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15 posts categorized "Home Health"

October 14, 2014

Apple HealthKit - Epic Integration at Ochsner Health System - David Harlow Interviews Dr. Richard Milani

Apple-healthkitThe first health system to announce that it had integrated HealthKit into its Epic EHR is Ochsner Health System in Louisiana. It is a 12-hospital, 40-clinic operation with over 900 physicians. I spoke recently with Dr. Richard Milani, Ochsner's Chief Clinical Transformation Officer. He was enthusiastic about the improvements in clinical outcomes realized to date through homegrown integrations of things like Withings scales, and sees significant expanded potential using the Epic-HealthKit integration including dissemination of data to clinicians for more efficient and effective management of care and presentation of data to patients in a way that may motivate behavior change to improve health status.

Continue reading "Apple HealthKit - Epic Integration at Ochsner Health System - David Harlow Interviews Dr. Richard Milani" »

November 21, 2012

Engage With Grace

As patients, as family members, as friends, as health care providers, we have all faced end-of-life issues at one time or another, and we will face them again. And again. 

Having been through this process twice in the past year, I can only repeat that it is important to have The Talk, to help ensure that your family members' and friends' wishes about end-of-life care are clear, are documented and, as a result, are followed. If it helps to get the conversation going, use the Five Questions in the slide at the end of this post. 

Download your copies of the Massachusetts health care proxy form or other states' proxy or living will forms -- and add specific instructions about nutrition, hydration, and anything else that is important to you so that everything is crystal clear.  Having the conversation is a starting point; we all need to follow through and make sure that our loved ones' wishes are documented, placed in medical records, discussed with physicians and other caregivers, and honored.

And with that I turn it over to @engagewithgrace for #blogrally12 (the latest edition from a group of us kickstarted by Alexandra Drane, Matthew Holt and Paul Levy.) If you blog, consider copying the rest of this post, and putting it up now through the end of Thanksgiving weekend. 

- O -

One of our favorite things we ever heard Steve Jobs say is… ‘If you live each day as if it was your last, someday you'll most certainly be right.’

We love it for three reasons:

1) It reminds all of us that living with intention is one of the most important things we can do.
2) It reminds all of us that one day will be our last.
3) It’s a great example of how Steve Jobs just made most things (even things about death – even things he was quoting) sound better.

Most of us do pretty well with the living with intention part – but the dying thing? Not so much.

And maybe that doesn’t bother us so much as individuals because heck, we’re not going to die anyway!! That’s one of those things that happens to other people….

Then one day it does – happen to someone else. But it’s someone that we love. And everything about our perspective on end of life changes.

If you haven’t personally had the experience of seeing or helping a loved one navigate the incredible complexities of terminal illness, then just ask someone who has. Chances are nearly 3 out of 4 of those stories will be bad ones – involving actions and decisions that were at odds with that person’s values. And the worst part about it? Most of this mess is unintentional – no one is deliberately trying to make anyone else suffer – it’s just that few of us are taking the time to figure out our own preferences for what we’d like when our time is near, making sure those preferences are known, and appointing someone to advocate on our behalf.

Goodness, you might be wondering, just what are we getting at and why are we keeping you from stretching out on the couch preparing your belly for onslaught?

Thanksgiving is a time for gathering, for communing, and for thinking hard together with friends and family about the things that matter. Here’s the crazy thing - in the wake of one of the most intense political seasons in recent history, one of the safest topics to debate around the table this year might just be that one last taboo: end of life planning. And you know what? It’s also one of the most important.

Here’s one debate nobody wants to have – deciding on behalf of a loved one how to handle tough decisions at the end of their life. And there is no greater gift you can give your loved ones than saving them from that agony. So let’s take that off the table right now, this weekend. Know what you want at the end of your life; know the preferences of your loved ones. Print out this one slide with just these five questions on it.

Have the conversation with your family. Now. Not a year from now, not when you or a loved one are diagnosed with something, not at the bedside of a mother or a father or a sibling or a life-long partner…but NOW. Have it this Thanksgiving when you are gathered together as a family, with your loved ones. Why? Because now is when it matters. This is the conversation to have when you don’t need to have it. And, believe it or not, when it’s a hypothetical conversation – you might even find it fascinating. We find sharing almost everything else about ourselves fascinating – why not this, too? And then, one day, when the real stuff happens? You’ll be ready.

Doing end of life better is important for all of us. And the good news is that for all the squeamishness we think people have around this issue, the tide is changing, and more and more people are realizing that as a country dedicated to living with great intention – we need to apply that same sense of purpose and honor to how we die.

One day, Rosa Parks refused to move her seat on a bus in Montgomery County, Alabama. Others had before. Why was this day different? Because her story tapped into a million other stories that together sparked a revolution that changed the course of history.

Each of us has a story – it has a beginning, a middle, and an end. We work so hard to design a beautiful life – spend the time to design a beautiful end, too. Know the answers to just these five questions for yourself, and for your loved ones. Commit to advocating for each other. Then pass it on. Let’s start a revolution.

