Tuberculosis Elimination Efforts in the United States in the Era of Insurance Expansion and the Affordable Care Act

Abstract

The Patient Protection and Affordable Care Act can enhance ongoing efforts to control tuberculosis (TB) in the United States by bringing millions of currently uninsured Americans into the health-care system. However, much of the legislative and financial framework that provides essential public health services necessary for effective TB control is outside the scope of the law. We identified three key issues that will still need to be addressed after full implementation of the Affordable Care Act: (1) essential TB-related public health functions will still be needed and will remain the responsibility of federal, state, and local health departments; (2) testing and treatment for latent TB infection (LTBI) is not covered explicitly as a recommended preventive service without cost sharing or copayment; and (3) remaining uninsured populations will disproportionately include groups at high risk for TB. To improve and continue TB control efforts, it is important that all populations at risk be tested and treated for LTBI and TB; that testing and treatment services be accessible and affordable; that essential federal, state, and local public health functions be maintained; that private-sector medical/public health linkages for diagnosis and treatment be developed; and that health-care providers be trained in conducting appropriate LTBI and TB clinical care.

Most provisions of the Patient Protection and Affordable Care Act (hereinafter, Affordable Care Act) went into effect in January 2014.¹ Its principal intents are to increase access to and affordability of health insurance, prohibit denial of coverage based on preexisting conditions, make improvements in health insurance, curb health-care costs, and improve health-care quality and outcomes.² In 2012, 46% (55 million) of adults aged 19–64 years in the United States had no health insurance for some time, and another 25% (30 million) had coverage that provided inadequate protection for health-care costs.³ The Congressional Budget Office estimated that the Affordable Care Act will extend insurance to approximately 92% of nonelderly (,65 years of age) legal U.S. residents by 2017.⁴

In 2013, 9,582 U.S. cases of tuberculosis (TB) were reported, a rate of 3.0 per 100,000 population, and the lowest rate in the nation's history.⁵ The nation's efforts to eliminate TB will require continued commitment of health-care resources. However, much of the legislative and financial framework that allows for effective TB control is outside the scope of the Affordable Care Act.

Although preventable and treatable, TB remains one of the world's deadliest diseases, with an estimated 9 million cases and 1.5 million deaths worldwide in 2013.⁶ TB is principally caused by respiratory spread of Mycobacterium tuberculosis (M. tuberculosis), which most often affects the lungs but can also affect the spine, bones, brain, and other organs. If untreated, infected people may progress to active disease (referred to hereinafter as TB) within weeks, or may remain asymptomatic indefinitely (referred to hereinafter as having latent TB infection [LTBI]). An estimated one-third of the world's population has LTBI.

In the United States, diagnosis of a TB case activates a local public health response that includes identification and evaluation of all people who have had close contact with the case to identify quickly and treat other people with TB and LTBI and break the chain of transmission. These contact investigations, especially in congregate settings, are complex and labor-intensive; they often require large, flexible workforces for weeks or months, and are not reimbursed by health insurance.⁷ Other public sector activities directed at limiting TB transmission include the systematic gathering and reporting of case-specific data (surveillance), provision of state and/or national reference laboratory support, and provision of directly observed treatment (DOT) (i.e., having a health-care worker or other designated individual watch the TB patient swallow every dose of prescribed drug to assure treatment adherence and prevent development of drug resistance).⁸ Most of these activities are not supported by health insurance.

Outpatient medical costs of treating a drug-susceptible TB case (using the standard regimen of two months of isoniazid, rifampin, pyrazinamide, and ethambutol, followed by four months of isoniazid and rifampin) are substantial, estimated at $3,970 in 2004 ($5,000 in 2013 dollars).⁹ An estimated 49% of U.S. patients with TB are hospitalized, either as part of their initial diagnostic work-up or as part of their treatment, which (including the costs of physicians) would cost an additional estimated $27,900 in 2013 dollars per person hospitalized.^10,11 To increase adherence and treatment completion, the Centers for Disease Control and Prevention (CDC) recommends providing DOT to all people with TB,¹² to all people with LTBI who are <5 years of age, to all people with LTBI who are receiving intermittent dosing regimens,^13,14 and to all those who are at high risk for TB and/or have characteristics that make them unlikely to complete treatment.¹⁴ Unfortunately, patients under TB care in the private sector are less likely to receive DOT,¹⁵ are less likely to have documented culture conversion of sputum cultures from M. tuberculosis positive to negative,¹⁵ and have a higher risk of death.¹⁶

