Health Reform For The Late 20th Century

I have to complement our Congressional leadership for its political fortitude and wisdom in preparing 2010 health reform legislation which is well suited to the 1970s and 80s. The late Richard Nixon, who brought us HMOs in a serious effort at health care reform (which became fouly mutated under the counter-evolutionary pressures of insurers, hospitals and other providers) would have been proud to see the 2010 reform just before "le affaire Watergate"cut his presidential career and his interest in American health care short.

What is being trumpeted as health reform is more of the old health system, redressed and reworked, with the old guard in control. The program has been shaped by pharmaceutical companies, insurers, chambers of commerce, hospital associations, device manufacturers, health care unions, high-roller physicians and other providers, through their lobbyist minions to be certain that their controlling interests and their profit centers are not perturbed, their stock prices ever climbing, their executive salaries not  diminished, and the care, which Americans will receive, not improved.

[Remember: a pharmaceutical (and other company which makes its money in health care)  profits by selling drugs over a long time for a chronic disease, not by efficiently curing a disease early in its course. An insurer makes money by keeping your doctor on the phone for 45 minutes, hoping that she will hang-up the phone,  rather than promptly authorizing the care you need.]

How are we going to staff the clinics and hospitals to provide the facilities and office visits that adding more than 30 million Americans to the insured list will demand ("the doctor is completely booked for the next ten weeks, but we have one appointment 71 days out with our new physician's assistant")?  Will the legislation's effect on doctors' offices cause them to look like overcrowded hospital emergency rooms where only visibly dying patients get immediate attention?

Under the 2010 health reform proposal, where are the skills neeeded to diagnose and treat cancers, degenerative diseases, trauma and neurologic disorders in our aging population to be gained?

Where are the financial incentives which will drive our younger generation to acquire an interest, skill and understanding of chemistry, math, physics, biology and the other sciences which will provide the springboard to careers in the healing professions? Is our "health reform" simply training generalist doctors to take care of sore throats, blood pressure elevations and type 2 diabetes using duplicative drugs purveyed by pharmaceutical companies?  Will the recruitment and education of coming generations prepare them to understand complex scientific concepts of statistics, DNA, genetics, epigenetics and their interrelationship with disease and health or is there concern among political and industrial leadership that a bright, well-trained and informed health care leadership will be too hard to control?

In a country which prides itself on its capitalist tradition, the proposed 2010 health reform incorporates few capitalist incentives to recruit the people and brains who we will need to make the system work and few capitalist incentives to improve the quality of care available to Americans.  It rewards the same individuals, interests, companies, systems and institutions which have traditionally lined up at the trough for slop.

It's perverse. The Republicans are less capitalist than the Democrats, the the conservative Democrats are less capitalist than the Republicans. Go figure!

Coal In The Stocking

In Dickensian fashion, there will be coal in the stockings of many Americans following the Christmas holiday, but for others there will be a big, freshly roasted, fat goose provided by Senators Liberman, Nelson and others who have been agents, not of reform, but of the special interests including the insurance, pharmaceutical and financial industries, as well as parochial supporters.

We have learned that money talks, that Congressional votes flow in the direction dictated by lobbyists who direct political campaign funds, and that health reform is a fiction which was used by both major parties to atttract attention, political support and financing without any real intention of implementing serious health care reform that Americans expect and deserve.

For most Americans this is the season of opportunities lost, deeds not done, and  needs not met. For others, the fat goose Congress has set at their tables, will provide bountiful feasts.

Shame.

Stem Cells and Biologicals

 A reader asks: "My question was, with the advent of cures for chronic diseases and other maladies, brought about by advances in stem cell based treatment, will the cost of the U.S. health care system decrease in the foreseeable future?"

Todays' New York Times describes the acquisition of stem cell (for treatment of inflammatory bowel disease) development rights from Athersys by Pfizer. New stem cell products, along with other biologicals which depend on genetic development (a number of which are already on the market for treatment of arthritis, neurologic disorders, bowel diseases and other immune-mediated disorders) have the promise of effectiveness (and some significant side-effects) at a very high price, amounting to many thousands of dollars a year for each patient treated and the likelihood that treatment will have to be continued for extended periods, guaranteeing income streams to those pharmaceutical companies.

While some of these products may "cure" the diseases which they target, many will be controllers which require prolonged continued use. It is understandable that pharmaceutical producers interested in the areas of stem cells and other biologicals for treatment of serious diseases have pressured Congress to extend patent protection to protect their investments and their streams of revenue and are setting their prices high to generate corporate profits.

While some of these products have social value, may keep people working and paying taxes, and sometimes produce more effective results than existing treatments, with relief from pain, deformity, debilitating disease and delay or prevention of imminent death, I see no reason to believe that they will lower the percentage of gross domestic product devoted to pharmaceutical costs and health care expenditures. The market will permit maximization of pharmaceutical companies' pricing and profit structure and foster pharmaceutical companies' choices, as to the stem cell and biological products they produce, to support drugs which are expensive and chronically used. The question is whether their use lowers other health care costs (i.e., physician and nursing services, hospital utilization, physical therapy, radiologic and therapeutic services) for a net reduction in health care expenditures.

If the net cost of all services is reduced because these new products promote efficiency, the nation will benefit. If stem cell and other biologic therapies simply add to an existing inefficient economic structure, the nation and you, the reader, as a health care purchaser will lose. 

A Long Day

Because I have been ill, my blogging has been curtailed.  To give you a sense of what has been going on - I'll describe yesterday.

Phone rang once at 5:20 AM. No one there.
As instructed, I appeared ( accompanied by my spouse) at the University Medical Center at 7:20 AM. Confusion prevailed since the department's computer had me scheduled to show up at 9:30, though someone from the department had called the night before with instructions to show up before 8:00 AM.  Sat and waited.

Called into the pre-op room, changed into hospital garb, climbed into the preop "bed,"  answered a lot of questions the answers to which were pretty much in the electronic medical record, though not entirely accurately in the electronic medical record. Nurse was very thorough and competent. Started on IV.  Waited.  Waited. A Fellow appeared and we discussed the proposed procedure, discussed my history, went through a limited physical exam, and negotiated some issues which were important to me relating to lab tests and operative procedure related events. Faculty member came and we had a sensible and appropriate (more mature) discussion of his plans and recommendations, the proposed procedure and the likelihood that my procedure would be significantly delayed because he had to treat a child and we agreed the child should come first (which was the faculty member's plan anyway). More waiting.  More waiting. Reminded nurse that I needed a simple blood test done and it was done. Told that the procedure was going to start soon.  It didn't, but eventually it did. Brought by a pleasantly chatty nurse to a high technology room containing 5 people and placed on a hard narrow table. IV running (fluids, pain relief and sedation). O2 running. Monitors running. Local anesthesia for a biopsy provided. Biopsy done with little pain or discomfort and lots of instruction for the Fellow who was there learning. Off the table to the wheeled transport. To another room for  recovery and two hours of fitful dozing. Then to another room for final awakening and sitting up. Then to a wheelchair to my car. Then home where I arrived after an almost 11 hour day.  Now the wait for pathology and lab results.

Response To An Important Reader's Comment

An anonymous reader commented: "How does a patient determine the factors you mentioned? A modestly sophisticate patient may determine these things over time, perhaps too late. Many patients do not have sufficient sophistication to determine and evaluate these factors. In the past, not too long ago, doctors' advice was taken quite uncritically. LCB"


My response invokes  recent experience. The story is real.

Like all of us, I develop  health problems from time to time.  In anticipation of my needing consultation from a  physiatrist or subspecialty surgeon, my internist ordered an MRI and  I visited a physiatrist to receive a series of treatments. These treatments failed; I needed a subspecialty surgical consultation. In discussing my expectations of the consultant with my referring internist, I said: I expected the consulting physician to: (1) be highly knowledgeable and experienced in the surgical subspecialty; (2)  have "good hands" (which to other physicians, means that he or she has excellent surgical dexterity and technique); (3) have a good base of medical knowledge and (4) good judgment. My internist (who at the time was being "trailed" by a medical student from a nearby university medical center) seemed a little surprised by my statement of expectations, but  gave me the name of two consultants, one within his group practice and the other outside. He asked me to see both physicians. The subspecialty surgeon within his group focused on the presenting diagnosis and told me that it was not the source of my problem but went no further, providing me with enough information to know that I was not going to receive the complex care I needed from him in that medical group.  I proceeded to the university medical center (to which my internist had sent a letter of referral) where I found a subspecialty surgeon (recommended by the department chairperson) who immediately demonstrated his qualifications to meet the expectations described above and will follow through with my care.

