American College of Obstetricians & Gynecologists Issues Public Comment to 3 Agencies
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The comment, on Docket No. EBSA-2023-0013-0001, was sent to HHS Secretary
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The
Background
Section 2713 of the
The benefits of birth control have been well documented. The
The Dobbs decision has made accessing abortion incredibly difficult, if not impossible, for millions of people across the nation. The Departments have stated in the past that the abortion access crisis caused by Dobbs has "placed a heightened importance on access to contraceptive services." It is vital to note, however, that improved access to contraception does not, and could not ever, replace access to abortion. Both services are essential in the full spectrum of reproductive health care, to which everyone deserves access in their own community.
The nation's experts predict that the current
Since 2012, ACOG has supported over-the-counter access to oral contraception./xi,/xii Access to contraception, especially methods that are user-dependent (versus those that are reliant on a partner, such as with condoms), is even more important today when reproductive access and choices are limited for many Americans. Based on the robust body of evidence supporting the safety and efficacy of hormonal contraception, ACOG supports the switch from prescription to over-the-counter access to progestin-only oral contraceptive pills (POPs) without age restrictions.
Access to and Utilization of OTC Products
Contraception
Contraception, including OTC contraception, is a critical preventive health service, essential in individuals' achievement of their health, social, and financial goals./xiii The ACA has already greatly advanced access to contraception, among other preventive services, partially rectifying existing disparities./xiv,/xv,/xvi However, many Americans continue to face multiple and persistent barriers to contraception more than ten years after the implementation of the ACA. These barriers significantly impact people of color and Indigenous people, young people, immigrants, LGBTQ+ communities, those working to make ends meet, and people with disabilities./xvii A national survey of people who identify as Black, Indigenous, and people of color found that nearly half experienced at least one challenge to accessing contraception in the last year./xviii
Nearly all women utilize some method of contraception during their reproductive lives./xix Data from the 2017-2019
Breastfeeding initiation rates in
The ACA requires most insurance plans to cover the cost of a breast pump and breastfeeding counseling without cost sharing. Current guidelines recommend "comprehensive lactation support services (including counseling, education, and breastfeeding equipment and supplies) during the antenatal, perinatal, and postpartum periods to ensure the successful initiation and maintenance of breastfeeding."/xxxi Additional guidance in 2023 states "breastfeeding equipment and supplies include, but are not limited to, double electric breast pumps (including pump parts and maintenance) and breast milk storage supplies./xxxii Access to double electric pumps should be a priority to optimize breastfeeding and should not be predicated on prior failure of a manual pump. Breastfeeding equipment may also include equipment and supplies as clinically indicated to support [nursing parents and infants] with breastfeeding difficulties and those who need additional services." While less data have been collected about OTC access to breastfeeding supplies, research shows out of pocket costs to breastfeeding supplies are a barrier to individuals wishing to breastfeed. While insurance plans may be covering breastfeeding supplies with no out of pocket costs, administrative burdens, such as requiring a prescription, can still be a barrier to needed supplies and supports for patients.
Implementation Issues
Point of Sale Coverage
ACOG continues to believe that cost-sharing should be eliminated for patients to improve access to important services and procedures. Studies show that cost-sharing has unintended consequences such as unbearable financial burdens, negative effects on access to health care and health outcomes, and increased use of emergency rooms./xxxiii Small levels of cost-sharing in the range of
Despite the ACA's provisions regarding contraceptive coverage with no out-of-pocket costs, accessing health care can be difficult and expensive. For example, millions of women live in contraceptive deserts or are otherwise far from a trusted provider; financial factors like needing to arrange transportation, childcare, and time off work (often in the absence of paid sick days can make getting contraception from a provider prohibitively expensive)./xxxv,/xxxvi Additionally, a process which requires payment by the patient to later be reimbursed is not tenable and does not provide the economic benefits of contraception as intended by the ACA. Without direct payment for OTC contraception, existing disparities will persist.
Currently, the limitations of payers' claims processing systems create challenges for access in out-of-network pharmacies and retail settings, which poses a serious challenge to people who have limited resources or difficulty accessing pharmacies. As noted above, reimbursement-based processes of implementing coverage still place a cost burden on individuals. Solutions to extend OTC coverage to retail settings may include a coverage "debit" card similar to electronic benefits transfer cards used for other programs. Federal requirements for insurers to provide coverage of OTC contraceptives that includes point of sale payment to all pharmacies and retail settings, without cost-sharing and without a prescription would help close the gaps in disparities and inequities. ACOG strongly urges the Departments to ensure point of sale coverage to consumers to ensure consumers face no financial barriers to care.
