How Physicians Can Dispute Open Payments Data

How can you keep erroneous information about your industry payments from becoming front-page news?

By Steven J. Cagnetta, Esq, and Steven K. Ladd
 

The Open Payments review and dispute process began on July 14, 2014 and is scheduled to run through September 8, 2014. The system was shut down “for maintenance” on August 3rd after the Centers for Medicare & Medicaid Services (CMS) learned that manufacturers mistakenly reported payments made to a number of physicians who shared a name but practiced in different states.

After a review of the errors, CMS announced on August 15th:

CMS took swift action to close the system and fully investigate issues which indicated possible data matching errors within the Open Payments system. Applicable manufacturers and group purchasing organizations (GPOs) submitted intermingled data, such as the wrong state license number or national provider identifier (NPI), for physicians with the same last and first names. This erroneously linked physician data in the Open Payments system. … Incorrect payment transactions have been removed from the current review and dispute process and this data will not be published this year.

This incident should further motivate physicians to review the payments being attributed to them.

QUESTIONS SURROUNDING PHYSICIANS’ ABILITIES TO TELL A FULL, ACCURATE STORY

There are many questions surrounding physicians’ rights to see that accurate data with contextual information are reported when CMS releases the Open Payments database to the public on September 30, 2014.

As discussed in “I Object! Questions Facing Physicians’ Rights to Dispute Sunshine Data” (Endovascular Today, June 2014), there have been serious concerns that companies could just ignore physicians’ versions of the facts and dismiss their Open Payments disputes outright. Further, as explained in “What Are You Doing for That Company?” (Endovascular Today, February 2014), contextual information should be associated with each payment in the public database.

EARLY SUCCESSES IN FIXING ERRORS

On behalf of a number of physicians, Primacea has disputed a variety of types of data submissions by industry firms. We took a collaborative approach to working out the disputes. Rather than initially entering the dispute on the Open Payments website, we reached out to the physicians’ primary company contacts and shared our concerns. These concerns fell into three categories:

• Payments for food and beverages that were never made
• Incorrect valuation of personal investments in reporting firms
• Missing contextual information on payments

One physician had eight data submissions from four firms. We successfully disputed every one of the submissions. The story of each of those disputes is told in this article with the physician’s permission. Identities have been changed, but the facts are real.

REGISTER, REVIEW, AND DISPUTE DATA

The process began with Dr. Smith registering on the Open Payments system (a process that took about 20 minutes with guidance). The system verified his information. After logging out and logging in again, he was able to designate an attorney at Primacea to be his agent.

Primacea downloaded Dr. Smith’s data using proprietary software and formatted several dozen data fields into a simple spreadsheet. This saved Dr. Smith the trouble of clicking back and forth between the main data screen and subsidiary “detail” screens. Dr. Smith reviewed the spreadsheet, called his agent and said, “Every one of these items is wrong, and I can prove it.”

Primacea then sent a customized email to each of the four firms, describing the submission and reason why we requested that it be corrected.

FOOD AND BEVERAGES NOT ACCEPTED

The first dispute was over a submission for food and beverages. Dr. Smith had never accepted any compensation or expense reimbursement from Amedco. He had gone to dinner with company employees in September, but he paid his share of the dinner using his personal credit card. The email began:

We are writing as the representative for Dr. John Q. Smith relating to his Open Payments disclosures. In our review of the CMS website, we found a disclosure by the company that did not comport with our records:

Entity Record ID Nature of Payment Date of Payment Amount ($)
Amedco 1543134124 Food and Beverage 2013-09-15 $72.56

Our understanding is that Dr. Smith has personally paid for all food and beverages and not accepted any such items from Amedco.

Dr. Smith’s contact at Amedco responded within an hour of the email being sent, agreeing that Dr. Smith had paid for his own meal and that he had never accepted any money in any form from the company. The contact forwarded the email to a colleague at Amedco, who wrote that the error would be corrected. Two days later, the payment no longer appeared on Dr. Smith’s Open Payments portal.

FOOD AND BEVERAGES NEVER RECEIVED

The second dispute was also over a submission for food and beverages. Dr. Smith had never accepted anything of value from Bpharma. He had gone to dinner with company employees in October, but he paid his share of the dinner using his personal credit card. The email began:

We are writing as the representative for Dr. John Q. Smith relating to his Open Payments disclosures. In our review of the CMS website, we found a disclosure by the company that did not comport with our records:

Entity Record ID Nature of Payment Date of Payment Amount ($)
Bpharma 1039137592 Food and Beverage 2013-10-02 $58.56

Our understanding is that Dr. Smith has personally paid for all food and beverages and not accepted any such items from Bpharma.

