Menu of Suggested Provisions For State Tuberculosis Prevention and Control Laws

C. Treatment

1. Case Management, Treatment Guidelines, and Required Treatment

a. Case Management and Treatment Plans

Descriptive Note: Case management is a critical part of TB programs’ and healthcare providers’ efforts toward ensuring that patients with TB are managed properly, rendered noninfectious, and cured of their disease. Patients with TB often face issues that complicate and can act as barriers to treatment, such as substance abuse, homelessness, unemployment, and lack of healthcare access. Effective case management may obviate the need for legal interventions. Case management requirements may appear in the form of guidelines or policy manuals, but some states have chosen to include case management provisions in their statutes and regulations. The second and third bullets below are examples of such laws, and have reportedly been effective in Florida and Massachusetts. The fourth bullet relates to case management in that it ensures continuity of care for patients with TB who are discharged from a hospital or any other institution which provides health care to residents.

• The department shall have the power and authority, and it shall be the duty of such department, to consult with physicians, hospitals, institutions, and individuals engaged in diagnosing and treating [persons with tuberculosis], provide to such persons and institutions clinical information, and refer cases for diagnosis and treatment upon the request of attending physicians. S.D. Codified Laws § 34-22-13 (2009).
• The department, its authorized representatives, or a physician licensed under [state licensure laws] shall prescribe an individualized treatment plan for each person who has active tuberculosis. The goal of the treatment plan is to achieve treatment to cure by the least restrictive means. The department shall develop, by rule, a standard treatment plan form that must include, but is not limited to, a statement of available services for treatment, which includes the use of directly observed therapy; all findings in the evaluation and diagnostic process; measurable objectives for treatment progress; and time periods for achieving each objective. Each treatment plan must be implemented through a case management approach designed to advance the individual needs of the person who has active tuberculosis. The person’s progress in achieving the objectives of the treatment plan must be periodically reviewed and revised as necessary, in consultation with the person. Fla. Stat. Ann. § 392.64 (LexisNexis 2009).
  • An individualized treatment plan shall be prescribed by providers licensed under [state licensure laws], for each person in their care who has suspected or confirmed active tuberculosis.
    • The treatment plan must be consistent with current standards of medical practice and include information regarding: 1) provisions for treatment to cure; 2) provisions for follow-up; 3) delivery of treatment, e.g., directly observed therapy if appropriate; 4) a case management approach as defined by department guidelines.
    • The treatment plan must be documented on [department form], incorporated by reference and available at [insert link here].
  • The county health department director, administrator or their designee shall document the case management approach as defined in department guidelines [name of department form], incorporated by reference, available at [link to website].
  • The county health department shall provide a complete explanation of tuberculosis, the medical risks associated with tuberculosis, the need to comply with the prescribed course of the treatment plan, and the consequences of non-compliance with the treatment plan to each patient suspected or proven to have tuberculosis, to the patient’s legal guardian or to the patient’s caregiver. The explanation shall be culturally, developmentally, educationally and linguistically appropriate and tailored to the understanding of the patient, the patient’s legal guardian or the patient’s caregiver. Fla. Admin. Code Ann. r. 64D-3.043 (2009).
• Case Management
  • Case management for tuberculosis is defined as the coordination of the necessary medical, nursing, outreach, and social service systems which ensure that all persons with confirmed [or] clinically suspected tuberculosis are started on appropriate therapy, and that all persons with confirmed tuberculosis complete an appropriate and effective course of treatment. [NOTE: “Or” in brackets replaced “and,” and the legal citation was retained].
  • The [state TB program] shall assign [regional TB nurses], as necessary, to work cooperatively and in consultation with local board of health authorities and the nurse case manager, designated by the local board of health, to ensure that a case management system is in place for every confirmed or clinically suspected case of tuberculosis.
  • The following measures are a requirement of the case-management system:
    • 1) The case shall be reported to the [state TB program], as required by [state law].
    • 2) All persons with confirmed and clinically suspected tuberculosis shall have a nurse case manager designated by the local board of health who will work in consultation and cooperation with the [regional TB nurse], as necessary, to manage persons with confirmed or clinically suspected tuberculosis. This case management is required regardless of the source of health care (public or private) and the ability to pay for the services or medications.
    • 3) In consultation with the treating health care provider, the nurse case manager, designated by the local board of health, determines that a medical treatment plan is in place and is in accordance with the American Thoracic Society (ATS) and federal Centers for Disease Control and Prevention (CDC) standards for care.
    • 4) The initial case assessment and contact investigation by the local board of health shall begin within three working days of notification of a potential case of tuberculosis. Contacts to the case shall be identified and categorized for their risk of tuberculosis infection as determined by their level of exposure and the person’s potential for generating air-borne tubercle bacilli (droplet nuclei). Contacts shall be investigated according to the ATS/CDC standards and the policies of the [state TB program]. Contact investigation reports shall be prepared and given to the [regional TB nurse] for the region, according to the policies developed by the [state TB program].
    • 5) Starting with the first visit to a potential case by the nurse designated by the local board of health, there shall also be an assessment of whether there are factors which affect adherence with therapy. This includes, but is not limited to: poor access to health care facilities; homelessness; work schedules; poverty; language barriers; cultural beliefs; substance abuse; mental health status; recent immigration; and medical conditions which may interfere with treatment.
    • 6) An individualized nursing care plan shall be developed by the board of health’s designated nurse case manager and, depending upon the identified risk factors for non-adherence to therapy, the plan shall include the following:
      • A plan to remove barriers to adherence through: enablers which increase access to care; incentives which motivate persons to remain on appropriate therapy; and referrals to community agencies and providers which can assist with identified psychosocial or medical problems.
      • Educational services to the individual who has confirmed or clinically suspected TB. The topics include but are not limited to the following: 1) how TB is spread; 2) how to prevent the spread of TB; 3) how to take medications; 4) the effects of TB if not adequately treated; 5) the importance of completing the prescribed course of treatment; 6) the patient’s responsibility in curing his or her own disease; 7) the consequences to the individual if he or she is unwilling to adhere to the treatment plan; and 8) causes of drug resistant TB and its effects.
      • The number of nursing and outreach worker visits and the level of social support shall depend upon the assessed level of adherence to therapy and medical status.
      • Directly Observed Therapy (DOT) by medical/nursing/outreach care givers or other individuals identified by the local board of health shall be employed when there is an identified risk to continued adherence to therapy.
      • Voluntary hospitalization/institutionalization in the case of persons with complex medical, psycho-social, and infection control management problems.
      • Involuntary hospitalization or confinement may be necessary when there is documented nonadherence to the appropriate medical follow-up and treatment for tuberculosis, and the public health is threatened as a result of this nonadherence. Least restrictive measures shall be employed before more restrictive measures are imposed. 105 Mass. Code Regs. 365.200 (2009).
• Hospital discharge
  • A health care provider managing a patient with suspected or confirmed infectious or potentially infectious TB disease in a hospital may discharge the patient upon meeting one of the following criteria:
    • 1) The patient has an established private residence verified as valid and stable by the public health department and this residence is not shared by any individual in a vulnerable population, unless it is known that this individual has latent TB infection;
    • 2) Tuberculosis is ruled out as a cause of disease;
    • 3) The patient is a resident of a congregate living facility, is homeless or reports a private residence that the public health department has not verified as valid and stable, and had sputum smears initially positive for AFB.
      • The patient must have three consecutive sputum smears negative for AFB collected at least eight hours apart;
      • The patient must have a nucleic acid amplification test negative for M. tuberculosis;
      • The patient must have at least one sputum culture negative for M. tuberculosis after initiation of appropriate anti-tuberculosis treatment; or
      • The Department’s TB Program may grant an exception based upon clinical evidence and interview of the patient; or
    • 4) The patient is a resident of a congregate living facility, is homeless or has reported a private residence that the public health department has not verified as valid and stable, and has no sputum smears positive for AFB, and has been on appropriate anti-TB medications for a period of at least two weeks and has no respiratory symptoms.
  • The Department’s [hospital licensing division] may investigate a hospital’s discharge of a patient who does not meet one of the criteria set forth at [first sub-bullet under “Hospital Discharge”] above.
    • Any hospital that fails to discharge a patient in accordance with [first sub-bullet under “Hospital Discharge”] above may be subject to penalties for licensure violations as identified by the Department’s Division of Health Facilities Evaluation and Licensure. N.J. Admin. Code § 8:57-5.5 (2009).

b. Treatment Guidelines

Descriptive Note: This section contains examples of provisions relating to treatment guidelines; one is general and the other specifically incorporates current CDC/ATS guidelines. When choosing to incorporate specific documents by reference, states may consider adding “as amended and supplemented” to include the most current version or supplement of the cited document.

• A health care provider who treats an individual with suspected or confirmed tuberculosis shall treat the individual according to guidelines established by the department. Utah Code Ann. § 26-6-8 (LexisNexis 2009).
• Treatment and control.
  • The Department incorporates by reference the ATS/CDC treatment standards as described in the segment entitled “Centers for Disease Control and Prevention. Treatment of Tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR 2003;52 (No. RR-11),” Centers for Disease Control and Prevention. Controlling Tuberculosis in the United States: Recommendations from the American Thoracic Society; CDC, and the Infectious Diseases Society of America. MMWR 2005; 54 (No. RR-12),” and “Centers for Disease Control and Prevention. Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection. MMWR 2000; 49 (No. RR-6).” In treating tuberculosis, health care providers must adhere to the standards listed in these documents.
  • A health-care provider who treats an individual with tuberculosis disease shall use the ATS/CDC treatment standards as a reference for the development of a comprehensive treatment and follow-up plan for each individual. The plan shall be developed in cooperation with the individual and approved by the local health department or the Program. Health-care providers shall routinely document an individuals’ adherence to prescribed therapy for tuberculosis infection and disease. If isolation is indicated, the plan for isolation shall be approved by the local health department or the Program. Utah Admin. Code r. 388-804-6 (2009).

c. Required Treatment

Descriptive Note: The provisions in this section are examples of laws that require individuals with TB to be treated; the first bullet grants authority to the health officer to issue an order requiring treatment, the second bullet authorizes health officials to petition the court for an order requiring treatment, and the third bullet requires the individual with TB to seek treatment. Language requiring “treatment to cure” may be considered for active TB treatment provisions. The final two bullets address treatment for latent tuberculosis infection (LTBI). Treatment of LTBI is generally initiated after the possibility of TB disease is excluded, and has been proven to greatly reduce the risk that individuals latently infected with TB will progress to TB disease.

• Where the health officer determines that the public health or the health of any other person is endangered by a case of tuberculosis or a suspect case of tuberculosis, the health officer may issue any orders he or she deems necessary to protect the public health or the health of any other person, and may make application to a court for enforcement of such orders. In any court proceeding for enforcement, the health officer shall demonstrate the particularized circumstances constituting the necessity for an order. Such orders may include, but shall not be limited to:
  • An order requiring a person who has active tuberculosis to complete an appropriate prescribed course of medication for tuberculosis and, if necessary, to follow required contagion precautions for tuberculosis. New York, N.Y., 24RCNY Health Code § 11.21 (2009).
• Physical Examination and Treatment
  • 1) Subject to the provisions of subsections 3) and 4), the department and its authorized representatives may petition the circuit court to examine or cause to be examined, or treat to cure or cause to be treated to cure, any person who has, or is reasonably suspected of having or having been exposed to, active tuberculosis.
  • 2) Subject to the provisions of subsections 3) and 4), a person who has active tuberculosis or is reasonably suspected of having or having been exposed to active tuberculosis shall report for complete examination or treatment to cure, as appropriate, on an outpatient basis to a physician licensed under [state licensure law], or shall submit to examination or treatment to cure, as appropriate, at a county health department or other public facility. When a person has been diagnosed as having active tuberculosis, he or she shall continue with the prescribed treatment on an outpatient basis, which includes the use of directly observed therapy, until such time as the disease is determined to be cured.
  • 3) A person may not be apprehended or examined on an outpatient basis for active tuberculosis without consent, except upon the presentation of a warrant duly authorized by a circuit court. In requesting the issuance of such a warrant, the department must show by a preponderance of evidence that a threat to the public health would exist unless such a warrant is issued and must show that all other reasonable means of obtaining compliance have been exhausted and that no other less restrictive alternative is available.
  • 4) A warrant requiring a person to be apprehended or examined on an outpatient basis may not be issued unless:
    • A hearing has been held with respect to which the person has received at least 72 hours’ prior written notification and has received a list of the proposed actions to be taken and the reasons for each such action. However, with the consent of the person or the person’s counsel, a hearing may be held within less than 72 hours.
    • The person has the right to attend the hearing, to cross-examine witnesses, and to present evidence. After review and consultation by the court, counsel for the person may waive the client’s presence or allow the client to appear by television monitor where available.
    • The court advises the person of the right to have legal counsel present. If the person is insolvent and unable to employ counsel, the court shall appoint legal counsel for the person pursuant to the indigence criteria in [determination of indigence law].
  • 5) The circuit court, legal counsel, and local law enforcement officials, as appropriate, shall consult with the department concerning any necessary infection control procedures to be taken during any court hearing or detention. Fla. Stat. Ann. § 392.55 (LexisNexis 2009).
• If, upon examination, it shall be determined that such person has tuberculosis in an active stage or in a communicable form, then it shall be the duty of such [person with tuberculosis] to arrange for admission of himself or herself as a patient in some medical care facility qualified to treat persons with tuberculosis or when there is no danger to the public or to other individuals as determined by the health officer, such person may receive treatment on an outpatient basis. Kan. Stat. Ann. § 65-116b (2009).

Treatment for LTBI

• Before therapy is started, persons with a positive TB screening test result shall receive a diagnostic evaluation for TB disease…If there is no evidence of disease, persons with TB infection should be considered for preventive therapy. Preventive therapy shall be conducted in accordance with the [incorporated publication]… Ill. Admin. Code tit. 77, § 696.150 (2009).

• The health officer shall: 1) Direct that testing for tuberculosis infection using a Centers for Disease Control and Prevention approved method be performed on contacts of cases of tuberculosis in a communicable stage. 2) Recommend appropriate treatment for latent tuberculosis infection; and 3) Provide for the supervised presumptive treatment of latent tuberculosis infection for a child younger than 4 years old identified as a close contact to a confirmed case or suspected case of active pulmonary tuberculosis. Md. Code Regs. 10.06.01.21 (2009).

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2. Directly Observed Therapy (DOT)

Descriptive Note: Directly observed therapy (DOT) may be defined as a course of treatment, or preventive treatment, for TB in which the prescribed course of medication is administered to the person or taken by the person under direct observation by a trained healthcare worker. DOT increases cure rates among patients with TB, and is also effective in decreasing drug resistance, treatment failure, relapse, and mortality. The provisions below are examples of existing laws on DOT; no citation is included for the third bullet because “or administration” was added after “ingestion” to account for patients who are prescribed injectable medication. The fourth bullet is an example of a regulation on DOT that is used in a state in which health officers are not necessarily physicians, and the state prefers DOT to be ordered or discontinued only by healthcare providers. The final bullet is an example of a law on DOT for patients with latent tuberculosis infection who are on preventive treatment.

• Directly Observed Therapy (DOT) shall be the standard for treatment of persons determined to have active tuberculosis disease. Exceptions may be granted by the health officer when necessary and for cause. Tuberculosis treatment shall continue by DOT until a prescribed course of therapy has been completed. Okla. Admin. Code § 310:521-3-3 (2009).
• Where the health officer determines that the public health or the health of any other person is endangered by a case of tuberculosis or a suspect case of tuberculosis, the health officer may issue any orders he or she deems necessary to protect the public health or the health of any other person, and may make application to a court for enforcement of such orders. In any court proceeding for enforcement, the health officer shall demonstrate the particularized circumstances constituting the necessity for an order. Such orders may include, but shall not be limited to:
  • An order requiring a person who has active tuberculosis and who is unable or unwilling otherwise to complete an appropriate prescribed course of medication for tuberculosis to follow a course of directly observed therapy. New York, N.Y., 24RCNY Health Code § 11.21 (2009).
• A health care provider shall place individuals with tuberculosis and suspected tuberculosis on a tuberculosis treatment regimen that is in accordance with current national and state standards of care, and that provide for direct observation by a trained health care worker of ingestion or administration of each dose of medication.
• Directly Observed Therapy
  • 1) Health care providers may prescribe DOT as a method to monitor the adherence of a patient to his or her prescribed treatment for tuberculosis disease.
    • Health care providers may utilize the Department’s TB Standards of Care as a guideline for appropriate utilization of DOT.
  • 2) Only the patient’s health care provider shall have the authority to order or discontinue DOT.
    • If a health care provider discontinues an order for DOT: Any health officer requiring DOT shall be immediately rescinded; and the health officer who petitioned the Superior Court for court ordered DOT, shall request that the court order be rescinded.
  • 3) The local health officer in the patient’s health jurisdiction of residence shall ensure the provision of DOT as ordered by a health care provider by providing field services as established at [regulation describing health officer responsibilities].
    • The provision of DOT on a daily, twice weekly or three times weekly basis shall continue until discontinued by the health care provider.
  • 4) The designated public health nurse case manager or designee for the health jurisdiction of the patient’s residence shall negotiate a time and place to provide DOT.
    • The patient may request a reasonable amendment to an established DOT schedule or location from the public health nurse case manager or designee.
    • The public health nurse case manager or designee shall consider the patient’s needs and the availability of resources in determining whether to make any accommodation.
  • 5) The public health nurse case manager shall intervene pursuant to [regulation on managing nonadherent TB patients] if a patient is not at least 80 percent adherent to a prescribed DOT regimen over any one-month period throughout the duration of treatment. N.J. Admin. Code § 8:57-5.9 (2009).

  DOT for LTBI

  • Directly Observed Preventive Therapy (DOPT). In settings where DOPT can be given by a responsible and trained employee or volunteer, twice-a-week DOPT should be considered. DOPT should especially be considered for persons who are at high-risk for TB disease, or at high-risk of nonadherence to preventive therapy. Ill. Admin. Code tit. 77, § 696.150 (2009).

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