As we continue to wait for the final regulations from the Centers for Medicare & Medicaid Services (CMS) to implement the Physician Payment Sunshine Act, several groups are getting creative to find ways to “Shine Light on the Sunshine Act.” One recent example is a chart that CBI made that gives a detailed overview of the act and implementing regulations. The chart includes data and references to several recent Sunshine Act surveys we have reported over the past few months.
One interesting statistic the chart should was current and future manufacturers’ plans for health care spending caps in relation to the proposed Sunshine Act. These statistics are interesting because the sole purpose of the Sunshine act is to shed light on relationships between physicians and industry.
- 9% of companies are unsure about their spending
- 28% of companies said they have no spending caps
- 42% of companies expect to me PhRMA guidelines
- 21% of companies will exceed PhRMA guidelines
For companies who are currently tracking spending
- 9% track only physicians
- 14% track only prescribers
- 23% track all licensed healthcare professionals
- 52% track all healthcare professionals
The chart also shows which entities manufacturers consider covered under educational and philanthropic grants during transparency reporting:
- 14% don’t know
- 4% multiple entities
- 6% educational partner
- 39% payee
- 4% requestor
- 6% LOA signatory
Current motivations for transparency reporting for manufacturers include (2011/2010):
- Voluntary (27%/26%)
- Not engaged in transparency reporting (53%/55%)
- CIA mandated (16%/7%)
- Report scope beyond CIA requirements (4%/12%)
The chart correctly notes that when payments are published online at a public website, there is a significant potential for unintended consequences. For example, the information could be misleading, which would lead to negative repurtations that could manipulate market perception. Moreover, large legitimate payments, necessary for the development of all drugs, could be mistrued as improper gifts. The chart also recognizes that policies by healthcare organizations, as a result of the increased scrutiny of physician-industry relationships caused by the Sunshine Act, could prohibit teaching hospitals from working with life-sciences manufacturers. This will potentially limit manufacturers’ interpretation with physicians, which will result in physicians being unaware of new drugs.
The chart shows that companies plan to report convention booth interactions with healthcare providers in the following ways:
- 38% capture all resultant spend
- 9% capture only items that exceed a set value
- 4% have no plans to capture resultant spend
- 9% are not providing items of value
- 38% don’t know
Companies plan to validate their data before public disclosure in the following ways:
- 11% no validation
- 18% internal certification
- 2% doctors validate
- 40% system validation / audit process
- 7% other
With respect to how manufactures intent to notify healthcare providers of their transparency intentions:
- 20% have produced and distributed communication materials
- 43% plan to produce and distribute communication materials
- 9% have no plans
- 28% are unsure
Finally, the chart shows how involved parties:
- 18% of manufacturers and HCPs find developing new procedures for justifying physician payments and ensuring the accurate reports of spending difficult
- 32% somewhat difficult
- 50% not difficult
With respect to how much change in the reporting process the Sunshine act will require:
- 17% expect significant change
- 45% moderate change
- 2% no change
- 26% not currently doing any reporting
With respect to whether education of all stakeholders are necessary.
- 75% are doing software upgrades
- 12% are training employees
- 13% are hiring employees/consultants.
Overall the chart shows that Sunshine like the sun will take a lot of energy. Perhaps some of that energy will be taken away from research and in the end some patient will suffer as a result of the reallocation of resources. But we will never see it directly.