Saturday, July 22, 2006

Medicare Part D and Soaring Profits

The New York Times featured an article, which contained some troublesome (but predictable) information about Medicare Part D. The pharmaceutical industry is beginning to reap a windfall from a surprisingly lucrative niche market: drugs for poor people. The windfall, which by some estimates could be $2 billion or more this year, is a result of the transfer of millions of low-income people into the new Medicare Part D drug program that went into effect in January. Under that program, as it turns out, the prices paid by insurers, and eventually the taxpayer, for the medications given to those transferred are likely to be higher than what was paid under the federal-state Medicaid programs for the poor. About 6.5 million low-income elderly people or younger disabled poor people were automatically transferred into the Part D program for drug coverage. Because their other health needs are still covered by Medicaid, they are called dual eligibles.The advent of Part D has not affected the drug coverage for the 45 million other low-income people whose drugs are still paid for under state Medicaid programs. Those programs closely monitor drug prices, and drug makers often typically end up paying rebates to the states.That means that taxpayers fund the soaring profits for insurance companies. I hope that this information will guide us to vote those politicians of the island , who supported this program . Most of them are REPUBLICANS!!! Oh, did I forget to mention that UnitedHealth Group Inc. reported a 26% increase in second-quarter profit, reflecting an acquisition and strong enrollment in its new Medicare drug-benefit plan.!! Thats your taxes at work!!

NYT July 18, 2006
Market Place
A Windfall From Shifts to Medicare
By MILT FREUDENHEIM
The pharmaceutical industry is beginning to reap a windfall from a surprisingly lucrative niche market: drugs for poor people.
And analysts expect the benefits to show up in many of the quarterly financial results that drug makers will begin posting this week.
The windfall, which by some estimates could be $2 billion or more this year, is a result of the transfer of millions of low-income people into the new Medicare Part D drug program that went into effect in January. Under that program, as it turns out, the prices paid by insurers, and eventually the taxpayer, for the medications given to those transferred are likely to be higher than what was paid under the federal-state Medicaid programs for the poor.
About 6.5 million low-income elderly people or younger disabled poor people were automatically transferred into the Part D program for drug coverage. Because their other health needs are still covered by Medicaid, they are called dual eligibles.
The advent of Part D has not affected the drug coverage for the 45 million other low-income people whose drugs are still paid for under state Medicaid programs. Those programs closely monitor drug prices, and drug makers often typically end up paying rebates to the states.
It is too early to calculate the full effect of the shift of the former Medicaid patients now covered by Part D. But analysts expect it to generate hundreds of millions of additional dollars this year for the drug companies, which have long chafed under the pricing restraints of the state programs.
Drugs tend to be cheaper under the Medicaid programs because the states are the buyers and by law they receive the lowest available prices for drugs.
But in creating the federal Part D program, Congress — in what critics saw as a sop to the drug industry — barred the government from having a negotiating role. Instead, prices are worked out between drug makers and the dozens of large and small Part D drug plans run by commercial insurers.
Since Part D went into effect, the pharmaceutical industry has raised the wholesale prices of its brand-name drugs an average of 3.6 percent. Although the actual amount spent depends on what each insurer negotiates, in many cases the drugs for those 6.5 million people who used to receive their medicines through Medicaid will cost more now.
Initially, the added costs will be paid by the insurers administering the new Medicare drug program. But when it comes time for the insurers to settle accounts with the government, the costs of the 6.5 million drugs for the transferees will end up being passed along to federal taxpayers, according to analysts and health care economists.
The windfall for the drug makers was made possible by a provision of the 2003 Medicare law that exempts Part D drugs from “best price” rebates that the drug makers have been required to give to the state Medicaid programs since 1991. Those rebates are meant to make sure that state Medicaid agencies pay no more than the best prices drug companies offer to any big commercial insurer.
Under Medicaid, the federal government and state agencies paid more than $14 billion annually for the drugs of the 6.5 million transferees. Without the best-price rebates, the cost would have been 25 percent higher, or about $17.5 billion, said Stephen W. Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota.
Nobody yet knows what the total drug bill will be for these people under Part D, beyond the assumption by many experts that it will be higher. Medicare will not have solid numbers until it can analyze the hundreds of monthly reports that the plans in the Part D system are required to file.
Yet, one indicator of the higher revenue from dual-eligibles has already been seen in reports by drug companies this year showing double-digit United States sales increases of certain drugs that are heavily used by Medicaid patients. For example, sales of Lamictal, an antipsychosis drug from GlaxoSmithKline, were up 33 percent, to $305 million in the first quarter; sales of Seroquel, an antipsychotic from AstraZeneca, were up 29 percent, to $590 million; and sales of Plavix, a blood thinner from Bristol-Myers Squibb, were up 26 percent, to $850 million.
Timothy Anderson, a pharmaceutical analyst with the Prudential Equity Group, estimates that if Part D were not in place the rebates for the makers for all of 2006 would have been more than $2 billion for 13 drugs widely used by the people transferred from Medicaid to Part D.
Dr. Anderson estimates that because the companies will not have to pay those rebates under Part D, revenue to Glaxo from Lamictal will increase by $298 million this year, AstraZeneca’s Seroquel sales will rise by $521 million, and Plavix revenue will increase $169 million. Estimates on the rebate increases because of Part D are few, but all are in general agreement on the size of the rebate to drug makers.
Medicaid programs have been especially important for drugs like Seroquel and Lamictal, which are prescribed for bipolar disorder and other mental health problems
About two million of the people transferred to Part D are disabled and younger than 65, and “more than half of them have mental health problems,” said Jim Verdier, a senior fellow at Mathematica Policy Research in Washington and a former Medicaid director in Indiana. “In the past, Medicaid was 80 to 90 percent of the total market for some high-end antipsychotic drugs,” Mr. Verdier said.
Over all, the Medicaid best-price rebates have averaged about 15 percent of the list prices of the manufacturers, but some states, including California, New York and Maine have obtained even larger rebates, Professor Schondelmeyer said.
Now, under Part D, all sorts of price deals will be negotiated by dozens of Medicare drug plans, large and small. The prices will be reported to Medicare, but under a provision of the law pushed by industry lobbyists, they will otherwise be kept secret.
Mark B. McClellan, administrator of the federal agency that oversees Medicare and Medicaid, said that the lowest-cost plans among the Part D offerings by commercial insurers were now getting “significantly better prices than Medicaid.” But he did not provide specifics.
Dr. McClellan also noted that his agency was requiring the states to return a combined total of $5.8 billion to Washington from federal funds dispensed to the Medicaid program. That money is based on a federal estimate of the amount states will be saving by no longer having to provide drugs to the dual-eligibles.
But the states, disparaging those refunds as “clawbacks,’’ have disputed the federal formula that was the basis for the repayments. Last month, the Supreme Court declined to hear a case filed by the attorneys general of Texas and four other states seeking to quash the repayment formula as unconstitutional.
Now the plaintiffs, which also include Kentucky, Maine, Missouri, and New Jersey, are expected to take the fight to lower courts. Ten other states have supported the plaintiffs.
The states say the federal formula assumes higher drug costs than many Medicaid programs have been spending.
“We get 32 percent back in drug rebates,” said Jude E. Walsh, a special assistant to Governor John Baldacci of Maine. She said Maine’s Medicaid drug costs were rising only 2 percent to 3 percent a year, compared with national trends that are three to four times that.
The drug companies, for their part, have played down the size of the expected windfall from Medicaid transferees. And Bush administration officials say they do not know how much they will end up spending on those people. “No one is willing to quantify it,” said Dr. Anderson, the Prudential analyst.
In one of the few public comments by a drug company official, Derica W. Rice, chief financial officer of Eli Lilly, told analysts on a conference call in April that Lilly expected “modest price benefits due to lower rebates as patients move from Medicaid to Plan D.”
Zyprexa, a Lilly drug for schizophrenia, is another medication widely prescribed for Medicaid patients.
The drug makers do have reason to worry about long-run prospects under the vast new Medicare Part D program. There are currently 81 Part D drug plan sponsors, large and small, with varying degrees of negotiating power. But the plans are expected eventually to merge into a handful of large survivors, each of them presumably having more bargaining power with drug companies.
A further concern is that as the true costs of Part D become known, Congress may eventually impose spending ceilings.
For now though, as the drug industry begins to report its quarterly profits, the market for those 6.5 million poor people is likely to look rather

