rfp1010003.doc

PART I - THE SCHEDULE

Request for Proposal SECTION A - SOLICITATION FORM No. AHRQ-10-10003 Date Issued: February 25, 2010 Date Questions Due: March 11, 2010 12:00 PM ET Date Notice of Intent Due: April 1, 2010

Date Past Performance Questionnaires Due:

April 15, 2010, 12:00 PM ET

Date Proposals Due: April 15, 2010 12:00 PM ET RECOVERY – The base period of this contract (24 months) will be funded by the American Recovery and Reinvestment Act of 2009 (Recovery Act, P.L. 111-5). Please review the required ARRA reporting requirements in Section H and I of this solicitation which will apply to the base period of this contract..

You are invited to submit a proposal to the Agency for Healthcare Research and Quality (AHRQ) for Request for Proposal (RFP) No. AHRQ-10-10003, entitled “Horizon Scanning System.” Your proposal must be developed and submitted in accordance with the requirements and instructions of this RFP.

A firm, fixed-priced contract is contemplated for a period of two years, with three 1-year option periods.

The Government anticipates awarding one contract from this solicitation.

The North American Industry Classification System (NAICS) code that best describes the requirement is 541611.

For this particular acquisition, the 2010 AHRQ recommended goal (as a percentage of total contract value for the base period) is 28% for Small Businesses, which shall include at least 5% (as a percentage of total planned subcontract dollars for the base period) for Small Disadvantaged Businesses, at least 5% (as a percentage of total planned subcontract dollars total planned subcontract dollars for the base period) for Women-Owned Small Businesses, and at least 3% (as a percentage of total planned subcontract dollars for the base period) for HUBZone Small Businesses and at least 3% (as a percentage of total planned subcontract dollars for the base period) for Service Disabled Veteran-Owned Small Businesses. These goals represent AHRQ’s expectations of the minimum level for subcontracting with small business at the prime contract level. Any goal stated less than the AHRQ recommended goal shall be justified and is subject to negotiation.

Offerors shall submit the following:

A.

Technical Proposal (See Section L.10) (Original and 11 copies)

B.

Past Performance Information (See Section L.11) (Original and 5 copies) C, Small Disadvantaged Business Participation Plan (See Section L.12) (Original and 2 copies) C.

Business Proposal (See Section L.13) (Includes Small Business Subcontracting Plan, Section K clauses, and completed Invoice Schedule – Attachment 6) (Original and 5 copies) Your technical proposal must be concisely written and should be limited to 80 typewritten pages (double-spaced), not including resumes or bibliographies, with no less than 11 point, double-spaced text (lists of deliverables, person loading charts, and similar materials need not be double-spaced so long as they are legible). See Section L.10 for additional details. This limitation is for administrative purposes only and exceeding the limitation shall not, of itself, be considered a basis for rejection of your proposal.

As part of the business proposal, offerors shall provide an original and five (5) copies of their cost/price proposal and the completed Invoice Schedule, see Section L.13 and Attachment 6.

Your proposal must provide the full name of your company, the address, including county, Tax Identification Number (TIN), DUN and Bradstreet No., and if different, the address to which payment should be mailed.

YOUR ATTENTION IS CALLED TO THE LATE PROPOSAL PROVISIONS PROVIDED IN SECTION L.3 OF THIS RFP. YOUR ATTENTION IS ALSO DIRECTED TO THE TECHNICAL PROPOSAL INSTRUCTIONS PROVIDED IN SECTION L.10 OF THE SOLICITATION.

If you intend to submit a proposal in response to this solicitation, please inform the Contracting Officer of your intent by completing the Proposal Intent Response Form (Attachment 3 to this solicitation) and send it to the Contracting Officer no later than April 1, 2010. You may send it to the address below or fax it to 301-427-1740, Attention: Sharon Williams, Contracting Officer.

Questions regarding this solicitation shall be received in this office no later than March 11, 2010 (See Section L.7). All questions shall be submitted electronically by e-mail to Sharon Williams, Contracting Officer at the following email address: sharon.williams@ahrq.hhs.gov.

Subject line shall read: “Proposal Questions RFP No. AHRQ-10-10003.”

Answers to questions will be provided in the form of an Amendment to this solicitation and will be posted on AHRQ’s web page: www.ahrq.gov under “Funding Opportunities,” “Contract Solicitations” and Federal Business Opportunities web page: www.fedbizopps.gov. It is your responsibility to monitor the web sites where the RFP will be posted to learn about any amendments to the solicitation.

Discussions with any other individual outside the Division of Contracts Management, may result in rejection of the potential offeror’s proposal.

The proposal shall be signed by an authorized official to bind your organization and must be received in our Contracts Office no later than 12 noon, local prevailing time, on April 15, 2010. Your proposal must be mailed to the following address:

Agency for Healthcare Research and Quality

Division of Contracts Management

540 Gaither Road

Rockville, Maryland 20850

Hand carried proposals may be dropped off at the above location. However, please allow ample time as proposals cannot be accepted until they have gone through security. We will not be held responsible for any delays that may be incurred getting your proposal through security.

