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8 posts from June 2012

June 28, 2012

The Supreme Court Upholds the ACA, with a Caveat About the Medicaid Expansion

Bottom line:  The individual mandate and all other provisions of the Accountable Care Act (with one exception, discussed below) were upheld by the Supremes, 5-4, as a tax, and not under the Commerce Clause (surprise!), with Chief Justice Roberts writing the majority opinion and the liberal wing of the court concurring (mostly).  The Medicaid expansion was upheld, but the provision that would have yanked all federal financial support for Medicaid programs in states that did not implement the Medicaid expansion as provided in the ACA was held unconstitutional.  Thus, a state may legally refuse to implement the Medicaid expansion provisions, and refuse the full coverage of that expense by the federales (all other Medicaid expenses are shared by state and feds).   

I highly recommend reading the opinions issued by the Supreme Court.  All of them. Especially the dissenting opinions. Dissents are fun to read because their authors have their eyes fixed on the future implications of the majority decision. In this case, for example, Justice Ginsburg articulates the reasons why the law should have been upheld based on the Commerce Clause, so that future cases may be decided, in part, based on her parsing of the arguments and precedents.  She sees the health care opinion as a deviation from a line of Commerce Clause cases (the wheat case and the medical marijuana case, most colorfully).  What makes them really, really fun to read, though, is the way they turn a knife in the majority's gut -- with a smile.  Subtle, but very cutting.  A lot of the old reductio ad absurdum.

A few examples, from Justice Ginsburg's dissent (cites and quotes omitted for clarity; plain English translations offered for the nonlawyers, or others, who may not find these quite as amusing as I do):

The Chief Justice's novel constraint on Congress' commerce power gains no force from our precedent and for that reason alone warrants disapprobation.

The Chief is making stuff up, and needs to be smacked down.

When contemplated in its extreme, almost any power lookds dangerous. The commerce power, hypothetically, would enable Congress to prohibit the purchase and home production of of all meat, fish, and dairy goods, effectively compelling Americans to eat only vegetables. Yet no one would offer the hypothetical and unreal possibility of a vegetarian state as a credible reason to deny Congress the authority ever to ban the possession and sale of goods. The Chief Justice accepts just such specious logic when he cites the broccoli horrible as a reason to deny Congress the power to pass the individual mandate.

The Chief says "broccoli," by which he means, we can't uphold the health reform law under the commerce clause, because if we did, then Congress could turn this country into a vegetarian state and we couldn't say boo. 

Under pre-ACA Medicaid, the Federal Govenrment pays up to 83% of the costs of coverage for current enrollees; under the ACA, the federal contribution starts at 100% and will eventually settle at 90%. Even if one agreed that a change of as little as 7 percentage points carries constitutional significance, is it not passing strange to suggest that the purported incursion on state sovereignty might have been averted, or at least mitigated, had Congress offered States less money to carry out the same obligations?

The Chief says Congress is messing with state sovereignty by paying states a higher percentage of Medicaid expansion costs than they get for existing Medicaid costs.

On this last point, it will be interesting to see if any states among the plaintiffs in the case continue to toe the line and refuse to implement the Medicaid expansion.

The dissent from the right offers some gems, too:

The Court regards its strained statutory interpretation as judicial modesty. It is not. It amounts instead to a vast judicial overreaching.  It creates a debilitated, inoperable version of health-care regulation that Congress did not enact and the public does not expect.  

The Court's disposition, invented and atextual as it is, does not even have the merit of avoiding constitutional difficulties.  It creates them.

With this sort of language in a fractured 5-4 decision, the Chief has not done very much to restore our collective confidence in the Court, an issue with which he may be concerned.

The commentariat has been out in full force, but the bottom line is the same across the polictical spectrum: like it or not, the Court has spoken -- perhaps more clearly than many had expected -- and the spectre of the Supremes is now removed from the health care reform equation.  Atul Gawande celebrates the benefit to be realized by broader health insurance coverage by offering vignettes of the experience of uninsurance.  He then dips into social science and economic theory in order to articulate a clear warning about the complexities -- health care is a "wicked problem" -- and the partisan chest-thumping and saber-rattling ahead. Clearly, we need to move on.  For some that means that it's time to get back to the work of implementing the law. (Here's a handy-dandy health reform implementation timeline from the good folks at the Kaiser Family Foundation.)  For some that means let's try to stop it, by any means necessary -- a vote in the House on July 11, and perhaps dumping a beer on Chief Justice Roberts' head(!) (Those wild and crazy congressional Republicans.)

There will no doubt be changes ahead, to account for economic and political realities after the election. Meanwhile, there's lots to be done.

Per aspera, ad astra!

