The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services scrapped its old self-referral voluntary disclosure program in 2009 (it dated back to 1998, and was revisited in 2008), and the Patient Protection and Affordable Care Act (PPACA) mandated that it be replaced. Just like clockwork, on the deadline for its promulgation the OIG obliged, and the new Self-Referral Disclosure Protocol is now posted and effective.
The new protocol could be clearer and offer more comfort, but it doesn’t. Makes one pine for the old policy’s clarity: In the old days, voluntary disclosure bought you a discounted fine for Stark violations — not like the new protocol’s wishy-washy, maybe-we’ll-give-you-a-discount language. The new protocol also fails to help a provider seeking to disclose past wrongs voluntarily in dealing with the Federales on a number of fronts simultaneously (e.g., for false claims violations, anti-kickback violations, etc., all arising from the same set of facts). We can perhaps blame Congress for that failure, rather than the OIG — the OIG is just implementing the statute as written.
Keep your eyes peeled for some tinkering on this front as the OIG gains some experience working under the new regime.
The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released an advisory opinion at the end of last month okaying a hospital’s proposal to provide insurance pre-authorization services free of charge to patients and physicians. This is an issue that has long vexed folks in the imaging world.
Clearly, this is a free service provided to referral sources (to the extent they are obligated by contract with third-party payors to obtain the pre-authorization before referring a patient for an MRI, for example), so why is the OIG okay with it? In their opinion, the OIG blesses the arrangement for four reasons. Read more »
Every time an experiment on human subjects in proposed in our hospital (or any hospital in the United States for that matter), there is an exquisitely sensitive tuning fork that exists to protect human subjects: the investigational review board or “IRB.” Any researcher who has ever brought a research proposal before an IRB knows that any hint of potential harm to a human subject that exists in a research project will kill the proposal faster than you can say “boo.”
An IRB submission is required for all research projects using human subjects in accordance with the Federal Policy for the Protection of Human Rights 45 CFR 46, the Food and Drug Administration (FDA) regulations 21 CFR 50, 56 , and with the Federalwide Assurance granted by the H.H.S. Office of Human Research Protections (OHRP). Every doctor, nurse, hospital administrator, drug or device company involved in human research knows this. Read more »
*This blog post was originally published at Dr. Wes*
If a website touted misleading healthcare information, you’d hope the government would do something about it. But what do you do when the government is the one feeding the public bad information?
Last week the Obama administration launched the new Healthcare.gov. It’s mostly an online insurance shopping website. It’s very much a federal government version of sites like eHealthInsurance.com or Massachsetts’ HealthConnector site, which have been around for years.
So when HHS Secretary Kathleen Sebelius, in announcing the new site, claims it gives consumers “unprecedented transparency” into the healthcare marketplace, you should wonder what she means. But that’s not the big problem with this site. Read more »
*This blog post was originally published at See First Blog*
Check out this darkly humorous advertising campaign from the U.S. Department of Health and Human Services. How do you convince men to go to the doctor and get the preventive healthcare that’s known to save lives? You make it all about television. Men + HD TV = “Yes.” This video is funny on so many levels.
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