The 8th Pillar of the Patient Centered Medical Home

The Patient Centered Medical Home (PCMH) model of care is built on seven principles. Seven is a lucky number in some cultures, but if you ever tried to stand something up on seven legs, you probably know that eight is better and sturdier. The medical home is missing a pillar, and strangely enough the missing pillar is the very reason why the concept was originally proposed. The seven principles of the PCMH were jointly formulated by the primary care medical societies in 2002 to describe the characteristics of a PCMH practice, and consist of a personal physician, physician directed medical practice, whole person orientation, coordinated and/or integrated care, quality and safety, enhanced access and appropriate payment. So what are we missing?

Back in 1967, the American Academy of Pediatrics (AAP) introduced the term “medical home” realizing that fragmented and incomplete medical records are an impediment to proper care for children with chronic conditions:

"For children with chronic diseases or disabling conditions, the lack of a complete record and a ‘medical home’ is a major deterrent to adequate health supervision. Wherever the child is cared for, the question should be asked, ‘Where is the child’s medical home?’ and any pertinent information should be transmitted to that place"

The pediatric medical home was a place where a longitudinal medical record would be compiled and aggregated from all care providers a sick child may encounter along the way, and the idea was that all those other providers of care would proactively inquire about a child’s medical home, and then promptly transmit their records to that central place, so that care can be adequately supervised by the child’s medical home. Not too bad for an idea that is almost half a century old, and little has changed since. Today’s medical records are increasingly electronic in format, but still scattered across various health care delivery locations. A primary care doctor may receive consult notes from specialists, but not always, and could in some cases download hospital notes from a physician portal or request that these be faxed over. The medical record available in a primary care practice whether PCMH designated or not, is never complete, which may not be a problem for generally healthy folks, but it certainly presents difficulties for people with chronic disease.

In the spirit of the first mention of the term “medical home”, an 8th principle should be added to the joint principles endorsed by the primary care associations, to establish the PCMH as the medical records aggregator. The 2002 joint principles of the PCMH have been operationalized by a variety of State and public organizations who certify primary care practices as PCMHs. Practices must meet an extensive set of requirements in several domains, and provide supporting documentation to that effect. For example, the current recognition program from NCQA, the leading PCMH certifying body, consists of 151 factors, some mandatory, some optional, and complicated methods for calculating the level of medical homeness a practice offers to its patients. As complex as the process may be, and as difficult as some measures are, the primary care practice has full control over all current PCMH defining factors (other than payment). This is not the case for our proposed 8th principle.  

To initiate the aggregation of medical records by the medical home, someone other than the primary care doctor, must ask the AAP question, “Where is the child’s medical home?”, and then proceed with information transmittal to that place. It is up to specialty clinics, hospitals, nursing homes and other facilities of care to initiate this aggregation. Obviously the PCMH must be able to receive, process and meaningfully aggregate the received information, and in return, make it available to all those other facilities as needed, and to patients at all times. Just like achieving current PCMH recognition does not require that you absolutely must have Electronic Health Records (EHR) software, meeting the 8th principle is entirely possible with nothing more than paper charts and a fax machine, although an EHR would make the process a lot easier for all involved.

So how would we go about adding a medical records home to the plain medical home? We could add half a dozen, or so, factors to be met to the existing NCQA standards and guidelines, while assuming that primary care practices have the necessary clout to force specialists and hospitals to push information back to the medical home on a consistent basis. Alternatively, we could just rely on the kindness of the “medical neighborhood” (a fairly new concept outlining how all providers should help PCMH practices) and hope for the best. Or, we could use the one giant lever at our disposal, which is being used for a variety of other purposes, and gradually add some measures to Meaningful Use.

Specialists have been complaining (and rightfully so) for almost two years that the Meaningful Use program was defined with primary care in mind. Here is an opportunity to add a specialty specific measure that will require all specialists to promptly transmit complete consult notes back to the referring primary care doctor. Hospitals should send ED summaries, admission notes, op-notes, discharge notes and instructions. And let’s make this achievable with large thresholds, by allowing fax, electronic fax, secure email (like Direct) or whatever the sender can use to send. We have plenty of time to insist on structured messages as the infrastructure for information exchange matures. The countermeasure for primary care docs would be the ability to incorporate the information into the electronic chart by scanning it in, receiving it electronically directly into the EHR and attaching it to the patient chart manually or automatically, or by any means necessary. Since most EHR products are capable of electronic faxing or secure email or both, the development effort for EHR vendors should be minimal. And I cannot imagine any doctor or hospital arguing that this measure imposes undue administrative burden, because this goes directly and unequivocally to better patient care.

This proposal wouldn’t be complete without addressing the small, but very energetic, minority of self-described patient advocates, who due to life changing events of their own, or because of other interests, are demanding that the mighty Meaningful Use lever be used to extract data from all medical facilities and transmit it in computable format to commercial medical records aggregators. The assumption being that “adequate health supervision” is most adequately performed by the patient and a myriad of completely free and exquisitely sophisticated tools to be defined later. There is no contradiction here, folks. If the patient prefers to have a separate medical records home, for one reason or another, by all means, let everybody transmit information to wherever the patient desires. If the patient doesn’t want anything transmitted, that’s fine too, and these “opt-out” choices would be counted as exclusions to the measure by primary care medical homes or specialists, or both. My guess would be that with all the managed and accountable care models proliferating out there, patients will be assigned to a medical home, and opt-out choices will be rare. Either way, and with the possible exception of Boston or Silicon Valley, most folks would welcome and be better served by medical records supervision delivered by real doctors and their clinical teams.

Speaking of doctors, I know that many of you consider the PCMH construct as nothing more than a burdensome layer of bureaucracy designed to bankrupt primary care. However, if you look at the seven original joint principles and the additional principle proposed here, it is impossible to argue that the essence of a “medical home” is inconsistent with good primary care, even though the processes around it may very well be. This is not much different than sitting for your medical boards, which may seem unduly bureaucratic, but do not invalidate the essence of being a physician. Furthermore, and adapting freely from Michelangelo, I would submit that the medical home is already there inside your practice and we only need to hew away the rough walls that obscure it from view, and from proper reimbursement.

