Federal Government Processes and Standards

Transcription

1 Federal Government Processes and Standards Marci Anderson, VAOIG Mark Myers, VAOIG 1

2 VA Structure and Best Practices Procurement in VA is not centralized. Contracts and task orders are awarded by the Office of Acquisition, Logistics, and Construction or by the various VA administrations, the largest being the Veterans Health Administration. 2

3 FY 2017 VA Contract Spend to Date (04/03/2017) VHA is SAO Central, East, & West Combined FY2016: $22.32 Billion, 217,602 transactions 3

4 OFFICE OF ACQUISITION AND LOGISTICS Funded through VA Supply Fund which is a revolving fund Office of Acquisitions provides overall policy for VA s acquisition operations Major units: Acquisition Resource Service (ARS) Acquisition Operations Service (AOS) Denver Acquisition and Logistics Center (DALC) National Acquisition Center (NAC) Technical Acquisition Center (TAC) (IT procurements) 4

5 OALC Org Chart 5 FTE: 1205

6 NAC ORGANIZATIONAL CHART National Acquisition Center Denver Acquisition & Logistics Center FSS Service National Contract Service Business Resource Service 6

7 FSS Service Vacant Director FSS Service James Booth (A) Deborah Zuckswerth(B) Chief, Med/Surgical James: Deborah: Bob Satterfield Chief, Services Diana Lawal Chief, Pharm/Dental Christine Szrom Chief, Program Mgmt & Resource Support

8 National Contract Service Steven Thomas Director National Contract Service Frank Zacchigna Chief, High Tech Medical Equipment Division Ronald Jenkins Chief, Medical/Surgical Program Fran DeRosa Chief, Pharmaceutical Division 8

9 PHARMACY BENEFITS MANAGEMENT SERVICES (PBM) Oversees the formulary for the entire VA system Manages pharmaceuticals and pharmaceutical-related policies Drug safety and efficacy evaluations Pharmacologic management algorithms Criteria for drug use Evidence-based practices promote, optimize, and assist VA providers with the safe and appropriate use of pharmaceuticals Allow formulary decisions that can result in substantial cost savings Standardize generic agents as well as specific drugs and drug classes for National Contracts Established an outcomes research section to undertake qualityimprovement and safety initiatives that ultimately monitor and determine the clinical impact of formulary decisions Responsible for processing non-famp data to produce FCPs Authority to make covered drug determinations 9

10 PBM CENTRAL OFFICE Michael A. Valentino -Chief Consultant for Pharmacy Benefits Management Services, Department of Veterans Affairs Central Office Responsible for planning and directing Drug benefit design Formulary management and pharmaceutical contracting Automated prescription fulfillment Professional pharmacy practice Emergency pharmacy services Drug therapy policy development Virginia S. Torrise, Pharm. D. - Deputy Chief Consultant - PBM Professional Practice and Clinical Informatics VA s formulary committees Pharmacy residency training Adverse drug event reporting Medication safety reviews Recruitment and retention initiatives Emergency pharmacy preparedness and pharmacy informatics development 10

11 PBM HINES Joseph J. Canzolino, R. Ph. Deputy Chief Consultant - Formulary Management Pharmacy Benefits Management Services VAMedSafe/Outcomes Research Emergency Pharmacy Service. Jennifer Zacher, Pharm. D. - Assistant Chief Consultant - PBM/EPS Management of VA National Formulary initiatives Advisor to the National Acquisitions Center on Pharmacy Issues Emergency Preparedness Ted Karnezis, RPh, Pharm. D. - Public Law Database Manager Management of Public Law Prices 11

12 VA Office Inspector General Office of Contract Review Roy Fredrikson Deputy Counselor to the IG Mark Myers Director Healthcare Resources Division Michael Grivnovics Director FSS Division Karen Summers Manager Healthcare Services Pre-Awards Gary Petrovich Manager Public Law Compliance Joseph Houston Manager Pharmaceutical FSS Pre-Awards Kim McKeithen Manager FSS Pre- Awards (non- Pharmaceutical) Ayhan Akbel Manager FSS Post- Awards Ernest Goebel Manager Construction

13 OFFICE OF CONTRACT REVIEW Performs Pre- and Post-Award reviews of FSS contracts awarded and administered at the NAC Pre-Award reviews are requested by and are advisory to the Contracting Officer. All pharmaceutical offers with estimated contract values over $5 million will be subject to a Pre- Award review. Primary objective is to determine whether CSP disclosures are accurate, complete and current and whether the offered price is reasonable. 13

14 OFFICE OF CONTRACT REVIEW Post-Award Reviews - compare disclosure data with sales transaction data to determine: compliance with PL section 603 billing at correct prices compliance with FSS contract clauses including: price adjustment clause, price reduction clause, payment of IFF 14

15 COORDINATION OF NAC, PBM, AND OIG Preaward Reviews NAC and OIG review CSPs and pricing schedules OIG obtains current FCPs from PBM (if covered drugs are offered) OIG conducts review and issues report to CO CO negotiates contract with OIG advice as needed. OIG coordinates with NAC Contracting Staff regarding any potential issues with offeror Postaward Reviews Can be initiated at the request of the CO, by the OIG, or in response to a voluntary disclosure NAC and OIG will discuss unique issues OIG report to CO with recommendations OIG may obtain open market purchase data through PBM if a covered drug is not offered timely, or is removed from the schedule prematurely. 15

16 COORDINATION OF NAC, PBM, AND OIG Public Law Updates PBM sends letter in October to contractors with covered drugs PBM reviews and calculates FCPs sends to contractor for concurrence PBM sends final FCPs to contractor and contracting officer If the contractor has concerns or disagrees with final FCP, need to timely discuss and resolve with PBM Contractor submits modification request and CO performs analysis (Max Cap and TC relationship) Mod is processed for January 1 implementation 16

17 Best Practices Understand what is required for submission for a new contract, contract extension, FCP, modification, price reduction and establish policies, procedures, and processes that will: Allow you to extract accurate, complete, and current information needed to submit an offer or modification, and calculate the FCP for each line item. Allow you to track information needed to ensure contract compliance such as place of manufacture and compliance with FDA laws and regulations. 17

18 Best Practices Submit offers timely to ensure award at the time you expect and before an existing contract expires. 3 months or less in advance of your desired award date will not be sufficient. Allow at least one year for optimal results. If you don t get a response from the NAC, contact them to determine the status. Same goes for requests for modifications Document progress, especially for addition for covered drugs 18

19 Best Practices Perform internal reviews periodically. If noncompliance issues are found, determine impact and if any, submit a voluntary disclosure to your CO with a copy to the OIG. For offers that require a preaward review, follow-up with CO once the review is complete. No more than 60 days should pass between the completion of the review and the award of the contract/modification. If the CO is not responsive, elevate concerns to the Chief and don t hesitate to elevate to the Director level if necessary. Disclose and negotiate. Don t selectively disclose based on criteria of your choosing. 19

20 Single v. Dual Pricing Ensure that you have the information needed to make an informed decision whether to offer single or dual pricing on the FSS for covered drugs. 20

21 Single v. Dual Pricing Covered drug is a single-source or innovator multiple-source drug, marketed under a New Drug Application or a Biological License Agreement Manufacturers must make VHCA covered drugs available for sale on an FSS contract at statutorily-capped pricing known as the Federal Ceiling Price (FCP) to be eligible for Medicaid and Medicare Part B reimbursement, and purchase by the Big Four Federal agencies: Big Four: VA, DoD, Public Health Service (PHS) (including Indian Health Service) (IHS)), and Coast Guard Other Government Agencies (OGAs) and other eligible FSS purchasers are not entitled to FCP, so VA allows manufacturers to decide whether to extend FCPs to the OGAs using the dual pricing option 21

22 Single v. Dual Pricing Single Pricers Provide FCP (or lower) pricing to all FSS-eligible purchasers as the FSS contract price Maintain single price list Dual Pricers Establish two prices: Big Four price: capped at FCP OGA: negotiated price that serves as the FSS contract price Maintain two price lists 22

23 Single Pricing Pros and Cons Pros: Simpler administratively: Only one price point to negotiate CSP disclosures will be limited only to prices that are equal to or lower than the FCP for offered products Only one price list to maintain Only one set of prices to monitor for compliance with the Price Reductions Clause Cons: Limitation on price increases Single pricing rules depress or inhibit increase in FCP in dual calculation years 23

24 Dual Pricing Pros and Cons Pros: Permits price increases and may limit other liabilities OGA price is usually higher than FCP OGA price allows for FCP to increase more quickly over time relative to single pricers (OGA price is used as the FSS Max Cap in the FCP calculation) Lower rebate liability under the TRICARE retail rebate program Cons: More complicated administratively: Two price points to negotiate CSP disclosures will be more involved to address FCP-based Big 4 price and the negotiated OGA price Two price lists to maintain Two sets of prices to monitor for compliance with the Price Reductions Clause 24

25 Dual Pricing Considerations Differential between MFC, Tracking Customer Price and calculated FCP Inflationary market could mean heavy additional discounts which would favor dual pricing Deflationary market could mean there is a potential for the Tracking Customer price to become the permanent FSS price Applies to all 42-2A products on contract. Overall benefit should be evaluated. 25

26 Making/Changing the Election The single/dual election is made at the time of contract award The election applies to all covered drugs on contract Vendor Response Document, Page 12, includes instructions, considerations and election form. Established single pricers can change to dual pricing at any time during the contract period (DML dated 11/1/2013) If a company changes its election (from single to dual) during the life of the contract, new CSP forms must be submitted to negotiate an FSS price 26

27 Trade Agreements Act All VA FSS and other national contracts (other than small business set-asides) include the Trade Agreements Act clause. The contractor has the responsibility to identify the country of origin, not the CO or the purchaser. For pharmaceuticals, maintain documents showing the country of origin for the API. For non-manufacturers, ensure that your subcontracts to obtain the products includes a provision that requiring your suppliers (both direct and indirect) to certify that the products provided are Trade Agreements Act compliant. Blanket non-availability determination for 42-2A items only. 27