Posts categorized "Patient safety"

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

April 21, 2009

HealthCamp Boston / SocialPharmer Boston Twitterstream via Cover It Live

HealthCamp Boston and SocialPharmer Boston are taking place today.  For those of you on site, please live tweet using hashtags #hcbos or #socpharm.  For those of you following along at home, please follow those hashtags in your reader of choice, or right here.  Separate windows are provided for #hcbos and #socpharm (each will have more than one thread, so mashing them together seemed too unwieldy).  The twitterstream will be archived here for future reference.  Information on audio and video archives will be available via the event website at some point in the future.



David Harlow
The Harlow Group LLC
Health Care Law and Consulting

April 20, 2009

HealthCamp Boston April 21 - Come join in the fun, or follow along at home

HealthCamp Boston and SocialPharmer Boston are happening tomorrow, April 21.  If you can't make it in person and would like to follow the events of the day, check back here at HealthBlawg for CoverItLive windows: one will be set to follow the #hcbos twitterstream, the other, the #socpharm stream.  If you are on twitter, use your reader of choice.  The tweets will be archived here for future reference.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

April 17, 2009

MGH pediatric heart surgery: Volume, volume, volume, or, How low can you go?

Today's Boston Globe reports that Massachusetts General Hospital has voluntarily suspended operation of its pediatric cardiac surgery program, following two significant negative outcomes.  MGH is conducting an internal investigation, much as UMass Memorial suspended its heart surgery program while investigating higher-than-average CABG mortality rates a while back (see HealthBlawg interview with UMMMC general counsel Doug Brown on its cardiac surgery program).  David Torchiana and MGH will certainly be able to identify opportunities for improvement, as did UMMMC, by going through this exercise.  UMass Memorial restarted its program after implementing quality improvements it identified through the review process.  The question on many minds today is whether it makes sense for MGH to continue to run such a program, with the relatively low volume that it has, given the resources and existing programs of Boston's nearby Children's Hospital.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

April 06, 2009

CVS and Google Health: adding lots of prescription data to PHRs

Users of Google Health can now import their CVS prescription data into their PHRs.  Not the first pharmacy to hook up with Google Health, but perhaps the largest.  The more info there is in a PHR, the better; incomplete records only lead to misinformation or lack of information, and when we're talking about prescription medications, that can lead to unfortunate interactions and an additional burden of illness.  Until human nature and the medical-industrial complex can both be sufficiently tweaked to yield more rationality most of the time, the aggregation and sharing of data in this fashion (if it can be done in a comprehensive, secure, and auditable manner since, after all, we don't trust people to remember what color their pills are and report accurately to a string of docs and pharmacists, much less to update their own prescription drug data on line) is, on balance, a positive development.  Google Health does not have access to all pharmacy data in the country yet, but give them time, and they will. 

TechCrunch recognizes that privacy issues abound here, as they do for the rest of Google Health.  For me, these issues are heightened by the fact that, as far as I know, Google still insists that it is beyond the reach of HIPAA and the ARRA/HITECH son-of-HIPAA provisions.  For me (as for most), these risks may well be outweighed by the benefits.  (I think my medical records are of less interest to inquiring minds than those of Britney Spears or the "octomom" -- but I recognize the concerns of folks with medical conditions that info on chronic conditions may get into the wrong hands/be used inappropriately, e.g., for employemnt decisions, though I think the solution to that problem should be in improvements to employment discrimination law.)

The privacy nuts and technophobes out there won't sign up for this service, despite the (mostly) good privacy track record of the financial industry; at the other end of the spectrum, the early adopters are already all over this.  My expectation is that general adoption is going to depend more on easy porting of medical records beyond prescription histories.  As e-Patient Dave so vividly demonstrated recently, unfortunately, we're not quite ready for prime time in that department.  The porting may work, but the data that gets ported may or may not be accurate and up to date.  I'd be interested in learning more about the accuracy of the data that gets imported to the Google Health from the various pharmacy systems before being willing to rely on this system as an improvement over the status quo.

A tip of the hat to Richard Dale, the Venture Cyclist, for pointing me to the TechCrunch post today.  

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

March 13, 2009

Massachusetts Code of Conduct finalized for Pharma, device manufacturers, health care providers

The code of conduct adopted in Massachusetts is the most restrictive set of rules in the nation, crows the Department of Public Health, and mutters the industry.  The final MA pharma and medical device conflict of interest rule is posted on the DPH website, together with related comments, memos and presentations.  In brief, the rule "sets out what is and is not permissible for pharmaceutical and medical device manufacturers with respect to providing meals, sponsoring continuing medical education and other conferences, and otherwise providing payments or other items of economic benefit to Massachusetts health care practitioners."

Some fear the new regulations will lead to a drop in medical conferences held in Massachusetts, further battering the local economy.

Some wonder whether they would have helped nip in the bud past medical research fraud (probably not).

So what do they do?  They implement part of the Massachusetts health reform law, part 2, so much of the commentary ought to have been (and was) directed at the legislature a while back, before it took action, and not at DPH, which is essentially just implementing the legislation.  The rules build on PhRMA and AdvaMed codes of conduct, but do go a wee bit further.  In DPH legalese:

Chapter 111N and 105 CMR 970.000 regulate pharmaceutical and medical device manufacturer conduct in three ways, requiring pharmaceutical and medical device manufacturers to:  (1) adopt and comply with a state-authored code of conduct, (2) provide compliance information to the Department, and (3) disclose sales and marketing related payments to covered recipients. Sections 970.006-970.008 of the Department’s proposed regulations set out what is and is not permissible for pharmaceutical and medical device manufacturers with respect to providing meals, sponsoring continuing medical education and other conferences, and otherwise providing payments or other items of economic benefit to Massachusetts health care practitioners.  Additionally, the Department’s proposed regulation outlines the statutory compliance directives in Section 970.005 and interprets the contours of the disclosure requirements for pharmaceutical and medical device manufacturers in Section 970.009.  Finally, the Department’s proposed regulation reiterates the penalties outlined in Chapter 111N and provides procedures for enforcing the code of conduct, compliance and disclosure requirements of 105 CMR 970.000.  The Department’s proposed regulations seek to address potential undue influence in interactions between pharmaceutical or medical device manufacturing companies and health care practitioners, and increase transparency with respect to such relationships without compromising Massachusetts health care consumers’ access to clinical trials and new discoveries and treatments arising from legitimate and beneficial industry interactions with health care practitioners.

See the final reg hotlink above for the full memo, FAQs, the full text of the regs, a presentation outlining the regs and comparing them with other states' regs, etc.

There's a lot to digest here.  Bottom line: Massachusetts may be in the vanguard on this front, but the industry and the rest of the nation will be following right along, as the pendulum swings to the pro-regulatory mindset.  There is less and less stomach in Washington and on Main Street for anything that even smells of financial impropriety, and the national imperative to get health care costs in check will likely fuel further action on this front. 

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

March 11, 2009

Steven Lash, CEO of Satori World Medical, speaks with David Harlow about medical tourism

Steven Lash, President and CEO of Satori World Medical, spoke with HealthBlawg last week about Satori's take on medical tourism, including its method of sharing cost savings with consumers who use Satori's services through employer-sponsored health plans.

The audio file of my interview with Steven Lash (about 20 minutes long) is available for download/podcast. A full transcript is at the end of this post (and in the linke transcript).

Sharing cost savings with employees through Health Reimbursement Accounts -- funded through tax-deductible contributions by the employer if an employee uses an overseas medical service, and are used to pay for an employee's health insurance premiums, deductibles and copayments in future years -- is one of the Satori innovations.  Lash distinguishes his offering from that of the Hannaford's-Aetna medical tourism plan which was announced with great fanfare, led to no employee taking advantage of an overseas procedure, and brought out a domestic provider that offered to match the overseas pricing Hannaford's had obtained.  He also presents a number of other aspects of his company's program in our conversation, including patient intake, patient choice, and quality assurance through selective contracting with JCI-accredited overseas providers for a limited set of services.

