Contraception 93 (2016) 392 – 397
Original research article
Are women benefiting from the Affordable Care Act? A real-world evaluation of the impact of the Affordable Care Act on out-of-pocket costs for contraceptives☆,☆☆ A. Law a,⁎, L. Wen a , J. Lin b , M. Tangirala a , J.S. Schwartz c , E. Zampaglione a a
Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA b Novosys Health, Green Brook, NJ, USA c Wharton School of Business, University of Pennsylvania, School of Medicine, Philadelphia, PA, USA Received 17 July 2015; revised 13 January 2016; accepted 13 January 2016
Abstract Objectives: The Affordable Care Act (ACA) mandated that, starting between August 1, 2012 and July 31, 2013, health plans cover most Food and Drug Administration (FDA)-approved contraceptive methods for women without cost sharing. This study examined the impact of the ACA on out-of-pocket expenses for contraceptives. Study design: Women (ages 15–44 years) with claims for any contraceptives in years 2011, 2012 and 2013 were identified from the MarketScan Commercial database. The proportions of women using contraceptives [including permanent contraceptives (PCs) and non-PCs: oral contraceptives (OCs), injectables, patches, rings, implants and intrauterine devices (IUDs)] in study years were determined, as well as changes in out-of-pocket expenses for contraceptives during 2011–2013. Demographics, including age, U.S. geographic region of residence and health plan type, were also evaluated. Results: The number of women identified with any contraceptive usage in 2011 was 2,447,316 (mean age: 27.6 years), in 2012 was 2,515,296 (mean age: 27.4 years) and in 2013 was 2,243,253 (mean age: 27.4 years). In 2011, 2012 and 2013, the proportions of women with any contraceptive usage were 26.3%, 26.2% and 26.9%, respectively. Over the three study years, mean total out-of-pocket expenses for PCs and non-PCs decreased from $298 to $82 and from $94 to $30, respectively. For non-PCs, mean total out-of-pocket expenses for OCs and IUDs decreased from $86 to $26 and from $83 to $20. Conclusions: Implementation of the ACA has saved women a substantial amount in out-of-pocket expenses for contraceptives. Implications: Mean total out-of-pocket expenses for FDA-approved contraceptives decreased approximately 70% from 2011 to 2013. Implementation of the ACA has saved women a substantial amount in out-of-pocket expenses for contraceptives. Longer-term studies, including clinical outcomes, are warranted. © 2016 Elsevier Inc. All rights reserved. Keywords: Contraceptives; Out-of-pocket expenses; Cost-savings; Affordable Care Act
1. Introduction The Affordable Care Act (ACA) health insurance reform legislation was signed into law on March 23, 2010 in the U.S. [1]. Beginning on August 1, 2012, the ACA mandated ☆
Funding: This research was supported by Bayer HealthCare. Conflict of Interest: A. Law, L. Wen, M. Tangirala and E. Zampaglione are employees of Bayer HealthCare Pharmaceuticals Inc. J. Lin is an employee of Novosys Health and served as a paid consultant to Bayer HealthCare Pharmaceuticals Inc. for the development of this study and manuscript. J. S. Schwartz served as a paid consultant to Bayer HealthCare Pharmaceuticals Inc. for the development of this study and manuscript. ⁎ Corresponding author. Tel.: +1-862-404-5855. E-mail address: [email protected] (A. Law).
☆☆
http://dx.doi.org/10.1016/j.contraception.2016.01.008 0010-7824/© 2016 Elsevier Inc. All rights reserved.
that health plans must cover most Food and Drug Administration (FDA)-approved contraceptive methods and sterilization procedures [oral contraceptives (OCs), injectables, contraceptive rings, contraceptive patches, contraceptive implants, intrauterine devices (IUDs), diaphragms, cervical caps and permanent contraceptive (PC) methods, like tubal ligation] and patient education and counseling for all women with reproductive capacity without cost sharing (i.e., copayment, coinsurance or deductible) [1,2]. These regulations were included in the recommendations of the Institute of Medicine, which concluded that access to contraception is medically necessary “to ensure women's health and well-being” [3]. Although phased in during 2012, the ACA provision of contraceptive coverage
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did not affect health plans widely until January 2013 when most initiated their new plan year. The IMS Institute for Healthcare Informatics conducted a study in years 2012 and 2013 that found the number of women who filled prescriptions for OCs with no copay increased from 1.2 million in 2012 to 5.1 million in 2013 [4,5]. The IMS study did not focus on changes in contraceptive use and only reported on overall OC use and costs [4]. Three other studies have evaluated changes in out-of-pocket costs for contraceptives between periods of time before and after implementation of the ACA contraceptive provision among women in the U.S. [6–8]. Based on a 10% sample of claims in the Optum claims database, a database of one national insurer, Becker et al. reported declines in out-of-pocket costs for contraceptives among 790,895 women in the first 6 months of 2013 from the first 6 months in 2012 [6]. Bereak et al. reported a decline in out-of-pocket costs specifically for IUDs among 417,221 women in the U.S. between January 2012 and March 2014 [7]. Sonfield et al. reported significant declines in out-of-pocket costs for contraceptives based on a patient survey of 892 women insured commercially between the fall of 2012 and spring of 2014 [8]. Although some studies have already evaluated the impact of the ACA contraceptive provision on out-of-pocket costs for contraceptives among women in the U.S., we sought to provide a more comprehensive analysis of the cost-savings for most FDA-approved contraceptives among women insured by multiple commercial health plan types by identifying women with contraceptive usage in years 2011, 2012 and 2013 from a large commercial claims database.
