April 2010

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Vicki Cornford has seen more than her share of medical bills, so she knew something was amiss when she received a surprise $500 invoice from an anesthesiologist. He had treated her daughter Amber, a nursing student, and only part of his fee was covered by insurance.

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Vicki Cornford of Roscoe, Ill., had long experience dealing with medical bills. But even she was thrown for a loop by “balance billing.”

First, some background. Ms. Cornford’s daughter Amber, now 21, was born with a rare bone disease that over the years has demanded constant monitoring, treatment and operations.

As a result, Ms. Cornford has dealt with all manner of billing hassles, including denied claims, administrative errors and endless paperwork.

But last fall, Amber, now a nursing student at Loyola University in Chicago and still covered under her father’s employer-sponsored health insurance plan, underwent yet another operation. A few weeks later, Ms. Cornford received a bill for about $500 from the anesthesiologist who treated her daughter.

That seemed strange. Ms. Cornford was sure she had seen a claim for the anesthesiologist on a recent explanation of benefits statement from her insurer. But this new bill, it turned out, was for the remainder of the anesthesiologist’s fee not covered by Ms. Cornford’s insurance.

“I’ve seen just about every mix-up possible over the years,” Ms. Cornford said. “But with this one I couldn’t understand why I was getting a bill.”

Ms. Cornford would soon become very familiar with the phenomenon known as balance billing. It is a controversial and sometimes illegal practice: doctors and other health care providers receive a discounted payment from the insurance company — an amount less than the fee they want to be paid — and then they bill the patient for the rest. Most states, including Illinois, have passed laws making balance billing illegal within an insurer’s medical network. And federal law prohibits balance billing by providers paid under Medicare.

But balance billing in these cases can still happen. If you receive a bill from an in-network provider that you are not expecting, call your insurer immediately. “Your insurance company is the best enforcer, if you will, of these laws,” said Jane Cooper, chief executive of Patient Care, a Milwaukee patient advocate firm.

Most cases occur when patients who are part of H.M.O.’s, P.P.O.’s and other network health care plans use an out-of-network doctor, lab hospital or other provider. H.M.O.’s, as a rule, will not cover any out-of-network fees unless for an emergency or for a pre-approved treatment so specialized that no one in the network can provide it. P.P.O.’s generally cover some percentage of out-of-network fees, usually 70 or 80 percent of so-called usual and customary charges.

When an H.M.O. or a P.P.O. does agree to pay an out-of-network surgeon, say, it is easy to be lulled into a false sense of security: Pre-approval means the entire bill will be paid, right? Maybe not.

Instead, through the dark art of balance billing, you may discover — usually only when the bill arrives — that the provider is looking to collect more than the insurance company has agreed to pay. The recent federal overhaul of health insurance laws does not directly address the balance billing issue.

“In many cases people just pay, figuring they owe the money and there’s nothing else they can do,” said Ms. Cooper. But there are ways to avoid balance billing in the first place — and to fight back if you believe this has happened to you.

STAY IN NETWORK This is really the best way you can avoid extra charges, Ms. Cooper said.

Of course, in many cases, particularly emergencies, you do not have a choice. But often patients will go to an outside doctor because of reputation or a recommendation from a family member or friend.

“There may very well be a professional who is just as qualified in your network,” Ms. Cooper said. “Then you can be sure the cost will be fully covered.”

DOUBLE-CHECK The first time you visit a doctor or other health care provider, always call and verify that he or she is indeed in your network, Ms. Cooper suggested. Web sites can be outdated and mix-ups do happen. A physical therapist with two offices for instance, may be considered part of your network in only one of those locations.

Erin Moaratty, a spokeswoman for the nonprofit Patient Advocate Foundation, notes that even if the hospital you are going to is in your network, some of the people who treat you there may not be.

That is what happened to Ms. Cornford. Her daughter’s anesthesiologist sent the extra bill because he was not under contract with Ms. Cornford’s insurer. Ultimately, a patient advocate at Ms. Cooper’s firm helped persuade the anesthesiologist to agree to accept the discounted fee from the insurer.

