TUBERCULOSIS (Screening)

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

References


Updated 9/22/11

Evidence Statement

Clinical Preventive Service Recommendations

U.S. Preventive Services Task Force
In 1996, the U.S. Preventive Services Task Force (USPSTF) recommended screening for latent tuberculosis infection (LTBI) with tuberculin skin testing (TST) for asymptomatic high risk persons.1

The USPSTF recognizes the importance of targeted screening for tuberculosis. However, the USPSTF has decided not to update its 1996 recommendation and rather defers to the guidelines of the Centers for Disease Control and Prevention (CDC) referenced below.

Centers for Disease Control and Prevention (CDC)
CDC has published guidelines on screening for LTBI,2 preventing transmission in health-care settings,5 investigating contacts of infectious TB patients,3 treating TB disease,4 and controlling TB in the United States.5

The CDC recommends conducting targeted testing of persons at high risk for TB (see below) to identify LTBI and TB disease early and treating those who have TB and LTBI to prevent transmission and prevent progression of LTBI to disease.2 Targeted testing programs should be conducted among groups at risk for recent infection with M. tuberculosis and those who, regardless of duration of infection, are at increased risk for progression to TB disease. The CDC does not recommend targeted testing of persons at low risk for TB, with the exception of initial (baseline) testing of persons whose future activity will place them at increased risk of exposure, such as some healthcare workers who may require serial screening.

Evidence Rating:
Not Specified — Each of the referenced CDC guidelines describes the evidence basis for the recommendations, but not all provide ratings.



The Value of Prevention

Economic Burden of Condition / Disease
From the late 1980s through the early 1990s, outbreaks of TB among HIV infected persons in the United States contributed to a surge in TB, reversing a steadily declining trend. Billings or charges for inpatient TB care increased 3.2-fold from 1985 through 1990.10 During that period, an estimated 77,700 TB hospitalizations resulted in about 1.1 million days of care.

The total direct medical expenditures for TB in a 1991 study of TB outpatient treatment, screening, and treatment for LTBI, contact investigation, and surveillance were estimated at $703 million and TB costs were estimated at $574 million (in year 1991 dollars.) In addition, 20,803 TB hospitalizations resulting in 413,980 days of inpatient care occurred.11 Extrapolating from a 1996 study at 10 mostly urban sites, an estimated 12,631 TB hospitalizations and approximately 270,650 days of inpatient care occurred in the United States in 1996.12 A study in 2000 estimated that there were over 11,000 TB hospitalizations resulting in more than 160,000 inpatient days.13 Approximately half of TB patients are hospitalized, which adds approximately $19,000 to the cost of treatment.12 While it appears that there might be a slight downward trend in TB hospitalizations as management practices have improved and the total number of TB patients declines each year, TB still places a substantial burden on the U.S. economy.

More recently, direct medical TB costs have been estimated (and updated to 2004 dollars) from several studies16-20 with the costs varying according to the kinds of treatment needed. Direct medical costs of LTBI screening and treatment caused by exposure to strains susceptible to normally-used drugs were approximately $208 to $311 per person without directly observed treatment (DOT).14 DOT improves the likelihood of completion of a full course of treatment. If drug susceptible TB disease is diagnosed, outpatient treatment costs are approximately $4,000 under daily DOT.15

Costs associated with MDR TB are likely to be much higher than for drug-susceptible tuberculosis due to longer hospitalization, longer and more complex treatment with more expensive and toxic medications, and higher mortality. Direct medical costs associated with MDR TB hospitalization range from $15,000 to $137,000 per case.16 In-patient MDR TB costs average $30,740 per person and $1,232 per person-day of hospitalization. Outpatient costs average $22,625, or $52 a day per person. Direct medical costs for both inpatient and outpatient MDR TB care average approximately $53,000 per person. For each infected contact of a patient with multidrug-resistant (MDR) TB in California, the cost of two years of follow-up and treatment to prevent the development of MDR TB was estimated to be $11,125.17

These direct medical costs are underestimates because they exclude the additional public health program costs of providing culturally appropriate outreach, interpreters, and transportation services. Also, in areas where the cost-of-living is much higher, such as San Francisco and New York City, medical costs may be 80% to 95% higher.19 Additional costs to society include the productivity losses associated with TB deaths and productivity losses.
Workplace Burden of Disease / Condition
The workplace burden of TB includes lost productivity, absenteeism, high hospitalization costs, and disease transmission to other employees. Hospitalization burdens include not only direct medical costs, but also the lost productivity of workers during hospitalization days. Outpatient care involves workers' lost productivity due to clinic visits or fatigue and other effects of the illness. In fact, productivity losses may last for months or longer if permanent physical effects are experienced.19

Disease transmission may result in a costly contact investigation as well as stigmatization and disruption of business. However, the risk of TB transmission in the workplace is highly variable, depending on factors such as the TB risk of clients served, the activities conducted by the business, and the TB risk posed by coworkers.8

Economic Benefit of Preventive Interventio
Successfully completing a treatment regimen for LTBI and thereby eliminating the preventable direct medical cost of illness due to TB disease saves $4,000 per case.19 Benefits rise if the case of disease that is prevented would have required hospitalization ($19,000 benefit) and even more if that case would have required treatment of a multi-drug-resistant strain ($15,000 to $137,000 benefit).12,16 Additional benefits include the reduction of worker productivity losses due to illness and the avoidance of stigmatization or work disruption that often follows a TB outbreak in a worksite. Early identification of TB disease can also be expected to substantially reduce the costs of contact investigations, which would be less extensive than if the patient were undiagnosed for a long period, and costs of secondary TB cases among contacts, which would be fewer than for contacts of later diagnosed cases.

Estimated Cost of Preventive Intervention
In 2004, the private-sector cost of tuberculosis screening averaged $22; approximately 95% of all paid claims fell within the range of $0 to $49 per screen.20

Estimated Cost of Treatment
Direct medical costs of LTBI screening and treatment (without DOT) for infection by presumed M. tuberculosis strains that can be treated by first-line drugs are approximately $208 to $311 per person.14 If employees miss work for the screening and treatment, productivity losses for the standard 9 months of treatment might also occur. The direct medical cost of illness due to TB disease is approximately $4,000 per case of drug susceptible TB disease treated by DOT.15

Costs rise if the case of disease requires hospitalization ($19,000) and even more for treatment of a multi-drug-resistant strain ($15,000 to $137,000).12,16

Cost-Effectiveness and/or Cost-Benefit Analysis of Preventive Intervention
For individuals at high risk for TB, the benefits of screening for LTBI and completion of treatment outweigh the costs if treatment reduces the risk of — and costs associated with — TB disease and hospitalization.21 Reducing the risk of medication-induced adverse events and any potential productivity losses associated with LTBI treatment would add to the benefit.



Condition / Disease Specific Information

Epidemiology of Condition / Disease
Tuberculosis is a bacterial disease caused by Mycobacterium tuberculosis, which usually attacks the lungs (pulmonary TB) but can attack any part of the body, including the kidney, spine, and brain. Symptoms of TB disease include:
  • a productive cough lasting more than 2 to 3 weeks,
  • chest pain,
  • coughing up blood,
  • fever,
  • chills,
  • night sweats,
  • appetite loss,
  • weight loss, and
  • easy fatigue.
A person who has developed infectious pulmonary or laryngeal TB disease can spread infection to others through coughing, sneezing, speaking, or singing.

When exposure to infectious TB occurs, the health department conducts a contact investigation.3 Studies of contact investigations in the United States reveal that 30% to 40% of close contacts of persons having infectious TB disease become infected with LTBI (as evidenced by a positive tuberculin skin test or "TST") and identify an additional two percent with active TB disease 8,9

Approximately 5% to 10% of persons with LTBI will progress to clinically active TB disease at some point in their lives.2 About half of those who progress will do so in the first 2 years after initial infection (i.e., recent infection). Treatment of LTBI reduces the risk of developing TB disease by 70% to 90%.2

Populations at high risk for TB include persons who had recent close contact with an infectious TB patient, foreign-born persons from areas where TB is common, HIV-infected and other immunosuppressed persons, homeless persons, substance users (e.g., injection drug users, crack cocaine users, alcoholics), low income, minorities, young children exposed to high-risk adults, health care workers who serve high-risk clients, residents and employees of high-risk congregate settings such as homeless shelters, correctional institutions, nursing homes, or mental institutions.