There are wildly varying estimates of the numbers of medical tourists originating in the U.S. -- 50,000 to 750,000 a year, depending on who you ask and how you count -- but that number seems likely to go up before it goes down.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


Interview of Steven Lash, President and CEO of Satori World Medical


March 6, 2009

David Harlow:  This is David Harlow on HealthBlawg, and I have with me today the President and CEO of Satori World Medical, Steven Lash.  Hello, Steven.

Steven Lash:  Good afternoon, David. How are you?

David Harlow:  Very well, thank you.  So Satori is a new entrant on the medical tourism field and I am interested in hearing from you about what sets Satori apart.

Steven Lash:  Great. I think there are several aspects that make us very different than everybody else currently in this space.  First of all, we have a superior quality assurance program and that’s on several levels, David. First of all we have a full time Chief Medical Officer who is board-certified and a fellow, a general surgeon who sets medical travel guidelines and policy in concert with our medical quality advisory committee, which is made up of leading physicians in their subspecialties.  Secondly, we performed a significant due diligence effort that included Dr.  Johnson as well as our VP of Network Development, Naimi Tanha, where they went to fourteen hospitals in seven countries over forty-five days, looking at specifics having to do with quality measures, mortality statistics, infection rates, blood-handling processes. They toured the facilities, and Dr. Johnson even scrubbed into surgery and observed surgical techniques at all the hospitals that are part of our network.  The third thing that makes us different is we started and specifically are working with patients that have financial sponsorship so as a result of that we have set up all our processes and infrastructure to match what health plans currently require for domestic networks, so Ms. Tanha, who’s our VP of Network Development, spent twenty years in California developing and managing networks for Aetna, Blue Shield and HealthNet, and she has duplicated those requirements internally here in the company as well.  The hospitals internationally are contractually obligated to participate in quality audits, quality reporting, et cetera.  A hundred percent of our hospitals are Joint Commission International accredited which is really our baseline because our quality program goes into significantly more detail than that, but that’s sort of a gating issue for our quality program.  Finally, one of the most unique aspects of our program is that, for the first time, the patient will get to share in the savings, who has a financial sponsor, so in other words if a patient needs a hip procedure say and it costs sixty thousand in the US and it costs twenty thousand dollars at one of our network facilities. That forty thousand dollars in savings: the patient will receive a portion of the savings through a health reimbursement account and that’s really what sets us apart.  We put a patent around our business model and for the patient to share in the savings, plus it’s a hundred percent medical benefit so there is no co-pay and no deductible so there’s a real economic incentive for people to take a serious look at the quality of care overseas and the ability to participate in some of the savings.

David Harlow:  So this is a sharing of savings with patients who are in self-insured plans through their employers or through third party payor plans as well?

Steven Lash:  Both, or in unions or associations or public sector employers.

David Harlow:  Now one employer who had engaged in a similar sort of plan -- not through your company, obviously --  Hannaford’s, a regional supermarket chain, has engaged with Aetna in setting up a program that basically gave their employees the option to go overseas at much reduced cost for services or obtain them locally and while they certainly got a lot of press for setting up that program, it turned out that nobody took advantage of it.  Do you have a concern about patients, members, employees being scared off, if you will, from the idea of going overseas for healthcare services, particularly for an involved surgical procedure?

