Presentation on theme: "The 340B Prime Vendor Program; Supporting All 340B Stakeholders"— Presentation transcript:
1The 340B Prime Vendor Program; Supporting All 340B Stakeholders Christopher Hatwig, President, Apexus
2340B IntentTo permit covered entities “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”H.R. Rep. No (II), at 12 (1992)We know the intent of the 340B Program by reading reports that summarize the legislative discussion during the time the 340B Program was enacted. The intent of the 340B Program is summarized as: To permit covered entities “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”There has been some discussion recently, and considerable dispute about the intent of the 340B Program. At 340B University, we are present material aligned with HRSA’s perspective, and so that is what is on the slide.There are some payers/PBMs, contract pharmacies, and other stakeholder groups that have different perspectives and have developed business practices that indicate a different perspective about program intent, but we are not going to discuss those today.
3Top Three C-Suite Myths “This program can run itself—or at least the pharmacy director can just manage it.”“Proposals from contract pharmacies or 3rd party vendors must be in our best interest if the bottom line looks good.”“The team can probably pull together the data for a 340B audit without much effort.”
4Prime Vendor Program History Statutory requirementCompetitively bid contract1999 first Prime Vendor contract awardedApexus awarded Health Resources and Services Administration (HRSA) agreement in & 2009
5Prime Vendor Program Entity benefits No cost to participate Exclusive access to:Sub-340B and sub-WAC pricing on pharmaceuticalsDiscounts on value added products, services, and suppliesApexus Generics ProgramPricing transparencySpend optimization reports and tools340B UniversityApexusAnswers Call Center
7Breakout of 340B Sales by Entity Why would a manufacturer want to contract with Apexus?Expedite product placement in a preferred positionAccess to influential IDN systems and/or teaching hospitalsIncrease contracting efficiencyGain federal price protection (non-FAMP, ASP, BP)Minimize credit/rebill activity, mitigate diversionIncrease market share via 340B market
8Relative Pricing Private Sector Pricing “Best Price” 63% PVP 42% Compared to other types of drug pricing in the marketplace, the 340B price is very competitive: here it is shown to be approximately 51% of Average Wholesale Price. Notable also is that the 340B price is less than the Medicaid Rebate.Adapted from a slide by Safety Net Hospitals for Pharmaceutical AccessSource: Data derived from Prices for Brand-Name Drugs Under Selected Federal Programs, Congressional Budget Office (June 2005)
9Apexus Focus Contract Services Apexus Answers Call Center TEAMWORKContract ServicesTRUTHApexus Answers Call CenterTEACHING340B University & 340B OnDemand
11Apexus Responsive to HRSA Policy As HRSA issues policy clarifications, Apexus must be flexible to offer solutions to enable entities to complyExamplesRefund ServiceGPO Prohibition
12GPO Prohibition Clarification – Purchase Flow for Some Hospitals Non-compliant StateCompliant State340B Registered Hospital340B340BAll Other(Default to GPO)Inpatient orNon-Covered Drugs(GPO)All Other Out-Patient Covered Drugs(Default to Non-GPO Account)
13Minimizing WAC Exposure Tool Accessible on the Apexus public website, under the Resource Center tab, you will find a document on how to minimize your WAC exposure.