Change Healthcare in the US

A recent article in the Wall Street Journal called for an overhaul of the US healthcare system. The author called for a move from an employer-based health care system to a universal system. The author states that "To fix health care in America, we have to accept that we're living through the most profound transformative economic revolution in the history of the world. It's happening so fast we can barely keep track of it. Intense global competition. Contingent work. The explosive economies of China and India. Technology in the workplace. Outsourcing. By the time they are 35, young people entering the job market today will already have worked in eight to 12 jobs. Employers will be pit stops for them, not permanent homes. In other words, we are rapidly moving from employer-managed work lives to self-managed work lives, in which workers must figure out on their own how to maintain things like health insurance and retirement." His analysis is correct, but his conclusion to establish a universal health care system may not be accepted by everyone. This probably would be just another article dealing with our healthcare mess, if not for the author: Andy Stern, is the President of the Service Employees International Union, comprised of one million nurses, doctors, hospital staff, nursing home and home care workers. We should listen to him and I think organized medicine should engage him in a discussion how to find solutions for our broken healthcare system.As a former union leader and organizer I strongly support such a cooperation.

Horse-and-Buggy Health Coverage
By ANDY STERN
WSJ, July 17, 2006; Page A10
There is no subject that gets more discussion, analysis and lament than health care in America. Enough already. It's time to assert one simple fact: The employer-based system of health coverage is over. This may sound shocking, coming from a union leader whose members bargain constantly with employers for health-care benefits. But the system is collapsing, crushed by out-of-control costs, a revolutionary global economy and masses of uninsured.
CEOs know this best: They dread the meeting with HR managers who tell them, once again, that their health-care costs are through the roof. So they look for any way to control costs. Co-pays go up, subsidies go down, coverage is dropped all together. In the last five years alone, the percentage of businesses offering health benefits has plummeted to 60% from 69%. Here's how bad it will continue to get: McKinsey & Company projects that by 2008, the average Fortune 500 company will spend as much on health care as they make in profit. How can we possibly compete in the global economy with that kind of burden?
I understand why CEOs are afraid of health-care costs. What I don't understand is why they are so timid about doing something about them. These are the people who revolutionized medicine, communication, technology, entertainment and investing. And yet when it comes to addressing the biggest economic issue their companies and their country face, they resort to bookkeeping. Where are the visionaries? The tough-minded magnates who make billions for shareholders? Stuck in the 20th century, that's where.
To fix health care in America, we have to accept that we're living through the most profound transformative economic revolution in the history of the world. It's happening so fast we can barely keep track of it. Intense global competition. Contingent work. The explosive economies of China and India. Technology in the workplace. Outsourcing. By the time they are 35, young people entering the job market today will already have worked in eight to 12 jobs. Employers will be pit stops for them, not permanent homes. In other words, we are rapidly moving from employer-managed work lives to self-managed work lives, in which workers must figure out on their own how to maintain things like health insurance and retirement.
A new national policy framework is the easy part. There seems to be broad consensus that we need a universal system that provides affordable coverage, choice of doctors and insurance plans, core benefits, and shared financing among employers, employees and government. There are a couple of thousand position papers out there to choose from. The problem isn't policy, it's leadership. And I don't mean Washington, D.C. The political class in both parties is full of words and bereft of action. They are not going to provide the answers until they are forced to. That force must come from the business community.
Today I sent a letter to every CEO in the Fortune 500 asking them to make health care their national priority. I urge corporate leaders to come forward. Our union members -- your employees -- will work with you. The old idea that business and labor can't work together for the common good is as outdated as lifetime jobs. The Service Employees International Union is the largest health-care union in the country. Our membership includes nearly one million nurses, doctors, hospital staff, nursing home and home care workers. We know health care. You know business. Together, let's build a new 21st-century American economy.
Mr. Stern, president of the Service Employees International Union, is author of "A Country That Works," forthcoming from Free Press.

IOM Report: Medication Errors

New IOM Report highlights the increasing incidence of medication errors.Medication errors harm 1.5 million people and kill several thousand each year in the United States, costing the nation at least $3.5 billion annually, the Institute of Medicine concluded in a new report see http://www.iom.edu/CMS/3809/22526/35939.aspx Recommendations to correct these problems include systemic changes like electronic prescribing and tips for consumers like advising patients to carry complete listings of their prescriptions to every doctor’s visit, the report said. As physicians we should proactively undertake every reasonable effort to reduce the incidence of medication errors. I use electronic prescribing for several years and have caught multiple errors related to drug-interactions, wrong dosage and limited legibility issues.

Institute Cites Medication Errors,
Suggests Changes to Cut Injuries
By SHIRLEY S. WANG
WSJ July 21, 2006; Page A11
Medication errors serious enough to cause injury occur 1.5 million times a year in the U.S., according to a report released by the Institute of Medicine of the National Academies.
The report makes ambitious recommendations for reducing the rate of errors, with U.S. agencies taking the lead, and recommends deadlines. It calls for $100 million in research to determine the best and most cost-effective measures.
A previous report from the IOM, which in 1999 estimated that medical errors of all types were responsible for as many as 98,000 deaths a year, spurred the government to pour $50 million into patient-safety initiatives and invigorated efforts among health-care providers and insurers to reduce errors. Hospitals are working on a number of initiatives, including the use of electronic order-entry systems.
The report recommends that all health-care providers use an electronic system to prescribe drugs by 2010. "Large hospitals are pretty much invested in moving in that direction," J. Lyle Bootman, dean at the University of Arizona College of Pharmacy said, though other medical settings, such as long-term-care facilities, may need more help with implementation. Dr. Bootman was co-chairman of the Committee on Identifying and Preventing Medication Errors, which drafted the IOM report.
The report also found that confusing drug labels and packaging are responsible for one-quarter to one-third of medication errors, including 30% of all medication-error deaths. The report urged the Food and Drug Administration and the federal Agency for Healthcare Research and Quality to work with industry to address problems by the end of 2007 and possibly standardize drug names and labels.
The report recommended that the National Library of Medicine create a centralized online database on drugs to help consumers. The NLM should also spearhead an initiative with the FDA and Centers for Medicare and Medicaid Services to consider a nationwide telephone hot line for people who can't read printed materials.
July 21, 2006

