File this under 'how to respond without really saying anything.' Twice last month, the Centers for Medicare & Medicaid Services and the US Department of Health & Human Services were scolded for missing an October 1 deadline for establishing guidelines on how drug and device makers are supposed to submit info on payments to physicians, and how that info would be made publicly available, as required by the Physician Payments Sunshine Provision of the Patient Protection and Affordable Care Act.
In separate letters, the agencies were criticized by a wide array of groups, including BIO, PhRMA, Consumers Union, AdvaMed, Community Catalyst and Pew Health Group, as well as two US Senators, Herb Kohl and Chuck Grassley (see back stories here and here). They worry that delays in establishing procedures for the submission and public reporting of required info will make it difficult for manufacturers to know whether they are meeting their legal obligations.
For those who do not recall, the Sunshine Act requires drug and device makers to report all payments to physicians - such as consulting fees, honoraria, travel, speaking gigs, entertainment and other goodies - to HHS, which must then publicly disclose the identity of the drug or device makers, physicians and the drug or device associated with the payment. Drug and device makers must start collecting info in January and posting it publicly in April 2013.
"Back on July 7 (and at other points in the summer), CMS officials indicated publicly that they expected to release a procedure in time to meet the statutory deadline of Oct 1. That's come and gone," Allan Coukell, who heads medical programs at The Pew Health Group, writes us. "The lack of action is creating uncertainty that the companies I've talked to say is costing them money. The administration needs to act and act quickly. Implementing the Sunshine provision will create transparency that is good for everybody."
Last week, the Obama administration began responding. Elizabeth Fowler, who advises the White House National Economic Council on health policy, told a conference that officials were aware the deadline has passed and regulations were being devised. Meanwhile, CMS Administrator Donald Berwick on Friday replied to Kohl in a letter that recounts an Obama directive to reduce regulatory burdens, a forum last March and subsequent follow-up meetings to review the Sunshine provision.
"I believe we can implement the statutory goals of Section 6002 (the Sunshine provision) while minimizing burden on the regulated parties. In that vein, CMS is carefully reviewing this statutory requirement and working hard to ensure we meet these goals," Berwick writes. "...I understand that your staff has already had informal conversations with agency staff to relay Congressional intent on this provision. I continue to welcome your input as we move forward. Your dedication to bringing transparency to physician-industry relationships is commendable. I look forward to continuing to work with you on this issue" (here is the letter).
But he never says when CMS may actually issue guidelines. Twice, he writes that "we have been working to implement the statutory provision." In other words, please do not ask me again about the guidelines. We know we missed the deadline, but we can not give you an inkling as to when they will become available, at least not in writing, because then we would be held to another deadline that we may miss. The irony, of course, is that this is the same administration that wanted to enact the Sunshine provision.
[UPDATE: We later received this response from Grassley: "The administrator’s response doesn’t tell us anything new. There’s no explanation for the delay and no indication of when to expect completion. It’s an inadequate response any way you look at it. Meanwhile, the US government just settled with a medical device maker for $2.4 million over allegations of kickbacks to doctors to use the company’s products. The payments to doctors are the kind that might be prevented through disclosure as soon as the Sunshine Act is in place. The longer we wait, the more taxpayers miss out on the benefits."]
6 Comments
This harks back to a stock phrase from the Tom Clancy novels featuring Jack Ryan:
"Don't know means 'don't know.' "
I wonder if telling the FDA that would work during an inspection? (Although the investigators would love to be able to add such a response to their form USFD-483 ...)
Can't speak for Devices, but all of the Big Pharma cos. that I've scoped out have complied with the Act.
This is one of the politicians work manual tools, "Double Speak" aka, "double talk"! Promise, but don't deliver as said. And, 'Our manual is different than yours'.
This comes down to an IT infrastructure implementation it sounds like to me. Right now HHS is running far behind on a lot of things in Health IT, but they are not alone by any means as other agencies are scrambling too with playing catch up with technology.
From the outside it doesn't look that difficult to set up a website for reporting purposes only but again as usual with government reporting there's more to it and granted it's down the line of priorities with other items being much more pressing:) I saw the one article put out on this with the listings and big deal, one of my clients, a doctor was paid 1k for a speech he made in 2009 from GSK:) We laughed at it.
This is really not for those folks anyway, but rather for the big payments that people want to see. Chuck Grassley is not the most digital illiterate person in Congress either and doesn't understand the expense of putting processes in place and some think it grows on trees. Same folks thought there was this burning need to put flawed Medicare claim data on the web too, huge cost there and for what? Law enforcement needs it but Dow Jones maybe saw this as a way for an IT firm to make a lot of money as this is costly to clean up and restructure data so it can be used by the public.
http://ducknetweb.blogspot.com/2011/04/digital-illiteracy-is-killing-us-with.html
Don't mind me though I used write the stuff and know the time and expense here, so to me it's a matter of priorities and while this would be nice to have, it's not directly impacting your or my life right now, and that's my 2 cents.
no, they haven't. they couldn't. there is no guideline with which to comply. they've complied with Massachusetts and Vermont and their Corporate Integrity Agreements (et cetera), but they haven't complied with the Sunshine provisions.
This exposes a symbiotic relationship that has been going between companies and CMS for years. CMS, the arbiters of all things Medicare and Medicaid, has notoriously been late with guidance, changed its mind and generally been vague with its guidance, when given.
Industry, usually not the folks in a compliance function, takes advantage of this by making the most money for their company. Usually when a CIA comes along and fines a company for some off-label or kickback, they also get hit with the fact that they weren't really following CMS's guidance.
CMS has never had encountered industry folks who know what they're talking about, are passionate and most importantly, proactive.
Industry has been preparing for the change in IT infrastructure for a few years. Is this going to take a couple of years like the feeds for CMS did, before we get guidance?