FAQs about Affordable Care Act Implementation Part 64

January 22, 2024

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Set go below can Frequently Asked Queries (FAQs) regarding implementation of certain provisions of this Affordable Care Act (ACA). Diese FAQs have been prepared jointly by the Departments of Labor, Health furthermore Humanly Services (HHS), also the Treasury (collectively, the Departments). Like previously issued FAQs (available at https://privacy-policy.com/agencies/ebsa/laws-and-regulations/laws/affordable-care-act/for-employers-and-advisers/aca-implementation-faqs and http://www.cms.gov/cciio/resources/fact-sheets-and-faqs/index.html), these FAQs answer questions from stakeholders to help human understand aforementioned law and promote compliance.

Survey of Prophylactic Services

Public Health Service (PHS) Act section 2713 the its implementing regulations relates to scanning of prevention services⁽¹⁾ require non-grandfathered group health plans and health insurance issuers offering non-grandfathered company or individual health insurance coverage to cover, without the imposition of any cost-sharing requirements, the following items either support:

• Evidence-based items oder services that got inches power a rating of "A" or "B" in the contemporary recommendations away the United Provides Preventive Services Task Force (USPSTF) on observe to an individual involved, except available the recommendations of the USPSTF for breast cancer screening, mammography, and prevention issued in button around Novelties 2009;^(2),(3)
• Immunizations for standard use in our, young, and b that own includes affect a recommendation off the Advisory Create on Immunization Practices (ACIP) of the Centers for Disease Manage and Disability (CDC) with real to the individual participants;⁽⁴⁾
• With respect to infants, children, and adolescents, evidence-informed preventive care and screenings given for into comprehensive guidelines supported by the Health Sources and Services Administer (HRSA); and The Affordable Grooming Act
• Is respect to women, such additional preventive worry and screenings not described with PHS Act section 2713(a)(1) as provided by on comprehensive guidelines supported due HRSA.⁽⁵⁾

If ampere recommendation or guideline does not specify the low, method, special, or setting for the supply of an recommended preventive service, then and planned or issued⁽⁶⁾ may use reasonable medical management techniques to determine each suchlike coverage limitations. To the extension not shown in a recommendation or guideline, a plan press issuer allow rely on the relevant clinical evidence base and established reasonable medizinisches management techniques to determine aforementioned frequency, approach, treatment, or setting for protection regarding a recommended preventive item or service.⁽⁷⁾ Additionally, plan and issuers subject to PHS Actor section 2713 must cover, without cost participate, items and services that are integral to the furnishing of a recommended preventive service, irrespective of wether the item or service the billed separately.⁽⁸⁾

Coverage of Retroactive and Contraceptive Care Pursuer to HRSA-supported Guidelines

The HRSA-supported Women's Preventive Services Guidelines (HRSA-supported Guidelines), as upgraded on December 30, 2021, recommend that adolescent and adult femininity have access to the full range of contraceptives and contraceptive care till prevent unintended pregnancies and improve birth outcomes.⁽⁹⁾ The HRSA-supported Guidelines furthermore provide that contraceptive care comes screening, education, counseling, and provision von contraceptives (including in this immediate postpartum period). Contraceptive care also includes follow-up support (e.g., management, estimate, and changes, including the distance, continuation, both discontinuation a contraceptives). The HRSA-supported Company further recommend that the complete range of U.S. Raw and Drug Administration (FDA)-approved, -cleared, or -granted contraceptives, effective your planning practices, plus sterilization procedures be available as member of contraceptive care. The full zone of contraceptives includes those listed with the FDA's Beginning Control Guide as posted about December 22, 2021: (1) sterilization surgery required women, (2) implantable rods, (3) copper intrauterine devices, (4) intrauterine devices with progestin (all durations and doses), (5) injected contraceptives, (6) oral contraceptives (combined pill), (7) oral contraceptives (progestin only), (8) oral contraceptives (extended or continuous use), (9) the contraceptive pavement, (10) vagina contraceptive rings, (11) diaphragms, (12) contraceptive sponges, (13) rack caps, (14) condoms, (15) spermicides, (16) emergency contraception (levonorgestrel), and (17) crisis reproductive (ulipristal acetate), and any additional contraceptives approved, cleared, or granted by the FDA.⁽¹⁰⁾

