Clinical Policy Title: Chlamydia screening

Transcription

1 Clinical Policy Title: Chlamydia 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: Policy contains: Chlamydia. C. trachomatis. Pelvic inflammatory disease. Sexually transmitted diseases. CP# Gonorrhea screening 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 Chlamydia trachomatis (C. trachomatis) to be clinically proven, and therefore medically necessary when any of the following criteria are met: 1. Non-pregnant women under age 25 who are sexually active or otherwise at risk (annually). 2. Women over age 25 who are at high risk (annually). 3. Sexually active men having sex with men, with no other risk factors (at least annually). 4. Sexually active men having sex with men if they are HIV-positive, have persistent high-risk behavior, or if partners have multiple partners (every three months). 5. Members who have signs or symptoms of C. trachomatis. 6. Pregnant women, during first prenatal visit, in the third trimester, and three months after treatment. 7. Screening should take place among persons age 15 and 65, and among persons of any age who are sexually active (USPSTF, 2007; LeFevre, 2014; CDC, 2017c). 1

2 Collecting urogenital specimen types for C. trachomatis is done using nucleic acid amplification tests, including first catch-urine for men and cervical swabs for women (CDC, 2015). Limitations: All other screening for C. trachomatis is considered investigational/experimental, and therefore not medically necessary. Alternative covered services: None. Background Chlamydia, or C. trachomatis, is a bacterium that is transmitted through sexual contact with the penis, vagina, mouth, or anus of an infected partner. The condition can also be spread from an infected mother to the baby during birth, which can cause conjunctivitis or pneumonia in some infants. C. trachomatis can lead to cervicitis in women and urethritis and proctitis in men and women. Other consequences associated with C. trachomatis include pelvic inflammatory disease, tubal factor infertility, ectopic pregnancy, and chronic pelvic pain (CDC, 2017b). Acute and subclinical pelvic inflammatory disease can permanently damage fallopian tubes, uterus, and surrounding tissues, and cause chronic pelvic pain, tubal factor infertility, and potentially fatal ectopic pregnancy (CDC, 2017a). An estimated 35 percent of pelvic inflammatory disease in United Kingdom females age years was caused by C. trachomatis; this figure rises to 53.5 percent for women age (Price, 2016a). The World Health Organization estimates the number of annual new cases of C. trachomatis to be 131 million, with a prevalence of 4.2 percent (Newman, 2015). In the U.S. the number of reported new cases was 1,598,354 in Large rises have occurred in the number of cases (+55 percent) and the rate per 100,000 population (+44 percent) in the past decade, with an increase reported each year. About 90 percent of cases are diagnosed at age (mostly age 15-24), and two-thirds are females. Large disparities exist in incidence rates per 100,000 among major racial/ethnic groups, including blacks (1125.9), Hispanics (374.9), whites (199.8), and Asians (119.3) in 2016 (CDC, 2017a). More specifically, U.S. prevalence percentages in those targeted for screening are as high as 4.7 percent for sexually active females age (13.5 percent among non-hispanic black females) from (Torrone, 2014). Most infected persons with C. trachomatis have no symptoms or physical findings for considerable periods of time, making the disease difficult to treat promptly and underlining the need for a strong screening effort. Infections are found in the cervix, urethra, and the upper respiratory tract in females, and in the urethra and testicles in men. Rectal symptoms can occur in both genders, and the infection can be found in the throats of both women and men, usually asymptomatic (CDC, 2017a). 2