Quantity Limitations
There is ample precedent for coverage of a 12-month supply of contraception. Currently, 25 states and the
While there are not established standards for what constitutes a 12-month supply for some OTC methods (e.g., condoms and emergency contraceptive pills), health plans should be prohibited from setting unreasonable quantity limits that would compromise individuals' ability to use these methods effectively. Plans should cover OTC products in all quantities that are packaged for retail sale (e.g., not limit coverage of condoms to boxes of 10 or 12, when they are also sold in larger box sizes). ACOG strongly recommends federal rules should require health plans to cover a 12-month supply of contraceptives (whether OTC or prescription) at one time.
In addition, health plans should be barred from placing limits on a patient's ability to switch contraceptive methods. Often a person must change methods due to side effects, a change in life circumstances, or find the method that works best for them. They should be able to do so without obstacles. For example, receiving a 12-month supply of oral contraceptives should not prevent a patient from switching to an IUD six months later. Similarly, health plans should be required to offer additional coverage in cases when a consumer's supply of contraceptives is lost or damaged. These protections would help ensure that health plans do not undermine enrollees' health in the name of preventing fraud and abuse.
Location/network requirements
There should be broad coverage of OTC products across locations. At minimum, this must include anywhere consumers can use their prescription benefit, including a drugstore pharmacy counter or an insurer's mail-order pharmacy service. Additionally, the federal government should work with health plans and retailers to develop ways for consumers to obtain OTC contraceptives with no copay at any retailers--for example, by using a plan-issued debit card or an electronic coupon via a QR code.
In order for consumers to have a full range of convenient options, plans should also be required to cover the full cost of OTC contraceptives when an enrollee buys the product up front without their insurance, at any location, and then submits the receipt for after-the-fact reimbursement. However, after-the-fact reimbursement must never be used by health plans as the preferred option--rather, they should ensure true point-of-sale coverage. ACOG recommends federal rules require health plans to cover OTC products in as many locations as possible--ideally, anywhere that OTC drugs and devices are sold, including coverage for telemedicine and mail-order options.
Services provided by obstetrician-gynecologists range throughout the lifespan and are critical for individuals seeking care. Applying network adequacy to all plans is a key piece in ensuring those seeking obstetrical and gynecological care have access to the providers and care they need. Through the Notice of Benefit and Payment Paraments (NBPP) rule making process, the Departments can set network adequacy standards for qualified health plans (QHP) and threshold standards for Essential Community Providers (ECP). ACOG recommends the Departments include retailers providing OTC coverage of preventive services to network adequacy standards through the NBPP rule making process to ensure broad access to these services, including contraception.
Uniform Guidance
As of 2023, eight states have passed laws requiring insurance coverage of OTC contraception. In states where coverage for OTC contraception is provided without a prescription, research shows that billing protocols for OTC contraception vary widely by health insurance plan and within state Medicaid programs, leading to confusion for pharmacists./xxxix And while state actions to increase access to OTC contraception without cost-sharing and without a prescription can be meaningful for people with private insurance, the reach of these actions is limited because the majority of those with private health insurance are enrolled in self-funded employer plans, which are not subject to state insurance requirements./xl ACOG urges the Departments to issue guidance clarifying that the preventive services provision requires that coverage of OTC preventive products, including contraception and breastfeeding supplies, without a prescription be comprehensive and seamless, no matter how a consumer acquires the product.
A national, uniform approach to processing claims for OTC products is critical. Pharmacists and pharmacies report that claims processing often varies between plans and product, and that as a result, there is confusion about how to process OTC claims. Due to market segmentation, each individual state has limited ability to effect the systemic changes needed to process insurance claims for OTC products. A national requirement for coverage creates the imperative for stakeholders to come to the table and develop a uniform approach to processing OTC coverage claims. ACOG recommends federal regulations create a uniform process for all plans to process OTC product claims.
Considerations from the States
To reduce access barriers to OTC contraception while also avoiding cost sharing, six states (CA, MD, NJ, NM, NY, and WA) have laws or regulations requiring state-regulated private health insurance plans (individual, small group, and large group markets) to cover, without cost sharing, at least some methods of OTC contraception without a prescription./xli With the exception of
While some states have taken action to expand access, others have taken legislative action that sets precedents to limit availability.
