Suit on Health Care Bill Appears Likely to Advance

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Recipes for Health - Corn and Green Bean Salad With Tomatillo Dressing

For the dressing:

1/4 pound fresh tomatillos, husked

1 serrano chili, seeded for a milder dressing and coarsely chopped

1 tablespoon fresh lime juice

10 cilantro sprigs

1 tablespoon chopped onion, soaked in cold water for five minutes, drained and rinsed

1 garlic clove, peeled

3 tablespoons extra virgin olive oil

Salt to taste

For the salad:

Kernels from 2 ears corn

3/4 pound green beans, trimmed and cut in 2-inch lengths (about 3 cups)

1 large or 2 medium tomatoes, cut in 1/4-inch dice

4 radishes, cut in half lengthwise then sliced thin in half-moons

2 tablespoons minced chives

Lettuce leaves for the platter or bowl

1/4 cup crumbled queso fresco (1 ounce)

1.Preheat the broiler. Cover a baking sheet with foil and place the tomatillos on top, stem side down. Place under the broiler at the highest rack setting and broil two to five minutes, until charred on one side. Turn over and broil on the other side for two to five minutes, until charred on the other side. Remove from the heat and transfer to a blender, tipping in any juice that may have accumulated on the baking sheet. Add the chili, lime juice, cilantro sprigs, onion, garlic and olive oil to the blender and blend until smooth. Taste and adjust salt, and set aside.

2.Steam the corn kernels (or steam the entire ear, then cut the kernels off) and beans above one inch of boiling water for five minutes, until tender. Remove from the heat, refresh with cold water and drain on paper towels. Place in a bowl and toss with the tomato, radishes, chives and the dressing. Line a platter or wide bowl with the lettuce leaves, top with the salad, sprinkle on the crumbled cheese and serve.

Yield:Serves six generously.

Advance preparation:You can prepare the dressing and the salad several hours before serving, but don’t toss together until ready to serve. Refrigerate in separate bowls.

Nutritional information per serving:129calories; 8 grams fat; 1 gramsaturated fat; 2 milligramscholesterol; 14 gramscarbohydrates; 3 gramsdietary fiber; 19 milligrams sodium (does not include salt added during preparation); 3 grams protein

Martha Rose Shulman can be reached atmartha-rose-shulman.com. Her new book,“The Very Best of Recipes for Health,” was recently published by Rodale Press.

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18 and Under - School Refusal May Signal Physical or Emotional Trouble

Asore throat. Acoughso bad it kept him up all night. Another sore throat. A weekend visit to the emergency room.“Can I just get a note for the school?” his anxious mother would ask, and I would print it out and sign it.

But I didn’t grasp the extent of the situation until I got a call from the school nurse. If my patient missed another couple of days, she told me, he would be required by law to repeat first grade; the school year wouldn’t count. Would I please make sure I was giving him all those absence notes for a very good reason?

School refusal— any kind of absenteeism, fromphobiato truancy, that can be traced to the child’s own actions and wishes— is at the very intersection of education,psychologyandpediatrics. So it should be a good place for teachers,psychologistsand pediatricians to work together.

In fact, though, as the pediatrician who should have been the first to notice the problem, I was pretty clueless. My patient was an anxious and somewhat quirky child— I had talked to his mother about the possibility of a developmental evaluation, but we had agreed to wait and watch him in first grade. In fact, he was avoiding things in school that made him uncomfortable— interactions on the bus, jostling on the playground. He was avoiding academic moments where someone might find out he was struggling. And he was sticking close to his mother, so she could keep an eye on him and he could keep an eye on her.

Dr. Helen Egger, a child psychiatrist and epidemiologist at Duke University Medical Center, has studied the relationship between school refusal and conditions like depression andanxiety disorder. About a quarter of the childrenin her studywho showed school refusal behavior hadanxietyproblems. And as she told me,“it can be as strongly associated with depression as with anxiety.”

As a developmental-behavioral pediatrician at Johns Hopkins, Dr. Barbara Howard sees the more extreme cases of school refusal— among them, children whose school days are complicated by medical or learning problems. Some have difficulty from the first day of kindergarten because they aren’t ready to separate from their parents or because they are particularly anxious, she told me; they need help with initial adjustment.

“We should be careful not to set kids up who are anxious,” she said.“Make sure they can take their favorite fuzzy bear with them.”