393
tubal ligations, interval tubal ligations, hysteroscopic sterilizations and minilapartomies) and any non-PCs (OCs, injectables, patches, rings, implants and IUDs) in years 2011, 2012 and 2013, were determined using the medial service claims records or prescription drug claims records in the database. A woman receiving multiple prescriptions of the same contraceptive type was counted only once in the category of “any contraceptive usage”, and thus, no double counting occurred. If a woman received multiple types of contraceptives (i.e., switching from OC to ring) in the same year, the woman was counted once for each contraceptive type. Costs of contraceptives for any contraceptives and by each contraceptive type, including total payment (both health plan and patient payment), patient copay and out-of-pocket payment (sum of copay, coinsurance and deductible), were determined during years 2011–2013. Such above-described cost data were measured on two different levels: cost per contraceptive healthcare claim and total annual cost per woman with contraceptives. Demographics, including age, U.S. geographic region of residence and health plan type, were also evaluated. 2.3. Statistical analyses Descriptive statistics were used to measure and describe contraceptive use, costs for contraceptives and demographics information for study populations in years 2011, 2012 and 2013. All statistical analyses were carried out using SAS 9.3.
3. Results 2. Materials and methods 2.1. Study population inclusion criteria Women (15–44 years of age) with any contraceptive usage and pharmacy and medical coverage in years 2011, 2012 and 2013 were identified from the Truven Health MarketScan® Commercial claims database. This claims database encompasses N 60 million unique deidentified patients that include active employees, early retirees, COBRA continuers and their dependents insured by employer-sponsored plans located in all 10 U.S. census regions. The database consists of healthcare claims data from N 100 different health insurance companies and self-insured employers. In compliance with the Health Insurance Portability and Accountability Act of 1996, it consists of fully deidentified data sets. Women were placed into three separate cross-sectional study populations for years 2011, 2012 and 2013. As this was a cross-sectional study with measurements evaluated in each year, the populations in the 2011, 2012 and 2013 cohorts may overlap with each other. 2.2. Measurements The number and proportions of women with one or more claims for any contraceptive, including PCs (postpartum
3.1. Study populations and proportions with contraceptive usage The total populations of women ages 15–44 years with claims in the MarketScan Commercial database included 9,320,237 in year 2011, 9,599,891 in year 2012 and 8,348,898 in year 2013. The number of women (aged 15– 44 years) identified with any contraceptive usage in 2011 was 2,447,316 (mean age: 27.6 years), in 2012 was 2,515,296 (mean age: 27.4 years) and in 2013 was 2,243,253 (mean age: 27.4 years). Demographics of the study populations are presented in Table 1. Of all women with claims in the database, the proportions with any contraceptive usage in years 2011, 2012 and 2013 were 26.3%, 26.2% and 26.9%, respectively (Fig. 1). Among women with any contraceptive usage, those who were aged 20–24 years were of the greatest proportions in years 2011, 2012 and 2013, followed by women aged 25–29 years. All U.S. geographic regions were well represented in the study populations from each year, with the highest proportions of women living in the South and North Central regions of the U.S. OCs were the predominant contraceptive type used with ~ 22% of all women using contraceptives in the claims database receiving them in all three study years (Fig. 1).
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Table 1 Demographics of overall study populations with any contraceptive usage in years 2011, 2012 and 2013 Study Year
Total number of women 15–44 years of age Total number of women 15–44 years of age with contraceptive use Age [years (mean), stdev] Age group (years) 15–19 20–24 25–29 30–34 35–39 40–44 Region Northeast North Central South West Health plan type HMO POS PPO Others
2011
2012
2013
9,320,237 2,447,316 (26.3%) 27.6 (7.7)
9,599,891 2,515,296 (26.2%) 27.4 (7.6)
8,348,898 2,243,253 (26.9%) 27.4 (7.6)
17% 23% 22% 17% 12% 9%
17% 24% 21% 17% 11% 9%
17% 25% 21% 17% 12% 9%
17% 24% 39% 17%
18% 25% 37% 18%
21% 22% 34% 20%
14% 7% 61% 11%
13% 7% 64% 10%
14% 8% 56% 16%
stdev: standard deviation; HMO: Health Maintenance Organization; POS: point-of-service; PPO: preferred provider organization.
Among all women using contraceptives in the claims database, the proportions receiving injectables, implants and IUDs increased from years 2011 to 2013 (Fig. 1). The proportions of women in the claims database who used PC methods were low in comparison to other contraceptive types (0.5% in all study years) (Fig. 1). 3.2. Copays and out-of-pocket costs of contraceptives in study years From 2011 to 2013, mean copays per contraceptive claim decreased from $15 to $4 (73.3%) for any contraceptives, from $8 to $3 (62.5%) for PCs, from $15 to $4 (73.3%) for non-PCs, from $14 to $4 (71.4%) for OCs, from $8 to $3 (62.5%) for injectables, from $29 to $11 for patches (62.1%), from $26 to $9 (65.4%) for rings, from $12 to $2 (83.3%) for implants and from $7 to $2 (71.4%) for IUDs. From 2011 to 2013, mean total annual copays per woman decreased from $67 to $19 (71.6%) for any contraceptives, from $12 to $5 (58.3%) for PCs, from $68 to $20 (70.6%) for non-PCs, from $66 to $19 (71.2%) for OCs, from $20 to $7 (65.0%) for injectables, from $136 to $50 (63.2%) for patches, from $123 to $42 (65.9%) for rings, from $21 to $4 (81.0%) for implants and from $8 to $2 (75.0%) for IUDs. From 2011 to 2013, mean out-of-pocket expenses per contraceptive claim decreased 66.7% for any contraceptives, 73.4% for PCs, 70.0% for non-PCs, 66.7% for OCs, 64.7% for injectables, 56.8% for patches, 61.8% for rings, 68.0% for implants and 76.3% for IUDs (Fig. 2a). From 2011 to 2013, mean total annual out-of-pocket expenses decreased in a similar manner (Fig. 2b). The proportions of commercially insured women with $0 out-of-pocket expenses for any
contraceptives increased from 10.1% in 2011 to 69.6% in 2013 (Fig. 3).
4. Discussion Using the MarketScan commercial claims database with claims from more than 100 different health insurance companies, nearly 2.5 million women who were using contraceptives in each study year of 2011, 2012 and 2013 were identified. Among these women, there was a substantial decrease in out-of-pocket costs for FDA-approved contraceptives 1 year preimplementation and postimplementation of the ACA contraceptive and family planning mandate. Among the women with claims in the MarketScan database, mean total annual out-of-pocket expenses decreased from $298 to $82 (~ 72%) for PCs and from $94 to $30 (~ 68%) for non-PCs. These findings generally are consistent with the findings of the study by Sonfield et al., which based on a survey of patient-reported contraceptive use and outof-pocket payments of 892 commercially insured women ages 18–39 years found that, between the fall of 2012 and spring of 2014, the proportion of women who did not pay any out-of-pocket costs for OCs increased from 15% to 67%, with similar results found for women using injectables, rings and IUDs [8]. The study of Becker et al., which evaluated out-of-pocket expenses for contraceptives among 790,895 women from one large national commercial insurer, reported a similar decline between the first 6 months of 2012 and the first 6 months of 2013 in out-of-pocket expenses for IUDs (68%), a much smaller decline in the out-of-pocket costs for OCs (38%) and little declines for the ring and patch
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contraception methods [6]. The shorter time frame of the Becker et al. study after the implementation of the ACA contraceptive provision may account for the observed lesser impact of it on the changes in out-of-pocket costs for certain contraceptives [6]. The differences across studies may also be due to differences in policies of the insurers represented in the database sources, which highlights the importance of evaluating the changes in out-of-pocket costs for contraceptives among women identified from multiple data sources to define the most accurate and generalizable estimates of changes in contraceptive costs. Based on our database claims analysis, the proportions of women using contraceptives who did not incur any outof-pocket expenses for IUDs increased from 54.8% in 2011 to 91.6% in 2013. These data complement the findings from the physician query of hormonal IUD coverage of insurance plans of 417,221 women, which found that 58% of women IUD users incurred out-of-pocket costs in January 2012 compared to only 13% of women in March 2014 [7]. An IMS study reported a somewhat smaller increase in the proportion of women without any copay for OCs, from 20% in 2012 to 50% in 2013 [4], which may be due to the IMS study inclusion of women with commercial, Medicare and Medicaid insurance coverage [4]. The predominant contraceptive type used among women in years 2011, 2012 and 2013 were OCs (22%) and is higher than that observed in the National Survey of Family Growth (NSFG) of women aged 15–44 years during years 2006– 2008, which reported that 17% had current use of OCs [9]. Among all women with contraceptive usage in the claims database, the proportions receiving injectables (1.3% to 1.6%), implants (0.2% to 0.4%) and IUDs (1.2% to 1.6%) increased during years 2011–2013. Thus, it appears that use of long-acting reversible contraception (LARC) methods, including implants and IUDs, may have increased from 2011 to 2013 among the commercially insured study populations in our study; however, further longer-term studies are needed to confirm these findings. Previous findings from the NSFG were that among women aged 15–44 years LARC use