Report Finds a Heavy Toll From Medication Errors
By GARDINER HARRIS
WASHINGTON, NYT July 20 — Medication errors harm 1.5 million people and kill several thousand each year in the United States, costing the nation at least $3.5 billion annually, the Institute of Medicine concluded in a report released on Thursday.
Drug errors are so widespread that hospital patients should expect to suffer one every day they remain hospitalized, although error rates vary by hospital and most do not lead to injury, the report concluded.
The report, “Preventing Medication Errors,” cited the death of Betsy Lehman, a 39-year-old mother of two and a health reporter for The Boston Globe, as a classic fatal drug mix-up. Ms. Lehman died in 1993 after a doctor mistakenly gave her four times the appropriate dose of a toxic drug to treat her breast cancer.
Recommendations to correct these problems include systemic changes like electronic prescribing and tips for consumers like advising patients to carry complete listings of their prescriptions to every doctor’s visit, the report said.
“The incidence of medication errors was surprising even to us,” said J. Lyle Bootman, dean of the University of Arizona College of Pharmacy. “The solutions are complex and far-reaching and will present challenges.”
The report is the fourth in a series done by the institute, the nation’s most prestigious medical advisory organization, that has called attention to the enormous health and financial burdens brought about by medical errors.
The first report, “To Err Is Human,” was released in 1999 and caused a sensation when it estimated that medical errors of all sorts led to as many as 98,000 deaths each year — more than was caused by highway accidents and breast cancer combined.
After the first report, health officials and hospital groups pledged reforms, but many of the most important efforts have been slow to take hold.
Drug computer-entry systems, which are supposed to ensure that hospital patients get the right drugs at the right dose, are used in just 6 percent of the nation’s hospitals, said Charles B. Inlander, president of the People’s Medical Society, a consumer advocacy group, and an author of the report released Thursday.
Electronic medical records can help ensure that patients do not receive toxic drug combinations. The 1999 report urged widespread adoption of these systems. Thursday’s report called for all prescriptions to be written electronically by 2010.
Just 3 percent of hospitals have electronic patient records, said Henri Manasse, chief executive of the American Society of Health-System Pharmacists. Few doctors prescribe drugs electronically.
Even simple medication safety recommendations — block printing on hand-written prescription forms — are widely ignored.
Arthur Levin, director of the Center for Medical Consumers and an author of the 1999 report, said that just about everyone in the health system was to blame. “This country has not taken seriously the alarms we sounded in 1999,” Mr. Levin said. “Why?”
Health organizations defended their efforts.
Alicia Mitchell, a spokeswoman for the American Hospital Association, said that since 1999 hospitals had “actively engaged in looking at using information technology to improve patient safety.”
A recent poll by the association of its members found that 92 percent intended to adopt electronic patient records, Ms. Mitchell said. But such systems are complicated and need to be built gradually, she said.
Thursday’s report urged the Food and Drug Administration to improve and standardize the drug information leaflets given consumers. It noted that confusing information on drug labels was an important cause of medication errors.
On Tuesday, the drug agency finished a years-long process by issuing voluntary guidelines to reform consumer drug information leaflets, said Dr. Scott Gottlieb, the agency’s deputy commissioner. Many of these leaflets are not regulated by the F.D.A.
And on June 30, the agency completed a lengthy effort to clarify and standardize information on drug labels. The new labels could prevent nearly 300,000 medication errors each year and will make electronic prescribing efforts far easier to carry out, Dr. Gottlieb said.
Thursday’s report said that the common practice whereby drug companies provided free drug samples to doctors should be discouraged because such samples were poorly controlled. It urged drug makers to package more pills in individual packages. And it criticized drug makers as failing to disclose the results of all clinical trials involving their drugs.
Alan Goldhammer, a spokesman for the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, said he differed with some of the report’s conclusions but concurred with the broad goals of increasing the use of information technology to reduce medication errors.
“Everybody is working on that right now,” he said.
Thursday’s report said that in any given week, four out of five adults in the United States took at least one medication. A third take at least five different medications. As the use of medications has soared, so, too have medication errors, Dr. Manasse said.
Effective strategies to prevent such errors have, however, been known for years, Mr. Inlander said.
“This is not rocket science,” Mr. Inlander said. “It’s simple. The key is having the will to make these changes in an organized and uniform way. And it’s not that expensive.”

Trial Bar Changes Name

What an ironey. The Trial Bar will change its name to the "American Association of Justice". Nice try. The wolves in sheep clothing are still wolves.
Bernd

Lawyers Anonymous
WSJ July 19, 2006; Page A12
What's in a name? More, it would seem, if the name doesn't contain the words "trial" or "lawyer."
At least that's the hope of the Association of Trial Lawyers of America, which today will ask its membership to vote to give that 60-year-old political lobbying institution a brand new moniker. ATLA's board of governors already resoundingly approved a switch, voting 91-5 last month to drop any reference to the lawyerly profession, and instead go with the impressively unspecific and high-minded "American Association for Justice." No word yet whether Webster's will formally protest.
Driving this switcheroo is ATLA's concern that more and more Americans are under the impression that trial lawyers are less interested in justice than they are in generating frivolous lawsuits that pad their own bank accounts. That widely held belief is what has in recent years propelled states from Texas to Ohio to enact tort reform, Congress to pass a class-action lawsuit cleanup, and voters to toss out elected judges who favor the plaintiffs bar.
All of which has ATLA (er, AAJ) a little bothered. As President Ken Suggs wrote in a recent letter to members, "Our research shows that if our message is about helping lawyers, we lose. On the other hand, if we're about getting justice and holding wrongdoers accountable, we win." As to whether the research also showed that one way to improve the trial bar's reputation is to stop fleecing the innocent, Mr. Suggs did not say. Instead, the group has tripled its communications staff and hired noted pollsters and campaign strategists to recast its image. As the old joke goes, it's 98% of lawyers who give the rest of them a bad name.