Steven Lash:  Well first our comment on the Hannaford experience: I am familiar with it.  Actually, the Aetna executive who put that program together sits on our medical quality assurance board so we are very familiar with it, and the hospital they contracted with is a very outstanding hospital, in fact that hospital is in our network as well.  I think there are two differences: Number one, there wasn’t an organized program around it, in other words we are a one-stop shop, where the patient makes one call and we take care of all the travel, all the hotel, everything is done for them, we kind of demystify it for them and that wasn’t the case in the Hannaford’s program.  Secondly, a companion goes along so somebody is a accompanying you on your trip. And the third thing that is again the most important is my understanding in the Hannaford experience, they only waived the co-pay and deductible which was about fifteen hundred dollars or two thousand dollars.  Our program is much more robust in terms of the sharing of the savings and for somebody making fifty thousand dollars a year who could have the opportunity of, let’s say, ten thousand dollars deposited in an HRA, where they won’t have any medical expense for two or three years is a lot more of an incentive then just waiving fifteen hundred or two thousand dollars’ co-pay and deductible, and I think in essence that’s why they haven’t seen much success.

David Harlow:  Just to be clear, HRA is a Health Reimbursement Account and that is a tax-free account that patients, members can draw on to pay medical expenses in subsequent years.

Steven Lash:  That is correct. It rolls over, year over year.  It is tax free to the employee and tax deductible to the employer so it kind of wins on both sides of the tax equation.

David Harlow:  Right.  So that payment assumes that the employer is exposed to the whole cost of the procedure, otherwise the employer wouldn’t have that excess money to pay out, isn’t that correct?

Steven Lash:  Well, it could be if it’s through a health plan, through an HRA, there could be premium rebates or premium discounts that can be applied from a health plan to the employer, so there are ways to have that employer receive that benefit even if it’s a fully insured program.

David Harlow:  Okay. Now I am interested in thinking about the volume of services, the volume of patients who would be going through programs such as these.  There have been wildly differing numbers put out there by different consulting firms in different studies ranging from seven hundred fifty thousand Americans making use of medical tourism in the past year to under fifty thousand.  I’m wondering what your sense is of this market and what portion of this market do you think you are able to capture with your new venture?

Steven Lash:  Well I’m not sure I can give you an answer of what's the size of the market -- it’s probably in between those two numbers -- because there is no real reporting agency that captures it.  I mean, there are a lot of people along the border that go across to Mexico for dental care, and not having seen the work papers on either organization I am not sure what's the right number but what I am confident of is we are just seeing an industry in its infancy that is going to start to take off and develop into a very large mainstream service for the delivery of healthcare in this country and the reason I say that is because there is I think now an acceptance that there is significantly high quality care delivered outside of the United States even though Americans tend to be very American centric.  I tell the story, when I was growing up I was going to buy a transistor radio, and I told my father I am going to buy a transistor radio, and he asked me what kind, and I told him a Sony, and he said: Sony? That’s Japanese, that’s crap technology.  He said, you know you ought to be buying an RCA.  We all know the end of that story.

David Harlow:  Yes.

Steven Lash:  And I think that there is a kind if grudging acceptance now that there is high quality care available internationally, and number two is, I think our model, with  cost savings participation by the individual, is truly unique and innovative, and with that, people will start to take advantage of the program and the quality that’s available internationally.

David Harlow:  Now a year or so ago there was famously a union representative calling out a company that was requiring a union member to go overseas for a surgery and essentially faced down this employer -- I believe it was an industrial employer in the Midwest -- and ended up having the union member get his surgery in the United States, saying you can’t force him to go overseas.  Do you think that anyone in that sort of position would see the financial benefit of a program like this as some sort of coercion? Or some sort of a coercive factor in limiting patients’ choice?  Do you see that, do you see the backlash against something that’s limiting patients’ choice in a negative way?

Steven Lash:  Well, you see, I think the beauty of our program is it is totally a hundred percent consumer choice, we don’t ask any network or anybody to reduce their patients’ -- I mean the employees’ -- options.  We become an additional benefit so they can still and are free to choose any provider that’s in their current network, in fact we almost insist that they don’t reduce anybody or any other network in their health plan.  So we are just an addition too, because this is consumer directed, the consumer has to make the choice, we are not forcing anybody to do anything and, you know, the word of the current period is transparency, there’s transparency around our quality and transparency around the economics and people are free to make any choice they want, they stay in country domestically, they know exactly what they have and what their economics are and what the quality is.  If they select the Satori Global Provider they know exactly the quality, they know the economics and it’s their choice, we don’t influence it one way or the other.

