SYPHILLIS - GENERAL (Screening)

Evidence Statement Benefit Plan Language Other Information and Resources Author(s)

References


Updated 10/27/11

Evidence Statement

Clinical Preventive Service Recommendations

U.S. Preventive Services Task Force Recommendation
The U.S. Preventive Services Task Force (USPSTF) strongly recommends that clinicians screen all persons at increased risk for syphilis infection. Clinicians should consider the characteristics of the communities they serve in determining appropriate screening strategies.1

For the USPSTF recommendation on syphilis in pregnant women, see Syphilis in Pregnant Women (Screening)

Evidence Rating: A (Strongly Recommended/Good Evidence)
Although the USPSTF found no new direct evidence that screening for syphilis infection leads to improved health outcomes in persons at increased risk, there is adequate evidence that screening tests can accurately detect syphilis infection and that antibiotics can cure syphilis.1 The USPSTF concludes that the benefits of screening persons at increased risk for syphilis infection substantially outweigh the potential harms.

NOTE:
The USPSTF recommends against routine screening of asymptomatic persons who are not at increased risk for syphilis infection. For more information, see Grade D recommendations.

Back to top


The Value of Prevention

Economic Burden of Condition/Disease
The lifetime medical cost per case of syphilis has been estimated at $572 (in year 2006 dollars).5 The economic burden per case of syphilis would be much higher if the costs of congenital syphilis and HIV infections occurring from the facilitating effect of syphilis were included in cost analyses.
Workplace Burden of Condition/Disease
Each case of syphilis costs an estimated $572 in direct lifetime medical costs and $112 in indirect lifetime costs.5
Economic Benefit of Preventive Intervention
Screening and early detection are key to averting costs associated with disease progression and long-term complications. The cost of new HIV cases attributable to syphilis was estimated to be $4,653 (in year 1996 dollars) for each new syphilis case.6 Treatment for early stage syphilis is also much less expensive than treatment for later stage disease: the baseline cost of treating early syphilis was estimated to be $41.26 (in year 2001 dollars) compared to $2,061.70 for late syphilis.7
Estimated Cost of Preventive Intervention
In 2007, the median private-sector cost of screening for syphilis was $5.8 Approximately 95% of all paid claims fell within the range of $2 to $25.8

For 2009, the Centers for Medicare & Medicaid Services (CMS) allowable fees for the tests shown above ranged from $6.23-$119.34 (2008 dollars).9 The cost per case of syphilis treated and cost per case of congenital syphilis prevented through screening will depend on population prevalence and other factors.
Estimated Cost of Treatment
The cost of treating syphilis will vary depending on the treatment medication and other factors. The public-sector cost of standard IM benzathine penicillin therapy (first-line treatment) ranged from $18.64 to $22.22 (in year 2001 dollars).7 Treatment for late-stage syphilis can cost upwards of $2,000 (in year 2001 dollars).7

Cost-Effectiveness and/or Cost-Benefit Analysis of Preventive Intervention
The cost-effectiveness of syphilis screening depends on numerous factors such as syphilis prevalence. The treatment of 100 adults with syphilis has been estimated to save over $65,000 in direct medical costs by preventing the potential consequences of untreated syphilis, such as neurosyphilis, cardiovascular, and congenital syphilis.5

Back to top


Condition / Disease Specific Information

Epidemiology of Condition/Disease
Surveillance data from the Centers for Disease Control and Prevention (CDC) indicate that the rate of syphilis among men, women and children has increased nationwide since its low in 2000.2 Between 2007-2008, rates among men and women increased approximately 13.1% totaling 46,277 cases of syphilis in 2008.2 Syphilis rates vary dramatically by region and are highest in the Southeastern United States and in concentrated pockets of metropolitan areas such as Atlanta, Baltimore, Chicago, Detroit, Indianapolis, Memphis, New Orleans, Newark, Richmond, St. Louis, and Washington, D.C.3 Syphilis is a serious sexually transmitted infection (STI) condition that, if left untreated, may result in cardiovascular and neurological complications leading to disability and ultimately death.1 Syphilis can also be transmitted from an infected mother to her infant during labor and delivery. Congenital syphilis can be particularly severe and results in fetal or infant death in 40% of cases.1 Infants who survive may suffer serious central nervous system abnormalities, deafness, bone and joint deformities, skin abnormalities, blood disorders, and other problems.
Condition/Disease Risk Factors
Prior to recent years, the populations at highest risk for syphilis infection (as determined by incident rates) included men who have sex with men and engage in high-risk sexual behavior, commercial sex workers, persons who exchange sex for drugs, and those in adult correctional facilities.1 In recent years, however, the CDC data has indicated increasing rates of infection among heterosexual couples in all racial groups.2

The prevalence of syphilis infection varies widely among communities and patient populations.1 Some populations have a particularly high risk of infection, specifically African-Americans and people living in the Southeastern United States.4 In 2007, the incidence of primary and secondary (P&S) syphilis was highest in persons in the 20- to 24-year-old age group (11.4 cases per 100,000 population).2

Back to top


Preventive Intervention Information

Preventive Intervention: Purpose of Screening
Screening for syphilis allows clinicians to identify affected patients and begin treatment earlier in the course of disease, potentially improving outcomes and avoiding the health and economic consequences of latent disease. Treatment also reduces the likelihood of spread to others.
Benefits and Risks of Intervention
No studies have documented the harms associated with screening for syphilis. Potential harms include partner discord, stigma, unnecessary anxiety or treatment in the case of a false-positive result, and opportunity costs (in terms of time and resources) to both the clinician and the patient. Harms of treatment include allergic reaction to penicillin, and side effects of the medication including the Jarisch-Herxheimer reaction (fever, headache, and pain that occurs during the 24 hours after initiating antibiotic treatment for syphilis due to the release of treponema antigens).1

The benefits associated with screening are great. Screening allows for early detection and treatment, preventing complications that may occur in later stages of disease, and it reduces the risk that syphilis will be spread to others. Antibiotic treatment for syphilis is effective and inexpensive. The USPSTF concluded that the benefits of screening persons at increased risk for syphilis infection substantially outweigh the potential harms.1
Initiation, Cessation, and Interval of Screening
The optimal screening interval for syphilis is unknown. Experts recommend that clinicians base the frequency at which they screen patients for syphilis on the patient's risk factors and the characteristics of the community in which they practice.
Intervention Process
A variety of syphilis tests are available and in development. Screening for syphilis typically involves the use of 2 different tests, a nontreponemal test and a treponemal-specific test, for screening and confirmation. For example, a nontreponemal blood test such as the venereal disease research laboratory (VDRL) or the rapid plasma reagin (RPR) may be performed, a second, different kind of test, such as the fluorescent treponemal antibody absorbed (FTA-ABS) or the T. pallidum particle agglutination (TP-PA) may then be used to confirm the results of the nontreponemal test.1

The tests for syphilis screening that are approved or pending FDA approval include:
  • Nontreponemal test such as the venereal disease research laboratory (VDRL) or the rapid plasma reagin (RPR) on serum specimens followed by a fluorescent treponemal antibody absorbed (FTA-ABS) or T. pallidum passive particle agglutination assay (TP-PA) for enzyme-linked immunosorbent assay (ELISA) for confirmation.
  • Immunochromatographic strip (ICS) point-of-care test on blood or serum specimen, when FDA approved.
  • Enzyme-linked immunosorbent assay (ELISA) or TP-PA for treponemal antibody in serum specimens followed by a VDRL or RPR test.
  • Dark field microscope examination of lesion specimens.

Follow-up tests should be performed using the same nontreponemal test initially used to document infection (e.g., VDRL or RPR) to ensure comparability.

Treatment Information
Syphilis is treated with penicillin. Penicillin dosage, preparation and length of treatment should be based upon disease stage.10 Azrithromycin and ceftriaxone have also been shown to be effective alternatives to penicillin, but are not currently endorsed by CDC recommendations.10 Health benefits should include provisions for treatment.

Back to top


Strength of Evidence

The level of evidence supporting the recommendation in this section is described below.
Evidence-Based Research:
U.S. Preventive Services Task Force (USPSTF)
Strength of Evidence: A (Strongly Recommended/Good Evidence)
  • The USPSTF found good evidence to support screening for syphilis among all persons at increased risk for syphilis infection.1

Back to top


Summary Plan Description

Covered Screening
Syphilis screening is a covered benefit. The following tests are covered:
  • Nontreponemal tests venereal disease research laboratory (VDRL) or the rapid plasma regain (RPR) on serum specimens followed by a fluorescent treponemal antibody absorbed (FTA-ABS) or T. palladium passive particle agglutination assay (TP-PA) for enzyme-linked immunosorbent assay (ELISA) for confirmation.
  • Line Immunoassay (LIA) point-of-care test on blood specimen, when FDA approved.
  • Enzyme-linked Immunosorbent Assay (ELISA) or TP-PA for treponemal antibody in serum specimens followed by a VDRL or RPR test.
  • Immunochromatographic Strip (ICS) point-of-care test on blood or serum specimen, when FDA approved.
  • RPR point-of-care test for nontreponemal antibody in serum specimens.
  • Dark field microscope examination of lesion specimens.
Initiation, Cessation, and Interval
Annual screening is a covered benefit for all beneficiaries at risk of infection. More frequent screening is provided, if medically indicated.

Back to top


CPT Codes

Syphilis (Screening)
86592 Syphillis test, qualitative
86593 Syphilis, quantitative
86781 Antibody, treponemal pallidum, confirmatory test
87166 Dark field examination (without specimen collection)
87164 Dark field examination (includes specimen collection)
87285 Treponema pallidum antigen, immunofluorescence

Back to top


Other Information and Resources

CDC Resource

Back to top


Author(s)

Campbell KP, Lentine D. Sexually transmitted infections (STIs) evidence-statement: screening and counseling. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser's Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006. Updated 2011.

Acknowledgments

The National Business Group on Health would like to thank the Centers for Disease Control and Prevention's Division of Sexually Transmitted Disease Prevention for their review and update of this statement in December 2009.

Back to top


References

  1. U.S. Preventive Services Task Force. Screening for syphilis infection. Summary of recommendations / Supporting documents. Rockville, MD: Agency for Healthcare Research and Quality; 2004.
  2. Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance, 2007. Atlanta, GA: U.S. Department of Health and Human Services; December 2008.
  3. The National Cervical Cancer Coalition. CDC issues new report on STD epidemics. [cited 2011 August 18]. Available from: http://www.nccc-online.org/patient_info/hpv_test/cdc_issues.html.
  4. Nelson HD, Glass N, Huffman L, Villemyer K, Hamilton A, Frame A, et al. Screening for syphilis: Brief update for the U.S. Preventive Services Task Force. AHRQ Publication No. 04-0545-B. Rockville, MD: Agency for Healthcare Research and Quality; 2004.
  5. Chesson H, Collins D, Koski K. Formulas for estimating the costs averted by sexually transmitted infection (STI) prevention programs in the United States. Cost Effectiveness and Resource Allocation. 2008;6(1):10.
  6. Chesson HW, Pinkerton SD. Sexually transmitted diseases and the increased risk for HIV transmission; implications for cost-effectiveness analyses of sexually transmitted disease prevention interventions. JAIDS 2000;24:48-56.
  7. Blandford JM, Gift TL. The cost-effectiveness of single-dose azithromycin for treatment of incubating syphilis. Sex Transm Dis 2003;30(6):502-8.
  8. Thomson Reuters. 2007 MarketScan® Commercial Claims and Encounters Database. 2009.
  9. Center for Medicare and Medicaid Services (CMS). Clinical Laboratory Fee Schedule 2009 [Internet]. CMS, Washington, DC.[modified January, 2009; cited 2009 Mar 17]. Available from: http://www.cms.hhs.gov/ClinicalLabFeeSched/02_clinlab.asp.
  10. U.S. Preventive Services Task Force. Screening for Syphilis: Brief Update. July 2004. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http://www.uspreventiveservicestaskforce.org/3rduspstf/syphilis/syphilup.htm. Accessed: August 18, 2011.