Wednesday, July 05, 2006

Health Care Costs on the Rise (Again)

Dear Friends and Colleagues:
Attached an article from today's Wall Street Journal.
Some of the findings should be of grave concern for each of us seeking affordable healthcare coverage.
1) The average annual medical cost for a family of four participating in a preferred provider organization, or PPO, program is up 9.6% from 2005 to $13,382 in 2006,
2) Fidelity Investments has estimated that a 65-year-old couple retiring without employer-provided health benefits will need $200,000 for out-of-pocket health-care expenses during retirement.
Guess, I have to be less concerned of a North Korean missile falling in my backyard, than healthcare costs spiraling out of control jeopardizing my families financial future.
Bernd

Health-Care Costs To Hit Workers, Retirees Harder
By JILIAN MINCER
July 5, 2006; Page D3
Americans should expect to pay more for medical costs whether they are employed or retired, according to two new studies. The reports, by Milliman Inc. and Watson Wyatt Worldwide, show that health-care costs are still rising at a fast pace -- despite slowing from double-digit rates in recent years -- and that businesses expect to curtail or limit retiree medical benefits.

"Both of the studies are reverifying the fact that health care is becoming more expensive," says Paul Fronstin, director of health research for the Employee Benefit Research Institute, or EBRI, a nonprofit research group in Washington. "We've seen this trend since the 1990s."

The average annual medical cost for a family of four participating in a preferred provider organization, or PPO, program is up 9.6% from 2005 to $13,382 in 2006, according to Milliman, a consulting and actuarial firm that released its second annual study Thursday. Unlike other major health-care cost studies, which look at costs in terms of annual premiums or just the employer's share, the Milliman study also factors in employees' costs, including out-of-pocket expenses.

A separate study by Watson Wyatt, a global management-consulting firm, found that businesses expect to further restrict or eliminate retiree medical plans.

The Milliman study says that employers are projected to pay about $8,362, or 62%, of the total medical cost for a family of four. The total is $13,382. The employee pays about $5,020, $2,810 in payroll deductions and $2,210 in cost sharing.

The Milliman Index is based on analysis of claim costs for millions of members in a variety of areas of the country.

The Milliman Medical Index also looked at the cost of health care in several major cities over the last year. New York City was the most expensive at $15,255, and Dallas the least expensive at $12,980.

The vast majority of businesses are planning to curtail medical plans for current and future retirees, according to the Watson Wyatt study. The survey of 164 companies found that 14% plan to eliminate the benefit for future retirees over age 65, and 6% plan to eliminate it for their current retirees over age 65.

While most employers who still provide the coverage plan to continue it, retirees should expect to pay more for their coverage. "The good news is that they're all not jumping out. The majority are still going to provide it," says Cara Jareb, director of retiree medical consulting at Watson Wyatt. "The bad news is they will be paying more for this coverage."

Nearly two-thirds of employers expect to increase the financial contribution for future retirees, and half expect to change the design of their plans. Twenty-four percent plan to tighten eligibility for future retirees.

Fidelity Investments has estimated that a 65-year-old couple retiring without employer-provided health benefits will need $200,000 for out-of-pocket health-care expenses during retirement.

In Store Clinics

LETTER TO THE EDITOR:


RE: Drugstore Diagnosis: No appointment necessary; by Maureen Glabman, Florida Medical Business, June 13-June 26,06:

The AMA House of Delegates emphasized during the Association's Annual Meeting that the in-store clinics are no substitute for a long-term relationship with a trained and board-certified medical doctor. These clinics may provide invaluable medical services for the insured, uninsured and underinsured who value the convenience and flexibility of getting treatment on a walk-in basis instead of having to schedule an appointment to see their physician. Even though the operators of those clinics claim that they do not substitute but complement the existing medical services at doctors offices, the delegates at the AMA Annual Meeting expressed concern about the clinics' impact on quality care, leading the house to adopt nine guidelines and direct the AMA to monitor the effects of the clinics on the health care marketplace.
These guidelines can be sumarized as follows:

* Encourage patients to establish a relationship with a primary care physician to
ensure continuity of care.
* Have a well-defined and limited scope of clinical services consistent with
state scope-of-practice laws.
* Use standardized medical protocols derived from evidence-based practice
guidelines to ensure patient safety and quality of care.
* Establish protocols for ensuring continuity of care with practicing physicians
within a local community.
* Set up a referral system with physician practices or other facilities for
appropriate treatment if the patient's conditions or symptoms are beyond the
scope of services provided by the clinic.
* Clearly inform patients in advance of the qualifications of their health care
practitioners as well as limitations in the types of illnesses that they can
diagnose and treat.
* Establish appropriate sanitation and hygienic guidelines and facilities to
ensure the safety of patients.

As a practicing family physician I cautiously support the establishment of in-store clinics as long as they abide by the above guidelines.
All in-store clinics should develop a working relationship with a local primary care physician to provide continuous medical care for patients diagnosed with chronic diseases requiring longitudinal medical care.
In store medical clinic may cater to consumers seeking quick and focused medical attention, but may also create a "quick-fix" mentality for the treatment of medical problems that require the attention of an experienced medical doctor.

