Physician Payment Disclosure Under Health Care Reform
Physician Payment Disclosure Under Health Care Reform
Although historically drug marketing has been targeted to physicians, recently, as reported by the Wall Street Journal, reallocation of marketing expenditures toward nonphysician/nondetailing channels has occurred. This includes a reduction of >33,000 drug-detailing sales representative jobs, a greater focus on influencing health care payers, and increasing use of "medical scientific liaisons" (MSLs).
MSLs differ from traditional drug-detailing sales representatives in that they are medical professionals themselves (eg, pharmacists, physicians, PhDs, nurses) who interact and detail to a wide variety of health care professionals. They primarily provide high-level promotion of medical information about industry products to physicians, key opinion leaders, academic institutions, payers, patient associations, and other key stakeholders. Health care economic departments, which often directly interface or house these MSLs within the industry, are now taking an active role in marketing to payers because payers increasingly are emerging as gatekeepers in prescription drug use, not physicians.
This shift in industry pharmaceutical promotion also notably includes the rapid rise in the use of direct-to-consumer advertising (DTCA). This form of marketing, which seeks to influence consumer-patients directly and induce a demand for prescription drugs, is the fastest-growing form of drug marketing; it experienced an increase in expenditures of 330% from 1996 to 2005 and has been associated with drugs of questionable safety profiles. DTCA is global in scope via the Internet, is cost effective compared with physician detailing, and has been expanded to high-traffic social media. With this transition in marketing focus and the resulting changing dynamic of the physician-patient relationship, industry marketing to physicians is becoming more irrelevant.
Collectively, these macro trends away from marketing to physicians toward other channels potentially undermine the stated goals and effect of the ACA's Sunshine provisions. The act's primary goals of increasing the transparency of industry-physician interactions and discouraging inappropriate COIs may instead be supplanted by other forms of undue influence directly to patients, payers, and other health care providers using emerging marketing strategies. Although the recent US Supreme Court ruling to uphold the majority of the ACA largely ensured the implementation of the recently published final rule, changing trends may result in an antiquated set of regulations that do not reflect the current and shifting reality of industry marketing practices and may be ineffective in efforts to contain costs.
Indeed, as patients become the focus of industry marketing efforts, the COI incentive structures change. In this regard, physicians may have less incentive to prescribe medications that previously were marketed with a physician focus. Yet physicians may respond to patient pressures for requested medications. With less clinical and efficacy knowledge/information, patients may be especially susceptible to marketing claims. Consequentially, pressures on physicians to prescribe heavily marketed drugs may shift from being based on physician COI-based pharmaceutical marketing to the increasing amount of patient requests for drugs—requests arising from DTCA. With physicians being ranked by patient satisfaction, experience, and other scores, including public (eg, Medicare) and private databases as well as inclusion in potential health plans, accountable care organizations, and other managed care, physicians may continue to face challenges associated with the influence of drug marketing.
Actively revisiting the ACA's Sunshine provisions on a periodic basis may provide opportunities for necessary adaptation to current industry trends. CMS should proactively evaluate whether the current statute permits it to expand to additional reporting categories that could generate COIs and that are within the congressional intent of the act. These could include (1) disclosure of payments/incentives to other nonphysician health care providers, administrators, and other health care service providers (eg, medical education and communication companies that are exempt when receiving indirect payments); (2) disclosure of exempted categories such as drug samples for therapeutic classes when a generic equivalent is available; (3) disclosure of direct-to-patient forms of rebates and incentives (such as prescription drug coupons); and (4) mandatory disclosure of other forms of influential marketing, including industry DTCA spending. If such expansion is beyond the scope of CMS' authority, it or other governmental bodies, such as the Office of the Inspector General (upon request from a member of Congress), should objectively examine what additional reporting categories might be necessary given current market conditions and trends and make recommendations to Congress for appropriate amendment of the Sunshine provisions, which could be phased in and implemented over time.
