From the monthly archives:

March 2010

With the government’s blessing, a drug giant is about to expand the market for its blockbuster cholesterol medication Crestor to a new category of customers: as a preventive measure for millions of people who do not have cholesterol problems.

Some medical experts question whether this is a healthy move.

They point to mounting concern that cholesterol medications — known as statins and already the most widely prescribed drugs in the United States — may not be as safe a preventive medicine as previously believed for people who are at low risk of heart attacks or strokes.

Statins have been credited with saving thousands of lives every year with relatively few side effects, and some medical experts endorse the drug’s broader use. But for healthy people who would take statins largely as prevention — which would be the case for the new category of Crestor patients — other experts suggest the benefits may not outweigh the potential side effects.

Among the risks raising new concerns, recently published evidence indicates that statins could raise a person’s risk of developing Type 2 diabetes by nine percent.

“It’s a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this,” said Dr. Mark A. Hlatky, a professor of health research and cardiovascular medicine at the Stanford University School of Medicine.

There is also debate over the blood test being used to identify the new statin candidates. Instead of looking for bad cholesterol, the test measures the degree of inflammation in the body, but there is no consensus in the medical community that inflammation is a direct cause of cardiovascular problems.

The Food and Drug Administration approved the new criteria last month for Crestor, which is made by AstraZeneca and is the nation’s second best-selling statin, behind Lipitor by Pfizer. AstraZeneca plans soon to begin a new marketing and advertising campaign for Crestor, based on the new F.D.A.-approved criteria.

Under those criteria, an estimated 6.5 million people in this country who have no cholesterol problems and no sign of heart problems will be deemed candidates for statins. That is in addition to the estimated 80 million who already meet the current cholesterol-based guidelines — about half of whom now take statins.

The new Crestor label says it may be prescribed for apparently healthy people if they are older — men 50 and over and women 60 and over — and have one risk factor like smoking or high blood pressure, in addition to elevated inflammation in the body.

Some patients have long complained of muscle aches from taking statins. And doctors periodically check patients who take the drugs to make sure liver enzymes are not abnormally high. Doctors, though, have generally seen those risks as being more than offset by the drugs’ benefits for people with high levels of “bad” cholesterol and a significant risk of cardiovascular disease.

But then came the unexpected evidence linking statins to a diabetes risk, reported last month in the British medical journal The Lancet. That report was based on an analysis of most of the major clinical studies of statins — including unpublished data and the results of the Crestor study that the F.D.A. reviewed.

“We’ve had this drug for a while, and we’re just now finding out that there’s this diabetes problem with it?” said Dr. Hlatky.

The F.D.A. acknowledged the diabetes risk, and told AstraZeneca to add it to Crestor’s label. But the agency nonetheless approved the new use on the basis of the clinical study, which showed a small but measurable reduction of strokes, heart attacks and other “cardiovascular events” among people taking the statin, compared with patients taking a placebo.

“It’s an important milestone for the company and for the patient,” said Jim Helm, AstraZeneca’s vice president for cardiovascular products. “We are already discussing this with physicians.”

The new Crestor guidelines continue a steady expansion of the number of people considered medical candidates for statins in this country over the last decade. The recommendations and guidelines have been expanded by various advisory panels — many of whose members have also done paid consulting work for the drug industry.

Another of those panels is now preparing statin guidelines due next year, which are expected to further expand the number of candidates for the drugs.

The clinical trial on which the F.D.A. approved the new Crestor use was an international study of nearly 18,000 people. It looked only at patients who had low cholesterol readings and an elevated level of inflammation in the body as measured by a test called high-sensitivity C-reactive protein, or CRP.

It was the inventor of the CRP test, Dr. Paul M. Ridker, a Harvard medical professor and cardiologist at Brigham and Women’s Hospital in Boston, who persuaded AstraZeneca to pay for the statin study, which he then led.

Dr. Ridker said his proposals for such a study had previously been turned down by the National Institutes of Health and at least two other companies. One was Pfizer, whose statin Lipitor will lose patent protection next year and will be sold in inexpensive generic forms. The other was Bayer, whose statin Baycol was removed from the market in 2001 after it was linked to 52 deaths from a rare muscle disorder.

Compared with those companies, AstraZeneca had more of a business interest in sponsoring Dr. Ridker’s study. Crestor, which had sales of $4.5 billion last year, will not be subject to generic competition until 2016 — and so the company has more years to benefit from expanded use of the product at name-brand prices. The drug, taken as a daily pill, sells for at least $3.50 a day, compared with only pennies a day for some generic statins.

Dr. Ridker, meanwhile, receives undisclosed amounts of royalties from the CRP test. For a decade, he has argued that his test is sometimes a better diagnostic tool than cholesterol scores. And he says the Crestor study proved his case.

“We found a 55 percent reduction in heart attacks, 48 percent reduction in stroke, 45 percent reduction in angioplasty bypass surgery,” Dr. Ridker said in a recent interview. “I felt I had one shot at a controversial hypothesis,” he said, “and it worked really well.”

So well, in fact, that the study was halted after following patients an average of 1.9 years instead of the planned five years. With such improvement, a data monitoring board concluded it would have been unethical to continue the trial.