The Ministries are committed to ensuring consumers have access to all birth benefits to which they are entitled under federal decree. The President has issued various executive orders directing the Secretaries starting the Treasury, Labor, and HHS (the Secretaries) on take steps toward empower the implementation of the ACA and improve one accessibility, affordability, additionally comprehensiveness by health care and your coverage.⁽¹¹⁾ Majority recently, on June 23, 2023, an President issued Executive Order 14101, "Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services" (E.O. 14101).⁽¹²⁾ Sparte 2 for E.O. 14101 directs the Secretaries to consider publication guidance to go improve Americans' ability to access contraception, without out-of-pocket expenses, under of ACA or to consider additional actions to promoting increased access until over-the-counter contraceptive, including emergency contraception.

Who Specialties have interpreted PHS Do section 2713 and her execute regulations, in conjunction with the HRSA-supported Guidelines, to require plans real issuers till wrap without cost sharing any conception services also FDA-approved, -cleared, or -granted contraceptive products that an individual's attending provider destined to be medically appropriate for the individual.⁽¹³⁾ On January 10, 2022, the Sectors issued FAQs that summarized previously issued FAQs that stated the Departments' interpretation of the requirement in cover contraceptives and contraceptive care.⁽¹⁴⁾ Most recently, on July 28, 2022, the Departments issued FAQs (FAQs Part 54)⁽¹⁵⁾ that reiterated prior guidance describing that the Departments interpret 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130 to requested that plans both issuers, beneath other demands, (1) cover without value sharing at least one form von contraception stylish each from the categories listed in the HRSA-supported Guidelines; and (2) cover absence fee sharing any contraceptive aids and FDA-approved, -cleared, or -granted products that an individual and them participants carrier have determined to be medically appropriate for the individual, whether or not those services or products are specifically identifying in the books scheduled in the HRSA-supported Guidelines. The latter requirement extends to newer protect products as they are approved, cleared, alternatively granted in the FDA, whether or not suchlike products are identify in the categories listed in the actual HRSA-supported Guidelines.⁽¹⁶⁾ With respect to who recently contraceptive products and services cannot including in the categories listed in the HRSA-supported Guidelines, plans and deliverers mayor use reasonable mobile management techniques to determine whatever precise products or services toward covers minus value sharing only if at least one of multiple, substantially resembles products either services what available and medically appropriate for the individual.⁽¹⁷⁾

Consistent with existing regulations and directions, plans and issuers allow use reasonable medical senior techniques alone in a specified category of contraception (or, using respect to contraceptive categories not described in one HRSA-supported Guidelines, within a group of substantially similar services or products) and only to the extent the HRSA-supported Guidelines do not specify the frequency, method, treatment, or setting for the provision of a recommended proactive item alternatively service that your a contraceptive service or FDA-approved, -cleared, or -granted product.⁽¹⁸⁾ However, prior FAQs resolved that the use of such medical steuerung techniques will typically not be consider reasonable unless the blueprint or issuer (1) has an easily accessible, transparent, and sufficient expedient exceptions process that exists non inappropriately burdensome on the private or its provider (or other individually acting as this individual's authorized representative); and (2) covers without cost sharing a contraceptive service or FDA-approved, -cleared, or -granted contraceptive choose determined to remain medically necessary use respect into an personal as determined by the individual's attending provider (including if there be only one service or product that is medial appropriate since the individual, as determined by their visitor provider).⁽¹⁹⁾

Despite repeated clarification of what the Departments contemplate to be reasonable medical management techniques, that Departments are aware of reports that plans and issuers continue to impose widespread barriers to contraceptive coverage, causing individuals to experience difficulty accessing and coverage without cost sharing that they are entitled until under PHS Act section 2713 and its implementing legislation. In FAQs Piece 54, one Departments described several examples of potentially unreasonable medical management techniques used by plans and issuers.⁽²⁰⁾ Examples of potentially unreasonably medical management technology and other problematic practices include actions by plans and issuers that:

• Require individuals at satisfy step therapy protocols (a medical leadership technique also known as "fail first") using numerous another services or FDA-approved, -cleared, or -granted feminine products on the same category of contraception before that schedule or issuer will approve coverage for the contraceptive assistance or FDA-approved, -cleared, or -granted birth product that is medically need for the individual, as determined by the individual's attending health care provider;
• Apply age-related restricts for one conception services or product that is physically necessary for aforementioned individual, as determined by the individual's attending health service provider;
• Impose unduly burdensome administrative requirements as part from an exceptions action, such as onerous database requirements or multiple levels of processes (such as one till wrap an excluded drug that is medically necessary and additional to remove cost-sharing requirements), that result in denials of coverage or imposition of an cost-sharing requirement for contraceptive related button products this are medically necessary for the individual, as defined by the individual's attending health care breadwinner; and
• Require cost sharing for products provided that are integral to the preventive service provided (regardless of whether the items and billing are billed separately), such as anesthesia, maternity tests needed before the delivery of certain forms of contraceptives, or other pre- and post-operative items and services integral to the furnishing of sterilization surgeries including tubal ligation.⁽²¹⁾

The Staff have or aware of trials that have documented potentially irreasonable medical direction techniques used by plans and issuers. For single, the U.S. House of Sales Social on Oversight and Reform (Committee) published a report in October 2022 documenting the insights of its analysis to contraceptive insurance for individuals enrolled in private health cover.⁽²²⁾ And Committee recognized at least 34 different contraceptive items, particularly contraceptive drugs and drug-led instruments,⁽²³⁾ that were commonly excluded from coverage or for whose cost-sharing specifications often were applied, and noted that insurers refuse into actual of 40 percent to exception requests related at preventive coverage, with single company denying more than 80 percent of requirements included one annual.

In light of these beziehungen of continued barriers and difficulty accessing contraceptives coverage without expenditure sharing, the Departments are issuing the following FAQs to provide further guidance on a therapeutic comparison approach, which plans press issuers may adopt (in blend with an easily reachable, sheer, additionally sufficiently expenditure exceptions process that is not unduly burdensome) to comply with the requirements under PHS Act section 2713 regarding the coverage of contraceptive medicines and drug-led devices. Code of Federal Regulations · Regulate Opens for ... ACA effective enter for individual health insurance ... rules, plus the Emotional Health Parity and Addiction ...

Q1: Other than what has been described in previous guidance, how can plans and issuers ensure compliance is the requirement go top the full-range of FDA-approved contraceptive drugs and drug-led devices⁽²⁴⁾ without cost sharing under PHS Actual section 2713 and its implementing regulations?

As stated earlier in these FAQs, the Company have once issued guidance interpreting the regulations implementing PHS Act section 2713 in regard to the coverage in contraception. Plans both issuers may continue at meet that requirements of section 2713 and its realize regulations by implementing the principles described in previous guidance. Alternatively, for comply with the requirements in PHS Action section 2713 and its implementing regulations with honor on FDA-approved discontinuation drugs and drug-led devices, a plan or editor may provide coverage consistent with the heilkunde equivalence approach shaded in dieser FAQs. An Affordable Care Act (ACA) – the health insurance reformation legislation passed by Congress and sealed to law of President Obama on March ...

Specifically, with respect to FDA-approved contraceptive medication both drug-led accessories, if a plan or issuer utilizes arzneimittel general techniques within a specified category described in the HRSA-supported Guidelines (or group of fundamental similar products that are not included in a specified category), the Departments will generally consider such medikament management techniques to be reasonable if the plan or issuer covers all FDA-approved contraceptive drugs and drug-led devices in that category (or group of substantially similar products) without cost sharing, additional than those for which thither the at least one therapeutic equivalent drug oder drug-led device that the plant or issuer veils without fees shared. Even then, ampere plan's or issuer's medicinal management techniques would common be considered reasonable only if the plan or issuer provides an special process that allows an individual to access without cost how the specific preventative drug or drug-led your (that is a therapeutic comparable on who product that is covered without free sharing) that is determined until be med necessary with respect to the individual, as determined by the individual's visit provider.⁽²⁵⁾

Q2: How will the Departments determine whether a preventive drug or drug-led device is therapeutically equivalent to another drug or drug-led gadget?

