The Obama administration filed its expected appeal on Monday of a judge's order to make the so-called "morning-after pill" available to anyone, without a prescription.

The federal government asked the 2nd U.S. Circuit Court of Appeals in New York to postpone federal judge Edward Korman’s ruling against the Health and Human Services Department’s requirement that anyone under 17 get a prescription for the emergency contraception.

Korman refused on Friday to stay his ruling while the appeals court considered the appeal, calling the government’s legal attempts “frivolous” and saying they were done in bad faith.

Women’s health groups had sued against the HHS decision, which had overruled the Food and Drug Administration’s original approval of Plan B birth control pills for women and girls of all ages. HHS Secretary Kathleen Sebelius had said she wasn’t comfortable seeing the pills freely available to girls as young as 11.

The FDA, which had protected against Sebelius’s decision, last month approved another drug application to make one brand available over the counter to girls as young as 15, but still requiring proof of age.

Korman railed against both decisions and has accused the government of simply trying to delay the inevitable.

For now, things are a bit confusing. The appeal, technically filed by the Food and Drug Administration, asks the appeals court to stop Korman's ruling from taking effect until the case is settled.

Teva Pharmaceutical’s single-pill option, called Plan B One-Step, is available with ID to anyone 15 and older. Anyone younger needs a prescription to get it.

Other versions of the medication are available to anyone 17 and older with proof of age, and to anyone younger with a prescription.

"You have to show an ID either way," said Judy Waxman of the National Women's Law Center. Waxman  predicts the appeals court will stay Korman's decision until a hearing can be scheduled on the appeal. "This could take months again until we get the Second Circuit decision," Waxman said in a telephone interview.

Related:

Judge refuses to delay Plan B ruling, has choice words for HHS

Judge: Make 'morning-after pill' available to all girls without prescription

The Obama administration has unveiled proposed rules spelling out how birth control expenses will be covered for employees of religious-affiliated groups opposed to contraception.

Here are some common questions and answers that help explain the administration’s contraceptive policy and the opposition.

Q. What does the new regulation require?

A. Under the rule, women employed by nonprofit religious organizations opposed to contraceptives, such as Catholic hospitals or colleges and student health plans, are entitled to get contraceptive services and products without a co-payment. But the organization is not required to bear the cost of the service.

In those workplaces, the employer must tell its insurer that it will not cover the costs, and the insurer automatically would notify workers that it will provide the coverage without cost sharing or other charges through separate individual health insurance policies, according to a fact sheet released by HHS.

In the rule, the administration says this procedure “would alleviate the need for the eligible organization to contract, arrange, pay, or refer for contraceptive coverage while providing contraceptive coverage to plan participants and beneficiaries at no additional cost.” It also says this should not increase costs for the insurer and may save money by eliminating some pregnancies.

The procedures will be a bit different for religious-affiliated workplaces that self-insure, which means the employer assumes the risk of the insurance but generally hires a private firm—often an insurer—to handle the administration of the coverage. In these plans, the administrator would “work with an insurer to arrange no-cost contraceptive coverage through separate individual health insurance policies,” the fact sheet says. The insurer could offset the costs of those policies through an “adjustment” in the fees that will be charged to insurers participating in the health marketplaces.

Q: What led to this proposal?

A: Last year, the administration announced that all insurance plans would be required to cover contraception as part of the list of free preventive services mandated by the 2010 federal health law. That regulation exempted houses of worship, like churches, from the requirement to provide contraceptive services at no cost to employees, but religious-affiliated institutions, such as universities and hospitals, would have to provide coverage for contraception.

Some religious groups, including the United States Conference of Catholic Bishops, objected on the basis that it violated their religious freedom. The resulting furor quickly engulfed the White House and even some Democrats and Catholic groups that had supported the health law, such as the Catholic Health Association, turned against the policy.

