Site moved to, redirecting in 1 second...

« May 2009 | Main | July 2009 »

12 posts from June 2009

June 25, 2009

David Harlow and John Moore talk with Gregg Masters about HITECH Act, Certified EHRs and Meaningful Use on Blog Talk Radio

John Moore and I spoke with Gregg Masters on Blog Talk Radio today about the HITECH Act provisions in ARRA, certification of electronic health records systems, and the meaning of "meaningful use."

The Meaningful Use "matrix" laying out the five-year plan, laying out care goals, objectives and measures across five health outcomes policy priorities is available on the Health IT at HHS website. Those policy priorities:

  1. Improve quality, safety, efficiency and reduce health disparities
  2. Engage patients and families
  3. Improve care coordination
  4. Improve population and public health
  5. Ensure adequate privacy and security protections for personal health information

The alphabet soup of government workgroups is working fast to firm up these and other definitions, which will help break up the logjam in EHR investment and implementation.

Have a listen and let us know what you think.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

June 24, 2009

A Declaration of Health Data Rights: Can't argue with it, but it's only a first step

I'm joining the party a day or two late, and am supporting:

A Declaration of Health Data Rights

In an era when technology allows personal health information to be more easily stored, updated, accessed and exchanged, the following rights should be self-evident and inalienable. We the people:
  • Have the right to our own health data
  • Have the right to know the source of each health data element
  • Have the right to take possession of a complete copy of our individual health data, without delay, at minimal or no cost; if data exist in computable form, they must be made available in that form
  • Have the right to share our health data with others as we see fit
These principles express basic human rights as well as essential elements of health care that is participatory, appropriate and in the interests of each patient. No law or policy should abridge these rights.

So, my first reaction: This is obvious stuff, right?  Say what you will about The People's Republic of Massachusetts, local law requires prompt provision of medical records to patients at nominal cost, and in the vast majority of cases, the rules are followed and everyone's happy.  In my own little world here in Boston, MA, The Hub of the Universe, I've never had a problem getting health data -- or pathology slides, or anything else -- released to me or shared with other clinicians when needed.  But, then, I suppose I'm an outlier: my physician is part of a totally wired multispecialty group practice, which has been wired for years and years; and I'm both an industry guy and a lawyer, so I know how to speak up when I need something, and perhaps folks are more apt to listen.  (Reminds me of the semi-apocryphal story of a classmate of mine who saw the "law student" stamp across the top of his medical chart at Mass. General years ago.)

Upon reflection, I realized that not everyone -- whether in Massachusetts or elsewhere -- has the same ease of access, and while the declaration is sort of a no-brainer, it is important to put it out there, and I'm happy to join the folks who got this thing going, including Adam Bosworth, David Kibbe, Jamie Heywood and Gilles Frydman (forgive me for leaving other names off this short list).  I discussed the Declaration with Gilles Frydman, who agreed that it is just a first step, but a critically important one to take while the national dialogue is focused on electronic health records.

Additional steps down the path will have to include other common-sense guarantees that are already enacted into law here and there, including guarantees concerning the rights of patients to obtain test results through their physicians or otherwise, the ability of patients to correct errors in their records (so we don't have easily-accessible garbage), as well as easy access to interoperable electronic health records and non-tethered personal health records.

There are good reasons why some physician notes in some patient records should not be shared with patients or family members (a subject for another day), but this Declaration is focused on data -- not free-text notes -- so those notes would not be covered.

What other rights along these lines would you like to see guaranteed?

Update 6/27/09:  Many supporters have signed onto the Declaration.  One notable exception: Jen McCabe, who was in on some early drafts, but feels strongly that the darn thing doesn't go far enough.  Jen has blogged about her thoughts on the subject and has laid out her own more comprehensive patients' healthcare information rights manifesto.

I agree with Jen's sense that the Declaration is a first step, a baby step, and that there's a lot farther to go.  However, I see this first step less as a near-futile gesture, and more a real first step, a way to to get the conversation moving at a time when it can converge meaningfully with parallel conversations about implementation of ARRA / HITECH Act / Son of HIPAA provisions.  As the old saying goes: A journey of 1,000 miles begins with one step.

Here's what I would like to see providers who are prepared to sign onto the Declaration do as a next step: Without waiting for government action, initiate a campaign to amend their HIPAA Notice of Privacy Practices (NPP) (perhaps now, perhaps as part of the NPP amendment that will have to be rolled out once the Son of HIPAA regs are finalized by next February) to incorporate into a standard form contract that binds the providers the next steps that Jen calls for now and that most, if not all endorsers of the Declaration would also agree are necessary and important.  This simple, yet far-reaching step, would have a greater impact than an endorsement by a provider organization.  These should include guarantees of the "common sense" rights articulated above as well as the following patient rights:

  • The right to correct erroneous data -- and a mechanism for noting disagreements with clinicians
  • The right to control access to data -- access for all purposes: care, payment, secondary use (including clinical research and marketing)

In the past, non-standard NPPs were drafted and distributed by patient advocacy groups for patients to use and add to their providers' NPP forms.  However, patient-specific NPPs are unadministrable.  In order for this to work, there needs to be adoption form the provider side, either as a result of new regulation, or as the result of a populist follow-on to the Declaration.

