Here Comes the Sun – Rulemaking cut
Sunshine’s getting closer, and we’re not talking sandals and patio seating.
With complete rules scheduled to be out this October, the Centers for Medicare and Medicaid (CMS) are spending the summer writing the whos, whats and whens of the Physician Payment Sunshine provisions, which will require drug and device companies to publicly report payments to doctors and teaching hospitals. And since the devil’s in the details, consumers and industry are weighing in with CMS on how to make Sunshine a source of light, not just heat.
On a recent open door call with the agency, industry and consumers weighed in on aspects they think are important to consider as it builds the Sunshine regulations and system. Representatives from Community Catalyst, Health Care for All (Massachusetts), Minnesota Prescription Coalition and the National Physicians Alliance joined representatives of BIO and PhRMA on the call.
Here are some of the key issues we heard (and were underscored by follow-up letters PhRMA and BIO published this week.)
Payment categories Categories of reported payments should be adequately detailed, clearly defined and discrete: payment for meals, travel, gifts and entertainment should be reported in separate categories, rather than lumped into broader catch all categories, or collapsed into research or education. This will prevent double-counting, make data comparable across companies and provide more accurate and comprehensive info for researchers and consumers.
In its letter, PhRMA proposes collapsing some payment categories: “some meals and travel could be reported as expenses associated with consulting activities, rather than individual line items.” But CMS should be careful, as collapsing categories could make the data less useful and might assign marketing-based payments –dinner at a nice restaurant, sports tickets—the false legitimacy of bona fide research payments.
Other things it’s important to define:
- Payments reported as “research” should meet the standards, in existing federal law, for systematic investigations, which does not include, for instance, marketing research;
- Payments reported as ‘education’ should refer to participation in an accredited CME program;
- “Consulting” should hew to the definition of bona fide services established in a number of widely accepted industry codes (AdvaMed, PhRMA) and include a written contract, deliverables and clinical research protocol;
- Community Catalyst emphasized that the name of the drug associated with each payment should include both the common name (in addition to the technical name) so consumers will recognize drugs they may be taking.
Accuracy All parties on the call agreed that industry and CMS should work together to make sure the data is as accurate as possible. Establishing detailed unambiguous guidelines and reporting forms as well as opportunities to correct data will help with that. So would coming up with a list of all potential recipients and assigning unique identifiers, industry and consumers said. Consumer groups also want to see aggressive enforcement to ensure accuracy and full participation by companies.
Speaking of all potential recipients, we’re baffled by a number that keeps coming up. Both on the call and in its letter to CMS, PhRMA cited a mid-size company that estimated it would have to report more than 1 million transactions with 300,000 physicians in the first year of Sunshine. Considering that there are a total of about 660,000 in the whole US (BLS), we are both impressed by the reach of that mid-size company and wide-eyed at its marketing budget. Unless they’re going pen by pen (which the law precludes), that’s a lot of dinners. Or research.
The point they’re making is—we think—is the burden of all this data. A million anything is hard to keep track of! But Vermont’s disclosure law provides some evidence that companies are already managing these data well, because though it is a small state, the Attorney General’s office in Vermont manages to collect comprehensive data from 141 manufacturers of pharmaceuticals, biologics and medical devices. And unless they aren’t complying, this means the companies are managing to get it to them. All that’s good news.
Background info So why do we need Sunshine? That’s an important question to answer on the Sunshine website, we think, so that consumers and other visitors have both context and rationale to frame what – let’s face it—is going to be a lot of numbers.
The risks associated with financial conflicts of interest are inherent in academic-industry relations, but gone unacknowledged, such COIs have the potential to bias patient care and prescribing. The Institute of Medicine has done excellent work framing the rationale for financial transparency.
Both PhRMA and BIO made a point of asking that the Sunshine website describe the benefits of academic-industry collaboration to patient care; we think such commentary, if included, must be counterweighed with evidence of the risks of financial marketing relationships on clinical care. Both aspects of the relationship are explored in the IOM research, and its process has included all stakeholders.
So what’s next?
CMS has an open comment period this spring and summer with a goal of having completed regulations up by October 1, 2011 so that companies can begin collecting data in 2012. The first year data is set to be published by CMS September 30, 2013.
More about Sunshine? Check out the Sunshine Act Guide.
–Kate Petersen, PostScript blogger