And when children are anxious about returning to school, she continued, it’s especially important to ask them whether there are particular problems— a bully, a bathroom with no doors on the stalls. Even so, finding and fixing such a problem doesn’t necessarily confer the coping skills an anxious child needs to feel comfortable in school.

The taxonomy of school refusal— from school phobia to truancy— is complicated, and it has changed over time. Experts now tend to break down the behaviors by motivation.

Children may avoid school because they are trying to avoid negative feelings, like anxiety and depression, or negative experiences, like exams or troubling social interactions. On the other hand, they may be pursuing some positive reward— a parent’s attention, the chance to play video games all day or, for older kids, more illicit pleasures.

And there is overlap, the experts point out: a child who misses a great deal of school for reasons that look like truancy may become increasingly anxious— and embarrassed— about going back. In fact, missing school intensifies both the academic pressures and the social pressures that are waiting when a child returns, setting up a dangerous cycle in which the more you’re absent, the more you want to stay out.

The important distinction is in the response.“If you have a child that’s very anxious, you’re going to use a lot of anxiety management techniques,” saidChristopher A. Kearney, professor and director of clinical training in the department of psychology at theUniversity of Nevada, Las Vegas. With the reward-seeking group, he continued,“increase incentives for going to school and supervision outside of school.”

If we look at school as children’s work, then absenteeism becomes a kind of red flag, a signal that something has gone wrong in a child’s health or emotional life, or within the family or in the school itself.

It’s the pediatrician’s job, of course, to make sure vague physical complaints don’t actually signal an undiagnosed disease. School absenteeism can be a marker for poor medical care, or for inadequate management of a chronic illness, likeasthma.

“It’s not a diagnosis, school refusal,” Dr. Egger said.“It’s not a disorder; it’s a symptom.” But it’s an important symptom, with consequences that can be harsh. It should send parents— and pediatricians, educators and psychologists— looking for ways to help.

The pediatrician, she continued, should ask,“Is this a primary issue around attending school that we can just address, or is this an indication of another disorder: anxiety, depression, sleep, somatic complaints?”

My patient didn’t have to repeat his grade. The school agreed to let him make up some of the time he had missed. And, he got the learning evaluation he needed, followed by classroom interventions that made a significant difference in his ability to learn. (I also suggested individual counseling for mother and son. He went, but missed many appointments; she refused.)

So what started with vague sore throats and nagging coughs ended with a list of important tasks for a long cast of characters. The school environment had to change. The child had to learn new coping skills. His mother had to change her approach to minor illnesses.

And his pediatrician had to wise up.

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Tax Provision of Health Care Law Opposed by Many in Both Parties

To improve compliance, the law requires businesses to file a 1099 tax form identifying anyone to whom they pay $600 or more for goods or merchandise in a year. Businesses will also have to send copies of the form to their vendors, suppliers and contractors.

Businesses denounce the requirement, and even the national taxpayer advocate at theInternal Revenue Service, Nina E. Olson, said the reporting burden might“turn out to be disproportionate as compared with any resulting improvement in tax compliance.”

The White House is nervous about a repeal, fearing that it could set a precedent for rolling back other unpopular features of the law. Moreover, the reporting requirement is expected to lead to a significant amount of revenue— $17 billion over 10 years— to help pay for the expansion of coverage and other health initiatives. It is unclear whether Democrats and Republicans can reach agreements on repealing the provision and on finding a way to offset the loss of money.

Under the law, businesses will be required to report purchases of items like office equipment, food and bottled water, gasoline, lumber and plumbing supplies if payments to any vendor in the course of a year total at least $600. They will, in many cases, also have to report payments for things like travel and telephone and Internet service.

The annual reports must include the vendor’s address and taxpayer identification number.

The Congressional Joint Committee on Taxation and some lawmakers say the reporting requirement will induce businesses to pay more of the tax they owe— just as individuals are more likely to pay tax on dividends and interest income knowing that such information has been reported to the I.R.S. by mutual funds, banks and other corporations.

Two Republicans, Representative Dan Lungren of California and SenatorMike Johannsof Nebraska, are leading efforts to repeal the reporting requirement.

In late July, 239 House Democrats voted for repeal, but the bill did not get the two-thirds majority needed for approval under the expedited procedure used then.

The Senate is scheduled to vote on a repeal, as an amendment to a small-business jobs bill, soon after it reconvenes this week.

President Obamastrongly supports the jobs bill, which would provide loans and tax breaks to small businesses. But he has not embraced a repeal of the reporting requirement.

