Can Medicaid Reimbursement Help Give Female Condoms a Second Chance in the United States?

Abstract

The female condom is the only other barrier contraception method besides the male condom, and it is the only “woman-initiated” device for prevention of sexually transmitted infections. Although studies demonstrate high acceptability and effectiveness for this device, overall use in the United States remains low.

The female condom has been available through Medicaid in many states since 1994. We provide the first published summary of data on Medicaid reimbursement for the female condom. Our findings demonstrate low rates of claims for female condoms but high rates of reimbursement.

In light of the 2009 approval of a new, cheaper female condom and the recent passage of comprehensive health care reform, we call for research examining how health care providers can best promote consumer use of Medicaid reimbursement to obtain this important infection-prevention device.

The female condom is the only other barrier contraception method other than the male condom, and it is the only “woman-initiated” device for prevention of sexually transmitted infections (STIs), including HIV. Male and female condoms are currently the only technologies that may provide protection against both pregnancy and STIs. Studies have demonstrated that the female condom's effectiveness in preventing pregnancy¹ and STIs² is comparable to that of the male condom. Studies have also shown that STI prevention counseling that addresses both male and female condoms results in more condom use than does counseling that addresses male condoms alone.³ Although the device is used predominantly by women, it is also increasingly used by men to have anal sex with men, despite lack of Food and Drug Administration (FDA) approval for such use.⁴ Acceptability and effectiveness studies consistently demonstrate that women at risk of STIs do use the device when it is available but that levels of use in the United States remain low.⁵ Several reports suggest there is a lack of leadership-level commitment to ensure improved distribution of the device in the public health care system.^5–7

The female condom has been a reimbursable over-the-counter device for Medicaid recipients in many US states for more than a decade. Medicaid is the largest provider of reproductive health care among low-income people in the United States, and low-income women represent a disproportionately large proportion of those newly diagnosed with HIV infections.^8–10 A significant proportion of HIV-infected Medicaid beneficiaries are women, and more than 60% of women living with HIV in the United States receive Medicaid.^11–13 Because the evolving HIV epidemic in the United States increasingly affects women, minorities, persons infected through heterosexual contact, and the poor,¹⁰ access to the female condom through Medicaid may represent a critical STI prevention policy for poor women in the United States.

Given the low profile of the female condom in the commercial sphere, we sought to document reimbursement for the female condom through Medicaid. We asked Medicaid representatives in each state about requests for female condoms and reimbursement for female condoms in response to those requests. Our goals were to provide a snapshot of female condom utilization through Medicaid and to inform a renewed dialogue about the device and its role in HIV prevention.

METHODS

In 2002, Female Health Company—the manufacturer of the only FDA-approved female condom—published on its Web site a list of contacts at state Medicaid programs in 40 states that were said to offer Medicaid reimbursement for the female condom. We began data collection by contacting those individuals. For the 10 states not on the manufacturer's 2002 list, we called the main number of each state's Medicaid office. Thus, the sample included all 50 states.

We sought to collect the following data: number of claims for reimbursement, number of units for which reimbursement was issued, total amount billed to the state Medicaid program, and total amount paid out by the program. We requested data for the period from 1997 through 2007. For consistency, we followed a script when making all data requests. At most state Medicaid programs, we had to make a series of contacts before we reached a staff member who could access data on reimbursement for female condoms. When a given contact was unable to provide the data we needed, we asked that contact to recommend the next person to whom we should direct our inquiry. Contact attempts continued until we obtained data, were told that the data could not or would not be provided, were told that the data would require payment, or were told that the state did not reimburse for the female condom. Data were collected from 2007 through 2009.

RESULTS

Figure 1 illustrates each state's reimbursement status and whether data were provided to researchers. Thirty-two states (64%) provided reimbursement; 18 states (36%) did not. Of those providing reimbursement, 29 (91%) provided data. A disproportionate number of nonreimbursing states are in the southeast.

FIGURE 1.

State Medicaid program reimbursement for the female condom and provision of reimbursement data to researchers: United States, 2007–2009.

Table 1 shows data from the 29 states that provided it, illustrating vast differences in reimbursement, claims, and reporting across those states. By far the highest numbers of female condoms were reimbursed in California, Illinois, Massachusetts, Michigan, New York, Texas, and Washington. Although some states provided thorough and comprehensive data across the 10-year period, others (e.g., Alaska) provided data for only one or two years. Some states (e.g., Massachusetts, Maryland) provided information about the number of female condom units distributed in response to claims made through Medicaid, but not about the number of claims submitted. Although some states had thousands of claims, many had few or none at all. Some states reimbursed hundreds of thousands of dollars per year, whereas others reimbursed less than $10 annually. Only three states—Iowa, Michigan, and Nevada—demonstrated steady increases in female condom reimbursement. The trend in most states was toward decreasing numbers of claims and units. Some of the states that did not reimburse for the device through Medicaid (e.g., Kansas) reported that they received claims for reimbursement.

TABLE 1.

Claims and Reimbursements for Female Condoms Among the 32 State Medicaid Programs That Reimbursed for Female Condoms, by Year: 1997–2007

	No. of Claims Submitted	No. of Female Condom Units Distributed	Total Amount Billed to Medicaid, $	Total Amount Paid by Medicaid, $
Alaska: 2005	1	1	…	2.55
Arizona
2006	6	6	…	8.19
2005	7	7	…	14.08
2004	20	18	…	16.90
Arkansas: 1997–2007	0	0	0.00	0.00
Californiaa
2003–2007	…	…	…	…
2002	586	20 161	…	53 554.38
2001	3 979	149 846	…	386 117.49
Florida
2007	1	3	…	11.69
2006	1	3	…	11.69
2005	0	0	…	…
2004	1	6	…	16.91
2003	5	30	…	84.55
Hawaii:b 1997–2007	…	…	…	…
Illinois
2007	990	928	…	50 433.47
2006	1 022	954	…	43 219.50
2005	947	913	…	31 730.86
2004	795	763	…	26 832.98
2003	1 517	1 446	…	36 889.43
2002	2 461	2 346	…	62 335.58
2001	1 940	1 873	…	75 006.29
2000	1 896	1 838	…	106 259.55
1999	2 266	2 180	…	126 826.61
1998	2 088	2 005	…	117 506.20
1997	2 589	2 487	…	116 306.54
Indiana
2005	2	2	…	44.00
2004	2	1	…	3.00
2003	2	1	…	3.00
Iowa
2007	98	945	…	283.50
2006	110	940	…	275.57
2005	54	592	…	166.65
2004	46	620	…	173.60
2003	9	132	…	36.78
Louisiana
2007	0	0	0.00	0.00
2006	1	1	…	3.61
2005	0	0	0.00	0.00
2004	1	12	…	8.97
1997–2003	0	0	0.00	0.00
Maryland
2007		11 140	…	508 685.50
1996–2006		29 371	…	1 294 874.59
Massachusetts
2007	…	16	…	132.32
2006	…	10	…	115.29
2005	…	39	…	235.79
2004	…	53	…	481.18
2003	…	93	…	1 434.58
2002	…	67	…	732.47
2001	…	107	…	1 022.00
2000	…	125	…	1 010.27
1999	…	141	…	1 078.88
1998	…	73	…	867.59
Michigan
2007	224	2 798	…	1 986.58
2006	180	2 438	…	1 145.86
2005	147	1 607	…	755.29
2004	141	1 384	…	622.80
2003	102	908	…	871.68
Minnesota
2007	587	7 097	…	828.47
2006	1 078	13 169	…	905.55
2005	1 165	15 309	…	610.27
2004	982	13 615	…	616.80
Montana
2007	2	8	12.00	12.00
2006	1	1	1.50	1.50
2005	0	0	0.00	0.00
2004	2	7	21.00	10.50
2003	1	1	9.75	9.75
Nebraska
2006	1	12	8.39	8.39
2005	1	24	12.78	12.78
2004	2	24	8.40	0.00
Nevada
2006	12	136	…	51.68
2005	1	12	…	4.56
2004	1	0	0.00	0.00
New Hampshire
2007	12	21	73.50	40.00
2006	88	133	398.94	220.00
2005	90	140	555.10	320.00
2004	64	97	460.08	150.00
2003	6	403	147.94	0.00
New York
2007	1 490	44 206	162 322.99	133 639.63
2006	1 157	25 113	88 716.99	71 350.50
2005	1 476	30 302	84 930.37	63 276.94
2004	4 316	102 067	119 843.69	101 067.93
2003	3 057	65 702	78 245.57	68 803.15
2002	746	12 183	36 888.26	30 779.53
2001	755	12 244	35 563.88	26 522.73
2000	768	11 149	32 463.12	22 933.73
1999	1 027	15 664	46 101.14	32 641.64
1998	1 065	16 482	49 478.51	34 734.37
1997	1 002	12 878	37 727.57	27 288.10
North Dakota
2006	2	…	6.00	6.00
2005	11	…	33.00	27.00
2004	13	…	39.00	23.00
Ohioc
2008	…	497	…	548.94
2007	…	525	…	2 171.33
2006	…	581	…	1 688.87
2005	…	290	…	684.85
2004	…	83	…	244.35
2003	…	5	…	84.00
Oklahoma: 2007	1	0	0.00	0.00
Pennsylvania: 2007	…	103	…	231.75
Texas
2006	31	37	…	268.13
2005	192	198	…	1 506.34
2004	30	30	…	245.78
2003	6	6	…	48.00
2002	1	1	…	12.00
2001	22	22	…	210.00
2000	33	33	…	294.00
1999	47	48	…	420.00
Utah: 1997–2007	0	0	0.00	0.00
Vermont
2003	2	60	180.00	137.30
2002	0	0	0.00	0.00
2001	2	60	180.00	127.44
Virginia: 2007–2008	0	0	0.00	0.00
Washington
2007	308	991	…	3 598.00
2006	317	970	…	3 854.00
2005	4 061	8 597	…	50 010.00
2004	2 241	4 818	…	28 096.00
2003	1 046	2 170	…	13 129.00
Wisconsin
2008	5	8	…	27.52
2007	68	167	…	567.72
2006	124	272	…	832.18
2005	62	131	…	411.36
2004	40	94	…	285.08
2003	3	5	…	17.20
2002	0	0	…	0.00
2001	0	0	…	0.00
2000	0	0	…	0.00

Note. Ellipses indicate that data were missing.

^aCalifornia would not provide data for 2003–2007 without charging a fee.

^bHawaii confirmed that they reimburse for the female condom, but did not provide data.

^cThe number of claims for Ohio includes both fee-for-service and managed care, but the dollar amount billed pertains only to fee-for-service claims.

DISCUSSION

From the perspective of prevention advocacy, the good news is that policy appears to have been working in many states: claims were being made for Medicaid reimbursement for female condoms. The bad news is that levels of utilization of this efficacious STI barrier device appear to have been uneven across states and very low in most states. Our findings raise many questions: Is the Medicaid reimbursement program underutilized? Or does Medicaid reimbursement activity simply provide a parallel to activity in commercial markets, suggesting that there is no market for the device? If Medicaid reimbursement is underutilized, how can we promote awareness of the device among health care providers who can write fiscal orders through Medicaid and can dispense the device to individuals at risk for STIs?

High-volume reimbursement activity in a state appears to be correlated with a high prevalence of AIDS cases. Five of the high-volume states in the current study (New York, California, Texas, Illinois, and Massachusetts) are among the 10 states with the highest AIDS prevalence.¹⁴ Is high volume in some states attributable to state or local initiatives promoting the device (e.g., the New York State Condom and New York City Condom programs),¹⁵ or is it caused by individual interest in the device? Are claims submitted only by women, or do some of these claims represent male users?

Latka¹⁶ reminded us that uptake of reproductive health devices can take considerable time. In this case, however, time spent on uptake may result in thousands of infections that could be averted and lives that might be saved if the female condom were more visible, more accessible, and more effectively promoted as an alternative to the male condom.

Lack of Support and Ignorance as Barriers

Barriers to use of the female condom have been well-documented, including lack of consumer satisfaction with the device,¹⁷ lack of consumer awareness of the device,^18,19 and lack of access to the device,²⁰ but there does not seem to have been much of an attempt to overcome these obstacles. Nevertheless, the device enjoys relatively high acceptability rates that range from 37% to 96%.^17,20 Mantell et al.¹⁹ and Kaler¹⁸ noted that there is a lack of support for the female condom among reproductive health providers, in terms of providers' willingness to promote the use of the device. Kaler indicated that successful uptake of the device will not be achieved in North America without better advocacy and promotion from key stakeholders.¹⁸ Hoffman et al.²⁰ summarized accessibility barriers in the United States, including ridicule in the press, limited promotion, high cost, and inadequate training of providers.

Few of the contacts we spoke to during our study were even aware that the device existed. Some contacts responded to our requests with amusement, confusion, resistance, or annoyance. A common first response was, “The female what?” It took many months, and in some cases a dozen or more contacts at a given program, to collect the data we sought. In such a climate, what would it take to convince key stakeholders to support the device consistently?

In 2009, the FDA granted market approval to the FC2, Female Health Company's second-generation female condom. The FC2 is significantly less expensive to manufacture and less expensive to the consumer than is its predecessor. One study (not US based) demonstrated that a well-designed program promoting female condom use, even as an alternative to male condom use, would probably be cost-effective and would save public-sector health funds.²¹ The public policy priority should be to identify accessible, affordable, feasible alternatives for barrier protection—including the female condom, which may have been given a second chance by the FDA's approval of the FC2—and to promote these alternatives to individuals at risk for HIV and other STIs.

Conclusions

We found that the female condom is available to Medicaid beneficiaries in 32 states. Financed by state governments and the federal government, Medicaid is among the largest payers for reproductive health services in the United States.⁸ Under federal law, Medicaid must cover family planning services. Most health insurance programs do not provide adequate coverage for family planning services.²² The federal Patient Protection and Affordable Care Act, signed into law on March 23, 2010, includes a provision that will allow 16 million more Americans to join Medicaid by 2019, guaranteeing family planning services (including access to the female condom) without cost sharing.²³

Our findings provide evidence that there is some Medicaid reimbursement for the female condom, suggesting the need for a new dialogue about whether knowledgeable providers can and should promote use of the newer, less expensive FC2 female condom. Moreover, there have recently been increasing calls by scientists, journal editors, mental health professionals, and health care providers for more promotion and support of the female condom,^5–7,24 including use of the device for protection during anal sex.⁴

Findings suggest that more research is needed to identify barriers to awareness of the device and to uptake of the product at the provider and consumer levels. There is also a need to examine why rates of claims for the device are so uneven across states and to identify strategies to increase access in low-utilization states. Increased access to the female condom (assuming that the devices are used for risk reduction) should translate into fewer transmissions of STIs, including HIV. Use of effective barrier devices for the prevention of HIV and STI transmission should be diligently promoted. Approval of the FC2 and a working Medicaid reimbursement policy provide a second chance to make the female condom a successful weapon in the war on AIDS.