As best you can, you need to make sure before you are admitted to an in-network hospital that you will be treated by doctors, anesthesiologists, radiologists, physical therapists and other providers who are in your network. That way you will not get hit with any “balance” bills.

NEGOTIATE UPFRONT If you know you must go out of network, be ready to talk money before you receive treatment, said Jennifer Jaff, executive director of Advocacy for Patients With Chronic Illness.

Keep in mind that insurers pay according to what they deem are “usual and customary” fees for a particular treatment in your area. So if your P.P.O. plan pays 80 percent of out-of-network fees, this means 80 percent of “reasonable and customary” fees. If your doctor charges well above what the insurance company deems reasonable and customary, you may be balance-billed for the difference in addition to the co-payment you expected, for 20 percent of the reasonable and customary fees.

Ask the out-of-network doctor (or his or her billing specialist) what the charge for your care will be. Then check with your insurer to see how that matches up with what it will pay for out-of-network service. Armed with this information, you can then negotiate with your doctor upfront to accept the insurance company payment or ask if he or she will negotiate with the insurer directly.

And if you want to use an out-of-network hospital, you’ll need to get pre-approval from your insurance company for all of the charges involved, not just your surgeon’s fee and the hospital charges.

NEGOTIATE AFTERWARD, TOO When confronted with a balance bill, do not hesitate to call the doctor and discuss payment. Ask why he or she feels the insurance payment is not sufficient and why you were not informed of the excess fees ahead of time.

Often, a provider will compromise, Ms. Cooper said. At the very least you can work out a payment plan and keep the bill out of collections.

FILE AN APPEAL If you feel your insurance company is allocating too little toward your health care provider’s payment and you are shouldering too much of the fee, consider a more formal appeal that asks your insurance company to pay more, Ms. Moaratty suggested. This is especially true if you can justify the extra fee.

Say, for example, complications resulted from a routine procedure and the treatment or surgery took much longer than expected. Or, if what started out as a routine doctor office visit actually entailed something more complicated. More information on how to file an appeal appeared in a Feb. 6 column, “Fighting Denied Claims Requires Perseverance.”

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After learning that their son, Andy, had fragile X syndrome, Katie Clapp and her husband, Dr. Michael Tranfaglia, started the Fraxa Research Foundation to fund research for the condition.

An experimental drug succeeded in a small clinical trial in bringing about what the researchers called substantial improvements in the behaviors associated with retardation and autism in people with fragile X syndrome, the most common inherited cause of these mental disabilities.

Katie Clapp and her son, Andy Tranfaglia, who was born with fragile X syndrome. She works to raise funds for research.

The surprising results, disclosed in an interview this week by Novartis, the Swiss pharmaceutical giant that makes the drug, grew out of three decades of painstaking genetic research, leaps in the understanding of how the brain works, the advocacy of families who refused to give up, and a chance meeting between two scientists who mistakenly showed up at the same conference.

“Just three years ago, I would have said that mental retardation is a disability needing rehab, not a disorder needing medication,” said Dr. Thomas R. Insel, director of the National Institute of Mental Health, who was told of the Novartis trial results. “Any positive results from clinical trials will be amazingly hopeful.”

Dr. Mark C. Fishman, president of the Novartis Institutes for BioMedical Research, cautioned against too much optimism. The trial involved only a few dozen patients, only some of whom benefited from treatment. The drug is likely to be years away from being commercially available and could fail in further clinical trials, he said.

“We have been reluctant to make this public because we still need to do more experiments, do them correctly and in a bigger way,” Dr. Fishman said. “But our group feels pretty good about the data.”

If authenticated in further, larger trials, the results could also become a landmark in the field of autism research, since scientists speculated that the drug may help some patients with autism not caused by fragile X, perhaps becoming the first medicine to address autism’s core symptoms.

One child in five thousand is born with fragile X syndrome, with mental effects ranging from mild learning disabilities to retardation so profound that sufferers do not speak, and physical effects that include elongated faces, prominent jaws, big ears, and enlarged testes. It mostly affects boys and earned its name because, under a microscope, one arm of the X chromosome seems nearly broken, with part hanging by a thread.

The gene for fragile X was discovered in 1991. Work since then has found that fragile X patients seem to experience an overload of unchecked synaptic noise — synapses being the junctions between brain neurons. The Novartis drug and others like it are intended to lower the volume of this noise so memory formation and high-level thinking can take place, allowing children to develop normally.

The Novartis trial, which began in 2008 in Europe with data analysis completed this year, was too brief to observe effects on basic intelligence. Instead, researchers measured a range of aberrant behaviors like hyperactivity, repetitive motions, social withdrawal and inappropriate speech. They gave one set of patients the drug and another a placebo, and after a few weeks switched treatments, with both doctors and patients unaware of which pill was which.

The results of the trial were something of a jumble until Novartis scientists noticed that patients who had a particular, undisclosed biological trait improved far more than others. “The bottom line is that we showed clear improvements in behavior,” Dr. Fishman said.

Told of the results, two parents of a fragile X patient were euphoric.

“This is what we have been working for and hoping for since our son was diagnosed with fragile X 17 years ago,” said Katie Clapp, president and co-founder of the Fraxa Research Foundation, a nonprofit organization dedicated to financing fragile X research. “This may be the key to solving the mystery of autism and other developmental disorders.”

Geraldine Dawson, chief science officer at Autism Speaks, the world’s largest autism advocacy organization, said that a growing body of research suggests that the many genetic causes of autism all seem to affect synapses, suggesting that a treatment for one form of the disease might help others.

“The exciting thing about these results is that it is our hope that these same medications may have similar positive benefits for people with autism who don’t have fragile X syndrome,” Dr. Dawson said.

Between 10 percent and 15 percent of autism cases result from fragile X syndrome or some other known genetic defect. While fragile X is the most common inherited cause of mental retardation, Down syndrome — which also causes retardation — is more common but is not inherited.

The Novartis trial results were not published or peer reviewed, and for commercial reasons Dr. Fishman refused to divulge many details. Dr. Luca Santarelli, head of neuroscience at Roche, confirmed that Roche is in the midst of testing a similar medicine in fragile X patients at four sites in the United States.

“So far we like what we see,” Dr. Santarelli said in his only characterization of their study.

One reason for the euphoria surrounding the Novartis trial is that it was seen as an especially difficult test of the drug’s effects. For ethical reasons, Novartis tested the drug only in adults. But the company and outside researchers believe that such compounds may prove most effective in young children, whose brains are far more likely to respond rapidly when barriers to learning are removed.

“This is perhaps the most promising therapeutic discovery ever for a gene-based behavioral disease,” said Dr. Edward M. Scolnick, former research chief at Merck and now director of the Stanley Center for Psychiatric Research at the Broad Institute at Harvard and the Massachusetts Institute of Technology.

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This Mexican sauce, traditionally made with de arbol chiles, is quite spicy. Small, narrow de arbol chiles are available from plenty of online sources. I’m offering two types of salsa here, a mild version that requires only chili powder and the authentic one. Whichever you choose to make, you’ll find it irresistible; the salsa is great with brown rice and any number of vegetables, grilled or steamed, or with a mixture of brown rice and edamame. The salsa is also wonderful with fish and shrimp.

Each week this series will present recipes around a particular type of produce or a pantry item. This is food that is vibrant and light, full of nutrients but by no means ascetic, fun to cook and a pleasure to eat.

1 tablespoon mild ground chili powder, or 6 de arbol chiles

1 1/4 pounds tomatoes, preferably roma tomatoes

1 plump garlic clove, skin on

1/2 to 1 teaspoon ground cinnamon, preferably Mexican

1 clove

1/2 teaspoon dried oregano, preferably Mexican

1/2 cup roasted unsalted peanuts

1 1/2 tablespoons canola oil

About 2 cups chicken or vegetable stock

Salt to taste

1. If using the dried chiles, heat a dry skillet or griddle over medium heat, and toast the chiles just until they change color — a few seconds on each side. Remove from the heat, and place in a bowl. Cover with hot water, and place a saucer on top to keep them submerged. Soak for 15 minutes. Drain and remove the stems.

2. Meanwhile, preheat the broiler. Cover a baking sheet with foil, and place the tomatoes on top. Place under the broiler a couple of inches from the heat. Broil until blistered and charred on one side, five to six minutes. Using tongs, turn the tomatoes over and repeat on the other side. Remove from the heat, and allow to cool until you can handle them, then cut away the core and transfer to a blender.

3. Meanwhile, heat a dry skillet over medium heat, and toast the garlic, turning often, until it smells toasty, has softened and is colored in spots. Remove from the heat. Remove the skin and trim away the root end. Add to the blender, along with the cinnamon, clove, chili powder (or the stemmed, soaked chiles), oregano and peanuts. Blend to a purée, adding a little stock if necessary.

4. Set a large, heavy saucepan over medium-high heat, and add the oil. When the oil is hot and a small amount of the purée sears when you add it to the pan, add all of the purée. It will splatter, so have a lid close by. Cook the purée, stirring constantly, until it thickens and darkens, five to eight minutes. Add the remaining stock, and combine well. Bring to a boil, and reduce to a simmer, stirring often, until the sauce has thickened and darkened, eight to 10 minutes. Season to taste with salt. The salsa should be thick. Remove from the heat, and serve hot or warm, with grains and vegetables (or with fish).

Yield: Makes 1 3/4 cups, serving about six.

Advance preparation: The salsa keeps well for several days in the refrigerator and freezes well. Reheat and stir after thawing.

Nutritional information per serving: 121 calories; 9 grams fat; 1 gram saturated fat; 0 milligrams cholesterol; 7 grams carbohydrates; 3 grams dietary fiber; 32 milligrams sodium (does not include salt added during cooking); 5 grams protein

Martha Rose Shulman can be reached at martha-rose-shulman.com.

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WASHINGTON — The fight over the new health care law shifted Thursday to the states, as some governors claimed federal money to run a new insurance pool for people with serious medical problems, while officials in other states said they would not operate the program.

Friday is the deadline for states to tell the Obama administration whether they want to run the high-risk insurance pool for uninsured people with pre-existing conditions, or whether they will leave the task to Kathleen Sebelius, the secretary of health and human services.

Democratic officials in Montana, Pennsylvania, Washington and Wisconsin, among other states, said they intended to operate the program under contract with the federal government. They were joined by Gov. Arnold Schwarzenegger of California, a Republican, who gave a rousing endorsement of President Obama’s health plan at a news conference.

But Republican officials in Georgia, Indiana, Nebraska and Nevada turned down the opportunity to run the high-risk pool, as did at least one Democratic governor, Dave Freudenthal of Wyoming.

Mr. Freudenthal said he worried that his state’s federal allotment of $8 million “may prove insufficient” to subsidize coverage for the next three and a half years. The temporary federal program runs from July to Jan. 1, 2014, when insurers will be required to accept all applicants.

Gov. Jennifer M. Granholm of Michigan, a Democrat, hailed the high-risk pool as “a first step in providing health care coverage for those who currently don’t have any.” Mr. Schwarzenegger said, “We are ready to roll up our sleeves and work with the federal government.” California expects to receive $761 million.

More than a dozen states have sued the federal government, challenging a provision of the new law that will require most Americans to carry insurance. But Mr. Schwarzenegger said, “The federal government has the right to force you into having a health care plan.”

Karen E. Timberlake, secretary of the Wisconsin Department of Health Services, said she and Gov. James E. Doyle, a Democrat, had decided to participate in the federal program. The state expects to receive $73 million from the federal government.

In Pennsylvania, Amy Kelchner, a spokesman for Gov. Edward G. Rendell, a Democrat, said he was eager to participate.

Jonathan E. Seib, health policy adviser to Gov. Christine Gregoire of Washington, a Democrat, said: “Even though the money is limited, it can provide assistance that would not otherwise be available to people with pre-existing conditions. We will manage the program within the dollars available, $102 million over three years.”

But Gov. Dave Heineman of Nebraska, a Republican, said, “We are very concerned that funding will not be sufficient,” even if the state limited enrollment in the new pool.

The insurance commissioner of Georgia, John W. Oxendine, a Republican running for governor, described the pool as “the first step in the recently enacted federal takeover of the United States health care system.”

Another Republican, Gov. Gary R. Herbert of Utah, said federal officials had not been able to tell him what would happen if the state exhausted its allocation of federal money before 2014.

“I have strong concerns that the program is severely underfunded and will ultimately result in yet another unfunded mandate on our state,” Mr. Herbert said.

Rate-Increase Plan Withdrawn

LOS ANGELES (AP) — Anthem Blue Cross withdrew plans to raise health insurance rates for Californians by as much as 39 percent after an independent audit determined that the company’s justification for raising premiums was based on flawed data, the state insurance commissioner, Steve Poizner, said Thursday. Anthem said separately that it would file a new application for a rate increase, perhaps as soon as next month. It added that any errors in its original application were inadvertent.

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After learning that their son, Andy, had fragile X syndrome, Katie Clapp and her husband, Dr. Michael Tranfaglia, started the Fraxa Research Foundation to fund research for the condition.

An experimental drug succeeded in a small clinical trial in bringing about what the researchers called substantial improvements in the behaviors associated with retardation and autism in people with fragile X syndrome, the most common inherited cause of these mental disabilities.

Katie Clapp and her son, Andy Tranfaglia, who was born with fragile X syndrome. She works to raise funds for research.

The surprising results, disclosed in an interview this week by Novartis, the Swiss pharmaceutical giant that makes the drug, grew out of three decades of painstaking genetic research, leaps in the understanding of how the brain works, the advocacy of families who refused to give up, and a chance meeting between two scientists who mistakenly showed up at the same conference.

“Just three years ago, I would have said that mental retardation is a disability needing rehab, not a disorder needing medication,” said Dr. Thomas R. Insel, director of the National Institute of Mental Health, who was told of the Novartis trial results. “Any positive results from clinical trials will be amazingly hopeful.”

Dr. Mark C. Fishman, president of the Novartis Institutes for BioMedical Research, cautioned against too much optimism. The trial involved only a few dozen patients, only some of whom benefited from treatment. The drug is likely to be years away from being commercially available and could fail in further clinical trials, he said.

“We have been reluctant to make this public because we still need to do more experiments, do them correctly and in a bigger way,” Dr. Fishman said. “But our group feels pretty good about the data.”

If authenticated in further, larger trials, the results could also become a landmark in the field of autism research, since scientists speculated that the drug may help some patients with autism not caused by fragile X, perhaps becoming the first medicine to address autism’s core symptoms.

One child in five thousand is born with fragile X syndrome, with mental effects ranging from mild learning disabilities to retardation so profound that sufferers do not speak, and physical effects that include elongated faces, prominent jaws, big ears, and enlarged testes. It mostly affects boys and earned its name because, under a microscope, one arm of the X chromosome seems nearly broken, with part hanging by a thread.

The gene for fragile X was discovered in 1991. Work since then has found that fragile X patients seem to experience an overload of unchecked synaptic noise — synapses being the junctions between brain neurons. The Novartis drug and others like it are intended to lower the volume of this noise so memory formation and high-level thinking can take place, allowing children to develop normally.

The Novartis trial, which began in 2008 in Europe with data analysis completed this year, was too brief to observe effects on basic intelligence. Instead, researchers measured a range of aberrant behaviors like hyperactivity, repetitive motions, social withdrawal and inappropriate speech. They gave one set of patients the drug and another a placebo, and after a few weeks switched treatments, with both doctors and patients unaware of which pill was which.

The results of the trial were something of a jumble until Novartis scientists noticed that patients who had a particular, undisclosed biological trait improved far more than others. “The bottom line is that we showed clear improvements in behavior,” Dr. Fishman said.

