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Health Insurers Create A New System To Limit Access To Expensive Radiology Tests

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I just got notice from Blue Cross that they will be implementing a radiology management program for all advanced diagnostic imaging services starting in 2010.  The costs of advanced diagnostic imaging (such as CT, MRI, cardiac nuclear medicine) are rising 10-20% per year.

Radiology management companies are an attempt by insurance companies to slow that growth curve. What does that mean if you are a doctor?  Let me tell you how the program will operate.  Blue Cross calls it their Radiology Quality Initiative or RQI, not to be confused with PQRI.  Here are the details of their radiology benefit management initiative.

Q:  What are the requirements? Read more »

*This blog post was originally published at The Happy Hospitalist Blog*

Ten Good Things About The U.S. Healthcare System

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President-elect Obama and Secretary of HHS designate, Tom Daschle, invited concerned Americans to discuss healthcare reform in community groups across the country. My husband and I hosted one such group at our home in DC yesterday. Although we had been instructed to compile a list of compelling stories about system failures – instead we decided to be rebellious and discuss “what’s right with the healthcare system” and compile a list of best practices to submit to the change.gov website.

The event was attended by a wide range of healthcare stakeholders, including a government relations expert, FDA manager, US Marine, patient advocate, health IT specialist, transportation lobbyist, real estate lobbyist, health technology innovator, Kaiser-trained family physician, medical blogger, and EMR consultant. Here is what they thought was “right” with the healthcare system:

1.    Customer Service. Market forces drive competition for business, resulting in increased convenience and customized service. Healthcare consumerism has driven patient-centered innovations that improve quality of life. Examples include convenient walk-in clinics, online scheduling, services available in a one-stop location, and seamless transfer of health information (such as within the Kaiser Health system).

Memorable Quote: “We have a tremendous amount of choice in our system. That’s very good for patients and I hope we never lose it.”

2.    Accommodations For People With Disabilities. Kaiser Permanente was cited as an organization that takes special interest in facilitating good patient experiences for vulnerable populations and people with disabilities. For example, extra time is allotted for travel to and from the clinic, and schedules are built with flexibility to accommodate mobility impairments.

Memorable Quote: “Kaiser trains all its staff to be sensitive to people with ethnic, racial, and sexual preference differences. They learn to listen to the patient, and never assume they know what they think or feel.”

3.    Specialty Care. So long as a person has health insurance, access to the very best specialists in the world is available in a very democratic fashion to all patients. Several success stories included surgery and follow up for major multiple trauma, and congenital anomaly repair.

Memorable Quotes: “I’m only here today because of the technical skills of a U.S. surgeon who saved my life…” “I’ve traveled all over the world, and I wouldn’t want to get my medical care in any other country.”

4.    Social Media. Internet-based tools and social media platforms are leveling the communication “playing field” between providers and patients. People are discussing their care and treatment options with others like them online, as well as socializing with physicians and receiving real-time input on health questions.

Memorable Quote: “On Twitter I have I.V. access to physicians. I asked a health question and within 10 minutes I had 6 physicians answer me.”

5.    Access To Allied Health Professionals. Scheduling time with mid-level providers is easy, convenient, and effective. Patients enjoy the ability to access generalist care with nurse practitioners (for example) who provide quality care at a more relaxed pace.

Memorable Quote: “I love my nurse practitioner. She really listens to me and her schedule is much more flexible than physicians I’ve known.”

6.    Drug Development For Rare Diseases. The U.S. government offers grants, extended patents, and exclusivity to drug companies willing to develop drugs for rare diseases. This dramatically improves the quality of life for patients who would otherwise have no treatment options.

Memorable Quote: “The FDA recently approved the first drug for Pompe’s disease. Only a few hundred patients in the U.S. have the disease, and yet this life-saving medication was developed for them thanks to government incentives.”

7.    Patient Autonomy. The healthcare consumerism movement has replaced medical “paternalism” with care partnership. Patients are seen as consumers with choices and options who must take an active role in their health.

Memorable Quote: “Patient accountability is key to better health outcomes. But they need guidance and decision support… General health literacy is at a sixth grade level.”

8.    Health Education. Technology has improved health education dramatically. Patient education about their disease or condition is often facilitated by demonstration of computer-based anatomic models.

Memorable Quote: “I think that doctors are getting much better at communicating with patients in ways they can understand.”

9.    Coordination of Care. Some hospitals like the Mayo Clinic do an excellent job of coordinating care. For example, they provide each patient with photos and names of all the physicians, nurses, and specialists who are on their care team. Nurses update the patient’s schedule daily to reflect the tests and procedures anticipated and provide dignity and sense of orientation to the hospital experience.

Memorable Quote: “The Mayo Clinic has gone Facebook.”

10.    Democratization of Information & Transparency. Patients have the right to view and maintain all their medical records. They have many PHR options, and may be provided with CDs or thumb drives of their personal radiologic information to take with them to their next provider. Many doctors write their notes with the understanding that the patient will be reading them.

