THCB

Categories

Category: Uncategorized

Let Them Eat Cupcakes

• 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

• 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.

Continue reading…

When Patients Can Obtain Their Own EKG

• 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:

Continue reading…

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

• 7

By Edmund Billings, MD

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.

Continue reading…

The Founding Fathers Write a Grant Proposal

• 4

By Jan Masaoka

“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

• 31

By Jaan Sidorov, MD

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.

Continue reading…

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

• 3

By Ashish Jha, MD

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…

When is a Health Care Facility not a Health Care Facility?

• 5

By David Dosa, MD

There are 900,000 people in the United States who reside in assisted living settings, at an average age of nearly 87. On average, these individuals pay privately between $3,000-$6,000 per month for services that often include room and board, medication delivery and pill box set-up, supervision, and assistance with activities of daily living. Assisted living facilities are an integral part of the health care delivery system for many of our nation’s frailest older adults.  Despite the high quality care that is often provided, the assisted living environment can often leave healthcare providers scratching their heads about what they can and cannot order for their patients.  My recent experience with such a facility involving a patient with possible influenza illustrates the complex middle ground these facilities occupy.

A phone call from an assisted living facility in town interrupted me from my afternoon schedule. The facility’s nurse introduced herself and began to give me a report about my 85-year-old patient with dementia.

“Mr. Smith has a fever to 102 and is coughing up some ugly looking sputum.  I’d like to order some labs and perhaps a chest X-ray. We might also want to consider an antibiotic.”

I asked the nurse a series of questions. Was my patient’s blood pressure unstable? Was he short of breath? Was he confused or disoriented?”

In each case, she told me, “no.”

“He is sitting quite comfortably watching a talk show on television. His only complaint is the occasional cough.”

I asked a few more questions and was reassured that he was otherwise fine. I told her that her initial request for blood work and a chest X-ray sounded like a good idea. We would wait on the antibiotic until the results came back.

“I’ll call you later today with the results,” she said.

Continue reading…

Why HHS Created Partnership Exchanges and Why More States Are Choosing Them

• 7

By Dan Diamond

New Hampshire: We’re in.

North Carolina: We’re not.

The two states on Tuesday were the latest to announce their intentions on the Affordable Care Act’s health insurance exchanges. States have until Feb. 15 to tell HHS whether they’ll retain even some control over the exchanges, or let the Obama administration run the exchanges for them.

And while New Hampshire made clear that it wants to partner with the federal government to launch an insurance exchange, North Carolina backed out of a previous plan to do exactly that.

By Friday, we’ll know where half a dozen other states stand, too.

Background on Partnership Model
The Affordable Care Act didn’t originally spell out the partnership model; under the law, states faced a binary choice of running their own insurance exchanges or punting the responsibility to the government.

But HHS officials realized they needed to tweak the ACA’s approach, as more than 30 states — increasingly led by Republicans, who took over 11 statehouses in the 2010 election — announced they planned to opt out of the exchanges altogether. This would leave HHS officials with “an awesome task in establishing and operating exchanges in [so many] different states and coordinating those operations with state Medicaid programs and insurance departments,” before open enrollment begins in October 2013, Paul Starr writes in The American Prospect.

As a result, the agency in 2011 introduced the partnership model in hopes of shifting some of the responsibility for running exchanges back to the states.

Under the hybrid approach, the federal government takes on setting up the exchange’s website and other back-end responsibilities, while states keep functions such as approving health plans and setting up consumer assistance programs. HHS also hopes that the partnership model will be a path for states that weren’t ready to run their own exchanges to take them over eventually.

Continue reading…

Choosing Alternative Medicine

• 116

By James Salwitz, MD

After a terribly painful and debilitating illness, Steve died.  He had been treated for Stage 2 Hodgkin’s Disease with a series of intense therapies including German enzymes, American antineoplastins, Mexican naturopathy and Chinese Herbs, complemented by focused meditation, innumerable vitamins, extreme diet modification and acupuncture for severe pain.  He fought the cancer with every ounce of his being, doing everything to survive, except the one thing that had an 85% chance of cure; chemotherapy.

I was struck this week by a comment on my website, which bemoaned the highly disorganized state of “alternative medicine” in this Country and in particular the “paltry sums” for alternative research funding by the National Institutes of Health (NIH). The writer suggested that not only could the quality of health be improved with alternative medicine studies, but would go a long way towards saving health care dollars.

It seems to me that the idea that we need more Complementary and Alternative Medicine (CAM) research goes right to the core of the confusion between so called “conventional medicine” and CAM.  There is a major difference between the medicine practiced by board certified, classically trained physicians and that of alternative practitioners.  That difference is research and data.

If an MD or DO is treating a cancer patient and that patient asks to see or understand the basic science and clinical studies which support the recommended therapy, that published data is readily available. Standard oncology treatment goes through 10-20 years of research, from the test tube, animal studies and through a series of supervised human multi-phase trials, until it is approved and offered to patients. Each step is refereed by competing and critical PhD and physician scientists and must be published in peer-edited journals for general review and criticism, all of which is public and transparent. Where it is not, and when people attempt to manipulate or falsify the system or data, massive blowback eventually occurs.

Continue reading…