Is Meaningful Use Too Successful?

Approximately a quarter million clinicians and hospitals have signed up for Meaningful Use incentives to date. Of those, almost a hundred thousand have received over $5 billion in incentives. In addition to the registered providers, there are significant numbers of practicing physicians who do not qualify for incentives, due to payor mix or practice characteristics, and who are also buying and using EHRs. Perhaps this is a bit slower than the most optimistic projections, but the entire program seems to be forging ahead rather well, and EHR adoption is steadily increasing.

The EHR incentive program is funded by taxpayer dollars to the tune of $30 billion, in the midst of a harsh recession, and is supposed to motivate our health care providers to purchase EHRs because according to the White House, the Secretary of Health and Human Services, the Centers for Medicare and Medicaid Services (CMS) and obviously the Office of the National Coordinator for Health Information Technology (ONC), EHRs are the cornerstone on which the nation will build strategies to control health care costs while improving population health and quality of care for individuals. Since health care has urgent problems that need to be resolved now, health care providers are receiving incentives to purchase software now, use it in prescribed ways now, and the bar is continuously raised until the ultimate goals are achieved. In addition to direct cash incentives to health care providers, both CMS and ONC are funding, through grant making, all sorts of other health care innovation activities, including new technologies, new care delivery models and novel payment arrangements.

One of the ONC initiatives is the Strategic Health IT Advanced Research Projects (SHARP) program aimed at development of new health information technologies. The SHARP grants, of $15 million each, were awarded over 2 years ago to several universities, with the ultimate goal to accelerate health IT adoption. The SHARP grant for “Health Care Application and Network Design” was awarded to Harvard University to “facilitate information exchange while ensuring the accuracy, privacy, and security of electronic health information”. The grantees chose to focus on developing an iPhone-like SMART platform for assembling EHRs. Not sure how this ties into network design or the accuracy, privacy and security of health information, and admittedly I have often expressed many reservations regarding the entire iPhone paradigm, both here and elsewhere, but this was 2 years ago.

This month’s issue of NEJM contains an article written by the Harvard SHARP grantees which is essentially a blistering attack on the EHR products currently on the market and those who manufacture and sell them. According to the authors, it is only a myth “that medicine requires complex, highly specialized information-technology (IT) systems”.  Since both authors are physicians, let’s assume that they are correct and medicine is as simple as they contend, in which case it is rather unclear to me why after two years and with $15 million in funding, they have not solved the problem in its entirety.

The answer is of course based on the vilification of very successful EHR vendors, since the authors “believe that EHR vendors propagate the myth that health IT is qualitatively different from industrial and consumer products in order to protect their prices and market share and block new entrants”. Although I don’t believe there is a dark EHR vendor conspiracy out there, and I don’t believe that health care has much in common with Twitter, Facebook and iTunes, I do agree that health care IT is similar to other “industrial” products, like say, banking, which maintains huge proprietary systems, based on Oracle and IBM software (very expensive) in private data centers (no Amazon clouds), and as funny as it may seem, one of the largest online brokerage firms is using the same MUMPS database as one of our largest EHR vendors, which by the way, is also used by the European project that is mapping the Milky Way galaxy. Just because something was first invented in the sixties (like the Internet), it doesn’t mean it has not changed since, and it doesn’t necessarily mean that it is now obsolete. Anyway, as it turns out, other industries cannot run multimillion dollar businesses with free iPhone apps either. Bummer.

Speaking of mythology, the article goes on to regurgitate the most common myth, asserting without citation that “[c]ommercial EHRs evolved from practice-management (i.e., billing) systems, and in response to the patient-safety movement, vendors tacked on documentation modules and order entry for physicians”. Really? Did Cerner start out as a billing system? Did Epic? What about the many smaller ambulatory EHRs, like Amazing Charts, that don’t even have a practice management module? And how about the shiny new entrants who seem to not be as blocked out as the authors imply? How about Practice Fusion and athenahealth? No, they are not built on a bits and pieces apps model, but they are new and doing rather well, I believe. One with no billing at all and the other ironically, exactly evolved from a billing system, and both regarded as great innovations.

The frustration expressed in this article is pretty common fare from folks trying to enter the EHR market only to discover that the simplicity they envisioned from the outside is nothing more than a mirage. Health IT is a cruel temptress in that way, and many have succumbed to her lures of quick riches. However, this particular article was written by people who are funded by ONC as part of a national effort to get doctors and hospitals to buy and use EHRs, and this article is titled “Escaping the EHR Trap — The Future of Health IT”. Are the authors arguing that the EHRs that ONC wants people to purchase today are a trap? Should doctors and hospitals stop their Meaningful Use efforts and wait until Harvard, if “properly nurtured” (with more taxpayer dollars, I presume), comes up with their version of EHR? Does ONC support this position?

On the ONC website, the description of the Harvard SHARP grant opens with this sentence: “Today's HIT environment is largely populated by outdated one-size-fits-most systems”. This is the same website that was purpose built to encourage health care providers to buy EHRs. Is ONC knowingly paying hospitals and doctors billions of dollars to buy “outdated” systems? I don’t think so, but I do believe that ONC should come up with some sort of response to this article, and perhaps be more careful with the contents of their website and with their grant making processes.

The Other Side of the EHR Mirror

For almost three years now, since the advent of the HITECH Act, and prompted by the exorbitant prices of health care, an animated electronic medical records debate has been unfolding on a national stage. It seems that every possible or impossible solution to our health care woes is in some shape or form dependent on widespread use of computerized medical records. Computers have been utilized to change almost every industry, making products and services cheaper, more accessible and in some instances better, so the hope is that computers can do the same for health care services. There are three fundamental ways in which computerization of an industry is advantageous: process automation, improved information processing and better communications. Arguably, we can use all three in health care.