Bernd Wollschlaeger, MD, FAAFp
Vice-President Dade County Medical Association
AMA Delegate

Sunday, July 02, 2006

Save 100,000 Lives Warrant a Second Opinion

Dear Friends and Colleagues:

Attached an article from a recent Wall Street Journal edition discussing the “ Save 100,000 lives” campaign initiated by Prof.Donald Berwick Hospitals participating in the effort had saved 122,300 lives, exceeding expectations. Much of the favorable press coverage mentioned that this was comparable with the estimated 44,000 to 98,000 lives lost each year to medical errors in hospitals.
By the 18-month mark of the campaign, more than 3,000 hospitals were participating, representing about three-quarters of all the nation's hospital beds. Most of these hospitals reported to the Institute for Healthcare Improvement (IHI) the number of admissions and deaths during the campaign period and in 2004 -- the group says information it received was about 86% complete.A simple comparison of the death rates before and during the campaign showed that roughly 33,000 fewer patients died in participating hospitals than would have been expected, based on the year-earlier results. IHI researchers admitted that campaign's effect won't be understood fully until the group can compare its hospitals with others that didn't participate, and compare the results with hospitals' death-rate trends before the campaign began. The group plans to gather those numbers in the next six months and include them in a paper to be submitted to a peer-reviewed journal.
Meanwhile, the numbers have been published in the mainstream media WITHOUT having undergone a stringent peer-review process. This definitely has created false expectations and impressions about the quality of care rendered at US hospitals.
The author correctly states that “ Both the recent study and the 1999 medical-errors analysis raise the question: Are all deaths equal? Both counted each life lost or saved the same way. A patient who has a terminal illness, who will die next week, but would have died this week because of medical error, counts as a life saved. So does the life of a child saved from medical error who is discharged from the hospital in good health.




Yours

Bernd Wollschlaeger,MD



PS: you can also find a list of recent e-mails and their content on my blog http://floridadocs.blogspot.com