“I don’t understand the antipathy out there,” said Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic, who has consulted for AstraZeneca among many other companies but says he donates the money to charity. “If somebody comes into my office and meets the criteria, am I going to deny them a drug that reduces their chance of a heart attack or stroke by 40 or 50 percent?”

But critics said the claim of cutting heart disease risk in half — repeated in news reports nationwide — may have misled some doctors and consumers because the patients were so healthy that they had little risk to begin with.

The rate of heart attacks, for example, was 0.37 percent, or 68 patients out of 8,901 who took a sugar pill. Among the Crestor patients it was 0.17 percent, or 31 patients. That 55 percent relative difference between the two groups translates to only 0.2 percentage points in absolute terms — or 2 people out of 1,000.

Stated another way, 500 people would need to be treated with Crestor for a year to avoid one usually survivable heart attack. Stroke numbers were similar.

“That’s statistically significant but not clinically significant,” said Dr. Steven W. Seiden, a cardiologist in Rockville Centre, N.Y., who is one of many practicing cardiologists closely following the issue. At $3.50 a pill, the cost of prescribing Crestor to 500 people for a year would be $638,000 to prevent one heart attack.

Is it worth it? AstraZeneca and the F.D.A. have concluded it is.

Others disagree.

“The benefit is vanishingly small,” Dr. Seiden said. “It just turns a lot of healthy people into patients and commits them to a lifetime of medication.”

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WASHINGTON — Under pressure from the White House, health insurance companies said Tuesday that they would comply with rules to be issued soon by the Obama administration requiring them to cover children with pre-existing medical problems.

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“Health plans recognize the significant hardship that a family faces when they are unable to obtain coverage for a child with a pre-existing condition,” said Karen M. Ignagni, president of America’s Health Insurance Plans, a trade group. Accordingly, she said, “we await and will fully comply with” the rules.

Ms. Ignagni made the commitment in a letter to Kathleen Sebelius, the secretary of health and human services, who had said she feared that some insurers might exploit a possible ambiguity in the new health care law to deny coverage to some sick children.

The White House immediately claimed victory.

In a Twitter message, Robert Gibbs, the White House press secretary, scored the tug of war as “Kids 1, insurance 0.”

Major provisions of the law take effect in 2014. Some, including a ban on “pre-existing condition exclusions” for children under 19, take effect in September. The law does not explicitly say that insurers must sell insurance to families with such children this year, but Democratic Congressional leaders and White House officials said that was their intent.

To eliminate any ambiguity, Ms. Sebelius said she would issue rules defining the scope of the new law.

Under these rules, Ms. Sebelius said, “children with pre-existing conditions may not be denied access to their parents’ health insurance plan,” and “insurance companies will no longer be allowed to insure a child but exclude treatments for that child’s pre-existing condition.”

In response to a question, Nick Papas, a spokesman for the Department of Health and Human Services, said the rules would require insurers to offer coverage to children with pre-existing medical problems, including children whose parents have not had health insurance in the past.

It was not immediately clear whether the rules would allow insurers to charge higher premiums to families with children with pre-existing conditions.

Some insurers said they were unclear about the language of the law, based on differing accounts, and looked forward to detailed guidance from the government.

“There has been some confusion regarding the elimination of pre-existing condition evaluation for children in the health care bill,” said Kristin E. Binns, a spokeswoman for WellPoint, one of the biggest insurers. She said the company would “follow the law on this and all matters.”

Insurers said they would accept the administration’s reading of the law, even if they did not fully agree with it, because they wanted to avoid a showdown over the politically explosive issue of health insurance for sick children.

Several lawyers said it would be relatively easy for Congress to clear up any confusion by revising the law.

“The real solution here is a legislative fix so all players in the industry can act according to a clear set of rules,” said William G. Schiffbauer, a lawyer whose clients include employers and insurance companies.

Jeff Smokler, a spokesman for the Blue Cross and Blue Shield Association, said its member companies were “fully committed to complying with the new law” and accepted the principles stated by Ms. Sebelius for coverage of children with pre-existing conditions.

Gail K. Boudreaux, executive vice president of the UnitedHealth Group, said she supported the administration’s effort to clarify the law “to ensure that no child will be denied access to health insurance because of a pre-existing condition.”

“We expect that the new regulations will eliminate any uncertainty about the law’s intent,” Ms. Boudreaux said.

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The Last Piece in Place

by admin on March 30, 2010

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“We’ve used mirrors and smoke to try to get the premiums to where they’re bearable.” — Dale B. Cole, Jr., business owner

More than a week after President Obama signed the sweeping new health care law, which will eventually provide insurance coverage for 32 million uninsured Americans, many of us are still scratching our heads. What just happened? And how and when will we start feeling its effect?

This week’s Science Times takes a thorough look at the new health care legislation.

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“All of a sudden I feel like I can think about my child’s future without worrying.” — April Kohrherr with Griffin, right

In the long term, the legislation will require most Americans to obtain health insurance. It will also offer federal subsidies to lower premiums and significantly expand eligibility for Medicaid.

The changes will mean that 94 percent of legal residents not covered by Medicare will have health insurance, up from 83 percent now, according to the Congressional Budget Office.

While the biggest changes will not take effect until 2014, some important provisions will begin as early as June, while others will kick in by the end of the year. These include significant new restrictions on the insurance industry and new protections for consumers who already have health insurance. There are also perks for Medicare recipients and help for young adults. And in just 90 days there will be new coverage for people who have lost health insurance and can’t qualify for an individual policy.

“The basic thrust of this law is that all of these nooks and crannies, all these gaps where private insurance has left you without any option, those are going to be taken away,” said DeAnn Friedholm, the campaign director of health reform for Consumers Union, the nonprofit publisher of Consumer Reports. “It’s complicated, but it does establish a very key, important policy that you’re going to have options, regardless of your health situation or your employment situation.”

Some of the specific details will be outlined in the coming weeks by the Health and Human Services department. However, here are answers to some commonly asked questions about the health care changes coming within the next year.

Q. I don’t have health insurance. How soon will the new law help me?

The answer depends on your age and reasons for not having insurance. If you haven’t had insurance for six months, and you can’t afford or don’t qualify for insurance because of a pre-existing medical problem, you may be eligible for a new federal “high risk” pool to be offered by the end of June.

The cost of the monthly premiums hasn’t been announced, but the rates are to be based on a “standard population,” suggesting they will be based on a healthier group than typically used to calculate premiums for high-risk plans. On average, an enrollee won’t pay more than 35 percent of covered benefits, and annual out-of-pocket costs won’t be more than $5,950 for individuals and $11,900 for families. In addition, there are no lifetime limits — meaning the policy won’t be canceled if someone requires expensive medical treatment

Q. How many people can sign up for the new plan?

Until national health officials specify the premium costs and exactly what will or will not be covered, nobody knows how many people can sign up. The $5 billion set aside by Congress must last until 2014, when other options become available. By comparison, 35 states already spend a combined total of $2 billion annually on high-risk insurance pools that cover 200,000 people.

Q. How is the new federal pool different from what is already offered by state high-risk pools or Medicaid?

The federal plan is expected to offer more-affordable coverage than the existing state plans and will not impose the same income restrictions as Medicaid. State plans also typically impose high deductibles and premiums (some charge as much as $1,200 a month), and up to 12-month waiting periods before covering pre-existing health problems.

The experience of April and Steve Kohrherr of Afton, Va., shows how existing public plans fall short for many families. Their oldest son, Griffin, 6, has hemophilia, a severe bleeding disorder. His care, which has included brain surgery for a life-threatening bleed as well as twice-weekly infusions with a clotting drug, totals $500,000 or more a year.

The high cost of Griffin’s care would disqualify him from most state plans. Adding Griffin to the small group plan at the restaurant where Mr. Kohrherr works would have increased premiums for all the workers, making it unaffordable for everyone. Griffin now is covered by Medicaid, but he will lose the benefit if his family’s income exceeds about $40,000. Ms. Kohrherr works part time, but goes without insurance because the family of four cannot afford the $200 monthly cost to add her to her husband’s policy.

“If anybody was in my shoes and held their kid who was close to death, and if they had to worry about insurance at that moment, then they would never have been against this bill,” Ms. Kohrherr said. “All of the sudden I feel like I can think about my child’s future without worrying.”

Q. How will the law affect children with pre-existing conditions?

Beginning in September, the new law is expected to stop insurance companies from rejecting children or excluding coverage because of pre-existing medical problems. That’s what happened to Diane Knight, 52, of Orem, Utah, when she tried to get health insurance for her 17-year-old daughter.

Although Ms. Knight and her husband had family insurance in the past, they lost it when they left their jobs to start a small business. When they discovered that they were unable to get new insurance because both had a past cancer diagnosis, they sought an individual policy just for their daughter. But she was rejected, too, because she had used expensive prescription acne cream when she was younger and the insurance company did not want to pay for that in the future.

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“I’m tired of paying for everyone else’s stupidity,” is a comment I read on the Internet last week after the health care bill was passed. It summed up the views of many Americans worried about shelling out higher premiums and taxes to cover the uninsured. Why should we pick up the tab when so much disease in our country stems from unhealthy behavior like smoking and overeating?

This weekâ??s Science Times takes a thorough look at the new health care legislation.

What is the government’s role in helping people make healthy lifestyle choices?

In fact, the majority of Americans say it is fair to ask people with unhealthy lifestyles to pay more for health insurance. We believe in the concept of personal responsibility. You hear it in doctors’ lounges and in coffee shops, among the white collar and blue collar alike. Even President Obama has said, “We’ve got to have the American people doing something about their own care.”

But personal responsibility is a complex notion, especially when it comes to health. Individual choices always take place within a broader, messy context. When people advocate the need for personal accountability, they presuppose more control over health and sickness than really exists.

Unhealthy habits are one factor in disease, but so are social status, income, family dynamics, education and genetics. Patient noncompliance with medical recommendations undoubtedly contributes to poor health, but it is as much a function of poor communication, medication costs and side effects, cultural barriers and inadequate resources as it is of willful disregard of a doctor’s advice.

A few years ago surgeons in Melbourne, Australia, were refusing to provide heart and lung surgeries to smokers, even those who needed the operations to stay alive. “Why should taxpayers pay for it?” said one surgeon quoted in media reports at the time. “It is consuming resources for someone who is contributing to their own demise.”