Process automation need not be construed as referring to the processing of people, although it often is. Health care has plenty of processes that can and should be automated. The most ubiquitous automation is in the form of electronic claim submission and the respective electronic remittance advice (ERA) from payers. The vast majority of physicians are using computers for this process, but even the most advanced practices still have billers in the back office eyeballing most outgoing claims and overseeing the electronic posting of payments. Not to mention the ever increasing burden of patient collections, or the sometimes automated process of checking eligibility for services, or the rarely automated process of verifying status of deductibles. Referrals and pre-authorizations are another labor intensive and time consuming set of processes that can and should be automated. Transitioning these largely administrative chores to the computer requires that rules and regulations are standardized in deference to physicians’ and patients’ judgment (nowhere on the horizon) and that computer software becomes much more reliable and “intelligent” than it currently is (slowly taking place). I’m sure you can think of other business processes than can, or may even already be automated with assistance from computers.

When it comes to automating clinical processes, current day computerized systems have precious little to offer, and perhaps that’s how it should be. Sure, many software products come with clinical decision support, order sets, template based protocols, algorithms and pathways, but none of these qualify as automation of processes, even in instances when a health system mandates adherence to protocols, because manual labor is always required and by definition, variability is certain to occur. However, bits and pieces of the larger clinical process can be and are automated, e.g. orders processing, calculations of numerical values and tracking of events. Other processes, such as transitions of care, could benefit from some automation as well (e.g. automatically sending admission/discharge information to a known primary care physician). When judiciously utilized, computer software can provide some measure of efficiency and quality assurance to the overall clinical process.

There is of course a certain overlap between those bits and pieces of clinical automation and the overarching information processing afforded by computerization. In most other industries held up as examples for what electronic health care should be, there is one basic entity that is being measured, calculated, analyzed, tabulated and displayed: dollars. Dollars across time, dollars across populations, dollars across products and services, dollars in and dollars out. The business of medicine, a.k.a. payers, is as good and as advanced in its electronic dollar information processing as any other industry, if not much better. Unfortunately, clinical information processing lacks a universal unit of measure for all things, and therefore requires much more sophisticated software, and larger efforts to collect the information to be processed. Meaningful Use and the various Quality Reporting programs are meant to facilitate and accelerate the collection of information, with the hope that sometime in the future the collected information will be of sufficient quality to enable meaningful information processing beyond what the insurance sector already does.

Industrial computer enabled communications can take two basic forms, ad-hoc and process driven, triggered by and directed to one of the following actors: customers, or personnel and machines, both of which can be internal or external to the business entity. Process driven communications, which are initiated by machines, are obviously part and parcel of process automation as discussed above. It is interesting to note that even in industries that are heavily computerized, communications to and from external entities, where a buyer/seller relationship does not exist, are either mostly manual and paper based, or very simplistic (e.g. ATM networks). And these are exactly the types of communications we are attempting to computerize in health care by means of health information exchange organizations and the Nationwide Health Information Network (NwHIN). We must realize that this is unprecedented in all those supposedly more computer savvy industries, particularly since the health information to be exchanged is very complex and to some extent “mission critical”.

Interactions of personnel with machines, i.e. use of Electronic Health Records (EHRs) by physicians and other clinical staff, has been the source of much angst and passionate debates on feasibility, merit, timing and approach, and having written thousands upon thousands of words on the subject, I will just say that when you compare health care enterprise software to other industries, ours is no worse, may very well be much better and most definitely includes many more choices than, say, banking software or supply chain software. The only difference is that the President of your bank is rarely in need of using the software, while the “president” of a medical practice must use the software all day, every day. This is where the problem is, and this where a solution is needed. Rearranging boxes and buttons on computer screens will not provide much relief.

Last, but not least, are the budding electronic communication channels between health care customers (patients) and health care industry machines. Here we take the fateful step to the other side of the EHR looking glass to see what patients see. Health care was never too terribly concerned with patients’ interactions with their medical records. Health care, although usually paid for when possible, was considered mostly an act of kindness, hence the “care” in health care. People did not “deliver” or “provide” care. Instead they “attended”, “administered”, “nursed” and generally cared for the sick, the wounded and the dying. The result was a rather unique relationship based on gratitude, fear, hope, trust, deference, commitment and all sorts of other human emotions. Examining the books was not in the realm of considerations and most patients lacked the basic abilities to do so. Over the years, health care, or rather medicine, has transformed into a profession and now it is morphing into a service business with providers and consumers. Like a bank. And everybody knows that you must keep an eye on the bookkeepers. As the preferred solution to our health care crisis is beginning to emerge, in the form of transferring more costs to consumers, so they can control expenditures by only purchasing what they can afford, it is becoming imperative to have smooth and comprehensive communications between patients and health care’s newfangled computers. Like a bank.

When EHRs started out, no special provisions were made for patients (or communications in general). Financial software started out much the same way, but since banking was always a consumer business, the advent of the Internet and now the mobile Internet, brought us very slick, very useful and very consumer friendly Portals. And health care was left behind. First very slowly, and more recently at an accelerated Meaningful Use pace, EHR vendors began providing Patient Portals, and providers began buying them and deploying them. The online services in Patient Portals range from pathetic to pretty darn good, but there is a long way to be traveled before we reach the functionality and usefulness available in the financial or retail sector. It will happen though, because just like nobody would open an account at a bank without online services, pretty soon nobody will be willing to purchase health services from a provider without a useful online presence. It will become a differentiating factor first and then it will become a given that you can get most of your health services online. Just like a bank.

The time when patient needs were overlooked by EHR vendors has long since passed, and I am expecting to see significant advances in consumer facing software in the next couple of years. Your customer should not need to go to Walmart for a telemedicine quickie, and shouldn’t need to “transfer” information to Microsoft for figuring out his health status, and shouldn’t have to download “free” apps to manage whatever ails them. You as a provider, and your now computerized health business, should be able to provide everything your customer needs (and more) on your own customer Portal, for the web, the iPhone and Android devices. And you will, because this is quickly becoming a cost of doing business. Just like a bank.