Readers can apply the same techniques. Tell the referring physician or other person what your expectations are. Ask for the names of several consultants and do not allow yourself to be locked into one medical group (may be difficult in an HMO setting).  Check your state medical board listing of disciplined physicians to learn if the doctor to whom you are being referred has had medical disciplinary or competency problems. Google the doctor and the practice. Ask friends, colleagues and others in your business and personal circles if they have had experience with the physician(s) to whom you have been referred. Pay attention to what they say about competency, focus, judgment, practice habits, experience as patients billing fairness and outcome.  Find out if the physician practices in a hospital and get an assessment of the quality of the institution (states have information about morbidity and mortality for certain procedures done at hospitals throughout the state and you can also ask to speak to the hospital's "Chief Medical Officer" for similar information).  If you will require surgery, get the statistics on frequency of the proposed surgery at the hospital or facility at which the doctor practices and the institution's and doctor's complication or failure rate.  Choose a physician who proposes to perform a procedure which he or she has performed many times before in an institution which has extensive experience with the proposed procedure: experience counts! And ask about the quality of the anesthesia services since anesthesia has its own serious set of risks.

These are some of the things a sophisticated, non-sophisticated person, or family member, can do.  Much of the important information is internet-available.

And finally, pay attention to your instincts: if you are uncomfortable with the doctor or your perception ofthe facility, find someone else or go somewhere else.

Evidence Is Only A Part of Evidence Based Medicine

EBM is the integration of clinical expertise, patient values, and the best evidence into the decision making process for patient care. Clinical expertise refers to the clinician's cumulated experience, education and clinical skills. The patient brings to the encounter his or her own personal and unique concerns, expectations, and values. The best evidence is usually found in clinically relevant research that has been conducted using sound methodology. 

There are serious subtleties in Sackett's straightforward statement. Has the physician, addressing your problem, necessary cumulative experience? How is relevant cumulative experience defined? How do patients judge a physician's total  education? How does a patient assess a physician's clinical skills?

What are some of the other important issues? Does the physician have a stable personal life? Is he or she in financial difficulty?  Did he or she have a knock-down drag-out fight with his or her spouse or children the night before he or she is scheduled to perform a technically difficult procedure, requiring a sharply focused mind,  for you?  Does the physician use too much alcohol or is he or she a drug-user?  Does he or she have a health problem which affects medical practice and judgment?  Is he or she a personal risk-taker and is that a personality characteristic you consider useful in your care?

Is the physician intellectually aggressive and knowledgable? Is the physician energetic or lazy?  Is the physician inappropriately fearful or self-defensive?  Does he or she seek-out and value the opinions of other physicians in the same specialty or does he or she dismiss those opinions which are inconsistent with his or her views. Does he or she know what evidence is important in your case, obtain that evidence and then carefully review it, integrating it with the available history, physical findings and other medical data about you? Does your physician seek consultation or make referrals or does he or she believe that he or she can "handle it all" even though his or her experience may be very limited?

Does your physician work in isolation? Does he or she test his or her ideas in study groups, professional lectures or other activities? Does he or she read leading medical journals or rely on pharmaceutical company sponsored education programs for updates? Are your physician's extra-curricular activities primarily medical-political, or is he or she focused on activities benefitting the comunity?

Does your physician work in a medical group run or owned by lay people? Are the physicians in the group setting its course or are they only paid employees for whom working conditions, patient volume, practice philosophy, professional standards,  office facilities, and financial production numbers are dictated by others?   Do the physicians in the group carefully observe each other so that substandard care is addressed and high quality care is rewarded? Is referral outside the group discouraged? What are the ethical standards and practices of the group? What is its mission?

"Evidence" is a single factor in a many-faceted  physician-patient relationship.  While the preparation, interpretation and value of medical evidence changes rapidly, the physician's wisdom, personal and professional judgment, compassion and competence in addressing life's issues tend to be stable. Don't get hung-up on evidence. Look for the subtleties.

Your X-Ray & Your Doctor's Computer Monitor

In yesterday's blog, I discussed two physicians' abilities to display and review the same MRI, on their desktop computer monitors (and their different conclusions). On its face, this display technology seems efficient, appropriate, and without any downside.

But there is a downside, which will probably elude anyone who has not practiced medicine collaboratively with person to person discussion between two (and sometimes more) physicians reviewing an x-ray: a radiologist and the physician who ordered the study. When these physicians spend a few moments together to jointly review critical patient information (history, physical findings, lab, clinical impressions), they both benefit professionally because the study is no longer a solo cold intellectual exercise conducted in a dark room or reviewed in another country. The study becomes a source of information enriched by these physicians' collaboration. The radiologist can augment the ordering physician's clinical knowledge and skill, providing input which causes the clinician to modify his or her care of the patient.; the ordering physician can call attention to study findings that the radiologist may not have considered important but are clinically relevant.

While computer monitors on pysicians' desks may  show reports and scans, they do not provide the depth of information vital to the care of a patient with serious illness. Computer medical technology may provide the illusion of superior efficiency, but someone needs to study the real cost of  this application of non-collaborative technology..

When To Find A Different Doctor

Today's blog reflects personal recent experience. I hope that it will help my readers.

Recently I visited several physicians concerning a medical problem. My internist recommended selecting two highly competent physicians in the relevant specialty (he did make recommendations). I had long ago learned how difficult it is for patients to evaluate the competency of  physicians to whom they are referred (even when they are, themselves, physicians), so I went about the process methodically, checking with other respected physicians, friends and academic leaders, as well as with the Medical Board of California's web site where I could verify credentials and freedom from serious disciplinary action.

I chose two doctors, one in a well-known group practice (my internist's) and the other at a nearby university medical center.

The first physician briefly reviewed my history (he had a computerized medical record), examined me, and with me and my wife, reviewed the abnormalities on an MRI which had been performed 6 months earlier.  He told me that he could not help me with the presenting pain symptom because the presumed responsible condition was not sufficiently severe to be its cause. He did not discuss several other abnormalities on the MRI, other than to note that they were there and they were not treatable by him because there was no evidence-based literature to support his specialty intervention.

The second physician also took a history, examined me, and reviewed the abnormalities on the MRI  (on his computer screen) done earlier and agreed with the first doctor that the MRI  demonstrated that the presenting diagnosis did not warrant surgery. But he went further to analyze and discuss the other abnormalities in the scan, which were not significantly addressed by the first physician, and to ask the question "why are these abnormalities here and what causes them?" He then,  citing applicable professional standards of practice, sent me for lab, x-rays and an additional MRI after dictating a clinical note in my presence.

When the first doctor showed the abnormalities on his computer screen, I was surprised that he did not give them more than cursory attention and comment. But I decided that if he had little interest or comment about them, I would recognize his professional limitations and demand more interest, attention, analysis and discussion from the second doctor. I didn't have to: the second doctor demonstrated interest, attention, analytical ability and the capacity to ask "why?"

My suggestion to readers is that if your doctor, hearing of an abnormality on taking a medical history, or seeing an abnormality in a laboratory test, x-ray or scan, doesn't ask "why,"  he or she is the wrong physician for you.  The physician who instinctively reaches for the prescription pad or gives a simple reassuring answer to what may be a serious clinical danger signal may not be providing competent care.  Find yourself another doctor who is less anxious to limit choices or exercise professional intellect.  Find a doctor who asks "why."

Sometimes doctors make mistakes. Sometimes patients are wrong, too. But you can protect yourself by asking your doctor "why?"

Does China Benefit From America's Health Care Reform?

Aside from the dubious benefit of turning $300+ per hour physicians into minimum-wage data input clerks, as they waste their time in entering computer data into terminals rather than spend their time actually talking to, examining and thinking about patients, there are other problems with the push to computerizing health care records.

Most of the computer equipment that I see these days has Chinese origin.I don 't fault Chinese engineers and entrepreneurs from developing their computer system production capacity and quality, but I do believe that a big chunk of the   "computerized medical records" budget will not lower America's  health care costs, will not create jobs in the health care industry and will not improve health care. But it will result in a huge American demand for Chinese-origin computer systems which will funnel money right out of American health care and into China's coffers, aggravating our economic recovery, unemployment and America's trade deficit with China. Not only will the push to computerize America's health records weaken our dollar, but as the New York Times points out today, "Little Benefit Seen, So Far, in Electronic Patient Records".

A Day At The Races

After passing crowds of people patiently lined-up in front of the building and noting the "Racetrack" sign which told me I was in the right place, I parked and then reported for assignment at 7:30 AM. We were told (and the deputy sheriffs and security people with whom I shared the lunch table verified) that the lines to receive the H1N1 flu vaccine had begin to form at 1 AM on a cold fall night.  Even the Santa Clara County Fairgrounds Exhibition Hall was cold and I wondered how well my stiff fingers would accomplish the job ahead and how I would stay warm in my cotton and Dacron tan public health uniform. My worries proved unnecessary.

It was clear that the Santa Clara County Public Health Staff had paid lots of attention to vital organizational details and logistics. Vaccinators (like me) wore distinctive orange jackets and logistics people, security, administrators, greeters, guides and translators each had distinctive garb. The enormous hall had serpentine Disney World-like crowd handling lanes. Tables and chairs lined each side of the hall and at each table were three vaccinators, supplies of syringes and vaccine and alcohol swabs and adhesive bandages and cotton balls and every other item which we would need to do our jobs throughout the day.  After a quick breakfast and a few organizational instruction meetings (i.e. - "don't get dehydrated," "drink water," be sure to take your 10 minute breaks," and be sure to stop for lunch") we set out for our tables.

The introductions at our table were brief. I worked with two paramedics who throughout the day did not waste words, motion, vaccine or supplies. At 9:30 AM when our first patients appeared, one of the paramedics had pre-filled syringes with vaccine and we were ready to go. We worked steadily throughout the day.

Each time we had an empty chair, we signaled a volunteer who directed individuals, and families, to us. Mothers, fathers, grandparents, young and older children of all character and description presented for H1N1 vaccine. They seemed well-informed (thanks to the people who were assigned to work the lines to provide information to the potential vaccine recipients) and almost always came with the paperwork which assured us that their vaccination experience would not involve unnecessary risks. The noise level was high because of screaming children, but because of the educational effort directed to the potential vaccine recipients, they were well-informed and relatively relaxed, which was reflected in most of their kids' simply accepting the injection or the nasal flu vaccine.

The hours passed quickly, Our stocks of vaccine dwindled. And the last vaccine recipients were cared-for. Unlike the iffy world of horse-racing, there no question about the benefit received by thousands of people whom we vaccinated, some of whom might otherwise be sickened or die from H1N1 influenza.

Public health prevention is better than trying to treat the complications of a preventable disease.

Make The Call

Whether you are a Republican,  Democrat, or an independent, call your U.S. Senators' offices and ask:
1. How much campaign money have (he,she, they) raised from pharmaceutical companies?
2. How much money  have (she, he, they) raised from insurers and insurers'associations?
3. How much money have (they, he, she) raised from hospital associations?

The fact that you called and raised these questions will make a difference. Just do it.

"I Want My Doctor"

Recently, my television screen has been filled with pictures of angry protestors, standing up against health care reform imposed by the federal government.  Prominent among the statements was a single refrain: "I want my doctor."

Sorry, but perhaps you haven't noticed.  The people who took your doctor away were not monstrous federal officials, but health insurance company executives.  They did that by selling health insurance plans to a company, then jacking up the premiums so that the company (whose employees had become a few years older and a greater insurance risk) would find another company.  Each company had its own contracted doctors in its network and when employers moved from one company to the next, they lost "my doctor" and replaced him or her with a new "my doctor."  The demoralizing effect on physicians was severe, as physicians came to realize that they were merely pawns in the insurance game, that the patient who sang their praises on December 31 would be moving to another doctor on January 1st, and that the historic physician-patient relationship no longer existed.  And those health insurance companies did something else: they negotiated rates of payment to the doctors which were actually less than the Medicare rates of payment, leading the most qualified doctors who provided high quality care, to drop out of some of the plans, retire or leave town, so that you couldn't see "my doctor" under any of the plans provided by the health insurers and your employers. Or of you did get to see "my doctor" it was not to spend the 15 or 20 minutes with you as was the doctor's customary practice, it was a 5 minute visit because that was what the health insurer, financed by you and your employer, was paying for. You may have also noticed that some of the new doctors in the network provided by your health care insurer and your employer weren't quite as well trained or qualified as your old "my doctor" who you couldn't see any more. Lots of reasons for that but you can imagine most of them.

So let's do away with the mythology that the big ugly federal givernment bureaucrat is taking away "my doctor."  That was done by health insurers, your employers, your unions and you.  Sorry.

Keep Your Eyes On The Ball

During the Reagan era, as a board member of the National Health Lawyers Association (which subsequently morphed into the American Health Lawyers Assocation) I learned of the enormous power vested in House-Senate conference committees, where proposed legislation may be rewritten and the vote for the rewritten, often very different bill than that originally passed by the house or senate, is straight up and down.

Instead of getting excited about the political hoopla surrounding health reform, I suggest my readers keep their eyes on the ultimate conference committee and its rewrite of health reform. That's where deals will be made, the decisions hammered out, and health reform will either be gutted or given the muscle that it needs to work. Take a look at Ezra Klein/Jim Horney's analysis of conference committee functions for insight into this legislative powerhouse.

The End Game

In chess, beginners can start the game with a flourish, but they lose. Average players can work into the middle-game with some wins and some losses. But the champion chess player excels in the end game where inventiveness, visualization, skill and guts make the difference between winning and losing.

Health care reform is approaching the end game. The issue is whether Reid, Pelosi and Obama have the inventiveness, ability to visualize, skill and guts to win true health care reform with a federal alternative insurance program.  Are the lobbyists for pharmaceuticals, insurers and health professionals going to determine how and whether Americans get the health care they need and the nation can afford? Are there any legislators who think in terms of what is best for America and its citizens rather than their political supporters?

Will Obama, Reid and Pelosi be check-mated?

A Reader's Question and My Response

Hurray for the doctor who recognizes that electronic medical records sometimes contain medical incorrect information which later physicians and nurses mistakenly believe and rely on to make important (but incorrect) decisions because everyone believes the myth that what's in a computer must be accurate. Hurray for the doctor who has staff validate the accuracy of the information that your wife gave on previous visits, because sometimes the information that patients provide is wrong. Hurray for the doctor who has protocols which express a high standard of information verification to protect his patient and the child she is carrying. If the doctor is as careful and consistent as your question suggests, your wife has chosen a careful and competent doctor.

HPK

On Tue, Oct 27, 2009 at 10:21 AM, Anonymous wrote:

Anonymous has left a new comment on your post "Is Something Rotten In Canada's Health IT Stimulus...":

My wife, JK visited her doctor today, at his office in a NYC hospital. She was interviewed by a sweet young thing who asked her the same questions, that she has been asked on her many visits, questions about her medical history.
Wouldn't it be sensible, time saving and more accurate if her records were available on a protected basis on a computer? It might, dare I say,even be cheaper.

We're From The Government & We're Here To Help You

This is not a good time for hospital emergency room or intensive care unit director physicians in your communities. If a more severe mutated form of H1N1 ("swine") influenza or a more lethal influenza such as H5N1 (avian) appears, one of these physicians may have to make decisions for which he or she is not likely to be professionally prepared, for which there are  no community accepted ethical standards, and which may leave the decider professionally liable for misconduct and exposed to personal financial ruin.

Quietly and without significant current public input or current public ethical discussion , national, state and local public health authorities have assumed the responsibility to order the take-over of public, private and non-profit hospitals, and determining the priorities to be applied when providing life-saving treatments during a national health emergency which swamps the system. As described in The New York Times, 10/25/2009 "Week in Review" section at page 3, the dilemma of "Choosing Who Gets the Breath of Life" and other serious issues of life-saving facility availability will be resolved by government-prescribed triage rules, rather than the rules which govern today's allocation of health care.  Who among this blog's readers knows what those triage rules are? Who gave appointed officials the authority to dictate this approach to medical decision-making?

Who among my readers knows which patients will be allowed to continue to receive respirator support and which patients will have that support terminated for the benefit of another person? Who among my readers knows which patients will have dialysis terminated so that another person can have access to the dialysis machine? Who among my readers knows whether, under the triage rules, some older citizens will be removed from life-saving support to benefit those who are younger, what the rules will be on allocation of support among various races, ethnicities, religions, social groups, economic status groups, political members, citizenship groups or occupational groups?

Decisions will have to be made. But having them made by appointed bureaucrats without vigorous current public input  and without active current discussion of the ethical issues is inappropriate.  The public has the right to participate in this discussion and those with experience and expertise in analyzing and formulating ethical choices and decisions should be heard.

After all, this is America.

Don't Blame The American Cancer Society

In the 1990s, health insurers, HMOs, PPOs, actuaries, and their "quality" evaluation certifying agencies, couldn't demonstrate that they were increasing survival (a meaningful endpoint - the "real thing") so they decided to boost their marketing appeal by convincing employers,  their insured, unsophisticated government bureaucrats and other "hangers-on," that  requiring providers to do lots of mammograms and  high numbers of prostate specific antigen tests constituted appropriate proxies for the real thing.  Of course, that wasn't true, but by hyping  untruths often and loud enough, and  casting  an aura of doing good, potential clients and some public charities interested in specific disease types spread the word for their own fund raising and economic purposes.

Today, the truth about excessive mammography for breast cancer and over-testing (using the PSA) for prostate cancer was published (New York Times, 10/21/09, page 1). We can now understand that some of the "good" that was done was actually unnecessary evaluation, testing and treatment which had no effect on patient outcome. The "sunshine enema" when the surgeon comes out of the operating room and tells the family that "we got it early" inferring "cure" (when actually the disease that was found was only possibly cancerous) has been exposed. We need to be more skeptical, to question the confidence limits of  treating physicians in the correctness of their diagnoses. Public skepticism about proposed treatments and the very real risks inherent in surgical procedures, radiation therapy, weird diets and drug treatment should be reflected in a demand for peer-reviewed scientific evidence that what is being proposed, is appropriate.

Exercise? It's A Matter of Understanding People!

Link to a VW commercial which says more about human nature and exercise than any infomational TV or a respected government health guru. Will health insurers rush out to emulate the exercise equipment shown?

Same Old, Same Old . . . .

Will health insurers proclaim that they cooperate with health reform, while they take aggressive measures to  avoid risk?  Will they play these games?

1. Devise drug formularies which provide limited access to expensive medications required for lifesaving treatment of serious diseases?
2. Provide a disincentive tier copayment system for drugs which makes them unaffordable for persons with serious diseases (genetic and acquired) requiring expensive new drugs?
3. Provide no or very limited network access (or high copayments) for consultation or follow up with expert physicians and facilities for patients with rare diseases which are expensive to treat?
4. Redline areas which traditionally have higher-than average claims costs?
5. Shift patient utilization and serious sickness risks to physicians or physician groups who are not financially equipped to shoulder these risks?
6. Provide low payment to physicians in certain specialties and geographic areas to discourage physicians from attracting high-cost, high-risk patients?
7. Adopt the 85% rule which means that if 85% of the patients do not complain, or on survey say that they are satisfied with the plan, that is sufficient? (Such a plan may discourage sick high-users who are in the 15% of the dissatisfied group.)
8. Deny benefits retroactively (i.e., an out of the area claim for a traveling patient who reasonably considered the condition to be an emergency)?
9. Use marketing measurements of "quality" rather than disease outcome measurements?
10. Discourage utilization by providing telephone roadblocks to patients and physicians obtaining authorization for care?

Follow The Money: NHLBI Awards $170 Million to Fund Stem Cell Research

If you want to know what the government research priorities are, and where the government views its agenda as most likely to be achieved,  see the NIH following release by clicking on the link..

Kidney Dialysis: Futile Care For Some Nursing Home Residents

Though most of my readers are unlikely to subscribe to the New England Journal of Medicine, Yahoo has done an excellent job in summarizing important issues described in Tumura and Covinsky's original 10/15/09 NEJM article, "Functional Status of Elderly Adults before and after Initiation of Dialysis" (N Engl J Med 361:16).

I read the original article, and Yahoo's summary, with particular interest because a family member chose to end dialysis, and be allowed to die with comfort-only care, when this person's quality of life had severely deteriorated. In my professional life, the issue of  starting or continuing dialysis for elderly nursing home patients has presented several times, and each time I have found the underlying questions troubling.

I will not repeat the summary or further describe Tumura and Consky's article. But I do want to highlight the nature of the decision made to perform dialysis for nursing home patients and the persons who participate in the decision.  Kidney failure in the elderly rarely presents precipitously, unless it results from a medication or procedure known to acutely damage kidneys (i.e., certain antibiotics or x-ray procedures).  As kidney function gradually deteriorates in the elderly, there are often coexisting and contributing serious diseases, such as diabetes, arteriosclerosis, heart disease, and hypertension.  And sometimes there may be age- related dementia or other serious neurologic impairment. The nursing home population, which may be considered for dialysis, is a frail impaired population for which kidney failure is just one of several illnesses which day by day take their increasing toll and in which simply performing the activities of daily living requires trained assistance for the patients.

There may be little or limited conversation between a patient and his primary physicians other than a statement that the doctor has found severe kidney disease and believes it "is time"  to refer the patient to a nephrologist (kidney doctor) and perhaps a vascular dialysis shunt surgeon for consideration of dialysis as a "life-saving" option. In due course the patient is seen by the consultants whose major professional interests and income may revolve around dialysis and the patient, and the patient's family, become convinced to pursue dialysis. Sometimes the patient and family are given full disclosure about the difficulties of performing and maintaining the vascular shunt for dialysis, and sometimes they are not.  Sometimes patients and their families are educated about transportation difficulties,  complications and discomforts associated with dialysis, and sometimes they are not.  Sometimes patients and their families mistakenly believe that dialysis may allow the kidneys to regain function. As the process, initiated in hope, proceeds, patients grow older and more impaired from their complicated medical conditions.

Perhaps a neutral ethicist or "ombudsperson" should be involved early in the decision-making process for all patients to whom chronic dialysis is being offered to evaluate patients' and their families' knowledge and understanding of what is being considered and offered: to perform a reality check with patients, their families, health care surrogates, caregivers, primary care physicians and consultants. If with medical advice, adequate information and understanding, the decision to proceed with dialysis is made, I suggest interval rechecks to verify that the decision remains unchanged rather than proceed unthinkingly simply because dialysis has been initiated.

My Worst Day "At The Office"

It was my last year at Stanford as a Senior Resident. Marie asked me if I wanted to make an extra $25, moonlighting as the doctor at a Redwood City, California,  High School football game. In those days, particularly to a medical resident with a checking account balance hovering at about $10.00 on a good day, the chance to make $25 was irresistable. Since sports medicine was not my field, I asked a  fellow resident  (an orthopedist) how to be a doctor at a high school football game: "Whatever you do, don't touch an injured player" was his advice. "All of the players have their own doctors, and if someone is really injured, call for an ambulance."

I showed up precisely at the designated time, but found that the game was in already in progress.  One of the grumpy  high school coaches showed me where I was supposed to sit and immediately left to go yell at his players on the field.  When a player was injured, I left the bench to make sure the student was OK. If he looked  bruised, I sent him to the bench for a 5 minute respite and went back to my seat.  By the time I sat down and looked at the field, his coach had been him back in the game, again and again and again.

It took about 2 minutes to figure out my role: I was there because California law required the presence of a doctor.  It did not require that the coach (or the student)  take the doctor's advice. And he didn't.

A few days ago, an article about dementia among former football players appeared.  Professional football teams and their managements were pictured as villains.  But my experience taught that the problem of player abuse began earlier, when high school football coaches sent injured students, for whom they were responsible, back into the game.

Is Something Rotten In Canada's Health IT Stimulus Program

See Dana Blankenhorn's report which begins:"The scandal involves charges of influence peddling regarding the 2007 award of a health IT contract to Pixalere Healthcare, now called Web Med Technology, for wireless diagnostic software." Pouring billions into our health system's electronic records and allied systems will open another door to health care fraud in America which may make predictions of cost-savings ludicrous..

Texting While Treating

Imagine yourself in a cab in Boston when the cab driver asks "is it OK with you if I text and drive?"  My guess is that you would say "no" (perhaps with some added expletives) because you understand the relationship between texting while driving, inattention to the road, and the increased possibility that you will be injured or killed in a crash.

Today, at my occasional Thursday noon lunch, some of the physicians were discussing the introduction of computerized medical records to their practices.  One doctor, whose practice is months into the process of medical computerization, complained that he couldn't concentrate simultaneously on the patient's statement of her history and the need to record the encounter into his computer.  The doctor was texting while practicing - no less a dangerous activity than proposed by the cabby.

But what if the cabby had said - "Look, the government says I must text when I drive?"  Or what if the doctor says "The government is telling me to text during our office visit?"  In either case, the risk is that inattention to the task at hand may result in injury to you.

So the next time you are in the doctor's office and the doctor's eyes are focused not on you, but on the keyboard and computer monitor in front of her, fasten your seatbelt and hold on: you may be the victim of a lifethreatening error caused by operator inattention.

The message to doctors: you can't deal with your patient's serious medical issues when your mind is focused on your computer.

Critical Political Effectiveness

A few days ago, my wife and I visited the Lyndon B. Johnson museum and Library at Austin'sUniversity of Texas campus. We saw a detailed history of Johnson's  life and political activities from childhood to death. What struck us was the thoroughness of his apprenticeship and life's training as a political figure and campaigner, his long-hours of work (often from 4 A.M. to midnight),  his extraordinary Congressional career which earned him respect, and political chips, from Representatives and Senators on both sides of the aisles, and his principles concerning civil rights which dated to his early career as a teacher in a Texas Mexican-American primary school.

When Lee Harvey Oswald murdered President Kennedy,  Vice President Johnson had the energy, talent, politcal experience, credibility, focus, commitment and contacts  to become an extraordinary President, actively involved in passage of  revolutionary civil rights  and health care reforms, including the establishment of Medicare.  However, his commitment to continuing the Vietnamese war eroded  public support and led to his decision not to seek reelection.

In my opinion, President Obama lacks a number of the presidential  qualities of President Johnson. Obama's decision to flee Washington to pursue the illusion of a Chicago Olympics, rather than to provide needed leadership to ineffective Harry Reid in the Senate battle over health care reform, demonstrates a lack of  focus and a failure of staff  to work with him to set an appropriate agenda. Obama abandoned the appearance of serious comitment to health care reform to chase after international games. Like the Olympics, his actions suggest amateurism.

HHS-OCR GINA Proposed Rule

HHS OCR Issues GINA Notice of Proposed Rulemaking



October 1, 2009



The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has issued a notice of proposed rulemaking to strengthen privacy protections for genetic information under the HIPAA Privacy Rule, as required by the Genetic Information Nondiscrimination Act of 2008 (GINA).  GINA gives individuals new privacy and nondiscrimination rights with respect to the use of genetic information in health insurance decisions and employment.  The proposed rule would modify the HIPAA Privacy Rule to clarify that genetic information is health information and to prohibit the use and disclosure of genetic information by health plans for underwriting purposes.  The proposal includes a 60-day public comment period.

Ethics, Equity, and Influenza Pandemic

We are in the middle of an H1N1 influenza pandemic. Fortunately, though H1N1 influenza is spreading rapidly in the United States, it has been a moderately severe infection (more like seasonal influenza) rather than deadly like its grim cousin, epidemic avian influenza. If you are wondering about ethical considerations, public health decision making and decisions, issues concerning limited resources, professional responsibilities and who may be treated and who may not be treated, please see the World Health Organization publication "Ethical considerations in developing a public health response to pandemic influenza."   It's worth reading. And after you have read it, contact your county public health department and learn how it has dealt with these issues which will be vitally important to you and your family when the next lethal pandemic, or public health emergency,  strikes.

DEFENSIVE MEDICINE - MALPRACTICE SUITS NOT THE ONLY ISSUE

Republicans, and now Democrats, proclaim that defensive medicine is a major factor in health care inflation. Defensive medicine is the practice by which physicians (and hospitals and other providers) order all of the tests and procedures required to meet the highest standards of professional (or institutional) practice in order to thwart malpractice accusations based on failure to consider, and test for,  all of a patient's conditions which might give rise to a professional negligence lawsuit. Defensive medicine does not necessarily constitute high-quality care, but does reflect a rational fear of loss of a malpractice lawsuit and attendant consequences. Unfortunately, more tests and procedures may expose patients to increased false positive and false negative results and lead to inappropriate and unnecessary medical risk.

But fears of malpractice actions aren't the only cause of defensive medicine.  Physicians are held to a local, and sometimes a national, standard of practice through a process called "Peer Review."  If the practice in the community is to perform tests and evaluations and a physician chooses to do fewer tests, he may find himself in front of a medical group, hospital, county or other institutional review board (perhaps with some competitors as peer reviewers), defending himself against charges of failure to practice in accordance with applicable professional standards. Unlike some malpractice lawsuit results, a finding against the physician being reviewed (improper "competence or conduct") has an increased likelihood of resulting in her receiving a negative report to professional organizations and to the state and federal government, jeopardizing her family relationships, personal reputation, professional license, malpractice insurance,  hospital privileges and medical staff membership,  and  provoking exclusion from state and federal health programs (Medicaid and Medicare). Defense of each such case at a hospital or local level may cost $100,000 or more in attorneys' fees for each side, and if the case escalates to an investigation and charges brought by a state or federal agency,  the cost may substantially increase.

While defensive medicine related to malpractice is well-known and understood, defensive medicine related to peer review may be more subliminal and less appreciated.  In either case, many physicians play it "safe."  Faced with the dire consequences of a failure to comply with professional standards, they may notch-up their ordering of  additional tests and procedures to test for unlikely, but not impossible diagnoses. You, or the insurer, get a bigger bill but the physician continues in practice, sleeps at night, and doesn't waste thousands of dollars on attorneys' fees.

If you were a physician, what would you do?

Our Diminishing Resources

In the closing statement of his last lecture to my graduating class, the late Ludwig Eichna, M.D., then chair of the Department of Medicine at Downstate Medical School, told us  that 50% of what we had learned in the preceding 4 years would be proved wrong in 10 years.  He was too conservative:  more than 50% proved to be wrong and the timeframe was half of what he predicted.

Medical school graduates move through their internships, residencies and fellowships and,  like fish wrenched from the ocean,  lose their freshness and even begin to smell. They practice with the skills they acquired in their training. They apply the principles they learned early in their careers. They receive their continuing medical education ("CME") from programs sponsored by hospitals (often directly or indirectly funded by pharmaceutical companies), not-for-profit or for-profit educational companies (which may be funded directly or indirectly by pharmaceutical companies or similar vendors), and become focused on common medical problems which present no great intellectual challenge. Like those ocean fish, their eyes glaze over and they lose their enthusiasm and skills for anything other than simple non-taxing straightforward cases for which they have had hours of lectures telling them which pharmaceutical product to prescribe that day (without recognizing that the courses they have had were really intended to push a commercial "cure" or "maintenance medication" for the problem they were dealing with in their 10 minute patient visits). I should be clear: there are legitimate continuing medical education courses, but they are often not as convenient in terms of location, access and time requirements, as the commercially-sponsored programs, though some publications (i.e., the New England Journal of Medicine and The Medical Letter) do provide CME through internet or other available access.