Engage with Grace.

Engage With Grace

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

September 30, 2011

Health 2.0 Fall 2011

I attended Health 2.0 in San Francisco this week, and participated in the new Health Law 2.0 pre-conference, moderating a lively panel discussion about reviews posted on listings and ratings websites, featuring attorneys and an entrepreneur.

Please take a look at the posts I've written about the conference, here at HealthBlawg, and on HealthWorks Collective:

Health 2.0 San Francisco, September 2011, "Son et Lumiere"

"This post comes to you from the Health 2.0 conference in San Francisco.  The main conference kicks off today, but it has been preceded by a week of code-a-thons and a variety of other events, including HealthCamp and the four-track pre-conference yesterday (Health Law 2.0, Patients 2.0, Doctors 2.0, Employers 2.0).  I moderated one of the Health Law 2.0 panels, and shook up some of my brothers and sisters at the bar by wearing my new Regina Holliday jacket -- I've joined the Walking Gallery.  (Follow the links, including the walking gallery back story, to learn more about who Regina is, and what this means.) ..."  (Read more on the Health 2.0 pre-conferences.)

Health 2.0 Kicks Off in San Francisco

"Todd Park, the HHS CTO, is a vigorous champion of data liberation.  He has moved the government to open its vast repositories of data (e.g. Medicare claims data) to sharing with the public to solve health care problems.  Data liberation is one of the watchwords of the participatory medicine movement, and is a goal that will be reached more easily through the proliferation of online tools that will facilitate health information exchange.  While we would hope that, in the future, this would be a core functionality of interoperable EHRs, It seems we just aren’t there yet.  Meanwhile, however, there are Health 2.0 companies ready to bridge the gap, and ensure that data from whatever source regarding an individual patient will be available to her clinicians...."  (Read even more on the Health 2.0 pre-conferences.)

Health 2.0 - Focus on High Quality, Low Cost & Connectivity

"The health care payor and provider worlds are concerned with access, cost and quality.  The federal government adds a population health gloss, and calls it the Triple Aim – better care for individuals, better health for populations, at reduced per-capita costs.  Those fundamental drivers are now having a clearer effect on the Health 2.0 ecosystem.  The demos and discussions I’ve observed thus far at this year’s conference are more consistently focused on addressing these issues than they have been in the past.  Early-stage, and more established, companies’ products are also notable in that they are focused on connectivity in a broader sense than before – whether that’s connectivity for data, so that sensors can share data with your personal tracking software, your doctor or your community, or connectivity for individuals, who can use online social tools to improve their own health status through online interactions in a number of different ways...." (Read more on Health 2.0 Day 1.) 

       Health 2.0 Conference: Data Liquidity Can Improve Care and Reduce Cost

"On the last day of Health 2.0, the key takeaway was this: data liquidity can improve health care and health status, and reduce cost.  Hey, we knew this already; the cool thing about hearing this message at Health 2.0 is that you get to hear it (1) while seeing the tools that will actually create that data liquidity that are ready for prime time, or almost ready for prime time and (2) from federal officials who are visibly excited about this stuff...." (Read more on Health 2.0 Day 2.)

In addition, please take a look at the Health 2.0 Fall 2011 vlog with David Harlow, featuring 18 mini-interviews on Health 2.0 and "data liberation" with some of your favorite Health 2.0 and ONC figures -- including Matthew Holt, Jane Sarasohn-Kahn, Farzad Mostashari and Lygeia Ricciardi -- and some new faces as well.

The conference was jam-packed, and of course there were many more worthwhile demos and presentations that I was not able to include in these brief collections of highlights.  I hope to see more of you at the next conference.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting
 

October 25, 2010

Connected Health Symposium 2010

I attended the Connected Health Symposium last week in Boston. I enjoyed many of the sessions (sometimes wished I could have attended two simultaneously, though the livetweeting helped on that front), and as usual enjoyed the hallway and exhibit floor conversations too.  As is often the case at conferences these days, I had the opportunity to meet several on-line connections in real life for the first time. 

(I will not attempt to give a comprehensive report of the symposium here; please see the livetweeting archive linked to above and other reports to get a sense of the rest of the event.)

This year's exhibit floor included a diverse mix of distance health tools.  Most striking from my perspective was the fact that most of these tools do one of two things: Enable patient-clinician videoconferencing, or upload data from in-home monitoring devices.  The best of the second category also trigger alerts resulting in emails or PHR/EHR alerts to clinicians if vital signs are out of whack, or phone calls to consumers or their caregivers if, for example, meds aren't taken on time (one company had a pill bottle with a transmitter in the cap that signals when it's opened; another had a Pyxis-like auto-dispenser, that looked like you'd need an engineer -- or a teenager -- to program it).  One tool -- Intel's -- seemed to combine most of these functions, and more, into one platform, but it's barely in beta, with only about 1,000 units out in the real world.

