Under HHS guidelines released Aug. 1, new private health plans must cover contraceptives without cost-sharing starting in the first benefit year that follows Aug. 1, 2012. However, insurers will be allowed to charge members cost-sharing for branded contraceptives when generic versions are available.

The guidelines for women's preventive health services were developed by the HHS Health Resources and Services Administration based on recommendations from an Institute of Medicine expert panel. IoM released its recommendations in mid-July. HHS has authority under the Affordable Care Act to regulate women's preventive health services in health plans.

The guidelines cover all FDA-approved contraceptive methods, sterilization procedures, and patient education and counseling. They also cover emergency contraceptives, including Teva's Plan B One-Step (levonorgestrel in a single dose) and Watson's Next Choice, a generic form of the original two-dose Plan B product. However, the OTCs must be obtained with a doctor's prescription to be eligible for waived cost-sharing, HHS officials said during a media call.

The guidelines do not cover abortifacient drugs. Most employer-sponsored plans already cover contraceptives, HHS notes.

The guidelines expand the range of preventive services that non-grandfathered plans must cover without cost-sharing under an interim final rule released by HHS in July 2010 (Also see "Adult Vaccines Stand To Gain From Preventive Care Rule, Outreach Is Next" - Pink Sheet, 19 July, 2010.). The cost sharing requirement bars copays, coinsurance and deductibles.

"Reasonable Medical Management"

However, the rule allows plans to use "reasonable medical management to help define the nature of the covered service" as it pertains to women's preventive services, HHS states. As a result, "plans will retain the flexibility to control costs and promote efficient delivery of care by, for example, continuing to charge cost sharing for branded drugs if a generic version is available and just as effective and safe."

The leading product in the category, Warner-Chilcott's Loestrin 24 FE (norgestimate and ethinel estradiol), is still patent-protected and so would be available without cost-sharing in new plans. According to data from IMS Health, Loestrin 24 FE held a 10% share of the oral contraceptive category in 2010 in terms of prescriptions and recorded sales of $553.5 million.

The preventive care rule applies to new plans, exempting from the coverage requirement those plans already in existence when the Affordable Care Act was enacted in March 2010. However, it would apply to those older plans if they change materially, such as by eliminating certain benefits, or substantially increasing copays, deductibles or other costs of coverage to consumers.

The grandfather provision has delayed the health plan industry's implementation of the preventive care rule to an extent. However, HHS projects that 34 million women will be enrolled in non-grandfathered plans by 2013, HHS Assistant Secretary for Health Howard Koh said during the call.

Explaining its rationale for including contraceptives among the preventive services for women, HHS stated in its announcement that "family planning services are an essential preventive service for women and critical to appropriately spacing and ensuring intended pregnancies, which results in improved maternal health and better birth outcomes."

The other preventive services included in the guidelines are: well-woman visits, gestational diabetes screening, human papillomavirus DNA testing for women ages 30 and older, counseling for sexually transmitted infections, counseling and screening for HIV, breastfeeding support, supplies and counseling and domestic violence screening.

Health Insurers Raise Concerns

In a statement, America's Health Insurance Plans raised concerns with the guidelines, arguing they "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."

Furthermore, AHIP maintains that "exceeding current evidence-based guidelines sets a troubling precedent for the IoM's future coverage recommendations, including essential health benefits that will significantly impact the affordability of coverage and the cost to taxpayers." IoM is developing recommendations on how HHS should approach developing the package of "essential benefits" that would be mandatory in health plans eligible to participate in the state-based insurance exchanges beginning in 2014 (Also see "HHS Description Of Drug Coverage In Exchange Plans Likely To Be Broad, Flexible - Report" - Pink Sheet, 20 May, 2011.).

Despite predictions that plans will increase member premiums to offset the cost of the new preventive care coverage requirements, HHS' Koh maintained that premiums are not expected to increase more than "minimally."

A Conscience Clause For Some Plans

In a separate interim final rule also announced Aug. 1, HHS recognizes that health plans with religious affiliations may object to the requirement that they cover contraceptives.

Based on feedback from "several" commenters, the department says it has sought to "provide for a religious accommodation that respects the unique relationship between a house of worship and its employees in ministerial positions."

Specifically, HHS will provide HRSA with "additional discretion to exempt certain religious employers from the guidelines where contraceptive services are concerned." The exemption could apply only to group health plans sponsored by certain religious employers and group health insurance offered in connection with such plans, HHS explains. Health insurance issuers in the individual market would not be eligible.

This process is modeled on the most common exemption available in the 28 states that already requires insurance companies to cover contraception. The interim rule is effective immediately but will be subject to a 60-day comment period.

-Cathy Kelly (c.kelly@elsevier.com)

Contraceptives Covered Without Cost-Sharing In HHS Prevention Rule

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