Memorandum of Understanding

Program Implementation

Workflow

Contacts

Training Topics

CDC Information

Cost Reimbursement

MEMORANDUM OF UNDERSTANDING KANSAS CITY FREE HEALTH CLINIC

& [VENUE]

This Memorandum of Understanding (MOU) details the collaborative working relationship between Kansas City Free Health Clinic and [venue] for the purposes of executing Routine Universal Screening for HIV – Linkage to Care (RUSH – Link), a program funded by the Missouri Department of Health and Senior Services’ (MDHSS) initiative: Expanded and Integrated Human Immunodeficiency Virus (HIV) Testing. [venue] agrees to: Implement expanded HIV testing that is consistent with the CDC’s Revised Recommendations for HIV Testing of

Adults, Adolescents, and Pregnant Women in Health-Care Settings at designated, agreed-upon [venue]sites (i.e. the xxxxxx location/s).

Integrate expanded HIV testing with specific services or programs offered by [venue] likely to reach the initiative’s target populations such as, but not limited to: _______. Anticipate performing ________ HIV tests per quarter.

Assure that all appropriate quality control policies and procedures related to rapid HIV testing are implemented, followed and monitored.

Coordinate with the Kansas City Free Health Clinic Expanded HIV Testing Coordinator on the collection, monitoring and reporting of the following required client-level data:

o For all HIV tests performed under this initiative: Client Variables: unique identifier, complete date of birth (DOB), gender, race, ethnicity HIV Test Variables: test date, test technology used, test result

Submit required client-level data monthly to the Kansas City Free Health Clinic Expanded Testing Coordinator by the 15th of the following month, and assist with completion of any other reports or site visits required by the funder.

Utilize the Linkage to Care system to link newly diagnosed HIV+ persons to medical care. Make staff available to participate in meetings and/or trainings related to this initiative coordinated through the

Expanded Testing Coordinator, MDHSS, and/or the Midwest AIDS Training and Education Center- Missouri (MATEC-MO), as scheduled.

Kansas City Free Health Clinic agrees to: Provide OraQuick rapid HIV test kits and controls as available and provided by MDHSS for [venue] to utilize in its

designated locations for expanded HIV testing. Collaborate on the development and implementation of procedures and protocols for [venue]’s expanded HIV testing

activities, including program monitoring and required data collection. Coordinate the submission of all required data and reports to MDHSS for this initiative, and facilitate site visits

required by the funder. Serve as a liaison to MDHSS to address progress, accomplishments, and challenges regarding the initiative. Share protocols with [venue] on how to access and utilize the region’s Linkage to Care system to ensure linkage to

medical care and case management for persons testing positive for HIV. Coordinate and provide necessary training of [venue] staff in collaboration with MDHSS and MATEC-MO.

The service provision outlined in this MOU is contingent upon the receipt of continuation funding

from the Centers for Disease Control and Prevention, through the Missouri Department of Health and Senior Services.

Kansas City Free Clinic Kansas City Free Clinic [Venue] Jessica Marsh, MSW Amber Rossman, LMSW Contact Expanded Testing Coordinator Manager of HIV Case Management

Kansas City Free Health Clinic Kansas City Free Health Clinic 3515 Broadway 3515 Broadway Kansas City, MO 64111 Kansas City, MO 64111 Phone: 816-777-1597 Phone: 816-777-2729 Email: jessicam@kcfree.org Email: amberr@kcfree.org

____________________________ _____________________________ __________________________ Name Date Name Date Name Date

October 19, 2009 1

INTEGRATING HIV SCREENING INTO ROUTINE PRIMARY CARE:

A HEALTH CENTER MODEL By

Cheryl Modica, PhD, MPH, BSN NACHC Consultant

The health center model has helped reduce health disparities among many poor and minority communities in such areas as diabetes, heart disease, and asthma. This approach has helped ensure that quality medical care is available not just to those who can pay for it, but also to those who need it most. We have an important opportunity to replicate our successes once again with HIV/AIDS. PREVENTION holds the key to our success in reducing the burden of HIV/AIDS in our communities. Prevention is only possible when we assume the stance that all patients, really all of the population, have a right and need to know their HIV status. Screening for HIV should be as routine as testing for cholesterol and blood sugar, something we routinely offer our patients. It is only through knowing one’s HIV status that one can access effective new treatments against HIV and other services that prolong and enhance one’s quality of life. And for persons who are HIV positive, it provides them with knowledge that allows them to modify their behaviors so as to not place others at risk for infection. “HIV screening” is used to describe assessment for HIV infection across a large population, in this case adolescent and adult health center patients. It typically employs simple test methods, such as finger stick tests or an oral swab, with results available in minutes – although any approved, conventional test can be used – and relies on counseling in the context of care rather than the historically cumbersome pre-test counseling process. “HIV testing” refers to confirmatory laboratory testing where samples, frequently obtained through venipuncture, are sent to an external laboratory for results and, if necessary, additional confirmatory tests. Conventional HIV testing typically utilizes a more comprehensive pre-test counseling process and a more extensive assessment of risks.

October 19, 2009 2

Adopting an HIV screening approach “normalizes” the process of HIV risk assessment and testing as patients come to expect these services within their routine primary care. This document provides a model for how your health center can design a process where everyone 13 to 64 years of age is screened for HIV as a routine part of medical care. The model, as well as many of the tools and resources referenced in this document were developed, tested, and successfully used by six community health centers participating in a Routine HIV Screening pilot supported by the Centers for Disease Control and Prevention (CDC)1. The National Association of Community Health Centers (NACHC) implemented this pilot from December 2006 through April 2008 in response to and in support of the CDC’s 2006 HIV Testing Recommendations. These Recommendations aim to make HIV testing a routine part of medical care and propose HIV screening for all patients ages 13-64 in all health care settings. For a summary of the Recommendations, read CDC Releases Revised HIV Testing Recommendations in Healthcare Settings. For the complete Recommendations, read Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. Now, let’s get your health center started on a 90 day path to routine HIV screening.

Step 1: Prework Step 2: Set up the Framework Step 3: Design the Patient Visit Process to Include Routine

HIV Screening Step 4: Identify a Point Person to Track Reactives Step 5: Adopt HIV Screening Codes for Reimbursement Step 6: Commit Step 7: Launch Step 8: Realign

1 The following health centers participated in the Routine HIV Screening pilot: Aaron E. Henry Community Health Services Center, Clarksdale, MS; Mantachie Rural Health Care, Mantachie, MS; Northeast Mississippi Health Care, Byhalia, MS; Blue Ridge Community Health Services, Hendersonville, NC; Piedmont Health Services, Carrboro, NC; Margaret J. Weston Community Health Services, Clearwater, SC.

October 19, 2009 3

STEP 1: PREWORK

Days# 1 – 45 Choose an HIV test Identify a point person for

inventory/management of HIV tests and controls

Solidify referral arrangements for HIV care Define working relationships with state/local

departments of health Delineate local case management/supportive

services Build state/local partnerships Schedule launch date Worksheet

Choose an HIV Test HIV tests use blood, urine or saliva samples to detect the presence of HIV antibodies. These antibodies develop when HIV attacks a person’s CD4 or T-cells, the cells that fight infection. The choice of which HIV test to use will often be driven by cost and what may be available from state or local resources, including your state Health Department. Additionally, the 340B discount drug pricing program is a potential source of tests for participating health centers. Routine HIV screening generally involves the use of a rapid HIV test. Rapid HIV tests use blood or oral fluid and produce a result in 10—20 minutes. While negative results are considered accurate, reactive results are viewed as “preliminary” and require further confirmatory testing before a person is considered infected with the HIV virus. There is a small window of error in all screening tests so it is possible a reactive result does not mean a person is infected with HIV. There are three Food and Drug Administration (FDA)-approved rapid tests that have received a Clinical Laboratory Improvements Amendments (CLIA) waiver, which means they are less complex and can readily be applied in a health center setting as well as alternate settings such as homeless shelters, substance abuse

October 19, 2009 4

treatment programs, mobile vans and health fairs. For waived tests, there are no federal requirements for personnel, quality assessment, or proficiency testing. To perform waived tests, an organization must obtain a certificate of waiver from the CLIA program (or, if authorized by the Centers for Medicare & Medicaid Services (CMS), be included with the CLIA-certified laboratory under a multiple-site exception) and follow the manufacturer’s instructions for the test procedure. The FDA also requires that persons tested with rapid HIV tests receive the “Subject Information” pamphlet provided with the test. The three FDA-approved waived tests are:

1. Uni-Gold Recombigen HIV 2. OraQuick ADVANCE Rapid HIV 1/2 Antibody Test 3. Clearview HIV 1/2 STAT-PAK

1.Uni-Gold Recombigen HIV

The Uni-Gold Recombigen HIV test is a waived test when used as a single-use rapid test for the detection of HIV-1 antibodies in whole blood obtained by fingerstick or venipuncture. It is intended for use as a point-of-care test. The test involves gathering a drop of blood (via fingerstick or from blood obtained through venipuncture) and dropping it over a sample port on the device. Wash solution is added to the sample port and test results are read 10 to 12 minutes after the specimen is added.

The Uni-Gold Recombigen HIV test includes an internal control that indicates whether the test is functioning correctly (assuming blood sample has been added). Positive and negative external controls should be run by each new operator before performing testing on patient specimens, whenever a new lot of test kits is used, if the conditions of testing or storage (e.g., temperature) fall outside the range recommended by the manufacturer, and at periodic intervals specified in the laboratory’s quality assurance program. External controls are not included in the test kits and must be ordered separately from the manufacturer. The controls require refrigeration and can be stored for 21 days after they are opened. The shelf life of the kits is 1 year from the date of manufacture if stored at room temperature.

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2. OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

The OraQuick ADVANCE Rapid HIV 1/2 Antibody Test is approved as a waived test for use with oral fluid specimens or whole blood specimens obtained by fingerstick or venipuncture. It is intended for use as a point-of-care test. Oral fluid samples are obtained by using an absorbent pad on the end of a test device to swab the outer surface of the upper and lower gums. This test device is then inserted into a vial containing developing solution. If whole blood is used, a sample is collected on a specimen loop then added to the developer solution and mixed. Whether whole blood or oral fluid is used, test results are read no sooner than 20 minutes but no later than 40 minutes after the OraQuick device is added to the developer solution.

The OraQuick ADVANCE test includes an internal control that verifies that specimen has been added and that the test has been run correctly. Positive and negative external controls should be run by each new operator before performing testing on patient specimens, whenever a new lot of test kits is used, if the conditions of testing or storage (e.g., temperature) fall outside the range recommended by the manufacturer, and at periodic intervals specified in the laboratory’s quality assurance program. External controls are not included in the test kits and must be ordered separately from the manufacturer. Controls have a shelf life of 1 year if unopened or 8 weeks after opening, if refrigerated. The shelf life of the kits is 6 months from date of manufacture if stored at room temperature.

3. Clearview HIV 1/2 STAT-PAK

The Clearview HIV 1/2 STAT-PAK is a single-use, waived rapid test that detects antibodies to HIV-1 and HIV-2 when used with whole blood obtained via fingerstick or venipuncture. The Clearview HIV test is intended as a point-of-care test.

The test involves gathering a drop of blood (via fingerstick or from blood obtained through venipuncture) and adding it to a sample port on the device. Buffer solution is then added slowly to the sample port and test results are read 15 to 20 minutes after the specimen is added. Reactive results may be observed and read earlier than 15 minutes. To verify a

October 19, 2009 6

nonreactive test result, the entire 15 minutes is needed. Results cannot be read after 20 minutes.

The Clearview HIV 1/2 STAT-PAK includes an internal control that verifies sample was added and the test is performing correctly. External controls are not included in the test kits and must be ordered separately from the manufacturer. The controls require refrigeration and can be stored for two years after they are opened. The shelf life of the kits is 24 months from the date of manufacture if stored at room temperature.

For additional information about HIV tests visit the CDC’s website at: http://www.cdc.gov/hiv/topics/testing/index.htm

October 19, 2009 7

At a Glance……FDA-Approved and CLIA-Waived HIV Rapid Tests

Test Name Method Time Needed to Develop

List Price Per Device^

Internal Control

External Controls

Shelf life of test (from date of manufacture)

Shelf life of controls

Manufacturer

Uni-Gold Recombigen HIV

Fingerstick Venipuncture 10-12 mins $15.75

Included

Ordered and priced separately $26.25 each

1 year

12 months 1 month (after opening)

Trinity Biotech www.unigoldhiv.com

OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

Fingerstick Venipuncture Oral Swab

20-40 mins $17.50 Included

Ordered and priced separately $25.00 each

1 year

12 months 21 days (after opening)

OraSure Technologies, Inc. http://www.orasure.com/

Clearview HIV 1/2 STAT-PAK

Fingerstick Venipuncture 15-20 mins $17.50

Included

Ordered and priced separately $50.00/set

2 years

2 years, even if opened; require refrigeration

Inverness Medical Professional Diagnostics http://www.invernessmedicalpd.com/poc/products/clr_hiv_statpak.html

October 19, 2009 8

Identify a Point Person for Inventory/Management of HIV Tests and Controls Regardless of the source for HIV rapid tests or the particular test used, it is critical that a staff person be identified who has responsibility for receiving, logging, and monitoring the use of HIV tests and controls. This person will need to ensure an adequate supply of tests is always on hand, that tests and controls are current (with those closest to their expiration date used before those with later expiration dates), and that orders are placed prior to supplies being exhausted. Typically the staff person who is responsible for the ordering and inventory of other laboratory tests can be given the responsibility for management of the HIV tests and controls. Solidify Referral Arrangements for HIV Care Prior to the start of routine HIV screening, it is necessary to determine if your health center will provide HIV related care for persons identified as HIV positive or whether you will refer out for HIV care. If you intend to refer patients off-site for HIV related services, it is critical that you establish referral arrangements prior to the start of routine HIV screening. For instance, if you intend to refer a person newly diagnosed with HIV infection to a local Ryan White Program, meet with contacts from this program first to discuss the best process for referring patients to their program. In some states, arrangements can be made with the Health Department Disease Intervention Specialists (DIS workers) working in your area so that they are available to provide counseling and follow-up with the patient at the same visit when you confirm their HIV infection. This latter arrangement can be particularly helpful if your health center does not employ a social worker or staff person dedicated to post-test counseling. DIS workers are also responsible for gathering the CDC data requirements on all HIV positive individuals, if not already gathered, and for tracking contacts of persons with HIV.

October 19, 2009 9

Define Working Relationships with State/Local Departments of Health In addition to the services of the DIS workers, your health center may benefit from other training or resources offered by your state or local Health Department. Communicate your plans for routine HIV screening with the state/local Health Department and meet with them to determine what resources/support they can provide. Possible resources include: HIV rapid tests, training, and patient follow-up and tracking. Delineate Local Case Management/Supportive Services Patients infected with HIV will require a full range of health and social services, including transportation, housing, and mental health support. Identify persons or organizations that can assist your health center in meeting these needs for your HIV infected patients (See also Step 4). Build State/Local Partnerships Integrating HIV screening into routine primary care puts your health center at the forefront of our nation’s fight against HIV/AIDS. This important activity provides your health center the opportunity to gather critical data that can inform local, state and national policies around the care and follow-up of persons with HIV/AIDS. As a result of your HIV screening efforts, new and unique opportunities for partnerships and/or research will likely emerge that can benefit both your patients and your health center. Schedule Launch Date Giving consideration to what is involved in Prework and other events and circumstances that may be occurring at your health center, schedule a date to begin routine HIV screening. If you have multiple sites, identify in advance whether you will launch routine screening simultaneously at all sites on the first day or whether you will stagger the start to routine HIV screening. The launch date should closely follow the staff-wide forum discussed in Step 6 and any necessary training your center will convene. This helps sustain the momentum for the start-up process and reinforces the importance of the initiative. Identify in advance the

October 19, 2009 10

person, or persons, responsible for trouble shooting any problems during start-up. Worksheet Use the Step 1: Prework Worksheet on the next page to track key activities through to completion.

October 19, 2009 11

Integrating HIV Screening into Routine Primary Care: A Health Center Model

Worksheet

Step 1: Prework

Key Activities HIV Test

Determine the test your center will use

OraQuick Advance Rapid HIV 1/2

Estimate quantity of tests for first six months of testing (# of unduplicated visits for patients 13-64 yrs of age)

Identify source(s) for tests

Tests will be provided through the Expanded and Integrated HIV Testing grant

Appoint a staff person to receive, manage, and coordinate test supplies

HIV Care Determine whether HIV follow-up care will be provided in-house or through referral

Contact Linkage to Care

If HIV care is through referral, specify referral agency and the name, phone and email for your leadership contact and staff contact (the person your staff calls when they want to make a referral)

Contact Linkage to Care

Identify the role of Disease Intervention Specialists (DIS), if any, in counseling or referral support

Contact Linkage to Care

October 19, 2009 12

State/Local Health Department List how the state/local health departments will support your HIV screening efforts

N/A

Local Case Management/Supportive Services

Identify persons or organizations that can assist your health center in meeting the health and social service needs of your HIV infected patients

Contact Linkage to Care

State/Local Partners Identify state/local organizations that your health center can partner with for routine HIV screening efforts. List agency, contact person, and what the partnership provides.

N/A

Launch Date Determine whether you will launch routine screening simultaneously at all sites on the first day or whether you will stagger the start to routine HIV screening

Schedule official date(s)

Identify staff member (s) to trouble shoot any problems during launch

October 19, 2009 13

STEP 2: Set Up the Framework

Days #2 – 30 Finalize tool for data collection and medical

record documentation Prepare test logs Develop a written informed consent, if required

by law Prepare patient educational materials Draft staff tools Worksheet

Finalize Tool for Data Collection and Medical Record Documentation While the CDC and others have recommended HIV screening as a routine part of primary care, our national health care system has quite a way to go to achieve this goal. Your health center can be at the cutting edge of this frontier. As such, you have the opportunity, and responsibility, to gather critical data on HIV prevalence, the acceptability of testing among various populations, and information on why people refuse HIV testing. Thus, data collection is a critical part of routine HIV screening, and your health center may find itself as part of a local, regional, state, or national initiative that requires participation in a data collection effort. Furthermore, your health center has the opportunity to report HIV testing data as part of its 330 grant funding and can use the data to apply for new grants and resources. In addition to collecting data for a larger initiative or purpose, your health center will also want to document in the patient’s health record that an HIV test has been offered and performed and results obtained. A template for data collection and medical record documentation was created specifically for the health centers participating in the Routine HIV Screening pilot. The centers piloted a simple tool that captures key information for each patient that is offered HIV screening. The Routine Testing Flow Sheet can be used as is or modified to meet your center’s needs.

October 19, 2009 14

Prepare Test Logs Similar to any lab test provided to patients, your health center should maintain a log of your routine HIV screening activity. Each time a test is performed, it should be recorded in a log with details about the test lot number, the date and time the test was performed, test results, results of quality controls, and the name of the person who performed the test. A log should also be maintained to document the specific details of all internal and external test controls that are performed. A sample HIV Test Results Log and Control Results Log have been developed and used by the Routine HIV Screening pilot health centers. These logs can readily be used for the Uni-Gold, OraQuick or Clearview HIV rapid tests. Informed Consent When adopting routine HIV screening in states that allow opt out testing, health center staff need to communicate the type and purpose of testing, allowing patients the opportunity to “opt out” of HIV testing, if desired. Scripted language can be provided to staff that assists them in offering an HIV test:

It is now recommended that all persons 13-64 years of age be tested for HIV.

____ Health Center is now offering this service to all patients in this age group as part of routine medical care.

If you would like to receive a free screening for HIV today we will do a simple fingerstick [oral swab].

The fingerstick [oral swab] is testing for HIV antibodies, which are what your body produces if you are infected with the HIV virus.

The test shows results in ten minutes [10-20 minutes depending upon test used] and is done while you are here for your visit. The results are accurate 99% of the time.

October 19, 2009 15

Would you like to have an HIV fingerstick [oral swab] test today?

In states where written consent is still required, consent can generally be incorporated into the health center’s general consent for care. To learn what laws apply in your state, look at the Compendium of State HIV Testing Laws compiled by the National HIV/AIDS Clinicians’ Consultation Center at the University of California at San Francisco. http://www.nccc.ucsf.edu/StateLaws/Index.html A sample General Consent for Care form that incorporates consent for HIV testing is available for your use. Additionally, health literacy experts have modified this general consent for care form in both English and Spanish. Prepare Patient Educational Materials It is helpful to provide patients with simple, clear information on HIV/AIDS and HIV testing. The health centers participating in the Routine HIV Screening pilot used a brochure that provides information on HIV testing in a clean, simple format and at a reading level that is accessible to most health center patients. There is a section at the end of the Patient Brochure where you can enter your health center-specific information. This brochure is also available in Spanish. Draft Staff Tools In providing HIV screening as a routine part of primary care, it is important to recognize that nurses and providers may need guidance in ways to discuss and offer testing. They likely will need guidance on how to inform patients of test results, particularly reactive rapid HIV test results. A sampling of tools has been developed to assist nurses and providers within the context of routine HIV screening. These tools provide suggested language for 1) discussing routine HIV screening and offering an HIV test; 2) language for delivering negative HIV rapid test results; and 3) language for delivering reactive HIV rapid test results (which should be done by the provider). These tools can readily be adapted for use with any type of HIV rapid test.

October 19, 2009 16

Additionally, the two tools for delivering test results can also be used as handouts to give to patients. If you choose to use them as handouts, be sure to enter your health-center specific information as well as specify which HIV rapid tests you offer. How to Offer Routine HIV Screening Negative Rapid HIV Test Result Handout -- English Negative Rapid HIV Test Result Handout -- Spanish Reactive Rapid HIV Test Result Handout -- English Reactive Rapid HIV Test Result Handout -- Spanish Worksheet Use the Step 2: Set Up the Framework Worksheet on the next page to track key activities through to completion.

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Integrating HIV Screening into Routine Primary Care: A Health Center Model

Worksheet

Step 2: Set up the Framework

Key Activities Data Collection and Documentation Tool

Finalize and print data collection and medical record documentation tool

Must include all patients that were offered HIV tests, patients that accepted HIV test, and patients that tested HIV+.

Test Logs Prepare an HIV Rapid Test Log for each testing site

If desired

Prepare an HIV Rapid Test Control Log for each testing site

Informed Consent Build informed consent into the health center’s general consent for care

Prepare a separate written consent only if required by local/state law

N/A

Patient Educational Materials Adapt and print copies of patient educational brochure, or other simple educational information; place in waiting areas and have available where staff will offer testing

Staff Tools Prepare tool for staff that will be discussing and offering HIV testing to patients

Prepare a handout that can be provided to patients, if desired, when test results are negative

Prepare a handout that can be provided to patients when their test results are “reactive” or “preliminarily positive”

October 19, 2009 18

STEP 3: Design The Patient Visit Process To Include Routine HIV Screening

Days# 2 – 30 Develop a patient visit flowchart that includes

routine HIV screening Define a process to respond to negative and

reactive test results and Western Blot confirmatory test results

Worksheet

Develop a Patient Visit Flowchart that Includes Routine HIV Screening While the circumstances of your clinic will determine where in the patient visit process routine HIV screening will occur, the most natural place is usually at the time of nursing intake/vitals. At the same time that nursing staff inquires as to the purpose of the visit and obtains key vitals, the patient can be informed that the health center offers ALL patients 13 – 64 years of age the opportunity to be screened for HIV and asked if they would like to be tested now. When offered in this manner, the requirements of either verbal consent or opt-out testing are generally satisfied. If written consent is required by your state, the health center can generally build consent for HIV testing into the organization’s overall consent for care while also discussing and offering HIV testing during the intake/vitals process. (See Step 2, Informed Consent and visit the Compendium of State HIV Testing Laws compiled by the National HIV/AIDS Clinicians’ Consultation Center at the University of California at San Francisco. http://www.nccc.ucsf.edu/StateLaws/Index.html Health Centers engaged in the Routine HIV Screening pilot used a model for the patient visit that added HIV screening into the vitals/intake portion of the visit. This particular flow process is graphically depicted in the Patient Visit Flow Process with Opt Out Routine HIV Screening and is suitable for use in states with opt-out testing. A slightly different Patient Visit Flow Process with Opt In Routine HIV Screening has been used by community

October 19, 2009 19

health centers in Ohio where written informed consent is required. Your center can use either of these flow processes as is or adapt one of them to fit the design of your existing patient visit. Define a Process to Respond to Negative And Reactive Rapid HIV Test Results and Western Blot Confirmatory Test Results It is also necessary to define the process for responding to negative and reactive HIV screening results within the patient visit, and to communicate this plan to all staff. In general, those patients who test “negative” to a rapid HIV test require no additional follow-up. Staff should, however, inform patients that rapid HIV tests might not be able to detect antibodies to HIV in persons recently infected (the time during which the rapid tests may not detect infection is called the “window period”). Therefore, staff members who offer the test, as well as those who provide the result, should inform all patients that if they believe they may have been infected recently (within the last three months), they should be tested again in three months. All “reactive” rapid HIV tests require follow-up. At the time a provider informs a patient of his or her “reactive” test result, the provider should reinforce that the result is preliminary and that additional blood work is needed to determine HIV status. A Western Blot is required for confirmation of HIV infection. After drawing the Western Blot, the patient should be given a follow-up visit appointment in 5 clinic days to receive the results of the Western Blot test. Additionally and based on prior arrangements, the local Disease Intervention Specialist (DIS) from the Health Department should be informed of all reactive rapid HIV test results (See Step 1, Solidify Referral Arrangements for HIV Care) so that he or she can be prepared to provide the patient with appropriate counseling and referral services when the results of the Western Blot are given to the patient at the five-day follow-up appointment. If the Western Blot result comes back negative, the patient should be instructed to return in three months for another test, as it may be that the Western Blot cannot detect recent infection due to the window period. If the result of the Western Blot is indeterminate, blood should be drawn for a second test.

October 19, 2009 20

However, if the initial Western Blot comes back positive, the person is confirmed to have HIV infection. The HIV Screening Algorithm graphically depicts a process for responding to reactive and negative rapid HIV test results as well the process for responding to negative, indeterminate and positive Western Blot confirmatory test results. The Post Test Counseling & Referral Algorithm graphically depicts the involvement of the local Disease Intervention Specialist in these processes. The Step-by-Step Response to Reactive Rapid HIV Test Results was developed for a group of Ohio health centers participating in a rapid HIV testing and data collection initiative in collaboration with the Ohio Department of Health. Worksheet Use the Step 3: Design the Patient Visit to Include Routine HIV Screening Worksheet on the next page to track key activities through to completion.

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Integrating HIV Screening into Routine Primary Care: A Health Center Model

Worksheet

Step 3: Design The Patient Visit To Include Routine HIV Screening

Key Activities Patient Visit Flow

Determine where in the patient visit process routine screening will occur

Create a flow chart of the redesigned patient visit

If desired

Responding to HIV Rapid Test Results Determine a process to respond within the visit to negative test results

Determine a process to respond within the visit to reactive test results

Including drawing confirmatory, delivering these results, and calling Linkage to Care

Create an algorithm to depict the process for responding within the visit to negative and reactive HIV rapid test results

Responding to Western Blot Confirmatory Test

Results

Determine a process to respond to negative test results

N/A

Determine a process to respond to indeterminate test results

N/A

Determine a process to respond to positive test results

N/A

Create an algorithm to depict the process for responding to Western Blot confirmatory test results

N/A

October 19, 2009 22

Step 4: Identify a Point Person to Track Reactives

Days# 10-30

Worksheet Prior to initiating routine HIV screening, it is vital that your organization identify a point person who will be responsible for tracking patients who have a “reactive” screening test. While the number of reactives will be small for most health centers, it is imperative that someone within the organization have responsibility for ensuring that confirmatory testing is performed, that the results of the confirmatory tests are reviewed and, if the person is infected with HIV, that the patient gets follow-up HIV related care and services. It is simply not enough to screen patients for HIV. With screening comes the responsibility to ensure that those patients identified as HIV-infected through this process are connected to a full complement of health and social support services. One key way to ensure these connections are made, and secure, is to identify a single point of contact to assume responsibility for these tasks. This point person can establish a Reactive Tracking Tool for each patient with a reactive test result. Worksheet Use the Step 4: Identify A Point Person to Track Reactives Worksheet on the next page to track key activities through to completion.

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Integrating HIV Screening into Routine Primary Care: A Health Center Model

Worksheet

Step 4: Identify a Point Person to Track Reactives

Key Activities Tracking Reactives

Identify a staff member within your organization who is responsible for ensuring that patients with reactive test results receive confirmatory testing and, if HIV infection is confirmed, follow-up HIV related care and services

Prepare a Reactives Tracking Sheet

October 19, 2009 24

Step 5: Adopt HIV Screening Codes for Reimbursement

Days# 30-45

As of Jan 1, 2008, providers can bill for performing an HIV test with a rapid test kit. Providers can add Modifier “92” for “Alternative Laboratory Platform Testing” to the usual laboratory procedure code for HIV testing within the CPT® system. The following is the CPT language for this service: “When laboratory testing is being performed using a kit or transportable instrument that wholly or in part consists of a single use, disposable analytical chamber, the service may be identified by adding modifier 92 to the usual laboratory procedure code (HIV testing 86701-86703). The test does not require permanent dedicated space; hence by its design it may be hand carried or transported to the vicinity of the patient for immediate testing at that site, although location of testing is not in itself determinative of the use of this modifier.” In May 2008, the American Academy of HIV Medicine (AAHIVM), in partnership with the American Medical Association (AMA), released Coding Guidelines for Routine HIV Testing in Health Care Settings. This is an easy to use resource to help health care providers, billing personnel, and others become familiar with the proper coding requirements for HIV testing as a routine part of patient care.

October 19, 2009 25

Step 6: Commit

Days# 60-90 Convene a staff-wide forum Convene profession-specific training Worksheet

Convene a Staff-wide Forum Just prior to launching routine HIV screening, health center leadership should gather all staff together for the purposes of: 1) stating their commitment to routine HIV screening; 2) sharing data that illustrates the importance of this screening effort; and 3) providing basic information to all staff about HIV/AIDS and its impact on the health center and the patients and community it serves. While health center leadership should spearhead this forum, other partners can be included such as state/local Health Department representatives, and staff from organizations where you will refer patients. This demonstration of leadership support, presentation of the need and importance of routine HIV screening, and partnership visibility, can be accomplished in a one-hour session with staff.

Convene Profession-specific Training Following the all-staff forum, staff can be broken up into profession-specific work groups. In a 45-60 minute session, providers can receive guidance in discussing HIV test results with patients, particularly “reactive” results; nurses can receive training in offering the test as well as training in administration of the test itself; and front desk and related staff can participate in a session on cultural sensitivity for persons with HIV and issues of confidentiality (also to be covered in the nurse and provider breakouts). Additional and ongoing profession-specific trainings can be added, as needed, during the start-up of routine HIV screening.

Worksheet Use the Step 6: Commit Worksheet on the next page to track key activities through to completion.

October 19, 2009 26

Integrating HIV Screening into Routine Primary Care: A Health Center Model

Worksheet

Step 6: Commit Key Activities Staff Wide Forum Schedule date for all-staff forum How will new staff get trained?

Prepare for the organization’s leadership to state its support for, and expectation around, routine HIV screening

Prepare to present local, state and national data to support routine HIV screening

N/A

Invite partners such as state/local Health Department representatives, and staff from organizations where patients will be referred

N/A

Profession-specific Training Provide profession-specific training on topics critical to implementation of routine HIV screening

October 19, 2009 27

Step 7: Launch

Days# 60-90 On the day (or days if launch will be staggered across multiple sites) pre-specified by leadership, begin offering HIV screening to all patients 13-64 years of age who come to your health center for primary care – regardless of the reason for their visit. The staff person or persons appointed to trouble shoot should be prepared to respond to problems as necessary.

October 19, 2009 28

Step 8: Realign Worksheet

As your health center gains experience with HIV rapid testing, you will develop and incorporate new ideas, tools and methods for screening, training, or service delivery. Additionally, you will want to identify someone to regularly visit the Expanded Testing Coordinator to look for new resources to apply to your HIV screening process.

Worksheet

Use the Step 8: Realign Worksheet to track key activities through to completion.

Integrating HIV Screening into Routine Primary Care: A Health Center Model

Worksheet

Step 8: Realign

Key Activities Check-in Identify the person responsible for periodic check-in with the Expanded Testing Coordinator

Negative Positive Rapid HIV Test Performed

Inform patient Provide “negative” handout if desired No further testing

Contact Linkage to Care Pager: 816-990-2411 **

Inform patient Draw Western Blot confirmatory test

Schedule appointment with patient to discuss confirmatory results

HIV Screening Workflow

Contacts Jessica Marsh, MSW Expanded Testing Coordinator Kansas City Free Health Clinic (816) 268-1899 jessicam@kcfree.org Amber Rossman, LMSW Manager of HIV Case Management Kansas City Free Health Clinic (816) 777-2729 amberr@kcfree.org Linkage to Care Coordinators Pager: (816) 990-2411

Midwest AIDS Training and Education Center-MO

Training Topics 2010

О HIV and Oral Health О Pre-exposure Prophylaxis О Non-occupational Exposure О Antiretrovirals in the Pipeline О HIV and Aging О A Global Perspective of HIV/AIDS О Intimate Partner Violence: Assessment and resources for the HIV infected О Hepatitis and Co-Infection О HIV and Mental Health О Other ________________________

О Immigration Law and HIV О HIV and Cancer (including anal squamous cell) О HIV and Cardiovascular Disease О Update on Ryan White Legislation and local programs О HIV and Pregnancy О Expanded HIV Testing О HIV and Health Disparities О HIV and Substance Use О Other ________________________

http://www.cdc.gov/hiv/testing/HIVStandardCare/science.htm http://www.cdc.gov/hiv/testing/HIVStandardCare/ MO laws http://www.nccc.ucsf.edu/docs/Missouri.pdf

A Package of Tools for Providers to Improve Quality of Care and Maximize Reimbursement

Introduction

The Centers for Disease Control and Prevention (CDC) recommends routine HIV screening of all adults, regardless of risk. A

critical part of developing and sustaining a screening program is integrating it into the mission of the organization in a financially

prudent manner.

In addition to the CDC guidelines, the U. S. Preventive Services Task Force (USPSTF) gives an "A" recommendation for

screening patients who are at risk for HIV, as well as any patient who requests a test. Several clinical specialty societies also

support routine screening.

This package of information on HIV testing and screening, including cost and reimbursement tools, assists clinical managers and

individual practitioners in starting or expanding an HIV screening or diagnostic testing program. The scope of these resources is

limited to screening and testing, and does not explore linkage-to-care issues.

Who Should Use This Guide

This information is designed for health care providers who are not necessarily experts on HIV, finance or reimbursement, and

serves as a guide to asking the right questions in each health system, hospital or clinic. Because each provider is different, it is

difficult to present precise cost and reimbursement information specific to each organization. However, the broad list of issues

presented serves as a framework for further research and discussion in an institution. The information is relevant to for:

Primary care clinics

Inpatient units

Emergency departments

Specialty clinics

Physician offices

Ancillary services

Outpatient services

HIV in the United States The CDC estimates:

One in five of the 1.1 million Americans infected with HIV does not know it.

Some 56,000 new infections occur annually.

HIV infections are often detected late, after the person has become noticeably ill. Within 12 months, these individuals' HIV status progresses to AIDS. In many cases, the patients had previous encounters with the health care system, but were never tested for HIV.

Some 25% of HIV-infected persons who are unaware of their status account for upwards of 70% of the new HIV transmissions.

CDC and USPSTF Recommendations

In part, the CDC recommends routine, voluntary HIV screening for:

All persons 13-64 in healthcare settings, not based on risk

All patients with TB and those seeking treatment for STDs

Repeat HIV screening of persons with known risk at least annually

For a complete list of CDC's recommendations, go to http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm. In addition,

CDC offers resources for primary care providers - http://www.cdc.gov/hiv/testing/HIVStandardCare. For the USPSTF

recommendations, go to - http://www.ahrq.gov/clinic/uspstf/uspshivi.htm.

Definitions

Diagnostic testing: Performing an HIV test for persons with clinical signs or symptoms consistent with HIV infection.

Screening: Performing an HIV test for all persons in a defined population.

This Package Includes

The tools in this package of cost and reimbursement materials include:

A summary of key issues, questions and resources

A chart highlighting which payers reimburse for testing and screening

A basic cost calculator to estimate expenses and revenue

Contact Information

For more information, contact Joan M. Miller, MHA, Senior Researcher, Health Research & Educational Trust, jmiller@aha.org or

(312) 422-2619.

Acknowledgement

This resource is made possible through funding from the Center for Disease Control and Prevention; National Center for

HIV/AIDS, STD and TB Prevention, Division of HIV/AIDS Prevention, through cooperative Agreement Number 5U65PS000818-

04. Its content are soley the responsibility of the authors and do not necessarily represent the official views of the CDC.

Suggested Citation

Miller, J; Hund, C; Akamigbo, A; HIV Testing and Screening Cost and Reimbursement Toolkit. www.hret.org/hiv-cost accessed

on date

Overview of Cost and Reimbursement Issues

Testing a patient for HIV is cost effective, when compared with the expense of treatment for HIV or AIDS. A 2006 study found the

average lifetime cost of care from diagnosis for an HIV-infected adult is $618,900 over 24 years.

Following is a list of resources and issues for a hospital or clinic to consider in starting or expanding a routine HIV screening or

diagnostic testing program.

Mission Compatibility

Consider how HIV screening may connect to the organization's mission pertaining to community health. Enhancing screening may make strategic sense for your institution.

If HIV screening is conducted as part of community outreach, it may be eligible to be included in a hospital's community benefit report to the Internal Revenue Service. For more information, consult with the person in your hospital who is responsible for community benefit reporting. This person may work in the finance, community benefit, or community health

departments. For more information on community benefit reporting, visit http://www.hret.org/disparities/projects/resources/aha-guidance-on-reporting-of-community-benefit.pdf.

Quality Improvement

Diagnosing an HIV-infected patient early results in lower treatment costs, avoidance of hospital readmission, a potential reduction in uncompensated care and fewer opportunistic infections. For more information on hospital readmissions, go to http://www.hret.org/care/projects/resources/Readmission_Guide.pdf

Given that many people in the U.S. who are infected with HIV are unaware of their status, diagnosing the infection can increase the likelihood of practicing precautionary behavior, thereby reducing the risk of transmitting the virus. HIV-infected persons who are unaware of their infection do not necessarily reduce risk behaviors.

Because medical treatment that lowers HIV viral load might also reduce risk for transmission to others, early referral to medical care could prevent HIV transmission in communities while reducing a person's risk for HIV-related illness or death.

Cited Sources

1. Schackman, B. Medical Care, November 2006; Vol 44: pp 990-997

Reimbursement Structures

Global, per diem or bundled payments may reduce spending and enhance quality, yet the structure of reimbursement makes it difficult to determine whether the cost of testing is covered by the lump sum paid for services. Speak with a reimbursement specialist at your facility for clarification. For more information on bundled payments, go to http://www.hret.org/bundled/resources/BundledPayment.pdf

Test Kits

The cost of tests is lowering, and conventional tests cost less than rapid tests. Vendor discounts are available. For a summary of the undiscounted prices for FDA-approved rapid HIV test kits, please go to http://www.hret.org/disparities/projects/resources/test-kits-purchasing-chart.pdf. For more information, speak with your purchasing or laboratory directors.

State and local health departments may provide test kits or staff to assist with testing, including laboratory services for confirmatory tests. In addition, they may provide personnel for staff training or assistance contacting patients' sex or needle-sharing partners who may be at risk for HIV.

Some clinics, public hospitals and other disproportionate-share hospitals are eligible for 340b drug pricing, which sets an upper limit on the price that drug manufacturers receive from covered entities for outpatient drugs. For details, go to http://www.hrsa.gov/opa/. For information on whether your facility qualifies, contact your pharmacy director.

Hospitals and providers may also engage in group-purchasing arrangements to reduce the cost of test kits. For information, contact your laboratory or purchasing directors.

Coding

Coding guidelines for HIV testing produced by the American Medical Association and the American Academy of HIV Medicine are available by going to http://www.hret.org/disparities/projects/resources/hiv-testing-cpt-coding-guide.pdf. Share this document with your medical staff as appropriate.

Insurance Coverage

Some states require third-party payers to reimburse providers for HIV screening. For information, contact your reimbursement specialist.

Many third-party payers reimburse clinics and providers for the cost of the tests and the time to perform them, counsel patients and link them to care. Check with your payers or the reimbursement specialists at your facility for information on reimbursement. A chart reviewing payer reimbursement for HIV screening and diagnostic testing can be accessed by going to http://www.hret.org/disparities/projects/resources/hiv-reimbursement-chart.pdf

The new health reform law, the Patient Protection and Affordable Care Act, requires that beginning in 2010 qualified health plans provide at a minimum coverage without cost-sharing for preventive services rated A or B by the U.S. Preventive Services Task Force (USPSTF). For HIV, this includes screening for adolescents and adults at increased risk, and additional preventive care and screenings for women, according to the clinical consideration go to http://www.ahrq.gov/clinic/uspstf/uspshivi.htm

Beginning July 2010, the Centers for Medicare and Medicaid Services began covering HIV screening according to the clinical considerations adopted by the USPSTF. For more information go to http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=229.

As part of health reform's prevention and wellness provisions, some providers that conduct HIV screening may be eligible for a 1% increase in Federal Medical Assistance Percentage. For more information go to http://www.kff.org/healthreform/8060.cfm.

Hospitals and come clinics may explore partnering with Federally Qualified Health Centers, which have enhanced funding for HIV testing and screening.

HIV Screening and Testing Reimbursement

For Hospitals, Physicians and Clinics

Reimbursement Charts: Following are charts that provide guidance on which types of payers reimbursement for HIV

testing and screening in difference settings. Scroll down to view charts on Routine HIV Screening, HIV Diagnostic Testing, and

Perinatal HIV Testing.

Routing HIV Screening

Definition: Performing an HIV test for subpopulations of persons in a defined population.

CDC Recommendations for Who Should Be Screened

In all health care settings, patients ages 13-64, at least once in a lifetime, unless undiagnosed prevalence among patient

population is <0.1%

For all patients initiating treatment for TB and STDs

Annually for patients at high risk

Setting Medicare1 Medicaid2 Private Plans3 Other Sources4

Hospital Inpatient Some Some states Some plans Some Hospital Outpatient Some Some states Some plans Some

1 Medicare reimburses for HIV screening according to the U.S. Preventive Services Task Force recommendations -- Screening: Human

Immunodeficiency Virus 2 The 2010 health reform law, the Patient Protection and Affordable Care Act (PPACA), includes prevention provisions for some states that

increases by 1% the Federal Medical Assistance Percentage for HIV screening. 3 PPACA requires qualified health plans to provide at minimum coverage without cost-sharing for preventive services rated A or B by the U.S.

Preventive Services Task Force. Screening: Human Immunodeficiency Virus 4 Possible sources: CDC, state or local health departments, Veterans Administration, HRSA (Ryan White), SAMHSA, local public jurisdictions,

private foundations

Hospital Emergency Department Some Some states Some plans Some Private Clinic Some Some states Some plans Some Public Clinic Some Some states; Yes in

all FQHCs Some plans Some

Veterans Administration NA NA NA Yes

HIV Diagnostic Testing

Definition: Performing an HIV test for persons with clinical signs or symptoms consistent with HIV infections.

CDC Recommendations for Who Should Be Tested

All patients with signs or symptoms of HIV infection or an opportunistic illness

Setting Medicare Medicaid Private Plans5 Other Sources6

Hospital Inpatient Yes Yes Yes Some Hospital Outpatient Yes Yes Yes Some Hospital Emergency Department Yes Yes Yes Some Private Clinic Yes Yes Yes Some Public Clinic Yes Yes Yes Some Veterans Administration NA NA NA Yes

5 The 2010 health reform legislation, the Patient Protection and Affordable Care Act, requires qualified health plans to provide at a minimum

coverage without cost-sharing for preventive services rated A or B by the U.S. Preventive Services Task Force. Screening: Human Immunodeficiency Virus 6 Possible sources: CDC, state or local health departments, HRSA (Ryan White), SAMHSA, local public jurisdictions, private foundations

Perinatal HIV Testing

CDC Recommendations for Who Should Be Tested

All pregnant women should be screened as early as possible in each pregnancy

A second test should be performed in the third trimester for women at high risk, including those living in regions with

elevated incidence of HIV and AIDS. These jurisdictions include Alabama, Connecticut, Delaware, the District of Columbia,

Florida, Georgia, Illinois, Louisiana, Maryland, Massachusetts, Mississippi, Nevada, New Jersey, New York, North Carolina,

Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas and Virginia.

Any women with undocumented HIV status at the time of labor

Any newborn whose mother’s HIV status is unknown postpartum

Stage of Pregnancy Medicare Medicaid Private Plans7 Other Sources8

Prenatal Yes Some states Some plans Some Third Trimester Yes Some states Some plans Some Labor Yes Some states Some plans Some Newborn Yes Some states Some plans Some

7 The 2010 health reform legislation, the Patient Protection and Affordable Care Act, requires qualified health plans to provide at a minimum

coverage without cost-sharing for preventive services rated A or B by the U.S. Preventive Services Task Force. Screening: Human Immunodeficiency Virus 8 Possible sources: CDC, state or local health departments, HRSA (Ryan White), SAMHSA, local public jurisdictions

Cost Calculator

This basic cost calculator (http://www.hret.org/disparities/projects/resources/HRET-HIV-Testing-Cost-Calculator.xls) is designed to

estimate revenue and expenses for HIV screening or testing. Fill in each section of the chart according to the instructions to

estimate monthly costs, monthly revenue and the average gain or loss for each test performed.

Before beginning, make sure to have the following information:

Labor rates for each category of staff member (decide whether to include fringe benefits)

The estimated number of hours per month/staff member to perform tests

A list of supplies and services used in testing, and their estimated monthly costs

The estimated number of patients tested per month by payor type

The estimated reimbursement rate by payor per test

To obtain this information, you may wish to consult with colleagues in:

Human Resources

Laboratory

Nursing

Medical Staff

Purchasing

Finance/Reimbursement

City or State Public Health

Download the cost calculator (http://www.hret.org/disparities/projects/resources/HRET-HIV-Testing-Cost-Calculator.xls)