RFR 190727 TB Outpatient Services~1.docx

The Commonwealth of Massachusetts Department of Public Health Bureau of Infectious Disease and Laboratory Sciences

Address: 305 South Street, Jamaica Plain, MA 02130

Contact Name: Jennifer Cochran

Telephone #: 617-983-6970

Fax #: 617-983-6990

Email: Jennifer.cochran@state.ma.us

Request for Response (RFR)

Document Title: Tuberculosis Outpatient Services

COMMBUYS BID Number: BD-18-1031-BID00-BID02-25058

DPH RFR Document Number: 190727

<March 23, 2018>

It is the responsibility of the prospective Bidder and awarded Contractor to maintain an active registration in COMMBUYS and to keep current the email address of the Bidder’s contact person and prospective contract manager, if awarded a contract, and to monitor that email inbox for communications from the Purchasing Department, including requests for clarification. The Purchasing Department and the Commonwealth assume no responsibility if a prospective Bidder’s/awarded Contractor’s designated email address is not current, or if technical problems, including those with the prospective Bidder’s/awarded Contractor’s computer, network or internet service provider (ISP) cause email communications sent to/from the prospective Bidder/Awarded contractor and the Purchasing Department to be lost or rejected by any means including email or spam filtering. To register go to www.COMMBUYS.com.

This BID requires the submission of electronic quotes. All Bidders are advised to allow adequate time for submission of their quotes by considering potential online impediments like Internet traffic, Internet connection speed, file size, and file volume. DPH is not responsible for delays encountered by Bidders or their agents, or for a Bidder’s local hardware failures, such as computers or related networks, associated with bid compilation or submission. Bids submitted via COMMBUYS are time stamped by the COMMBUYS system clock which is considered the official time of record.

1.0 Procurement Scope and Description:

The Massachusetts Department of Public Health (MDPH), Bureau of Infectious Disease and Laboratory Sciences (BIDLS), Division of Global Populations and Infectious Disease Prevention (Division) seeks to establish a network of licensed medical facilities with the clinical expertise and capacity to assure access to, and provide quality services for, outpatient diagnosis, medical management, and engagement and retention in care for persons at risk for tuberculosis (TB). MDPH will establish contracts under a Master Service Agreement (MSA). MDPH seeks services that are accessible and culturally, linguistically, and clinically competent for populations at risk for TB disease and latent TB infection, especially vulnerable persons who have limited access to prevention and clinical services because of economic, cultural, linguistic, or social reasons.

The Department seeks to engage qualified institutions, facilities, or group practices with the required medical expertise and ability to coordinate medical, laboratory, and radiology services required to care for persons with tuberculosis. This procurement is open (i.e., rolling), and bidders may submit unsolicited proposals during the entire contract period. The original deadline for contracts starting July 1, 2018 is 5:00 p.m. May 25, 2018.

Early, barrier-free access to TB outpatient services is essential to protect the public health and to effective tuberculosis control. Through this procurement, MDPH will purchase that access by (1) assuring prompt and low-threshold access for patients regardless of insurance status by creating a payer of last resort source of revenue for providers; (2) defining standards of care including coordination with state and local public health; and (3) allowing flexibility at the facility level to develop and implement a model that draws on available and developing capacity and expertise.

This procurement requires that the selected vendors will maximize third party reimbursement for TB outpatient services. MDPH will pay patient visit co-pays up to an established amount and serve as the payer of last resort for underinsured or uninsured patients receiving TB outpatient services. The framework for billing relies on use of Current Procedural Terminology (CPT) codes associated with ICD-10 diagnostic codes for tuberculosis (see Attachments 1 and 2). MDPH will implement a HIPAA-compliant electronic billing process; requirements include that all delivered services paid by a third party be reported on an 837 HIPAA “encounter”.

MDPH has previously awarded contracts for delivery of an integrated system of communicable disease prevention, screening, and care services relative to HIV, hepatitis C virus (HCV), sexually transmitted infections (STIs), and latent tuberculosis infection for services that began November 1, 2017.[footnoteRef:1] Providers who have been funded to serve persons born outside the United States (US) are expected to incorporate testing for TB infection, and to provide or facilitate linkage to appropriate medical treatment. This current procurement for TB outpatient services will support already-funded integrated service providers by providing consultations, medical evaluations and treatment support for their patients identified with TB disease or latent TB infection, as needed. [1: See https://www.commbuys.com/bso/external/bidDetail.sdo?docId=BD-17-1031-BID00-BID09-11157&external=true&parentUrl=bid ]

Over the course of the TB outpatient services contract cycle, demand for TB expert consultation and medical evaluation for primary care patients may grow. In 2016, the United States Preventive Services Task Force (USPSTF) recommended screening and testing of primary care patients at risk for latent TB infection and, as a result, screening and testing for latent TB infection in primary care settings is expected to increase. While some primary care providers will have the capacity to evaluate and manage their patients who test positive for TB infection, others will rely on TB experts, including those designated through this procurement, for guidance related to medical evaluation, treatment, and monitoring.

