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Progress Note: So, It Turns Out Starting a Business Is Really, Really Hard…

I am not sure if my lack of blogging is a good sign or a bad one. It’s been a week and a half since I started my new practice and I finally am getting this chance to come up for air. It’s been an über hectic and very draining time, but I am happy to report that the end of the week was significantly better than the beginning.

Here are some things I am learning.

1. Starting a business is really, really hard

I did my best to make my business as simple as possible, mainly because I understand my own deficiencies when it comes to business-related activities. Of course, being in a leadership role of a practice for the past 16 years helps me understand incredibly confusing concepts like accounts receivable, budgets, paying bills, and avoiding going to jail for spending all the collections on lottery tickets and reporting it as “research.” I purposefully designed the business to require as little accounting as possible, and in general I think I accomplished that. People come in to see me, pay me by swiping their card on the nifty card-reader on my iPhone, and I email them the receipt. That’s not the hard part (aside from people touching the “skip signature” button with their hand while they are signing).

The hardest part of starting a business for me is knowing what overhead items are necessary and what are not. Building the office took a month longer than I expected and cost twice as much. Yet I signed “yes” to all of the things that added cost. Some of them were necessary, like doing the things needed to comply with ADA, compliance with electrical code, and having furniture. But where to draw the line? I want the office to send a message of “professional, yet welcoming,” which means it can’t look cheap but doesn’t look posh either. I want the office to be consistent with my logo, a door opening that says “come on in,” and “welcome.” But everything adds cost, and mounting cost is tough when delay in opening means I am earning nothing.

Everyone is willing to give advice, but most of the advice given has little foundation in my reality. People say “it will all work out,” or “you’ll do great,” reassuring me that I don’t have to fret about things. It’s as if I can sit back and relax while things “work out.” The reality is that the reason they will work out is that I will spend most of my waking hours (and some while I’m not awake) working, worrying, thinking about details, and trying to plan for a very uncertain future. Continue reading…

Is the Patient Safety Movement in Critical Condition?

These should be the best of times for the patient safety movement. After all, it was concerns over medical mistakes that launched the transformation of our delivery and payment models, from one focused on volume to one that rewards performance. The new system (currently a work-in-progress) promises to put skin in the patient safety game as never before.

Yet I’ve never been more worried about the safety movement than I am today. My fear is that we will look back on the years between 2000 and 2012 as the Golden Era of Patient Safety, which would be okay if we’d fixed all the problems. But we have not.

A little history will help illuminate my concerns. The modern patient safety movement began with the December 1999 publication of the IOM report on medical errors, which famously documented 44,000-98,000 deaths per year in the U.S. from medical mistakes, the equivalent of a large airplane crash each day. (To illustrate the contrast, we just passed the four-year mark since the last death in a U.S. commercial airline accident.) The IOM report sparked dozens of initiatives designed to improve safety: changes in accreditation standards, new educational requirements, public reporting, promotion of healthcare information technology, and more. It also spawned parallel movements focused on improving quality and patient experience.

As I walk around UCSF Medical Center today, I see an organization transformed by this new focus on improvement. In the patient safety arena, we deeply dissect 2-3 cases per month using a technique called Root Cause Analysis that I first heard about in 1999. The results of these analyses fuel “system changes” – also a foreign concept to clinicians until recently. We document and deliver care via a state-of-the-art computerized system. Our students and residents learn about QI and safety, and most complete a meaningful improvement project during their training. We no longer receive two years’ notice of a Joint Commission accreditation visit; we receive 20 minutes’ notice. While the national evidence of improvement is mixed, our experience at UCSF reassures me: we’ve seen lower infection rates, fewer falls, fewer medication errors, fewer readmissions, better-trained clinicians, and better systems. In short, we have an organization that is much better at getting better than it was a decade ago. Continue reading…

Divided Health Care Nation

Rapid change is engulfing health care across the United States, but the strategic responses of organizations to these changes are sharply divided. In the shift that has been broadly shorthanded “from volume to value,” many organizations across the country are deeply engaged in moving toward “value” by building new partnerships, affiliations, capacities and economic structures, striving to bring better health and health care to more people for less money.

At the same time, some organizations are using the chaos and fluidity of the moment to double down on the old way, aggressively seeking greater volume reimbursed at higher rates. For now, within their regions, some of these organizations appear to be “winning” at the game, building greater market share and margin and increasing their budgets. But is this in fact the wisest strategy to follow in the long run, not only for their institutions but for the good of their missions and the people they serve?

Moving toward Value

Virtually all serious attempts to answer the question, “Why do we pay so much more for health care in the United States?” have pointed to the competition for reimbursements under a commodified, insurance-supported fee-for-service system. If what you pay for is items off of a list, what you will get is lots of items, especially the more profitable ones. That’s how we end up with a system in which waste (stuff we could simply do without) is pegged by repeated studies at one-third or higher.