Insurance expansions that are part of the Affordable Care Act can enhance efforts to control TB by bringing millions of uninsured Americans into the health-care system.^2,3 The closest model of an insurance expansion to the Affordable Care Act has been the subsidized health-care insurance experience in Massachusetts; in that setting, cost reductions have been observed even with increased access to and use of preventive services.¹⁷ Although the Affordable Care Act is focused on access to diagnosis, care, and prevention, controlling TB entails public health activities that are beyond the capacity of most private practitioners and that are not expected to be affected by the law. These public health activities include:

• Administration of DOT to all TB patients and to high-risk groups and children with LTBI;

• Controlling TB outbreaks and conducting contact investigations;

• Surveillance;

• Overseas screening and post-entry follow-up of immigrants and refugees for TB and LTBI;

• Epidemiologic, programmatic, laboratory, and clinical research to improve diagnosis, treatment, and prevention;

• Development, implementation, and evaluation of guidelines, policies, and protocols;

• Ensuring an uninterrupted supply of TB drugs and diagnostics;

• Providing regional and national TB laboratory services including diagnostic smears and culture of sputum and tissue, rapid molecular testing for diagnosis and drug-susceptibility testing, and genotyping of isolates;

• Providing free training for and expert consultation to public and private practitioners; and

• Legal actions (e.g., proceedings to ensure isolation, travel restriction, or detention of infectious people).¹⁸

THREE MAJOR ISSUES CENTRAL TO TB CONTROL

We summarize three major issues central to TB control at federal, state, and local levels that will persist independently of Affordable Care Act implementation.

Federal, state, and local TB control programs will remain responsible for essential TB services

Because newly insured patients may not initiate their search for TB diagnostic and treatment services at public health departments if they can obtain health services through private providers or federally qualified health centers (FQHCs),¹⁹ there is a misperception that TB programs will no longer be needed after the insurance expansions of the Affordable Care Act. The Affordable Care Act will not substantially reduce the need for the aforementioned public sector TB control activities and for the involvement of federal, state, and/or local health departments. Section 317 E of the Public Health Service Act authorizes federal support of TB control programs,²⁰ and CDC maintains cooperative agreements with 50 states, nine large cities, and eight territories and U.S.-affiliated Pacific Island jurisdictions to provide TB prevention, control, and laboratory support.

Currently, 77% of U.S. TB patients receive most or all of their clinical care through health departments. Under the Affordable Care Act, access to private providers for primary and preventive services will increase through the expansion of FQHCs underwritten by the Community Health Center Fund.²¹ Unfortunately, with decreasing TB incidence, most U.S. private sector clinicians have never seen or treated a TB case.²²

Because FQHCs emphasize coordinated primary and preventive services or a medical home for patients, some TB clinical care will be transferred from health department clinics to providers lacking experience in diagnosing, treating, and managing TB and LTBI. If patients are not able to receive direct clinical services in their medical home without preauthorization, health departments may not be able to provide adequate TB care unless the health department or the patient bears the cost. Narrow networks or managed care plans may also involve insurance coverage with high deductibles that would deter patients from agreeing to necessary but costly diagnostic tests (e.g., CAT scans, bronchoscopy, and tissue biopsies) and treatment.

Developing and supporting TB-related training of health-care providers other than physicians (e.g., nurse practitioners, physician assistants, and pharmacists) will also be increasingly important as more types of providers involved in the medical home begin to diagnose or treat TB and LTBI. Because health departments may be in greater demand as sources of TB expertise after implementation of the Affordable Care Act,²³ successful models of health department collaboration with private, FQHC, and other providers would include supporting consultation and training, sharing of case management and outcomes data, and providing feedback on performance measures. One such model that was developed for hepatitis C in New Mexico, Project Extension for Community Healthcare Outcomes (Project ECHO), links primary care clinics in rural areas with the University of New Mexico's School of Medicine using an Internet-based audiovisual network, and now also addresses treatment issues for mental health disorders, substance abuse, gestational diabetes, and rheumatologic diseases.²⁴

LTBI testing and treatment is not covered explicitly as a recommended preventive service without cost sharing

