First Pull-Ups, Then Combat, Marines Say

WASHINGTON — How many pull-ups does it take to make a female Marine?

The answer, starting next January: a minimum of three, the same number required of male Marines.

If anyone thought the military's decision to allow women into combat units would lead to exceptions for women when it came to fitness and physical strength, this is one service's "gender neutral" answer — or at least part of the answer.

Like the men, women will have to perform the exercises on the Marine Corps's annual physical fitness test as "dead hang" pull-ups, without the benefit of the momentum from a lower-body swing. Like the men, women can do the pull-ups underhanded or overhanded, as long as their chins break the plane of the bar.

The new requirement replaces the old "flexed arm hang" for women, in place since 1975, which had to be held for a minimum of 15 seconds.

"The physical requirements of female Marines, commensurate with their roles, have increased greatly since 1975," said Col. Sean D. Gibson, a spokesman for the Marine Corps Combat Development Command in Quantico, Va. "The pull-up is a better test of muscular strength."

But the new Marine Corps regulations are just part of a sweeping re-examination of fitness standards in the military that Defense Secretary Leon E. Panetta's announcement last week ending the ban on women in combat only accelerated.

As it stands now, service members face a gantlet of overlapping fitness tests throughout the vast sprawl of the American military, from initial ones that recruits have to pass to annual fitness (and weight) tests to specific physical requirements that must be met for combat jobs.

The Pentagon says it will not lower standards for women, but is nonetheless reviewing the requirements for hundreds of what are called military occupational specialties to see if they actually match up with the demands of each job.

Some combat jobs that might open to women may require them to meet only specific requirements rather than a wide range of fitness standards.

"We're going to ensure that our tank crewmen are fully capable of removing 50-pound projectiles from the ammunition rack and loading them into the main gun in a sustained manner in a combat situation," said George Wright, an Army spokesman.

But for now, the Army has no immediate plans to change its sex-adjusted recruitment and annual fitness tests, even though the Marine Corps, which tenaciously promotes itself as the most hard-bodied service, has started to toughen up its standards for women.

But even for the pull-ups, the Marines are still making some exceptions. To get a perfect grade, women will have to do only 8, compared with the 20 required for men.

"I don't think it's a very high bar," said Capt. Ann G. Fox, a Marine Reserve officer who during her first deployment in 2004 worked with the Iraqi Army and who thinks women could do better if it was required of them. "I think the test should be the same as the men 20 pull-ups. People train to what they're tested on."

That was the experience of Greg Jacob, who was a commander at the combat training school for enlisted Marines at Camp Geiger, N.C., and said that he asked his female trainers to do the same number of pull-ups as their male students, even though women were not required at the time to do pull-ups at all.

"I saw women who could only do one or two pull-ups be able to bust out, over the course of four or five months, eight pull-ups," he said. "And that was because they were training to that standard."

Mr. Jacob, now the policy director for the Service Women's Action Network, an advocacy group that worked to end the female combat ban, acknowledged the physiological differences between men and women, but said they were overstated. "There are lots of men who don't have the same muscle mass as other men," he said. "There is physical diversity regardless of gender."

Many jobs in the military, he said, have nonnegotiable physical demands. "Whether you were a man or a woman, you had to throw a live grenade 15 meters," he said. "If a woman throws the hand grenade 10 meters, it's going to blow up in her face and kill her."

In the Army, no pull-ups are required of either men or women on the annual fitness test, but like the Marines, there are different standards for each sex. A 17- to 26-year-old man in the Army has to run two miles in 15 minutes, 54 seconds or less and do at least 42 push-ups; a woman in the same age group has to run two miles in 18 minutes, 54 seconds or less and do at least 19 push-ups.

The requirements decrease as service members age, although a woman who is 62 or older in the Army still has to run two miles in 25 minutes or less.

Marines, typically, raise the bar. A 17- to 26-year-old male Marine has to run three miles in 28 minutes or less on his annual fitness test; compared with 31 minutes or less for a female Marine of the same age.

The Marines also require all men and women to pass an annual combat fitness test, even though until now women were not officially permitted in combat. The sex-adjusted test drills Marines in how to respond under fire.

All of the tests pale in comparison with one of the most brutal male preserves in the military, the Marines' 86-day Infantry Officer Course at Quantico, Va., which is intended to screen and train potential infantry officers. The test makes extraordinary physical and mental demands on its participants.

Last fall, two female officers went through the course as an experiment and failed, inviting questions — even though large numbers of men fail — of whether women were up to it.

Gen. James F. Amos, the commandant of the Marine Corps, held out the possibility that they are. In comments to reporters in San Diego on Thursday, he said he had met with two more female officers who had signed up for the next Infantry Officer Course, starting in March. "It looks like they're in great shape and they're excited about it," he said.

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Baseball Officials Navigate Puzzle of Anti-Aging Clinics

This article is by Steve Eder, Lizette Alvarez and Michael S. Schmidt.

MIAMI — Revive Miami, an anti-aging clinic, was tucked at the end of a hallway on the fourth floor of an office building on a bustling street crowded with restaurants and stores.

The clinic's door was locked this week; the company had apparently shut down. But a business card was wedged against the door. An investigator for Major League Baseball had stopped by, seeking answers.

Baseball officials and law enforcement officers are trying to penetrate the often opaque world of anti-aging clinics, which have proliferated in the Miami area in recent years and have become linked to some of the sport's biggest stars. Anthony Bosch, a former partner of the Revive Miami founders, is at the center of the growing baseball doping scandal.

In this region's teeming medical industry, with businesses offering promises of weight loss, muscle gain and mood enhancement, the clinics can take on a glamorous sheen in their efforts to entice wealthy clients. But that was hardly the case behind the scenes at the clinic where Bosch, 49, treated patients in recent years, according to a business partner.

Bosch was a "disaster," disorganized and unreliable and at times "incoherent," said Xavier Romero, a former patient of Bosch's who later invested with Bosch.

A newspaper, Miami New Times, reported this week that it had obtained medical records from the clinic Biogenesis of America that linked six major leaguers, including Alex Rodriguez and Melky Cabrera, to the use of banned substances. Biogenesis was run by Bosch.

Bosch, through a lawyer, has denied the claims, and several of the players whose names appeared in the article have issued statements denying involvement.

The allegations have once again tied baseball to performance-enhancing drugs and left the sport's officials scrambling. Without more substantial evidence, they are limited in their actions.

Romero's connection to the anti-aging industry began in mid-2011, when a friend recommended he see Dr. Tony Bosch at a clinic called Biokem. Romero, 28, had always been skinny and was trying to bulk up. Soon after seeing Bosch, he began to put on weight, adding about 30 pounds.

"He was God to me," said Romero, who later learned that Bosch was not a licensed doctor. "No one could do that for me, no matter what I ate."

Romero said he was so impressed by the results that he decided to invest with Bosch and his partner Carlos Acevedo, who were interested in expanding. Using capital Romero provided, the three set out to launch Revive Miami L.L.C., which initially shared space with Biokem.

It was Bosch's job, Romero said, to use his contacts to get the prescriptions necessary to fuel the business, although it remains unclear how he obtained chemicals like human growth hormone. However, Romero said he quickly grew uncomfortable with Bosch and his work ethic, and in the spring of 2012, he and Acevedo decided to move Revive Miami to its own offices a few miles away, leaving Bosch behind to launch Biogenesis of America.

Romero said that when they parted, Bosch told him, "You are going to come back to me in six months because you failed — because I'm the king." The two have not spoken since, and both clinics appear to be out of business.

Bosch's lawyer, Susy Ribero-Ayala, declined to respond to Romero's comments.

Hernan Dominguez Jr., who said he was a longtime friend of Bosch's, said the portrayal of Bosch in the news media was unfair.

"Because a businessman fails in various ventures does not make him a failure," Dominguez said in an electronic message. "Because a man and a woman fail in a marriage doesn't make them failures. It makes them human. He has a fantastic relationship with his ex-wives and all his children. Public records may be accurate, but they do not reflect a person's relationship with his friends and family."

Choosing a Different Path

Bosch grew up in a wealthy Miami neighborhood filled with majestic banyan trees and graduated from one of Miami's best-known preparatory schools, Christopher Columbus High, an all-boys institution founded by the Marist Brothers, a Catholic organization.

Steve Eder and Lizette Alvarez reported from Miami, and Michael S. Schmidt from Washington. Alain Delaquérière contributed research from New York.

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Birth Control Rule Altered to Allay Religious Objections

WASHINGTON — The Obama administration on Friday proposed yet another compromise to address strenuous objections from religious organizations about a policy requiring health insurance plans to provide free contraceptives, but the change did not end the political furor or legal fight over the issue.

The proposal could expand the number of groups that do not need to pay directly for birth control coverage, encompassing not only churches and other religious organizations, but also some religiously affiliated hospitals, universities and social service agencies. Health insurance companies would pay for the coverage.

The latest proposed change is the third in the last 15 months, all announced on Fridays, as President Obama has struggled to balance women's rights, health care and religious liberty. Legal experts said the fight could end up in the Supreme Court.

Kathleen Sebelius, the secretary of health and human services, said the proposal would guarantee free coverage of birth control "while respecting religious concerns."

But Kyle Duncan, the general counsel of the Becket Fund for Religious Liberty in Washington, which is representing employers in eight lawsuits, said the litigation would continue. "Today's proposed rule does nothing to protect the religious freedom of millions of Americans," Mr. Duncan said.

Religious groups dissatisfied with the new proposal want a broader, more explicit exemption for religious organizations and protection for secular businesses owned by people with religious objections to contraceptive coverage.

The tortured history of the rule has played out in several chapters. The Obama administration first issued standards requiring insurers to cover contraceptives for women in August 2011, less than a month after receiving recommendations to that effect from the National Academy of Sciences. In January 2012, the administration rejected a broad exemption sought by the Roman Catholic Church for insurance provided by Catholic hospitals, colleges and charities. After a firestorm of criticism from Catholic bishops and Republican lawmakers, the administration offered a possible compromise that February. But it left many questions unanswered and did not say how coverage would be provided for self-insured religious organizations.

Under the new proposal, churches and nonprofit religious organizations that object to providing birth control coverage on religious grounds would not have to pay for it.

Female employees could get free contraceptive coverage through a separate plan that would be provided by a health insurer. Institutions objecting to the coverage would not pay for the contraceptives.

Insurance companies would bear the cost of providing the separate coverage, with the possibility of recouping the costs through lower health care expenses resulting in part from fewer births.

Chiquita Brooks-LaSure, who helped develop the proposal as deputy director of the federal office that regulates health insurance, said: "Under the proposed rule, insurance companies — not churches or other religious organizations — will cover contraceptive services. No nonprofit religious institution will be forced to pay for or provide contraceptive coverage, and churches and houses of worship are specifically exempt."

Moreover, she said, "Nonprofit religious organizations like universities, hospitals or charities with religious objections won't have to arrange, contract or pay for coverage of these services for their employees or students."

But some of the lawsuits objecting to the plan have been filed by businesses owned by people who say they have religious reasons for not wanting to provide contraceptive coverage. Under the proposed rule, "for-profit secular employers" would have to provide birth control coverage to employees, even if the business owners had a religious objection to the idea.

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Ferrol Sams, Doctor Turned Novelist, Dies at 90

Emory University Photo & Video

Ferrol Sams, shown in 1983, was a well-established middle-aged country doctor in Georgia before he began writing novels.

Ferrol Sams, a country doctor who started writing fiction in his late 50s and went on to win critical praise and a devoted readership for his humorous and perceptive novels and stories that drew on his medical practice and his rural Southern roots, died on Tuesday at his home in Lafayette, Ga. He was 90.

The cause, said his son Ferrol Sams III, also a doctor, was that he was "slap wore out."

"He lived a full life," his son said. "He didn't leave anything in the tank."

Dr. Sams grew up on a farm in the rural Piedmont area of Georgia, seven mud-road miles from the nearest town. He was a boy during the Depression; books meant escape and discovery. He read "Robinson Crusoe," then Mark Twain and Charles Dickens. One of his English professors at Mercer University, in Macon, suggested he consider a career in writing, but he chose another route to examining the human condition: medical school.

When he was 58 — after he had served in World War II, started a medical practice with his wife, raised his four children and stopped devoting so much of his mornings to preparing lessons for Sunday school at the Methodist church — he began writing "Run With the Horsemen," a novel based on his youth. It was published in 1982.

"In the beginning was the land," the book begins. "Shortly thereafter was the father."

In The New York Times Book Review, the novelist Robert Miner wrote, "Mr. Sams's approach to his hero's experiences is nicely signaled in these two opening sentences."

He added: "I couldn't help associating the gentility, good-humored common sense and pace of this novel with my image of a country doctor spinning yarns. The writing is elegant, reflective and amused. Mr. Sams is a storyteller sure of his audience, in no particular hurry, and gifted with perfect timing."

Dr. Sams modeled the lead character in "Run With the Horsemen," Porter Osborne Jr., on himself, and featured him in two more novels, "The Whisper of the River" and "When All the World Was Young," which followed him into World War II.

Dr. Sams also wrote thinly disguised stories about his life as a physician. In "Epiphany," he captures the friendship that develops between a literary-minded doctor frustrated by bureaucracy and a patient angry over past racism and injustice.

Ferrol Sams Jr. was born Sept. 26, 1922, in Woolsey, Ga. He received a bachelor's degree from Mercer in 1942 and his medical degree from Emory University in 1949. In his addition to his namesake, survivors include his wife, Dr. Helen Fletcher Sams; his sons Jim and Fletcher; a daughter, Ellen Nichol; eight grandchildren; and nine great-grandchildren.

Some critics tired of what they called the "folksiness" in Dr. Sams's books. But he did not write for the critics, he said. In an interview with the Georgia Writers Hall of Fame, Dr. Sams was asked what audience he wrote for. Himself, he said.

"If you lose your sense of awe, or if you lose your sense of the ridiculous, you've fallen into a terrible pit," he added. "The only thing that's worse is never to have had either."

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Focus on Mental Health Laws to Curb Violence Is Unfair, Some Say

In their fervor to take action against gun violence after the shooting in Newtown, Conn., a growing number of state and national politicians are promoting a focus on mental illness as a way to help prevent further killings.

Matthew Staver for The New York Times

Gov. John W. Hickenlooper of Colorado, a Democrat, has proposed a broad overhaul of the state's mental health system.

Legislation to revise existing mental health laws is under consideration in at least a half-dozen states, including Colorado, Oregon and Ohio. A New York bill requiring mental health practitioners to warn the authorities about potentially dangerous patients was signed into law on Jan. 15. In Washington, President Obama has ordered "a national dialogue" on mental health, and a variety of bills addressing mental health issues are percolating on Capitol Hill.

But critics say that this focus unfairly singles out people with serious mental illness, who studies indicate are involved in only about 4 percent of violent crimes and are 11 or more times as likely than the general population to be the victims of violent crime.

And many proposals — they include strengthening mental health services, lowering the threshold for involuntary commitment and increasing requirements for reporting worrisome patients to the authorities — are rushed in execution and unlikely to repair a broken mental health system, some experts say.

"Good intentions without thought make for bad laws, and I think we have a risk of that," said J. Reid Meloy, a forensic psychologist and clinical professor at the University of California, San Diego, who has studied rampage killers.

Moreover, the push for additional mental health laws is often driven by political expediency, some critics say. Mental health proposals draw support from both Democrats and Republicans, in part because, unlike bans on semiautomatic weapons or high-capacity magazines — like the one proposed in the Senate last week — they do not involve confrontation with gun rights groups like the National Rifle Association.

"The N.R.A. is far more formidable as a political foe than the advocacy groups for the mentally ill," said Dr. Jeffrey A. Lieberman, chairman of psychiatry at Columbia University and president-elect of the American Psychiatric Association.

Indeed, the N.R.A. itself, in response to the massacre in Newtown, argued that mental illness, and not the guns themselves, was at the root of recent shooting sprees. The group called for a national registry of people with mental illness — an alternative that legal experts agree would raise at least as many constitutional alarms as the banning of gun ownership.

For mental health groups, the proposals under consideration are tantalizing: By increasing services for those with mental illness, they raise the possibility of restoring some of the billions of dollars cut from mental health programs in recent years as budgets tightened in the financial downturn. The measures also hold out hope for improvement of a mental health system that many experts say is fragmented and drastically inadequate. And some proposals — those to revise commitment laws, for example — have the support of some mental health organizations.

But some mental health and legal experts say that politicians' efforts might be better spent making the process of involuntary psychiatric commitment — and the criteria for restricting firearms access once someone has been forcibly committed — consistent from state to state. And some proposals have caused concern, raising questions about doctor-patient confidentiality, the rights of people with psychiatric disabilities and the integrity of clinical judgment.

Especially troublesome to some mental health advocates are provisions like New York's, which expand the duty of practitioners to report worrisome patients — a model likely to be emulated by other states. New York's law, part of a comprehensive package to address gun violence, requires reporting to the local authorities any patient "likely to engage in conduct that would result in serious harm to self or others." Law enforcement officials would then be authorized to confiscate any firearm owned by such a patient.

John Monahan, a psychologist and professor of law at the University of Virginia, said that such laws are often superfluous.

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Hip Implant’s Risks Inadequately Assessed, DePuy Report Found in 2010

A review conducted internally by Johnson & Johnson soon after it recalled a troubled hip implant found that the company had not adequately assessed the device's potential risks before it was used in more than 90,000 patients, court testimony on Thursday showed.

The engineering report, which was done in 2010, also found that Johnson & Johnson's orthopedic unit had used inadequate or incorrect standards in trying to assess some of those risks before first selling the implant in 2003. The device at issue — the Articular Surface Replacement, or A.S.R. — proved to be among the most flawed orthopedic devices sold in recent decades.

The report was introduced on Thursday in Los Angeles Superior Court, in the first A.S.R.-related lawsuit to go to trial against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 similar lawsuits have been filed in the United States.

In videotaped testimony shown in court, Jimmy Smith, a compliance manager at DePuy, was asked about the report, and he said it indicated that company officials had not used appropriate engineering controls to try to anticipate the device's problems.

"They did their job, but they could have done it better," Mr. Smith said.

Separately, a DePuy engineer, Graham Isaac, testified on Thursday that before selling the A.S.R., the company only tested its performance on laboratory equipment at one angle of implantation.

Depending on the surgical technique and a patient's build, orthopedic surgeons can implant the cup component of an artificial hip at a variety of angles. And because the A.S.R. had a design flaw, normal variance from the single angle at which DePuy had tested it made it more likely for the joint's cup and ball components to strike each other, releasing metallic debris inside a patient.

DePuy conducted the post-mortem review of the A.S.R. in November 2010, just three months after it recalled the all-metal implant, but it never released the analysis. It also, apparently, did not conduct a similar review in response to the mounting number of complaints about the device that it received from doctors and others in 2008 and 2009.

Lorie Gawreluk, a spokeswoman for DePuy, said that she could not comment on any details of the lawsuit, but that the company believed that the evidence would show it acted appropriately. The trial's proceedings were monitored over the Courtroom View Network.

The A.S.R. is projected to fail within five years in about 40 percent of patients who received the implant. That early failure rate, which is expected to grow over time, is many times higher than the failure rate for most hip replacements.

In the post-recall review in 2010, DePuy engineers examined the criteria and "controls," or standards, that were used nearly a decade earlier when company officials tried to anticipate how the A.S.R. might perform. Because the version of the device that was sold in the United States was never clinically tested in patients, officials used the controls to assess the implant.

Among other things, DePuy officials failed to anticipate that the A.S.R. would have a high rate of wear as a patient moved, even though the control referenced in the device's records demonstrated "that the product is more likely to experience contact between the head and rim" than competing implants.

In previously recorded testimony presented in court on Wednesday, DePuy's president, Andrew Ekdahl, was shown an e-mail in which he was warned about the A.S.R.'s problems nearly three years before it was recalled.

Mr. Ekdahl and other DePuy executives have asserted that they acted properly and in a timely fashion to the device's problems. The company spokeswoman, Ms. Gawreluk, said Mr. Ekdahl would not be made available for an interview.

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During Trial, New Details Emerge on DuPuy Hip

When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.

But that same executive, it turns out, had supervised the implant's introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.

In addition, the executive also held a senior marketing position at a time when Johnson & Johnson decided not to tell officials outside the United States that American regulators had refused to allow sale of a version of the artificial hip in this country.

The details about the involvement of the executive, Andrew Ekdahl, with the all-metal hip implant emerged Wednesday in Los Angeles Superior Court during the trial of a patient lawsuit against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 lawsuits have been filed against DePuy in connection with the device — the Articular Surface Replacement, or A.S.R. — and the Los Angeles case is the first to go to trial.

The information about the depth of Mr. Ekdahl's involvement with the implant may raise questions about DePuy's ability to put the A.S.R. episode behind it.

Asked in an e-mail why the company had promoted Mr. Ekdahl, a DePuy spokeswoman, Lorie Gawreluk, said the company "seeks the most accomplished and competent people for the job."

On Wednesday, portions of Mr. Ekdahl's videotaped testimony were shown to jurors in the Los Angeles case. Other top DePuy marketing executives who played roles in the A.S.R. development are expected to testify in coming days. Mr. Ekdahl, when pressed in the taped questioning on whether DePuy had recalled the A.S.R. because it was unsafe, repeatedly responded that the company had recalled it "because it did not meet the clinical standards we wanted in the marketplace."

Before the device's recall in mid-2010, Mr. Ekdahl and those executives all publicly asserted that the device was performing extremely well. But internal documents that have become public as a result of litigation conflict with such statements.

In late 2008, for example, a surgeon who served as one of DePuy's top consultants told Mr. Ekdahl and two other DePuy marketing officials that he was concerned about the cup component of the A.S.R. and believed it should be "redesigned." At the time, DePuy was aggressively promoting the device in the United States as a breakthrough and it was being implanted into thousands of patients.

"My thoughts would be that DePuy should at least de-emphasize the A.S.R. cup while the clinical results are studied," that consultant, Dr. William Griffin, wrote.

A spokesman for Dr. Griffin said he was not available for comment.

The A.S.R., whose cup and ball components were both made of metal, was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use here in standard hip replacement that used the same cup component as the resurfacing device. Only the standard A.S.R. was sold in the United States; both versions were sold outside the country.

Before the device recall in mid-2010, about 93,000 patients worldwide received an A.S.R., about a third of them in this country. Internal DePuy projections estimate that it will fail in 40 percent of those patients within five years; a rate eight times higher than for many other hip devices.

Mr. Ekdahl testified via tape Wednesday that he had been placed in charge of the 2005 introduction of the standard version of the A.S.R. in this country. Within three years, he and other DePuy executives were receiving reports that the device was failing prematurely at higher than expected rates, apparently because of problems related to the cup's design, documents disclosed during the trial indicate.

