Monday, August 8, 2011

Women's Preventative Services Rule Issued Under Health Care Reform

By Sara Hansard

Rules requiring new health insurance plans to cover women's preventive health services without charging copayments, coinsurance, or deductibles were issued jointly Aug. 1 by three agencies that are implementing the health care reform law.

The Department of Health and Human Services' Centers for Medicare & Medicaid Services, the Department of Labor's Employee Benefits Security Administration, and the Department of the Treasury's Internal Revenue Service issued an interim final rule adopting guidelines recommended July 19 by the Institute of Medicine (19 HCPR 1167, 7/25/11).

The interim final rule was published in the Aug. 3 Federal Register (76 Fed. Reg. 46621), but the effective date of the rule is Aug. 1, when it was released. Comments on the interim final rule are due Sept. 30.

The IRS also issued a separate proposed rule which would amend excise tax regulations. Comments on the IRS proposed rule, also published in the Aug. 3 Federal Register (76 Fed. Reg. 46677), are due Oct. 3.

In a telephone press briefing with reporters, HHS Secretary Kathleen Sebelius called the guidelines “historic,” saying they will “help women get the preventive care they need to stay healthy.”

Group and individual health insurance policies with plan years beginning on or after Aug. 1, 2012, will have to cover a wide range of preventive services without requiring cost-sharing payments, including contraception, well-woman visits, breastfeeding supplies and support, domestic violence screening, screening for gestational diabetes, human papillomavirus DNA testing for women 30 years and older, sexually transmitted infection counseling, and human immunodeficiency virus screening and counseling.

“This kind of care can prevent illness and improve health,” Sebelius said. “But for too long, too many Americans have gone without it, in many cases because it cost too much,” she said. A recent study found that each year more than half of women avoid or delay key preventive care because of cost, which hurts public health and drives up health care costs, she said. As one example, she said it is estimated that if 90 percent of mothers were able to breast-feed in the first six months, it would save the lives of 1,000 infants and save the health care system $13 billion each year.

The Patient Protection and Affordable Care Act requires plans begun after the law was enacted in 2010 to cover preventive services for men and women without requiring policyholders to make cost-sharing payments, and rules were issued in 2010 for that requirement.

The interim final rule issued Aug. 1 implements a provision of PPACA requiring that preventive services specifically for women be covered without cost sharing. Previously, preventive services for women had been recommended one by one or as part of guidelines for men as well, HHS said.

“Grandfathered” plans that began before PPACA was enacted and that meet HHS criteria for not making many changes are not required to meet the preventive service requirements.

‘Millions’ of People Will Be Affected

Howard Koh, HHS assistant secretary for health, said during the press briefing that “millions of people will be positively affected” by the rules. “This puts forward a national standard for the first time and will have broad impact,” he said.

Some 88 million people will be in nongrandfathered plans by 2013, of which about 34 million will be women ages 18 to 64, he said. “New plans are being created all the time,” Koh said.

The administration also released an amendment allowing religious institutions that offer insurance to their employees the choice of whether to cover contraception. HHS said this provision is based on “the most common accommodation for churches available in the majority [18] of the 28 states” that already require insurance companies to cover contraception. The agency asked for comments on this provision.

Sebelius said the guidelines “reflect common sense,” and they bring “fairness to the health insurance market for women.” Birth control is the most common drug prescribed to women ages 18 to 44, she said. Not covering it “would be like not covering flu shots or any of the other basic preventive services that millions of Americans count on every day.”

Women have unique medical needs, and are more likely than men to suffer from some serious illnesses, such as diabetes, Koh said. On average, women need to use more preventive services than men, yet women typically earn lower incomes than men and are often less able to pay, he said. As a result, they are more likely to forgo some services because of cost, he said.

Plans may use reasonable medical management to help define the nature of the covered service, and plans have the flexibility to control costs and promote efficiency by such methods as imposing cost-sharing payments for branded drugs if a generic version is available and safe, HHS said.

Small Increase in Premiums

Mayra Alvarez, director of public health policy in HHS's Office of Health Reform, said during the briefing that HHS believes the rules will result in a “very small increase” in premiums since most employer plans already cover the services.

But America's Health Insurance Plans, which represents about 1,300 insurers covering about 200 million people, issued a statement from President and Chief Executive Officer Karen Ignagni saying that the preventive care coverage recommendations “would increase the number of unnecessary physician office visits and raise the cost of coverage.”

While Koh said that the IOM recommendations adopted in the interim final rule are based “on the best available science and data,” Ignagni said the IOM recommendations “would broaden the scope of mandated preventive services beyond existing evidence-based guidelines, suspend current cost-sharing arrangements for certain services, and encourage consumers to obtain a prescription for routine supplies that are currently purchased over the counter. Exceeding current evidence-based guidelines sets a troubling precedent for the IOM's future coverage recommendations, including the essential health benefits that will significantly impact the affordability of coverage and the cost to taxpayers.”

Under PPACA HHS is to release rules later this year on “essential health benefits” that health insurers must cover.

Consumer Groups Applaud Rule

Health care consumer groups applauded the interim final rule. “Investing in these essential services makes good health and economic sense,” Families USA Executive Director Ron Pollack said in a statement.

But Debra Ness, president of the National Partnership for Women & Families, said in a statement that, while the group supports much of the interim final rule, it is “disappointed that the administration is considering a refusal clause that would allow some employers to refuse to provide their employees with coverage for contraception.” The clause is “unnecessary and potentially harmful,” and was not recommended by the IOM, she said.

Both Koh and Alvarez indicated that the administration hopes to make preventive care coverage more uniform for private as well as public health plans. The women's preventive interim final rule pertains to new commercial plans, “but we are working very hard to improve prevention throughout the country regardless of the source of insurance,” Koh said, noting that some PPACA prevention provisions affect both Medicare and Medicaid. “We are moving steadily toward creating a true system of prevention for the country,” he said.

The interim final rule issued by CMS, EBSA and the IRS is at

The IRS proposed rule is at

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