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Let Them Eat Cupcakes

Can the FDA ban cupcakes?

While this may seem like a silly question, the Center for Science in the Public Interest (“CSPI”) has filed a petition with the FDA urging the agency to regulate the amount of sugar (including high fructose corn syrup) in soft drinks. According to the executive director of CSPI, sugar is a “slow-acting but ruthlessly efficient bioweapon” that causes “obesity, diabetes, and heart disease.”

If soft drinks are a problem, surely cupcakes are too. A twelve-ounce can of Coca-Cola contains 39 grams of sugar. A seasonally-appropriate red velvet cupcake from Sprinkles contains 45 grams of sugar—and who can eat just one? National cupcake consumption increased 52% between 2010 and 2011, and U.S. consumers ate over 770 million cupcakes last year. Sugary soft drink consumption, on the other hand, is down 23% since 1998 and 37% since 2000.

While the FDA can’t regulate sugar as a bioweapon, it probably could regulate sugar as a food additive.

Under the Food, Drug, and Cosmetic Act, a food additive is “any substance the intended use of which results or may reasonably be expected to result—directly or indirectly—in its becoming a component or otherwise affecting the characteristics of any food.” This broad definition would include sugar. The FDA does not, however, regulate food additives that are “generally recognized as safe” (“GRAS”). Presumably the FDA considers sugar to be GRAS—for now. Continue reading…

A Kinder, Gentler Approach to Managing Health Care Risk

Health care’s purchasers crave certainty. But complexity – and therefore uncertainty – rules. Assurances are hard to come by.

The most common question asked by prospective clients of my onsite clinic/medical management firm is how much less their employee health benefits will cost if they deploy our services. They often expect that we’ll review their claims history and nail down what their health care will cost once we’re involved. Looking in the rear view mirror can inform the future, but it isn’t foolproof.

The Complexity of Health Care Risk

The challenge here is that so many different mechanisms contribute to the need for care, the ways care is accessed, the ways care is delivered, and the ways it is priced. Even mechanisms that, in isolation, are strong, often are inadequate in the context of larger cost drivers.

This means that while predicting results in general terms is straightforward, doing so with any precision or specificity is a challenge. My firm can point to consistent previous performance with other clients, and show that in most cases we generate a 15+ percent overall savings on group health expenditures, net of the clinic investment. And we can detail how our management of the process is both broader and more targeted than the management of risks before we arrived. But while we’ll sometimes guarantee certain performance targets, we also know that the cards can and will sometimes fall against us.

Continue reading…

When Patients Can Obtain Their Own EKG

With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”

While this sounds nice, how, exactly, does one become a “prescribed patient?”  Once a doctor “prescribes” such a device, what are his responsibilities?  Does this obligate the physician to 24/7/365 availability for EKG interpretations?  How are HIPAA-compliant tracings sent between doctor and patient?  How are the tracings and medical care documented in the (electronic) medical record?  What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely?

At this point, no one knows.  We are entering into new, uncharted medicolegal territory.

But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, “live” medical device.  But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.

This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them.  So I sent AliveCor’s Dr. Dave Alpert a tweet and later received this “how to” e-mail response from their support team:

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Is Interoperability Possible in HIT? And if it Is, Do We Even Want it?

Anyone who understands the importance of continuity of care knows that health information exchange is essential. How are we supposed to cut waste and duplication from the healthcare system and truly focus on patient welfare if doctor B has no idea what tests doctor A conducted, or what the results were?

The predominant proprietary HIT vendors know this, yet have engaged in prolonged foot-dragging on interoperability and even basic data interfacing. Yes healthcare IT is their business, but interoperability is not in their nature.

As we’ve seen before, the problem is with the business model.

The proprietary business model makes the vendor the single source of HIT for hospital clients. Complexity and dependence are baked into both solutions and client relationships, creating a “vendor lock” scenario in which changing systems seems almost inconceivable.

In the proprietary world, interfacing with third-party products is a revenue generation strategy and technical challenge; the latter, though unnecessary, justifies the former. When we go looking for the reasons that healthcare is a laggard compared with other industries, this single-source model—the obstacle to much-needed competition and innovation—is a primary culprit.

To be fair, provider organizations, with little if any incentive to exchange patient data before the advent of Meaningful Use, haven’t shown much collaborative spirit either. In the fee-for-service model, why would a healthcare organization let patients slip from their grasp? Health reform is finally mandating needed change, but when will proprietary vendors actually enable the interoperability hospitals and practices soon have to demonstrate?

Recent rumblings from Washington, DC, suggest the feds are losing patience.

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The Founding Fathers Write a Grant Proposal

“Just look at this second sentence!” groaned Samuel Adams. “‘We hold these truths to be self-evident . .’ This flies in the face of ‘evidence-based practice’! We’ll never get funded!”