3 C. trachomatis can lead to peri-hepatitis, or Fitz-Hugh-Curtis Syndrome, in which the liver capsule is inflamed and pain is present in the right upper quadrant. Arthritis, along with urethritis and conjunctivitis, may also be a result of the bacterium. The risk of acquiring Human Immunodeficiency Viris is raised by the presence of C. trachomatis. Newborns of infected mothers have greater risk of pre-term delivery, conjunctivitis, and pneumonia. A review of 12 studies calculated elevated risk from presence of C. trachomatis of 35 percent for preterm labor, 52 percent for low birth weight, and 84 percent for perinatal mortality, all significant. C. trachomatis was not associated with elevated risk for premature membrane rupture, abortion, and postpartum endometritis (Silva, 2011). A variety of tests are used to diagnose chlamydia, including nucleic acid amplification tests and cell cultures. The most common methods of diagnosis are vaginal swabs for females and urine samples for males; urine samples can also be used for women. Rectal and pharyngeal swabs are also used. A seven-day course of antibiotics is the preferred treatment for persons with C. trachomatis, including infants. Abstinence is advised until the course is complete. Treatment removes the infection, but not permanent damage from the disease. Re-testing is recommended in three months (CDC, 2017a). Screening for C. trachomatis is important, since many cases have no obvious symptoms. Young persons should be a focus; a national survey revealed 91.5 percent of Medicaid women age 18 to 25 selfreported to be sexually active (Tao, 2015). The Affordable Care Act requires private insurers issuing or renewing plans starting September 23, 2010 to provide certain preventive services recommended by the U.S. Preventive Services Task Force, including chlamydia for sexually active women under 25 years and older, at-risk women (Loosier, 2014). The U.S. Preventive Services Task Force (USPSTF) recommended screening for C. trachomatis for all sexually active and other at-risk women under age 25 who are not pregnant, along with older, nonpregnant women at risk. No recommendation could be made for women age 25 and older not at high risk, regardless of whether they are pregnant. Sufficient evidence was not found to recommend when males should be screened for C. trachomatis (LeFevre, 2014). The National Institute for Health and Care Excellence (NICE) has also issued a guideline that only covered populations under 18 (NICE, 2007). The U.S. Centers for Disease Control and Prevention (CDC) concurred with the USPSTF, adding sexually active women under 25 and older women with risk factors should be screened annually. The CDC also specified that pregnant women should be screened at the first prenatal visit and in the third trimester. It indicated sexually active men having sex with men should be screened at least annually (every three months if they are HIV-positive), have persistent high-risk behavior, or if their partners have multiple partners (CDC, 2017c). The Health Plan Employer Data and Information Set (HEDIS) administered by the National Committee for Quality Assurance measures the percent of female members in a plan who are age 16 to 24, identified as sexually active who had at least one C. trachomatis test during the past year (NCQA, 2016). 3

4 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 29, Search terms were: chlamydia, and C. trachomatis. 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 A Cochrane review of six trials (n=359,078) addressed the effectiveness of C. trachomatis screening. After three yearly screening invitations (n=317,304), no change was observed in chlamydia test positivity (intervention and control 4.1 versus 4.3 percent). After four years of screening, chlamydia prevalence (n=4465) was significantly (28 percent) lower. Screening was linked with a reduction in pelvic inflammatory disease 12 months later (n=21,686). Epididymitis risk in 14,980 invited men was 20 percent lower (not significant) than those not invited after 12 months (Low, 2016). HEDIS data compiled by the National Committee for Quality Assurance show that 2015 screening rates of members differ according to type of plan. The data displayed here show Medicaid HMO plans had the highest rates of screening, followed by commercial HMO and commercial PPO plans (NCQA, 2016): Women age Years Age Years Medicaid HMO 51.5% 60.6% Commercial HMO 41.9% 52.3% Commercial PPO 38.2% 47.7% The Group Health Cooperative of Seattle increased female testing rates by 23 percent from While the C. trachomatis rate rose 79 percent (449 to 806 cases per 100,000 person-years), pelvic inflammatory disease rate declined 43 percent (823 to 473 cases per 100,000 person-years, p<.01). 4

5 Male chlamydia rates more than doubled, from 91 to 218 per 100,000 person-years (Scholes, 2012). In 10 states, of 261,000 Medicaid-insured women age classified as sexually active, the C. trachomatis testing rate was 45.6 and 57.5 percent for white and black women, and 63.5 and 46.8 percent for women diagnosed and not diagnosed with a sexually transmitted disease the prior year (Patel, 2016). The risks of not screening at-risk population segments has also been addressed by the U.K. National Chlamydia Screening Programme, begun in An untreated C. trachomatis infection results in pelvic inflammatory disease in 17.1 percent of cases, and salpingitis in 7.3 percent of cases (Price, 2016b). A systematic review of 25 programs, eight each in the U.S. and Australia, found screening targeted mostly at persons age 15-29, men who have sex with men, and sex workers produced a C. trachomatis rate of 7.7 percent. Participation rates in community centers, sporting venues, and bars were high, while streets, public community areas, and sex on premises venues had low rates (Hengel, 2013). A systematic review/meta-analysis of 19 studies determined infertility was significantly more prevalent (Odds ratio = 2.2) in persons with C. trachomatis. In 15 studies, significance (Odds ratio = 4.9 and 3.3 for males and females) was documented for asymptomatic patients with C. trachomatis than those without. The study called for screening and treatment focused on asymptomatic patients (Ahmadi, 2016). A worldwide review of 27 studies of over 47,000 students found a median positivity of 4.7 percent for C. trachomatis, and a 100 percent median treatment rate. Two studies reported repeat positivity rates 21.1 and 26.3 percent and thus more outcomes need to be reported in school screening (Jamil, 2014). A study of 4093 male students at the University of Pennsylvania revealed C. trachomatis positivity of 3.1 and 3.7 percent for those screened using urogenital and extragenital methods; 26.4 percent of cases would have been missed if screening had only used urogenital methods (Drinkard, 2017). A recent Cochrane review of 15 studies (n=1754) assessed efficacy of antibiotics to treat C. trachomatis. All drugs had significantly greater cure rates than placebo. The drugs amoxicillin, erythromycin, clindamycin, and azithromycin had similar outcomes to each other in cure, repeat infection, and pregnancy complications (preterm birth, preterm rupture of membranes, low birthweight). Erythromycin was observed to have more side effects than azithromycin and clindamycin (Cluver, 2017). Another study found a modest improved efficacy for doxycycline versus azithromycin (Kong, 2014). New information about the hazards of C. trachomatis is still emerging. A meta-analysis of 22 studies with 4291 cervical cancer cases and 7628 controls included five studies that concluded C. trachomatis was significantly linked to elevated risk of cervical cancer risk in prospective and retrospective studies (P < 0.001), which had been a controversial research topic (Zhu, 2016). A systematic review of 33 articles on C. trachomatis and other sexually transmitted diseases found many commercially used tests had sensitivities over 90 percent, but specificities under 50 percent. In 2010, the Chlamydia Rapid Test, a new point-of-service test, showed limited sensitivity (52 64 percent) but high specificity (97 percent) in detecting the disease (Hislop, 2010). Since then, greater accuracy of 5

6 point-of-service tests have been reported, offering potential improvements in care since results can be obtained minutes after the test, while the patient is still in the office (Herbst de Cortina, 2016). C. trachomatis can be tested at home. A Cochrane review of 10 studies (n=10,479) found specimens collected at home had a statistically lower percent with a positive test than those at a clinic, or 11.6 versus 18.5 percent; authors called for comparisons of outcomes between the two groups (Fajardo- Bernal, 2015). A systematic review of seven trials showed home based screening improved uptake, and was preferred by subjects (Odesanmi, 2013), which matched the finding of an earlier study of 19,773 screening invitations in the U.K. (Low, 2007). A review of 21 studies (n=6100) compared sensitivity and specificity of self-collected vaginal swabs versus clinically-collected cervical swabs for females (92 and 98 percent), and urine self-samples versus urethra clinician collected samples (88 and 99 percent). Authors state data support vaginal swab as the recommended specimen in home-based screening (Lunny, 2015). Persons being treated for chlamydia 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. When a heterosexual partner is unlikely to seek timely evaluation and treatment, the CDC and the American College of Obstetrics and Gynecology consider Expedited Partner Therapy as a useful option, especially for male partners of females treated for gonorrhea or chlamydia. This approach involves the treatment of sex partners of patients diagnosed with chlamydia or gonorrhea by providing prescriptions or medications to the patient to take to his/her partner without prior examination of the partner (ACOG, 2015; CDC, 2017d). 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, 2017d). 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 Cluver (2017) Content, Methods, Recommendations Key points: Comparing treatments to Systematic review and meta-analysis of 15 studies (n=1754) of antibiotic treatment to 6

7 Citation prevent maternal infection and adverse neonatal outcomes in pregnant women with C. trachomatis Low (2016) Content, Methods, Recommendations pregnant women with C. trachomatis Three studies compared erythromycin, clindamycin, amoxicillin versus placebo; Five studies compared antibiotics (erythromycin, clindamycin, amoxicillin, azithromycin). Erythromycin and clindamycin both significantly better vs. placebo (RR = 2.64, 4.08) Amoxicillin and azithromycin have similar results vs. erythromycin Key points: Effects of chlamydia screening vs. standard care on chlamydia infection and transmission in pregnant/ non-pregnant women, men Cochrane review of six trials (n=359,078) invited for screening Study of 317,304 in the Netherlands found no change in chlamydia test positivity after three yearly invitations (intervention 4.1% vs control 4.3%) Four randomized trials (n=21,686) found 32% lower pelvic inflammatory disease risk in women in intervention group vs. control, 12 months after single screening offer Epididymitis risk in men invited for screening, 12 months after a screening offer, was 20% lower risk for epididymitis than in those not invited; quality of evidence very low Lunny (2015) Key points: To compare accuracy of home vs. lab collection of chlamydia detection Review of 21 studies of 6100 paired sample subjects. Six studies of self-collection by vaginal swab vs. clinician-collected cervical swab had the highest sensitivity (92%), and specificity (98%), vs. urine in the urethra or cervix. Six studies comparing urine self-samples to urethra clinician-collected samples in males produced a sensitivity of 88% and specificity of 99%. Data support vaginal swab as specimen of choice in home chlamydia screening Hengel (2013) Outreach strategies used to increase participation in screening for C. trachomatis and other STDs Scholes (2012) Long term trends of C. trachomatis in a managed care population Key points: Study of 25 screening programs, including 8 in the U.S. and 8 in Australia Most common targets were persons years (52%), men who have sex with men (24%) and sex workers (8%). Mean positivity rate for C. trachomatis was 7.7% Median participation rate 53%; median of 79.6% of participants were tested Highest median participation rates found in community service venues (81.4%), and social venues (80.4%), lowest found in street/public community areas (23.9%) and sex on premises venues (10.4% and 24.3%). Key points: Study of Group Health Cooperative (Seattle) members age 15-44, 1997 vs Female chlamydia testing rates rose 23% (220 to 270 tests/1000 person years. Chlamydia diagnosis rate rose 79%, 449 to 806 cases/100,000 person years (P = 0.01). Pelvic inflammatory dis. fell 43%, 823 to 473 cases/100,000 person-years (P< 0.01). In men, chlamydia testing rates increased nearly 3.5-fold, from 12 to 42 tests/1000 person-years. Chlamydia rates for men more than doubled, from 91 cases/100,000 person years to 218/100,000; P < 0.01) as did urethritis diagnosis rates (P < 0.01). 7

8 References Professional society guidelines/other: American Academy of Family Physicians. Expedited Partner Therapy. AAFP Policies Updated April Accessed October 18, American College of Obstetricians and Gynecologists (ACOG). Expedited partner therapy in the management of gonorrhea and chlamydial infection. ACOG Committee Opinion Number 632. Washington DC: ACOG, Opinions/Committee-on-Gynecologic-Practice/Expedited-Partner-Therapy-in-the-Management-of- Gonorrhea-and-Chlamydial-Infection. Accessed October 18, LeFevre ML; U.S. Preventive Services Task Force. Screening for chlamydia and gonorrhea: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(12): National Committee for Quality Assurance (NCQA). Chlamydia screening in women. NCQA, Accessed September 29, National Institute for Health and Care Excellence (NICE). Sexually transmitted infections and under-18 conceptions: prevention. London: NICE, February Accessed September 29, U.S. Centers for Disease Control and Prevention (CDC). Chlamydia CDC Fact Sheet (Detailed). Atlanta GA: CDC, last reviewed September 26, 2017(b). Accessed September 29, U.S. Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases Surveillance. Atlanta GA: CDC, last reviewed September 26, 2017(a). Accessed September 29, U.S. Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases Treatment Guideline. Atlanta GA: CDC, last reviewed January 25, 2017(c). Accessed September 29, U.S. Centers for Disease Control and Prevention. Expedited Partner Therapy Updated July 3, 2017(d). Accessed October 18, U.S. Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 8

9 2015. Morbidity and Mortality Weekly Report, Recommendations and Reports. June 5, 2015, Volume 64, Number 3, p Accessed November 13, U.S. Preventive Services Task Force (USPSTF). Screening for chlamydial infection: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2007;147(2): Peer-reviewed references: Cluver C, Novikova N, Eriksson DO, Bengtsson K, Lingman GK. Interventions for treating genital Chlamydia trachomatis infection in pregnancy. Cochrane Database Syst Rev Sep 22;9:CD doi: / CD pub2. 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): 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 Syst Rev. 2015;(9):CD Hengel B, Jamil MS, Mein JK, Maher L, Kaldor JM, Guy RJ. Outreach for chlamydia and gonorrhea screening: a systematic review of strategies and outcomes. BMC Public Health. 2013;13:1010. Doi: / Herbst de Cortina S, Bristow CC, Joseph Davey D, Klausner JD. A systematic review of point of care testing for chlamydia trachomatis, Neisseria gonorrhoeae, and trichomonas vaginalis. Infect Dis Obstet Gynecol. 2016;2016: Doi: /2016/ Hislop J, Quayyum Z, Flett G, Boachie C, Fraser C, Mowatt G. Systematic review of the clinical effectiveness and cost-effectiveness of rapid point-of-care tests for the detection of genital chlamydia infection in women and men. Health Technol Assess. 2010;14(29):1-97, iii-iv. 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): Jamil MS, Bauer HM, Hocking JS, et al. Chlamydia screening strategies and outcomes in educational settings: a systematic review. Sex Transm Dis. 2014;41(3): Kong FY, Tabrizi SN, Law M, et al. Azithromycin versus doxycycline for the treatment of genital chlamydia infection: a meta-analysis of randomized controlled trials. Clin Infect Dis. 2014;59(2):

10 Loosier PS, Malcarney MB, Silve L, et al. Chlamydia screening for sexually active young women under the Affordable Care Act: new opportunities and lingering barriers. Sex Transm Dis. 2014;41(9): Doi: /OLQ Low N, Redmond S, Uuskula A, et al. Screening for genital chlamydia infection. Cochrane Database Syst Rev Sep 13;9:CD Low N, McCarthy A, Macleod J, et al. Epidemiological, social, diagnostic and economic evaluation of population screening for genital chlamydial infection. Health Technol Assess. 2007;11(8):iii-xiii, 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 Newman L, Rowley J, Vander Hoorn S, et al. Global estimates of the prevalence and incidence of four curable sexually transmitted infections in 2012 based on systematic review and global reporting. PLoS One. 2015;10(12):e doi: /journal.pone Odesanmi TY, Wasti SP, Odesanmi OS, Adeqbola O, Oquntuase OO, Mahmood S. Comparative effectiveness and acceptability of home-based and clinic-based sampling methods for sexually transmissible infections screening in females aged years: a systematic review and meta-analysis. Sex Health. 2013;10(6): Patel CG, Chesson HW, Tao G. Racial differences in receipt of chlamydia testing among Medicaidinsured women in Sex Transm Dis. 2016;43(3): Price MJ, Ades AE, Welton NJ, Simms I, Macleod J, Horner PJ. Proportion of pelvic inflammatory disease cases caused by chlamydia trachomatis: consistent picture from different methods. J Infect Dis. 2016;214(4): Price MJ, Ades AE, Soldan K, et al. The natural history of Chlamydia trachomatis infection in women: a multi-parameter evidence synthesis. Health Technol Assess. 2016b;20(22): Doi: /hta Scholes D, Satterwhite CL, Yu O, Fine D, Weinstock H, Berman S. Long-term trends in Chlamydia trachomatis infections and related outcomes in a U.S. managed care population. Sex Transm Dis. 2012;39(2): Silva MJ, Florenci GL, Babiatti JR, Amaral RL, Eleuterio Junior J, Goncalves AK. Perinatal morbidity and mortality associated with chlamydial infection: a meta-analysis study. Braz J Infect Dis. 2011;15(6):

11 Tao G, Hua J, Chen JL. Understanding sexual activity and Chlamydia testing rate based on linked national survey and Medicaid claims data. PLoS One. 2015;10(4):e Doi: /journal.pone Torrone E, Papp J, Weinstock H; Centers for Disease Control and Prevention (CDc). Prevalence of chlamydia trachomatis genital infection among persons aged years United States, MMWR Morb Mortal Wkly Rep. 2014;63(38): Zhu H, Shen Z, Lui H, Zhang W, Zhu X. Chlamydia trachomatis infection-associated risk of cervical cancer: A meta-analysis. Medicine (Baltimore). 2016;95(13):e3077. 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 Culture, chlamydia, any source Infectious agent antigen detection by immunofluorescent technique; Chlamydia trachomatis Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Chlamydia trachomatis Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, direct probe technique Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, amplified probe technique Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, quantification Infectious agent antigen detection by immunoassay with direct optical observation; Chlamydia trachomatis 11

12 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 12