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increased from 3.7% in 2007 to 8.5% in 2009 [10]. Among women with claims in the MarketScan database, use of LARC methods is lower than that previously observed in the NSFG and our data suggest that there is not a large upward trend in LARC use in the U.S., at least among those in younger age groups (mean age of our study population: 27 years). Among women with claims in the MarketScan database, the percentage of women who used permanent contraception methods was low (0.5% in all study years). These data contrast with that of the NSFG, which reported that 27% of all women 15–44 years of age used sterilization; however, as mentioned our study, population had a mean age of 27 years and it also substantially differed in age distribution than that of the NSFG 2006–2008 study population [9]. The greater proportions of women using female sterilization found in the NSFG may also be related to inclusion of women in the study population with other insurance types (i.e. Medicaid). Approximately half of the pregnancies in the U.S. are unintended, with direct costs alone estimated at $4.5 billion annually [11,12]. The contraceptive provisions of the ACA have the potential to reduce this cost burden and additionally eliminate some of the disparities in reproductive healthcare by allowing women to choose more effective contraceptive methods without incurring out-of-pocket costs [13]. A recent study by the Kaiser Family Foundation in which information was collected from 20 different insurance carriers in 5 states reported that although most carriers are complying with the ACA provision of access to all FDA-approved contraceptives without cost sharing, some plans still impose limitations [e.g., some plans do not cover different contraceptive methods with similar hormonal formulations (i.e., OCs, patches and rings)] [14]. As of 2013, among the commercially insured women within our study population, approximately 30% still have cost sharing for contraceptives. 4.1. Limitations and strengths The MarketScan database consists of claims submitted by healthcare providers to insurance companies for reimbursement on behalf of individuals employed by various companies,
Fig. 1. Proportions of women with claims for any contraceptives and for different contraceptive types of study populations in years 2011, 2012 and 2013. Non-PCs: non-PCs with breakdown of OCs, injectables, patch, rings, implants and IUDs.
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Fig. 2. Mean out-of-pocket expenses per contraceptive claim (a) and mean total annual out-of-pocket expenses per woman (b) for contraceptives among the study populations in years 2011, 2012 and 2013. Non-PCs: non-PCs with breakdown of OCs, injectables, patch, rings, implants and IUDs.
and such claims are subject to possible coding errors. Additionally, some contraceptives may be used for reasons other than contraception. While the MarketScan database is based on a large sample, the sample is not random and may fail to generalize well to other populations, especially women covered by other payer types, such as Medicaid or women who are not covered by employer provided health insurance. The study populations were composed of reproductive-aged women with claims in the MarketScan commercial database, which encompasses more than 60 million employees, spouses
and dependents located in all 10 U.S. census region and that, thus, is generally representative of U.S. reproductive-aged female population with commercial insurance.
5. Conclusions The shift toward preventive healthcare is a federally recognized mechanism to improve the access, quality and outcomes of healthcare in this nation and implementation of
Fig. 3. Proportions of commercially insured women with $0 total annual out-of-pocket expenses for contraceptives among the study populations in years 2011, 2012 and 2013. Non-PCs: non-PCs with breakdown of OCs, injectables, patch, rings, implants and IUDs.
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the ACA, in regard to women's reproductive healthcare, has greatly impacted the costs of FDA-approved contraceptives. The results of this large database claims analysis show that, for many commercially insured women in the U.S., out-of-pocket costs of FDA-approved contraceptives have decreased nearly 70% since the implementation of the ACA. This improvement in women's reproductive healthcare may lead to better family planning and lower the risk for unintended pregnancy in the U.S. Other studies in the near future will need to be undertaken to examine whether removing the cost barriers of more effective contraceptives positively influences their use and improves clinical outcomes. Acknowledgements Editorial assistance was provided by Melissa Lingohr-Smith, PhD, of Novosys Health. References
[1] U.S. Department of Health and Human Services. Women's Preventive Services Guidelines. Washington, D.C. Available from: http://www. hrsa.gov/womensguidelines/ [Accessed March 30, 2015]. [2] Federal Register. Rules and Regulations. 54.9815-2713 Coverage of preventive health services; 2013. [Vol 78, No. 127, Available from: http://www.gpo.gov/fdsys/pkg/FR-2013-07-02/html/2013-15866.htm Accessed March 30, 2015]. [3] Institute of Medicine. Clinical Preventive Services for Women: Closing the Gaps. 2011 Available from: http://www.iom.edu/Reports/2011/Clinical-PreventiveServices-for-Women-Closing-the-Gaps.aspx [Accessed March 30, 2015]. [4] IMS Institute for Healthcare Informatics. Medicine Use and Shifting Costs of Healthcare. Report by the IMS Institute for Healthcare Informatics; 2014. [Parsippany, NJ]. Available from:
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http://www.plannedparenthoodadvocate.org/2014/IIHI_ US_Use_of_Meds_for_2013.pdf. [Accessed March 30, 2015]. [5] Burke A, Simmons A, Office of The Assistant Secretary for Planning and Evaluation. Issue Brief. Increased Coverage of Preventive Services with Zero Cost Sharing Under the Affordable Care Act. Washington D.C.: U.S. Department of Health & Human Services; 2014. [Available from: http://aspe.hhs.gov/health/reports/2014/PreventiveServices/ ib_PreventiveServices.pdf Accessed March 30, 2015]. [6] Becker NV, Polsky D. Women saw large decrease in out-of-pocket spending for contraceptives after ACA mandate removed cost sharing. Health Aff 2015;34:1204–11. [7] Bearak JM, Finer LB, Jerman J, Kavanaugh ML. Changes in out-ofpocket costs for hormonal IUDs after implementation of the Affordable Care Act: an analysis of insurance benefit inquiries. Contraception 2016;93:139–44. [8] Sonfield A, Tapales A, Jones RK, Finer LB. Impact of the federal contraceptive coverage guarantee on out-of-pocket payments for contraceptives: 2014 update. Contraception 2015;91:44–8. [9] Mosher WD, Jones J. Use of contraception in the United States: 1982– 2008. National Center for Health Statistics. Vital Health Stat 23 2010:1–4. [10] Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007–2009. Fertil Steril 2012;98:893–7. [11] Finer LB, Zolna M. Unintended pregnancy in the United States: incidence and disparities, 2006. Contraception 2011;85:478–85. [12] Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception 2012;87:154–61. [13] Mehta P. Addressing reproductive health disparities as a healthcare management priority: pursuing equity in the era of the Affordable Care Act. Curr Opin Obstet Gynecol 2014;26:531–8. [14] Kaiser Family Foundation, The Lewin Group. Coverage of contraceptive services: a review of health insurance plans in five states. Menlo Park, CA. 2015 Available from: http://files.kff.org/attachment/reportcoverage-of-contraceptive-services-a-review-of-health-insuranceplans-in-five-states [Accessed March 30, 2015].
Original research article
Are women benefiting from the Affordable Care Act? A real-world evaluation of the impact of the Affordable Care Act on out-of-pocket costs for contraceptives☆,☆☆ A. Law a,⁎, L. Wen a , J. Lin b , M. Tangirala a , J.S. Schwartz c , E. Zampaglione a a
Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA b Novosys Health, Green Brook, NJ, USA c Wharton School of Business, University of Pennsylvania, School of Medicine, Philadelphia, PA, USA Received 17 July 2015; revised 13 January 2016; accepted 13 January 2016
Abstract Objectives: The Affordable Care Act (ACA) mandated that, starting between August 1, 2012 and July 31, 2013, health plans cover most Food and Drug Administration (FDA)-approved contraceptive methods for women without cost sharing. This study examined the impact of the ACA on out-of-pocket expenses for contraceptives. Study design: Women (ages 15–44 years) with claims for any contraceptives in years 2011, 2012 and 2013 were identified from the MarketScan Commercial database. The proportions of women using contraceptives [including permanent contraceptives (PCs) and non-PCs: oral contraceptives (OCs), injectables, patches, rings, implants and intrauterine devices (IUDs)] in study years were determined, as well as changes in out-of-pocket expenses for contraceptives during 2011–2013. Demographics, including age, U.S. geographic region of residence and health plan type, were also evaluated. Results: The number of women identified with any contraceptive usage in 2011 was 2,447,316 (mean age: 27.6 years), in 2012 was 2,515,296 (mean age: 27.4 years) and in 2013 was 2,243,253 (mean age: 27.4 years). In 2011, 2012 and 2013, the proportions of women with any contraceptive usage were 26.3%, 26.2% and 26.9%, respectively. Over the three study years, mean total out-of-pocket expenses for PCs and non-PCs decreased from $298 to $82 and from $94 to $30, respectively. For non-PCs, mean total out-of-pocket expenses for OCs and IUDs decreased from $86 to $26 and from $83 to $20. Conclusions: Implementation of the ACA has saved women a substantial amount in out-of-pocket expenses for contraceptives. Implications: Mean total out-of-pocket expenses for FDA-approved contraceptives decreased approximately 70% from 2011 to 2013. Implementation of the ACA has saved women a substantial amount in out-of-pocket expenses for contraceptives. Longer-term studies, including clinical outcomes, are warranted. © 2016 Elsevier Inc. All rights reserved. Keywords: Contraceptives; Out-of-pocket expenses; Cost-savings; Affordable Care Act
1. Introduction The Affordable Care Act (ACA) health insurance reform legislation was signed into law on March 23, 2010 in the U.S. [1]. Beginning on August 1, 2012, the ACA mandated ☆
Funding: This research was supported by Bayer HealthCare. Conflict of Interest: A. Law, L. Wen, M. Tangirala and E. Zampaglione are employees of Bayer HealthCare Pharmaceuticals Inc. J. Lin is an employee of Novosys Health and served as a paid consultant to Bayer HealthCare Pharmaceuticals Inc. for the development of this study and manuscript. J. S. Schwartz served as a paid consultant to Bayer HealthCare Pharmaceuticals Inc. for the development of this study and manuscript. ⁎ Corresponding author. Tel.: +1-862-404-5855. E-mail address: [email protected] (A. Law).
☆☆
http://dx.doi.org/10.1016/j.contraception.2016.01.008 0010-7824/© 2016 Elsevier Inc. All rights reserved.
that health plans must cover most Food and Drug Administration (FDA)-approved contraceptive methods and sterilization procedures [oral contraceptives (OCs), injectables, contraceptive rings, contraceptive patches, contraceptive implants, intrauterine devices (IUDs), diaphragms, cervical caps and permanent contraceptive (PC) methods, like tubal ligation] and patient education and counseling for all women with reproductive capacity without cost sharing (i.e., copayment, coinsurance or deductible) [1,2]. These regulations were included in the recommendations of the Institute of Medicine, which concluded that access to contraception is medically necessary “to ensure women's health and well-being” [3]. Although phased in during 2012, the ACA provision of contraceptive coverage
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did not affect health plans widely until January 2013 when most initiated their new plan year. The IMS Institute for Healthcare Informatics conducted a study in years 2012 and 2013 that found the number of women who filled prescriptions for OCs with no copay increased from 1.2 million in 2012 to 5.1 million in 2013 [4,5]. The IMS study did not focus on changes in contraceptive use and only reported on overall OC use and costs [4]. Three other studies have evaluated changes in out-of-pocket costs for contraceptives between periods of time before and after implementation of the ACA contraceptive provision among women in the U.S. [6–8]. Based on a 10% sample of claims in the Optum claims database, a database of one national insurer, Becker et al. reported declines in out-of-pocket costs for contraceptives among 790,895 women in the first 6 months of 2013 from the first 6 months in 2012 [6]. Bereak et al. reported a decline in out-of-pocket costs specifically for IUDs among 417,221 women in the U.S. between January 2012 and March 2014 [7]. Sonfield et al. reported significant declines in out-of-pocket costs for contraceptives based on a patient survey of 892 women insured commercially between the fall of 2012 and spring of 2014 [8]. Although some studies have already evaluated the impact of the ACA contraceptive provision on out-of-pocket costs for contraceptives among women in the U.S., we sought to provide a more comprehensive analysis of the cost-savings for most FDA-approved contraceptives among women insured by multiple commercial health plan types by identifying women with contraceptive usage in years 2011, 2012 and 2013 from a large commercial claims database.
393
tubal ligations, interval tubal ligations, hysteroscopic sterilizations and minilapartomies) and any non-PCs (OCs, injectables, patches, rings, implants and IUDs) in years 2011, 2012 and 2013, were determined using the medial service claims records or prescription drug claims records in the database. A woman receiving multiple prescriptions of the same contraceptive type was counted only once in the category of “any contraceptive usage”, and thus, no double counting occurred. If a woman received multiple types of contraceptives (i.e., switching from OC to ring) in the same year, the woman was counted once for each contraceptive type. Costs of contraceptives for any contraceptives and by each contraceptive type, including total payment (both health plan and patient payment), patient copay and out-of-pocket payment (sum of copay, coinsurance and deductible), were determined during years 2011–2013. Such above-described cost data were measured on two different levels: cost per contraceptive healthcare claim and total annual cost per woman with contraceptives. Demographics, including age, U.S. geographic region of residence and health plan type, were also evaluated. 2.3. Statistical analyses Descriptive statistics were used to measure and describe contraceptive use, costs for contraceptives and demographics information for study populations in years 2011, 2012 and 2013. All statistical analyses were carried out using SAS 9.3.
3. Results 2. Materials and methods 2.1. Study population inclusion criteria Women (15–44 years of age) with any contraceptive usage and pharmacy and medical coverage in years 2011, 2012 and 2013 were identified from the Truven Health MarketScan® Commercial claims database. This claims database encompasses N 60 million unique deidentified patients that include active employees, early retirees, COBRA continuers and their dependents insured by employer-sponsored plans located in all 10 U.S. census regions. The database consists of healthcare claims data from N 100 different health insurance companies and self-insured employers. In compliance with the Health Insurance Portability and Accountability Act of 1996, it consists of fully deidentified data sets. Women were placed into three separate cross-sectional study populations for years 2011, 2012 and 2013. As this was a cross-sectional study with measurements evaluated in each year, the populations in the 2011, 2012 and 2013 cohorts may overlap with each other. 2.2. Measurements The number and proportions of women with one or more claims for any contraceptive, including PCs (postpartum
3.1. Study populations and proportions with contraceptive usage The total populations of women ages 15–44 years with claims in the MarketScan Commercial database included 9,320,237 in year 2011, 9,599,891 in year 2012 and 8,348,898 in year 2013. The number of women (aged 15– 44 years) identified with any contraceptive usage in 2011 was 2,447,316 (mean age: 27.6 years), in 2012 was 2,515,296 (mean age: 27.4 years) and in 2013 was 2,243,253 (mean age: 27.4 years). Demographics of the study populations are presented in Table 1. Of all women with claims in the database, the proportions with any contraceptive usage in years 2011, 2012 and 2013 were 26.3%, 26.2% and 26.9%, respectively (Fig. 1). Among women with any contraceptive usage, those who were aged 20–24 years were of the greatest proportions in years 2011, 2012 and 2013, followed by women aged 25–29 years. All U.S. geographic regions were well represented in the study populations from each year, with the highest proportions of women living in the South and North Central regions of the U.S. OCs were the predominant contraceptive type used with ~ 22% of all women using contraceptives in the claims database receiving them in all three study years (Fig. 1).
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Table 1 Demographics of overall study populations with any contraceptive usage in years 2011, 2012 and 2013 Study Year
Total number of women 15–44 years of age Total number of women 15–44 years of age with contraceptive use Age [years (mean), stdev] Age group (years) 15–19 20–24 25–29 30–34 35–39 40–44 Region Northeast North Central South West Health plan type HMO POS PPO Others
2011
2012
2013
9,320,237 2,447,316 (26.3%) 27.6 (7.7)
9,599,891 2,515,296 (26.2%) 27.4 (7.6)
8,348,898 2,243,253 (26.9%) 27.4 (7.6)
17% 23% 22% 17% 12% 9%
17% 24% 21% 17% 11% 9%
17% 25% 21% 17% 12% 9%
17% 24% 39% 17%
18% 25% 37% 18%
21% 22% 34% 20%
14% 7% 61% 11%
13% 7% 64% 10%
14% 8% 56% 16%
stdev: standard deviation; HMO: Health Maintenance Organization; POS: point-of-service; PPO: preferred provider organization.
Among all women using contraceptives in the claims database, the proportions receiving injectables, implants and IUDs increased from years 2011 to 2013 (Fig. 1). The proportions of women in the claims database who used PC methods were low in comparison to other contraceptive types (0.5% in all study years) (Fig. 1). 3.2. Copays and out-of-pocket costs of contraceptives in study years From 2011 to 2013, mean copays per contraceptive claim decreased from $15 to $4 (73.3%) for any contraceptives, from $8 to $3 (62.5%) for PCs, from $15 to $4 (73.3%) for non-PCs, from $14 to $4 (71.4%) for OCs, from $8 to $3 (62.5%) for injectables, from $29 to $11 for patches (62.1%), from $26 to $9 (65.4%) for rings, from $12 to $2 (83.3%) for implants and from $7 to $2 (71.4%) for IUDs. From 2011 to 2013, mean total annual copays per woman decreased from $67 to $19 (71.6%) for any contraceptives, from $12 to $5 (58.3%) for PCs, from $68 to $20 (70.6%) for non-PCs, from $66 to $19 (71.2%) for OCs, from $20 to $7 (65.0%) for injectables, from $136 to $50 (63.2%) for patches, from $123 to $42 (65.9%) for rings, from $21 to $4 (81.0%) for implants and from $8 to $2 (75.0%) for IUDs. From 2011 to 2013, mean out-of-pocket expenses per contraceptive claim decreased 66.7% for any contraceptives, 73.4% for PCs, 70.0% for non-PCs, 66.7% for OCs, 64.7% for injectables, 56.8% for patches, 61.8% for rings, 68.0% for implants and 76.3% for IUDs (Fig. 2a). From 2011 to 2013, mean total annual out-of-pocket expenses decreased in a similar manner (Fig. 2b). The proportions of commercially insured women with $0 out-of-pocket expenses for any
contraceptives increased from 10.1% in 2011 to 69.6% in 2013 (Fig. 3).
4. Discussion Using the MarketScan commercial claims database with claims from more than 100 different health insurance companies, nearly 2.5 million women who were using contraceptives in each study year of 2011, 2012 and 2013 were identified. Among these women, there was a substantial decrease in out-of-pocket costs for FDA-approved contraceptives 1 year preimplementation and postimplementation of the ACA contraceptive and family planning mandate. Among the women with claims in the MarketScan database, mean total annual out-of-pocket expenses decreased from $298 to $82 (~ 72%) for PCs and from $94 to $30 (~ 68%) for non-PCs. These findings generally are consistent with the findings of the study by Sonfield et al., which based on a survey of patient-reported contraceptive use and outof-pocket payments of 892 commercially insured women ages 18–39 years found that, between the fall of 2012 and spring of 2014, the proportion of women who did not pay any out-of-pocket costs for OCs increased from 15% to 67%, with similar results found for women using injectables, rings and IUDs [8]. The study of Becker et al., which evaluated out-of-pocket expenses for contraceptives among 790,895 women from one large national commercial insurer, reported a similar decline between the first 6 months of 2012 and the first 6 months of 2013 in out-of-pocket expenses for IUDs (68%), a much smaller decline in the out-of-pocket costs for OCs (38%) and little declines for the ring and patch
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contraception methods [6]. The shorter time frame of the Becker et al. study after the implementation of the ACA contraceptive provision may account for the observed lesser impact of it on the changes in out-of-pocket costs for certain contraceptives [6]. The differences across studies may also be due to differences in policies of the insurers represented in the database sources, which highlights the importance of evaluating the changes in out-of-pocket costs for contraceptives among women identified from multiple data sources to define the most accurate and generalizable estimates of changes in contraceptive costs. Based on our database claims analysis, the proportions of women using contraceptives who did not incur any outof-pocket expenses for IUDs increased from 54.8% in 2011 to 91.6% in 2013. These data complement the findings from the physician query of hormonal IUD coverage of insurance plans of 417,221 women, which found that 58% of women IUD users incurred out-of-pocket costs in January 2012 compared to only 13% of women in March 2014 [7]. An IMS study reported a somewhat smaller increase in the proportion of women without any copay for OCs, from 20% in 2012 to 50% in 2013 [4], which may be due to the IMS study inclusion of women with commercial, Medicare and Medicaid insurance coverage [4]. The predominant contraceptive type used among women in years 2011, 2012 and 2013 were OCs (22%) and is higher than that observed in the National Survey of Family Growth (NSFG) of women aged 15–44 years during years 2006– 2008, which reported that 17% had current use of OCs [9]. Among all women with contraceptive usage in the claims database, the proportions receiving injectables (1.3% to 1.6%), implants (0.2% to 0.4%) and IUDs (1.2% to 1.6%) increased during years 2011–2013. Thus, it appears that use of long-acting reversible contraception (LARC) methods, including implants and IUDs, may have increased from 2011 to 2013 among the commercially insured study populations in our study; however, further longer-term studies are needed to confirm these findings. Previous findings from the NSFG were that among women aged 15–44 years LARC use
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increased from 3.7% in 2007 to 8.5% in 2009 [10]. Among women with claims in the MarketScan database, use of LARC methods is lower than that previously observed in the NSFG and our data suggest that there is not a large upward trend in LARC use in the U.S., at least among those in younger age groups (mean age of our study population: 27 years). Among women with claims in the MarketScan database, the percentage of women who used permanent contraception methods was low (0.5% in all study years). These data contrast with that of the NSFG, which reported that 27% of all women 15–44 years of age used sterilization; however, as mentioned our study, population had a mean age of 27 years and it also substantially differed in age distribution than that of the NSFG 2006–2008 study population [9]. The greater proportions of women using female sterilization found in the NSFG may also be related to inclusion of women in the study population with other insurance types (i.e. Medicaid). Approximately half of the pregnancies in the U.S. are unintended, with direct costs alone estimated at $4.5 billion annually [11,12]. The contraceptive provisions of the ACA have the potential to reduce this cost burden and additionally eliminate some of the disparities in reproductive healthcare by allowing women to choose more effective contraceptive methods without incurring out-of-pocket costs [13]. A recent study by the Kaiser Family Foundation in which information was collected from 20 different insurance carriers in 5 states reported that although most carriers are complying with the ACA provision of access to all FDA-approved contraceptives without cost sharing, some plans still impose limitations [e.g., some plans do not cover different contraceptive methods with similar hormonal formulations (i.e., OCs, patches and rings)] [14]. As of 2013, among the commercially insured women within our study population, approximately 30% still have cost sharing for contraceptives. 4.1. Limitations and strengths The MarketScan database consists of claims submitted by healthcare providers to insurance companies for reimbursement on behalf of individuals employed by various companies,
Fig. 1. Proportions of women with claims for any contraceptives and for different contraceptive types of study populations in years 2011, 2012 and 2013. Non-PCs: non-PCs with breakdown of OCs, injectables, patch, rings, implants and IUDs.
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Fig. 2. Mean out-of-pocket expenses per contraceptive claim (a) and mean total annual out-of-pocket expenses per woman (b) for contraceptives among the study populations in years 2011, 2012 and 2013. Non-PCs: non-PCs with breakdown of OCs, injectables, patch, rings, implants and IUDs.
and such claims are subject to possible coding errors. Additionally, some contraceptives may be used for reasons other than contraception. While the MarketScan database is based on a large sample, the sample is not random and may fail to generalize well to other populations, especially women covered by other payer types, such as Medicaid or women who are not covered by employer provided health insurance. The study populations were composed of reproductive-aged women with claims in the MarketScan commercial database, which encompasses more than 60 million employees, spouses
and dependents located in all 10 U.S. census region and that, thus, is generally representative of U.S. reproductive-aged female population with commercial insurance.
5. Conclusions The shift toward preventive healthcare is a federally recognized mechanism to improve the access, quality and outcomes of healthcare in this nation and implementation of
Fig. 3. Proportions of commercially insured women with $0 total annual out-of-pocket expenses for contraceptives among the study populations in years 2011, 2012 and 2013. Non-PCs: non-PCs with breakdown of OCs, injectables, patch, rings, implants and IUDs.
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the ACA, in regard to women's reproductive healthcare, has greatly impacted the costs of FDA-approved contraceptives. The results of this large database claims analysis show that, for many commercially insured women in the U.S., out-of-pocket costs of FDA-approved contraceptives have decreased nearly 70% since the implementation of the ACA. This improvement in women's reproductive healthcare may lead to better family planning and lower the risk for unintended pregnancy in the U.S. Other studies in the near future will need to be undertaken to examine whether removing the cost barriers of more effective contraceptives positively influences their use and improves clinical outcomes. Acknowledgements Editorial assistance was provided by Melissa Lingohr-Smith, PhD, of Novosys Health. References
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