Dr. Smith’s contact at Bpharma responded within 4 hours of the email being sent, agreeing that Dr. Smith had not received a meal or anything else of value from the company. The contact forwarded the email to a colleague at Bpharma, who confirmed Dr. Smith’s submission and forwarded it to the Bpharma specialist responsible for Open Payments submissions and corrections. The specialist wrote that he would correct the submission, but, due to company policy, only after the submission was formally disputed on the Open Payments portal. Primacea then entered the dispute in the Open Payments portal, copying the text of the emails that confirmed Dr. Smith’s position.

VALUATION OF PERSONAL INVESTMENT CHALLENGED

The third dispute concerned an investment that Dr. Smith made in a medical company.

We are writing as the representative for Dr. John Q. Smith relating to his Open Payments disclosures. In our review of the CMS website, we found a disclosure by the company that did not comport with our records:

Applicable Manufacturer...Name Cbio
Applicable Manufacturer...Registration ID 100099910909
Interest Held by: Physician-Covered Recipient
Dollar Amount Invested: $50,000
Value of Interest: $88,339.23
Terms of Interest: Preferred or Common Stock

Our understanding is that Cbio was acquired by Dbiotech, Inc. earlier this year and that Dr. Smith has not received the stated Value of Interest as listed in Cbio’s data submission.

Dr. Smith’s contact at Cbio responded within a day of the email being sent, forwarding it to the company’s former CFO who was then acting as a consultant to Dbiotech. The former CFO scheduled a call with Primacea that included a discussion of common and preferred stock valuation methods and how the company was off by more than a factor of three in its results. The former CFO promised to correct the error.

LACK OF CONTEXTUAL INFORMATION DISPUTED

The fourth dispute concerned accurate data submissions that did not include any contextual information.

We are writing as the representative for Dr. John Q. Smith relating to his Open Payments disclosures. In our review of the CMS website, we found five disclosures by the company that, while accurate in our opinion, are incomplete in that they did not include the context for the payments.

Entity Record ID Nature of Payment Date of Payment Amount ($)
Edevice 1734246987 Food and Beverage 2013-11-09 $16.13
Edevice 1734246983 Food and Beverage 2013-11-09 $15.28
Edevice 1734246986 Food and Beverage 2013-11-18 $35.84
Edevice 1734246985 Food and Beverage 2013-11-20 $102.43
Edevice 1734246984 Food and Beverage 2013-11-20 $38.91

We recommend physicians and their industry counterparts include, as part of public disclosures, the positive reason for their collaborations (see "What Are You Doing for That Company?"). In the words of CMS: “We agree that information on the context of a payment or other transfer of value could be useful. We believe it could help the public better understand the relationships between the industry and covered recipients…”

Accordingly, we request that you add to each of the five disclosures for Dr. Smith the following language in the Contextual Information field:

Provided input on scientific and trial strategies for new devices designed to improve the minimally invasive treatment of atrial fibrillation.

Dr. Smith’s contact at Edevice responded within 3 hours of the email being sent, saying “Thanks for bringing this to our attention and allowing us to respond before disputing the disclosure. I will discuss this with our General Counsel and reply or have her reply.”

Edevice’s General Counsel called Primacea and began the conversation by saying that she had pulled the detail of Dr. Smith’s filing, reviewed invoices for work he did for the company before the Open Payments disclosure period, and talked with the heads of sales and marketing to understand the purpose of the meals (she had clearly done her homework). The General Counsel then asked, “Please explain why you want to add the contextual information.”

Primacea explained that Dr. Smith’s desire to add the contextual information came from showing his patients and the public that the meals and associated discussions were the natural continuation of work that he had done and may continue to do for the company. Without contextual information, his patients and the public may conclude that the company was “plying him with food and alcohol to influence how he practices medicine.”

Since that was “obviously not the case,” the Edevice General Counsel agreed to add contextual information to all the data submissions. She suggested a shorter description: “Discussions concerning new devices designed to improve the minimally invasive treatment of atrial fibrillation.”

PRESENT COURSE OF ACTION IS CLEAR

The final outcome of the Open Payments dispute process and the ultimate disclosure date is still pretty murky. Nonetheless, whether directly or through an appointed agent, physicians should take whatever steps necessary to ensure the information being disclosed about them is correct. While the process now may be time consuming and frustrating, we have seen evidence that it is possible to correct errors. Once these payments are disclosed, mistakes will be available for the world to see, and the opportunity to correct them will have been lost.

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.

 

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