FAQS ABOUT AFFORDABLE CARE ACT 
IMPLEMENTATION PART 54 
 
July 28, 2022 
 
Set out below are Frequently Asked Questions (FAQs) regarding implementation of the 
Affordable Care Act. These FAQs have been prepared jointly by the Departments of Labor, 
Health and Human Services (HHS), and the Treasury (collectively, the Departments). Like 
previously issued FAQs (available at https://www.dol.gov/agencies/ebsa/about-ebsa/our-
activities/resource-center/faqs and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs#Affordable_Care_Act), these FAQs answer questions from stakeholders to help people 
understand the law and promote compliance. 
 
COVERAGE OF PREVENTIVE SERVICES 
 
Public Health Service (PHS) Act section 2713 and its implementing regulations relating to 
coverage of preventive services1 require non-grandfathered group health plans and health 
insurance issuers offering non-grandfathered group or individual health insurance coverage to 
cover, without the imposition of any cost-sharing requirements, the following items or services:2 
  Evidence-based items or services that have in effect a rating of A or B in the current 
recommendations of the United States Preventive Services Task Force (USPSTF) with 
respect to the individual involved, except for the recommendations of the USPSTF 
regarding breast cancer screening, mammography, and prevention issued in or around 
November 2009;3 
  Immunizations for routine use in children, adolescents, and adults that have in effect a 
recommendation from the Advisory Committee on Immunization Practices (ACIP) of the 
Centers for Disease Control and Prevention (CDC) with respect to the individual 
involved; 
  With respect to infants, children, and adolescents, evidence-informed preventive care and 
screenings provided for in comprehensive guidelines supported by the Health Resources 
and Services Administration (HRSA); and 
 
1 See 26 CFR 54.9815-2713; 29 CFR 2590.715-2713; and 45 CFR 147.130. 
2 In addition, under section 3203 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act and its 
implementing regulations, plans and issuers must cover, without cost-sharing requirements, any qualifying 
coronavirus preventive service pursuant to section 2713(a) of the PHS Act and its implementing regulations (or any 
successor regulations). The term qualifying coronavirus preventive service means an item, service, or 
immunization that is intended to prevent or mitigate coronavirus disease 2019 (COVID-19) and that is, with respect 
to the individual involved (1) an evidence-based item or service that has in effect a rating of A or B in the 
current USPSTF recommendations; or (2) an immunization that has in effect a recommendation from ACIP 
(regardless of whether the immunization is recommended for routine use). On November 6, 2020, the Departments 
published interim final rules with a request for comment regarding this requirement, Additional Policy and 
Regulatory Revisions in Response to the COVID-19 Public Health Emergency (85 FR 71142). 
3 The USPSTF published updated breast cancer screening recommendations in January 2016. However, section 223 
of Division H of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260) requires that for purposes of PHS Act 
section 2713, USPSTF recommendations relating to breast cancer screening, mammography, and prevention issued 
before 2009 remain in effect until January 1, 2023. 
1 
       
 
  With respect to women, such additional preventive care and screenings not included in 
the recommendations of the USPSTF described above as provided for in comprehensive 
guidelines supported by HRSA.4 
 
If a recommendation or guideline does not specify the frequency, method, treatment, or setting 
for the provision of a recommended preventive service, then the plan or issuer may use 
reasonable medical management techniques to determine any such coverage limitations. To the 
extent not specified in a recommendation or guideline, a plan or issuer may rely on the relevant 
clinical evidence base and established reasonable medical management techniques to determine 
the frequency, method, treatment, or setting for coverage of a recommended preventive health 
item or service.5 Additionally, plans and issuers subject to section 2713 of the PHS Act must 
cover, without cost sharing, items and services that are integral to the furnishing of a 
recommended preventive service, regardless of whether the item or service is billed separately.6 
 
Coverage of Food and Drug Administration (FDA)-Approved, Cleared, or Granted 
Contraceptive Products Pursuant to HRSA-Supported Guidelines 
 
The currently applicable HRSA-supported Womens Preventive Services Guidelines (2019 
HRSA-Supported Guidelines), as updated on December 17, 2019, recommend that adolescent 
and adult women have access to the full range of female-controlled FDA-approved contraceptive 
methods,7 effective family planning practices, and sterilization procedures to prevent unintended 
pregnancy and improve birth outcomes.8 The 2019 HRSA-Supported Guidelines provide that 
contraceptive care should include contraceptive counseling, initiation of contraceptive use, and 
follow-up care (for example, management and evaluation as well as changes to, and removal or 
discontinuation of, the contraceptive method), and that instruction in fertility awareness-based 
methods, including the lactation amenorrhea method, should be provided for women desiring an 
alternative method.  
 
On December 30, 2021, HRSA accepted updates to the existing guidelines regarding 
breastfeeding services and supplies, well-woman preventive care visits, access to contraceptives 
and contraceptive counseling, screening for human immunodeficiency virus, and counseling for 
sexually transmitted infections (2021 HRSA-Supported Guidelines).9  
 
 
4 For accommodations and religious and moral exemptions with respect to coverage of certain recommended 
contraceptive services, see 26 CFR 54.9815-2713A; 29 CFR 2590.715-2713A; and 45 CFR 147.131 through 
147.133. 
5 See 26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); and 45 CFR 147.130(a)(4). 
6 See 85 FR 71142, 71174 (Nov. 6, 2020). 
7 The Departments note that the FDA approves, clears, and grants contraceptive products and not methods. 
8 See https://www.hrsa.gov/womens-guidelines-2019.  
9 HRSA Updates the Affordable Care Act Preventive Health Care Guidelines to Improve Care for Women and 
Children (Jan. 11, 2022), available at https://www.hhs.gov/about/news/2022/01/11/hrsa-updates-affordable-care-act-
preventive-health-care-guidelines-improve-care-women-children.html. 
2       
 
In general, a non-exempt10 plan or issuer subject to PHS Act section 2713 must provide coverage 
pursuant to 26 CFR 54.9815-2713(a)(1), 29 CFR 2590.715-2713(a)(1), and 45 CFR 
147.130(a)(1) for plan years (in the individual market, policy years) that begin on or after the 
date that is one year after the date the recommendation or guideline is issued. In addition, in the 
event of changes in recommendations or guidelines, a plan or issuer generally must provide 
coverage through the last day of the plan or policy year, even if the recommendation or guideline 
changes.11 Therefore, plans and issuers must currently provide coverage consistent with the 2019 
HRSA-Supported Guidelines, and must provide coverage consistent with the 2021 HRSA-
Supported Guidelines beginning with plan years (in the individual market, policy years) starting 
on and after December 30, 2022. The guidance provided in these FAQs regarding the 
contraceptive coverage requirement under PHS Act 2713 is equally applicable to both the 2019 
HRSA-Supported Guidelines and the 2021 HRSA-Supported Guidelines, unless otherwise 
specified. References in this document to the HRSA-Supported Guidelines should be understood 
to include both the 2019 HRSA-Supported Guidelines and the 2021 HRSA-Supported 
Guidelines, unless otherwise specified. 
 
On January 10, 2022, the Departments issued an FAQ that summarized previously issued 
FAQs12 related to coverage of contraceptive services and provided examples of practices 
reported to the Departments that denied contraceptive coverage to participants, beneficiaries, and 
enrollees. The FAQ also reminded plans and issuers that are subject to the contraceptive 
coverage requirements of their responsibility to fully comply with the requirements of PHS Act 
section 2713 and the Departments regulations and guidance. This includes the requirement that 
 
10 On November 15, 2018, the Departments published final regulations concerning religious exemptions at 83 FR 
57536 and moral exemptions at 83 FR 57592, as well as accommodations regarding this coverage. On August 16, 
2021, the Departments issued FAQs about Affordable Care Act Implementation Part 48, available at 
https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-48.pdf and 
https://www.cms.gov/files/document/faqs-part-48.pdf, in which the Departments indicated their intent to initiate 
rulemaking to amend these final regulations. References to plans and issuers throughout these FAQs refer to plans 
and issuers that are not exempt from the requirement to coverage contraceptive services and products without cost 
sharing. 
11 See 26 CFR 54.9815-2713(b); 29 CFR 2590.715-2713(b); and 45 CFR 147.130(b). For purposes of section 2713 
of the PHS Act, a recommendation or guideline in the comprehensive guidelines supported by HRSA is considered 
to be issued on the date on which it is accepted by the Administrator of HRSA or, if applicable, adopted by the 
Secretary of HHS. 75 FR 41726, 41729 (July 19, 2010). 
12 See FAQs about Affordable Care Act Implementation Part 51, Families First Coronavirus Response Act and 
Coronavirus Aid, Relief, and Economic Security Act Implementation (Jan. 10, 2022), available at  
https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf and 
https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf (FAQs Part 51), 
which summarizes FAQs about Affordable Care Act Implementation Part XII (Feb. 20, 2013), available at 
https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and  
https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12 (FAQs Part XII); FAQs 
about Affordable Care Act Implementation Part XXVI (May 11, 2015), available at 
https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and 
https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf (FAQs 
Part XXVI); and FAQs about Affordable Care Act Implementation Part 31, Mental Health Parity Implementation, 
and Womens Health and Cancer Rights Act Implementation (Apr. 20, 2016), available at 
https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and 
https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf (FAQs Part 
31). FAQs Part XXVI, Q5, make clear that a plan or issuer cannot limit sex-specific recommended preventive 
services based on an individuals sex assigned at birth, gender identity, or recorded gender. 
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if an individuals attending provider determines that a particular service or FDA-approved, 
cleared, or granted contraceptive product is medically appropriate for a specific individual, a 
plan or issuer must cover that service or product for that individual without cost sharing, whether 
or not the service or product is specifically identified in the current FDA Birth Control Guide.13  
 
