Let the Sunshine Part 1 – The Case of the Missing Guidelines

It may have escaped the notice of some that The Physician Payment Sunshine Act – legislation proposed that would bring greater transparency to the relationship between medical product manufacturers and medical providers – became law when the Patient Protection and Affordable Care Act was signed by President Obama in March, 2010.  It seems to have taken Health and Human Services (HHS) by surprise when the agency failed to release guidance by the October 1 deadline detailing how reporting would take place under the Act, prompting a letter from Senator Charles Grassley to the Centers for Medicare and Medcaid Services (CMS) demanding to know why the deadline was passed and when the guidelines would be issued.

The Act requires that as of January 1, 2012, medical product manufacturers will begin to record all financial relationships with health care providers and teaching hospitals.  This includes, but not limited to, payments for travel expenses (such as to medical meetings), speaking fees, research support, consulting fees, honoraria, entertainment and the like. After collecting this information, it must be reported to HHS by the manufacturers by March 2013 and HHS will begin publishing it on the internet by September 2013.

The only problem is that HHS and/or CMS have not told manufacturers specifically what the information is that needs to be collected and in what format human growth hormone hgh.  Any guidance would have some time built in for public comment and modification to the guidance.  In fact, the law states that “….the Secretary shall consult with the Inspector General of the Department of Health and Human Services, affected industry, consumer advocates, and other interested parties in order to ensure that the information made available to the public … is presented in the appropriate and overall context.” (emphasis added)

Time is growing short.  There are only about 9 weeks left until 2012.

In his letter to CMS, Senator Grassley had posed a number of questions, most pointedly, when the guidelines would be issued.  He demanded a response in writing by October 14. He did not get one.  That prompted an unusual memorandum issued by the Senator’s office addressed to “Reporters and Editors”.

“It’s disappointing that the agency is going so slowly on this issue. Of all the undertakings for CMS, this seems like one of the most straightforward tasks. The law was enacted a year and a half ago, and the legislation was pending for a long time before that. It wasn’t a surprise. I’ll continue to look for CMS to get this done sooner rather than later.”

Next up – what increased transparency might bring.

For more information and resources on the Sunshine Act, see the Pew Prescription Project.

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