicians and
  • The reputation of the hospital, which may be adversely impacted should negative information about an affiliated physician or department chair be published. 

“Physicians are concerned that the relationships they currently maintain with the medical device and pharmaceutical industry are being construed as suspect,” Daboul said.  “Just because a physician receives a transfer of value from an industry member does not mean the physician is ethically compromised. T he vast majority of transactions involve fair market value payments in exchange for consulting, speaking, and research.  Like other professionals, physicians earn compensation for these services.”

She also noted that “Physicians are also concerned about the accuracy of the data. The last thing that a physician wants is erroneous data published on a publicly searchable database.  This information is important to watchdog groups, and no physician wants to be the poster child on a list called ‘Doctors for Dollars.’”

Daboul explained that the Sunshine Act may have several unintended consequences, for example, limiting sales rep access to physicians due to physician practices banning food.  As we previously noted, a recent study published in the Journal of Clinical Hypertension found that limiting physician access to pharmaceutical sales reps can have the effect of reducing responses to negative and positive information about a drug.

“Additionally, the Sunshine Act may change the relationship between the physician and patient. Assuming that patients review the public data prior to visiting their physician, the patient may be better informed about treatment decisions,” she explained.

To help hospitals navigate through the Sunshine Act, Daboul said that MMIS is working with many organizations, medical societies, hospital groups, physician groups and medical device and pharmaceutical companies to provide much needed education to the physician community. “Unfortunately, as our recent survey suggests, there is a lack of knowledge on the part of many physicians regarding what the new transparency laws require of them,” she said.  MMIS is leading an education initiative by talking to all healthcare transparency stakeholders, encouraging them to take a proactive approach and demand an opportunity to review data before it's submitted to CMS

Ultimately, Daboul said that CMS “must successfully define a reporting structure that is unambiguous for the industry.  It must represent, to consumers, the nature of the interactions between physicians and the medical device and pharmaceutical industry.  It is also important for consumers to recognize the existence of relationships between their physician and the industry in a positive light, as most of these relationships are ethical. In fact, many of the relationships physicians maintain have a very positive effect on patient care.”

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What kind of effect will this have on psychiatrists? Especially those with private practices?

There may be almost no way to stop the regulatory arbitrage that allows companies to get around legislation and bribe and trick physicians into using unsubstantiated dangerous products off-label on a truly mass scale, but no one can help us if it's not even reported.

It's a tragedy the prescription of psychotropic drugs has gotten so out of hand the the majority of the population is taking them.
The CDC released in 2008 a figure of 49% of the population taking at least one psychotropic drug, with a majority sub-group taking 3 drugs per person on average. Two-thirds of the patients had been prescribed psychotropic drugs off-label by GMs. There were 100,000 deaths from adverse side effects in 2008.

I can see why physicians would be concerned about bad data being released, but how is it even possible 47% of those surveyed were unaware of this policy change? Yikes!

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