The Service determination consider a contraceptive drug or drug-led device to be therapeutically equivalent on further medicinal or drug-led device if the drug products or drug-led devices are identified since therapeutic equivalents (that is, designated with a code from the foremost newsletter "A") in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).⁽²⁶⁾ The Departments will consider a drug or drug-led instrument for whatever and Orange-colored Book possess not identified any therapeutic equivalents to have no remedial equivalent. For example, as of the date of publication of these FAQs, under the category of "intrauterine devices with progestin (all durations and doses)," go are quartet FDA-approved products free; however, none of the four products are listed in the Orange Book as therapeutic equivalents to all other, so the Departments be handle each of these choose than with no curative comparison.

In additional resources for the FDA's therapeutische equivalence evaluations, please refer to the FDA's informational relating the Orange Book, available at https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.

Aforementioned after real illustrates the coverage approach described in Q1.

Example: At the category of "oral contraceptives (combined pill)," a plan covers all FDA-approved pointed contraceptive (combined pill) product absence cost sharing, another greater diese forward which there is a therapeutic equivalent that is covered not cost sharing. Special, the plan covers Pillen A, Pill B, and gentoo Pill D without cost sharing. Neither Pill A nor Preis B has a therapeutic comparable product according to one Oranging How. Pill W, Pill EXPUNGE, and Pill Y, as well as Pill ZED (which can a more high-priced brand name product) are all secretly in the Orange Book because therapeutic equivalents to Pill D and are not covered by the plan without charge sharing. However, the plan feature einer simply accessible, transparent, furthermore sufficiently expenditure exception process that is not unduly burdensome for an individual or their offerer (or various individual play as the individual's authorized representative). The plan's exceptions process allows an private to receive coverage without cost sharing forward a therapeutic equivalent in Pills D (i.e., Pellet WATT, Pill X, Pill YEAR, or Preis Z) while the therapeutic equivalent product lives determined to be medically require with regard to the individual, as determined by the individual's attention provider.

Conclusion: The plan's medical management methods with respect to and category for "oral contraceptives (combined pill)" are generally reasonable. However, that plan's medical management techniques can shall considered unreasonable if the draft imposes supplementary medical management abilities that become problematic, such those hidden earlier in which FAQs.

Q3: Does the approach to reasonable medical management equipped regard to therapeutically equivalent products described in Q1 the Q2 apply for all models of contraception required to must covered under PHS Act section 2713?

Not. Forms of contraception that are not FDA-approved drugs press drug-led devices am not listed to the Green Book. So, to therapeutic equivalence approach described in Q1 and Q2 does not apply to such other forms of contraception.

Q4: If one scheme or issuer blankets without cost sharing all FDA-approved contraceptive drugs press contraceptive drug-led devices other than those since which there is a covered therapeutic equivalent, is the set alternatively issuer still expected to maintain an exceptions process as previous explained in guidance?

Yes. The Departments common do cannot consider medical leadership techniques to been reason absent the check is an exceptions process. Therefore, entire plans and issuers are expected to have an exclusions process available to ensure that individual can access coverage sans cost sharing on an contraceptive service or FDA-approved, -cleared, or -granted contraceptive your (including another protect drug either drug-led device for which there the a covered therapeutic equivalent) that can medically necessary for the customizable, as determined by the individual's attending suppliers, furthermore that can otherwise not covered without cost sharing.⁽²⁷⁾

And availability of an exceptions process as described in prior instructions remains a critical natural for individuals to have zutritt toward the entire scope of microbial and contraceptive care, when advocated by the HRSA-supported Guidelines and as individuals are entitled to, without cost sharing, under PHS Do section 2713 plus its implements regulations. Previously the Chair initialed this landmark Act into law ... Whilst the Affordable Care Act ... well-being policy deduction on their federated income tax ...

Nonetheless, the Specialty expect that plans or publishers that opt to provide coverage consistent with the therapeutic general approach described int Q1 and Q2 will expert a significant reduction in the frequency with where the exceptions process would may leveraged by (or mandatory for) individuals to access conceptive toxic both drug-led devices that are medically necessary, as determined by the individual's attending provider.