The Departments are issuing the following FAQs in response to reports that individuals continue 
to experience difficulty accessing contraceptive coverage without cost sharing; to clarify 
application of the contraceptive coverage requirements to fertility awareness-based methods and 
to emergency contraceptives; and to address federal preemption of state law. The Departments 
are committed to ensuring consumers have access to the contraceptive benefits, without cost 
sharing, that they are entitled to under the law, and will take enforcement action as warranted. 
Violations may be subject to an excise tax under section 4980D of the Internal Revenue Code 
(Code) or a civil money penalty under section 2723 of the PHS Act, as applicable.  
 
Q1: Are plans and issuers required to cover items and services that are integral to the 
furnishing of a recommended preventive service, such as anesthesia necessary for a tubal 
ligation procedure? 
 
Yes. In the preamble to interim final rules issued in November 2020 in response to the COVID-
19 Public Health Emergency (November 2020 interim final rules), the Departments reiterated 
that regulations and guidance issued with respect to the preventive services requirements 
generally require plans and issuers subject to section 2713 of the PHS Act to cover, without cost 
sharing, items and services that are integral to the furnishing of the recommended preventive 
service, regardless of whether the item or service is billed separately.14 The preamble to the 
November 2020 interim final rules cited previous guidance issued with respect to colonoscopies, 
clarifying that a plan or issuer may not impose cost sharing for polyp removal during or 
anesthesia provided in connection with a preventive screening colonoscopy. Other examples 
included covering, without cost sharing, collection of a specimen for recommended screenings or 
tests typically performed by laboratories and administration of a recommended immunization by 
a medical professional. 
 
The requirement to cover, without cost sharing, items and services that are integral to the 
furnishing of a recommended preventive service also applies to coverage of contraceptive 
services under the HRSA-Supported Guidelines, including coverage for anesthesia for a tubal 
ligation procedure or pregnancy tests needed before provision of certain forms of contraceptives, 
such as an intrauterine device (also known as an IUD), regardless of whether the items and 
services are billed separately. 
 
 
13 See FAQs Part 51, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-
center/faqs/aca-part-51.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-
Part-51.pdf.  
14 85 FR 71142, 71174 (Nov. 6, 2020). 
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Q2: Are plans and issuers required to cover, without the imposition of any cost sharing, 
contraceptive products and services that are not included in a category of contraception 
described in the HRSA-Supported Guidelines?15  
 
Yes. The 2019 HRSA-Supported Guidelines include a recommendation that adolescent and adult 
women have access to the full range of female-controlled FDA-approved contraceptive methods, 
effective family planning practices, and sterilization procedures as part of contraceptive care.16 
The range of identified categories of contraception in the currently applicable 2019 HRSA-
Supported Guidelines17 include: (1) sterilization surgery for women, (2) surgical sterilization via 
implant for women, (3) implantable rods, (4) copper intrauterine devices, (5) intrauterine devices 
with progestin (all durations and doses), (6) the shot or injection, (7) oral contraceptives 
(combined pill), (8) oral contraceptives (progestin only), (9) oral contraceptives (extended or 
continuous use), (10) the contraceptive patch, (11) vaginal contraceptive rings, (12) diaphragms; 
(13) contraceptive sponges, (14) cervical caps, (15) female condoms, (16) spermicides, (17) 
emergency contraception (levonorgestrel), and (18) emergency contraception (ulipristal acetate); 
and additional methods as identified by the FDA.18 Plans and issuers must cover without cost 
sharing at least one form of contraception in each of the categories above.19  
 
In addition, as clarified in FAQs Part 51, the Departments interpret 26 CFR 54.9815-2713, 29 
CFR 2590.715-2713, and 45 CFR 147.130 as applied to the HRSA-Supported Guidelines to 
require plans and issuers to cover without cost sharing any contraceptive services and FDA-
approved, cleared, or granted contraceptive products that an individual and their attending 
provider have determined to be medically appropriate for the individual, whether or not those 
services or products are specifically identified in the categories listed in the HRSA-Supported 
Guidelines, including contraceptive products more recently approved, cleared, or granted by 
 
