Phase 1 of the Physician Payments Sunshine Act is in now submitted, but the real force of the Act comes later this year (or early next year) when company payments to physicians are made public. An unfortunate reality of the Sunshine Act is that unfortunately it can pit doctors against pharmaceutical companies—companies are penalized for not reporting payments to physicians, while physicians may suffer unwarranted damage to their reputations if these reported payments are incorrect or misinterpreted. During last month's National Disclosure Summit, Julia Galperin, Director of Commercial Compliance Operations at Genentech; Sylvia J. Trujillo, Senior Attorney, Legislative Counsel Division at American Medical Association; and Andrew Rosenberg, co-founder of Thorn Run Partners, spoke to how companies can both protect the reputation of physicians and continue to maintain these important relationships. Policy and Medicine's own Tom Sullivan moderated the panel.
ProPublica and the PharmFree Scorecard
To properly frame the implications of the Sunshine Act for physicians, it is important to understand some earlier transparency initiatives, including ProPublica's "Dollars for Docs" and the "PharmFree Scorecard."
In 2010, the investigative website ProPublica received a $1 million grant from the Pew Charitable Trust to set up Dollars for Docs as a way to track what pharmaceutical companies were spending on doctor's speaking and consulting fees. To do this, ProPublica went through fifteen companies' corporate integrity agreements and created a master database of the spend information. They then planted stories in newspapers around the country that honed in on physicians who had been paid the most.
This past year, ProPubica also obtained access to the Centers for Medicare and Medicaid (CMS) database for Part D prescribers. ProPublica took aim at the highest prescribers of Forest Laboratories' drug, Bystolic, and matched those numbers up with payments of speaker fees to those prescribers. The two highest prescribers received relatively modest 2012 speaker fees of $3,750 each.
We looked at Massachusetts' top 50 doctors in terms of fees paid from 2009 to 2011 to see how transparency from state reporting affected company spend. In fact, company payments went down only 2% from 2010 to 2011. The interesting point was not how companies reacted, but how physicians did. In the three years we looked at, the majority of doctors disappeared from the top 50 list after showing up for one year. "When doctors makes it on the top 50 list," Sullivan noted, "they tend to drop off. Some of that could be because of reputation and concern that they're on the list." Among hospitals, overall payments dropped more significantly than for doctors, from $16.7 million in 2010 to $12.7 million in 2011.
In addition to ProPublica, the American Medical Students Association (AMSA) publishes the "PharmFree Scorecard" that purports to evaluate the conflict of interest policies at American medical schools. The PharmFree Scorecard is funded through the Consumer and Prescriber Education grant program, which resulted from the Neurontin settlement back in 2004. Each year, the AMSA ranks schools for "A" to "F" based on the schools relationship with industry and frames all physician-industry collaboration as per se negative or unethical.
"Sunshine Track": Genentech's Approach to Protecting Relationships with Physician Clients
In light of the cumbersome reporting requirements of the Sunshine Act, many pharmaceutical companies have placed their sole efforts on data capture efforts. Given that companies have to track every small transfer of value they make, this is understandable. Genetech, however, recognized the integral role physicians play both from a public reporting standpoint, and from a business client standpoint.
Genentech decided in 2011 to post publicly their payment information. Genetech is not under a current corporate integrity agreement (which often require Sunshine-like reports), so they created an external portal around transparency two years before the first Sunshine Act deadline. One quarter before Sunshine reports are due, Genentech will permit physicians to access their data under the Genentech Sunshine Track.
Julia Galperin, Director of Commercial Compliance Operations at Genentech, stated that Genentech had several business drivers for their Sunshine Track initiative.
- Commitment to Genentech customers:
Sunshine Track allows physicians to feel confident in the accuracy of the data prior to reporting to CMS. It also emphasizes Genentech's commitment to transparency and partnership. "At the end of the day, we wanted the physicians to know that we're in this together," Galperin stated. So far, "a couple hundred" physicians have signed up already, but she expects even more traction as reporting periods pass and the CMS' public database deadline approaches.
