SOLICITATION NOTICE
B -- Evidence Base for Genetic Testing: Notice of Intent to Sole Source
- Notice Date
- 5/6/2015
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Program Support Center, Division of Acquisition Management, 12501 Ardennes Avenue, Suite 400, Rockville, Maryland, 20857, United States
- ZIP Code
- 20857
- Solicitation Number
- 15-PSC-NAS052115
- Point of Contact
- Michele Namoski, Phone: 301-443-3337
- E-Mail Address
-
SHELLEY.NAMOSKI@PSC.HHS.GOV
(SHELLEY.NAMOSKI@PSC.HHS.GOV)
- Small Business Set-Aside
- N/A
- Description
- Pursuant to the authority of FAR 6.302-1 The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services, on behalf of the Defense Health Agency (DHA) intends to negotiate on a sole source basis, a cost reimbursement order under the PSC Basic Ordering Agreement (BOA) with the National Academy of Sciences, for a study on "Evidence Base for Genetic Testing. This is a pilot project that will establish an evidence base and evaluation framework for the clinical and predictive utility of emerging genetic tests. The Assistant Secretary of Defense for Health Affairs Office has determined that there is a need for sound clinical evidence supporting the use of these tests. The Institute of Medicine (IOM) is an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public. Established in 1970, the IOM is the health arm of the National Academy of Sciences (NAS). The NAS and IOM have the unique ability to assemble the nation's preeminent experts in scientific and medical topical areas who are then able to render high quality advice and guidance as well as unparalleled objectivity to address the emerging clinical and ethical challenges posed by LDTs. Private companies access to the level of expertise needed to perform this work and their actual experience in performing work in this emerging field is far less than what can be provided by the National Academy of Sciences (NAS)/Institute of Medicine (IOM). Commercial entities cannot access medical, scientific and ethical subject matter experts from academia, industry and the government in a manner comparable to the IOM. Because of their unique organization, mission, structure, and the fact that scholarly participants serve as unpaid volunteers, only the NAS/IOM can provide the expertise, objectivity and independence required for this important effort. Checks and balances exist at every step to protect the integrity of IOM reports and to maintain public confidence in their findings. The FDA considers LDTs as "medical devices" and, in accordance with TRICARE's regulatory language, must be approved by the FDA prior to being covered. Currently the FDA is utilizing "enforcement discretion" regarding regulatory oversight of LDTs, meaning LDTs are available in the market without FDA approval. Some laboratories have applied for, and received, FDA approval of their LDTs. TRICARE covers those FDA approved LDTs that meet TRICARE criteria for coverage (e.g., diagnostic testing that will influence the medical management of a patient). The overwhelming majority of labs, however, have not applied to the FDA for approval of these tests. As a result, and in accordance with their own regulations, DHA denies claims for non-FDA approved LDTs. In the commercial health care industry (e.g., Blue Cross, etc.) coverage of LDTs varies and normally still entails some type of review of safety and efficacy. Most insurers currently cover more LDTs than TRICARE. However, Commercial providers, VA and Medicare are not required to abide by the FDA-approval requirement. Given the complexity of the issue, from a regulatory, scientific, and financial perspective, the NAS/IOM is the only organization that can access leading medical, scientific, bioethicist and regulatory expertise while maintaining objectivity and independence which is required for this effort. A cost reimbursement order will be negotiated and awarded under the PSC Basic Ordering Agreement with the National Academy of Sciences. The anticipated period of performance shall be for eighteen (18) months from date of award. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform a review of scientific and medical literature to determine the evidence base for different types of genetic tests for patient management. Background: Laboratory Developed Tests (LDTs) are defined by the Food and Drug Administration (FDA) as tests that are developed by a single laboratory for use only in that laboratory. LDTs include tests that detect certain genetic abnormalities where the results can assist in the diagnosis or medical treatment of the condition. There are also LDTs being offered as over the counter tests. Determining what test has value (and how much value) in the diagnosis and treatment of a medical condition has risen to the forefront of medicine. Understanding this emerging issue is important from both a clinical and financial perspective. There are also ethical considerations surrounding LDTs, as some are used to identify medical conditions in unborn babies as well as medical conditions that may not be curable. Thus, an independent Workgroup of eminent scientific and medical scholars from multiple disciplines is needed to review available literature and provide recommendations on the efficacy, utility, predictive value, and ethical issues for the numerous (and growing) LDTs. Objectives: The contractor shall convene a workgroup of recognized experts to examine relevant scientific and medical literature to determine the evidence base for different types of genetic tests. The workgroup will provide recommendations to advance the development of an adequate evidence base for genetic tests to improve patient care and treatment as well as recommend a framework for decision making regarding the use of genetic tests in clinical care. The contractor shall form a workgroup of approximately 14 people with expertise (at a minimum) in genetics, bioethics, general medicine, genomic medicine, and epidemiology who will perform comprehensive research to develop the evidence base for different types of genetic tests. The workgroup will make recommendations on evidence supporting various genetic tests as well as provide a framework to support decision making with respect to the tests. Workgroup must meet the following criteria: Recognized experts and leaders in the field of genetics and Laboratory Developed Tests (LDTs). From the potential candidates, approximately 14 members should be selected with expertise (at a minimum) in genetics, bioethics, general medicine, genomic medicine, and epidemiology who will perform comprehensive research to develop the evidence base for different types of genetic tests. Working group members must possess MD or PhD credentials in addition to having documented expertise in the fields mentioned above. Expertise can be determined by profession/position, published scholarly/peer reviewed works, industry awards/recognition, or other comparable means. Board Director: Must be a recognized industry expert possessing a doctor of medicine, doctor of philosophy or equivalent degree in one of the following medical or scientific disciplines: genetics, bioethics, general medicine, genomic medicine, or epidemiology and possess extensive experience in conducting similar projects that establish an evidence base for an emerging medical technology. The candidate must have at least 15 years of experience in one of these medical/scientific disciplines and must be generally known for his or her experience through published articles/scholarly works; oral presentations at seminars, conferences and peer groups; or through other widely known venues. The workgroup shall examine relevant scientific and medical literature to determine the evidence base for different types of genetic tests. Record of literature reviewed and conclusions must be maintained and provided to the appropriate Government technical representative. Study workgroup will typically gather information through: 1) meetings that are open to the public and that are announced in advance through the National Academies website; 2) the submission of information by outside parties; 3) reviews of the scientific literature; and 4) the investigations of the workgroup members and staff. In all cases, efforts are made to solicit input from individuals who have been directly involved in, or who have special knowledge of, the problem under consideration. Workgroup Meetings. Conduct up to five workgroup meetings to discuss/review the results of the literature review and provide meeting minutes within sixty days of the culmination of each session. Contractor will be required to travel, including at least five workgroup meetings during the performance of this contract. Locations are yet to be determined, but will likely be in five separate geographic regions of the United States to allow for widespread attendance by interested constituencies (e.g., north, south, east, west and central). Estimated number of trips (inclusive of all funded attendees) is 80. Contractor will be authorized travel expenses consistent with the substantive provisions of the Joint Travel Regulation (JTR). Pre-Publication of report to be provided with recommendations to advance the development of an adequate evidence base for genetic tests to improve patient care and treatment as well as recommending a framework for decision making regarding the use of genetic tests in clinical care, followed by the publication of the final report. This is not a solicitation for competitive proposals. All responsible sources that have the requisite qualifications to perform the work above may submit a statement of capabilities via e-mail to shelley.namoski@psc.hhs.gov, which will be considered by the agency. The e-mail subject line must reference: 15-PSC-NAS052115 Capability Statement Submission. Responses must be double-spaced with 1" margins on all sides and use a standard font no smaller than 12 point. The statement of capabilities must include: 1.) Cover Letter/Capabilities Statement illustrating organization's technical capabilities and expertise, as it relates to the requirements presented in this notice. 2.) A list of at least 3-5 Past Performance references to include: a.) Description of previous work efforts; b.) Contract number; c.) Point of contact. The response must be sequentially numbered, beginning on the first page after the table of contents. Responses are due by May 21, 2015 at 1:00 PM Eastern Day Light Savings Time. Responses received after the due date and time may not be considered. A determination by the Government not to compete this requirement based upon responses to this Notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive requirement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/PSC/DAM/15-PSC-NAS052115/listing.html)
- Place of Performance
- Address: District of Columbia, United States
- Record
- SN03721288-W 20150508/150506234830-d0956873d580c7d26f6e1642fac55936 (fbodaily.com)
- Source
-
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