1.0.1 Background Information:

Tuberculosis is a disease of public health concern. The TB diagnostic and care continuum construct describes the steps from screening for TB risk, diagnosis of TB disease or latent TB infection, linkage with care for treatment, and retention in care through treatment completion. Outpatient TB services are an essential element to ensuring the health of the community and the general public. MDPH intends to achieve wide geographic and service access for TB care.

Referrals for TB outpatient services will come from a variety of sources such as primary care providers, emergency departments, state and local public health departments, and specialty clinics. Vendors comprising the TB outpatient network will provide the medical evaluation, treatment recommendations and consultation for these patients. Demand for clinical expertise in TB diagnosis and management is expected to be high. In recent years:

· Medical providers have reported over 400 individuals with suspected TB disease annually to MDPH. Approximately half of these reported cases are confirmed as TB. The initial work-up phase, however, may be of the same intensity for individuals in whom TB is later ruled out.

· Massachusetts has reported a higher proportion of multi-drug resistant tuberculosis (MDR-TB) cases than the country as a whole. Management of MDR-TB requires specialized expertise to assure cure.

· Public health programs identify close contacts to persons with infectious TB for whom evaluation must be timely and appropriate. TB experts review both the source case presentation and the health status of the individual identified as a contact, in order to recommend appropriate action, including treatment regimens to which the strain is susceptible and window treatment for high risk contacts.

· Refugees and immigrants complete an overseas medical examination in accordance with technical instructions written by the U.S. Centers for Disease Control and Prevention (CDC)[footnoteRef:2] prior to arrival in the U.S. MDPH is notified of individuals in whom a TB condition has been documented during the medical examination, and post-arrival follow-up is required of local public health and TB outpatient clinics. Timely follow-up and evaluation by a TB provider is a high priority. [2: See https://www.cdc.gov/immigrantrefugeehealth/pdf/tuberculosis-ti-2009.pdf ]

· The United States Preventive Services Task Force (USPSTF) has recommended testing persons born in, or former residents of, a country with an elevated tuberculosis rate and persons who live in or have lived in high-risk congregate settings, such as homeless shelters and correctional facilities.[footnoteRef:3] The Grade B recommendation is accompanied by insurance coverage of screening and testing as an essential health benefit, with no out-of-pocket costs to patients. MDPH anticipates an increase in referrals of primary care patients with positive TB infection test results, i.e., by interferon-gamma release assay (IGRA) or tuberculin skin test (TST). Some primary care providers may have the capacity to manage treatment following the initial TB evaluation and consultation; others may request management through a TB outpatient service through the course of treatment. [3: JAMA. 2016;316(9):962-969. doi:10.1001/jama.2016.11046]

· Persons who are or will be immunosuppressed due to medical conditions or planned therapies should be screened for tuberculosis as a clinical standard of care. Ruling out TB disease and appropriately managing TB disease or latent TB infection will likely be achieved through referral to TB specialists.

The tuberculosis clinic model has evolved with implementation of health care reform and the decline in the number of tuberculosis cases diagnosed in Massachusetts. With regard to health care reform, hospitals have increasingly, and successfully, received payment from third party payers for TB services. MDPH funds have been available to hospitals to cover patient co-pays for insured individuals, and to be the payer of last resort for uninsured individuals. This diversified funding base has complemented MDPH funding to support clinical services for conditions of public health importance. Concurrently, the demand for TB clinic services has declined in some, but not all, areas of the state. In response, some hospitals have looked to develop flexible service models that can meet demand for appointments. Other hospitals have been successful in managing designated, fixed-hour clinics staffed for TB services.

Early, barrier-free access to TB outpatient services is essential to protect the public health and to effective tuberculosis control. Through this procurement, MDPH will purchase that access by (1) assuring prompt and low-threshold access for patients regardless of insurance status by creating a payer of last resort source of revenue for providers; (2) defining standards of care including coordination with public health; and (3) allowing flexibility at the facility level to develop and implement a model that draws on available capacity and expertise. Examples of models include integrated infectious disease services (e.g. HIV, TB, STD, HCV) and integrated pulmonary medicine services.

1.2 Applicable Procurement Law

Executive Branch Goods and Services

1.3 Whether Single or Multiple Contractors Are Required For Contract(s):

Check One (“X”):

1.4 Calendar Rule Type:

1.5 Acquisition Method: Fee for Service:

1.6 Use of a Procurement by a Single or Multiple Departments:

· Identify additional Eligible Entities by name or type.

The Purchasing Department reserves the right to add or remove additional authorized users during the contract term.

1.7 Expected Duration of Contract:

Anticipated Initial Duration up to: __5__ year(s) _0___months;

Anticipated Renewal Options: _2___ options to renew for __2___ year(s) each option

Final End Date of this Contract: __June 30, 2027____________________

1.8 Anticipated Expenditures, Funding Or Compensation For Expected Duration

Estimated Value of Procurement (Including Anticipated Renewal Options):

Amount $3,000,000_____

Check One (“X”):

Will Federal Funds be used to fund any part of Contract(s)?

*Providers receiving federal grant funds will be considered sub-recipients for federal grant purposes and will be required to comply with applicable federal requirements, including but not limited to sub-recipient audit requirements under OMB Circular A-133.

Capital, Trust and Federal Accounts Only: Any funds designated in the budget that are unspent in any fiscal year will not be available for expenditure in the subsequent fiscal year.

Notice concerning rates of payment: MDPH reserves the right to change the method of payment during the life of the contract. Rates of payment and reimbursement structures may change.

Commercial Earnings Fees: Revenues generated by for-profit organizations that are awarded contracts under this RFR may not exceed expenses incurred except in cases where a ‘for profit earnings fee’ has been negotiated between the Department and the contractor and incorporated into the approved contract. Should no earnings factor be recognized in the contract, the earnings fee shall be assumed to be zero.

2.0 Specifications

2.1 Framework

The MDPH Bureau of Infectious Disease and Laboratory Sciences (BIDLS), Division of Global Populations and Infectious Disease Prevention (Division) works to reduce the burden of TB in Massachusetts through a multi-faceted approach within the framework of assessment, assurance, policy development, and prevention. The overall goal is TB elimination. Strategies to achieve this goal are consistent with national standards[footnoteRef:4]: [4: Centers for Disease Control and Prevention. Essential components of a tuberculosis prevention and control program. MMWR 1995;44(No. RR-11).]

· Identifying and treating persons who have active TB;

· Finding and screening persons who have had contact with persons with active TB to determine whether they are infected with Mycobacterium tuberculosis or have active TB, and providing appropriate treatment to treatment completion;

· Screening populations at high risk for TB infection and the development of TB disease to detect infected persons, and providing appropriate treatment to prevent progression to active TB.

Diagnostic, clinical care and treatment services across the Commonwealth are essential to TB prevention and control. The expertise to diagnose and manage active TB is required to stop transmission of TB in the community. In low-burden countries such as the US, maintaining these services and expertise is a high priority. In Massachusetts, the TB case rate has been relatively stable and aligned with national case rate at approximately 3 per 100,000 population. While the burden of TB was disproportionately borne in the 26 cities and towns where 77% of persons diagnosed with TB resided, 148 jurisdictions were identified as having one or more residents diagnosed with TB over the five-year period 2012-2016. Two hundred three (58%) of the 351 cities and towns in Massachusetts were “TB free” during this period. TB diagnostic and clinical services should be in geographically accessible locations when considering these higher burden areas. Additional TB data for Massachusetts are posted on-line.

Evaluation and management of persons exposed to M. tuberculosis often requires specialized expertise. In addition, because the risk for progression to active TB disease is high in recently infected individuals, timeliness of diagnostic and clinical services is of high priority.

Scaling up treatment of latent TB infection (LTBI) is essential to TB elimination efforts in Massachusetts and across the United States. In September 2016, the United States Preventive Services Task Force (USPSTF) recommended screening adults who are at increased risk for latent TB infection.[footnoteRef:5] This action is likely to increase both testing for latent TB infection and the demand for expert medical evaluation and treatment for those with positive test results. [5: https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/latent-tuberculosis-infection-screening ]

Many individuals at risk for latent TB infection and TB disease receive medical care in community health centers or from other primary care providers. Over the term of this procurement cycle, MDPH expects expansion of a primary care-based model for the treatment of patients with uncomplicated latent TB infection (see Figure 1). In this model, patients will be screened for TB infection in their community health centers or primary care homes (inclusive of clinical settings, such as gastroenterology specialty practices where patients are screened prior to the use of certain biologic therapies). Primary care providers may refer patients with positive TB test results to TB outpatient services for medical evaluation and treatment recommendations for patients with latent TB infection, consistent with national treatment guidelines. Latent TB infection treatment can be managed in primary care settings with expert clinical support to primary care providers through TB outpatient service providers and MDPH, or by TB outpatient service providers.

Thus, TB experts affiliated with TB outpatient service sites funded through this procurement will be expected to provide care and treatment for patients with latent TB infection and complex management issues (e.g. those exposed to drug resistant TB and those with co-morbidities), as well as to patients with active or suspected active TB disease.

