Road To Hellth

Oct
20

Posts Worth Reading

It’s my pleasure this week to welcome a guest post from Dr. Vance Harris, a family doctor who practices in Redding, California. Dr. Harris makes some excellent observations about two aspects of ObamaCare related to expanding the role of nurse practitioners.

The first is that giving NPs the privileges and responsibilities of actual physicians will somehow magically be separable from having them take on many of the same characteristics that our political Leaders are so quick to criticize in doctors. These include having to practice expensive defensive medicine, becoming the object of politically-inspired suspicion and fear, and havingthe audacity to ask to be paid for their work. What medically unsophisticated supporters of government-guided healthcare like Peter Orzag seem to miss, is that people in healthcare behave the way they do because of incentives and disincentives. If you place different sets of faces into the same dysfuntional situation, they will tend to take on the same business characteristics as those they are replacing.

The second aspect is the blind assumption that, because NPs have lower nominal salaries than physicians, they cost less to use. This is the sort of basic mistake that people make all the time with respect to medicine – they miss the concept of economic productivity. If you call a nurse a doctor, that doesn’t mean that he or she will perform like a doctor. Their education and training is very different. Why would you expect that they will be equally expert, efficient or versatile in a physician-type clinical practice where anything and everything can come through the door?

I also wanted to take this opportunity to salute Dr. Jame Gaulte and his retired doc’s blog for his recent post entitled:

ACO and HMO, A distinction with or with/out a difference – Are ACOs an example of Underware Gnome Economics?

You have to love posts like this that are both humorous and brutally accurate.

Categories : DAP Blog Entries

Oct
20

More Flawed Assumptions Underlying “Reform”

by Vance Harris, M.D.

by Vance Harris, MD

One year ago many people pointed out that assuming there would be doctors to care for new patients covered through health care reform was a huge assumption. It turns out this is exactly what has happened. A recent RAND publication found we are currently 35,000 physicians short of what we need. Health Care Reform brings in an estimated 32 million new patients to this system. Each year aging baby boomers add an additional 7 million new Medicare patients.

While the demand for ‘health care providers’ is huge, what we really need is caring, compassionate, and cost conscious physicians. We need those who put the patient’s health above all else, doctors who can say no to needless tests and procedures. We need doctors who actually care enough about their patients to work a little harder and dig a little deeper for the right diagnosis. Where will we find doctors who won’t live in fear of being sued if a rare diagnosis is missed or if a patient isn’t fully truthful or balanced in what they present?

Information in 30 second stories from the media and access to the internet has made instant experts of everyone. Patients are being counseled to not believe their doctor and to question everything they are told. One recent columnist wrote on CNN instructing all of us to “Not let our health be less important than our relationship to the doctor.” While this makes a great sound bite, I would point out that our health may depend on a trusting relationship with our physician. Assuming your doctor doesn’t care and that he is not trying will not develop a trusting and caring relationship. Aqusatory questions and demanding suggestions do little to engender the kind of thorough dedication we need from compassionate physicians.

Such an approach will only ensure defensive guarded statements from cautious physicians covering their liability from hostile patients. When this type of relationship is encountered, doctors pull away emotionally and practice defensive medicine, hoping the patient will move on to another unsuspecting physician.

The latest proposal to heal our dying Health Care System is to enroll more primary care physicians and expand the Nurse Practitioner system. Once again here are some very flawed assumptions.

Training more physicians to be primary care physicians does little good if no one wants the job! Existing primary care physicians are at the bottom of the pay scale and have more paperwork and administrative duties than any other specialty. Not only are they discouraged, overworked and underappreciated by political rhetoric that constantly casts a rather sinister shadow over their ethics and abilities, but they are on the verge of total financial annihilation. Existing cuts scheduled for December and January 1st total over 32%. To those who think we can solve our national health care crisis by abandoning primary care physicians, I would raise an alarm.

Primary care physicians work 60 plus hours a week examining patients, ordering proper labs and tests (most of which now require a letter to the insurance company pleading for their permission), and writing summary letters for specialists needed to help with more complex patients. Our population is aging as baby boomers hit retirement and they are sicker than any previous generation. Our society is getting heavier and less active each year. This means earlier onset of disease states with diabetes, heart disease and Alzheimer’s poised to financially cripple our entire system.

Cutting the heart of our medical care system at a time like this is ludicrous. Recent news articles extol the virtues of Nurse Practitioners as a solution to our crisis. Again I say, you are making some huge assumptions here.

In their 2 years of post graduate training Nurse Practitioners are not provided the opportunity to experience the width or the breadth of medicine that doctors receive in their 7-12 years of total immersion. Unfortunately, medical problems are getting more complex in our aging society and complex problems don’t always announce themselves when appointments are scheduled.

Physicians struggle to get 100% of all our diagnoses right in a society that will not tolerate even a slip in judgment once in a career. Imagine the pressures on these replacement professionals with their limited training, as they struggle to diagnose diseases they have not seen nor been trained to manage. More errors in diagnosis, delays in treatment, increased use of expensive tests and referrals to specialists drowning in a backlog of patients waiting to be seen will be the result. This will happen.

For those who see these lesser trained providers as an economic savior I point out another incorrect assumption. There will be NO COST SAVINGS. I see 30-34 patients a day, the reality of paying my bills and the demand given so few of us out here in primary care. Nurse Practitioners may see 15-20 patients a day as they focus on what they have to offer. They will focus on one or two problems at each visit. Unfortunately the real world is filled with patients who bring their list of 4-5 problems to each appointment. Even with 22 years of experience following 4 years of medical school and three years training in family practice, I struggle daily to keep up with the tsunami like flow of problems I have to address. The pressure is overwhelming most of the time.

Nurse Practitioners salaries average about $80,000 a year and with benefits, vacation time, sick days and holiday pay their yearly cost easily exceed $120,000 each. Private practice physicians receive no sick time pay, no vacation time, no holiday pay and enjoy no retirement plan or even the most basic right we all demand- health care. It easily requires 2 Nurse Practitioners to replace what I do each day even if we assume they have the training to deal with many complex problems. At the end of my day, I work another 2 hours attending to the required paperwork. This is the best bargain in the country as each physician now works for free. No one is paid to do this ever increasing mountain of paperwork. I suspect that salaried practioners will want to be paid and after an eight hour day seeing complex patients they might even demand overtime. That puts the cost of replacing me at just under $360,000 a year. Now that plan is going to save the system a LOT of money as we get better care, fewer referrals, and less expensive testing from those with a fraction of the training we currently give physicians. Yea, that sounds like a proposal a politician might make in an election year.

Dr. Vance Harris is a family practitioner in Redding, CA

Categories : Political Hellth

Oct
8

Healthcare Nannies Invite Themselves In

by Dr. Doug Perednia

To tell the truth, she does't really care whether you want her in the house with you or not.

In a recent post, we asked whether everyone should have a healthcare nanny. That is, do we all want various entities prying into our medical information and alerting us and our doctors about whether we’ve had our medications refilled, have gotten all of those “recommended” tests, and have been taking our pills and otherwise behaving as directed by the latest federal guidelines? One of the real-life cases we considered was that of CVS Caremark, a large national pharmacy that has decided to act as a de facto nanny for many patients who have used them to purchase their prescriptions. (And as it turns out, even some who didn’t.)

Well, it looks as if there’s at least one group that’s unhappy with the love CVS is showing its customers: competing pharmacies.

As reported this week by Health Data Management Magazine’s website:

“Six independent pharmacies in Texas have filed a lawsuit against CVS Caremark, charging the national pharmacy chain and mail-order pharmacy benefit management firm with racketeering under the federal RICO law, trade secret misappropriation and violations of the HIPAA privacy rule.

The suit alleges privacy violations that started only months after the CVS/pharmacy unit of CVS/Caremark in early 2009 agreed to pay a $2.25 million fine and institute corrective action plans following a federal government investigation of potential HIPAA violations.”

It seems that CVS/Caremark operates not only a pharmacy, but also a pharmacy benefits management business for insurance companies that gives it access to personal medical information such as diagnoses, physicians, prescribing patterns and the identifies of the pharmacies that patients are using to purchase their medications. This is, of course, all of the information that a healthcare nanny would normally want to tailor his/her/its nagging messages. It also happens to be the very same information that an aggressive pharmacy would want to have in order to maximize its sales and undercut competitors. This is exactly what CVS/Caremark is accused of doing. Businesswire fills in the details:

“The suit claims CVS Caremark violates the firewall between the retail pharmacy and the pharmacy benefit manager (PBM) entities as required when the Federal Trade Commission approved the CVS and Caremark 2007 merger. Instead, the combined company built an information technology platform that straddles all of CVS Caremark’s business segments, capturing in-depth patient data for marketing and other purposes in violation of HIPAA patient privacy laws…

Patient information gathered from non-CVS pharmacies includes names, addresses, birth dates, medical diagnoses, prescription histories, and prescribing physicians. CVS Caremark mines the accumulated patient- and pharmacy-specific data to identify individual patient buying practices, their physicians’ prescribing practices, and individual pharmacy business volume.

The American Pharmacies plaintiffs say patients report being forced, via higher copayments and refusal to cover maintenance medications, to leave their pharmacy where the patient and pharmacist have a long-time professional and personal relationship. Other patients report moving to a CVS Caremark network pharmacy out of fear of losing all health insurance coverage.

CVS Caremark contacts patients via direct mail and phone calls about their prescriptions, urging, and in some cases mandating, plaintiffs’ patients to use CVS Caremark retail or mail order stores. The patients’ physicians also are targeted to change prescribing practices to include drugs from CVS Caremark-favored drug makers.”

So what can we learn from all of this?

First, our healthcare system has some serious problems delivering justice and implementing effective punishment. CVS/Caremark is a $44 billion company with revenues of $25 billion and an operating profit of almost $1.6 billion in 2009. Last year it paid its CEO $30.4 million. It clearly has a track record of playing fast and loose with personal and identifiable medical information. Does anyone really think that a company of this size and market power would change its behavior in any meaningful way as the result of a measly $2.25 million fine – a penalty that represents 0.14% of their annual profit (about one-half of one day’s worth)? The complete lack of personal and meaningful accountability in large healthcare corporations is a recurring theme that has been well documented time and again by Dr. Roy Poses over at the Health Care Renewal Blog. Healthcare business executives see these fines as a simple cost of doing business. No more, no less. The only way to get through to large corporations such as this one is to make such punishments personal, by holding the executive management personally responsible for deliberate misuse or abuse of medical information.

Second, the idea of healthcare nannies proving to be a “Scary Mary” Poppins is hardly far-fetched. Those of us who may want healthcare nannies for ourselves, (or who may think that healthcare nannies are a good idea for others), should ask ourselves why a person or organization wants to be a healthcare nanny? What’s in it for them? Did we hire them? If not, who are they working for and why? There are hard dollar costs involved in being a healthcare nanny – no one is going to do it for free. This is one gift horse whose mouth warrants a good looking over.

Finally, we can expect government agencies such as Medicare, Medicaid and the Department of Health and Human Services to begin being, sponsoring or abetting healthcare nannies in the near future. The government’s push to force physicians to use electronic medical records is specifically – and overtly – intended to ensure that data can be readily collected, analyzed and aggregated by anyone in a position of healthcare authority who wishes to use it. This new, universal and federally mandated pool of electronic data is simply perfect for implementing a national healthcare nanny program. Needless to say this raises a number of questions about privacy, invasiveness and the extent to which government should be involved in personal medical matters. Why would the government go into the healthcare nanny business, and how would it justify doing so?

The answer is important, so bear with us.

Over at The Covert Rationing Blog, Dr. Rich has argued rather convincingly that the personal and patient-oriented nature of the doctor-patient relationship has recently been stealthily replaced by something new. It’s the “new medical ethics”, whose most important premise is that, as described in an article an article by Hall and Berenson in the Annals of Internal Medicine (volume 128, p 395):

“It is untenable for the medical profession to continue asserting an idealistic ethic that is contradicted so openly in clinical practice. . .We propose that devotion to the best medical interests of each individual patient be replaced with an ethic of devotion to the best medical interests of the group. . .”

In other words when you’re sick, “society” (as represented by your friendly insurer or government functionary), now has valid seat at the table when it comes to deciding how your case will be managed, whether you like it or not. Our current political Leaders and many prominent medical organizations clearly subscribe to this new view of the physician-patient relationship.

