Clinical Policy Title: Gonorrhea screening

Transcription

1 Clinical Policy Title: Gonorrhea screening Clinical Policy Number: Effective Date: December 1, 2017 Initial Review Date: October 19, 2017 Most Recent Review Date: November 16, 2017 Next Review Date: November 2018 Related policies: CP# CP# Chlamydia screening Treatment for infertility Policy contains: Gonorrhea. Neisseria gonorrhea. Sexually transmitted infection. Sexually transmitted disease. Pelvic Inflammatory Disease. Salpingitis. Endometritis. ABOUT THIS POLICY: AmeriHealth Caritas Louisiana has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Louisiana s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Louisiana when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Louisiana s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Louisiana s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Louisiana will update its clinical policies as necessary. AmeriHealth Caritas Louisiana s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Louisiana considers the use of screening for Neisseria gonorrhoeae (N. gonorrhoeae) to be clinically proven, and therefore medically necessary when any of the following criteria are met (CDC, 2015; USPSTF, 2014; USPTSF, 2016): 1. Women under age 25 who are sexually active. 2. Women over age 25 who are at increased risk (i.e. they have a new partner, or their sexual partner has multiple partners, or they have multiple partners). a. Women in category 1 and 2 above who test positive and are treated should be retested three months after treatment. 3. Pregnant women, during first prenatal visit and in the third trimester. They should be retested three months after treatment. 4. All women who are diagnosed with gonococcal Pelvic Inflammatory Disease should be retested three months after completing treatment. 1

2 5. Sexually active men having sex with men, with no other risk factors (at least annually), at sites of contact (urethra, rectum, pharynx), regardless of condom use. Men in this category should be tested every three to six months if they are at increased risk (i.e. they or their sexual partners have multiple partners). 6. Persons who are HIV-positive and sexually active should be screened at their first HIV assessment, and at least annually thereafter. Depending on individual risk behaviors and the local epidemic, it may be necessary to screen more frequently. 7. Members who have signs or symptoms of N. gonorrhoeae. 8. Screening of extra-genital sites should be based on self-reported risk. 9. Screening should take place among persons ages 15 to 65, and among persons of any age who are sexually active. Nucleic acid amplification testing is recommended for gonorrhea in urine and in genital sites (CDC, 2015). Nucleic acid amplification tests for the genetic code of gonorrhea. First-catch urine or endocervical swabs are appropriate sources. While gram stain may be sufficiently sensitive to detect gonorrhea in urine or urethral secretions of symptomatic men, it is not sensitive enough among asymptomatic men. The CDC considers MB/GV stain of urethral secretions as an alternative point-of-care diagnostic test that performs similarly to Gram stain. Gram stain is considered to be an insufficient test of endocervical, pharyngeal, and rectal specimens. Nucleic acid amplification testing has not been approved by the FDA for detecting gonorrhea in specimens from rectal, oropharyngeal, or conjunctival sites. Some nucleic acid amplification tests may have low specificity for oropharyngeal specimens. Culture should be used for detection of gonorrhea from these sites. Laboratories should maintain the ability to culture for gonorrhea for cases of suspected child sexual assault in prepubescent boys and extragenital sites in prepubescent girls. Nonculture tests do not provide antimicrobial resistance results. Therefore, when treatment failure is suspected or documented, both culture and antimicrobial susceptibility testing should be performed. Limitations: All other screening for N. gonorrhoeae is considered investigational/experimental, and therefore not medically necessary. Alternative covered services: None. Background 2

