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FBO DAILY ISSUE OF JULY 27, 2006 FBO #1704
SOLICITATION NOTICE

R -- Training for using Centers for Medicare and Medicaid Services (CMS) Medicare, Medicaid, State Children's Health Insurance Programs (SCHIP), and Medicare Current Beneficiary Survey (MCBS) data for rese

Notice Date

7/25/2006
 

Notice Type

Solicitation Notice
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-1019535
 

Response Due

8/7/2006
 

Archive Date

8/22/2006
 

Description

NOTICE: INTENT TO AWARD RE: FDA1019535 SUBJECT: Training for using Centers for Medicare and Medicaid Services (CMS) Medicare, Medicaid, State Children's Health Insurance Programs (SCHIP), and Medicare Current Beneficiary Survey (MCBS) data for research. Description: The Food and Drug Administration?s Center for Drug Evaluation and Research (CDER), through the Centers for Medicare and Medicaid Services (CMS), intends to negotiate a sole-source award with The University of Minnesota Research Data Assistance Center (ResDAC). ResDAC is located at : University of Minnesota/ResDAC 420 Delaware Street D355 Mayo Memorial Bldg Minneapolis, MN 55455 FDA anticipates issuing a firm-fixed price contract. The contract period will be for as period of one year and will commence from date of award. Background: The Centers for Medicare and Medicaid Services (CMS) offers researchers and other health care professionals a broad range of quantitative information gathered from its claims data by special request. These include Identifiable Data Files that contain actual beneficiary-specific and physician-specific information. CMS is also responsible for administering the Medicare, Medicaid and State Children's Health Insurance Programs (SCHIP), as well as a number of health oversight programs and also provides researchers access to special survey data, and limited datasets by special arrangements. These data are made available to the public, subject to privacy release approvals and the availability of computing resources. In addition, Section 1013 of Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 authorizes research, demonstrations, and evaluations to improve the quality, effectiveness, and efficiency of the Federally administered Medicare program and of the two programs for which funding and administration is shared with the States: Medicaid and SCHIP. The research and other activities undertaken and authorized by Section 1013 may address: 1) The outcomes, comparative clinical effectiveness, and appropriateness of health care items and services (including prescription drugs); and 2) Strategies for improving the efficiency and effectiveness of Medicare, Medicaid, and SCHIP programs, including the ways in which health care items and services are organized, managed, and delivered under such programs. Congress is encouraging FDA and CMS to find ways to utilize existing and soon-to-be-collected Part ?D? Medicare data to foster drug safety, and to make the most economic use of pharmaceuticals covered by federal health programs. As a result, the FDA has ongoing discussions with its sister agency, CMS, concerning prospects for gaining access to its giant Medicare claims databases through the establishment of an inter-agency (IAG) collaboration. FDA has begun a ?pilot? program to investigate the value to researchers of Medicare Part ?B? outpatient data and FDA is expecting to gain access to the Part ?D? (prescription drug benefit) claims database when it becomes available for Drug Surveillance and Research. Separate from establishing an IAG, FDA is interested in procuring training on CMS data from organizations that have established agreements with CMS to provide instruction in using Medicare and/or Medicaid data for research and CMS data privacy requirements. CMS data are complex and are created for claims reimbursements and not research specifically, and therefore FDA requires offerors to have documented experience in the use of the data, to have direct access to the data, and to have de-identified the data. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products. The funding of "Training for using Centers for Medicare and Medicaid Services (CMS) Medicare, Medicaid, State Children?s Health Insurance Program (SCHIP), and Medicare Current Beneficiary Survey (MCBS) data for research" would serve as a mechanism for FDA staff to obtain comprehensive training on the use of CMS data files and their complexities with the goal of performing drug surveillance and epidemiology studies needed to address drug safety concerns of public health or regulatory importance. Objectives: FDA staff comprehensive training on CMS Medicare and Medicaid programs, the various administrative and research files and codes that can be used for research studies. Hands-on training in the use of Medicare and Medicaid data files. Information on how billing data are generated, the codes used, significant changes over time, and any restrictions on reimbursement that could affect research conclusions. Work to include training covering the specific topics: 1) An understanding of the basic structure and content of CMS Medicare, Medicaid, and SCHIP programs and changes over time; 2) An overview of the various CMS data files available for research including extract and data retrieval capabilities of CMS Data Warehouse; 3) Details on how the billing data are generated, the codes used in each database to capture demographic and medical events, and any restrictions on reimbursement that may affect how and when claims are processed; 4) Hands-on, direct access to data with interactive sessions using PC-based tutorial of CMS Medicare and Medicaid program data information; Other Requirements Software Knowledge FDA staff currently has various levels of familiarity with SAS and, for some, with STATA. If other software is used, there may be a need for a brief training session required on the software to be used. The Offeror shall provide information and documentation in support of the following: 1) Experience with training or a combination of experience using CMS data and evidence of demonstrated ability of instructors to train staff using CMS data. Offerors shall identify key personnel who will provide the training and submit their current curriculum vita. 2) Technical, analytical, statistical, epidemiological and clinical capability to support training FDA staff. Offerors shall also possess the ability to train FDA personnel in the use of the data as well as in technical issues relating to the use of the data. 3) Structure and format of training, and training agenda; 4) Training manuals, data dictionaries, and user guides; 5) Training for a minimum of 20 FDA staff members and a maximum of 30 for the hands-on training; 6) Hands-on, direct access to data with interactive sessions using PC-based tutorial: a. Documentation that data used for the hands-on training are not restricted and that practice files can be shared with a third party such as FDA; b. Documentation that data are HIPAA compliant. No patient, provider, or health plan-specific identifiers will be required by FDA. It shall be solely the Offeror?s responsibility to de-identify the data for FDA use. c. Capability of providing practice data to the FDA staff during the training session. If possible, post-training data made available for practice would be desirable. 7) A schedule of available dates for the training; 8) A training plan to include facility, software (SAS or STATA); and computer equipment requirements. Facility access must be within 25 Mile radius of the FDA White Oak campus located at 10903 New Hampshire Ave, Silver Spring, MD 20993-0002. Sole Source Rationale The University of Minnesota?s ResDAC Program is uniquely qualified to conduct the project described in this requirement. Their mission is to educate the research community and Federal agencies about how to obtain and how to use Medicare and Medicaid data. As part of their CMS contract, ResDAC maintains a help desk and extensive internet site dedicated to explaining CMS data distribution policies and procedures. In addition, ResDAC is required to conduct workshops and training programs in order for researchers to receive hands on experience in using CMS data. While many contractors have access to CMS data, the ResDAC project is the only contract that CMS supports to assist the research and Federal community in understanding and obtaining Medicare and Medicaid data.. Evaluation Criteria was based on the qualifications and requirements as stated above. The Government could not achieve the specific objectives of this contract through any other means or with any other resources. THE PROPOSED SIMPLIFIED ACQUISITION ACTION IS FOR SUPPLIES OR SERVICES FOR WHICH THE GOVERNMENT INTENDS TO SOLICIT AND NEGOTIATE WITH ONLY ONE SOURCE UNDER AUTHORITY OF FAR 15.203 INTERESTED PERSONS MAY IDENTIFY THEIR INTEREST AND CAPABILITY TO RESPOND TO THE REQUIREMENT OR SUBMIT PROPOSALS WITHIN 10 DAYS AFTER THE DATE OF PUBLICATION OF THIS NOTICE. A DETERMINATION BY THE GOVERNMENT NOT TO COMPETE THIS PROPOSED SIMPLIFIED ACQUISITION BASED UPON RESPONSES TO THIS NOTICE IS SOLELY WITHIN THE DISCRETION OF THE GOVERNMENT. INFORMATION RECEIVED WILL NORMALLY BE CONSIDERED SOLELY FOR THE PURPOSE OF DETERMINING WHETHER TO CONDUCT A COMPETITIVE PROCUREMENT.
 

Place of Performance

Address: FDA White Oak campus, 10903 New Hampshire Ave,, Silver Spring MD

Zip Code: 20993-0002

Country: UNITED STATES
 

Record

SN01097089-W 20060727/060725220319 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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