Rationing Our Finite Resources… with Our Eyes Open

Two articles published in the latest NEJM issue are devoted to “our finite resources” and the inevitability of rationing care. First Dr. Howard Brody is attempting to rephrase the issue as one of “waste avoidance” and is delving into the ethics of practicing waste avoidance which is defined as withholding non-beneficial care. Of course non beneficial is not a cut and dry label, so Dr. Brody is envisioning that “[a]n ethical system for eliminating waste will include a robust appeals process”, where “[p]hysicians, as loyal patient advocates, must invoke the process when (according to their best clinical judgment) a particular patient would benefit from an intervention even if the average patient won't”. While the sentiment is commendable, I am not clear who exactly should physicians appeal to “according to their best clinical judgment” and I am not certain where the newly empowered and engaged patient go. Or is all this empowerment and engagement talk just a cruel joke?

The second article in NEJM, which is authored by M. Gregg Bloche, M.D., J.D. and titled “Beyond the “R Word”? Medicine's New Frugality”, is arguing that it is very unlikely that we could actually cut the waste, which is estimated at 30% of costs, and even if we do, costs will continue to rise and we are just postponing the inevitable. The inevitable, in the kind doctor’s opinion, is denying beneficial care. No beating around the bush any longer. Just say it and do it. Of course, the empowered patients are nowhere to be found in this article either, although it is full of advice for politicians on how to go about stopping therapeutic advances in their tracks, because “we can't afford all the things that medicine can achieve” and “we must make painful choices between health care and other needs”. Sadly Dr. Bloche J.D. did not elaborate on his “other needs”.

But the most disturbing experience for me was reading the comments posted to both articles, mostly by physicians, and mostly supportive of the need to ration care to patients. One physician commenter in particular seemed to see rationing as “a logical corollary of our responsibilities as physicians” because physicians are citizens before they become physicians and they have duties and responsibilities to their fellow citizens which “are not superceded [sic] by the mythical primacy of the doctor-patient relationship”.
Well, if we must ration our finite resources, let’s ration them with our eyes open, as Dr. Berwick wisely stated. So here is some eye opening material for your rationing pleasure….
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Random Non-profit Hospital Quotes

“Millions of dollars have been spent transforming the hospital into a beautiful, soothing, healing environment. Artwork graces the walls and soft music fills the hallways. ……..
“Hospital food” is also out-of-the-ordinary at Fauquier Health; The Bistro on the Hill provides food options for patients and their guests. Earning a reputation of its own in Warrenton, the Bistro serves everything from brick-oven pizza to gourmet pasta, from a fresh soup and salad bar to shrimp stir-fry. Bakers keep the dessert case filled with fresh cakes and pies, cookies and tarts. Community groups frequently congregate at The Bistro, and catering for off-site events is available.” http://www.fauquierhealth.org/about-us

“A six-story pavilion is under construction on the west side of Missouri Baptist Medical Center. The patient tower is part of a major building project that also will see construction of a new Clinical Learning Institute, new entry way, parking lot and nature trails for the campus at 3015 N. Ballas Road. The West Pavilion will add 216,000 square feet to the medical center and will house the medical center's new main entrance lobby; four floors of private patient rooms for surgical patients; four new operating rooms; and a new outpatient surgery center that will connect to the hospital's current operating room suites. "Medicine has changed a lot since 1965 (when Missouri Baptist relocated to its present location), when patient rooms were smaller and they still actually had patient wards," said Jesse Arevallo, facility and campus planning director. "The new standard of care requires a larger building footprint," he said. "This project, creating state-of-the art equipment and facilities, will tremendously benefit patients and the community." The private hospital rooms will allow the medical center to find a new use for its semi-private rooms in the main part of the hospital. "So we're not actually adding beds, but replacing," Arevallo said. The West Pavilion will cost $140 million. It is slated for completion by July 2013.” http://www.stltoday.com/suburban-journals/metro/news/missouri-baptist-medical-center-to-add-six-story-patient-tower/article_7efd4ea4-fdcd-538d-abc5-cbc464d531f6.html

“Patient-centered amenities abound in the new Cancer Center facility
As patients and families enter the lobby of the Cancer Center facility, they will step into a cozy, living room-style space with fireplace, sofas, chairs and decorative carpeting. A nearby café will offer indoor and outdoor seating and a health-focused menu with fruits and vegetables from local farmers. ……  A focal point of the building is a central, five-story, light-filled atrium, which looks down on spiraling artwork filled with inspirational quotes from Duke cancer patients and friends.” http://construction.dukemedicine.org/projects 20 

Highest Paid Non-Profit Hospitals CEOs in the Midwest

1. Randall O’Donnell; Children’s Mercy Hospital and Clinics; Kansas City, Missouri: $6 million
2. Javon Bea; Mercy Health System; Janesville, Wisconsin: $4.5 million
3. James Skogsbergh; Advocate Health Care; Oak Brook, Illinois: $4 million
4. Dean Harrison; Northwestern Memorial Hospital; Chicago, Illinois: $3.4 million
5. Richard Pettingill; Allina Health System; Minneapolis, Minnesota: $3.3 million
6. Joseph Swedish; Trinity Health; Novi, Michigan: $2.7 million
7. Lowell Kruse; Heartland Regional Medical Center; St. Joseph, Missouri: $2.5 million
8. Steven Lipstein; BJC Health System; St. Louis, Missouri: $2.2 million
9. Kevin Schoeplein; OSF Healthcare System; Peoria, Illinois: $2.2 million
10. Thomas Sieber; Genesis Healthcare System; Zanesville, Ohio: $2.1 million
11. Paul Pawlak; Silver Cross Hospital; Joliet, Illinois: $2 million
12. Toby Cosgrove; Cleveland Clinic; Cleveland, Ohio: $1.9 million
13. William Petasnick; Froedtert Memorial Hospital; Milwaukee, Wisconsin: $1.9 million
14. Fred Manchur; Kettering Medical Center; Dayton, Ohio: $1.9 million
15. Patrick Magnon; Children’s Memorial Hospital; Chicago, Illinois: $1.8 million
16. Kenneth Hanover; University Hospital; Cincinnati, Ohio: $1.8 million
17. J. Luke McGuinness; Central Dupage Hospital; Winfield, Illinois: $1.8 million
18. Daniel Evans Jr.; Clarian Health Partners; Indianapolis, Indiana: $1.8 million
19. James Madera; University of Chicago Medical Center; Chicago, Illinois: $1.8 million
20. James Anderson; Cincinnati Children’s Hospital Medical Center; Cincinnati, Ohio: $1.8 million
http://medcitynews.com/2011/08/nonprofit-hospital-ceo-salaries-in-the-midwest-whos-on-top/