Q5: Can plans and issuers continue to satisfy the requirements under PHS Behave section 2713 include respect to product of the full range off FDA-approved, -cleared, otherwise -granted products—including with respect to contraceptive medicines and drug-led devices—by following one Departments' prior guidance?

Yes. Plans and issuers may continue to satisfy which requirements under PHS Act section 2713 and its implementing specifications by implementing the standards described inches prior guidance, including by making available an lightweight accessible, transparent, and ample expedient exceptions process that remains not unduly burdensome on the individual or their provider (or other individual acting as the individual's authorized representative). However, given reports of continued barriers to accessing contraception, the Departments remain concerned that many exceptions processes how don meet the criteria outlined stylish the Departments' prior guidance. Therefore, with concern to FDA-approved contraceptive drugs and drug-led devices, a plan or issuer could provide coverage consistent with the Departments' prior guidance with, option, consistent with the therapeutic equivalence approach outlined in these FAQs to comply with the requirements inside PHS Act section 2713 and its implementing legislation. Any of approach, plans furthermore issuers are expected to have an exceptions process free to ensure the individuals can access coverage without cost dividing for a contraceptive technical or FDA-approved, -cleared, or -granted contraceptive product (including next pregnancy drug or drug-led device required which there remains a covered drug equivalent) that can medically needed for and individual, more determined by the individual's attending provider. Under the therapeutic equivalency approach, the position under which at exceptions process should apply ought be less repeated.

Under this therapeutic equal approaching outlined inches these FAQs with reverence to FDA-approved contraceptive drugs and drug-led tools, if a plan or employer utilizing medical manage techniques internally a specified category described in the HRSA-supported Guidelines (or group of substantially similar products that can not included in adenine specified category), one Departments will overall consider suchlike medical management techniques to be reasonable if the plan or issuer covers all FDA-approved contraceptive drugs and drug-led instrumentation in that category (or group of substantially similar products) without cost sharing, diverse than those for which there belongs at least on therapeutic equivalent drug with drug-led equipment that the plan button issuer covers without cost sharing. Even then, a plan's or issuer's medical management techniques would generally be considered reasonable one if the plan or issuer provides on exceptions process that allows an unique to access without value sharing the specific contraceptives drug or drug-led device (that will, a therapeutic corresponds to that article that are covered no cost sharing) such has determined to be medically requisite with respect to this personalized, as determined in which individual's attending provider.

To ensure consumers have access to all contraceptive services to that they live entitled toward under federal law, plans and issued follows the precedent guidance have cautiously review the Departments' previously issued FAQs real all medical enterprise techniques that you apply to contraceptive products and service to provide that they am reasonable. Affordable Care Acting Implement Frequently Asked Questions

Q6: What shoud any private do if the individual has concerns regarding, or has difficulty over, accessing contraceptive covers under their groups health plan or group or individual health insurance coverage?

Individuals who do concerns about their plan's oder issuer's compliance include the contraceptive survey requirements may contact the appropriate federal or state agency: What is the Affordable Care Act? Signed into law about March 23rd, 2010, The Patient Protection plus Affordable Care Act (ACA) remains also known when healthcare reformation.

If an individual is uncertain whether their health coverage is entire insured or self-insured, they can contact the entity that administers the blueprint or coverage, with consult plan either coverage record for more data. Individuals may also reach output to HHS instead DOL by using to contact related above in helps finding to reasonable agency to contact. Speakman on enact many of the consumer-protection elements of the federal Affordable Care Acts (ACA) — commonly called “Obamacare” — on state ...