The proportion of TB cases in the United States occurring among foreign-born persons increased progressively during the 1990s; in 2004, persons born outside the United States accounted for 54% of reported cases.6 Although foreign-born persons who received a diagnosis of TB in 2004 were born in approximately 150 countries worldwide, fivecountries of origin accounted for over half of foreign born persons with TB:
  • Mexico (25%),
  • the Philippines (11%),
  • Vietnam (8%),
  • India (7%), and
  • China (5%).
The number of states in which greater than 50% of the total reported cases occurred among foreign-born persons increased from five(10%) in 1992 to 22 (44%) in 2004.6

Among U.S. states and cities, this profile can change rapidly, reflecting changes in patterns of immigration and refugee settlement.11 Globally, half of new TB cases each year occur in India, China, Indonesia, Bangladesh, and Pakistan.7

In the United States, the majority of healthcare workers do not have a high risk for TB, but some, such as respiratory therapists, appear to be at greater risk.8,9

Persons who work in, or are served by, clinics or community health organizations providing care to HIV-infected persons are considered a priority population for targeted testing and treatment of TB and LTBI because of the risk of transmission to this highly vulnerable population.5

Condition / Disease Risk Factors
An individual at high risk for TB has one or more of the following characteristics:
  • recent exposure to a person having infectious TB;
  • history of previous TB disease or positive tuberculin skin test or QuantiFERON-TB Gold result;
  • HIV infection or other immunosuppressive medical condition;
  • being a young child with contact to a high-risk adult;
  • history of injection or non-injection drug use;
  • birth outside the United States in a region where TB is common;
  • being a resident or employee of a high-risk congregate setting;
  • being a member of a low-income minority population; or
  • being a health care worker who serves high-risk persons.
However, TB should be suspected in any patient who has had a persistent cough for more than 2 to 3 weeks, with at least one additional symptom, including fever, night sweats (sufficient to require changing of bed clothes or sheets), weight loss, or hemoptysis (coughing up blood).



Preventive Intervention Information

Preventive Intervention: Purpose of Counseling
Screening/testing individuals at high risk for TB allows clinicians to identify affected persons and begin treatment. Early identification and treatment of TB disease improves outcomes and reduces the risk of transmission. Identification of LTBI and completion of LTBI treatment reduces an individual's risk of developing TB disease by 70% to 90%.2

Benefits and Risks of Intervention
Clinicians should individualize their decision to conduct targeted testing and treatment for TB and LTBI to the specific patient's risks and environment. Routine testing for TB or LTBI is not recommended for persons who are not at high risk for TB. The TST is subject to variability like all medical tests, but many of the inherent variations in administering and reading tests can be avoided by careful attention to details and the clinical provider should be aware of these details. Interferon gamma release assays (IGRA), such as the QuantiFERON-TB® (QFT) Gold blood test can be used instead of the TST for LTBI screening. CDC has published guidelines for the use of approved IGRAs,23 and will do so for additional tests as they become available. For individuals at high risk for TB, thebenefits of LTBI screening and completion of treatment outweigh the costs.21

Screening high-risk populations for TB disease by asking about the major TB symptom, a cough of 2 to 3 weeks duration, has been shown to be effective,23 and is likely to be cost-effective over routine screening using chest radiographs. This intervention is simple, inexpensive, and is potentially cost-effective in many settings.

Initiation, Cessation, and Interval of Counseling
TB and LTBI testing programs should be conducted among groups at high risk for recent infection with M. tuberculosis and those who, regardless of duration of infection, are at increased risk for progressing to TB disease (e.g., HIV-infected or other immunosuppressed persons with certain medical conditions, injection drug users, those with a history of inadequately treated TB disease).

Workers in health-care settings who have face-to-face contact with patients with suspected or confirmed TB disease or clinical TB specimens should be included in a screening program.8
  • In settings where routine screening is mandated but classified as low risk for TB exposure (where persons with TB disease are not expected to be encountered), workers should receive baseline testing using a two step TST or an IGRA upon hiring (with appropriate follow-up evaluation for those found to have positive TST or IGRA results); additional screening is not necessary unless TB exposure occurs.
  • In settings classified as medium risk (where workers will or will possibly be exposed to persons with TB disease or TB clinical specimens), workers should receive baseline two-step TST and annual screening for TB symptoms; workers who are TST-negative at baseline should also receive annual TST.
  • " If the setting has potential ongoing TB transmission, more frequent TST may be needed until infection control lapses have been corrected.8
Intervention Process
For the majority of infected persons, the only evidence of LTBI is an immune response to mycobacterial antigens, demonstrated by a positive TST or IGRA result. In the United States, the preferred skin test for LTBI is the intradermal, or Mantoux method, injection of 0.1 ml (5 TU) of purified protein derivative (PPD). Tests should be read by a trained professional 48 to 72 hours after the skin test has been applied. Multiple puncture tests (e.g., Tine and Heaf ) and PPD strengths of 1 TU and 250 TU should not be used.2

IGRAs have been shown to have a lower likelihood of giving false-positive readings. IGRAs provide significant advantages in delivery (e.g., no patient return for test reading) that may actually make them more cost-effective than the TST in populations that are likely to have high rates of false-positive TST results because of prior vaccination with the BacilleCalmette-Gerin (BCG). However, data on IGRA performance in high-risk populations are being evaluated.

Screening high-risk populations for TB disease by asking about the major TB symptom, a cough of 2 to 3 weeks duration, is simple, inexpensive, and is potentially cost-effective in many settings.

Treatment Information
Health benefits should include provisions for follow-up and treatment services. A daily 9-month regimen of isoniazid (300 mg for adults, 10 to 15 mg/kg up to 300 mg for children) is recommended for treatment of LTBI caused by isoniazidsusceptible strains of M. tuberculosis. Completion of 270 doses within a 12- month period is optimal.2 Twice-weekly dosing is an acceptable alternative (76 doses within 12 months).2 A daily regimen of rifampin (10 to 20 mg/kg, 600 mg maximum) for 4 months is also an acceptable alternative and is the recommended choice for contacts to isoniazid-resistant TB patients; completion is considered optimal with 120 doses taken within 6 months.2 Directly-observed treatment (DOT) improves the outcome of TB disease treatment and is therefore recommended over self-administered therapy (SAT), and has been shown to be cost-effective to prevent the development of drug resistant TB disease.24 DOT is also recommended for LTBI treatment of vulnerable populations, such as HIV-infected persons or young children.



Strength of Evidence

The level of evidence supporting the recommendations contained in this chapter is described below.
Recommended Guidance:
Centers for Disease Control and Prevention (CDC)
Strength of Evidence: Not Specified. Each of the referenced CDC guidelines describes the evidence basis for the recommendations, but not all provide ratings.
  • " The CDC recommends conducting targeted testing of persons at high risk forTB and treating those who have TB and LTBI to identify TB disease early, prevent transmission, and prevent progression of LTBI to disease.2
  • " The CDC recommends, if routine TB screening is mandated in low-risk settings, the provision of baseline LTBI testing upon hiring, with the addition of annual screening for TB symptoms in medium-risk settings.8


Summary Plan Description

Covered Screening
Screening for tuberculosis is a covered benefit and may include the use of the following:
  • Chest radiography
  • Intracutaneous administration of purified protein derivative (PPD)
  • Tuberculin using the Mantoux method, called the tuberculin skin test (TST)
  • Mycobacteriology services for smears, cultures
  • QuantiFERON®-TB Gold (QFT-G)
  • Sputum induction
Initiation, Cessation, and Interval
Screening is a covered benefit for all persons at high risk of tuberculosis and may be conducted as medically indicated. Follow up re-testing is covered as medically indicated. Note: Routine testing for TB or LTBI is not recommended for persons who are not at high risk of TB.



CPT Codes

Tuberculosis (Screening)
71010 Chest xray, single view
71020 Chest xray, two views, frontal and lateral
71030 Chest xray, complete, minimum of four views
86580 Skin test, tuberculosis, intradermal
86480 Tuberculosis test, cell mediated immunity measurement of gamma interferon antigen response
94640 Sputum induction for diagnostic purposes
87116 Culture, tubercle or other acid-fast bacilli (eg, TB, AFB, mycobacteria) any source, with isolation and presumptive identification of isolates



Other Information and Resources

Business Group Resource(s)

CDC Resource



Author(s)

Marks S. Tuberculosis evidence-statement: screening. 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.



References

1 U.S. Preventive Services Task Force. TB screening recommendations: Summary of recommendations / Supporting documents.Rockville, MD: Agency for Healthcare Research and Quality. Available at: http://www.ahrq.gov/clinic/uspstf/uspstubr.htm. Accessed May 29, 2009.
22 Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection.MMWR. 2000;49(RR-6):1-54.
3 Centers for Disease Control and Prevention. Guidelines for the investigation of contacts of persons with infectious tuberculosis: Recommendations from the National Tuberculosis Controllers Association and Centers for Disease Control and Prevention. MMWR. 2005;54(RR-15):1-47.
4 Centers for Disease Control and Prevention.Treatment of tuberculosis. MMWR. 2003;52(RR-11):1-80.
5 Centers for Disease Control and Prevention. Controlling tuberculosis in the United States. MMWR. 2005;54(RR-12):1-81.
6 Centers for Disease Control and Prevention. Reported tuberculosis in the United States, 2004. Atlanta, GA; US Department of Health and Human Services, CDC; 2004.
7 Dye C. Global epidemiology of tuberculosis. Lancet. 2006;367:938-40.
8 Centers for Disease Control and Prevention.Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR. 2005;54 (RR-17):3, 10-11.
9 Seidler, A, Nienhaus, A, and Diel, R. Review of Epidemiological Studies on the Occupational Risk of Tuberculosis in Low-Incidence Areas.Respiration. 2005; 72: 431-446.
10 Rosenblum LS, Castro KG, Dooley S, Morgan M. Effect of HIV infection and tuberculosis on hospitalizations and cost of care for young adults in the United States, 1985 to 1990. Ann Intern Med. 1994;121(10): 786-792.
11Brown RE, Miller B, Taylor WR, et al. Health-care expenditures for tuberculosis in the United States. Arch Intern Med.1995;155:1595-1600.
12 Taylor Z, Marks SM, Rios Burrows NM, Weis SE, Stricof RL, Miller B. Causes and costs of hospitalization of tuberculosis patients in the United States. Int J Tuberc Lung Dis. 2000;4:931-9. Updated to 2004 dollars by using a factor of 1.28.
13 Hansel NN, Merriman B, Haponik EF, Diette GB. Hospitalizations for tuberculosis in the United States in 2000: Predictors of in-hospital mortality. Chest. 2004;126(4):1079-1086.
14 Lambert L, Rajbhandary S, Qualls N, et al. Costs of implementing and maintaining a tuberculin skin test program in hospitals and health departments. Infect Control Hosp Epidemiol. 2003;24:814-20. Updated to 2004 dollars by using a factor of 1.18.
15 Marks SM. Potential TB treatment cost savings using moxifloxacin-based regimens. TB Notes. 2006;1:13-15.
16 16 Rajbhandary SS, Marks SM, Bock NN. Costs of patients hospitalized for multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2004;8:1012-6. Updated to 2004 dollars by using a factor of 1.19.
17 Porco T. California Department of Health Services TB Control Program, personal communication; 2005.
18 United States Bureau of the Census. Cost of living index-selected metropolitan areas. Statistical abstract of the United States: 2011: Table 727. Washington, DC: United States Bureau of the Census;2011
19 Hansel NN, Wu AW, Chang B, Diette GB. Quality of life in tuberculosis: Patient and provider perspectives. Qual Life Res. 2004;13:639-652.
20 Thomson Medstat. Marketscan. 2004.
21 Marks SM, Taylor Z, Miller BI. Tuberculosis prevention versus hospitalization: Taxpayers save with prevention. J Health Care Poor Underserved. 2002;13(3):392-401.
22 Centers for Disease Control and Prevention. Guidelines for using the QuantiFERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR. 2005;54(RR-15):49-55.
23 Golub JE, Mohan CI, Comstock GW, Chaisson RE. Active case finding of tuberculosis: Historical perspective and future prospects. Int J Tuberc Lung Dis. 2005;9(11):1183-1203.
24 Burman WJ, Dalton CB, Cohn DL, Butler JR, Reves RR.A cost-effectiveness analysis of directly observed therapy vsselfadministered therapy for treatment of tuberculosis. Chest. 1997 Jul;112(1):63-.