First CMS Attempt at Transparency Is Remarkably Cloudy

On September 30, 2014, the Centers for Medicare & Medicaid Services (CMS) completed the long-awaited release of physician-industry data from its Open Payments database. As might be expected, the release was beset with many of the same types of technical issues found with healthcare.gov last year and, unfortunately, did little to advance its goal of transparency relating to how pharmaceutical and device manufacturers financially interact with physicians.

One of the bigger issues with the site was that viewing and downloading the data was difficult. In fact, by some estimates, the datasets were more than 4 million lines, much too large to read in an Excel spreadsheet. The next Open Payments database publication will take place in June 2015. It will include a full 12 months of data (for all of 2014) plus the 40% of 2013’s five months of data that was not published this year. One can only imagine the size of those datasets.

WHAT DO WE KNOW?

According to the Open Payments fact sheet (bit.ly/OpenPaymentsFactSheet), the database reports on 4.4 million payments by 1,419 manufacturers to 546,000 physicians totaling $3.5 billion in value over the August through December 2013 time period.

Of the nation’s 926,000 physicians, defined as MDs, DOs, dentists, chiropractors, optometrists, and podiatrists that are subject to Open Payments reporting, 59% will find themselves in the 2013 database. Only 26,000 (5%) of the reported physicians registered to review their payments in advance. There were no records as to whether this number reflected the widely reported difficulties in accessing the site (see the American Medical Association’s take at bit.ly/ AMAOpenPaymentsMediaGuide) versus physician disinterest (or lack of time).

CMS reports that 12,579 records, comprising less than 0.3% of all records, were disputed. Less than 30% of those disputes were resolved. The 9,000 unresolved disputes made up transactions averaging more than $50,000 each.

CMS TAKES A STAND ON (OR AT LEAST TRIES TO EXPLAIN) “CONTEXT”

For some time, we have been discussing how understanding the context of a disclosure is a critical piece to making any disclosure meaningful or usable for the public. Taking a position that can be best described as neutral (http://bit.ly/OpenPaymentsDataInContext)., CMS states in bold print that “Open Payments does not identify which financial relationships are beneficial or which may cause conflicts of interest.” The remainder of the page fails to describe any of the potential benefits of these collaborations and discusses potential conflicts of interest. CMS refers to a 2009 Institute of Medicine report that stated the primary goal of providing beneficial care to patients, conducting valid research, and offering excellent medical education can be “at risk of being compromised by the undue pursuit of financial gain or other secondary interests.”

CMS also encourages patients to discuss physicianindustry relationships with their physicians. At the same time, the site encourages physicians to review “the data reported about you in the Open Payments system [to] ensure that this information is accurate. You can also [use] the information … to plan for questions from patients.”

HEADLINES EMPHASIZE PAYMENTS ONLY

The New York Times reported “Financial Ties Between Doctors and Health Care Firms Are Detailed” on October 2, 2014, and “Men Dominate List of Doctors Receiving Largest Payments From Drug Companies” on October 8, 2014. Of significant concern to physicians, the first article notes “ethical lapses, where doctors with financial interests in companies do not fully disclose them.” It references one cardiologist who received more than $100,000 from a relationship with a company that was not disclosed in a journal article.

As a recurrent theme, the articles named several physicians and the payments that they received, but no mention of the positive impact of the work done. The absence of this context leads to confusion and further misunderstanding of the critical role that physicians play in the advancement of medicine.

HOW CAN YOU SEE WHAT’S BEING REPORTED?

To give you a taste of what you might experience, we have included a few pages from OpenPaymentsData.CMS. gov. As noted in “CMS Releases Open Payments Data; Concerns Raised Over Accuracy and Context” (evtoday.com/2014/09/30/cms-releases-first-round-of-open-payments-data)., it is not a user-friendly site. When looking for information, site visitors are presented a view into database reporting software (Figure 1).

The three orange icons contain research payment data, ownership “payment data,” and general payment data.

Other datasets contain physician profile data and “deidentified” research, ownership, and general payment data. From the start, the titles and even the user interface are not what one would conclude to be consumer friendly or even easy to understand.

If you are searching about a particular physician, you might click on “General Payment Data with Identifying Recipient Information–Detailed Dataset 2013 Reporting Year” (the third orange and fifth overall icon), which provides a view into the multimillion-record database (Figure 2).

The process does not get easier as you dig down. As an example, we tried to research payments for David Kessler, MD, an FDA commissioner in the 1990s whose payments were highlighted in The New York Times article. We first needed to filter the data to focus on payments to a single physician. Typing “Kessler” into the “Physician_Last_Name_ is” box in the Filter section finds all general payments to all physicians with the last name “Kessler.” For the 2013 published payments, that results in 614 rows and 63 columns of data being displayed.

Because scrolling through that much information on a web browser is practically impossible, we next clicked on the small blue “Export” tab near the top of the browser window (Figure 3).

The right pane switches from Filter to Export, so we chose to download the data in XLSX (Excel) format. Next we opened the downloaded XLSX file in Excel, sorted on Physician_First_Name and Physician_Middle_Name, and, finally, deleted records unrelated to “David A. Kessler.” We found five payments totaling $232,265.00, all from Aptalis Pharma US, Inc. (Figure 4).

Unfortunately, there were no data in the “Contextual_ Information” fields associated with these payments. Thus, neither patients nor the public at large have any real idea as to what Dr. Kessler’s interactions with the firm were designed to achieve. For a deeper discussion on the value of contextual information, see “What are you doing for that company?” in the “Physician Counsel” series on PracticalNeurology.com (or at http://evtoday.com/2014/02/ what-are-you-doing-for-that-company).

PHYSICIANS: BE PREPARED

Given the complexity of using the CMS database tool, it seems likely that the public will be getting their Open Payments information from the press (or, in the worst cases, from government investigations or court cases). For physicians with significant disclosures, this means that you (or your employer) may be given a short window to try to provide context to specific disclosures. If that happens, our advice is simple: Be prepared. The best way to kill a story is to provide clear and accurate context as to the value of the work was completed. For the busy physician without any support, getting prepared may seem like a daunting task. However, the alternative (misguided press coverage, investigations, etc.) is no doubt worse.

Primacea provides tools to physicians and leading hospitals to facilitate transparency in innovation and manage compliance obligations. For more information, please follow @ Primacea on Twitter or visit www.primacea.com.

Steven J. Cagnetta, Esq, is Founder and Chief Counsel at Primacea, Inc. in Andover, Massachusetts. He may be reached at (781) 369-2900; steve.cagnetta@primacea.com.

Steven K. Ladd is Founder and President at Primacea, Inc. in Andover, Massachusetts. He may be reached at (617) 901- 3140; steven.ladd@primacea.com.