David Harlow:  Great.  I guess that was the reaction that some people were having to other sorts of plans where it was not a choice, where that was the sole option provided.

Steven Lash:  Yeah and that’s not something we subscribe to at all.

David Harlow:  Okay.  Another question that people often raise about medical tourism is what happens in case of complications?  Either complications that arise while overseas just after going through a procedure, or complications that may turn up a couple weeks after returning home.  Have you had experience to date with situations such as that and how have those been handled, or if not how would you anticipate those being handled?

Steven Lash:  Well we have not had that as an experience to date.  A couple things: number one, all our patients are vetted in terms of their ability to travel and the medical guidelines that our quality advisory committee and our chief medical officer implement.  So for example a patient who is obese, had a stroke, has diabetes, is not going to be eligible to go anywhere in our system because we know there are going to be complications and issues with that, so that’s kind of the first thing.  Right now, the existing companies don’t do a medical triage whatsoever in terms of their abilities for travel, so that’s kind of the first distinction.  So there are going to be patients that want to use Satori that we will not allow to participate in our program, because we think there is a health risk there or medical risk there.

David Harlow:  How would that screening be done?

Steven Lash:  We review the charts -- because we take a medical history and our chief medical officer is involved and we would make sure they meet the medical travel guidelines that we have established.  So that’s kind of the first situation, so we eliminate kind of out of the chute, if you will, some of that potential.  The second thing that’s different from our program is all our patients have relationships with an insurance company, or some sort of financial sponsor, and a physician.  So we schedule their follow up care before they leave the country.  So, in other words, if someone is going for a hip overseas, we have a follow up appointment with an orthopedist before they leave.  So that is kind of another way which we mitigate some of the negativity around medical travel.  The third issue: our institutions and our centers are the best of the best.  Now that doesn’t mean that something untoward couldn’t happen.  I can tell you that for surgical procedures that we are selecting and utilizing -- because we are not doing hundreds of procedures, we have a handful that we are doing -- we are going to do up to about twenty -- that the surgeon knows within twenty-four, and maybe at the latest seventy-two, hours your course of treatment and your recovery as to whether or not you are going to do well or you are not going to do well and so that all is managed.  Our patients spend an average of seventeen days in country, so there is plenty of time for follow-up care and making sure that they are on the road to recovery prior to them getting on a plane and being released for medical travel.

David Harlow:  Okay, you anticipated my next question, which is what is the range of services for which you’re contracting with the overseas providers?  You mentioned a handful, or a limited range, of those procedures, and what would those be, what sorts of procedures are they?

Steven Lash:  Okay.  First of all, all our procedures are non-emergent, high-cost surgical procedures.  We have four cardiac procedures, we have four orthopedic procedures, so the cardiac are defibrillator, pacemaker, valve and CABG, the orthopedic is hip replacement, one knee, double knee and hip resurfacing.  We are currently in the process of doing our due diligence with the institutions, we are going to be adding this year shoulder, spine, bariatric, hysterectomy, prostatectomy -- I think that’s it, and then we are going to be adding, kind of as an accommodation to some people that have asked us to, dental in a limited network and then cosmetic in a limited network.

David Harlow:  Okay.  Are these procedures available at all of the facilities in your network or do they specialize?

Steven Lash:  No, and the reason they don’t is because of our quality program.  There are, for instance, hospitals in our network that do cardiac surgery, but we will not approve patients to go there for cardiac surgery because they don’t do enough of them to meet our quality standards.  We use things like HealthGrades as an example, Leapfrog Group, and other measures to determine the quality so we screen our institutions to make sure they are doing enough volume for our patients to go there because, as you know, it’s like anything:  if you do enough of them you get very good and we don’t believe that if you do fifty open heart procedures a year -- basically one a week -- you get very good.

