Tucked away deep within the 2,000-plus pages of the recently upheld Affordable Care Act is a tiny section of the law that could have a sizable impact on emergency physicians.
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ACEP News: Vol 31 – No 09 – September 2012Section 6002 – a mere seven pages – details what is known as the Physician Payment Sunshine Act, a statute designed to give the public access to information regarding payments made to doctors from manufacturers of drugs, medical devices, and medical supplies through a searchable website.
And that intent is a good one, said ACEP President Dr. David Seaberg. But good intentions don’t guarantee good results.
“Surely the need for transparency is a good concept, especially if [a payment] is significant in value and could sway a physician’s judgment in terms of using drugs or devices,” Dr. Seaberg said. “That’s been shown in the past. But this rule really overreaches in terms of the bureaucracy it will create. It’s going to present a real problem for physicians.
“It’s a real bureaucratic overreach in what they’re trying to do. The basic concept is good, but this particular ‘sunshine rule’ is not where it should be.”
Exactly how the law will work is still something of a mystery. At press time, the Centers for Medicare and Medicaid Services (CMS) still had not released a final version, and it has postponed the collection of data until at least the beginning of 2013.
One thing that is known, however, is that the threshold for reporting payments or gifts is a mere $10 ($100 per payer during the calendar year).
As ridiculous as that sounds – “Two lattes and you’re up to 10 bucks,” ACEP Federal Affairs Director Barbara Tomar said – it’s written into the statute itself and is not open to interpretation by CMS.
And that, Dr. Seaberg and Ms. Tomar said, could quickly become problematic even though the physicians are not required to report anything themselves.
ACEP is trying to help members stay one step ahead by collecting their National Provider Identifier (NPI) numbers at this year’s Scientific Assembly held Oct. 8-11 in Denver. Providing NPIs to health care service providers, device manufacturers, and pharmaceutical companies puts the burden of making the reports on those companies giving the cash, stock, or in-kind items or services.
However, physicians also will need to keep their own detailed and accurate records in order to be able to dispute any erroneous reports. With such a low threshold, those records will be many.
“If somebody is reporting about your behavior, you’d better keep track of your own records, which imposes the same burden on both the reporters and the people being reported on,” Ms. Tomar said. “That’s part of the concern. Now you’ve got to keep all these records – any affiliation you had, any conference where you were a speaker, and so on. It just gets to be extremely onerous in terms of both content and time for record-keeping.”
That was one of the concerns expressed in a letter to CMS from a group of 50 national physician organizations and 43 state medical associations in response to the proposed rule. Among the other issues with the CMS proposal: the requirement that indirect payments must be reported even for CME in which the manufacturer has no control over content or speakers; the short 45-day window given to check the annual report and dispute any inaccuracies before the report is posted; and lack of a process for arbitrating disputes about the report’s accuracy.
That last item is a particular point of contention. In its proposal, CMS said the federal government should not “be actively involved in arbitrating disputes” between manufacturers and doctors, leaving them to resolve the issues themselves.
The physician groups called for CMS to establish an independent arbitrator or to use the total specified by the doctor on the website, with any disputed numbers flagged to notify the public. Those steps are important because, as the letter noted, while a few disputes with doctors won’t harm the manufacturer’s standing, “physicians may have their careers and professional reputations damaged as a result of one disputed report.”
The law does give doctors some breaks. For example, items such as product samples that are not intended to be sold and educational materials provided by manufacturers for patients do not have to be reported.
Overall, though, physicians will need to be far more aware than ever before of where the money and other items coming into their practice are actually coming from. And while that isn’t a bad idea, this particular way of putting it into practice may cause problems.
“I run a medical school, and we’ve changed our rules in terms of exposure of drug and device representatives to our residents and physicians,” Dr. Seaberg said. “They can’t accept any gifts over $50, and we have very strict rules now in terms of our graduate medical education and continuing medical education. And those are good. We support that. But the $10 threshold is way too low to have any meaning. The reporting has to be done within 45 days. The time period is short and it’s going to be a lot of paperwork, and frankly, there’s no oversight on that, either. Certainly, there are some good intentions here, but this goes way too far.”
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