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Healthcare Policy & Reform

3 Takeaways from HIMSS 2014 — Policy and Otherwise


Dan Haley, athenahealth VP of Government AffairsNow that another HIMSS conference is in the books, here are a few things that occurred to me as I wandered the vast expanse of the Orange County Convention Center (West), in no particular order:

Regulators are from Mars… My colleagues and I had a lot of conversations about regulatory oversight of health IT, both actual and possible, including talks with no small number of government officials. (For relevant background on this important issue, see this Boston Globe article and this one from VentureBeat. Or geek out and dive into this comprehensive report from the Bipartisan Policy Center). My major takeaway: Regulators are from Mars, and innovators are from Venus. When it comes to the crucially important issue of appropriate oversight of low-risk health IT, we are talking directly past each other. There are a number of reasons for this, none of which presumes nefarious intent on anyone’s part:

  • First, as reinforced during HIMSS, it is impossible to rationally discuss the possible harm of over-regulation with a regulator. The level of regulation will forever be that which the regulator deems appropriate; ergo, there can be no over-regulation. Res ipsa loquitur. The very real possibility of innovation-killing regulatory overreach is simply beyond the regulator’s ken. Doesn’t compute. No hablan.
  • Second, regulators expect the rest of us to put unreasonable stock in the purity of their intentions. They repeatedly say they have no intention of stifling innovation. To the contrary! They have no present intention to over-burden health IT with heavy-handed regulation, but they want desperately to preserve the right to change their minds (much more on this in our recent whitepaper that unpacks the primary criticisms of the PROTECT Act).

    This is great, but at a certain point intentions don’t matter. The FDA is simply ill-equipped to regulate gently, and lacks both the expertise and infrastructure to regulate software and a basic understanding of the crucially important differences between health information technology and their traditional areas of jurisdiction. Hence: the ill-advised present effort to shove the round peg of health IT in the square regulatory hole of FDA’s medical devices framework. Your friendly municipal firefighter may earnestly intend to water your houseplants, but if you invite him in to complete the task and his only tool is a fire hose you’d better hope your homeowners’ policy covers flood damage.
  • Finally, on crucially important sub-issues, regulators and innovators may as well exist in separate realities. The FDA’s Bakul Patel recently sought to quell concerns about the implications of FDA regulation of software by noting that, in 80 percent of cases, the agency “met the statutory 90-day timeframe” in 2013 for review of mobile medical apps. He intended this as reassurance! Ninety days, I have no doubt, is light speed in the context of device approval. But in the brave new world of information technology—and the obstructions it can help bypass—90 days might as well be eternity.

Orlando is not New Orleans. The logistics and vibe of last year’s HIMSS conference in New Orleans were awesome. Orlando is not New Orleans. The visitor version of Orlando is magical when you are a kid. Kids don’t attend HIMSS. If HIMMS organizers are taking votes, mine is to go back to the Big Easy.

Finally wise to the game? The bestest-best news to come out of HIMSS 2014 from a policy perspective, and maybe even an industry perspective, was the Centers for Medicare & Medicaid Services’ (CMS) dual announcement that there will be no further delays for either Meaningful Use Stage 2 or ICD-10 implementation. Despite the short-term upheaval that both deadlines will almost certainly cause for any providers (and their patients) whose vendors have fallen short of expectations, moving ahead will benefit the overall system in the long term. athenahealth’s clients understand why.

We’ve consistently argued against repeated calls for delay and lowered standards in the Meaningful Use program. And we are the only health IT service to guarantee ICD-10 readiness. Meanwhile, many other companies are expending tremendous time and money to slow down and dumb down these programs, in part because their legacy software systems are simply not up to the demands of the 21st century information economy—and because delays prolong their abilities to sell their systems and collect government subsidies. They can’t keep up? Then, clients should not be penalized for those failings.

Compared to the rest of our economy, health IT lags years behind information technology in routine use. That is unacceptable. And we won’t catch up by slowing down.