David Harlow:  Right, that’s not where I would want to go.

Steven Lash:  Right, and we don’t want to send our patients there either.  So we do not authorize them for certain procedures if they don’t meet our volume and quality thresholds.

David Harlow:  Got it. So that’s on top on the Joint Commission International accreditation?

Steven Lash:  Right.  That’s another difference between our network and the existing ones, people can choose to go wherever they want.

David Harlow:  Okay.  What sort of volume are you seeing to date?  I don’t know how much of this information you’re comfortable sharing, but I would be interested in any information you are willing to share about enrollment in your programs to date -- whether it’s through the McGregor agency or others -- and what sort of numbers of overseas procedures you have been seeing to date.

Steven Lash:  Well, we do not disclose that information but I can tell you that we are gaining a significant amount of traction in the marketplace, and we will be happy to put you on our list for announcements and all that.  We anticipate -- I would be happy to share this with you -- several hundred patients receiving services this year.

David Harlow:  Okay, great.  To wrap things up, I would be interested in your reaction to the White House Health Care Summit yesterday and thoughts about whether anything that is likely to happen in the US in the next year or so may have an impact one way or the other on your business and the services that you are providing.

Steven Lash:  Well first of all I certainly applaud President Obama for getting all the constituencies together to talk about health care reform because it’s certainly -- as somebody who has been in this space for about twenty-five years -- certainly it’s a difficult one to really master because some of the flaws in our system are so endemic to the way our country has grown up that I am not sure that it’s going to be easily cured.  I do feel that the program that he is talking about and the path that they are talking about moving down is only going to be helpful to our company and our business, for a couple of reasons.  First of all, one of the things that we do is, by providing access to these international centers of excellence at their cost, we help US organizations compete on a global basis by lowering their health care cost and having them having the same access as their international competitors do to a lower healthcare cost because as you know health care cost is a huge driver on the P&L in today’s environment.

David Harlow:  Right.

Steven Lash:  The second thing is if they are talking about providing more people access to insurance plans, that will give rise to us as an opportunity. You know, the sense that I have from the reports that I have read out of the summit, there is nothing but looking at cost savings and new techniques for lowering costs and to the extent we provide a competitive environment for that to happen, I think that’s terrific.

David Harlow:  Well, Steven, thank you very much for taking the time.  This is David Harlow at HealthBlawg and I have been speaking with Steven Lash, President and CEO of Satori World Medical. Thanks again Steven.

January 01, 2009

No ambulance diversion rule takes effect in Massachusetts

Massachusetts' no diversion rule took effect today.  This is a change long prepared for, but not likely felt immediately in area hospitals -- after all, New Year's Day is not a big day for elective surgeries and hospital discharges, and some of the key changes needed in hospitals in order to accommodate the new rule involve reworking of scheduling and workflows in these two arenas.

As it happens, I rang in the New Year with friends, including Catherine Bromberg, external communications director for the Massachusetts Hospital Association, who took some time out of her day to share MHA's member hospitals' collective experience with preparations for the new initiative with one of our local network affiliates.  Jonathan Epstein, one of the state's regional EMS directors, was also featured.  See the diversion story in text and video.  For details and links to the policy, see my earlier post on the no diversion policy and my conversation with Alasdair Conn, MD, ED chief at Mass General.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

December 15, 2008

Massachusetts Health Care Quality and Cost Council: Quality and cost transparency or veils?

One of the much-ballyhooed (and predictably delayed and diluted) innovations of the 2006 Massachusetts health care reform and universal access law is the development of an online resource providing cost and quality data in a consumer-friendly format.  MyHealthCareOptions debuted last week (see HCQCC press release).  After taking it for a spin, I must express my disappointment with the current state of affairs.

