City and County of San Francisco v. Azar II et al

Filing 1

COMPLAINT for Declaratory and Injunctive Relief against Alex M. Azar II, Roger Severino, U.S. Department of Health and Human Services (Filing fee $ 400.00, receipt number 0971-13312627.). Filed by City and County of San Francisco. (Attachments: #1 Exhibit A, #2 Civil Cover Sheet) (Herrera, Dennis) (Filed on 5/2/2019) Modified on 5/8/2019 (gbaS, COURT STAFF).

EXHIBIT A

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 88
RIN 0945 AA10
Protecting Statutory Conscience Rights in Health Care; Delegations of
Authority
AGENCY:
ACTION:
SUMMARY:

DATES: Effective Date

FOR FURTHER INFORMATION CONTACT:

SUPPLEMENTARY INFORMATION:
Electronic Access

,

I. Background

A. Statutory History

e.g.

id.

see, e.g.,

e.g.

See e.g.
Clinical Medicine

Religion, Conscience, and Controversial Clinical Practices
Ethical Diversity and the Role of Conscience in
. Obstetrician–Gynecologists’

The Church Amendments.

Objections to and Willingness to Help Patients Obtain an Abortion
Adjudicating Rights or Analyzing Interests: Ethicists’ Role in the
Debate Over Conscience in Clinical Practice
Private Religious Hospitals: Limitations Upon Autonomous Moral Choices in Reproductive
Medicine
Medical Ethics at
Guantanamo Bay and Abu Ghraib: The Problem of Dual Loyalty,

et seq.

Id

et seq

The Coats Snowe Amendment.

Id.
The Weldon Amendment.

See, e.g.

E.g.

Id
Conditions on Federally Appropriated Funds Requiring Compliance with
Federal Conscience and Anti Discrimination Laws.

The Patient Protection and Affordable Care Act’s Conscience and Associated
Anti Discrimination Protections.

Id.

See also

Other Protections Related to the Performance of Advance Directives or Assisted
Suicide.

See

see
also

Protections Related to Counseling and Referrals Under Medicare Advantage
Plans, Medicaid Plans, and Managed Care Organizations.

See, e.g.,

Federal Conscience and Anti Discrimination Protections Applying to Global
Health Programs.

.

Exemptions from Compulsory Medical Screening, Examination, Diagnosis, or
Treatment.

Conscience Clauses Related to Religious Nonmedical Health Care.

see

https://www.medicare.gov/coverage/rnhci items and services.html
https://www.cms.gov/Medicare/Provider Enrollment and
Certification/CertificationandComplianc/RNHCIs.html

See, e.g.,

See, e.g. Kong v. Scully
Parle

Children’s Healthcare v. Min De

B. Regulatory History

2008 Rule.

See

Proposed Changes in 2009 Resulting in New Final Rule in 2011.

Id
II. Overview of the Final Rule
A. Overview of Reasons for the Final Rule

Allegations and Evidence of Discrimination and Coercion Have Existed Since
the 2008 Rule and Increased Over Time.

See Nat’l Inst. of Family and Life Advocates v. Becerra

http://www.washingtonpost.com/wp dyn/content/article/2009/02/27/AR2009022701104.html

New
England Journal of Medicine

https://www.cmda.org/library/doclib/pollingsummaryhandout.pdf
also

see

See

Mendoza v.
Martell

Cenzon DeCarlo v. Mount

Sinai Hosp.

Hellwege v. Tampa
Family Health Ctrs.

Danquah v. University of Medicine and Dentistry of New Jersey

LI Hospital issues abortion apology to nurses
http://nypost.com/2010/04/28/li hospital issues abortion apology to nurses

See, e.g. Roman Catholic Diocese of Albany v. Vullo
Means v. U.S. Conference of Catholic Bishops
ACLU v. Trinity Health Corporation
Health
See also

Minton v. Dignity
Chamorro v. Dignity Health

https://www.acog.org/Clinical Guidance and Publications/Committee Opinions/Committee on
Ethics/The Limits of Conscientious Refusal in Reproductive Medicine

Recently Enacted State and Local Government Health Care Laws and Policies
Have Resulted in Numerous Lawsuits by Conscientious Objectors.

National
Institute of Family and Life Advocates v. Becerra,
NIFLA

Greater
Baltimore Center for Pregnancy Concerns, Inc. v. Mayor and City Council of Baltimore
cert. denied

infra

Evergreen Ass’n,
Inc. v. City of New York

Austin
LifeCare v. City of Austin
Centro
Tepeyac v. Montgomery County

Pregnancy Care Center of Rockford v. Rauner

Nat’l Instit. of Family and Life Advocates v. Rauner

Calvary Chapel Pearl Harbor v. Chin

NIFLA

See,

e.g. Mountain Right to Life v. Harris
A Woman’s Friend Pregnancy Resource Clinic v.
Harris
Harris

Livingwell Medical Clinic v.

et
seq.

available at
Id. at

See
Re: Limitations or Exclusions of Abortion Services

See Foothill Church v. Rouillard

available at

Skyline Wesleyan Church v. California Department
of Managed Health Care

See, e.g. Roman Catholic Diocese of Albany v. Vullo

See

Vermont Alliance for Ethical Health Care, Inc. v. Hoser

See

supra

California’s assisted dying loophole: Some doctors won’t help patients die
http://www.sfchronicle.com/news/
article/California s assisted dying loophole Some 11761312.php

Confusion Exists About the Scope and Applicability of Federal Conscience and
Anti Discrimination Laws.

ee Means v. U.S. Conference of Catholic
Bishops
Trinity Health Corp.
Dignity Health
Chamorro v. Dignity Health

ACLU v.
Minton v.

Coffey v. Pub. Hosp. Dist. No. 1

See, e.g.
et seq.

et seq.

See
Courts Have Found No Alternative Private Right of Action to Remedy Violations.

Cenzon DeCarlo v. Mount Sinai Hospital

had not implied a remedy
Id

Cenzon DeCarlo v. Mount Sinai Hosp.
aff’d by

.

Hellwege v. Tampa Family Health Centers

Id.

Nat’l Instit. of Family and Life Advocates, v. Rauner

Addressing Confusion Caused by OCR Sub Regulatory Guidance.

http://www.adfmedia.org/files/CDMHCInvestigationClosureLetter.pdf

at all

see

supra,

See Foothill Church v. Rouillard

at 9

available at

Additional Federal Conscience and Anti Discrimination Laws.

B. Structure of the Final Rule

III. Analysis and Response to Public Comments on the Proposed Rule

A. General Comments

Comment:

Response:

Id

See

infra

Comment:

Response:

Comment:

Response:

infra
Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Compliance by the Department.

Compliance through funding instruments and agreements.

Grants and cooperative agreements.

Contracts.

See

see also

e.g.

Other rulemaking authorities.

e.g

Debarment and suspension.

See
e.g.,

Receipt and processing of complaints.

Administrative Law Treatise
JEM
Broad. v. FCC
Hoctor v. Dept. of Agriculture

Comment:

Response:

B. Section by Section Analysis53
Purpose (§ 88.1)

Summary of Regulatory Changes:

Definitions (§ 88.2)

Administered by the Secretary.

Summary of Regulatory Changes:

Assist in the Performance.

Comment:

Response:

Comment:

Response:

Danquah

Comment:

Response:

Danquah

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Morales v. Sociedad Espanola de Auxilio Mutuo y Beneficencia
Arrington v. Wong

See

required

study

performance

Comment:

Response:

Comment:

Response:

Summary of Regulatory Changes:

Department.

Summary of Regulatory Changes

Discriminate or Discrimination.
iscrimination,”

discriminate

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

per se
Response:

“on the basis that

Comment:

Response:

Comment:

Response:

Summary of Regulatory Changes:

Entity.

Comment:

Response:

Entity

See Burwell v. Hobby Lobby Stores, Inc

Comment:

Response:

Comment:

Response:

“Applicability” see

Applicability

Summary of Regulatory Changes:

Federal financial assistance.
financial assistance

Comment:

Federal

Response:

See

See, e.g., Jarno v. Lewis

DeVargas

v. Mason & Hanger Silas Mason Co
Budget Rent a Car

Cook v.
Shotz v. American Airlines

Venkatraman v. REI Systems

Summary of Regulatory Changes:

Health care entity.

Comment

Response

Comment

Response

Citizens United v. FEC,

Hobby Lobby

See, e.g.,

Burwell v. Hobby Lobby Stores, Inc.

See, e.g., Hobby Lobby
Citizens United
in association with other individual persons

Comment

Response

Comment

Response

e.g.,

Comment

Response

Comment

Response

Comment

Response

Comment

Response

Comment

Response

Summary of Regulatory Changes

Health program or activity.
program or activity”

Health

Comment:

Response:

Comment:

Response:

Comment:

Response:

Summary of Regulatory Changes:

Health service program.
program

Comment

Response:

Health service

i.e.

Comment:

Response:

Summary of Regulatory Changes

Id

related

Individual.

“Individual

Comment:

Response:

Summary of Regulatory Changes:

Instrument.

“Instrument

Summary of Regulatory Changes:

OCR.

Summary of Regulatory Changes:

Recipient.

“Recipient

Comment

Response:

“Applicability”
“Requirements and prohibitions”

Summary of Regulatory Changes:

Referral or refer for.

Comment:

Response

Comment:

Response:

Refer,

see also Refer,

refer

available at

Comment:

Response:

Comment:

Response:

Roe v. Wade

Doe v. Bolton

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

NIFLA

Comment:

available at

Response:

Sharpe Holdings v. U.S. Dept. of Health & Human Services

Comment:

Response:

NIFLA

Comment:

Response:

See
Comment:

Response:

Summary of Regulatory Changes:

State.

“State

Summary of Regulatory Changes:

.
Sub recipient.

Comment:

Response:

Summary of Regulatory Changes:

Workforce.

Comment:

Response:

See

Comment:

Response:

Summary of Regulatory Changes:

Applicable requirements and prohibitions (§ 88.3)

88.3(a). The Church Amendments.

Comment

Response:

See e.g.
Comment:

Response:

See, e.g., Vt. Alliance for Ethical Healthcare, Inc. v. Hoser,
or other procedures
Franciscan Alliance, Inc. v. Burwell,

Comment:

Response:

Comment:

Response:

Comment:

Response:

Franciscan
Alliance, Inc. v. Burwell

Religious
Sisters of Mercy, et al., v. Burwell

Franciscan Alliance.

Comment:

Response:

Comment:

Response:
individual

Summary of Regulatory Changes:

88.3(b). Coats Snowe Amendment.

Comment:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Summary of Regulatory Changes:

88.3(c). Weldon Amendment.

Comment:

Comment:

Response:

See Grove City College v. Bell

Comment:

National Family Planning and Reproductive Health Association v.
Gonzales,

Response:

Comment:

Response:

See, e.g.

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

abortion

Summary of Regulatory Changes:

See

compare

with

88.3(d). Medicare Advantage, Department of Defense and Labor, Health
and Human Services, and Education Appropriations Act, 2019 and Continuing
Appropriations Act, 2019, Pub. L. 115 245, Div. B, sec. 209.

Summary of Regulatory Changes:

88.3(e). Section 1553 of the Affordable Care Act, 42 U.S.C. 18113.

Comment:

Response:

Roe v. Wade

Doe v. Bolton
Roe

Doe

Comment:

Response:

supra

supra

Summary of Regulatory Changes:

See Hibbs v. Winn

88.3(f). Section 1303 of the Affordable Care Act, 42 U.S.C. 18023.

Comment:

et seq.
Response:

See, e.g.,
Connecticut Nat’l Bank v. Germain

Summary of Regulatory Changes:

88.3(g). Section 1411 of the Affordable Care Act, 42 U.S.C. 18081.

Summary of Regulatory Changes:

88.3(h). Counseling and referral provisions of 42 U.S.C. 1395w
22(j)(3)(B) and 1396u 2(b)(3)(B)).

Comment:

Response:

Summary of Regulatory Changes:

88.3(i). Advance Directives, 42 U.S.C. 1395cc(f), 1396a(w)(3), and 14406.

Comment:

Response:

Comment:

Response:

Summary of Regulatory Changes:

88.3(j). Global Health Programs, 22 U.S.C. 7631(d).

Comment:

Response:

Comment:

Response:

i.e.

Summary of Regulatory Changes:

88.3(k). The Helms, Biden, 1978, and 1985 Amendments, 22 U.S.C.
2151b(f); e.g., Consolidated Appropriations Act, 2019, Pub. L. 116 6, Div. F, sec.
7018.
Comment:

Response:

See, e.g

Summary of Regulatory Changes:

88.3(l). Newborn and Infant Hearing Loss Screening, 42 U.S.C. 280g 1(d).

Comment:

Response:

Comment:

Response:

Summary of Regulatory Changes:

88.3(m). Medical Screening, Examination, Diagnosis, Treatment, or Other
Health Care or Services, 42 U.S.C. 1396f.

Comment:

Response:

Summary of Regulatory Changes:

88.3(n). Occupational Illness Examinations and Tests, 29 U.S.C. 669(a)(5).
Comment:

Response:

Summary of Regulatory Changes:

88.3(o). Vaccination, 42 U.S.C. 1396s(c)(2)(B)(ii).

Comment:

Response:

Comment:

Response:

Summary of Regulatory Changes:

88.3(p). Specific Assessment, Prevention and Treatment Services, 42 U.S.C.
290bb 36(f), 5106i(a).
Comment:

Response:

.

Summary of Regulatory Changes:

88.3(q). Religious nonmedical health care, 42 U.S.C. 1320a–1, 1320c 11,
1395i 5, 1395x(e), 1395x(y)(1), 1396a(a), and 1397j 1(b).

Comment:

Response:

Comment:

Response:

Comment:

Response:

Children’s Healthcare
Is a Legal Duty, Inc. v. Min De Parle,

Comment:

Response:

Summary of Regulatory Changes:

Assurance and Certification of Compliance Requirements (§ 88.4)

See Grove City College

Comment

Response:

Comment:

Response:

Assurance of Compliance

Id

Comment:

Response:

Comment:

Response:

e.g

Id
Id

Comment:

qui tam
Response:

qui tam

qui tam

Comment:

Response

”

Comment:

Response:

Comment:

See, e.g
Compare
with

infra

Response:

Comment:

Response:

See Medicare Advantage Program Payment System

Comment:

Response:

Summary of Regulatory Changes:

See id.

Notice of Rights under Federal Conscience and Anti Discrimination Laws (§
88.5)

Comment

Response:

supra
Comment:

Response

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Summary of Regulatory Changes:

Compliance Requirements (§ 88.6)

Comment:

Response:

Comment

Response

supra

supra

Comment:

Response:

See e.g.,

See

Comment:

Response:

Comment:

Response:

See

Summary of Regulatory Changes:

Enforcement Authority (§ 88.7)

Comment:

Response:

See, e.g.,

see

Comment

Response

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

Comment:

Response:

See, e.g EEOC v. Abercrombie & Fitch Stores, Inc.,

Comment:

Response:

Comment:

Response:

Summary of Regulatory Changes:

Relationship to Other Laws § 88.8

Comment

Response:

Comment:

Response

Whitman v. Am. Trucking Ass’ns

e.g.,

e.g.,

Morales v. Trans World Airlines, Inc.,

Comment:
et seq.

et seq ,

Response:

See Maher v. Roe
Harris v. McRae,

Comment:

Response:

See, e.g.,

adopted

Id.
adopted

Id.)

Comment:

Response:

Comment:

Response:

Comment:

Response:

See
Harris v. McRae,

Maher v. Roe
Rust v. Sullivan
Roe v. Wade

Doe v. Bolton

Comment:

Response:

Corporation of Presiding Bishop of the Church of Jesus
Christ of Latter day Saints v. Amos

Hobbie v. Unemployment
Appeals Comm’n of Fla.,
Burwell v. Hobby Lobby Stores, Inc.,

Comment:

Response:

Summary of Regulatory Changes:

Rule of Construction § 88.9

Comment

Response

Summary of Regulatory Changes:

Severability § 88.10

Comment

Response

Summary of Regulatory Changes:

Appendix A to Part 88—Notice of Rights under Federal Conscience and Anti
Discrimination Laws

Summary of Regulatory Changes:

IV. Regulatory Impact Analysis

Table 1. Accounting Table of Benefits and Costs of All Changes

BENEFITS
Quantified Benefits
Non quantified Benefits

Present Value over 5
Years by Discount
Rate
(Millions of 2016
Dollars)
3 Percent 7 Percent

Annualized Value
over 5 Years by
Discount Rate
(Millions of 2016
Dollars)
3 Percent 7 Percent

COSTS
Quantified Costs
Non quantified Costs

3 Percent

7 Percent

3 Percent

7 Percent

1. Need for the Rule
(i) Problems That This Rule Seeks to Address

supra

See supra

see
supra

See supra

See
Re: Limitations or Exclusions of Abortion Services
See
Foothill Church v. Rouillard
Skyline Wesleyan Church v. California Department of Managed Health Care
See. e.g.

Cenzon DeCarlo v. Mount Sinai Hosp.

infra

supra

See also

(ii) How the Rule Seeks to Address the Problems

e.g.,

See

See, e.g. Vermont All. for Ethical Healthcare, Inc. v. Hoser
Hellwege v. Tampa Family Health Centers
National Institute of Family and Life Advocates, et al. v. Rauner,
See also supra

infra

2. Affected Persons and Entities

(i) Scope of Persons and Entities Covered by 45 CFR Part 88 in 2011 Rule

i.e.,

See
Professionals,

Free to Do No Harm: Conscience Protections for Healthcare

(A) The Department

E.g
Id

(B) State and Local Governments

See, e.g.

Id

(C) Persons and Entities

E.g.
E.g.,
E.g.
Id.

et seq
et seq

See

(ii) Persons and Entities Obligated to Comply with Additional Federal Laws
that this Rule Implements and Enforces

Id.

e.g

e.g

(iii) Methodology

i.e
infra
regulated entities

infra

id.
See

e.g

et al.,
Id

(iv) Quantitative Estimate of Persons and Entities Covered by this Rule

See

e.g

Table 2: Estimated Number of Persons and Entities Covered by This Final Rule

See

https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents
/FY2019CongressionalJustification.pdf
https://www.census.gov/geo/maps data/data/tallies/all_tallies.html

https://www.census.gov/data/datasets/2015/econ/susb/2015 susb.html

e.g.

e.g.

Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id

e.g.

e.g.

e.g.

Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id

supra

e.g.

e.g.

Subtotal,

392,236

613,367

Subtotal,
TOTAL, estimated entities subject to
this rule

392,301

613,497

Id

supra

Id

supra

Id
Id
Id

supra

See supra

http://taggs.hhs.gov

may

(A) Estimated Persons and Entities Required to Sign an Assurance and
Certification of Compliance

Infra
Calculating Estimated Sub Recipients

But see supra

sub recipients

i.e

supra

See, e.g

i.e.

Calculating Exempted Recipients in § 88.4(c)(1) (4)

i.e

e.g.

Table 3: Estimated Range of Recipients Subject to the Assurance and
Certification Requirements (§ 88.4)

Total, Recipients Subject to § 88.4

122,558

195,222

https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents
/FY2019CongressionalJustification.pdf

(B) Estimated Number of Recipients Incentivized to Provide Voluntarily a
Notice of Rights (§ 88.5)

supra

consider

i.e.

i.e.

infra

Table 4: Estimated Number of Firms Associated with Each Recipient Type
Likely to Modify the Notice of Rights in Appendix A (§ 88.5)

e.g.

e.g.
Total, Firms Likely to Modify Pre Written Notice Text

infra

112,876

166,354

infra

Table 5: Number of Physical Establishments of Each Recipient Type Estimated
to Voluntarily Provide Notice of Rights in Year 1 (§ 88.5)

https://www.census.gov/data/datasets/2015/econ/susb/2015 susb.html
Id

e.g.

e.g.

https://www.ihs.gov/budgetformulation/includes/themes/responsive2017/display_objects/documents
/FY2019CongressionalJustification.pdf
https://www.census.gov/geo/maps data/data/tallies/all_tallies.html

https://www.census.gov/data/datasets/2015/econ/susb/2015 susb.html
Id
Id
Id
Id
Id
Id
Id
Id
Id

e.g.

Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id
Id

e.g

e.g.
e.g.

e.g.

Id
Id
Id
Id

supra

Id

supra

Id

supra

Id
Id
Id

supra

TOTAL

3.

Estimated Burdens

infra

http://taggs.hhs.gov

523,470

817,836

261,735

408,918

335,327

infra

See, e.g Vermont All. for Ethical Healthcare, Inc. v. Hoser
Hellwege v. Tampa Family Health Centers
National Institute of Family and Life Advocates, et al. v. Rauner,
See also supra

Table 6: Cost Summary of the Final Rule

$135

$724

$150

$36

$15

Total Costs (undiscounted)

$394 $167 $167 $167 $167

$1,061

(i)

Familiarization Burden

https://www.bls.gov/oes/current/oes_nat.htm
Id
Id
Id
Id
ee, e.g.,

(ii)

Burden Associated with Assurance & Certification (§ 88.4)

Infra

supra
supra

i.e.

See
https://www.hhs.gov/sites/default/files/grants/grants/policies regulations/hhsgps107.pdf
Id

Table 7: Summary of Assurance and Certification Costs
Total Costs
Cost Categories

Total Costs

(iii)

$155.6

$142.2

Burden Associated with Voluntary Actions to Provide Notices of Rights
(§ 88.5)
supra

supra

Burden for Voluntary Posting in Physical Locations

Burden for Web Posting

i.e.
i.e.

Burden for Posting in Two Publications

i.e.

See

Burden to the Federal Government

i.e.

e.g.

i.e.

(iv)

Record Keeping (§ 88.6(b))

de minimis
(v)

Reporting a Finding of Noncompliance (§ 88.6(d))

See
See also id

i.e.

(vi)

Voluntary Remedial Efforts

(vii)

OCR Enforcement and Associated Costs

de minimis

See

See

4. Estimated Benefits

Would Accommodating Some Conscientious Objections by Physicians
Promote Quality in Medical Care?

Free to Do No Harm: Conscience Protections for Healthcare
Professionals,
see also
Moral
distress: A review of the argument based nursing ethics literature

(i)

Historical Support for Conscience Protections

pubs.uchicago.edu/founders/documents/v1ch16s23.html

http://press

(ii)

Expected Postive Impact on the Recruitment and Maintenance of Health
Care Professionals

https://founders.archives.gov/documents/Washington/05 04 02 0188
Free to Do No Harm: Conscience Protections for Healthcare
Professionals,
Protection of Health Care
Providers’ Rights of Conscience in American Law: Present, Past, and Future,

Id
Id
About Us,
http://aaplog.org/about us

d., with

(iii)

Expected Postive Impact on Patient Care by Religious Health Care
Professionals and Organizations

When There’s a Heartbeat: Miscarriage Management in Catholic Owned
Hospitals

Means v. U.S. Conf. of Catholic Bishops

reduction in miscarriages that involve a complication

Reproductive Health Care in Catholic Facilities: A Scoping Review
Reproductive Health Care in Catholic Owned Hospitals

supra

Compare Kaiser Foundation Health Plan and Hospitals Report: 2017 Financial Results,
Journey: Year in Review,
Facts and Stats
Thrive: Give Back

with Our One Ascension

(iv)

Expected Reduction in the Moral Distress that Individual Providers
Experience

Moral Damage to Health Care Professionals and Trainees: Legalism and
Other Consequences for Patients and Colleagues

the experience that resisting participation in doing wrong exposes one to harm. Moral distress is
generated in the health care work environment when a practitioner is aware that he is acting other
than how he is motivated to act, but he believes that he cannot act as he is motivated to act without
suffering some morally significant harm

The relationship between moral distress, professional stress, and intent to stay in the
nursing profession

(v)

Expected Patient Benefits from this Rule

et al Impact of the Doctor Patient Relationship,
Id.

Minorities: A Review,

et al Potential Barriers to the Use of Health Services Among Ethnic

Id.
Ethical Diversity and the Role of Conscience in Clinical Medicine

Recognizing Moral Disengagement and Its Impact on Patient Safety

Moral distress: A review of the argument based nursing ethics
literature

supra
Role of Conscience in Clinical Medicine

Professionals,

Ethical Diversity and the

Free to Do No Harm: Conscience Protections for Healthcare

i.e.

(vi)

Expected Societal Benefits from this Rule

Cultivating Conscience: How Good Laws Make Good People

The Disappearance of Religion from Debates about Religious Accommodation
United States v. Seeger
Objector,
Religion Is Special Enough

The Conscientious

(vii)

Analysis of Expected Effects of This Final Rule on Access to Care

per se

supra
infra

See
Conscientious objection and refusal to provide reproductive healthcare: A White
Paper examining prevalence, health consequences, and policy responses
Conscientious objection to abortion and
reproductive healthcare: a review of recent literature and implications for adolescents

See
Willingness to Help Patients Obtain an Abortion

Obstetrician–Gynecologists’ Objections to and

available at
The Harmony between Professional Conscience Rights and Patients’
Right of Access

The effect of the rule’s protection of refusals to refer for services

Attitudes and Experiences of Oncology Patients
Id

Euthanasia and Physician Assisted Suicide:

Conscientious refusals to refer: findings from a national physician survey

The change in the number of patients who delay or forgo health care for fear of
being denied a health service

See, e.g.,

Other comments on access to care

supra

5. Analysis of Regulatory Alternatives

supra

supra

See supra
See e.g. Cenzon DeCarlo v. Mount Sinai Hospital
Family Health Centers
Advocates, et al. v. Rauner

Hellwege v. Tampa
National Institute of Family and Life

supra

Federalism

Id
Id

See supra
See
Professionals,

Free to Do No Harm: Conscience Protections for Healthcare

require

Id
See supra

Impact on Tribal Entities

supra

Information Collection for § 88.4 (Assurance and Certification)
(i)

Summary of the Collection of Information

Operationalizing the Assurance of Compliance Requirement

Operationalizing the Certification of Compliance Requirement

Home

See id

(ii)

Need for Information

e.g.,

(iii)

Id
Id

Use of Information

(iv)

Description of the Respondents

(v)

Number of Respondents

supra

See

See

See
(vi) Burden of Response

supra

supra

Information Collection for § 88.5 (Notice)
(i)

Summary of the Collection of Information

(ii)

Need for Information

(iii)

Use of Information

(iv)

Description of the Respondents

(v)

Number of Respondents

i.e

(vi)

Burden of Response

supra

supra

(vii)

Burden for Voluntary Posting in Physical Locations

i.e

(viii) Burden for Voluntary Web Posting

(ix)

i.e.

Burden for Voluntary Posting in Two Publications

i.e

supra

i.e.

supra
supra

See

i.e.

(x)

i.e.

Burden to the Federal Government

Compliance Procedures (§ 88.6(d))

E.g

(i)

Summary of the Collection of Information

(ii)

Need for Information

(iii)

Use of Information

(iv)

Description of the Respondents

(v)

Number of Respondents
supra

(vi)

Burden of Response

supra

LIST OF SUBJECTS

PART 88— PROTECTING STATUTORY CONSCIENCE RIGHTS IN HEALTH CARE;
DELEGATIONS OF AUTHORITY

Authority
e.g.

e.g
e.g.

§ 88.1 Purpose.

§ 88.2 Definitions.

Assist in the Performance

Department

Discriminate

Discrimination

Entity

Federal financial assistance

Health care entity

e.g.

Health service program

Instrument

OCR

Recipient

Referral

refer for

State

Sub recipient

Workforce

§ 88.3 Applicable requirements and prohibitions.
The Church Amendments, 42 U.S.C. 300a–7.
Applicability

et seq

et seq

Requirements and prohibitions

The Coats Snowe Amendment (Section 245 of the Public Health Service
Act), 42 U.S.C. 238n.
Applicability

Requirements and prohibitions

Weldon Amendment (See, e.g., Pub. L. 115 245, Div. B, sec. 507(d)).
Applicability

Prohibition

Medicare Advantage (See, e.g., Pub. L. 115 245, Div. B, sec. 209).
Applicability

Prohibition

Section 1553 of the Affordable Care Act, 42 U.S.C. 18113.
Applicability

Prohibition

Section 1303 of the Affordable Care Act, 42 U.S.C. 18023.
Applicability

Requirements and prohibitions

Section 1411 of the Affordable Care Act, 42 U.S.C. 18081.
Applicability

Requirement

(1)

Counseling and referral provisions of 42 U.S.C. 1395w 22(j)(3)(B) and
1396u 2(b)(3)(B)).
Applicability

Requirements and prohibitions

Advance Directives, 42 U.S.C. 1395cc(f), 1396a(w)(3), and 14406.

Applicability

Prohibitions

Global Health Programs, 22 U.S.C. 7631(d).
Applicability

Prohibitions

The Helms, Biden, 1978, and 1985 Amendments, 22 U.S.C. 2151b(f); see, e.g.
Consolidated Appropriations Act, 2019, Pub. L. 116 6, Div. F, sec. 7018.
Applicability

Prohibitions

1

5

1
5

1
2
3

4

5

1
5
Newborn and Infant Hearing Loss Screening, 42 U.S.C. 280g 1(d).
Applicability

Requirement

Medical Screening, Examination, Diagnosis, Treatment, or Other Health
Care or Services, 42 U.S.C. 1396f.
Applicability

Requirements and prohibitions
et seq.

Occupational Illness Examinations and Tests, 29 U.S.C. 669(a)(5).
Applicability

Requirements
et seq.

Vaccination, 42 U.S.C. 1396s(c)(2)(B)(ii).
Applicability

Requirement

Specific Assessment, Prevention and Treatment Services, 42 U.S.C. 290bb
36(f), 5106i(a).
Applicability

et
seq.
et seq.

Requirements and prohibitions

Religious nonmedical health care, 42 U.S.C. 1320a–1(h), 1320c 11, 1395i 5,
1395x(e), 1395x(y)(1), 1396a(a), and 1397j 1(b).
Applicability

Requirements and prohibitions

(1)

(2)

(1)

(2)

§ 88.4 Assurance and certification of compliance requirements.
In general.
Assurance

Certification

Specific requirements
Timing

Form and manner

Duration of obligation.

Compliance requirement

Condition of continued receipt

Assurances and certifications in applications

Enforcement of assurances and certifications

Remedies for failure to make assurances and certifications

Exceptions

§ 88.5 Notice of rights under Federal conscience and anti discrimination laws.
In general

Placement of the notice text

Content of the notice text.

Combined nondiscrimination notices

§ 88.6 Compliance requirements.
In general

Records and information

Cooperation

Reporting requirement

Intimidating or retaliatory acts prohibited

§ 88.7 Enforcement authority.
In general

Complaints

Compliance reviews

Investigations

Failure to respond

Related administrative or judicial proceeding

Supervision and coordination

Referral to the Department of Justice

Resolution of matters

e.g.
e.g

e.g

Noncompliance with § 88.4.

§ 88.8 Relationship to other laws.

§ 88.9 Rule of construction.

§ 88.10 Severability.

Appendix A to Part 88—Model Text: Notice of Rights under Federal Conscience
and Anti Discrimination Laws

https://ocrportal.hhs.gov/ocr/portal/lobby.jsf

http://www.hhs.gov/conscience

Alex M. Azar II
Secretary
Department of Health and Human Services.