FAQS ABOUT AFFORDABLE CARE ACT 
IMPLEMENTATION (PART XXVI)  
 
May 11, 2015 
 
Set out below are additional Frequently Asked Questions (FAQs) regarding implementation of 
the Affordable Care Act. These FAQs have been prepared jointly by the Departments of Labor 
(DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments). 
Like previously issued FAQs (available at http://www.dol.gov/ebsa/healthreform/ and 
http://www.cms.gov/cciio/resources/fact-sheets-and-faqs/index.html), these FAQs answer 
questions from stakeholders to help people understand the Affordable Care Act and benefit from 
it, as intended. 
 
Coverage of Preventive Services 
 
Section 2713 of the Public Health Service Act (PHS Act) and its implementing regulations 
relating to coverage of preventive services1 require non-grandfathered group health plans and 
health insurance coverage offered in the individual or group market to provide benefits for, and 
prohibit the imposition of cost-sharing requirements with respect to, the following: 
 
  Evidenced-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;  
  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  
  With respect to women, evidence-informed preventive care and screening provided for in 
comprehensive guidelines supported by HRSA, to the extent not included in certain 
recommendations of the USPSTF.2 
                                                            
1  26 CFR 54.9815-2713, 29 CFR 2590.715-2713, 45 CFR 147.130.  
2 Womens Preventive Services: Required Health Plan Coverage Guidelines (HRSA Guidelines) were adopted and 
released on August 1, 2011, based on recommendations developed by the Institute of Medicine (IOM) at the request 
of HHS. Womens preventive services recommended therein are required to be covered without cost sharing for plan 
years (or, in the individual market, policy years) beginning on or after August 1, 2012.  Under the HRSA 
Guidelines, group health plans established or maintained by religious employers (and group health insurance 
coverage provided in connection with such plans) are exempt from the requirement to cover contraceptive services 
under section 2713 of the PHS Act, as incorporated into the Employee Retirement Income Security Act and the 
Internal Revenue Code.  45 CFR 147.131(a).  Additionally, accommodations are available to group health plans 
   
If a recommendation or guideline does not specify the frequency, method, treatment, or setting 
for the provision of a recommended preventive service, the plan or issuer may use reasonable 
medical management techniques to determine any such coverage limitations.3 
 
Coverage of BRCA Testing 
 
As described in a previous FAQ,4 PHS Act section 2713 addresses coverage for evidence-based 
items or services with a rating of A or B in the current recommendations of the USPSTF, as 
well as coverage for preventive care and screenings as provided for in comprehensive guidelines 
supported by HRSA. The USPSTF recommends with a B rating to screen women who have 
family members with breast, ovarian, tubal or peritoneal cancer with 1 of several screening tools 
designed to identify a family history that may be associated with an increased risk for potentially 
harmful mutations in breast cancer susceptibility genes (BRCA 1 or BRCA 2). Women with 
positive screening results should receive genetic counseling and, if indicated after counseling, 
BRCA testing.5  The previous FAQ clarified that HHS believes that the scope of this 
recommendation includes both genetic counseling and BRCA testing, if appropriate, for a 
woman as determined by her health care provider.6   
  
Some confusion remains as to whether the recommendation applies to women who have had a 
prior non-BRCA-related breast cancer or ovarian cancer diagnosis, even if those women are 
currently asymptomatic and cancer-free.  A woman with a personal history of cancer may have 
an increased risk of a harmful mutation even if no other family members are known to have such 
a history.7  Primary care screening, genetic counseling and genetic testing if indicated, may help 
her prevent other future cancers.   
 
Q1:  Must a plan or issuer cover without cost sharing recommended genetic counseling and 
BRCA genetic testing for a woman who has not been diagnosed with BRCA-related cancer 
but who previously had breast cancer, ovarian cancer, or other cancer?   
 
