Request for Proposals.pdf

(And Health Research Inc.)

Request for Proposals

RFP # - C043113

AIDS Intervention Management System (AIMS)

Issued: September 16, 2026

PERMISSIBLE SUBJECT MATTER CONTACT:

Pursuant to State Finance Law § 139-j(3)(a), the New York State Department of Health (hereinafter referred to as the “Department”) identifies the following allowable person to contact for communications related to the submission of written bids, written questions, pre-bid questions, and debriefings.

Michele Kerwin New York State Department of Health AIDS Institute, Office of Administration and Contract Management Corning Tower, Room 359 Governor Nelson A. Rockefeller Empire State Plaza Albany, New York 12237 Telephone: (518) 402-5049 Email Address: AIGPU@health.ny.gov

DESIGNATED CONTACT:

Pursuant to State Finance Law §§ 139-j and 139-k, the Department identifies the following designated person to whom all communications attempting to influence the Department’s conduct or decision regarding this procurement must be made.

Ryan VanDerVoort Bureau of Contracts New York State Department of Health Corning Tower, Room 2827 Governor Nelson A. Rockefeller Empire State Plaza Albany, New York 12237 Telephone: 518-474-7896 Email Address: Ryan.Vandervoort@health.ny.gov mailto:AIGPU@health.ny.gov mailto:Ryan.Vandervoort@health.ny.gov

TABLE OF CONTENTS

(Hyperlinked; click to go directly to desired topic.)

TABLE OF CONTENTS

1.0 CALENDAR OF EVENTS

2.0 OVERVIEW

2.1 Introductory Background

2.2 Important Information

2.3 Term of the Agreement

3.0 BIDDERS’ QUALIFICATIONS TO PROPOSE

3.1 Minimum Qualifications

4.0 SCOPE OF WORK

4.1 Tasks/Deliverables

4.2 Staffing

4.3 Reporting

4.4 Information Technology

4.5 Security

4.6 Transition

4.7 Payment

4.8 Subcontracting

4.9 Contract Insurance Requirements

4.10 Minority & Women-Owned Business Enterprise (M/WBE) Requirements

4.11 Participation Opportunities for NYS Certified Service-Disabled Veteran-Owned Businesses.. 23

5.0 ADMINISTRATIVE INFORMATION

5.1 Restricted Period

5.2 Questions

5.3 Right to Modify RFP

5.4 The Department and HRI’s Reserved Rights

5.5 Debriefing

5.6 Protest Procedures

5.7 Freedom of Information Law (“FOIL”)

5.8 Piggybacking

6.0 PROPOSAL CONTENT

6.1 Administrative Proposal

6.1.1 Attachment B - Administrative Proposal Cover Sheet

6.1.2 Bidder’s Disclosure of Prior Non-Responsibility Determinations

6.1.3 Freedom of Information Law – Proposal Redactions

6.1.4 Vendor Responsibility Questionnaire

6.1.5 Vendor Assurance of No Conflict of Interest or Detrimental Effect

6.1.6 M/WBE Forms

6.1.7 Encouraging Use of New York Businesses in Contract Performance

6.1.8 Bidder’s Certified Statements

6.1.9 Diversity Practices Questionnaire

6.1.10 Executive Order 177 Prohibiting Contracts with Entities that Support Discrimination

6.1.11 Executive Order 16 Prohibiting Contracting with Businesses Conducting Business in Russia 28

6.1.12 State Finance Law Consultant Disclosure Provisions

6.1.13 Sales and Compensating Use Tax Certification (Tax Law, § 5-a)

6.1.14 Gender-Based Violence and the Workplace Certification

6.2 Technical Proposal

6.2.1 Attachment C - Technical Proposal Cover Sheet

6.2.2 Table of Contents

6.2.3 Documentation of Bidder’s Eligibility Responsive to Section 3.0 of RFP

6.2.4 Technical Proposal Narrative

6.3 Cost Proposal

7.0 PROPOSAL SUBMISSION

7.1 No Bid Form

8.0 METHOD OF AWARD

8.1 General Information

8.2 Submission Review

8.3 Technical Evaluation

8.4 Cost Evaluation

8.5 Composite Score

8.6 Reference Checks

8.7 Best and Final Offers

8.8 Award Recommendation

9.0 ATTACHMENTS

ATTACHMENT A

ATTACHMENT B

ATTACHMENT C

ATTACHMENT D

ATTACHMENT E

ATTACHMENT F

ATTACHMENT G

ATTACHMENT H

ATTACHMENT I

1.0 CALENDAR OF EVENTS

RFP C043113 – AIDS Intervention Management System (AIMS)

EVENT DATE

Issuance of Request for Proposals September 16, 2026

Deadline for Submission of Written Questions September 30, 2026 at 4:00 p.m. ET

Responses to Written Questions Posted by the Department On or About October 14, 2026

Deadline for Submission of Proposals November 5, 2026 4:00 p.m. ET

Anticipated Contract Start Date 3/1/2027

2.0 OVERVIEW

Through this Request for Proposals (“RFP”), the Department and Health Research, Inc. (HRI) is seeking competitive proposals from qualified organizations to conduct quality of care reviews, program evaluations, focused clinical studies, and quality improvement activities for health-related services provided to individuals enrolled in New York State’s Medicaid program and to all people living with HIV/AIDS (PLWHA), within the purview of the AIDS Intervention Management System (AIMS) program as further detailed in Section 4.0 (Scope of Work). It is the intent of the Department to award one (1) State contract and one (1) HRI contract from this procurement.