- Operational efficiency and effectiveness:
Galparin noted that the Sunshine Track system resolves data issues on an ongoing basis and directly in Genentech's Aggregate Spend system. In other words, Sunshine Track acts as the "front face" of Genentech aggregate spend system and can show any and all data the company has collected.
Perhaps most importantly, because the system acts independently of the CMS deadlines, Galparin stated that Genentech has a reduced risk of depending on CMS' dispute period.
- Reduced disputes:
Sunshine Track provides a "real-time" way to validate data with spend recipients. "Who better to validate the data than the actual physicians with whom we've had spend?" asked Galperin.
Sunshine Track operates on a user-friendly interface in which physicians can securely register and log-in to the system. Galperin stated that Genentech has contracted out with a third party for security purposes that also builds security sites for banks and credit agencies. Once physicians register, they can log-in with a secure ID and view information relating to their transactions, including the date and time of the transaction, the amount, the reason for the transaction, and the brand the physician interacted with. Physicians also have access to a number they can call with questions about their information.
As noted above, Genentech's Sunshine Track is updated in real-time. Galperin described the process of tracking payments: "As soon as invoices are paid, it makes it into our aggregate spend system and it makes it onto our Sunshine Track. It is as real time as we can possibly get it."
American Medical Association Perspective
The National Disclosure Summit mainly featured compliance-based seminars directed at industry. Sylvia J. Trujillo, Senior Attorney, Legislative Counsel Division at American Medical Association (AMA) provided a helpful discussion of the Sunshine Act from the perspective of physicians.
Trujillo first noted that the AMA embraces transparency. Physicians follow a longstanding code of professional ethics that mandates transparent relationships between physicians and industry. While the Sunshine Act addresses certain aspects of the ethical code, the Act does not set forth ethical requirements. Nor, more concerning from the AMA's perspective, do the reporting requirements in the Sunshine Act constitute indicia of unethical behavior.
The AMA's "rapidly emerging concern", according to Trujillo, is not that there is transparency, but that the transparency is being equated with unethical behavior which may undermine trust in the physician-patient relationship. Organizations like ProPublica promote this line of thinking. The AMA has worked diligently to show that industry-physician relationships are not prima facie evidence of wrongdoing.
The most unfortunate scenario would be for innovation and the dissemination of medical knowledge to suffer if people incorrectly question relationships that are completely appropriate and important for improving health outcomes.
Thus, the AMA's approach to maintaining the relationships between physicians and industry is to focus on the incredible innovation at stake. Trujillo notes that the mapping of the human genome and the clinical applications of genomic knowledge will revolutionize the practice of medicine from disease-based practice to prevention-based. Furthermore, she stated: "We are also at a pivotal stage with respect to the role of technology and the application of technology in new ways through, for example telemedicine." Currently, there are "seismic changes in medicine that require industry interaction with physicians to give patients some of the best quality of care that has been unprecedented in the history of humankind."
No one wants to see such promising areas of medicine become frozen in time because of the Sunshine Act. But the truth is, the Act has presented significant challenges to keeping the momentum going. AMA's current concerns include:
- Low levels of physician awareness of Sunshine provisions:
Trujillo states that at this point it is impossible to know what the effect of the Sunshine Act will be for physicians. She notes that it is likely that the federal Sunshine database will be different than state databases—the Open Payments system will be centralized, easily searchable, and likely to receive a lot of media attention. The state reporting activities have received very low levels of physician engagement. Trujillo cautioned the audience that physicians will become "painfully aware" of the new database if they are not alerted to the requirements.
- Manufacturer and GPO ongoing notice to physicians:
Trujillo applauded Genentech's lead in offering physicians the opportunity to correct their spend information before damaging, inadvertent payments are published.
AMA appreciates that the Sunshine Act requires manufacturers to track "staggering amounts of data." However, Trujillo believes "due process required CMS to require ongoing notice." Additionally, she notes that ongoing notice provides pharmaceutical and device companies a "brand building activity." AMA is promoting the use of company websites and strongly urging companies to utilize the CMS' aggregate spend app.