Enthusiasm from investors and IT personnel aside, computer diagnosis programs are not much help to physicians who never had or have lost,  or don't have the time,  to exercise the skills in history-taking they may have once learned.  Computer diagnosis programs don't provide help to physicians who have lost, or never had, adequate skills in physical diagnosis.  Lab tests may mislead physicians through false positives and false negatives, causing unnecessary additional testing and procedures which add not only cost to our system, but expose patients to inappropriate and unnecessary risks. X-rays and CT scans expose patients to potentially high doses of ionizing radiation

Many states have mandatory continuing medical education requirements, meaning that some physicians get at least 25 hours of dozing a year as the lights in auditoriums are turned-down for PowerPoint programs of the day, provided to the speaker by a pharmaceutical company or device manufacturer with the expectation that their investments will generate increased sales of their products.

Health Care Reform will require an up-to-date, well-trained, physician force whose competency is continuously upgraded.  Is there anything that you have heard from the President or Congress which will deal with these issues? Is there a line-item in the health care reform budget for updating and upgrading physicians' knowledge bases? Is anyone thinking about training 20th century doctors to take care of 21st century patients?

Max Baucus' Health Reform Proposal

I received this Chairman's health reform mark up courtesy of the American Society of Hematology. As you will note, it is scheduled for mark-up by the Senate Committee on Finance on September 22, 2009, though it is without Republican support and there is a question as to whether the Democratic Senate leadership has the votes needed to bring it to the floor. 

Where Do I Get Prescribing Information?

You may have heard about the uproar concerning "Comparative Effectiveness" proposals which would require head-to-head comparisons of various treatments or drugs in studies which have the power (i.e., which usually means a large number of subjects tested) to determine which treatments or drugs provide the "best" results.

We haven't seen many head-to-head drug tests because they are economically risky for participating manufacturers. Several years ago in a head-to-head test a well-known cholesterol-lowering "statin" didn't fare well against another manufacturer's product, teaching the industry a lesson about losing market share, losing sales, requiring your company to spend a lot more money on promotion to convince doctors to prescribe your drug, making discount deals with HMOs and other entities,  hurting your stock price . . .  Well, you get the picture.  So pharmaceutical manufacturers and holders of patents and rights on other forms of therapies are understandably reluctant to expose their products to the truth about their effectiveness, as compared to other products.

The issue really isn't rationing.  It is access to statistically valid information about the effectiveness of various therapies.  It will be difficult for a pharmaceutical company to convince the doctors at a pharmaceutical company lunch, or in its advertising, to prescribe its product when the objective evidence clearly favors another manufacturer's product (or maybe even no treatment). Your doctor often selects a drug for your treatment for entirely irrational reasons, not because your doctor is irrational, but because the system keeps accurate verifiable information from her. I met with a group of doctors and a drug company representative a few days ago and listened to information which omitted an important "black box" requirement which had just been implemented by the FDA

I get prescribing information from The Medical Letter On Drugs and Therapeutics to which I have subscribed for more than 30 years. Articles begin with the rationale for the FDA's approval of the subject drug, a review of its pharmacology, a review of clinical studies and adverse effects, an analysis of drug interactions and medically significant issues, and a conclusion, which often suggests that practitioners should delay prescribing the drug in question until more data becomes available. The Medical Letter is non-profit, has no advertisements, is neutral in tone, and provides reliable information.

By the way, until we have Comparative Effectiveness evaluations, why don't you ask your own doctor where he gets his information.  Is it impartial?  Is it truthful?  Is it complete? Does it come with a free lunch?

#37 - The Production

For a satirical put-up on the U.S. ranking of #37 in health care, go to:

http://www.youtube.com/watch?v=yVgOl3cETb4

"Insurance Insecurity"

HealthReform.gov has published "Insurance Insecurity" which is a fast read intended to bolster public perception that the health insurance industry has failed to serve the public interest. Sources are also provided, which will be helpful to professionals and academics.

A Sort-Of Historical Speech

It was a textbook, "let's make a deal" speech, aimed at obtaining concensus on the principles which President Obama laid out, so  that later, the principles could be expanded to provide the real muscle and meaning behind the vague wording. For its purpose, it was well done. I found myself asking for more specifics, but having watched/listened to several of Obama's internet-based presentations, knew that I and other Americans stood no chance of getting specifics  tonight. It was not what I had hoped for in my blog of September 6, 2009.

Having spent a long afternoon today at a biomedical ethics meeting dealing with serious issues of life and death, I resented the failure of Obama to discuss anything other than the business of health reform.   I also found myself resentful of the Republicans, massed and unsmiling in their dark blue suits, unwilling to let their politics yield to human and national needs, and almost expecting someone among them to stand up to demand that Social Security be repealed.

In all,  it was  not a memorable night.  Perhaps there will be substance soon to come.

And don't forget  ethics.

The One Bright Spot in Our Severe Unemployment Landscape

Current American employment and unemployment statistics are dismal, except for health care which is helping to carry our economy.  Government reports show increasing non-health industry numbers for the unemployed and  underemployed. Congress, in its infinite wisdom, may  pass health reform legislation which profits its political contributors and philosophical allies, but cripples our health care system and puts health care workers out on the street for "efficiency's sake" while protecting those in the financial industry who are responsible for our economy's collapse. 
 

This is a dangerous time for health care and for our economy.

In summary of the report:

1. In August, the number of unemployed persons increased by 466,000 to 14.9 million, and the unemployment 

rate rose by 0.3 percentage point to 9.7 percent. The rate had been little changed in June and July, after increasing 0.4 or 0.5 percentage point in each month from December 2008
through May. Since the recession began in December 2007, the number of unemployed persons has risen by 7.4 

million, and the unemployment rate has grown by 4.8 percentage points. 

2. Total non-farm payroll employment declined by 216,000 in August. Since December 2007, employment has

fallen by 6.9 million. In recent months, job losses have moderated in many major industry sectors. In August, 

construction employment declined by 65,000, in line with  the trend since May. Monthly losses had averaged

117,000 over the 6 months ending in April. Employment in the construction industry has contracted by 1.4 million

since the onset of the recession. Starting in early 2009, the larger share of monthly job losses shifted from 

the residential to the nonresidential and heavy construction components. In mining, employment 

declined by 9,000 over the month.

In August, manufacturing employment continued to trend downward, with a decline of 63,000. The pace of job loss 

has slowed throughout manufacturing in recent months. Motor vehicles and parts lost 15,000 jobs
in August, partly offsetting a 31,000 employment increase in July.

Financial activities shed 28,000 jobs in August, with declines spread throughout the industry. Job loss in 

financial activities has slowed since the beginning of the year. Employment in the industry has declined by 

537,000 since the start of the recession.

Wholesale trade employment fell by 17,000 in August. Employment in information continued to trend down 

over the month.

Employment in the retail trade industry was little changed in August. Employment also was little changed 

in professional and business services over the month. From May through August, monthly employment
declines in the sector averaged 46,000, compared with 138,000 per month from November through April. 

Job loss in its temporary help services component has slowed markedly over the last 4 months.

Employment was little changed in August both in transportation and warehousing, and in leisure and hospitality.

3. Employment in health care continued to rise in August (28,000), with gains in ambulatory care and in nursing and residential care. Employment in hospitals was little changed in August; job growth in the industry slowed in early 2009 and employment has been flat since May.  Health care has added 544,000 jobs since the start of the recession.

A Season Of Discontent?

For Jews, the month of Elul is a time of stocktaking, introspection, reconciliation and spirituality, activities which America's  leadership might emulate with respect to our health care system. It is not a time for  a Quicken-type printout of  life's balance sheet and a perfunctory paper plan for change, nor is it a time to measure health care only in economic terms.  It is a time to ask how our health system reflects out national values, where have we achieved our goals and where have we fallen short, to genuinely express regret over our national failure to provide appropriate health care to all Americans, to recognize that our unwillingness to take societal responsibility for health care represents a serious deficiency in the American spiritual system, to acknowledge that there is a greater good which must be achieved,  to describe, adopt and implement an appropriate Health Plan and then move-on.