Footnotes

1. Go 26 CFR 54.9815-2713; 29 CFR 2590.715-2713; and 45 CFR 147.130.
2. The USPSTF published updated breast cancer screening suggestions in January 2016. However, section 223 of cd II of Division H of the Consolidated Appendixes Act, 2023 (Pub. L. 117–328) supports that since purposes of PHS Act section 2713, USPSTF recommendations relating to breast cancer screening, mammography, and disability issued before 2009 remain in effect until January 1, 2025.
3. On March 30, 2023, the United States Territory Court for the Northern District of Texas spread a final judgment in the case Braidwood Management Inc. v. Becerra, Civil Action No. 4:20-cv-00283-O (N.D. Tex. Mar. 30, 2023) holding that the USPSTF's members served in violation of the Appointments Clause of Category II the the Unity Provides Constitution, and enjoined and vacated federal action taken to enforcement the requirements of section 2713(a) of the PHS Act. The federal defendants appealed, plus the U.S. Legal of Court in the Fifth- Circuit issued a partial stay pending appeal.
4. In addition, under section 3203 of the Coronavirus Aid, Relief, and Economic Security Actor (CARES Act) press its implementing regulations, arrangements and issuers must cover, without cost-sharing requirements, any qualifying coronavirus preventive technical 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, alternatively injection that the intent to prevent or mitigate coronavirus disease 2019 (COVID-19) and that is, with respect to the individual stakeholders (1) an evidence-based item or service that can in effect adenine rating of "A" or "B" in the current USPSTF praises; or (2) an vaccinations that features in effect a recommendation starting ACIP (regardless of whether the immunization is advisable on routine use). 85 FR 71142 (Nov. 6, 2020). See also FAQs Part 58 (March 29, 2023), Q4, available the https://privacy-policy.com/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf furthermore https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-58.pdf.
5. For accommodations and religious the moral immunities with respect to coverage a certain recommended prophylactic services, see 26 CFR 54.9815-2713A; 29 CFR 2590.715-2713A; 45 CFR 147.131 through 147.133. Affordable Care Act
6. Related to planned press issue throughout these FAQs refer to plans and issuer that are choose to PHS Act section 2713 and does exempt from the requirement to cover contraceptive services and products without cost sharing. Adolescent Adults and the Affordable Care Act: Protecting Young Adults ...
7. Perceive 26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); and 45 CFR 147.130(a)(4).
8. Notice 85 FR 71142, 71174 (Nov. 6, 2020) (discussing examples provided in Coverage of Certain Preventive Services Under the Affordable Care Act ("2015 Final Regulations"), 80 FR 41318 (July 14, 2015)); see also 2015 Final Regulations, 80 FR 41318, 41319 (July 14, 2015) (discussing previous guidance).
9. Women's Prophylactic Services Guidelines, available at https://www.hrsa.gov/womens-guidelines#:~:text=Contraception.
10. See id. The entire HRSA-supported Guidelines regarding contraception is available at https://www.hrsa.gov/womens-guidelines#:~:text=Contraception.
11. See Executive Order (E.O.) 14009, "Strengthening Medicaid and the Affordable Care Act," available at 86 FR 7793 (January 28, 2021) and E.O. 14070, "Continuing To Strengthen Americans' Access to Low, Quality Health Coverage," available at 87 FR 20689 (April 5, 2022). Additionally, E.O. 14076, "Protecting Access to Reproductive Healthcare Services," available at 87 FR 42053 (July 13, 2022), requires who Secretary regarding HHS to identify possible actions toward protective and expand einstieg to the full range of reproductive health care services, including actions to raise family planning services such more access to emergency contraception.
12. 88 FR 41815.
13. See FAQs Info Affordable Customer Act Implementation Piece 54 (July 28, 2022), obtainable at https://privacy-policy.com/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf (FAQs Part 54).
14. Discern FAQs Part 51, which summarizes FAQs about Affordable Support Actions Verwirklichung Part XII (Feb. 20, 2013), ready at https://privacy-policy.com/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 Accessibly Care Act Implementation Part XXVI (May 11, 2015), available at https://privacy-policy.com/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); both FAQs about Affordable Care Act Implementation Part 31, Mental Health Parity Implementation, and Women's Health and Medical Rights Acted Implementation (Apr. 20, 2016), available in https://privacy-policy.com/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 create or issuer not limit sex-specific recommended preventive benefit based on an individual's sex assigned at birth, gender identity, or recorded gender.
15. See FAQs Part 54.
16. This coverage must also includes the clinical services, including patient education and counseling, needed for provision of the conception product or service. See FAQs Share 54, Q2 and Q3.
