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June

15, 2012

Submitted Electronically Centers for Medicare & Medicaid Services Department of Health and Human Services, Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re: Advance notice of proposed rulemaking (ANPRM), 77 Fed. Reg. 16501 (Mar. 21, 2012), File Code No. CMS-9968-ANPRM; relative to the underlying Certain Preventive Services under the Affordable Care Act (Mandate), finalized at 77 Fed. Reg. 8725 (Feb. 15, 2012). Dear Sir or Madam: Bioethics Defense Fund and Life Legal Defense Foundation, two public-interest legal organizations whose mission is to advocate for the dignity of human life and the fundamental freedom of conscience, submit Section 1 of this comment on behalf Rev. Thomas V. Berg, PhD, chair of moral theology at St. Josephs Seminary in Yonkers, New York; and James C. Capretta, a public policy expert and Fellow at the Ethics and Public Policy Center in Washington, D.C. Section 2 of this comment is submitted on behalf of Maureen L. Condic, PhD, a research scientist and professor of human embryology at the University of Utah.1 This comment addresses two foundational issues concerning the Administrations insistence that the mechanism for providing free access to contraceptives, sterilization and abortion-inducing drugs must be through private employers group insurance, with an extremely narrow religious exemption that is both unworkable2 and unlawful. The two issues we address are as follows: 1 This comment is presented on behalf of Dr. Maureen L. Condic in her individual capacity; 2Nikas and Bordlee, Three Things Everyone Should Know about the HHS Mandate, National Review Online (Feb. 7, 2012), available at http://www.nationalreview.com/corner/290366/three-things-everyone-should-know- about-hhs-mandate-nikolas-t-nikas (A religious employer is defined in the rule as an organization that meets all four of the following criteria: (1) the organizations purpose is

(1) Material Cooperation with Evil. The comment first addresses how the ANPRM is wholly unacceptable as a compromise to the underlying Mandate because it unavoidably compels Catholic and other religiously observant employers to engage in what the Western moral tradition understands as unjustified material cooperation with evil. (2) Drugs Capable of Terminating Human Life. Second, the comment presents the biological facts that undergird one of the specific evils that objecting employers would be forced to materially cooperate with, namely that some of the U.S. Food & Drug Administration (FDA) approved drugs required to be covered are capable of terminating the life of a human being at the embryonic stage of development by various modes of action. Regarding a legal and policy analysis, we adopt by reference the arguments set forth in the comment filed by the U.S. Conference of Catholic Bishops on May 15, 2012,3 concluding that the ANPRM and underlying Mandate are each unjust and unlawful. Before addressing our two foundational issues, we emphasize that the ANPRMs proposed means of accommodating non-exempt objecting employers is akin to the cure being worse than the disease. Rather than rescinding the ill-advised Mandate in full, or at least enacting a meaningful conscience exemption, the ANPRM proposes rules that would directly entangle government into the business of non-exempt religious organizations, in certain violation of the First Amendment and other statutory protections. For example, the ANPRM goes so far as to propose that self-insured religious organizations be required to make their employee contact information available to a government agency so that the government itself can directly contact the religious organizations employees to offer them products and services that the employer holds to be gravely immoral. 77 Fed. the inculcation of religious values (Catholic food banks are out); (2) the organization primarily employs persons who share the religious tenets of the organization (Catholic universities are out); (3) the organization serves primarily persons who share the religious tenets of the organization (Catholic hospitals are out); and (4) the organization is a nonprofit that is a house of worship or religious order. Given that houses of worship and religious orders exist with a mission to serve the least amongst us regardless of their faith, that means requirement (3) is not met, so everyone is out.) 3 United States Conference of Catholic Bishops, Comment on Certain Preventive Services (May 15, 2012), available at www.usccb.org/about/general- counsel/rulemaking/upload/comments-on-advance-notice-of-proposed-rulemaking-on- preventive-services-12-05-15.pdf 2

Reg. at 16507 (The third-party administrator would send a copy of the religious organizations self-certification to OPM4 along with information on plan participants and beneficiaries.) This particular proposal within the ANPRM is simply one egregious example of many of the excessive government entanglements with religion proposed in the ANPRM, with no concern for the protections the First Amendment. For non-exempt religious employers who contract with separate insurance companies, the ANPRMs attempt to shift the requirement to offer morally objectionable drugs and services from the employer to the employers contracted insurer does not and cannot change the moral calculus. The ANPRM and the underlying Mandate still compel Catholic and morally observant employers to violate core religious beliefs about the dignity of human life and human sexuality as set forth below. No mere revision to the ANPRM is capable of making the Mandate pass muster. The Mandate must simply be rescinded in full. 1. The Accommodation Proposed in the ANPRM Compels Religious Employers to Engage in Unjustified Material Cooperation with Evil The ANPRM seeks comment on how the Administration would implement a so-called accommodation that purports to move the Mandates obligation to offer free coverage for contraception, sterilization, and abortion-inducing drugs from employers to the employers insurer. It has been suggested that this accommodation will allow religiously affiliated employers to continue to offer insurance to their workers without violating any basic tenets of their faith. This suggestion betrays a flawed understanding of the proper approach to assessing the morality of the choices presented to employers under the supposed accommodation. Under the ANPRMs proposed accommodation, the Administration would mandate insurers who are contracted with and paid by objecting employers to directly contact the objectors employees to offer free coverage for products and services that violate the employers religious beliefs, even though the initial contract between the employer and its insurer excludes them. Thus, if the employer continues to offer health insurance to its employees, it will know in advance that such insurance will provide the immoral products and services at no cost to its employees. Consequently, even under the ANPRMs proposed accommodation, a religious employers simple act of continuing insurance benefits to its employees will compel the employer to be a key cog in the process of facilitating access to what it believes are gravely immoral products and services. This being a key cog in the process is termed in Catholic moral theology as material cooperation with evil (as opposed to formal cooperation, which would mean intentionally and willfully being a cog in an evil endeavor). 4 The United States Office of Personnel Management (OPM) is an independent agency of the United States government that manages the civil service of the federal government. 3

Under certain extremely narrow exceptions that are certainly not met here, material cooperation can at times be licitly tolerated in view of very serious reasons that cannot be met by alternative means. In the present case, grounds for justifiably tolerating material cooperation are not present, and no amount of government tinkering can salvage the profound moral defect of the Mandate or the ANPRMs so-called accommodation. On the contrary, it is the opinion of a broad spectrum of moralists in the natural law tradition that the evident moral good of providing group health insurance does not constitute a sufficiently serious reason to tolerate material involvement in the offering of products and services that are gravely at odds with the employers religious commitment to protect the dignity of every human life, and witness to the world about the right ordering of human sexuality.5 The fact that the ANPRM sets up a contrived accounting scheme is of no moral consequence. The objecting employer will know that the government-imposed rules will convert his act of providing health insurance into an act that he knows will facilitate moral evil. The Mandate and ANPRM thus place the employer in the untenable position of having to violate his or her conscience in order to assist employees with health insurance benefits. Thus, even under the ANPRMs proposed accommodation, non-exempt employers will be forced to violate their beliefs based on the Administrations insistence that the mechanism for providing free contraceptive services to the public must be through private and religious employers group insurance. The Administrations so-called accommodation changes nothing of moral substance and is simply unacceptable.6 2. The Mandate Violates Core Religious Beliefs about the Protection of Human Life by Requiring Coverage of Drugs Capable of Terminating Human Life. As established above, the ANPRM does not alleviate the employers moral complicity in the provision of insurance coverage for sterilization procedures, contraceptive counseling, and U.S. Food & Drug Administration (FDA) approved contraceptive drugs, some of which are capable of terminating the life of a human being at the embryonic stage of development by various modes of action. 5 See Berg & Capretta, Assessing Obamas Assault on Religious Liberty, LEGATUS MAGAZINE (April 2, 2012), available at http://www.legatusmagazine.org/?p=6430. 6 See Unacceptable, a statement drafted on February 15, 2012 and signed by over 500 academics, policy leaders, religious leaders, and journalists, responding to President Obamas announcement of a so-called compromise to the Mandate. The original drafters of the letter are Harvards Mary Ann Glendon, Princetons Robert P. George, Notre Dames Carter Snead, Catholic University of Americas president John Garvey and Yuval Levin, of the Ethics and Public Policy Center, and is available at http://www.becketfund.org/wp- content/uploads/2012/04/Unacceptable-4-11.pdf 4

This section presents a concise review of the science of human embryology in order to highlight the gravity of the conscientious objections that are disregarded by the Mandate and the ANPRM. In accord with the teaching of the Catholic Church and the religious and moral traditions of many denominations, many Catholic organizations and observant employers ascribe intrinsic moral value to every human being from conception (fertilization) to natural death. Such employers therefore believe that drugs designed to be fatally toxic to, or to otherwise cause the death of, an individual human being at the embryonic stage of life are gravely immoral whether the death of the human embryo occurs prior to or after the human embryos implantation into the uterine wall. The plurality of views within our society regarding the moral worth of human beings at the embryonic stage of development gives rise to incompatible notions of how much respect is owed to pre-implantation human embryos. Differing views on the moral worth of the human embryo before uterine implantation result in debates concerning a myriad of bioethical issues, including abortion, contraception, in vitro fertilization, human embryo cloning and embryonic stem cell research that requires the human embryos destruction. Despite this plurality of views, the necessary action of rescinding the preventive services Mandate does not require the Administration to declare or adopt any position concerning the moral worth or legal rights of the human embryo prior to uterine implantation. Religious liberty rights enshrined in the First Amendment and in federal statute dictate that the Administration simply recognize that private employers are entitled to make a judgment to refrain from actions that violate the employers religious beliefs or moral convictions, especially when it concerns the life of a vulnerable human being. A definitive medical school textbook states, Human development begins at fertilization when a male gamete or sperm (spermatozoon) unites with a female gamete or oocyte (ovum) to produce a single cell a zygote. This highly specialized, totipotent cell marked the beginning of each of us as a unique individual. Keith L. Moore and T.V.N. Persuad, THE DEVELOPING HUMAN: CLINICALLY ORIENTED EMBRYOLOGY 16 (7th ed. 2003). Based on universally accepted scientific criteria, non-exempt objecting employers understand that the life of the unique individual, commences at a scientifically well- defined moment of sperm-egg fusion (fertilization or conception) when the one-celled human embryo comes into being. See Maureen L. Condic, Ph.D., When Does Human Life Begin? A Scientific Perspective (October 2008), available at http://www.bdfund.org/whitepapers. Because this new being is an integrated self-directed organism that is of human genetic constitution, objecting employers understand that the human embryo is indeed a human being from the one-celled stage onward. Id. 5

As established by the science of human embryology, the implantation of the human embryo into the uterine wall does not mark the beginning of the life of the human embryo. Rather, implantation is simply an event instigated by the human embryo of its own accord in the course of normal biological development to continue the life of the new individual human being that came into existence at fertilization. The Mandate will force employers to provide insurance coverage for counseling and provision of drugs such as Plan B and ella (ulipristal acetate) so-called emergency contraceptives that are capable of causing the death of a human being at the embryonic stage of life. Plan Bs major mechanism of action is to delay ovulation so as to prevent fertilization. However, according to an FDA fact sheet, If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation). FDA website, http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm (last checked May 3, 2012). In human embryology, a fertilized egg is known as a human embryo. Plan B is therefore capable of causing the death of a human being at the embryonic stage of life. In 2010, the FDA approved ella tablets as emergency contraception to be taken orally within 120 hours (five days) after intercourse. While ellas major mechanism of action is to delay ovulation beyond the life span of the sperm, the known chemical effects of ella are also consistent with this drug causing the death of a human embryo by both preventing implantation, and by causing the demise of a human embryo that is already implanted in the mothers womb by inducing menstrual bleeding, thereby terminating a pregnancy. The drug ella is, therefore, capable of inducing abortion as that term is understood in state and federal law because the drugs known chemical effects are consistent with the ability to cause the demise of a human embryo that has already implanted in the mothers womb. In regard to drugs or devices whose major or only mechanism of action is prevention of ovulation that would prevent the abortifacient effects, there are still valid religious interests that the Mandate and ANPRM violate. The religious teachings of the Catholic Church regarding the sanctity of the marriage act as both unitive and procreative give rise to the reality that many employers, whether a religious organization or an observant private individual, hold sincere religious objections to providing coverage for sterilization and all contraceptive drugs, whether abortion-inducing or not. The ANPRM does nothing to prevent the Mandate from forcing such employers to provide insurance coverage for surgical sterilization and all contraceptive drugs and services, including Plan B and ella, free of charge to its own employees and students, in violation of the their sincerely held religious beliefs and moral convictions. 6

Conclusion As observed by Thomas Jefferson, God who gave us life gave us liberty.7 The wisdom of our founders enshrined in the U.S. Constitution condemn the Mandates crass disregard for the rights of individuals and employers to hold sacred both their respect for human life and religious liberty. No employer should be forced by the government to choose between providing health insurance for its employees or acting in accord with religious beliefs and moral convictions. In a futile attempt to salvage the Mandate, the ANPRM takes an approach that exacerbates the underlying problem and raises even more problems with free exercise rights and excessive government entanglement in violation of the First Amendment. The unjust and unlawful Mandate must be rescinded. Sincerely, Nikolas T. Nikas President, CEO and General Counsel Dorinda C. Bordlee Vice President, Senior Counsel BIOETHICS DEFENSE FUND 6811 E. Voltaire Avenue Scottsdale, AZ 85254 info@bdfund.org Catherine W. Short LIFE LEGAL DEFENSE FOUNDATION P.O. Box 1313 Ojai, CA 93024 LLDFO@cs.com On behalf of: Rev. Thomas Berg, PhD James C. Capretta Maureen L. Condic, PhD 7 Thomas Jefferson (1774)(as inscribed in the Jefferson Memorial). 7

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