Memorable Quote: “One day soon, hospital stays will no longer occur in a black box. Family members and friends will be invited by the patient to view their daily schedule online, while nurses update planned procedures, events, and meetings. Family members won’t miss the opportunity to meet with the patient’s care team, because it will be on the schedule. MyChart (from EPIC) is working on making this hospital experience a reality at the Mayo Clinic soon.”

***

Thanks so much to all of you who attended. My husband will be preparing a report for the transition team shortly.

Making the Right New Year’s Resolution … And Keeping It

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By Steve Simmons, MD

What do New Year’s Resolutions tell us about ourselves?  Will they cast light on our hopes for the coming years or embody regrets best left in the year past?  Resolutions tell us about our hopes, about who we want to be, and if made for the right reasons can lead us to the person we wish to be tomorrow.  A positive approach utilizing the support of family, friends, and caregivers will help us follow through with our resolutions and improve our chances for success.

For the last two years, resolutions to stop smoking, drinking, or overeating, have ranked only ninth on the New Year’s Resolutions list, while getting out of debt, losing weight, or developing a healthy habit are the top three.  If you find this surprising, you are in the company of many physicians. Yet this demonstrates the positive approach preferred by a majority making a New Year’s resolution. For each person making a resolution to stop or decrease a bad behavior, five choose to increase or start a good behavior, instead.  We can learn from this and maintain a positive focus when considering and following through on a resolution.  Keep in mind that only 40% find success on the first try and 17% of us need six tries to ultimately keep a resolution.

Avoid making hasty New Year’s resolutions based on absolute statements, which all too often meet with failure at the outset.  We recommend an approach based on The Stages-of-Change-Model, developed from studying successful ex-smokers.  For 30 years, primary care doctors have used this model to help their patients successfully rid themselves of a variety of bad habits.  The Model’s foundation is the understanding that real change comes from within an individual.

Below, I’ve outlined the five typical stages a person progresses through in changing a behavior, using the example of a smoker:

1.    Stage One/Pre-contemplative: This is before a smoker has thought about stopping.
2.    Stage Two/Contemplative: A smoker considers stopping smoking.
3.    Stage Three/Preparation: The smoker seeks help, buys nicotine gum, etc.
4.    Stage Four/Action: The smoker stops smoking.
5.    Stage Five/Maintenance and Relapse Prevention: Still not smoking, but if our smoker smokes again, keeps trying to stop, learning from mistakes.

The family and friends of a resolution maker are an intrinsic part of success and should avoid a negative approach. Instead, help them move through the stages, advancing when ready at their own pace.  The following exchange is typical of an office visit where a spouse’s frustration spills over, finding release:

“Dr. Simmons, Tell John to stop smoking!” John’s wife demands of me.

“Mr. Smith, you really should stop smoking,” I request of John.

“Well Doc, I don’t want to and that’s not why I’m here,” John says, pushing his Marlboros deeper into his shirt-pocket, clearly agitated with his wife and me.

“I’m sorry Mrs. Smith, John doesn’t want to stop, perhaps I could hit him over his head, knock some sense into him?”

Once negative energy has been interjected between me and my patient, I struggle to find an appropriate response.  Should I use humor to redirect?  I have rarely seen someone stop a bad habit after being berated.  I would prefer a chance to help him think about smoking and how it’s affecting his health.  Does he know that smoking is making his cough worse?  Has he been thinking about stopping lately?  Nagging seems to be more about our own frustration than a desire to help and should be avoided since the effect is usually the opposite intended.

A resolution can show the path to a happier and healthier life.  If you or someone close to you is planning to make a New Year’s resolution, just start slow, stay positive, have a strong support network….and one more thing: Resolve to stay Resolved.

Should The FDA Deny Access To Promising Cancer Drugs Under All Circumstances?

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I was reading a good blog post about ethics violations in clinical trials in India, and was reminded of an interesting case in the U.S.  Several years ago a 21-year-old woman (Abigail Burroughs) with terminal cancer (who had exhausted all treatment options) was denied the option of purchasing a drug that was in the final process of receiving FDA approval. The FDA ruled that terminally ill patients should not be permitted to purchase drugs until the drugs have completed the approval process, citing safety concerns. Their arguments also included that:

1. Patients cannot make a truly informed decision regarding whether or not to try a medicine that has not yet been fully tested.

2. Allowing access to drugs before they are FDA approved would undermine the clinical trial process.

3. If terminally ill patients could buy treatments, others would soon expect health plans to cover these costs for others.

4. Allowing access to drugs before they were proven effective would add to the public’s general confusion about evidence-based medicine and promote magical thinking.

I don’t know how you feel about this, but it makes me squirm a little bit. Although I appreciate the FDA’s position (and my colleague Dr. Jim Sabin has blogged about his support for the ruling) it just seems a little heavy-handed, especially in light of the details of the Abigail case. Here’s what I wrote to Dr. Sabin:

About the Abigail case… I think they were trying to get access to Erbitux for Abigail, and it was in phase III trials at the time (so there was mounting evidence for its efficacy – their request to purchase it wasn’t scientifically unreasonable.)

