Federal Register - October 7, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations
received in response to the 2021 NPRM, abandoning major portions of this approach has damaged the patientprovider relationship. Moreover, the 2019 rule required prenatal referral even if the patient objected, an approach which also does not comport with wellaccepted public health and clinical care principles.
On January 28, 2021, President Biden issued a Memorandum on Protecting Womens Health at Home and Abroad. 8 The Memorandum stated that women should have access to the healthcare they need. For too many women today, both at home and abroad, that is not possible. Undue restrictions on the use of Federal funds have made it harder for women to obtain necessary healthcare. The Federal Government must take action to ensure that women at home and around the world are able to access complete medical information, including with respect to their reproductive health. The Memorandum then instructed the Department to review the Title X Rule and any other regulations governing the Title X program that impose undue restrictions on the use of Federal funds or womens access to complete medical information and shall consider, as soon as practicable, whether to suspend, revise, or rescind, or publish for notice and comment proposed rules suspending, revising, or rescinding, those regulations, consistent with applicable law, including the Administrative Procedure Act.
HHS reviewed the 2019 regulations pursuant to the Presidents memorandum. Following this review, on April 15, 2021, the Department issued a Notice of Proposed Rulemaking NPRM for public comment 86 FR
19812, April 15, 2021, proposing rules to revise the 2019 regulation by essentially readopting the 2000
regulations. 65 FR 41270 July 3, 2000.
The 2000 regulations were consistent with applicable statutory commands, were widely accepted by grantees, enabled the Title X program to operate successfully, and led to no litigation over their permissibility.
Based on the evidence that has emerged since the adoption of the 2019
rule, as well as a fresh consideration of the evidence that existed at the time, the negative public health consequences of the 2019 rule are clear. The rule dramatically reduced access to family planning and preventive health services that are essential for hundreds of 8 Available at https www.whitehouse.gov/
briefing-room/presidential-actions/2021/01/28/
memorandum-on-protecting-womens-health-athome-and-abroad/.
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thousands of clients, especially for the low-income clients Title X was specifically created to serve. The 2019
rule decreased the number of providers willing to participate in the Title X
program, further reducing access to family planning services within states across the country and in rural and urban communities alike. The 2019 rule shifted the Title X program away from its history of providing client-centered quality family planning services and instead set limits on the patientprovider relationship and the information that could be provided to the patient by the provider. The 2019
rule resulted in increased costs for grantee reporting that are unnecessary for ensuring grantee compliance.
Continued enforcement of the 2019 rule raises the possibility of a two-tiered healthcare system in which those with insurance and full access to healthcare receive full medical information and referrals, while low-income populations and other disproportionately impacted communities, such as those in rural regions, minority clients, and adolescent clients, are relegated to inferior access.
The populations served by Title X may already face health inequities driven by financial and access barriers to quality care that would be exacerbated by continuing to allow limited or delayed healthcare choices and biased or insufficient healthcare information.
Given that so many individuals depend on the Title X program as their primary source of healthcare, the Department recognizes that this is a situation that must be rectified with urgency in the interest of public health and equity.
Most importantly, in readopting the 2000 rule, this final rule removes the strict physical separation requirements that were imposed on top of existing obligations for separation between abortion services and Title X project related activities. It also allows Title X
providers to provide truly nondirective counseling and refer their patients for all services desired by the client, including abortion services. The 2000
regulations successfully governed the Title X program for decades and were widely accepted by grantees.
The 2019 rule imposed an interrelated set of requirements that are difficult to disentangle provision by provision. For example, 59.5a5 prohibited funded projects from providing, promoting, referring, or supporting abortion as a method of family planning. Section 59.13 concurrently required assurance that a project did not include abortion as a method of family planning backed by documentary evidence of Subsections 59.1459.16. The interrelatedness of these requirements
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was underscored by 59.7b requiring applicants to clearly address how the proposal will satisfy the requirements of the regulation, before even proceeding to competitive consideration. Most of the 2019 provisions did not function independently of each other.
The Department did initially propose keeping portions of two provisions from the 2019 rule regarding compliance reporting 59.5a12 on state sexual abuse notification laws and subrecipient monitoring 59.5a13. As further explained below, these provisions created administrative costs for grantees and the government with no measurable benefits. These provisions, like the entire 2019 rule, depended on assumptions about how the program should work and grantee compliance even with no evidence of grantee noncompliance.
Given these considerations, the Department has determined that the most appropriate course is to revoke the 2019 rule in its totality. Every court to rule on the 2019 rule also believed that all of its provisions were of a piece and either struck down or upheld the rule in its entirety. See, e.g., Mayor of Baltimore v. Azar, 973 F3d 258, 292 4th Cir. 2020
Despite the severability clause, the Final Rule is not severable because it is clear HHS intended the Final Rule to stand or fall as a whole, and the agency desired a single, coherent policy, the predominant purpose of which is to reinstitute the 1988 Rule..
As compared to the 2019 rule, new provisions added to the re-adoption of the 2000 rule operate independently of each otherand the 2000 ruleto enhance the program. Particularly as the program operated for decades under the 2000 rule, the 2021 additions are severable from the 2000 rule. For example, while adding to the statutory goals of reaching low-income and underserved individuals, if the added grant evaluation criteria of equity, 59.7a3, was excised, the program could still accomplish its mission successfully using the 2000 criteria alone. And, were a court to strike down the new income verification measures in 59.5a9, the program would be able to accomplish its mission using the 2000
criteria alone.
In addition to readopting the requirements as they existed prior to the 2019 rule, the 2021 rule also includes several revisions that will strengthen the Title X program and ensure access to equitable, affordable, client-centered, quality family planning services for all clients, especially for low-income clients, while retaining the longstanding prohibition on directly promoting or performing abortion that follows from
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