2009 Insurance Companies Total CEO Compensation

• Aetna, Ronald A. Williams: $18,058,162
• Coventry, Allen Wise: $17,427,789 (took over from Dale Wolf)
• WellPoint, Angela Braly: $13,108,198
• United Health, Stephen Helmsley: $8,901,916
• Cigna, David Cordoni: $6,593,921 (took over from CEO H. Edward Hanway)
• Cigna, H. Edward Hanway: $18,800,000
• Humana, Michael McCallister: 6,509,452
• Health Net, Jay Gellert: $3,643,342
http://www.healthreformwatch.com/2011/03/16/health-insurance-ceo-total-compensation-in-2009/ 

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Following Dr. Brody’s reasoning, I can certainly see some golden opportunities here for ethical waste avoidance, with a proper appeals process in place, of course. And as painful as it may be, some of the beneficial ambiance provided by fireplaces, freshly baked brioche and well-fed executives will need to be cut as well, because Dr. Bloche is largely correct and we do have other needs, which could be addressed by having corporations, whose cash flows allow for millions of dollars in real estate investments and executive compensation, pay their taxes first.

If you think that this is a liberal overreaction to a couple of academic papers, think again. In the January 2010 issue of NEJM, Dr. Brody suggested that each specialty should pick a “Top Five” list of expensive tests and treatments that should be discouraged. Today we have the ABIM Choosing Wisely campaign of exactly five “don’ts” for each specialty. What I find fascinating is that routine EKGs, for example, are discouraged twice in the ABIM lists, but places like the top ranked Mount Sinai hospital seem to think that having those routine EKGs and much more is a very good idea (if you have $6,000) and will “help you and your associates live longer, healthier lives through the highest measures of preventive care”. So is Mount Sinai with its “award-winning physicians” correct? Or is ABIM correct? Or do we advocate two standards of care based on the size of your wallet?

As to Dr. Bloche J.D., his Huffington Post bio, suggests that amongst his many degrees and honors he “was a health care advisor to President Obama’s 2008 campaign, as well as the presidential transition, and he spoke frequently for the campaign as a “surrogate.””.  Is he speaking as a “surrogate” (whatever that may be) when suggesting that we must ration beneficial care (Mount Sinai executive customers excluded, of course)?

I don’t have the answers to these questions, but the implications to non-policy makers are pretty clear. To all the ePatients, participatory patients, engaged and empowered patients out there, I would suggest that you devote as much time to budding policies as you do to obtaining access to your electronic data, because having real time visibility into how your care is being denied will provide very little comfort, even if it is supplied to you in a computable and transferable structured data format.
To all practicing doctors, if you passively allow yourselves to be represented by learned articles like the ones cited here because you are too busy seeing patients, the day will come when, in the eyes of the public,  your profession will be no different than that of an IRS auditor, including financial and social rewards. Yes, you will most likely retire by then, but this is the Medicine you are going to experience in your old age, and this is the Medicine you are bequeathing to your children and grandchildren, and this is not the Medicine that was entrusted to you by previous generations of physicians.

What’s Up Doc? Medicare Carrots and Sticks

The Patient Protection and Affordable Care Act (PPACA) of 2010 mandates that certain administrative simplifications should be made to reduce overhead costs of health care. Since administrative complexity obeys the conservation laws of physics, for every bit of complexity that is removed, a new chunk of bureaucratic complexity must be added to the system. With that in mind, CMS has created and is proposing to grow an array of financial incentives and penalties for health care providers. This collection of carrots and sticks is intended to be used as so many levers to control and fine tune the practice of medicine by encouraging adoption of health information technology, measuring processes and steering physicians to low cost treatment methods.

Since confusion is abundant, and confusion leads to anger, fear and sometimes outright panic, which in turn causes folks to dump perfectly good private practices on the first hospital that knocks on their door, I thought it would be beneficial to clarify a few things and look at the situation from an objective mathematical perspective. Below are concise descriptions of the current CMS incentives and penalties programs, and a dollar amount evaluation of their possible effect on your bottom line.

Electronic Prescribing

A bit outdated in the EHR era, the eRx incentive program began in 2009 and is due to expire in its entirety by 2015, when no bonuses and no penalties will be assessed for this initiative.
The Rules: Currently, 10 electronic prescriptions in the first half of the year will ward off the penalties for next year, and 25 electronic prescriptions during the entire year will get you the incentive next year. The prescriptions must be written for Medicare patients’ unique visits with associated E&M codes and a “qualified” electronic prescribing system must be used. Any eRx module in a certified Complete EHR will do and if you use a standalone system, make sure it states that it is “qualified” for CMS incentives.
The Numbers: The incentives are 1% this year and 0.5% in 2013. There are no incentives available after that. Incentives are calculated as a percentage of the total Medicare Physician Fee Schedule (MPFS) allowable charges for the calendar year. The penalties are -1%, -1.5%, -2% in 2012, 2013 and 2014 respectively. There are no penalties after 2014. Penalties are applied as an adjustment to ongoing MPFS payments during the penalty year. Note that you cannot receive eRx and Meaningful Use Medicare incentives in the same year. You can do so for Medicaid EHR incentives.

Physician Quality Reporting System (PQRS)

This is the successor of PQRI (the “I” was for initiative) and it started in 2010 in its current format with no proposed expiration date. It is important to keep in mind that the contents of your PQRS reports will be made public on the Physician Compare website maintained by CMS.
The Rules: You will have to report on at least three clinical quality measures, or one group of measure, for the reporting year. You may report your measures via claims, registries, EHR or a special group reporting tool. The reporting is limited to Medicare patients and although the registry option offers a 6 months reporting period, most other methods require that you report on 30% to 80% of pertinent patients for the whole year. If you choose claim reporting, make sure you don’t let charges entered close to year-end linger around, because CMS may not get them in time to calculate your incentive. Both Incentives and penalties are calculated and applied as they are for the eRx program.
The Numbers: You could have gotten a 1% incentive in 2011, but starting in 2012 and through 2014, the incentive is a constant 0.5%. There are no incentives authorized after 2014. Penalties begin in 2015 with -1.5% and continue to -2% from 2016 and beyond. There is no end date for the penalties. PQRS incentives are independent of eRx and Meaningful Use and may be combined with either one.

