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."]