Most Republicans want a full repeal. In a recent speech, the House Republican leader, RepresentativeJohn A. Boehnerof Ohio, said the“1099 mandate” showed how the health care law could“wreak havoc on employers and entrepreneurs.”

Republicans also see the new requirement as an example of the intrusive role they say the I.R.S. will play in enforcing the health care law, including its requirement for most Americans to carry insurance.

Senate Democratic leaders prefer a proposal by Senator Bill Nelson, Democrat of Florida, that would reduce the scope of the reporting requirement. Under Mr. Nelson’s plan, businesses with 25 or fewer employees would be exempt from the new requirement, and the reporting threshold for larger businesses would be set at $5,000, rather than $600.

Mr. Nelson says more than 90 percent of companies would qualify for the small-business exemption under his proposal.

But Mr. Johanns said this“half-measure” was unacceptable.

Stephanie Cathcart, a spokeswoman for the National Federation of Independent Business, said many businesses would still have to keep track of their payments to each vendor to see if they exceeded the $5,000 threshold for the year.

SenatorBlanche Lincolnof Arkansas, a vulnerable Democrat running for re-election, voted for the health care law but supports Mr. Johanns’s effort to repeal the reporting requirement.

“We must not create unnecessary burdens for small businesses that serve as the backbone of Arkansas’s economy,” Mrs. Lincoln said.

To help make up for the loss of revenue, Mr. Johanns would cut spending from a new prevention and public health fund. Mr. Nelson would increase taxes on big oil companies.

In the House, RepresentativeScott Murphyof New York has led the Democratic efforts to repeal the reporting requirement.

“This 1099 reporting was a well-intentioned provision to try to catch people who were cheating on their taxes,” Mr. Murphy said.“But it has some unintended consequences and could be a huge hassle for a lot of small businesses.”

The reporting requirement was in the health care overhaul bill unveiled in mid-November by the Senate Democratic leader,Harry Reidof Nevada. But it drew little attention at the time— it was one of more than 15 revenue-raising measures in the bill— and many lawmakers were apparently unaware of it when they voted for final passage of the legislation.

Four Democratic senators who voted for the bill have sent a letter to the I.R.S. expressing concern that“the new requirements may place a hardship on small businesses.” The letter was signed byEvan Bayhof Indiana,Mark Begichof Alaska,Ben Nelsonof Nebraska andJeanne Shaheenof New Hampshire.

For years, lawmakers have complained about the gap between taxes owed and taxes paid voluntarily. Reducing this gap is a top priority for some lawmakers, but resistance to the new reporting requirement shows how difficult it is to achieve that goal.

In a report on the tax gap, the I.R.S. said that“there is a serious problem with underreporting” of income by sole proprietors, who own unincorporated businesses by themselves. The Bush administration twice urged Congress to help close the gap by expanding information-reporting requirements.

Ms. Olson, the independent taxpayer advocate, said the new reporting requirement would apply to over 38 million businesses, including 26 million sole proprietorships and 2 million farms.

“The I.R.S. will face challenges making productive use of this new volume of information reports,” Ms. Olson said.

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Conversations - Views of Health Care Economics From a C.E.O. Named Bush - Question

Based in Watertown, Mass., Athenahealth offers a suite of administrative services for medical practices. It collects payments from insurers and patients, and it manages electronic health records and patient communication systems. All of this is done remotely through the Internet— or“in the cloud,” as Mr. Bush puts it. Doctors don’t have to install or manage software or pay licensing fees; instead, Athenahealth keeps a percentage of the revenue.

Lately, Athenahealth’s stock price has been hammered by news of aninternal accounting auditandmissed earnings expectations. By July its shares had fallen by more than half from their January high. (They have since reversed some of that decline.)

Even so, the company’s sales have grown substantially over the last couple of years. While the bill collection service still accounts for most of the sales, the company’s fastest-growing business has been its electronic records segment, which has benefited from provisions in the 2009 stimulus law and this year’s health care overhaul.

What follows is a condensed version of a conversation with Mr. Bush about how he built a small medical practice into a national enterprise with nearly 1,200 employees, and how the new health care law is likely to affect businesses— small firms as well as his own.

Q.Athenahealth got its start when you purchased a birthing practice in California back in 1997. But you’re not a doctor— why did you buy it?

A.You know, Bush family noblesse oblige. I wanted to take advantage of all this education and support I’ve had and do well by doing good, and health care seemed like a place that no one else in my family had been much. A new approach to health care seemed to me to be the oil fields of 1997.