This is not a season of discontent.  It is a time for hard work and political commitment  which will bring appropriate health care to all Americans, the poor, the rich, the weak, the old, and all of our children. It is a time when our mirrors' reflections should allow us to observe ourselves with pride, knowing that as a nation we have done the right thing.

Kathleen Sebelius Secretary, HHS: Reform To Help Older & Senior Women

Strengthening the Health Insurance System: How Health Insurance Reform Will Help America’s Older and Senior Women

Executive Summary

While all Americans shoulder the burden of rising health care costs and increasingly inadequate health insurance, the 17 million older women (ages 55-64) and 21 million senior women (ages 65 and older) in America have unique situations and health care needs that make them particularly susceptible to rising costs – at a time in their lives when access to affordable health care is increasingly important. Health insurance reform will remove these hurdles to ensure that older and senior women, along with all other Americans, get the quality, affordable health care they deserve.


Link To Report: http://www.healthreform.gov/reports/seniorwomen/index.html

Health Reform: Freedom and Responsibility for Physicians

Harold S. Luft, Ph.D, of the Palo alto Medical Foundation Research Institute and the University of California, San Francisco (Luft:) recently published a New England Journal of Medicine paper, "Health Care Reform - Toward More Freedom, and Responsibiity, for Physicians" (N Engl M Med 361;6 NEJM Org 8/6/09). His  concept of "more freedom and responsibility" particularly resonated with me, because it is consistent with research which I performed as a Fellow of the Health Research Council of the City of New York in the 1960s (HRC) ), which demonstrated that health care organizations under physician leadership and professional control provided patient care far more effectively and efficiently than non-physician led organizations.  My years of practice and organizational responsibilities in a large physician practice (San Jose Medical Group), as hospital chief of staff, as a member and officer of the board of trustees of a large health system, and as a director of the California Hospital Association, confirmed my academic conclusions: physicians must have the freedom (a right) to practice medicine, the responsibilities (obligations) consistent  with a highly professional exercise of those responsibilities, and  must organize themselves (with adequate capitalization) to accomplish the goal of appropriate patient care in the public interest.

 Luft is pessimistic: he doubts the ability of government to slow health care cost growth. He views insurers' (including a public system) tools for health care cost control to be only two: financial disincentives for patients and fee reductions for providers, neither of which have reduced historic health care inflation. He proposes a two-prong system consisting of  universal coverage for high cost services (the 60% solution - my term, not his) , such as hospital care and ongoing care for chronic illness, and a reorganized ambulatory care (the 40% solution) system. Hospitals and their physician systems would receive bundled payments to be allocated internally under each system's unique internal arrangements under the 60% solution. Ambulatory physicians and groups would receive payment at usual and customary rates. Luft proposes measures to avoid conflicts of interest, a highly sophisticated care and outcome information system and other strategies to encourage high quality outcome achieval with high level efficiency. His focus is on rational incentives for patients, physicians, other providers and institutions.

Patients, in ambulatory care, would chose programs meeting their own health care needs, financial capacities and philosophies. Credit-card type fee payment, from the program level chosen by the patients, would be processed just like any commercially existing credit card (drawing down the program pool left for use by the patient), eliminating ravenous administrative overhead. If patients wanted more care, they would  buy a plan offering more; if they felt they could get by with less extensive and expensive ambulatory care, they would save money through Luft's structure.  If they become very ill, requiring hospitalization or ongoing chronic care, they would be covered through the 60% solution pool.

Luft's paper deserves to be read and widely discussed. Whether his rational and sensible approach can be implemented in an environment of  inflammatory politics, economic uncertainty, greed, ego-involvement and scant attention to serious ethical issues, is something for each reader to consider. Check with your local medical library for the New England Journal's August 6 edition, pp. 623-28.

9/1/2009 - Link to cited article: Link to article: http://ihps.medschool.ucsf.edu/News/news/luftnejm.pdf

Inflation Is In The Eye Of The Beholder

On Agust 24, 2009, the LA Times carried an AP report that Social Security payments (LA Times)  for 2010 (and maybe 2011)  won't be increased because there is no inflation, leading to a decrease in net Social Security checks because the drug benefit premiums will rise.  Sounds reasonable: no inflation, no COLA, no increase in those monthly deposits to Social Security beneficiaries.

But wait - There's more! See what the U.S. Department of Health and Human Services has to say about inflation , when it comes to the government's ability to "charge" for inflation.

"HHS Issues Rules Adjusting Penalties under the Patient Safety and Quality Improvement Rule for Inflation (Penalty Inflation)


"As required by the Federal Civil Penalties Inflation Adjustment Act of 1990 (Inflation Adjustment Act), the U.S. Department of Health and Human Services (HHS) issued both a direct final rule and a proposed rule today adjusting for inflation the maximum civil money penalty amount for violations of the confidentiality provisions of the Patient Safety and Quality Improvement Act. These confidentiality provisions are enforced by the Office for Civil Rights (OCR).

"The Inflation Adjustment Act requires HHS to adjust for inflation the Patient Safety Act’s civil money penalty amount at least once every four years, beginning from the Patient Safety Act’s date of enactment, which was July 29, 2005. These rules adjust the maximum civil money penalty amount for a violation of the confidentiality provisions of the Patient Safety and Quality Improvement Act from $10,000 to $11,000.

"The public has 30 days to comment on these rules. If no adverse comments are received, the direct final rule will go into effect 90 days after publication, and the proposed rule with be withdrawn. If, however, adverse comments are received during the comment period, the direct final rule will be withdrawn. For more information, visit the OCR web site at http://www.hhs.gov/ocr/privacy/."

While there may be a perfectly sensible reason for the penalty inflation adjustment (such as a catch-up to the time that there was inflation 4 years ago), it seems incongruous to deny Social Security beneficiaries a COLA while now imposing a COLA equivalent on government-levied penalties.

H1N1 Influenza - Conflicting Concerns Unclear Plans

Ten days ago, I spent several hours at an excellent Santa Clara County Public Health Department Emergency Medical Services for Medical Volunteers for Disaster Response. I won't tell you about my snazzy new federally-compliant government identification card or about the uniforms we're going to get. What I will tell you is the tone of concern that permeated the discussion of the Swine Flu pandemic. We were told that medical personnel who actually take care of patients will be high priority recipients of the H1N1 vaccine (two injections to a series - approximately 5 weeks to full immunity). Pregnant women, school children, and young people up to age 24 (perhaps to age 30) will also lead the list of those targeted for the vaccine series, along with migrant workers.  Significant plans for non-hospital care of influenza patients in staffed centers for those who are sick (but not critical) are in the works, where they will be able to receive hydration and respiratory therapy.  I asked whether the Medical Volunteers would receive the vaccine, since we would potentially be the staff for the centers and would need two injections and five weeks to build protective immunity, but was informed that no decision had yet been reached on that issue. We talked about Tamiflu and learned that when the commercial doses run out, there will be reserves of public health reserves to draw upon (but asked my self whether the influenza will be Tamiflu resistant by that time). The public will be advised not to go to their physicians' offices or hospital emergency departments for routine influenza care, but to be in contact with health care providers for illness that has life-threatening characteristics (high fever, dehydration, severe shortness of breath).

Incidentally the H1N1 vaccine, in my county, will be made available to the usual medical provider sources, but public announcements of vaccine availability and administration will be limited.

To my surprise, Thomas Frieden, head of the CDC provided a more reassuring picture concerning the severity of the expected US epidemic in an interview today (CDC-Frieden: or Click on Title Above for Linkage).

My suggestion to high risk people is that they contact their health care providers about the availability of the H1N1 vaccine from them.  While children in schools, young adults in colleges, and pregnant females are likely to have ready access to the vaccine, I don't know what the picture will be for those now healthy age 30 - 65 individuals.  When plans solidify, I will pass the information on to you

New HHS Rule

HHS Issues Rule Requiring Individuals Be Notified of Breaches of Their Health Information

August 19, 2009

As required by the Health Information Technology for Economic and Clinical Health (HITECH) Act passed as part of American Recovery and Reinvestment Act of 2009 (ARRA), the U.S. Department of Health and Human Services (HHS) issued “breach notification” regulations today requiring health care providers and other HIPAA covered entities to notify affected individuals following a breach of unsecured protected health information.