Told of the results, two parents of a fragile X patient were euphoric.

“This is what we have been working for and hoping for since our son was diagnosed with fragile X 17 years ago,” said Katie Clapp, president and co-founder of the Fraxa Research Foundation, a nonprofit organization dedicated to financing fragile X research. “This may be the key to solving the mystery of autism and other developmental disorders.”

Geraldine Dawson, chief science officer at Autism Speaks, the world’s largest autism advocacy organization, said that a growing body of research suggests that the many genetic causes of autism all seem to affect synapses, suggesting that a treatment for one form of the disease might help others.

“The exciting thing about these results is that it is our hope that these same medications may have similar positive benefits for people with autism who don’t have fragile X syndrome,” Dr. Dawson said.

Between 10 percent and 15 percent of autism cases result from fragile X syndrome or some other known genetic defect. While fragile X is the most common inherited cause of mental retardation, Down syndrome — which also causes retardation — is more common but is not inherited.

The Novartis trial results were not published or peer reviewed, and for commercial reasons Dr. Fishman refused to divulge many details. Dr. Luca Santarelli, head of neuroscience at Roche, confirmed that Roche is in the midst of testing a similar medicine in fragile X patients at four sites in the United States.

“So far we like what we see,” Dr. Santarelli said in his only characterization of their study.

One reason for the euphoria surrounding the Novartis trial is that it was seen as an especially difficult test of the drug’s effects. For ethical reasons, Novartis tested the drug only in adults. But the company and outside researchers believe that such compounds may prove most effective in young children, whose brains are far more likely to respond rapidly when barriers to learning are removed.

“This is perhaps the most promising therapeutic discovery ever for a gene-based behavioral disease,” said Dr. Edward M. Scolnick, former research chief at Merck and now director of the Stanley Center for Psychiatric Research at the Broad Institute at Harvard and the Massachusetts Institute of Technology.

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At a recent social gathering, a doctor friend who has been in private practice for almost 15 years revealed something that caused one physician to nearly choke on her drink, another to gasp in disbelief and the rest of us to stop what we were doing and gawk as if he had committed some grave social faux pas.

“I love what I do,” he announced to all of us. “I really love being a doctor.”

His wife, suddenly aware of the silence that fell upon the room, inched closer to her husband. “He really does,” she said nodding to confirm what some of the rest of us couldn’t quite believe.

While I had often heard older, usually retired, physicians speak about their love of doctoring, hearing a doctor currently in practice talk about the job with such fondness was so rare that it left us stunned. More frequently, doctors’ conversations about work reflect a sense of disenchantment, frustration and even anger — not toward patient care or doctoring per se, but toward the increasingly intrusive role of insurance companies and government agencies.

One colleague told me late one night, just a few months before she left medicine altogether, that she was proud of being a conscientious doctor who spent time with patients and thus could often avoid costly tests and referrals. “But look at me,” she said, the anger in her voice nearly palpable over the phone. “I’m at the office late every night taking care of mindless paperwork, just so the insurance companies can deny payment.”

For nearly three decades, editorials, online posts and surveys have noted this rising frustration and anger among practicing physicians. But over the last two years, the pot of emotions seems to have boiled over. In all the recent discussions about health care reform, what had heretofore played out only beyond earshot of the exam room suddenly was very public: the tangled, uneasy and often antagonistic relationship between practicing doctors and the insurance companies who pay for the services they deliver.

As a primary care doctor posted recently on Sermo, the nation’s largest online community of physicians: “We are our own worst enemies, as we have allowed insurance companies and Medicare to set the value of our services. Clearly those values they impose have nothing to do with our contribution to the health of our patients or the cost savings we bring about.”

The fraught nature of the relationship became clear again last month when Sermo and athenahealth, a provider of Internet-based business services for medical offices, released the results of a national survey of 1,000 physicians. Nearly two-thirds of doctors felt that the current health care environment was detrimental to the delivery of care, and more than half believed that the care quality would only decline over the next five years. Less than a fifth of doctors felt they could make clinical decisions based on what was best for the patient rather than on what payers were willing to cover. And an overwhelming majority believed that getting reimbursed was becoming increasingly complex and burdensome.

