In the last couple of weeks there were two interesting articles in the New York Times about patient-physicians communications.

Value of Empathy
In the first  piece, Dr. Pauline Chen discusses an academic article that explored the way physicians communicate empathy to their patients who have serious and life threatening illnesses.  The conclusion of the research, (which looked at the experience of people who had lung cancer), was that physicians miss 90% of the opportunities to connect empathetically with their patients.

The researchers speculated that physicians don’t engage patients empathetically because they are concerned that this would take too much time. However, according to Dr. Chen, the researchers found that “empathy, expressed throughout the patient-doctor encounter, may actually help alleviate problems with time.”  This occured because when empathy was not acknowledged at the beginning of the visit, patients would to try to elicit that type of support from the physician, which could actually extend the time of the visit.

Patients Make a List
The second article was from Jane Brody – a wonderfully gifted health writer – who wrote about ways patients can improve their communications and interactions with clinicians.  Her list had two parts: 6 things to keep written down and bring to your doctor appointments, and 4 tips on how to interact with clinicians.  Her list of 6 things you should keep written down is a good one, and in essence [with my annotations] it is:

1. Questions for the doctor
2. Diary of symptoms
3. List of medicines, supplements and vitamins you take - with name, dosage and how frequently you take them. [Also, please tell your doctor if you are not taking the medicines as instructed for any reason, including if you are having a problem affording any of them.]
4. Your understanding of how you are supposed to be treating your medical problems [Doctors may think that because they told you something at your last visit that you both understood what they said and are following their guidance.]
5. Medical history for yourself and your immediate family
6. Your use of alcohol, tobacco and any drugs not included in #3

The other 4 items on Jane Brody’s list are also valuable:

1. “Be willing to see a physician’s assistant or nurse practitioner for routine care.”  [They will likely be able to spend more time with you on preventive and wellness care issues.]
2. Ask if the doctor uses email for non-urgent issues and questions.   [Some physicians do and some don’t – possibly because they don’t get reimbursed for communicating with patients via email or over the phone.]
3. If the doctor tells you to go to the Emergency Room because of your symptoms, don’t wait.  [Go right away.  Don’t wait for your TV show to be over, for the laundry to finish, or to put on makeup or shave.]
4. If you are told you have a life threatening condition or you need surgery, get a second opinion.

Physicians Use Lists Too
Lists are clearly good things to use so that important things are not forgotten.  People involved with critical, safety-conscious activities like flying airplanes have used lists to make sure that everything is set before takeoff and landing.  After what has probably been too long, such lists are making their way into modern medicine in a more standardized way.

Last December, Atul Gawande wrote in The New Yorker about how such lists are being used to improve the quality of care and save live (and money) in Intensive Care Units.  The first standardized and studied checklist was for putting in a central intravenous line.  The results were remarkable – lowering infection rates in lines that had been in patients for 10 day from 11% to essentially zero.  Peter Pronovost and his collaborators have since developed many other such checklists, (or protocols as they may sometimes be called), and their use has expanded to many, but still probably not most hospitals.

While these lists are clearly beneficial and valuable, like many medical advances, they are first developed and used for the most critically ill patients in hospitals.  This makes sense, because for hospitalized patients a mistake - or action not taken - can mean the difference between life and death.  And hospitals are also places where systematic changes can be implemented and the results measured.

More Use of List by Physicians
Physicians treating patients outside of hospitals often have lists too, but they are often incomplete and are certainly not standardized.  For example, the charts for most patients have problem lists, which list the individual’s medical problems.  However, it is up to the physicians to refer to them, otherwise, the only problem that may be addressed by the clinician will be the one that brought the patient to the office that day – so any needed preventive or wellness care (like an annual eye exam for someone with diabetes) might be overlooked. This is one reason why the list recommended by Jane Brody is so important.

So while physicians may have their own lists, and they know the reason why each patient has come to see them that day, they might be better served by making a list for each patient’s visit so they can make sure to cover all the things that are needed for that individual patient – and of course, that list should also include a reminder to connect empathetically to the patient.  (This is the same concept as having an agenda before any business meeting that not only lists the topics to be covered, but also states an overall objective and concludes with a wrap-up of actions to be taken – a practice I try to follow and force others to do when I’m invited to a meeting.)

Optimism for the Future
In the future, more diagnostic and treatment protocols and guidelines will be developed and configured into standardized checklists to be used in the outpatient setting.  Integrating these into electronic medical records (EMRs) – which include prioritized problem lists with links to recommended preventative exams and monitoring tests – will certainly help improve the quality of care and control the growth in costs.  Of course, this is predicated upon the development of EMRs that can provide such information in ways that are easily used by physicians and their associates.  (This too might be an area where the medical IT industry can learn from those designing airplane information systems.)

