November 4th, 2011 by DavidHarlow in Health Policy, Opinion
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The final Accountable Care Organization regulations are out, the initial flurry of commentary is out (including my own ACO webinar with simultaneous #ACOchat tweetchat – available for replay; slides here : “ACOs, Bundled Payments and the Future of Health Care“), and we can now all catch our collective breath and contemplate the draft vs. final ACO regulation comparisons, the meaning of this new, final set of regulations, guidances and statements from CMS, FTC, DOJ, OIG, and IRS on ACOs and Medicare Shared Savings Programs, and all of the attendant antitrust, antikickback, Stark, and other fraud and abuse matters, and of course tax issues.
So, now that these final regulations are out, and the mythical characteristics of the ACO will soon be dispelled (see under: unicorn), I propose a new animal kingdom metaphor for discussion of Accountable Care Organizations:
The Camel’s Nose is in the Tent.
The definition of a camel, as those of you who tuned into my ACO webinar already know, is Read more »
*This blog post was originally published at HealthBlawg :: David Harlow's Health Care Law Blog*
October 28th, 2011 by DavidHarlow in Opinion
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I’m back from my pilgrimage to Rochester, MN for the Third Annual Health Care Social Media Summit at the Mayo Clinic, presented by Ragan Communications. I had a great time, and want to share the experience with you. So please take a look at the archived #mayoragan tweets, my presentation on health care social media and the law, and my blog posts about the pre-conference and the summit itself posted at HealthWorks Collective. Here are some excerpts:
Mayo Ragan Social Media Summit Pre-Conference:
A recurring theme in my hallway conversations [today] was that it is impossible to transplant a successful program from one location to another without taking into account myriad local conditions (social media program, heart transplant program – same problem). As I always say to folks Read more »
*This blog post was originally published at HealthBlawg :: David Harlow's Health Care Law Blog*
October 10th, 2011 by DavidHarlow in Health Policy, News
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On September 14, HHS released for comment draft lab results regulations that will, if finalized, effectively bathe the Achilles’ heel of health data in the River Styx of ¡data liberación! All lab results will be made available to patients, just like all other health data. (See the HHS presser and YouTube video from the recent consumer health summit. Todd Park, HHS CTO, is also the chief activist for what he calls ¡data liberación!)
Forgive me for mixing my metaphors (or whatever it is I just did), but even though there are just a couple dozen words of regulations at issue here, this is a big deal.
When HIPAA established a federal right for each individual to obtain a copy of his or her health records, in paper or electronic format, there were a couple of types of records called out as specifically exempt from this general rule of data liberation, in the HIPAA Privacy Rule, 45 CFR § 164.524(a)(1): psychotherapy notes, information compiled for use in an administrative or court proceeding, and lab results from what is known as a CLIA lab or a CLIA-exempt lab (including “reference labs,” as in your specimens get referred there by the lab that collects them, or freestanding labs that a patient may be referred to for a test; these are not the labs that are in-house at many doctors’ offices, hospitals and other health care facilities — the in-house labs are part of the “parent” provider organization and their results are part of the parents’ health records already subject to HIPAA).
(“CLIA” stands for the Clinical Laboratory Improvement Amendments of 1988, which established quality standards for certain laboratory testing.)
This carveout of lab results from patient-accessible records has long been a thorn in the side of the e-patient. This month, Read more »
*This blog post was originally published at HealthBlawg :: David Harlow's Health Care Law Blog*
September 24th, 2011 by DavidHarlow in Opinion
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I spoke on health care social media and regulatory compliance at the Health Care Compliance Association’s New England Regional Annual Conference last week. As you may expect, the room was full of the folks who, generally speaking, are the folks who block social media sites on health care organization networks. I sent a link to an online bio to one of the session organizers in advance, and even that site was blocked by his facility’s network. Clearly, we have a long way to go in educating health care compliance professionals about the risks and benefits of using health care social media, and an appropriate approach to balancing these risks and benefits so as to establish an appropriate social media presence for each health care organization.
My talk was followed by a presentation by two federal prosecutors, one of whom reminded the audience that they may need to produce copies of all online postings in response to government document requests or subpoenas. We may quibble about the scope of material that might be covered by such a production request, but the key takeaway from this comment should be Read more »
*This blog post was originally published at HealthBlawg :: David Harlow's Health Care Law Blog*
September 1st, 2011 by DavidHarlow in Health Policy, News
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Many health care provider organizations have not been overly eager to jump onto the Accountable Care Organization (ACO) bandwagon, citing high startup costs and uncertain returns on investment given the complexity of the program. Well, recently, the CMS Center for Innovation has announced the Bundled Payment for Care Improvement initiative. This initiative incorporates elements of earlier CMS demonstration projects — the gainsharing demos and ACE (acute care episode) bundled payments demonstrations which the HealthBlawger has helped a number of clients around the country qualify for in the past — and builds on the broad authority granted to the CMS Center for Innovation under health reform.
The advantages to proceeding with a Bundled Payment for Care Improvement project include the opportunity to participate in CMS shared savings programs while only providing limited commitment of organizational resources, i.e., limited to one or more discrete service lines or episodes of care. Of course, investments in a culture of collaboration must be made, but the system-wide investment in IT and other infrastructure at the level called for in order to qualify as an ACO would not necessarily be required in order to proceed with this initiative.
There are a number of different models open to participants, and nonbinding letters of commitment are due as early as late September.
From the CMS Center for Innovation announcement: Read more »
*This blog post was originally published at HealthBlawg :: David Harlow's Health Care Law Blog*
