Once again, the Centers for Medicare & Medicaid Services is being scolded for missing the October 1 deadline for establishing guidelines on how drugmakers are supposed to submit information 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.

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 the US Department of Health and Human Services, 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.

But CMS blew past the October 1 deadline without a word. And the lack of information is troubling a growing number of people. Earlier this month, for instance, US Senators Chuck Grassley and Herb Kohl wrote to CMS administrator Don Berwick for an explanation (see here). Now, an interesting assortment of groups - BIO, PhRMA, Consumers Union, AdvaMed, Community Catalyst and Pew Health Group - have written US Health & Human Services Secretary Kathleen Sebelius - to complain as well.

“Many companies have already invested significant resources in preparing to comply with the Sunshine provision,” they write. “…However, delays in establishing procedures for the submission and public reporting of the required information will make it increasingly challenging for manufacturers to know whether they are meeting their statutory obligation as they begin to collect data in 2012…An absence of established procedures could harm both the companies who are trying to comply with the law and the public who stands to benefit from increased transparency of these relationships” (read the letter).

The Sunshine provision was passed after a long-running Senate probe, which was spearheaded by Grassley, into undisclosed conflicts of interest among physicians and the pharmaceutical and device industries. At issue are concerns that financial ties may unduly influence both medical research and any subsequent medical practice. The law, however, has also generated some bitterness among physicians who say payments do not sway their judgment.

The law also requires drugmakers and group purchasing organizations (GPOs) to report all ownership or investment interests held by a doctor or family member, and that info must be disclosed as well. Details, by the way, must be made public by September 30, 2013, and penalties for violations can range from $1,000 to $100,000. However, drugmakers and GPOs must start collecting payment data beginning January 1, 2012, which is coming up.

We have asked CMS for a response and will update you accordingly. We should note, though, that we asked CMS for a reply after Grassley and Kohl issued their letter and CMS did not issue a peep.

pic thx to Jerome Kassirer