Federal healthcare regulators are cautiously moving to delay the implementation deadline of yet another healthcare reform Website, as an array of voices in the medical, pharmaceutical, and healthcare industries say the data collection practices behind the Website are not yet effective.

The database in question, administered by the Centers for Medicare and Medicaid Services through the Sunshine Act, requires drug and medical device companies to disclose the costs of all meals, travel, and other expenses provided to doctors and other medical professionals. The information is set to be made public via a government Website on Sept. 30.

Last week, however, CMS agreed to delay public access to the site temporarily (the agency did not specify how long the delay might be) while it reviews complaints about the financial data already collected. Industry groups had hoped for a delay of six months or longer, to sort out confusion about system glitches, non-participation by doctors, and a lack of any guidance from the CMS to the public about how all this data should be put into proper context.

Pharmaceutical and medical device businesses have had to report their payments to doctors since June. Doctors, on the other hand, have been slow to register with CMS to report their own transactions and to review any data that pertains to them. One recent survey of 500 doctors found that 44 percent of them knew about the CMS Open Payments Website, but only 7 percent had actually visited it. Lobbying groups for the medical community also say doctors who do attempt to register have encountered error messages and similar glitches that thwarted their participation.

The American Medical Association signed a separate letter to CMS requesting a six-month delay in making the database public. CMS repeatedly missed its own deadlines, the letter said, and “there are widespread concerns that the implementation of this new system for data collection … will not be ready and will likely lead to the release of inaccurate, misleading, and false information.”

“You know that physicians have not really been in on this when, at this late date, you see a letter from the AMA to CMS saying, ‘This is too quick’,” says Maria Gonzalez Knavel, a partner at the law firm Foley & Lardner who counsels health care clients on compliance issues.

The AMA particularly faulted the registration process. Registration requires more than 20 individual steps, the AMA complained, and can take anywhere from 30 minutes to several hours because the 300-page user guide is so confusing. What’s more, registration must be completed in one sitting or else all a doctor’s previously entered data is lost, and for a long period the site only worked with the Internet Explorer Web browser. (The site now works with other browser software.)

“This system is not ready for prime time, yet the deadline to dispute reports before they’re made public is just a month away,” says Dr. Jack Resneck, a member of the AMA Board of Trustees.

Manufacturers experienced similar glitches and confusion when they first attempted to enter their information, says Andrew Furlow, an associate at the law firm Hogan Lovells who advises healthcare businesses. “Our clients, in the future, would like to see a much smoother process for registering and submitting data,” he says.

Call for Context

Beyond confusion and inaction among doctors, another concern is how to help the public understand all the data it will be able to see. In a recent letter to CMS, a coalition of 26 industry groups wrote: “The potential for public confusion is why Congress mandated CMS provide context along with the Sunshine data’s release. Multiple industry stakeholders have offered blueprints as to how context could be provided. To date, however, we have heard nothing from CMS regarding how the data will be explained.”

“You know that physicians have not really been in on this when, at this late date, you see a letter from the AMA to CMS saying, ‘This is too quick.’”
Maria Gonzalez Knavel, Partner, Foley & Lardner

One example of why context is important: At a large hospital chain, a single doctor may have final authority over all industry partnerships; people viewing the database, however, could misconstrue that point person as personally receiving millions of dollars in compensation and honoraria.

“We don’t want this release of the data to be so maligned in the public eye that physicians are hesitant to participate in research or other important components of drug discovery as a result of the negative press they seem to be getting,” says John Murphy, assistant general counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA). “Physicians are a crucial partner at every step of the process.”

Even with context paired to the data, concerns run high that the database could still fracture the relationship drug and device manufacturers have with doctors as they develop and promote new products. Cegedim Relationship Management, a consulting firm in the life sciences industry that conducted the 500-doctor survey mentioned earlier, says manufacturers “should expect to see some impact to their physician relationships.”