Last February, President Barack Obama said the administration would revise the policy to make sure that the religious-affiliated groups did not have to pay for the coverage. But while announcing a compromise, he also insisted that women working at those groups should have access to contraceptives without charge. "No woman's health should depend on who she is or where she works or how much money she makes," Obama said at the time.

Q. What was the nature of the opposition to the initial rule?

A. Catholic religious leaders and Republican politicians characterized the rule as an attack on religious liberty and an overreach by the Obama administration. The U.S. Conference of Catholic Bishops led the opposition, with dozens of bishops all over the country making statements against it. Several bishops said that they would have no choice but to stop insuring employees altogether if the contraception mandate goes into effect.

The Catholic opposition is rooted in belief that life begins at conception and, therefore, anything that prevents conception is a sin. Though surveys have shown that as many as 98 percent of Catholic women have used birth control at some point, a survey last year found that voters are split over the question of whether employers such as Catholic hospitals and universities should be required to provide contraceptive insurance coverage for employees.

Q: Wouldn't this mean that the religious institutions would still pay for birth control as part of the insurance they provide to their workers?

A: Administration officials say no. While birth control will be covered, by not requiring employers to pay anything additional or to tell employees how to get the services, the administration believes it has brokered a satisfactory compromise. White House officials said last year that actuaries they consulted said that covering contraceptive services would not increase costs for employers and could actually save insurers money by preventing pregnancy. They pointed to the Federal Employees Health Benefit plan, which had no increase in premiums after contraception coverage was added.

The trade association for insurers, America's Health Insurance Plans, issued this statement last year from Press Secretary Robert Zirkelbach: “Health plans have long offered contraceptive coverage to employers as part of comprehensive, preventive benefits that aim to improve patient health and reduce health care cost growth. We are concerned about the precedent this proposed rule would set. As we learn more about how this rule would be operationalized, we will provide comments through the regulatory process."

Q. How does the new federal rule and religious exemption compare with contraceptive coverage laws currently on the books in states?

A. The big difference is that under the federal rule birth control will be available without the employee being responsible for a copayment. That is currently true in just a handful of states. Some 28 states have mandated coverage of birth control, and 20 of those have some sort of exemption for religious employers. According to a report by the Guttmacher Institute, the state exemptions range from very narrow definitions, such as only for churches, to broader exemptions, including religious elementary and secondary schools. The most expansive state exemptions allow religious-affiliated colleges and hospitals not to provide birth control coverage.

The federal compromise cleaves closely to laws on the books in Hawaii, Connecticut and West Virginia. In all of those states, insurers must cover contraceptives for employees of institutions who choose not to do so for religious reasons. The federal rule, though, is unlike state laws that require the religious employers to tell workers where contraception coverage is available.

Q. What about the legal challenges to the plan?

The mandate to cover contraceptive care has inspired at least 44 lawsuits against the government, according to The Becket Fund for Religious Liberty, a legal organization fighting the mandate. The plaintiffs, who include private employers with strong religious views, generally argue that the contraception policy conflicts with the 1993 Religious Freedom Restoration Act, which prohibits the federal government from imposing a "substantial burden" on a person's "exercise of religion" unless it can prove that doing so is "the least restrictive means of furthering [a] compelling governmental interest." 

The administration contends that the mandate is only an indirect burden on religious employers. Courts around the country are taking up the cases and results have been mixed. Some scholars believe the issue could land eventually at the Supreme Court.

The proposed rule does not provide the non-religious businesses who are suing the same ability to avoid providing contraceptive coverage that is afforded religious-affiliated groups.

Getty Images stock

The White House has a new proposal aimed at helping employers with religious objections opt out of paying for birth control coverage.

The Obama administration is taking another stab at a compromise over the contentious issue of making employers pay for birth control, offering a way for women to get the coverage without forcing religiously affiliated organizations to pay for it.

The proposed new rule would have insurance companies provide the coverage free of charge through separate, individual health insurance policies. It’s not quite clear how much it would cost or who, exactly, would end up paying for it.

“Under the proposed accommodations, the eligible organizations would not have to contract, arrange, pay or refer for any contraceptive coverage to which they object on religious grounds," the Health and Human Services Department said in a statement.

The 2010 Affordable Care Act requires all health insurers to pay for a woman’s contraceptive care without charging her anything. Religious organizations such as the Catholic Church, which oppose artificial birth control, have objected strongly. While churches and other overtly religious organizations were always exempted, things were a little fuzzier for religiously affiliated organizations, such as universities, and private employers who said they had their own personal conscientious objections.

Some employers who don’t oppose birth control in general oppose the requirement that products such as emergency birth control, which they equate with abortion, be supplied.

At least 44 lawsuits have been filed against the government over the issue, The Becket Fund for Religious Liberty, a legal organization helping oppose the mandate, says. It has been a big thorn in the side for the Obama administration.

A year ago the White House came up with a compromise but it did not settle the matter. The new approach tweaks it a little, leaving almost all the responsibility for covering women whose employers object up to private health insurance companies.

Some employers are self-insured, meaning they pay all the costs of health insurance for their workers. Usually, they employ an insurance company to administer the plan. The new compromise leaves it to these third-party administrators to sort out which insurance company will pay for a woman’s birth control through a separate policy.

The insurance company would get a break on user fees that will be charged to join the state health insurance exchanges – the marketplaces where people can go buy health insurance starting in 2014 if they cannot get coverage through an employer, Medicare, Medicaid, Tricare or some other public policy.

The White House argues that it in fact saves money to provide contraception for free. It costs way more to pay for a pregnancy, the administration argues. The Institute of Medicine said in 2011 that it would save the country money and make medical sense to cover birth control for free, so more people would use it.

“Women who work or go to school at these organizations will have free contraceptive coverage and will no longer have to pay hundreds of dollars a year that could go to rent,” said Chiquita Brooks-LaSure, of the Health and Human Services Department’s Center for Consumer Information and Insurance Oversight.

Brooks admitted the administration doesn’t know how much the proposal would cost. “We have not estimated the cost. We certainly welcome comment on that,” she told reporters in a conference call.

Health insurers had no immediate comment. A spokesman for America's Health Insurance Plans, which represents the industry, said the group was studying the proposals.

The new rules also say religious organizations will be defined just as they are by the Internal Revenue Service.

Left-leaning and women's health groups welcomed the policy.  “As we go through this, we want to make sure that the details pan out, but it does seem as if it works,” Marcia Greenberger, Co-President of the National Women’s Law Center, told NBC News in a telephone interview. “Of course, women assume that contraception is part of their health care and it is widely accepted because it is almost universally used.”

"Today's draft regulation affirms yet again the Obama administration's commitment to fulfilling the full promise of its historic contraception policy," said Ilyse Hogue, president of NARAL Pro-Choice America.

“We know that Catholics in the pews support this position, as 98 percent of Catholic women use contraception and 58 percent of Catholics support insurance coverage for contraception,” said Louise Melling of the American Civil Liberties Union. “The ACLU will defend the health and religious liberty needs of employees and hopes the intense recent debate is now be behind us.”

The U.S. Conference of Catholic Bishops said it was studying the proposal. The Susan B. Anthony List, a political action committee that helps campaign for anti-abortion lawmakers, rejected the proposal.

“Once again, President Obama’s so-called ‘compromise’ is unacceptable – religious and moral freedom is not up for negotiation. There must be no religious ‘test’ by the government as to who, and what type of entities, are entitled to a conscience,” said the group’s Marjorie Dannenfelser. “The taking of human life is the antithesis of health care.”

The Family Research Council agreed. "The mandate continues to force religious non-profit institutions as well as companies guided by a well-articulated and longtime moral code, such as Hobby Lobby, to violate their faith, threatening serious fines in the millions of dollars if they refuse to comply," said Anna Higgins, director of the group's Center for Human Dignity.