NOTE:

The U.S. Postal Service’s “Express Mail” does not deliver to our Rockville, Maryland address. Packages delivered via this service will be held at a local post office for pick-up. The Government will not be responsible for picking up any mail at a local post office. If a proposal is not received at the place, date, and time specified herein, it will be considered a “late proposal.”

The RFP does not commit the Government to pay any cost for the preparation and submission of a proposal. It is also brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed acquisition.

In accordance with Federal Acquisition Circular (FAC) 2001-16, all contractors must be registered in the central contractor registration (CCR) database in order to conduct business with the government [See Section I - FAR clause 52.204-7 Central Contractor Registration (OCT 2003), Alternate 1 (Oct 2003)]. As stated in paragraph (h) of this clause, additional information can be obtained at http://www.ccr.gov or by calling 1-888-227-2423, or 269-961-5757.

Requests for any information concerning this RFP should be referred to Sharon Williams,

(301) 427-1781 or e-mail: sharon.williams@ahrq.hhs.gov. Please note e-mail requests should state subject as RFP AHRQ 10-10003.

TABLE OF CONTENTS

PART I

Pages Section A Solicitation 1-3

Table of Contents

Section B Supplies or Services & Prices/Costs 5-6

Section C Description/Specification/Work Statement 7-28

Section D Packaging and Marking 29

Section E Inspection and Acceptance 29

Section F Deliveries or Performance 30-34 Section G Contract Administration Data 35-36

Section H Special Contract Requirements

37-44

PART II

Section I Contract Clauses 45-49

PART III

Section J List of Attachments

PART IV

Section K Representations and Instructions 51-61

Section L Instructions, Conditions & Notices to Offerors 62-85

Section M Evaluation Factors for Award

86-90

Attachments 1.

Past Performance Questionnaire and Contractor Performance Form 91-96

2. SF LLL-A, Disclosure of Lobbying Activities

97101 3.

Proposal Intent Response Sheet

4.

Small Business Subcontracting Plan

103-112 5.

Breakdown of Proposed Fixed Price and Labor Hours/Rates

113-114

6.

Invoice Schedule

115-128

SECTION B-SUPPLIES OR SERVICES AND PRICES/COSTS

B.1

BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

“Horizon Scanning System” – The purpose of this solicitation is to establish a system to conduct horizon scanning of healthcare technology in order to better inform comparative effectiveness research investments at the AHRQ through the Effective Healthcare Program.

See Section C for a complete description.

B.2

FIRM FIXED PRICE

The firm fixed price of this contract is as follows:

Total Amount for Base Contract:

Please complete the Invoice Schedule - Attachment 6 by entering your proposed prices for each deliverable/task (including option periods). Include the completed Invoice Schedule in your Business Proposal.

B.3

OPTION PERIODS

In the event that the option period is exercised, the firm fixed price will be increased by the following amounts:

Option 1

Option 2

Option 3

B.4

PROVISIONS APPLICABLE TO DIRECT COSTS

a.

Unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

(1) Acquisition, by purchase or lease, of any interest in real property;

(2) Rearrangement or alteration of facilities;

(3) Purchase or lease of any item of general purpose-office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

(4) Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more, with a life expectancy of more than two years) and "sensitive items" (defined and listed in the Contractor's Guide for Control of Government Property, 1990, regardless of acquisition value;

(5) Travel to attend general scientific meetings;

(6) Foreign Travel;

(7) Any costs incurred prior to the contract's effective date;

(8) Rental of meeting rooms not otherwise expressly paid for by the contract;

(9) Any formal subcontract arrangements not otherwise expressly provided for in the contract;

(10) Consultant fees in excess of $1000/day;

(11) Information Technology hardware or software and

(12) Food and Beverages.

b. This contract is subject to the provisions of Public Law (P.L.) 99-234 which amends the Office of Federal Procurement Policy Act to provide that contractor costs for travel, including lodging, other subsistence, and incidental expenses, shall be allowable only to the extent that they do not exceed the amount allowed for Federal employees. The Contractor, therefore, shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.

SECTION C- DESCRIPTION/SPECIFICATION/WORK STATEMENT

I.

BACKGROUND

A.

COMPARATIVE EFFECTIVENESS AND THE AMERICAN RECOVERY AND REINVESTMENT ACT

The American Recovery and Reinvestment Act (ARRA) appropriates $1.1 billion for comparative effectiveness research (CER), of which $300 million is allocated to the Agency for Healthcare Research and Quality (AHRQ). The goal of CER, an integral component of AHRQ’s health services research program, is to improve health outcomes and the quality of care by providing evidence to inform and enhance medical decisions made by patients and their medical providers.

