United States Conference of Catholic Bishops
Comment on Interim Final Rules
Regulation 45 CFR Part 147 (2011)
1. As the FDA's own medical advisers
explained long ago: "The oral contraceptives present society
with problems unique in the history of human therapeutics. Never
will so many people have taken such potent drugs voluntarily
over such a protracted period for an objective other than for
control of disease." U.S. Food and Drug Administration, Advisory
Committee on Obstetrics and Gynecology, Report on the Oral
Contraceptives 1 (1966).
2. By "the mandate," we are referring, of course, only to the
requirement that health plans cover
contraceptives, sterilization, and related education and
counseling. We are not referring to the
entire list of preventive services for women. Moreover, our
references to the HHS mandate and
the HHS exemption should be taken as applying to all three
departments that issued the interim
final rule. Any relief requested here from HHS is sought from
all three departments.
3. These earlier comments are also available
4. U.S. Food and Drug Administration,
"FDA Drug Safety
Communication: Safety Review of
possible increased risk of blood clots with birth control pills
containing drospirenone" (May 31, 2011).
5. R. Heffron, et al., "Hormonal contraceptive use and risk of
HIV-1 transmission: a prospective
cohort analysis," Abstract, 6th IAS Conference on HIV
Pathogenesis, Treatment and Prevention,
International AIDS Society (July 17-20, 2011) (available at
http://pag.ias2011.org/abstracts.aspx?aid=1715). As long ago as
1999, an NIH-funded analysis
of 28 prior studies found "a significant association between
oral contraceptive use and HIV-1
seroprevalence or seroincidence." C. Wang, et al.,
"Risk of HIV
Infection in Oral Contraceptive
Pill Users: A Meta-analysis," 21 Journal of Acquired Immune
Deficiency Syndromes (1999), 51-58 at 51.
6. Since 1997, at least 21 bills have been introduced in Congress
to mandate prescription
contraceptive coverage in private health plans (generally to
apply to plans that have other
prescription drug coverage), under the titles "Equity in
Prescription Insurance and Contraceptive
Coverage Act" or "Prevention First Act." A Senate committee
hearing was held on two of these
bills-in 1998 and then in 2001. No committee or subcommittee of
Congress has ever reported
out any of these 21 bills.
7. The state contraceptive mandates and exemptions are listed in
8. Here we address the HHS mandate. Equally radical is the undue
narrowness of the HHS
exemption, addressed below. Each problem, of course, exacerbates
10. The drug in question is ulipristal (HRP 2000, or Ella). See
A. Tarantal, et al., "Effects of Two
Antiprogestins on Early Pregnancy in the Long-Tailed Macaque
(Macaca fascicularis)," 54
Contraception 107-115 (1996), at 114 ("studies with mifepristone
and HRP 2000 have shown
both antiprogestins to have roughly comparable activity in
terminating pregnancy when
administered during the early stages of gestation"); G.
Bernagiano & H. von Hertzen, "Towards
more effective emergency contraception?", 375 The Lancet 527-28
(Feb. 13, 2010), at 527
("Ulipristal has similar biological effects to mifepristone, the
antiprogestin used in medical
11. For the most recent enactment of the Weldon amendment, see
Act, 2010, Pub. L. 111-117, Div. D, Â§ 508(d) (Dec. 16, 2009).
The amendment remains in legal
effect through a series of Continuing Resolutions.
12. A plan claiming the protection of the Weldon amendment is not
required to assert a religious
or moral objection to abortion or abortion referral. This is
clear from the statutory text; the
amendment says nothing about religious or moral objections. The
government simply may not
create a mandate for involvement in abortion services that would
discriminate against plans that
decline such involvement for any reason.
13 Those states are Arizona, Idaho, Kentucky, Louisiana,
Mississippi, Missouri, North Dakota,
Oklahoma, Rhode Island, Tennessee, and Virginia. See Ariz. Rev.
Stat. Â§ 20-121; Idaho Code Â§Â§41-1848, 41-2142, 41-2210A, 41-3439; Ky. Rev. Stat. Ann. Â§
304.5-160; La. Stat. Ann. tit. 22 Â§1014; Miss. Code Â§Â§ 41-41-95 to 41-41-99; Mo. Ann. Stat. Â§
376.805; N.D. Cent. Code Â§ 14-02.3-03; Okla. Stat. Ann. tit. 63, Â§ 1-741.3; R.I. Stat. Â§
27-18-28; Tenn. Code Ann. Â§ 56-26-134;Va. Acts 2011, c. 823.
14. In this section, we address only the legal defects in the HHS
mandate. In a later section of
these comments, we address similar defects in the HHS exemption.
15. See Guttmacher Institute,
"In Brief: Fact Sheet: Facts on
Contraceptive Use in the United
States" (June 2010) ("Nine in 10
employer-based insurance plans cover a full range of
prescription contraceptives" in the United
16. Indeed, some have defended the mandate precisely on the
grounds that the great majority of
secular employers already purchase contraceptive coverage,
indicating that a central goal of the
mandate is to force those with moral or religious objections to
do the same.
17. The fact that the mandate's coercion is
targeted is further obscured by those who, without a hint of
irony, would describe the mandated abortion, contraception, and
sterilization as "free." See, e.g., Jenny Gold,
"Free Birth Control For Many, Courtesy of HHS," Kaiser
Health News (Aug. 1, 2011); Althea Fung, "HHS
Require Free Preventive
Services for Women," National Journal (Aug. 2, 2011). But these "services" never have been, and never will
will always have to pay for them. The only difference after the
mandate is that those who pay
for the "services" will now include people and groups who object
to them in conscience. Calling
the coverage "free" leaves the impression that there is no
longer any bill to pay at all; in reality,
the same bill is being newly foisted on those with moral and
religious objections to paying it.
18. This line of cases was left intact by
Employment Division v.
Smith, 494 U.S. 872 (1990),
which otherwise significantly narrowed the range of claims
triggering strict scrutiny under the
Free Exercise Clause. Id. at 877. See infra Section
19. While some may defend the mandate by citing a government
interest in reducing unintended
pregnancies and abortions, there is ample evidence that programs
advancing ready access to
contraceptives fail to serve that interest. See USCCB
Secretariat of Pro-Life Activities,
Sheet: Greater Access to Contraception Does Not Reduce
Abortions" (Mar. 17, 2011),
"Fact Sheet: Emergency Contraception Fails to Reduce Unintended
Pregnancy and Abortion"
(Apr. 6, 2011).
In an analysis of 23 published studies from 10 countries, not
one study showed easier access to
"emergency contraception" achieving any statistically
significant reduction in rates of
unintended pregnancy or abortion. E. Raymond et al., "Population
Effect of Increased Access to
Emergency Contraceptive Pills," Obstetrics & Gynecology 109
20. The decision to issue the mandate as part of an interim final
(rather than proposed) rule raises
additional questions under the APA. Given the concerns express
here, we obviously disagree
with HHS's assessment that it was in the "public interest" (76
Fed. Reg. at 46624) to have issued
the mandate at all, let alone as an interim final rule. HHS gave
the public no prior notice of the
mandate, and the public interest was not served by waiving the
usual notice and comment period.
21. It bears repeating that these state contraceptive mandates do
not apply to all plans; thus, all of
them are less sweeping than the HHS mandate. See supra Section
22. HHS should clarify why the fourth prong includes a reference
to Section 6033(a)(1). That
provision deals with all Form 990 filers. Subsections
(a)(3)(A)(i) and (iii), however, collectively
relate to churches, their integrated auxiliaries, conventions or
associations of churches, and the
exclusively religious activities of any religious order.
23. ACLU Press Release,
Applauds CA Supreme Court Decision Promoting Women's Health and
Ending Gender Discrimination in Insurance Coverage" (Mar. 1,
2004) ("The ACLU crafted the statutory exemption [at issue]â€¦.").
24. Citations are provided in Addendum B.
25. Arizona, Arkansas, Connecticut, Delaware, Hawaii, Maine,
Missouri, Nevada, New Jersey, New Mexico, New York, North
Carolina, Oregon, Rhode Island,
West Virginia, Wisconsin, and Michigan. Our count includes only
those states with conscience
protection set out in the state contraceptive mandate itself.
The number of states with a
conscience exemption from a state contraceptive mandate may
actually be higher than 19, if one
takes into account freestanding state conscience provisions. For
example, Illinois has a
contraceptive mandate, but also has a law relieving health care
payers of any liability for
declining to pay for or arrange for the payment of any health
care service that violates that
payer's conscience. Ill. Comp. Stat. Ann. Â§ 70/11.2.
26. California, New York, and Oregon.
27. Arizona, Arkansas, Connecticut, Delaware, Hawaii, Maryland,
Missouri, New Mexico, North
Carolina, Rhode Island, West Virginia, and Michigan. Five other
states (Maine, Massachusetts,
Nevada, New Jersey, and Rhode Island) have an exemption that is
broader in some respects,
narrower in others.
28. Arizona, Connecticut, Delaware, Maine, Maryland,
Massachusetts, Missouri, Nevada, New
Jersey, New Mexico, Rhode Island, and West Virginia.
29. Connecticut, Delaware, Hawaii, Maine, Maryland,
Massachusetts, Missouri, Nevada, New
Jersey, New Mexico, Rhode Island, and West Virginia.
30. Arkansas, Connecticut, Delaware, Maine, Maryland,
Massachusetts, Missouri, Nevada, New
Jersey, New Mexico, North Carolina, Rhode Island, and West
31. Arkansas, Connecticut, Delaware, Hawaii, Maine, Maryland,
Missouri, Nevada, New Jersey, New Mexico, North Carolina, Rhode
Island, and West Virginia.
32. For the most recent enactment, see Consolidated
Appropriations Act, 2010, Pub. L. No. 111-117, Div. F, tit. III ("Provided further, That in awarding
grants for natural family planning under
section 104 of the Foreign Assistance Act of 1961 no applicant
shall be discriminated against
because of such applicant's religious or conscientious
commitment to offer only natural family
33. For the most recent enactment, see id., Div. C, tit. VII, Â§
728 ("Nothing in this section shall
apply to a contract with â€¦ any existing or future plan, if the
carrier for the plan objects to such
coverage on the basis of religious beliefsâ€¦ In implementing this
section, any plan that enters
into or renews a contract under this section may not subject any
individual to discrimination on
the basis that the individual refuses to prescribe or otherwise
provide for contraceptives because
such activities would be contrary to the individual's religious
beliefs or moral convictions").
34. For the most recent enactment, see id., Div. C, tit. VIII, Â§
811 ("Nothing in this Act may be
construed to prevent the Council or Mayor of the District of
Columbia from addressing the issue
of the provision of contraceptive coverage by health insurance
plans, but it is the intent of
Congress that any legislation enacted on such issue should
include a 'conscience clause' which
provides exceptions for religious beliefs and moral
35. These are only examples. A fuller compendium of federal
conscience laws and regulations is
36. It will not be lost upon impressionable students that their
religiously-affiliated school says one
thing about the moral status of contraception and sterilization
but practices quite another in
providing coverage for those very items.
37. See supra Section
38. Larson v. Valente, 456 U.S. 228 (1982) (the government may
not pick and choose among
different religious organizations when it imposes some burden);
Church of Lukumi Babalu Aye v.
Hialeah, 508 U.S. 520 (1993) (government may not target one
religion for a particular burden); Wilson v. NLRB, 920 F.2d 1282 (6th Cir. 1990) (holding that
section 19 of the National Labor
Relations Act, which exempts from mandatory union membership any
employee who "is a
member of and adheres to established and traditional tenets or
teachings of a bona fide religion,
body, or sect which has historically held conscientious
objections to joining or financially
supporting labor organizations," is unconstitutional because it
discriminates among religions and
would involve an impermissible government inquiry into religious
tenets), cert. denied, 505 U.S.
39. Our discussion of the church plan exemption is not intended
to suggest that such an exemption
would be adequate. Indeed, such an exemption would be
inadequate, because it would fail to
protect many stakeholders with a moral or religious objection to
contraceptives or sterilization,
including individuals, insurers, and even many
40. As was true of the HHS mandate, the failure to allow the
usual notice and comment as to the
HHS exemption raises additional questions under the APA.