The speakers this year seemed to return again and again to several major themes: (1) Is any particular connected health solution scalable? (2) Who will pay for connected health, or mobile health (mHealth)? and (3) Does it work?

These issues are, of course, interconnected.  With the current ACO (Accountable Care Organization) feeding frenzy, and expectations of health reform's full implementation as background, there was a palpable sense, or hope, that all this health-tech-geeky goodness will be snapped up by the ultimate payors for health care. 

Who the ultimate payors are depends on your vision of the future.  Is it health care providers, who will be squeezed by bundled payment demos and mainstream Medicare payment changes coming down the pike under the Affordable Care Act?  Providers have an incentive to save more money than they'll be losing through payment reform under the ACA (and perhaps even the implementation of the SGR [link is to a post on the subject from over a year ago; Congress still hasn't faced the music]-- the latest "doc fix" is slated to expire after the election and fall in the laps of the lame duck Congress).  Is it health care insurers, who are being squeezed by state regulators?  Consider, for example, the recent Massachusetts experience with the Connector -- the model for state insurance exchanges -- and the governor insisting on limited rate increases, with the dispute ending up in court.  Is it premium-paying or self-insured employers?  Is it consumers, or patients?

In addition, the future of ACOs and the rest of health reform implementation is a little unssettled, to say the least.  The law has been thrown to the courts in a series of constitutional challenges, and will be thrown to a new Congress in January.  So even if an investment in some of these systems could eliminate a significant chunk of a physician practice's overhead expense, who's going to invest those up-front dollars right now?

Some of the pricey hi-tech solutions raise my perennial question as well: How many childhood vaccines could we buy with that money?  Roni Zeiger of Google Health tweeted a similar comment attributed to Bill Gates during a presentation on genome sequencing: "I'll get my genome sequenced after we cure the top 20 infectious diseases."

In short, there is recognition that some connected health tools can have a positive impact on health status of individuals and populations, but the key questions center on the cost-effectiveness of those interventions.

One speaker, B.J. Fogg, of the Standford Persuasive Technology Lab, said: "Many crummy trials beat deep thinking," encouraging folks to continue to throw stuff against the wall and see what sticks.  I would take issue with this approach.  For example, the home monitoring devices I described above only upload data to their own proprietary software.  Only one vendor (Intel) seemed to be close to designing an interoperable interface to standard PHRs.  It seems to me that this is a key feature of any such system, and the sooner the vendors adopt this thinking, the sooner they will be able to demonstrate the utility of their products and grow their markets.

On the "Does it work?" front, many speakers addressed the issue of behavior change.  All of the tools discussed at the symposium are, in essence, intended to make change in personal behaviors easier to accomplish.  While much of the behavior change discussion was laced with paternalism, it had, at its core, a remarkable patient-centered orientation.  This orientation was emphasized by a discussion on process and outcome measures of the future, to be used as a means for calculating incentive payments to health care providers.  One speaker insisted that the most useful measures will be patient-centric measures: patient satisfaction, patient compliance, etc.  The difficulty lies in reaching the point where patient and consumer behavior is being changed appropriately. 

This raises the question: How do we reach consumers?  What incentives will people resond to?  What options do we need to present to individuals, and how?

Sheena Iyengar delivered a terrific keynote on choice, making the point that in our society we have too many choices -- about everything: breakfast cereal to jam to mutual funds in our retirement plans to Medicare Part D plans.  Research shows that the optimal number of choices to lay out before human beings is 7+2, and that more choice results in no choice at all being made -- no mutual funds selected for retirement, no Medicare drug supplement plan selected to help with prescription medication costs.

Kevin Volpp, from the UPenn Leonard Davis Institute Center for Health Incentives, spoke about how we do, and can, incentivize healthy behaviors, noting that many accepted approaches are shown through research to be ineffective -- e.g., posting calorie counts on menus, CDHPs, reducing copays.  One interesting positive note: lotteries can improve compliance with healthy behaviors in a cost-effective manner.  Volpp gave a compelling example of a medication compliance study that increased compliance by giving compliant patients the chance to win money in a lottery if they took their meds.

Overall, there was consensus that the reason we don't have all the latest tech available in service of health care is that the economic model for health care in this country is broken, thanks to skewed incentives based on the fee for service model.

To me that seems to be too facile an excuse, explaining only the failure of health care providers to adopt these tools on their own initiative.  Gary Gottlieb, CEO of Partners Healthcare addressed one plenary session and emphasized that the work of the folks in the room was critical to the success of Partners -- precisely because of the cost-saving potential of the solutions at various stages of development.  This is of critical importance to Partners as it seeks to prepare for success as an ACO and, more broadly, for success in a market less willing to see things its way than in the past.

