INSURANCE COVERAGE OF PRESCRIPTION CONTRACEPTIVES

Robyn E. Zolman

April 23, 2002

Class of 2002

INSURANCE COVERAGE OF PRESCRIPTION CONTRACEPTIVES

TABLE OF CONTENTS

INSURANCE COVERAGE OF PRESCRIPTION CONTRACEPTIVES

ABSTRACT

Since the FDA approved the first oral contraceptive in the 1960s, prescription contraceptives have become a major part of women’s health care. Yet even though contraceptives are central to women’s health, most insurers refuse to include coverage for prescription contraceptives in their prescription drug plans. This paper explains why contraceptives are vital to women’s health, and why the refusal to include this coverage in health insurance plans has a discriminatory effect on women. It then describes the developments in the recent movement to mandate that all health plans include prescription contraceptive coverage, detailing the progress that has been made through legislative lobbying in the state legislatures and in Congress, and through litigation in the federal courts. This description emphasizes how the reforms effected on these various government levels interact, and how success on all three levels is necessary to ensure a truly comprehensive national mandate of prescription contraceptive coverage. It also discusses the impact of the movements to switch oral contraceptives to over-the-counter status and to institute a no-fault liability scheme to address products liability suits against contraceptive manufacturers on the contraceptive coverage movement. It concludes that while the contraceptive coverage movement has seen remarkable success, there is much work to be done, and recommends a primary focus on litigation as the most promising strategy for achieving sweeping reform.

INTRODUCTION

Contraception is an extremely important issue for all women. Women are fertile for about half of their lives, and a woman who desires only two children will need contraception for more than twenty years. [1] If contraceptives are not covered by insurance, women will spend between $7000 and $10,000 on contraceptives during their lifetimes.[2] Studies have found that this cost is one of the main reasons that women do not use birth control. [3] The failure to use birth control contributes to the fact that approximately half of the pregnancies in the United States each year are accidental — a majority of unintended pregnancies occur in women who do not use any birth control method. [4] Cost also plays a role in causing unintended pregnancies because the most effective contraceptive methods require a prescription and treatment by a physician, making them more costly to obtain and to use than the less effective over-the-counter methods. [5]

Troubled by these statistics, women’s groups have long pressed the government to mandate the coverage of prescription contraceptives by insurance companies and employers, and have urged courts to recognize that the refusal to cover contraceptives is discriminatory. Such efforts met with no real success until 1998, when the Food and Drug Administration (FDA) approved the drug Viagra, an oral treatment for male impotence. [6] Doctors wrote 270,000 prescriptions for Viagra within the first month, and soon thereafter about half of the country’s insurers announced that they would cover the costs of the drug.[7] This number is greater than the percentage of insurers that cover prescription contraceptives, and activists seized on the coverage of Viagra to illustrate that the exclusion of prescription contraceptive coverage is discriminatory and unfair. Coverage for Viagra sparked this surge in activism because Viagra can be seen as a “quality of life” drug, rather than one that is medically necessary. Insurers most commonly deny prescription contraceptive coverage by characterizing contraceptives as not medically necessary but instead promoting quality of life, and activists characterized insurers’ willingness to provide coverage for one “quality of life” drug and not the other as clearly discriminatory.[8] Activists emphasize that the first contraceptive pill was submitted to the FDA for approval in 1960, and that most women have paid for their own prescription contraceptives for around forty years.[9] In fact, oral contraceptives, the most commonly used prescription contraceptive, are the only class of FDA-approved prescriptions that is routinely excluded from insurance coverage.[10] As a result, women pay sixty-eight percent more in out-of-pocket medical costs than men do.[11] In 1998 Maryland responded to these arguments and was the first state to pass legislation that requires health insurance plans that provide coverage for prescription drugs to also cover any FDA-approved contraceptive drug or device. [12] As of March, 2002, fifteen other states had followed, passing laws or regulations that require equitable prescription contraceptive coverage in the private market.[13]

On the federal level, the response has been mixed. The federal legislative changes have been much less substantial than those in the state legislatures. In each year since 1997 sponsors have reintroduced the Equity in Prescription Insurance and Contraceptive Coverage Act (EPICC),[14] but it has been stalled in committee. EPICC would amend the Employee Retirement Income Security Act of 1974 (ERISA)[15] by requiring private health insurers that cover prescription drugs to also cover prescription contraceptives. A recent federal district court decision does mark substantial progress on the federal judicial level, however. In Erickson v. Bartell Drug Co. ,[16] a case of first impression, the court held that an employer’s failure to cover prescription contraceptives in its health plan that covers other prescription drugs is sex discrimination in violation of the Pregnancy Discrimination Act (PDA), which amended Title VII of the Civil Rights Act of 1964.[17] The application of an employment law antidiscrimination statute to an employer’s self-funded insurance plan was a novel argument raised against these discriminatory insurance practices, and the court’s decision was the most substantial victory yet for proponents of contraceptive coverage.

This paper traces the recent developments in the debate over the coverage of prescription contraceptives. Part I provides a background description of the different types of prescription contraceptives and the importance of contraceptive coverage. It then describes the current system for regulating insurance in the United States. Part II describes developments on the state level to address contraceptive coverage, illustrating the diversity in opinions throughout the states as to whether such coverage should be mandated and the variation in the different statutes enacted. Part III describes the steps taken at the federal level in Congress to mandate prescription contraceptive coverage. Part IV discusses the successful use of Title VII, an employment law antidiscrimination provision, to mandate insurance coverage, and the potential use of other civil rights laws to mandate coverage in circumstances not covered by Title VII. Part V discusses two additional reform movements related to prescription contraceptives: the movement to switch oral contraceptives to over-the-counter status and the movement seeking to address the impact of products liability litigation on contraceptive research and development by enacting a no-fault liability statute, and illustrates how these two additional movements interact with the movement to mandate insurance coverage of contraceptives. The paper then concludes with the observation that while the challenges to achieving prescription contraceptive coverage are great, and the current state of affairs leaves much to be accomplished, important progress has been made to ensure gender equity in health care coverage. The conclusion synthesizes the various strategies explored throughout the paper and suggests which are the most promising and the most powerful, and identifies what other steps may be taken in the interim as the long term strategies of litigation and legislative lobbying slowly produce results.

I. BACKGROUND

To lay a foundation for the discussions in the remainder of this paper, this section explores three different background issues necessary for understanding the arguments for and against prescription contraceptive coverage and the responses of legislatures and judges to claims for equal coverage. The first is an overview of the various types of prescription contraceptives, as well as their cost, effectiveness, and the frequency with which they are included in insurance plans. This description illustrates why prescription contraceptives are more desirable than over-the-counter methods, despite their higher cost. The second background topic addressed is the need for and feasibility of insurance coverage of prescription contraceptives. Underlying each of the statutes passed or bills proposed in the states and in Congress, and the judicial and agency decisions on contraceptive coverage, is a common set of statistics that illustrates why prescription contraceptives are necessary for women, their families, and for society. These statistics focus on the economic, social, and personal cost of unintended pregnancy. The feasibility of insurance coverage of contraceptives is also important background information because the prohibitive cost is uniformly asserted as the primary argument against legislative, administrative, or judicial decisions to mandate contraceptive coverage. Finally, this section discusses the current system for regulating insurance in the United States. This discussion is necessary to understand why state legislation alone is not sufficient to reach all health insurance plans, why judicial decisions in this area have been so powerful, and why ultimately Congressional action is necessary to ensure that all women have coverage for prescription contraceptives.

A. An Overview of Prescription Contraceptives

1. The Five Traditional Prescription Contraceptives . — When activists, legislatures, and courts use the term “prescription contraceptives,” they are generally referring to five different birth control methods: oral contraceptives, the intrauterine device (IUD), the diaphragm, Norplant, and Depo-Provera. Each of these contraceptive methods has a greater cost than nonprescription over-the-counter methods, such as condoms, foam, and spermicidal jellies, but they are much more effective at preventing pregnancy.[18] It is important to note preliminarily that the cost of prescription contraceptives, while a substantial burden on women who must pay for them out-of-pocket, has not skyrocketed as have prescription drug costs generally. In fact, contraceptive manufacturers are subject to considerable price pressure precisely because so many women pay for their contraceptives out-of-pocket. [19] Furthermore, the number of alternative prescription contraceptives available to women and the lower cost of generics available after patents have expired also play a role in controlling the rise of prescription contraceptive costs.[20] Even if these costs have not risen dramatically in recent years, however, the fact that women must pay out-of-pocket for prescription contraceptives is clearly an inequality in health care coverage and imposes a barrier to obtaining the most effective varieties of contraceptives.

Oral contraceptives are the most common prescription contraceptive in the United States, used by 27% of female contraceptive users. [21] They are between 97% and 99.9% effective when used properly, and cost between fifteen and twenty-five dollars per month, with an additional fee for an examination prior to use.[22] Only 33% of private insurance plans provide coverage for oral contraceptives, while 84% of health maintenance organizations (HMOs) provide coverage.[23] Yet even these statistics may be misleading, because coverage of oral contraceptives does not mean that all types of oral contraceptives are covered.[24] There are three main varieties of oral contraceptives, monophasic, biphasic, and triphasic, and the monophasic variety comes in four different dosage levels. [25] Naturally, one of these varieties may work better for individual women than another. [26] Many insurance plans that do cover prescription contraceptives do not cover each of the three varieties and the four different dosage levels within the monophasic variety, meaning that if a woman desires a specific type of oral contraceptive that her insurance does not cover, she may still be forced to pay for her own prescription costs.[27]

The IUD, which is a small device inserted into the uterus, is 97% to 99.2% effective and can remain in place for up to eight years.[28] At a cost of between 150 and 300 dollars not including the exam, it is one of the cheapest forms of contraception.[29] Still, 75% of indemnity insurers and preferred provider organizations (PPOs) do not cover the IUD.[30] After a number of highly publicized products liability lawsuits involving IUDs such as the Dalkon Shield and the Copper-7, however, the IUD is relatively uncommon in the United States, and manufacturers have removed all but one IUD from the market in response to these lawsuits. [31]

The diaphragm is a latex cup inserted into the vagina prior to intercourse. It is 82% to 94% effective, and can last for several years.[32] Diaphragms cost between thirteen and twenty-five dollars, not including the cost of the exam prior to use.[33] Between 19% and 21% of private insurers cover the diaphragm, and 81% of HMOs do so.[34]

Norplant, available since FDA approval in 1991, involves the insertion of six capsules under the skin of the upper arm and can last for five years with a 99.6% effectiveness.[35] It costs between 500 to 600 dollars for examination and insertion, and 100 to 200 dollars for removal.[36] Coverage for Norplant is also excluded by three-quarters of indemnity insurers and PPOs.[37] Norplant was also subject to immense products liability litigation after its introduction, and in 1999 American Home Products, its manufacturer, settled with 36,000 plaintiffs for fifty million dollars. [38] But despite the amount of products liability litigation, its manufacturer and the FDA still maintain that Norplant has been subject to extensive testing and is safe for use.[39]

Finally, Depo Provera, approved by the FDA in 1992, is a shot given by a physician every three months with 99.7% effectiveness.[40] It costs between thirty and seventy-five dollars per injection, not including the cost of the exam, and has been similarly excluded from insurance coverage.[41]

When the statistics on the current insurance coverage of each individual contraceptive method are aggregated, only fifteen percent of indemnity plans cover all of these five contraceptives, and forty-nine percent cover none of them. HMOs provide better coverage, with eighty-four percent covering oral contraceptives and fifty percent covering all of the five main types of contraceptives.[42] Clearly, however, comprehensive coverage for prescription contraceptives is still far from universal.

2. Newly Developed Prescription Contraceptives . — The five methods discussed above are the standard prescription contraceptives and have been for some time, in part because new contraceptive research and development has been quite low in the United States. A National Academy of Sciences report estimates that the United States has fallen a decade behind Europe in contraceptive development, [43] with only two United States manufacturers engaged in any contraceptive research and development.[44] As will be discussed in Part V, the high amount of products liability litigation in the United States has been identified as the primary reason for the absence of research and development activity.[45] The possibility of litigation makes the introduction of new contraceptive products risky and unattractive to manufacturers relative to pursuing the development of other pharmaceuticals.[46]

In the last two years, however, the FDA approved three additional types of contraceptives. These new contraceptives give women more options from which to select a method that fits their specific lifestyles, and this may allow women who are unable for health or personal reasons to use the current prescription methods to gain the higher effectiveness of prescription contraceptives. As a result, even more women will be likely to use prescription contraceptives rather than over-the-counter methods. If consistent with current practice the majority of insurance companies will not cover these new contraceptives, leaving even more women spending more of their own money to obtain prescription contraceptives.

The first of the new contraceptives approved by the FDA was Lunelle. Approved in October 2000, it is an injection similar to Depo-Provera that is given by a healthcare provider once a month. [47] It costs between thirty and thirty-seven dollars per injection, and is 99% effective.[48] In October 2001, the FDA approved NuvaRing, a ring that is inserted in the vagina monthly and releases contraceptive hormones.[49] It is anticipated to be widely available by mid-2002. NuvaRing is 98% to 99% effective, and its cost is comparable to that of oral contraceptives.[50] In late November 2001, the FDA approved Ortho Evra, a small square patch that releases hormones when applied to the body.[51] The patch must be changed once a week for three weeks, is 98% to 99% effective, and is excepted to cost as much as oral contraceptives. [52] Ortho Evra is also anticipated to be widely available in 2002.

The development of these new methods is an important step that is likely to increase women’s access to effective contraceptives that meet their individual needs. But as more women become increasingly reliant on prescription contraceptives, insurance coverage for contraceptives becomes even more important.

3. The Impact of Generics on the Cost of Contraceptive Coverage . — After a patent has expired on a drug, another pharmaceutical company can manufacture a generic equivalent of the name-brand drug.[53] The generic manufacturer must demonstrate to the FDA that the generic drug is pharmaceutically equivalent, meaning that it contains the same active ingredient, requires the same dosage and administration, and is of the same strength and concentration.[54] The manufacturer must also conduct bioequivalence studies showing no significant difference in the rate and extent of absorption. [55]

Currently, oral contraceptives are the only prescription contraceptive drugs that offer generic equivalents; the patents for Depo Provera and Lunelle injections have not yet expired.[56] But even within oral contraceptives, many newer patents have not yet expired. A recent survey indicates that there are thirteen commonly available oral contraceptives with generic equivalents, and ten without. [57] There are, however, a number of oral contraceptive patents expiring in 2002, [58] which should lead to more generic options. Generic manufacturers are anxious to enter the market because they can quickly capture a large portion of the brand-name drug’s market share, yielding substantial profit.[59] Furthermore, products liability has not been a strong factor discouraging the entry of generic manufacturers of oral contraceptives into the market.[60]

At a cost of between twelve and fifteen dollars a month, [61] generic oral contraceptives provide a small monthly savings in contraceptive coverage costs and a substantial savings of between thirty-six and 120 dollars on an annual basis. The availability of generic substitutes also plays a role in controlling the cost of brand-name oral contraceptives, because brand-name manufacturers must keep their prices low to stay competitive. [62] And even if a particular brand-name oral contraceptive is protected by patent and thus has no generic substitute, other oral contraceptives within the same variety will have generic substitutes, giving an incentive to switch to a generic substitute for a similar contraceptive if the price of the brand-name contraceptive is too high. The availability of generic substitutes for many oral contraceptive varieties thus helps to lessen the burden on women who must pay for their own contraceptive coverage. Yet it similarly reduces the cost of prescription contraceptive coverage for insurers as well. Thus, even though the availability of generic substitutes may control the cost of oral contraceptives, the fact that women must cover the cost themselves still imposes a significant burden on women and increases their out-of-pocket health care costs above those of men.

The availability of generic contraceptives also impacts the extent of coverage offered by insurers who do include prescription contraceptives in their health plans. Most insurers require the substitution of generic contraceptives when available, or charge a higher copayment for name-brand contraceptives equal to the generic copayment plus the difference in cost between the generic and brand-name contraceptive. [63] Furthermore, some insurers will only cover generic contraceptives, excluding brand-name contraceptives regardless of whether a generic substitute is available. [64] As patents continue to expire this will be less of a problem, but currently there is only a generic substitute for one of the six triphasic varieties,[65] making coverage for triphasic contraceptives quite limited if insurers impose generic-only rules. As discussed above, each specific type of oral contraceptive differs from the others, and not all of them are appropriate for all women.[66] The limited coverage actually offered by many insurers who state that they cover prescription contraceptives illustrates that even with thirty-three percent of private insurance plans and eighty-four percent of HMOs providing coverage, a number of women who use those insurance providers may still find themselves covering their own contraceptives. [67] Thus, while the availability of generic contraceptives helps reduce the cost to women who must pay for them out-of-pocket, generic availability also can limit the breadth of coverage provided by insurers who do cover prescription contraceptives.

B. The Importance and Feasibility of Prescription Contraceptive Coverage

Access to contraception is important to the health and well-being of women and families. If women cannot afford effective prescription contraceptives, they are likely to use less effective or appropriate methods or to not use any contraception at all, both of which increase the risk of unintended pregnancy. The costs of unintended pregnancy are well-documented, and include “a litany of physical, emotional, economic, and social consequences.” [68] Women with unintended pregnancies are less likely to obtain prenatal care, more likely to engage in unhealthy activities, more likely to deliver unhealthy babies, and more likely to have abortions.[69] Unintended pregnancies also impose substantial unanticipated financial burdens, especially if the newborn is unhealthy. Additionally, unintended pregnancies have social and economic costs for women, as they interfere with their ability to participate in and contribute to “the marketplace and the world of ideas.” [70]

As unintended pregnancies are highly problematic for the women who endure them and for society as a whole, it is important to reduce them by increasing prescription contraceptive coverage. It is also economically feasible to do so. One of the most commonly asserted arguments against mandating insurance coverage for contraceptives is that given the number of women who use prescription contraceptives and the length of time for which they use them, the cost would be prohibitive, particularly for small businesses. However, it is estimated that this coverage would cost $21.40 per employee per year, $17.12 paid by the employer and $4.38 paid by the employee.[71] This is substantially less than the cost of covering Viagra, which is estimated to cost between 100 and 300 dollars per month per employee.[72] It also provides substantial savings for a woman who would currently pay between 175 and 300 dollars for oral contraceptives each year.[73]

Adding contraceptive coverage to health plans would also lead to a great potential cost savings for insurers. Insurers bear the costs of prenatal care and delivery for unintended pregnancies, which are estimated to be ten times the cost of covering a year’s worth of contraceptives. [74] The coverage of these expenses is nearly universal — between ninety-seven and ninety-eight percent of indemnity plans and HMOs cover childbirth and related expenses.[75] Unintended pregnancies are also much more likely to result in low birth weight babies, and the costs of covering such deliveries and follow-up care for the first year of life average between 14,000 and 30,000 dollars.[76] Additionally, two-thirds of indemnity insurers and ninety percent of HMOs cover the cost of abortion, and almost half of the unintended pregnancies each year end in abortion. [77] Abortion costs range from 140 to 1700 dollars, also substantially more than the cost of covering contraceptives.[78] Consistent with these statistics, an American Journal of Public Health study concluded that contraceptive coverage would pay for itself. [79]

There are other opportunities for cost savings associated with prescription contraceptive coverage as well. As described above, each of the prescription contraceptive methods requires an examination by a physician before the prescription is given. Many women who cannot afford prescription contraceptives similarly cannot afford these examinations, and thus lose the opportunities for the early detection of many different diseases that such examinations provide.[80] The physical examination required to obtain prescription contraceptives generally includes a Pap smear to screen for cervical cancer, a breast exam and breast self-examination instructions, blood pressure tests, and tests for sexually transmitted diseases (STDs), as well as counseling for STD and AIDS risk factors.[81] Early detection and early intervention are critical to effective treatment of these diseases, and they can provide great savings in future medical costs.