In addition, proactive measures to better curb or counter improper industry marketing practices beyond transparency efforts should also be examined critically in tandem, including (1) implementing strict bans or limits on noneducational forms of marketing (eg, meals, gifts, entertainment); and (2) funding academic detailing initiatives that provide evidence-based information to clinicians to "counter-detail" against industry-sponsored claims. Academic detailing programs, which use trained health care professionals who promote evidence-based medicine free of commercial interests, have been associated with positive changes in physician education about drug use and have been used successfully by certain states and in other countries such as Canada and Australia. This differs from academic participation in speaking and consulting boards; in general, academic detailing programs require COI disclosures for participation, are not funded by industry, and involve detailing by uninterested parties.
Given constitutional possible limitations to banning commercial free speech and restricting pharmaceutical detailing, efforts at transparency could be supplemented by implementing professional licensure and accreditation standards for industry representatives who engage in promotion, including specifically pharmaceutical sales representatives and MSLs. Similar efforts have been attempted in the District of Columbia, which is sought to license pharmaceutical sales representatives individually, imposes penalties on licensed representatives for misleading marketing, requires adherence to certain minimum requirements, and implements fees. Fees from such accreditation/registration programs could then act as a funding mechanism for state-based academic detailing programs while concomitantly discouraging the presence of industry-initiated marketing.
These efforts could be championed by progressive state governments supplementing and enhancing the ACA; the Sunshine provisions specifically allow for states to implement additional transparency requirements provided they do not overlap with specific data required to be collected under the act. Hence, limited federal preemption of the act and carefully crafted state legislation would allow states flexibility that could be extended to efforts already in place in states such as California and Massachusetts and support other pending legislation advocating for gift bans, academic detailing, and sales representative registration.
Taking this proactive stance could provide states with methods to recoup health care costs lost to overuse of prescription drugs and focus industry marketing efforts on evidence-based practices while also adapting to the changing realities of drug marketing globally. In particular, an emphasis should be placed on proactively examining new forms of industry promotion that are emerging quickly, such as the use of social media.
Limited Impact? Shifting Landscape
Although historically drug marketing has been targeted to physicians, recently, as reported by the Wall Street Journal, reallocation of marketing expenditures toward nonphysician/nondetailing channels has occurred. This includes a reduction of >33,000 drug-detailing sales representative jobs, a greater focus on influencing health care payers, and increasing use of "medical scientific liaisons" (MSLs).
MSLs differ from traditional drug-detailing sales representatives in that they are medical professionals themselves (eg, pharmacists, physicians, PhDs, nurses) who interact and detail to a wide variety of health care professionals. They primarily provide high-level promotion of medical information about industry products to physicians, key opinion leaders, academic institutions, payers, patient associations, and other key stakeholders. Health care economic departments, which often directly interface or house these MSLs within the industry, are now taking an active role in marketing to payers because payers increasingly are emerging as gatekeepers in prescription drug use, not physicians.
This shift in industry pharmaceutical promotion also notably includes the rapid rise in the use of direct-to-consumer advertising (DTCA). This form of marketing, which seeks to influence consumer-patients directly and induce a demand for prescription drugs, is the fastest-growing form of drug marketing; it experienced an increase in expenditures of 330% from 1996 to 2005 and has been associated with drugs of questionable safety profiles. DTCA is global in scope via the Internet, is cost effective compared with physician detailing, and has been expanded to high-traffic social media. With this transition in marketing focus and the resulting changing dynamic of the physician-patient relationship, industry marketing to physicians is becoming more irrelevant.
Collectively, these macro trends away from marketing to physicians toward other channels potentially undermine the stated goals and effect of the ACA's Sunshine provisions. The act's primary goals of increasing the transparency of industry-physician interactions and discouraging inappropriate COIs may instead be supplanted by other forms of undue influence directly to patients, payers, and other health care providers using emerging marketing strategies. Although the recent US Supreme Court ruling to uphold the majority of the ACA largely ensured the implementation of the recently published final rule, changing trends may result in an antiquated set of regulations that do not reflect the current and shifting reality of industry marketing practices and may be ineffective in efforts to contain costs.