While physicians have railed in the past about guidelines and protocols forcing them to practice cookbook medicine, I hope that in the coming years they will welcome them as a way to standardize and simplify their practices so that they can actually work to individualize care for every patient, and connect empathically with them as individuals.  In decades past, that was one of the primary functions of the local doctor, and perhaps if that function again rises in prominence, the interpersonal rewards of practicing primary care medicine will help it grow in popularity with graduating medical students and residents.

It was reported yesterday that Pfizer will stop doing research and development in heart disease, anemia and osteoporosis to concentrate in other areas such as cancer, diabetes, and immunology/inflammatory diseases.

This is interesting since Pfizer has (and had) a large number of products in heart disease, including Lipitor, and pharmaceutical companies have typically continued to do research in areas where they have had products because they have established sales people who are knowledgeable about the disease area and have relationships with clinicians in those areas.  The countervailing force is that many effective medicines to treat heart conditions (like high blood pressure and high cholesterol) are available in generic forms and thus the value bar (benefit/cost ratio) that new medicines must reach to be competitive is much higher than when they competing against other non-generic medicines.

However, one common and very expensive heart condition where better medical treatments are needed is heart failure - often called congestive heart failure (CHF).  According the the National Heart Lung and Blood Institute, 5 million Americans have heart failure, and 300,000 die from it each year.  The costs for these patients are very significant: Total costs for treating heart failure in the US are estimated to be $34.8 billion in 2008, and Medicare spent $4.7 billion for hospitalizations related to CHF in 2006.

The chart below from the Centers for Disease Control and Prevention shows the rate of hospitalization (per 1000 people) for heart failure in the US by age group over the years 1979-2004 - clearly a growing problem.

 Hospitalization Rate (per 1000 people) by Age Group for Heart Failure
1979-2004

So what does this mean for better treatments for CHF? According to the pharmaceutical industry’s web site database, there are currently 35 therapies in clinical trials for heart failure or congestive heart failure - including 3 based upon stem cell therapies, 1 based upon cell transplantation, and 1 using gene therapy.  (This compares to the 105 therapies in development for cancer, and 81 for pain.)  So I guess there will continue to be new treatments developed for heart failure, just probably not by Pfizer.  But, recognizing that there are lots of medical problems and limited resources need to be prioritized, will this be OK for current and future patients with heart failure?

Companies allocate and prioritize research and development resources according to three fundamental factors:

1. Unmet Medical Need
2. Scientific Opportunities and Discoveries
3. Market Potential

It is this last one that apparently Pfizer has decided has decreased, so they will be putting their resources into other areas where the combination of all three factors looks more appealing.  As long as all the research-based biopharma companies don’t make those decisions in the same direction (i.e. into and out of the same diseases), then research resources will likely be allocated in a reasonable way to meet societal needs. In that way the needs of people with heart failure will be balanced against those with cancer, chronic pain, diabetes, neurological diseases and immune dysfunctions - which is what society and patients really should want, since people often have multiple diseases or medical problems, so they should want new and better treatments for all of them.

Addendum: The memo from Pfizer’s R&D leadership about their strategic realignment has been posted by Forbes - click here.

In talking to people about the problems with the US healthcare system, two fundamental truths have become apparent.

First, people really want the type of healthcare that is envisioned in science fiction such as Star Trek, where almost any ailment is treated with a single injection or pill, or a few waves of a healing wand. Unfortunately, medical science hasn’t accomplished that, except in a few instances – antibiotics for a bacterial infection, or perhaps relocating a dislocated finger or shoulder (and those still require weeks to heal and therapy to regain strength and mobility).

And second, the ongoing problem of healthcare literacy and communications may be getting worse as the complexity of medical treatments increases.  Literacy and communications problems impair good healthcare when patients don’t understand what their doctors are telling them, how to take their medicines, or what disease they have.  When this happens  patients have much greater difficulty properly taking care of themselves.  A few examples and data:

• The American Academy of Family Physicians has a Literacy Toolkit which they promote with the twin facts that only 50% of “patients take medications as directed,” and “nearly 90 million American adults have difficulty understanding and using health information.”
• A July 9^th ABC news story reported about an Annals of Emergency Medicine article showing that 78% of Emergency Room patients had some misunderstanding of their doctor’s instructions, but only 20% realized that they didn’t fully understand the instructions.
• More patients are misusing medicines in dangerous ways. The actor Heath Ledger’s accidental overdose was the most recent high profile example of this. And CNN reported Monday about an Archives of Internal Medicine study showing that deaths of this type have increased 700% in 20 years.