Could the CMS’s announcements illustrate that DC policymakers are finally wise to the delay-and-subsidize game? Here’s hoping. That news alone would make this trip to Orlando worthwhile.

Check out Dan Haley’s Google+ Profile. Follow @DanHaley5 on Twitter.


Healthcare Policy & Reform | Models of Care

The Challenges and Opportunities for Primary Care Physicians: An Interview with Dr. Robert Brook


Robert H. Brook, MD, ScD, is a leading pioneer in the study of health care quality. As a long-time physician leader at the RAND Corporation and UCLA’s David Geffen School of Medicine, Dr. Brook directed seminal studies on the effects of health insurance and payment on quality of care. In winning the 2005 Institute of Medicine’s Lienhard Award, given for outstanding achievement in improving health care services in the U.S., Dr. Brook was cited as “the individual who, more than any other, developed the science of measuring the quality of medical care and focused U.S. policymakers’ attention on quality-of-care issues and their implications for the nation’s health.”

I was fortunate to sit down with Dr. Brook recently. In the first part of my interview, presented below, he addresses the ways roles may shift among primary care physicians, nurse practitioners (NPs) and specialists, and speculates on the future of primary care.

A lot of ink is being spilled on how the primary care shortage is expected to worsen under coverage expansion. How do you see that issue?
The question of whether there is going to be a primary care shortage really depends on the model of primary care. Right now there are about one billion visits a year to physicians, about half of those to primary care doctors. An extraordinary number of these visits are routine physical exams, urinary tract infections, colds, and patients with metabolic syndrome (high blood pressure, cholesterol, weight problems, and diabetes).

Many people argue that all of those things could be treated by a nurse practitioner (NP) and that eventually a large number of these visits will not result in a primary care physician visit at all. About 30 randomized trials show that when nurse practitioners manage such patients, there is really no difference in terms of outcomes. So maybe nurses and NPs are the ones that need to get people to exercise or lose weight, or take their medication. These activities are really important but don’t require seven or eight years of medical training, and other providers may be able to do them as well as or better than physicians can.

Now, the other side of the coin is that many people with chronic diseases – like rheumatoid arthritis, asthma, epilepsy – are being managed by specialists and, in many cases, there is no real need for that. If you have stable epilepsy and take one drug, it’s not clear if you need to see a neurologist for follow-up visits. That is something a primary care physician could do.

If you go down the list of specialists, you’ll see a lot of them are not really working toward the full scope of what they know how to do. So the question of whether there will be a primary care physician shortage really depends on what roles PCPs, NPs, physicians’ assistants, and specialists will end up playing.

Okay, what role do you prefer PCPs play?
In my opinion, a better role for primary care doctors is making complex diagnoses and managing patients who have multiple conditions and medications. Patients also desperately need a physician to coordinate their care when they are moving between their home, the hospital and the nursing home, and across specialties for different conditions. The current coordination across settings is much less than desirable, especially for elderly people. The primary care doc should be spending time with the complex patients and situations that can’t be easily managed.

This may not be a vision shared by the leaders of primary care. However, I think there is value in moving the primary doctor away from sore throats and physicals—and even fine tuning blood pressure or diabetes—and toward more complex diagnoses and coordination. I think there is a good chance PCPs will be spending less of their time with patients who are basically well.

Do you think we actually have a PCP shortage?
At this moment, there is a big push in virtually all states to allow NPs to practice to their full license. If that comes, and with the number of people the NP and nursing schools are producing, there won’t be a shortage.

For any panel of patients, 5-10% make up most of the costs. Clearly, these are the patients for whom you would want the expertise of a well-trained PCP to help manage and coordinate and provide value. For the other 90% of patients, it is not clear to me that they need a primary care doctor.

The difference in the hourly charges of an NP and a primary care provider do not vary much and will not solve the cost problem. The real question is: Will you pay a primary care physician more because he or she can take these very complex patients and reduce the total expenditures on them by a significant amount because their care is managed better? Additionally, will PCPs take on risk for a population’s health and employ other professionals to work with them?