Maintenance of Certification (MOC)

The MOC program is only available for those who successfully report PQRS measures and is available only through the incentives phase of PQRS.
The Rules: You need to participate in a Maintenance of Certification program and complete a practice assessment more frequently than is required to qualify for or maintain board certification. Make sure that your board is indeed qualified by CMS for this program, since not all are.
The Numbers: This is a very simple program that will pay an additional 0.5% of MPFS to what you already receive for PQRS reporting. The program expires after 2014 and there are no penalties associated with it.

The EHR Incentives Program (Meaningful Use)

Saving the best for last, this is the big one and most advertised one. The Meaningful Use program started in 2011 and is projected to continue indefinitely. It has been likened to an escalator, where the requirements become more comprehensive and more complex every two or three years.
The Rules: You must buy an ONC Certified Complete EHR (or a collection of certified modules) and meet a set of required measures every calendar year. The measures are adjusted every two (or three) years, from the current Stage 1 to future Stages 2, 3 and presumably others. There are two tracks for this program, one for Medicare and one for Medicaid participants. Meaningful Use is a very comprehensive set of measures reaching into every aspect of medical practice and is inclusive of both electronic prescribing and the reporting of clinical quality measures. The EHR incentives program and the electronic prescribing program are mutually exclusive under Medicare incentives.
The Numbers: The program offers 5 years of decreasing incentives followed by incrementally increasing penalties for non-participation. The maximum incentives under the Medicare track is $44,000, plus 10% of that if you practice in a designated health professional shortage area, and $63,750 for the Medicaid track. You can join the Medicare track as late as 2014 (you will lose about half the incentive) and the Medicaid track can be started as late as 2016 with no loss of incentives. However, in 2015 penalties, in the form of adjustment to your Medicare allowed charges, will begin to apply for those not participating in either track. CMS is proposing to backdate the penalties, so they apply in 2015 to those who have not become Meaningful Users by October 1st of 2014, effectively moving up the compliance date mandated by legislation. The penalties start at -1% of MPFS in 2014 and increase by 1% every year until they reach -5% in 2019 and continue at the -5% level indefinitely.

Bottom Line

For illustration purposes, let’s say you see 10 Medicare patients every day, you work 5 days every week and 50 weeks every year in a health professional shortage area. Accounting for different E&M charges, you are looking at approximately $200,000 per year paid to you by Medicare, and clearly this is a best case scenario. Let’s further assume that the proposed reimbursement cuts and the proposed increases to primary care reimbursement balance each other out and your Medicare revenue stays flat in today’s dollars. How will the carrots and sticks affect your income?
Scenario 1: You do all that is required and are rewarded with nothing but carrots between 2011 and 2020. In addition to your claims reimbursement, you will receive from CMS $57,400 over the current decade, which is $5,740 per year or $478 per month, totaling less than 3% increase in your average Medicare reimbursement.
Scenario 2: You ignore all CMS programs and do your own thing, and stick with your decision through 2020. You will of course not get any incentives and you will lose a total of $72,000 over this decade, or an average of $7,200 per year, which is $600 per month, or the equivalent of 3.6% of your Medicare revenue over 10 years.

It is important to note that, while the incentives are temporary, the penalties are applied indefinitely, converging to 7% MPFS, or $14,000 per year in our imaginary scenario. The sticks are larger than the carrots. These numbers do not bring into account costs of opportunities lost, such as performance bonuses and additional payments per-member-per-month that are becoming available from private and public payers for special endeavors such as medical homes and other quality improvements, and require the same infrastructure be exercised in the same fashion as the Medicare incentives programs described above.

But wait, there is more: The Value Based Payment Modifier (VBPM)

If you are fortunate enough to practice in Iowa, Kansas, Missouri, or Nebraska, you are part of a preamble to a new Medicare program which proposes to add a modifier to your charges based on the ratio of cost to quality for services rendered to Medicare members. So far physicians of all specialties in the selected pilot States have received Quality and Resource Use Reports (QRURs) outlining their performance and costs based on 2010 claim submissions. The program is in its definition stage and there are no clear numbers associated with the proposed modifier, and no explanation on how such modifier would be calculated, but it seems that by far, this is going to be a much more significant stick or carrot than anything outlined above. The legislation mandates that this program goes into effect in 2015 and by 2017, most physicians paid under the MPFS will see the VBPM applied to claims they submit to Medicare. [More on the VBPM in a future post…]

CMS incentives and penalties proposed programs 2011-2020 (click to enlarge)

 These are the visible carrots and sticks. Now it’s your turn to do the math and make your decision. Note that Scenarios 1 and 2 above are the extremes. You can always jump on the wagon at a later point, with less incentive and/or less penalties. The wagon, though, is accelerating pretty quickly.

NwHIN: Government Governance of Governances

Today, the Office of the National Coordinator for Health Information Technology (ONC) has released a Request for Information (RFI) regarding the governance of a Nationwide Health Information Network (NwHIN). The document outlines ONC’s current thinking on the subject and poses 66 questions to the public. The NwHIN is the proposed vehicle by which secure and presumably trusted health information exchange is facilitated and accelerated. The NwHIN consists, or is envisioned to eventually consist, of a set of standards and policies to govern health information exchange over the Internet. It does not include the actual infrastructure for such exchange. Below is a brief summary of the RFI highlights and the obligatory commentary on the proposed governance methodology.