In all models of evaluation and treatment management, MDPH will directly provide core public health activities, including technical assistance, disease investigation and response, surveillance, and monitoring of treatment outcomes.

Figure 1: A model for screening in primary care and evaluation by TB outpatient service

2.2 Procurement goals and objectives

The goal of this procurement is to establish a network of facilities that will provide outpatient medical services needed to prevent and control tuberculosis in Massachusetts. The highest priority services are those associated with diagnosis and management of persons with active TB disease. In accordance with Massachusetts regulation 105 CMR 365, facilities will work in partnership with state and local public health departments, as services for patients with suspected or confirmed active tuberculosis disease and their contacts are delivered within the context of a public health case management system.

The TB outpatient facilities will also provide diagnosis and care management expertise for persons infected with M. tuberculosis that is not in an active disease state, i.e., latent TB infection.

Facilities that meet benchmarks will be recognized as Tuberculosis Centers of Excellence for their expertise and commitment to public health. This could lead to greater collaboration with MDPH and researchers in the field, and opportunities for joint publication and/or conference presentations.

The overarching objectives of this procurement are:

1. To provide expert outpatient TB clinical services in settings that ensure timely access and continuity of care for persons without regard for health insurance coverage.

2. To ensure diagnosis, treatment and medical management for persons with TB disease or suspected TB disease that is in accordance with established treatment guidelines and achieves treatment completion rates of 95% or higher.

a. To ensure collaboration and communication with public health entities in their response to active or suspected active TB at the state and local level.

3. To provide medical evaluation and treatment recommendations for persons referred following (a) identification as a contact to a person with infectious TB, (b) identification through the overseas medical examination, (c) a positive test for latent TB infection (i.e. interferon gamma release assay (IGRA) or tuberculin skin test (TST)), or (d) other criteria as determined by MDPH.

a. To provide consultation to referring primary care or other health care providers for management of latent TB infection treatment among their patients referred to and evaluated at the facility.

4. To provide treatment and management of persons with latent TB infection to achieve treatment completion rates of 80% or higher.

5. To support patient engagement and retention in care to achieve successful treatment outcomes.

6. To use evaluation and quality improvement strategies across systems of TB care to promote elimination of TB in Massachusetts.

In addition, the Division and BIDLS have the shared objective of supporting the integration of TB clinical services into the public health response to HIV, hepatitis C, and sexually transmitted infection (STI), and supporting best practices for integrated prevention and care across these disease areas.

2.3 Eligible applicants and venues

MDPH seeks applications from institutions, facilities, or group practices with the required medical expertise and ability to coordinate medical, laboratory, and radiology services as well as additional resources, such as those for audiology or intravenous therapy, to care for persons with tuberculosis. Applicants must utilize an electronic medical record (EMR) and document TB services in the EMR.

Hospitals licensed in Massachusetts, including not-for-profit, for-profit, and academic medical centers are eligible applicants. Provider networks/medical groups and community health centers are also eligible. Applications from individual practitioners will not be considered.

MDPH is particularly interested in receiving proposals that are from providers currently funded by the MDPH Office of HIV/AIDS (OHA) for integrated communicable disease prevention and care services as well as proposals that seek to coordinate their services with one or more providers funded under that RFR. See the “Intent to Award Notice RFR 181926” at https://www.commbuys.com/bso/external/bidDetail.sdo?docId=BD-17-1031-BID00-BID09-11157&external=true&parentUrl=bid for the list of providers awarded contracts.

Through this procurement, MDPH will qualify applicants that have the capacity to:

· Coordinate the delivery of tuberculosis diagnostic and treatment services that are in accordance with national standards as established by the Centers for Disease Control and Prevention (CDC), the American Thoracic Society (ATS) and the Infectious Disease Society of America (IDSA) [see https://www.cdc.gov/tb/publications/guidelines/pdf/clin-infect-dis.-2016-nahid-cid_ciw376.pdf]. MDPH guidelines are published on-line at www.mass.gov/dph/cdc/tb. Note that services to be arranged may include home infusion therapy.

· Collaborate with primary care and other health care providers for latent TB infection evaluation and management by providing initial evaluation for referred patients, providing treatment recommendations for patients whose providers will manage that treatment in primary care, and providing treatment for those patients whose providers do not have the capacity to treat in primary care.

· Adhere to surveillance and reporting requirements through implementation of electronic data transfer in collaboration with MDPH to facilitate disease reporting, patient monitoring, program evaluation, and quality improvement.

· Collaborate with MDPH to implement electronic billing processes through which the facility will report all delivered services paid by a third party using 837 HIPAA Health Claims & Equivalent Encounter Information.

In addition, applicants must meet the requirements outlined below.

· Applicants must have the physical space to meet infection control requirements (e.g., access to a negative pressure room) either on-site or through linkages (as in the Emergency Department), to appropriately care for patients with potentially infectious tuberculosis.

· Applicants must have the clinical and ancillary resources necessary to adhere to standards of care for TB. These resources include medical personnel, radiology, and laboratory services. The medical services requirement is for at least one physician with expertise in TB; additional staff may include mid-level practitioners and nurses. Medical care may be provided through integrated infectious disease services or pulmonary services. Radiology services may be provided onsite or through referral networks, with initial results and films available to TB clinicians in a timely manner. These services must be accessible to patients, with a payment structure that is consistent with the intent of the procurement. Agreements for billing and payment through the TB outpatient provider are required.

· Applicants must use an electronic medical record. Surveillance and reporting to MDPH will meet regulatory requirements (105 CMR 300.000) and be inclusive of the TB care continuum from evaluation through completion of treatment. MDPH is committed to electronic data transfer as the preferred mechanism for reporting and successful applicants will be expected to collaborate with MDPH to implement processes for electronic data transfer.

· Applicants must utilize systems in patient registration and billing that eliminate financial barriers to tuberculosis care, including designating MDPH as payer of last resort.

· Applicants must have effective systems and referral networks to accept community referrals from hospitals, clinicians, local public health, homeless shelters, jails/corrections, and other community providers.

Applicants must provide care in a manner that is responsive to the language and culture of persons seeking services, documenting preferred language in the electronic medical record and providing interpreter services.

2.4 Priority populations

At the population level, certain groups are at greater risk for TB and/or have greater needs for TB services. Priority populations for TB outpatient services include persons born in countries outside the United States with high rates of tuberculosis, persons with travel to areas where tuberculosis is endemic, contacts to persons with infectious TB disease, and persons experiencing homelessness.

At the individual level, TB response is based on priority. For the purposes of this procurement for TB outpatient services, three priority levels are defined.

Priority 1: Individuals with suspected or diagnosed TB disease Assuring access to diagnostic and treatment services for persons with suspected or confirmed TB disease is the highest priority for MDPH. These services must meet national standards for TB care. Treatment plans must be specific to individual patient needs. Patients may be referred for outpatient services from the inpatient setting or from another provider.

TB outpatient services are essential to protecting the health of the public by coordinating clinical expertise and public health services to diagnose tuberculosis and limit its transmission in the community. For persons with suspected or confirmed active TB, public health resources complement the TB outpatient services.

By regulation (105 CMR 365), all persons with confirmed or clinically suspected tuberculosis will have a nurse case manager designated by the local board of health who will work in consultation and cooperation with MDPH and the clinical provider. This nursing case management is required regardless of the source of health care (from a private provider and through the MDPH TB outpatient services system), insurance coverage, or ability to pay for the services or medications. The regulation also notes that providers responsible for medical management of persons with confirmed or clinically suspected tuberculosis disease shall work in cooperation with the local board of health and MDPH for the purposes of case management. Thus, outpatient TB services for persons with suspected or confirmed TB disease will be delivered within the context of a collaborative case management system with MDPH and local public health.

Because early access to care and timely diagnosis of TB disease are essential to interrupting transmission and protecting the public health, TB outpatient services must be available and responsive to requests for evaluation of individuals with suspected TB disease.

Priority 2: Individuals at high risk for progressing to active TB disease if infected Priority 2 for TB outpatient services is established to meet the public health goal of identifying and treating individuals at high risk for latent TB infection progressing to TB disease. These individuals should be given high priority for TB outpatient services:

· Close contacts to persons with infectious TB, with special attention to children under 5 years of age and persons who may have symptoms consistent with TB. Contacts are at particularly high risk for infection with progression to active disease. Local public health nurses, often in collaboration with MDPH, will identify close contacts to persons with infectious TB. Testing for TB infection, either by IGRA or TST, is also managed at the community level. Some contacts with a negative IGRA or TST result (including children under 5 years of age and persons with immunosuppression) should be evaluated for treatment of latent TB infection after TB disease has been ruled out, in accordance with national guidelines. Local public health nurses may support the TB outpatient service by providing education and monitoring of contacts in the community throughout the course of treatment.

· Newly arrived refugees and immigrants with TB conditions identified overseas (Class A TB/Class B TB). Refugees and immigrants complete a medical examination, the Technical Instructions for which are written by CDC[footnoteRef:6], prior to entering the US. The Technical Instructions outline criteria for classification of TB (No class, Class A, Class B1, Class B2, Class B3). CDC notifies MDPH of refugees and immigrants with a TB class (A, B1, B2, or B3) whose destination is Massachusetts; MDPH notifies the local board of health of the arrival. Assuring a domestic evaluation for TB is a responsibility of public health. In Massachusetts, the TB outpatient service provider plays an essential role in this evaluation. Note that although some persons may have a negative TB test (IGRA or TST), TB evaluation is still required. [6: CDC Tuberculosis Screening and Treatment Technical Instructions using Cultures and Directly Observed Therapy (DOT) for Panel Physicians https://www.cdc.gov/immigrantrefugeehealth/exams/ti/panel/tuberculosis-panel-technical-instructions.html ]

· Persons with positive test for TB infection (IGRA or TST) result and high risk for progression to disease including persons meeting any of these criteria:

· Current immunosuppression

· Documented recent TB test conversion

· Documented poorly controlled diabetes or other medical conditions that increase risk

· Abnormal chest X-ray consistent with previously untreated TB

· Young age, i.e., children under 15 years of age, with special attention to children under 5 years of age.

For persons meeting the Priority 2 criteria, completion of treatment is the goal.

Priority 3: Individuals with positive TB infection test results requiring medical evaluation to rule out active TB disease, and treatment for latent TB infection Priority 3 is inclusive of the population of asymptomatic persons who are generally screened by IGRA or TST in a primary care setting, whose IGRA or TST result is positive, AND who are known to be at higher risk for latent TB infection or developing TB disease if infected, including:

· Persons who were born or lived in countries of high TB prevalence

· Persons tested for TB by a Civil Surgeon as part of the medical examination required by the US Citizenship and Immigration Services (USCIS) for Adjustment of Status to Permanent Resident

· Persons who are experiencing or have recently experienced homelessness

· Persons who are residents in congregate settings

· Persons who inject drugs / have substance use disorder

· Persons with medical conditions known to increase the risk of TB

· Persons with planned immunosuppression

· Persons who have been locally identified as being in a high-risk group Providers awarded MDPH integrated services contracts may have management and adherence support resources for patients with latent TB infection, particularly for those patients whose latent TB infection treatment is managed by the integrated services provider.

Note: Persons who do not meet any risk criteria, and who are tested for latent TB infection as part of work or school requirements, are not included in Priority 3. Thus, while the facility may opt to evaluate and treat these individuals, doing so should not result in delayed appointments for individuals who are in a higher priority group.

2.5 Standards for services

TB outpatient care, including laboratory monitoring, must be provided in accordance with national guidelines. Key standards for TB outpatient services are outlined below, following the priorities outlined above. Note that these are not intended to be all-inclusive. Rather, the intent is to provide a framework for applicants to review.

Table 1: TB outpatient standards by priority group

High risk LTBI/TB Priority 3:

LTBI after risk assessment

Access to services for new patients

Time [in calendar days] from request/referral to first appointment

New Evaluation

<5 days

TB outpatient services provider is expected to see new referrals within a reasonable time frame. The TB provider is not expected to be an urgent care provider for diagnostic purposes; if acute evaluation is needed, referral should be to Urgent Care or ED

Recent hospital discharge <30 days - for patients being referred from in-patient setting as part of hospital discharge; the timing of the first outpatient appointment is to be coordinated with discharge planner to assure that the patient is being discharged with an adequate supply of medications in hand to last until the outpatient appointment Discharge planning in collaboration with MDPH is required by Regulation.

New Evaluation

<30 days

Expedite appointments for any child under age 5 years who has been identified as a contact to a person with infectious TB; children should be seen more quickly due to possibility of rapid progression to disease.

Children (and other high-risk patients) with symptoms should be seen within 1 day or referred to Urgent Care or ED (as previous column).

Individuals may be referred by community providers, local public health, or MDPH. Individuals may not have a primary care provider; evaluation should not be delayed until primary care is established

A positive TB test (IGRA or TST) is not required; individuals may have a negative IGRA or TST result

New Evaluation

<45 days

Individuals are generally referred by a primary care provider based on a positive TB test (IGRA or TST) that was done based on identified risk for TB

and/or Good clinical practice ATS/CDC/ IDSA; recommendations posted by CDC[footnoteRef:8] or MDPH and/or good clinical practice [8: See https://www.cdc.gov/tb/publications/guidelines/default.htm ]

Short-course regimens preferred ATS/CDC/ IDSA; recommendations posted by CDC8 or MDPH and/or good clinical practice

Short-course regimens preferred

Alternatively, encourage treatment management at primary care/ community health center level (i.e., evaluate to rule out active TB, provide treatment recommendation to PCP)

Treatment can be managed by the TB outpatient provider, particularly for patients with complex clinical presentations

Alternatively, encourage treatment management at primary care/ community health center level (i.e., evaluate to rule out active TB, provide treatment recommendation to PCP)

Clinical and/or radiologic improvement; microbiologic improvement

Sputum monitored monthly for smear and for culture conversion (pulmonary TB) Patients for whom treatment is recommended should be seen monthly at minimum for safety and adherence

Monitoring is managed by treating provider, i.e., TB outpatient services or primary care provider Patients for whom treatment is recommended should be seen monthly at minimum for safety and adherence

Monitoring is managed by treating provider, i.e., TB outpatient services or primary care provider

MDPH and/or local public health CHW may be available to support retention in care and adherence

Directly Observed Therapy (DOT) is the standard for certain patients per MDPH criteria (see Attachment 3)

The local public health nurse is expected to support engagement and retention in care for close contacts and overseas arrivals with classified TB conditions

MDPH and/or local public health CHW may be available to support retention in care and adherence

School nurses may assist in case management and DOPT for children and adolescents

DOPT may be provided for priority patients Integrated services provider may provide adherence support for patients treated at their agencies

Each successful applicant is expected to develop and implement strategies to achieve early, barrier-free access to TB services without regard to insurance coverage. Early access is vital to timely diagnosis and the interruption of transmission in the community. Providers in the TB service network will establish mechanisms, policies and procedures to assure timely access to care. These include:

· Elimination of financial barriers for persons appropriate for referral and care such as no requirement for health insurance, in-network referrals, prior approval or other administrative approvals at the time of referral or visit, and registration and billing mechanisms that identify MDPH as the payer of last resort.

· Policies and procedures that address key points of contact (e.g., registration, telephone/on-line information resources) and processes to assure and facilitate access to and utilization of services.

· Ability to prioritize referrals to assure immediate access for persons at highest risk of active TB, supported with policies and procedures that articulate criteria for and processes for referrals, communications with referring providers, and capacity to monitor outcomes including engagement in care.

Collaboration with community providers to promote and facilitate communication for the purpose of referral and response to confirm engagement, diagnosis, treatment and outcome. Collaborations are documented formally (e.g. via Memoranda of Agreement/Understanding).

2.6 Medications

MDPH is committed to providing access to TB medications at no cost to patients through the facility outpatient pharmacy or through a designated community pharmacy. To meet this commitment, MDPH is implementing a TB Drug Assistance Program. The TB Drug Assistance Program is designed to broaden access to TB drugs and reduce hospital pharmacy costs associated with the historical model of MDPH drug procurement and supply management. Through the TB Drug Assistance Program, pharmacies use patient insurance to the extent that it is available. Patient out-of-pocket costs are covered by the TB Drug Assistance Program as well as all drug costs for uninsured or underinsured patients. The model of state-purchased drugs will continue until pharmacies have transitioned to the TB Drug Assistance Program; this transition will be complete within the first contract cycle.

2.7 Coordination with MDPH

MDPH will provide support to the TB outpatient network, including:

1. Surveillance: Tuberculosis disease and latent TB infection are reportable to MDPH under 105 CMR 300.180. MDPH will manage surveillance data. MDPH is committed to working with designated TB outpatient sites to maximize electronic data transfer to report care and patient management. With routine reporting in place, facility-specific reports on the TB care cascade will be prepared by MDPH on a regular basis for review with sites.

MDPH will continue active surveillance and monitoring for persons with suspected or confirmed active tuberculosis disease and their contacts from identification to completion of treatment. MDPH and CDC monitor performance indicators that are established by the CDC (see National TB Indicators Project [https://www.cdc.gov/tb/publications/factsheets/statistics/ntip.htm]).

2. Clinical guidance: MDPH will provide clinical guidance as needed for management of patients with tuberculosis. This capacity is available 24/7. Key MDPH resources include the TB Medical Officer, TB public health nursing advisors, the State Epidemiologist, and the BIDLS Medical Director. In addition, the Global TB Institute is a CDC-supported Center of Excellence that also offers a medical consultation service (see http://globaltb.njms.rutgers.edu/tb_consultation/index.php)

3. Investigation and case management: MDPH staff, including epidemiologists, public health nurses and community health workers, have expertise in TB disease response. These staff work in collaboration with health care providers, local public health, and patients to assure timely and appropriate investigation, response and patient management. MDPH is committed to working with partners to improve the TB care continuum and achieve high rates of cure for persons with tuberculosis disease and treatment completion for persons with latent TB infection.

4. Public health laboratory: Public health and clinical services are supported by the Massachusetts State Public Health Laboratory (MA SPHL). The TB Laboratory processes specimens for smear, nucleic acid amplification testing (NAAT), speciation and drug susceptibility testing as well as management of specimens for genetic sequencing. The MA SPHL is the preferred laboratory for TB testing, and TB outpatient services providers will be encouraged to submit specimens to the MA SPHL. For persons who have positive cultures for M. tuberculosis from any site, the M. tuberculosis-positive isolate must be submitted to the MA SPHL for confirmation of identification and drug-susceptibility testing, no matter where the laboratory performing the culture is located (see http://www.mass.gov/eohhs/docs/dph/laboratory-sciences/mandatory-specimen-submission.pdf).

Specimens labeled as TB clinic patients and submitted by approved applicants to the MA SPHL’s TB Laboratory will be processed without charge to the submitter or patient’s insurance.

5. Education and technical assistance. MDPH staff, including physicians, public health nurses, epidemiologists and community specialists, is available for education and technical assistance. MDPH staff experienced in meeting the needs of recent immigrants, persons experiencing homelessness, and others at risk for TB, is able to provide guidance to the TB care network. MDPH provides 24/7 coverage for infectious disease support. MDPH provides ongoing training, Grand Rounds, and on-line training. In addition, the CDC Division of Tuberculosis Elimination (DTBE) supports a network of TB Regional Centers of Excellence that provide on-line and in-person education. Examples for medical personnel include the TB Intensive training, individualized training, and the annual New England TB Clinicians Conference.

2.8 Allowable Costs

This procurement will support payment of medical care, laboratory, radiology and additional required services for tuberculosis care per the ICD-10 code. MDPH is the payer of last resort. The sample list of CPT codes is included as Attachment 2. This list will be reviewed based on submitted CPTs and updated annually at minimum.

For insured patients, MDPH will pay visit co-pays up to a maximum amount determined annually (currently $40/visit).

MDPH will not support payment of deductibles or co-insurance associated with care. MDPH is looking at steps to address financial barriers to care.

CORI Checks

In order to ensure that employees or other persons regularly providing client or support services in any program of an EOHHS Department or in vendor agency programs funded by an EOHHS Department are appropriate for serving in their positions, a Criminal Offender Record Information (CORI) check shall be performed on candidates for positions in such programs or facilities, in accordance with 101 CMR 15.00 (EOHHS regulations governing Criminal Offender Record Checks). These regulations establish a core standardized policy regarding the review of criminal records for employment. It is the policy of EOHHS that an individual’s background including any CORI and other relevant information be carefully considered so that the vulnerable populations served by EOHHS are protected. It is also the policy of EOHHS that qualified rehabilitated offenders are given a fair opportunity to be employed and successfully reintegrated into the workforce. In addition, as provided in 101 CMR 15.09(5), the hiring authority must comply with the requirements of the Division of Criminal Justice Information Services (formerly the CHSB) governing CORI at 803 CMR 2.00 et seq.

3.0 Performance Requirements and Contract Monitoring

Successful bidders will be qualified as TB Outpatient Service providers. Vendors must agree to adhere to requirements mandated by MDPH. MDPH will monitor contracts by a variety of methods that may include programmatic site visits (inclusive of client record review), fiscal site visits, analysis of data submissions, invoice and expenditure review, quality assurance assessments, and additional mechanisms as appropriate.

Vendors must maintain clinical and fiscal documentation of their TB services, and must permit MDPH and agents officially acting on behalf of MDPH access to this documentation, including electronic medical/health and other records. Vendors must maintain systems that ensure compliance with MDPH policies regarding data security. MDPH will require that vendors participate in quality improvement activities, which include but are not limited to, the development and implementation of quality management plans, throughout the procurement period.

MDPH will monitor service quality and health outcomes. Vendors will be required to meet process and outcome objectives associated with, at a minimum, prioritized populations and TB diagnosis, as follows:

· 95% of persons with TB disease complete an appropriate course of treatment in a timely manner;

· 80% of persons initiating treatment for latent TB infection will be treated to cure.

MDPH may modify and add required objectives during the course of the procurement to reflect changes in the health care system and/or changes in state budget allocations.

MDPH is developing capability for enhanced disease surveillance through implementation of electronic reporting. The mechanism for electronic surveillance used by MDPH is Electronic medical records Support for Public health (ESP), an open-source software application used to securely extract, analyze, and transmit data pushed from electronic health records to MDPH. Facilities successful under this procurement will be encouraged to participate, and will be provided with technical assistance necessary to install and participate in ESP (see https://espnet.atlassian.net/wiki/spaces/EP/pages/42958879/ESP+Implementation+Kit+Materials). Information regarding installation and configuration, along with technical specifications is available for download. MDPH will consider other strategies to facilitate electronic transfer of disease surveillance and program reporting data, particularly as an interim step to the implementation of ESP.

4.0 Contract Invoicing

4.1 Overview

Payment for TB outpatient services will be at unit rates determined by Massachusetts regulations, i.e., Medicaid/MassHealth rates for medicine, laboratory and radiology. Units of service are based on established CPT codes linked with tuberculosis ICD-10 codes. Facilities can code MDPH as the payer of last resort. Facility charges will not be reimbursed by MPDH and out-of-pocket charges should not be billed to patients receiving TB outpatient services, regardless of insurance coverage.

Co-pay rates are…