Studies on Medical Errors Warrant a Second Opinion
June 29, 2006
In December 2004, Harvard professor Donald Berwick launched an ambitious effort aimed at improving U.S. hospitals. His goal was to save 100,000 lives in the next 18 months by convincing hospitals to take steps to cut down on errors and improve care.
Two weeks ago, a group led by Dr. Berwick announced the results to great fanfare: Hospitals participating in the effort had saved 122,300 lives, exceeding expectations. Much of the favorable press coverage mentioned that this was comparable with the estimated 44,000 to 98,000 lives lost each year to medical errors in hospitals.
But such estimates have an inherent drawback: It is difficult, in many cases, to connect whether a patient dies to a single medical error or procedure. Dr. Berwick's group compared death rates during the study with those before the study, but there's no way to know that the improvements came from the group's campaign and not other factors. Also, the group relied on self-reported numbers from hospitals. It's possible that only hospitals with positive outcomes shared information.
Questioning the Numbers
Several of Dr. Berwick's colleagues told me they admire his goals but question his number. "I have no doubt the campaign was a good thing and saved a lot of lives," said Robert Wachter, a professor in the department of medicine at the University of California, San Francisco, and the author of a book about medical errors. "I don't think it saved 122,300." He added that, like in a political campaign, the health-care campaign used "statistics selectively to try to mobilize your base to do good. It's understandable. It's not good science."
H. Gilbert Welch, senior research associate with the Department of Veteran Affairs in White River Junction, Vt., and a critic1 of medical-error estimates, said, "I think there's been a tendency in the errors business to first overstate the size of the problem, and now, I'm afraid, to overstate the effect of interventions on the other side."
The study received broad press coverage, with many accounts headlining the 122,300 number. U.S. News & World Report's headline read2, "122,000 Who Lived." An Associated Press report on the study was published in several newspapers, including The Wall Street Journal3.
The Institute for Healthcare Improvement4, the group behind the study, promised hospitals it wouldn't release the data they provided. However, it offered a customizable press release5 for those that wished to trumpet their results, and several newspaper reports (such as those in the Toledo Blade6 and the Fresno Bee7) included anecdotes and quotes supplied by nearby participating hospitals.
The IHI press release8 was careful to say only that hospitals in the campaign saved 122,300 lives, and Dr. Berwick, who serves as IHI's president and chief executive, told me "it would be stupid" to say the group's campaign was solely responsible. "We think we added to it," he said. IHI is a Boston-based nonprofit organization aimed at improving health care. Its funding comes from charitable foundations and hospitals.
Other Factors
Many hospitals had already undertaken their own efforts to boost the quality of care, prodded by groups such as the Centers for Disease Control and Prevention. But many of the news articles simply stated that the campaign saved all those lives, without qualification. (Numbers Guy readers Dean Anderson, Kirk Jeffrey and Curtis L. Russell spotted some of these articles and suggested I look at this number.)
The IHI initiative called on hospitals to institute six steps9. While one of the steps was aimed at reducing mistakes in administering drugs, the rest appear to focus less on errors and more broadly on improving care: Hospitals were encouraged to take additional steps to prevent infections, for instance. (Not all participating hospitals followed all of the recommended steps.)
By the 18-month mark of the campaign, more than 3,000 hospitals were participating, representing about three-quarters of all the nation's hospital beds. Most of these hospitals reported to IHI the number of admissions and deaths during the campaign period and in 2004 -- the group says information it received was about 86% complete.
IHI filled in the numbers for the rest by extrapolating, a step criticized by Dr. Wachter, who said that those hospitals with the best results may have been more likely to report. "It would be like going to your high-school reunion and extrapolating from the divorce rate and waist line [of those who show up] that everyone is married and stays thin," he said.
A simple comparison of the death rates before and during the campaign showed that roughly 33,000 fewer patients died in participating hospitals than would have been expected, based on the year-earlier results. But that calculation was flawed, Dr. Berwick argued, because the mix of patients changes -- you wouldn't compare mortality among 10 heart-attack victims and 10 sufferers of the flu.
So the group tried to come up with a number that would capture how much sicker patients were during the study than the year earlier. It relied on estimates from three companies that have access to a wide range of data from hospitals, including information on patients' diagnoses and their ages. Partly because the population is aging, those companies all reported that patients are, on average, arriving at hospitals in worse condition than they had in previous years. Based on the data, the group adjusted its estimate upward to 122,300. (IHI explains its methods in a document10 on its Web site.)