Star Trek directly addressed communications challenges in a Next Generation episode, (Darmok and Jilad at Tanagra), where the crew of the Enterprise encounters an alien race whose words are understandable, but none of it makes any sense. It turns out that the alien’s language is based upon metaphors, and since the Enterprise’s crew doesn’t understand the context for the metaphors – the mythology and stories behind the metaphors – communications is nearly impossible….. until of course Captain Picard figures it all out in 60 TV minutes.

Unfortunately clinicians and patients aren’t able to resolve communications challenges like TV characters. When clinicians use words and concepts that their patients don’t understand, patients can’t correctly follow their instructions, and end up relying on what they think they heard or understand.

A classic example of this is that many people think taking antibiotics makes them resistant to antibiotics.  While it is true that antibiotic resistance is an issue of concern, it is the bacteria that become resistant to the medicines – not the patients. But patients who believe that they will become resistant may not take the full dosages of their antibiotics, or for as long as the doctor has prescribed – inactions that can actually increase the rate of bacterial resistance and not adequately treat the patient’s infection – bad outcomes for both society and the individual.

This is just one example of how misunderstanding a disease or a treatment can produce adverse consequences. Similar misunderstandings about diseases like diabetes and high blood pressure also lead to inadequate treatments and poor outcomes. For example, many patients believe they can tell when their blood pressure is high – and only then do they take their medicine. But high blood pressure (or hypertension) is called the “silent killer” because people can’t feel high blood pressure – except sometimes when it is dangerously high.

Which brings us back to Star Trek. One of the great things about the one-dose cure is that the patient doesn’t have to understand their disease or remember to take their medicines for the treatment to be effective, so literacy and communications problems are less of an issue for quality of care.

Lessons for Healthcare Reform
The lessons here for health reform are twofold: First, producing one-shot cures will require a lot more research and development – which needs to occur at the same time as we are improving the healthcare delivery system. And second, a fundamental area for improving healthcare delivery is communications and literacy. If patients don’t understand their disease, how to take their medicines, or modify their lifestyle, etc., then that is not their fault – that is the fault of the healthcare delivery system, and we should be able to find ways to fix it because this is not a new problem.

The leadership of HHS had a tele-conference on Monday to highlight the new Medicare incentives for physicians to adopt e-prescribing systems.  What the Washington Post and Kaiser Family Foundation reported about this press briefing that wasn’t in the HHS press release was that the Acting Administrator of CMS said that the per physician cost of e-prescribing systems is about $3,000 up front, and then $80-400/month for operation and maintenance.

These numbers caught my eye, because with the incentives in the Medicare bill, the break-even point for physicians is as follows:

First, let’s assume that the per month cost is $240 (the mid-point between $80 and $400), or $2,800 per year. Since the Medicare incentives for e-prescribing are a net 2% of Medicare reimbursements, that means to break-even the physician has to have $144,000/year in Medicare reimbursements – just for the operation and maintenance costs.  Additionally if the up front costs are spread over two years ($1,500/year), that raises the break-even point another $75,000, to $219,000/year.

For some clinicians, this amount of revenues from Medicare might be low, and therefore, it would make sense to get an e-prescribing system. However, if the doctor only sees a minority of Medicare patients, then the incentives could be a penalty.  Which is exactly what Congress expects the financial effects of the e-prescribing incentives to be. According to the Congressional Budget Office, “CBO estimates that the net budgetary effect of the electronic prescribing provision will be to reduce Medicare spending by $0.2 billion over the 2008-2013 period and $2.1 billion over the 2008-2018 period.”

Of course, if other insurers were to match (or exceed) Medicare’s incentive payments for having e-prescribing systems, then obviously the break-even point for physicians would come down, since the calculations wouldn’t balance solely on Medicare revenues.  However, I’m not aware that other insurers are rushing to provide financial incentives for physicians to use e-prescribing systems.

Additional Points
There are additional important points about e-prescribing that need to be made.  First, e-prescribing can have additional costs for physicians’ offices in the form of training time and lost productivity, and unlike electronic medical records, e-prescribing itself is unlikely to improve the office’s billing accuracy and revenues.  Second, e-prescribing can certainly provide clinical benefits by reducing medical errors with better communications about individual prescriptions.  I wrote about these issues a couple of weeks ago (see “Challenges to Making E-Prescribing Increase Efficiency and Improve Quality”), but want to reinforce one point here: Going from paper to computer communications can also introduce new opportunities for medical errors – particularly if people rely on the computer generated information while they might question the legibility or accuracy of a hand-written prescription. That is, technology is great, but its appropriate role needs to be understood by the users, who also have to use it correctly for it to provide real value.

With two notable government actions in the last couple of weeks there has been significant movement towards increasing the use of e-prescribing.

DEA Proposed Rule
The Drug Enforcement Agency (DEA), proposed regulations on June 27th that would make it possible for controlled substances to be prescribed electronically. Interestingly, this was released right after a National Journal article on this topic.

The DEA’s proposed rule is very important, because while it is appropriate to place stronger safeguards on medicines that are likely to be abused (which is the criteria for being a DEA scheduled medicine), having controlled medicines prescribed by pen and paper while all other medicines are e-prescribed would be a logistical problem and obviate many of the potential benefits of e-prescribing.  And technologically, if banks and others can provide secure login systems and other security measures, I would think that e-prescribing systems could be similarly secure to make sure that unauthorized people aren’t electronically writing themselves prescriptions for thousands of narcotics pills using a legitimate doctor’s DEA number.  (See more about this in the e-quackery section below.)

Medicare Bill Contains Carrots and Sticks for E-Prescribing
The Medicare bill which passed Congress yesterday included a provision to increase the incentives for physicians to use e-prescribing technologies.  These incentives are a small percentage add-on to allowed Medicare charges for physicians who are e-prescribing starting in 2009, and a cut to payments for allowed Medicare charges starting in 2011 for physicians who are not e-prescribing.

Movement in a Good Direction
Together these actions move the US healthcare system towards greater e-prescribing, something that if done right, should increase efficiency (with lower administrative costs), and improve quality of care and patient safety by creating a better system for detecting and preventing adverse drug reactions from known drug allergies and drug-drug interactions.  The use of computerized prescription order systems for patients in hospitals has been shown to accomplish both of these improvements, but how e-prescribing will work in the outpatient world remains to be seen.

Challenges to Making E-Prescribing Increase Efficiency and Improve Quality
There are many challenges for e-prescribing in clinicians’ offices.  Like electronic medical records, they have to buy and install the systems, learn how to use them, and then keep them updated – since new prescriptions keep getting approved etc.  Because of these challenges, it is estimated that only about 6-7% of physicians’ offices are currently using e-prescribing systems.

Optimally e-prescribing systems should be an integrated part of the office’s electronic medical records system so that it could identify potential problems with drug allergies, or the need to alter dosages for patients with impaired kidney or liver function.  And at a minimum, a free standing e-prescribing system should be able to keep track of each patient’s prescriptions to flag drug-drug interactions, otherwise it may become nothing more than a sophisticated fax machine – which some could argue (but I wouldn’t) is a rudimentary form of e-prescribing.

While, e-prescribing systems should provide alerts about drug-drug interactions,  potential allergic reactions, and the need for dosing adjustments, systems that constantly flash up reminders for such things when they’re not relevant, leads users to ignore them altogether. I take a lesson about this hazard from my brother who works on designing aircraft information systems. Clearly pilots need to know certain things at the right time, but I doubt any pilot would fly better or more safely if they kept getting an alert about it being unsafe to land the airplane because the wheels were up – even with the plane at 30,000 feet.  OK – that may be a bit of an extreme example, but if the e-prescribing system doesn’t know anything about the patient, it may send similarly useless alerts and lead those using it to ignore all alerts – which could be worse than having no alerts at all, since it having them pop-up and be ignored could provide a false sense of security.

This illustrates what most people involved with healthcare reform recognize - improving the quality and efficiency of healthcare in the US requires making the systems work better since our practitioners are generally already pretty good.  But giving these good people flawed systems won’t help them, their patients (i.e. us), or our overall healthcare system.

This brings me to one last point.  How many e-prescribing systems will each clinician’s office need?  I certainly hope that every pharmacy chain/group won’t require their own version of an e-prescribing system, nor will each payer, insurer or regulator require a different electronic or paper output of the prescription information for reimbursement or quality auditing purposes.  If that becomes the case, then e-prescribing will face even greater hurdles.

Since they do good work in this area, I also want to include the eHealth Initiative’s  summary of the challenges for e-prescribing systems:

• Financial burdens – Physician practices face varying financial burdens related to e-prescribing, including covering the implementation, training and maintenance costs.
• Workflow changes and change management – Although e-prescribing efficiencies and time savings are gained in the long run, introducing e-prescribing, and electronic health records (EHRs), can be difficult, time consuming, and requires adequate planning, training, and support, particularly in the beginning.
• Continued needs for greater connectivity – The infrastructure exists for connectivity among pharmacies, physician practices, payers and pharmacy benefit managers (PBMs), but some pharmacies, payers/PBMs and mail order pharmacies are not yet connected.
• Medication history – Although e-prescribing is an improvement over relying on paper medical records and patients’ memories, the information that is available may not always be comprehensive or accurate and therefore tools to adequately reconcile medication histories from multiple sources are needed.