Dr. Rich has discussed at length how these new ethics adversely affect the independence and objectivity of physicians, but they clearly have implications for healthcare nannyism as well. One logical implication is that society has the right to intervene (or at least exert influence) on behalf of the interests of the group when it comes to the personal management of your health and medical conditions. If refusing to take your pills as directed is likely to lead to a more expensive outcome that Medicare will have to cover, your societal representative (in this case whoever is representing Medicare), has not only the right, but the obligation to remind you to take those damned pills. If your electronic medical record shows you to be overweight, we’ll “alert” you to eat less. If it says that you are underweight, we’ll remind you to chow down. Just had surgery? Time to clean that wound. Are you diabetic? Why aren’t you checking your blood sugars and transmitting them to us regularly? The possibilities are endless.

If you think that any of this is far-fetched or unlikely, think again. With the growth of “pay-for-performance” programs, the federal government has already begun what amounts to a “healthcare nanny” program for physicians. From the perspective of our current political Leaders, there is absolutely no reason why it should or will stop there. Patients are at least as responsible for their ultimate health outcomes as their physicians. If (as they believe) the solution to our healthcare problems lies in expanding coverage without regard to cost, while punishing those who deviate from mandated guidelines of care, patients will have to uphold their end of the management plan.

Legend has it that Mary Poppins makes her appearance when an east wind blows. With the passage of the Accountable Care Act the Obama administration and its supporters in Congress have decided that the winds of healthcare will henceforth blow from Washington.

You can expect your own healthcare nanny to arrive before long. Like those coming from self-interested companies like CVS/Caremark she’ll let herself in. And we predict that this time she won’t take “no” for an answer.

(Hat tip to Dr. Rich for his excellent reporting on, and analysis of, the “new medical ethics”.)

Categories : Abuse of Power

Oct
4

American Medicine’s “Don’t Ask, Don’t Tell”

by Dr. Doug Perednia

The FDA's View of the World?

The other day, I happened to be talking to Mark, a sales representative from one of the pharmaceutical companies. He’s the type of rep that many doctors don’t mind seeing – someone who is careful of your time, is happy to hunt down the answers to questions that come up on the medications his company makes, and brings by useful information about new drugs that seem to be practice-appropriate. He looked slightly drawn. I knew that he was covering a bigger geographic area because so any of his colleagues have been laid off in the past few years.

“I’m glad to see you.” I said. “I wanted to ask if you knew anything about the use of [drug X] in acne. I was reading somewhere the other day that it might be useful in some tough-to-treat cases that tend to scar.” Mark’s normally warm smile disappeared in an instant. Something akin to terror flashed in his eyes. He backed away just a bit.

“I can’t…I can’t tell you anything about that,” he stammered. “It’s not an FDA-approved use of the drug. I could lose my job if I say anything about it.”

And so he could. Despite the fact that using his company’s treatments for this purpose is perfectly legal and, according to a number of good studies, both safe and effective. My simple question had run afoul of one of those regulatory potholes that characterize the Road to Hellth. This one has to do with the “off-label” use of medications.

In the real world, it’s terribly difficult, expensive and time-consuming to get a new (or old, for that matter) drug approved by the FDA. To do so one has to submit reams of data showing that the medication is safe and effective for the treatment of a particular and specific illness. In FDA-speak, a disease or condition and specific set of circumstances for which you’ve demonstrated the drug’s effectiveness is called an “indication”. Once the drug is approved, the manufacturer can advertise its use to your doctor for that indication.

How difficult and expensive and time-consuming can it be? Very. The cost and time required to get from the initial clinical trials to simply submitting a drug for FDA approval averages about $125 million and 6-11 years. Once the final application is submitted it then takes an additional 1-2 years for the final decision to be made. The overall probability of success in the whole process is only about 9%. This process has to be repeated for every separate indication that a manufacturer might wish to have approved. All of these costs are tacked onto the price of drugs that ultimately reach you, the consumer.

Under the circumstances it should be no surprise that most drug makers would rather be attacked by alligators than submit multiple FDA applications for all of the different uses a given medication might have. As a result, the vast majority of new drugs are just approved for the one or two major indications that seem to represent the biggest market.