“Physicians have concerns about the power and undue influence of third parties and insurance companies,” said Dr. Daniel Palestrant, founder and chief executive of Sermo. “When it comes to medical practice, they are saying this just doesn’t work. They are acting in effect like the canaries in a coal mine.”

These canaries may be right. Last year, a study published in the health policy journal Health Affairs found that physicians in private practice on average spent nearly three weeks in time and $68,000 in staffing per year dealing with the particular administrative constraints of third-party payers. Doctors who were specialists could better afford to support these costs; but primary care physicians devoted as much as a third of their average yearly income (including benefits) to these interactions with the various health plans.

No wonder a lot of doctors are unhappy.

“The complexity is mind-boggling,” said Dr. Lawrence P. Casalino, chief of the division of outcomes and effectiveness research at Weill Cornell Medical College and lead author on the study. Patients in a single practice are covered by a multitude of health plans, each of which offers different services and limitations to subscribers. Complicating matters further, large companies and their employees will often have their own versions of a plan.

With each plan permutation, it becomes more and more difficult for a doctor to know how to provide care that will work with a patient’s particular coverage. One of the doctors who was surveyed in the Health Affairs study wrote: “It’s like going to the gas station to gas up your car and having to change the nozzle on the gas pump because you have a Toyota and the pump was made to fit Fords.”

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Australia could become the first nation to ban brand images and colors on cigarette packages under a wide-ranging set of antismoking measures that the government unveiled Thursday.

Starting July 1, 2012, tobacco products would have to be sold in the plainest of packaging — with few or no logos, brand images or colors. Promotional text would be restricted to brand and product names in a standard color, position, type style and size, rendering them not unlike the bland boxes that carry generic prescription drugs.

Restrictions on Internet advertising, a hefty increase in the tax on tobacco products and new antismoking campaigns are also among the initiatives.

The government said the moves would cut tobacco consumption and generate billions of dollars of revenue that would be plowed into the health system. The action won praise from the World Health Organization, which welcomed the measures as “a new gold standard for the regulation of tobacco products.”

The proposals would radically limit how tobacco companies can design packaging, and remove, in the words of the Australian government, “one of the last remaining frontiers for cigarette advertising.”

Leading tobacco companies strongly criticized the measures, questioning their effectiveness and saying they would encourage counterfeiting.

“Plain packaging has not been introduced in any country in the world and there is no evidence to support the government’s notion that this will reduce consumption,” Imperial Tobacco said in a statement from its Sydney office. “Plain packaging would seriously harm our brands and infringe the intellectual property rights in which both Imperial Tobacco and its shareholders have invested.”

Philip Morris International declined to say whether it would take legal action against the measure but argued that the imposition of plain packaging would represent “an unconstitutional expropriation of valuable intellectual property, violating a variety of Australia’s international trade obligations.”

British American Tobacco’s Australia unit echoed this, saying it believed that the plain packaging proposals “would not hold up to close scrutiny.”

But in a TV broadcast, Prime Minister Kevin Rudd said, “We, the government, will not be intimidated by any big tobacco company.”

Cigarette boxes would continue to carry graphic health warnings, including photographs of the effects of smoking-related diseases. Currently some boxes show a mouth infected with cancer and a gangrenous foot, said Simon Chapman, a professor of public health at the University of Sydney and a member of the National Preventative Health Taskforce, which recommended the new plain packaging.

The measures announced on Thursday also include a 25 percent increase in the excise tax on tobacco products, which was to come into force as of midnight. That will increase the cost of a packet of 30 cigarettes by about 2.16 Australian dollars, to around 16.70 Australian dollars ($15.40).

According to the government, that measure alone is expected to reduce tobacco use by about 6 percent. The government said that as of 2007, 16.6 percent of Australians over age 14 smoked.

