The Sunshine Act passed last year, requiring medical device companies to disclose compensation or gifts given to surgeons valued at more than $10, with few exceptions. The Centers for Medicare and Medicaid Services collected data from device companies and expected to publish interactions on the CMS website starting September 2014, but everything didn't go as planned.
There has been debate, delays and new decisions regarding the Sunshine Act, impacting surgeons across specialties but especially in orthopedic and spine care, as surgeons often work close with device companies to develop and train on new innovations.
Here are 25 things to know about the Sunshine Act and where it's headed:
1. In July, 26 physician organizations sent a letter to CMS asking for clarification on aspects of the Act. First and foremost, the organizations asked CMS to provide context for the information released instead of just posting datasets, which the agency did for hospital and physician prices.
2. The letter went on to ask CMS to provide physicians with a preview of the proposed contextual information. CMS already allows physicians to see the amounts attributed to them before this information is published online and correct any mistakes.
3. The physician organizations' letter asked CMS to delay Open Portal launch until March 31, 2015 to give physicians more time to register and fix issues.
4. There are multiple requirements in the Sunshine Act, and professional organizations worry physicians aren't aware of them all. The 26 physician organizations asked CMS to expand educational efforts and physician outreach with information on what is reported, when it will be reported and what the report will look like.
5. The proposed Physician Fee Schedule for 2015 includes changes to the Sunshine Act for payments when physicians are speaking at Continuing Medical Education programs, which could have unintended consequences on the medical education landscape. CMS recommended eliminating exemption payments for speakers at certain accredited continuing medical education exclusion to the Sunshine Act, requiring medical device companies to report payments to physicians for CME
6. The current Open Payments database is cumbersome and some feel "overly personal" which could lead physicians not to complete their registrations.
7. CMS decided to delay the public launch of its Open Payments website listing medical device company payments to physicians. The Open Payments portal was temporarily suspended on Aug. 4.
8. A physician who saw payments to another physician with the same name under his records notified CMS of the mistake and delayed the roll-out. The system was taken offline for CMS to investigate the issue and physicians were not able to review their information during that two week period.
9. CMS plans to adjust deadlines for the database publication. The database is expected to "go live" on Sept. 30.
10. CMS announced it would withhold one-third of the records received from pharmaceutical and medical device companies because errors were identified in mid-August.
11. Records with mistakes are returned to the manufacturers and organizations. They will not be posted until June 2015, according to a ProPublica report.
12. There could be tens of millions of records withheld. CMS will include information on the website about the missing payments when it's launched.
13. The Open Payments system went back online on Aug. 14 and physicians now have until Sept. 8 to review and correct their data. Typically, physicians will have 45 days to review their data.
14. The payments posted online are intended for patients to see their physician's involvement with device companies, but any payment from a pharmaceutical or medical device manufacturer to a physician who prescribes a product manufactured by the company providing the payment could be viewed as potentially inappropriate remuneration intended to influence prescribing behavior, according to a ReedSmith report.
15. When the data is made public, HHS' Office of the Inspector General, the DOJ and whistle-blowers' attorneys will likely use the data in fraud investigations and filing False Claims Act lawsuits.
16. In addition to citing the payment, CMS will include the name of the drug or device that forms the basis of the payment, and tying payment to a particular drug or type of device could raise suspicions of off-label promotion. This is especially true for physicians receiving payments outside of the scope of a pharmaceutical or medical device's approved indication.
17. Currently, only drug and biologic manufacturers are required to report marketed names while device manufacturers and medical suppliers can report either the marketed name, product category or therapeutic area.
18. ProPublica reported medical device company payments to healthcare professionals promoting their drugs during speaking engagements are dropping in most cases, but for some companies — like Johnson & Johnson — the payments are increasing. Payment disclosure is one of the factors impacting the amount device companies spend.
19. In preparation for the Sunshine Act, the Pharmaceutical Research and Manufacturers of America created a campaign raise awareness for the value their collaboration with physicians has, according to a ProPublica report. Surgeons can bring a unique, real world perspective to device development, and few other organizations beyond device companies are able to fund studies for new devices, which cost several million dollars.
20. The Sunshine Act has also put some physicians on the defensive. Many are rethinking their relationships with device companies that will now report even meals out in addition to consulting and speaking fees. However, there are some surgeons in the spine industry that will continue these relationships built on the drive to innovate.
21. The increased scrutiny has eliminated some questionable and unethical surgeon consulting relationships, which is a good thing, says Frank M. Phillips, MD, professor of orthopaedic surgery at Rush University Medical Center and co-director of the Minimally Invasive Spine Institute at Midwest Orthopaedics at Rush in Chicago. Societies began demanding more disclosures for research articles and presentations at their meetings as well.
22. Patients haven't traditionally been upset when physicians received remuneration for their work with device companies; studies show patients don't see these relationships as problematic as long as they are ethical, and some even seek out sometimes surgeons with these relationships as being leaders in the field.
23. Academic spine surgeons may be feeling the pinch more than most; they are often involved in research activities and publishing data on new products, and those studies take time and effort to complete, which must be compensated because of the additional staff required to run these trials.
24. The negative tone of this new legislation and media coverage has made an impression on young surgeons. When Dr. Phillips first began practicing, it was acceptable to form a relationship with device companies to enable surgeons to take their promising ideas to the next level; now those types of relationships are disincentivized and new ideas may never make it past the surgeon's imagination.
25. Even established spine surgeon innovators are worried they'll be vilified for receiving royalty payments from implant manufacturers for products they developed. As a result, some are not innovating; others are finding creative ways to market their devices or launch start-ups with venture capital money or crowdfunding.