Indeed, as patients become the focus of industry marketing efforts, the COI incentive structures change. In this regard, physicians may have less incentive to prescribe medications that previously were marketed with a physician focus. Yet physicians may respond to patient pressures for requested medications. With less clinical and efficacy knowledge/information, patients may be especially susceptible to marketing claims. Consequentially, pressures on physicians to prescribe heavily marketed drugs may shift from being based on physician COI-based pharmaceutical marketing to the increasing amount of patient requests for drugs—requests arising from DTCA. With physicians being ranked by patient satisfaction, experience, and other scores, including public (eg, Medicare) and private databases as well as inclusion in potential health plans, accountable care organizations, and other managed care, physicians may continue to face challenges associated with the influence of drug marketing.
Reform
Actively revisiting the ACA's Sunshine provisions on a periodic basis may provide opportunities for necessary adaptation to current industry trends. CMS should proactively evaluate whether the current statute permits it to expand to additional reporting categories that could generate COIs and that are within the congressional intent of the act. These could include (1) disclosure of payments/incentives to other nonphysician health care providers, administrators, and other health care service providers (eg, medical education and communication companies that are exempt when receiving indirect payments); (2) disclosure of exempted categories such as drug samples for therapeutic classes when a generic equivalent is available; (3) disclosure of direct-to-patient forms of rebates and incentives (such as prescription drug coupons); and (4) mandatory disclosure of other forms of influential marketing, including industry DTCA spending. If such expansion is beyond the scope of CMS' authority, it or other governmental bodies, such as the Office of the Inspector General (upon request from a member of Congress), should objectively examine what additional reporting categories might be necessary given current market conditions and trends and make recommendations to Congress for appropriate amendment of the Sunshine provisions, which could be phased in and implemented over time.
In addition, proactive measures to better curb or counter improper industry marketing practices beyond transparency efforts should also be examined critically in tandem, including (1) implementing strict bans or limits on noneducational forms of marketing (eg, meals, gifts, entertainment); and (2) funding academic detailing initiatives that provide evidence-based information to clinicians to "counter-detail" against industry-sponsored claims. Academic detailing programs, which use trained health care professionals who promote evidence-based medicine free of commercial interests, have been associated with positive changes in physician education about drug use and have been used successfully by certain states and in other countries such as Canada and Australia. This differs from academic participation in speaking and consulting boards; in general, academic detailing programs require COI disclosures for participation, are not funded by industry, and involve detailing by uninterested parties.
Given constitutional possible limitations to banning commercial free speech and restricting pharmaceutical detailing, efforts at transparency could be supplemented by implementing professional licensure and accreditation standards for industry representatives who engage in promotion, including specifically pharmaceutical sales representatives and MSLs. Similar efforts have been attempted in the District of Columbia, which is sought to license pharmaceutical sales representatives individually, imposes penalties on licensed representatives for misleading marketing, requires adherence to certain minimum requirements, and implements fees. Fees from such accreditation/registration programs could then act as a funding mechanism for state-based academic detailing programs while concomitantly discouraging the presence of industry-initiated marketing.
These efforts could be championed by progressive state governments supplementing and enhancing the ACA; the Sunshine provisions specifically allow for states to implement additional transparency requirements provided they do not overlap with specific data required to be collected under the act. Hence, limited federal preemption of the act and carefully crafted state legislation would allow states flexibility that could be extended to efforts already in place in states such as California and Massachusetts and support other pending legislation advocating for gift bans, academic detailing, and sales representative registration.
Taking this proactive stance could provide states with methods to recoup health care costs lost to overuse of prescription drugs and focus industry marketing efforts on evidence-based practices while also adapting to the changing realities of drug marketing globally. In particular, an emphasis should be placed on proactively examining new forms of industry promotion that are emerging quickly, such as the use of social media.
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