QPharma Survey Addresses Sunshine Act Implications
By Mia Burns (mia.burns@ubm.com)
QPharma recently conducted a survey of 300 U.S. physicians to obtain the latest data available regarding the understanding that covered recipients possess about the Physician Payment Sunshine Act and its requirements. The participants came from a range of various specialties and sub-specialties. Survey questions contained topics that included awareness of reporting thresholds, fees to charity, and whether Sunshine Act requirements will influence physicians’ future interactions with industry.
QPharma Chief Medical Officer Peter Shaw, M.D. directed the survey. “If you are going to do something, then you should know the implications of what you do,” he told Med Ad News Daily.
According to the survey, 25 percent of specialists claim to fully understand the Sunshine Act and 30 percent of primary care physicians have minimal or no understanding of the Sunshine Act. “Until most of the physicians have a good understanding of not only what the Sunshine Act is, but understand their responsibility, there should be some degree of concern because this could lead to inaccurate data,” says Maria A. Galdos, ACFE, CHC, senior manager, healthcare compliance, Qpharma. “Further, the implication to providers could be: 1) a violation of fraud and abuse laws; 2) non-compliance with federal regulations on conflicts in clinical research, or 3) may present a reputational risk due to the appearance of impropriety, even if the payment or other financial relationship with an applicable manufacturer has not influenced medical practice by the physician or his or her affiliated institution. The goal should be to protect the relationships between industry and physicians as they can be very valuable and the messages that companies send out to physicians or to physicians for their patients regarding this transparency should be to convey that these transactions are necessary and important to ensure that new treatments are discovered and more patients are treated.”
Galdos also told Med Ad News Daily, “The important message here is to get the word out to the doctors by distributing something as simple as the physician ONE page Sunshine Act 101 sheet. Taking it a step further, if physicians are concerned about patient perception, developing a ONE page Patient Sunshine Act 101 sheet different from what CMS provided could be a very good way to shed positive light on the relationship between industry and physicians. Since, the assumption exists that relationships between pharmaceutical companies and healthcare providers are unhealthy; this sheet could be used to demonstrate the value between physician and industry relationships. Disclosing these payments could help the public to understand why and how this money is being spent. In fact, these relationships drive innovation and clinical research.”
In addition, 62 percent of doctors who stated that they accept samples were unaware that there is a section of the Sunshine Act requiring disclosure of samples, and 56 percent did not know that a record of these samples will be provided to the FDA, according to the survey. “You would expect the majority of physicians to know,” Dr. Shaw told Med Ad News Daily.
One of the survey questions asked participants if their perception of their understanding of the Physician Payments Sunshine Act had changed after going through the questionnaire. The second portion of the questions asked physicians how well they believed that they actually understood the transparency laws. Among the respondents who stated that they fully understood the Sunshine Act at the start of the survey, 17 percent felt that after completing they had no understanding of the transparency laws, according to QPharma. Regarding the
respondents who stated they had no understanding of the Sunshine Act at the start of the survey, 86 percent felt that after completing they had some understanding of the transparency laws.
“Companies should get the word out by preparing a one sheet physician act 101 sheet,” Galdos told Med Ad News Daily. “CMS has provided this, but it is more than one page and the one page fact sheet could be left at the doctor’s office every time a rep visits. The rep need not to comment on the piece, just leave it. Further, the one page 101 sheet should have a toll free number where physicians can call with questions.”
QPharma recently conducted a survey of 300 U.S. physicians to obtain the latest data available regarding the understanding that covered recipients possess about the Physician Payment Sunshine Act and its requirements. The participants came from a range of various specialties and sub-specialties. Survey questions contained topics that included awareness of reporting thresholds, fees to charity, and whether Sunshine Act requirements will influence physicians’ future interactions with industry.
QPharma Chief Medical Officer Peter Shaw, M.D. directed the survey. “If you are going to do something, then you should know the implications of what you do,” he told Med Ad News Daily.
According to the survey, 25 percent of specialists claim to fully understand the Sunshine Act and 30 percent of primary care physicians have minimal or no understanding of the Sunshine Act. “Until most of the physicians have a good understanding of not only what the Sunshine Act is, but understand their responsibility, there should be some degree of concern because this could lead to inaccurate data,” says Maria A. Galdos, ACFE, CHC, senior manager, healthcare compliance, Qpharma. “Further, the implication to providers could be: 1) a violation of fraud and abuse laws; 2) non-compliance with federal regulations on conflicts in clinical research, or 3) may present a reputational risk due to the appearance of impropriety, even if the payment or other financial relationship with an applicable manufacturer has not influenced medical practice by the physician or his or her affiliated institution. The goal should be to protect the relationships between industry and physicians as they can be very valuable and the messages that companies send out to physicians or to physicians for their patients regarding this transparency should be to convey that these transactions are necessary and important to ensure that new treatments are discovered and more patients are treated.”
Galdos also told Med Ad News Daily, “The important message here is to get the word out to the doctors by distributing something as simple as the physician ONE page Sunshine Act 101 sheet. Taking it a step further, if physicians are concerned about patient perception, developing a ONE page Patient Sunshine Act 101 sheet different from what CMS provided could be a very good way to shed positive light on the relationship between industry and physicians. Since, the assumption exists that relationships between pharmaceutical companies and healthcare providers are unhealthy; this sheet could be used to demonstrate the value between physician and industry relationships. Disclosing these payments could help the public to understand why and how this money is being spent. In fact, these relationships drive innovation and clinical research.”
In addition, 62 percent of doctors who stated that they accept samples were unaware that there is a section of the Sunshine Act requiring disclosure of samples, and 56 percent did not know that a record of these samples will be provided to the FDA, according to the survey. “You would expect the majority of physicians to know,” Dr. Shaw told Med Ad News Daily.
One of the survey questions asked participants if their perception of their understanding of the Physician Payments Sunshine Act had changed after going through the questionnaire. The second portion of the questions asked physicians how well they believed that they actually understood the transparency laws. Among the respondents who stated that they fully understood the Sunshine Act at the start of the survey, 17 percent felt that after completing they had no understanding of the transparency laws, according to QPharma. Regarding the
respondents who stated they had no understanding of the Sunshine Act at the start of the survey, 86 percent felt that after completing they had some understanding of the transparency laws.
“Companies should get the word out by preparing a one sheet physician act 101 sheet,” Galdos told Med Ad News Daily. “CMS has provided this, but it is more than one page and the one page fact sheet could be left at the doctor’s office every time a rep visits. The rep need not to comment on the piece, just leave it. Further, the one page 101 sheet should have a toll free number where physicians can call with questions.”
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