Safeguarding the Rights of Conscience as Protected by Federal Statutes
Notice of proposed rulemaking (NPRM).
CFR Part: "45 CFR Part 88"
RIN Number: "RIN 0945-AA18"
Citation: "88 FR 820"
Page Number: "820"
"Proposed Rules"
Agency: "
SUMMARY: The Department proposes to partially rescind the
DATES: Written comments must be received on or before
ADDRESSES: You may submit comments, identified by the Regulatory Information Number (RIN) [RIN 0945-AA18] by any of the following methods. The first is the preferred method. Please submit your comments in only one of these ways to minimize the receipt of duplicate submissions.
1. Federal eRulemaking Portal. You may submit comments electronically to https://www.regulations.gov. Submit your comments as an attachment to your message or cover letter. [Attachments should be in Microsoft Word, WordPerfect, or Excel; however, Microsoft Word is preferred.] Follow the instructions for sending comments contained in the website link "Comment or Submission" and enter the keywords, "Conscience Recission NPRM."
2. By regular, express or overnight mail. You may mail written comments to the following address only:
3. Delivery by hand (in person or by courier). If you prefer, you may deliver your written comments before the close of the comment period to the same address:
Because of staffing and resource limitations, and to ensure that no comments are misplaced, the agency cannot accept comments by facsimile (FAX) transmission. All comments received on a timely basis will be posted without change to https://www.regulations.gov, including any personal information provided.
Docket: For complete access to the docket to read background documents or comments received, go to https://www.regulations.gov and search for Docket ID number HHS-OCR-0945-AA18.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
If you are a person with a disability and/or a user of assistive technology who has difficulty accessing this document, please contact the
I. Background
Statutory Background
Several provisions of Federal law prohibit recipients of certain Federal funds from coercing individuals and entities in the health care field into participating in actions they find religiously or morally objectionable. They include the following provisions.
The Church Amendments [42 U.S.C. 300a-7]
The conscience provisions contained in 42 U.S.C. 300a-7 (collectively known as the "Church Amendments") were enacted at various times during the 1970s in response to debates over whether receipt of Federal funds required the recipients of such funds to perform abortions or sterilizations. The first conscience provision in the Church Amendments, 42 U.S.C. 300a-7(b), provides that "[t]he receipt of any grant, contract, loan, or loan guarantee under [certain statutes implemented by the
The second conscience provision in the Church Amendments, 42 U.S.C. 300a-7(c)(1), prohibits any entity that receives a grant, contract, loan, or loan guarantee under certain Department-implemented statutes from discriminating against any physician or other health care personnel in employment, promotion, termination of employment, or the extension of staff or other privileges because the individual "performed or assisted in the performance of a lawful sterilization procedure or abortion, because he refused to perform or assist in the performance of such a procedure or abortion on the grounds that his performance or assistance in the performance of the procedure or abortion would be contrary to his religious beliefs or moral convictions, or because of his religious beliefs or moral convictions respecting sterilization procedures or abortions."
The third conscience provision, contained in 42 U.S.C. 300a-7(c)(2), prohibits any entity that receives a grant or contract for biomedical or behavioral research under any program administered by the Department from discriminating against any physician or other health care personnel in employment, promotion, termination of employment, or extension of staff or other privileges "because he performed or assisted in the performance of any lawful health service or research activity, because he refused to perform or assist in the performance of any such service or activity on the grounds that his performance or assistance in the performance of such service or activity would be contrary to his religious beliefs or moral convictions, or because of his religious beliefs or moral convictions respecting any such service or activity."
The fourth conscience provision, 42 U.S.C. 300a-7(d), provides that "[n]o individual shall be required to perform or assist in the performance of any part of a health service program or research activity funded in whole or in part under a program administered by [the Department] if his performance or assistance in the performance of such part of such program or activity would be contrary to his religious beliefs or moral convictions."
The final conscience provision contained in the Church Amendments, 42 U.S.C. 300a-7(e), prohibits any entity that receives a grant, contract, loan, loan guarantee, or interest subsidy under certain Departmentally implemented statutes from denying admission to, or otherwise discriminating against, "any applicant (including applicants for internships and residencies) for training or study because of the applicant's reluctance, or willingness, to counsel, suggest, recommend, assist, or in any way participate in the performance of abortions or sterilizations contrary to or consistent with the applicant's religious beliefs or moral convictions."
Public Health Service Act Sec. 245 [42 U.S.C. 238n] (Coats-Snowe Amendment)
Enacted in 1996, section 245 of the Public Health Service Act (PHS Act) prohibits the Federal Government and any State or local government receiving Federal financial assistance from discriminating against any health care entity on the basis that the entity (1) "Refuses to undergo training in the performance of induced abortions, to require or provide such training, to perform such abortions, or to provide referrals for such training or such abortions;" (2) refuses to make arrangements for such activities; or (3) "attends (or attended) a post-graduate physician training program, or any other program of training in the health professions, that does not (or did not) perform induced abortions or require, provide, or refer for training in the performance of induced abortions, or make arrangements for the provision of such training." For the purposes of this protection, the statute defines "financial assistance" as including, "with respect to a government program," "governmental payments provided as reimbursement for carrying out health-related activities." In addition, PHS Act Sec. 245 requires that, in determining whether to grant legal status to a health care entity (including a State's determination of whether to issue a license or certificate), the federal government and any State or local government receiving federal financial assistance shall deem accredited any post-graduate physician training program that would be accredited, but for the reliance on an accrediting standard that, regardless of whether such standard provides exceptions or exemptions, requires an entity: (1) to perform induced abortions; or (2) to require, provide, or refer for training in the performance of induced abortions, or make arrangements for such training.
Medicaid and Medicare
The Medicaid and Medicare statutes include certain conscience provisions as well. In particular, the Balanced Budget Act of 1997, Public Law 105-33, 111 Stat. 251 (1997), prohibits Medicaid managed care-managed organizations and Medicare Advantage plans from prohibiting or restricting a physician from informing a patient about his or her health and full range of treatment options. See id. 40011852(j)(3)(A), 111 Stat. at 295 (codified at 42 U.S.C. 1395w-22(j)(3)(A)) (Medicare Advantage); id. 4704(b)(3)(A), 111 Stat. at 496 (codified at 42 U.S.C. 1396u-2(b)(3)(A)) (Medicaid managed care). However, it also provides that Medicaid managed care-managed organizations and Medicare Advantage plans are not required to provide, reimburse for, or cover a counseling or referral service if the organization or plan objects to the service on moral or religious grounds. See id. 40011852(j)(3)(B), 111 Stat. at 295 (codified at 42 U.S.C. 1395w-22(j)(3)(B)) (Medicare Advantage); id. 4704(b)(3)(B), 111 Stat. at 496-97 (codified at 42 U.S.C. 1396u-2(b)(3)(B)) (Medicaid). The organization or plan must, however, provide sufficient notice of its moral or religious objections to prospective enrollees. 42 U.S.C. 1395w-22(j)(3)(B)(ii) (Medicare Advantage), 1396u-2(b)(3)(B)(ii) (Medicaid managed care).
These Medicare and Medicaid statutes also contain conscience provisions related to the performance of advanced directives. See 42 U.S.C. 1395cc(f), 1396a(w)(3), and 14406(2). And finally, they contain provisions related to religious nonmedical health care providers and their patients. See 42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395x(e), 1395x(
Weldon Amendment
The Weldon Amendment, originally adopted as section 508(d) of the Labor-HHS Division (Division F) of the 2005 Consolidated Appropriations Act, Public Law 108-447, 118 Stat. 2809, 3163 (
The Weldon Amendment provides that "[n]one of the funds made available in this Act [making appropriations for the Departments of Labor,
Affordable Care Act
In 2010,
Section 1553 provides that the federal government, any state or local government, and any health care provider that receives federal funding under the ACA, or any health plan created under the ACA, may not subject an individual or health care entity to discrimination on the ground that the individual or entity does not provide services for the purpose of causing or assisting in the death of any individual, including through assisted suicide, euthanasia, and mercy killing. See 42 U.S.C. 18113(a). Section 1553 provides that the
Section 1303 provides that a State may choose to prohibit abortion coverage in its qualified health plans, 42 U.S.C. 18023(a)(1), and that such a plan is not required to provide abortion coverage as part of its "essential health benefits," id. 18023(b)(1)(A)(i). However, a qualified health plan that declines to provide abortion coverage must provide notice of this exclusion to potential enrollees. Id. 18023(b)(3)(A). And no qualified health plan may discriminate against any health care provider or facility because it refuses to provide, pay for, cover, or refer for abortions. Id. 18023(b)(4). Section 1303 states that nothing in the ACA shall be construed to preempt state laws on abortion or federal laws on conscience protection, willingness or refusal to provide abortion, and discrimination based on that willingness or refusal to provide, pay for, cover, or refer for abortion or to provide or participate in training to provide abortion, id. 18023(c)(1)-(2), or to relieve health care providers of their obligations to provide emergency services under federal or state laws, including the Emergency Medical Treatment and Labor Act, id. 18023(d). Section 1303 also states that it does not "alter the rights and obligations of employees and employers" under Title VII. See id. 18023(c)(3).
Section 1411 addresses exemptions to the ACA's "individual responsibility requirement." 42 U.S.C. 18081(b)(5)(A). Under this section, the Department may grant exemptions based on hardship (which the Department has stated includes an individual's inability to secure affordable coverage that does not provide for abortions (84 FR 23172), membership in a particular religious organization, or membership in a "health care sharing ministry." /1/
FOOTNOTE 1 In 2017
Other Provisions
A number of additional provisions relating to conscience and religious liberty have also been the subject of previous HHS rulemaking. These include provisions related to compulsory health care services generally (42 U.S.C. 1396f and 5106i(a)), under hearing screening programs (42 U.S.C. 280g-1(d)), occupational illness testing (29 U.S.C. 699(a)(5)), vaccination programs (42 U.S.C. 1396s(c)(2)(B)(ii)), and mental health treatment (42 U.S.C. 290bb-36(f)). These also include conscience and nondiscrimination provisions tied to certain funding in global health programs and other funds administered by the Secretary. See 22 U.S.C. 7631(d) and 22 U.S.C. 2151b(f).
Rulemaking
No statutory provision requires the promulgation of rules to implement the conscience provisions outlined above. On
1. Educate the public and health care providers on the obligations imposed, and protections afforded, by Federal law;
2. Work with state and local governments and other recipients of funds from the Department to ensure compliance with the nondiscrimination requirements embodied in the Federal health care provider conscience protection statutes;
3. When such compliance efforts prove unsuccessful, enforce these nondiscrimination laws through the various Department mechanisms, to ensure that Department funds do not support coercive or discriminatory practices, or policies in violation of Federal law; and
4. Otherwise take an active role in promoting open communication within the health care industry, and between providers and patients, fostering a more inclusive, tolerant environment in the health care industry than may currently exist.
"Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law," 73 FR 78072, 78074.
The final rule went into effect on
On
On
In response to the 2018 Proposed Rule, the Department received more than 242,000 comments, from a wide variety of individuals and organizations, including private citizens, individual and institutional health care providers, religious organizations, patient advocacy groups, professional organizations, universities and research institutions, consumer organizations, and State and Federal agencies and representatives. Comments dealt with a range of issues surrounding the proposed rule, including the Department's authority to issue the rule, the need for the rule, what kinds of workers would be protected by the proposed rule, the rule's relationship to Title VII of the Civil Rights Act and other statutes and protections, what services are covered by the rule, whether the regulation might be used to discriminate against patients, how the rule would affect access to care, legal arguments, and the cost impacts and public health consequences of the rule.
On
Following the issuance of the 2019 Final Rule, a number of States, localities, and non-governmental parties filed suit challenging the rule in the
FOOTNOTE 2 Each court held that the portions of the rule deemed unlawful were so intertwined with any lawful portions that the entire rule would be vacated, rather than individual provisions. See City & Cnty. of San Francisco v. Azar, 411 F. Supp. 3d at 1024-25 ("When a rule is so saturated with error, as here, there is no point in trying to sever the problematic provisions. The whole rule must go."); New York v. HHS., 414 F. Supp. 3d at 577 ("[T]he rulemaking exercise here was sufficiently shot through with glaring legal defects as to not justify a search for survivors."). END FOOTNOTE
Because the 2019 Final Rule never took effect, HHS has been operating under the 2011 Final Rule continuously since it was finalized. It currently accepts, investigates, and processes complaints under the framework created by the 2011 Final Rule. There are no significant reliance interests stemming from the 2019 Final Rule because the rule was vacated before it became effective. Because the 2019 Final Rule never went into effect, no person or entity could have reasonably relied on its provisions. It is possible that health care providers or individuals have reasonably relied on the 2011 Final Rule because it has remained operational.
As part of this proposed rulemaking, HHS seeks comments on the approach contemplated by the 2019 Final Rule as well as comments on the general framework that OCR has been employing since 2011--applying the plain text of the underlying statutes to the facts at issue on a case-by-case basis.
II. Proposed Rule
The Department is proposing to partially rescind the final rule entitled "Protecting Statutory Conscience Rights in Health Care; Delegations of Authority," published in the
Though the Department received comments supporting and opposing the 2018 Proposed Rule (the basis for the 2019 Final Rule), the overwhelming majority of comments were in opposition to the rule.
Groups supporting the 2018 Proposed Rule said it would provide needed clarity and strengthen protections for conscience rights in health care. For example, a comment jointly filed by the
FOOTNOTE 3 Letter from USCCB, NAE, CMA, CLS, ELRC, and FRC to HHS (
FOOTNOTE 4 Letter from the
FOOTNOTE 5 Id. END FOOTNOTE
Other commenters opposed to the 2018 Proposed Rule raised a number of concerns, including that the rule would create confusion, place unnecessary burdens on covered entities, limit access to patient care, and result in individuals being denied access to services, with vulnerable populations being particularly affected. The
FOOTNOTE 6 Letter from the AMA to HHS (
FOOTNOTE 7 See Letter from AAFP to HHS (
FOOTNOTE 8 Letter from APA to HHS (
FOOTNOTE 9 Letter from AAMC to HHS (
FOOTNOTE 10 Letter from Attorneys General to HHS (
FOOTNOTE 11 E.g., Letter from Nat'l
FOOTNOTE 12 Letter from The Nat'l
Comments received on the 2018 Proposed Rule made valuable points about the importance of federal conscience protections as well as the importance of access to care free from discrimination. For this and other reasons, the Department is proposing to retain certain provisions from the 2019 Final Rule with modifications while rescinding others, and generally reinstating 2011 framework that has been in effect for some time.
The Department proposes to retain three aspects of the 2019 Final Rule: (1) the application to statutes first referenced in the 2019 Final Rule; (2) several enforcement provisions; and (3) a voluntary notice provision. The provisions proposed to be retained have been modified to address concerns raised by many of the commenters--and echoed in federal district court decisions--about the Department's underlying rulemaking authority. /13/ The new proposed rule relies on the Department's housekeeping authority under 5 U.S.C. 301, which permits the Department to issue regulations concerning its own internal procedures and operations, and therefore allows for the modifications in this proposed rule.
FOOTNOTE 13 See, e.g., New York v. United States Dep't of Health & Hum. Servs., 414 F. Supp. 3d 475, 521-22 (S.D.N.Y. 2019) (neither housekeeping authority nor general compliance powers are a basis for substantive rulemaking). END FOOTNOTE
First, the Department proposes to expand the category of "federal health care provider conscience protection statutes" covered by the rule to include the statutes that HHS added to
Second, the Department proposes to retain a number of provisions from the 2019 Final Rule related to complaint handling and investigations. In the proposed
Finally, the Department proposes to retain the 2019 Final Rule's voluntary notice provisions, with some modifications to address concerns identified above. Notice of conscience protections and nondiscrimination laws under those provisions is an important means of promoting compliance. Such notices inform the public, patients, and workforce, which may include students or applicants for employment or training, of protections under the Federal conscience and nondiscrimination laws and this rule.
This proposed notice would advise persons and covered entities about their rights and the Department's and/or recipients' obligations under Federal conscience and nondiscrimination laws. The notice may also provide information about how to file a complaint with OCR if an individual believes that these laws have been violated, and may provide additional information to the patient on how to seek care.
Proposed paragraph (b) sets forth locations where the notice should appear: on the Department's and recipient's website(s), and in a physical location of each Department and recipient establishment where notices to the public and notices to their workforce are customarily posted. Proposed paragraph (c) would encourage covered entities to utilize the model notice and, if the recipient does not have a conscience-based objection to doing so, to provide information about alternative providers that may offer patients services the recipient does not provide for reasons of conscience. The Department proposes that recipients should be permitted to tailor their notice to their particular circumstances and communities, and paragraph (d) of
The 2019 Final Rule, at
We encourage any relevant comments, including those that will assist the Department in assessing alternatives and reevaluating the necessity for additional regulations implementing the statutory requirements.
The Department proposes to rescind the other portions of the 2019 Final Rule because those portions are redundant, unlawful, confusing or undermine the balance
The proposed partial rescission n is informed by the three district court decisions that vacated the 2019 Final Rule prior to it taking effect and identified a number of serious questions that warrant additional careful consideration. Among other things, the litigation has raised significant questions regarding the complaints of statutory violations that served as a predicate for the 2019 Final Rule.
The Federal health conscience protection and nondiscrimination statutes represent
Patients also have autonomy, rights, and moral and religious convictions. And they have health needs, sometime urgent ones. Our health care systems must effectively deliver services--including safe legal abortions--to all who need them in order to protect patients' health and dignity.
III. Statutory Authority
The Secretary proposes to partially rescind the
IV. Request for Comment
The Department seeks comments in order to determine whether or not to rescind the 2019 Final Rule in part or in its entirety or to modify that rule or parts of it, as well as to determine whether or not to leave in place the framework created by 2011 Final Rule, with additional authorities added to that framework, or otherwise to modify it. In particular, the Department seeks the following:
1. Information, including specific examples where feasible, addressing the scope and nature of the problems giving rise to the need for rulemaking, and whether those problems could be addressed by different regulations than those adopted in 2019 or by sub-regulatory guidance;
2. Information, including specific examples where feasible, supporting or refuting allegations that the 2019 Final Rule hindered, or would hinder, access to information and health care services, particularly sexual and reproductive health care and other preventive services;
3. Information, including specific examples where feasible, regarding complaints of discrimination on the basis that an individual or health care entity did not provide services for the purpose of causing or assisting in the death of any individual, including through assisted suicide, euthanasia, and mercy killing, as described in section 1553 of the ACA, and comments on whether additional regulations under this authority are necessary;
4. Information, including specific examples where feasible, regarding complaints of discrimination by a qualified health plan under the ACA on the basis that a health care provider or facility refused to provide, pay for, cover, or refer for abortions, as described in section 1303 of the ACA and comments on whether additional regulations under this authority are necessary;
5. Information, including specific examples where feasible, from health care providers regarding alleged violations of the conscience provisions provided for in the Medicaid and Medicare statutes, including the provisions codified at 42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395w-22(j)(3), 1395x(e), 1395x(
6. Information, including specific examples where feasible, regarding alleged violations of any of the other authorities that appeared in the 2019 Final Rule but not the 2011 Final Rule;
7. Comment on whether the 2019 Final Rule provided sufficient clarity to minimize the potential for harm resulting from any ambiguity and confusion that may exist because of the rule, and whether any statutory terms require additional clarification;
8. Comment on whether the provisions added by the 2019 Final Rule are necessary, collectively or with respect to individual provisions, to serve the statutes' or the rule's objectives, including with regard to whether the Department accurately evaluated the need for additional regulation in the 2019 Final Rule, and whether those provisions should be modified, or whether the rule's objectives may also be accomplished through alternative means, such as outreach and education;
9. Comment on the proposal to retain a voluntary notice provision, including comments on whether such notice should be mandatory, and what a model notice should include; and
10. Comment on the proposal to retain portions of the 2019 Final Rule's enforcement provisions in the proposed
V. Preliminary Regulatory Impact Analysis
Introduction
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is an economically significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule would result in either a small reduction in costs to small entities or no impact on costs to small entities, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. This finding is consistent with the regulatory flexibility analysis of the final rule that would be partially rescinded by this regulatory action, which "concluded that this rule does not have a significant economic impact on a substantial number of small entities" (84 FR 23255).
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing "any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of
Detailed Economic Analysis
HHS considered several policy alternatives, in addition to the approach of the proposed rule. This economic analysis considers the likely impacts associated with the following three policy options: (1) rescinding the 2019 Final Rule without exceptions; (2) adopting the approach of the proposed rule, which partially rescinds the 2019 Final Rule, and modifies other provisions; and (3) adopting the approach of the proposed rule, except further modifying the notice provision to require mandatory notices instead of voluntary notices. To simplify the narrative of this RIA, we present the impacts of rescinding the 2019 Final Rule in its entirety first, and then present the impacts of a partial rescission with modifications. These modifications correspond to the policy option of the proposed rule, and the policy option of mandatory notices. This RIA then summarizes the impacts of each policy option against common assumptions about the baseline scenario of no further regulatory action.
Policy Option 1: Rescinding the 2019 Final Rule
Rescinding the final rule entitled "Protecting Statutory Conscience Rights in Health Care; Delegations of Authority," published in the
Under our primary baseline scenario, Policy Option 1 would entirely reverse the impacts of the 2019 Final Rule. To analyze the impacts of Policy Option 1 under this scenario, we provisionally adopt the estimates of the likely impacts of the 2019 Final Rule in its RIA, although we understand that commenters raised questions whether, for example, certain of the non-quantified benefits that the 2019 Final Rule anticipated would in fact be realized. The RIA identified five categories of quantified costs: (1) familiarization; (2) assurance and certification; (3) voluntary actions to provide notices of rights; (4) voluntary remedial efforts; and (5) OCR enforcement and associated costs. The narrative of the RIA described an approach for estimating each of these costs, and Table 6 of the RIA summarized the timing and magnitude of these quantified costs (84 FR 23240). In addition to identifying quantified costs, the RIA identified non-quantified costs associated with compliance procedures and non-quantified costs associated with seeking alternative providers of certain objected to medical services or procedures. The RIA did not identify any quantified benefits, but identified non-quantified benefits associated with compliance with the law; protection of conscience rights, the free exercise of religion and moral convictions; more diverse and inclusive providers and health care professionals; improved provider-patient relationships that facilitate improved quality of care; equity, fairness, nondiscrimination; increased access to care. We request public comment on whether the non-quantified benefits and costs identified in the 2019 Final Rule's RIA would likely be realized, absent any further regulatory action.
Table 1 of the 2019 Final Rule's RIA reported the present value and annualized value of the quantified costs and summarized the non-quantified costs and benefits of the 2019 Final Rule (84 FR 23227). That RIA reported estimates of the present value of the total costs over a 5-year time horizon of
Under our alternative baseline scenario, we assume that the 2019 Final Rule would never take effect, even without any additional regulatory action. Under this baseline scenario, Policy Option 1 would maintain the current status quo, which is characterized by the 2011 Final Rule (76 FR 9968). Thus, for this baseline scenario, we conclude that Policy Option 1 would result in only de minimis impacts that we do not quantify, such as resolving any regulatory uncertainty associated with the 2019 Final Rule, which has been vacated by three federal courts but not rescinded. We report the impacts of Policy Option 1 under this alternative baseline scenario in Table A.
Policy Option 2: The Proposed Rule
The proposed rule would partially rescind the 2019 Final Rule, with certain exceptions. Specifically, the Department proposes to retain three aspects of the 2019 Final Rule: (1) the addition to part 88 of statutes including the 2019 Final Rule; (2) several enforcement provisions; and (3) a voluntary notice provision. However, as described in greater detail in the Preamble, the Department is also proposing to modify each of these provisions of the 2019 Final Rule. For example, the voluntary notice provision in the proposed rule would clarify that providing these voluntary notices would not satisfy an entity's substantive obligations imposed upon covered entities by the underlying statutes.
We considered the likely impacts of each of the three retained aspects of the 2019 Final Rule. We identify quantifiable impacts associated with retaining the aspects of the 2019 Final Rule related to the enforcement provisions and quantifiable impacts related to the voluntary notice provision. We adopt the analytic approach contained in the 2019 Final Rule's RIA to quantify these impacts, including an assumption in that RIA that about half of covered entities would provide notices voluntarily. For the provisions related to enforcement, the 2019 RIA estimated an annual impact of about
To quantify the net impact of the proposed rule, we subtract the costs associated with enforcement and voluntary notice provisions from our earlier estimates of the total cost savings of rescinding the 2019 Final Rule. As an intermediate step, we converted the 2016 dollar estimates to 2021 dollars using the Implicit Price Deflator for the Gross Domestic Product. Compared to our primary baseline, we estimate that the proposed rule, if finalized, would result in annualized cost savings in 2021 dollars of
Policy Option 3: The Proposed Rule With an Alternative Notice Provision
We analyzed a third policy option, which is similar to the proposed rule, but would further modify the notice provision by requiring covered entities to post these notices in designated places. The 2019 Final Rule's RIA assumes that about half of covered entities would provide these notices on a voluntary basis, and we carried this assumption through in this analysis, including in our analysis of the costs of the proposed rule. Under Policy Option 3, we anticipate that all covered entities would provide notices, and therefore estimate that costs of mandatory notices would be double that of our estimates of the costs of voluntary notices.
To quantify the net impact of Policy Option 3, we subtract the costs associated with enforcement and mandatory notice provisions from our earlier estimates of the total cost savings of rescinding the 2019 Final Rule. Compared to our primary baseline, we estimate that Policy Option 3 would result in annualized cost savings in 2021 dollars of
Summary of Impacts
This analysis estimates the costs associated with the proposed rule and for two policy alternatives. For the proposed rule, we estimate the present value of the costs of -
Table A-Accounting Table of Costs
Present value by discount Annualized value by
rate discount rate
Baseline scenario and policy option 3 Percent 7 Percent 3 Percent 7 Percent
Primary Baseline:
Option 1 - $ 1,008.0 - $ 818.6 - $ 240.5 - $ 244.5
Option 2 - 834.2 - 657.2 - 202.5 - 205.2
Option 3 - 675.7 - 509.6 - 168.0 - 169.2
Alternative Baseline:
Option 1 0.0 0.0 0.0 0.0
Option 2 173.8 161.4 37.9 39.4
Option 3 332.2 309.0 72.5 75.4
Notes: Option 2 corresponds to the Proposed Rule. Negative costs indicate the Policy Option, if finalized would result in cost savings.
The RIA of the 2019 Final Rule also identified certain non-quantifiable impacts. That RIA discussed potential impacts related to compliance with the law; impacts related to conscience rights; impacts related to the composition of providers and health care professionals; impacts related to provider-patient relations; impacts related to equity, fairness, and nondiscrimination; impacts related to access to care; and additional non-quantified cost savings associated with compliance procedures (recordkeeping and compliance reporting) and seeking of alternative providers of certain objected to medical services or procedures. We request public comment on whether the non-quantified impacts identified in the 2019 Final Rule's RIA would likely be realized, absent any further regulatory action; and request comment on the extent to which each of the Policy Options, including the proposed rule, would result in comparable impacts.
We also request comment on whether covered entities have incurred costs attributable to the 2019 Final Rule that would not be averted by the proposed rule, if it is finalized; and further request data that would allow us to refine our quantified cost-savings estimates. For example, we request information that would allow us to quantify costs that covered entities previously incurred and are not recoverable, such as the costs associated with familiarization of the 2019 Final Rule.
List of Subjects in 45 CFR Part 88 Adult education, Authority delegations (Government agencies), Civil rights, Colleges and universities, Community facilities, Conflicts of interest, Educational facilities, Employment, Family planning, Freedom of information, Government contracts, Government employees, Grant programs-health, Grants administration, Health care, Health facilities, Health insurance, Health professions, Hospitals, Immunization, Indians--Tribal government, Insurance, Insurance companies, Intergovernmental relations, Laboratories, Maternal and child health, Medicaid, Medical and dental schools, Medical research, Medicare, Mental health programs, Nursing homes, Occupational safety and health, Prescription drugs, Public assistance programs, Public health, Religious discrimination, Reporting and recordkeeping requirements, Research, Scholarships and fellowships, Schools, Scientists.
For the reasons set forth in the preamble, the Department proposes to revise 45 CFR part 88 as follows:
PART 88--ENSURING THAT DEPARTMENT OF HEALTH AND HUMAN SERVICES FUNDS DO NOT SUPPORT COERCIVE OR DISCIMINATORY POLICIES OR PRACTICES IN VIOLATION OF FEDERAL LAW
Sec.
88.1Purpose.
88.2Complaint handling and investigating.
88.3Voluntary Notice of Federal conscience and nondiscrimination laws.
88.4Severability.
Appendix A to Part 88--Model Text: Notice of Rights Under Federal Conscience and Nondiscrimination Laws
Authority:5 U.S.C. 301.
The purpose of this part is to provide for the enforcement of the Church Amendments, 42 U.S.C. 300a-7; the Coats-Snowe Amendment, section 245 of the Public Health Service Act, 42 U.S.C. 238n; the Weldon Amendment, Consolidated Appropriations Act, 2022, Pub. L. 117-103, div. H, title V General Provisions, section 507(d)(1) (Mar.15, 2022); Sections 1303, 1411, and 1553 of the ACA, 42 U.S.C. 18023, 18081, and 18113; certain Medicare and Medicaid provisions, 42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395w-22(j)(3)(A)-(B), 1395x(e), 1395x(
(a) Delegated authority. OCR has been delegated the authority to facilitate and coordinate the Department's enforcement of the Federal health care provider conscience protection statutes, which includes the authority to:
(1) Receive and handle complaints;
(2) Conduct investigations;
(3) Consult on compliance within the Department;
(4) Seek voluntary resolutions of complaints; and
(5) Consult and coordinate with the relevant Departmental funding component, and utilize existing regulations enforcement, such as those that apply to grants, contracts, or other programs and services..
(b) Investigations. An OCR investigation of a complaint alleging failure to comply with the Federal health care provider conscience protection statutes may include, a review of the pertinent practices, policies, communications, documents, compliance history, circumstances under which the possible noncompliance occurred, and other factors relevant to determining whether the Department, Department component, recipient, or sub-recipient has failed to comply. OCR may use fact-finding methods including site visits; interviews with the complainants, Department component, recipients, sub-recipients, or third-parties; and written data or discovery requests. OCR may seek the assistance of any State agency.
(c) Supervision and coordination. If as a result of an investigation OCR makes a determination of noncompliance with responsibilities under the Federal health care provider conscience protection statutes, OCR will coordinate and consult with the Departmental component responsible for the relevant funding to undertake appropriate action with the component to assure compliance.
(d) Resolution of matters. (1) If an investigation reveals that no action is warranted, OCR will in writing so inform any party who has been notified by OCR of the existence of the investigation.
(2) If an investigation indicates a failure to comply with the Federal health care provider conscience protection statutes, OCR will so inform the relevant parties and the matter will be resolved by informal means whenever possible.
(a) In general. OCR considers the posting of a notice consistent with this part as a best practice, and encourages all entities subject to the federal health care provider statutes to post the model notice provided in Appendix A.
(b) Placement of the notice text. The model notice in Appendix A should be posted in the following places, where relevant:
(1) On the Department or recipient's website(s);
(2) In a prominent and conspicuous physical location in the Department's or covered entity's establishments where notices to the public and notices to its workforce are customarily posted to permit ready observation;
(3) In a personnel manual, handbook, orientation materials, trainings, or other substantially similar document likely to be reviewed by members of the covered entity's workforce;
(4) In employment applications to the Department or covered entity, or in applications for participation in a service, benefit, or other program, including for training or study; and
(5) In any student handbook, orientation materials, or other substantially similar document for students participating in a program of training or study, including for postgraduate interns, residents, and fellows.
(c) Format of the notice. The text of the notice should be large and conspicuous enough to be read easily and be presented in a format, location, or manner that impedes or prevents the notice being altered, defaced, removed, or covered by other material.
(d) Content of the notice text. A recipient or the Department should consider using the model text provided in Appendix A for the notice, but may tailor its notice to address its particular circumstances and to more specifically address the conscience laws covered by this rule that apply to it. Where possible, and where the recipient does not have a conscience-based objection to doing so, the notice should include information about alternative providers that may offer patients services the recipient does not provide for reasons of conscience.
(e) Combined nondiscrimination notices. The Department and each recipient may post the notice text provided in Appendix A of this part, or a notice it drafts itself, along with the content of other notices (such as other nondiscrimination notices).
Any provision of this part held to be invalid or unenforceable either by its terms or as applied to any entity or circumstance shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event such provision shall be severable from this part, which shall remain in full force and effect to the maximum extent permitted by law. A severed provision shall not affect the remainder of this part or the application of the provision to other persons or entities not similarly situated or to other, dissimilar circumstances.
Appendix A to Part 88--Model Text: Notice of Rights Under Federal Conscience and Nondiscrimination Laws [
*****
Dated:
Secretary,
[FR Doc. 2022-28505 Filed 12-30-22;
BILLING CODE 4153-01-P
NsureHub Partners With Ladder To Make Life Insurance Easy For Its Customers
Duck Creek Technologies Announces First Quarter Fiscal 2023 Financial Results
Advisor News
- Fewer report having retirement savings than a year ago
- Paul Brahim becomes 2025 FPA president
- How can people tell if you are sincere?
- Ex-employees sue Verizon over pension transfer deal with Prudential, RGA
- Gary Brecka, Cardones file dueling lawsuits in battle of social media stars
More Advisor NewsAnnuity News
- AmeriLife To Acquire Crump Life Insurance Services
- Sapiens wins XCelent award for Customer Base and Support for UnderwritingPro for Life & Annuities
- SB 263 expected to bring chaos to Calif. insurance, annuity sales come Jan. 1
- Lincoln Financial hires industry veteran Tom Morelli as Vice President, Investment Distribution
- Structured settlements protect young injury victims | H. Dennis Beaver
More Annuity NewsHealth/Employee Benefits News
- Humana Earns Equality 100 Award in Human Rights Campaign Foundation’s 2025 Corporate Equality Index
- New York Life Wealth Watch 2025 Outlook: Americans’ financial confidence holds despite continued debt and inflation challenges
- Analysis Group Reports Findings in Managed Care and Specialty Pharmacy (Impact of social determinants of health on esketamine nasal spray initiation among patients with treatment-resistant depression in the United States): Drugs and Therapies – Managed Care and Specialty Pharmacy
- Americans’ rage at insurers goes beyond health coverage – the author of ‘Delay, Deny, Defend’ points to 3 reforms that could help
- Ask The Medicare Specialist
More Health/Employee Benefits NewsLife Insurance News
- New York Life Wealth Watch 2025 Outlook: Americans’ financial confidence holds despite continued debt and inflation challenges
- AI’s evolving role in life insurance underwriting
- Globe Life fends off shareholder lawsuits alleging the company misled investors
- Court orders UnitedHealth companies to pay millions to Mass. consumers
- AmeriLife To Acquire Crump Life Insurance Services
More Life Insurance News