The purpose of this RFP is to select one contractor to assist both the Department and HRI with AIMS program activities according to the standards and protocols detailed in this procurement. HRI is a not-for-profit corporation affiliated with the Department whose mission is to independently assist the Department and to build a healthier future for New York State and beyond through the delivery of funding and program support to further public health and research programs. It is the intent of the Department to enter into contracts with one

(1) bidder selected as a result of this RFP.

2.1 Introductory Background

The Department is the lead state agency for New York State’s Medicaid program and is responsible for Medicaid managed care organizations (MCOs), HIV Special Needs Plans (SNPs), managed long-term care plans (MLTCs), and Medicaid fee-for-service (FFS). Medicaid populations under the purview of the AIMS program include, but are not limited to, individuals with or at risk of acquiring HIV/AIDS, hepatitis C (HCV), and/or sexually transmitted infections (STIs). The AIMS program was established to fulfill mandates from the federal and state laws and requirements detailed below.

Federal law, Title XIX of the Social Security Act, requires states to review the appropriateness of care provided to recipients in the Medical Assistance program. State law, Section 2803(d) of the Public Health Law, provides authorization for the Commissioner of Health to review the appropriateness and necessity of health care services provided to Medical Assistance program recipients as well as the review of payments made to hospitals through the Medicaid program.

Public Health requirement NYCRR 504.3(a) describes the duties of the provider related to maintenance of records to receive payment and the need to provide records and information upon request of the Department.

Section 365 of the NYS Social Services Law outlines the “character and adequacy of assistance” regarding “Medical Assistance” and payment of medically necessary care by qualified providers.

Federal legislation regarding Medical Assistance review activities includes the Federal Peer Improvement Act, which requires appropriateness of reviews, and the Omnibus Reconciliation Act of 1986, Public Health Law 99- 509, Section 9431. The Peer Improvement Act provides states with alternative mechanisms for implementing review activities: contracting with federally designated Quality Improvement Organization (QIO) or QIO-like organizations (subject to 75% federal financial participation) or conducting reviews themselves through a contract with an identified medical review organization (subject to 50% federal financial participation).

For more information regarding QIO and QIO-like entities please visit the Centers for Medicare & Medicaid Services (CMS) website at https://www.cms.gov/.

Other helpful CMS links:

https://www.cms.gov/medicare/quality/quality-improvement-organizations https://www.cms.gov/becoming-qio-entity http://www.cms.gov/files/document/qin-qio-directory.pdf https://www.cms.gov/files/document/qio-entity-certification-list-june-2024.pdf

2.2 Important Information

The Bidder must review, and is requested to have its legal counsel review, Attachment 8, the DOH Agreement (Standard Contract), as the successful Bidder must be willing to enter into the Contract awarded pursuant to this RFP in the terms of Attachment 8, subject only to any amendments to the Standard Contract agreed by the Department during the Question and Answer Phase of this RFP (see, Section 5.2). Please note that this RFP and the awarded Bidder’s Bid will become part of the Contract as Appendix B and C, respectively.

It should be noted that Appendix A of Attachment 8, “Standard Clauses for New York State Contracts”, contains important information, terms and conditions related to the Contract to be entered into as a result of this RFP and will be incorporated, without change or amendment, into the Contract entered into between the Department and the successful Bidder. By submitting a response to this RFP, the Bidder agrees to comply with all the provisions of the Contract, including all of the provisions of Appendix A.

Note, Attachment 7, the Bidder’s Certified Statements, must be submitted by each Bidder and includes a statement that the Bidder accepts, without any added conditions, qualifications or exceptions, the contract terms and conditions contained in this RFP including any exhibits and attachments, including, without limitation, Attachment 8. It also includes a statement that the Bidder acknowledges that, should any alternative proposals or extraneous terms be submitted with its Bid, such alternate proposals or extraneous terms will not be evaluated by the Department.

Any qualifications or exceptions proposed by a Bidder to this RFP should be submitted in writing using the process set forth in Section 5.2 (Questions) prior to the deadline for submission of written questions indicated in Section 1.0 (Calendar of Events). Any such qualifications or exceptions that are not proposed prior to the deadline for the submission of written questions will not be considered by the Department after contract award.

Any amendments the Department makes to the RFP as a result of questions and answers will be publicized on the Department’s web site and will be available and applicable to all Bidders equally.

In addition to State funds, a portion of the award made as a result of this RFP may be supported by https://www.cms.gov/ https://www.cms.gov/medicare/quality/quality-improvement-organizations https://www.cms.gov/becoming-qio-entity http://www.cms.gov/files/document/qin-qio-directory.pdf https://www.cms.gov/files/document/qio-entity-certification-list-june-2024.pdf https://www.health.ny.gov/funding/forms/attachment_8.pdf https://www.health.ny.gov/funding/forms/attachment_8.pdf https://www.health.ny.gov/funding/forms/attachment_8.pdf https://www.health.ny.gov/funding/forms/attachment_7.pdf https://www.health.ny.gov/funding/forms/attachment_8.pdf federal funds administered by Health Research, Inc. (HRI). As a result, there may be more than one contract awarded to the winning bidder based on funding streams. Contracts awarded using federal/HRI funds will be issued by HRI, and will utilize contract language provided in Attachment G.

The Contractor must maintain an active registration in the System for Award Management (SAM) at SAM.gov, have no exclusions or delinquent federal debt.

2.3 Term of the Agreement

The term of the Contracts that will be entered into pursuant to this RFP between the Department, Health Research, Inc. and the successful Bidder is expected to be for a period of five (5) years commencing on the date shown on the Calendar of Events in Section 1.0, subject to the availability of sufficient funding, successful Contractor performance, and approvals from the New York State Attorney General (AG), and the Office of the State Comptroller (OSC).

3.0 BIDDERS’ QUALIFICATIONS TO PROPOSE

3.1 Minimum Qualifications

The Department will only accept bid proposals from bidders who meet all minimum requirements.

• The bidder must be designated by the Centers for Medicare and Medicaid Services (CMS) as a Quality Improvement Organization (QIO) for NYS or approved for NYS on the list of Certified QIO-like organizations as of the proposal submission date listed on page 1 of this RFP.

• The bidder cannot be a NYS health care facility, an association of health care facilities conducting business in NYS, or an affiliate* of a NYS health care facility; and

• Consistent with federal regulations 42 CFR 438.354 regarding standards of independence, the bidder must attest that they are independent from the state Medicaid program and from any Medicaid Managed Care organization (MCO) they would be required to review. Such attestation must be included in your organization’s Technical Proposal.

*Affiliate is defined as an independent or partially integrated entity that has a formal business, professional, or contractual relationship with the main facility.

Experience acquired concurrently is considered acceptable.

For the purposes of this RFP, a “prime contractor” is defined as one who has the contract with the owner of a project or job and has full responsibility for its completion. A prime contractor undertakes to perform a complete contract and may employ (and manage) one or more subcontractors to carry out specific parts of the contract.

Failure to meet these Minimum Qualifications will result in a proposal being found non-responsive and eliminated from consideration.

4.0 SCOPE OF WORK

This Section describes the services that are required to be provided by the selected bidder. The selected bidder must be able to provide all of these services throughout the contract term.

PLEASE NOTE: Bidders will be requested to provide responses that address all of the requirements of this RFP as part of its Technical Proposal.

The terms “bidders”, “vendors” and “proposers” are also used interchangeably. For purposes of this RFP, the use of the terms “shall”, “must” and “will” are used interchangeably when describing the Contractor’s/Bidder’s duties.

https://www.health.ny.gov/health_care/managed_care/mcplans.htm

It is a priority of the Department to ensure individuals with or at risk of acquiring HIV/AIDS, hepatitis C (HCV), and/or sexually transmitted infections (STIs) have access to quality health care and achieve equity in health status. In 2014, New York State became the first jurisdiction to launch a statewide initiative to end AIDS by reducing the number of persons living with HIV for the first time since effective HIV treatment became available. Ending the Epidemic (ETE) in New York State will maximize the availability of lifesaving, transmission-interrupting treatment for HIV, improving the health and lifespan of New Yorkers. As persons retained in successful treatment who have achieved, and maintained viral suppression are effectively not able to sexually transmit the virus, the provision of appropriate medical care for persons living with diagnosed HIV to achieve and maintain viral suppression is a key feature of the ETE initiative.

4.1 Tasks/Deliverables

The Contractor shall complete all activities as described in the following subsections. Some projects will not be conducted every year. In addition, it is possible that, over the five-year contract period, changes in the health care system and emerging health issues may require modifications to the work required and/or populations reviewed. The AIMS program will collaborate with the contractor each contract year to finalize review activities based on changing needs and priorities.

The Contractor will be required to work collaboratively with the Department, Medicaid managed care organizations (MCOs), and providers including, but not limited to primary care providers, AIDS Adult Day Health Care (AADHC), and Health Homes when completing the tasks as outlined in Parts A, B, C, and D.

All materials and methodologies must be approved by the AIMS program prior to implementation. The Contractor will be expected to attend meetings with AIMS program staff, as detailed in the scope of work. The Contractor shall follow nationally accepted medical criteria as directed by the AIMS program and approved review partners, for all contracted reviews such as the continuously updated guidance for cases of HIV, HCV, STIs, and other areas reviewed in the RFP.

The Contractor will be monitored and evaluated by the Department throughout the five-year contract at minimum on an annual or as needed to assess the quality and timeliness of deliverables, ability to implement a cost-effective system, and personnel management for conducting the activities set forth in this RFP. The Contractor will also be evaluated in the following areas:

• Ability to collaborate with the Department and the AIMS program through timely communication defined as bi-weekly email, coordination, and at a minimum of monthly face-to-face/virtual meetings;

• The execution of the review process as outlined in the scope of work; with incorporation of feedback as agreed upon between the Department and the Contractor;

• Ensuring assessment of a representative sample, quality, and timeliness of the review findings and deliverables including but not limited to summary documents, and raw data;

• The accuracy and complete conveyance of review findings, delivered in accordance with the modality and timeframes determined by the Department, as well as agreed upon between the Department and the Contractor;

• Secure and safe maintenance of Medicaid data in accordance with State and Federal law; quality assurance and improvement throughout each review process including but not limited to tool development, evaluator training, chart reviews, data analysis, and data reporting.

The Department and AIMS program will monitor contractor performance through a variety of methods, including the reporting processes outlined in Section 4.3. In the event the Department and AIMS program determine that the Contractor’s performance is unsatisfactory, the Contractor may be placed on corrective action which may include a performance improvement plan to address deficiencies.

4.1.A. Quality of Care Reviews

At the direction of the Department, the Contractor will conduct quality of care reviews, program evaluations, focused clinical studies, and quality improvement activities for health-related services provided to individuals enrolled in the NYS Medicaid program within the purview of the AIMS program, including persons living with or at risk of acquiring HIV, HCV, and/or other STIs at sites of care designated by the Department, including, but not limited to: acute, long term, ambulatory, and correctional settings throughout NYS. Ambulatory care, commonly known as outpatient care, refers to medical services that do not require an overnight hospital stay.

Such activities will assist the Department in ensuring health-related services provided to individuals enrolled in the state’s Medicaid program and all people living with HIV/AIDS, within the purview of the AIMS program, are appropriate, necessary, and equitable.

The Contractor will perform record reviews, conducted in accordance with clinical practice guidelines established by the Department. They will identify and summarize issues and concerns related to the care and treatment provided to populations under the purview of the AIMS program. The Contractor's work will involve services provided to the Medicaid population, whereas at least 55% of the individual records reviewed must involve a Medicaid recipient. The Department will be responsible for follow-up with providers regarding review results and summaries that indicate a need for improvement.

The Contractor will be required to obtain and review related documents including but not limited to medical charts, case management records and/or policy and procedure documents, and (when necessary) provide technical assistance on the document submission process. It is standard that documentation be provided or submitted through electronic secure file transfer protocols, or through the provision of remote access to electronic records. Some review sites include primary care provider sites, which may require the applicant to invest additional support staff time and administrative activities to collect data/records. For each quality-of-care review, the Department will work with the Contractor to identify a list of sites of care that will be required to provide medical charts for review.

Quality of care review activities are conducted remotely, unless otherwise specified, and must meet Health Insurance Portability and Accountability Act (HIPAA) requirements and comply with the laws and regulations of the United States Codified in 42 CFR Part 2 (the Federal Confidentiality Law), Chapter 584 of the laws of the State of New York (the New York State HIV Confidentiality Law), and the applicable portions of the New York State Department of Health Regulation Part 63 (AIDS Testing and the Confidentiality of HIV Related Information).

The AIMS program will work with the Contractor to develop an annual work plan to specify medical charts, case management charts and/or policy documentation for reviews. The Contractor will be responsible for outreach to identified health care providers per specified contact information provided by the Department and will relay any conflicts or concerns in obtaining records to the AIMS program.

4.1.A.i Ambulatory Care Reviews

At the direction of the Department, the Contractor shall conduct quality of care reviews for services provided to individuals with or at risk of acquiring HIV/AIDS, HCV, and/or STIs at hospital outpatient departments and primary care provider sites. Ambulatory care refers to medical services that do not require an overnight hospital stay. The actual number of review tools required is determined between the Department and the Contractor during the planning period for each review. The Contractor will be responsible for developing and applying an agreed upon sampling method for medical record selection, collecting and compiling data, and preparing reports that describe the performance of each provider reviewed. Data and reports will be submitted to the AIMS program by deadlines determined by the Department and the Contractor.

Reviews could include, but are not limited to, the following topic areas:

• Hepatitis C (HCV) Infection: HCV infection is the leading cause of serious liver disease in the United States. Untreated HCV can lead to cirrhosis, liver cancer, and/or liver transplantation. Numerous statewide policy updates approved through the Department and Governor’s budget offices have been implemented as of May 2024. It is required that HCV screening tests be ordered for all pregnant https://www.hivguidelines.org/ persons during each pregnancy. If the HCV screening test is reactive, an HCV ribonucleic acid (RNA) test is performed on the same specimen, or a second specimen collected at the same time. All pregnant persons with a detectable HCV RNA test receive follow-up care. HCV test results are recorded in the pregnant person's medical record at or before the time of hospital admission for delivery. Quality and program evaluation reviews are essential pieces to monitoring progress towards HCV elimination and health policy implementation.

• HIV Testing: The goal of identifying persons with HIV who remain undiagnosed and linking them to health care is a pivotal piece of the Ending the Epidemic (ETE) Blueprint Recommendations. Reviews may be conducted to assess HIV testing practices as part of routine medical care.

• Post-Exposure Prophylaxis (PEP): PEP is a medicine that an individual can take if they are HIV negative and believe they may have been exposed to HIV and/or STIs. PEP needs to be taken as soon as possible after exposure, ideally within two (2) hours. The sooner PEP is taken, the more likely it is to stop HIV or sexually transmitted infections. Reviews may be conducted to assess PEP prescribing practices and adherence to recommended clinical guidelines, including specific assessment of Doxycycline post-exposure prophylaxis (doxy PEP) to prevent bacterial sexually transmitted infections.

• Pre-Exposure Prophylaxis (PrEP): PrEP is a medicine that reduces the risk of HIV acquisition in sexually active males and females. PrEP is one piece of a comprehensive plan to reduce the risk of HIV. Reviews will be conducted to assess PrEP prescribing practices and adherence to clinical guidelines including Sexually Transmitted Infection testing. In 2022, long acting injectables for PrEP became recognized as the preferred regimen, but not all clinical settings are prepared to administer via this method.

• Congenital Syphilis: Rates of primary and secondary syphilis continue to rise. All pregnant persons should be screened for syphilis at the time pregnancy is first identified, during the third trimester, and again upon delivery. Sexual health should be a part of routine prenatal care, regardless of the outcome of the first syphilis test. Reviews may be conducted on prenatal syphilis testing practices as part of routine medical care.

• Sexually Transmitted Infection (STI) Testing Practices: Over 167,000 cases of chlamydia, gonorrhea, and syphilis were newly diagnosed in New York State in 2023 with all rates increasing each year. An important part of STI prevention is screening and treatment with a recommended regimen. It is anticipated that a review may analyze many aspects of STIs including adhering to the recommended screening and treatment regimens.

• Emerging Health Issues: As New York State continues to expand its vision to End the Epidemic beyond 2025, it is expected that health system changes and emerging health issues will drive other reviews over the five-year contract period. Reviews will be determined by the Department of Health’s mission “to protect and promote health and well-being for all, building on a foundation of health equity.”

4.1.A.ii. Department of Corrections and Community Supervision (DOCCS) Reviews

Section 206 of the State Public Health Law mandates the Department to review policies and practices in facilities operated by DOCCS as well as county and local jail facilities. DOCCS and jail systems are required to apply the standards of HIV/AIDS, HCV, and COVID-19 care as set forth by the Department. DOCCS reviews will include the following:

• State Facility Reviews: Each year of the contract, the Contractor will assess a different “hub” or regional grouping of prisons. There are approximately 42 DOCCS facilities distributed across eight (8) hubs.

This may change based on facility closures that take place with New York State gubernatorial approval during this RFP contract period. The number of patients involved will vary based on the group of prisons selected because the prison population is constantly changing. All DOCCS reviews occur on-site, until an electronic medical record can be established and inclusive of all medical data. The Contractor will be required to deploy staff to the assigned hub each year to review approximately 300 to 1,000 medical charts. The number of records may change from year to year during the RFP period. The Contractor is expected to adapt to meet the needs of this review per updated policy guidelines in collaboration with the Department.

• County/Local Jail Reviews: Oversight responsibility of county and local jails varies throughout the State.

Policy reviews will be conducted to assess compliance with NYS Public Health Law and the HIV/AIDS and HCV care standards set forth by the NYS Department of Health. The Contractor will also review medical records to assess the quality of care provided by the county/local jails. County/local jail reviews typically occur remotely. Two jail system reviews occurred during the last five-year contract.

4.1.A.iii. Maternal-Pediatric HIV Prevention and Care Program (MPPC) Reviews

At the direction of the Department, the Contractor will conduct an MPPC evaluation review of the services and resources rendered to HIV positive mothers and their HIV-exposed newborns to monitor prevention of perinatal transmission of HIV and additional STIs based on current clinical need and viral trends. The Contractor may conduct chart reviews to validate the New York State third trimester HIV testing rate against data collected from the Department’s Newborn Screening Program. Maternal medical record progress notes may be reviewed for documentation of sexual partner(s), HIV and/or additional sexually transmitted infection status and/or if the partner was tested or referred for HIV or sexually transmitted infection testing. Postpartum appointment scheduling (completion) and viral load testing (status) at the time of appointment may be assessed. A review assessing completion of appointment scheduling and/or viral load testing status captures the timeframe between initiation of antiretrovirals (ARVs) and achievement of viral load suppression, as applicable when assessing HIV diagnoses.

The reviews scope may include medical records from four (4) levels of care: prenatal, intrapartum/postpartum, newborn, and pediatric. The Contractor must locate, track, and solicit charts applicable to each level of care for every Department identified maternal-infant dyad. Each medical record selected for the MPPC review is assessed using the tool designed for that level of care. The tools are developed in collaboration with the Department to reflect current standards of care, applicable state laws and regulations, social determinants of health, and to collect descriptive data on characteristics of and care provided to the individual cases reviewed.

The Department will provide case identification information to the Contractor. Please refer to section 4.1.E of the RFP for further information on review tool and data management requirements for the AIMS program.

4.1.A.iv. Focused Clinical Studies

The focused clinical studies will look at aspects of care and outcomes for individuals with, or at risk of acquiring HIV, HCV, and/or STIs. The Contractor will work cooperatively with the Department during the five-year contract period in designing and conducting such focused clinical studies. The purpose of all studies is to obtain valid information that will enable the Department to make an assessment regarding quality of care and collectively develop an effective process to improve care in identified areas. Focused clinical studies will involve retrospective medical record and/or care management record reviews, data collection activities, review of administrative data systems, and analysis. Focused clinical studies evaluate health service delivery issues such as coordination, continuity, access, and availability of needed services.

Simple focused clinical studies require the request and review of records from only one provider or organization. Complex focused clinical studies involve a higher quantity of data abstracted, multi-indicator comparison, and complexity of reporting. A complex focused clinical study requires the contractor to request and review records from more than one provider or organization. Billing for focused clinical studies occurs based on the number of individual records reviewed regardless of the frequency of record access once records are sent. Clinical focused studies are typically conducted remotely. The Department will define the specific aim of a focused clinical study, the stated goal(s), sample methodology, intended use of the data, type of data to be collected, the tools and guidelines to be used, and the statistical tests to be performed on the data.

Focused clinical studies could include, but are not limited to, the following topic areas:

• Viral Load Suppression: As of 2024, approximately 9,600 HIV-infected persons who are receiving care are not maintaining viral load suppression. Viral load suppression is not only important for the health of people with HIV, but because persons with suppressed viral loads cannot transmit HIV to their sexual partners, suppression is also important for public health. It is anticipated that a study to identify causes and a range of solutions to this issue may be pursued.

• HIV/AIDS and Aging: New York State is home to more than 100,000 PLWHA; with 33% of those individuals being over the age of 60. Many of these individuals are older adults who have complicated health due to comorbidities, behavioral health, and long-term care needs. A study which examines the various aspects of HIV/AIDS and aging is anticipated.

• HIV/AIDS Mortality: To understand the primary and contributory factors of mortality among people living with HIV/AIDS, it is necessary to analyze existing data and review clinical records to better understand the factors leading to death. This information may inform development of quality measures that address the common preventable causes of death.

• Health Homes and Health Homes Serving Children: People living with HIV/AIDS who are high utilizers of Medicaid-funded services may be enrolled in a Health Home to better manage and coordinate their care. The Department may require an assessment of the impact of Health Home participation by adults and/or children living with HIV/AIDS on cost and outcomes of their care as a review.

• AIDS Adult Day Health Care (AADHC): People living with HIV/AIDS may receive services from an AADHC. The AADHCs are listed as Home and Community Based Services (HCBS) providers. The Department may require an assessment of the impact of AADHC participation by adults living with HIV/AIDS on cost and outcomes of services provided, as a review.

• Drug User Health: Drug use is associated with several unique health risks and people who use drugs are less likely to access health care on a regular basis. Drug user health encompasses many different areas including Medication Assisted Treatment (MAT), buprenorphine prescribing, methadone treatment, opioid overdose prevention, linkage and navigation services – including telehealth services, environmental services, and community-based services, and patient-centered, culturally competent care. A study which examines the various aspects of drug user health is anticipated.

• Congenital Syphilis: Rates of primary and secondary syphilis continue to rise. All pregnant persons should be screened for syphilis at the time pregnancy is first identified, during the third trimester, and again upon delivery. Sexual health should be a part of routine prenatal care, regardless of the outcome of the first syphilis test. Reviews may be conducted on prenatal syphilis testing practices as part of routine medical care.

• Sexually Transmitted Infection (STI) Testing Practices: Newly diagnosed cases of chlamydia, gonorrhea, and syphilis in New York State can fluctuate annually, depending on several factors. An important part of STI prevention is screening and treatment with a recommended regimen. It is anticipated that a review may analyze many aspects of STIs including adhering to the recommended screening and treatment regimens.

• Expedited Partner Treatment (EPT): EPT allows health care providers to provide a patient’s sexual partner(s) with either antibiotics or a written prescription. EPT is a strategy that can serve as an alternative to referring sexual partner(s) for clinical examination when they are unable, unlikely, or unwilling to seek care.

• Emerging Health Issues: As NYS continues to expand its vision to End the Epidemic beyond 2030, it is expected that health system changes and emerging health issues related to changes at the federal and state level, will drive other reviews over the five-year contract period resulting from this RFP. Reviews will be an essential piece to monitoring such changes.

• Health Equity: Health disparities are differences in the rates of disease and health status among groups of people. Individuals with or at risk of acquiring HIV/AIDS, HCV, and/or STIs are often profoundly affected by health disparities. Health disparities are driven by social determinants of health which are defined as the conditions in which people are born, live, learn, grow, work, and age. The ability to secure employment and good working conditions; quality education; safe neighborhoods and housing;

access to healthy and nutritious food; access to social support networks; and quality health care services directly impacts risks of health conditions and outcomes, especially for individuals with or at risk of acquiring HIV/AIDS, HCV, and/or STIs.

4.1.B. AIMS Managed Care Responsibilities

The Contractor will conduct remote contractual quality and compliance reviews of Medicaid managed care organizations (MCOs) focusing on, but not limited to, these following areas:

4.1.B.i. HIV SNP (Special Needs Plans) Comprehensive Quality of Care Review

The Contractor will conduct administrative and care management/coordination record reviews to verify the following:

• Documentation of eligibility status of HIV SNP enrollees (Section 6.11 of the Medicaid Managed Care/Family Health Plus/HIV Special Needs Plan/Health and Recovery Plan Model Contract hereafter referred to as the MMC Model Contract. The MMC Model Contract can be found through this link:

https://www.health.ny.gov/diseases/aids/general/resources/snps/contract.htm-Up to 100% of HIV SNP enrollee files may be reviewed, although, at the direction of the Department’s AIDS Institute, sampling may be applied if the enrollment levels exceed available review resources. Additionally, the MMC Model Contract specifies activities HIV SNPs are required to perform for new enrollees, including timely orientation, assignment of primary care provider, and assignment of a case manager (Section 10.34 of the MMC Model Contract).

• Documentation for Medicaid Managed Care (MMC) enrollees living with HIV for completion of comprehensive assessments within required time frames. The Contractor will assess whether social determinants of health and needs identified in the initial assessment, specifically mental health, chemical dependence, and treatment adherence, become part of the person-centered plan of care.

These requirements are delineated in the MMC Model Contract, Section 10.34. Additionally, the Contractor will review documentation of MMC ongoing assessment of care management needs and efforts to find and re-engage enrollees who are lost to follow-up. The requirements are delineated in the MMC Model Contract, Section 10.34. These reviews include assessment of the MMC Model Contract’s collaboration and coordination with health homes or other programs to which members may be assigned.

4.1.B.ii. Medicaid Managed Care Organizations (MCOs) Comprehensive Quality of Care https://www.health.ny.gov/diseases/aids/general/resources/snps/contract.htm

The Contractor will conduct administrative and care management/coordination record reviews to verify the following:

• Documentation of eligibility status of enrollees living with HIV (Section 6.11 of the MMC Model Contract). A 10% sample of enrollee files may be reviewed, although, at the direction of the Department’s AIDS Institute, alternative sampling may be applied if the enrollment levels exceed available review resources. The MMC Model Contract outlines activities MCOs are required to perform for new enrollees, including timely orientation, assignment of primary care provider, and assignment of a case manager (Section 10.34 of the Medicaid Managed Care Model Contract).

• Documentation for MMC enrollees living with HIV for completion of comprehensive assessments within required time frames. The Contractor will assess whether social determinants of health and needs identified in the initial assessment, specifically mental health, chemical dependence, and treatment adherence, become part of the person-centered plan of care. These requirements are delineated in the MMC Model Contract, Section 10.34. Additionally, the Contractor will review documentation of MMC ongoing assessment of care management needs and efforts to find and re-engage enrollees who are lost to follow-up. The requirements are delineated in the MMC Model Contract, Section 10.34. These reviews include assessment of the Medicaid Managed Care’s collaboration and coordination with health homes or other programs to which members may be assigned.

4.1.B.iii. Managed Care Organization (MCO) Ending the Epidemic (ETE) Quality Assurance and/or Policy Evaluation

The Contractor may utilize an annual sample, matching the viral load suppression data submitted to the participating MCO ETE plans, for the following:

• Measure outreach efforts to engage or re-engage virally unsuppressed members, living with HIV, back in care;

• Compare viral load suppression rates of members living with HIV, from the last HIV viral load test prior to initiation of engagement/re-engagement efforts and subsequent HIV viral load tests following implementation of engagement efforts;

• Analyze outreach strategies, linkage to care, and retention in care policies for compliance with the Department’s AIDS Institute guidelines; and

• Measure outreach efforts to engage members with an HIV negative or unknown status, in utilization of PrEP.

4.1.C. Policy and Procedure Documentation Reviews

At the discretion of the Department, the Contractor will be required to validate up to 20% of the sample, to confirm accurate and sufficient data response. Policies need to meet current NYS program-specific guidance which includes but is not limited to clinical guideline standards, public health law, and regulatory requirements.

It is preferred that policy documentation be sent to the Contractor via electronic system, with PDF uploads accepted in the event electronic system is not accessible. Review topics may include but are not limited to any of the topics outlined in the scope of work of the program evaluation reviews and focused clinical studies sections in this RFP.

4.1.D. Quality Improvement and Technical Assistance

The Contractor will validate up to 20% of the review sample to confirm accurate and sufficient data response.

Quality assurance measures to verify a representative sample include:

• Ensuring documentation of any data gaps through detailed written description(s);

• Tracking, monitoring, and ensuring consistency of tool interpretation and data input between at least two evaluators; and

• Verification that sample demographics accurately reflect broader study population trends.

4.1.E. Review Tools and Data Management

The Contractor will be sent finalized tools that are developed by the Department and/or AIMS program review partners. The Contractor must ensure all electronic data collection tools and supporting documentation (including submission of guidance documents) accurately include review tool content approved by the Department. It is anticipated that the Contractor will receive a (1) Clinically Focused tool, (2) Demographics tool, and a (3) Social Determinants of Health tool as relevant for each review. Once the tools are approved by the Department, the Contractor is responsible for electronically adapting review tools into a data collection software and/or program to be referenced during each review period by evaluators.

4.1.E.i. Review Tool Categories

Review tool categories include (1) Clinically Focused tool, (2) Demographics tool, (3) Social Determinants of Health tool and (4) Quality Assurance tool. Every review will have a Clinically Focused tool, a Demographics tool and a Quality Assurance tool. A Social Determinants of Health tool may be used for a review at the discretion of the Department, when relevant. It is expected that each tool will have a cost that is commensurate to its complexity (low, medium, or high). Further details on each review tool category are as follows:

• Demographics Tool (Low Complexity): This tool consolidates all population demographics to a simple chart structure for every review.

• Social Determinants of Health Tool (Medium Complexity): This tool captures population-relevant social health outcomes including but not limited to housing, employment, food security, transportation, education, communication, healthcare system engagement, community and social support.

• Clinically Focused Tool (High Complexity): This tool focuses on health service delivery issues including but not limited to care and/or service coordination, continuity, access, and/or availability.

• Quality Assurance Tool (Low Complexity): This tool captures information as it relates to the Contractor’s quality assurance throughout the review process including but not limited to case status information, chart outreach frequency, and gaps in chart documentation. This tool serves as the basis for the accompanying Quality Assurance Review Summary.

4.1.E.ii Electronic Adaptation of Review Tools

Electronic adaptation of the review tools includes programming tools into a data collection software and/or program such as REDCap, Mahalo, Castor (EDC), Medidata Rave, OpenClinica, Oracle Clinical, Zeltea (IBM), and TrialKit. The data collection software and/or program must have the ability to do the following:

• Incorporate data collection information into standard templates

• Incorporate and edit branching logic to track and update data forms throughout the review process

• Relate distinct forms to and between each other, as individual questions from one review tool by trigger responses from a second, third and/or fourth review tool

• Program option of multiple response selections for every tool question

• Program textbox response option as the final response option of any given tool question

4.1.E.iii. Data Collection Based on the Review Tools

The Contractor will accurately input review data into their electronic data collection software and/or program as directed per all associated review tools. During the data collection process, up to 20% of all charts will be validated for quality assurance to establish and monitor for inter-rater reliability (IRR).

The hours associated with any component of the data collection including but not limited to evaluator training, evaluator review of chart, and input of data into the electronic data collection software, will be incorporated into the cost of each chart reviewed and not included in the cost of the review tools. The additional 20% of validated charts will be billed under the quality assurance line within the budget.

4.1.E.iv. Data Analysis

Based on feedback from the Department, the Contractor will be responsible for developing and applying a sampling method for medical record selection, collecting and compiling data, and preparing reports that assess the performance of each healthcare entity and/or documentation reviewed. The Contractor will be responsible for the management of the data collected from each review, as well as data analysis and reporting as outlined in sections 4.1.A, 4.1.B, and 4.1.C of the RFP. Data analysis may include basic descriptive statistics (counts, means, medians, standard deviations) and other statistical tests such as regression analysis, analysis of variance (ANOVA) and Pearson’s chi-square. The Department, upon review of data analysis deliverables provided by the Contractor, may request modifications and/or updates based on identified review needs where necessary. Please refer to sections 4.3 and 4.4 of the RFP for further information on data management and reporting requirements for the AIMS program.

Billable hours for data management will include all data analysis tasks outlined in this section. Billable data management hours will not include programming tools via data collection software or data collection processes such as chart counts and/or record of policy documentation page counts.

4.1.F. Review Timelines and Deliverables

Each review type defined in Sections 4.1.A. and 4.1.B. will have a pre-review period, review period, and post-review period as outlined below:

Pre-Review Period (Sections 4.1.A., 4.1.B., and 4.1.E.i – ii.):

• The Department shares the defined review scope and design with the Contractor through a review summary which includes the definition of the study aim, measurement indicators, methodology (including definition of the study population and sampling techniques), data collection, and data analysis and interpretation).

• The Contractor shares digitized tools with the Department and the associated review teams based on the defined review scope.

• The Department and the associated review teams approve the tool format to be utilized by the contractor during the review period in training evaluators and collecting review data.

• The Contractor programs the review tools into their electronic data collection software.

• The Contracted evaluators are trained on the finalized review tool and instructions via established training manuals as reviewed with and agreed to by the Department.

• The Department shares approved electronic letter correspondence to providers and/or healthcare organizations requesting data or medical records with the Contractor.

• The Contractor sends electronic letter correspondence to providers and/or healthcare organizations requesting data or medical records, formally beginning review period.

Review Period (Sections 4.1.A., 4.1.B., 4.1.C., 4.1.D., 4.1.E.iii.):

• The Contractor monitors all documentation associated with the review (i.e. data, medical records and/or policy-related documents) as it is submitted to ensure data compliance and completeness as defined by the Department. If discrepancies are found, the Contractor will work with providers and/or healthcare organizations by providing technical assistance regarding reconciling files, submission process, and data formats.

• A mid-point review meeting between the Contractor and the Department will be scheduled to address any questions or data gaps identified by evaluators at the review mid-point.

• An end-point review meeting between the Contractor and the Department will be scheduled, to discuss data trends and notes identified by evaluators at the conclusion of the review.

• Additional meetings will be added as needed.

Post-Review Period (Sections 4.1.A., 4.1.B., 4.1.E.iv., and 4.5):

• The Contractor will finalize data management and editing as outlined via specific deliverables requested by the Department contract management and review teams for each review.