- Indirect reportable transfers:
According to Trujillo, a "big problem area" will be indirect reportable transfers where a manufacturer requires, instructs, or directs payments through third parties and that third party fails to notify the physician that they are attributing the value to him or her. Currently, there is no requirement that the third party provide such notice to physicians. AMA believes that there is actually a legal obligation to do so for purposes of due process. CMS, however, has not taken this position.
- Physician opportunity to provide context:
Manufacturers are allowed to provide context to the transfers of value they report. However, physicians—the individuals that potentially could suffer the most reputational harm due to improper reporting—currently do not get their own opportunity to provide context.
Trujillo concluded that the AMA's advocacy surrounding other aspects of the Sunshine Act has not ended. "We're very concerned about reprints and textbooks. We believe unambiguously the statute provided for an exclusion of both items. These both clearly benefit patients." Furthermore, the AMA will continue to provide education to physicians as CMS releases more information about Sunshine Act registration.
What Companies Can Do To Protect Covered Recipients
Andy Rosenberg, co-founder of Thorn Run Partners and Senior Advisor of the CME Coalition spoke about what companies can do to help protect their customers, the covered recipients.
Rosenberg first noted that uncertainty surrounds many aspects of the Sunshine Act. For example, the Sunshine Act was drafted to encourage certain activities, such as continuing medical education, but the exemptions are not very clear.
In addition to the vagueness of the Sunshine Act, Rosenberg states that the law, perhaps unintentionally, pits doctors against commercial supporters. The Sunshine Act penalizes commercial supporters harshly under for failing to report all of their spend data. On the other hand, overzealous sharing of transparency can hurt doctors' reputation. Doctors may also be exposed to legal liability in malpractice suits. Trial lawyers will be able to make inferences of conflicts of interests based completely legitimate industry relationships.
Finally, the Sunshine Act drives a wedge into patient trust of their physician. "It creates a narrative that their doctors are not there for them, but that they are there for themselves. This is a damaging dynamic [ ] to promote and integrate into the relationship that most people want to have with their physician, which is one of trust," Rosenberg stated.
To address the problems associated with the Sunshine Act, Rosenberg believes companies should focus in communication with doctors on the patient outcomes and benefits to be gained from industry-physician relationships. When companies start this compelling, honest dialogue with their physician-partners, Rosenberg believes companies should utilize resources similar to Genentech's website. The website should embrace transparency and honesty. Companies should make it clear to their partners "in as explicit a way as possible" the reporting rules that they are under. Physicians should be given the choice ahead of time on whether to attend or participate in a particular event.
Rosenberg agreed with the AMA's concern that third party events are a real concern. He believes companies need to have trusting relationships with third parties to ensure that information that needs to be captured is being captured and that physicians are able to understand in advance what sort of data will be collected on them.
The opposing interests of physicians and companies under the Sunshine Act has resulted in, as Rosenberg pointed out, a reluctance to own up to relationships and to justify them. Rosenberg believes this is the opposite solution that companies should strive for. Companies should be "more transparent, open, honest, and confident in making the case for why the relationship is justifiable and useful," and stress the ultimate benefit to patients.
Rosenberg noted that other trade association representing industry need to be as concerned about these issues as the AMA has been. He further believes that companies who partner with patient groups can make powerful partnerships around shared objectives. This provides "an opportunity to share goals and share the halo with patient groups that also have an interest in a very responsible way of managing this set of issues."
"Ultimately it is in the patient's interest for these communications to be forthright and for the partnerships with doctors to continue for the sake of innovation and better patient care," Rosenberg concluded.
In anticipation of the public release of Sunshine data, companies should have plans to protect their physician-client's reputation, especially if the relationship is highlighted in an article or otherwise publicized. We suggest companies make sure that their communications departments are aware of the coming disclosures, as they are often capable of keeping the press and customer in mind.