Ultimate payors have always had the incnetive to improve health care processes and outcomes, and they are getting more and more sophisticated about it.  ACO's may be the latest (provider-centric) frame for the discussion, but the (ultimate payor-centric) patient-centered medical home frame has been around for a while, and may even prove to be a key engine for ACO success.

Back to patients. The key to success in transforming health care in this country is patient engagement, so patient-centered care, delivery of information to patients, and the enabling of patient community are the goals that health care providers and their connected health vendors need to focus on.

The concluding presentation from Joe Kvedar demonstrated that patients are more likely than we may expect to prefer interacting with computers vs. people in certain circumstances.  As symposium participants struggled with the challenge of scaling their solutions, this insight provided some comfort.  In an earlier session, Adam Bosworth described his goal for Keas as broader than scaling an individual solution.  He hopes to have his company's service act as a platform for other developers' applications -- creating an ecosystem for health apps benefiting individuals and underwritten by the ultimate payors for health care (in Keas' case, employers).

Scaling, payment, utility -- several of the challenges lined up opposite the connected health community.

All in all, this year's Connected Health Symposium showed that the potential exists for (lower case) meaningful use of a whole heck of a lot of tools and toys.  The challenge is to execute on this potential.   

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

December 28, 2009

Health Reform: What's a Provider to Do?

What should health care providers be doing in anticipation of the likely passage of an historic health reform bill?  There are at least three possibilities: (1) Lament the passing of the good old days and oppose it; (2) Insist that it isn't good enough because it is lacking some key provision (tort reform; SGR replacement; robust public option); or (3) Embrace it, because incrementalism works, and prepare for what's coming down the pike.

As you may guess, I would recommend taking the third approach, which requires focused preparation for the road that lies ahead.  So, what is a provider to do?

In the future, there will be pilots, demonstrations and mainstream programs trying to do more with less: providing health insurance and health care services to more people, with effectively fewer dollars per capita.  Payors -- be they public sector or private sector -- will therefore be squeezing providers.  The House and Senate versions of the health reform bill are equally clear on this point.  Providers therefore need to be proactive in preparing themselves to provide high-quality health care services at competitive rates.Instead of simply resigning themselves to negotiating percentage discounts off of current rates of payment, all providers need to be prepared to negotiate global payments, pay for performance deals, quality incentives and more -- as some forward-thinking provider organizations have been doing for some years now.

In order to be able to negotiate these terms effectively, providers must have a good handle on their own cost structure, and must begin to work at developing broader alliances of providers so as to be better positioned for negotiations with public and private payors.

In my years of experience in working with health care providers at that moment -- the point in time when folks with otherwise disparate interests realize the tremendous value of working together effectively in order to simultaneously promote better clinical outcomes for patients and better financial outcomes for providers -- I am always heartened by the epiphanies of the providers who realize that a new approach, or a new structure, can take them beyond their historical, positional, sometimes defensive attitudes, and into a future that they are able to shape and help define.

I look forward to working with more providers and provider organizations at this critical juncture so that they can be prepared for the future that will soon be upon us, and so that they can have a hand in crafting that future.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


October 26, 2009

Connected Health Symposium 2009 Wrap-up

I attended the Connected Health Symposium last week in Boston and got a healthy dose of the past, present and future in health care connectivity, connectedness and connections.  As always, I enjoyed connecting in person with a whole host of folks I know online -- including those who know my twitter handle, @healthblawg, better than my name.

The conference was kicked off by Stuart Altman, who regaled us with tales of his days with the Nixon Administration, and made a couple of key points:

  • The health care spending crisis is cased by rising prices, not rising utilization
  • Any federal health insurance reform will cause cost-shifting to the privately insured, the states, the young
  • Therefore the key to successful reform lies in reforming the payment system as well as the delivery system; otherwise we're "trying to grow flowers in a toxic environment."
  • Value-based purchasing (P4P), gainsharing, global payments are reasonable options for payment reform
  • Incentives for providers to use home-based systems will help heal the system at large, and promote connected health, which in turn promotes quality and efficiency
(But n.b.: while remote monitoring and home care will improve quality and reduce cost overall, it is not necessarily cost-effective for every patient.)
 
The conference closed the next afternoon with the official launch of the Journal of Participatory Medicine, presented to the group by members of the editorial board, re-emphasizing the need expressed in the intervening two days of sessions for clinicians to include patients in all aspects of managing their own care.  (On this theme, see the JOPM kickoff on-line conference from earlier in the week, including e-Patient Dave's webcast How Great EHRs Empower Participatory Medicine; free registration required). 

In between these two sessions, we heard from a wide range of speakers, panelist and vendors.  I offer here an idiosyncratic sampling of some of the many overlapping sessions.  (Please see the archived tweetstream from the conference, a couple of audio recordings of panel discussions on EHRs and PHRs, and please post links to other blog posts about the conference in comments below.) 