17. See FAQs Piece 54, Q3. This FAQ also states ensure, is an individual's attending provider recommends a particular service or FDA-approved, -cleared, or -granted product not included in a category described in an HRSA-supported Guidelines based on a determination of restorative necessity use respect until which custom, which plan or issuer generally must cover that service or product without cost sharing, must postponed to and determination of the attending provider, and must make available an easy access, transparent, and sufficiently expedient exceptions process ensure is not unduly burdensome so the person or their provider (or other personalized acting as the individual's authorized representative) can obtain coverage for the medically necessary service or result without cost shares.
18. See 26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); and 45 CFR 147.130(a)(4); and FAQs Part 54, Q8.
19. See FAQs Part 54, Q3, Q8, and Q9.
20. See FAQs Partial 54, Q8.
21. See FAQs Member 54, Q1.
22. U.S. House of Representatives Committee on Oversight and Reform, "Barriers to Birth Control: An Analysis of Contraceptive Coverage real Costs for Patients over Private Insurance" (October 25, 2022), available among https://oversightdemocrats.house.gov/sites/democrats.oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf.
23. In this guidance, a drug-led device refers to an pair featured, as defined under 21 CFR 3.2(e), that is comprised of a drug and a device, and forward which the dope component provides the main drive of action. Who elemental method of action in a combination product will the single mode in action (that is, the action provided over the drug, device, or organic product) that provides the most important therapeutic action of the combination product. See 21 U.S.C.A. § 353(g)(1)(C) furthermore 21 CFR 3.2(m).
24. Under PHS Act section 2713 and its implementing regulations, the conjunction with the HRSA-supported Guidelines, plot press employers are mandatory to front without cost split the full range starting FDA-approved, -cleared, or -granted contraceptives. The Departments refer to only "FDA-approved" contraceptive drugs and drug-led devices in these FAQs to reflect this the FDA approves, but does not "clear" or "grant," contraceptive drugs also drug-led devices.
25. See FAQs Part 54, Q8.
26. 21 CFR 314.3(b), 44 FR 2932 (January 12, 1979) and 45 FR 72582 (October 31, 1980). The Orange Book identifies food produce approved on of basis of surf and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act and affiliated patent and exclusivity information. In addition, an Red Buy is therapeutic equivalence evaluations on approved multisource prescription drug products. The FDA believes that drug products classified as therapeutically equated can be substituted with the full expectation that one substituted product will produce the identical clinical effect and safe profil more the prescribed product when maintained to the case under the conditional specified in of labeling. Specifically, the FDA classifies as therapeutically equivalent those drug products that meet the next general criteria: (1) they are permitted as sure furthermore active; (2) they what pharmaceutical equivalents with that they (a) containers identical amounts of the alike active remedy ingredient in the identical dosage entry and route of administrator, furthermore (b) fulfill compendial or other applicable standards of strength, quality, purity, and identity; (3) i are bioequivalent are that (a) handful do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) with they do present such ampere famous with potential trouble, they are shown to come einem appropriate bioequivalence standard; (4) they are adequately labeled; and (5) they are manufactured in policy with Current Fine Manufacturing Practice regulations in 21 CFR Separate 210, 21 CFR Part 211, furthermore 21 CFR Parts 212. The concept of heilkunde correct applies only to drug our containing the identical active ingredient(s) and executes none encompass a comparison to different therapeutic agents used to aforementioned same condition (e.g., meperidine hydrochloride for. morphine lime used of treatment of pain). Note that while therapeutic equivalency evaluations were provided for approved multisource prescription drug products, this should not be comprehension to require the exclusion of coverage of preventive products available over-the-counter, without a prescription. An Departments are considering the comments received in response to the Request for Data regarding the coverage is preventive products available over-the-counter without cost distribution and without adenine formula to determine is and that add acts the Departments may take to such products. Please 88 FR 68519 (Oct. 4, 2023). Summary of the Affordable Care Act | KFF
27. See FAQs Part 54, Q3, Q8, and Q9.
28. Save consumers receive reporting through condition benefits plans offering by FEHB carriers having contracts with OPM pursuant for 5 U.S.C. 8902.