E-Dispensing – Bad!!  And E-Quackery – Bad Too!!!
One of the other challenges for e-prescribing may be the practical and policy interactions between physicians’ e-prescribing and internet sites that sell medicines directly to a patient without a prescription.  While e-prescribing potentially can improve efficiency and quality, e-dispensing can lead to bad fiscal and clinical outcomes from patients getting fake, adulterated or dangerous pills and potions.

Information on the worst examples of e-dispensing is in a recent report from Columbia’s National Center on Addiction and Substance Abuse (CASA).  Their recent annual report found that the number of web-sites selling controlled medicines without a prescription has decreased from the start of 2007 to the start of 2008 - from 581 to 365.  The CASA report also found, “Of those sites not requiring prescriptions, 42 percent explicitly stated that no prescription was needed, 45 percent offered an “online consultation,” and 13 percent made no mention of a prescription.”

I’m not sure if anyone knows what the total number of patients using these sites is, or the number of prescriptions they are filling, so it’s unclear if this reduction represents a real decline in the “industry,” or just its consolidation and maturation.  What CASA also found - and that I find especially worrisome - is “an emerging practice of Internet sites selling prescriptions for controlled drugs that can be filled at local pharmacies. The report also found sites selling online “medical consultations” which enable Internet users to get controlled drugs online without a proper prescription.”  I call this e-quackery, because this is physicians acting inappropriately, or non-physicians acting in the role of a physician and practicing medicine without a license by writing prescriptions.

Other notable findings from the CASA report include:

• Of the few sites that require prescriptions, half permit the prescription to be faxed, allowing significant opportunity for fraud.
• Benzodiazepines (like Xanax and Valium) continue to be the most frequently offered drugs for sale with 90 percent of sites selling them; followed by opioids (like Vicodin and OxyContin) at 57 percent of sites, and stimulants (like Ritalin and Adderall) at 27 percent of sites.
• According to DEA estimates, in 2007 eleven percent of prescriptions filled by traditional pharmacies were for controlled substances compared to 80 percent of prescriptions filled by Internet pharmacies.
• There are no controls blocking access to these sites by children and teens.

Conclusions
Just to bring things full circle – clearly e-dispensing and e-quackery are bad, so perhaps the greater use of legitimate and appropriate e-prescribing will help to clamp down on these illegal and dangerous activities.  And from a personal perspective, I can also only hope that it will reduce the ongoing flow of spam emails for on-line medicines - and the similar onslaught of spam blog comments to this blog that you never see because I delete them, but which like spam emails, just chew up time from every day.

p.s. Sorry about the long post – but this is an important and complicated topic.

Most of what I’ve read and previously written about electronic health records has been about making them work better or getting more clinicians to use them. Security of patients’ on-line data hasn’t been a major topic of concern. I’ve assumed that this was because these concerns had mostly been addressed back in the late 1990s during the development of the Health Insurance Portability and Accountability Act (HIPAA), or because those creating systems to allow medical information to be internet accessible – like those coalitions building dedicated Health Information Exchanges and companies like Microsoft, Google, and BlueCross BlueShield insurance plans – have resolved the security concerns.

Global Cyber-Security
However, I just read the cover story in the May 31st National Journal (”China’s Cyber-Militia”), which made me question these assumptions. The article doesn’t mention healthcare or electronic medical records, but it makes me very concerned because it discusses how Chinese hackers (or hackers working through computers based in China) have been responsible for serious industrial/utility computer breeches, and how government and private sector officials at the highest level are very concerned about this and the trend towards even more cyber-infiltrations.

If I had heard this third-hand I’d be inclined to dismiss it as extremist or Luddite hysterics. But the National Journal is solidly in the mainstream of responsible journalism, and even when their article cites reports from other publications (such as the New Yorker) they reinforce the point with information from other sources and direct interviews with knowledgeable insiders.

Some of the specific points in the article that made me sit up and take notice were:

The February, 2008 blackout affecting 3 million people in South Florida was probably caused by “a Chinese PLA [People’s Liberation Army] hacker attempting to map Florida Power and Light’s computer infrastructure apparently made a mistake. “The hacker was probably supposed to be mapping the system for his bosses and just got carried away and had a ‘what happens if I pull on this’ moment.” The hacker triggered a cascade effect, shutting down large portions of the Florida power grid, the security expert said. “I suspect, as the system went down, the PLA hacker said something like, ‘Oops, my bad,’ in Chinese.”