Along with other DePuy executives, he also participated in a meeting that resulted in a proposal to redesign the A.S.R. cup. But that plan was dropped, apparently because sales of the implant had not justified the expense, DePuy documents indicate.

In the face of growing complaints from surgeons about the A.S.R., DePuy officials maintained that the problems were related to how surgeons were implanting the cup, not from any design flaw. But in early 2009, a DePuy executive wrote to Mr. Ekdahl and other marketing officials that the early failures of the A.S.R. resurfacing device and the A.S.R. traditional implant, known as the XL, were most likely design-related.

"The issue seen with A.S.R. and XL today, over five years post-launch, are most likely linked to the inherent design of the product and that is something we should recognize," that executive, Raphael Pascaud wrote in March 2009.

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.

The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about "high concentration of metal ions" in the blood of patients who received it.

DePuy never disclosed the F.D.A. ruling to regulators in other countries where it was still marketing the resurfacing version of the implant.

During a part of that period, Mr. Ekdahl was overseeing sales in Europe and other regions for DePuy. When The Times article appeared last year, he issued a statement, saying that any implication that the F.D.A. had determined there were safety issues with the A.S.R. was "simply untrue." "This was purely a business decision," Mr. Ekdahl stated at that time.

This article has been revised to reflect the following correction:

Correction: February 1, 2013

A headline on Thursday about a patient lawsuit against DePuy Orthopaedics, a unit of Johnson & Johnson, misstated the start of the trial in some copies. It began last week, not on Wednesday.

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Insurance Industry Report Faults High Fees for Out-of-Network Care

Michael Nagle for The New York Times

Angel Gonzalez, 36, faced huge bills after emergency gallbladder surgery, despite having good insurance coverage. "I was on the hook for more than I made in a year."

Just over a year ago, Angel Gonzalez, 36, awoke with searing chest pain at 2 a.m. A friend drove him to the closest emergency room.

Though he was living on $18,000 a year as a graduate student, Mr. Gonzalez had good insurance and the hospital, St. Charles in Port Jefferson, N.Y., was in his network. But the surgeon who came in to remove Mr. Gonzalez's gallbladder that Sunday night was not.

He billed Mr. Gonzalez $30,000, and an assistant billed an additional $30,000. Mr. Gonzalez's policy covered out-of-network providers, but at a rate it considered appropriate: $2,000. "I was on the hook for more than I made in a year," Mr. Gonzalez said.

A health insurance industry report to be released on Friday highlights the exorbitant fees charged by some doctors to out-of-network patients like Mr. Gonzalez. The report, by America's Health Insurance Plans, or AHIP, contrasts some of the highest bills charged by non-network providers in 30 states with Medicare rates for the same services. Some of the charges, the insurers assert, are 30, 40 or nearly 100 times greater than Medicare rates.

Insurers hope to spotlight a vexing problem that they say the Affordable Care Act does little to address. "When you're out of network, it's a blank check," said Karen Ignagni, president and chief executive of AHIP. "The consumer is vulnerable to 'anything goes.' "

"Unless we deal with cost, we won't have affordability," she added. "And unless we have affordability, we won't have people participating" under the Affordable Care Act.

Among the fees on the report's list are a $6,205 outpatient office visit to a doctor in Massachusetts for which Medicare would have paid $152; a $12,000 bill for examining a tissue specimen in New York for which Medicare would have paid $128; and a $48,983 surgeon's fee for a total hip replacement in New Jersey that Medicare would have reimbursed at $1,543. Many of the highest billers were in New York, Texas, Florida and New Jersey.

Elisabeth R. Benjamin, co-founder of the Health Care for All New York coalition, who is often at odds with the insurance industry, said that "is one area we totally agree on." She continued, "Out-of-network billing is just out of control."

Even when out-of-network fees are compared with average commercial insurance reimbursements, which are usually greater than Medicare, she said, "It's pretty outrageous."

Doctors say the report is skewed because it focuses on a few dozen cases of overcharging that are not representative of their billing. In response to the insurers' report, the American Medical Association noted on Thursday that a recent analysis found that doctors' services account for just 16 percent of health care costs.

"There are outliers in every profession, in every business," said Dr. Andrew Y. Kleinman, a plastic surgeon who is vice president of the Medical Society of the State of New York.

Dr. Kleinman also noted that insurers had effectively shifted the costs of out-of-network care onto patients by changing reimbursement formulas. Instead of the rates commercial insurers usually pay doctors, insurers increasingly are basing their out-of-network payments on Medicare rates, usually far lower.