3 At cases per 100,000 in 2016, Neisseria gonorrhoeae (gonorrhea) infections are the second most common notifiable disease in the United States after Chlamydia trachomatis (chlamydia) (CDC, 2017). This represents an increase of 18.5 percent over the previous year, and an increase of 48.6 percent over a historic low in Infection may be spread to mucous membrane tissue through unprotected sexual contact, or to neonates during birth. The male urethra and female cervix are the most commonly infected sites, but mucosal infections of rectal, pharyngeal, and conjunctival tissue are also commonly reported. Transmission from the pharynx to the male urethra has been documented. Males often experience urethritis and painful urination within a few days after exposure, generally prompting them to seek medical treatment, but often not in time to prevent transmission to their sexual partners (CDC, 2015). Cervical, oral, and rectal infections tend to be asymptomatic or to result in mild symptoms, making identification and treatment more challenging. It is unknown whether untreated reservoirs of infection in these tissues are contributing to the current increase in multi-drug resistant gonorrhea. Adolescent or adult ocular infection is likely to have a unilateral presentation and patients may initially be treated for presumptive bacterial conjunctivitis before receipt of laboratory results (Sadowska-Przytocka, 2016). Infants are prophylactically treated at birth to prevent ocular infection, in case gonorrhea bacteria are present in the vagina (USPSTF, 2014). Sequelae of N. gonorrhoeae include Pelvic Inflammatory Disease, arthritis, Fitz-Hugh-Curtis syndrome (infectious hepatitis), epididymitis, and disseminated gonococcal infection. Pelvic Inflammatory Disease may be caused by gonorrhea, chlamydia, cytomegalovirus, Mycoplasma hominis, Ureaplasma urealyticum, and Mycoplasma genitalium (Risser, 2017). It often develops near the start of the menstrual cycle after inoculation, when the infection ascends the reproductive tract. Mild to moderate cases of Pelvic Inflammatory Disease may present with endometritis and salpingitis, or may be asymptomatic, while more severe cases may present with tubo-ovarian abscess or pelvic peritonitis. Patients may also report increased or prolonged menstrual bleeding, more painful or longer lasting dysmenorrhea, dysuria, dyspareunia, and increased vaginal discharge. Pelvic inflammatory disease can result in chronic pain, infertility, and tubal pregnancy. Even mild or asymptomatic cases of Pelvic Inflammatory Disease may result in infertility (Weisenfeld, 2012). Disseminated gonococcal infection may occasionally be complicated by perihepatitis, endocarditis, or meningitis (CDC, 2015). Risk factors for gonorrhea include inconsistent condom use among persons who are not in a mutually monogamous relationship, sex with a new partner, sex with a partner who has a concurrent or multiple partners, sex with more than one concurrent partner, and sex with a partner who has a sexually transmitted infection (USPSTF, 2014). Additionally, abuse of alcohol or other substances and early sexual debut increase the risk for sexually transmitted infections (NICE, 2007). Males and females ages 15 to 29 tend to have the highest infection rates (CDC, 2017). Among the gonorrhea diagnoses reported in 2016 with race and ethnicity included in the report, most racial minorities were disproportionately affected. The case rate per 100,000 among Blacks (481.2) was 8.6 times that among Whites (55.7). The case rate among American Indians/Alaska Natives (242.9) was 4.4 that among Whites. The case rate among Native Hawaiians/Other Pacific Islanders (165.8) was three times that of Whites. The rate among 3

4 Hispanics (95.9) was 1.7 times that among Whites. The rate among Multiracial persons was (62.3) was 1.1 times that among Whites. Only among Asians (28.3) was the rate lower than that among Whites. During 2012 to 2016, the case rate increased among every racial/ethnic group. Reinfection after treatment is common, and inoculation and treatment do not confer immunity (Edwards, 2016). Providers should consider the community context in which they serve and may choose to reach out to the local public health authority for information on local epidemics (USPSTF, 2014). Searches AmeriHealth Caritas Louisiana searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on September 26, Search terms were: gonorrhea, test, and diagnosis. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Individuals at increased risk of sexually transmitted infection should be identified through taking a sexual history (NICE, 2007). Non-genital sites of infection are often asymptomatic (CDC, 2015; Drinkard, 2017). Screening of non-urogenital sites should be risk-based and based on patient self-reported behavior. Taking thorough sexual health histories allows those persons at risk of extragenital infection to be identified and screened. There are currently no recommendations for screening women at extragenital sites. A two-year prospective study in two Baltimore public sexually transmitted disease clinics found an extragenital gonococcal prevalence of 2.4% among women who reported extragenital exposure (Trebach, 2015). Gonorrhea and chlamydia have the same risk factors and similar symptoms, but require different treatment. Therefore patients are usually tested for both. 4