                                                                                                                                                                                                
established or maintained by certain eligible organizations (and group health insurance coverage provided in 
connection with such plans), as well as student health insurance coverage arranged by eligible organizations, with 
respect to the contraceptive coverage requirement. 
3 See 26 CFR 54.9815-2713(a)(4), 29 CFR 2590.715-2713(a)(4), 45 CFR 147.130(a)(4). 
4 See Frequently Asked Questions about Affordable Care Act Implementation, Part XII, Q6, available at 
http://www.dol.gov/ebsa/faqs/faq-aca12.html and http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/aca_implementation_faqs12.html.   
5 See USPSTF recommendation, available at: 
http://www.uspreventiveservicestaskforce.org/Page/Topic/recommendation-summary/brca-related-cancer-risk-
assessment-genetic-counseling-and-genetic-testing.   
6 See Frequently Asked Questions about Affordable Care Act Implementation, Part XII, Q6, available at 
http://www.dol.gov/ebsa/faqs/faq-aca12.html and http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/aca_implementation_faqs12.html.   
7 Nelson HD, Fu R, Goddard K, Mitchell JP, Okinaka-Hu L, Pappas M, Zakher B. Risk Assessment, Genetic 
Counseling, and Genetic Testing for BRCA-Related Cancer: Systematic Review to Update the U.S. Preventive 
Services Task Force Recommendation. Evidence Synthesis No. 101. AHRQ Publication No. 12-05164-EF-1. 
Rockville, MD: Agency for Healthcare Research and Quality; 2013. 
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  Yes.  The USPSTF recommends that primary care providers screen women who have family 
members with breast, ovarian, tubal, or peritoneal cancer with 1 of several screening tools 
designed to identify a family history that may be associated with an increased risk for potentially 
harmful mutations in breast cancer susceptibility genes (BRCA1 or BRCA2). Women with 
positive screening results should receive genetic counseling and, if indicated after counseling, 
BRCA testing.  The USPSTFs Final Recommendation Statement related to BRCA testing 
indicates that the recommendation applies to asymptomatic women who have not been 
diagnosed with BRCA-related cancer.8 Therefore, as set out in the recommendations described 
above, as long as the woman has not been diagnosed with BRCA-related cancer, a plan or issuer 
must cover preventive screening, genetic counseling, and genetic testing without cost sharing, if 
appropriate, for a woman as determined by her attending provider, consistent with PHS Act 
section 2713 and its implementing regulations.9 
 
Coverage of Food and Drug Administration (FDA)-approved Contraceptives 
 
The HRSA Guidelines include a recommendation for all FDA-approved contraceptive methods, 
sterilization procedures, and patient education and counseling for all women with reproductive 
capacity, as prescribed by a health care provider.  On February 20, 2013, the Departments issued 
an FAQ stating that the HRSA Guidelines ensure womens access to the full range of FDA-
approved contraceptive methods including, but not limited to, barrier methods, hormonal 
methods, and implanted devices, as well as patient education and counseling, as prescribed by a 
health care provider.10  The FAQ further clarified that plans and issuers may use reasonable 
medical management techniques to control costs and promote efficient delivery of care, such as 
covering a generic drug without cost sharing and imposing cost sharing for equivalent branded 
drugs.  However, in these instances, the FAQ stated that a plan or issuer must accommodate any 
individual for whom a particular drug (generic or brand name) would be medically inappropriate, 
as determined by the individual's health care provider, by having a mechanism for waiving the 
otherwise applicable cost sharing for the brand or non-preferred brand version.11  
 
                                                            
8 See USPSTF Final Recommendation Statement.  BRCA-Related Cancer: Risk Assessment, Genetic Counseling 
and Genetic Testing (December 2013), available at 
http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/brca-related-cancer-
risk-assessment-genetic-counseling-and-genetic-testing. 
9 See 26 CFR 54.9815-2713, 29 CFR 2590.715-2713 and 45 CFR 147.130. 
10 The Departments previous FAQ referred to categories of specific contraceptive delivery mechanisms including, 
barrier methods, hormonal methods, and implanted devices. See Frequently Asked Questions about Affordable 
Care Act Implementation, Part XII, Q14, available at http://www.dol.gov/ebsa/faqs/faq-aca12.html and 
http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html.  The FDA Birth 
Control Guide identifies the different contraceptive methods.   See FDA Birth Control Guide at 
http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356451.pdf.  To 
reduce confusion and for ease of use, these FAQs hereinafter refer to methods when referring to the 18 birth 
control methods for women currently referenced in the FDA Birth Control Guide that must be covered under PHS 
Act section 2713 and its implementing regulations, and also refer to FDA-approved items when referring to 
specific products currently approved or cleared by the FDA within a method. 
11 See Frequently Asked Questions about Affordable Care Act Implementation, Part XII, Q14, available at 
http://www.dol.gov/ebsa/faqs/faq-aca12.html and http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/aca_implementation_faqs12.html.   
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  These FAQs provide further guidance on the scope of coverage required for contraception and 
the extent to which plans and issuers may utilize reasonable medical management.  Specifically: 
 
1)  Plans and issuers must cover without cost sharing at least one form of contraception in 
each of the methods (currently 18) that the FDA has identified for women in its current 
Birth Control Guide.12  This coverage must also include the clinical services, including 
patient education and counseling, needed for provision of the contraceptive method. 
 
2)  Within each method, plans and issuers may utilize reasonable medical management 
techniques.  A plan or issuer generally may impose cost sharing (including full cost 
sharing) on some items and services to encourage an individual to use other specific 
items and services within the chosen contraceptive method.  For example, a plan may 
discourage use of brand name pharmacy items over generic pharmacy items through the 
imposition of cost sharing.  Similarly, a plan may use cost sharing to encourage use of 
one of several FDA-approved intrauterine devices (IUDs) with progestin.   
 