A growing number of high-end, flexible health plans offer policies that cover outside providers at, for example, 140 percent of Medicare. "They're selling you an insurance product you can't use," Dr. Kleinman said. "You're buying an insurance policy where the out-of-network benefit is worthless."

The industry's own report suggests that using Medicare rates as a benchmark will lead to patients' picking up much more of the cost for out-of-network care, whether they carefully select a specialist or, as in the case of Mr. Gonzalez and many others, have no choice in the matter.

Had Mr. Gonzalez been 65 or older, Medicare would have paid only $958 for the surgery. The average commercial price is $12,292, according to FAIR Health, an independent nonprofit group that tracks information on health care costs.

But Mr. Gonzalez's health plan, United Healthcare, determined the fee should be $1,273, of which the company paid $838. Mr. Gonzalez filed appeals, which were rejected. He then contacted Community Health Advocates at the Community Service Society of New York for help, and the group's caseworkers negotiated with the surgeon on his behalf.

After months of wrangling, the surgeon agreed to accept a significantly reduced payment: $340.

Consumer advocates and health insurance executives are calling for greater transparency in health care pricing, including upfront disclosure of prices of medical procedures and services.

"The health care industry can give you an estimate, just like any other industry," said Carrie H. Colla, an assistant professor at the Dartmouth Institute for Health Policy and Clinical Practice, noting that the Dartmouth-Hitchcock Medical Center has a patient price estimator online.  

"It's just not current practice right now," Dr. Colla said. "Sometimes a doctor won't even know. The patient really has to push for it."

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I.R.S. to Base Insurance Affordability on Single Coverage

WASHINGTON — The Obama administration adopted a strict definition of affordable health insurance on Wednesday that will deny federal financial assistance to millions of Americans with modest incomes who cannot afford family coverage offered by employers.

In deciding whether an employer's health plan is affordable, the Internal Revenue Service said it would look at the cost of coverage only for an individual employee, not for a family. Family coverage might be prohibitively expensive, but federal subsidies would not be available to help buy insurance for children in the family.

The policy decision came in a final regulation interpreting ambiguous language in the 2010 health care law.

Under the law, most Americans will be required to have health insurance starting next year. Low- and middle-income people can get tax credits to help them pay premiums, unless they have access to affordable coverage from an employer.

The law specifies that employer-sponsored insurance is not affordable if a worker's share of the premium is more than 9.5 percent of the worker's household income. The I.R.S. said this calculation should be based solely on the cost of individual coverage, what the worker would pay for "self-only coverage."

"This is bad news for kids," said Jocelyn A. Guyer, an executive director of the Center for Children and Families at Georgetown University. "We can see kids falling through the cracks. They will lack access to affordable employer-based family coverage and still be locked out of tax credits to help them buy coverage for their kids in the marketplaces, or exchanges, being established in every state."

In 2012, according to an annual survey by the Kaiser Family Foundation, total premiums for employer-sponsored health insurance averaged $5,615 a year for single coverage and $15,745 for family coverage. The employee's share of the premium averaged $951 for individual coverage and more than four times as much, $4,316, for family coverage.

Under the I.R.S. rule, such costs would be considered affordable for a family making $35,000 a year, even though the family would have to spend 12 percent of its income for full coverage under the employer's plan.

The tax agency proposed this approach in August 2011 and made no change in the definition of "affordable coverage" despite protests from advocates for children and low-income people and many employers. Employers did not want to be required to pay for coverage of employees' dependents. But they said that family members should have access to subsidies so they could buy insurance on their own.

However, that would have increased costs to the government, which would have been required to spend more on subsidies.

Paul W. Dennett, senior vice president of the American Benefits Council, which represents many Fortune 500 companies, said: "Individuals who do not have affordable family coverage should be eligible for premium tax credits in the exchange. The final rule does not provide that."

Under the law, people who go without insurance will generally be subject to tax penalties. In a separate proposed regulation issued on Wednesday, the Internal Revenue Service said that the uninsured children and spouse of an employee would be exempt from the penalties if the cost of coverage for the entire family under an employer's plan was more than 8 percent of household income.

Bruce Lesley, the president of First Focus, a child advocacy group, said: "The administration recognizes that the cost of family coverage will be unaffordable for many families. They will not have to pay the penalty. But that will not be much of a consolation to families who cannot get health insurance for their kids."

The 2010 health care law extended Medicaid to many childless adults and others who were previously ineligible. The Supreme Court said the expansion of Medicaid was an option for states, not a requirement as Congress had intended.

Kathleen Sebelius, the secretary of health and human services, said Wednesday that she wanted to use her discretion to prevent the imposition of tax penalties on certain uninsured low-income people in states that choose not to expand Medicaid.

A rule proposed by her department would guarantee an exemption from the penalties for anyone found ineligible for Medicaid solely because of a state's decision not to expand the program. The administration said this was "an appropriate use of the hardship exemption."