The article also discusses how the massive August 2003 blackout in the Northeastern US is believed to have been due to Chinese hackers – despite the public explanation that it was caused by overgrown trees in Ohio hitting high voltage lines.

The article even delves into how Chinese hackers are infiltrating corporate computer systems to steal company technology and business secrets, plans and strategies. For example, it includes a security expert’s story about one company’s experience of entering into face-to-face business discussions in China where “the Chinese based their starting points for negotiations on the Americans’ end points.” As Joel Brenner, the US government’s chief counterintelligence officer is quoted in the article, “If you travel abroad and are the director of research or the chief executive of a large company, you’re a target.”

Security of Online Health Records
Two potential weaknesses of utility and corporate computer systems may be because their systems are from third party vendors or were built with older architecture designed before on-line security was a concern. Because the computer systems for electronic health records and information exchanges are being built by the companies who are using them or have ongoing contracts for maintaining them – and are probably being built with newer software architectures – perhaps they are better protected.

The other reason why online health records may be more secure than utility or corporate systems is that hackers probably don’t have the financial or geopolitical incentives to break into medical record depositories. However, I can imagine situations or incentives for groups (aside from pure nihilism) that could change that – butI don’t want to speculate here and give anybody any ideas.

But if one of the great potential values of electronic medical records is having them joined together into Health Information Exchanges, and hackers are apparently able to infiltrate and wreak havoc in sophisticated computer networks, then I hope those developing EMR and HIE systems are really paying attention to security issues. If patients have concerns that their personal information is hackable, this could lead to a tremendous backlash against the use of a technology that should be very valuable for improving the quality of care and reducing the long-term growth in healthcare costs.

The FDA announced today that they have sent letters to 25 companies to stop selling fake cancer cures. That is, things that the companies claim cure cancer, but have never been tested, or approved by the FDA. The FDA has a web-site with more information about this, and a sub-page that lists 125 Fake Cancer Cures.

I know the FDA gets lots of flack for not doing enough - and not doing it fast enough - I applaud the FDA for taking this action, and encourage them to do more because I have found the advertisement and selling of these non-medicines troubling for a long time.

Cancers are serious diseases by anyones definition, and real medical science is making great strides in developing better treatments and cures, and in overall improving the lives of people living with cancer - both through traditional drugs and biologics, as well as with complementary therapies. But those profiting from selling fake medicines are selling false hope.

I would like the FDA go after more of these people who are profiting from selling fake medicines marketed as cures for other diseases and conditions - particularly ones that may be for symptoms of serious conditions. For example, every time I see the plastic-faced grinning guy on TV hawking a non-FDA approved “natural male enhancement” product, I wonder about all the men who may still be too embarrassed to talk to their physician about their erectile dysfunction problem - which unknown to them is being caused by a serious medical problem, like cancer. And of course for men who are buying this stuff who don’t have ED, then it would be nice if they could talk to their physician about therapy to address the route causes of their feelings of sexual inadequacy.

But of course, the FDA currently has insufficient resources to cover all of it’s multiple priorities - which is why Congress and the Administration are discussing how to provide more funding. Until that happens, I hope the FDA continues being vigilant and stops as many of these purveyors of false hope as they can - at least so these people don’t get the idea that because the FDA’s resources are stretched a bit thin, that the FDA won’t bother them.

Memorial Day weekend is the traditional start of summer. This weekend also brought me in touch with some other markers of time, including:

• A great celebration of life event for the passing of a friend’s father – a terrific gentle bear of a man who had faded away in recent years after more than four score years
• A double birthday party for the children of some friends – a 9 year old and a first birthday
• Senator Kennedy’s long tenure and track-record of accomplishments – which were chronicled in many news reports following his being diagnosed with a brain tumor

I was also reminded of the importance of planning over time by a recent op-ed that mentioned a national organization’s call for increasing medical school enrollment in order to avoid a future shortage of physicians. Since the time from the start of medical school to the end of clinical training is generally 7-10 years, this pipeline is similar to the process for developing drugs. Each require many years for the development process as well as for increasing output capacity – which are both limited by money and other resources (trained people, physical structures and equipment).