The regulations require covered entities to promptly notify affected individuals, the Secretary of HHS, and in some cases, the media, of a breach. Smaller breaches may be reported to the Secretary on an annual basis. The regulations also require business associates of covered entities to notify the covered entity of breaches at or by the business associate. The regulations were developed after considering public comment received in response to an April 2009 request for information and after close consultation with the Federal Trade Commission (FTC), which has issued companion breach notification regulations that apply to vendors of personal health records and certain others not covered by HIPAA.

To determine when information is “unsecured” and notification is required by the HHS and FTC rules, HHS is also issuing in the same document as the regulation an update to its guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals. Entities subject to the HHS and FTC regulations that secure health information as specified by the guidance through encryption or destruction are relieved from having to notify in the event of a breach of such information. This guidance will be updated annually.

The HHS interim final regulations are effective 30 days after publication in the Federal Register and include a 60-day public comment period. For more information, visit the OCR web site.


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They Are Not Wishing You Well

In the world of politics, as in the Mideast, nothing is what it seems. The best example is the rejection of a federal health system and the support for a system of health cooperatives by some denizens of the depths of Washington politics.

I estimate that a federal health system option would be a rousing success, putting pressure on health insurers, hospitals, health systems and others to rein-in excessive costs and to focus resources on the people who really count - patients. Health cooperatives, in limited areas, have demonstrated that they can do a good job. But in dealing with nationwide insurers, nationally organized health care providers, national or statewide health care and hospital systems, and other vendors of care, the cooperative model holds no promise of success and will represent, what insurers, hospital systems, health systems and others described above want - an impotent isolated series of cooperatives, which hold no competitive threat, or fail miserably.

Alternatively, the health cooperative system might allow health care redlining which results in areas with adverse health statistics to be abandoned by health insurers with the patients shunted to health cooperatives which cannot afford the sudden mass of very sick people shifted to their rolls. If insurers are forbidden to underwrite, that will not prevent them from choosing not to do business in a particular area or with a particular employer or group of employers.

The call for the cooperatives in Congress is not a call for cooperatives to succeed, it is means of torpedoing a federal health system option. It is a means for insurers to remain insulated from real competition, to allow health care systems to roll merrily on building grandiose suburban facilities as monuments to their executives and donors, to allow certain physicians to order unnecessary tests and provide unnecessary procedures, to cause health care costs to inflate, and to otherwise generate the fiction that these Congressional spokespersons, lobbyists and other interests have the public's good at heart, when that is not the case. They have their own campaign funds and political supporters interests at heart. After all, they get their care through the federal employee system and that's just not good enough for the rest of America.

FDA - Investigational Drug Rules Updated

The American Society of Hematology has notified me that the FDA's Dr. Richard Pazdur has issued a statement concerning "Expanded Access to Investigational Drugs for Treatment Use" and "Charging for Investigational Drugs." These are two significant new rules.

Links follow (for cut and paste use).

http://edocket.access.gpo.gov/2009/pdf/E9-19004.pdf and
http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf.

Touch Those Out Of Touch

As a board certified hematologist, my career often involved caring for patients whom I knew were soon going to die. Some of these patients were pregnant and in their twenties, many were middle-aged men and women, and some were older folks. They were professionals, religious leaders, politicians, business people, and workers and they represented all religions and all walks of life. Talking with patients about their prognoses was painful for me, as a doctor, and of course difficult for my patients. But even more difficult was imminent death in someone who had not considered or planned for that eventuality and who was surrounded by a family which was unprepared for, and often unwilling to accept, the possibility of a loved-one's death.

I serve on a multidisciplinary biomedical ethics committee which acts as a consultant to hospital medical staff members, patients, their families and others, often in matters of life and death. Our committee makes non-binding recommendations to patients and, more often, their families which affect life, death, quality of life, living arrangements, touch on religious preferences, and sometimes involve the appropriateness of proposed or rejected medical treatment. Although we are experienced and professional, it is sad to have us - as strangers to affected patients and their families - suggest resolution of situations which should have been resolved by those most involved - primarily patients, and when appropriate, their families.

My understanding is that payment by the federal government for end-of-life planning counseling services has been dropped, at the urging of a small group of Senators and politically-connected pressure groups. These services can provide peace of mind to those who are not yet patients, patients and patients' families, as well as practical solutions to individual problems. Planning is best done by the person whose life experiences give him or her the right to make his or her own life and death decisions.

I suggest that my readers contact the organizations listed below to express their wishes and expectations concerning this issue. Send your own message or forward this blog. But don't stand by silent, because when the time comes, no one may speak for you and you might not have your own plan.

Republican National Committee - - - www.gop.com
Republican Congressional Committee - www.nrcc.org
Republican Senatorial Committee - - - www.nrsc.org
Democratic National Committee - - - www.democrats.org
Democratic Congressional Committee - - - www.dccc.org
Democratic Senatorial Campaign Committee - - - www.dscc.org/home

Health Insurers' Wish Lists

Like children, hoping for a rewarding visit from Santa Claus in December, Health Insurers have their own wishes, waiting to be granted. While kids want Santa to come with a full sack of goodies, the insurers might want (and have already negotiated for) an empty sack from Congress and President Obama. Read on -

1. No weakening of anti-trust protection of insurers for the their activities constituting the "business of insurance."

2. No meddling by the federal government in the salaries and bonuses of health insurance company executives and their key staff.

3. No action by the federal government which might draw major employers away from traditional health care insurers to an insurance pool or public plan.

4. No interference by the federal government with health insurers' drug distributing subsidiaries ability to extract rebates, discounts and other incentives from pharmaceutical companies, as well as providers of other health care goods and services, and not pass them on to patients and employers.

5. No entry by the federal government into administration of health plan enrollments and premium collection and distribution which would cut into health insurers' profitable administrative overhead revenues.

6. No extension of federal fraud and abuse laws to the products, services and arrangements provided by insurers, their subsidiaries and contracting parties.

7. No national standard uniform contract for health care insurers with patients, employers and other similarly interested parties.

8. No single payer system.

9. No federal requirement of freedom of access by all health insurers to all physicians, nurses, hospitals and other organization which provide health care services (see #11).

11. No American standard of enforceable performance by health insurers for the services and products they sell to employers and patients, and no weakening of the ERISA protection of insurers against private lawsuits by injured patients and their families.

12. No restriction on the ability of health care insurers to purchase networks of providers and facilities who will then provide services only to each owner-insurers' clientele.

13. No unionization of health care professionals, such as physicians.

14. No interference with the system by which 50 states regulate insurers.

15. No restriction on commercial "free speech" by health insurers.

10. (Inadvert. omitted - added 8/17/09) - No requirement that the insurance companies be required to provide high-technology prostheses.

It Wasn't The Government Saying Goodbye Too Soon

I recall one of our Thursday lunches, to which the physician organizer invited representatives of a local hospice to talk about hospices and specifically about their hospice's services to patients and their families. It was an informative interesting talk, enlivened by a lot of questions from doctors. But the really interesting conversation came after the hospice people left.

Several cancer specialists angrily complained about a local hospital. These physicians found that immediately upon a patient's diagnosis of cancer, someone in the hospital (perhaps social services?) arranged for a prompt hospice consult before a cancer specialist could review the case with the patient, his or her family, the patient's primary physician, pathologists, radiologists, and other experts. Patients and their families were having "the crepe" hung for them, with the gloomiest possible prognosis. The cancer specialists said that patients were being whisked out of the hospital, consigned to hospice care, when they could have been treated palliatively (even during hospice care), to relieve pain and suffering and perhaps to prolong life, or could have explored the possibility of an effort at curative treatment.

Now, this wasn't the government convening a "let's shorten your life" committee. The physicians felt this was an apparent hospital policy.

Before we again shake our fingers at Senators and Representatives, and accuse our government of rushing people off to die to save money, let's think about other actors: insurers, hospitals and institutions which - if there are no ethical safeguards - could be advantaged by hastening the process of dying.