Friday, December 13, 2013

Hobby Lobby Part II -- What’s it all about?

Marty Lederman

Are the Hobby Lobby and Conestoga Wood cases about employee health insurance plan coverage of contraception, writ large, or—as the plaintiffs in those two cases would have it—“only” about coverage of “abortifacients,” or about four discrete forms of birth control?  Something less?  Something more?

As I'll try to explain in this post, the cases do not, in truth, have anything to do with abortion or “abortifacients” as those terms are generally understood under federal law or in the medical and scientific communities.  Beyond that, however, it is hard to know for certain exactly which forms of birth control are specifically challenged in these two cases.  Nevertheless, what is clear is that the Supreme Court’s decision in these cases could implicate legal requirements imposed upon for-profit employers that reach well beyond any particular birth-control methods—indeed, beyond contraception itself.

As I noted in my opening post, the plaintiffs in the two cases before the Court allege that the “Preventive Services” Rule, issued by the Departments of Health and Human Services, Labor and Treasury, “substantially burdens” their exercise of religion for purposes of RFRA based on the following logic: 
(i) federal law requires the companies in question to offer their employees access to a medical insurance plan;

(ii) the HHS Rule requires such an insurance plan to provide for coverage of “abortifacients”;

(iii) the companies’ provision of such insurance coverage would require the individual owners of the companies to “participat[e] in, provid[e] access to, pay[] for, train[] others to engage in, or otherwise support[] [the use of] abortion-causing drugs and devices”; and

(iv) the owners’ religions forbid them from doing so, because such actions make them “complicit” in their employees’ eventual use of “abortifacients.”
In my next post, I will examine the fundamental predicate of the plaintiffs’ argument—number (i) above—which is that federal law requires large employers to offer their employees access to a medical insurance plan, upon threat of serious sanction.

And in future posts, I’ll discuss whose exercise of religion is at stake in these cases—the corporations’, the individual plaintiffs’ as owners of the companies, or the individual plaintiffs’ as managers of those companies; whether the plaintiffs have carried their burden of showing a “substantial burden” on that religious exercise; and, if so, whether the government can justify denials of exemptions under the RFRA test.

In this post, however, I start with a discussion of the second step in plaintiffs’ argument—their assertion that the HHS Rule requires an employee health insurance plan to provide for coverage of “abortifacients.”

1.  Let’s begin with what the challenged HHS Rule requires.  As I’ll discuss in my next post, neither the HHS Rule nor any other federal law requires employers to offer a health-care plan to their employees.  What the Rule does, instead, is to specify certain coverage that must be contained in such plans that are offered.

Even prior to 2010, federal law required that group health insurance plans include coverage for several things, such as minimum hospital stays for mothers and newborns after birth, 29 U.S.C. § 1185; reconstructive breast surgery if the plan otherwise covers mastectomies, id. § 1185b; and routine patient costs for items and services furnished in connection with participation in certain clinical trials, 42 U.S.C. § 300gg-8. 

The ACA made a significant addition to this list:  Congress decided that virtually all Americans should be entitled to a wide array of affordable “preventive health services.”  Many people receive such services through Medicare, or Medicaid, or by purchasing a plan (often with substantial government subsidies) on a government-run “exchange.”  But many Americans receive their health insurance from a plan offered by their employers.  Accordingly, the ACA requires that such employer plans--like all other plans--include the specified “preventive health services,” which must be made available without cost-sharing, that is, without requiring plan participants and beneficiaries to make copayments or pay deductibles or coinsurance.  Id. § 300gg-13.  These services include:  cholesterol screening; colorectal cancer screening; diabetes screening for those with high blood pressure; certain immunizations; and “evidence-informed preventive care and screenings” for infants, children, and adolescents.

Most importantly for present purposes, the ACA also requires coverage “with respect to women, [of] such additional preventive care and screenings . . . as provided for in comprehensive guidelines supported by the Health Resources and Services Administration.”  Id. § 300gg-13(a)(4).  This particular addition was based upon a legislative record showing that “women have different health needs than men, and these needs often generate additional costs.”  155 Cong. Rec. 29,070 (2009) (statement of Sen. Feinstein).  As Judge Rovner explained in her dissenting opinion in a recent case,
In proposing the amendment, Senator Mikulski noted that many women forego preventive screenings for the conditions that statistically are most likely to result in their death — breast, cervical, colorectal, ovarian and lung cancer, and heart and vascular disease — either because they lack insurance, the services are not covered by their insurance plans, or because the large copayments required by their insurance companies for these screenings are beyond their financial means.  “Women of childbearing age incur 68 percent more out of pocket health care costs than men,” she pointed out. “My amendment guarantees access to critical preventive screening and care for women to combat their number one killers and provides it at no cost. This amendment eliminates a big barrier of high copayments.”
As noted above, the list of covered preventive care and screenings for women is to be derived from “comprehensive guidelines supported by the Health Resources and Services Administration,” or HRSA.  On August 1, 2011, HRSA adopted and released those Guidelines, which were based upon assessments made in a study by the Institute of Medicine.  HRSA determined that plans should include coverage without cost-sharing for: specified annual well-woman visits; gestational diabetes screening; HPV DNA testing; testing for sexually transmitted diseases and HIV screening and counseling; breastfeeding support, supplies and counseling; domestic violence screening and counseling; and . . . “all Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education and counseling for women with reproductive capacity.”

The FDA has approved 20 contraceptive methods and sterilization procedures.  Under the HHS Rule, group health plans must provide coverage without cost-sharing for 18 of these 20 methods and procedures.  The required coverage extends to:
-- the female condom
-- the diaphragm
-- the sponge
-- the cervical cap
-- spermacide
-- the “combined pill” (with estrogen and progestin)
-- the progestin-only “mini-pill”
-- the “extended/continuous use” pill
-- the patch
-- the vaginal ring
-- a progestin shot
-- Plan B and other levonorgestral-based pills
-- ella (a pill with ulipristal acetate)
-- the copper IUD
-- a levonorgestrel-releasing IUD with progestin
-- an implantable rod
-- female sterilization surgery; and
-- a female sterilization implant
(Presumably because the statute itself refers to preventive care “with respect to women,” HHS does not require coverage of the other two FDA-approved birth-control methods:  condoms and vasectomies.)

2.  Let’s turn next to what the plaintiffs in these two cases object to covering in their employees’ health insurance plans.

As I explained in my initial post, the heart of the plaintiffs’ claims in these two cases is that the HHS Rule will require the owners of the two companies to be complicit in (in Hobby Lobby’s words, to “participate in, provide access to, pay for, train others to engage in, or otherwise support”) the use of what they refer to as “abortion-causing drugs and devices,” or “abortifacients.”

Now, as far as scientific and medical understandings are concerned—and, more to the point, as far as understandings under federal law are concerned—this is a null set, because none of the covered 18 forms of FDA-approved birth control involves abortion.  Indeed, the HRSA-approved list could not include drugs that cause abortions, because plans must include what’s on the HRSA list, and the Act itself specifically allows plans to exclude abortion services.  42 U.S.C. § 18023(b)(1).

So are these cases about nothing at all?

No, they are certainly about something—but only because of the particular religious beliefs of the plaintiffs, not because they in fact involve “abortifacients.”  Both sets of plaintiffs allege that, in their view, human life begins at the point where an egg and sperm unite, even before the embryo is implanted in the uterine wall, and that it is immoral to take steps to “terminate” such human life, even by preventing the embryo’s implantation.  (See, e.g., paragraph 109 of the Hobby Lobby complaint, and paragraphs 30 and 92 of the Conestoga Wood complaint.)

In medical and scientific circles, preventing implantation is not an abortion.  Federal law adopts the same understanding—namely, that an abortifacient works by destroying an embryo already implanted in the uterine lining.  (Federal law doesn’t define “abortion,” as such; but a long-established federal regulation defines a “pregnancy” to “encompass[] the period of time from implantation until delivery.” 45 C.F.R. 46.202(f).  See also 62 Fed. Reg. 8610, 8611 (Feb. 25, 1997) (“Emergency contraceptive pills are not effective if the woman is pregnant; they act by delaying or inhibiting ovulation, and/or altering tubal transport of sperm and/or ova (thereby inhibiting fertilization), and/or altering the endometrium (thereby inhibiting implantation).”)

The plaintiffs, by contrast, do call such implantation-prevention an “abortion,” and thus they denominate drugs that prevent implantation “abortifacients,” even though the legal, medical and scientific communities do not treat them as such.

In the end, plaintiffs’ unconventional terminology does not matter for purposes of their RFRA claim:  Wholly apart from questions of nomenclature, plaintiffs appear to sincerely believe it is immoral to deliberately use a drug or device that prevents implantation of an embryo.  And therefore they are challenging the HHS Rule only as it applies to such drugs or devices.

OK, so which of the 18 forms of FDA-approved birth control covered by the HHS Rule prevent embryo implantation? 

Well, that’s uncertain.  As far as I know, none of the 18 methods primarily operates by preventing implantation.  Indeed, my understanding is that it is not conclusively established that any of them does.

Hobby Lobby nevertheless objects to four of these 18 methods because they might prevent implantation:  the copper IUD, the levonorgestrel-releasing IUD with progestin, and two “emergency” contraceptive drugs, Plan B and ella.  In support of this list, Hobby Lobby cites the FDA’s own website

That FDA website states that Plan B and ella work “mainly” by preventing the release of an egg from the ovary; that the copper IUD “prevents sperm from reaching the egg, [and] from fertilizing the egg”; and that the progestin-based IUD “may thicken the mucus of [the] cervix, which makes it harder for sperm to get to the egg.”  Plaintiffs do not object to such contraceptive functions of these birth-control methods—that is to say, they do not object to the primary ways in which these methods work. The FDA site also states, however, that Plan B “may” prevent implantation of an embryo “by changing the lining of the womb”; that ella “may also work by changing the lining of the womb (uterus) that may prevent attachment (implantation)”; that the copper IUD “may prevent the egg from attaching (implanting) in the womb (uterus)”; and that the progestin-based IUD “thins the lining of [the] uterus” (without mention of preventing implantation).

The FDA’s statements about the possibility of Plan B and ella preventing implantation are open to serious question.  One amicus brief, for instance, argues that recent studies have demonstrated that Plan B “does not cause changes to the endometrium (uterine lining) that would hamper implantation,” and that although whether ella has an effect sufficient to prevent implantation of a fertilized egg “is unknown,” there is “no scientific evidence showing” that it is able to prevent implantation, either.

Even so, the Hobby Lobby plaintiffs claim that the very risk of such effect renders it religiously impermissible for them to facilitate use of those four drugs.  In other words, they appear to be arguing, not only that their religion prohibits the use of any drug or device that has a remote chance of preventing implantation of the embryo, but also that their religion prohibits the Hobby Lobby owners/managers from providing (or paying for) a health-care plan that some employees may use to subsidize purchase of such drugs, because in some unknown but small percentage of cases the use of such drugs might result in implantation-prevention. 

As for the Conestoga Wood complaint, it mentions Plan B and ella in passing, but it does not otherwise explain which of the FDA-approved birth control methods the Conestoga Wood owners consider to be objectionable “abortifacients”; it simply refers more vaguely to “several drugs or devices that may cause the demise of an already conceived but not yet attached human embryo.”  Therefore there is no way of knowing at this early stage of the litigation which forms of birth control are at stake in the Conestoga Wood case—even by the plaintiffs’ own lights.  Perhaps it’s the four methods identified by Hobby Lobby . . . or fewer; or perhaps even more:  For example, although the FDA website doesn’t mention it, the FDA-approved labeling for Seasonale, a birth-control pill, reads:  “Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and changes in the endometrium (which reduce the likelihood of implantation.”  Is Seasonale a potential “abortifacient” in the eyes of Conestoga Wood’s owners?  We don’t yet know.  What we do know is that there are plenty of groups (and presumably employers) out there who think that more than four of the FDA-approved methods of birth control are morally problematic because they might prevent implantation of the embryo in some case:  See, for example, this website, concluding that ten or more of the methods involve “embryocide.”

In sum, these two cases nominally involve objections to at least four of the 18 FDA-approved forms of birth control covered by the HHS Rule—the two types of IUDs, ella and Plan B—even though none of them is, in fact, an abortifacient as that term is understood in the law and in the medical and scientific communities, even though none of them primarily works by preventing embryo implantation, and even though there is little or no evidence that some of those methods ever prevent pregnancy by inhibiting implantation.  

But the two cases might involve even more than four of the 18 FDA-approved methods—perhaps most of them.  Alternatively, it might turn out, after discovery and the courts’ assessment of the evidence, that even on plaintiffs’ own RFRA theories, they would be entitled to exemptions for fewer than four of the methods—if, for example, the trial courts were to conclude that there is no evidence that some of those methods prevent implantation of an embryo. 

The plaintiffs’ claims might also raise a bunch of thorny issues of implementation:  Would the exemption extend, for instance, to cases in which employees use birth control in a manner that is virtually certain not to result in prevention of implantation (such as timely use of an IUD, which ought to prevent fertilization before implantation could ever be an issue)?    

3.  On the other hand . . . although the scope and implementation of possible exemptions for these particular plaintiffs might be uncertain and speculative at this very preliminary stage of the litigation, the implications for what is at stake in the Supreme Court’s decision certainly extend well beyond any particular birth-control methods—indeed, beyond contraception itself.

Several of the other plaintiffs who have brought challenges to the HHS Rule, for instance—including most or all of the Catholic objectors—object to each and every form of FDA-approved contraception, because they claim that their religious teachings condemn contraception as such.  If the Court were to rule in favor of Hobby Lobby and Conestoga Wood, then, the decision might well require the government to afford RFRA exemptions to other for-profit employers to permit exclusion of all contraceptives and sterilization procedures from their employee plans.

Nor is the case only about contraception.  It is very easy to contemplate employers who have religious objections to other forms of mandated preventive health services, such as vaccinations for chicken pox, Hepatitis A, and Rubella.  Others may object to coverage of routine patient costs for items and services furnished in connection with participation in certain clinical trials.  (This last example, and others along this slippery slope, are described in much greater detail at pages 68-77 of Judge Rovner’s dissenting opinion in the Seventh Circuit’s recent Korte decision.)

Indeed, the impact of the Court's decision will hardly be limited to preventive care, or health insurance, either.  Federal law imposes countless requirements and restrictions on for-profit employers, many of which conflict with sincerely held religious views of the owners or managers of the regulated enterprises.  A ruling in favor of plaintiffs here, then, could presage RFRA claims for “myriad exceptions flowing from a wide variety of religious beliefs,” U.S. v. Lee, 455 U.S. at 260, in the commercial sphere.

In one of his posts, Eugene Volokh stresses that, under RFRA, a court is not ordinarily supposed to consider the costs of exemptions beyond those specifically sought by the plaintiffs before the court: 

Under RFRA, it’s not enough for the government to point to how the Affordable Care Act writ large supposedly protects health.  Nor is it enough for the government to point to how the coverage for contraceptives generally would protect health.  Rather, the question is whether denying the limited religious exemption that is being sought here — the exemption for the particular potentially implantation-preventing contraceptives to which the claimants object — would undermine a compelling interest in protecting health, so that denying the exemption would be the “least restrictive means” of protecting health. “RFRA requires the Government to demonstrate that the compelling interest test is satisfied through application of the challenged law ‘to the person’ — the particular claimant whose sincere exercise of religion is being substantially burdened.”  (quoting from the Court’s O Centro decision).

In the ordinary case (such as O Centro itself), that may well be the proper method of RFRA adjudication, at least for a lower court.  In this case, however, the Supreme Court will almost certainly be taking a wider view, for at least two reasons. 

First, both of these cases come to the court at a very preliminary stage, before any discovery has been taken and without any factual findings.  Therefore, as explained above, we don’t even know which forms of birth control would be covered by the exemptions sought by the plaintiffs.  (What if it turned out that none of the methods in question actually prevent implantation, for instance?  What if most of the 18 methods could do so, at least in theory?)  Nor will the Court know exactly how and to what extent the government’s interests—and women’s health and economic equality—would be implicated by an employee plan that covered some particular forms of contraception and not others, a question that the trial courts have not yet considered.  So, to the extent the case truly were only about the exemptions sought by the plaintiffs in these two cases, the case would hardly be ripe for the Court’s consideration.

Second, and more fundamentally, there have been a slew of cases filed by for-profit employers against the HHS Rule (45, by the Becket Fund’s count); and presumably the Court granted the petitions in these two particular cases in order to afford some significant guidance to the lower courts in resolving those dozens of other cases.  A decision limited to the RFRA balancing in the idiosyncratic circumstances of particular employers objecting to so-called “implantation-preventing contraceptives” would be unlikely to resolve the hard questions in those other cases—most of which involve more categorical objections to all manner of contraception.

For these reasons, I doubt the Court will limit its analysis to forms of birth control to which these plaintiffs object.  Its rationale is likely to extend to religious objections to all forms of contraception, at a minimum . . . and perhaps further still.