Q.So what led you into the administrative services business?

A.I ran into all of the problems that medical practices ran into, all of which were unrelated to medical care. I couldn’t get my claims paid, I couldn’t make payroll because of all of these ridiculous regulatory and insurance rules that were changing all the time and were very esoteric, and the technical infrastructure to connect and move around was incredibly poor.

We had 13 little offices up and down San Diego County, and they were running up against scale-based obstacles, things that would need real management infrastructure and capital to do properly. So we built a little Web site for ourselves called Athenanet, and pretty soon all the doctors in the neighborhood wanted to be on Athenanet.

In fact, when we were trying to raiseventure capitalto go do more birthing centers, and it wasn’t happening, one of the venture capitalists said in passing that he would give me $11 million for an unlimited license to Athenanet {laughs}. And I think our pre-money valuation for the whole company was $7 million. It was as if a budding, small airline wakes up to find that they invented theSabresystem.

Q.Your revenue has grown 40 percent in each of the last two years, from $98 million to $189 million—

A.Don’t you love it?

Q.Well, not as much as you do.

A.And yet, the Street hates me. I don’t know.

Q.What’s going on in the health care industry to deliver that kind of growth to you?

A.We are a disruptive technology. We are the only cloud-based service in an industry segment full of sclerotic, enormous, personality-free corporations that have been in business making 90 percent margins doing nothing for decades and decades.

Q.What keeps other companies from building cloud-based systems?

A.For software companies, the biggest barrier to entry is that they give up their business model. Those companies would get hammered on Wall Street if they started selling a service that they have to deliver at a loss for five years. In terms of new entrants, there are two things that we’ve done that would take a good decade to replicate. One, we’ve built out the health care Internet. We’ve been building connections into insurance companies and laboratories and hospital medical records for years and years and years.

And the other barrier to entry is that rules engine. Every time a doctor anywhere in the country gets a claim denied, we have analysts ask theFive Whys. When we get to root cause, we write a new rule into Athenanet and from that day on, no other doctor gets that particular denial from that particular insurance company ever again. We now know of 40 million ways that a doctor can have a claim denied in the United States. The average practice has to rework about 35 percent of their claims, and we only have to rework about 5 percent of ours.

Q.What’s the prognosis for bill collecting underhealth care reform?

A.Well, there’s going to be new connectors and a whole series of new insurance products that will be managed by the states’ health insurance commissioners. And the law provides for every state to do all of these its own way, so they will have their own rules and regulations, and each state will do it differently. That sounds like springtime in Complexity Land.

Q.What do you think will happen to the total cost of health care under reform?

A.Oh, it’s going to go through the roof! It’s widely accepted that this is not a cost-reform bill— it’s an access bill. It’s in fact a cost-expansion bill.

Q.Last year, Dr. Atul Gawande made a pretty cogentcase, writing inThe New Yorker, not just that the small pilot projects in the reform would control costs but that they are the only way to control costs in an industry as sprawling as health care.

A.I e-mail a lot with Atul and he’s a product ofthe Borg, at some big institution, and thinks in terms of papers and grants from Washington. I totally agree that demonstration projects are what changes a market, but outside of the Borg, we call those businesses. I suppose Washington trying to be an innovator also is fine, but at some point the demonstration project is going to have to be consumers using their judgment about which things they want.

Q.If you were still a small company, or if you were starting a business now, would health care reform help or hurt you as an employer?

A.Well, certainly the idea that somebody else is going to pay a lot of my health insurance cost, at the micro level, makes a lot of sense. It’d be great, yeah, thanks— anything else you want to pay for? If you actually ever have to start paying this thing, all of this accelerates the increase in the cost. Eventually, consumers will need to eat a big part of their health care cost, because health care will fundamentally consume the entire G.D.P. in the not-too-distant future.

Everybody agrees that this is good in the way that it creates engagement in society by those who are outcasts. So if you’re feeling like you don’t want to believe in America anymore because you don’t have health insurance, well, now you can believe a little more. It’s bad in terms of the macro economy. But I don’t know which one is more important in the grand scheme for today.

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After Fine, Botox Awaits F.D.A. Approval for Migraine

It happens with smartphones, social networks and even designer handbags. But it is not supposed to happen with prescription drugs marketed to doctors, according to federal law.