You’ve watched your profession undergo so much change over your career. How do you feel about these changes? How do you advise young people considering medicine?
The sad part of medicine is going to bed and telling yourself, “I could have done this better if all of the physicians and other providers worked together.” We don’t have to spend a lot more money, and we might even be able to do it less expensively, if only we can work as a team.

Technology is increasingly giving physicians more and more information about their patients. The challenge is to use it to provide better care at lower cost.

Finally, I do get angry when people who fill out tax forms or manage money, or do plenty of other things, make gazillions of dollars. A lot of doctors are really struggling in expensive cities. I don’t think that’s fair or appropriate.

But listen, even with the bad part, what can be better than helping someone that’s sick? It’s just a high. If I were a baseball player, I might say that somebody is paying me to play a game. But somebody is paying me to help people. I think going into medicine is the best thing a person can do in life.

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The second part of my interview with Dr. Brook will focus on how emerging technologies will affect the future practice of medicine. Look for it next month.

Check out Josh Gray’s Google+ Profile. Follow @JoshGray_HCIT on Twitter.


All Things EMR | Healthcare Policy & Reform

Dear Health Care Mandates, I’ve Reached My Tipping Point


Dr. Sally GinsburgAs a physician, not a day goes by without a new acronym I need to look up, a new policy I need to follow, another box I need to click or another criteria I need to meet—and this is just to keep up. While the health care picture and its various unknowns loom ever larger in the news, and health information emails overstuff my inbox, it is worth noting that in the midst of all the new legislative, corporate and regulatory initiatives are many individuals just trying to deliver good medical care to patients. It’s not enough to just have an EMR these days; you need to have a team of people capable of explaining the multitude of imperatives being slung at you from all directions that, inevitably, will show up in said EMR.

Recently, the New England Journal of Medicine (NEJM) published an article promoting the concept of the physician as financial counselor. The article suggests that physicians should take time to discuss the cost of care with their patients. Really? Shall I do this while I am examining their eyes and ears? Or, maybe when they are telling me how they learned to cut their wrists to relieve tension? I don’t think I am the only physician in the country who was a bit taken aback by that article.

Here’s another recommendation: The American Academy of Pediatrics (AAP) strongly suggests that, in addition to the mainstay pediatric questions, we need to have discussions about TV and mobile screen time, guns in the home, managing violence, bullying, postpartum depression, and the list goes on. Anything else?

Don’t get me wrong. I think all these issues are important and worth discussing. But as it turns out, the more thorough I am the further behind I get. Just asking an adolescent female about her periods takes ten minutes.

And then, of course, there is the documentation of the visit, made somewhat more dizzying by the number of entries required by Stage 2 Meaningful Use, Pay-for-Performance, Patient-Centered Medical Home status, etc. EMR vendors need to be as knowledgeable about these requirements as clinicians, and must take them into account as they build and enhance their user interface and workflow, all so that I can focus on what I do best – provide care.

I mentioned acronyms earlier, and that’s because they’re inescapable. There’s an explosion of the creation and use of acronyms littered throughout health care, for just about everything: ACO, ACA, CMS, HIE, ICD-10… it’s becoming a nightmarish tangle of letters and terms. And each acronym’s accompanying mandate adds to the volume of information we need to keep up with just to stay in practice. How are physicians to keep pace in this seemingly endless line of red tape? I don’t think we can, at least not without help anyway.

I’m looking up terms far too often these days, and I know that when I need to google a term, I am in trouble.

It goes like this: I need to understand what the PHO is telling me about the shared risk contract, how the ACA affects patient co-pays for a WCC if you bill a 25 modifier, and that the ABP needs me to complete my MOC before 2015. No kidding. It’s nuts out there.

I believe this frenetic and dynamic work life we live as physicians is taking its toll. There are more and more primary care physicians retiring—often early—and fewer and fewer medical students interested in taking their places. Even my physician friends who I view as extremely easygoing and positive are finding it increasingly difficult to keep smiling.

