Legislating morality progressively - the contraceptive coverage mandate, religious freedom, and public health policy and ethics.

• Author: DeBoer, Michael J.
• Position: I. Introduction through III. Analysis Under the Religious Freedom Restoration Act B. The RFRA Standard, p. 62-90 - Issues of Reproductive Rights: Life, Liberty, and the Pursuit of Policy

1. INTRODUCTION II. STATUTORY AND REGULATORY BACKGROUND REGARDING THE CONTRACEPTIVE COVERAGE MANDATE A. The Relevant Affordable Care Act Provisions B. The Regulations 1. The July 2010 Interim Final Rulemaking 2. The Institute of Medicine Committee Recommendations 3. The HRSA August 2011 Comprehensive Guidelines 4. The August 2011 Amended Interim Final Rulemaking 5. The February 2012 Final Rulemaking 6. The February and August 2012 Guidance 7. The March 2012 Advance Notice of Proposed Rulemaking (ANPRM) 8. The February 2013 Proposed Rulemaking 9. The July 2013 Final Rulemaking 10. The June 2013 Guidance Documents C. Some Observations Regarding the Processes Used to Develop the Mandate III. ANALYSIS UNDER THE RELIGIOUS FREEDOM RESTORATION ACT A. The Departments' Rulemakings B. The RFRA Standard C. The Supreme Court's Ruling D. Other Challenges IV. ANALYSIS UNDER A PUBLIC HEALTH POLICY AND ETHICS FRAMEWORK A. The ACA, the Mandate, Public Health, and Social Justice B. A Brief Overview of the Analytical Framework 1. The General Moral Considerations a. The Nine General Moral Considerations b. The Balancing of General Moral Considerations of Indeterminate Weight or Strength 2. The Justificatory Conditions C. An Application of the Analytical Framework 1. The First Three General Moral Considerations 2. The Other General Moral Considerations a. Justice b. Autonomy/Liberty c. Integrity d. Transparency e. Trust 3. The Justificatory Conditions a. Effectiveness b. Proportionality c. Necessity and Least Infringement d. Public Justification D. The Administration's Failure of Deliberation and Justification in This Public Health Initiative V. CONCLUSION I. INTRODUCTION

   In the area of reproductive rights in the United States, one of the biggest developments in the last several years has been the so-called contraceptive coverage mandate. The mandate requires employers, group health plans, and health insurance issuers to cover all United States Food and Drug Administration (FDA)-approved contraceptive methods, sterilization procedures, and patient education and counseling. (1) The Obama Administration chose to mandate this coverage in rules it promulgated, specifying the preventive health services for women that must be covered under the Affordable Care Act (ACA). (2)

   Since its promulgation, hundreds of citizens, businesses, and nonprofit and religious organizations have challenged the mandate in dozens of lawsuits, which are at various stages of litigation. (3) The Supreme Court of the United States ruled on two cases that were brought by family-owned businesses that objected to four of the twenty FDA-approved contraceptives. (4) Both Hobby Lobby Stores, Inc. (Hobby Lobby) and Conestoga Wood Specialties Corporation (Conestoga Wood) objected to two drugs, commonly known as "Plan B" and "Ella," as well as to two intrauterine devices (IUDs) that operate after fertilization and prevent uterine implantation of fertilized eggs (human embryos), thus causing an abortifacient effect. (5) Although Hobby Lobby and Conestoga Wood objected to paying for these four methods of contraception, they otherwise provided health insurance to their employees, including methods of contraception that they do not oppose on religious grounds. (6)

   This Article studies the contraceptive coverage mandate from three different perspectives. First, it provides a historical treatment of the regulatory rules adopted by agencies in the Obama Administration--specifically, the Departments of the Treasury, Labor, and Health and Human Services, which this Article collectively refers to as "the Administration" or "the Departments"--that imposed the mandate, focusing specifically on the rulemaking processes used to develop and promulgate the rules. In performing this historical study, the Article traces the development of the mandate from its root in the ACA to full implementation in legislative (substantive) rules finalized by the Administration in the summer of 2013. (7) Second, this Article evaluates the mandate under the legal framework established by Congress in the Religious Freedom Restoration Act (RFRA), (8) focusing especially on the Administration's RFRA analysis in its rulemaking materials and the Supreme Court's recent ruling regarding the mandate. (9) Third, it analyzes the mandate under a moral and policy-based framework proposed by a team of leading bioethicists, public health policy analysts, and scholars. It applies the team's proposed framework to determine whether the Departments that developed and adopted the mandate satisfied the various moral and policy considerations that these experts have highlighted. (10)

   The analyses in this Article will establish the following four points:

   (1) The Administration chose to employ regulatory procedures that failed to ensure transparency, hindered meaningful public participation, hampered dialogue between policymakers and interested individuals and organizations, and deprived the public of the deliberative process agency rulemaking is supposed to afford.

   (2) In its rulemaking, the Administration's consideration of the First Amendment and RFRA was cursory and untimely. Consequently, the Administration failed adequately to consider the religious freedom implications of creating by regulatory rule a positive right to coverage that conflicted with a negative right grounded in the First Amendment that Congress had reinforced in RFRA.

   (3) In developing the mandate, the Administration failed adequately to address basic moral and policy considerations that provide concrete guidance for evaluating and justifying public health initiatives. Consequently, the Administration's deliberations about and justifications for this public health initiative were unsatisfactory, failing adequately to resolve conflicts that the initiative created among general moral considerations.

   (4) In adopting the regulatory rules and imposing the mandate, the Administration "legislated" its conception of morality. The mandate does not simply represent the policy judgments of the policymakers, but also the moral judgments of the policymakers based upon their progressive moral vision and values. (11) Thus, although the mandate is framed in regulatory, 8 9 10 11 public health, social scientific, and medical terminology, it advances a particular moral vision, is premised upon the moral values held by the policymakers, and reflects their conception of what is "good" and what constitutes a "good society." (12)

2. STATUTORY AND REGULATORY BACKGROUND REGARDING THE CONTRACEPTIVE COVERAGE MANDATE

   1. The Relevant Affordable Care Act Provisions

      The ACA did not mandate that employers and health insurance plans cover contraceptives, sterilization, or patient education and services. Rather, the ACA required group health plans and health insurance issuers offering group or individual health insurance coverage to cover several broad categories of preventive health services. (13) The following were among the required preventive health services:

      (1) Evidence-based items or services recommended with a rating of A or B by the United States Preventive Services Task Force (USPSTF); (14) and

      (2) As to women, preventive care and screenings (in addition to those items and services recommended by the USPSTF) provided for in comprehensive guidelines supported by the U.S. Health Resources and Services Administration (HRSA). (15)

      The ACA prohibited the imposition of cost-sharing requirements (e.g, copayments, coinsurance, and deductibles) as to these covered items and services. (16) As the grandfathered status of health plans is lost over time, most health plans and health insurance issuers (and employers) will be required to cover the specified preventive services free of charge to beneficiaries and employees. (17)

   2. The Regulations

      Subsequently, the Obama Administration adopted regulatory rules implementing these provisions of the ACA. It was in these rulemakings that the Administration decided to include all FDA-approved contraceptive methods, sterilization procedures, and patient education and counseling within the required package of covered preventive health services.

      1. The July 2010 Interim Final Rulemaking

         In July 2010, about four months after the ACA was enacted, (18) the Administration issued a set of interim final rules. (19) These interim final rules, consistent with the ACA, required health plans and health insurance issuers to provide coverage of the following relevant categories of items and services:

         (1) Evidence-based items and services recommended by the USPSTF with a rating of A or B; and

         (2) For women, evidence-informed preventive care and screening provided for in comprehensive guidelines supported by the HRSA. (20)

         The regulatory materials indicated that the Department of Health and Human Services (HHS) was developing comprehensive guidelines for preventive care and screening for women and expected to issue them no later than August 1, 2011. (21)

         These interim final rules were effective on September 17, 2010, the same date comments from the public and interested persons were due. (22) The Departments' decision to issue interim final rules, instead of following the standard notice-andcomment process that would have ensured meaningful public participation and full vetting of the rules before they went into effect, (23) meant that the rules would be effective without comments from the public on any proposed rules being reviewed and considered by the Departments prior to the effective date. (24) The Administration justified its decision to sidestep standard rulemaking procedures and instead to use the truncated rulemaking process on the following two grounds:

         (1) Statutory grounds in the Internal Revenue Code, the Employee Retirement Income Security Act, and the Public Health Service Act; (25) and

         (2) Good cause because "a full public notice and comment process" was impracticable and contrary to the public interest. (26)

         The Departments' position...