Highlights

The 64 page document, as its title clearly states, is focused on creating trust in the exchange of health information at a National level. To that end, ONC is proposing to define a set of policies and regulations to be adhered to by participants in information exchange as “conditions for trusted exchange” (CTE). Consistent with current direction and the funding of Health Information Exchange (HIE) organizations, ONC is envisioning a set of entities specifically built for, or specializing in, the exchange of health information. These new entities (or new services) are named Nationwide Health Information Network Validated Entities (NVEs), and very much resemble what was previously referred to as Health Internet Service Providers (HISPs) in the context of the Direct Project based exchange.

Going forward, ONC proposes to assume responsibility for “oversight of all entities and processes established as part of the governance mechanism”, including management and endorsement of CTEs, “selection and oversight processes for an accreditation body that would be responsible for accrediting organizations interested in becoming validation bodies” and “[a]uthorizing and overseeing validation bodies which would be responsible for validating that eligible entities have met adopted CTEs”. For starters, ONC proposes three types of CTEs with the understanding that many others will be added in the future. Here is an (almost) verbatim list of the proposed CTEs:

Safeguards

[S-1]: An NVE must comply with a good portion of the HIPAA regulations as if it were a covered entity.
[S-2]: An NVE must only facilitate electronic health information exchange for parties it has authenticated and authorized, either directly or indirectly.
[S-3]: An NVE must ensure that individuals are provided with a meaningful choice regarding whether their Individually Identifiable Health Information (IIHI) may be exchanged by the NVE.
[S-4]: An NVE must only exchange encrypted IIHI.
[S-5]: An NVE must make publicly available a notice of its data practices describing why IIHI is collected, how it is used, and to whom and for what reason it is disclosed.
[S-6]: An NVE must not use or disclose de-identified health information to which it has access for any commercial purpose.
[S-7]: An NVE must operate its services with high availability.
[S-8]: If an NVE assembles or aggregates health information that results in a unique set of IIHI, then it must provide individuals with electronic access to their unique set of IIHI.
[S-9]: If an NVE assembles or aggregates health information which results in a unique set of IIHI, then it must provide individuals with the right to request a correction and/or annotation to this unique set of IIHI.
[S-10]: An NVE must have the means to verify that a provider requesting an individual’s health information through a query and response model has or is in the process of establishing a treatment relationship with that individual.
Interoperability
[I-1]: An NVE must be able to facilitate secure electronic health information exchange in two circumstances: 1) when the sender and receiver are known; and 2) when the exchange occurs at the patient’s direction.
[I-2]: An NVE must follow required standards for establishing and discovering digital certificates.
[I-3]: An NVE must have the ability to verify and match the subject of a message, including the ability to locate a potential source of available information for a specific subject.
Business Practices
[BP-1]: An NVE must send and receive any planned electronic exchange message from another NVE without imposing financial preconditions on any other NVE.
[BP-2]: An NVE must provide open access to the directory services it provides to enable planned electronic exchange.
[BP-3]: An NVE must report on users and transaction volume for validated services.

Considering the broad spectrum of CTEs, the entities accredited to validate NVEs will need a very broad range of capabilities to do a proper job at validation and monitoring of exchanges. ONC allows for the possibility that NVEs may be fully or partially validated, similar to EHRs being certified as Complete or Modular, and in both cases it is assumed that NVEs will be able to publicly advertise their compliance status. All these definitions are in a proposal stage, and ONC is requesting input on pretty much the entire proposed structure. You have 30 short days to file your response.

Commentary

This is a very technical subject and, with the notable exception of those actively working in health care IT, this publication may not elicit any interest in the physician or patient population. However, there is one item in this RFI which prompted me to hurry up and write this post, because after consistently complaining for several years, my wishes have been answered in the form of the beautiful [S-6] CTE!! So here are my impressions of this lovely thought and the document that surrounds it.

The Exquisite
After what seems like an eternity, ONC officially recognizes that de-identified information can be rather easily re-identified and that those who happen to own the hardware infrastructure where people’s medical records are stored do not have an inherent right of ownership to those records. I would very much like to see ONC extend this regulation to every HIT vendor, not just those specializing in exchange of information, since if it is pertinent to NVEs, it must be also pertinent to EHRs, HIEs, ancillary software vendors and, yes, pharmacy software vendors. I am not naive enough to believe that CTE [S-6] will survive the rule making process, but for the moment, the detailed description of the dangers inherent in the wholesale of patient data is reason for celebration.

The Good
All Safeguards CTEs (with the exception of [S-9], which could cause havoc in the many places where data originated from), are proposing to put in place regulations that are beneficial to the privacy and security of patients and their medical information. The Interoperability CTEs are also very sensible and actually a bit restrained. Put together, these 12 CTEs, if complied with, should create enough trust in exchanging entities to allay the concerns of physicians and patients regarding the transfer process itself. Other concerns may persist, but it was not the intent of this RFI to address those. Releasing an RFI prior to a formal notice of proposed rulemaking (NPRM), is also a positive sign that ONC is open to considering other opinions (too bad that this is how [S-6] will be killed off). So, even if you don’t clearly see your dog in this fight, read the document (it’s very readable and informative), find your dog, and back him up.

The Bad
The Business Practice CTEs are overreaching into the world of private business. ONC is asking if NVEs should perhaps be required to be non-profit. Not a good idea, but even if they are, those entities will need to have a sustainable business model, or forever be dependent on Government grants. If their dreams of making billions from health data are to be crushed, then they must be allowed to make a living by selling services. Current hype notwithstanding, software is not free to develop and maintain in a professional and trustworthy manner. The reporting CTE [BP-3] sounds too much like big government and should not be necessary. Most vendors are incessantly advertising their number of customers and transactions, and perhaps statistics is something NVEs should be paid for to provide.

The Ugly
Bureaucracy, lots of it, expanded and extended indefinitely into the future with no end in sight.

And now we wait for the public comments to be submitted, the NPRM to be published, more public comments, the final rule to be issued, and the “governance of governances” to be established. Keeping my fingers crossed for little [S-6] to make it to the finish line….