Though some were outraged by this stance — the Australian Medical Association called it “unconscionable” to ration services based on personal habits — many doctors agreed with it. Like the majority of Americans, they saw nothing wrong with patients paying for the consequences of their actions.

The problem is that punitive measures to force healthy behavior do not usually work. In 2006, West Virginia started rewarding Medicaid patients who signed a pledge to enroll in a wellness plan and to follow their doctors’ orders with special benefits, including unlimited prescription-drug coverage, programs to help them quit smoking and nutrition counseling. Those who did not sign up were enrolled in a more restrictive plan that, among other things, limited drug coverage to only four prescriptions a month.

The program, by many accounts, is failing. As of August 2009, only 15 percent of 160,000 eligible patients had signed up. Patients with limited transportation options were having a hard time committing to regular office visits. And experts say there is no evidence that restricting benefits for noncompliant patients has promoted healthy behaviors.

As a cardiology fellow, I once took care of a young man with severe congestive heart failure. We were supposed to start him on a blood thinner early in his hospitalization, but it got overlooked. Fed up with the delays in getting his blood sufficiently thinned, he left the hospital against medical advice. He said he had to go home to care for his toddler.

He came to the clinic a week later looking very embarrassed. He had left without prescriptions, so he had been taking no medications since he left, leaving him short of breath. To compound the problem, he had been eating cold cuts, cheap and readily available, which made his condition even worse. But the attending physician refused to give him prescriptions. She said that he had to go to a walk-in clinic. She said he had to learn personal responsibility.

Healthy living should be encouraged, but punishing patients who make poor health choices clearly oversimplifies a very complex issue. We should be focusing on public health campaigns: encouraging exercise, smoking cessation and so on. Of course, this will require a change in how we live, how we plan our communities.

“It’s the context of people’s lives that determines their health,” said a World Health Organization report on health disparities. “So blaming individuals for poor health or crediting them for good health is inappropriate.”

I must admit I often feel like my colleagues who grouse about spending all day treating patients who do not seem to care about their health and then demand a quick fix. I do not relish paying more taxes to treat patients who engage in unhealthy habits. But then I remind myself that we all engage in socially irresponsible behavior that others pay for. I try to eat right and get enough exercise. But then I also sometimes send text messages when I drive.

The whole point of insurance is to reduce risk. When people inveigh against the lack of personal responsibility in health care, they are really demanding a different model, one based on actual risk, not just on spreading costs evenly through society. Sick people, they are really saying, should pay more. Which model we eventually adopt in this country will say a lot about the kind of society we want to live in.

Sandeep Jauhar is a cardiologist and the author of â??â??Intern: A Doctorâ??s Initiation.â?

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Dr. Robert Colton, an internist in Boca Raton, Fla., has a problem, and he knows it. His patients come in wanting, sometimes demanding, tests and treatments that are unnecessary, just adding to the nation’s huge health care bill. He even has patients, he says, who come in and report that their chief complaint is, “I need an M.R.I.

This week’s Science Times takes a thorough look at the new health care legislation.

Does the new health care bill do enough to curb overuse of care?

And what does Dr. Colton do?

“I do the damn test,” he said. “There is no incentive for me, Rob Colton, to reduce overutilization. If the person wants it, what are you going to do, say no?”

And the new health care legislation, he says, is not going to make a bit of difference.

To truly change the nation’s chronic overuse of medical care, there will have to be a substantial change in the way patients think about health care, how medicine is practiced and how it is paid for, economists and doctors say.

The legislation does little to help in those areas. It is important, medical experts say, because it opens the door to medical care for millions of people who were shut out because they could not afford insurance or because they had pre-existing conditions or had reached lifetime caps on insurance payments. But controlling overuse is not its focus.

Some, like Jonathan Gruber, a health economist at M.I.T., say change eventually has to come because the nation is on an unsustainable path.

“Unless we are prepared to spend 50 percent of our G.D.P. on health care, it has to happen,” Dr. Gruber said.

And at least the legislation takes a stab at the overuse problem, he said. For example, in a few years it will tax expensive health care plans. The idea is that if employers offer less expensive plans, with higher co-payments and deductibles, patients might demand less expensive care. Then there are the insurance exchanges that will compete for customers and might lower costs by refusing to pay for unnecessary tests and procedures.

“The relative comparison is not the perfect world,” Dr. Gruber said. “The relative comparison is the world without this bill.”

But it will not be easy to put the brakes on overuse. Estimates of the amount of medical care that is unnecessary range from 10 to 30 percent, although no one knows for sure. Many doctors concede that they see overuse and that it has just become a part of the medical landscape.

Doctors often blame patients for demanding useless care, but many also concede that patients often have too little knowledge or power to say no to tests or treatments. The new law includes money for comparative effectiveness studies, and those can give guidance on which tests and treatments are better than others. But the law in no way forces patients or doctors to choose one test or treatment over another or to aim for the cheapest alternative. And it does nothing to change the reimbursement system, in which doctors often make more money if they order more tests, for instance.

In radiology, for example, there are clear guidelines, based on medical evidence, for CT scans of the head and neck. Among other things, the guidelines say CT scans are not necessary after most car accidents. Many patients have no real risk of brain injury from an accident, and there are good methods of deciding who is at risk and who is not. The guidelines have not put a dent in overuse.