The site does not provide very much meaningful data.  For example, hospitals' differing rankings on quality of care are mostly undercut by notes saying that the differences are not statistically significant.  In other cases, both cost and quality data are unavailable.  In any event, cost data are not given in dollars but in ranges ($, $$, $$$, etc.), and quality data is given in the form of star ratings, as a result of the long negotiations among payors, providers and the state agency, as is par for the course in this sort of cost and quality disclosure exercise.

Many of the categories of data described on the site are empty -- I hope they are placeholders for data to be provided in the near future, but I am concerned that the data will not be forthcoming.

Even if the site were more fully realized, how would it affect health care purchasing behavior?

Except for the tiny minority of patients with truly consumer-directed health care (e.g., gold-plated indemnity plans or high deductible health plans combined with health savings accounts and no network restrictions) patients go to health care providers based on referrals from their primary care providers, within networks defined by their health care insurers.  The health care insurers that had the tiny bit of data on the new website coaxed out of them have much more data available in-house, and they have been using this information for years on developing provider networks and encouraging utilization of an appropriate mix of highest-possible-quality, lowest-possible-cost providers, consistent with the demands of patients and premium payers for world-class health care in teaching hospitals and at their affiliated providers.

In sum, cost and quality transparency won't change health care purchasing behavior unless the data provided is much more robust and employers and other premium payors are in a position to demand that health care insurers change their contracting practices.  Unfortunately, I do not think that the data will be much more robust in the near term, and I do not think that any employer or health plan will be prepared to engage in development of tiered health plans, restricting access to certain groups of providers.

Cost and quality transparency will change behavior only if there is a sea change both in the quality of this data and in the impact of the health care purchasing decision on the patient's pocketbook. 

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

November 21, 2008

Patient Safety Organization regulations finally finalized

PSO regulations under the Patient Safety and Quality Improvement Act of 2005 have finally wended their way through interminable process and have made it to publication as final regulations in today's Federal Register, effective January 19, 2009.

The introductory commentary on the rule explains that it

create[s] a voluntary system through which providers [may] share sensitive information relating to patient safety events without fear of liability, which should lead to improvements in patient safety and in the quality of patient care. The [rule reflects] an approach to the implementation of the Patient Safety Act intended to ensure adequate flexibility within the bounds of the statutory provisions and to encourage providers to participate in this voluntary program. The . . . rule emphasize[s] that this program is not federally funded and will be put into operation by the providers and PSOs that wish to participate with little direct federal involvement. However, the process for certification and listing of PSOs will be implemented and overseen by the Agency for Healthcare Research and Quality (AHRQ), while compliance with the confidentiality provisions will be investigated and enforced by the Office for Civil Rights (OCR).

AHRQ explains further:

The goals of the Patient Safety Act are to encourage the expansion of voluntary, provider-driven initiatives to improve the safety of health care; to promote rapid learning about the underlying causes of risks and harms in the delivery of health care; and to share those findings widely, thus speeding the pace of improvement. The Patient Safety Act:
  • Encourages the development of Patient Safety Organizations (PSOs)—organizations that can work with clinicians and health care organizations to identify, analyze, and reduce the risks and hazards associated with patient care.
  • Fosters a culture of safety by establishing strong Federal confidentiality and privilege protections for information assembled and developed by provider organizations, physicians, and other clinicians for deliberations and analyses regarding quality and safety.
  • Accelerates the speed with which solutions can be identified for the risks and hazards associated with patient care by facilitating the aggregation of a sufficient number of events in a protected legal environment.

The integration of state peer review protections, HIPAA protections and PSO confidentiality rules will serve to close some gaps that existed in the patchwork system we have had to date.

All in all, this is a welcome step forward for the further development of evidence-based medicine, taking into account details of negative outcomes and using those outcomes as learning opportunities for the system as a whole without exposing individual providers to additional potential liabilities.  Through the improved protections, these regulatory changes will enable provider organizations to realize more fully the patient care improvement promise of EHRs as well.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

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