However, because increasing this output capacity takes time, it is important to invest in them before the need is there. Senator Kennedy has understood that for decades, as has been evident by his long support for biomedical research funding. We can only hope that it will provide substantial benefits to him in his latest fight. And if not, then the hope is that these investments will benefit the generation of the birthday celebrants from last weekend. I believe this will happen since decades ago cancer was seen as a dreaded diagnosis, but now for many patients, it is curable or manageable – just ask, John Lester, the Red Sox pitcher who went from cancer patient to pitching a no-hitter in less than 2 years. And the hope for the future is that if the family or friends of today’s nine year olds have to face cancer in several decades, they will be able to use one of their favorite words of today - “boring.” (“School is boring.” “The beach is boring.” “That’s boring.” “This is boring.”)

The promise of today’s research into cancer and other diseases is that over time, treatments will become boring. Boring is the best type of medical problem to have, because it indicates that it’s treatment is so routine, easy and palatable that both the physician and the patient have no anxiety about it.

Past research and development weren’t enough for my friend’s father – who had a terrific life and shared Senator Kennedy’s passion for sailing. Time will tell if the last few decades of research were enough to make Senator Kennedy’s treatment boring. As summertime comes and goes this year and next, here’s hoping that more and more of the medical problems we and our families see are boring. I think it is fitting that as Memorial Day 2008 passes, we recognize these events and promises of the future, and remember what has been, but also what can possibly be.

A few weeks ago I wrote about the challenges of adopting electronic medical records to provide value for different stakeholders and the entire health care system. Well, this week the Congressional Budget Office released a paper on “Evidence on the Costs and Benefits of Health Information Technology.” This paper is a reasonable review and synthesis of the literature, but it’s important to recognize that the CBO’s mission is to focus on how federal legislation can change government spending.

While the paper concludes that savings from adopting HIT are generally uncertain, it does make some supportive comments about its value. For example the paper states that “the net effect of more use of health IT would probably still be lower overall costs than would otherwise be the case.” Another perspective about the value of HIT systems in the CBO paper is that HIT systems have a fundamental role as an enabling tool for improving the performance of the health system by making it “easier to reduce health spending if other steps in the broader health care system are also taken to alter incentives to promote savings.” One specific way HIT systems do this is by promoting greater financial integration among payers and providers as they collaborative fund HIT systems because each will share in the benefit of the systems. (The paper also notes that by making more clinical information available in electronic form, HIT systems can help facilitate cost effectiveness research which can also lead to cost savings.)

In terms of Federal funding to support HIT use, the paper notes that, “Given that the returns of health IT to the providers who invest in such systems are less than the returns to society as a whole, an argument could be made that the federal government’s intervention is necessary to raise the rate of the technology’s adoption to be more in line with its total returns.” And, “Relying on private markets to act, however, would probably lead to a slower rate of adoption than if the federal government intervened.”

How then should the federal government promote greater use of HIT systems? Aside from the leading role the government has already taken is setting standards for many technical specifications of HIT systems, the CBO paper states that the three primary avenues are:

1. Mandating use of HIT system
2. Financial incentives to use HIT system
3. Grants to subsidize purchase of HIT systems
   

So while the CBO study is a good synopsis, it doesn’t really add much that is new: In looking for ways to control healthcare costs, health information systems are only one piece of the puzzle, but they are a crucial for improving the efficiency of healthcare delivery, avoiding preventable mistakes – like adverse reactions from known drug allergies– and helping people get better faster by not making them wait to be treated while tests are repeated.

What I conclude from all this is that investing in HIT systems is like encouraging preventive care and testing. Both have up front costs that produce future benefits, and both are only valuable when used appropriately. Perhaps if we relabeled HIT systems as a type of preventive health intervention, there would be more widespread public support, since everyone likes prevention - right?

What do you think?

Electronic medical records (EMRs) have been touted as one of the solutions for healthcare’s cost and quality problems. But why haven’t we seen more benefits from EMRs?

Disconnect Between Costs and Benefits
The simple answer is that there is a disconnect between those who have to pay for EMRs and those who benefit from them. For example, many (if not most) national health reform proposals call for investing billions of dollars in EMR systems claiming that EMRs will save the healthcare system lots of money. However, these savings projections hide many important factors related to the timing of any potential savings, and how different stakeholders would be affected. Three specific questions should be asked about investment for any new technology such as EMRs:

1. What are the direct and indirect costs and savings for the innovation?
2. What are the expected time-frames for each of these effects?
3. How do each of these effect different stakeholders?