Provider Impacts
Many of the issues identified in implementation, such as prior authorization and prescription requirements, impact patients and providers. ACOG strongly believes that policies which add burden to physicians ultimately impact patient access. For example, utilization management mechanisms such as prior authorization are typically unnecessary and can be barriers to accessing critical care and services. In addition to the burden physicians and their practices experience in regard to prior authorization, patient safety is also often at risk. A 2021 survey conducted by the
The current standards around OTC coverage pose a burden for both patients and providers working in the most underserved communities. This is only exacerbated by the exodus of physicians from states with abortion bans. There are increased demands on physicians via appointments, phone calls, and electronic messaging from patients to write prescriptions without an appointment. In many of these circumstances, the physician isn't compensated for their labor and time, adding to burnout as these physicians try to keep up with patient needs. Allowing patients to seek OTC products without a prescription has the opportunity to increase the capacity for physicians to provide other services and take on new patients. Additionally, OTC products exist because the FDA has determined that the products have minimal risks associated with them, and patients are able to discern for themselves usage. Given these facts, ACOG supports OTC coverage of these products and services to help support physicians and prevent health issues or patients concerns without relying on a physician visit or prescription requirement.
Health Equity Across Federal Programs
People from racially and ethnically marginalized communities are more likely to face barriers to accessing reproductive health care and are less likely to use hormonal contraception, in part, due to these obstacles. Data also support that uninsured people and those for whom English is not their first language face even more difficulty accessing prescription contraception./xlvii While preferences for contraceptive method and attitudes toward pregnancy may explain some differences in contraceptive use by Black, Hispanic, and White individuals, clinician-related factors also contribute to disparities in reproductive health care. Survey data show that Black individuals are more likely than White people to be pressured to initiate contraception by a clinician and that Hispanic women are more likely to be counseled about permanent sterilization./xlviii While efforts to dismantle racism in health care and reform clinician bias are essential, additional avenues for individuals to access contraception on their own terms provides equity in family planning. Ensuring OTC coverage of preventive services without a prescription is a small step the Departments can take to address growing health disparities and inequities within the health care system.
Adolescents and young adults especially may face substantial barriers to accessing desired contraception. In a 2022 survey from Advocates for Youth, 88 percent of the respondents reported difficulty accessing birth control./xlix Many young people experience challenges scheduling, traveling to, and attending an appointment with a clinician to get a prescription for contraception. This can lead to delays starting birth control or some may never access contraception. Adolescents also have unique privacy needs that are often compromised by documents from their parents' insurance coverage./l Based on these unique challenges and the safety and efficacy of oral contraception, ACOG supports OTC contraception availability without age restrictions. ACOG recommends the Departments include provisions in rulemaking to allow for privacy in explanation of benefit statements for OTC contraceptive products.
The Departments must take steps to ensure an equitable roll out of OTC coverage across all federal programs. Specifically, to help close the gap on health inequities and disparities for reproductive care, the
Medicare, originally designed as a hospital benefit for older Americans, now include approximately 1.7 million people ages 18 through 44./li HHS, along with CMS, should take this opportunity to update coverage policies to align with ACA recommendations and also allow for coverage of OTC contraception.
Within Medicaid, contraceptives are covered under three different benefit categories, the prescription drug benefit, the family planning benefit, and the essential health benefits preventive services benefit, and federal action is needed to ensure a smooth roll out OTC coverage of contraception. States can cover OTC contraceptive drugs under the prescription drug benefit, which would allow the state to receive drug rebates from the manufacturer but would require the beneficiary to have a prescription. Alternatively, states can cover OTC contraceptive drugs and devices under the family planning benefit without a prescription, but any OTC product covered without a prescription, under either the family planning benefit or the essential health benefit for preventive services, would be ineligible for a rebate, making it more expensive for Medicaid programs. Additionally, with the ACA Medicaid Expansion group and those only eligible for family planning services, multiple actions are needed. For ACA Medicaid Expansion beneficiaries, current ACA guidance says coverage must include a list of specific OTC contraceptives, but a prescription may be required by the Medicaid plan. For all other Medicaid beneficiaries, current federal law and regulations allow but do not require states to cover OTC contraceptives. ACOG recommends CMS issue a federal standing order for OTC contraceptives applying to all Medicaid beneficiaries nationwide to remove policy barriers to OTC coverage for state Medicaid programs. Additionally, ACOG recommends CMS issue guidance to states outlining OTC coverage requirements for Medicaid beneficiaries, including the expansion group, provide technical assistance to states, and promote the coverage availability to beneficiaries.
Enforcement and Oversight
ACOG recommends that the Departments provide clear information about the ACA's requirements and specifically about coverage of OTC preventive products to all impacted groups including private health plans, Medicaid managed care plans, pharmacy benefit managers, state insurance regulators, state Medicaid agencies, pharmacies, retailers, community-based organizations, providers, and consumers. Similarly, the Departments will need to disseminate instructions for implementation by programs and providers and access by patients. Moreover, ACOG strongly recommends that the Departments partner to monitor compliance with the revised requirements, impose appropriate corrective actions and penalties for plans that fail to do so, and work with state regulators to coordinate oversight and enforcement across the entire health coverage marketplace.