As I wrote above: Please join in; what other rights would you like to see guaranteed as part of the Declaration?  What are your thoughts on this approach?

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

June 23, 2009

America's Agenda: Health Care For All - Conversation with Dick Gephardt on bipartisan business-labor-payor coalition prodding policymakers into action

I had the opportunity to speak with Dick Gephardt and Mark Blum yesterday, courtesy of America's Agenda: Health Care For All.  Mark is the organization's Executive Director.  Dick Gephardt is a board member and is also . . . Dick Gephardt.  The organization has been engaged in some bipartisan efforts to promote health care reform at the state level (e.g., Vermont), and is now trying its hand at the national stage, having sponsored a series of "summit conversations" over the past few months.  This is one of a new breed of political action committee, which strives to bridge gaps between Democrats and Republicans (Tommy Thompson is also a board member), Big Labor and Big Business and Big Healthcare (members range from SEIU to IBM to PhRMA to Catholic Healthcare West), and promote health care reform.  As is true of many proposals on the table these days, the group's consensus document on national health reform takes the mom-and-apple-pie approach, endorsing a federal disease prevention initiative, a national strategy to improve efficiency and coordination of chronic disease care, strengthening comprehensive primary care, improving evidence for practice guidelines and quality standards, aligning incentives to promote best practices, promoting HIT to reduce waste and enable care coordination, and guaranteed access to care.  The $2.4 trillion question remains: How do we pay for all this health care goodness?

Gephardt was in a leadership position in Congress during the "HillaryCare" campaign in 1993-94.  In his view, comprehensive reform stands a better chance now because the Obama Administration has set out basic goals to be achieved that are straightforward and positive, and has turned it over to Congress to work out the details -- in contrast to the HillaryCare plan drafted in private by a panel of experts and dumped on legislators' desks.  "In the end, the only thing that matters is votes in the House and Senate," Gephardt said, and the only way to secure those votes is to engage Senators and Representatives in the development and drafting of the bills, which was not done in the Clinton era.  His other observations: Stakeholders in the process have remained engaged this time around; in the '90s, many big stakeholders opted out early and just attacked the process.  In order to succeed, a health reform plan needs to offer tangible benefits to the 85% or so of the population who already have health insurance (e.g., savings or efficiencies); otherwise there can’t be a successful political outcome.  "We can't just talk about who do we tax to cover the uninsured; we need to talk about savings for everyone."

I asked Gephardt whether and how the spirit of bipartisanship that we see these days among many prominent former government officials "reaching across the aisle" could be instilled into current political leaders.  His observation: it's hard, given the degree to which the parties have become polarized, yet some Republicans, notably Senators Grassley and Enzi (ranking minority members on key committees), are able to engage in policy discourse.  Gephardt noted that given the range of views within the Democratic Party, there needs to be as much attention paid to keeping the conservative and progressive wings of the party engaged as there is to keeping lines of communication open across the aisle.  Gephardt and Blum both said that there seems to be more common ground this time around because business, labor and provider communities are all feeling pain and recognize that reform is needed.  However, it seems to me that shared pain does not guarantee shared views on the right prescription to ease that pain.  The prescription involves a lot of money, and the stakeholders under various plans floating around Congress these days are weighing in, making swift passage seem less likely as time goes on.  See, e.g., the letter from AHIP to Sen. Kennedy, as reported in the Wall Street Journal.

Blum pointed to the organization's success in helping garner support for the Vermont health care reform plan enacted a couple of years ago.  After the plan was initially vetoed by the governor, and his approval ratings didn't budge, America's Agenda came to town and recommended taking a different tack, based on polling data showing that the key issue for Vermonters (most of whom were already insured and were unmoved by the rhetoric about universal coverage) was concern about being able to continue to pay for one's own health care in the future.  Focusing on that angle led to passage of the bill and its signing by the governor, Blum said.  A more recent model for success is the West Virginia five-year plan, enacted within the past month.  Again, local conditions dictated strategy and tactics.  And again, it will be very interesting to see whether and how the broad promise enacted will ultimately be funded and implemented.

