The 5th Aggregate Spend and Sunshine Conference, hosted by ExL Pharma, provided comprehensive insight into “lessons learned” from the first reporting year under the Physician Payments Sunshine Act, while preparing industry members for the dispute resolution period to come in the next few months.
Jeremy Lazarus, past president of the American Medical Association (AMA), spoke first about how important it is for companies to appreciate and manage physician expectations as we near closer to the public release of Sunshine data on September 30, 2014. Lazarus’ presentation focused on AMA’s efforts to embrace transparency, while also working to maintain safeguards and create a meaningful, accurate picture of physician relationships with industry.
Currently, physicians face an unprecedented number of challenges: they have to demonstrate “quality,” an amorphous requirement; show “meaningful use” of electronic health systems; and transition to ICD-10. Now the Sunshine Act is an additional administrative burden. Lazarus noted that transparency is certainly something all doctors strive for, but the original draft of the Sunshine Act would have included an almost limitless number of indirect transfers that would obscure the importance of industry and physician collaboration.
Lazarus used the Medicare payment release of this past year as an example of a data-dump gone wrong. AMA lobbied for physicians to have time to review the data before it was published. Unfortunately, physicians did not get this opportunity. CMS released the data a mere week after announcing their plan. The data contained a multitude of errors and absolutely no context. Some doctors faced real consequences because of this. For example, as we noted in our coverage in April, some physician practices report all of their reimbursements under one doctor’s identifying information. The press provided only limited explanations as to why one doctor could earn such large payments, but certain news outlets strongly implied fraud. As another example, Medicare released personal information about a doctor who had hidden her address from a violent patient, and requested such information remain private. Other physicians have just been barraged with phone calls from the media.
As compared to the Medicare release, information surrounding the Sunshine Act data should provide more context to the payment. The Final Rule at least removed some onerous and potentially misleading reporting requirements. However, the benefits come with certain drawbacks that could be improved upon.
AMA was pleased that CMS gave physicians the ability to check the data that companies would be reporting about them, as well as the ability to challenge the data. This minimum safeguard, though, is undermined by the fact that CMS has provided a very short, as yet undetermined, window for dispute resolutions. The AMA is advocating for physicians to have more time to register and review the data contained in the CMS database for accuracy prior to publication. Furthermore, manufacturers can unilaterally dismiss a physician’s complaint if the two parties don’t come to a resolution. The AMA believes that unresolved issues should be flagged in the registry. They are actively challenging this aspect of the law.
We’ve heard that companies are taking different approaches for the first year of disputes. Some have a formalized process already in place, while others are taking a “wait and see approach.” No one really knows how many doctors will dispute their information. Approximately 7,000 physicians have downloaded CMS’ Open Payments tool, so at least some providers are interested in tracking their payments.
Lazarus noted that AMA was pleased that the Final Rule excluded medical residents. Medical residents don’t have a National Provider Identifier (NPI), nor does every state require licensure for residents. Thus, requiring companies to track spend would be an unreasonable order. The issue with residents doesn’t stop there, however, and is tied to the inaccuracy of the NPPES database. After residency, medical residents often don’t update their information within the system. Practicing physicians often change specialties or move without changing their information.
Furthermore, Lazarus noted AMA’s approval of the continuing medical education (CME) carve out. The Sunshine Act’s requirements for CME speaker payments parallels thorough requirements of the Accreditation Council for Continuing Medical Education (ACCME) for keeping promotion out of education. Without the exemption, we would see another aspect of companies having to track an almost inscrutable indirect transfer of value based on ACCME procedures.
But fundamental issues remain. The Sunshine Act’s requirement for manufacturers to track any payment over $10 (and, worse, any payment if the aggregate over the year is $100) exponentially increases errors and the burden on manufacturers, as well as physicians who are going to track their information. The AMA has pushed for a $50 limit.
AMA also strongly believes reprints and journals should have been exempted (the $50 limit would also help here). We have noted that the reprint reporting requirement presents a clear disincentive for clinicians to accept high-quality, independent educational materials, an outcome that was unintended when the provision was passed into law. Physicians are already accepting less educational materials.
Reprints directly benefit patient care because they put cutting edge information at physicians’ fingertips. Interactions are essential for the free flow of scientific material, and for physicians have tools to make proper treatment decisions. Lazarus noted that any “chill on this exchange” would make physicians operate “half blind.”
AMA: Collaboration is Needed
AMA believes all manufacturers need to work with physicians for a mutually beneficial relationship. First of all, Lazarus noted that a large amount of physicians still don’t know about the Sunshine Act. Some of this has to do with the fact that no clear Sunshine rule even existed until recently—and CMS has not completely clarified a wide range of questions. But now that reports are in, companies should be the one to inform their clients about the pending disclosure, not the media once the data is released.
One of AMA’s main sticking points with the Sunshine Act has been CMS’ insistence that ongoing notice from manufacturers to physicians is voluntary. AMA believes it should be mandatory. For one thing, ongoing notice gives pharmaceutical companies an opportunity to build their brand by offering an open and honest discussion with their physician clients. We reported on Genentech’s “Sunshine Track” database, which does just that. The Genentech system provides real-time updates to doctors. As soon as invoices are paid, the data populates the aggregate spend system, which instantly makes it onto the Sunshine Track.
Obviously, reports need to be accurate about what they portray. While manufacturers could face monetary penalties for improper data, physicians may face even bigger consequences to their reputations.
The scariest issue with inaccurate data? Other branches of government using incorrect numbers to build a case for fraud. CMS just announced that they would share information with the Department of Justice if the information “is deemed reasonably necessary to CMS deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such program.” Accuracy is important.
AMA also believes physicians should have input on the context surrounding their payments. This seems only fair given the harm that the lack of context surrounding the Medicare payment caused. Context around industry payments to physicians would be important, for example, in the situation where research payments are assigned to a single principal investigator. Most people perusing the raw data would have no idea that these investigators receive no additional benefit beyond their salary that would constitute a “gift.”
AMA believes industry-physician collaboration is essential for the next generation of clinical care. Physicians are always striving for new medicine to help benefit patients, and collaboration is a necessary ingredient for meaningful patient care. AMA is concerned that the Sunshine Act could have a chilling effect on these industry partnerships and specifically drug discovery. Companies should maintain open and honest dialogue with their doctors in order to keep the collaboration alive while also preparing physicians for a new era of transparency surrounding these important relationships. As the Open Payments release edges closer, both groups should embrace collaboration and be able to articulate how research improves outcomes and leads to better care for generations of patients.