While 39 percent of physicians in its survey said the database won’t affect their interactions, 29 percent said it will “somewhat affect them” and 10 percent said it will “greatly affect them.”

What Will Be Reported

The following is from a fact sheet published by Centers for Medicare and Medicaid Services detailing the information that will soon be made public from submitting doctors, drug makers, and medical device manufacturers.
Are payments provided to a consulting firm or third party, whom in turn provide the payment (in whole or part), to a physician reportable under the Open Payments?
Yes, Open Payments requires reporting of both direct and indirect payments and other transfers of value provided by an applicable manufacturer or applicable group purchasing organization to a covered recipient. An indirect payment is a payment or transfer of value made by an applicable manufacturer, or an applicable group purchasing organization, to a covered recipient, or a physician owner or investor, through a third party, where the applicable manufacturer, or applicable group purchasing organization, requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient(s), or a physician owner or investor.
Are payments for medical research writing and/or publication included in reporting research payments?
Under Open Payments, a payment reported as research falls within a research payment category if it is subject to either: 1) a written agreement; 2) a contract; or 3) a research protocol. Payments for medical research writing and/or publication would be included in the research payment, if the activity (here, medical research writing/publication) was included in the written agreement or research protocol and paid as a part of the research payment.
To determine if an applicable manufacture (or applicable group purchasing organization) has met the $100 aggregate threshold for reporting small payments to a covered recipient or physician owner/investor, is it required to aggregate small payments or other transfers of value different across different nature of payment categories?
Yes. To determine if payments or other transfers of value exceed the $100 threshold and must be reported, applicable manufacturers and applicable group purchasing organizations must aggregate payments of less than $10 across multiple nature of payment categories. For example, if the applicable manufacturer provides a physician with multiple separate payments valued under $10 each and the cumulative amount of those separate payments exceeds $100 during the year (e.g. 6 hot dogs - $9 per hot dog, 3 sporting tickets - $9 per ticket, and 3 cab fares - $9 per cab), the threshold will have been met and these payments must be reported.
Source: Centers for Medicare and Medicaid Services.


Knavel appreciates both the intent of the law and the great expense and manpower companies expended to meet its requirements. “On the other hand, the relationship between the industry and the medical profession is longstanding, and has led to advancements in medicine,” she says. “If you don’t have physicians involved in the development of new technologies, that’s going to have a chilling effect on the advancement of medical technology.”

“We don’t want this release of data to be so maligned in the public eye that physicians are hesitant to participate in research or other important components of drug discovery as a result of the negative press they seem to be getting,” Furlow says.

What’s Next?

Moving forward, all involved will wait and see what leniency CMS provides and whether a longer-term delay is granted. “The government always gives itself more time, but doesn’t always extend that courtesy to others,” Knavel says. She believes that moving forward, healthcare companies will want to better coordinate their compensation-driven dealings with doctors and the data collection that comes with it.

“It is easier to do things on the front end if you can, than after entering into a new relationship,” she says.

Companies and their trade groups will also need to spend more money and effort on public outreach, Knavel says, to combat perceptions that compensation to doctors is inherently a conflict of interest. “They need to educate the public as to why it’s a good thing to have these relationships. That hasn’t been done yet.”

Cegedim’s research bears this out. More companies are reporting planning “pre-submission reviews” with covered recipients. Of the physicians it surveyed, 85 percent would like to review data before it is submitted to CMS, and 80 percent said they would like to be informed of the value of goods and services before accepting them.

The AMA also has some suggestions for CMS, as detailed in its recent letter. First and foremost is to streamline the process. The group is also pushing back against a recently proposed rule change that, starting in 2015, would end the exclusion of continuing medical education data from reporting when the industry donor is unaware of the speakers and other participants before committing to fund the activity. The AMA is also pushing for CMS to exclude journal article reprints, medical textbooks, and other services used to educate physicians, “because they have a direct benefit to patients.”