15 In prior FAQs related to contraceptive coverage, the Departments referenced the FDA Birth Control Guide as the 
source for categories of contraceptives that must be covered without cost sharing. The Departments are citing the 
HRSA-Supported Guidelines for the list of contraceptive categories to better align these FAQs with the language of 
the Affordable Care Acts preventive service coverage requirements. Despite the change in wording, there is no 
substantive difference and the requirements for plans and issuers remain the same. For the FDA Birth Control 
Guide, see https://www.fda.gov/media/150299/download. 
16 The 2019 HRSA-Supported Guidelines recommended the full range of female-controlled U.S. Food and Drug 
Administration-approved contraceptive methods. The 2021 HRSA-Supported Guidelines expanded the 
recommendation to encompass contraceptives that are not female-controlled, such as male condoms (which must be 
covered with a prescription by plans and issuers for plan years (in the individual market, policy years) that begin on 
or after December 30, 2022). The 2021 HRSA-Supported Guidelines do not include male sterilization. 
17 The 2021 HRSA-Supported Guidelines include the following categories: (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, cleared, or granted by the FDA. 
18 Womens Preventive Services Guidelines, available at https://www.hrsa.gov/womens-guidelines/index.html. 
Additionally, the Guidelines state that instruction in fertility awareness-based methods, including the lactation 
amenorrhea method, although less effective, should be provided for women desiring an alternative method. 
19 See FAQs Part XXVI, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-
activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/Downloads/aca_implementation_faqs26.pdf. 
5       
 
FDA.20 This coverage must also include the clinical services, including patient education and 
counseling, needed for provision of the contraceptive product or service.  
 
Q3: May plans and issuers use reasonable medical management techniques for 
contraceptive products or services not included in the categories described in the HRSA-
Supported Guidelines? 
 
For contraceptive services or FDA-approved, cleared, or granted contraceptive products that are 
not included in a category described in the HRSA-Supported Guidelines, plans and issuers may 
use reasonable medical management techniques, as permitted under 26 CFR 54.9815-2713(a)(4), 
29 CFR 2590.715-2713(a)(4), and 45 CFR 147.130(a)(4), to determine which specific products 
to cover without cost sharing only if multiple, substantially similar services or products that are 
not included in a category described in the Guidelines are available and are medically 
appropriate for the individual.21 If a plan or issuer uses reasonable medical management 
techniques with respect to multiple, substantially similar services or products, the plan or issuer 
must cover at least one such service or product without cost sharing.   
 
If the individuals attending provider recommends a particular service or FDA-approved, 
cleared, or granted product not included in a category described in the HRSA-Supported 
Guidelines based on a determination of medical necessity with respect to that individual 
(including if there is only one service or product that is medically appropriate for the individual, 
as determined by their attending provider), the plan or issuer must cover that service or product 
without cost sharing . The plan or issuer must defer to the determination of the attending 
provider, and make available an easily accessible, transparent, and sufficiently expedient 
exceptions process that is not unduly burdensome so the individual or their provider (or other 
individual acting as the individuals authorized representative) can obtain coverage for the 
medically necessary service or product without cost sharing as required under PHS Act section 
2713 and its implementing regulations and guidance.    
 
Q4: The currently applicable 2019 HRSA-Supported Guidelines recommend instruction in 
fertility awareness-based methods including the lactation amenorrhea method for women 
desiring an alternative method. Under the 2021 HRSA-Supported Guidelines, are plans 
and issuers required to continue to provide coverage for instruction in fertility awareness-
based methods without cost sharing? 
 
Yes. The 2021 HRSA-Supported Guidelines include screening, education, counseling, and 
provision of contraceptives (including in the immediate postpartum period).22 Counseling and 
education under the 2021 HRSA-Supported Guidelines includes instruction in fertility 
awareness-based methods, including lactation amenorrhea. 
 
 
20 See FAQs Part 51, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-
center/faqs/aca-part-51.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-
Part-51.pdf. 
21 For more information on reasonable management techniques, see Q8. 
22 See Womens Preventive Service Guidelines, available at https://www.hrsa.gov/womens-guidelines. 
6       
 
Q5: Are plans and issuers required to cover FDA-approved emergency contraception, 
including emergency contraception that is available over-the-counter (OTC)? 
 
Yes. Consistent with the HRSA-Supported Guidelines and as clarified in previous guidance 
regarding coverage of OTC contraceptives, plans and issuers must cover without cost sharing (1) 
emergency contraception (levonorgestrel), and (2) emergency contraception (ulipristal acetate), 
including OTC products, when the product is prescribed for an individual by their attending 
provider.23  
 
Plans and issuers are required to cover these products without cost sharing including when they 
are prescribed for advanced provision. 
 
Plans and issuers are also encouraged to cover OTC emergency contraceptive products with no 
cost sharing when they are purchased without a prescription. 
 
Q6: Can a health savings account (HSA), health flexible spending arrangement (health 
FSA) or health reimbursement arrangement (HRA) reimburse expenses incurred for OTC 
contraception obtained without a prescription?  
 
Yes. An HSA, health FSA, or HRA can reimburse an individual for the cost (or portion of the 
cost) incurred for OTC contraception to the extent that cost is not paid or reimbursed by another 
plan or coverage.24 
 
Note that, under section 223(f) of the Code, a distribution from an individuals HSA is not 
included in the individuals gross income if it is used to pay for qualified medical expenses, 
which, under section 223(d)(2) the Code, are medical expenses incurred by an individual (or the 
individuals spouse or dependent) but only to the extent such amounts are not compensated for 
by insurance or otherwise. Therefore, expenses incurred for contraception paid or reimbursed 
by a plan or issuer are not qualified medical expenses for purposes of an HSA. If the entire cost 
of contraception is not paid or reimbursed by the plan or issuer, qualified medical expenses 
include the portion of the cost not paid or reimbursed by the plan or issuer. 
  
Similarly, the cost (or the portion of the cost) of contraception paid or reimbursed by a plan or 
issuer cannot be reimbursed by a health FSA or HRA, but if costs for OTC contraceptives are not 
paid or reimbursed by a plan or issuer, they may be reimbursed from a health FSA or HRA.  
 
As stated in Q5, plans and issuers must cover the cost of certain OTC contraceptives when 
prescribed for an individual by their health care provider. Plans and issuers that will cover costs 
of OTC contraceptives without a prescription should advise individuals not to seek 
reimbursement from an HSA, health FSA, or HRA for the cost (or the portion of the cost) of 
 
23 See FAQs Part XII, Q15, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-
activities/resource-center/faqs/aca-part-xii.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/aca_implementation_faqs12. 
24 Section 3702 of the CARES Act amended sections 223 and 106 of the Code for any period beginning on or after 
January 1, 2020, by removing statutory language which limited the excludable expenses under those provisions to 
prescribed drugs and insulin. See also IRS Notice 2021-15, 2021-10 IRB 898.  
7       
 
contraception paid or reimbursed by the plan or issuer and not to use an HSA, health FSA, or 
HRA (including any related debit card) to purchase contraception for which the individual 
intends to seek reimbursement from the plan or issuer.  
 
Finally, if an individual mistakenly takes a distribution from an HSA for contraception costs paid 
or reimbursed by a plan or issuer, the individual must either (1) include the distribution in gross 
income, or (2) if and as permitted under Q&A-37 and -76 of IRS Notice 2004-50, 2004-33 IRB 
196, repay the distribution to the HSA. If an individual mistakenly receives reimbursement from 
a health FSA or HRA for contraception costs covered by a plan or issuer, the individual should 
contact the health FSA or HRA administrator regarding correction procedures. 
 
Q7: Should plans and issuers consider covering a 12-month supply of contraceptives that 
can be filled at one time?  
 
Yes. Literature on contraception use shows that dispensing a 12-month supply at one time can 
increase the rate at which use of contraceptives continues, decrease the likelihood of unintended 
pregnancy, and result in cost savings.25 Therefore, the Departments encourage plans and issuers 
to cover the dispensing of a 12-month supply of contraception, such as oral contraceptives, 
without cost sharing, though covering a 12-month supply is not required under PHS Act section 
2713 and its implementing regulations and guidance.  
 
Q8: How can a plan or issuer determine whether a medical management technique is 
reasonable for purposes of the requirements under PHS Act section 2713? 
 
Whether a medical management technique is reasonable depends on all the relevant facts and 
circumstances. With respect to contraception, plans and issuers may utilize reasonable medical 
management techniques only within a specified category of contraception and only to the extent 
the HRSA-Supported Guidelines do not specify the frequency, method, treatment, or setting for 
the provision of a recommended preventive service that is a contraceptive service or FDA-
approved, cleared, or granted product. With respect to the HRSA-Supported Guidelines as they 
pertain to contraception, plans and issuers must cover, without cost sharing, at least one form of 
contraception in each category that is described in the HRSA-Supported Guidelines (or, with 
 
25 See, e.g., CDC Select Practice Recommendations for Contraception Use, 2016, available at 
https://www.cdc.gov/reproductivehealth/contraception/mmwr/spr/combined.html (which note that The more pill 
packs given up to 13 cycles, the higher the continuation rates. Restricting the number of pill packs distributed or 
prescribed can result in unwanted discontinuation of the method and increased risk for pregnancy.); Foster, D. G., 
Hulett, D., Bradsberry, M., Darney, P., & Policar, M. (2011). Number of oral contraceptive pill packages dispensed 
and subsequent unintended pregnancies. Obstetrics and gynecology, 117(3), 566572, available at 
https://doi.org/10.1097/AOG.0b013e3182056309 (which states that individuals receiving a one-year supply of 
contraceptives have been found to have 30 percent lower likelihood of having an unplanned pregnancy and 46 
percent lower likelihood of having an abortion compared to similar individuals who only received one or three 
month supplies of contraceptives); Judge-Golden CP, Smith KJ, Mor MK, Borrero S. Financial Implications of 12-
Month Dispensing of Oral Contraceptive Pills in the Veterans Affairs Health Care System. JAMA Intern 
Med. 2019;179(9):12011208. doi:10.1001/jamainternmed.2019.1678 (which found that 12-month dispensing of 
oral contraceptives for women in the Veterans Affairs Health Care System was associated with a reduction of 24 
unintended pregnancies per 1,000 women per year and an annual cost saving to the health system of $87.12 per 
woman compared to 3-month dispensing).   
8       
 
respect to contraceptive categories not described in the HRSA-Supported Guidelines, at least one 
form of contraception in a group of substantially similar services or products).26 
 
If a plan or issuer utilizes medical management techniques within a specified category of 
contraception (or, with respect to contraceptive categories not described in the HRSA-Supported 
Guidelines, a group of substantially similar services or products), the use of those techniques will 
not be considered reasonable unless the plan or issuer has an easily accessible, transparent, and 
sufficiently expedient exceptions process that is not unduly burdensome on the individual or 
their provider (or other individual acting as the individuals authorized representative) and covers 
a service or FDA-approved, cleared, or granted product determined to be medically necessary 
with respect to an individual, as determined by the individuals attending provider. 
 
The Departments have continued to receive complaints and reports that participants, 
beneficiaries, and enrollees are being denied contraceptive coverage, in some cases due to the 
application of medical management techniques that are not reasonable based on all the relevant 
facts and circumstances.  
 
Examples of unreasonable medical management techniques (which are the subject of a number 
of complaints regarding plans and issuers, as well as their pharmacy benefits managers or other 
service providers) may include situations like the following:  
  Denying coverage for all or particular brand name contraceptives, even after the 
individuals attending provider determines and communicates to the plan or issuer that a 
particular service or FDA-approved, cleared, or granted contraceptive product is 
medically necessary with respect to that individual;  
  Requiring individuals to fail first using numerous other services or FDA-approved, 
cleared, or granted contraceptive products within the same category of contraception 
before the plan or issuer will approve coverage for the service or FDA-approved, cleared, 
or granted contraceptive product that is medically necessary for the individual, as 
determined by the individuals attending health care provider;  
  Requiring individuals to fail first using other services or FDA-approved, cleared, or 
granted contraceptive products in other contraceptive categories before the plan or issuer 
will approve coverage for a service or FDA-approved, cleared, or granted contraceptive 
product in a particular contraceptive category ; and  
  Imposing an age limit on contraceptive coverage instead of providing these benefits to all 
individuals with reproductive capacity.27 
 
The Departments expect plans and issuers to remove impermissible barriers and ensure that 
participants, beneficiaries, and enrollees have access to the contraceptive coverage they need, as 
required under the law.  
 
 
26 See FAQs Part XXVI, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-
activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/Downloads/aca_implementation_faqs26.pdf. 
27 See also FAQs Part XXVI, Q6, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-
activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/Downloads/aca_implementation_faqs26.pdf.  
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Q9: If a plan or issuer utilizes medical management techniques within a category of 
contraceptives, what constitutes an easily accessible, transparent, and sufficiently expedient 
exceptions process that is not unduly burdensome on the individual or their provider (or 
other individual acting as a patient's authorized representative)?  
 
The Departments will determine whether a plans or issuers exceptions process is easily 
accessible, transparent, sufficiently expedient, and not unduly burdensome based on all the 
relevant facts and circumstances, including whether and how the plan or issuer notifies 
providers, participants, beneficiaries, or enrollees of the exceptions process, and the steps the 
individual or their provider (or other individual acting as a patient's authorized representative) 
must take to utilize the exceptions process.  
 
The Departments will consider an exceptions process to be easily accessible if plan 
documentation includes relevant information regarding the exceptions process under the plan or 
coverage, including how to access the exceptions process without initiating an appeal pursuant to 
the plans or issuers internal claims and appeals procedures, the types of information the plan or 
issuer requires as part of a request for an exception, and contact information for a representative 
of the plan or issuer who can answer questions related to the exceptions process. Additionally, 
the Departments will consider an exceptions process to be transparent if, at a minimum, the 
information relevant to the exceptions process (including, if used, a standard exception form with 
instructions) is included and prominently displayed in plan documents (including in or along 
with the summary plan description for plans subject to the Employee Retirement Income 
Security Act (ERISA)), and in any other plan materials that describe the terms of the plans or 
issuers coverage of contraceptive items and services (such as a prescription drug formulary). 
The Departments also encourage plans and issuers to make this information available in a format 
and manner that is readily accessible, such as electronically (on a website, for example) and on 
paper. 
 
The Departments previously stated that plans and issuers may develop a standard exception form 
with instructions as part of ensuring that the plans or issuers exceptions process is easily 
accessible, transparent, sufficiently expedient, and not unduly burdensome on the individual or 
provider (or other individual acting as a patients authorized representative).28 The Departments 
strongly encourage plans and issuers to develop and utilize a standard form and instructions, 
similar to the Medicare Part D Coverage Determination Request Form, for the exceptions 
process.29 If they have not done so already, the Departments encourage plans and issuers to make 
any form and instructions available through paper and electronic means and include them with 
other information provided regarding the exceptions process and with other plan materials. 
 
 
28 See FAQs Part 31, Q2, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-
activities/resource-center/faqs/aca-part-31.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/Downloads/FAQs-31_Final-4-20-16.pdf. 
29  The Medicare Part D Coverage Determination Request Form is available at 
https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/CoverageDeterminations-. 
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Q10: May a plan or issuer require a participant, beneficiary, or enrollee to appeal an 
adverse benefit determination using the plan or issuers internal claims and appeals 
process30 as the means for an individual to obtain an exception? 
 
No. If plans and issuers are utilizing reasonable medical management techniques, requiring 
individuals to appeal an adverse benefit determination using the plans or issuers internal claims 
and appeals process as the means to obtain an exception would be unduly burdensome on the 
individual or provider (or other individual acting as the individuals authorized representative). 
Therefore, a plan or issuer does not have an easily accessible, transparent, and sufficiently 
expedient exceptions process that is not unduly burdensome on the individual (or provider or 
other individual acting as a patient's authorized representative) if the plan or issuer requires 
participants, beneficiaries, or enrollees to appeal an adverse benefit determination using the 
plans or issuers internal claims and appeals process to obtain an exception. 
 
Q11: Does federal law preempt a state law that prevents the application of PHS Act section 
2713? 
 
Yes. PHS Act section 2724(a) and ERISA section 731 specify that state law will be preempted to 
the extent it prevents the application of a provision of title XXVII of the PHS Act or part 7 of 
ERISA, respectively.31 As explained in Health Care Financing Administration (HCFA) Bulletin 
No. 00-03, state law prevents the application of a PHS Act provision if the state law makes it 
impossible for an issuer to comply with Title XXVII.32 
 
Q12: What actions will HHS take if a state law is determined to prevent the application of 
PHS Act 2713?  
 
Under PHS Act section 2723 and implementing regulations at 45 CFR 150.101, et seq., states 
have primary enforcement authority over the market requirements in Part A of title XXVII of the 
PHS Act with respect to issuers that issue, sell, renew, or offer health insurance coverage in the 
state in the individual or group market. However, under PHS Act section 2723(a)(2), if the 
Secretary of HHS makes a determination that a state has failed to substantially enforce a 
provision of Part A of title XXVII of the PHS Act, the Secretary must enforce that provision in 
the state. 
 
 
30 Regulations related to internal claims and appeals processes are codified at 26 CFR 54.9815-2719, 29 CFR 
2560.503-1, 29 CFR 2590.715-2719, and 45 CFR 147.136. 
31 See also 45 CFR 146.143(a) and 148.210 and 29 CFR 2590.731(a). Note that, as described earlier, the preventive 
services requirements set forth in PHS Act section 2713 are applicable to group health plans that are subject to 
ERISA and the Code through ERISA section 715 and Code section 9815, respectively. 
32 If a state law simply permits but does not require an action that is prohibited under Title XXVII, the state law 
would not be applicable. The issuer simply could not take advantage of the state law provision. See HCFA Program 
Memorandum, The Relationship of Certain Types of State Laws to the Application of the Guaranteed Availability 
Requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in the Small Group 
Market, Program Memorandum/Insurance Commissioners/Insurance Issuers, Transmittal No. 00-03 (June 2000), 
available at https://www.cms.gov/Regulations-and-Guidance/Health-Insurance-
Reform/HealthInsReformforConsume/downloads/HIPAA-00-03.pdf. 
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If HHS receives information33 indicating that a state may be enforcing a state law that is 
inconsistent with or otherwise prevents the application of PHS Act section 2713such as a state 
law prohibiting issuers from covering an FDA-approved, cleared, or granted contraceptive 
product or serviceHHS may initiate the investigatory process described in 45 CFR 150.209 
through 150.219 to determine whether the state is failing to substantially enforce PHS Act 
section 2713. If, as a result of HHSs investigation, HHS concludes that the state is enforcing 
such a state law, HHS will issue a determination that the state is failing to substantially enforce 
PHS Act section 2713 and provide notice of the effective date of HHSs enforcement with 
respect to issuers in that state. 
 