For people with newly acquired TB infection, the estimated probability of progression to TB is 5%–10% during a lifetime;²⁵ however, the probability is greater with certain underlying health conditions (e.g., human immunodeficiency virus [HIV] infection²⁶ and diabetes).²⁷ Diagnosing and treating LTBI prevents TB in approximately 70%–90% of patients.¹⁴ Estimated LTBI prevalence for the U.S. population in the 1999–2000 National Health and Nutrition Examination Survey was 4.2%; a higher prevalence was seen among people living in poverty (6.1%) and among people born outside the United States (18.7%).²⁸

Despite the societal benefits of preventive services, U.S. health care has tended to emphasize disease treatment rather than prevention. When cost sharing is imposed, the use of preventive services decreases, especially among low-income populations.^29,30 The Affordable Care Act places unprecedented emphasis on prevention by requiring non-grandfathered private health insurance and expanded Medicaid programs to cover the following preventive services without patient copays or cost sharing: (1) vaccinations recommended by the Advisory Committee on Immunization Practices, (2) screening and preventive care included in existing health guidelines for children and adolescents and in guidelines to be developed for women through the Health Resources and Services Administration, and (3) preventive services rated as “A” (strongly recommended) or “B” (recommended) by the U.S. Preventive Services Task Force (USPSTF). The USPSTF is an independent panel of experts that systematically reviews evidence for the effectiveness of clinical preventive services and assigns one of five letter grades, with an “A” grade signifying high certainty that the net benefit of a service is substantial and a “B” grade signifying high certainty that the net benefit of a service is moderate or that there is moderate certainty that the net benefit is moderate to substantial.

For LTBI, successfully testing and completing treatment for TB strains that can be treated by first-line drugs costs approximately $300–$400 per person (in 2013 dollars).^10,31 Although the USPSTF had rated TB preventive testing services as an “A” in its 1996 published recommendations, it deferred to CDC's recommendations and no longer assigned a rating for LTBI testing after 1996; this transition occurred at a time when USPSTF ratings and recommendations were not yet used as criteria applied for reimbursement for services. The USPSTF still “recognizes the importance of targeted screening for tuberculosis” and defers to CDC,³² which recommends testing people at high risk for TB. 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 test for TB infection (i.e., tuberculin skin test or interferon-gamma release assay), HIV infection or other immunosuppressive medical condition, history of injection or non-injection drug use, birth outside of the United States in a region where TB is common, is a young child in contact with a high-risk adult, is a resident or employee of a high-risk congregate setting, is a member of a low-income minority population, or is a health-care worker who serves high-risk people.¹⁴ However, no USPSTF recommendations currently exist for LTBI testing.

Lack of a USPSTF rating for LTBI testing has the effect of excluding such testing without cost sharing from the Affordable Care Act's insurance coverage mandate. To develop a recommendation statement, the USPSTF is currently engaged in reviewing evidence for screening for LTBI in adults.³³ Unfortunately, a lack of insurance coverage for LTBI testing and treatment may discourage LTBI testing and treatment by primary care providers of newly insured people, even if they are at high risk. However, in states that have opted to include Medicaid coverage for LTBI testing and treatment, some low-income people are covered for LTBI testing and treatment.³⁴

Based on estimates of untreated U.S. LTBI prevalence of 4.2%²⁸ and of 25 million people who will become newly insured because of the Affordable Care Act,⁴ 1,050,000 newly insured people with LTBI could be treated to prevent TB if their LTBI were identified.

Populations remaining uninsured are likely to have disproportionately more people at high risk for TB than the population that will be covered by health insurance

Populations remaining uninsured after the Affordable Care Act include poor parents whose incomes place them above Medicaid eligibility levels, all childless adults who reside in states that did not expand Medicaid eligibility (an estimated 4 million),³⁵ and undocumented immigrants (approximately 12 million) regardless of income. Foreign-born populations are at higher risk for TB infection due to exposure in countries of origin.^28,36 Under the Affordable Care Act, some foreign-born people will have increased eligibility for health coverage. Lawfully present immigrants will be eligible to purchase health coverage in the Exchanges; depending on income, they may also be eligible for premium subsidies.³⁷ However, some lawfully present immigrants, foreign-born students, and long-term visitors may choose not to obtain insurance. Immigrants who are lawful permanent residents or other qualified non-citizens may also be eligible for Medicaid and Children's Health Insurance Program (CHIP) coverage if they meet their state's income eligibility rules. To get Medicaid and CHIP coverage, most long-term permanent residents or green card holders have a five-year waiting period, although states may remove the waiting period. However, undocumented people will continue to be ineligible for Medicaid and Medicare and will not have access to health insurance under the Affordable Care Act.³⁸ In 2010, there were approximately 5 million lawfully present immigrants who had been in the United States for fewer than five years and an estimated 11.2 million undocumented people.³⁹ Excluding certain, especially foreign-born, populations from health insurance coverage under the Affordable Care Act means that many people living in the United States will still not have health insurance coverage for preventive services and might disproportionately go on to develop and transmit TB.

Delays in TB diagnosis and treatment contribute to ongoing transmission, regardless of insurance status. Among 27 U.S. TB outbreaks during 2002–2008, a prolonged infectious period was the most common contributory factor, occurring in 24 (89%) of these outbreaks; delayed diagnosis due to late access to care was a factor in six of the 27 outbreaks (22%).⁴⁰ Compared with documented foreign-born or U.S.-born people, undocumented people with TB more commonly reported severe symptoms (e.g., having a cough) and longer duration of symptoms before diagnosis, both of which are consistent with delayed diagnosis and later initiation of treatment, which makes transmission more likely.³⁶

Based on annual TB incidence of 3.0 cases per 100,000 population in the United States,⁵ there would be 480 cases of TB in a year among 16 million people who are uninsured and at high risk (i.e., undocumented people and resident aliens who have been in the country for fewer than five years). By diagnosing and treating LTBI, and thereby preventing TB in 70%–90% of these 480 cases, the estimated direct medical cost of treating these TB cases (in 2013 dollars) that would be averted annually is in excess of $8 million using the following equation:

$$\text{A}\times \left[\left(\text{B}\hspace{0.17em}\left[480\right]\times \text{C}\left[\$4,900\right]\right)+\left(\text{D}\hspace{0.17em}\left[235\right]\times \text{E}\hspace{0.17em}\left[\$27,900\right]\right)\right]$$

where A is the efficacy of treatment for LTBI in preventing TB (70%–90%), B is the number of cases of TB among 16 million uninsured people, C is the average outpatient cost for a TB case,⁹ D is B 3 0.49 (i.e., the number of cases among the uninsured who are hospitalized for TB diagnosis or treatment), and E is the additional average cost of TB-related hospitalization for an estimated 49% hospitalized.^10,11 This estimate is conservative because it assumes a TB incidence at parity with that of the general population and does not include costs for treating cases of drug-resistant TB, costs to society associated with TB deaths and productivity losses, and program costs of providing culturally appropriate outreach, interpreters, and transportation services.⁹

DISCUSSION

The Affordable Care Act's provisions for expanded health insurance will improve access to early diagnosis and care and to preventive services for those having coverage. However, as insurance expansions are implemented, public health functions critical to TB control will remain the responsibility of federal, state, and/or local health departments. These public health functions include surveillance, outbreak and contact investigations, DOT, assurance of drug access and treatment completion, regional and national laboratory services, clinical consultation, research, policy/protocol development, provision of expert consultation and training, oversight of overseas and post-entry screening for TB in immigrants and refugees, and exercising quarantine authority where necessary. Because LTBI testing is not covered explicitly without cost sharing and because a significant number of people at high risk for TB are likely to remain uninsured, challenges will remain in delivering preventive services of individual and societal benefit.

TB preventive services without out-of-pocket payments (i.e., cost sharing) need to be provided to all populations at high risk; without a USPSTF recommendation on TB testing, however, providing these services might be difficult to achieve. Other efforts that can improve progress toward TB elimination include development of (1) TB/LTBI testing and treatment outreach programs that include high-risk populations regardless of insurance status and (2) a private sector medical/public health model that builds on the strengths of health departments (e.g., TB expertise, laboratory services, training and education, and quality assurance) and providers (e.g., community access, manpower, and strong provider-patient relationships) to augment efforts to control TB. U.S. TB control efforts can continue to improve if all populations at risk are tested and treated for TB and LTBI; preventive services are accessible and affordable; essential federal, state, and local public health functions are maintained; private sector medical/public health linkages for TB diagnosis and treatment are developed and maintained; and health-care providers are trained and monitored to conduct appropriate diagnostic, treatment, and prevention practices, especially focused on high-risk populations.