The joke among radiologists, said Dr. Howard P. Forman, a radiologist and health services researcher at Yale, is that “the indication for getting a head CT after a car accident is if you have a head.”

The law includes pilot programs that Medicare is testing that pay doctors more for delivering better care at a lower cost. For example, groups of doctors can share in the savings to Medicare if they spend less money and improve the quality of their patients’ care.

Such programs, linking medical outcomes and payments, might help if they were translated into Medicare policy, said Dr. Mark B. McClellan, the former leader of the Centers for Medicare and Medicaid Services, who is now at the Brookings Institution. But more should be done, Dr. McClellan said, considering the scope of the overuse problem.

“It would be good to have more arrows in the quiver,” he said.

It is no surprise that Congress shied away from a serious effort to hold down overuse. The public has made it clear that it does not want to be told what medical care it can and cannot have.

“The minute you attack overutilization you will be called a Nazi before the day is out,” said Uwe E. Reinhardt, a health economist at Princeton.

Some hold out hope for the comparative effectiveness studies.

But “there is no direct link between the development of that evidence and the use of that evidence,” said Bryan R. Luce, senior vice president for science policy at United Biosource Corp., a Washington consulting firm.

The idea of the comparative effectiveness guidelines is a sort of an “if you build it, they will come” notion, said Dr. J. Sanford Schwartz, a health economist and internist at the University of Pennsylvania. But that is not going to be sufficient, he said. There needs to be a way to effectively link what the guidelines say and how they are put into effect, how they are interpreted, what insurers pay for and what doctors do.

One way to make those links is to do what some other countries do — say that there will be no payments for care that is not deemed the most cost-effective. But politicians shy away from such measures, Dr. Luce said. “That is not likely to happen soon, particularly at a national level,” he said.

It would mean rationing, said Dr. Robert D. Truog a professor of medical ethics, anesthesia, and pediatrics at Harvard Medical School. “That’s the word nobody wants to use. It’s just a firecracker. Nobody wants to touch it.”

The result is a crazy system in which, he points out, a government-appointed task force on screening mammography was explicitly forbidden to consider the costs of offering mammograms to women for whom the benefit is very small.

“The point is that as long as a health care system has anything less than an infinite budget, there is a need to decide which types of health care will be funded and which will not,” Dr. Truog said.

But that does not seem to be in the offing. And some, like Dr. Schwartz, despair.

“Einstein once said, ‘Insanity is doing the same thing over and over again and expecting a different result,’ ” Dr. Schwartz said.

Meanwhile in Florida, Dr. Colton says, he and his doctor friends would welcome a way to stop overuse. They would, he said, embrace guidelines and a payment system that denies reimbursement for unnecessary medicine and protects doctors from malpractice suits if they follow the guidelines.

“I really believe that in our heart of hearts most doctors want to curb this,” Dr. Colton said. “We know what we are doing. And we are frustrated, too. But we can’t help ourselves. There is nothing to stop us and nothing to be gained by stopping.”

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WASHINGTON — Just days after President Obama signed the new health care law, insurance companies are already arguing that, at least for now, they do not have to provide one of the benefits that the president calls a centerpiece of the law: coverage for certain children with pre-existing conditions.

Senator John D. Rockefeller IV criticized insurance companies that say they do not yet have to cover pre-existing conditions.

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Mr. Obama, speaking at a health care rally in northern Virginia on March 19, said, “Starting this year, insurance companies will be banned forever from denying coverage to children with pre-existing conditions.”

The authors of the law say they meant to ban all forms of discrimination against children with pre-existing conditions like asthma, diabetes, birth defects, orthopedic problems, leukemia, cystic fibrosis and sickle cell disease. The goal, they say, was to provide those youngsters with access to insurance and to a full range of benefits once they are in a health plan.

To insurance companies, the language of the law is not so clear.

Insurers agree that if they provide insurance for a child, they must cover pre-existing conditions. But, they say, the law does not require them to write insurance for the child and it does not guarantee the “availability of coverage” for all until 2014.

William G. Schiffbauer, a lawyer whose clients include employers and insurance companies, said: “The fine print differs from the larger political message. If a company sells insurance, it will have to cover pre-existing conditions for children covered by the policy. But it does not have to sell to somebody with a pre-existing condition. And the insurer could increase premiums to cover the additional cost.”

Congressional Democrats were furious when they learned that some insurers disagreed with their interpretation of the law.

“The concept that insurance companies would even seek to deny children coverage exemplifies why we fought for this reform,” said Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

Senator John D. Rockefeller IV, Democrat of West Virginia and chairman of the Senate commerce committee, said: “The ink has not yet dried on the health care reform bill, and already some deplorable health insurance companies are trying to duck away from covering children with pre-existing conditions. This is outrageous.”

The issue is one of many that federal officials are tackling as they prepare to carry out the law, with a huge stream of new rules, official guidance and brochures to educate the public. Their decisions will have major practical implications.

Insurers say they often limit coverage of pre-existing conditions under policies sold in the individual insurance market. Thus, for example, an insurer might cover a family of four, including a child with a heart defect, but exclude treatment of that condition from the policy.