“Regardless of whether insurance companies or third party administrators use their dollars for an employee’s free abortifacients and contraceptives, the provision of these drugs and devices still necessarily depends on the religious employer’s health insurance plan. They remain the gateway for drugs and services to which they object."

 HHS says 90 percent of American women use or have used birth control. The Centers for Disease Control and Prevention estimates that 10.7 million U.S. women use birth control pills. Despite this, CDC says nearly half of all pregnancies are unintended, which in turn can often lead to poor health for the mother and baby.

The proposals will be open for public comment for 60 days before they take effect.

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Pediatricians treating teenaged girls should consider writing just-in-case prescriptions for the morning-after pill,  the American Academy of Pediatrics (AAP) said on Monday.

It’s the second recommendation in a week from a major doctor’s group that would make contraception more widely available to women. Last week, the American College of Obstetricians and Gynecologists recommended making all birth control pills available over the counter.

The Food and Drug Administration says emergency contraception – the so-called morning after pill – should be available to any woman who needs it without a prescription. But Health and Human Services Secretary Kathleen Sebelius overruled the FDA a year ago. Now, federal policy says girls under 17 need a prescription to get it.

AAP says many teenaged girls need emergency contraception, and their pediatricians should help make it easy for them to get it. “Studies have shown that adolescents are more likely to use emergency contraception if it has been prescribed in advance of need,” the group said in a policy statement.

“Despite significant declines over the past two decades, the United States continues to have teen birth rates that are significantly higher than other industrialized nations,” it added.

Morning-after pills can prevent pregnancy -- they don’t cause abortions -- if they are used within five days of intercourse.

Dr. Susan Wood, who resigned her job as assistant commissioner for women's health at the FDA in 2005 in a dispute over the then-Bush administration’s handling of the birth control issue, called the decision a significant one. “It's not often you see physician organizations saying that their patients are better off without the physician involvement,” Wood told Reuters.

"We do hope that pediatricians read the policy statement and follow the recommendations," said Dr. Cora Breuner, a pediatrician at Seattle Children's Hospital who led the AAP panel that produced the recommendations. "The Academy prides itself on a devoted membership."

Emergency contraception for adolescents has been one of the most politically fraught areas in health care for almost a decade.
 
In 2005 the FDA declined to approve any over-the-counter sales of the Plan B morning-after pill, overruling its own advisory panel, as well as its own scientists. Last December the FDA reversed  its stance when it approved over-the-counter sales with no age limits. When Sebelius overruled the decision, it meant many women must present proof of age to get the pills.

Virtually every medical organization with expertise in the area supports making emergency contraception available for sale to girls and women of all ages who might need it. The American Academy of Pediatrics, the American Congress of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine joined forces to denounce Sebelius’s action last year.

“The decision to continue restricting access to this safe and effective product is medically inexplicable,” AAP president Dr. Robert Block said in a statement at the time. One of the reasons Sebelius gave for her decision was the worry that girls as young as 11 might get the pills and might not understand the consequences. But the pediatricians have said they do not share that worry.

Arthur Caplan, head of the division of medical ethics at NYU Langone Medical Center and an NBC News contributor, calls it a "remarkable and innovative idea." 

"Having emergency contraception readily available will surely lead to fewer young women getting pregnant and fewer abortions.   The battle over abortion should not hinder making this sort of safe and reliable emergency pill easily available especially to those who may be coerced into sex, forget to take their birth control or have a partner whose birth control method fails," Caplan said. "Improvements in medicine are shifting the arena for discussing reproductive ethics from abortion clinics and surgical procedures to choices made by individual women talking to their doctor, nurse, pharmacist and others whom they trust.  Those on all sides of contraceptive availability need to come to terms with this new moral reality."

