GONORRHEA (Screening)

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

References


Evidence Statement

Clinical Preventive Service Recommendations

U.S. Preventive Services Task Force Recommendation
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen all sexually active women, including those who are pregnant, for gonorrhea infection if they are at increased risk for infection (that is, if they are young or have other individual or population risk factors).1

Evidence Rating: B (Recommended/At Least Fair Evidence)
The U.S. Preventive Services Task Force found fair evidence that screening tests can accurately detect gonorrhea infection and good evidence that antibiotics can cure gonorrhea infection. There is fair evidence that screening pregnant women at high risk for gonorrhea, including women at high risk because of younger age, may prevent other complications associated with gonococcal infection during pregnancy, such as preterm delivery and chorioamnionitis.1



Condition / Disease Specific Information

Epidemiology of Condition/Disease
Gonorrhea is a sexually transmitted bacterial infection (STI) that can be asymptomatic and can go undetected.2 Left untreated in women complications of gonorrhea include chronic pelvic pain, pelvic inflammatory disease (PID), ectopic pregnancy, and infertility. Pregnant women infected with gonorrhea are at an increased risk for pregnancy complications such as chorioamnionitis, premature rupture of membranes, and preterm labor, and stillbirth.1,3 Infected women may also pass the disease to their infants during pregnancy, labor, and delivery. Gonococcal ophthalmia can cause conjunctivitis leading to corneal scarring and blindness.

In men, gonorrhea can cause urethritis or epididymitis, but few serious or long-term complications. Gonorrhea may also increase both men and women's susceptibility to HIV.

Gonorrhea also increases both men and women's susceptibility to other STIs, including HIV.

Gonorrhea is the second most common sexually transmitted bacterial pathogen in the United States.3 Approximately 330,000 cases of gonorrhea were reported by state health departments in the United States in 2008. The actual number of gonorrhea infections is thought to be much higher since reporting of gonorrhea cases is incomplete.4
Condition/Disease Risk Factors
Risky sexual behaviors such as unprotected sex and sex with multiple partners, etc are major risk factors for gonorrhea. As with most STIs, younger populations are at highest risk. The highest reported rates of gonorrhea among any sex and age group are among women 15 to 24 years of age.4 The rate of gonorrhea among African-Americans is 20 times higher than the rate among whites.4 Gonorrhea rates are also higher in the South than in other regions.4

Persons with gonorrhea often are coinfected with chlamydia. Therefore persons treated for gonorrhea should also be routinely treated for chlamydia.5

The Value of Prevention

Economic Burden of Condition/Disease
The lifetime medical care cost of gonorrhea has been estimated at $68 per case for men and $343 per case for women (in year 2006 dollars).6

Workplace Burden of Condition/Disease
In addition medical and disability-related costs, the workplace burden of the disease includes:
  • Productivity losses per untreated case of gonorrhea have been estimated at $34 for men and $171 for women (in year 2006 dollars);7
  • Direct medical costs for infected adolescents who are covered by their parent's insurance plan; and
  • Productivity losses associated with the time employee caregivers dedicate to attending to sick dependents (i.e., children or spouses).
Economic Benefit of Preventive Intervention
Because screening for gonorrhea allows for the early recognition of disease and leads to earlier treatment, it may prevent the costly complications of late-stage disease such as PID. The average lifetime cost of PID has been estimated to range from $1,060 to $3,180 in year 2000 dollars.8 The average lifetime cost for women who develop major complications of PID is $6,350 for chronic pelvic pain, $6,840 for an ectopic pregnancy, and $1,270 for infertility; mathematical modeling suggests that 79% of these costs are expected to occur within 5 years of the precipitating infection.8

Estimated Cost of Preventive Intervention
In 2007,the median private-sector cost of screening for gonorrhea screening was $18.9 Approximately 95% of paid claims fell within the range of $4 to $74.9