Translating this success to the national stage requires identifying the health care delivery system reforms that can drive down costs, according to both Blum and Gephardt.  If everyone's covered, they say, we can spread costs over more premium payors and manage chronic conditions more effectively and efficiently.  I pushed on this point, given the evidence demonstrating that preventive care doesn't necessarily save money in the long run, because (a) preventive care for all is more expensive than treating the small numbers of cases of any illness or injury that could have been prevented and (b) the people who benefit from such care tend to live longer and eventually suffer from costly illnesses.  Blum insisted that employers such as IBM have found that given a long enough time horizon (10-15 years), the savings are there, and preventive care pays off (4:1).  I am not convinced; I think that given an even longer time horizon -- e.g., into retirement -- the costs will spike, but then that's no longer IBM's problem . . . it's everyone's problem.  Now, I'm not opposed to primary and preventive care; I would just prefer that the trade-offs and consideration of all costs and benefits be explicit.  This is a big social policy issue, not just a health care issue, given the amount of money that's at stake and the potential for rationing engendered by the price tag.

Other topics touched on included the question of whether for-profit insurance companies should be permitted to reap the financial benefit of health care expenditure savings (Gephardt pointed to legislative language calling for community rating, limitation of pre-existing condition exclusions and, in the House Tri-Committee health care reform bill released as a discussion draft within the past week, regulation of medical loss ratios so as to prevent windfalls to commercial insurers; this last provision seems destined for the dustbin of history sooner rather than later).  In addition, I asked whether contributors to America's Agenda's campaigns are skewing their focus (Blum said the $12 million contributed by PhRMA to the SCHIP fight was firewalled away from the current campaign regarding health care reform).

Bottom line: America's Agenda has done a good job of bringing the policy debate out of the back rooms and onto the internet, and has also made important contributions to enabling state-level reforms.  It remains to be seen whether this new stripe of activism will gain significant traction in Washington, or whether the business-labor-payor alliance will simply break down as we get closer to the massive financial issues at stake in the debate.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

June 15, 2009

#hcsm means Healthcare Communications and Social Media: Last night's legal edition was fast and furious

Tom Stitt and Dana Lewis host a weekly "tweetchat" on healthcare communications and social media, known as healthsocmed or hcsm.  Last night, Daniel Goldman, legal counsel at The Mayo Clinic, aka @danielg280, and I, aka @healthblawg, were lawyers-on-the-spot for a special legal edition.  There were interesting questions raised regarding social media, patients, providers, privacy, HIPAA, and lots more.  There were innumerable cross-conversations going on.  One participant noted later that over 900 tweets had been posted in the #hcsm tweetstream in the hour or so allotted (about twice the usual volume), which made it impossible to follow all of them in real time, unfortunately.  I had the chance to look over the stream afterwards, and offer some follow-up responses to questions not fully answered during the session. 

@HITshrink posted some organized excerpts from the stream on his blog; check them out for a more orderly taste of the experience.

Kudos to Tom and Dana for making this happen.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Carnivalia at the intersection of law and medicine

Blawg Review is up at Family Lore, across the pond.  Grand Rounds is up at ACP Internist.  Enjoy!

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

June 12, 2009

Peter Neupert and the latest on Microsoft HealthVault

I had the opportunity to speak with Microsoft SVP Peter Neupert today, on a conference call with a few other health care bloggers.  He was wrapping up the Microsoft connected health conference (check out the tweetstream at #msftchc, which this year brought the HealthVault developers and Amalga users together for the first time, and he seemed jazzed about the synergies. 

Neupert described himself as a "technology optimist," and described Microsoft's current phase of activity as "putting technology pillars in place" so that folks can build applications on the HealthVault open platform.  He acknowledged the difficulties in getting providers and patients to jump aboard, however, noting that physicians have concerns about the reliability of patient-entered data (which communication-enabled devices can now upload automatically) and patients have a variety of concerns about uploading personal health information online.

One of the panels at the conference included David Kibbe discussing the need for modular EHRs for small physician practices.  In response to a question, Neupert described some of his efforts together with the Markle Foundation to articulate a framework for "meaningful use" that would be more focused on outcomes than on the technology itself.  I've discussed before the problems of certification through a set of standards promoted by current market leaders -- it could stifle innovation and limit availability of tools appropriate for a variety of practice settings.  Neupert recounted an experience in California a number of years ago where promotion of e-prescribing by giving away computers and software to physicians resulted in only minimal adoption.  Adoption by physicians will occur if the tools are useful and can adapt to physician workflow, or if the case can be made that workflow ought to change.  Cleveland Clinic and Kaiser Permanente pilot projects have been exploring this issue.

Other issues raised included mHealth, to which Neupert responded that the HealthVault platform is device-agnostic, and that mobile developers were represented at the conference, and HIPAA concerns as a potential barrier to provider and patient adoption.  Neupert joked, "I've never heard of HIPAA; I don't know what that means."  He then noted that the HIPAA conversation comes at different points in the dialogue, depending on whether the dialogue is with providers (comes earlier) or patients (comes later).