The new law says that health plans and insurers offering individual or group coverage “may not impose any pre-existing condition exclusion with respect to such plan or coverage” for children under 19, starting in “plan years” that begin on or after Sept. 23, 2010.

But, insurers say, until 2014, the law does not require them to write insurance at all for the child or the family. In the language of insurance, the law does not include a “guaranteed issue” requirement before then.

Consumer advocates worry that instead of refusing to cover treatment for a specific pre-existing condition, an insurer might simply deny coverage for the child or the family.

“If you have a sick kid, the individual insurance market will continue to be a scary place,” said Karen L. Pollitz, a research professor at the Health Policy Institute at Georgetown University.

Experts at the National Association of Insurance Commissioners share that concern.

“I would like to see the kids covered,” said Sandy Praeger, the insurance commissioner of Kansas. “But without guaranteed issue of insurance, I am not sure companies will be required to take children under 19.”

A White House spokesman said the administration planned to issue regulations setting forth its view that “the term ‘pre-existing’ applies to both a child’s access to a plan and his or her benefits once he or she is in a plan.” But lawyers said the rules could be challenged in court if they went beyond the law or were inconsistent with it.

Starting in January 2014, health plans will be required to accept everyone who applies for coverage.

Until then, people with pre-existing conditions could seek coverage in high-risk insurance pools run by states or by the secretary of health and human services. The new law provides $5 billion to help pay claims filed by people in those pools.

Federal officials will need to write rules or guidance to address a number of concerns. The issues to be resolved include defining the “essential health benefits” that must be offered by all insurers; deciding which dependents are entitled to stay on their parents’ insurance; determining who qualifies for a “hardship exemption” from the requirement to have insurance; and deciding who is eligible for a new long-term care insurance program.

As originally conceived, most of the new federal requirements would have taken effect at the same time, in three or four years. The requirements for people to carry insurance, for employers to offer it and for insurers to accept all applicants were tied together.

But as criticism of their proposal grew, Democrats wanted to show that the legislation would produce immediate, tangible benefits. So they accelerated the ban on “pre-existing condition exclusions” for children.

Consumers will soon gain several other protections. By July 1, the health secretary must establish a Web site where people can identify “affordable health insurance coverage options.” The site is supposed to provide information about premiums, co-payments and the share of premium revenue that goes to administrative costs and profits, rather than medical care.

In addition, within six months, health plans must have “an effective appeals process,” so consumers can challenge decisions on coverage and claims.

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WASHINGTON — Urgent warnings by government experts about the risks of routinely using powerful CT scans to screen patients for colon cancer were brushed aside by the Food and Drug Administration, according to agency documents and interviews with agency scientists.

Dr. Julian Nicholas, a gastroenterologist, warned the Food and Drug Administration against CT scans for colon cancer screenings.

After staying quiet for a year, the scientists say they plan to make their concerns public at a meeting of experts on Tuesday called by the F.D.A. to discuss how to protect patients from unnecessary radiation exposures. The two-day meeting is part of a growing reassessment of the risks of routine radiology. The average lifetime dose of diagnostic radiation has increased sevenfold since 1980, driven in part by the increasing popularity of CT scans. Such scans can deliver the radiation equivalent of 400 chest X-rays.

An estimated 70 million CT (for computed tomography) scans are performed in the United States every year, up from three million in the early 1980s, and as many as 14,000 people may die every year of radiation-induced cancers as a result, researchers estimate.

The use of CT scans to screen healthy patients for cancer is particularly controversial. In colon cancer screening, for instance, the American College of Radiology as well as the American Cancer Society have endorsed CT scans, in a procedure often called a virtual colonoscopy, while the American College of Gastroenterology recommends direct examinations in which doctors use a camera on a flexible tube.

For patients, navigating the debate can be difficult because doctors, patient advocacy groups and manufacturers often endorse positions that are in their economic self-interest. Radiologists, who often own and use CT machines, for instance, often endorse their use; while gastroenterologists, who often own and use camera scopes, often favor their own methods. Patient groups often get financing from drug and device makers, or physician-specialty groups.

The Food and Drug Administration, charged with sorting out such competing claims, has been just as torn on the issue. The internal dispute has grown so heated that a group of agency scientists who are concerned about the risks of CT scans say they will testify at the Tuesday meeting that F.D.A. managers ignored or suppressed their concerns, and that the resulting delay in making these concerns public may have led hundreds of patients to be endangered needlessly.

Scores of internal agency documents made available to The New York Times show that agency managers sought to approve an application by General Electric to allow the use of CT scans for colon cancer screenings over the repeated objections of agency scientists, who wanted the application rejected. It is still under review.

After an agency official recommended approving G.E.’s application, Dr. Julian Nicholas, a gastroenterologist who trained at Oxford University and the Mayo Clinic and worked under contract with the agency, responded by e-mail that he felt strongly that approving the application could “expose a number of Americans to a risk of radiation that is unwarranted and may lead to instances of solid organ abdominal cancer.”

Dr. Robert Smith, a former professor of radiology at both Yale and Cornell and an F.D.A. medical officer, wrote that he agreed with Dr. Nicholas because “the increased radiation exposure to the population could be substantial and would raise a serious public health/public policy issue,” documents show.