There is a growing disconnect between how physicians define good health care and what lawyers, politicians, and insurance executives view as “quality health care.” Most of the decision-makers have never even seen a patient or provided care, yet they can—and they do—dictate how health care is delivered. They are counting on us being overwhelmed and under-organized.

Doctors are selling out to big hospital corporations in dizzying numbers. Fewer and fewer independent groups will have the resources or the wherewithal to remain standing. This is why it is increasingly important that we make sure our EMR vendors have our backs, and become a partner in addressing our needs. After all, an EMR is where all this stuff shows up. This is a tool that actually affects my rhythms during the encounter. This is where I can sink or swim when it comes to certain mandates and demands. The EMR vendor’s role and expectations are changing just as ours are, but the key is finding the vendors that realize that.

Dr. Sally Ginsburg is an athenahealth client and a pediatrician at Pioneer Valley Pediatrics in western Massachusetts.


Healthcare Policy & Reform | mHealth

Channeling Inigo Montoya at the mHealth Summit


Dan Haley, athenahealth VP of Government AffairsThis week I had the pleasure of speaking at the 5th annual mHealth Summit, on a panel entitled, “An Industry Perspective: Impacts of FDA Oversight.” I wrote about the issue back in August, specifically about the potential Food and Drug Administration (FDA) regulation of health IT, including mHealth. Quite a bit has happened since then, including the FDA’s release of their “final” mhealth guidance, which provides every bit as much ‘regulatory certainty’ as any document bearing the header “contains nonbinding recommendations” on every single page), and last month’s filing of the SOFTWARE Act by a bipartisan group of Members of Congress interested in putting parameters in place around the FDA.

Disclaimer: athenahealth is on record as supporting the SOFTWARE Act. (Hey, even if we weren’t, you’ve gotta hand it to the drafters for their dedication to the art of the legislative acronym.)

Both the guidance and the Act came up repeatedly during our lively panel discussion. Here are some of my big takeaways:

  1. The dividing line is clear. FDA regulation of health IT is complicated, but dividing proponents and opponents is not: you either trust the FDA to exercise its near-limitless “enforcement discretion” with a deft-enough touch to both protect patients and innovators… or you don’t.

    While I am big fan of giving the benefit of the doubt in my day-to-day life, there is simply no historical support for the proposition that the FDA is capable of regulating gently. However, there is plenty of recent evidence for the opposite proposition (see, e.g., the once-thriving-now-virtually-nonexistent domestic medical device industry).

    One of my co-panelists suggested that you’d need a scalpel to carefully separate those technologies that should be regulated from those that shouldn’t be. I agree. But the FDA doesn’t work with a scalpel. It works with a sledgehammer.
  2. Regulators are from Mars, innovators are from Venus. I freely admit that I do not understand people, like at least one co-panelist, who thinks it is a *good* idea for the FDA to get more heavily involved in regulating health IT. As I see it, health IT is one of the relatively few thriving industries in our struggling economy, and a veritable wellspring of innovations that improve patient care (and even save lives) while creating relatively few legitimate risks to patient safety. Their arguments are counter-intuitive, their reasoning ahistorical, and their conclusions illogical. By the same token, I believe my co-panelist (an attorney who makes his living parsing FDA regulations) was genuinely flummoxed when he exclaimed at one point, “I just don’t understand the arguments against an FDA role here.” We sat and spoke together about a single topic for an hour, but mostly talked past each other—like we were speaking different languages, or living in different realities.
  3. Everybody talks about innovation. Read the FDA’s final mhealth guidance. Watch the FDA’s Jeffrey Shuren, MD testify before the Energy & Commerce Committee (E&C). The most oft-seen/heard word (okay, other than “the”) is “innovation.” Everyone wants to encourage/foster/spur/increase “innovation” in health IT.