In the real world, the fact that a drug is approved for one use doesn’t necessarily mean that it’s not also useful for lots of other medical problems. For example, Botox® was first approved in 1989 for use in treating eye muscle spasms. It wasn’t until 2002 that the FDA approved it for treating wrinkles, even though doctors started using it for this purpose in the early 1990s. Using a drug for an indication that isn’t approved by the FDA is perfectly legal. As one medical malpractice insurer explains on their website:

“Once approved, a drug product may be prescribed by a licensed physician for any use that, based upon the physician’s professional opinion, is deemed to be appropriate…

The FDA recognizes that off-label use of drugs by prescribers is often appropriate and may represent the standard of practice. In today’s medicine, many pediatric uses are not on a label. The reason for this off-label practice is the issue of drug or product testing experimentation in children. Many standard treatments in oncology and HIV therapy involve off-label use of medications. There are no rigorous data available on the extent or profile of off-label uses.”

This sort of thing is incredibly common, and even necessary in order to provide good care. In the area of dermatology, about one-third of all prescriptions written are for an non-FDA approved, off-label use of the drug prescribed.

Despite the practical importance of off-label prescribing, it should be obvious that its very existence creates problems for the folks at the FDA. If many or most drugs can be used for non-approved usage, doesn’t that undermine their regulatory authority? If their job is to control access to medical treatments by means of the approval process, how can they allow patients to be treated without their approval?

In response, what they’ve come up with is modern American medicine’s equivalent of “don’t ask, don’t tell”, but with a twist: multi-million dollar fines for conspicuous telling, and a weird attempt to recruit every doctor in the country as an FDA informer. Welcome to the Truthful Prescription Drug Advertising and Promotion, or the “Bad Ad” Program (BAP).

The basic policy behind the BAP is that while off-label indications exist for many drugs, drug makers can only talk about them if they’re willing to fork over the money for FDA approval first. Otherwise the FDA will slap them with huge lawsuits and fines. It did just this recently for drug makers Allergan and Novartis, and collected billions of dollars in the process. And it wants every American doctor to sign on as an unpaid FDA tattletale.

No wonder Mark is paranoid.

Here’s the recruitment material from the FDA website:

“The Prescriber’s Role – Recognize and Report

FDA’s educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.

The “Bad Ad” Program is administered by the agency’s Division of Drug Marketing, Advertising, and Communications in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”

And here are some concrete examples of the behaviors that the FDA is looking to stamp out in the public interest:

“Examples of Violations

Example of Omission of Risk

You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.

This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.

Example of Unapproved Use

You are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.

This presentation would be illegal because it promotes an off-label use.

Example of Overstating the Effectiveness

‘Doctor Smith, Drug X delivers rapid results in as little as 3 days.’

This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.”

Finally, there’s the pitch to be a snitch:

“What You Can Do: Recognize & Report

The prescriber can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading drug advertising and promotion.

Recognize –

Be aware of the many advertisements and promotions that you see every day.

Report –

Help FDA stop violations by reporting activities and messages that you consider false or misleading.”

Frankly, I find the whole thing to be somewhat bizarre.

Let’s say you’re a doctor. Presumably you’re grown up, and can read and evaluate information as well as the next person. You have patients who are failing all of the “approved” therapies, and would like a drug company to share with you whatever information that they might have about a promising off-label use. If they answer your question it’s a crime and you’re supposed to squeal on them to the FDA. But if you ask the same question of anyone else in the world, it’s not?

Now let’s look at the patient’s perspective. You have a medical problem that’s not responding well to conventional therapy. Wouldn’t you want your doctor to know that there are off-label alternatives? Would you really care who told him/her about them?

Of course the FDA does have a responsibility to the public to ensure that medications are safe and effective, but isn’t the most important barrier here the incredibly high cost and time involved with securing approval? Isn’t it perhaps worth an investigation to see whether something can be done to address this root cause of the problem?

Personally, I’m going to hold out for a bounty for each drug rep I turn in. If they make it high enough, it might be more profitable than actually providing those stuffy old healthcare services.

Categories : Bureaucracy Run Amok

Archive for October 2010

Posts Worth Reading

ACO and HMO, A distinction with or with/out a difference – Are ACOs an example of Underware Gnome Economics?

More Flawed Assumptions Underlying “Reform”

Healthcare Nannies Invite Themselves In

American Medicine’s “Don’t Ask, Don’t Tell”

“Examples of Violations

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