That is the charge leveled againstAllergan, the maker ofBotox, in a phalanx of false-claims lawsuits and federal inquiries that resulted last week in the company’sagreeing to pay $600 million to resolve criminal and civil complaints of illegal marketing tactics.Allergan also agreed to plead guilty to one misdemeanor chargeof misbranding Botox from 2000 through 2005, but the company denied the other allegations.

Allergan’s settlementwith the Justice Department resolves the latest crackdown by the federal government against major drug makers. Last year,PfizerandEli Lillypaid hefty sums to resolve federal charges of illegal marketing.

The lengthy federal investigation of Allergan tracked the rise of Botox in an ever-expanding market. Over the last decade, Botox has gained fame— and talk show notoriety— as a wrinkle killer. Along the way, the drug has become a blockbuster brand, with worldwide sales last year of about $1.3 billion, in no small part because it can also be used to treat a variety of muscle and gland disorders.

TheFood and Drug Administrationhas over time approved the injections to mitigate uncontrolled blinking, certain neck muscle spasms, excessive underarmsweating, andwrinklesbetween the eyebrows. This year, the agency again expanded the use of Botox, permitting injections for increasedmuscle stiffnessin the elbows and hands, and it is now considering whether to approve Botox as a preventive treatment for severe migraines.

Meanwhile, Allergan is currently studying Botox as a treatment for overactive bladders, and owns patents on dozens of other potential Botox treatments.

The company denies most of the complaints in lawsuits by whistle-blowers and federal prosecutors. But documents released by the Justice Department related to the settlement outlined claims that Allergan had systematically built Botox sales by promoting it for unapproved treatments to relieve conditions like migraines, pain, muscle spasticity andcerebral palsyin children.

Doctors are allowed to prescribe drugs in unapproved ways as they deem medically appropriate, but it is illegal for a drug maker to promote those unapproved, or off-label, uses. Court filings have described an aggressive marketing strategy, saying that Allergan financed and widely disseminated a video, featuring a well-known neurology professor, to promote Botox as aheadachetreatment; set up an educational Web site called the Neurotoxin Institute, registered by Ogilvy Healthworld, an advertising agency, to promote Botox treatments to doctors; and paid kickbacks to doctors to induce them to prescribe Botox.

“What concerns F.D.A. is that, if companies can promote off-label uses without submitting evidence showing the drug to be safe and effective, it potentially puts patients at risk and subverts the drug approval system,” Dr. Joshua M. Sharfstein, the principal deputy commissioner of the F.D.A., said in a phone interview about the case on Tuesday.

Without an independent determination by agency experts on the optimal doses and precautions for a particular drug treatment, he said, doctors can wind up prescribing medications without good evidence.

Except for the one misbranding charge, Allergan has denied the criminal and civil accusations, including those of kickbacks and fraud, said Caroline Van Hove, a company spokeswoman, adding that the allegations were not proved.

“I want to be clear that Allergan is not charged with misleading doctors or causing any patient harm,” Ms. Van Hove wrote in an e-mail to a reporter on Monday,“and we adamantly deny any implication that this occurred.”

Allergan, she added, has spent hundreds of millions of dollars in medical research and development of new uses for Botox. The drug is approved in 81 countries to treat 21 different conditions, she said. Several drug makers finance the Neurotoxin Institute, an independent scientific group, she added.

The settlement agreement comes at a delicate moment for the potentially vast new use of Botox to prevent chronic migraines, a debilitating condition. The agency is expected to decide by the end of October on Allergan’s application for that use, which was submitted just last year.

Even so, according to evidence in a separate product liability lawsuit, Botox headache shots already had sales in the United States of nearly $56 million in 2007, signaling growing use for that treatment.

Ms. Van Hove of Allergan said the company had not promoted Botox for migraines, but it had communicated appropriate scientific information about studies on that use.

If the F.D.A. approves the headache shots, she added, the treatment will“address a significant and outstanding need in the treatment of chronicmigrainethat cannot be dismissed or discredited as a result of this settlement.”

Dr. Sharfstein of the F.D.A. said the Allergan settlement for off-label marketing would not influence the agency’s scientific review of the migraine application.“I think the approval should follow the evidence,” he said.

Millions of dollars are indeed at stake for Allergan.

The British medicines agency recently approved Botoxas a migraine treatment. If the F.D.A. were to follow Britain’s lead, some Wall Street analysts have estimated that sales of the drug for migraines could reach $1 billion or more annually worldwide by 2016.

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National Briefing - Health -‘Magic Mushrooms’ May Help Cancer Patients, Study Says

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