    Despite the panel’s rather profound disagreements, this was a point on which we found common cause; but I’m not sure we were talking about the same thing. At that E&C hearing, as Dr. Shuren of the FDA uttered “innovation” over and over, I found myself thinking of that great Inigo Montoya line from the movie The Princess Bride: “You keep using that word. I do not think it means what you think it means.”

    There are infinite ways to foster innovation in health IT, where it’s currently flourishing—including leaving it alone. Subjecting low-risk technologies to the enormous burdens of the FDA’s medical device regulation regime isn’t high on the list.
  4. Everyone understands the implications of increased regulation. For me, this is maybe the most important takeaway. One of my summit co-panelists is a consultant who helps clients navigate the FDA approval process. Despite his obvious pecuniary interest in having an entire industry subject to that process, he seemed genuinely troubled when he quantified the “huge” up-front investment that health IT start-ups should probably make in “regulatory research and compliance” to guard against the possibility of FDA regulation.

    That point, more than any other, underscored the danger that overzealous regulation poses to innovation in health IT. Simply stated, “huge” amounts invested to comply with regulatory requirements are “huge” amounts not invested in new technologies—and “huge” barriers to entry for entrepreneurs who start out without enormous resources at their disposal.

This brought me back to that E&C hearing, where Dr. Shuren casually highlighted the implications of FDA regulation. Asked by a committee member to address fears that mHealth regulation could extend to popular mhealth devices, Dr. Shuren was unequivocal: “I don’t want anyone regulating my iPad. I like my iPad.”

Now replace Dr. Shuren’s singular opinion with that of the millions of doctors and patients who currently benefit from the use of low-risk health IT functionality, and substitute “health IT” for “iPad.” You’ll have a good encapsulation of what’s at stake in the debate over appropriate regulatory oversight of health IT.

I would love to continue this conversation and get your thoughts on my takeaways. Share your point of view on FDA’s regulation of health IT in the comments below.

Check out Dan Haley’s Google+ Profile. Follow @DanHaley5 on Twitter.


Healthcare Policy & Reform | Practice Management

My Prognosis for Health Care in 2014


“The only constant is change.”

Sure, it’s an old cliché that’s been around for about 2500 years, but it’s true. And the sentiment has never been more relevant for the health care industry than right now.

Upcoming initiatives like ICD-10 and Stage 2 Meaningful Use demand a lot from medical practices, and have driven us at athenahealth to fill 2013 with plenty of planning, education and focus on behalf of our clients. But the view even further ahead portends massive change, and has led to some hard-working speculation about what’s to come.

Beyond mandates and programs that affect everyday operations throughout health care, there are conditions in play that are changing long-time processes and expectations about how and where care is delivered, and how caregivers are compensated for delivering that care. As the Chief Operating Officer at athenahealth, it’s my responsibility to see where the industry is going, ease the enormous pressures on our clients, and determine what we must do to uphold our vision of helping make health care work as it should.

What are the major factors for us to consider in determining and understanding what’s ahead?

  • A huge increase in health care spending as the population gets older, with total spending on the way to becoming 20% of the U.S. GDP (Gross Domestic Product).
  • The $575 billion incentive known as health care reform.
  • A scramble for patient volume, marked by hospitals acquiring hospitals and physicians acquiring physicians.

Dr. Jason Hwang, acclaimed co-author of The Innovator’s Prescription: A Disruptive Solution for Healthcare, said:

“It’s not that health care is doing a poor job, it’s improving, but it just doesn’t change the way we want it to.

For that change to happen, what disruptive innovation theory tells us, is that it’s almost always a new entrant, or, in this case, many new entrants to the industry that figure out a better way of doing things.”

This Wednesday, November 20th at 12:15 p.m. ET, I’m hosting a webinar to discuss these new entrants, my health care “prognosis” for 2014, and how “a better way of doing things” can affect our shared health care future.

Hope you can all make it!

Register today for this exciting webinar event with Ed Park and learn what your practice or organization can expect from health care changes.


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