In 2008, the Centers for Medicare & Medicaid Services (CMS) allowable fees for the CPT codes shown above ranged from $3.28-$102.49.10 The cost per case of gonorrhea treated through screening will depend on population prevalence and other factors.
Estimated Cost of Treatment
A recent study of insurance claims data found average payment for treatment to be $85 (2007 dollars); this cost may also include dual treatment for chlamydia.11

Cost-Effectiveness and/or Cost-Benefit Analysis of Preventive Intervention
A recent study that focused on gonorrhea screening in urban emergency departments found that screening women between 15 and 29 years of age using urine-based nucleic acid amplification tests (NAAT) was cost-saving compared to no screening.12



Preventive Intervention Information

Preventive Intervention: Purpose of Screening
Screening for gonorrhea allows clinicians to identify affected patients and begin treatment earlier in the course of disease, thus potentially improving outcomes and avoiding the health and economic consequences of latent disease. Screening is particularly important for women because many women who are infected with gonorrhea have no symptoms and are thus unaware of their condition.13

Benefits and Risks of Intervention
The benefits of screening for gonorrhea are substantial. Screening allows for early recognition and treatment, dramatically reducing complications, other long-term effects, and the transmission of the infection to others. Few studies have documented the risks associated with screening for gonorrhea. Possible risks include partner discord, stigma, opportunity costs (in terms of time and resources) for both the clinician and the patient, and side effects of treatment. As with all types of screening, the risk of false-positive results may cause undue anxiety or unnecessary treatment. The USPSTF found that the benefits of screening sexually active women at increased risk of infection for gonorrhea outweigh the harms associated with screening.1

Initiation, Cessation, and Interval of Screening
Routine screening for gonorrhea is recommended for all women under the age of 25 that are sexually active and women over the age of 25 who are at risk of infection, especially women who are in one or more of the following established high-risk groups: commercial sex workers, drug users, women with a prior history of gonorrhea, other STIs new or multiple sexual partners, and inconsistent condom use. In communities with high prevalence of gonorrhea, broader screening may be warranted, especially in setting serving persons who are at increased risk.1

The frequency of screening is left to the discretion of the provider and should be based on the individuals' risk factors and previous history of STIs.

All pregnant women at risk for gonorrhea should be screened during the first trimester, ideally during the first prenatal care visit. Pregnant women at continued risk of infection should be re-screened again during the third trimester.1

Intervention Process
Several effective methods of screening and diagnosis for gonorrhea are currently available1:
  • Culture of swab specimens from exposed sites (urethra and endocervix).
  • Nucleic acid amplification assays on endocervical, male urethral or vaginal swab specimens or first-catch urine specimens.
  • Microscopic examination of Gram-stained urethral specimens from symptomatic men.
  • Non-amplified nucleic acid hybridization tests on endocervical, male urethral swab specimens.
Treatment Information
Gonorrhea can be effectively treated with antibiotics. However, due to the increasing prevalence of fluoroquinolone resistance in Neisseria gonorrhoeae, CDC no longer recommends the use of fluoroquinolones for the treatment of gonococcal infections and associated conditions such as pelvic inflammatory disease (PID). Consequently, only one class of drugs, the cephalosporins, is still recommended and available for the treatment of gonorrhea in the U.S. These changes are reflected in CDC's updated treatment guidelines.14

The CDC also recommends treating patients for chlamydia unless chlamydial infection has been ruled out via a negative NAAT.14

Recommended regimens for uncomplicated gonococcal infections of the cervix, urethra, and rectum include:
  • Ceftriaxone 125 mg IM in a single dose;
  • Cefixime 400 mg orally in a single dose
The recommended regimen for uncomplicated gonococcal infection of the pharynx is ceftriaxone 125mg IM in a single dose.14



Strength of Evidence for the Clinical Preventive Service

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: B (Recommended/At Least Fair Evidence)
  • The U.S. Preventive Services Task Force found fair evidence that screening tests can accurately detect gonorrhea infection and good evidence that antibiotics can cure gonorrhea infection. There is fair evidence that screening pregnant women at high risk for gonorrhea, including women at high risk because of younger age, may prevent other complications associated with gonococcal infection during pregnancy, such as preterm delivery and chorioamnionitis.1


Summary Plan Description

Covered Screening
Gonorrhea screening is a covered benefit. The following tests are covered:
  • Culture of swab specimens from exposed sites
  • Microscopic examination of Gram-stained urethral specimen
  • Non-amplified nucleic acid hybridization tests on genital swab specimens
  • Nucleic acid amplification assays
Initiation, Cessation, and Interval
Annual screening is a covered benefit for all women aged 25 years and younger. Coverage is provided for women over age 25, if medically indicated. Gonorrhea screening is a covered benefit for all pregnant women at their first prenatal care visit. Women who are at high risk for gonorrhea or are previously untested are eligible for re-screening during the third trimester or as medically indicated.



CPT Codes

Gonorrhea (Screening)
87081 Culture, presumptive, pathogenic organisms, screening only
87205 Smear, primary source with interpretation; Gram or Giemsa stain for bacteria, fungi, or cell types
87590 Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, direct probe technique
87591 Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, amplified probe technique
87492 Infectious agent detection by nucleic acid (DNA OR RNA); Neisseria gonorrhoeae, quantification
87800 Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; direct probe (also used for organisms other than Neisseria gonorrhoeae)
87801 Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; amplified probe (also used for organisms other than Neisseria gonorrhoeae)



Other Information and Resources

Business Group Resource(s)

CDC Resource



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.

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.



References

1 Glass N, Nelson H, Villemyer K. Screening for gonorrhea: Recommendation statement. U.S. Preventive Services Task Force. AHRQ Publication No. 05-0579-A. Rockville, MD: Agency for Healthcare Research and Quality; May 2005.
2 Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. 2006 Disease Profile, 2008.
3 Glass N, Nelson HD, Villemyer K. Screening for gonorrhea: Update of the evidence for the U.S. Preventive Services Task Force. AHRQ Publication No. 05-0579-B. Rockville, MD: Agency for Healthcare Research and Quality; May 2005.
4 Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance, 2007. Atlanta, GA: U.S. Department of Health and Human Services; December 2008.
5 Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR. 2006;55(11).
6 Chesson HW, Blandford JM, Gift TL, Tao G, Irwin KL. The estimated direct medical cost of sexually transmitted diseases among American youth, 2000. Perspect Sex Reprod Health. 2004; 36(1):11-19.
7 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.
8 Yeh JM, Hook EW, Goldie SJ. A refined estimate of the average lifetime cost of pelvic inflammatory disease. Sex Transm Dis. 2003;30(5):369-78.
9 Thomson Reuters. 2007 MarketScan® Commercial Claims and Encounters Database. 2009.
10 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.
11 Owusu-Edusei J, Kwame , Gift TL, Chesson HW. Treatment Cost of Acute Gonococcal Infections: Estimates From Employer-Sponsored Private Insurance Claims Data in the United States, 2003-2007. Sex Trans Dis. (in press).
12 Aledort JE, Hook III EW, Weinstein MC, Goldie SJ. The cost-effectiveness of gonorrhea screening in urban emergency departments. Sex Transm Dis. 2005;32(7):425-436).
13 Center for Disease Control and Prevention. Gonorrhea - STD Fact Sheet. Atlanta, GA: Centers for Disease Control and Prevention; 2004. Available at: http://www.cdc.gov/std/Gonorrhea/STDFact-gonorrhea.htm. Accessed December 23, 2008.
14 Centers for Disease Control and Prevention. Update to CDC's Sexually Transmitted Diseases Treatment Guidelines, 2006: Fluoroquinolones No Longer Recommended for Treatment of Gonococcal Infections. MMWR. 2007;56: 332-336.