Meaningful Use Stage 1 - Redux

Escher - Relativity, 1953

The public comments for the proposed rules for Meaningful Use Stage 2 are closing now. After reading the public submissions of several organizations, I decided not to comment, since what I wanted to say was covered by much better heeled organizations, and I am not convinced that individuals can influence government in any shape or form nowadays. Instead, I thought that this would be a good time to look back at Meaningful Use Stage 1 and see if there are any lessons to be learned, something that CMS did not deem necessary to do before moving up the escalator to Stage 2. This is a bit peculiar considering that only 5% of physicians were able to attain Meaningful Use so far, and according to a new study published in Health Affairs, less than 14% of physicians said that their EHR has all the bells and whistles necessary for Meaningful Use Stage 1. Since Meaningful Use Stage 2 is largely an amplified version of Stage 1, it may be useful to look back and identify the most troublesome aspects, prior to significantly increasing their magnitude.

Computerized Physician Order Entry (CPOE) – On the surface, asking that 30% of prescriptions be entered in the EHR seems like an almost trivial task. Where else would you enter them? A closer look reveals that there is some complexity in the definition of the denominator for this measure, and the requirement is that 30% of patients who have at least one active medication on their medication list should be prescribed at least one item using CPOE. Does this mean that the doctor must prescribe something for a third of patients seen? While this may make sense for a primary care doctor with an elderly panel, it does not make sense for other specialties, where patients have most of their medications prescribed elsewhere. And the exclusion for those who write less than 100 scripts per reporting period, which is now one full year, is not an adequate answer either. Perhaps a better measure would be to require a much higher percentage of all prescriptions written, to be entered through the CPOE module, regardless of whether the patients come in with existing meds or not. This is not an easy thing to measure though, but it could be done if EHRs were required to have the prescriber identified in the medication list.

Clinical Summaries – Probably one of the most confusing measures for both patients and physicians requires that 50% of patients be given a visit summary within 3 days of the encounter. This is reasonable and even a bit lax if you have at least 50% of patients using your patient portal. If not, and if you are actually handing out printed summaries, the measure makes little sense. First, the 3 days period is completely contrived. You either give people a summary when they walk out the door, or you don’t. How many patients do you know who will return in the next couple of days to the office to pick up their visit summary? Or how many patients would hang around the office waiting a couple of hours to get that summary? Zero. You either print the thing out before patients check out, or the patient will leave without it. Printing summaries at the end of the visit means that all components have been updated in the EHR during the visit. If you still dictate most of your note, or if you finish notes at the end of the day, or between patients, your summaries may not be accurate. The second problem with this measure is that not all patients want a summary, but Meaningful Use is not making any allowances for patient preferences. So what do people do? They either print all summaries on paper and shred the ones left behind, or print them to electronic file (to trigger the EHR count) and only generate paper if the patient wants a summary. A much more realistic measure would require that summaries be given to 100% of patients who request one during the visit and 100% of summaries are made available on the portal within 48 hours of the encounter. Click fewer boxes, kill fewer trees.

Electronic Copy of Medical Records – This most peculiar measure requires that half of all patients requesting medical records are accommodated within 4 business days. Why only half? HIPAA guarantees the right of all patients to obtain copies of their medical records. Meaningful Use requires an electronic option. If the EHR is capable of packaging a chart in electronic format, why would you only give a copy to half of the people who want it? How does CMS know who wants a copy of their records? There is a checkbox of course, and if there’s that checkbox, and if you clicked it, chances are very good that you will also click the button to generate a chart export, which should give you a perfect 100% score, which should have been a requirement to meet this measure.

Public Health Reporting – There are two public health measures to choose from in Stage 1, immunizations data and syndromic data, and only a test of capability was required, even a failed test was just fine. Should have been a slam-dunk, but it was not. Most public health entities were not ready to receive electronic data and most certified EHRs were incapable of transmitting anything in spite of being certified to that capability. I have no suggestions for how to improve these measures other than refraining from requiring nonexistent things and ensuring that EHR certification is slightly more than fee-for-rubber-stamping.

Medications Reconciliation – This action is required to occur for 50% of care transitions. Since certified EHRs are not required to provide true electronic reconciliation of two datasets and since one almost never has a structured second medication list from an outside source, the best case scenario consists of clicking on two boxes – one at the front desk, designating the visit as a “transition of care”, and one during the visit, validating that the physician (or assistant) opened the medication list page. This measure should have been postponed until the ability to measure, and the tools to actually perform reconciliation, become available.

Security Risk Review – Nobody knows what that is. It is, however, a wonderful opportunity for IT guys to relieve small practices of anything between $2,000 and $5,000, and suggest that the server should reside in a cabinet and that the virus protection software should be updated. Why is CMS getting itself involved with HIPAA and security is a mystery to me, considering that these things are under the purview of the Office of Civil Rights (OCR), which is actively pursuing the matter independently of Meaningful Use. This measure should not have existed.

Clinical Quality Measures – Much has been written about the inadequacy of the chosen quality measures for anything but primary care. Also the seemingly multiple choices of measures are largely theoretical because certified EHRs are not required to certify for all measures and users are basically stuck with whatever the EHR vendor chose to certify, whether the certified measures are applicable to the practice or not. For example, one very popular EHR only has diabetic menu measures available. If you are, say, a dermatologist, you will have to report weight management as part of the core and also dismal measures for your ongoing management of HbA1c. The other major problem with clinical quality measures is their hidden complexity and the not immediately obvious data elements required to calculate the measure and particularly the exclusion of patients from a given measure. A very interesting example of how some EHRs deal with such complexity is the new and fairly common checkbox next to any given diagnosis to mark the condition as terminal in less than 6 months, since this is an exclusion to the weight management core measure. Seriously? And this should be made available on the patient portal too? Clinical quality measures should be carefully reconsidered and dialed back to a sensible set that is truly meaningful.

Meaningful Use Stage 1 created a lot of confusion amongst providers trying in earnest to meet the measures and gobbled up scarce resources in organizations big and small. Many of the measures are being attested to with very little confidence in accuracy, definition and meaningfulness. It would have probably been a very good idea for CMS to go out there and survey its existing and potential meaningful users to seek some authentic guidance, instead of relying on professional advocates (and occasional testimony from carefully selected users), before putting in place the next theoretical step on the now famous escalator.