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

SCOTUS on the ACA - The Supreme Court Rules on the Health Reform Law

The long-awaited decision is here. 5-4, upheld. Roberts with the majority, Kennedy dissents.

Per SCOTUSblog:

The money quote from the section on the mandate: Our precedent demonstrates that Congress had the power to impose the exaction in Section 5000A under the taxing power, and that Section 5000A need not be read to do more than impose a tax. This is sufficient to sustain it.


The Court holds that the mandate violates the Commerce Clause, but that doesn't matter because there are five votes for the mandate to be constitutional under the taxing power.


The key comment on salvaging the Medicaid expansion is this (from Roberts): "Nothing in our opinion precludes Congress from offering funds under the ACA to expand the availability of health care, and requiring that states accepting such funds comply with the conditions on their use. What Congress is not free to do is to penalize States that choose not to participate in that new program by taking away their existing Medicaid funding."


The Court holds that the Anti-Injunction Act doesn't apply because the label "tax" is not controlling.

Supreme Court Decision in the Health Reform Cases

Please check back for additional information and analysis here at HealthBlawg.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

June 27, 2012

OCR Releases HIPAA Privacy and Security Audit Protocol

Having completed an initial 20 HIPAA privacy and security compliance audits since last fall, and with 95 additional audits in the pipeline, OCR has just released its HIPAA privacy and security audit protocol, together with information about the audit pilot program.  As always, information like this is extremely valuable to the regulated community.  Covered entities and business associates should avail themselves of the information contained in the audit protocol and related materials so that they may prepare themselves for the eventuality of an audit or investigation -- whether as part of the current audit plan or otherwise -- and focus their compliance efforts.

(Links updated 06/01/2013)


From the OCR website: 

The OCR HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate. OCR established a comprehensive audit protocol that contains the requirements to be assessed through these performance audits. The entire audit protocol is organized around modules, representing separate elements of privacy, security, and breach notification. The combination of these multiple requirements may vary based on the type of covered entity selected for review.

  • The audit protocol covers Privacy Rule requirements for (1) notice of privacy practices for PHI, (2) rights to request privacy protection for PHI, (3) access of individuals to PHI, (4) administrative requirements, (5) uses and disclosures of PHI, (6) amendment of PHI, and (7) accounting of disclosures.

  • The protocol covers Security Rule requirements for administrative, physical, and technical safeguards.
  • The protocol covers requirements for the Breach Notification Rule.

OCR reported on the first 20 audits it conducted as well:

OCR Audit Presentation - First 20 Audits

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 


June 19, 2012

The Supreme Court decision on the health reform law (has not yet been issued)

I am drowning in a deluge of blog posts, op-ed pieces, newspaper articles and more about the health reform decision that the Supremes have not yet announced. (And yes, I admit I was following the liveblogging from the Court Monday morning just in case, y'know, something happened.) In my unscientific survey sample, most pundits seem to be saying that the decision will be a big anticlimax -- not to worry: real change is happening in the private sector no matter what; whether or not there's an individual mandate won't really affect the market for health insurance; health insurance carriers are going to keep many of the law's provisions in place even if it is overturned, etc., etc. Those who aren't saying it's no big deal are issuing advice that earns the Captain Obvious Award -- e.g., premium levels will likely go up if the individual mandate is struck down, but everything else remains untouched.

How often do we see so many pieces written about something that hasn't happened yet, most of which insist that when it happens it won't really matter? It all seems to be symptomatic of a group psychopathology more than anything else. My concern is that, no matter the outcome, we are likely to see more coverage of the law, the decision, the implications, the legislative and administrative wrangling to follow -- with partisan shouting added to the mix -- until well after the inauguration early next year, and possibly until the date that the mandate is now supposed to take effect, January 1, 2014.

What we really need, instead, are a clear understanding of the decision and its ramifications, and a roadmap to planning for life after the decision, to be used by insurers, employers, state Medicaid programs and -- oh, yes -- citizens. I'll reserve my comments until after the decision is released.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

June 15, 2012

Social Media Speaking Engagements - Live and on the Web

I'll be talking social media to lawyers of all stripes here in Boston, and to health care lawyers via the interwebs, over the next two weeks.

For Massachusetts lawyers: Massachusetts Bar Association - LOMAP Super Marketing Conference II will be offered free of charge on Tuesday June 19 at the MBA.

For health care lawyers nationwide: Join me and other experts for a Social Media in Healthcare webinar on Wednesday June 27.  Register via the link for a 50% FOH (Friend of the HealthBlawger) discount.

If you can't make it, take a look at my free white paper: Health Care Social Media: Getting Started Without Getting In Trouble

David Harlow
The Harlow Group LLC
Health Care Law and Consulting   

June 13, 2012

David Harlow Interviewed on Health 2.0 TV

Health Law 2.0 Interview on Health 2.0 TV

David Harlow, The Harlow Group LLC
Health Law 2.0 addresses the pressing legal issues for both large and small Health 2.0 companies in the regulated world of health care.  David Harlow’s experience in both the public and private sectors over the past twenty years affords him a unique perspective on legal, policy and business issues facing the health care community.  Health care providers, vendors and payors of all shapes and sizes rely on him to help navigate the maze of regulatory and business issues facing them on a daily basis.

This segement was taped at the 2012 Health 2.0 Spring Fling in Boston.  For more video, see Health 2.0 TV.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting  

June 11, 2012

DC Health Data and Innovation Week 2012

I spent part of last week at the DC Health Data and Innovation Week.  I attended HealthCamp DC, The Walking Gallery, the Health Datapalooza and part of the Privacy Summit.  I've already shared snapshots of HealthCamp and The Walking Gallery -- but for more, see yesterday's Washington Post article on the Walking Gallery.  Also, please check out Dave Chase's account of the White House roundtable on patient access to health data. The Health Dataplooza was kicked off by US CTO Todd Park, whose opening keynote to a crowd of 1200 in person, and many more at the other end of the livestream, concluded with a rousing: "God bless the United States of America! God bless you! May the Force be with you! Rock on!"  The re-imagined website provides easy access to health data -- that's what it's all about, now, isn't it? -- and information on health data challenges.  Speaking of challenges, Mike Painter of the RWJF Aligning Forces for Quality initiative presented the AF4Q developer challenge $100,000 prize to SymCat at the Health Datapalooza, and the HealthBlawger caught up with one of the two founders, Craig Monsen, in a random walk through the Health Datapalooza exhibit hall and lobby areas, video camera in hand.  Here's the HealthBlawg Health Datapalooza vlog, including conversations with Craig and eight other health data entrepreneurs of one sort or another:    

One of the nine is Fred Trotter, who describes his efforts to make a clean version of the NPI database public.  That work was a key underpinning of the new Participatory Medicine Seal program announced at the Health Datapalooza consumer session by The Society of Participatory Medicine's Alan Greene. (Disclosure: I am the Society's public policy chair.) Patients are invited to nominate their physicians for inclusion in this recognition program. Patients may be recognized as well. The session also included presentations and panels moderated by members of the ONC leadership team -- Farzad Mostashari and Lygeia Ricciardi -- and was punctuated by an exercise break

You can review the tweetstreams of HealthCamp DC #hcdc, The Walking Gallery #thewalkinggallery and the Health Datapalooza #healthdata at your leisure to get a fuller sense of the week.

As usual, it was a pleasure to see -- in real life -- members of my online community, to see some new faces, and to forge some new relationships as well.  There is always a lot of excitement at events like this, and the challenge -- of course -- is to harness that excitement, bring it home, bring it back to the workshop, and make sure that good work continues to address the problems of health access, cost and quality.  Data can help us solve these problems, but data, apps, programs and cool data visualizations will not solve these problems by themselves.  There is a flurry of tools out there now -- over time, we'll be able to apprehend more clearly which are going to be truly useful.

I look forward to seeing continued progress.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

June 08, 2012

HealthCamp DC and The Walking Gallery

HealthCamp DC and The Walking Gallery

If you could change any law or rule to improve frictionless sharing of health care information and health care generally for patients, what would you do?

Storified by David Harlow · Fri, Jun 08 2012 16:12:15

On Monday June 4, 2012 HealthCampDC took place at the Kaiser Permanente Center for Total Health in DC, followed by an "installation" of The Walking Gallery.  I enjoyed the opportunity to spend a day engaged in terrific discussions about health care with folks I know virtually and "in real life" -- and to meet in person some folks who I've known on line for a while, all as part of DC Health Data and Innovation Week.
RT @tedeytan: My favorite sign is back! #hcdc @DCHealthWeek @ Kaiser Permanente Center for Total Health Harlow
Sitting next to @EndoGoddess and @healthblawg at #hcdc while @ekivemark opens up for the dayAndre Blackman
After introductions, Hal Wolf from Kaiser Permanente gave a "Firestarter" talk to get the juices flowing.
Hal Wolf from KP - How do we handle the many-to-many conversation in #healthcare #hcdcDavid Harlow
New buzzword alert: #socialexhaust #hcdcDavid Harlow
#hcdc Hal Wolfe firestarting Scrimshire
@anitasamarth @Lygeia @SusannahFox @lostonroute66 @ekivemark we have come a long way. #Hcdc Eytan, MD
Love this. “@healthblawg: Members of #thewalkinggallery are docents of their lives. - @reginahollliday #hcdc”Trish Doherty
Emerging theme: how to motivate behavior change: If u build it will they come? (No.) 16K health apps - has it changed anything really? #hcdcDavid Harlow
We split into two groups to hear patient-focused and provider-focused "4x4"s -- four slides, four minutes, presenting current projects and current questions that presenters would like to have answered in the course of the day.  These were followed by agenda-setting and the breakout sessions.  Since I am putting this together a few days after the fact I cannot easily retrieve everyone's tweets about everything that took place at HealthCamp DC.  For the full picture, check out the HealthCamp DC tweet archive.    
RT @healthblawg: Rashomon of #Healthcare @2healthguru: Four peeps in same room w/ doc all 'hearing' diff things @grantverstandig #hcdcCasey Quinlan
I'll focus for a bit on the session that I led: "I Fought the Law ..." which was a free-ranging discussion kicked off by my question: What laws would you like to see changed in order to promote easier access to health data and better outcomes for patients? 
Great question! @healthblawg: What #laws need to change to make #healthcare better? #hcdc #TheWalkingGallery Dombrowski MD
Getting ready for @healthblawg's session at #hcdc on fighting law in healthcare. W/ @MightyCasey @fredtrotter @MsWZ & others. Lupus Advocate
at #hcdc hearing @healthblawg talk about #bbos (Big Brother Over Shoulder) in healthcare. Coloring inside the lines = adoption/progressCasey Quinlan
#hcdc the culture clash of law and legality and innovation with @healthblawg :)MsWZ
In @healthblawg's breakout session about what is legal in patient engagement innovation. @sunnykay brings up time issue for docs #hcdcAndre Blackman
A few other tidbits from here and there:
Heard @healthcampdc: If sensor and/or app is not tied to "why did this ahppen?" or "what can I do?" it is not helpful #hcdc #mHealthThe Doctor Weighs In
RT @healthblawg: "Health isn't just body fluids and brainwaves ... we need hi tech & also hi touch" #HCDC wrapupGregg Masters
"Wellness is social, health is private" Agree? #hcdcDavid Harlow
Now @paintmd reviews his breakout session #hcdc @ Kaiser Permanente Center for Total Health Blackman
Which is more harmful paper Hacking vs. EMR Hacking= Which is worse?Black market health care record $18.00 Date of birth etc. #hcdcLisa Fields
For other Storfy takes on HealthCamp DC, see: Disruptive Women and: 
@s_eller @sdbj @healthblawg @Lilly_COI You've been quoted in my #Storify story "#TheWalkingGallery rocks at #hcdc!"
And some bloggage:
Awesome post MT @LAlexanderson was so excited after #hcdc yesterday, had to try to get as much down on "e-paper": Mary Andrawis
... including Ted Eytan's post on what he thought was the Best. HealthCamp. Ever.
RT @TiffanyAndLupus: "You can't build something for patients if you don't ask us what we patients want!" ~@kaitbr #hcdc #pwpTrish Doherty
“@tedeytan: #hcdc soon, #theWalkingGallery jackets will take over @kptotalhealth”MsWZ
I love this pic. “@kptotalhealth: Conversations continuing after breakout sessions completed. #hcdc #dchealth”Trish Doherty
RT @healthblawg: #theWalkingGallery on a Lego map of the USA. Yes, really. @ReginaHolliday at work #hcdc Permanente
Thanks @ekiveMark @HealthCampHQ @KPTotalHealth 4 #HCDC / Thanks to @ReginaHolliday 4 #TheWalkingGallery!!! Dombrowski MD
It's mini-me! on #theWalkingGallery on a Lego map of the USA #hcdc Harlow
Watching live video stream of HealthCamp DC right now! Thx @2healthguru for the heads up #hcdc Sevilla, MD
Many members of The Walking Gallery changed their Twitter avatars to images of their jackets for the week.  Here are some of them:
RT @HealthcareWen: #TheWalkingGallery COLLAGE Thanks to #health #advocacy #painter @ReginaHolliday #hcdc #healthdata #S4PM #ptsafety Total Health Ctr
RT @kptotalhealth: Wrap-up of HealthCamp DC and Walking Gallery—& 2 photo slide shows: #dchealth #hcdc #thewalkinggallery #healthdataDennis Cryer
After the "formal" HealthCamp unconference wound down, The Walking Gallery began -- with some topical musical entertainment and, of course, walking.
#thewalkinggallery a little raw video footage from yesterday #hcdc #healthdata Harlow
RT @HealthcareWen: "Give me my damn #data" by @RossMartin @ePatientDave @MightyCasey @motorcycle_guy @ACMImimi #TheWalkingGallery #hcdc
I look forward to continuing the conversation -- and the walk.  Please join us at HealthCamp Boston, September 14 - the day before the Medicine 2.0 conference.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting