The Affordable Care Act (ACA) – the health insurance reform legislation passed by Congress and signed into law by President Obama on March 23, 2010 – helps make prevention services affordable and accessible for all Americans by requiring most health insurance plans to provide coverage without cost sharing for certain recommended preventive services. Preventive services that have strong scientific evidence of their health benefits must be covered and plans can no longer charge a patient a copayment, coinsurance or deductible for these services when they are delivered by a network provider.
Under the ACA, most private health insurers must provide coverage of women's preventive health care – such as mammograms, screenings for cervical cancer, prenatal care, and other services –with no cost sharing. Under section 2713 of the Public Health Service Act, as modified by the ACA, non-grandfathered group health plans and non-grandfathered group and individual health insurance coverage are required to cover specified preventive services without a copayment, coinsurance, deductible, or other cost sharing, including preventive care and screenings for women as provided for in comprehensive guidelines supported by HRSA for this purpose.
The law recognizes and HHS understands the unique health needs of women across their lifespan. The purpose of WPSI is to improve women’s health across the lifespan by identifying preventive services and screenings to be used in clinical practice and, when supported by HRSA, incorporated in the Guidelines.
The HRSA-supported Women’s Preventive Services Guidelines (Guidelines) were originally established in 2011 based on recommendations from a Department of Health and Human Services' commissioned study by the Institute of Medicine (IOM), now known as the National Academy of Medicine (NAM).
Since the establishment of the Guidelines, there have been advancements in science and gaps identified in clinical practice. To address these, in 2016, the Health Resources and Services Administration (HRSA) awarded a five-year cooperative agreement, the Women’s Preventive Services Initiative (WPSI), to the American College of Obstetricians and Gynecologists (ACOG) to convene a coalition of clinician, academic, and consumer-focused health professional organizations to conduct a scientifically rigorous review to develop recommendations for updated Guidelines in accordance with the model created by the NAM Clinical Practice Guidelines We Can Trust. The American College of Obstetricians and Gynecologists (ACOG) formed an expert panel, also called the WPSI, for this purpose.
In March 2021, ACOG was awarded a subsequent cooperative agreement to review and recommend updates to the Guidelines. Under ACOG, WPSI reviews existing Women’s Preventive Services Guidelines at least once every 5 years, or upon the availability of new evidence, as well as new preventive services topics. New topics for future consideration can be submitted on a rolling basis at the Women’s Preventive Services Initiative website.
HRSA supports the Women’s Preventive Services Guidelines (Guidelines) listed below that address health needs specific to women.
In December 2022, HRSA approved updates to the Guidelines for two listed preventive services: Screening for Gestational Diabetes Mellitus (to be retitled as “Screening for Diabetes in Pregnancy”) and Screening for Diabetes Mellitus after Pregnancy (to be retitled as “Screening for Diabetes after Pregnancy”). The Guidelines are provided in the table below.
| Type of Preventive Service | Current Guidelines | Updated Guideline Beginning with Plan Years Starting in 2025 |
|---|---|---|
| Screening for Urinary Incontinence | WPSI recommends screening women for urinary incontinence annually. Screening should ideally assess whether women experience urinary incontinence and whether it impacts their activities and quality of life. The Women’s Preventive Services Initiative recommends referring women for further evaluation and treatment if indicated. | The Women’s Preventive Services Initiative recommends screening women for urinary incontinence annually. Screening should assess whether women experience urinary incontinence and whether it impacts their activities and quality of life. If indicated, facilitating further evaluation and treatment is recommended. |
WPSI recommends that adolescent and adult women have access to the full range of contraceptives and contraceptive care to prevent unintended pregnancies and improve birth outcomes. Contraceptive care includes screening, education, counseling, and provision of contraceptives (including in the immediate postpartum period).**** Contraceptive care also includes follow-up care (e.g., management, evaluation and changes, including the removal, continuation, and discontinuation of contraceptives).
WPSI recommends that the full range of U.S. Food and Drug Administration (FDA)- approved, -granted, or -cleared contraceptives, effective family planning practices, and sterilization procedures be available as part of contraceptive care.
The full range of contraceptives includes those currently listed in the FDA's Birth Control Guide*****: (1) sterilization surgery for women, (2) implantable rods, (3) copper intrauterine devices, (4) intrauterine devices with progestin (all durations and doses), (5) injectable contraceptives, (6) oral contraceptives (combined pill), 7) oral contraceptives (progestin only), (8) oral contraceptives (extended or continuous use), (9) the contraceptive patch, (10) vaginal contraceptive rings, (11) diaphragms, (12) contraceptive sponges, (13) cervical caps, (14) condoms, (15) spermicides, (16) emergency contraception (levonorgestrel), and (17) emergency contraception (ulipristal acetate), and any additional contraceptives approved, granted, or cleared by the FDA. Additionally, instruction in fertility awareness-based methods, including the lactation amenorrhea method, although less effective, should be provided for women desiring an alternative method.******
While not included as part of the HRSA-supported guidelines, the Women's Preventive Services Initiative, through ACOG, also developed implementation considerations, available at the Women's Preventive Services Initiative website, which provide additional clarity on implementation of the guidelines into clinical practice. The implementation considerations are separate from the clinical recommendations, are informational, and are not part of the formal action by the Administrator under Section 2713.
* Non-grandfathered plans and coverage (generally, plans or policies created or sold after March 23, 2010, or older plans or policies that have been changed in certain ways since that date) are required to provide coverage without cost sharing consistent with these guidelines beginning with the first plan year (in the individual market policy year) that begins on or after December 30, 2022. Before that time, non-grandfathered plans are generally required to provide coverage without cost sharing consistent with the guidelines as previously updated in 2019.
** (I)(a) Objecting entities—religious beliefs.
(1) These Guidelines do not provide for or support the requirement of coverage or payments for contraceptive services with respect to a group health plan established or maintained by an objecting organization, or health insurance coverage offered or arranged by an objecting organization, and thus the Health Resources and Service Administration exempts from any Guidelines requirements issued under 45 CFR 147.130(a)(1)(iv) that relate to the provision of contraceptive services:
(i) A group health plan and health insurance coverage provided in connection with a group health plan to the extent the non-governmental plan sponsor objects as specified in paragraph (I)(a)(2) of this note. Such non-governmental plan sponsors include, but are not limited to, the following entities:
(A) A church, an integrated auxiliary of a church, a convention or association of churches, or a religious order;
(B) A nonprofit organization;
(C) A closely held for-profit entity;
(D) A for-profit entity that is not closely held; or
(E) Any other non-governmental employer;
(ii) An institution of higher education as defined in 20 U.S.C. 1002 in its arrangement of student health insurance coverage, to the extent that institution objects as specified in paragraph (I)(a)(2) of this note. In the case of student health insurance coverage, section (I) of this note is applicable in a manner comparable to its applicability to group health insurance coverage provided in connection with a group health plan established or maintained by a plan sponsor that is an employer, and references to “plan participants and beneficiaries” will be interpreted as references to student enrollees and their covered dependents; and
(iii) A health insurance issuer offering group or individual insurance coverage to the extent the issuer objects as specified in paragraph (I)(a)(2) of this note. Where a health insurance issuer providing group health insurance coverage is exempt under this paragraph (I)(a)(1)(iii), the plan remains subject to any requirement to provide coverage for contraceptive services under these Guidelines unless it is also exempt from that requirement.
(2) The exemption of this paragraph (I)(a) will apply to the extent that an entity described in paragraph (I)(a)(1) of this note objects to its establishing, maintaining, providing, offering, or arranging (as applicable) coverage, payments, or a plan that provides coverage or payments for some or all contraceptive services, based on its sincerely held religious beliefs.
(b) Objecting individuals—religious beliefs. These Guidelines do not provide for or support the requirement of coverage or payments for contraceptive services with respect to individuals who object as specified in this paragraph (I)(b), and nothing in 45 CFR 147.130(a)(1)(iv), 26 CFR 54.9815–2713(a) (1)(iv), or 29 CFR 2590.715-2713(a)(1)(iv) may be construed to prevent a willing health insurance issuer offering group or individual health insurance coverage, and as applicable, a willing plan sponsor of a group health plan, from offering a separate benefit package option, or a separate policy, certificate or contract of insurance, to any individual who objects to coverage or payments for some or all contraceptive services based on sincerely held religious beliefs.
(II)(a) Objecting entities—moral convictions.
(1) These Guidelines do not provide for or support the requirement of coverage or payments for contraceptive services with respect to a group health plan established or maintained by an objecting organization, or health insurance coverage offered or arranged by an objecting organization, and thus the Health Resources and Service Administration exempts from any Guidelines requirements issued under 45 CFR 147.130(a)(1)(iv) that relate to the provision of contraceptive services:
(i) A group health plan and health insurance coverage provided in connection with a group health plan to the extent one of the following non-governmental plan sponsors object as specified in paragraph (II)(a)(2) of this note:
(A) A nonprofit organization; or
(B) A for-profit entity that has no publicly traded ownership interests (for this purpose, a publicly traded ownership interest is any class of common equity securities required to be registered under section 12 of the Securities Exchange Act of 1934);
(ii) An institution of higher education as defined in 20 U.S.C. 1002 in its arrangement of student health insurance coverage, to the extent that institution objects as specified in paragraph (II)(a)(2) of this note. In the case of student health insurance coverage, section (I) of this note is applicable in a manner comparable to its applicability to group health insurance coverage provided in connection with a group health plan established or maintained by a plan sponsor that is an employer, and references to “plan participants and beneficiaries” will be interpreted as references to student enrollees and their covered dependents; and
(iii) A health insurance issuer offering group or individual insurance coverage to the extent the issuer objects as specified in paragraph (II)(a)(2) of this note. Where a health insurance issuer providing group health insurance coverage is exempt under this paragraph (II)(a)(1)(iii), the group health plan established or maintained by the plan sponsor with which the health insurance issuer contracts remains subject to any requirement to provide coverage for contraceptive services under these Guidelines unless it is also exempt from that requirement.
(2) The exemption of this paragraph (II)(a) will apply to the extent that an entity described in paragraph (II)(a)(1) of this note objects to its establishing, maintaining, providing, offering, or arranging (as applicable) coverage or payments for some or all contraceptive services, or for a plan, issuer, or third party administrator that provides or arranges such coverage or payments, based on its sincerely held moral convictions.
(b) Objecting individuals—moral convictions. These Guidelines do not provide for or support the requirement of coverage or payments for contraceptive services with respect to individuals who object as specified in this paragraph (II)(b), and nothing in § 147.130(a)(1)(iv), 26 CFR 54.9815–2713(a) (1)(iv), or 29 CFR 2590.715-2713(a)(1)(iv) may be construed to prevent a willing health insurance issuer offering group or individual health insurance coverage, and as applicable, a willing plan sponsor of a group health plan, from offering a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option, to any individual who objects to coverage or payments for some or all contraceptive services based on sincerely held moral convictions.
(III) Definition. For the purposes of this note, reference to “contraceptive” services, benefits, or coverage includes contraceptive or sterilization items, procedures, or services, or related patient education or counseling, to the extent specified for purposes of these Guidelines.
*** General Notice
On July 29, 2019, the District Court for the Northern District of Texas issued an injunction preventing the enforcement of “the Contraceptive Mandate, codified at 42 U.S.C. § 300gg–13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv), 29 C.F.R. § 2590.715–2713(a)(1)(iv), and 26 C.F.R. § 54.9815–2713(a)(1)(iv), against any group health plan, and any health insurance coverage provided in connection with a group health plan, that is sponsored by an Employer Class member[,]” to the extent that such coverage conflicts with the Employer Class member’s sincerely held religious objections to such coverage, in connection with DeOtte v. Azar, No. 4:18-CV-00825-O, 2019 WL 3786545 (N.D. Tex. July 29, 2019). The injunction also prevents the enforcement of “the Contraceptive Mandate” to the extent it requires an "Individual Class member[] to provide coverage or payments for contraceptive services" to which the individual objects based on sincerely held religious beliefs, if a health insurance issuer and, if applicable, a sponsor of a group health plan, is willing to offer the Individual Class member a separate policy or plan that omits such contraceptive coverage. On December 17, 2021, the Fifth Circuit vacated the injunction in DeOtte v. Nevada, No. 19-10754 (5th Cir. Dec. 17, 2021). However, as of the date of this publication, the Fifth Circuit has yet to issue a mandate in connection with its order, and the injunction remains in place.
**** Education and counseling includes all methods of contraception, including but not limited to, hormonal, devices, surgical, barrier, and fertility-based awareness methods, including lactation amenorrhea.
***** FDA's Birth Control Guide
This refers to FDA’s Birth Control Guide (PDF - 450 KB) as posted on December 22, 2021 with the exception of sterilization surgery for men, which is beyond the scope of the WPSI.
****** Notice
This sentence, included at the end of the "Contraception" section of the previous Guidelines, remains at the conclusion of the "Contraception" section of the 2021 Guidelines per a Final Order issued on December 6, 2022, in Tice-Harouff v. Johnson, Eastern District of Texas (Tyler Division), Case No. 6:22-cv-201-JDK. This is consistent with footnote **** above, which indicates that education and counseling within the "Contraception" section of the 2021 Guidelines includes fertility awareness-based methods, including lactation amenorrhea.