Andy Hackbarth, an IHI senior engineer who helped crunch the numbers, said the campaign's effect won't be understood fully until the group can compare its hospitals with others that didn't participate, and compare the results with hospitals' death-rate trends before the campaign began. The group plans to gather those numbers in the next six months and include them in a paper to be submitted to a peer-reviewed journal, Mr. Hackbarth told me.
A Personal Connection
Dr. Berwick found himself at the center of the quality-of-care issue following the hospitalization of his wife, Ann, in 1999. She waited 60 hours for treatment while gravely ill, and three times was left alone on a gurney, though she did eventually recover and leave the hospital. He was the subject of a front-page article11 in the Journal in 2002.
When he launched the campaign in 2004, Dr. Berwick said he was losing patience with the health-care system's halting efforts to respond to a 1999 estimate of deaths due to medical error. That study, from the Institute of Medicine, a National Academy of Sciences group that advises Congress on health, found that 44,000 to 98,000 people die each year because of medical errors. Those numbers remain frequently quoted to this day, even though the numbers are based in part on the experiences of hospital patients 22 years ago.
Much of the public's outraged reaction to the Institute of Medicine report focused on rare, terrifying cases such as botched surgeries or gross misdiagnoses. In an episode of her talk show, Oprah Winfrey asked about 260 members of her studio audience to stand up, and told them that, by a "conservative estimate ... this is the number of people who die every day in hospitals from medical mistakes." Then, her show featured one guest who was misdiagnosed with cancer and underwent a hysterectomy and six months of chemotherapy. Another guest's breasts were removed after she was falsely diagnosed with cancer because of a paperwork mix-up.
But critics of the study pointed out that many of the errors were less blatant. The estimates were based on reviews of hospital discharges in three states -- New York in 1984 and Colorado and Utah in 1992 -- looking for any "adverse events" caused by treatment, and not the underlying condition being treated. But not all adverse events are preventable. For example, if a drug deemed necessary causes dangerous side effects in 1% of patients, it's not known which 1% will suffer. For those who do, that's unquestionably an adverse event, but it may not have been a medical error -- it's certainly less clear-cut than having the wrong leg removed in surgery. (The study tried to estimate which adverse events were preventable, but had difficulty establishing clear cause-and-effect relationships.)
Dr. Berwick told me he considers the Institute of Medicine study "as good a quantitative estimate as we've got," adding, "the point is that [errors] are very large causes of morbidity." (Some estimates have put the figure higher than 98,000. Health Grades Inc., which maintains a Web site12 that measures hospitals based on mortality and complication rates, counted13 195,000 deaths annually between 2000 and 2002.)
Both the recent study and the 1999 medical-errors analysis raise the question: Are all deaths equal? Both counted each life lost or saved the same way. "A patient who has a terminal illness, who will die next week, but would have died this week because of medical error, counts as a life saved," Dr. Berwick told me. So does the life of a child saved from medical error who is discharged from the hospital in good health.
Harold C. Sox, Jr., editor of the Annals of Internal Medicine in Philadelphia, told me that averting deaths is, of course, a good goal, but there are other improvements to care worth pursuing. "Another target could be trying to improve the quality of death, for people for whom death is inevitable, and, as much as possible, to match where death actually occurs with what the patient desires," he said.
Although Dr. Wachter remains critical of the lived-saved estimate trumpeted by Dr. Berwick's group, he told me that he believes even questionable numbers can galvanize the public for the improvement of health care. "There will always be tension between good science and the laudable goal of [Dr. Berwick] and others to move the calcified health-care system forward," he said.
* * *

Medical Errors and Structured Communication

Dear Friends and Colleagues:
Attached an article from a recent Wall Street Journal edition discussing the efforts to reduce the medical error incident rate related to communication errors.
The article describes how several hospitals are developing "structured communication" models to aloow for the seamless transfer of patients from shift to shift.
This is especially important in the context of residency work hour limitations necessitating more frequent patient transfers, which may be associated with a higher error rate unless structured communication models are being followed.
Yours
Bernd Wollschlaeger,MD

PS: you can also find a list of recent e-mails and their content on my blog http://floridadocs.blogspot.com

Hospitals Combat Errors at the 'Hand-Off'- New Procedures Aim to Reduce Miscues as Nurses and Doctors Transfer Patients to Next Shift
June 28, 2006; Page D1

