No Enforcement, Ever…Yet
The real surprise in the CMS spokesman’s email came in response to my request for records of any enforcement actions taken in 2017, and an explanation of why if there were none.
The response: “CMS has not finalized any enforcement actions with the Open Payments program, nor may CMS comment on current enforcement actions. A description of any final enforcement actions would be made available on the Open Payments website as required by statute (42 USC 1320a-7h(c)(1)(C)(iv)).”
Consistent with that statement, I was unable to find a record of a single enforcement action by CMS, ever, for failing to submit. The law imposes penalties of up to $150,000 for accidental failure to file reports, and up to $1 million for intentional failure to file, so possibly no company has failed to submit.
However, the number of companies submitting has fallen each year, from 1,627 in 2014 to 1,609 in 2015, to 1,600 in 2016, to an apparent 1,525 in 2017. The 2017 total is pending the “refresh.”
Some enforcement might be about to start. Mary Riordan, a senior attorney in the Health and Human Services’ Office of Inspector General, reportedly told an audience at the Pharmaceuticals Compliance Congress in October 2017 that HHS would begin cracking down within a year on companies which didn’t submit. Given the normal slippage in government timetables, “within a year” might mean soon.
Background
Affordable Care Act Section 6002 established the Open Payments Program, under which CMS collects information about the payments drug and device companies make to physicians and teaching hospitals for travel, research, gifts, speaking fees and meals.
It also identifies ownership interests that physicians or their immediate family members have in drug and device companies.
Prior to the Sunshine Act, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) often required parties to a corporate integrity agreement to comply with similar “sunshine” reporting requirements.
Now, CMS collects this data from all drug and device companies and publishes it annually.
The first cycle of payment data (covering payments made August 1 through December 31, 2013) became publicly accessible in September 2014. This information was subsequently updated in December 2014 to include previously disputed payments.
The second cycle of payment data covered the calendar year 2014 and became publicly accessible on June 30, 2015.The third cycle covered 2015 data that was published on June 30, 2016, and the fourth covered 2016 data that was published June 30, 2017.
The fifth cycle covering payments for calendar year 2017 is currently underway. Physicians and the public can view previously published data for 2013-2016 by searching on the Open Payments web site.