Ed Markey, via videolink from DC, preached to the converted that the health care system needs CPR - connectivity, privacy and research (as the Center for Connected Health's Director, Joe Kvedar, tweeted, Markey has a terrific speechwriter).  Markey has been delivering, having had a hand in building the national broadband network from his seat on the telecom committee, and in beefing up HIT privacy and security in the HITECH Act.

Jim Mongan, CEO of Partners, made the poignant comment that liberty, on the one hand, and justice for all, on the other hand, may be at odds with each other, and the unsurprising comment (from his perch atop a large IDS)  that large IDS's are the way to go.

"It's the Network." Verizon's Rajeem Kapoor pitched his company's big entry into health care connectivity, noting that of 100,000 preventable errors per year in the US, 20% are due to the lack of immediate access to patient data.

A recurring theme: health care plans are designed by negotiation between payors and providers ... they need to include patients

Tom Lee, also from Partners, said that payors and providers are engaged in co-evolution, and that they need to work together or else chaos will result.  Lee also said: Global payment isn't about bending the cost curve, it's about enhancing value -- a different perspective than Altman's, but not unexpected from a large delivery system representative.  The "alternative contract" offered by Blue Cross Blue Shield of Massachusetts is a global payment contract with risk adjustments, quality bonuses, and other bells and whistles, per Andrew Dreyfus (from BCBSMA) designed to fairly compensate and avoid perverse incentives for providers.  The global payment system to be rolled out in Massachusetts over the next five years (maybe) is intended to separate insurance risk (not to be passed onto providers as it was in capitation's bad old days) and performance risk, or quality risk, which lies appropriately with the providers.

Since the current health care system is straddling the past and future, fee for service reimbursement in an age where a more holistic approach to care is recognized as preferred, Partners is paying physicians participating in a medical-home-like program a management fee to replace some of the lost FFS income.  A panel on patient incentives yielded the observations that silos within health insurance companies lead to irrational decisions: a cost to one division could yield a many-times-larger savings to another division, but the first has no incentive to incur that cost.

In a panel discussion called The Futurists, Jay Sanders of WellDoc said we need to bring the exam room to where the patient is, and to personalize medicine (i.e., normal for me is not normal for you).  Roy Schoenberg of American Well described his company's next step, plans to allow PCPs to bring specialists into the in-person patient visit; he also cited a Gartner prediction: By 2013, 25% of all health care encounters that can happen virtually, will.  We also heard about implantable wireless sensors that will be able to transmit a stream of data and household robots from Microsoft. 

In an interesting back-to-the-future answer to the question: What's the killer app? we heard this answer from Paul Williamson of Cambridge Consultants: Family-provided, wireless-enabled care.  This vision of the future was echoed later in the day by Joe Kvedar, who posited as an ideal a world in which the patient coordinates self-managed care with a clinician as coach and an employer as enabler.  A related recurring theme: The need to move to more of a team approach to care.

Some of the toys in the exhibit hall (some called it vaporware) seemed more geared to the futurists (e.g., Intel's offering, a wired home hub for communication among providers, case managers, family members and patients, now being put through its paces in a few demos), but some are ready to go now, sporting tags signifying their compliance with Continua connectivity standards (the Continua Alliance is a standards organization jump-started by Joe Ternullo, assistant director of the Center for Connected Health, who, along with director Joe Kvedar and the Center's staff, put on a terrific conference) -- and some are positively old warhorses already in widespread use, like Honeywell's offering, with interfaces for automated home monitoring and communication of data directly into interoperable EHRs or standalone software.
 
The Myca/HelloHealth presentation highlighted the robustness of the Myca platform (employee health programs -- Qualcomm was featured at length; are there others?), medical home programs for small physician practices with "fractional use" of physician extenders -- a new twist on the Vermont and South Carolina medical home pilots), PHR integration already there or on the way, lab results integration coming soon (Quest); reiterated the slow rollout of HelloHealth (12 practices so far); and demonstrated (in part via BCBS Ventures' investment in the company) that Jay Parkinson & Co. may not be able to put as much space between themselves and third-party payors as they may like.  (This issue is not limited to HelloHealth, of course; the retail clinic sector, also founded on the premise of dissociation from third-party payors, has had to retrench; and some of the speakers also pointed to insurance companies as players not to be overlooked, due to the Willie Sutton factor . . . that's where the money is.)

Linda Magno, head of demonstration projects at CMS highlighted experiences with some demos and shared the podium with a couple of physician demo sites.  Key takeway from her presentation was that payors (beyond government payors) are just not willing to pay more for improved quality.  (Putting the Medicare managed care program / fiasco in the best possible light, her comment is consistent with the dismantling of that program, which pays higher prices, theoretically in exchange for more comprehensive care, because it was costing more than traditional FFS Medicare.)

Mark Bard, of Manhattan Research, shared some of his data re: physician internet use (doubled on-line work hours in past five years, and 2/3 of docs use smartphones in their practices -- using apps 15-20 times a day), and patient use of "Health 2.0" tools (doubled to 80 million in past two years).  This demonstrates that moving health care to the cloud will not leave all providers and patients behind. 