5 In populations that do not have the option of clinic-based testing, or that refuse a clinical exam or may not go for testing, home-based self-specimen collecting for gonorrhea through use of a vaginal swab for women or a urine sample for men has the potential of reaching individuals for testing, diagnosis and treatment of infection in urogenital tracts. While one meta-analysis found that the sensitivity and specificity of home tests were acceptable but noted that there are no guidelines for collection (Lunny, 2015), a systematic review found that high heterogeneity prohibiting pooling of the samples, and concluded that the matter needs further study (Farjardo-Bernal, 2015). The problem of drug resistance presents a major and ongoing threat to gonorrhea treatment. The Centers for Disease Control list multi-drug resistant gonorrhea as one of three urgent hazard-level threats to the population of the United States (CDC, 2013). The genetic material of gonorrhea bacteria has an ability both to mutate and to acquire resistant material from other bacteria (Wetzler, 2016). Over a period of 70 years of developing resistance to various antibiotic treatments, extended-spectrum cephalosporins (ceftriaxone and cefixime) are currently the single remaining class of antibiotics recommended for monotherapy across many settings. A growing number of reports of international treatment failures and isolation of strains highly resistant to ceftriaxone, as well as isolation of crossdrug resistant strains, have led to fears of an untreatable gonorrhea superbug (Unemo, 2012). Development of new antibiotics and a vaccine are urgently needed (Edwards, 2016). Gonococcal treatment recommendations necessarily shift based on the epidemiology of antimicrobial treatment resistance development (CDC, 2015). Resistance to fluoroquinolones was identified in the United States in 2007, leaving cephalosporins as the only class of drugs remaining for treatment of gonorrhea in the nation. Only one regimen is currently recommended for treatment of urogenital, pharyngeal, and rectal gonorrhea in the U.S.: dual therapy with ceftriaxone (250 mg IM in a single dose) and azithromycin (1 g orally in a single dose), administered together and on the same day, preferably under direct observation. If ceftriaxone is not available, an alternate dual regimen of cefixime (400 mg orally in a single dose) combined with azithromycin (1 g orally in a single dose) may be used, however, the latter is not as effective against pharyngeal infection, and it is feared that use of cefixime could hasten the development of resistance to ceftriaxone. For treatment of persons with a known cephalosporin or IgE-mediated penicillin allergy, and for treatment of sites other than the urogenitalia, pharynx and rectum, it is recommended to consult an infectious disease specialist (CDC, 2015). It is recommended to consult the Centers for Disease Control s Gonococcal Isolate Surveillance Project ( and state health departments for the most recent information on drug susceptibility and resistance. Persons being treated for gonorrhea should refrain from sexual contact for seven days, and their sexual partners from the past 60 days should be treated. Treatment of sexual partners prevents reinfection and limits further transmission. Sexual partners may be referred for free treatment to local public health authorities. In circumstances when a heterosexual partner is unlikely to seek timely evaluation and treatment, the 5

6 Centers for Disease Control considers Expedited Partner Therapy, the clinical practice of treating the sex partners of patients diagnosed with chlamydia or gonorrhea by providing prescriptions or medications to the patient to take to his/her partner without the health care provider first examining the partner [italics in original], to be a useful option for facilitating partner management, especially for male partners of females treated for gonorrhea or chlamydia (CDC, 2016; 2017). Expedited Partner Therapy has been shown to reduce gonorrhea reinfection rates, however, its self-administration necessitates oral dosing of medication (cefixime 400 mg accompanied by azithromycin 1 mg), rather than the optimal intramuscular injection of ceftriaxone 250 mg accompanied by an oral dose of azithromycin 1g. The CDC does not recommend Expedited Partner Therapy for men who have sex with men. While ongoing evaluation of Expedited Partner Therapy is needed, it should be available as an option for managing the treatment of partners. It is not intended to replace other strategies such as provider-assisted referral, when available (CDC, 2017). Expedited Partner Therapy is not allowed in every state. The current legal status of Expedited Partner Therapy may be found at The American Academy of Family Physicians supports Expedited Partner Therapy and recommends that clinicians should determine state legal requirements (AAFP, 2017). Policy updates: None. Summary of clinical evidence: Citation Fajardo-Bernal (2015) Home-based versus clinicbased specimen collection in the management of Chlamydia trachomatis and Neisseria gonorrhoeae infections Lunny (2015) Content, Methods, Recommendations Key points: Home testing could be a way for those who refuse to go to clinics or to have a clinical exam to be tested. Heterogeneity did not allow the samples to be pooled. Sample sizes were small. Potential harms of home testing were not studied. This area remains investigational. Key points: Self-collected versus clinician-collected sampling for chlamydia and gonorrhea screening: A systemic review and meta-analysis While 21 studies were overall included in this meta-analysis, only seven examined gonorrhea. In men, clinician-collected urethra swabs were compared with self-collected urine in three studies (total n = 1012). All samples were collected in the clinic. The pooled sensitivity was 0.92 (95% CI ) and specificity was 0.99 (CI ). Two different assays were used. Sensitivity was lower in two studies that used Amplicor- Cobas, reducing specificity to 0.90 (CI ). LCx had higher specificity. In women, clinician-collected cervical swabs were compared with self-collected urine in three studies (total n = 2066). All samples were collected in the clinic. The pooled sensitivity was 0.79 (95% CI ). The pooled specificity was 0.99 (CI ). 6

7 Citation Trebach (2015) Content, Methods, Recommendations They each used a different assay. One study which had a sensitivity of 0.32 (CI ) may have had a problem with samples which were repeatedly frozen and thawed or the result may be due to the assay used (primer plus Amplicor-Cobas). In women, clinician-collected cervical samples were compared with self-collected vaginal swabs in one study (n = 309). The sensitivity was 0.98 (95% CI ) and specificity was 0.97 (CI ). In men and women, clinician collected rectal samples were compared with self-collected rectal swabs. For females (n = 697), the sensitivity was 0.85 (95% CI ) and specificity was 1.0 (CI ). For males (n = 929), the sensitivity was 0.88 (CI ) and specificity was 0.98 (CI ). In men who have sex with men, clinician-collected pharyngeal samples were compared with self-collected swabs (n = 473). Sensitivity was 0.91 (95% CI ) and specificity was 0.97 (CI ). Vaginal swab self-collection is supported most strongly. Male urine testing was viable, while the others were weaker. Screening tests should be highly sensitive. Issues with sample size and handling of specimens were sources of bias. Rectum and throat samples were tested using nucleic acid amplification testing which was an off-label use. There were insufficient studies that investigated these sites. Key points: Neisseria gonorrhoeae and Chlamydia trachomatis among women reporting extragenital exposures There are routine recommendations for extragenital screening among men who have sex with men and among people living with HIV but not among other populations. A two-year prospective study in two Baltimore sexually transmitted disease clinics tested all patients who reported extragenital exposures in the preceding three months, and compared extragenital infection prevalence. A total of 10,389 participants were included, among whom 88% were African-American. The mean age was 29 years; 42% were female, and 7% were men who have sex with men. 2.4% of women, 2.6% of men who have sex with women, and 18.9% of men who have sex with men had positive findings for extragenital N. gonorrhea. In women, 30.3% of infections would have been missed without extragenital screening. Six to ten times as many women compared to men who have sex with men would need to be tested to identify one case in women. Being 18 or under was the highest predictor of extragenital infection in women. Younger ages were four times as likely as women over 18 to have an extragenital infection, and there was a similar difference among men who have sex with men. It remains to be studied whether extragenital testing can be cost-effective. In men, it may depend on the impact of rectal infection on HIV incidence. It is unknown whether extra-genital testing can be cost-effective in women. Limitations: culture was used rather than nucleic acid amplification testing. Nelson (2014) Key points: Screening for gonorrhea and chlamydia: Systematic review to update the U.S. This systematic review updates the 2005 and 2007 systematic reviews on gonorrhea and chlamydia screening for the U.S. Preventive Services Task Force. Six studies of diagnostic accuracy for gonorrhea included in this review compared 7

8 Citation Preventive Services Task Force Recommendations Hosenfeld (2009) Content, Methods, Recommendations nucleic acid amplification with culture or expanded reference standards (positive result on two nonculture tests or two different specimens, or positive result on the original test and a confirmatory test). They were mostly performed in asymptomatic persons and three were performed in settings of prevalence > 5 percent. Nucleic acid amplification tests demonstrated sensitivity of percent in studies without major limitations. Specificity was > 97 percent across all specimens and tests. In women, nucleic acid amplification tests showed little variation between endocervical, clinician- and self-collected vaginal, and urine specimens. In men, urethral specimens had slightly lower sensitivity than urine specimens. These are improved performance results compared to the 2005 review. Only FDA-approved use was included. Tests used included transcription mediated amplification (TMA); polymerase chain reaction (PCR), including a new rapid test; strand displacement amplification (SDA) Gonorrhea infection can be detected by nucleic acid amplification tests using male and female urine and clinician-collected endocervical, vaginal, and male urethral specimens. Gonorrhea can also be detected by culture, which is recommended for diagnosing resistant strains and for detecting strains with decreased antimicrobial susceptibility. Antimicrobial susceptibility testing can only be performed using culture. All sexual partners from the 60 days previous should be evaluated and treated for infection. All patients diagnosed with gonorrhea should be retested 3 months after treatment. While screening with NAATs is accurate for diagnosing gonorrhea and chlamydia in asymptomatic persons regardless of specimen or anatomical site, use of these tests in non-urogenital sites has not been approved by the FDA. Key points: Repeat infection with chlamydia and gonorrhea among females: A systematic review of the literature A total of 47 studies from the United States and other industrialized countries were included that estimated reinfection with gonorrhea or chlamydia in females. Among 17 studies that included females with gonorrhea, a median of 11.7% were reinfected upon retesting. A risk factor for reinfection was younger age. The high rate of reinfection necessitates retesting. Research should test interventions to lower reinfection rates and to increase retesting rates. References Professional society guidelines/other: American Academy of Family Physicians. Expedited Partner Therapy. AAFP Policies Updated April Accessed October 16, Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 8

9 2015.MMWR Recomm Rep 2015;64(No. RR-3): Atlanta: U.S. Department of Health and Human Services; Accessed October 4, Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, Atlanta: U.S. Department of Health and Human Services; Accessed October 4, Centers for Disease Control and Prevention. Expedited Partner Therapy Updated July 3, Accessed October 16, Centers for Disease Control and Prevention. Guidance on the use of Expedited Partner Therapy in the treatment of gonorrhea. Updated December 9, Accessed October 16, Centers for Disease Control and Prevention. Gonococcal Isolate Surveillance Project (GISP). Division of STD Prevention. Updated July 29, Accessed October 4, Centers for Disease Control and Prevention. Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseria gonorrhoeae MMWR (RR02); Centers for Disease Control and Prevention. Screening recommendations and considerations referenced in treatment guidelines and original sources. Atlanta: U.S. Department of Health and Human Services; Updated August 22, Accessed September 26, Centers for Disease Control and Prevention Sexually transmitted disease surveillance. Atlanta: U.S. Department of Health and Human Services; Updated September 26, Accessed September 26, National Institute for Health and Care Excellence (NICE). Sexually transmitted infections and under-18 conceptions: prevention. London: NICE, February Accessed September 26, Nelson HD, Zakher B, Cantor A, Deagas M, Pappas M. Screening for gonorrhea and chlamydia: Systematic review to update the U.S. Preventive Services Task Force Recommendations. AHRQ Publication No EF-1 Rockville (MD); Agency for Healthcare Research and Quality; Accessed October 4, U.S. Preventive Services Task Force (USPSTF). Final Evidence Review for Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication

10 Accessed October 3, U.S. Preventive Services Task Force (USPSTF). Final Recommendation Statement: Chlamydia and Gonorrhea: Screening mydia-and-gonorrhea-screening. Accessed October 3, Peer-reviewed references: Drinkard LN, Huxta RA, Halbritter A, Nguyen GT, Malebranche D. The case for extragenital screening of chlamydia trachomatis and Neisseria gonorrhoeae in the college health setting. Sex Transm Dis. 2017;44(5): doi: /OLQ Edwards JL, Jennings MP, Apicella MA, Seib KL. Is gonococcal disease preventable? The importance of understanding immunity and pathogenesis in vaccine development. Crit Rev Microbiol. 2016;42(6): doi: / x Fajardo-Bernal L, Aponte-Gonzalez J, Vigil P, et al. Home-based versus clinic-based specimen collection in the management of Chlamydia trachomatis and Neisseria gonorrhoeae infections. Cochrane Database of Systematic Reviews. 2015(9). doi: / CD pub2. Hosenfeld CB, Workowski KA, Berman S, et al. Repeat infection with chlamydia and gonorrhea among females: A systematic review of the literature. Sex Transm Dis. 2009;36(8): doi: /OLQ.0b013e3181a2a933. Lunny C, Taylor D, Hoang L, et al. Self-collected versus clinician-collected sampling for chlamydia and gonorrhea screening: A systemic review and meta-analysis. PLoS One. 2015;10(7):e doi: /journal.pone McAnena L, Knowles SJ, Curry A, Cassidy L. Prevalence of gonococcal conjunctivitis in adults and neonates. Eye. 2015;29(7): Risser WL, Risser JM, Risser AL. Current perspectives in the USA on the diagnosis and treatment of Pelvic Inflammatory Disease in adolescents. Adolesc Health Med Ther. 2017;8: doi: /AHMT.S Trebach JD, Chaulk CP, Page KR, Tuddenham S, Ghanem KG. Neisseria gonorrhoeae and Chlamydia trachomatis among women reporting extragenital exposures. Sex Transm Dis. 2015;42(5): Doi: /OLQ Sadowska-Przytocka A, Czarnecka-Operacz M, Jenerowicz D, Grzybowski A. Ocular manifestations of 10

11 infectious skin diseases. Clin Dermatol. 2-16;34: doi /j.clindermatol Unemo M, Nicholas RA. Emergence of multidrug-resistant, extensively drug-resistant and untreatable gonorrhea. Future microbiol. 2012;7(12): doi: /fmb Wetzler LM, Feavers IM, Gray-Owen SD, Jerse AE, Rice PA, Deal CD. Summary and recommendations from the National Institute of Allergy and Infectious Diseases (NIAID) Workshop Gonorrhea Vaccines: the Way Forward. Clin Vaccine Immunol. 2016;23(8): doi: /CVI Wiesenfeld HC, Hillier SL, Meyn LA, Amortegui AJ, Sweet RL. Sub-clinical Pelvic Inflammatory Disease and infertility. Obstet Gynecol. 2012;120: doi: /AOG.0b013e31825a6bc9. CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments Infectious agent antigen detection by immunoassay with direct optical observation; Neisseria gonorrhoeae Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, direct probe technique Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, amplified probe technique Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, quantification ICD-10 Code Description Comments Z11.3 Encounter for screening for infections with a predominantly sexual mode of transmission HCPCS Level II Code N/A Description No Applicable Codes Comments 11