Q13: What actions will the Departments take to otherwise enforce the requirements of PHS 
Act section 2713? 
 
The Employee Benefits Security Administration (EBSA) enforces Title I of ERISA with respect 
to two million private employment-based group health plans, which cover approximately 137 
million participants and beneficiaries. When EBSA identifies violations in a particular group 
health plan, EBSA will work to ensure that the plan makes the necessary changes to any 
noncompliant plan provision and re-adjudicates any improperly denied benefit claims. To 
achieve the greatest impact, EBSA investigators often work with the plans service providers 
(such as third-party administrators) to obtain broad corrections, not just for the particular 
plans investigated, but for other plans that contract with the service provider. EBSA may also 
require the plan or service provider to provide notice to potentially affected participants and 
beneficiaries. In addition to seeking such retrospective relief, EBSA also will work to ensure that 
the plan corrects the violation prospectively, or in other words, for the remainder of the plan year 
and for future plan years so that participants and beneficiaries receive the benefits to which they 
are entitled. 
 
The Centers for Medicare & Medicaid Services (CMS) enforces the preventive services 
requirements and other applicable provisions of Title XXVII of the PHS Act with respect to non-
Federal governmental group health plans, such as plans for employees of state and local 
governments. In addition, CMS enforces applicable provisions of Title XXVII of the PHS Act 
with respect to health insurance issuers selling products in the individual and fully-insured group 
markets in states that elect not to enforce or fail to substantially enforce the preventive services 
requirements or another PHS Act provision. In states that are not enforcing the preventive 
services requirements, CMS reviews health insurance policy forms of issuers in the individual 
and group markets for compliance with the preventive services requirements before health 
insurance products are offered for sale. CMS also performs market conduct examinations, in 
which issuers are audited for compliance with the preventive services requirements in states 
where CMS is responsible for enforcement and in states with a collaborative enforcement 
agreement when the state requests assistance. When CMS identifies a violation by a non-federal 
governmental group health plan or issuer subject to its authority, CMS requires the plan or issuer 
 
33 45 CFR 150.205 identifies sources of information that may trigger an investigation of state enforcement, including 
a complaint received by HHS, information learned during informal contact between HHS and state officials, a report 
in the news media, information obtained during periodic review of state health care legislation, information from the 
governors and commissioners of insurance of the various states regarding the status of their enforcement of PHS Act 
requirements, and any other information that indicates a possible failure to substantially enforce. 
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to undertake corrective actions to remedy the violation. This may include revising plan 
documents, notifying enrollees of the violation and allowing them to submit new claims, and re-
adjudicating previously denied claims. Additionally, CMS may impose civil money penalties on 
a non-federal governmental group health plan or issuer subject to CMSs authority that violates 
the preventive services requirements or other PHS Act provisions.  
 
The actions described in this FAQ are examples of actions the Departments may take with 
respect to violations of the preventive services requirements. The Departments may take other 
actions within their respective authorities as appropriate to enforce the requirements of PHS Act 
section 2713. 
 
Q14: What should an individual do if the individual has difficulty accessing contraceptive 
coverage under their group health plan or group or individual health insurance coverage? 
 
Consumers who have fully-insured coverage and who have concerns about their health insurance 
issuers compliance with these requirements may contact their State Department of Insurance 
(For contact information, visit https://content.naic.org/state_web_map.htm).    
 
Consumers who have concerns that their State Department of Insurance is not enforcing the 
contraceptive coverage requirements may contact CMS at: 
contraception_complaints@cms.hhs.gov. 
 
Consumers who are covered by a non-federal, public-sector employer-sponsored plan (such as a 
state or local government employee plan) and have concerns about their plans compliance with 
these requirements may contact CMS at contraception_complaints@cms.hhs.gov or  by calling 
toll free at 1-888-393-2789. 
 
Consumers who are covered by a private-sector, employer-sponsored group health plan and have 
concerns about their plans compliance with these requirements may contact the Department of 
Labor at https://www.dol.gov/agencies/ebsa/about-ebsa/ask-a-question/ask-ebsa or by calling toll 
free at 1-866-444-3272.  
 
If an individual is uncertain whether their health coverage is fully-insured or self-insured, they 
can contact the entity that administers the plan or coverage, or consult plan or coverage 
documentation for more information. Individuals may also reach out to HHS or DOL by using 
the contact information above for help finding out the appropriate agency to contact. 
 
The HHS Office for Civil Rights (OCR) enforces federal civil rights laws that prohibit 
discriminatory restrictions on access to health care. If an individual believes that their or another 
persons civil rights or health information privacy rights have been violated, they can file a 
complaint with OCR at https://www.hhs.gov/ocr/complaints/index.html or call toll-free at 1-800-
368-1019. 
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