The CMS Open Payments Scandal

Exclusive to Orthopedics This Week

Missing data. Missing dollars.

Centers for Medicare and Medicaid Services’ (CMS) Open Payments System may be so racked with flaws that as much as $800 million or more in payment records are missing.

Furthermore…and this may be an even bigger story…CMS has never taken an action to enforce compliance.

First, the Data Flaws

In October, I downloaded the entirety of all three 2017 Open Payments databases on how much was paid to physicians for research, in ownership granted, and in the broad category of “general” payments, filtered for payments to orthopedists, and started crunching numbers.

I saw two oddities right away.

1. Totals for 2017 were $410 million lower than the totals for 2016. The economy, corporate profits, corporate tax benefits, healthcare spending, and general availability of money were all greater in 2017 than in any recent prior year. In the prior two year-to-year periods, the total rose $400 million and then $390 million. Logically, in the absence of some other factor, payments should have risen by about $400 million again. Instead, payment supposedly fell by about that amount.
2. According to the database, a certain manufacturer, which is annually one of the top 10 in payments to orthopedists, had zero payments to any physician in 2017. I asked the company why. Their media person said, “[company] filed our 2017 report on March 29, 2018 (2 days before the March 31 deadline). Unfortunately, and unbeknownst to us, CMS had problems with their attestation function, which meant our ultimate approval didn’t go through on their end…. Dozens of other companies were affected as well. CMS has fully acknowledged that the problem was on their end (not ours) so they have begun an outreach program with affected companies…[and] our 2017 data will now be posted in 2019.”

A CMS spokesman said there hadn’t been any such problems, so I asked the company for proof. The company sent me copies of two emails sent by CMS confirming receipt of its general and research data. See the image for the full text of one of these emails. The company’s name is being withheld to avoid singling it out, given that the CMS email confirms that it did submit.

I emailed the CMS spokesperson again and cited what the company had said.

He wrote back: “We reviewed [company’s] communications with the Open Payments teams during and after the Program Year 2017 submission window and have found nothing resembling the alleged claims or other information you describe. We believe our CMS response is a fair and accurate assessment of the situation…as we close out this request.”

The email from CMS also said, “CMS has not conducted any outreach efforts related to the timely submission of Program Year 2017 data at this time.”

In other words, that’s their story, they’re sticking to it, and stop asking.

CMS announced in mid-November that it will publish a “refresh” of the Open Payments data in January 2019.

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.