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Thank you for the opportunity to comment on the request for information on the Coverage of Over-the-Counter (OTC) Preventive Services. As articulated above, ACOG believes access to OTC preventive services without a prescription is critical to the health and well-being of our patients. We urge the Departments to develop federal regulations that create robust coverage of OTC preventive services and provide support and guidance for implementation. Should you have any questions, please contact
Sincerely,
Senior Director, Health Economics & Practice Management
i Simmons, A et. al. The Affordable Care Act: Promoting Better Health for Women.
ii
iii
iv
v Schindler AE. Non-contraceptive benefits of oral hormonal contraceptives. Int J Endocrinol Metab. 2013;11(1):41-7
vi Access to contraception. Committee Opinion No. 615.
vii "Penalizing Abortion Providers Will Have Ripple Effects Across Pregnancy Care", Health Affairs Forefront,
viii Hoyert DL. Maternal mortality rates in
ix Ibid.
x Feltner C , Weber RP , Stuebe A , Grodensky CA , Orr C , Viswanathan M . Breastfeeding programs and policies, breastfeeding uptake, and maternal health outcomes in developed countries. Comparative Effectiveness Review No. 210. AHRQ Publication No. 18-EHC014-EF.
xi Over-the-counter access to oral contraceptives. Committee Opinion No. 544.
xii Over-the-counter access to hormonal contraception. ACOG Committee Opinion No. 788.
xiii
xiv See, e.g., Geetesh Solanki et al., The Direct and Indirect Effects of Cost-Sharing on the Use of Preventive Services, 34 Health Servs. Research 1331, 1347-48 (2000);
xv
xvi See IMS Inst. for Healthcare Informatics, Medicine Use and Shifting Costs of Healthcare: A Review of the Use of Medicines in
xvii Dehlendorf C, Rodriguez MI, Levy K, Borrero S, Steinauer J. Disparities in Family Planning. Am J Obstet Gynecol. 2010;202(3):214-220. doi:10.1016/j.ajog.2009.08.022
xviii
xix Kavanaugh ML, Pliskin E. Use of contraception among reproductive-aged women in
xx Daniels K, Abma JC. Current Contraceptive Status Among Women Aged 15-49:
xxi Curtis KM, Jatlaoui TC, Tepper NK, Zapata LB, Horton LG, Jamieson DJ, et al.
xxii
xxiv Grindlay K, Grossman D. Prescription Birth Control Access Among
xxv Grindlay, Kate, and Grossman, Dan. "Interest in Over-the-Counter Access to a Progestin-Only Pill among Women in
xxvii
xxviii Breastfeeding Challenges. ACOG Committee Opinion No. 820.
xxix
xxx Stuebe AM , Horton BJ , Chetwynd E , Watkins S , Grewen K ,
xxxi Women's Preventive Services Guidelines.
xxxii Women's Preventive Services Guidelines.
xxxiii The Effects of Premiums and Cost Sharing on Low-Income Populations: Updated Review of research Findings. (2018,
xxxiv Ibid.
xxxv Contraceptive Deserts. Power to Decide. https://powertodecide.org/what-we-do/contraceptive-deserts
xxxvi
xxxvii Extended Supply of Contraception. Fact Sheet. Power to Decide. https://powertodecide.org/what-wedo/information/resource-library/extended-supply-contraception
xxxviii Tri-Agency FAQ. FAQs About Affordable Care Act Implementation Part 54.
xxxix
xl Ibid.
xli State Private Insurance Coverage Requirements for OTC Contraception Without a Prescription. KFF.
xlii Legislature of the
xliii
xliv Healthy Texas Women 1115 Waiver Public Forum Slides.
xlv Klibanoff E. Appeals court considers whether
xlvi
xlvii Dehlendorf C, Rodriguez MI, Levy K, Borrero S, Steinauer J. Disparities in family planning. Am J Obstet Gynecol. 2010 Mar;202(3):214-20. doi: 10.1016/j.ajog.2009.08.022. PMID: 20207237; PMCID: PMC2835625
xlviii Ibid.
xlix BEHIND THE COUNTER: Findings from the 2022
l Confidentiality in adolescent health care. ACOG Committee Opinion No. 803.
li Jimenez G. For Young People on Medicare, a Hysterectomy Sometimes is More Affordable Than Birth Control.
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Original text here: https://downloads.regulations.gov/EBSA-2023-0013-0268/attachment_1.pdf
TARGETED NEWS SERVICE (founded 2004) features non-partisan 'edited journalism' news briefs and information for news organizations, public policy groups and individuals; as well as 'gathered' public policy information, including news releases, reports, speeches. For more information contact
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