More than one speaker concluded that we need to subsidize healthy choices as well as tax unhealthy ones (e.g., tax the Big Mac and subsidize the salad). 

John Halamka and John Glaser presented interesting personal counterpoint on the issue of changing behavior, Halamka saying he easily chose diet and exercise over putting "poison" (Lipitor) into his body, Glaser saying he went for the stent and still enjoys his hamburgers.

Other keynoters:

Nicholas Christakis (looking at obesity as a social network epidemic, using Framingham Heart Study data - see NY Times magazine treatment), offered a couple of terrific analogies: First, carbon makes coal, graphite and diamonds - the difference depends on the interconnections between carbon atoms.  Second, the form of the network yields its function: are you finding the mastodon, or killing the mastodon?  As Christakis was winding down, I tweeted: "Unanswered Q: How do we design health care interventions to leverage IRL social networks?"  The immediate, slightly tongue-in-cheek, response from @cascadia (Sherry Reynolds), tweeting from the Pacific Northwest: "Ask women with actual friends."

Jason Hwang (co-author of The Innovator's Prescription, applying principles of disruptive innovation to health care) spoke about technology as enabling decentralization in health care as in other industries, through commoditization of historically valuable and expensive expertise, and the need to replace the hospital-centric model with new types of networks.  This shift is already under way, of course.

Bottom line: Given the crushing cost of hospital-based health care services, the current and growing primary care physician shortage, and the expectation of high-quality health care services accessible to all, the Center for Connected Health is letting us all know that the road to the future is the information superhighway, paved with intelligent payment reforms -- but that the nodes in the network will always be human beings.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

September 25, 2009

HITECH Act security breach rules now effective; federales give a six-month pass. Now's the time to kick compliance efforts into high gear

Two key Son of HIPAA rules mandated by the HITECH Act are now effective.  Both the FTC and HHS have finalized their security breach notification requirements and have assured the regulated community that they have six months to get their collective houses in order.

Please take the time to peruse both the HHS Son of HIPAA security breach notification rule and the FTC Son of HIPAA security breach notification rule.  I discussed the impact of the breach notification rules and their enforcement when they were issued as "guidance" and draft regs in April at HealthCamp Boston and will be posting more information about them in the near future.

A few points to consider for now:

  • The HHS breach notification rule layers encryption standards -- how to render health information "unusable, unreadable or indecipherable" -- for data at rest, data in use and data in motion, on top of the HIPAA privacy and securty rules.
  • Encryption is not required, but a security breach with respect to non-encrypted data triggers public notice requirements (i.e., alert the media) in addition to data subject notice requirements.
  • The FTC rules widen the net, imposing HIPAA-"covered-entity"-like obligations on business associates including, e.g., PHR vendors and other non-covered-entity repositories of health information. 
  • As an aside, greater regulation of other business associates under HIPAA will be effective in February; business associates will have to implement policies and procedures similar to those now required only of covered entities.
  • Enforcement will be ratcheted up after six months.  Greater sanctions are available for regulators to impose, and the FTC is a tougher enforcer than HHS has been on the HIPAA front to date.

With all this in mind, now is the time to examine policies and procedures, update them to comply with new rules -- Son of HIPAA rules and related/overlapping FTC Red Flag Rules (effective November 1) and state data security rules -- train staff to follow the policies and procedures consistently, and communicate commitment to these standards to your various consituencies: patients, other health care providers, business partners, etc. 

The Harlow Group LLC stands ready to assist covered entities and PHR providers in assessing the regulatory landscape, conducting an audit of current policies and procedures, and moving from a gap analysis to developing a fully compliant program and staying ahead of the curve going forward.  Please be in touch to learn more about our approach.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

July 15, 2009

Red Flags Rule: The FTC piles on, because HIPAA, ARRA and overlapping state laws just weren't enough

Update 5/28/10:  Red Flags? Nah ... nothin' but blue skies.  The FTC delays implementation of the Red Flags Rule yet again, to December 31.

Update 11/3/09:  The FTC announced that implementation of the Red Flags Rule will be delayed once more, this time until June 1, 2010.  The announcement came on the heels of losing a court case to the American Bar Association -- the court ruled that the rule does not apply to lawyers -- and on the heels of a legislative attempt to bar its applicability to small health care, accounting and legal practices.  Stay tuned.  

Update 7/29/09:  The FTC announced today that implementation of the Red Flags Rule will be delayed once again, this time til November 1, 2009.  The agency promises to roll out additional information targeted at low-risk entities covered under the rule.  Thus far, nothing has changed with respect to the rule and its ultimate effect, so organizations subject to the rule should take the extra time to assess their compliance needs and implement their plans in advance of November 1.