I have very mixed feelings about the FDA ruling. I understand that we don’t want to 1) set a precedent that would lead to insurers having to pay for expensive experimental therapies 2) discourage people from entering clinical trials 3) allow drug makers to profit from “false hopes” in terminal cases. However, couldn’t we add enough caveats to make it reasonable to allow patients who have exhausted all other options to purchase (with their own money) drugs that have shown promise but are not yet FDA approved?

What if we said that the drugs had to be in phase III trials, with enough evidence to suggest a plausible benefit for the patient? Terminal patients are rarely good candidates for clinical trials (I don’t think we’d be poaching from the CT pool), few can afford to buy monoclonal antibodies (and the like) on their own so if there were trials for terminal patients, they’d still have great incentive to join, and I’m not sure that just because a patient can buy a treatment that insurance will HAVE TO follow suit.

Something about limiting personal choices (for those who have the means to make them) seems un-American to me. There are very low risks of harm in monoclonal antibody treatments (so the argument that the FDA must err on the side of patient safety doesn’t really fit the Abigail case). Yes, it’s sad for those who can’t afford to buy every possible therapy – but why should we deny access for those who can? With the right caveats, I think we could allow people like Abigail to try every remaining option. But of course I agree that phase I drugs are just not far enough along the research pipeline to make educated choices about them.

Maybe Abigail was a casualty of the one-size-fits-all, population-based rules that are appropriate most of the time, but fail in exceptional cases. I predict that this sort of thinking (where evidence-based protocols are applied in a cook book manner to all patients with a given disease) will dominate the healthcare landscape in the coming years as we seek to reign in costs and do the best thing for most. I just wish there were a way to bend rules on the edges a bit. What do you think?

What Do Cigarettes and Phenergan Have In Common? Hint: Nothing

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For some reason, people just love to misrepresent the issues underlying the Wyeth vs. Levine case. I have written extensively about this case here and here because I found it so amazing that the media has bungled the story so badly – and that no one is really calling them on it.

In case you don’t recall – Ms. Levine was the victim of medical malpractice. An anti-nausea drug (phenergan) was injected into (or very near) her artery by accident (the potential consequences of such an error are clearly indicated on the drug label). Tragically, the resulting chemical reaction with the oxygen in her artery caused such severe tissue irritation that her arm eventually had to be amputated. Ms. Levine settled out of court for $700,000 with the clinic where the injection occurred. Unfortunately the story doesn’t stop there.

Ms. Levine’s attorney counseled her to sue the drug manufacturer for inadequate label warnings (the potential hazard is in fact mentioned on the label six times – though it does not forbid IV administration of the drug, though it recommends a low dose and slow push). In a precedent-setting judgment, a jury in Vermont decided that the FDA-approved label was inadequate, and that it should have fully contraindicated administration via IV push. The jury awarded Ms. Levine $6.8 million and Wyeth contested the judgment, bringing the case to the US Supreme court in November, 2008. The case has not yet been decided, though it has been compared to deceptive labeling of “light cigarettes.”

How on earth is a drug that has been successfully administered (without harmful side effects and with good efficacy) over 200 million times in the U.S. equivalent to cigarettes (a known carcinogen with no therapeutic value)? It’s an exceedingly poor analogy.

To put it another way, if a nurse took an insulin syringe and injected it into a diabetic’s eyeball, causing blindness, should I say that the insulin manufacturer (because it did not forbid the injection into the eye) was engaging in deceptive labeling and should be at fault for the patient’s loss of vision?  The PA who injected the phenergan into Ms. Levine’s artery, and our hypothetical nurse who injected insulin into an eyeball are the ones to blame.

But wait, it gets worse.

The attorney (David C. Frederick) who is arguing Ms. Levine’s case in front of the Supreme Court is being considered by our President elect for the position of Solicitor General of the United States. Yes, this very man who is engaged in a law suit that could potentially set a precedent that would allow all 50 states to set up their own mini-FDAs with the lay public (i.e. juries) deciding what drug label language should say.

The pro-Levine camp argues that a court ruling in favor of Wyeth would preempt consumers from being able to sue drug companies for damages related to incomplete disclosure of risks (such as the Vioxx case) but in reality, the Wyeth vs. Levine case has no bearing on pharmaceutical non-disclosure, since Wyeth did not hide the irritant risks of phenergan from the FDA. They have been known for decades.

So Wyeth vs. Levine is NOT about deceptive labeling or non-disclosure of risks – it’s about whether medically uneducated juries should have the power to set arbitrary drug labeling language standards in order to facilitate litigation against deep-pocketed pharmaceutical manufacturers whenever a patient is harmed in a case of medical malpractice.

I understand that many folks are frustrated with pharmaceutical wrong doing (and there are many cases of it), but this is just not one of them. In America, we are not supposed to bring pre-conceived notions to bear on law suits, but objectively review the facts in each case, separate from our general feelings about those involved. I do think that Wyeth isn’t getting a fair shake in the media because of the general mistrust/dislike of Big Pharma. But everyone has a right to a fair trial. I sure hope they get it.

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