Prescription Drug Event (PDE) Processing

THIS IS NOT A FORMAL REQUEST FOR PROPOSAL (RFP) AND DOES NOT COMMIT THE CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS) TO AWARD A CONTRACT NOW OR IN THE FUTURE. This is a Sources Sought announcement in support of the Centers for Medicare & Medicaid Services (CMS), Center for Drug and Health Plan Choice (CPC). CMS is seeking a business that shall be responsible for managing drug information from common data files used for purposes of prescription drug event (PDE) processing, formulary and pricing file submissions, Medicare Prescription Drug Plan Finder (MPDPF) display, and production of public use files. Per FAR 19.502-2 if through this market research it is determined that there are two or more small businesses that can perform this requirement it will be set aside for small business. Background: CMS is responsible for regulating and overseeing the implementation of the Medicare Prescription Drug Benefit by Part D sponsors. This responsibility includes ensuring accurate payment to Part D sponsors, ensuring beneficiaries have access to a broad range of medically appropriate drugs through formularies that do not substantially discourage enrollment by certain groups of beneficiaries, and ensuring that the MPDPF displays accurate formulary and pricing information to assist beneficiaries with choosing to enroll in a Part D plan. These payment, formulary and MPDPF related activities require CMS to collect drug specific information from Part D sponsors. CMS collects Prescription Drug Events (PDEs) through its Drug Data Processing System (DDPS) for each Part D claim paid by a Part D sponsor. The PDE consists of approximately 40 data elements from the claim, one of which is the National Drug Code (NDC) for the dispensed drug product. CMS has established edits in DDPS to prevent Part D sponsors from submitting PDEs for drug products that do not meet the definition of a Part D drug. These edits will reject PDEs for non-Part D drugs so that associated dollar amounts will not be considered for purposes of determining risk sharing amounts and paying reinsurance. Currently, CMS establishes edits on NDCs from its common table that represents a comprehensive compilation of NDCs from First DataBank and Medi-Span. CMS requires Part D sponsors to submit their formularies for review and approval. CMS created the Formulary Reference File (FRF) tool to streamline the formulary submission and review process. Currently, the FRF is a list of proxy national drug codes (NDCs) that Part D sponsors choose from to identify the Part D drugs that are included on their formularies. The drugs identified on the Part D formularies will be used for display on the MPDPF and will be incorporated into the public use file(s) (PUF). Beginning in 2010, CMS will be changing the FRF to a list of RxNorm codes in place of proxy NDCs. However, Part D sponsors will still be required to submit an NDC on their pricing file for purposes of pricing display on the MPDPF. This pricing file will consist of representative NDCs that are cross walked to the FRF RxNorm codes. Task Description: The Contractor will be responsible for managing drug information from common data files used between the Medicare Plan Payment Group (MPPG), Medicare Drug Benefit and C & D Data Group (MDBG), and Office of Beneficiary Information Services (OBIS) for purposes of PDE processing, formulary and pricing file submissions, MPDPF display, and the production of public use files. The contractor will coordinate the maintenance and update of the various data files to ensure that the information is accurate and relevant to Part D. In addition, the contractor will be responsible for investigating inquiries related to these data and providing recommendations/solutions as needed. Specific tasks may include, but are not limited to, the following: - Develop and maintain drug information for the FRF, MPDPF pricing files, PDE edits and public use file(s) in accordance with CMS requirements. - Develop and maintain the FRF tool using RxNORM data in accordance with CMS requirements. - Develop and maintain an RxNORM to NDC crosswalk for NDCs included on the FRF, MPDPF pricing files, and PDE common table in accordance with CMS requirements. - Develop and maintain representative NDCs for pricing files in accordance with CMS requirements. - Evaluate new drug additions and deletions to commercial NDC databases utilized by CMS to determine the relevancy and effect on FRF and PDE edits. - Develop and maintain RxNORM and NDC based data files for Part D excluded-category and over-the-counter drug products in accordance with CMS requirements. - Develop and maintain an NDC to FDA approval crosswalk. Required Demonstrated Knowledge and Experience: Any potential offeror must demonstrate the following: 1. Knowledge and operational understanding of Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA); and relevant parts of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), the Tax Relief and Health Care Act of 2006, and the QI, TMA, and Abstinence Programs Extension and Hurricane Katrina Unemployment Relief Act of 2005. 2. Knowledge and experience researching drug indications and specialized information using the compendia in the regulation (42 CFR Section 423.100). 3. Experience working with multiple commercially-available drug databases, including integrating and/or mapping drug information from multiple sources, providing database analyses, systematically evaluating data changes, and developing solutions to reconcile differences among the databases. 4. Experience working with FDA drug databases. 5. Experience working with RxNorm drug databases. 6. Experience developing and customizing comprehensive, historical drug databases to meet client-specific requirements. 7. Experience obtaining database software licenses. 8. Understanding of electronic pharmacy claims processing. 9. Experience distributed among the personnel in accordance with their responsibilities for particular tasks: - Staff should be knowledgeable about the Medicare Part D program and the definition of a covered Part D drug as well as drug categories excluded under the benefit. - Appropriately skilled pharmacists/staff knowledgeable and experienced with interpreting and investigating changes in market availability and/or approval status of drugs. - Appropriately skilled pharmacists knowledgeable and experienced with working with commercially and publicly available drug databases. - Appropriately skilled data analysts knowledgeable and experienced with working with commercially and publicly available drug databases. 10. Experience with maintaining strict data confidentiality standards including all requirements for use of, access to, and storage of CMS data files and for fulfilling all HIPAA regulations. Additional Information Requested: The following specific information is requested: (a) company descriptive literature; (b) specific related corporate experience directly related to our requirements; (c) a sample RxNorm codes to NDC crosswalk based on the drugs found on the current CY2009 FRF including general methodologies and limitations of the data; and (d) an algorithm of review procedures to identify a drug that may qualify as a Part D covered drug. Capability Statement: Interested contractors must submit a capability statement to demonstrate the minimum requirements outlined above. Please address each requirement in order as listed above. Capability statements shall also include the following business information: a. DUNS b. Company Name c. Company Address d. Current GSA Contracts e. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. f. Type of Company under NAICS 541512 (i.e., small business, minority owned, 8(a), veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index.asp . g. Company Point of Contact, Phone and Email address h. Point of Contact, Phone and Email address of individuals who can verify the demonstrated capabilities identified in the responses. All teaming arrangements shall also include the above-cited business information. All capability statements can be submitted via e-mail, facsimile, or regular mail to the point of contact listed below no later than 2:00 pm eastern standard time January 30, 2009. Responses shall be limited to ten (10) pages. Point of Contact: Mr. Jason Forrester, Contract Specialist Phone: (410) 786-8147 Fax: (410) 786-9088 Email: jason.forrester@cms.hhs.gov Mailing Address: Centers for Medicare & Medicaid Services, ATTN: Mr. Jason Forrester Mail stop C2-21-15 7500 Security Blvd Baltimore, MD 21244 Note: This synopsis is for information and planning purposes and is not to be construed as a commitment by the Government. This is not a solicitation announcement for proposals and no contract will be awarded from this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow-up information requests. Respondents will not be notified of the results of the evaluation. All information submitted in response to this announcement must arrive on or before the closing date.