3)  If utilizing reasonable medical management techniques within a specified method of 
contraception, plans and issuers must have an easily accessible, transparent, and 
sufficiently expedient exceptions process that is not unduly burdensome on the individual 
or a provider (or other individual acting as a patient's authorized representative). 
 
a.  If an individuals attending provider13 recommends a particular service or FDA-
approved item based on a determination of medical necessity with respect to that 
individual, the plan or issuer must cover that service or item without cost sharing.  
The plan or issuer must defer to the determination of the attending provider.  
Medical necessity may include considerations such as severity of side effects, 
differences in permanence and reversibility of contraceptives, and ability to 
adhere to the appropriate use of the item or service, as determined by the 
attending provider.   
 
                                                            
12 The contraceptive methods for women currently identified by the FDA include: (1) sterilization surgery for 
women; (2) surgical sterilization implant for women; (3) implantable rod; (4) IUD copper; (5) IUD with progestin; 
(6) shot/injection; (7) oral contraceptives (combined pill); (8) oral contraceptives (progestin only); (9) oral 
contraceptives extended/continuous use; (10) patch; (11) vaginal contraceptive ring; (12) diaphragm; (13) sponge; 
(14) cervical cap; (15) female condom; (16) spermicide; (17) emergency contraception (Plan B/Plan B One 
Step/Next Choice); and (18) emergency contraception (Ella).  The FDA Birth Control Guide additionally lists 
sterilization surgery for men and male condoms, but the HRSA Guidelines exclude services relating to a mans 
reproductive capacity. See Preamble to Proposed Rules regarding coverage of certain preventive services at 78 FR 
8458 (February 6, 2013).  See also FDA Birth Control Guide at 
http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356451.pdf. See also 
FDA publication, Birth Control: Medicines to Help You, available at 
http://www.fda.gov/ForConsumers/ByAudience/ForWomen/FreePublications/ucm313215.htm#Hormonal_Methods. 
13 An attending provider means an individual who is licensed under applicable state law, who is acting within the 
scope of the providers license, and who is directly responsible for providing care to the patient relating to the 
recommended preventive services.  Therefore, a plan, issuer, hospital, or managed care organization is not an 
attending provider. 
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  b.  This exceptions process must make a determination of the claim according to a 
timeframe and in a manner that takes into account the nature of the claim (e.g., 
pre-service or post-service) and the medical exigencies involved for a claim 
involving urgent care.   
 
Because the Departments prior guidance may reasonably have been interpreted in good faith as 
not requiring coverage without cost sharing of at least one form of contraception in each method 
identified by the FDA, the Departments will apply this clarifying guidance for plan years (or, in 
the individual market, policy years) beginning on or after the date that is 60 days after 
publication of these FAQs.  
 
Q2:  If a plan or issuer covers some forms of oral contraceptives, some types of IUDs, and 
some types of diaphragms without cost sharing, but excludes completely other forms of 
contraception, will the plan or issuer comply with PHS Act section 2713 and its 
implementing regulations?   
 
No.  Plans and issuers must cover without cost sharing the full range of FDA-identified methods. 
Thus, plans and issuers must cover without cost sharing at least one form of contraception in 
each method that is identified by the FDA.  The FDA currently has identified 18 distinct methods 
of contraception for women. A plan or issuer generally may use reasonable medical management 
techniques and impose cost sharing (including full cost sharing) to encourage an individual 
patient to use specific services or FDA-approved items within the chosen contraceptive method.  
If utilizing reasonable medical management techniques, plans and issuers must have an easily 
accessible, transparent, and sufficiently expedient exceptions process that is not unduly 
burdensome on the individual (or a provider or other individual acting as a patient's authorized 
representative) to ensure coverage without cost sharing of any service or FDA-approved item 
within the specified method of contraception as described in Q&A-3 below.  In this example, 
even though the plan provides coverage in multiple methods, the plans exclusion of some of the 
methods for women currently identified by the FDA means the plan fails to comply with PHS 
Act section 2713 and its implementing regulations.   
 
Q3:  If multiple services and FDA-approved items within a contraceptive method are 
medically appropriate for an individual patient, what is a plan or issuer required to cover 
without cost sharing? 
 
If multiple services and FDA-approved items within a contraceptive method are medically 
appropriate for an individual, the plan or issuer may use reasonable medical management 
techniques to determine which specific products to cover without cost sharing with respect to 
that individual.  However, if the individuals attending provider recommends a particular service 
or FDA-approved item based on a determination of medical necessity with respect to that 
individual, the plan or issuer must cover that service or item without cost sharing.  The plan or 
issuer must defer to the determination of the attending provider with respect to the individual 
involved.  As previously stated, the plan or issuer must cover at least one service or item within 
each of the methods (currently 18) identified by the FDA for women. 
 
