United States Conference of Catholic Bishops
Comment on Interim Final Rules
Regulation 45 CFR Part 147 (2011)

---

Notes

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 online.

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 https://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 Addendum B.

8.  Here we address the HHS mandate. Equally radical is the undue narrowness of the HHS exemption, addressed below. Each problem, of course, exacerbates the other.

9.  See https://www.healthcare.gov/news/factsheets/womensprevention08012011a.html.

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 abortion").

11. For the most recent enactment of the Weldon amendment, see Consolidated Appropriations Act, 2010, Pub. L. 111-117, Div. D, § 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. § 20-121; Idaho Code §§41-1848, 41-2142, 41-2210A, 41-3439; Ky. Rev. Stat. Ann. § 304.5-160; La. Stat. Ann. tit. 22 §1014; Miss. Code §§ 41-41-95 to 41-41-99; Mo. Ann. Stat. § 376.805; N.D. Cent. Code § 14-02.3-03; Okla. Stat. Ann. tit. 63, § 1-741.3; R.I. Stat. § 27-18-28; Tenn. Code Ann. § 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 States).

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 Regulations Require Free Preventive Services for Women," National Journal (Aug. 2, 2011). But these "services" never have been, and never will be, free-someone 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 I.D.3.

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, "Fact Sheet: Greater Access to Contraception Does Not Reduce Abortions" (Mar. 17, 2011), and "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 (2007): 181-8.

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 I.B.

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, "ACLU 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]….").

24. Citations are provided in Addendum B.

25. Arizona, Arkansas, Connecticut, Delaware, Hawaii, Maine, Maryland, Massachusetts, 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. § 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 Virginia.

31. Arkansas, Connecticut, Delaware, Hawaii, Maine, Maryland, Massachusetts, Michigan, 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 planning").

33. For the most recent enactment, see id., Div. C, tit. VII, § 728 ("Nothing in this section shall apply to a contract with … any existing or future plan, if the carrier for the plan objects to such coverage on the basis of religious beliefs… 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, § 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 convictions").

35. These are only examples. A fuller compendium of federal conscience laws and regulations is available at https://old.usccb.org/prolife/issues/abortion/crmay08.pdf.

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 I.D.

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. 1218 (1992).

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 religiously-affiliated organizations.

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.