The Department of Health and Human Services uses the definition of CER set forth by the Federal Coordinating Council for Comparative Effectiveness Research:

Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

Federal Coordinating Council for Comparative Effectiveness Research. (June 30, 2009).

Report to the President and the Congress on Comparative Effectiveness Research.

U.S. Department of Health and Human Services. http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf, accessed July 1, 2009.

The purpose of CER is to provide information that helps clinicians and patients choose the preventive, diagnostic, treatment, or other healthcare options which best fit an individual patient's needs and preferences. Clinicians and patients need to know not only that a treatment works on average but also which interventions work best for specific types of patients, for example elderly patients, members of racial and ethnic minorities, or patients with specific comorbidities. Policy makers and public health professionals need comparative effectiveness information to inform system-level decisions, for example designing prevention programs both for patients and for those not regularly accessing the health care system. CER is essential for translating new discoveries into better health outcomes for Americans, accelerating the application of beneficial innovations, and delivering the right treatment to the right patient at the right time.

AHRQ will use ARRA funds to expand and broaden existing CER activities and to support new initiatives in CER. All activities undertaken will be consistent with Titles III and IX of the Public Health Services Act; Part A of title XI of the Social Security Act; and Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This effort is designed to increase the national output of comparative effectiveness research; in addition, it will build research infrastructure and capacity, allowing future studies to address questions where data are currently not sufficient to provide guidance about competing alternatives and to improve the efficiency with which the research infrastructure is able to respond to pressing health care questions. AHRQ’s research activities will be performed using rigorous scientific methods within a previously-established process that emphasizes stakeholder involvement and transparency.

AHRQ ARRA-funded programs will include activities to identify emerging issues and existing gaps in CER; synthesize comparative effectiveness evidence, generate new CER, improve the infrastructure for gathering data to support comparative effectiveness studies, enhance public participation, and support training and career development.

Among these activities, this solicitation presents AHRQ’s effort to implement its own healthcare horizon scanning framework and infrastructure in order to identify new and emerging issues for comparative effectiveness investments. The goal of this effort is to provide AHRQ with a systematic process to identify healthcare technologies that are purported to or may hold potential to have a high clinical, system and/or cost impact in the US and to analyze the contextual landscape in which these technologies exist. The background information that follows describes the context in which the AHRQ Healthcare Horizon Scanning System will exist, including AHRQ’s current and future work in CER through the Effective Health Care (EHC) Program.

B.

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

The mission of the AHRQ is to improve the quality, safety, efficiency, and effectiveness of healthcare for all Americans. Toward this end, AHRQ conducts and supports health services research in leading academic institutions, hospitals, physicians' offices, health care systems, and many other settings across the country as part of a broad research portfolio that touches on nearly every aspect of health care. AHRQ-supported researchers are working to answer questions about:

· Clinical practice.

· Outcomes of care and effectiveness.

· Evidence-based medicine.

· Primary care and care for priority populations.

· Health care quality.

· Patient safety/medical errors.

· Organization and delivery of care and use of health care resources.

· Health care costs and financing.

· Health care system and public health preparedness.

· Health information technology.

AHRQ’s ultimate goal is to disseminate research findings to produce healthier, more productive individuals and an enhanced return on the Nation's substantial investment in healthcare. Essential to this goal is the translation of research into healthcare practice. Healthcare providers, patients, policymakers, payers, administrators, and others use AHRQ research findings to make informed decisions, improving health care quality, accessibility, and outcomes of care.

C.

THE EFFECTIVE HEALTH CARE PROGRAM

AHRQ’s CER initiative, the Effective Health Care (EHC) Program, was launched in 2005 under the authorization of Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. Section 1013 instructs AHRQ to conduct and support CER, strategically focusing on comparing the outcomes, clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services, with broad and ongoing consultation with relevant stakeholders.

The EHC Program's primary principle is that all Americans should have the best available evidence upon which to base decisions about health care interventions and services. Patients, health care providers (including nurses, doctors and other clinicians), and policymakers all share an interest in health decisions. One of their greatest challenges, however, is finding reliable and practical data that can inform these decisions. The EHC Program is dedicated to fulfilling this need by supporting high-quality research and making current, reliable evidence on health care interventions available and accessible to those who need it.

The EHC Program is guided by several principles which shape its activities:

· Focus on Effectiveness. The EHC Program focuses on evidence of the relative benefits and risks of different treatments and therapeutic approaches for a clinical condition in different populations. It does not make treatment recommendations. Instead, it enables health care decision-makers, including patients and providers, to use effectiveness findings along with other considerations to make decisions that reflect their own needs and values.

· Transparency & Open Processes. Extensive opportunities for stakeholder input and public comment help ensure that the EHC Program will respond to the most pressing issues and that final products will be useful to health care decision-makers.

· Usability & Real World Applicability. Comprehensive research reports and other technical reports are distilled into key findings to make them more accessible to a variety of audiences. Summary guides and other translation products target consumers, clinicians, and policymakers with relevant information.

· Driving Research Forward. The EHC Program identifies topics requiring further study and then both conducts and supports timely research to address these issues. At the same time, it develops and refines methodologies to improve comparative effectiveness research.

· Consideration of Vulnerable Populations and Priority Conditions. In selecting research topics, priority is given to healthcare services that: 1) impose high costs on Medicare, Medicaid, or SCHIP; 2) may be over- or under-utilized; 3) may significantly improve the prevention, treatment, or cure of diseases and conditions that impose high direct or indirect costs on patients or society; and 4) place a big burden on people, especially the AHRQ “priority populations.” Priority is given to research topics that address inequities or vulnerable populations, which include low-income groups, minority groups, women, children, the elderly, and individuals with special healthcare needs (including those with disabilities, those requiring care for chronic conditions or end-of-life care, or those living in inner-city or rural areas). Other considerations include the following: appropriateness, importance, duplication, feasibility, and potential value. Additionally, the AHRQ Priority Conditions guide research, synthesis, and translation and dissemination priorities for the AHRQ EHC program. The AHRQ priority conditions are as follows:

· Arthritis and nontraumatic joint disease

· Cancer

· Cardiovascular disease

· Dementia (including Alzheimer’s Disease)

· Depression and other mental health disorders

· Developmental delays, attention-deficit hyperactivity disorder, and autism

· Diabetes mellitus

· Functional limitations and disability

· Infectious Disease, including HIV/AIDS

· Obesity

· Peptic ulcer disease and dyspepsia

· Pregnancy, including preterm birth

· Pulmonary disease/asthma

· Substance abuse

Additional information on the AHRQ priority conditions and the Effective Health Care Program can be found at http://effectivehealthcare.ahrq.gov/ C.1. EHC Component Programs

The EHC Program has three approaches to developing and translating current, unbiased information on the comparative effectiveness of different treatments and clinical practices (see figure above). Each of these approaches is encompassed in one or more component programs of the EHC Program.

1. Synthesizing research: The EHC Program systematically reviews, critically appraises, and synthesizes scientific literature into comprehensive evidence reports.

AHRQ created the Evidence-based Practice Centers (EPCs) in 1997 to synthesize existing scientific literature about important health care topics and to promote evidence-based practice and decision-making. The EPCs are located at 14 public- and private-sector research institutions throughout the United States and Canada. The EPCs have addressed a range of topics, mostly related to significant diseases or health problems affecting Medicare or Medicaid beneficiaries or other special populations.

The major products of the EPCs are evidence reports, including systematic reviews; technology assessments; technical briefs; and research reviews covering non-clinical methods topics. All reports are based on rigorous, comprehensive syntheses, and analyses of the scientific literature and emphasize detailed documentation of methods. The reports do not make clinical recommendations or recommendations related to coverage and reimbursement policies. A list of published EPC evidence reports can be reviewed at www.ahrq.gov/clinic/epcix.htm.

With the launch of the EHC Program in 2005, the EPCs began to conduct Comparative Effectiveness Reviews, a type of systematic review that compares relative benefits and harms among a range of available treatment or interventions for a given condition. Comparative Effectiveness Reviews provide building blocks to support evidence-based practice and decision making. They address questions about treatments or diagnostic tests to help clinicians and patients choose the best options and help healthcare policy makers formulate decisions about health care services and quality improvement. An important component of Comparative Effectiveness Reviews is the systematic identification of research gaps and the recommendation of studies and approaches to fill those gaps. A list of published EPC Comparative and Effectiveness Reviews can be found on the Effective Health Care Program website (www.effectivehealthcare.ahrq.gov). For more information about Comparative Effectiveness Reviews, please visit the EPC website.

With ARRA funding, the EPCs will significantly expand their efforts in topic development, topic refinement, and evidence synthesis. The EPCs will advance research methods and update methods guidance. ARRA funding will also allow for advances in identifying evidence gaps to further consider the timing, value, and feasibility of research that would fill the gaps as well as coordination with other funders and researchers able to conduct the needed research.

2.

Generating new research: The EHC Program develops new scientific knowledge to address knowledge gaps and to meet the needs of clinical and health policy decision-makers.

The DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network was created in 2005 as part of the EHC Program to develop scientific evidence and new analytic tools to inform patients, providers, and policy-makers involved in decisions about the effectiveness, comparative effectiveness, appropriateness, safety, efficiency, and outcomes of healthcare items and services. The DEcIDE Network is comprised of 13 academic, clinical, and practice-based organizations with access (or partners providing access) to electronic health information databases and the capacity to conduct timely research. The types of databases represented in the DEcIDE Network include electronic medical record data, pharmacy records, public and private health insurance data, long-term care data, and special databases such as disease, medical procedure, or medical device registries.

The DEcIDE Network conducts practical studies using electronic health data to examine the outcomes, comparative clinical effectiveness, safety, and appropriateness of health care items and services. Current DEcIDE Network research focuses on the outcomes of prescription drug use and other interventions for which randomized controlled trials would not be feasible or timely, or would raise ethical concerns that are difficult to address. Other projects focus on electronic registries, methods for analyzing health databases, and prospective observational or interventional studies. Several of the DEcIDE Centers are part of three multi-center research consortia that focus specifically on Diabetes, Cancer, and Cardiovascular Disease research. Examples of reports generated by the DEcIDE Research Network may be found at http://effectivehealthcare.ahrq.gov.

Another source of new evidence, the Centers for Education and Research on Therapeutics (CERTs), has collaborated with the EHC Program to generate new scientific evidence and provide education that advances the optimal use of therapeutics (i.e., drugs, medical devices, and biological products). Established in 1999, the CERTs is a cooperative agreement program administered by AHRQ in consultation with the U.S. Food and Drug Administration, and is comprised of 14 research centers. CERTs projects focus on therapeutic areas chosen based on a demonstrated need for improved clinical practice or implementation in that area. CERTs projects for the Effective Health Care Program may be found at http://certs.hhs.gov/about/certsovr.htm.

ARRA funding will increase DEcIDE activities for conducting new comparative effectiveness research. In addition, AHRQ will invest significantly in investigator-initiated research through grant mechanisms. Grants funded under the AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) will be large projects in comparative effectiveness aimed at generating new knowledge to help inform decision-making in priority areas of clinical care and should have high likelihood of creating major advancements in clinical care. Grants funded as AHRQ Prospective Outcome Systems using Patient-specific Electronic data to Compare Tests and therapies (PROSPECT) studies will focus on developing infrastructure and improving the methodology for collecting prospective data from electronic clinical databases to generate new evidence on the comparative effectiveness of healthcare interventions. The Electronic Data Methods Forum will convene PROSPECT studies investigators with other experts and relevant stakeholders in health information technology and in outcomes research to identify the challenges to conducting comparative effectiveness research using electronic data and to propose realistic solutions to advance this field of research.

3. Translating and disseminating research: The EHC Program turns complex research reports into understandable summary guides for different audiences and gets them into the hands of decision-makers who can use them.

The John M. Eisenberg Clinical Decisions and Communications Science Center, located at Baylor College of Medicine in Houston, Texas, takes a systematic approach to translating complex scientific evidence produced by EHC Program into short, understandable, and actionable materials and products. The Eisenberg Center creates a variety of products, ranging from summary guides to decision aids and other materials, presenting research results in plain language for three audiences: consumers (patients, family members, and others who are not medical professionals), clinicians, and policy makers.

The Eisenberg Center works closely with AHRQ to disseminate the translation products to the appropriate audiences and in a manner that encourages utilization. The Eisenberg Center also designed and maintains the Effective Health Care Web site, www.effectivehealthcare.ahrq.gov.

With ARRA funding, AHRQ will increase efforts in translation and dissemination through the Eisenberg Center. Increased grant funding will also support the development and implementation of innovative approaches to integrating comparative effectiveness research findings into clinical practice and health care decision making. Investments will be in multiple geographically dispersed translation, implementation, and evaluation projects to be carried out by local organizations such as medical societies, state institutions of higher learning, patients, community advocacy organizations and others to promote education, dissemination and application of comparative effectiveness research.

C.2. Topic Identification

The EHC Program is built around stakeholder-driven research. Stakeholders are involved in the process of identifying, selecting, and refining topics for investigation, and they also inform prospective researchers who apply for CER research grants. Currently the program has a formal process by which any person may nominate a topic for comparative effectiveness research using a web-based form. The EHC Program also actively seeks out topic nominations. Previous strategies have involved targeted outreach to specific organizations and in-person group meetings with an array of health care decision-makers and researchers to identify clinical research questions of interest. A topic selected to move forward using an established set of criteria can proceed to an EPC or DEcIDE Center for further development as a research review or new research, respectively. Additionally, research gaps identified by the EPCs subsequently guide the DEcIDE Program to identify new areas of research.

It is anticipated that an AHRQ Healthcare Horizon Scanning System will help inform stakeholders as they participate in the topic nomination process. Reports from horizon scanning will be made public to help inform stakeholders about technologies that have potential for a high impact on clinical care in the future and stakeholders can consider the information from these reports along with their experience and expertise to identify potential topics for future EHC research. In addition to informing AHRQ CER priority setting, reports produced from horizon scanning will also inform other funders of research.

It is also important for the AHRQ Healthcare Horizon Scanning System to be responsive to the needs of the EHC Program. Topics are nominated for comparative effectiveness research on a continuing basis, and horizon scanning information will be useful in research priority setting. Therefore, in addition to periodic reports, the AHRQ Healthcare Horizon Scanning System will allow for the timely production of reports on healthcare technologies of interest at the request of the Agency.

Investigators requesting AHRQ grant funding also select topics for comparative effectiveness research. The AHRQ Healthcare Horizon Scanning System will inform investigators as they consider research topics. Reports made public from AHRQ horizon scanning will help inform investigators about healthcare technologies that have potential for a high impact on clinical care in the future as they consider areas in which to focus their own research.

D.

IDENTIFICATION OF NEW AND EMERGING ISSUES (HORIZON SCANNING) FOR COMPARATIVE EFFECTIVENESS RESEARCH

Horizon scanning involves two processes. The first is the identification and monitoring of new and evolving healthcare interventions that are purported to or may hold potential to diagnose, treat, or otherwise manage a particular condition. The second is the analysis of the relevant healthcare context in which these new and evolving interventions exist in order to understand their potential impact on clinical care, the healthcare system, patient outcomes and costs. Important considerations in an analysis of the relevant healthcare context include potential alternative treatments, the availability of care in different geographic regions, training needed for providers, and other contextual issues that are likely to impact healthcare delivery and health outcomes. The healthcare interventions of interest for horizon scanning are those that have yet to diffuse into or to become part of established healthcare practice. Horizon scanning is focused on the healthcare interventions that are still in the early stages of development or adoption.

Currently, many public and private entities around the world are involved in the horizon scanning of medical technology and have developed methodologies for identifying target technologies that have the potential for a large future impact. EuroScan, for example, is an international organization composed of government-funded agencies involved in the area of horizon scanning, and counts among its 20 member organizations the Australia and New Zealand Horizon Scanning Network (ANZHSN) and the National Horizon Scanning Centre (NHSC) in the UK. Horizon scanning has been used for long-term planning, anticipating future needs, and generating information about changes in the delivery and use of new and existing technologies (ANZHSN, 2006). It has also been used by decisionmakers to identify areas requiring additional research.

Healthcare interventions and technology have been defined in a variety of ways. In its definition of healthcare interventions, the IOM includes drugs, tests to screen for or monitor disease, surgical techniques, and therapeutic alternatives, as well as different means of delivering healthcare (IOM, 2009). The Federal Coordinating Council for Comparative Effectiveness Research has defined medical technology as “medications, procedures, medical and assistive devices and technologies, diagnostic tests, behavioral change, and delivery system strategies” (FCC, 2009).

The EuroScan has identified the following technology categories of interest for horizon scanning (Langer, 2006):

· New Technologies: technology in the adoption phase that has been available for clinical use for a short period of time.

· Emerging Technologies: technology not yet available for use in the health care system (i.e., pharmaceutical products in Phase II and III trials).

· Established Technologies with new indications

· Technologies that are a part of a group of developing technologies that may as a whole have an impact

The technologies to be targeted in horizon scanning shall meet the criteria of “newness” as described by the four Euroscan categories of interest. These areas of innovation shall henceforth, be referred to as the “target” technologies in this RFP. We include all healthcare interventions and technology as defined in the IOM and Federal Coordinating Council definitions above as areas of interest for horizon scanning, though with an emphasis on clinical interventions. Moreover, the product of this solicitation shall be referred to as the AHRQ Healthcare Horizon Scanning System.

AHRQ has been involved in some forms of horizon scanning for reports that were produced at the request of the Center for Medicare and Medicaid Services (CMS) and in the production of technical briefs, which are reviews focused on emerging clinical interventions for which there are limited published data. Examples of these reports include the following:

· Genetic Tests for Non-Cancer Diseases/Conditions: A Horizon Scan

· Horizon Scan: Lipoprotein Subfractions for Identifying Patients at Increased Risks for Cardiovascular Disease

· Technical Brief: Particle Beam Radiation Therapies for Cancer

The topics of AHRQ technical briefs are selected through the topic identification and nomination process discussed above and not identified by a horizon scanning methodology designed to forecast the future impact of these technologies. These previous horizon scans and technical briefs include some components of horizon scanning. Information for these reports was obtained from published narrative reviews and the gray literature in order to describe the regulatory, clinical, and contextual status of identified technologies and to predict the impact of these technologies on clinical care, the healthcare system, patient outcomes, and costs in the near future.

The work requested as part of this RFP will create the infrastructure for AHRQ to conduct comprehensive horizon scanning including both the identification of target technologies and the assessment of their contextual landscape. The AHRQ Healthcare Horizon Scanning System will establish a clearly defined methodology and criteria to identify target healthcare technologies with potential for a high clinical, system, and/or cost impact that may be worthy of comparative effectiveness research investment. Furthermore, the work described in this RFP calls for a review of the evidence for the most up-to-date methods for horizon scanning, including the identification, prioritization, assessment, and monitoring of target technologies in healthcare, thus allowing for effective strategies to be appropriately incorporated into the AHRQ process in the future.

II.

STATEMENT OF WORK

A. GOAL

The purpose of this contract is to meet an immediate need at AHRQ to establish a horizon scanning system. Through this procurement, AHRQ will quickly and efficiently implement a horizon framework and infrastructure to immediately generate information that will inform comparative effectiveness research investments through the Effective Health Care (EHC) Program. It is expected that a majority of the effort necessary to accomplish the required tasks below will be dedicated to the implementation of a horizon scanning system and to the actual conduct of horizon scanning. Through this project, AHRQ will accomplish the following goals:

1) To develop and implement an innovative horizon scanning protocol to identify and monitor target technologies in healthcare.

2) To develop and implement a framework for forecasting which target technologies have the highest potential impact on clinical care, the healthcare system, patient outcomes and cost.

3) To evaluate components of existing horizon scanning systems and their respective protocols in order to identify best practices and effective methods.

There is no publicly available, comprehensive system for horizon scanning in the United States. AHRQ is looking to implement a horizon scanning framework and infrastructure that builds on prior work to identify, monitor, and assess target technologies in healthcare but also includes novel and inventive methods that improve upon existing systems. Although some of the principles and procedures developed for other countries may be applicable in the United States, there is a need for a horizon scanning process that takes into account the unique characteristics of the healthcare system in this country. Moreover, the AHRQ Healthcare Horizon Scanning System will utilize methods developed to meet the specific needs of AHRQ and the EHC Program. Through these horizon scanning activities, AHRQ will be able to identify and monitor potential future topics for comparative effectiveness research.

B. PERFORMANCE PERIOD OF CONTRACT

This contract will have a period of performance of a base period consisting of 24 months. There are three (3) 12-month option periods (possible funding with annual appropriations based on availability of funds). Contractor shall fully perform all of tasks specified in this Statement of Work (SOW), beginning in the first full performance period. It should be noted that the Government is not obligated to exercise any options.

The first full performance period will start on the effective date of contract (EDOC), and conclude two (2) years later with options to further extend the contract up to three (3) additional years.

C. Specific requirements

The requirements of this Contract are as follows:

· TASK 1- Participate in a “Kick-off” meeting with AHRQ to discuss goals, objectives and assigned tasks of the project.

· TASK 2- Revise and finalize the horizon scanning system submitted in response to the RFP in preparation for implementation.

· Task 3- Implement the AHRQ Healthcare Horizon Scanning System.

· TASK 4- Report on findings from horizon scanning activities.

· TASK 5- Review methods of horizon scanning used by public and private organizations in the US and internationally.

· Task 6- Develop a plan to evaluate the AHRQ Healthcare Horizon Scanning System.

· Task 7- Keep the AHRQ PO and CO up-to-date on Contract activities and manage the Contract in accordance with all relevant laws and regulations.

Completion of the following tasks and subtasks will provide AHRQ with timely information on potential future comparative effectiveness research topics and will aid in the prioritization of research funding. Unless otherwise noted, the Contractor shall perform tasks and subtasks during the first full Performance Period of the Contract.

TASK 1- Participate in a “Kick-off” meeting with AHRQ to discuss goals, objectives and assigned tasks of the project.

Subtask 1.1- Kick-off Meeting. Meet in Rockville, MD with AHRQ staff within two (2) weeks of the effective date of the contract (EDOC) to discuss the goals, objectives, and assigned tasks of the project. The meeting will be attended by the Contractor and AHRQ staff. Tasks 2 and 3 will be a significant discussion item for the meeting. A schedule for future meetings (either in-person or via conference calls) shall be established to facilitate future communication between AHRQ and the Contractor.

Subtask 1.2- Meeting Materials. Prepare a meeting agenda and meeting materials that will facilitate discussion of project tasks at the “Kick-off” meeting. These materials shall be submitted to the AHRQ Project Officer (PO) for review and approval at least one (1) week in advance of the meeting.

Subtask 1.3- Work and Management Plan. Within two (2) weeks of meeting adjournment, develop a comprehensive work and project management plan for all tasks outlined in the SOW and incorporate those areas addressed in the “Kick-off” meeting. This document shall include an updated project timeline based on discussions with AHRQ at the kick-off meeting. It should also provide a timeline for future meetings (in-person and conference calls) and identify all relevant Contractor personnel and provide their contact information. The work and project management plan shall be submitted to the AHRQ PO and Contracting Officer (CO) for review and approval.

Task 1 Deliverables

· Agenda for “Kick-off” meeting and other meeting materials (1 week before meeting)

· Comprehensive work and project management plan for all project tasks (2 week after meeting) TASK 2- Revise and finalize the horizon scanning system submitted in response to the RFP in preparation for implementation.

The Contractor shall revise the proposed horizon scanning system submitted in response to the RFP. The horizon scanning system developed by the Contractor shall consist of three components: 1) a protocol to identify and monitor target healthcare technology; 2) a methodology to analyze contextual factors of target healthcare technology and forecast future impact; and 3) an indexing framework to link target technologies identified and monitored in horizon scanning.

Subtask 2.1- Identification and Monitoring. Revise and finalize the proposed protocol submitted in response to the RFP to identify and monitor target healthcare technologies (see TPI- L.10.B.2.b). The identification and monitoring protocol shall include a detailed description of the methods that shall be used to: 1) identify target technologies; 2) prioritize which technologies to monitor; and 3) monitor target technologies over time. The Offeror shall also describe its methods for deciding when a previously identified and monitored technology will no longer be monitored. The protocol shall give AHRQ the ability to request that the Contractor monitor a particular healthcare technology, and the Contractor shall be responsible for monitoring any healthcare technology at the request of the AHRQ PO. The protocol shall also include a list of key data elements that will be captured for each target technology, including information on the technology itself and information on contextual factors surrounding a target technology that may affect its use in a clinical or healthcare setting. Some key elements that should be considered include, but are not limited to, the following:

· Information on the technology: name, description, mode of administration, dose range, manufacturer, stage of development, FDA status, cost of the technology.

· Information on patients and setting: indication, incidence and prevalence of the condition, setting(s) for use of the intervention, types of providers and training needed for the intervention, adjunct techniques and interventions.

· Information on the clinical pathways of the technology: clinical algorithms for use, including selection of patients for the procedure, prior and concurrent ancillary treatments, and follow-up care.

· Information on the alternatives to the intervention: usual care for the condition and other recommended treatments from published guidelines.

· Information on the commercial status of the technology: current number of units in physician offices, hospitals, or other settings; geographic distribution of access to the technology; and awareness and attitudes of physicians and patients toward the technology

· Any other data elements as needed for the metrics in Subtask 2.2.

The revised identification and monitoring protocol shall be submitted to the AHRQ PO within four (4) weeks of the EDOC, and the Contractor shall work with the AHRQ PO to incorporate suggested changes into the protocol. The final protocol shall be submitted to the AHRQ PO no later than 75 days after the EDOC. The final horizon scanning protocol shall be subject to the approval of the AHRQ PO, and AHRQ shall have the right to make the horizon scanning protocol available to the public.

Subtask 2.2- Analysis & Forecasting. Revise and finalize the proposed methodology submitted in response to the RFP to analyze the relevant contextual factors and forecast the future impact of target healthcare technologies identified and monitored in horizon scanning (see TPI- L.10.B.2.c). This analysis shall utilize data elements collected as part of Subtask 2.1. The analysis of the context in which a target healthcare technology exists shall consist of an analysis of the factors that affect the current and potential future clinical, system, and cost impact of the target healthcare technology.

The analysis of contextual factors considered in the methodology shall be used to forecast the future clinical, system, and cost impact of the technology. This methodology shall include metrics for measuring “high impact” based on a technology having a forecasted significant clinical, system, and/or cost impact in the future. These metrics shall be developed and finalized from the proposed metrics submitted in response to the RFP (see TPI-L-10.B.2.d). The primary perspective for these metrics shall be that of the patient and clinician. The analytic horizon shall be chosen to accurately reflect all important consequences resulting from the target technology and to predict which target technologies will have the largest clinical, system and cost impact (based on the metrics that will be defined in the methodology). The forecasting methodology may be incorporated into the protocol to identify and monitor target healthcare technologies required as part of Subtask 2.1.

The revised forecasting methodology shall be submitted to the AHRQ PO within four (4) weeks of the EDOC, and the Contractor shall work with the AHRQ PO to incorporate suggested changes into the methodology. The final forecasting methodology shall be submitted to the AHRQ PO no later than 75 days after the EDOC. The final forecasting methodology shall be subject to the approval of the AHRQ PO, and AHRQ shall have the right to make the final forecasting protocol available to the public.

Subtask 2.3 – Indexing and Linking. Develop and revise the framework submitted in response to the RFP to index information on target technologies being monitored (see TPI- L.10.B.2.e). The indexing framework shall allow target technologies to be linked with one another and will enhance information queries on target technologies. Possible data elements and categories that should be considered for use in indexing include, but are not limited to, those data elements collected as part of Subtask 2.1 as well as data elements used for analysis and forecasting in Subtask 2.2. This framework shall incorporate the identification and monitoring protocol required as part of Subtask 2.1 as well as the analysis and forecasting methodology required as part of Subtask 2.2. The Contractor shall submit documentation outlining and describing its indexing framework to the AHRQ PO for review. This documentation shall include a description of how data elements captured on target healthcare technologies will be used to make links to other target healthcare technologies.

A description of the revised linking framework shall be submitted to the AHRQ PO within four (4) weeks of the EDOC, and the Contractor shall work with the AHRQ PO and other AHRQ staff to incorporate suggested changes into a framework.