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  Q4:  If a plan or issuer covers oral contraceptives (such as the extended/continuous use 
contraceptive pill), can it impose cost sharing on all items and services within other FDA-
identified hormonal contraceptive methods (such as the vaginal contraceptive ring or the 
contraceptive patch)?   
 
No.  The FDA currently identifies 18 distinct methods of contraception for women, and the 
HRSA Guidelines are designed to provide womens access to the full range of these 
contraceptive methods identified by the FDA, as prescribed by a health care provider.  Thus, 
plans and issuers must cover without cost sharing at least one form of contraception within each 
method the FDA has identified.  For the hormonal contraceptive methods, coverage therefore 
must include (but is not limited to) all 3 oral contraceptive methods (combined, progestin-only, 
and extended/continuous use), injectables, implants, the vaginal contraceptive ring, the 
contraceptive patch, emergency contraception (Plan B/Plan B One Step/Next Choice), 
emergency contraception (Ella), and IUDs with progestin.  Accordingly, a plan or issuer may not 
impose cost sharing on the ring or the patch.   
 
Coverage of Sex-specific Recommended Preventive Services 
 
Q5:  Can plans or issuers limit sex-specific recommended preventive services based on an 
individuals sex assigned at birth, gender identity or recorded gender? 
 
No. Whether a sex-specific recommended preventive service that is required to be covered 
without cost sharing under PHS Act section 2713 and its implementing regulations is medically 
appropriate for a particular individual is determined by the individuals attending provider. 
Where an attending provider determines that a recommended preventive service is medically 
appropriate for the individual  such as, for example, providing a mammogram or pap smear for 
a transgender man who has residual breast tissue or an intact cervix  and the individual 
otherwise satisfies the criteria in the relevant recommendation or guideline as well as all other 
applicable coverage requirements, the plan or issuer must provide coverage for the recommended 
preventive service, without cost sharing, regardless of sex assigned at birth, gender identity, or 
gender of the individual otherwise recorded by the plan or issuer. 
 
Coverage of Well-woman Preventive Care for Dependents 
Q6: If a plan or issuer covers dependent children, is the plan or issuer required to cover 
without cost sharing recommended womens preventive care services for dependent 
children, including recommended preventive services related to pregnancy, such as 
preconception and prenatal care? 
Yes.  Non-grandfathered group health plans and health insurance issuers offering non-
grandfathered group or individual health insurance coverage must cover specified recommended 
preventive care services without cost sharing, consistent with PHS Act section 2713 and its 
implementing regulations, for all participants and beneficiaries under a group health plan (and all 
individuals enrolled in individual market coverage).  If the plan or issuer covers dependent 
children, such dependent children must be provided the full range of recommended preventive 
services applicable to them (e.g., for their age group) without cost sharing and subject to 
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  reasonable medical management techniques, in accordance with the requirements of PHS Act 
section 2713 and its implementing regulations.14  For example, the HRSA Guidelines 
recommend well-woman visits for adult women to obtain the recommended preventive services 
that are age- and developmentally-appropriate, including preconception care and many services 
necessary for prenatal care.15  Therefore, consistent with PHS Act section 2713 and its 
implementing regulations, plans and issuers must cover without cost sharing these recommended 
preventive services for dependent children where an attending provider determines that well-
woman preventive services are age- and developmentally-appropriate for the dependent. 
 
Coverage of Colonoscopies Pursuant to USPSTF Recommendations  
Q7: If a colonoscopy is scheduled and performed as a preventive screening procedure for 
colorectal cancer pursuant to the USPSTF recommendation, is it permissible for a plan or 
issuer to impose cost sharing with respect to anesthesia services performed in connection 
with the preventive colonoscopy? 
No.  The plan or issuer may not impose cost sharing with respect to anesthesia services 
performed in connection with the preventive colonoscopy if the attending provider determines 
that anesthesia would be medically appropriate for the individual.  
                                                            
14 Section 2714 of the PHS Act and the implementing regulations provide that a group health plan or health 
insurance issuer that makes available dependent coverage of children must make such coverage available for 
children until attainment of 26 years of age.  29 CFR 2590.715.2714 (a)(1) and 45 CFR 147.120(a)(1).  The rules 
also provide that nothing in the regulations requires a plan or issuer to make coverage available for the child of a 
child receiving dependent coverage. 29 CFR 2590.715-2714(c) and 45 CFR 147.120(c). 
15 See HRSA Guidelines, available at http://www.hrsa.gov/womensguidelines/.  See also Frequently Asked 
Questions about Affordable Care Act Implementation Part XII for additional clarifications about well-woman visits 
and other HRSA guidelines, available at  http://www.dol.gov/ebsa/faqs/faq-aca12.html and 
http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html. 
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