STATE OF TEXAS TEXAS STATE BOARD OF PHARMACY

Transcription

1 STATE OF TEXAS TEXAS STATE BOARD OF PHARMACY REQUEST FOR INFORMATION NO PRESCRIPTION DRUG MONITORING PROGRAM Reference: CLASS: 920 ITEM: 05 Posting Date: 12/08/2014 RESPONSE DEADLINE: 4:00PM CT SUBMIT PRINT RESPONSES BY US MAIL or DELIVER TO: Texas State Board of Pharmacy Attn: David Hardy/RFI Guadalupe St., Ste Austin, TX

2 Purpose The Texas State Board of Pharmacy anticipates the introduction of legislation that proposes an orderly transition of certain records and regulatory functions of the Texas Prescription Monitoring Program (PMP) program from the Department of Public Safety (DPS) to The Texas State Board of Pharmacy (TSBP). PMP is an electronic program used for the collection and storage of prescription transaction information relative to controlled substances and other drugs of concern to Texas residents. This information is then made available to authorized users for health safety and reporting purposes. The Texas State Board of Pharmacy is seeking information and cost estimates from qualified solutions providers that would assist in the proposed transition. The TSBP is also seeking recommendations from experienced solutions providers that would provide improved functionality, stability and usability as well options what could provide significant cost savings. This request for information (RFI) is for information purposes only. No contract will be issued under this RFI. History In preparation for implementing a transition plan to move the Texas Prescription Program (TPP), the Prescription Drug Monitoring Program (PDMP) and the online web access, known as Prescription Access in Texas (PAT), from the Texas Department of Public Safety (TxDPS) to the Texas State Board of Pharmacy (TSBP), an invitation has been issued for the request of information from qualified contractors. Qualified contractors should be able to provide information and costs substantiating their proficiency in the collection, management and communication of electronic data relative to prescription transaction information for controlled substances and other drugs of concern as determined by TSBP. Generally, a qualified contractor would be capable of collecting data from the reporting entities, house the data in a secure site or coordinate data management securely, and be able to establish a secure web portal to facilitate automated communication for authorized users. Such system would ideally be capable of supporting interstate data sharing, integrating with electronic health records (EHRs), health information exchange (HIE) and pharmacy dispensing systems to facilitate prescriber and dispenser access to PDMP data, reducing time and effort needed to obtain a patient s history, seamlessly, in as close to real time as possible. The Texas Prescription Program (TPP) collects prescription data on all control substances (schedules II- V) dispensed by pharmacies licensed in the State of Texas. The TxDPS, Regulatory Services Division has been the housing agency of the program, since its creation in 1982, responsible for monitoring data for prevention of drug diversion, evaluating trends for aberrations and investigating drug diversion. The 67 th Texas Legislature passed legislation in 1981 which created TPP for the monitoring of schedule II control substances and required manual collection and monitoring until September 1, After this date, dispensing pharmacies were required to submit their prescription data to TxDPS via electronic transfer through a private contractor. Beginning September 1, 2008 the collection of data expanded to include all control substances (schedules II-V). In 2009, Article 22 of H.B created an interagency Council composed of the Director of the TxDPS and the Executive Directors of the TSBP and the Texas Medical Board or their designees. The Interagency Council was charged to develop a transition plan for the orderly transfer from the TxDPS to the TSBP of certain records and regulatory functions relating to dispensing controlled substances by prescription under Chapter 481, Health and Safety Code. As the result of the report to the 82 nd Texas Legislature, TxDPS was urged to establish an electronic prescription 2

3 drug monitoring program (PDMP) with secure online access for prescribers, pharmacists, regulatory agencies and law enforcement. The program, called PAT, was piloted in the beginning of August 2011 and became fully operational and accessible to registered user in August The PAT began collecting data from dispensers on September 1, 2011 and began responding to a pilot group in June The most recently collected statistics are as follows: Approximately 6800 pharmacies now report dispensing activity on a weekly basis, some as often as daily. The program has received approximately 41.5 (in 2011) million prescriptions and now averages approximately 3.5 million prescription transactions per month. Of the approximate 120,000 prescribers and dispensers eligible to apply for authorized access (as of 2013). Currently, the operation funds for the program are provided by fees collected via the Control Substance Registration Program (CSR). The TxDPS is responsible for registering all persons or institutions that manufacture, distribute, analyze or dispense controlled substances in Texas. Registrants include practitioners (medical doctors, dentists, veterinarians, podiatrists and optometric glaucoma specialists), mid-level practitioners (advanced practice registered nurses and physician assistants), pharmacies, hospitals, manufacturers, researchers, teaching institutions, distributors and analysts. STATEMENT OF WORK 1 Data collection For the anticipated requirements below, respondents should indicate a recommended solution and identify the associated costs. 1.1 Prepare and provide to statutorily authorized dispensers, as indicated by the Board, any instructions necessary to comply with the reporting requirements, including technical assistance. The Board will reserve the right to review and approve any communication prior to its distribution. 1.2 Receive electronic prescription information transmitted directly from the dispensers, seven days a week, and twenty-four hours a day. Daily volume is expected to exceed 135,000 or 50 million per year. 1.3 Collect the electronic data in standardized format(please specify the format used) Also receive such data transmissions in a secure format, such as via , telephone modem, physical media (diskette, CD, DVD, tape), FTP, Virtual Private Network (VPN), SSL website and other agreed upon media. 1.4 Accept written paper reports on a form approved by the Board, or a universal claim form, provided the dispenser has been granted a waiver by the Board. 1.5 Collect the data elements for all controlled substance prescription transactions, as well as any other drugs identified by the Board, including the following: 3

4 1.5.1 Prescriber s registration number, with suffix if applicable, as assigned by the U.S. Drug Enforcement Administration (DEA), and the National Provider Identifier (NPI) number as assigned by the U.S. Centers for Medicare and Medicaid Services (CMS) Patient s information, including name, address, date of birth, gender and identification number (e.g., driver s license number) Prescription information including, but not limited to, prescription number, date of issuance, date of dispensing, number of refills authorized on the original prescription, refill number (if applicable) and method of payment Drug information including, but not limited to, National Drug Code (NDC) number, quantity dispensed and days supply Dispenser information including DEA registration number and NPI number. 1.6 Accept a report of no (or zero) prescriptions issued in a given time period and provide a report of those submissions to the Board staff. 1.7 Accept submission of data from dispensers under common ownership in a single joint transmission, provided each dispenser is clearly identified for each prescription dispensed. 1.8 Perform data checks to ensure the submitted data is compliant with the quality standards established by the Board relative to accuracy and completion. 1.9 Notify the dispenser when a dispenser s data file does not meet the quality standards for accuracy and completion, specifying the data deficiency, and ensure the dispenser corrects and resubmits the data. The Board should be notified when a dispenser fails to submit a resubmit data in a timely manner Allow a dispenser to submit corrected data and display the corrected data with a notice that the data has been corrected Provide a toll-free number and address by which dispensers may contact the respondent to resolve problems and receive information concerning data transmissions. The toll free number and addressee should be staffed seven days a week with extended hours, preferably 24 hours a day. 4

5 1.12 Provide a method for Board staff to: Sort and view the upload history of a dispenser by timeframe, number of prescription errors, zero reports filed and trends Check the accuracy of a specific upload Provide a method for Board staff to produce reports, on demand or scheduled, displaying information about all uploads by a dispenser, including contact information for each dispenser and the reported date ranges of the submission Provide a method for Board staff to produce reports displaying records that were uploaded containing incomplete, invalid, or missing DEA or NPI numbers Convert any historical program data from the existing system. Anticipated data retention period is three years. If additional retention is required, please address any additional limitations. 2 Data Management For the anticipated requirements below, respondents should indicate a recommended solution and identify the associated costs. 2.1 Collect and load data into the database. Please address the location of the data. Regardless of its physical location the database and all of the data in the database shall belong to the Board. 2.2 Convert the DEA registration numbers reported to the system into the corresponding prescriber or dispenser name and address. 2.3 Convert the NPI number reported to the system into prescriber or dispenser name and address. 2.4 Convert NDC number to the drug name, strength, dosage form and controlled substance schedule, both at the point of data import and also retrospectively upon receiving NDC number updates. A current reference source of NDC numbers should be maintained. 2.5 Additionally: 5

6 2.5.1 Provide data access, data management and data cleansing capabilities seamlessly integrated with data mining for ease of data analysis Provide option for geocoding of patients, prescribers and dispenser locations to enable geographic analysis of the relationships to identify potential criminal activity, abuse or a localized trend in a specific health-related issue Electronically cleanse and standardize the data to identify individuals using different but similar names, different but similar addresses, etc Allow for the query of relational or multi-dimensional data. 2.6 Describe the tools that will be provided to electronically assist in the identification of illegal and unprofessional activities. 2.7 Describe how the deletion/purging and sanitizing of data would occur for data that exceeds its retention date. 3 Secure Web Services For the anticipated requirements below, respondents should indicate the recommended solution and identify the associated costs. 3.1 Provide a secure website for access to the information the database. 3.2 Authenticate user registrations before providing login accounts. Users include: prescribers, dispensers, designated agency personnel, authorized Board personnel and law enforcement officers. Address compliance with the privacy and security standards of the Health Insurance Portability and Accountability Act (HIPAA) and common standards for privacy and security. Provide examples. 3.3 Allow multiple users to access the system and the same application at the same time. Based on respondent s experience, postulate peak volumes and identify potential volume related technical issues to be considered. 3.4 Permit a registered user to request and receive information, including automatic reports, via the secure Internet connection, without intervention by Board staff. Please specify the percentage of report requests requiring Board intervention. 6

7 3.5 Provide log-in and log-off capability, and further, permit registered users to change their passwords without assistance. 3.6 Permit a registered user to establish/deactivate delegate subaccounts for their agent(s), and further, provide a mechanism for the user to monitor the system activity of those delegates online and through a reporting mechanism. 3.7 Provide the Board with the capability of communicating information of interest to registered users of the web-based program through broadcast alerts and postings on the system home page. 3.8 Provide data breach notifications to prescribers, dispensers, the Board and any other parties in accordance with HIPAA regulations. 4 Queries and Reports For the anticipated requirements below, respondents should indicate the recommended solution and identify the associated costs. 4.1 Prepare audit reports for the Board at the end of each reporting period identifying dispensers that have either not submitted a report or have been rejected. 4.2 Allow authorized Board personnel to search, correlate, query and match records on all variables contained in the records in order to discover all instances in which the records of a single patient are misidentified and matched with another patient in error. 4.3 Create at least three basic reports: an individual report, a prescriber report and a dispenser report. The format of all reports shall be approved by the Board. 4.4 Specify, identify and report the number of registered user requests by user type (e.g.: prescriber, dispenser, law enforcement). 4.5 Enable the Board to perform ad hoc queries. 4.6 Provide de-identified data for population health use. 4.7 Produce automatic threshold reports and a robust reporting module that allows for the modification of parameters. Expected criteria may consist of, but is not 7

8 limited to, the number of prescriptions dispensed, number prescribers used, and the number of dispensers used in a designated period of time. 4.8 Provide the ability to generate alerts to prescribers and dispensers of patients who have been identified as exceeding specific threshold levels. Board staff should have the ability to review a patient s auto-populated prescription history report and choose whether an alert should be sent to specific prescribers and dispensers of that patient. 4.9 Provide the ability to share and request prescription monitoring information from other states. 5 Other Requirements For the anticipated requirements below, respondents should indicate the recommended solution and identify the associated costs. 5.1 Provide a disaster recovery plan for data pertaining to this system in the event the program is unavailable due to human error, equipment failure or a natural disaster. Please address any historical statistics on system unavailability for other states (i.e., on average, how long is the system down or otherwise unavailable on a monthly basis for reasons other than natural disaster). 5.2 Provide continuing technical assistance for dispensers and the Board 5.3 Provide training for system use for authorized Board personnel. SUBMISSION REQUIREMENTS 6 Submissions 6.1 Responses must clearly address the costs associated with the specifications as outlined in the Statement of Work (Sections 1-5). The Request for Information is for INFORMATION PURPOSES ONLY. No contract will be awarded from this RFI. 6.2 Electronic responses are permitted. responses should be clearly identified as RFI# and sent to david.hardy@pharmacy.texas.gov. Print responses or responses in CD or other media format should be directed to: Texas State Board of Pharmacy Attn: David Hardy/RFI Guadalupe St., Ste Austin, TX

9 6.3 The cost of preparing and submitting any response is solely that of the respondent. TSBP will not reimburse directly or indirectly respondents for any cost of responding to this RFI. 6.4 TSBP will comply with the Texas Public Information Act (Chapter 552, Gov't Code) as interpreted by judicial opinions and opinions of the Attorney General of the State of Texas. Information, documentation, and other material in connection with this solicitation or any resulting contract may be subject to public disclosure pursuant to the Texas Public Information Act. Please clearly mark any information considered to be proprietary or a trade secret. 6.5 The timeline for submissions is as follows: 12/8/2014 RFI posted. 12/11/2014 Questions related to the RFI due. 12/15/2014 Proposed date to post responses to questions, if any. 1/5/2015 Responses due. Questions should be directed to David Hardy, phone: , fax: , david.hardy@pharmacy.texas.gov. 9

10 RESPONDENT INFORMATION Respondents must provide the following: Entity Name: Street Address: City/State/Zip: Telephone Number (area code & number): FAX Number (area code & number): Address: Authorized Respondent Representative Respondent Date 10