Alberto Gutierrez, deputy director of the F.D.A. office with responsibility over radiological devices, said in an interview that the right course on CT colonography was far from clear.

“This device that you’ve mentioned has not been cleared or approved at this time, and that should tell you that the process we go through is not done,” Dr. Gutierrez said.

Arvind Gopalratnam, a spokesman for G.E. Healthcare, wrote in an e-mail message that research had shown that “CT colonography can be a very valuable, noninvasive screening tool to help diagnose colorectal cancer at early stages and ultimately improve overall survival rates.”

For decades, scientists at the F.D.A. approved many radiological medical devices with minimal oversight, declaring them modest improvements over older devices and thus not needing extensive reviews or clinical trials to prove their safety and efficacy. But these devices now play a central role in American medicine, helping not only to diagnose a wide array of ailments, but also to treat cancers.

And the agency has done little to assess whether the rapid proliferation of scans is in the best interests of patients, and whether the machines themselves properly protect patients or are beneficial for all of their now-routine uses.

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New Tool Could Help in Testing for H.G.H.

by admin on March 29, 2010

A test similar to one used in cancer treatments has antidoping officials encouraged that they have found a new, and important, way to catch athletes using human growth hormone.

The test uses the same science that detects bone and breast cancer. A laboratory technician takes several milliliters of blood and spins the sample in a centrifuge. The blood is then mixed with chemicals, a reaction occurs and an instrument is used to measure the illumination in the blood.

The intensity of the light, antidoping experts say, signals whether the person has used H.G.H. over the past 10 to 14 days. The procedure is known as the biomarkers test.

Antidoping officials are usually eager to trumpet new testing methods, and skeptics have at times accused them of overstating scientific developments. Nevertheless, the officials maintain that the biomarkers test is a significant advancement over the current test for human growth hormone. That test can only detect H.G.H. that has been used in the previous 24 to 48 hours.

Officials for the World Anti-Doping Agency, which oversees the testing protocols of Olympic athletes and many professional athletes outside the United States, said that after more than a decade of research, the biomarkers test was only months from being put into use on athletes.

The introduction of the test by WADA will probably intensify the debate over H.G.H. blood testing that is taking place in Major League Baseball and the N.F.L. The debate intensified last month after a professional rugby player in England was suspended after testing positive for H.G.H. It was the first time that an athlete had been suspended for an H.G.H. positive in the six years that testing has been used, and it clearly made an impression on officials in baseball and the N.F.L.

Since the suspension, the N.F.L. has said that it has asked its players union to accept blood testing for H.G.H. Baseball’s commissioner, Bud Selig, has asked his deputies to pursue the quick implementation of the existing H.G.H. test in the minor leagues, where the consent of baseball’s players union is not required.

In turn, officials of the two unions have expressed reservations about the existing test, which they point out has caught only one athlete. Adding to their caution is that there has never been blood testing for performance-enhancing drugs in either league.

But even as the H.G.H. debate continues, the science of H.G.H. testing has progressed.

David Howman, the director general of WADA, said that he believed that the biomarkers test would make it harder for anyone in the N.F.L. and Major League Baseball to argue that there were not viable tests for H.G.H.

“The other test is scientifically reliable, and so is the new one,” Howman said. “Anyone who tells you otherwise hasn’t looked at the science.”

According to antidoping officials, the creators of the test said that they set the threshold for a positive extremely high, similar to other levels used in tests conducted by WADA.

H.G.H. is a naturally occurring substance in the body. Injections of it are believed to decrease fat and increase muscle growth. In any number of instances, it has been used by athletes who are rehabilitating after injuries. In the United States, it is illegal to possess H.G.H. without a prescription, and its use as a performance-enhancer is banned by all major sports around the world.

“H.G.H. has been used with great impunity since the 1970s,” Howman said. “It’s very available to athletes. They use it freely, and they usually don’t use things that can’t help them.”

The biomarkers test detects chemicals in the body that are raised when H.G.H. levels spike; the existing blood test simply detects the presence of synthetic H.G.H. Because the tests take different measurements, antidoping officials say that both will be used in the future.

“They are complementary,” said Larry Bowers, the chief science officer for the United States Anti-Doping Agency. “The biomarkers test can’t detect use in the first 48 hours, so that is why you use both of them. It’s another tool for us to use.”

Travis Tygart, the head of Usada, said: “It’s obviously very significant and it is why over the past several years, we have invested money in not just the direct test but the new marker test. We knew that the two of them would provide a significant deterrent.”

The N.F.L.’s top drug testing official, Adolpho Birch, said in a statement that the league was aware of the biomarkers test and was following its development.

“Our advisers keep us informed on the scientific progress and we are in regular contact with Usada and WADA officials,” Birch said. “The Partnership for Clean Competition, a research consortium that we founded along with other partners, recently held a conference at which the state of the research in this area was thoroughly discussed.”

A spokesman for the N.F.L. Players Association did not return e-mail or telephone messages seeking comment. Nor did a spokesman for the baseball players union. Rob Manfred, baseball’s top drug-testing official, said in a statement that the commissioner’s office was looking into the test and consulting with its medical adviser.

The antidoping officials, meanwhile, said they were in the final stages of reviewing the science behind the biomarkers test.