The additional tax revenue, estimated to total 5 billion Australian dollars over four years, would be invested in the nation’s health system, the government said.

The government will have to submit the proposal on the packaging changes to Parliament.

Next month in the United States, a rule banning the sale and marketing of tobacco products to teenagers, which was first proposed 15 years ago, will go into full effect. The rule was never adopted by the Food and Drug Administration because the Supreme Court had ruled that legislation was needed to empower the F.D.A. to regulate tobacco products. That legislation passed in 2009 and was signed by President Obama last June.

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The Food and Drug Administration on Thursday approved the first treatment that uses a so-called cancer vaccine, a drug that trains the body’s own immune system to fight the disease.

The drug, Provenge, developed by the Dendreon Corporation, was approved to treat advanced prostate cancer. In clinical trials it extended the lives of patients about four months compared with a placebo.

Getting the immune system to attack cancer has tantalized scientists for decades, because it promises to have fewer side effects than the harsh chemotherapy now used. But until now the approach has yielded little but disappointment.

“The big story here is that this is the first proof of principle and proof that immunotherapy works in general in cancer, which I think is a huge observation,” said Dr. Philip Kantoff, chief of solid tumor oncology at the Dana-Farber Cancer Institute in Boston and the lead investigator in Dendreon’s largest clinical trial for the drug. ”

Provenge is not a preventive vaccine like those for measles, hepatitis or even the new ones for cervical cancer, which prevent a viral infection that causes the cancer. Rather, it is a so-called therapeutic vaccine, used after prostate cancer has already been diagnosed.

Provenge has become a cause célèbre among some patients. When the F.D.A. declined to approve the drug three years ago, some prostate cancer patients and investors protested.

“I think it’s fair to say that people are waiting for it,” said Jan Manarite, who runs the telephone help line in Florida for the Prostate Cancer Research Institute, a patient advocacy group.

Some patients may be disappointed, however, because the company said it could produce enough vaccine to supply only 2,000 patients in the next year. Dendreon said Provenge would be available at first only in 50 centers that participated in the clinical trials. But manufacturing capacity will be expanded greatly in the coming year.

Provenge is personalized for each patient. The patient’s white blood cells are collected through a process often used for blood donations, and certain immune cells are separated out. The cells are then incubated with a protein often found on prostate tumors, combined with an immune system booster. The treated cells are then infused back into the patient three times over the course of a month.

A full treatment will cost $93,000. Dendreon officials defended that price, saying it was in line with those of other cancer drugs in terms of cost per extra month of life provided by the drug.

Men with prostate cancer typically have either radiation treatment or surgery to remove the prostate gland, followed by drugs that reduce the levels of the hormone testosterone, which fuels prostate tumors. Provenge was approved for men whose cancer has spread in the body and for whom the hormone-deprivation drugs no longer work but who still have minimal symptoms, or none at all.

The only approved treatment for these men before Thursday was the chemotherapy drug Taxotere, also known as docetaxel, which in clinical trials extended lives by about two or three months.

In the largest clinical trial of Provenge, involving 512 men, those who got Provenge had a median survival of 25.8 months after treatment, while those who got a placebo lived a median of 21.7 months. After three years, 32 percent of those who got Provenge were alive, compared with 23 percent of those who got the placebo. The main side effects were fever, chills, fatigue and pain.

Doctors expect that Provenge might be used before Taxotere because it has fewer side effects. Many patients do not start on chemotherapy until their symptoms, mainly bone pain, have become obvious.

Provenge is the first approved product for Dendreon, which was founded in 1992 by two professors at Stanford, Dr. Edgar Engleman and Dr. Samuel Strober. Dendreon executives said the company had spent about $1 billion developing Provenge.

David Miller, chief executive of Biotech Stock Research, predicted that sales of Provenge would reach $1 billion annually within two or three years. Dendreon’s stock rose 27 percent on Thursday to $50.18, more than double its level a year ago.

Dendreon hopes to use the same technique to make other cancer vaccines, including one for bladder cancer. There are dozens of other cancer vaccines in development by other companies.

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