About 20 states are expected to expand Medicaid; governors in other states are opposed or uncommitted. Many illegal immigrants, prisoners and members of certain religious groups opposed to the acceptance of insurance benefits will also be exempt from penalties if they forgo coverage, the administration said.

The Congressional Budget Office predicts that 30 million people will be uninsured in 2016 and that 6 million of them will pay penalties.

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During Trial, New Details Emerge on DuPuy Hip

When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.

But that same executive, it turns out, had supervised the implant's introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.

In addition, the executive also held a senior marketing position at a time when Johnson & Johnson decided not to tell officials outside the United States that American regulators had refused to allow sale of a version of the artificial hip in this country.

The details about the involvement of the executive, Andrew Ekdahl, with the all-metal hip implant emerged Wednesday in Los Angeles Superior Court during the trial of a patient lawsuit against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 lawsuits have been filed against DePuy in connection with the device — the Articular Surface Replacement, or A.S.R. — and the Los Angeles case is the first to go to trial.

The information about the depth of Mr. Ekdahl's involvement with the implant may raise questions about DePuy's ability to put the A.S.R. episode behind it.

Asked in an e-mail why the company had promoted Mr. Ekdahl, a DePuy spokeswoman, Lorie Gawreluk, said the company "seeks the most accomplished and competent people for the job."

On Wednesday, portions of Mr. Ekdahl's videotaped testimony were shown to jurors in the Los Angeles case. Other top DePuy marketing executives who played roles in the A.S.R. development are expected to testify in coming days. Mr. Ekdahl, when pressed in the taped questioning on whether DePuy had recalled the A.S.R. because it was unsafe, repeatedly responded that the company had recalled it "because it did not meet the clinical standards we wanted in the marketplace."

Before the device's recall in mid-2010, Mr. Ekdahl and those executives all publicly asserted that the device was performing extremely well. But internal documents that have become public as a result of litigation conflict with such statements.

In late 2008, for example, a surgeon who served as one of DePuy's top consultants told Mr. Ekdahl and two other DePuy marketing officials that he was concerned about the cup component of the A.S.R. and believed it should be "redesigned." At the time, DePuy was aggressively promoting the device in the United States as a breakthrough and it was being implanted into thousands of patients.

"My thoughts would be that DePuy should at least de-emphasize the A.S.R. cup while the clinical results are studied," that consultant, Dr. William Griffin, wrote.

A spokesman for Dr. Griffin said he was not available for comment.

The A.S.R., whose cup and ball components were both made of metal, was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use here in standard hip replacement that used the same cup component as the resurfacing device. Only the standard A.S.R. was sold in the United States; both versions were sold outside the country.

Before the device recall in mid-2010, about 93,000 patients worldwide received an A.S.R., about a third of them in this country. Internal DePuy projections estimate that it will fail in 40 percent of those patients within five years; a rate eight times higher than for many other hip devices.

Mr. Ekdahl testified via tape Wednesday that he had been placed in charge of the 2005 introduction of the standard version of the A.S.R. in this country. Within three years, he and other DePuy executives were receiving reports that the device was failing prematurely at higher than expected rates, apparently because of problems related to the cup's design, documents disclosed during the trial indicate.

Along with other DePuy executives, he also participated in a meeting that resulted in a proposal to redesign the A.S.R. cup. But that plan was dropped, apparently because sales of the implant had not justified the expense, DePuy documents indicate.

In the face of growing complaints from surgeons about the A.S.R., DePuy officials maintained that the problems were related to how surgeons were implanting the cup, not from any design flaw. But in early 2009, a DePuy executive wrote to Mr. Ekdahl and other marketing officials that the early failures of the A.S.R. resurfacing device and the A.S.R. traditional implant, known as the XL, were most likely design-related.

"The issue seen with A.S.R. and XL today, over five years post-launch, are most likely linked to the inherent design of the product and that is something we should recognize," that executive, Raphael Pascaud wrote in March 2009.

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.

The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about "high concentration of metal ions" in the blood of patients who received it.

DePuy never disclosed the F.D.A. ruling to regulators in other countries where it was still marketing the resurfacing version of the implant.

During a part of that period, Mr. Ekdahl was overseeing sales in Europe and other regions for DePuy. When The Times article appeared last year, he issued a statement, saying that any implication that the F.D.A. had determined there were safety issues with the A.S.R. was "simply untrue." "This was purely a business decision," Mr. Ekdahl stated at that time.

This article has been revised to reflect the following correction:

Correction: January 30, 2013

An earlier version of this article, in the summary, described the start of the DePuy trial incorrectly. It began last week, not this week.

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