For hospitals, the "hand-off" has long been the Bermuda Triangle of health care: Dangerous errors and oversights can occur in the gap when a patient is moved to another unit or turned over to a new nurse or doctor during a shift change.
Now, with growing evidence that communication breakdowns during such transfers are the single largest source of medical error, the Joint Commission on Accreditation of Health Care Organizations is requiring hospitals for the first time to establish standards for hand-off communications -- and break down long-standing cultural barriers in the exchange of patient information between doctors and nurses.
The stakes are high, as hospitals that fail to comply with Joint Commission patient safety standards risk losing accreditation, which is often required for reimbursement from Medicare and private insurers. Hospitals generally have some hand-off procedures, but they tend to be ad-hoc arrangements that vary from unit to unit or even nurse to nurse. Many hospitals have only begun to implement new checklists, forms and routines that will formalize these structures.
But a few hospitals and health-care quality groups have been ahead of the pack, borrowing communication strategies used in aviation and the military, where hand-off failures can lead to devastating accidents. The non-profit Institute for Healthcare Improvement, for example, is working with hospitals on a communication model known as SBAR -- an acronym for Situation, Background, Assessment and Recommendation -- adapted from a program used to quickly brief nuclear submariners during a change in command.
Oakland, Calif.-based managed-care giant Kaiser Permanente, which operates 30 medical centers, has pioneered use of the model to help nurses and doctors quickly organize their thoughts and convey the most critical information in just 60 seconds. At OSF St. Joseph Medical Center in Bloomington, Ill., cases of harm to patients fell by more than half in the year after the SBAR program was implemented in October 2004. And the Veterans Administration is funding development of a hand-off tool for medical teams using similar principles at its hospitals.
"A hand-off is a precision maneuver, but in medicine it has been left to happenstance," says Richard Frankel, a professor of medicine at Indiana University who is working on safety programs with the VA medical center in Indianapolis.
Reduced work hours for medical residents, which went into effect in 2003, have reduced the likelihood that a patient will be harmed by a resident whose judgment is impaired by fatigue, notes Dr. Frankel, but shorter shifts "just increases the number of hand-offs during any given day not done with precision."
Bungled hand-offs range from a patient getting a dose of a drug that was already administered on a previous shift, to doctors inappropriately reviving a patient because they aren't aware of a "do not resuscitate" order, says Leora Horwitz, a specialist in internal medicine at Yale University and the West Haven, Conn., VA Hospital.
In a survey published last month in the Archives of Internal Medicine, Dr. Horwitz found that few internal-medicine residency programs around the country have a comprehensive transfer-of-care system in place. While the onus shouldn't be on patients to convey such information, she advises patients and families: "If you think there's something important for the doctor to know, say it."
The University Health System Consortium, an alliance of 95 academic medical centers, recently published guidelines on how to best comply with the new Joint Commission standards, including using programs such as SBAR. This fall, the consortium will offer its members on online training program for residents, "Do No Harm," which will include strategies for improving hand-off communication.
John Whittington, patient safety officer at OSF St. Joseph Medical Center, says the SBAR "quick briefing" model can help overcome differing communication styles, such as nurses who give long, descriptive reports and doctors who say, "just give me the headlines," and don't want a nurse's opinion. OSF started training staffers to use the SBAR communication model in 2004, offering pocket cards and laminated "cheat sheets" posted at each phone.
At first, nurses and other staffers were hesitant to provide the "R" -- for recommendation -- to physicians, Dr. Whittington says, but doctors were asked to encourage staff to do so. By last year, the briefing format was used by more than 98% of nurses and the rate of adverse events -- defined as an unexpected medical problem that causes harm -- fell to 39.6 from 89.9 per 1,000 patient days, Dr. Whittington says.
"It does sound like this is something we should have been doing for the last 100 years, but one of the reasons errors are made during hand-offs is the longstanding culture of medicine," says Frank Mazza, vice president of medical affairs at Austin, Texas-based Seton Healthcare Network. Seton began using the SBAR model in its four labor-and-delivery units in January 2005, as part of an effort to eliminate complications for patients and make it easier for nurses to quickly brief each other and doctors.
It was rough at first, Dr. Mazza says, as nurses overcame hesitancy about making assessments, "but we now have complete buy-in from the medical staff."
At Doctors Hospital, in Coral Gables, Fla., part of the Baptist Health South Florida system, patients get a "Ticket to Ride" whenever they leave their hospital room, be it a transfer to another unit or a roundtrip down the hall for an X-ray. With checklists for tests, procedures and nurse's observations, the new peach-colored form helps relay patients seamlessly between staffers -- much the way air-traffic controllers hand off planes as flights move across regional airspaces.

Some large hospital groups and academic medical centers with electronic medical records have had considerable success with automated logs to document transfers, but the use of such technology is still rare. Brigham and Women's Hospital in Boston, for example, has used a computerized sign-out system for several years, and is developing a more-advanced version for the sickest patients in the ICU. David Bates, chief of the Division of General Medicine, says electronic systems are the only way to ensure the safe hand-off of large numbers of patients in a busy hospital, "so a standard set of information can get exchanged every time."
As part of its transition to electronic medical records, Kaiser has developed a Nurse Knowledge Exchange computer program, which allows departing nurses to create customized electronic reports on patients for the incoming nurses, such as lab results or medication changes. But the nurse coming on duty also makes bedside rounds with the outgoing nurse, and engages patients when possible in a discussion of treatments and progress.
"In almost all serious avoidable episodes of patient harm, communication failures play a central role," says Michael Leonard, physician leader for patient safety at Kaiser's Colorado division. By teaching caregivers new models of "structured communication," he adds, "we can make sure that we are all in the same movie."
• Email me at informedpatient@wsj.com1.