After a couple of delays, the FTC Red Flags Rule will be effective August 1, 2009.  This rule requires "creditors" under certain "covered accounts" to maintain a heightened alertness to numerous categories of "red flags" that may indicate that the consumer who is the rightful account holder is the victim of identity theft.  If a red flag is triggered, the creditor must take steps to notify the consumer and correct any inappropriate information included the creditor's records.

As you probably already know, the FTC is extending its reach with this rule (among others) into the health care sector.  (Cf. the FTC's role in enforcing certain Son of HIPAA provisions.)  The AMA has all but dropped a draft complaint on the FTC's desk, citing assorted legal precedents in its correspondence with the FTC arguing that the Red Flags Rule should not apply to physician practices.  The FTC is unmoved -- except to the extent that it has been willing to delay the effective date twice (from November 2008 to May 2009 to August 2009).

At any rate, the August 1 effective date is around the corner, and affected health care entities need to develop and implement compliance plans now, if they haven't already.  (Even the AMA says so, and has published guidance and a sample policy for members.)

A few more general comments before stepping back and examining the language of the rule and its applicability to health care providers.

The federales are taking something of a common-sense approach here, recognizing that a compliance plan needs to be tailored to the specific entity, the nature of its "covered accounts" and its operations.  Bank of America, N.A. and Springfield Medical Associates, P.C. will have very different compliance plans, because their potential red flags and the potential risks are vastly different.

Affected health care providers need to understand that the Red Flag Rule requirements overlap with HIPAA and state privacy law requirements (and looming Son of HIPAA requirements in ARRA), but will not be satisfied by implementation of existing privacy policies and compliance plans.  Review of the intersection of existing policies and procedures with the new rule's requirements is the first order of business.

As with any other new regulatory scheme, preparing a compliance plan and putting it on the shelf won't cut it.  The rule calls for regular monitoring of the plan and issues that arise by a senior manager.  Furthermore, best practices would dictate the training of staff to deal with individual issues and, most importantly, with the affected consumers.

Even if not clearly subject to the Red Flags Rule, providers should undertake to comply, for a couple of interrelated reasons:

  • Good patient PR.  Data security is top of mind these days.  Much of the effort required under the rule should be expended anyway simply to respond to market pressures calling for improved data security.
  • Potential liability.  The creative trial attorney will seek to use the Red Flags Rule as establishing a standard of care for the stewardship of personal information.  The incensed jury will go along.  The health care provider caught in the middle between thieves and victims may be the only perceived deep pocket available.

OK, so what is a "creditor" and what is a "covered account?"

Any entity that accepts payment other than payment in full at the time of service is a creditor.  Health care providers that go the cash-on-the-barrelhead route aren't creditors; all others are creditors.

The FTC Guide defines covered accounts as follows: either

  • a consumer account you offer your customers that’s primarily for personal, family, or household purposes that involves or is designed to permit multiple payments or transactions; or
  • any other account that a financial institution or creditor offers or maintains for which there is a reasonably foreseeable risk to customers or to the safety and soundness of the financial institution or creditor from identity theft, including financial, operational, compliance, reputation, or litigation risks.” Examples include small business accounts, sole proprietorship accounts, or single transaction consumer accounts that may be vulnerable to identity theft. Unlike consumer accounts designed to permit multiple payments or transactions – they always are “covered accounts” under the Rule – other types of accounts are “covered accounts” only if the risk of identity theft is reasonably foreseeable.

Any creditor with covered accounts must have a red flags rule compliance plan in place with policies and procedures for dealing with "red flags" -- i.e., signs that personal information may have been compromised.  The World Privacy Forum suggests that the following red flags are the ones most applicable in the health care context:

• A complaint or question from a patient based on the patient’s receipt of:
   o a bill for another individual
   o a bill for a product or service that the patient denies receiving
   o a bill from a health care provider that the patient never patronized or
   o a notice of insurance benefits (or Explanation of Benefits) for health services never received.
• Records showing medical treatment that is inconsistent with a physical examination or with a medical history as reported by the patient.
• A complaint or question from a patient about the receipt of a collection notice from a bill collector.
• A patient or insurance company report that coverage for legitimate hospital stays is denied because insurance benefits have been depleted or a lifetime cap has been reached.
• A complaint or question from a patient about information added to a credit report by a health care provider or insurer.
• A dispute of a bill by a patient who claims to be the victim of any type of identity theft.
• A patient who has an insurance number but never produces an insurance card or other physical documentation of insurance.
• A notice or inquiry from an insurance fraud investigator for a private insurance company or a law enforcement agency.

If a situation is flagged, a creditor must take steps to mitigate the risk of identity theft or continued identity theft.  Again, the World Privacy Forum notes:

There need to be uniform but appropriately flexible answers to these questions:

  • What do we do when a patient claims fraud is in their files?
  • What do we do when a patient says the bills are for services she did not receive?
  • What do we do for patients and other impacted victims when we uncover a fraudulent operation?
  • When we have a real case of medical identity theft, how can we work with patients to fix the records and limit future damages?
  • What do we do when a provider has altered the patient records?
  • How do we handle police reports and requests for investigation from victims?