The most common form of emergency contraception is a high dose of a regular birth control pill such as Plan B and Plan B One-Step from Teva Pharmaceutical Industries Ltd or Next Choice from Watson Pharmaceuticals Inc. They generally sell for $10 to $80 and are most effective in the first 24 hours.

All work by preventing ovulation, not by stopping the implantation of a fertilized egg. "These are not abortifacients," said Breuner.

A 2006-08 survey found that 14 percent of sexually experienced girls had used emergency contraception, up from 8 percent in a 2002 survey. The most common reason given was condom failure, but 13 percent of the girls said it was because of rape.

A 2010 analysis of seven randomized studies of emergency contraception found that teens who had a morning-after prescription in were not more likely to have sex or less likely to use contraceptives.

"It's just common sense that requiring a prescription is a barrier," said Bill Alpert, chief program officer of the National Campaign to Prevent Teen and Unplanned Pregnancy. "If an august and respected medical group like AAP is suggesting providing emergency contraception to minors is OK, that is a big deal."

That is especially so when teens face other obstacles to getting emergency contraception. For instance, a 2012 study that had 17-year-olds telephone pharmacies asking about morning-after pills found only 57 percent of them correctly told the caller that she could get the drugs without a prescription.

Also, some physicians refuse to provide the prescriptions to teenagers, while others do so only in cases of rape, AAP's research shows, suggesting that the refusal "may be related to the physician's beliefs about whether it is OK for teenagers to have sex."

There are no good data on how many physicians write prescriptions ahead of time for emergency contraception. "But we do know that pediatricians don't even talk about it, let alone offer advance prescriptions," said Breuner. "We tend not to like bringing up stuff that's controversial."

Related stories:

Insurers must provide birth control free of charge

Judge dismisses suit over contraception mandate 

No Plan B for young teens, HHS says

Starting Wednesday, millions of American women will no longer pay for birth control pills, Pap smears or mammograms -- not even a co-pay. Women also have the right to free breast-feeding support, supplies for pregnancy-related diabetes, also known as gestational diabetes, and even screening for domestic violence.

It's not clear how many women will take advantage of the new policy, but the US Health and Human Services Department estimates that 47 million women, ages 15 to 64, have private health insurance plans that will be affected. The 2010 health reform law requires that policies provided by private health insurance companies pay for a list of women’s health preventive services, starting August 1.

However, there may be a delay in services for many women. The law applies to new policies -- women with existing coverage may have to wait for their policies to renew for the requirements to kick in, which could take months. Many health insurers already provide this coverage.

The new rules are based on guidelines from the independent, non-partisan Institute of Medicine, which said paying for these services will save money and lives down the road.

“We want healthy women to have healthy babies,” said Dr. Jennifer Howse, president of the March of Dimes Foundation, a charity that works to prevent birth defects. “Receiving regular medical care greatly increases the likelihood that important messages can be delivered to pregnant women around issues such as nutrition and tobacco cessation, and provides opportunities to detect potentially dangerous conditions like gestational diabetes or high blood pressure.”

There are a few exceptions. Purely religious employers don’t have to provide the services to employees if they object. Related groups, such as Catholic-affiliated universities, have objected so the Obama administration offered what it called an accommodation, forcing the insurance companies themselves to pay for the coverage. But the religious associations still object, as do Republicans in Congress. They have promised to repeal the whole law if they win enough seats in the November election.

On Friday, a federal judge in Colorado ruled that a Catholic-owned heating and air conditioning company in Denver did not have to provide contraception coverage for its workers.

Americans also get refunds starting today from health insurance companies that spent too much on administrative expenses. The law requires health insurance companies to spend at least 80 percent of premiums on actual medical care and not on salaries, office rental and other overheads.

While opponents continue efforts to repeal the health care law, HHS secretary Kathleen Sebelius cheered the the promise of free screening for women's health services. 

"For too long insurance companies have stacked the deck against women, forcing us to pay more for coverage that didn't meet our needs,” Sebelius said Tuesday.

Related links:

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Colorado business wins opt-out of birth control mandate

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By Cari Nierenberg
MyHealthNewsDaily Contributor

Women who use long-acting methods of birth control are less likely to wind up pregnant than women who use shorter-term methods, which require daily or monthly remembering, a new analysis says.

The results showed that women using birth control pills, skin patches or vaginal rings were 20 times more likely to have an unplanned pregnancy than women who used intrauterine devices (IUDs) or implants placed under the skin of the upper arm. 

"We were surprised at the magnitude of the difference between the contraceptive methods," said study author Dr. Jeffrey Peipert, a professor of obstetrics and gynecology at the Washington University School of Medicine, in St. Louis.

The study, which appears Thursday (May 24) in the New England Journal of Medicine, is one of the largest ever done in the U.S. to compare birth control failure rates over a three-year period, Peipert said. It's also one of the few to include a large number of women using IUDs and implants. Previous studies were based on surveys and depended on women's recall of contraceptive failure, he noted.

Given the findings, Peipert said women and health professionals should consider this question: Would we use a medication that was 20 times less effective for cancer or heart disease?

Unplanned pregnancies
Half of the roughly 6 million pregnancies in the United States each year are unplanned. And of those 3 million, about half are attributed to the incorrect or inconsistent use of birth control.

The unintended-pregnancy rate in the U.S. is higher than in other developed countries, including France and the United Kingdom, where use of IUDs is much higher, the researchers said. The pill remains the most commonly used contraceptive method in the United States.

In the new study, researchers tracked almost 7,500 women ages 14 to 45 considered at risk for an unplanned pregnancy. All women were given the contraceptive of their choice free of charge, and they also received counseling about each method's risks, benefits and effectiveness.

The largest group, nearly 5,800, chose IUDs or implants. Slightly more than 1,500 women selected pills, patches or vaginal rings, and the smallest group, 176 women, chose an injectable form of birth control known as DMPA, short for depot medroxyprogesterone acetate.

During the study 334 unplanned pregnancies occurred. Of these, 156 were attributed to contraceptive failure (improper or inconsistent use), The remaining 178 pregnancies were due to other reasons, including the non-use of contraceptives.

The highest failure rate was seen in women using birth control pills, patches or rings. There were 133 pregnancies among women using these methods, which means the failure rate was 4.5 percent. There were 21 women who became pregnant while using IUDs and implants, and two women while using DMPA.

While a woman's method of birth control mattered, her age also made a difference. 

Researchers found that women younger than 21 who relied on oral contraceptives, patches or rings had almost twice the rate of unintended pregnancies as older women who used the same contraceptives. That's because younger woman are more likely to forget to take their pills or to change a patch or ring, the researchers said.

Less mental effort is needed for IUDs, which can stay in the uterus for five to 10 years, depending on the type. Implants are effective for up to three years. It's estimated that 5.5 percent of U.S. women who use birth control currently use IUDs.

Making decisions
"This is an extremely well-done study, and I really applaud that the researchers did it," says Dr. Lynn Goltra, an OB/GYN who is director of family planning at Massachusetts General Hospital in Boston. "It shows that the failure rate is 20 times higher for labor-free birth control methods than labor-intensive ones."

In other words, the more effort a woman has to put into a birth control method, the more likely it is to fail.

Goltra, who was not involved in the research, said women under-utilize IUDs. "They're hassle-free, incredibly safe, and as effective as sterilization," she said.

Some women don't like the idea of placing something foreign inside their body or under their skin, Goltra said. There are also risks to using IUDs, she noted; for example, there's a very small risk of introducing an infection into the uterus that might affect fertility, and skin implants may cause unpredictable bleeding.

It also may be that women are less familiar with long-acting birth control methods, and they hear less information about them from their friends.

"If a woman's goal is to prevent pregnancy, she should be using the most effective method of birth control," Goltra said. "Long-acting reversible contraceptives are the most effective."

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