Another delegate had a different complaint: “This mission statement is way too long!” he wailed. “Mr. Jefferson, no one will ever read this ‘Declaration of Independence’ of yours.”

In the meantime, George Washington had been working up a budget for the revolutionary war (earlier called the innovative war). His initial figures were daunting: $37 million would have to be raised by the collaborative, which would need to be matched by $114 million from the states. And of course, they didn’t have a dime (or rather, a shilling).

But let’s go back to the meeting, where they had just decided to give the collaborative a name: the Continental Congress.

Donor Prospecting

The meeting chair pounded his gavel: “Next on the agenda is Fundraising Prospects. Mr. Hancock, your report?”

John Hancock looked up, startled, but recovered his poise: “We’ve developed a list of foundations to approach. Unfortunately, none of them have giving areas that include democratic revolutions, perhaps because there hasn’t been a democratic revolution before. They also want to know who else is funding it, and how we’re going to continue the funding when their grants run out. And several of them aren’t funding right now because they’re doing something called ‘strategic planning.’Continue reading…

The Rise of the Non-Physician Expert

I remember when one of my patients with coronary artery disease suggested that he be given a course of an antibiotic to lower his future risk of a heart attack. The patient had done his homework, quoting literature that pointed to a possible infectious link to atherosclerosis. He also was aware of the theory that aspirin’s benefit had less to do with blood thinning than reducing underlying inflammation.

Fast forward to the Feb 2-8 Economist that has an editorial pointing out that U.S. legal expertise may not require the completion of three years of law school. Why not, it asks, cut the requirement back to two years or, even better, skip the school requirement entirely and license anyone who can pass the bar exam?

And then there’s the Feb. 11 Wall Street Journal, where “Notable and Quotable” refers to the “BA Bubble.” Charles Murray argues that a looming oversupply of college graduates may portend a decline in the employment value of a liberal education. Work careers may consist of serving as “apprentices” and “journeymen” before becoming “craftsmen.”

All of which makes me wonder if the vaunted Doctor of Medicine degree may be vulnerable.

Why should physician education be immune from a perfect storm of over-priced graduate education, “alternative” web-enabled learning with on-the-job-training? The declining value of the formal credential may be less about the university degree and more about competency, turbocharged by flexible licensing and a discerning consumer.

Non-physician health care professionals are arguing that their expertise is enough to enable them to deliver babies, administer anesthesia, prescribe drugs and perform surgery. My traditionalist colleagues argue that patient safety is at stake and that lay persons may not be able to discern all of the possible risks, benefits and alternatives. When things go occasionally wrong in the delivery suit, operating room or with a drug, they say a credentialed and experienced doc can make the difference between life and death.

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The 30-day Readmission Rate: Not a Quality Measure but an Accountability Measure

Should we hold hospitals accountable for what happens after a patient leaves the hospitals’ doors? A year ago, I thought the answer was no. A hospital’s job was to take care of sick patients, make them better and send them on their way. With more thought and consideration, I have come to conclude that I was probably wrong. It may be perfectly reasonable to hold hospitals accountable for care beyond their walls, but we should be clear why we’re doing it. Readmissions are not a good quality measure – but they may be a very good way to change the notion of accountability within the healthcare delivery system.

The debate around the readmissions measure has come to the forefront because of the CMS Hospital Readmission Reduction Program, which penalizes hospitals for “greater than expected” readmission rates. It has raised the question — does a hospital’s 30-day readmission rate measure the “quality of care” it provides? Over the last three years, the evidence has come in, and to my read, it is unequivocal. By most standards, the readmissions metric fails as a quality measure.

Why do I say that readmissions are a poor measure of hospital quality? First, we have to begin by thinking about what makes a good quality measure. Quality is about the essence of the thing being produced – a good or a service. The job of a car is to get you from place A to place B and a high-quality car may be one that does the job reliably, safely, or maybe even comfortably. The job of a restaurant is to provide a meal that you don’t have to cook — and a high quality restaurant may provide food that is fresh, tasty, or with an attention to service that you enjoy. What is the job of a hospital? When you get sick and require hospital services, a high-quality hospital should give you the right treatments, attend to your needs while you’re there, and make sure nothing bad (i.e. a new nosocomial infection) happens along the way. That’s how we measure hospital quality.

Quality measures for healthcare come in three flavors – structural measures (do you have enough intensivists manning your ICU?), processes measures (did you give the heart attack patient his or her aspirin?) and outcomes measures (did the pneumonia patient die?). The elemental part of both structural measures and process measures is that they have to be tied to an outcome we care about. If having more intensivists in the ICU does not lead to lower ICU mortality (or lower complication rates), we wouldn’t think it’s a particularly good quality measure. We know that giving aspirin to heart attack patients lowers their chances of dying by 25%. We have multiple randomized trials. We don’t need much more evidence. Hospitals that have the right structures in place and reliably deliver the right treatments can reasonably be called high-quality hospitals.

Continue reading…

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