For EMRs the answers to these questions are:

• There is a very large upfront costs for hardware, software, training, and converting paper records into an electronic format. Installation costs in outpatient settings have been estimated to be $40,000-50,000 per physician. In addition, clinical specialties that see patients more episodically (like surgeons), may find it easier to convert to EMRs than clinicians whose patients have chronic conditions (like diabetes) where it is important to have their long-term medical information in the EMR.
• EMRs can increase physicians’ billing revenue by enabling them to provide more accurate and complete information to payers, and thus get paid for more of the services they are actually providing and have fewer claims returned because of insufficient information. (Clinician’s increased revenues would also represent increased costs for payers.)
• EMRs ability to increase the efficiency of processing payments could reduce the staffing needs for clinicians and payers.
• EMRs can reduce the need for repeating tests when patient’s medical records cannot be found. This would result in savings for payers and patients, but might also result in lost income for the clinicians that provide those tests and related services.

The table below illustrates how each of these effects of EMRs falls into different types of costs and saving for different stakeholder groups:

Direct & Indirect Costs & Savings by Stakeholder Groups for EMR Adoption

One of the significant challenges of EMR systems is convincing people (particularly physicians and payers) that they will have real benefits that are worth the costs. Two articles have questioned the size and scope of benefits EMRs can produce: Linder et. al. in the Archives of Internal Medicine from July 2007 found that EMRs didn’t correlate with better quality indicators based upon a national survey of ambulatory care sites. The other was a April 2008 perspectives piece by Hartzband and Groopman in the New England Journal of Medicine. They noted that EMRs can “force doctors to give “standard” rather than “customized” care,” and concluded that, “We need to make this technology work for us, rather than allowing ourselves to work for it.”

Recent EMR Adoption Initiatives
Recognizing these potential pitfalls of EMRs, two recent initiatives to increase EMR use in doctors’ offices are taking different approaches – one in the State of Massachusetts and the other by Medicare:

The Massachusetts program is funded primarily by $50 million from Blue Cross and Blue Shield of Massachusetts to a non-profit third party organization (Massachusetts eHealth Collaborative) that is providing direct funding and technical assistance to three pilot areas in the state. The Massachusetts pilots are also being evaluated as they are implemented. (More about that below.)

In contrast, Medicare’s demonstration program will pay physician practices for installing EMR systems based upon the number of Medicare patient they see, and it also ties future year payments to reporting of quality information (year 2) and then being able to demonstrate actual quality improvements (years 3, 4, and 5). Medicare has called these additional requirements as “Pay for Reporting” for year 2, and “Pay for Performance” for years 3, 4, and 5.

The challenge for Medicare’s demonstrations is about money. With estimates of more than $40,000 per physicians for installation and training for a new EMR system, physicians may take a Missourian “show me” attitude – or maybe it’s more Jerry Maguire “show me the money” attitude. However, the Medicare demonstration projects are not guaranteed money and the payments are made retroactively. According to Medicare’s Acting Administrator in April:

“…the total potential payment over the five year course of the demonstration is up to $58,000 per physician, up to $290,000 per practice. And again the degree to which a practice scores on the Clinical Quality Measures and scores higher on the Office Systems Survey will determine the level of incentive that they get. Also I want to point out that, again, payments are retrospective and practices can, again, use the funds as they feel appropriate for their practice.”

Part of the reason Medicare is structuring it’s demonstration this way is because under Federal law it must be budget neutral so that the demonstration’s costs will be offset by savings to the Medicare program.

Before looking at how the value of EMRs are being evaluated, it is worth mentioning the EMR system used by the Veterans Administration’s health program. The VA’s VistA System is reported to be clinically useful , but it does not support billing which is a big problem for non-VA users. That is the primary reason why although the VistA system is free, it hasn’t been adopted by non-VA users.

Evaluating the Value of EMR Adoption
Massachusetts’ EMR initiative was started based upon the widespread belief that EMRs can produce overall clinical and economic value. However, as noted above, there have been some analytical and academic questions raised about this general premise. To demonstrate the clinical and economic effects of the EMR pilots in Massachusetts, their initiative has at least six components to evaluate the economic and clinical value by measuring both quantitative and qualitative outcomes. These are being rolled out in a logical fashion, and are summarized below:

Evaluations of Massachusetts EMR Pilot Projects

* HIE: Health Information Exchange – a system being implemented in coordination with the EMR pilots to enable physician offices to have access to all of a patients’ medical information from all clinicians within the community.
Source: Conversation with Micky Tripathi, President and CEO of Mass eHealth Collaborative, and Mass eHealth Collaborative Spring 2008 Newsletter

Conclusions: (Sorry about the very long posting)
Electronic medical records systems have the potential to improve quality and reduce costs, but there are significant barriers to their adoption by independent and small groups of physicians. The results of Massachusetts’ evaluations and the success (or “lessons learned”) of Medicare’s demonstration program will be important for guiding future Federal, State or private sector efforts to promote (or require) the use of EMRs in the US.

Any other thoughts about EMRs?