The answers to these questions need to viewed not just from the provider’s perspective, but also from the victim’s perspective, which can differ substantially.

There are a number of useful resources available for health care providers seeking to take stock of their situation, establish Red Flags Rule compliance policies and procedures, and undertake staff training on the subject.  For example, the FTC, the AMA and the World Privacy Forum have all released valuable guidance documents (all linked to above) that would assist any organization with coming into compliance. 

As with any effort of this sort, it is often valuable to have someone outside the organization come in to review existing policies, procedures and workflow in order to highlight potential risks and opportunities for improvement.  The HealthBlawger and members of the HealthBlawger's virtual consulting network are available to come in and assess, plan and help implement compliance strategies for organizations large and small touched by the Red Flags Rule.

Whatever the size or nature of your business, please take a moment to consider how the Red Flags Rule may apply to its operations, and how it may relate to other regulatory schemes such as HIPAA and state laws.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

March 06, 2009

David Harlow quoted in Medicare Compliance Alert on pre-employment background checks

Take some advice from the HealthBlawger in screening new employees.  Check out some specifics in the current edition of DecisionHealth's Medicare Compliance Alert, offered in point-counterpoint format with tips from my friend Bill Mandell.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

November 26, 2008

Engage With Grace

As patients, as family members, as friends, as health care providers, we have all faced end-of-life issues at one time or another, and we will face them again.  And again. 

This weekend, the "Engage With Grace" message is being broadcast virally, through a "blog rally," at a time when many people are with family and friends over the long weekend.  (Thanks to Paul Levy and Charlie Baker for getting the issue out of the blogosphere and onto page one of the Boston Globe today, too.)  The point is: we all need to have the potentially uncomfortable conversation with people close to us about what kind of treatment we would want, and they would want, if incapable of making or communicating health care decisions.  (If you really want to monopolize Thanksgiving dinner conversation, you could also start the family health history conversation being promoted by the Surgeon General.)

End-of-life decisionmaking has long been an issue of great personal and professional interest to me, and I am proud to have played a role in having out-of-hospital DNR orders recognized in Massachusetts by EMS providers, as an example. 

Download your copies of the Massachusetts health care proxy form or other states' proxy or living will forms -- and add specific instructions about nutrition, hydration, and anything else that is important to you so that everything is crystal clear.  My mom kept a stack of living will forms in the dining room when I was growing up, and was not shy about raising the issue with dinner guests and offering to witness their directives.  Having the conversation is a starting point; we all need to follow through and make sure that our loved ones' wishes are documented, placed in medical records, discussed with physicians and other caregivers, and honored. 

When I have the opportunity to speak to groups of lawyers or health care providers, I often ask for a show of hands: how many of you have health care proxies?  The percentage seems to have increased over time, but it is still not where it needs to be.  If groups that should be above average in this respect are not all raising their hands, then we clearly have a lot to do in terms of educating the general public about the need to have the sometimes difficult conversation with friends and family members.  That's what the Engage With Grace project is all about.  And with that, I turn over this post to Engage With Grace:

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We make choices throughout our lives - where we want to live, what types of activities will fill our days, with whom we spend our time. These choices are often a balance between our desires and our means, but at the end of the day, they are decisions made with intent. But when it comes to how we want to be treated at the end our lives, often we don't express our intent or tell our loved ones about it.

This has real consequences. 73% of Americans would prefer to die at home, but up to 50% die in hospital. More than 80% of Californians say their loved ones "know exactly" or have a "good idea" of what their wishes would be if they were in a persistent coma, but only 50% say they've talked to them about their preferences.  But our end of life experiences are about a lot more than statistics. They're about all of us.

So the first thing we need to do is start talking. Engage With Grace: The One Slide Project was designed with one simple goal: to help get the conversation about end of life experience started. The idea is simple: Create a tool to help get people talking. One Slide, with just five questions on it. Five questions designed to help get us talking with each other, with our loved ones, about our preferences.

And we're asking people to share this One Slide - wherever and whenever they can.at a presentation, at dinner, at their book club. Just One Slide, just five questions. Lets start a global discussion that, until now, most of us haven't had.Here is what we are asking you: Download The One Slide and share it at any opportunity - with colleagues, family, friends. Think of the slide as currency and donate just two minutes whenever you can. Commit to being able to answer these five questions about end of life experience for yourself, and for your loved ones. Then commit to helping others do the same. Get this conversation started.

Let's start a viral movement driven by the change we as individuals can effect...and the incredibly positive impact we could have collectively. Help ensure that all of us - and the people we care for - can end our lives in the same purposeful way we live them. Just One Slide, just one goal. Think of the enormous difference we can make together.

(To learn more please go to www.engagewithgrace.org. This post was written by Alexandra Drane and the Engage With Grace team)

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David Harlow
The Harlow Group LLC
Health Care Law and Consulting