“At the end of the day, it’s about clean athletes,” Tygart said. “They ought to demand it. You don’t want to play in a sport where you don’t have the capabilities of testing for potent substances like human growth hormone that are significant performance-enhancers.”

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Health Law Cuts the Cost of Being a Woman

by admin on March 29, 2010

Being a woman is no longer a pre-existing condition. That’s the new mantra, repeated triumphantly by House Speaker Nancy Pelosi, Senator Barbara A. Mikulski and other advocates for women’s health. But what does it mean?

This week’s Science Times takes a thorough look at the new health care legislation.

Do you think the new health care bill does enough for women?

In the broadest sense, the new health care law forbids sex discrimination in health insurance. Previously, there was no such ban, and insurance companies took full advantage of the void.

“The health care industry and health care insurance in general has been riddled with the most discriminatory and unfair practices to women,” said Marcia D. Greenberger, the founder and co-president of the National Women’s Law Center. “This law is a giant leap forward to dismantling the unfairness that has been a part of the system.”

Until now, it has been perfectly legal in most states for companies selling individual health policies — for people who do not have group coverage through employers — to engage in “gender rating,” that is, charging women more than men for the same coverage, even for policies that do not include maternity care. The rationale was that women used the health care system more than men. But some companies charged women who did not smoke more than men who did, even though smokers have more risks. The differences in premiums, from 4 percent to 48 percent, according to a 2008 analysis by the law center, can add up to hundreds of dollars a year. The individual market is the one that many people turn to when they lose their jobs and their group coverage.

Insurers have also applied gender-rating to group coverage, but laws against sex discrimination in the workplace prevent employers from passing along the higher costs to their employees based on sex. Gender rating has taken a particular toll on smaller or midsize businesses with many women, like home-health care, child care and nonprofits. As a result, some businesses have been unable to offer health coverage or have been able to afford it only by using plans with very high deductibles.

In addition, individual policies often excluded maternity coverage, or charged much more for it. Now, gender rating is essentially outlawed, and policies must include maternity coverage, considered “an essential health benefit.”

“It has to be a part of the premium just like heart attacks, prostate cancer or any other condition,” Ms. Greenberger said.

Despite her enthusiasm for many aspects of the new law, Ms. Greenberger said she was profoundly disappointed in provisions that she thought would limit women’s access to abortion services.

Advocates for women’s health said one of the new law’s benefits would be to ban the denial of health coverage to women who have had a prior Caesarean section or been victims of domestic violence. Some companies providing individual policies have refused coverage in those circumstances, regarding Caesareans or beatings as pre-existing conditions that were likely to be predictors of higher expenses in the future.

In a statement issued Thursday, Senator Mikulski said: “One of my hearings revealed that a woman was denied coverage because she had a baby with a medically mandated C-section. When she tried to get insurance coverage with another company, she was told she had to be sterilized in order to get health insurance. That will never, ever happen again because of what we did here with health care reform.”

Peggy Robertson, 41, who lives in Centennial, Colo., is the woman to whom Senator Mikulski referred. Ms. Robertson was interviewed by The New York Times in June 2008 and testified at the hearing last October. Her husband, a chiropractor, is self-employed, so they rely on the individual market to cover them and their two sons. In 2007, they had insurance, but considered switching companies when a broker suggested they might find a better deal. They applied to a company called Golden Rule, which is based in Indianapolis and owned by UnitedHealthcare. The company rejected Ms. Robertson because of her Caesarean, explaining in a letter that she would have been eligible if she had been sterilized. When Ms. Robertson went public with her story, the word “sterilized” seemed to provoke particular outrage, she said.

Golden Rule later began offering coverage to women who had had Caesareans, but by charging extra if they wanted maternity coverage, or issuing policies that excluded maternity care.

In a telephone interview on Friday, Ms. Robertson said: “Barbara Mikulski told me, she promised me, ‘This will never happen again.’ She did it. It’s wonderful.”

Ms. Robertson’s only disappointment was that some of the new rules would not take effect until 2014.

But Ms. Greenberger said that while it is true that the specific requirements will be delayed until 2014, some changes should actually happen much sooner, because the law’s overarching ban on sex discrimination takes effect immediately. The legalese outlawing sex discrimination is not easy to find or to parse, but it refers to existing laws, like the Civil Rights Act and Title IX, to say that the same protections apply to people seeking health care and insurance.

The passage, Sec. 1557 on page 368 of the 2,074-page bill, says: “Except as otherwise provided for in this title (or an amendment made by this title), an individual shall not, on the ground prohibited under Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.), Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.), the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), or Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any health program or activity, any part of which is receiving federal financial assistance, including credits, subsidies, or contracts of insurance, or under any program or activity that is administered by an executive agency or any entity established under this title (or amendments).”

What it means, Ms. Greenberger said, is that no organization receiving any federal money at all — as insurers generally do — can discriminate on the basis of sex. Gender rating, she said, “is a problem whose days are numbered.”

Ms. Greenberger acknowledged that insurance companies were masters at protecting their bottom line, but said she did not see an obvious way around the new rules. “I never want to underestimate what a creative mind might be able to come up with,” she said, “but I believe this is pretty straightforward.”

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