Although there are clearly costs associated with mandating coverage of prescription contraceptives, the benefits are substantial and extend beyond the women who receive the prescription coverage. All of society bears the costs of unintended pregnancies, and as a cost-effective method of reducing these costs, mandating coverage of contraceptives must be seriously considered.

C. The Regulation of Insurance in the United States

Insurance plans are subject to different sources of regulation depending on the specific type of plan. As a result, no single mandate will guarantee that every insured woman will have access to prescription contraceptive coverage.[82] ERISA is a broad federal statute that regulates all aspects of health plans that are “established or maintained by employers engaged in commerce or by employee organizations.” [83] In other words, it applies to employers with self-funded insurance plans. Such plans may be fully self-insured, whereby employers contract with conventional insurers or administrators to process claims, or may be partially self-insured, whereby employers contract with conventional insurers both to process claims and to insure against very large claims.[84] ERISA does not require employee benefit plans to provide specific benefits. [85] It does, however, preempt any state mandates imposed on self-funded insurance plans, while state mandates regarding the health care benefits of non-self funded insurance policies are not preempted. [86]

This preemption structure is accomplished in the statute through two separate exemptions. ERISA first provides that the “law[s] of any State which regulate[] insurance, banking, or securities”[87] are exempted from ERISA preemption of state law. It then provides that self-insured benefit plans are exempt from the State regulation of insurance exemption, stating that a self-insuring employer is not “deemed to be an insurance company”[88] for purposes of the statute. Congress took this approach in ERISA in part because even though insurance is considered part of interstate commerce, Congress has traditionally deferred regulation of insurance to the states.[89] As a result of this deferral, state laws regulating insurance predated ERISA, and Congress did not want to disrupt this system when it enacted ERISA.[90] However, Congress also wanted to protect employers from conflicting state and federal laws regarding their benefit plans, and thus exempted employers’ self-funded benefit plans from state insurance regulations. [91]

The majority of Americans have health insurance subject to ERISA,[92] meaning that the state regulations mandating coverage for prescription contraceptives are inapplicable to them. Indeed, self-insuring is one of the major trends in private health insurance precisely because it allows employers to avoid state regulation.[93] Self-insuring is also attractive because damages under ERISA for denial of benefits are limited to specific performance, rather than the full range of contract remedies and punitive damages that may be available under state law.[94] Therefore, for a truly comprehensive mandate of prescription contraceptive coverage, state laws are needed to reach traditional insurance plans, and a Congressional amendment of ERISA is needed to reach employer-funded plans.

Judicial construction of Title VII and the PDA provides an alternative to Congressional amendment of ERISA that is almost equally effective. ERISA explicitly provides that it does not preempt federal law,[95] and hence other federal antidiscrimination provisions may be used to require employers with self-funded plans to provide coverage.[96] Title VII applies to all employers with over fifteen employees,[97] capturing all but the smallest businesses, and prevents discrimination in the terms or conditions of employment on the basis of sex. The PDA explains that “sex” includes “on the basis of pregnancy, childbirth, or related medical conditions.”[98] The federal district court ruling in Erickson , which found that an employer violated Title VII because its self-funded benefit program excluded prescription contraceptive coverage but covered all other prescriptions,[99] is a highly encouraging step in the direction of judicially mandated coverage that closes the self-funding loophole that allowed employers to avoid covering prescription contraceptives. The Erickson case and other opportunities for the judiciary to take action in the face of Congressional hesitation are discussed later in this paper.

The nature of our insurance regulation system makes the campaign for equality in insurance coverage necessarily a multi-faceted one. But as the following Parts will show, each of the different governmental players has shown a willingness to consider the issue. As the momentum behind the movement continues to build, it is likely that the favorable actions taken by the more willing government branches will encourage those that are more hesitant to follow.

II. MANDATED COVERAGE AT THE STATE LEVEL

Activists working to achieve equity in prescription coverage achieved their first and most widespread success on the state level. In 1998, Maryland was the first state to enact a law mandating contraceptive coverage. Since that time, many states have followed with laws or regulations addressing contraceptive coverage for state employees and in the private insurance market. Each state has taken a different combination of steps toward coverage, but the movement has been decidedly in the direction of greater coverage, with increasing numbers of bills introduced and statutes passed each year. This Part will summarize the different approaches taken in the states, identifying which are the most beneficial and effective and which provide much more limited coverage. It will consider both statutes and regulations relating first to public employees and then to private insurance. It will conclude with a discussion of conscience clauses, which are frequently inserted in state statutes and provide an exception for religious insurers and employers who are opposed to contraception.

A. Contraceptive Coverage for Public Employees

Generally speaking, public employee health plans are more likely to cover prescription contraceptives than private insurance plans.[100] As will be discussed in Part III, Congress has recently mandated that federal employee health plans cover all FDA-approved prescription contraceptives. On the state level, thirty-nine states require some level of coverage.[101] There is a great variation in the comprehensiveness of coverage in these thirty-nine states, however, and few provide truly comprehensive coverage similar to that provided on the federal level. But this number is still encouraging, especially given that only ten states mandated any type of coverage for state employees in 1999.[102]

States mandate coverage in a variety of different ways and at various levels of comprehensiveness. Thirteen states provide the most secure and comprehensive coverage for state employees, in the form of a statute mandating that all state employee health plans that provide prescription coverage also cover each of the FDA-approved prescription contraceptives.[103] Six other states require their state employee health plans to cover all prescription contraceptives, but do so by state policy rather than by statute.[104] While state statutes are generally preferable to state policies because they are more difficult to change and are thus less likely to change over time, the fact that a total of nineteen states mandate comprehensive coverage illustrates the success of the movement toward more equitable health care coverage.

Twenty states require at least some coverage for contraception in at least some of the state employee insurance plans. California is the only state that requires partial coverage for prescription contraceptives by statute. Its statute requires that each of the state employee health care plans that covers prescription drugs must also cover “a variety of” FDA-approved prescription contraceptives, but the statute does not mandate coverage of all of these methods.[105]

The rest of the states that mandate partial contraceptive coverage do so by a number of other, non-statutory methods. Coverage of oral contraceptives only is now required in Alabama not as the result of a state statute, but after a state Employee Insurance Board decision.[106] Other states have state policies that specifically require coverage of contraceptives. These policies also vary greatly in the comprehensiveness of the coverage they require. For example, the Arkansas State and Public School Employees Life and Health Insurance Board policy requires coverage of oral contraceptives only, [107] while the state policy in Massachusetts requires coverage of all contraceptive drugs and devices. [108] Many other states have policies that fall somewhere in-between, mandating that only some insurers provide comprehensive coverage, that all insurers provide less-than-comprehensive coverage, or some combination of the two. [109] As an additional variation, in some states with policies mandating less than full prescription contraceptive coverage the state health plans voluntarily provide coverage beyond the state policy requirements, giving women more options than the state requires them to have.[110] While this is beneficial to the women who receive the additional coverage, it is not necessarily as likely to remain consistent as it would be if comprehensive coverage were mandated by state policy or statute.

The rest of the states do not have any contraceptive coverage mandate, whether by statute, Board decision, or policy. In these states prescription contraceptives are generally at least partially covered by state benefit plans, however. Arizona does not have a statute or official policy mandating coverage, but does have state guidelines for prospective health plans that recommend coverage. [111] These guidelines are a weaker mandate than even the Board decisions or policies of other states, despite the fact that they have led state insurance plans to include the recommended coverage. Also, some states have employee health plans that include contraceptive coverage even though no state law, policy, or guidelines mandate coverage. Two of these state insurance plans voluntarily provide comprehensive coverage of all FDA-approved contraceptives, but most provide only partial coverage.[112] While the women who are state employees benefit from this voluntary coverage, it is not very protective because state health insurance plans are contracts that are periodically renewed, so at any renewal date the prescription contraceptive coverage could be removed from the plan.[113] Thus, the fact that state employees already receive such coverage is not a valid reason to avoid passing a statute or at least implementing a state policy mandating that the coverage continue.

Although much progress has been made in this area, there are still some states that have not only failed to mandate or recommend that state employee health plans include contraceptive coverage, but that also do not have any state health plans that voluntarily cover contraceptives. Montana and North Dakota have no such requirements, and their state health plans currently provide coverage for oral contraceptives only if prescribed for medically necessary, non-contraceptive purposes.[114] Wyoming state health plans provide no coverage for any contraceptive under any circumstances.[115] While clearly the minority, these states still employ many women who are completely denied equitable health care coverage. Activists should target these states using the models of other states as an example of the feasibility of mandating this coverage.

B. Contraceptive Coverage Mandates for Private Insurance

Since 1998, fifteen states have passed statutes that require all insurers that cover prescription drugs and devices to cover prescription contraceptives as well. [116] Additionally, Washington has issued an administrative regulation mandating private insurance coverage for contraceptives and outpatient services.[117] Six other states have either laws, regulations, or policies that provide for some level of private insurance contraceptive coverage.[118] Given the number of bills introduced each year, it is likely that these numbers will continue to rise. In 2001, twenty-two states considered a total of fifty-five bills to provide private insurance coverage for contraceptives, and in 2000, twenty-five states and the District of Columbia also considered fifty-five total bills. NARAL predicts that in 2002 ten more states will seriously consider such legislation, with New York, Pennsylvania, and Wisconsin deemed likely to enact legislation. [119]

As discussed in the background section above, this state legislation requires insurers to provide prescription contraceptive coverage. It does not extend to employers who maintain their own benefit plans.[120] It is therefore important to remember that despite the great success of activists in lobbying for private insurance mandates at the state level, these mandates do not reach the many women whose employers have chosen to self-insure.

1. Mandates applicable to all state insurers . — The fifteen state statutes that have been enacted all require broad coverage of prescription contraceptives, but there is still a great deal of variation in the extensiveness of their mandates. Activists pressing for legislation in other states should be conscious of the subtle differences between the current statutes and the implications of those differences, and should push for the most comprehensive coverage in their lobbying efforts. The broadest statutes require coverage of all FDA-approved prescription contraceptive drugs and devices, as well as coverage of all related contraceptive services, so long as the insurer otherwise covers prescription drugs, devices, and outpatient services. These services generally include the appointment necessary to prescribe the contraceptive, and if necessary to insert the contraceptive as well. Additionally, these statutes explicitly forbid a number of actions by insurers, such as imposing different deductibles, copayments, or waiting periods than are imposed on other prescription drugs, denying eligibility for plan coverage because of current or potential future use of contraceptives, offering women financial benefits to take less comprehensive contraceptive coverage, penalizing a health care professional for prescribing contraceptives, or providing incentives to encourage health care professionals not to prescribe contraceptives.[121] These statutes are explicit as to coverage requirements and restrictions on insurers, which helps limit potential loopholes or gaps in coverage and clearly notifies insurers what is expected of them. As such, they are the ideal template to aid in constructing future state statutes.

The next level of comprehensiveness is illustrated by the Hawaii statute. It requires coverage of all FDA-approved prescription contraceptive drugs and devices and all contraceptive services, provided that the insurer normally provides such coverage outside of the contraceptive context.[122] It also requires that the insurers impose no unusual copayments and no waiting period.[123] Finally, with respect to oral contraceptives it specifically requires that insurers cover one brand from each of the three main varieties, with additional brands covered if deemed medically necessary for a particular individual.[124] This provision is unique to Hawaii law, and is very important because it recognizes that not all oral contraceptives are the same and ensures that a woman may obtain the specific type of oral contraceptive that best meets her needs.[125] Activists should also press for the inclusion of this provision in future state statutes.

A number of states have mandates that fall into a more intermediate category. Within this intermediate category, three statutes and the Washington regulation provide the most comprehensive mandate. They require that insurers who cover prescription drugs and outpatient services also cover all FDA-approved contraceptive drugs and devices, as well as all outpatient contraceptive services, and impose a requirement that there be no copayment or deductible greater than those normally imposed by the insurer.[126] While comprehensive in coverage, with the exception of the copayment restrictions these mandates are missing the explicit limitations on actions that insurers may take to limit women’s use of their contraceptive coverage. Three other states require simply that insurers cover all FDA-approved prescription contraceptive drugs, devices, and services if they normally provide such coverage, without imposing any deductible or copayment restrictions.[127] Slightly below this level, three more states mandate coverage of any FDA-approved contraceptive drug or device if the insurer normally provides such coverage, and prohibit insurers from imposing any unusual deductible or copayment.[128] These statutes do not cover contraceptive outpatient services, however, which is a significant omission because these services are quite costly and are required before an individual can obtain a prescription for a contraceptive.

At the lowest level of comprehensiveness, two states require coverage of any FDA-approved prescription contraceptive drug or device if the insurer provides prescription drug coverage generally, but do not require coverage of contraceptive outpatient services and do not impose any deductible or copayment restrictions.[129] They therefore do not include the valuable services coverage and also do not explicitly prohibit insurers from charging additional deductibles or otherwise discouraging women from seeking contraceptive coverage. Furthermore, allowing insurers to charge women additional deductibles would defeat one of the main purposes of requiring this coverage in the first place. The California statute, the least comprehensive of all the state statutes, requires coverage of “a variety” of prescription contraceptive methods, but leaves the determination of which methods to cover to the insurer.[130] It therefore does not guarantee that all FDA-approved prescription contraceptives will be covered. The statute does provide that if none of the covered methods are appropriate for an insured individual, another FDA-approved contraceptive shall be provided and covered,[131] but this exception still imposes a burden on the woman who desires to use a specific method not for medical reasons but because of personal preference. Additionally, the statute does not include coverage for contraceptive outpatient services, and does not restrict insurers from charging additional copayments or deductibles.

The variation seen within these statutes illustrates the many different methods a legislature can use to mandate prescription contraceptive coverage. It also shows the importance of careful and comprehensive wording. For example, a legislature may have failed to specify that the statute covers outpatient contraceptive services or to explicitly restrict insurers from imposing unusual deductibles because it had assumed such terms would be implied within the statute’s language. But when compared to other state statutes that did specify those particular aspects of coverage, it might find itself with what is in effect a less comprehensive statute than it had intended. When imposing a mandate that may be unpopular with many insurers who must operate under its terms, it is best to be as specific and comprehensive as possible, and activists should be conscious of this when lobbying other state legislatures in the future.

2. Less comprehensive state mandates . — Six other states have laws, regulations, or policies that mandate some level of private insurance contraceptive coverage, but are not widely applicable to all insurers. Instead, they each target one or a few specific types of insurance providers. Colorado regulations require that basic and standard health benefit plans, designed for employees of small employers, include coverage for contraception and contraceptive counseling. [132] Idaho state policy requires insurers of small employers to cover oral contraceptives, Norplant, Depo Provera, and IUDs.[133] It also recently eliminated a requirement that insurers in the individual market cover oral contraceptives.[134] A Kentucky statute and a New Jersey regulation both require insurers in the individual and small group markets to offer a plan that includes prescription contraceptive coverage. [135] Minnesota regulations require HMOs to provide comprehensive coverage including prescription drugs,[136] and it has interpreted these rules to include prescription contraceptives.[137] Oklahoma has similarly interpreted a regulation requiring HMOs to cover “preventative health services,” including “family planning services.”[138] Lastly, Virginia does not mandate any contraceptive coverage, but it does require insurers and HMOs that cover prescription drugs to offer and make available coverage for FDA-approved contraceptives at the option of the purchaser.[139] While clearly better than no coverage at all, these statutes and regulations are insufficient to provide women with equality in health care benefits.

C. Conscience Clauses

One important element of many state laws mandating contraceptive coverage is the “conscience” or “denial” clause. While the actual language and precise effect of these clauses differ in each state, they generally allow employers and insurers to refuse to provide contraceptive coverage if they oppose contraception on religious grounds.[140] To avoid ERISA preemption of state law related to employers’ self-funded benefit plans, these statutes only reach employers who do not self-insure. Currently, twelve of the sixteen state laws and regulations that require insurers to cover contraceptives include such provisions, allowing both employers and insurers that object to refuse to provide or pay for the coverage.[141] In addition, in 2001 twenty-three states considered bills that added conscience clauses to current state law.[142]

1. The Content of Conscience Clauses . — Conscience clauses differ greatly in their definition of religious employer. Some use a very broad definition, while others use a definition with strict limits. The particular definition matters greatly, because the larger the exemption, the more female employees may be denied coverage for their contraceptives despite the state mandate to the contrary. California’s statute, discussed in detail below, is a very narrow statute that is limited to religious employers who exist to inculcate religious values, primarily employ and serve those of the same religion, and who qualify under a specific religious provision of the Internal Revenue Code.[143] Connecticut, by contrast, has a denial clause that broadly defines religious employers as church-controlled or church-affiliated organizations whose religious beliefs oppose the use of contraceptives.[144] At the far extreme, states such as Maryland simply exempt “religious organizations” without any further definition or restriction.[145] The statutes are all consistent, however, in requiring that an insured must be given notice if the statutory exemption affects the coverage of her benefit plan.[146]

Additionally, the conscience clauses in California, Connecticut, Hawaii, North Carolina, and Maine provide an exception to the conscience clause that provides that no religious employer or insurer may deny coverage of contraceptives if they are prescribed for reasons other than contraception.[147] Activists lobby aggressively for the inclusion of these exceptions because in the case of oral contraceptives they have the potential to swallow the rule and to render the religious exemption meaningless. Oral contraceptives are known to provide many health benefits beyond contraception, including a reduction in ovarian cancer, benign cysts of the breasts and ovaries, pelvic inflammatory disease, and heavy, irregular, and painful menstruation.[148] Thus, cooperative health care professionals could prescribe oral contraceptives citing these valid non-contraceptive reasons to allow the employee of a religious employer to avoid the religious exemption. As oral contraceptives are the most commonly used prescription contraceptive,[149] the inclusion of these provisions does much to soften the impact of the religious exemption. It is important to note, however, that the states that included this exception to the exemption all fell into either the strictest or intermediate category of conscience clauses, meaning that their conscience clause statutes were already limited in scope. None of the states with the very broad conscience clauses have adopted this type of exception, and it is for these broad statutes that the exception would be the most useful.

Activists vigorously oppose conscience clauses as part of state contraceptive coverage mandates because they provide a loophole for employers and insurers to avoid complying with the state statutes and regulations.[150] As a result, they leave many women without the state-mandated coverage regardless of whether they personally hold religious beliefs that oppose contraception. When birth control is seen as a part of women’s basic health care, each woman should have the right to decide whether she will use prescription contraceptives without being influenced, financially or otherwise, by the religious views of her employer or insurer. If these clauses must be included for a legislature to consider passing a contraceptive equity statute, activists should urge the state legislatures to include exemptions with strict definitions and exceptions for non-contraceptive uses.

2. Legal Challenges to Limited Conscience Clauses . — A recent California Court of Appeal decision upholding the state’s contraceptive coverage mandate in the face of a constitutional challenge by a religious institution that did not meet California’s limited conscience clause exemption recognized many of these arguments against conscience clauses. The case was the first constitutional challenge to any state’s contraceptive statute.[151] While California still has a religious exemption, the court’s upholding of the statute and its narrow religious exemption is a great victory for the prescription contraceptive movement.

In Catholic Charities v. California ,[152] Catholic Charities, a public benefit corporation that provides social services to the poor and needy in society, alleged that the state statute’s limited religious exemption impermissibly burdens its religious beliefs and thus violates both the Free Exercise Clause and the Establishment Clause of the First Amendment.[153] The California statute requires employers who offer health insurance coverage that includes coverage for prescription drugs to also cover prescription contraceptives.[154] Catholic Charities provides prescription drug coverage to its employees, and is thus required by the California statute to provide contraceptive coverage.[155] It alleges that it cannot comply with the statute because contraception is “intrinsically evil and a grave sin” under the tents of Catholicism, and that it cannot facilitate, even financially, anyone engaging in that conduct.[156] But the Catholic faith also requires it to provide fair wages and benefits, including insurance coverage, so it is not able to comply with the statute by failing to provide any prescription coverage.[157]

California’s statute includes an exemption for religious employers whose religious beliefs oppose contraception, but it is limited to religious employers who meet four criteria: inculcation of religious values is the purpose of the entity, the entity primarily employs persons who share its religious tenets, the entity serves primarily persons who share its religious tenets, and the entity is a nonprofit organization under Section 6033(a)(2)(A)(i) or (iii) of the Internal Revenue Code, which exempts “churches, their integrated auxiliaries, conventions or associations of churches, and the exclusively religious activities of any religious order.”[158] While it is a religious employer, Catholic Charities did not meet any of these four criteria because it serves the general public and thus people of all faiths, it does not try to inculcate those it serves with its beliefs, its employees are seventy-four percent non-Catholic, and it is a Section 501(c)(3) organization, rather than one organized under Section 6033(a)(2)(A)(i) or (iii).[159]

Before addressing the specific First Amendment arguments raised to challenge the statute and its narrow religious exemption, the court provided a detailed description of California’s statutory scheme and its purpose. It approved the legislative findings that insurance practices that excluded contraceptive coverage were discriminatory because they excluded an essential part of a woman’s health care.[160] It also discussed the costs of unintended pregnancies and the need for contraception for women to “achieve and maintain economic and social parity and independence.”[161] Additionally, the court described how the conscience clause exemption was added at the request of various Catholic groups, and how the legislature carefully structured the exemption to be sufficiently narrow to avoid undermining its antidiscrimination and public welfare goals.[162]

The court then turned to the specific First Amendment arguments against the statue’s limited religious employer exemption. It found that the limited exemption did not violate the Free Exercise Clause because it is “an otherwise valid and constitutional law in an area in which the state is free to regulate, [and] is neutral and of general applicability.”[163] Under the Supreme Court’s decision in Employment Division v. Smith ,[164] such a law is not subject to strict scrutiny, and thus does not require that the state justify its statute by identifying a compelling government interest.[165] The court stated that the law is a neutral law of general application because it does not require all insurers to provide contraceptive coverage, but merely requires such coverage if coverage of other prescriptions is provided. The law also regulates insurance, which the states are free to regulate because Congress has deferred its power to regulate insurance as part of interstate commerce. The court also stated that the state’s interest in preserving the public health and eliminating gender discrimination were well-substantiated, legitimate purposes for enacting the statute.[166]

The court emphasized that if a law is neutral and generally applied, as the statute was in this case, then a religious exemption is not even required by the Free Exercise Clause.[167] It thus implied that the statute would be upheld without any religious exemption at all. In such a case, the court reasoned, the fact that a limited exemption was added could not violate the Free Exercise clause. The court then addressed the Establishment Clause argument by stating that just because the legislature agreed to accommodate the requests of concerned Catholic organizations in its statute does not mean that it violated the Establishment Clause, because the exemption is neutral toward all religions.[168] It therefore held that the fact that the statute has an incidental effect on the religious beliefs of Catholic Charities because it does not fit within the limited religious exemption does not render the statute invalid under the First Amendment.[169]

The Catholic Charities case is currently on review before the California Supreme Court,[170] and its decision in the case will have a profound effect on the future of conscience clauses both in California and elsewhere. As the first case to challenge any state statute relating to contraceptive coverage, it will be watched closely by activists, insurers, employers, legislatures, and courts nationwide. If the court upholds California’s limited religious exemption, it would be a strong endorsement of the constitutionality of strictly limited exemptions. Furthermore, the court in its dicta might even support the constitutionality of state statutes that do not provide any religious exemption at all.[171] None of the state statutes that mandate contraceptive coverage and do not include any religious exemption have been challenged thus far, and the California Supreme Court’s decision may impact whether such challenges are brought in the future. The Court of Appeal’s decision, with its detailed analysis of the reasons for strictly limiting any religious exemption, lays a strong foundation for the California Supreme Court to affirm.

In summary, the states as a whole have been incredibly responsive to women’s claims for equality in health care coverage. When the specific provisions are analyzed, however, it becomes clear that the steps taken by some states are much more comprehensive than those taken by others. Thus, there is still much more work to be done on the state level. Activists must fight to strengthen the currently existing mandates and tighten or eliminate any exceptions, and must also encourage those states that have not yet taken any significant action to do so, following the models of those states with the broadest mandates.

III. MANDATED COVERAGE AT THE CONGRESSIONAL LEVEL

There has been much more hostility to mandated coverage of prescription contraceptives in Congress than in the states as a whole, and initiatives to achieve federally mandated coverage have met with little success. Given the limited reach of the state mandates and their inapplicability to self-funded employer benefit plans, a federal mandate for insurance coverage is needed both to reach self-funded plans and to serve as a model to those states that have not yet passed their own mandates. Congress has, however, taken action to ensure prescription contraceptive coverage for low-income women and for federal employees. Those two actions will be discussed in turn, and this section will conclude with a discussion of the as yet unsuccessful attempts to pass a broad federal contraceptive coverage mandate.

A. Mandated Coverage For Low-Income Women

The federal government has taken a position strongly in favor of providing contraceptives to women in lower-income brackets, as seen in two different federal programs. The first program is Medicaid, which subsidizes the health care and contraceptive costs of sixteen percent of all women who are of reproductive age. [172] Medicaid is a joint federal-state initiative to provide low-income Americans with health care services in which participating states establish and administer a plan in compliance with federal guidelines. The states pay participating health care providers for services rendered and the federal government reimburses the states for part of their Medicaid expenses.[173] In 1994, Medicaid provided 322 million dollars worth of contraceptive funding.[174] The second program is the Title X Family Planning program. Family planning clinics receiving Title X grants provide discounted reproductive and contraceptive services to 6.5 million women. [175] The Department of Health and Human Services administers the Title X Family Planning Program, which awards grants to nonprofit organizations that give contraceptive services, training, assistance, and support to low and middle-income women.[176] Federal funding to Title X clinics in 2001 topped 265 million dollars.[177] Both Medicaid and Title X programs use sliding fee scales, with women who fall below 100 percent of the poverty level receiving services at no charge.[178] Thus, many low and middle-income women may obtain prescription contraceptives at no or reduced cost.

The federal government has mandated that Medicaid and Title X programs make family planning and contraceptive services a priority, and a number of legislative provisions aid in the implementation of this mandate.[179] In 1972 Congress made coverage of prescription contraceptive devices and related medical care a mandatory part of all state Medicaid programs, and provision of these services is also required for Title X funding.[180] The Medicaid statute provides additional incentives to comply with its mandate, including reimbursement of ninety percent of the costs of providing contraceptives and contraceptive services, which is double the reimbursement rate for other benefits, and prohibiting the imposition of cost-sharing requirements that are otherwise allowed for covered benefits.[181]

The cost savings that have resulted from publicly funding contraceptive services through these programs provide a clear picture of the magnitude of cost savings that would result from a broader mandate. It is estimated that these publicly funded programs prevent about 1.5 million unintended pregnancies each year, and over one half million abortions.[182] This amounts to over one billion dollars saved in medical expenses that would have had to cover these unplanned births and abortions, or a savings of $4.40 in public costs for medical care for every dollar spent on public contraceptive services.[183]

In the area of government-subsidized health care, therefore, Congress has taken significant steps to ensure that women receiving subsidized services have access to prescription contraceptives. This is particularly important because the women eligible for these services are the least likely to be able to afford their own prescription contraceptives. The amount the government has saved in covering contraceptives illustrates the cost savings available when prescription contraceptives are covered. Its willingness to mandate contraceptive coverage by private insurers and employers who do not receive government funding is much more limited, however, which indicates that while the government clearly views contraception as important, it does not view forcing the majority of women to pay their own contraceptive costs as a problem that merits federal action. Presumably, so long as all women have theoretical access to prescription contraceptives, the inequity in how they are charged for them by health plans that cover all other prescriptions is not of primary concern.

B. Mandated Coverage for Federal Employees

Congress also took action in 1998 to mandate prescription contraceptive coverage in federal employee health benefit plans that cover prescription drugs.[184] Known as the Snowe-Reid Amendment, this bill makes a broad range of prescription contraceptive coverage available to the 1.2 million women insured under government health plans.[185] The bill mandates coverage for each of the five most common forms of prescription birth control, and like many state statutes mandating prescription contraceptive coverage it includes a conscience clause exemption for plans operated by organizations whose religious or moral beliefs oppose birth control. [186] In debating this amendment it was established that its implementation would cost less than 500,000 dollars, which amounts to just over forty cents per woman insured under the plans.[187] In fact, in 2001 the Office of Personnel Management reported that the 1998 mandate did not create additional costs or impose a differential premium on women.[188] This is clearly a substantial economic benefit to these women, imposing a slight additional cost per woman in order to save them hundreds of dollars a year paying for their own prescription contraceptives. While passing a broad federal mandate would send a much stronger message, this is certainly a step in the right direction, and serves as a good model for state legislatures and insurers that such coverage is both economical and good public policy. Indeed, this was one of the primary purposes of the amendment, which sponsor Senator Snowe described as a “cost effective approach to effecting the kind of public health policy that should set an example for the rest of the nation’s insurers to follow.”[189]

Yet even though prescription contraceptive coverage has been proven to be cost effective, the status of mandated coverage for federal employees insured under federal health plans is not entirely secure. Congress renewed contraceptive coverage for federal employees for both 2000 and 2001 as part of the Treasury and General Government Appropriations Act, [190] but the Bush Administration’s fiscal year 2002 budget eliminated prescription coverage from the Federal Employee Health Benefits program.[191] The reversal of this Congressional mandate received strong disapproval in Congress, however, and the contraceptive coverage provision has remained intact.[192] After an overwhelming vote of 334–94 in the House to restore coverage, the Bush Administration reported that it no longer objected to the wording of the bill. [193] But although this coverage has continued, the Bush Administration’s decision to eliminate it from the budget illustrates that the current administration does not support prescription contraceptive coverage, and this weakens the message of strong federal support that proponents of the bill intended to send to their state counterparts.

C. A Comprehensive Statutory Mandate

While Congress has taken steps to mandate prescription contraceptive coverage in the limited cases of low-income women and those covered by federal employee benefit plans, it has been very reluctant to go farther. In particular, despite the introduction of the Equity in Prescription Insurance and Contraceptive Coverage Act (EPICC) in every year since 1997, the bill has never emerged from committee.[194] EPICC would amend ERISA to require private insurers that cover prescription drugs to also cover prescription contraceptives.[195] It is not limited to certain contraceptives but includes any contraceptive that is FDA-approved.[196] It would also require plans that include coverage for outpatient medical services to include outpatient contraceptive services in that coverage.[197] It defines these services to include the consultations, examinations, and procedures related to the use of prescription contraceptives. As noted in the state-law context, including these services in its mandate in addition to coverage of the actual contraceptives is important because these examinations are necessary to obtain the prescription coverage and can be a substantial additional cost.

As discussed above, this statute is particularly important to achieving a universal mandate of prescription contraceptive coverage because ERISA-governed plans are not subject to state regulation. Until EPICC is passed, self-insurance will continue to be an option for many employers, especially those not covered by Title VII, to avoid the state coverage mandates. EPICC extends even further, however, because it also amends the Public Health Service Act,[198] applying the same coverage requirements to coverage by insurers in the individual market.[199] This is another important area of coverage, and is something that very few of the state law mandates have required.[200] Sensitive to the interaction of state and federal law, EPICC also provides that it does not preempt any state law that establishes a standard or requirement giving greater protection than EPICC.[201]

Congressional support for EPICC is still low, but is gradually rising. Currently there are 112 House co-sponsors and 42 Senate co-sponsors, and on September 10, 2001, the Senate Health, Education, Labor and Pensions Committee held a hearing on EPICC, the first hearing on contraceptive coverage equity since 1998.[202] A number of EPICC supporters testified at the hearing, including Senator Reid, a co-sponsor of the bill, Anita Nelson, MD, representing the American College of Obstetricians and Gynecologists, Marcia D. Greenberger, co-president of the National Women’s Law Center, Kate Sullivan, Director of Health Care Policy for the U.S. Chamber of Commerce, and Jennifer Erickson, activist and lead plaintiff in the Erickson case, which is discussed later in this paper. [203] Testimony at the hearing emphasized that contraceptives are basic to women’s health, that unintended pregnancy has substantial costs for women and for society, and that covering contraceptives is cost effective. [204] The testimony also referred repeatedly to the many states that have mandated contraceptive coverage, and the recent federal district court and EEOC decisions, as lending support for a Congressional mandate.[205] Since the 2001 hearings, however, the committee has taken no action on EPICC.[206] As the hearing occurred the day before the terrorist attacks of September 11, 2001, the inaction may not reflect the true level of support for the bill but instead a reorientation of the Congressional agenda in light of those events. Yet it is notable that the committee took no action after the 1998 hearing either, and the bill has still never been reported out of committee.[207]

Congress has the potential to substantially impact the frequency and comprehensiveness of contraceptive coverage in the United States, but its efforts thus far have been quite limited. As public opinion in favor of coverage continues to rise, as more states continue to pass laws mandating coverage, and as the economic efficiency of coverage becomes more apparent, however, it seems likely that Congress will enact EPICC or a similar bill in the future.

IV. ADMINISTRATIVE AND JUDICIAL COVERAGE MANDATES

Finding that Congress has been hesitant to enact a federal mandate of contraceptive coverage, activists have turned to the federal courts and administrative agencies to press their claims for equality in prescription drug coverage. Because most women receive their prescription drug coverage as part of a benefit plan provided in connection with their own or their spouses’ employment, activists turned to employment law antidiscrimination provisions to support their claims. Sylvia Law first framed the denial of prescription contraceptive coverage as sex discrimination in 1998, and suggested the use of Title VII of the Civil Rights Act of 1964 to obtain a judicial mandate of coverage.[208] Her article was persuasive in determining the outcome of an Equal Employment Opportunity Commission (EEOC) decision in late 2000[209] and a United States District Court decision in 2001,[210] both of which held that denying coverage of prescription contraceptives violates Title VII. Other commentators have recently urged the use of the Americans With Disabilities Act (ADA) [211] and Title IX[212] as other possible avenues to judicially mandated coverage, but no cases have been brought under either of these statutes.[213]

A. Title VII and the Pregnancy Discrimination Act

Title VII makes it unlawful for an employer to “fail or refuse to hire or to discharge any individual, or otherwise to discriminate against any individual with respect to his compensation, terms, conditions, or privileges of employment because of such individual’s race, color, religion, sex, or national origin.”[214] Fringe benefits, such as employee health and benefit plans, are considered to be “compensation, terms, conditions, or privileges of employment” within the Title VII definition.[215] Title VII applies to any employer with more than fifteen employees, so it covers a majority of the employers in the United States, and most importantly those employers who are sufficiently large to be able to self-insure and thus to avoid state regulation of their benefit plans.[216] There is also a religious exemption in Title VII, similar to the conscience clauses often inserted in state laws that were discussed above. Title VII states that its requirements do not apply to “a religious corporation, association, educational institution, or society with respect to the employment of individuals of a particular religion to perform work connected with the carrying on . . . of its activities.”[217] This provision is interpreted very narrowly, however, and the Ninth Circuit has held that it only applies to hiring and firing, and does not apply to benefit decisions.[218] It thus appears to pose less of a challenge than the state conscience clauses.

As it has been interpreted by the courts, Title VII prohibits two different kinds of discrimination. The first, most explicit form of discrimination is disparate treatment, or purposefully discriminating against a given employee because of her status as a member of a protected group.[219] The second form of discrimination is disparate impact, which involves policies that are neutral on their face, and perhaps even in their intent, but have a disparate impact on a protected group.[220] This form of discrimination is important because it is often difficult to prove the intent to discriminate required under disparate treatment doctrine. [221] Cost is not a defense to either of these types of Title VII discrimination claims, as it is to discrimination claims brought under the Americans With Disabilities Act (ADA),[222] and this eliminates one of the most commonly asserted arguments against prescription contraceptive coverage.[223]

When bringing suit against an employer whose benefit plans do not cover prescription contraceptives, female employees may assert both types of discrimination claims. A disparate treatment claim could be alleged because the benefit plan specifically excludes contraceptives from its prescription coverage, and while this policy does not exclude women on its face, it is a sex-based exclusion that affects only women. Under this theory, allowing employers to defend against disparate treatment claims by asserting that they are not explicitly discriminating against women would be contrary to the obvious effect of their policies. These assertions were accepted in the recent EEOC decision discussed in detail below.[224] Female employees could also bring disparate impact claims, asserting that the exclusion of contraceptives is an inequality in treatment that may be facially neutral but has a disparate impact on female employees. For a disparate impact claim, female plaintiffs must show that the exclusion of prescription coverage has a disparate impact on women, and the employer is given a chance to show that the provision is job-related and consistent with business necessity.[225] Such a showing would be difficult for an employer to make in the prescription contraceptive context. The district court addressed this type of claim in the Erickson decision discussed below.[226]

The most difficult part of the Title VII prohibition of discrimination is the phrase “on the basis of . . . sex.” In General Electric Co. v. Gilbert ,[227] the Supreme Court approved a comprehensive disability plan that did not include pregnancy, despite the fact that only women can become pregnant, reasoning that pregnancy differs from other disabilities. The court stated that pregnancy differs because it is not a disease and is often voluntary and even desired.[228] As a result, the benefit package provided by the employer covered the same risk categories for women and men, and the fact that pregnancy-related disabilities were an additional risk unique to women did not destroy the parity of benefits offered.[229] The Court concluded that “gender-based discrimination does not result simply because an employer’s disability-benefits plan is less than all-inclusive.”[230] The dissent responded that in determining whether an employment policy treats men and women equally, the Court must look at the comprehensiveness of the coverage provided to each sex. In this case the coverage was less comprehensive for women, as they were the only sex at risk for pregnancy, and thus the policy was discriminatory.[231]

The Court’s decision in Gilbert sparked a great protest, and this protest led Congress to overturn the Gilbert decision by passing the Pregnancy Discrimination Act (PDA) as an amendment to Title VII.[232] The PDA clarifies that “on the basis of sex” in Title VII includes “on the basis of pregnancy, childbirth, or related medical conditions” and requires that “women affected by pregnancy, childbirth or related medical conditions shall be treated the same for all employment-related purposes, including receipt of benefits under fringe benefit programs.”[233] Thus, it made explicit that Title VII’s prohibition against sex discrimination includes discrimination on the basis of pregnancy. With this clarification of the statute, the disability plan in Gilbert would constitute sex discrimination regardless of the fact that it covers the same illnesses and conditions for men and women, that is, that it does not discriminate on its face, because it does discriminate on the basis of pregnancy.

The Supreme Court in later decisions interpreting the PDA has emphasized that the PDA does not require employers to provide pregnancy benefits when other disability benefits are not granted, it just represents a floor below which pregnancy benefits may not drop.[234] The Court’s view of the PDA as a “floor” is important, because it allows state laws that give special protection and benefits to pregnancy. The Court has also made clear that “pregnancy” in the statute also includes the potential for pregnancy, and that any classification based on a woman’s ability to become pregnant “must be regarded . . . in the same light as explicit sex discrimination.”[235] This broad interpretation of pregnancy is also very important to female plaintiffs asserting that the denial of contraceptive coverage is intentional disparate treatment sex discrimination. Two ground-breaking decisions in the last two years have made use of these various statutory provisions and judicial decisions. Both the EEOC and a federal district court found that together the statutes and judicial decisions render the exclusion of prescription contraceptive coverage from otherwise comprehensive prescription drug plans discriminatory.

B. The EEOC Decision

Title VII established the EEOC as an executive agency with broad powers in the employment law area.[236] Although employees have a private right of action under Title VII, they must first file a complaint with the EEOC and give the EEOC the chance to investigate, work for conciliation, and if desired, to file its own suit.[237] This requirement is intended to encourage conciliation of claims before litigation. The EEOC investigates complaints filed by employees and determines if there is reason to believe the complaints are legitimate. If so, it attempts to work with the employer through informal conciliation to remedy the problem. If it is unable to do so, it can bring a court action against the employer.[238] Title VII gives courts authority to enjoin illegal practices and to provide any equitable relief they deem appropriate.[239] If the EEOC does not elect to bring a court action, it must then issue a “right to sue” letter allowing the employee to bring her own suit in federal or state court.[240]

As part of its investigation process, the EEOC may issue a Commission Decision, which is a formal determination that there is “reasonable cause to believe that unlawful discrimination has occurred with respect to a specific charge.”[241] After such a decision is issued, the EEOC takes efforts to resolve the dispute through conciliation.[242] Title VII strictly requires confidentiality during the EEOC administrative review and conciliation period, so all party names in the decision are kept confidential to promote privacy and facilitate cooperation in the conciliation process.[243] If conciliatory resolution following a Commission Decision is unsuccessful, the EEOC can decide to bring its own suit or issue a right to sue letter, but the EEOC has no authority to issue enforcement orders itself.[244] Thus, while a Commission Decision may amount to a determination that an employer has violated Title VII and may include guidance as to how to avoid such violations in the future, it alone cannot lead to an enforcement action against the employer or any other employer with the same type of contraceptive coverage restrictions. If an employer hesitates to cooperate with the EEOC after such a decision is issued, however, the decision may play a large role in a later determination by a court that the employer has violated Title VII. Furthermore, a decision may have broader effect, as other employers, deemed to be on notice of that decision, face the possibility of lawsuits if they do not comply with its requirements.[245]

In December of 2000, the EEOC issued a Commission Decision on contraceptive coverage that was the first administrative or judicial statement on whether the failure to cover contraceptives violates Title VII. Two parties filed charges with the EEOC asserting that their employers’ health insurance plans violated Title VII because they cover prescription drugs, vaccinations, preventative medical care, and surgical means of contraception (that is, sterilization), but do not cover prescription contraceptive drugs or devices, regardless of whether they are used for birth control or other medical purposes.[246] The EEOC determined that the exclusion violates the PDA, irrespective of whether the contraceptives were used for medical purposes.[247] The EEOC explained that the PDA prevents two different kinds of discrimination against pregnant women: it prevents employers from treating pregnant women differently from other women, and prevents employers from excluding pregnancy in their benefit plans. It determined that because the Supreme Court has interpreted the PDA to include discrimination against women as a result of their ability to become pregnant, and contraception is a means by which a woman controls her ability to become pregnant, the PDA clearly prohibits discriminating against an employee for using contraceptives.[248] It then reasoned that an employer similarly cannot discriminate in its health insurance plans by denying benefits for contraceptives when it provides such coverage for other similar drugs.[249] It supported this interpretation with the fact that Congress specifically exempted coverage of abortions from the PDA, which illustrated that it understood that without an exemption the PDA may be determined to require such coverage. It did not, however, specifically exempt contraceptives from its terms, but its exemption of abortion shows that it could have had it desired to do so.[250]

Looking at the particular plans at issue, the EEOC found that they covered a number of other preventative drugs and services, such as vaccinations, blood pressure drugs, weight loss drugs, preventative care examinations and services such as mammograms, and preventative dental care.[251] The EEOC also responded to the employers’ argument that they cover medical treatment only if there is a problem with the employee’s health, criticizing them for not recognizing pregnancy as a serious medical condition that has serious health risks for a woman.[252] The EEOC also emphasized that an employer’s motive is irrelevant if discrimination is found, and that the exclusion of contraceptive coverage for financial reasons is not a defense to a violation of Title VII.[253] Finally, the EEOC rebutted the employers’ defense that they had not engaged in disparate treatment discrimination because they did not explicitly distinguish between men and women. It argued that as prescription contraceptives are only available for women, their refusal to cover them is a sex-based exclusion, and stressed that the “policy need not specifically refer to that group in order to be facially discriminatory.”[254] The EEOC also recognized that a claim for disparate impact could be successfully asserted, but that its finding of disparate treatment discrimination rendered addressing such a claim unnecessary.[255] In its instructions to the parties at the conclusion of its decision, the EEOC also emphasized that to avoid violating Title VII in the future, the employers must extend coverage to the full range of prescription contraceptives, not just one specific type.[256]

While not an enforceable judgment against the employers charged, as a statement of government agency policy on the issue this is a decision of great importance to the pursuit of equity in insurance coverage. In particular, the EEOC’s finding of disparate treatment discrimination, which is the harder of the two types of discrimination to prove, will be a strong weapon in future litigation to obtain contraceptive coverage mandates from the courts. Indeed, the court’s decision in the Erickson case discussed below referred to the EEOC’s decision as support for its resolution of the case.

C. Erickson: The First Federal Court Decision

Erickson v. Bartell Drug Co. , decided in June 2001, was the first federal suit to allege that the denial of prescription contraceptives from an otherwise comprehensive medical plan violated Title VII. Judge Lasnik decided the case on summary judgment, and determined that the defendant’s health plan did constitute sex discrimination.[257] Judge Lasnik discussed the scattered legislative history of Title VII, and determined that while Congress’s intent is relatively unclear, Congress has generally only interfered with judicial interpretations of Title VII when the courts have restricted Title VII’s application.[258] He then asserted that Congress made its intent more clear through the PDA, which recognized the “special or increased healthcare needs associated with a woman’s unique sex-based characteristics” and “required employers to provide women-only benefits or otherwise incur additional expenses on behalf of women in order to treat the sexes the same.”[259] Judge Lasnik analogized the facts of the Erickson case to those in Gilbert , the Supreme Court case that led to the enactment of the PDA, because on its face Bartell’s policy treated men and women the same — neither sex received coverage for prescription contraceptives. He concluded, however, that the PDA’s reversal of Gilbert indicates that facial parity of coverage is not sufficient to justify an exclusion of benefits unique to women. Thus, the importance is the relative comprehensiveness of coverage, not its facial parity.[260]

The Judge also considered Bartell’s defenses to its limited coverage.[261] He responded to the argument that contraception differs from the kind of illness normally treated by prescription drugs by citing numerous statistics on the effect of contraception on women’s health and the benefits of avoiding unintended pregnancies.[262] He also mentioned that Bartell’s health plan covered a number of other preventative drugs, arguing that pregnancy may be “natural,” but it is also a medical condition that women often desire to avoid for much of their lives.[263] Bartell also argued that control of fertility is not within the definition of “pregnancy, childbirth, or related medical conditions” as set out in the PDA. Judge Lasnik responded that regardless of whether contraception falls within the precise definition set out in the PDA, Congress’s intent, evidenced by its quick and clear overruling of Gilbert by enacting the PDA, was an interpretation of Title VII that “necessarily precludes the choices Bartell has made in this case.”[264] Bartell also asserted that its plan was neutral and excluded all “family planning” drugs, but Judge Lasnik pointed out many inconsistencies in the plan’s coverage[265] and responded more broadly that excluding prescription contraceptives could not be considered neutral or equal because the coverage is less comprehensive for female employees than it is for males.[266] Finally, Judge Lasnik responded to Bartell’s argument that it should be able to limit the scope of its benefit plans to control costs by emphasizing that cost is not a defense to discrimination under Title VII.[267] He noted that there are many ways an employer can reduce the cost of its benefit program by implementing less comprehensive coverage, but that it cannot do so in a discriminatory manner.[268]

The effect of the Erickson decision on the movement to cover prescription contraceptives has been profound. The federal decision substantially bolstered the effectiveness of activists’ efforts on the state level by reducing the loopholes available to employers to avoid regulation. Since the decision, women have filed suits throughout the country to press the issue in other federal and state jurisdictions.[269] The EEOC also reports that it is continuing to receive charges of discrimination against employers whose plans exclude contraceptives.[270] While Bartell has announced plans to appeal,[271] the Erickson decision is well-grounded in federal antidiscrimination law, and especially given the support of the EEOC’s recent decision, it seems unlikely to be reversed on appeal.

There are other important implications of the Erickson decision as well. First, it gives states the authority to enforce Title VII against employers whose self-funded health plans cover prescriptions but not prescription contraceptives, despite ERISA preemption. While ERISA preemption would prevent the states from imposing mandatory benefit requirements on these employers independently,[272] states have an important role in enforcing Title VII.[273] The Supreme Court addressed the precise issue of the relationship between state implementation of Title VII and ERISA preemption of state laws regulating employer-funded benefit plans in Shaw v. Delta Air Lines, Inc. ,[274] and recognized that state laws “play a significant role in the enforcement of Title VII.”[275] The Shaw case arose when the New York Court of Appeals, two weeks after the Supreme Court decided Gilbert , held that an employer whose self-funded benefit plan treats pregnancy differently from other disabilities engages in sex discrimination in violation of the New York Human Rights Law.[276] The Shaw Court reversed this decision, holding that while a state may apply its own, broader definition of discrimination to insurance plans and actors not subject to ERISA, ERISA preemption prevented the application of these broader state laws to ERISA plans.[277] However, the Court in Shaw also held that after Congress passed the PDA, overruling the Court’s Gilbert decision and affirming that pregnancy discrimination is sex discrimination within Title VII, the state would not be preempted from applying its Human Rights Law to ERISA plans.[278] The Court’s reasoning was based on the fact that ERISA does not preempt federal law, and thus a Title VII antidiscrimination mandate applies to all ERISA plans.[279] Furthermore, Title VII explicitly does not preempt state antidiscrimination laws that do not conflict with it, and encourages the passage of consistent state antidiscrimination laws to aid in the enforcement of Title VII.[280] Thus, the Court reasoned that “[g]iven the importance of state fair employment laws to the federal enforcement scheme, [ERISA] preemption of the [state] Human Rights law would impair Title VII to the extent that the Human Rights law provides a means of enforcing Title VII’s commands.”[281]

The interaction of the Shaw decision and the Erickson court’s finding that Title VII prohibits employers from excluding prescription contraceptive coverage from their otherwise comprehensive prescription drug plans could therefore have a substantial impact on the preemption of state legislation regarding employer-funded benefit plans. As the Shaw Court recognized, the states play a large role in enforcing Title VII, and the Erickson decision clears a path for states to enact laws that prohibit employers from denying women contraceptive coverage in their comprehensive benefit plans. Before the Erickson court’s interpretation of Title VII as barring such discrimination, these laws would have been subject to ERISA preemption, but after that decision they may be seen as a valid state interpretation and implementation of Title VII, and thus not subject to ERISA preemption under Shaw .[282] This should increase the effective enforcement of the Erickson decision, because as often happens with judicial decisions, many employers may choose not to comply with Erickson and wait for a specific enforcement of Erickson ’s mandate against them.[283] Adding state enforcement of Title VII against these employers by removing the ERISA preemption loophole should provide those employers who are reluctant to comply with greater incentives to do so. Indeed, that is one of the main reasons that Title VII encourages state implementation of Title VII.[284]

The Erickson case also has implications for whether a suit may be brought directly against the federal government alleging that the failure of ERISA to mandate coverage of prescription contraceptives renders it unconstitutional. Such a suit may be premised on the Supreme Court’s decision in Davis v. Passman , [285] in which the Court recognized an implied right of action for gender discrimination under the Due Process Clause of the Fifth Amendment. In Davis , a former Congressional staff member sued arguing that her employer, a Congressman, discriminated against her on the basis of sex by terminating her employment because she was a woman.[286] She sued under the Fifth Amendment because Congress had excluded itself from all otherwise available statutory remedies, so the Constitution was her only available option to redress the discrimination.[287]

Using Davis as a precedent, a suit could be brought alleging that since gender discrimination in employment is unconstitutional, the failure of ERISA to mandate the coverage of prescription contraceptives allows gender discrimination to continue in violation of the Fifth Amendment. Activists have not yet taken this approach, however, and have focused instead on lobbying Congress to amend ERISA through EPICC. But the ability to use this approach may be foreclosed by the Erickson decision. One important factor underlying the Davis decision was that the plaintiff had no other remedy to address the gender discrimination but the Constitution.[288] Erickson , however, provides such a remedy through Title VII, which was not available in Davis . And as just described above, the Shaw decision expressly allows state antidiscrimination legislation to address gender discrimination in employer benefit plans after such discrimination is found to violate Title VII, providing another possible remedy to address discrimination in employee benefit plans. Furthermore, ERISA by its very nature does not mandate that employer benefit plans include specific benefits of any type.[289] It may be difficult to convince a court that ERISA is unconstitutional because it does not mandate prescription contraceptive coverage when a federal antidiscrimination statute prohibits excluding the coverage and ERISA explicitly states that it does not preempt federal statutes. Thus, while such a suit may still be an option, as the Erickson decision makes available a statutory remedy that is not preempted by ERISA, it would likely render such a suit unsuccessful. [290]

Overall, the Erickson decision has proven to be very important to the fight for contraceptive coverage, but there are still areas that cannot be reached by state law or Title VII decisions. For example, smaller employers with less than fifteen employees are exempt from Title VII, and individuals who must purchase their own health insurance in states that do not mandate such coverage would have no Title VII remedy.[291] Erickson is most definitely a step in the right direction as a strong statement from the federal judiciary that excluding such coverage is discriminatory, but both state and Congressional legislation should still be pushed to ensure comprehensive contraceptive coverage for all women.

D. Beyond Title VII: Alternative Theories for Judicially Mandated Coverage

1. The Americans With Disabilities Act (ADA) . — Melissa Cole has suggested the ADA as a potential avenue for women to pursue prescription contraceptive coverage.[292] The ADA is a less attractive option after the Erickson decision because Title VII is a much broader antidiscrimination statute, but if Erickson is overturned or other jurisdictions with pending cases decide the Title VII issue differently, the ADA has a very strong potential to mandate coverage of prescription contraceptives for a select group of women. Congress passed the ADA in 1990, and it is distinct from Title VII in that it includes not only an antidiscrimination provision, but also a “reasonable accommodations” provision.[293] It thus requires that employers incur costs, so long as they do not constitute an “undue hardship” to the employer, to accommodate the physical limitations of an employee with a disability.[294] Such costs could include the cost of covering prescription contraceptives in employee benefit plans, which would not likely be classified as imposing an undue hardship.[295]

The main limitation of using the ADA to obtain widespread contraceptive coverage is apparent from the Act’s title: it only applies to women with disabilities.[296] The ADA defines disability as “a physical or mental impairment that substantially limits one or more of the major life activities of such individual.”[297] Cole argues that women for whom pregnancy poses a risk of heart failure, seizure, or hypertension, or whose health requires them to take prescription medicines that could complicate pregnancy, fall within this definition because the possibility of pregnancy is so threatening as to constitute a substantial limitation on the major life activity of reproduction.[298] This assertion is supported by the Supreme Court’s decision in Bragdon v. Abbott ,[299] which held that reproduction is a “major life activity” under the ADA.[300]

There is a potential complication to her assertion, however, because the Supreme Court also stated clearly in Sutton v. United Air Lines, Inc. [301] that the ADA requires that an employee be presently limited in a major life activity, not potentially limited at a later date.[302] Yet if the possibility of pregnancy poses a serious risk to a woman, she is presently limited in the major life activity of reproduction, even if the adverse health risks lie in the future. Cole acknowledges that a number of courts have followed an EEOC guidance position and have explicitly held that pregnancy is not a disability,[303] but asserts that if pressed courts would recognize the difference between pregnancy in general and pregnancy for women with serious health risks.[304]

Women for whom pregnancy poses serious health risks thus appear to meet the definition of disability in the ADA. As a result, they could make use of Title I of the ADA, which prohibits employers from discriminating against individuals with disabilities in providing fringe benefits.[305] The EEOC has interpreted Title I as requiring that “employees with disabilities be accorded equal access to whatever health insurance coverage the employer provides to other employees.”[306] Thus, if employers provide prescription drug coverage generally, women for whom pregnancy poses a serious health risk should be entitled to coverage of prescription contraceptives. While the ADA includes a safe harbor for benefit plan terms based on actuarial principles that underlie traditional underwriting practices,[307] the exclusion of prescription contraceptives is not based on risk assessment principles, but on cost savings to insurers, which would not fall within this safe harbor.[308]

The ADA, therefore, also holds promise as a statute that may be useful in working for equality in contraceptive coverage. Its limited scope renders it less useful than Title VII, but it is relevant to the debate over coverage for many women and should not be ignored. A recent charge filed with the EEOC has asserted both ADA and Title VII claims, and may lead to an EEOC Commission Decision on the ADA issue in the near future.[309]

2. Title IX of the Education Amendments of 1972 . — Title IX is not an employment law statute, but instead bars sex discrimination in any education program or activity receiving federal financial assistance.[310] As such, it has the possibility of reaching student health care plans and thus of filling a major gap left by the current mandates of prescription contraceptive coverage. Kathleen Bergin provides a detailed treatment of Title IX in her recent article,[311] explaining how it may be the only way to reach many college women who are not protected by either state or federal legislative mandates or by the recent judicial decision under Title VII.

The health care financing system in the United States provides two primary methods for contraceptive coverage: employer-based health plans and public-sector subsidies. Most women fall into one of these two general systems for health care provision. As they are generally “young, unmarried, and unemployed,” college-age women are the least likely to be insured, and student health insurance plans provide an attractive option for many of these women.[312] College women are generally not employed full time and are generally not the partner or spouse of individuals who are employed full time, but instead tend to work part time, temporary jobs.[313] As a result, they do not have access to employer-funded health plans. Many college women are covered by their parents’ insurance coverage, but such coverage generally extends only to full time, unmarried undergraduate students and has strict age limits, excluding nearly all non-traditional students as well as those in graduate programs.[314] Furthermore, college women are unlikely to meet eligibility requirements for publicly subsidized healthcare. Medicaid generally requires women to be single mothers or pregnant and to have an income below a certain level, and Title X clinics require that women meet strict income restrictions that are much lower than the income of the average college woman.[315]

Bergin surveyed the student health benefits at the fifteen largest public universities in the United States, and found that only one provides coverage for contraceptives that was equal to the coverage for other prescriptions. Five schools provide limited coverage with restrictions such as deductibles or a cap on reimbursements, and nine expressly exclude coverage.[316] The coverage provided by these universities as a whole is clearly far from comprehensive, leaving many college-age women without prescription contraceptive coverage and thus at a high risk of unintended pregnancy.

Title IX specifically provides that “no person shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any education program or activity receiving Federal financial assistance,” and this provision extends to “all the operations” of the institution, regardless of whether they are educational in nature.[317] Title IX regulations make clear that the antidiscrimination requirements extend to university sponsored health insurance policies and that sex discrimination under Title IX has a scope similar to that set forth in the PDA, thus explicitly including pregnancy and the potential for pregnancy.[318] As does Title VII, Title IX prohibits policies that are facially neutral but have a discriminatory effect on women, relieving women from having to prove discriminatory intent.[319]

The burden of proof required to assert a Title IX claim should be easily met by college women challenging their schools’ health plans. Title IX requires plaintiffs to establish a prima facie case that the effect of a facially neutral practice clearly disadvantages one sex.[320] The many studies cited and approved by state legislatures, Congress, and the Erickson court when addressing contraceptive coverage in other contexts provide ample evidence of the costs of denying women this coverage and of the fact that these costs are borne solely by women. After a plaintiff establishes her prima facie case, the university may argue that the policy is an “educational necessity.” Courts often analogize this to the “business necessity” defense to disparate impact claims brought under Title VII, and require that it be a legitimate educational goal.[321] It is difficult to conceive of an educational goal that is served by denying coverage of prescription contraceptives, and therefore it seems likely that universities would not be able to defend their current contraceptive coverage policies successfully in the face of a Title IX challenge.[322]

The possibility of using Title IX to address the inequality in prescription contraceptive coverage in college health plans provides another encouraging example of the potential for activists to work to extend contraceptive coverage to a large group of women not reached by the current reforms. The Erickson court’s finding that denial of such benefits violates the antidiscrimination provision of Title VII, and its findings of fact with regard to the cost and consequences of failing to extend such coverage should provide strong support for a similar finding under Title IX.

The administrative and judicial developments described in this section have been the most recent of all the governmental responses, and they have also been the most uniformly supportive of activists’ claims for equality in health care coverage. Activists should continue to push for findings of discrimination in other federal and state courts under both federal and state antidiscrimination statutes, and should highlight the judicial findings that the failure to cover these benefits for women is discriminatory when working at the state and federal legislative levels as well.

V. OTHER RELATED REFORM MOVEMENTS

The movement to mandate insurance coverage of prescription contraceptives is also greatly impacted by two other important reform movements related to prescription contraceptives. The first advocates changing oral contraceptives to over-the-counter status, and the second advocates the establishment of a no-fault liability scheme to address products liability claims related to contraceptives. Both of these movements are motivated, as is the prescription contraceptive coverage movement, by an understanding of the costs of unintended pregnancy and a desire to reduce those costs by ensuring greater, cost-effective access to contraceptives. In that sense they are all mutually supportive, but the specific reforms urged by each individual movement differ greatly. Any activist working to mandate prescription contraceptive coverage should be conscious of the existence of these other movements, and should have an understanding of their goals and the implications of the reforms they propose on the prescription contraceptive coverage movement.

A. A Switch to Over-the-Counter Status for Oral Contraceptives

Many activists urge that it is not necessary to require a prescription for oral contraceptives, and that they should instead be classified as over-the-counter (OTC) drugs. This switch has been proposed for years, and has sparked great controversy. There are three ways to switch a drug from prescription to OTC status: the holder or a new drug application may submit a further application asking FDA to approve a switch; the drug’s manufacturer or any individual may petition the FDA to switch; or the switch may be approved through the OTC Drug Review process. [323] The OTC Drug Review process is the most common means for switching drugs to over-the-counter status,[324] and involves an advisory review panel of experts appointed by the FDA Commissioner to deliberate the safety and effectiveness of potential OTC drugs and to recommend a switch to OTC status.[325]

The 1951 Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act[326] clarified the definition of prescription drugs as, among other factors, drugs “not safe for use except under a practitioner’s supervision.”[327] This definition involves the consideration of three factors: “toxicity, potentiality for harmful effect, and the method of use or collateral measures necessary to use.”[328] When considering these factors, a number of issues are considered, including safety, effectiveness, adequate labeling, the benefit-to-risk ratio of a drug, and social policy. [329]

Activists argue that under each of the factors mentioned above, oral contraceptives are appropriate for OTC status. They argue specifically that any significant risks of taking oral contraceptives have been minimized with the development of low-dosage alternatives, and that pregnancy is seven times more dangerous for women than taking oral contraceptives. [330] They also argue that with adequate labeling they can be taken safely and effectively, and that women do not need a physician’s supervision to take the pill appropriately.[331] For support, they point to Japan and the Philippines, which have both seen a successful switch of oral contraceptives to OTC status.[332] Activists also urge that the benefits, both to society and each individual woman, are much greater than the risks. They focus on the increase in access that would result from allowing women to obtain oral contraceptives privately without engaging the formal medical system.[333] They also emphasize the reduction in cost, which is “the great barrier to women obtaining contraceptives” that would come with OTC status. [334]

Despite the strength of these arguments, the FDA has not taken any action to switch the status of oral contraceptives. The movement to change to OTC status has drawn sharp criticism, which indicates that the FDA will proceed especially slowly and carefully in considering this issue. Opponents argue that there are serious side effects from taking the pill, including blood clots and a possible link to breast cancer, and that a physician’s assistance is necessary to determine whether oral contraceptives are safe for a given woman because some women, such as those who smoke, are at a greater risk from taking oral contraceptives than are others.[335] In general, they advocate erring on the side of women’s safety and ensuring that doctors can monitor women using oral contraceptives for any potential problems. Additionally, they emphasize that it is difficult to use oral contraceptives correctly without counseling and guidance, and that labeling is not sufficient to explain what to do in unusual situations, such as when a woman forgets to take the daily pill.[336] Opponents also argue that OTC availability could lead to a loss of preventative health care for women because they will no longer have the incentive to schedule routine health appointments if they are not necessary to obtain their contraceptive prescriptions. [337] Finally, the potential availability to teenagers is commonly asserted as a reason to maintain the prescription status, arguing that this access would discourage abstinence and encourage teenage sexual activity. [338]

The FDA has stated that it has a number of concerns, including the potential side effects of taking oral contraceptives and whether they may be taken effectively without a physician’s supervision.[339] The possible interaction with other drugs, such as the risk of failure of oral contraceptives when a woman is also taking antibiotics, was identified as one specific concern with women’s ability to take the pill effectively on their own.[340] The FDA has also stated that it has received no applications from oral contraceptive manufacturers requesting an OTC switch, and no manufacturer has taken a public position on the issue.[341] Many commentators assert that the lack of a manufacturer sponsor may keep FDA from making a decision, unless there is overwhelming public support for the shift.[342] At a two-day FDA hearing in 2000 on the potential shift of a number of prescription drugs to OTC status, most of the testimony with regard to oral contraceptives was negative,[343] indicating that overwhelming public support is not necessarily forthcoming on this controversial issue.

As this description should make clear, some of the most fundamental arguments in support of the shift of oral contraceptives to OTC status, such as the need for increased access to contraceptives to promote women’s health and the substantial barrier posed by the cost of oral contraceptives, are also shared by the prescription contraceptive coverage movement. Yet the implications of the success of the OTC movement on the contraceptive coverage movement must be considered. Advocates of OTC status assert that a reduced price is one of the main benefits of switching to OTC, but admit that this switch may actually cause the price of oral contraceptives to go up for those whose insurance provides prescription contraceptive coverage.[344] The movement toward mandated coverage for contraceptives has been remarkably successful, and the prospects for even greater success in the future are strong. As a result, many women have finally been relieved from the burden of paying for their own prescription contraceptives. Since oral contraceptives are the most commonly used type of prescription contraceptive,[345] the success of the OTC movement would drastically reduce the success of the insurance movement in ensuring that women are not forced to pay these costs. Regardless of whether oral contraceptives may be safely used without physician supervision, they are still a vital part of women’s health care for a great number of women, and a shift to OTC status does not address the discrimination inherent in the fact that women are forced to pay more out-of-pocket health care costs than men.

The switch to OTC status certainly facilitates women’s use of oral contraceptives in ways beyond merely reducing the cost, but proponents of both movements agree that cost is the major impediment to the use of prescription contraceptives.[346] The success of activists working to achieve universal mandates of coverage for prescription contraceptives in reducing the cost barrier should be considered by those in the OTC movement, because with the increasing success of the former movement, more women will be adversely impacted by the success of the latter. Activists leading both of these movements should be conscious and careful of the interaction between them, and of how that interaction impacts the specific goals of each movement.

B. Using No-Fault Liability to Address Products Liability Claims

A second major movement related to prescription contraceptives advocates the legislative establishment of a no-fault liability scheme to address products liability claims related to contraceptives. Products liability lawsuits against prescription contraceptive manufacturers have been a constant fixture in the legal system since the first suits filed against oral contraceptive manufacturers in the late 1960s. [347] Currently products liability suits against oral contraceptive manufacturers are quite rare, but most of the other prescription contraceptives have been targeted.[348] IUDs provide one prominent example. The Dalkon Shield IUD, placed on the market in 1970, caused twenty deaths and numerous injuries, including miscarriages, infections, infertility, and the need for hysterectomies.[349] Over 325,000 suits were filed, and the damages from the litigation forced the manufacturer into bankruptcy in 1985.[350] While the Dalkon Shield is the most prominent example, all but one of the IUDs, including the Copper-7, have been removed from the market to avoid the cost of defending products liability lawsuits. [351] Manufacturers are also reluctant to introduce new IUDs to the United States, even though there is more widespread use of IUDs in Europe.[352] Norplant, introduced in 1991, was also subject to a number of products liability suits, and recently settled with 36,000 plaintiffs for 50 million dollars, despite the fact that its manufacturer had spent 114 million dollars on testing before it was marketed. [353] As a result of the negative publicity, few women are using Norplant, even though the FDA has stood by its declaration that Norplant is safe and effective. [354]

As a whole, products liability litigation has had a negative impact on contraceptive research and development. While no major types of contraceptives have exited the market entirely, with the exception of all but one of the IUDs, manufacturers have little incentive to put the money and time into developing entirely new contraceptives or new delivery methods for the hormones currently used in many prescription contraceptives.[355] The effect of this drop in research and development has been dramatic, leading commentators to exclaim that "the United States is the only country other than Iran in which the birth control clock has been set backward during the past decade,”[356] that “research in the area of contraceptive drugs and devices has been stalled for a generation in the United States,”[357] and that “the United States [has] fallen a decade behind Europe in the development of new contraceptives.”[358] In 1970 there were thirteen major pharmaceutical companies doing contraceptive research and development in the United States, and today there are only two, and their research is limited to new forms of oral contraceptives.[359] While the last few years saw the introduction of a few new contraceptives,[360] commentators argue that they are not entirely new contraceptive methods but are generally different methods for delivering the same hormones, and that their introduction in the United States was substantially later than their introduction in Europe.[361] They also argue that vigorous research and development would lead to much greater variety in new contraceptive methods than those recently introduced.[362]

Defending against products liability litigation is a disincentive to research and development for a number of reasons. The primary impact of products liability has been the substantial cost of defending the lawsuits. Even though manufacturers are most often successful when defending the suits, the cost of defending them is a substantial burden.[363] Such suits also raise the cost of product liability insurance.[364] These litigation and insurance costs are compounded by the substantial cost of research and development itself, as well as the cost of testing for safety and effectiveness to obtain FDA approval for any new contraceptive drug or device.[365] Furthermore, in addition to the cost of developing and testing products and defending suits is the negative publicity that these suits generate, making women fear that the product is unsafe and thus hesitant to try it or any other new contraceptive methods.[366]

The reduction in research and development has serious consequences for increasing the variety of prescription contraceptives available. Variety is especially important because each particular method may not work for each woman’s health needs and lifestyle.[367] It is therefore crucial to have variety in order to increase the number of women who can safely and effectively use prescription contraceptives. Clearly a wide variety of unsafe prescription contraceptives is not desirable, but many commentators doubt whether some recent targets of products liability suits were actually manufacturing unsafe contraceptives with dangerous consequences. As an example, Anna Birenbaum traces the progress of the Norplant products liability litigation, explaining that in the first three years on the market only twenty suits were brought against its manufacturer, but after products liability attorneys began recruiting plaintiffs through a variety of means including billboard advertisements, the number of plaintiffs grew to 36,000 by 1999.[368] Meanwhile, as of 2001 no suits have been brought in any of the forty-three other countries where Norplant is sold.[369] American Home Products decided to settle even though it had won twenty pre-trial judgments and three of the four cases that proceeded to trial, in part because of the sheer number of claims it was facing.[370]

Surely every contraceptive will have an adverse impact justifying a products liability suit on a given number of women, but the tactics of many products liability attorneys and the massive number of claims asserted make it likely that this litigation is reducing the number of safe and effective contraceptive options available to women, by causing manufacturers to remove them from the market or by causing women to fear that they may be unsafe. It is also reducing the opportunities for a greater variety of safe and effective prescription contraceptives in the future.

To address this clear problem and to try to encourage contraceptive research and development in the United States, many have proposed the legislative enactment of a no-fault liability scheme to deal with products liability claims against contraceptive manufacturers.[371] The goal of this system is to protect and compensate injured parties while simultaneously shielding manufacturers from excessive tort liability. This response is based on the experience with the vaccine crisis in the early 1980s that led to the enactment of the National Childhood Vaccine Injury Act of 1986.[372] Fearing enormous potential liability, manufacturers were exiting the vaccine market, leading to a crisis in the vaccine supply.[373] They were increasingly unwilling to engage in vaccine research and development and production.[374] The Act established a no-fault compensation scheme that does not require a claimant to prove causation or negligence.[375] Participation in the program is mandatory for all those injured after a given date, though a claimant may choose to reject the compensation award and sue under state tort law if she desires.[376] The Act is funded by a tax on each dose of vaccines sold, and compensation claims are paid out of a vaccine injury compensation trust fund.[377] The Act has been successful, and has ensured the continuing availability of vaccines.[378]

Supporters argue that a the enactment of a similar statute would provide a necessary stimulus to encourage manufacturers to invest in contraceptive research and development.[379] This system would recognize that inevitably some women will be injured by prescription contraceptives and provide compensation for those women, but would eliminate any incentives on the part of products liability attorneys to amass large classes of plaintiffs and pursue manufacturers for large settlements. Supporters claim that the savings in litigation costs would be so substantial that the cost of funding the compensation trust fund could be absorbed by manufacturers without an increase in sales prices.[380]

Activists admit that there are clearly differences between vaccines and prescription contraceptives, one major difference being that vaccines were required before children could enter school, while contraceptives clearly are not required.[381] Furthermore, the vaccine crisis involved an actual crisis in the vaccine supply, not just in vaccine research and development, while contraceptives are still readily available but manufactures exhibit a hesitancy to invest in the development of new contraceptive methods.[382] The fact that there is no contraceptive shortage may therefore render the contraceptive products liability “crisis” less severe than the vaccine crisis.

Yet supporters argue that vaccines and prescription contraceptives are quite similar in important respects, such as the fact that both are given to a large number of individuals with normal health histories, and that as a result there will most likely be a steady stream of products liability claims given the inherent, even if unlikely, possibility of side effects.[383] Further, as they are both given to young and healthy individuals successful products liability suits tend to result in high damage awards, making the litigation risk for both products unusually high compared to other pharmaceutical products.[384] Additionally, although there may be no contraceptive shortage as a result of products liability suits, supporters argue that continuing development of new contraceptive methods is necessary and important, and that it will not occur in any meaningful way without legislative action.[385] Finally, it may be argued that while childhood vaccination was a clear government priority at the time of the enactment of the Childhood Vaccine Injury Act, the provision of effective and safe contraceptives is also a national priority given the importance of contraceptives to women’s health and well-being.[386] Supporters therefore argue that despite the difficulties in setting up such a system, including the determination of a number of issues such as what events are compensable, how the system should be funded, and how much money should be distributed through the system, these systems have been established before, in the childhood vaccine crisis and in other circumstances, and have proved to be a successful method for addressing the products liability problem.[387]

This movement intersects with the prescription contraceptive coverage movement in that they both recognize the importance of having a variety of contraceptive alternatives available to women as a part of women’s basic health care. The two movements therefore may in time prove to be mutually reinforcing, because at the core of both of them lies an effort to convince both government officials and society at large of the importance of prescription contraceptives.

CONCLUSION: STRATEGIES FOR THE FUTURE

In describing the developments in the movement for equity in prescription contraceptive coverage over the last few years, the primary goal of this paper has been to illustrate that this movement is multifaceted and complex, requiring coordinated activism on a variety of different governmental levels to achieve results. The health care and health insurance systems in the United States necessarily make it so, and to work effectively for change, activists must understand what the state legislatures, Congress, and the federal and state courts can each accomplish. When working at any of these three levels, they must also have a sense of what has been done in each of the others, in order to effectively anticipate concerns that may be raised, and to support their claims with arguments that other government branches have reached the same conclusions. Especially at the state level, having a clear picture of what actions the other states have taken, and of how slight changes in wording may lead to very different interpretations, will greatly aid in lobbying for the most protective legislation possible. By tracing the arguments made, and the successes and failures seen on each of these different levels, this paper has sought to provide this overarching sense of the movement as a whole and the interrelatedness of its various elements. It has also illustrated the implications that the success of two other powerful contraceptive reform movements may have on the movement for contraceptive coverage.

But given that there are constraints of time and finances on any reform movement, activists must prioritize and focus their efforts on the most promising and most powerful areas for reform if they hope to have the most widespread effect. In the case of the contraceptive coverage movement, this presents a challenge, because at least given the progress of the movement thus far, the most powerful and most promising areas for reform appear to be different. As this paper has emphasized throughout, federal legislation is the most powerful single reform possible, and if enacted it would have the most sweeping effect. If Congress were to enact EPICC, it would mandate that all employers and all insurers provide coverage through amendments to ERISA and the Public Health Service Act, reaching areas that State legislation or judicial enforcement of Title VII alone could not reach. The enactment of EPICC would therefore be the ultimate achievement of the prescription contraceptive coverage movement.

While federal legislation may be the most powerful and most sweeping possible reform, it is clearly not the most promising or likely one. Activists have had much greater success in the state legislatures and with the federal judiciary, and while the number of EPICC supporters in Congress has grown, the bill has languished in committee for over five years. The most promising reform in terms of being the most likely to achieve sweeping success going forward is pursuing the Title VII litigation strategy. The state law reform movement has seen great success, but as the states most open to the idea of legislatively mandating contraceptive coverage continue to enact such statutes, the states most hostile to instituting such reforms will be those remaining, meaning that at some point in the future activism on the state level may not be as successful as it has been in the first three years of the movement. But a litigation strategy may hold a great deal more promise. The Title VII arguments are strong and well-grounded in federal antidiscrimination law, and the Erickson and EEOC decisions are crucial in their recognition of the Title VII claims. With the strength of the Title VII claims and the precedent set by the Erickson court, supplemented by clear support from the EEOC, litigation appears to be the most promising strategy for the future.

In determining what is the optimal activism strategy for future reform efforts, the movement must therefore recognize that the most promising and most powerful reform efforts do not appear to be the same. In light of this fact, vigorously pursuing a Title VII litigation strategy should be the top priority going forward, because it holds great promise of likely and relatively immediate success, and it also holds a great deal of power in that it reaches nearly all employer-funded benefit plans. This litigation strategy must recognize that merely obtaining favorable judicial decisions in each circuit will not be enough, however, and that instead many cases will have to be brought against employers who have not complied with the judicial decisions mandating that they provide contraceptive coverage. But as the decisions continue to come down mandating coverage and employers become more aware that federal antidiscrimination law mandates that they provide this coverage, voluntary employer compliance should become increasingly common. Furthermore, as judicial decisions continue to mandate that employers provide contraceptive coverage, this support can be asserted in Congress as evidence of the widespread national support for federally mandated contraceptive coverage.

Therefore, while Congressional action would be more sweeping and immediate if successful, the prospects of success in the near future are much less than the prospects of success with a litigation strategy. As activism movements are always at risk of loosing steam, the most aggressive efforts should be focused on strategies with the most immediate and promising results. The rapid and recent success of the contraceptive coverage movement has currently captured much of the nation’s attention, and activists should make use of this success and support to press forward for the most promising reforms in order to keep that attention focused on the movement’s claims and its successes.

Each of the reform efforts discussed in this paper, however, have the downside of being relatively long-term. Even litigation, which should offer the most immediate results, is a slow- moving process. But each month that women continue to pay for their own contraceptives is further prolonging the discrimination in health care, and activists should thus consider other short-term strategies that may keep women from having to cover these costs themselves while the longer-term litigation and legislative lobbying strategies continue. Planned Parenthood has led the short-term activism part of the movement, developing a comprehensive campaign termed “Cover my Pills.”[388] The main theme of this campaign is activism on the individual level, and it urges women whose employers do not cover contraceptives to provide their employers with information regarding the importance of contraceptive coverage and then to simply ask their employers to provide this coverage.[389] The campaign provides women with information and strategy tips to use in talking with their employers. The purpose of the campaign is to prevent employers from relying on the common excuse that their employees had never asked for contraceptive coverage. While it may seem unrealistic, the campaign has achieved great success, and many employers have proven to be responsive when confronted with employee requests and information regarding the cost-effectiveness of contraceptive coverage.[390] The individual activism campaign has also extended to women on college campuses covered by college health plans. Universities have responded favorably when students have campaigned around the issue and brought their requests before the University and the public.[391]

An additional short-term approach that has proven successful has been including contraceptive coverage in the list of demands made by unions when renegotiating their contracts. Labor union membership nationwide includes over five million women, and the potential for success when unions press employers to provide prescription contraceptive coverage has been termed “huge.”[392] Many large unions, including AFL-CIO and the Teamsters, have signed a resolution of support and have encouraged their members to advocate for the inclusion of contraceptive coverage.[393] The Coalition of Labor Union Women has also put together an information kit to help members work for coverage, including sample letters to give to employers and to Congress.[394] Unions therefore represent another possible short-term approach to achieving coverage.

While focusing national efforts on long-term and sweeping reforms, it must not be forgotten that these reforms take time, and that there are many opportunities for activism to achieve short-term results. These activism efforts have proven remarkably successful thus far, and it is likely that as both short-term and long-term efforts continue to prove successful, they will become mutually reinforcing, leading to even greater success in both the short and long terms.

In its relatively short lifespan, the contraceptive coverage movement has been extraordinarily successful, which is an indication that it is an issue whose time has most certainly come. By stepping back and surveying all that has been accomplished, activists will be able to sharpen their focus on the most pressing changes still unmade, and to push for reforms that will greatly strengthen the successes that have already been achieved. In the end, millions of women from all walks of life will be able to reap the substantial benefits of their efforts.

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[1] THE ALAN GUTTMACHER INSTITUTE, CONTRACEPTION COUNTS: THE NEED FOR SERVICES 1 (1999), http://www. guttmacher.org/pubs/state_facts99/alabama99.pdf [hereinafter CONTRACEPTION COUNTS ].

[2] 144 Cong. Rec. S9181-01 (daily ed. July 29, 1998) (statement of Sen. Snowe).

[3] See Sylvia A. Law, Sex Discrimination and Insurance for Contraception , 73 WASH. L. REV. 363, 364 (1998).

[4] CONTRACEPTION COUNTS , supra note 1, at 1; Sarah E. Bycott, Controversy Aroused: North Carolina Mandates Insurance Coverage of Contraceptives in the Wake of Viagra , 79 N.C. L. REV. 779, 785 (2001).

[5] Lisa A. Hayden, Gender Discrimination Within the Reproductive Health Care System: Viagra v. Birth Control , 13 J.L. & HEALTH 171, 180 (1999).

[6] Kathryn Kindell, Prescription for Fairness: Health Insurance Reimbursement for Viagra and Contraceptives , 35 TULSA L.J. 399, 399 (2000).

[7] Id.

[8] Id . at 405. While they make this argument to illustrate the inconsistency in insurers’ coverage, most activists do not accept the definition of prescription contraceptives as “quality of life” drugs. Instead, they allege that prescription contraceptives are medically necessary as part of women’s basic health care. See, e.g. , id . at 399-400 (arguing that while Viagra and prescription contraceptives clearly serve different purposes, they are similar in that they both have a goal of enabling sex at will, and are both medically necessary because without them sex at will is not possible).

[9] Suzanne White Junod, FDA's Approval of the First Oral Contraceptive, Enovid , UPDATE, July-Aug 1998, http://www.fda.gov/oc/history/makinghistory/enovid.html.

[10] See Catholic Charities v. California, 109 Cal. Rptr. 2d 176, 182 (Cal. Ct. App. 2001).

[11] Hayden, supra note 5, at 188.

[12] NARAL FOUNDATION, THE CONTRACEPTION REPORT: A STATE-BY-STATE REVIEW OF ACCESS TO CONTRACEPTION 29 (2001) [hereinafter CONTRACEPTION REPORT ].

[13] Id . at viii. These states include California, Connecticut, Delaware, Georgia, Hawaii, Iowa, Maine, Missouri, Nevada, New Hampshire, New Mexico, North Carolina, Rhode Island, Texas, Vermont, and Washington. Id . Six other states have laws or regulations that provide a lesser level of coverage: Colorado, Idaho, Kentucky, Minnesota, New Jersey, and Oklahoma. Id .

[14] Equity in Prescription Insurance and Contraceptive Coverage (EPICC) Act of 2001, S. 104, H.R. 1111, 107th Cong. (2001); EPICC Act of 1999, S. 1200, H.R. 2120, 106th Cong. (2001); EPICC Act of 1997, H.R. 2174, 105th Cong. (1997).

[15] 29 U.S.C. §§ 1101-1461 (2000).

[16] 141 F. Supp. 2d 1266 (W.D. Wash. 2001).

[17] 42 U.S.C. § 2000e(k) (2000). See Bartell , 141 F. Supp. 2d 1276-77.

[18] Hayden, supra note 5, at 180. Condoms, for example, have an 84% effectiveness rate. Id.

[19] William M. Brown, Deja Vu All Over Again: The Exodus from Contraceptive Research and How to Reverse It , 36-37 BRANDEIS L.J . 1, 26 (2000) (discussing factors that have kept prescription contraceptive prices relatively low compared to prescriptions in general). Cost is, indeed, a main reason women do not use prescription contraceptive methods. See supra note 5 and accompanying text. Cost is also a primary reason given by activists supporting the switch of oral contraceptives to over-the-counter status. See infra note 334 and accompanying text.

[20] Id . (explaining how women will shift to other prescription contraceptive methods in response to cost). The price impact of generics is discussed below. See infra notes 61-62 and accompanying text.

[21] Law, supra note 3, at 369.

[22] Kindell, supra note 6, at 414 n.181.

[23] Law, supra note 3, at 369-70 & n.35.

[24] See infra Part II (discussing the various levels of contraceptive coverage currently provided by insurers in the fifty states, and illustrating that without a state mandate to do so, very few insurers voluntarily cover all of the different types of contraceptives and each of the different varieties of oral contraceptives).

[25] See Frederick R. Jelovsek, Which Oral Contraceptive is Best for Me? , Women’s Diagnostic Cyber, at http://www.

wdxcyber.com/ncontr13.htm; Advance PCS, Performance Drug List , (2002) at http://www.druglist.com/obgyn.htm.

[26] See Jelovsek, supra note 25 (listing the specific oral contraceptives that are best for treating a number of different problems, including acne, bleeding, too light menstrual flow, depression, moodiness, headaches, breast soreness, weight gain, and severe menstrual cramps).

[27] Additionally, as will be discussed below, insurers almost uniformly require the substitution of generic oral contraceptives when available. See infra notes 63-67 and accompanying text.

[28] Kindell, supra note 6, at 414 n.182.

[29] Id.

[30] Law, supra note 3, at 371.

[31] Janet Benshoff, Protecting Consumers, Prodding Companies, and Preventing Conception: Toward a Model Act for No-Fault Liability for Contraceptives , 23 N.Y.U. REV. L. & SOC. CHANGE 403 (1997). The products liability suits against the IUD manufacturers and prescription contraceptive manufacturers generally are discussed in detail in Part V.

[32] Kindell, supra note 6, at 414 n.183.

[33] Id.

[34] Law, supra note 3, at 370 n.39.

[35] Law, supra note 3, at 371; Kindell, supra note 6, at 414 n.184.

[36] Kindell, supra note 6, at 414 n.184.

[37] Law, supra note 3, at 371.

[38] Anna Birenbaum, Shielding the Masses: How Litigation Changed the Face of Birth Control , 10 S. CAL. REV. L. & WOMEN’S STUD. 411, 412 (2001).

[39] Id . at 413. The Norplant products liability litigation is discussed in detail in Part V.

[40] Kindell, supra note 6, at 414 n.185.

[41] Id.

[42] Bycott, supra note 4, at 787.

[43] See W. Kip Viscusi, Liability , in THE CONCISE ENCYCLOPEDIA OF ECONOMICS , at http://www.econlib.

org/library/Enc/Liability.html (discussing the National Academy of Sciences report).

[44] Birenbaum, supra note 38, at 424. Johnson and Johnson’s Ortho and AHP’s Wyeth-Ayerst are the only two, and both are focusing on new oral contraceptives rather than entirely new contraceptive methods. Id . at 423.

[45] See infra Part V (discussing the research and development crisis with regard to contraceptives and legislation that may alleviate the problem by encouraging further contraceptive research and development).

[46] See Brown, supra note 19, at 33-35; Benshoff, supra note 31, at 409.

[47] Monthly Birth Control Shot Gets FDA’s Stamp of Approval , MILWAUKEE JOURNAL SENTINEL , Oct. 9, 2000.

[48] Id.

[49] Rita Rubin, Birth Control Insert Gains FDA Approval , USA TODAY , Oct. 4, 2001.

[50] Id.

[51] Rita Rubin, Weekly Patch Gets FDA Approval as Contraceptive Device Ortho Evra is Found as Effective as Pills , USA TODAY , Nov. 21, 2001, at 13D.

[52] Id.

[53] Ass’n of Reproductive Health Professionals, Understanding Low-Dose Oral Contraceptives: Generic Equivalent OCs, at http://www/arhp.org/clinical/CP_low_dose/equivalent.htm.

[54] Id .

[55] Id .; see also PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW 576-77 (2d. ed 1991).

[56] See Advance PCS, supra note 25.

[57] Id. Notably, the triphasic variety, which are the newest variety of contraceptives, has six different name brands, and only one of them has a generic equivalent available. Id .

[58] Amy Tsao, Label Generic Drug Makers Successful , BUSINESS WEEK ONLINE , Dec. 27, 2001, at http://www.

businessweek.com/bwdaily/dnflash/dec2001/nf2001122.7_2230.htm.

[59] Id . (describing the profitability of selling generic contraceptives and the positive impact of FDA generic approval on generic manufacturers’ stock prices); Barr Labs Wins FDA Approval to Sell Generic Mircette , BLOOMBERG NEWS , Apr. 8, 2002 (describing how a generic contraceptive can expect about half of the brand-name’s market share within a few months of approval). One reason generics are able to capture such a large market share is that insurers often require the substitution of generic drugs for their brand-name equivalent. See infra notes 63-67 and accompanying text.

[60] See Brown, supra note 19, at 26 (describing how products liability suits against drug companies manufacturing oral contraceptives are very uncommon as doses have been reduced and warnings have become more comprehensive).

[61] Jelovsek, supra note 25.

[62] See Tsao, supra note 58.

[63] Aetna, 2002 Medication Formulary Guide , at http://www.aetna.com/formulary/online_2002p.html. A few insurers explicitly exempt contraceptives from these higher brand-name copayments, however. See, e.g. , Advocate Health Care, Pharmacy Features , Jan. 1, 2002, at http://careers.advocatehealth.com/Benefits/MediPlan/

PharFeat2002.htm.

[64] Association of Reproductive Health Professionals, Contraceptive Formulations , (2002) at http://www.arhp.org/

PP/2Notes.htm.

[65] See supra note 57 and accompanying text.

[66] See supra notes 25-26 and accompanying text.

[67] It is important to note that insurers apply generic-substitution rules to all prescriptions, not just oral contraceptives. It is the generic-only rule that is unique to contraceptives, and it is this rule that can reduce the actual coverage provided because many women may require a brand-name contraceptive for which a generic substitute is not available. See supra note 64.

[68] Erickson v. Bartell Drug Co., 141 F. Supp. 2d 1266, 1273 (2001).

[69] Id .

[70] Id. ; see also Law, supra note 3, at 364-68.

[71] Hayden, supra note 5, at 186.

[72] Id . at 186, 188. At a cost of about $10 per pill, these estimates vary greatly depending upon the number of pills taken each month. Id .

[73] Kindell, supra note 6, at 416.

[74] Id. at 417. The cost of childbirth alone, without any complications, averages between 3000 and 5000 dollars. Hayden, supra note 5, at 187.

[75] Bycott, supra note 4, at 788.

[76] Kindell, supra note 6, at 417.

[77] Id. Forty-four percent of unintended pregnancies end in abortion. Hayden, supra note 5, at 187.

[78] Bycott, supra note 4, at 787; Law, supra note 3, at 367 n.19.

[79] See Janet Benshoff, By Covering Viagra, Insurers Show that Men’s Sexual ‘Well-Being’ is More Vital than Women’s , CHI. TRIB ., June 7, 1998, at 9 (describing the American Journal of Public Health study).

[80] Of course, many insurers who do not cover prescription contraceptives do cover the cost of women’s annual preventative care appointments, but some activists argue that women are less likely to schedule these appointments if they do not need them to obtain their prescription contraceptives. See infra note 337 and accompanying text. Under this argument, women who cannot afford prescription contraceptives may be less likely to schedule preventative care appointments even if their insurers do cover those appointments.

[81] Kindell, supra note 6, at 416.

[82] Id. at 419.

[83] BARRY R. FURROW ET AL., HEALTH LAW 500 (2995); Jeffrey D. Zimon, Erickson v. The Bartell Drug Company, The Pregnancy Discrimination Act and its Implications for Employee Benefit Plans , 2001, at http://www.fedbar.org/

labouringoar.html; see also 29 U.S.C §§ 1101-1461 (2000).

[84] Kindell, supra note 6, at 401.

[85] Zimon, supra note 83.

[86] See Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 733 (1985). The Supreme Court has interpreted ERISA narrowly to increase the states’ ability to regulate health plans, but has consistently held that state laws mandating the provision of benefits in employer-funded health plans are not free from preemption. See, e.g. , New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 657 (1995); DeBuono v. NYSA-ILA Medical & Clinical Servs. Fund, 520 U.S. 806, 814-15 (1997).

[87] 29 U.S.C. § 1144(b)(2)(A) (2000).

[88] Id . § 1144(b)(2)(B).

[89] Kindell, supra note 6, at 401.

[90] Bycott, supra note 4, at 793 & n.86; Metro , 471 U.S. at 728-29.

[91] Law, supra note 3, at 395.

[92] Bycott, supra note 4, at 792 n.80; Kindell, supra note 6, at 401.

[93] Kindell, supra note 6, at 401-02.

[94] Id. at 402.

[95] 29 U.S.C. § 1144(d) (2000).

[96] See Shaw v. Delta Air Lines, 463 U.S. 85 (1983) (holding that ERISA does not prevent state authorities from enforcing Title VII); Bycott, supra note 4, at 793. See infra notes 285-290 and accompanying text (discussing the possible use of Davis v. Passman , 442 U.S. 228 (1979), as a basis for a suit against the federal government alleging that ERISA is unconstitutional for failing to mandate coverage of prescription contraceptives in light of Shaw and the recent Erickson decision).

[97] 42 U.S.C. § 2000e(b) (2000).

[98] Id . § 2000e(k).

[99] Erickson v. Bartell Drug Co. 141 F. Supp. 2d 1266, 1276-77 (W.D. Wash. 2001).

[100] CONTRACEPTION REPORT , supra note 12, at ix.

[101] Id . The report lists thirty-eight states, but left out Arkansas, which does have a policy mandating coverage. See infra note 107. When Arkansas is added to the count provided in the NARAL report, there is a total of thirty-nine.

[102] Id .

[103] See CONN. GEN. STAT. § 38a-503e (2001); DEL. CODE ANN. tit. 18, § 3559 (2000); GA. CODE ANN. § 33-24-59.6; HAW. REV. STAT. §§ 431:10-A-116.6, -116.7, 432:1-604.5 (2000); IOWA CODE § 514C.19 (2000); ME. REV. STAT. ANN. tit. 24, § 2756, -2847-G, -4245, 4247 (West 1999); MO. REV. STAT. § 376.1199 (2001); NEV. REV. STAT. §§ 689A.0415, .0417, 689B.0376, .0377, 689C.1715, 1717, 695B.1916, .1918 (1999); N.H. REV. STAT. ANN. §§ 415:18- i, 420-A:17-c, -B:8-gg (1999); N.C. GEN. STAT. § 58-3-178 (2000); R.I. GEN. LAWS §§ 27-18-57, -20-43, -41-59 (2000); VT. STAT. ANN. tit. 8, § 4099 c(2000); VA. CODE ANN. § 2.2-2818( B)(6) (2001).

[104] Massachusetts, Mississippi, Oregon, Tennessee, Utah, and Washington have taken this approach. See infra note 108 and accompanying text.

[105] CAL. HEALTH & SAFETY CODE §1367.25 (1999). As a result of this statutory language, none of California’s public employee HMO and PPO plans cover all types of approved prescription contraceptives. CONTRACEPTION REPORT, supra note 12, at 8.

[106] Id. at 3.

[107] Id . at 6. The Idaho, Minnesota, New Jersey, and South Dakota state policies also require coverage of oral contraceptives only. Id . at 18 (Idaho), 33 (Minnesota), 43 (New Jersey), 56 (South Dakota).

[108] Id . at 30. Mississippi, Oregon, Tennessee, Utah, and Washington have policies with the same requirements. Id . at 34 (Mississippi), 51 (Oregon), 57 (Tennessee), 60 (Utah), 64 (Washington).

[109] The state policy in Florida requires that all HMOs cover all contraceptive drugs and devices, but does not require the same of state PPO plans. As may be expected, the PPO plans not subject to the state policy cover contraceptives only if necessary for reasons not related to contraception. Id. at 14. Kansas, Oklahoma, and South Carolina policies require coverage of oral contraceptives, Norplant, and Depo Provera. Id . at 23 (Kansas), 50 (Oklahoma), 55 (South Carolina). Kentucky policy requires coverage for contraceptives, but that term is not defined; all Kentucky programs currently cover oral contraceptives, Depo Provera, and diaphragms, while a few additionally cover Norplant and IUDs. Id . at 25. Louisiana and New York policies require coverage of oral contraceptives, Norplant, and Depo Provera, and employees may choose from HMOs that also cover IUDs and diaphragms. Id . at 27 (Louisiana), 45 (New York). Michigan policy requires coverage of prescription drugs, including oral contraceptives, and all state employee plans currently cover oral contraceptives and IUDs, while others also cover Depo Provera and Norplant. Id . at 32. Ohio requires coverage of at least one type of contraceptive, and currently all state employee plans cover oral contraceptives and Depo Provera, with select plans also covering Norplant, IUDs, and diaphragms. Id . at 49 Pennsylvania policy mandates coverage of oral contraceptives and Depo Provera. Id . at 52. Texas policy requires HMOs to cover all FDA-approved contraceptives, and all other state employee plans to cover oral contraceptives. Id. at 59. West Virginia policy requires the state PPO plan to cover all five common types of prescription contraceptives, and employees may select HMO plans that cover oral contraceptives, Depo Provera, IUDs, and diaphragms. Id. at 65. Wisconsin policy requires coverage of all of the five common types of prescription contraceptives, with the exception of Norplant. Id. at 66.

[110] Louisiana, Michigan, Minnesota, and New Jersey are examples. See supra notes 107 (Minnesota and New Jersey), 109 (Louisiana and Michigan).

[111] Id. at 5. As a result of Arizona’s guidelines, all of the state employee’s health plans cover oral contraceptives, Norplant, and IUDs. There are other plans that cover Depo Provera and diaphragms as well. Id .

[112] The Alaska and New Mexico state health insurance plans cover all prescription contraceptive drugs and devices, even though there is no state coverage mandate. See id . at 4 (Alaska), 44 (New Mexico). Health plans in Arizona, Colorado, Illinois, Indiana, Maryland, and Nebraska also voluntarily cover prescription contraceptives, though none of them cover all five primary types. See supra note 111; CONTRACEPTION REPORT, supra note 12, at 5 (Arizona), 9 (Colorado), 19 (Illinois), 21 (Indiana), 29 (Maryland), 39 (Nebraska). In the District of Columbia, all employee health plans voluntarily cover all five primary types of prescription contraceptives. See id. at 13.

[113] Id .

[114] Id . at 37 (Montana), 48 (North Dakota).

[115] Id. at 68.

[116] Id . at ii. After Maryland passed the first statute in 1998, nine states followed in 1999, three in 2000, and three in 2001. Id.

[117] WASH. ADMIN. CODE § 284-43-822 (2001).

[118] CONTRACEPTION REPORT , supra note 12, at viii.

[119] Id. at x. Arizona and Massachusetts have passed legislation in 2002, and both bills are currently awaiting signature, giving a total of seventeen state statutes. See NATIONAL CONFERENCE OF STATE LEGISLATURES , Health Insurance Coverage For Contraceptives , Mar. 2002, at http://www.ncsl.org/programs/health/contrace.htm [hereinafter NCSL] (Massachusetts); Planned Parenthood, Contraceptive Equity Bill Passed by Arizona Legislature, Goes to Governor for Signature, Apr. 16, 2002, at http://www.covermypills.org (Arizona).

[120] See supra notes 86-91 and accompanying text.

[121] As an illustration of the variation even within the most comprehensive statutes, each of the following statutes excludes a different element from the summary list provided in the text. See, e.g. , IOWA CODE § 514C.19 (2000) ( not including the waiting period restriction); NEV. REV. STAT. 689A.0415, .0417, 689B.0376, .0377, 695B.1916, .1918, 695C.1715, .1717 (1999) ( not including the prohibition of paying women to take less than required coverage); N.C. GEN. STAT. §§ 58-3-178, -50-155 (2000) ( not including the waiting period restriction and specifically excluding coverage of emergency contraceptives); TEX. INS. CODE. art. 21.52L (2001) (not including the limitation of providing incentives to health care providers not to prescribe contraceptives).

[122] HAW. REV. STAT. §§ 431:10A-116.6, -116.7 (2000).

[123] Id.

[124] Id.

[125] See supra note 26 and accompanying text.

[126] DEL. CODE ANN. tit. 18, § 3559 (2000); MD. CODE ANN., INS. § 15-826 (2000); VT. STAT. ANN. tit. 8, § 4099 c (2000); WASH. ADMIN. CODE § 284-43-822 (2001)

[127] ME. REV. STAT. ANN. tit. 24-A, § 2756, -2847-G, -4245, -4247 ( West1999); N.H. REV. STAT. ANN. §§ 415:18- i, 420-A:17- c420-B:8- gg (2000); MA HB 2193 (2002).

[128] GA. CODE ANN. § 33-24-59.6 (2001) ( also prohibiting insurers from reducing prescription reimbursement rates for women who receive contraceptive benefits); MO. REV. STAT. § 376.1199 (2001); N.M. STAT. ANN. § 24-8-6 (2000)

[129] CONN. GEN. STAT. §§ 38 a-503 e, -530 e(2001); R.I. GEN. LAWS §§ 27-18-57, -19-48, -20-43, -41-59 (2000).

[130] CAL. HEALTH & SAFETY CODE § 1367.25 (1999); CAL. INS. CODE § 10123.196 (1999).

[131] Id.

[132] 3 COLO. CODE REGS. § 4-6-5 (2001). The term “contraception” is not defined in the regulation, making its comprehensiveness unclear. See CONTRACEPTION REPORT , supra note 12, at 9.

[133] See CONTRACEPTION REPORT , supra note 12, at 18.

[134] Id.

[135] KY. REV. STAT. ANN. § 304.17A-250 (2000); N.J. ADMIN. CODE tit. 11, § 20-3.1, 21-3.1 (2001).

[136] MINN. R. 4685.0100, subp.5, 4685.0700, subp.1 (2001).

[137] See CONTRACEPTION REPORT , supra note 12, at 33.

[138] OKLA. ADMIN. CODE § 310:655-5-1(10)(A), (C) (2001); CONTRACEPTION REPORT , supra note 12, at 33. Michigan, Montana, New Jersey, Ohio, and West Virginia have similar HMO requirements, but they have not interpreted “family planning services” to require coverage of prescription contraceptives. Id . at 32 (Michigan), 37 (Montana), 42 (New Jersey), 49 (Ohio), 65 (West Virginia). See MICH. COMP. LAWS § 500.3501 (2001); MONT. CODE ANN. §§ 33-31-102(2) (h)(iv), -202(1)( b), 402(1)( c) (2000); N.J. ADMIN CODE tit. 8, § 38-5.4 (2001); OHIO REV. CODE ANN. § 1751.01(A)&), 1751.01(N), 1751.05(A)(3) ( West2001); W. VA. CODE §§ 33-25A-2(1), (11), -25A-4, -25A-18 (2000) . North Dakota and Wyoming also have such HMO requirements, but “family planning services” has not yet been interpreted to either include or exclude prescription contraceptive coverage. CONTRACEPTION REPORT , supra note 12, at 48 (North Dakota), 69 (Wyoming); see N.D. ADMIN. CODE § 45-06-07-06.2(d) (2001); WYO. RULES , ch. 13, § 7(c)(ii)(B) (2001). Given that the majority of other states have interpreted these rules not to include contraceptive coverage, however, it is most likely that a similarly restrictive interpretation would govern in these states as well.

[139] VA. CODE ANN. § 38.2-3407.5:1 (2000). The Virginia statute also prohibits the imposition of any unusual copayment on contraceptives. See NCSL, supra note 119.

[140] Twenty-five states also have separate statutory provisions that allow health care providers and pharmacists to refuse to provide or counsel on contraceptive services. See CONTRACEPTION REPORT , supra note 12, at xiii.

[141] Id. These states are California, Connecticut, Delaware, Hawaii, Maine, Maryland, Missouri, Nevada, New Mexico, North Carolina, Rhode Island, and Texas. Id .

[142] Id . at xiv. Some of these states added these clauses to existing law, while others considered new bills to require contraceptive coverage that included these clauses. Id .

[143] See CAL. HEALTH & SAFETY CODE § 1367.25( b) (1999); CAL. INS. CODE § 10123.196(d) (1999). Other states also strictly define the applicability of the conscience clause exemption. See HAW. REV. STAT . §§ 431:10A-116.6, -116.7 (2000) (defining religious employer as a nonprofit entity that is not staffed by public employees, that primarily employs those who share its religious tenets, and that has a primary purpose of inculcating religious values); N.C. GEN. STAT. §§ 58-3-178, -50-155 (2000) (defining religious employer as a tax exempt organization with a primary purpose of inculcating religious values, and that primarily employs those with the same religious beliefs).

[144] CONN. GEN. STAT. §§ 38a-503e, -530e (2001). Other states use language that imposes restrictions similar to those in the Connecticut statute. See ME. REV. STAT. ANN . tit. 24-A, §§ 2756, -2847-G, -4245, -4247 (West 1999) (“a tax-exempt church or association of churches or an elementary or secondary school controlled, operated or principally supported by a church or association of churches”); R.I. GEN. LAWS §§ 27-18-57, -19-48, -20-43, -41-59 (2000) (defining religious employer as a “church” or “qualified church-controlled organization” as defined by federal law).

[145] MD. CODE ANN., INS. § 15-826 (2000). Other states use similarly broad language. See DEL. CODE ANN. tit. 18, § 3559 (2000) (“religious employer”); MO. REV. STAT. § 376.1199 (2001) (“entity operated according to moral, ethical, or religious tenets contrary to contraception”); NEV. REV. STAT . 689A.0415, .0417, 689B.0376, .0377, 695B.1916, .1918, 695C.1715, .1717 (1999) (“religious organization”); N.M. STAT. ANN . §§ 59A-22-42, -23-4, -47-33 (2001) (“religious entities”); TEX. INS. CODE ANN. § 21.52L (Vernon 2001) (“religious organization”).

[146] Bycott, supra note 4, at 809 & n.168 (citing statutes). Most states require written notice, while others require just reasonable and timely notice. Id .

[147] See CAL. HEALTH & SAFETY CODE § 1367.25( b) (1999); CAL. INS. CODE § 10123.196(d) (1999); CONN. GEN. STAT. §§ 38a-503e, -530e (2001); HAW. REV. STAT . §§ 431:10A-116.6, -116.7 (2000); N.C. GEN. STAT. §§ 58-3-178, -50-155 (2000); ME. REV. STAT. ANN . tit. 24-A, §§ 2756, -2847-G, -4245, -4247 (West 1999).

[148] Bycott, supra note 4, at 809-10.

[149] See supra note 21 and accompanying text.

[150] CONTRACEPTION REPORT , supra note 12, at xiv.

[151] Catholic Charities v. California, 109 Cal. Rptr. 2d 176, 181 (Cal. Ct. App. 2001).

[152] 109 Cal. Rptr. 2d 176 (Cal. Ct. App. 2001).

[153] Id. at 185.

[154] CAL. HEALTH & SAFETY CODE § 1367.25 (1999); CAL. INS. CODE § 10123.196 (1999).

[155] Id. at 181.

[156] Id. at 184.

[157] Id.

[158] Id. at 183; see CAL. HEALTH & SAFETY CODE § 1367.25( b); CAL. INS. CODE § 10123.196(d).

[159] Catholic Charities , 109 Cal. Rptr. 2d at 181. Section 501(c)(3) of the Internal Revenue Code is a general nonprofit exemption, while Section 6033(a)(2)(A)(i) and (iii) specifically exempts churches and the religious activities of a religious order.

[160] The court cited the findings of discrimination in the EEOC decision and the Erickson case, both discussed below, with approval.

[161] Catholic Charities , 109 Cal. Rptr. 2d at 182.

[162] Id. at 183.

[163] Id . (citing Employment Division v. Smith , 494 U.S. 872, 878-79 (1990)); see id. at 186.

[164] 494 U.S. 872 (1990).

[165] Id. at 878-79.

[166] Catholic Charities , 109 Cal. Rptr. 2d at 187-89.

[167] Id. at 189.

[168] Id .

[169] Id . Catholic Charities also asserted a number of additional detailed objections to the statute that are beyond the scope of this paper, including that the government may not refuse to extend a system of exemptions from a general requirement in cases of “religious hardship,” id . at 192, that when the free exercise claim of a church is involved strict scrutiny should be used, id. at 193, that strict scrutiny applies when Free Exercise Clause and Establishment Clause claims are both alleged, id. at 194-95, and various other claims under the California Constitution, id . at 196. The court rejected each of these arguments with a detailed analysis. Id. at 206.

[170] CONTRACEPTION REPORT, supra note 12, at xv.

[171] The California Court of Appeal’s decision did this to some extent. See Catholic Charities , 109 Cal. Rptr. 2d at 189.

[172] Kathleen A. Bergin, Contraceptive Coverage Under Student Health Insurance Plans: Title IX as a Remedy for Sex Discrimination , 54 U. Miami L. Rev. 157, 166-67 (2000).

[173] Id . at 166 n.51.

[174] Id. at 167 n.57.

[175] Michelle Andrews, Birth Control is Changing, and its Price is Rising , N.Y. TIMES , Apr. 21, 2002.

[176] Bergin, supra note 172, at 167 n.54.

[177] Andrews, supra note 175. While this is an increase over the funding of 118 million dollars in 1994, see Bergin, supra note 172, at 167, when adjusted for inflation, Title X funding has declined fifty-seven percent between 1979 and 2001, while the number of patients using Title X clinics has substantially increased. Andrews, supra note 175.

[178] Bergin, supra note 172, at 167.

[179] Id. at 168.

[180] Id. ; see 42 U.S.C. § 1396d(a)(4)(C) (2000) (Medicaid); 42 C.F.R. § 59.5(a)(10)(b) (1998) (Title X). Interestingly, women who receive their contraceptives from Title X clinics may have trouble receiving the new contraceptive methods discussed in the background section above. Title X clinics receive contraceptives at a deep discount from manufacturers, paying only about $1.50 for a month of oral contraceptives. Part of this low cost is because there is enough competition in the oral contraceptive market that manufacturers have an incentive to offer Title X clinics large discounts. See Andrews, supra note 175. With the new contraceptives, Ortho Evra and NuvaRing, there is no competition from other brands, and the manufacturers financially cannot offer such steep discounts. Id . Clinics have negotiated with Ortho Evra’s manufacturer, Johnson & Johnson, for a price of fifteen dollars a month for the new contraceptive patch, but this may still be more than clinics can afford with their limited budgets. Id . As a result, the women who use Title X clinics may find that in order to have their contraceptive costs covered, their contraceptive options are more limited. Id .

[181] Bergin, supra note 172, at 168; see 42 U.S.C. §1396b(a)(5) (2000) (reimbursement); id . § 13960(a)(2)(D) (2000) (cost sharing).

[182] Bergin, supra note 172, at 161.

[183] Id. at 161-62.

[184] CONTRACEPTION REPORT , supra note 12, at ix.

[185] Kindell, supra note 6, at 418; see FY 1999 Omnibus Appropriations Act, Pub. L. No. 105-277, Tit. VI, § 656.

[186] Kaiser Family Foundation, Women’s Groups, Lawmakers Distressed at Budget’s Cut of Required Contraceptive Coverage for Federal Employees , in KAISER DAILY REPRODUCTIVE HEALTH REPORT , Apr. 12, 2001, at http://www.
report.kff.org/archive/repro/2001/4/kr010412.1.htm.

[187] Kindell, supra note 6, at 418.

[188] Kaiser Family Foundation, supra note 186 (describing the report of the Office of Personnel Management).

[189] 144 Cong. Rec. S9181-01 (daily ed. July 29, 1998) (statement of Sen. Snowe).

[190] Planned Parenthood, FACT SHEET: Equity in Prescription Insurance and Contraceptive Coverage , 2002, at http://www.plannedparenthood.org/library/BIRTHCONTROL/EPICC_facts.html.

[191] CONTRACEPTION REPORT , supra note 12, at ix.

[192] Id. ; see Juliet Eiperin, House Panel Rebuffs Bush on Federal Contraceptive Coverage , WASH. POST , July 18, 2001, at A6.

[193] Cynthia L. Cooper, Unions, Congress Consider Contraceptive Equity ,WOMEN’S NEWS, Sept. 7, 2001, at http://www.womensenews.org/article.cfm/dyn/aid/643/context/archive.

[194] Bycott, supra note 4, at 781; see, e.g. , EPICC Act of 2001, S. 104, H.R. 1111, 107th Cong. (2001); EPICC Act of 1999, S. 1200, H.R. 2120, 106th Cong. (2001); EPICC Act of 1997, H.R. 2174, 105th Cong. (1997).

[195] CONTRACEPTION REPORT , supra note 12, at 1.

[196] Center for Reproductive Law and Policy, The Facts: The Equity in Prescription Insurance and Contraceptive Coverage Act , July 2001, at http://www.crlp.org/pub_fac_epicc.html.

[197] Planned Parenthood, supra note 190; see EPICC Act of 2001, S. 104, H.R. 1111, 107th Cong. (2001) (defining contraceptive services as "consultations, examinations, procedures, and medical services, provided on an outpatient basis and related to the use of contraceptive methods (including natural family planning) to prevent an unintended

pregnancy").

[198] 42 U.S.C. § 300gg-41 (2000).

[199] EPICC Act of 2001, S. 104, H.R. 1111, 107th Cong. (2001).

[200] See supra note 132-135 and accompanying text.

[201] Id.

[202] CONTRACEPTION REPORT , supra note 12, at 1; Cooper, supra note 193. The only other hearing was held in 1998. See Insurance Coverage of Contraceptives: Hearings on Insurance Coverage of Contraceptives, S. 766 Before the Senate Comm. on Labor and Human Resources (1998). The committee took no action on the bill following this hearing. Those who testified at the 1998 hearing included Senators Snowe and Reid, who sponsored the bill, a Maryland State Legislature representative, the president of Planned Parenthood, and the past president of the American College of Obstetricians and Gynecologists. See Insurance Coverage of Contraceptives: Witness List, Senate Committee on Labor and Human Resources, Hearing on S. 766 , available at 1998 WL 407260.

[203] See Improving Women’s Health: Why Contraceptive Coverage Matters, Hearing on S. 104 Before the Senate Comm. on Health, Education, Labor and Pensions (2001), available at 2001 WL 26186300 (opening statement of Sen. Mikulski, hearing chair), 2001 WL 26186301 (statement of Sen. Reid), 2001 WL 26186302 (statement of Jennifer Erickson), 2001 WL 26186303 (statement of Anita Nelson, MD), 2001 WL 26186304 (statement of Kate Sullivan), 2001 WL 26186305 (statement of Marcia D. Greenberger) [hereinafter 2001 Hearings ].

[204] See id . Kate Sullivan, from the U.S. Chamber of Commerce, was the only individual to testify against the bill at the hearing, calling it a mandate that will “further increase costs and jeopardize the affordability and availability of health plans for workers." See 2001 WL 26186304. The Chamber, however, opposes all insurance mandates. See Susan A. Cohen, Federal Law Urged as Culmination of Contraceptive Insurance Coverage Campaign , in THE GUTTMACHER REPORT, Oct. 2001, at http://www.guttmacher.org/pubs/journals/gr040510.html.

[205] See 2001 Hearings , supra note 203.

[206] See Cohen, supra note 204.

[207] See Bycott, supra note 4, at 781.

[208] Law, supra note 3.

[209] United States EEOC Decision on Coverage of Contraception, at 4 (Dec. 14, 2000), at www.eeoc.gov/docs/

decision-contraception.html [hereinafter EEOC Decision].

[210] Erickson v. Bartell Drug Co., 141 F. Supp. 2d 1266, 1274 (W.D. Wash. 2001).

[211] Melissa Cole, Beyond Sex Discrimination: Why Employers Discriminate Against Women With Disabilities When Their Employee Health Plans Exclude Contraceptives From Prescription Coverage , 43 ARIZ. L. REV. 501 (2001); cf. Stephen T. Kaminski, Must Employers Pay for Viagra? An Americans with Disabilities Act Analysis Post-Bragdon and Sutton , 4 DEPAUL J. HEALTH CARE L . 73 (2000) (providing a detailed analysis of the possible use of the ADA to mandate insurance coverage of Viagra).

[212] Bergin, supra note 172.

[213] It might also be possible to bring a suit directly against the federal government alleging that the failure to require contraceptive coverage makes ERISA unconstitutional using the Supreme Court decision in Davis v. Passman , 442 U.S. 228 (1979), but no cases have been asserted under this theory thus far. The availability of Title VII as a remedy will most likely render Davis inapplicable and the constitutional argument more difficult, however, and this is discussed more fully below. See infra notes 285-290 and accompanying text.

[214] 42 U.S.C. § 2000e-2(a)(1) (2000).

[215] See Newport News Dock Co. v. EEOC, 462 U.S. 669, 675 (1983).

[216] 42 U.S.C. § 2000e(b).

[217] Id . § 2000e-1(a).

[218] Law, supra note 3, at 384-85; see EEOC v. Fremont Christian School, 781 F.2d 1362 (9th Cir. 1986).

[219] See, e.g. , McDonnell Douglas Corp. v. Green, 411 U.S. 792 (1973). Under the classic disparate treatment scenario the burden of proof shifts between the plaintiff and the defendant. To make a case for disparate treatment, a plaintiff must first make a prima facie showing of discrimination by proving that she belongs to a protected group, applied and was qualified for a job, was rejected, and the position remained open. The defendant must then give a legitimate, nondiscriminatory reason for the action. Plaintiff can then respond by showing that the reason is pretext for actual discrimination. Id. The generic McDonnell Douglas standard does not explicitly apply to benefit plan discrimination claims, but the framework of the plaintiff making a prima facie case of discrimination, the defendant providing a nondiscriminatory reason for the action, and the plaintiff rebutting that reason can be used in these circumstances.

[220] See, e.g. , Griggs v. Duke Power Co., 401 U.S. 424 (1971).

[221] SAMUEL ESTREICHER & MICHAEL C. HARPER, EMPLOYMENT DISCRIMINATION AND EMPLOYMENT LAW 131 (2000).

[222] 42 U.S.C. § 12101 et seq. (2000).

[223] Erickson v. Bartell Drug Co., 141 F. Supp. 2d 1266, 1274 (W.D. Wash. 2001); EEOC Decision, at 4 (Dec. 14, 2000), at www.eeoc.gov/docs/decision-contraception.html.

[224] See EEOC Decision, (Dec. 14, 2000), at www.eeoc.gov/docs/decision-contraception.html.

[225] 42 U.S.C. § 2000e-2(k).

[226] Erickson , 141 F. Supp. 2d 1266.

[227] 429 U.S. 125 (1976).

[228] Id. at 136.

[229] Id . at 138-39.

[230] Id.

[231] Id. at 152-53 (Brennan, J., dissenting).

[232] ESTREICHER & HARPER, supra note 221, at 338.

[233] 42 U.S.C. § 2000e(k) (2000).

[234] See California Fed. Svgs. & Loan Ass’n v. Guerra, 479 U.S. 272, 280 (1987).

[235] Int’l Union, UAW v. Johnson Controls, 499 U.S. 187, 211 (1991).

[236] ESTREICHER & HARPER, supra note 221, at 55.

[237] Id. at 1057; see 42 U.S.C. § 2000e-5(b).

[238] ESTREICHER & HARPER, supra note 221, at 55.

[239] Id. ; see 42 U.S.C. § 2000e-5(g)(1).

[240] See 42 U.S.C. § 2000e-5(f)(1).

[241] Press Release, EEOC, EEOC Issues Decision on Two Charges Challenging the Denial of Health Insurance Coverage For Prescription Contraceptives (Dec. 13, 2000), at http://www.eeoc.gov.press/12-13-00.html.

[242] EEOC, Questions and Answers: Commission Decision on Coverage of Contraception (Dec. 14, 2000), at http://www.eeoc.gov/docs/quanda-decision-contraception.html.

[243] Id .; see 42 U.S.C. 2000e-5(b).

[244] ESTREICHER & HARPER, supra note 221, at 55.

[245] CONTRACEPTION REPORT , supra note 12, at xi.

[246] EEOC Decision, at 1 (Dec. 14, 2000), at www.eeoc.gov/docs/decision-contraception.html.

[247] Id . at 2.

[248] Id.

[249] Id.

[250] Id. at 3.

[251] Id.

[252] Id. at 4.

[253] Id.

[254] Id.

[255] Id. at 5.

[256] Id.

[257] Erickson v. Bartell Drug Co., 141 F. Supp. 2d 1266 (W.D. Wash. 2001).

[258] Id. at 1269. In reference to Congress’s intent with regard to Title VII being unclear, Judge Lasnik repeated the familiar story of the addition of gender discrimination into the Title VII statute. A southern Senator opposed to the Civil Rights Act of 1964, of which Title VII was a part, proposed an amendment adding “sex” to Title VII in the hope that this would effectively “kill” the legislation. Yet he had apparently miscalculated, and all future attempts to remove “sex” from Title VII were unsuccessful. The Congressman ultimately voted against the legislation altogether. Id.

[259] Id . at 1271, 1270.

[260] Id. at 1271. Judge Lasnik emphasized that Title VII does not require that employers offer certain benefits, but does require equity in the benefits an employer chooses to offer. Id. at 1272.

[261] In addition to the defenses discussed above, Bartell also raised two weaker defenses: it asserted that in the many years since the enactment of Title VII, no court has found that excluding contraceptives constitutes sex discrimination, and also that the issue should be decided by the legislature, not the courts. To the former, Judge Lasnik responded that the issue had not been raised until this case, giving no weight to the absence of any judicial support, and to the latter, he simply responded that it is the judiciary’s role to interpret existing laws and apply them to particular facts. Id. at 1275-76.

[262] Id. at 1273. These statistics were discussed above in this paper. See supra notes 68-70 and accompanying text.

[263] Id . at 1274.

[264] Id .

[265] Id. at 1275. For example, the plan excluded prescription contraceptives and infertility drugs, but it did include coverage for prenatal vitamins, which the court asserted could fall within the “family planning” category. Id .

[266] Id .

[267] Id. at 1274.

[268] Id.

[269] CONTRACEPTION REPORT , supra note 12, at xi. The case of Mauldin v. Wal-Mart Stores, Inc. was filed in federal district court in Atlanta, and Washington ACLU and Washington NARAL v. Regence Blue Shield was filed in Washington state court. See id . Furthermore, the federal district court recently denied the defendant’s motion to dismiss in EEOC v. United Parcel Service, Inc. , 141 F. Supp. 2d 1216 (D. Minn. 2001), a case similar to Erickson .

[270] See Cole, supra note 211, at 502 & n.6.

[271] See Kaiser Family Foundation, Federal Judge Rules Seattle-Based Pharmacy Chain Must Cover Prescription Contraceptives for Employees , in KAISER DAILY REPRODUCTIVE HEALTH REPORT, Jun. 13, 2001, at http://www.

kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=5164.

[272] See supra note 86 and accompanying text.

[273] Law, supra note 3, at 396.

[274] 463 U.S. 85 (1983).

[275] Id. at 101.

[276] Law, supra note 3, at 398.

[277] Shaw , 463 U.S. at 108.

[278] Id . at 102.

[279] Id .

[280] See 42 U.S.C. § 2000e-7 (2000).

[281] Shaw , 463 U.S. at 102. The only other case to consider this issue is Champion Int’l Corp. v. Brown , 731 F.2d 1406 (9th Cir. 1984), in which the court repeated the holding in Shaw and held that ERISA preempted a state law regulating employer pension plans that was inconsistent with federal pension plan law. Id . at 1409.

[282] Law, supra note 3, at 399; see also Catherine L. Fisk, ERISA Preemption of State and Local Laws on Domestic Partnership and Sexual Orientation , 8 UCLA WOMEN'S L.J . 267 (1998) (applying a similar analysis to ERISA preemption of state authority to require employers to provide benefits for same-sex couples using the federal Defense of Marriage Act).

[283] CONTRACEPTION REPORT , supra note 12, at xi (stating that after Erickson , “employers that refuse to comply voluntarily with federal law and are not required to comply through a lawsuit will still be able to purchase health plans that exclude contraceptive coverage”).

[284] See Law, supra note 3, at 397-99.

[285] 442 U.S. 228 (1979).

[286] Id . at 230.

[287] Id . at 247.

[288] See Davis, 442 U.S. at 248.

[289] See supra note 85 and accompanying text.

[290] If Erickson is reversed on appeal, however, or if other federal courts rule differently on the Title VII issue, activists may want to consider filing a suit based on the Davis case, particularly in light of Congress’s reluctance to resolve the issue by enacting EPICC. Additionally, those employees whose employers are not covered by Title VII, and who therefore do not share in the benefit of the Erickson decision, may be successful in filing a suit challenging ERISA’s constitutionality.

[291] CONTRACEPTION REPORT , supra note 12, at xi.

[292] Cole, supra note 211; cf. Kaminski, supra note 211 (discussing the coverage of Viagra using an ADA approach).

[293] ESTREICHER & HARPER, supra note 221, at 517; see 42 U.S.C. § 12112(b)(5)(A) (2000).

[294] 42 U.S.C. § 12112(b)(5)(A).

[295] This is especially true given the cost savings that are realized when women increasingly use prescription contraceptives. See supra notes 74-79 and accompanying text.

[296] This illustrates why using the ADA to mandate coverage of Viagra would be a much more sweeping remedy. If impotence may be classified as a disability covered by the ADA, then by definition all men using Viagra would be suffering from a disability, while all women using contraceptives clearly are not. Cf . Kaminski, supra note 211.

[297] 42 U.S.C. § 12102(2)(A).

[298] Cole, supra note 211, at 508. It is less clear whether women who take birth control pills to reduce the pain of cysts or for other medical reasons not related to the danger of pregnancy would fit within the ADA’s definition of substantially limiting a major life activity.

[299] 524 U.S. 624 (1998).

[300] Id. at 641.

[301] 527 U.S. 471 (1999).

[302] Id. at 482.

[303] Cole, supra note 211, at 516 n.95 (citing cases).

[304] Id. at 516-17.

[305] See 42 U.S.C. § 12112(b)(2) (2000).

[306] 29 C.F.R. app. Pt. 1630, § 1630.5 (2000); see Cole, supra note 211, at 544.

[307] 42 U.S.C. § 12201(c).

[308] See Cole, supra note 211, at 558.

[309] See Woman Files Bias Charges Against Airline Over Health Coverage , ASSOCIATED PRESS , Apr. 23, 2001.

[310] 20 U.S.C. § 1681 (2000).

[311] See Bergin, supra note 172.

[312] Id. at 158.

[313] Id. at 169.

[314] Id. at 169-70.

[315] Id.

[316] Id. at 171-72. The University of Wisconsin was the only University to provide comprehensive coverage. Id. at 172 n.86. The University of Minnesota, Ohio State University, Texas A&M, the University of Texas, and the University of Michigan all provide limited coverage. Id . at 172 nn.87, 88. Purdue University, the University of Illinois, Penn State University, New York University, the University of Southern Florida, the University of Arizona, Arizona State University, the University of Florida, and the University of Indiana expressly exclude coverage. Id . at 172 n.89.

[317] 20 U.S.C. § 1681 (2000); see Bergin, supra note 172, at 173-74.

[318] 34 C.F.R. §§ 106.39, 106.40(b)(4) (2000).

[319] Bergin, supra note 172, at 174.

[320] Id. at 175-76.

[321] Id. at 176 & n.110 (citing cases).

[322] Bergin discusses and persuasively refutes four possible defenses that educational institutions may raise to a Title IX challenge in addition to an educational necessity theory: that contraception coverage is not included in the language of Title IX, that Title IX only applies to the actual program receiving federal funds, that Title IX does not apply to the administrative functions of educational institutions, and that Title IX does not apply to third party operations. See Bergin, supra note 172, at 176-90.

[323] HUTT & MERRILL, supra note 55, at 416 n.2.

[324] Id . at 416 n.3.

[325] Id.

[326] 21 U.S.C. §§ 301 et seq. (2000).

[327] HUTT & MERRILL, supra note 55, at 418. The other two components of the definition are “habit forming drugs listed in section 502(d) of the Act and their derivatives” and “drugs limited to prescription sale under an NDA.” Id. These two categories are limited, however, so that consideration of switching a drug to OTC status is generally limited to the part of the definition given in the main text. Id.

[328] Id . at 419.

[329] See Food and Drug Administration, Questions and Answers: Over-the-Counter Drug Products Public Hearing , at http://www.fda.gov/cder/meeting/otcqu-600.htm [hereinafter Questions and Answers ]; HUTT & MERRILL, supra note 55, at 420; see also 21 C.F.R. § 330 (2000). FDA regulations define safety as a “low incidence of adverse reactions or significant side effects under adequate directions for use and . . . low potential for harm . . . from abuse under conditions of widespread availability.” Id. § 330.10(4)(i). Effectiveness is defined as “a reasonable expectation that, in a significant proportion of the target population, the pharmacological effect of the drug, when used under adequate directors for use and warnings against unsafe use, will provide clinically significant relief of the type claimed.” Id. § 330.10(4)(ii).

[330] See Ori Twersky, Going Over-the-Counter? Legislators to Debate Future of the Pill , June 14, 2000, at http://

webmd.lycos.com/content/article/1728.58469; No Prescription for the Pill? , June 29, 2000, at http://www.cnn.com/

2000/HEALTH/women/06/29/pill.prescriptions [hereinafter No Prescription ].

[331] Id .

[332] No Prescription , supra note 330.

[333] Id .

[334] Twersky,supra note 330.

[335] Id . It is also argued that with the great variety in oral contraceptives, a physician is needed to help women choose the specific type of oral contraceptive that is best and safest for her, and that women will be increasingly subject to advertising by manufacturers that may lead them to choose a contraceptive for its other benefits regardless of whether it is appropriate for their physical needs.

[336] As taking the pill daily is vitally important to maintaining its effectiveness, it is argued that women taking the pill without the advice of a physician could actually face a higher risk of pregnancy by not taking it appropriately.

[337] Twersky,supra note 330. One activist has responded to this argument as “discriminatory, degrading, and paternalistic.” Id.

[338] Victoria Stagg Elliott, Move to Non-Stop Use of Oral Contraceptives Stirs Debate , July 31, 2000, at http://www.

ama-assn.org/sci_pubs/amnews/pick_00/hlsb0731.htm.

[339] Twersky,supra note 330 (describing the views of an FDA official).

[340] Id. ; see also FDA, Questions and Answers , supra note 329.

[341] Id .; see also Elliott, supra note 338.

[342] Twersky,supra note 330; Elliott, supra note 338.

[343] Elliott, supra note 338.

[344] Twersky,supra note 330.

[345] See supra note 21 and accompanying text.

[346] See, e.g. , sources citedsupra note 3 and accompanying text (the contraceptive coverage movement); Twersky,supra note 330 (the OTC movement).

[347] Brown, supra note 19, at 26.

[348] Id .; see also Stephen L. Isaacs & Renee Holt, Drug Regulation, Product Liability, and the Contraceptive Crunch: Choices are Dwindling , 8 J. LEGAL MED. 533, 541 (1987).

[349] Brown, supra note 19, at 10 n.55.

[350] Id .

[351] Id . at 32 & n.147. Executives at Monsanto, which acquired Cooper-7’s manufacturer Searle in 1985, reported that they removed the IUD from the market because they were unwilling to risk the company’s assets for the sake of minor products. Id . at 32 n.147. The company spent $1.5 million in one year to successfully defend itself against four lawsuits related to the Copper-7. Annual sales of the Copper-7 were only $11 million, so the company chose to discontinue it. Viscusi, supra note 43; see also Benshoff, supra note 31, at 403 n.1. Ortho’s Paraguard IUD is the only IUD currently on the market. Brown, supra note 19, at 32.

[352] Brown, supra note 19, at 32.

[353] Birenbaum, supra note 38, at 412, 425-30.

[354] Id . at 413, 431.

[355] Benshoff, supra note 31, at 405; Birenbaum, supra note 38, at 413, 424; Brown, supra note 19, at 30.

[356] Carl Djerassi, The Future of Birth Control; Our Present Methods are Outdated — and Unless We Act Now, They'll Never Be Better , WASH. POST , Sept. 10, 1989, at C1.

[357] Brown, supra note 19, at 30.

[358] Viscusi, supra note 43.

[359] Brown, supra note 19, at 45; Birenbaum, supra note 38, at 423. Johnson and Johnson’s Ortho and American Home Products’s Wyeth-Ayerst are the two companies. Id .

[360] See supra notes 47-52 and accompanying text (describing these new contraceptive methods).

[361] Brown, supra note 19, at 30-32.

[362] See id. ; see also Birenbaum, supra note 38, at 424.

[363] Manufacturers of the Copper-7 IUD and of Norplant were both successful in nearly all of the suits brought against them, but expended large amounts of money in defending themselves. See Viscusi, supra note 43 (Copper-7); Birenbaum, supra note 38, at 430-31 (Norplant).

[364] See Benshoff, supra note 31, at 405.

[365] Birenbaum, supra note 38, at 411. As an example, American Home Products spent 114 million on testing Norplant before introducing it to the market. Id .

[366] Benshoff, supra note 31, at 405; see also Brown, supra note 19, at 34. Both Norplant and IUDs are prominent examples. See supra note 354 and accompanying text (Norplant); 351 and accompanying text (IUD).

[367] Birenbaum, supra note 38, at 424.

[368] Id . at 430-31. Birenbaum describes how many of the women who sued American Home Products testified that they had kept their Norplant implants, or that they had planned to get a second five-year Norplant inserted after the litigation. Id .

[369] Id .

[370] Id .

[371] See, e.g. , Brown, supra note 19, at 42-45; Benshoff, supra note 31, at 409-16.

[372] Pub. L. No. 99-660, 100 Stat. 3755 (1987) (codified at 42 U.S.C. § 300aa-1 (2000)).

[373] Benshoff, supra note 31, at 413-14.

[374] See HUTT & MERRILL , supra note 55, at 719.

[375] Id .

[376] Id . For a more specific discussion of the various provisions of the Act, see id .; Benshoff, supra note 31, at 413-15; Brown, supra note 19, at 1-12.

[377] 26 U.S.C. § 4131(a) (2000); see HUTT & MERRILL , supra note 55, at 719.

[378] Brown, supra note 19, at 2.

[379] See, e.g. , Brown, supra note 19, at 3.

[380] Benshoff, supra note 31, at 430. This fact is important, because the determination of whether the establishment of such a scheme is warranted is clearly impacted by whether it would lead to an increase in the price of contraceptives and would thus impose an added burden on all the women who use them.

[381] Brown, supra note 19, at 42-45.

[382] Id . The IUD is the only prescription contraceptive that has essentially been driven from the market.

[383] Benshoff, supra note 31, at 409.

[384] Id .

[385] Id . at 408.

[386] Evidence of the success of the movement to mandate coverage of prescription contraceptives may be used to support the assertion that ensuring effective and safe contraceptives is indeed a national priority.

[387] Benshoff, supra note 31, at 413-30. In addition to the Childhood Vaccine Injury Act, Benshoff discusses the Price-Anderson Act, used to encourage entry into nuclear energy development, as well as the Virginia Birth-Related Neurological Injury Compensation Act and the Longshore & Harbor Workers Compensation Act as models of past no-fault liability systems. See id .

[388] For detailed descriptions of the campaign, see http://www.covermypills.org.

[389] See Planned Parenthood, All it Takes is One Person , at http://www.covermypills.org/action.

[390] See Planned Parenthood, Tell Your Story , at http://www.covermypills.org/story/archive.asp (detailing the many successes that women have had when asking their employers to provide contraceptive coverage).

[391] See Planned Parenthood, Fair Access to Contraception on Campus , at http://www.covermypills.org/facts/

campus.asp. In the limited time since the University campaign has begun, New York University and the University of Virginia have added contraceptive coverage to their student health plans in response to student petitions, and the University of Illinois has added contraceptive coverage for its employees. Id .

[392] CONTRACEPTION REPORT , supra note 12, at 3 (quoting Carolyn Jacobson, director of the Coalition of Labor Union Women’s Contraceptive Equity Project).

[393] Gloria T. Johnson, President’s Letter , Jan. 2, 2002, at http://www.cluw.org/presidentletter.html. The International Association of Machinists & Aerospace Workers and the American Federation of State, County and Municipal Employees also support contraceptive coverage. See CONTRACEPTION REPORT , supra note 12, at 3; IAM, Contraceptive Coverage Alert , at http://www.goiam.org/visit.asp?c=2023.

[394] Id .