Category: Uncategorized

Killed by The New York Times?

Feb 20, 2013• 13

By John Schumann, MD

Readers know that I am skeptical of medical practices that defy logic, or as we say in the business, evidence. Among the most controversial issues that beguile all of us (patients and docs) is this business about the PSA test.

A loyal reader sent me a doctor-written column with the provocative headline “My Patient, Killed by The New York Times.”

First, keep in mind that the website that posted this, Mediaite, is all about the media covering (really fawning and dishing) itself. The purpose of this story, with its provocative headline, sad outcome, and mea culpa tone, is to generate “buzz.”

Then understand that this is a story of one patient who made an informed decision to forego PSA testing, based on the fact that he was an intelligent person without symptoms who’d read the literature (or at least responsible press coverage of said evidence). He did not want to open the Pandora’s Box (literally: crapshoot) that is PSA screening.

Yes, he wound up with advanced prostate cancer and subsequently died. Had he had his prostate removed or radiation to ablate his cancer, and wound up with horrible side effects (impotence, incontinence) would he value the trade-off?

I offer you the counter-anecdote of Ted, who in a discussion with me, insisted that he get a PSA test because his heroes Joe Torre and Norman Schwarzkopf told him to. When it came back at 4.10 ng/dL (threshold 4.00), he went for biopsy (what else to do?) which showed low grade, gland-confined prostate cancer. Fearful of the “C” word, he couldn’t live with the idea of doing nothing (“watchful waiting”) about his cancer. So he chose external beam radiation, with the hope that it would be less damaging than radical surgery.

The Four Things You Should Absolutely, Positively Do For Somebody at Risk of Developing Alzheimer’s

Feb 19, 2013• 6

By Leslie Kernisan, MD

Do they need a PET scan to confirm the presence or absence of amyloid plaque?

More importantly, would doing such PET scans make meaningful impacts on patients’ health?

Those are the questions that a Medicare expert panel recently considered, and their impression, after carefully reviewing lots of high-quality research, is that we don’t yet have evidence supporting the benefit of using the PET scans. Unsurprisingly, some experts disagree, including a working group convened by the Alzheimer’s Association. This group of experts reviewed the evidence and common clinical scenarios, and concluded that in certain select situations, use of the PET scan would be appropriate. (See their guidelines here.)

As someone who evaluates many memory complaints, I’m certainly interested in Medicare’s inquiry, and in whether they’ll decide to cover the scan. (The NYT’s New Old Age Blog has a nice summary of the debate; a good read if you haven’t seen it yet, esp the comments.)

Also, I blogged last fall about how I thought the new scan could and wouldn’t help clinicians like myself evaluating cognitive complaints, especially in those who likely have early dementia. In particular, I commented on the difficult period of uncertainty that we often go through, as we wait to see if subtle problems progress or not.

Would the PET scan meaningfully help with that period of uncertainty? Hard to say, and it hasn’t yet been tested. I myself think that this period of uncertainty can be pretty hard on families, but measuring this burden is tricky. (Much easier to measure hospitalizations and utilization!)

I also suspect that it’ll be hard to prove benefit from “knowing earlier,” in large part because our healthcare system is currently so poorly equipped to meaningfully help people with a new dementia diagnosis.

Which brings me to the part of this story that has me annoyed.

A Call for Apps at the HDI Forum IV: Health Datapalooza

Feb 19, 2013• 4

By Graeme Ossey

We are excited to announce that the Health Data Initiative (HDI) Forum IV: Health Datapalooza will be held on June 3 and 4, 2013 at the OMNI Shoreham Hotel in Washington, DC. Last year, HDI had over 1,400 of the world’s leaders in health care featuring speakers and attendees in data science, software development, management, policy and technology.

The event will highlight the latest trends in efforts to liberate health data and effectively use it, through keynote presentations, code-a-thons, interactive panels and an “Apps Expo.” The “Apps Expo” is an exciting opportunity to collaborate with innovative developers and designers who are changing the health care landscape.

HDI IV is looking for great apps that are dedicated to meaningful use of health care data. The apps’ developers and data experts will interact with attendees who are looking for new tools to grow their business. If you’re interested in featuring your product in the “Apps Expo” or if you would like to present or exhibit at Healthdatapalooza please submit your idea here. Apps will be judged on the following criteria:

My Patient’s Keeper

Feb 19, 2013• 11

By Leora Horwitz, MD

Six years ago, my husband saved my life.

I had a severe allergic reaction to a medicine in the hospital in the middle of the night; he ran for the nurse. As for me, despite being a doctor myself, I couldn’t even breathe, let alone call for help. And so, even before and certainly since, I advise my patients not to be alone in the hospital if they can help it. I don’t even think anyone should be alone for office visits. There is too much opportunity to misunderstand the doctor, forget to ask the right questions, or misremember the answers.

National organizations like the American Cancer Society give the same advice: when possible, bring a friend.

As a patient safety researcher and an advocate for high quality healthcare, however, I find giving this advice distasteful. Is a permanent sidekick really the best we can do to keep patients safe? What about those who are already vulnerable because they don’t have such a superhero in their lives, or that superhero just has to punch in at some inflexible job?

Let’s take another look at the circumstances that ended up with my husband shouting, panic-stricken, in the hallway. The medicine I was given is known to cause severe allergic reactions. It is so well-established, in fact, that the standard protocol for giving this medication is to give a small test dose first. It was the test dose that nearly did me in. The hospital followed standard procedure by giving me the test dose. But they chose to do it at midnight, when the hospital is staffed by a skeleton crew, even though the medicine wasn’t urgent. Strike one for safety.Continue reading…

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

Feb 18, 2013• 17

By Rob Lamberts, MD

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?

Feb 18, 2013• 18

By Bob Wachter, MD

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

Feb 17, 2013• 6

By JOE FLOWER

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.

Let Them Eat Cupcakes

Feb 17, 2013• 8

By Katie Booth

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

Feb 16, 2013• 19

By BRIAN KLEPPER

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.

When Patients Can Obtain Their Own EKG

Feb 16, 2013• 18

By Dr. Wes

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: