Implantable Penile Prosthesis for Erectile Dysfunction: Insurance Coverage in the United States

Abstract

Introduction:

A manufacturer’s benefit verification database was evaluated to ascertain United States health plan insurance coverage for implantable penile prostheses for erectile dysfunction.

Methods:

All-payer and employer-sponsored health plan benefit verification databases were queried to determine implantable penile prosthesis approval status. For the all-payer analysis, data by payer were available and presented for 2019-2021 to assess approval status varied by payer and over time. For the employer-sponsored health plan analysis, data by payer were available from 2018-2021.

Results:

Benefit verification records for the all-payer database were available for 3,167 patients in 2019, 3,016 in 2020, and 2,837 in 2021. Insurance type was preferred provider organization (27.5%), Medicare Advantage (26.9%), Medicare (15.9%), or point-of-service (10.5%). Most patients were approved or verified for implantable penile prosthesis coverage (79.4% in 2019, 79.6% in 2020, and 78.4% in 2021). Coverage was most extensive for government-based insurance (Medicare 98.7%, Medicare Advantage 97.1%, Tricare 100%, and Veterans Affairs 80.0%) but was also favorable for commercial insurance (75.0%). The most common reason for lack of coverage was employer exclusion; the proportion of patients with no coverage due to exclusion increased from 13.5% in 2019 to 17.5% in 2021. Analyses of the employer-sponsored health plan database (n=3,083 patients) showed that 63.1% of patients were approved or verified for coverage and 34.2% did not have coverage due to health plan exclusions.

Conclusions:

Approximately 80% of patients had implantable penile prosthesis coverage. Employer exclusion was the most common reason for lagging coverage; rates of employer exclusion increased 29.3% from 2019-2021.

Erectile dysfunction (ED) is estimated to affect as many as 30 million American men,¹ and the projected treatment costs of ED to the United States (US) health care system have been estimated to amount to up to $15 billion.² ED constitutes a large burden on employers and society given its high prevalence and negative impact on quality of life (QoL) and productivity.^3-5 Several medical and surgical treatment options are available for the treatment of ED, including oral and parenteral drugs, injectable vasodilator agents, vacuum erection devices, implantable penile prostheses (IPPs), lifestyle modifications, or psychosexual therapy. An IPP is a definitive treatment to restore sexual function among men with ED.⁶ In most cases, IPP is provided for those patients who have failed to respond, did not tolerate, or are unwilling to consider other treatments. However, the AUA guideline states that “using the shared decision-making process as a cornerstone for care, all patients should be informed of all treatment modalities that are not contraindicated, regardless of invasiveness or irreversibility, as potential first-line treatments.”⁷

Treatment for ED is widely considered medically necessary. Many U.S. commercial insurers, as well as Medicare, have published coverage policies detailing the medical necessity of ED treatment.⁸ However, evidence has demonstrated that only 23% of employed men who have been diagnosed with ED actually receive treatment paid for by their employer-sponsored health plan (ESHP).³ Over the past 10 years, ED treatment with phosphodiesterase type 5 inhibitors remained constant, whereas use of other treatments, including IPP, has declined.³ The extent of insurance coverage for IPP has not yet been adequately ascertained; hence, it is unclear whether this is a barrier to access for IPP treatment. The objective of the current study was to utilize a U.S. IPP manufacturer’s benefit verification databases to ascertain the insurance coverage for IPP for ED.

Materials and Methods

Health plan insurance benefit verification is the process of verifying the patient’s active medical coverage and eligibility with the insurance company. Accurate insurance verification enables a higher likelihood of a submitted claim without any errors or other issues, including incomplete documentation (ie, a “clean claim”). Inadequate verification of eligibility and plan-specific benefits may increase the risk of wrongful claim rejections, denials, and billing issues. Manufacturer benefit verification programs are available to providers who seek coverage information and assistance for their patients’ reimbursement for various treatments. Not all providers use benefit verification systems as their use is completely voluntary and optional. Manufacturers typically record some information from the interaction with the provider, including basic patient insurance information and also the outcome of the benefit verification case. The databases are proprietary and owned by each individual manufacturer. Also, not all manufacturers offer this optional provider support.

Data Sources

Two separate databases from a single IPP manufacturer, the “all-payer” and “ESHP” benefit verification databases, were queried to determine IPP approval status for patients seeking IPP. The “all-payer” database included data for patients with commercial payer insurance (ie, publicly traded insurance companies such as UnitedHealth, Aetna, or Humana), private payer insurance (ie, privately held insurance companies such as Blue Cross Blue Shield), and government or public payer insurance (ie, Medicare, Medicaid, Department of Defense Tricare, Veterans Affairs [VA], and Indian Health Service). The ESHP database included data for patients with health insurance selected and purchased by an employer and offered to eligible employees and their dependents (also called group plans). For the ESHP analysis, the data from the all-payer database were analyzed by health plan and by employer to extract only the subset of plans that were sponsored by an employer.

For the all-payer analysis, data were available for 2019, 2020, and 2021 and the data were presented by payer and by year to determine how approval status varied by payer and over time. For the ESHP analysis, data by payer were available and extracted for patients from 2018-2021.

Patient Population

Patients identified as an IPP candidate in the benefit insurance verifications who had a diagnosis of ED, who were seeking IPPs, and had a record of insurance benefit verification from 2018-2021 were included in the evaluation.

Outcomes Evaluated

Data extracted from the insurance benefit verification databases are described in the Table.

Table.

Data Extracted From the Insurance Benefit Verification Databases

Data element	Description of elements
Dates	• Closed date of the benefit verification • Cycle time from initiation to close of the benefit verification period (duration in d)
Coverage status	• Verified (medical benefits were verified and the procedure is covered) • Approved (health plan approved a prior authorization for the procedure) • No coverage–exclusion (employers’ health plan excludes medical benefits through the employer-sponsored health plan for a penile prosthesis) • Cancelled (request sent by physician’s office to cancel the verification of benefits) • Denied–not medically necessary (request for procedure was denied for not being medically necessary) • No coverage–Medicaid (state Medicaid excludes coverage for IPP) • No coverage–in-network benefits only (not covered because out of network) • No coverage • Denied • No coverage–Medicare Part A (not covered under Medicare Part A) • Material not provided (insurance benefit verification process unable to continue as the medical documentation requested was not received from the provider’s office)
Type of insurance	• Government • Commercial • Military • Worker’s Compensation • Other
Policy type	• Medicare • Medicare Advantage • Medicaid • Medicaid Replacement • Tricare • Veterans Affairs • Preferred provider organization • Health maintenance organization • Open access plus • Exclusive provider organization • Point-of-service • Indemnity • Worker’s Compensation • Other

Abbreviation: IPP, implantable penile prosthesis.

Data Analyses

All patient insurance policy and coverage data were analyzed descriptively. Means (SD) or medians (interquartile range [IQR]) were reported for continuous variables, and frequencies (%) were reported for categorical variables. Data management and statistical analyses were conducted using Microsoft Excel (Redmond, Washington).

Results

All-payer Benefit Verification

Benefit verification records for the all-payer database were available for 3,167 patients in 2019, 3,016 patients in 2020, and 2,837 patients in 2021. For the 2021 cohort, most patients had preferred provider organization (PPO; 27.5%), Medicare Advantage (26.9%), Medicare (15.9%), or point-of-service (POS; 10.5%) coverage (Figure 1).

Figure 1.

Types of insurance coverage for the all-payer benefit verification analysis (2021). EPO indicates exclusive provider organization; HMO, health maintenance organization; OAP, open access plus; POS, point-of-service; PPO, preferred provider organization; VA, Veterans Affairs.

The IPP approval status for all-payers by year is presented in Figure 2. Approximately 80% of patients were either approved or verified for IPP coverage from 2019-2020 (79.4% in 2019, 79.6% in 2020, and 78.4% in 2021). The most common reason for lack of coverage was due to employer exclusion, and the proportion of patients with no coverage due to exclusion increased from 13.5% in 2019 to 15.6% in 2020 and to 17.5% in 2021. This represents a 29.3% increase in exclusions from 2019 to 2021.

Figure 2.

Implantable penile prosthesis approval status for all payers by year (2019-2021). Case status meanings: Verified: medical benefits were verified, and the procedure is covered. Approved: the health plan approved a prior authorization for the procedure. No Coverage-Exclusion: the employer’s health plan excludes medical benefits through the employer-sponsored health plan for a penile prosthesis. Cancelled: A request was sent by the physician’s office to cancel the verification of benefits. Denied-Not Medically Necessary: the request for the procedure was denied for not being medically necessary. Material Not Provided: the insurance benefit verification process was unable to be continued as the medical documentation requested was not received from the provider’s office. No Coverage-Medicaid: the state Medicaid excludes coverage for penile prosthesis.

Figure 3 presents the IPP approval status for the 2021 all-payer benefit verification analysis by type of insurance coverage. Similar to the overall annual analysis, the data illustrate how many patients had favorable IPP coverage (ie, either approved or verified), particularly patients with Medicare (98.7%), Medicare Advantage (97.1%), Tricare (100%), and VA (80.0%) insurance. More than half of patients with Medicaid had favorable IPP coverage (54.6%); however, only 22 Medicaid patients were available in the benefit verification database. Nearly two-thirds of patients with Medicaid Replacement had favorable coverage (63.8%). More than two-thirds of patients with PPO and exclusive provider organization (EPO) insurance had favorable coverage (68.8% and 67.5%, respectively), more than one-half with POS, health maintenance organization (HMO), and Indemnity insurance had favorable coverage (61.2%, 58.1%, and 54.5%, respectively), and approximately one-third of patients with Open Access Plus (OAP) insurance had favorable coverage (34.4%). The overall coverage rate among patients with commercial insurance was 75.0%. Again, plan-specific exclusion of IPP was the most common reason for lack of coverage, amounting to 27.5% for patients with Medicaid Replacement, 27.7% for PPO, 30.9% for EPO, 34.1% for POS, 36.5% for HMO, 45.5% for Indemnity, and 61.3% for OAP.

Figure 3.

Implantable penile prosthesis approval status for the all-payer cohort by type of insurance status. Case status meanings: Verified: medical benefits were verified, and the procedure is covered. Approved: the health plan approved a prior authorization for the procedure. No Coverage-Exclusion: the employer’s health plan excludes medical benefits through the employer-sponsored health plan for a penile prosthesis. Cancelled: A request was sent by the physician’s office to cancel the verification of benefits. Denied-Not Medically Necessary: the request for the procedure was denied for not being medically necessary. Material Not Provided: the insurance benefit verification process was unable to be continued as the medical documentation requested was not received from the provider’s office. No Coverage-Medicaid: the state Medicaid excludes coverage for penile prosthesis. EPO indicates exclusive provider organization; HMO, health maintenance organization; OAP, open access plus; POS, point-of-service; PPO, preferred provider organization; VA, Veterans Affairs.

ESHP Benefit Verification

For the ESHP database, benefit verification records from 2018-2021 were available for 3,083 patients. Among patients with ESHPs, 63.1% were either approved or verified and 34.2% did not have coverage due to exclusions (Figure 4).

Figure 4.

Implantable penile prosthesis approval status for employers for 2018-2021. Case status meanings: Verified: medical benefits were verified, and the procedure is covered. Approved: the health plan approved a prior authorization for the procedure. No Coverage-Exclusion: the employer’s health plan excludes medical benefits through the employer-sponsored health plan for a penile prosthesis. Cancelled: A request was sent by the physician’s office to cancel the verification of benefits. Denied-Not Medically Necessary: the request for the procedure was denied for not being medically necessary. Material Not Provided: the insurance benefit verification process was unable to be continued as the medical documentation requested was not received from the provider’s office.

Discussion

ED has profound consequences given its increasing prevalence and its effect on physical well-being, QoL, self-esteem, relationships, self-worth, and productivity. Evidence has demonstrated that only 23% of employed men who have been diagnosed with ED receive treatment paid for by their ESHP.³ Per AUA guideline recommendations, it is imperative to ensure that all types of effective ED treatments are consistently accessible to patients. IPPs are an essential component in the urologist’s armamentarium for ED management⁹ as many men become refractory to medical therapy and/or are seeking a more effective and permanent therapy.¹⁰ Penile prosthesis is a well-known treatment option with high satisfaction rates (92%-100% in patients and 91%-95% in their partners). Some research has shown that ED patients who underwent penile implant surgery had significantly better erectile function and treatment satisfaction rates than patients who received phosphodiesterase type 5 inhibitors.¹¹ Furthermore, IPPs provide a durable treatment with devices functioning for up to 20 years.^12,13

Over the past 10 years, the usage of IPPs has declined.³ The reasons for this decline are unclear; however, it may be at least partly be due to benefit exclusion of penile prosthesis among men with ESHPs.³ The decline could also be secondary to decreases in referrals for IPP stemming from the misnomer that plans will likely not cover IPP placement and a lack of awareness of available support in seeking coverage from benefit verification services. The current study utilized a manufacturer’s benefit verification databases to ascertain whether insurance coverage was a barrier to access to IPP treatment for ED. Our study findings showed that insurance coverage from 2018-2021 for IPPs was approximately 80%, but that it varied depending upon the insurance and policy type. The proportions of patients with IPP coverage by insurance type, in descending order, were Tricare (100%), Medicare (98.7%), Medicare Advantage (97.1%), VA (80.0%), PPO (68.8%), EPO (67.5%), Medicaid Replacement (63.8%), POS (61.2%), HMO (58.1%), Medicaid (54.6%), Indemnity (54.5%), and OAP (34.4%).

Most patients were denied IPP coverage due to an employer plan exclusion. The proportion of patients with no coverage due to an employer exclusion was 17.5% in 2021, and this proportion had increased by 29.3% from 2019 to 2021. This finding was confirmed in our analysis of the ESHP benefit verification database, which illustrated that 34.2% of patients with ESHP did not have IPP coverage due to an employer exclusion from 2018-2021. This is a significant concern as these ESHP exclusions create confusion and frustration for clinicians. ESHPs usurp the clinicians’ determination of medical necessity under the health plan’s medical policy, make it difficult for providers to implement ED treatment guidelines⁷ appropriately, and limit essential treatment for patients with ED.⁸ Employer exclusions for IPP coverage have significant implications for employers, including employee satisfaction, retention, and productivity.^4,8

There is a paucity of data evaluating insurance coverage among men with ED seeking IPP. However, the findings from this study are mostly consistent with the 2 previous analyses we were able to identify. A poster presented by Mazur et al at the 2018 AUA Annual Meeting analyzed de-identified data from 2 IPP manufacturers’ insurance verification benefits databases from 2016-2017 to estimate how many men had coverage for ED treatments across the U.S.¹⁴ Among 4,592 total verification cases, 3,795 cases (82.6%) had coverage benefits for ED treatment. Among those with ED benefits, 683 cases (14.9% of total cases; 18% of those with ED benefits) had an IPP exclusion.

Another prior study by Masterson et al evaluated the trends in insurance coverage of IPP among patients at the University of Miami Miller School of Medicine between 2016-2017.¹⁵ The authors found that the largest insurer for IPP in the Miami region was Medicare (39.5%). Among men seeking IPP with commercial insurance coverage, 48.0% were unable to obtain the device due to exclusions in their coverage or denials.¹⁵ These figures are higher than those we observed in our current nationwide analysis. The reason for the discrepancy is likely the different patient populations represented in the respective databases. The source of the data for the Miami study was a manually maintained medical record database of IPP claims that were already excluded or denied; hence, one would expect higher exclusion or denial rates. In comparison, our study utilized a manufacturer’s IPP benefit verification database that covered a broader patient population (ie, patients whose providers had reached out to the manufacturer to assist them with benefit verification). The appeal process to request IPP coverage is challenging, and prior authorization and assistance through the IPP manufacturer benefit verification system may increase the likelihood of successful IPP coverage.

One of the most significant reasons that ED is undertreated is that men with ED do not seek treatment.¹⁶ Men are often hesitant to discuss sexual problems with their clinicians and less frequently consult family physicians for health-related problems.¹⁷ This reduces men’s chances of recognizing and treating their disease and results in physicians delivering less preventive care, screening, and testing. Counseling rates for sensitive topics such as sexual health and emotional well-being are especially low in men.¹⁷ Among men who do not seek treatment, younger men are likely to believe that their ED will resolve spontaneously, whereas older men resist seeking treatment because they feel that ED is a natural part of aging.¹⁶ However, despite its increasing prevalence among older men, ED is not a normal or inevitable part of the aging process.^18,19

Diagnosis and effective treatment of ED may even lead to the improvement in patients' treatment and compliance with other comorbidities.²⁰ ED may be a signal for underlying cardiovascular disease and may provide opportunities for earlier assessment of vascular dysfunction. As a surrogate marker of cardiovascular and/or pulmonary health, ED presence may provide a quick and inexpensive first-line assessment of the pulmonary and cardiovascular health of men.²¹ Taking care of a patient with ED is an opportunity to decrease modifiable cardiovascular risk factors.²² As an example, Montorsi and colleagues evaluated patients with coexisting ED and coronary artery disease (CAD) and found that 67% of the patients reported that the symptoms of ED were clinically evident before the symptoms of CAD presented.²³ The mean time interval between the onset of ED and CAD was 38.8 months and the time interval ranged from 1-168 months, illustrating the opportunity for earlier intervention.

Finally, emerging evidence is illustrating how COVID-19 has had a uniquely harmful impact on men's health and erectile function through biological, mental health, and health care access impacts.²⁴ The COVID-19 pandemic also postponed or delayed the evaluation and treatment of ED, potentially prolonging and exacerbating ED problems.²⁴ As we emerge from the pandemic, it is important to evaluate and address the long-term consequences of COVID-19, including the potential sexual function sequalae.^24,25 The findings from this study highlight that extensive insurance coverage for IPP exists in the U.S. The burden of ED post–COVID-19 necessitates improved awareness and consistency in health care access of all types of ED treatments, including IPP treatment.

Our study evaluated more than 12,000 IPP benefit verification cases and covered a timespan of up to 4 years. However, a limitation of this study is that the data represent the cases that providers submitted to the manufacturer benefit verification system, and the data may not be generalizable to all patients seeking IPPs. Provider use of manufacturer benefit verification systems is completely voluntary and optional and not all providers use the benefit verification system. Based on 12,612 IPP cases documented in the IPP manufacturer database in 2022, it is estimated that providers used the manufacturer IPP benefit verification system for approximately 27% of IPP cases. Another limitation pertaining to generalizability is that the current study used data from a single IPP manufacturer, as these databases are proprietary and data are not homogenously collected among manufacturers. Hence, the data from the current study may not reflect the other IPP manufacturer’s benefit verification cases. Another limitation of this study is that the benefit verification databases, as is the case with all retrospective database analyses, may have clerical inaccuracies, coding errors, or missing data. Furthermore, the benefit verification databases are limited in the variables that are available for analysis, including an absence of clinical information for the patient.

Conclusions

ED has profound consequences on our society given its increasing prevalence and effect on physical well-being, QoL, self-esteem, relationships, self-worth, and productivity. It is, therefore, important to ensure that all types of effective ED treatments are consistently accessible to patients. The current study showed that 4 in 5 patients in the IPP manufacturer benefit verification database gained IPP approval. Coverage was more extensive for government-based insurance than commercial insurance. Employer exclusions were the primary reason for lagging coverage among patients with commercial/ESHP coverage, and rates of employer exclusion increased 29.3% from 2019-2021. IPP coverage exclusions usurp clinicians’ determination of medical necessity under the health plan’s medical policy and make it difficult for providers to appropriately implement ED treatment guidelines.