Bottom line: It's early yet, folks, but HealthVault has significant promise as an open platform for health care records and their many uses.  We'll see how long it takes to realize that potential.

Update 6/25/09: Archived presentations and videos from the 2009 Connected Health Conference are now available on line.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

June 11, 2009

Health Care Reform edition of Health Wonk Review is up

Joe Paduda does a great job pulling together the best of recent policy posts from the health blogosphere -- and tops it off with some insightful wonkishness of his own -- in today's edition of Health Wonk Review at Managed Care Matters.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Blog Talk Radio: David Harlow featured in health care reform discussion on Gregg Masters' Net Health Reform

I had the pleasure of discussing the current crop of health care reform policy options with Gregg Masters and a number of callers today on Blog Talk Radio.  The hour-long show is available for your listening pleasure here (streaming or download).  Please let me know if you like the content and/or format.  Gregg (aka @2healthguru on twitter, where we first met) and I plan to produce future shows and are interested in your comments and suggestions on focused topics for discussion.

Thanks for listening and for your feedback.

For further reading, some of the materials we discussed include the three Senate Finance Committee policy options reports and related materials, Obama's letter to Senate Democrats, his radio/internet address from last weekend, Senator Kennedy's draft Affordable Health Choices Act, and the Tri-Committee draft released by the House Committees on Ways and Means, Energy and Commerce and Education and Labor.  There are a number of milestones on the march through committees and to the floors of both chambers, and on to the President's desk in October/November.  And finally, a useful tool for those of you keeping score at home is the Kaiser Family Foundation health reform proposal comparison.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

June 08, 2009

Health Care Reform: Two out of Three Ain't Bad?

Folksy ads for a local furniture store chain 'round these parts proclaim "quality, comfort and price; that's nice."  In the continuing saga of slouching towards health care reform, we need to deal with quality, access and cost.  The problem is, we can't really do everything at once. 

Now that Obama has weighed in again on the subject -- the weekend radio and internet address, following on the heels of his letter to a couple dozen senators on health reform priorities -- Paul Levy has quite the discussion going at his blog, Running a Hospital, after suggesting that not all of the President's goals can be achieved at once.  We're in agreement that the health care reform effort is balanced on a three-legged stool, and I would concur that the current discussion in Washington is tending more towards the let's-fix-everything-all-at-once end of the spectrum, which is untenable.  I've said it before and I'll say it again: what we need is incrementalism, baby.

Here in the People's Republic of Massachusetts, we started with coverage, which is as good a place as any.  I would observe, though, that the starting point (along with a variety of other characteristics of the Massachusetts approach) are idiosyncratic and a product of the political wrangling/horsetrading that went on in order to get all stakeholders into the big tent.  (We're experimenting in just one of 50 laboratories here.)  Another (larger) playing field, and different (more) players are likely to yield a different set of compromises.  And that's OK, as long as the ball gets moved a bit further down the field (to mix a few metaphors).  I thought Obama's earlier approach, circa White House Health Care Summit ("you know what I'm looking for, guys; send me a bill I can sign") was politically brilliant; getting down and dirty on the details should be left to the operatives, so that Chuck Grassley doesn't get to score points by tweeting about Obama sightseeing in Europe over the weekend (though, gee, did he forget it was D-Day?).  I thought Obama better appreciated the need for results in this arena vs. taking the opportunity to do a little grandstanding.

So, I'd like to see Obama back off: more looking Presidential; less arm-twisting.  Staking out the range of options to be considered is a good thing, and hanging back a bit until there's a solid bill on his desk -- understanding that the White House is certainly involved in the private discussions leading up to such a bill being finalized -- would be even better.  Seems to me that's the clearest way forward for now.  While there is the potential for taking some giant steps this year, I'm OK even if the end result is less ambitious than is now hoped for.  Why?  Because I believe incrementalism is the way to go here, and it will end up being the first step of a long journey.

If you're interested in discussion of the leading health care reform policy and payment options on the table, please join Gregg Masters and me on Blog Talk Radio this Thursday, June 11, 12:00 Noon Pacific, 3 PM Eastern, and follow the continuing conversation here, there and on twitter.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

June 05, 2009

Nursing home arbitration agreements under fire

An Illinois law bars the use of pre-dispute arbitration agreements signed at the time of admission.  This law was upheld by the Illinois appellate court.  The Supremes refused this past week to hear an appeal, letting the lower court ruling stand, despite the existence of a federal law that permits the enforcement of such agreements.  Massachusetts has ruled in favor of the enforceability of arbitration agreements covering nursing home disputes.  As I've written in the past, Federal legislation has been introduced that would have the same effect as the Illinois law, but arbitration (and mediation) are often far preferable to court process for resolution of many types of disputes.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting