41NHA-S3922 - Scope of Work and Deliverables.docx

41NHA-S3922 - SCOPE OF WORK AND DELIVERABLES

NEVADA AVERAGE ACQUISITION COST (NVAAC)

SCOPE OF WORK

Contractor shall operate and update the NVAAC Program, based on actual acquisition drug prices for all Covered Outpatient Drugs (CODs), including brand and generic legend drugs as well as covered over-the-counter drugs.

GENERAL REQUIREMENTS

1. SURVEY REQUIREMENTS

Contractor shall provide for the submission of survey instruments and Invoices by Pharmaceutical Purchasing Entities (Entities), as identified by NVHA, on at least a quarterly basis.

1.1. Contractor shall collect pricing of drugs purchased under the 340B discount program but exclude those prices from the calculation of NVAAC.

1.2. Contractor shall develop and adhere to a survey schedule that addresses fluctuating prices of COD and allows for updating of NVAAC prices at least weekly.

1.2.1. Contractor shall survey Entities on at least a quarterly basis.

1.2.2. NVHA may direct the Contractor to survey specific Entities on a less frequent basis. These Entities must be surveyed at least biannually (twice yearly).

1.3. Contractor shall accept survey instruments and Invoices via facsimile, mail, and electronic submission from Entities or drug wholesalers on behalf of surveyed Entities.

1.3.1. Contractor shall evaluate the validity of submitted invoices and other documents containing drug prices.

1.3.2. When the Contractor identifies a potentially fraudulent invoice, Contractor shall immediately contact the submitting Entity and attempt to validate the pricing and allow the submitting Entity to correct their submission within 5 calendar days.

1.3.3. When pricing cannot be validated, Contractor shall provide NVHA with the identity of the submitting Entity

1.4. Contractor shall be solely responsible for requesting and collecting all information from Entities and other relevant sources needed to create, operate, and maintain the NVAAC Program.

1.4.1. Contractor shall identify Entities that are delinquent in providing required survey instruments, invoices, and other required documentation.

1.4.2. Contractor shall issue a delinquency letter to non-compliant Entities identifying, at minimum, the date the original documentation was due, the number of days the Entity is delinquent, and the date by which the delinquent Entity must submit the required documentation.

1.5. Any financial data provided by Entities or their wholesalers used in the analysis, creation, and/or maintenance of NVAAC prices are non-public data and protected from disclosure pursuant to Nevada Revised Statutes Chapters 239 and 600A. Contractor shall maintain the confidentiality of all information submitted to the Contractor for use in the NVAAC Program.

1.5.1. Contractor shall develop and maintain security measures to ensure that access to submitted information is limited to only Contractor personnel working on the NVAAC Program and NVHA employees identified by the NVHA as having clearance to access confidential information.

1.5.2. Contractor shall maintain secure methods for the transmission, receipt, storage, and disposal of survey submissions, invoices, and related information used to support the NVAAC Program shall limit access to such information to authorized personnel.

2. ADDITIONAL PROCESSES

Contractor shall develop and implement solutions to address special processes, including but not limited to:

2.1. Drug shortages

2.2. NVAAC for drugs with limited reporting

2.3. Exceptions to NVAAC

2.4. Verification process that products are available at the NVAAC price within Nevada and nationally.

3. NVAAC DETERMINATION REQUIREMENTS

Contractor shall develop and maintain a statistical analysis and averaging process for the determination of NVAAC prices.

3.1. Contractor shall calculate NVAAC pricing at:

3.1.1. The National Drug Code (NDC) level

3.1.2. A group level based on generic equivalency of products as determined by the federal Food and Drug Administration. Contractor may use drug-pricing compendia (e.g., Medi-Span or First Databank) generic group codes but must indicate in their proposal the specific codes it intends to use.

3.1.3. The Healthcare Common Procedure Coding System (HCPCS) code level

3.2. Contractor shall use National Council for Prescription Drug Programs (NCPDP) billing units of measure for NVAAC prices.

4. NVAAC DISSEMINATION

Contractor shall interface with NVHA’s fiscal agent(s) and Pharmacy Benefit Manager (PBM) to ensure NVAAC prices are accurately updated and transmitted weekly as identified by NVHA.

4.1. Contractor shall maintain appropriate safeguards to ensure the secure and timely transmission of NVAAC prices to fiscal agent(s) and the PBM and protect confidentiality, integrity, and availability of transmitted information.

4.2. Contractor shall allow the fiscal agent(s) and PBM to report errors in the data transmitted. Contractor shall review and correct reported errors within one day of notification by fiscal agent(s) or PBM.

5. PROVIDER APPEALS

Contractor shall develop and implement a provider appeal process to identify issues related to NVAAC prices. This process shall include gathering complaints submitted via the webpage/website and coordinating with NVHA staff to assess their validity.

5.1. In addition to a webpage/website form, the Contractor shall provide for a toll-free help desk.

5.1.1. The help desk shall provide for inquiries related to the NVAAC during regular business hours (Pacific Time).

5.1.2. Contractor shall ensure adequate staffing to handle help desk calls. Staffing adequacy changes must have NVHA approval.

5.2. Contractor shall respond to inquiries within one business day. Contractor shall ensure issues are thoroughly reviewed and the response provided to the inquirer shall address all concerns submitted in the inquiry. Contractor shall develop and maintain a tracking system that logs all inquiries/complaints. Contractor shall ensure the tracking system protects confidential or proprietary information and limits access to NVHA and authorized Contractor personnel.

Contractor shall track at minimum:

5.2.1. Call/inquiry date

5.2.2. Resolution date

5.2.3. Provider name and contact information

5.2.4. Resolution result

5.3. Contractor shall have the tracking system generate an Unresolved Inquiries report on a daily basis.

5.4. Contractor shall develop inquiry categories and establish a category prioritization list. Contractor shall obtain NVHA approval for the initial category priority list and any subsequent changes to the list.

6. REPORTING

6.1. Contractor shall develop, at minimum, the reports listed in this section. Contractor shall obtain NVHA approval of report contents and structure prior to implementation of a report. Contractor shall generate reports monthly as directed by NVHA:

6.1.1. NVAAC Price Report that shows NDC, Brand Name, Generic Name, Strength, Dosage Form, Unit of Measure, and NVAAC price

6.1.2. NVAAC Change Report comparing percent change between the current NVAAC prices and most recent previous prices

6.1.3. NVAAC comparison to NADAC/FUL/Nevada MAC/WAC/ASP reports

6.1.4. NVAAC report concerning the actual or estimated savings generated for the State during the immediately preceding two calendar years from the establishment and utilization of the NVAAC

6.1.5. 340B drug pricing report that shows NDC, Brand Name, Generic Name, Strength, Dosage Form, Unit of Measure and average 340B price

6.1.6. NVAAC Entity Delinquency Report that identifies Entities that have not met the reporting deadline requirements.

6.1.7. NVAAC Suspected Fraudulent Reporting report that identifies pharmacies and wholesalers that are suspected of submitting fraudulent information, including but not limited to invoices.

6.2. NVHA may direct the Contractor to issue required reports on a less frequent basis.

6.3. Contractor shall provide for ad hoc reporting requests from NVHA.

6.3.1. Contractor shall develop a standardized form for NVHA staff to request ad hoc reports.

6.3.2. Contractor shall respond to the ad hoc request within one calendar day with questions to clarify the ad hoc

6.3.3. Contractor shall identify the report delivery date within two calendar days after receiving final clarification of report requirements from NVHA.

6.4. The timing (due date) for reports is as follows:

6.4.1. Every Monday for weekly reports

6.4.2. By the 3rd day of every month for monthly reports

6.4.3. By January 3rd and July 3rd for biannual reports

6.4.4. By January 3rd for annual reports

7. TRANSPARENCY WEBSITE

Contractor shall maintain a web-based NVHA hosted NVAAC site, which provides for current and archived (prior) NVAAC price lists. All content of the NVAAC site must be approved by NVHA before deployment to the NVHA website(s).

7.1. If Contractor proposes to use a drug search function, the search function would be in addition to—and not in lieu of—NVAAC price lists. Any proposed search function shall allow, at minimum, the use of the following data elements:

7.1.1. Brand Name

7.1.2. Generic Name

7.1.3. NDC

7.1.4. HCPCS

7.2. The Contractor webpage/website shall provide:

7.2.1. Frequently Asked Questions section

7.2.2. Mechanism for providers to submit an appeal of NVAAC prices.

7.2.3. Links to relevant reports as approved by NVHA staff.

7.2.4. Links to relevant websites, including but not limited to CMS drug pricing websites.

7.3. Webpage(s)/website contractor develops and maintains shall be hosted on the NVHA website.

7.4. Contractor shall provide the documentation, configuration requirements, and implementation guidance necessary for NVHA to securely deploy and maintain the Contractor-developed NVAAC webpage(s). Contractor-developed components shall comply with applicable contractual security and disclosure requirements.

8. CONTRACTOR STAFF ORGANIZATIONAL STRUCTURE AND IDENTIFICATION OF KEY PERSONNEL

8.1. Contractor shall provide qualified personnel to perform the work necessary to accomplish the tasks defined in the Scope of Work. The State reserves the right to request the removal of any member of the Contractor's staff from the project. Contractor shall describe their proposed organizational structure for this project, including:

8.2. An organizational chart that clearly displays management structure and lines of responsibility for all operational areas.

8.3. A listing of key personnel including:

8.3.1. Individual names, titles, brief job descriptions, qualifications and full-time equivalents (FTEs) dedicated to this Contract, as well as the office locations for this Contract.

8.3.2. Whether each key personnel position will be filled by a Contractor’s employee or a subcontractor.

8.3.2.1.1.1. Summary of recruitment timelines and contingency plans for any key personnel positions that remain open at the time of Contract award.

9. SERVICE PERFORMANCE STANDARDS, MINIMUM SERVICE LEVELS, AND FINANCIAL PENALTIES

9.1. The following Service Performance Standards will be used to measure the performance of service provided by Contractor to NVHA.

9.2. Contractor shall perform the services at or above the Minimum Service Levels indicated below.

9.3. Upon request, Contractor shall provide to NVHA reports measuring its performance for each Service Performance Standard. The reports will contain the detail and accuracy reasonably necessary for NVHA to verify whether Contractor achieved or failed to achieve the Minimum Service Level for each Service Performance Standard in a specified time frame.

9.4. If Contractor fails to achieve Minimum Service Levels, NVHA shall assess financial penalties as designated in Table A: Service Performance Standards against the fees paid to Contractor.

9.5. If Contractor fails to achieve the Minimum Service Levels, Contractor shall promptly:

9.6. Correct the problems and restore services to meet the Minimum Service Levels as soon as practicable.

9.7. Provide reasonable evidence to NVHA that the causes of such problems have been or shall be corrected.

Table 9A: Service Performance Standards

Measurement Financial Penalty

Contractor surveys Nevada Medicaid enrolled pharmacies on at least a quarterly basis and if a subset of pharmacies are surveyed quarterly, all enrolled pharmacies are surveyed at least biannually (twice yearly).

Not more than 5% of the total value of the bid or contract

Contractor appropriately calculates NVAAC prices based on methodology agreed upon in the contract.

Not more than 5% of the total value of the bid or contract

Reports Reporting includes any scheduled reoccurring or individually requested agreed upon scheduled reports will be delivered:

· Every Monday for weekly reports

· By the 3rd day of every month for monthly reports

· By January 3rd and July 3rd for biannual reports

· By January 3rd for annual reports Any exceptions to above deadlines MUST BE approved by Nevada Medicaid Pharmacy Services.

$500 per report per day greater than 10 days.

Must deliver NVAAC data to fiscal agent(s) and PBM per the calendar schedule established by the Contractor, NVHA staff and fiscal agent(s), and PBM. Exceptions MUST BE approved by Nevada Medicaid Pharmacy Services.

$500 per day for each missed deadline where an extension was not approved.

Webpage Contractor maintains an NVAAC webpage/website as approved by the NVHA and the webpage/website content is accessible to the public 24 hours a day, 7 days a week, excluding scheduled and communicated maintenance periods.

$500 per day for each Work Order request not delivered on time unless previously agreed to by NVHA.

Contractor maintains a provider appeals process as approved by NVHA. Contractor provides an initial response to inquiries and appeals within one business day. Contractor maintains an appeal tracking system accessible to designated NVHA staff.

Not more than 5% of the total value of the bid or contract

Contractor performance or system related issues documented to NVHA within 24 hours through agreed upon issue tracking process. All problems resolved within 10 business days or by agreed upon schedule. Exceptions to deadlines approved by Nevada Medicaid.

$500 per day per missed deadline for each problem not resolved at the performance guarantee.

Financial Penalties

9.8. Aggregate Penalties total for Contractor’s failure to meet Minimum Service Levels shall not exceed 5% of the total cost of the Contract.

9.9. NVHA will collect penalties by withholding the assessed amount from the Contractor’s next invoice.

9.10. Service Performance Standards I -V

9.10.1. Compliance will be determined by NVHA.

9.10.1.1. All delivered files or report accuracy is 100%. Accuracy is determined by dividing the total number of records by the total number of records in error. Any file or report provided below 100% accuracy is deemed as not meeting the delivery deadline until the time it is complete and 100% accurate.

9.10.1.2. Any variations from the stated requirements must be approved by NVHA’s Chief Information Officer and designated SRU Staff.

9.10.1.3. Data entered by NVHA is not measured as inaccurate to Contractor if the data was entered incorrectly.

9.10.1.4. Extensions to deadlines must be approved by NVHA’s Chief Information Officer and designated SRU Staff by signed letter or email from the Chief Information Officer and designated SRU Staff email accounts.

9.10.1.5. NVHA shall notify Contractor in writing of intent to deduct penalty at least 30 days prior to deduction from Administrative Fees.

9.11. Service Performance Standard V

9.11.1. Upon receipt of quarterly data tables from NVHA, Contractor must review report and ensure all existing facilities are complete and accurate and enter any new facilities to the compliance report due to NVHA monthly. If any identified issues include, but not limited to, missing data elements, or non-compliance, the facility must be contacted by Contractor within 15 days of receipt of the data tables.

9.11.1.1. If a facility does not provide a response or a compliant submission, Contractor must contact non-compliant facilities again within 15 days and every 15 days thereafter until compliance is achieved.

9.11.1.2. Contractor must provide NVHA with a communication status log of all facilities identified as non-compliant with and the dates and method of communication to each facility until compliance is achieved.

9.11.1.3. The communication log must be updated and submitted to NVHA quarterly, no later than 10 days in the following quarter.

10. NOTIFICATION OF SUBCONTRACTORS, DATA SHARING, SELLING, AND STORAGE LOCATIONS

10.1. Contractor shall be required to disclose all subcontractors prior to awarding the contract.

10.2. Contractor shall not be permitted to share or sell any data collected while performing the duties of this contract, whether for profit or not, without the written approval of NVHA. After the contract award, Contractor shall be required to disclose any new subcontractor arrangements that involve the sharing of NVHA data and is subject to NVHA approval. Notification to NVHA will take place prior to the commencement of work with any subcontractor or data sharing opportunity. Failure of Contractor to notify NVHA of any data requests outside of NVHA or of any subcontractor performing work related to NVHA or on NVHA data without prior NVHA approval shall result in a financial penalty.

10.3. Contractor shall disclose to NVHA where all physical locations of NVHA data are stored and accessed. Contractor shall notify NVHA of any changes to the physical location where NVHA data is stored or accessed. Notification to NVHA will take place prior to any data migration and is subject to NVHA approval. Failure to notify NVHA of any changes to the location of NVHA data, or moving same data without NVHA approval, shall result in a financial penalty.

10.4. Contractor shall ensure subcontractors, affiliates, or third parties supporting services under this Contract are subject to security and confidentiality obligations commensurate with the services performed and the sensitivity of NVHA information to which they have access.

11. INFORMATION SECURITY AND DATA PROTECTION

11.1. Contractor shall maintain an information security program commensurate with the size, scope, complexity, and risk associated with services provided under this Contract and the sensitivity of information collected, processed, transmitted, or maintained on behalf of NVHA.

11.2. Contractor shall maintain administrative, technical, and physical safeguards designed to protect confidential, proprietary, and sensitive information from unauthorized access, disclosure, alteration, loss, or destruction. Such safeguards shall include, at minimum, access controls, authentication mechanisms, encryption, logging and monitoring, vulnerability management, secure configuration management, incident response capabilities, workforce security awareness training, and business continuity/disaster recovery processes appropriate to the services provided under this Contract.

11.3. Contractor shall ensure that access to NVHA information is limited to authorized personnel with a business need to know and shall maintain processes for timely provisioning, modification, and removal of access.

11.4. Contractor shall notify NVHA of any actual or suspected security incident, unauthorized access, unauthorized disclosure, or compromise involving NVHA information or systems in accordance with contractual notification requirements.

11.5. Contractor shall cooperate with reasonable NVHA security reviews, risk assessments, and requests for information necessary to validate compliance with security and privacy expectations associated with this procurement.

12. PRIVACY AND SECURITY

12.1. Contractor shall maintain current privacy and information security policies, procedures, and technical safeguards appropriate to the systems, environments, and information used to support services under this Contract, including any systems used to store, transmit, access, or process NVHA information. Contractor shall comply with all applicable federal and State privacy and security requirements relevant to the services provided, including, as applicable, HIPAA and HITECH requirements.

12.2. Contractor shall provide the name(s) of its Security Officer(s) who is responsible for all security-related compliance activities, practices, and policies. The name(s) of the Security Officer(s) will be provided to NVHA upon award of the contract.

12.3. Contractor shall provide the name(s) of its Privacy Officer(s) who is (are) responsible for all privacy-related compliance activities, practices, and policies. The name(s) of the Privacy Officer(s) shall be provided to NVHA upon award of the contract.

12.4. Contractor shall maintain comprehensive privacy and security policies and procedures and provide relevant policies, or summaries thereof, to NVHA annually or upon material revision, whichever occurs first.

12.5. Contractor shall maintain a written plan within its privacy and security policies and procedures describing how security incidents and data breaches will be addressed.

12.6. Contractor shall ensure information considered confidential, proprietary, or personal (employee/participant information) by NVHA is not stored or transferred outside of agreed and designated storage and processing systems.

12.7. Contractor shall maintain processes for vulnerability management, access management, incident response, and continuity of operations appropriate to the services provided under this Contract.

12.8. Contractor shall maintain appropriate safeguards to ensure confidential or proprietary information obtained through performance of this Contract is protected from unauthorized access, disclosure, or use.

12.9. Contractor shall ensure NVHA information is stored and processed only within approved systems and locations disclosed to NVHA and shall notify NVHA in advance of material changes to hosting, storage, subcontractor access, or data processing locations.

13. COSTS AND INVOICING

13.1. Invoices shall be submitted monthly to NVHA and as noted in “41NHA-S3922 - Cost Schedule”. The monthly billing amount shall be determined by dividing the annual fixed cost, as set forth in “41NHA-S3922 – Cost Schedule.”

13.2. Invoices shall be emailed to nvhapcu@nvha.nv.gov.

13.3. Upon review of invoices and acceptance by NVHA, payments shall be made 30 days of invoice receipt, providing all required information, documents and/or attachments have been received.

13.4. Invoices shall include the following:

· Contract CETS #xxxxxx

· Deliverable/task completed