14340B Covered Outpatient Drugs Prescription drugsOver-the-counter drugs (with a prescription)Clinic administered drugsBiologicsInsulinInpatient drugsVaccinesInpatient drugsDrug not directly reimbursedThe 340B Statute refers to Section 1927 (k) of the Social Security Act to define the term “Covered outpatient drugs.” It is a long and complex definition, but we’ve simplified it for you here. 340B Covered outpatient drugs are basically outpatient prescription drugs sold by a manufacturer participating in the Medicaid Drug Rebate Program. This may include over the counter drugs sold with a prescription, clinic administered drugs, biologics, and insulin.There is also a limiting definition: The term “covered outpatient drug” does not include any drug, biological product, or insulin provided as part of, or as incident to and in the same setting as, any of the following (and for which payment may be made under this title as part of payment for the following and not as direct reimbursement for the drug).Also excluded is any drug for which a National Drug Code number is not required by the Food and Drug Administration or a drug or biological used for a medical indication which is not a medically accepted indication.To try and simplify this for you, we’ve put the types of drugs that typically meet the definition of covered outpatient drugs in the green circle, and the types of drugs or attributes that do not meet the definition of covered outpatient drugs in the red circle.The definition of covered outpatient drug has recently become of great interest to entities, particularly those entities which are not allowed to purchase through a GPO. The reason: certain 340B entities may not purchase COVERED OUTPATIENT DRUGS through a GPO. But if a drug doesn’t meet this definition, then the drug could be purchased through a GPO.FDA doesn’t require NDC
15Strategy #1: Covered Outpatient Drug Q: Can a hospital subject to the GPO Prohibition use a GPO for drugs that are part of/incident to another service and payment is not made as direct reimbursement of the drug (“bundled drugs”)?A: If the entity interprets the definition of covered outpatient drug referenced in the 340B Statute (Social Security Act 1927 (k)) and decides that bundled drugs do not meet this definition, a GPO may be used for drugs that are not covered outpatient drugs. The decision the entity makes should be defensible, consistently applied in all areas of the entity, documented in policy/procedures, and auditable.It is the expense in the middle (non-GPO/WAC) account that has troubled many hospitals. So, let’s talk about a few strategies we can use to minimize our expenses.Since entities may interpret the definition of covered outpatient drug, there are some key product areas that might be able to be purchased on a GPO. Examples might include anesthesia gases, IV solutions, some contrast media.
16Strategy #2: GPO “Only” Clinics 340B UniversityStrategy #2: GPO “Only” ClinicsMay , 2013In certain off-site outpatient hospital facilities that meet all of thefollowing criteria:Are located at a different physical address than the parent;Are not registered on the OPA 340B database as participating in the 340B Program;Purchase drugs through a separate pharmacy wholesaler account than the 340B participating parent; andThe hospital maintains records demonstrating that any covered outpatient drugs purchased through the GPO at these sites are not utilized or otherwise transferred to the parent hospital or any outpatient facilities registered on the OPA 340B database.To assess compliance with the GPO Exclusion, does the entity use a GPO for covered outpatient drugs only when all of these criteria are met?Are located at a different physical address than the parent;Are not registered on the OPA 340B database as participating in the 340B Program;Purchase drugs through a separate pharmacy wholesaler account than the 340B participating parent; andThe hospital maintains records demonstrating that any covered outpatient drugs purchased through the GPO at these sites are not utilized or otherwise transferred to the parent hospital or any outpatient facilities registered on the OPA 340B database.There have been some situations where entities have non-entity owned (but umbrella organization owned) pharmacies offsite of a 340B registered facility, and the entity uses a GPO in that location.
18Look Familiar?Call Center Confessional? Confidential, access to staff who have “heard it all before….” We are not a tattle-tale facilitator service.
19Apexus Answers National 340B source of truth, communicates HRSA policy Staff in constant communication with HRSA to ensure messaging is consistentFAQs available here: https://www.340bpvp.com/resource-center/faqs/Average monthly interactions ~2,000Tiered levels of response: can handle from basic to complexAvg 2013 monthly interactions=1826 (calls + + chat)
21Learn. Share. Prepare.National experts share leading practices at this one or two day live educational programAligned with HRSA policy, compliance-focusedOnly HRSA-endorsed compliance trainingCE for pharmacists and technicians offeredInteractive, opportunities to network, leave with tools to equip your entity10+ Sessions in 2014E-based learning coming in Summer 2014 (including C-suite modules)
22Free and Trusted 340B Tools Strategies to Minimize WAC ExposureSample 340B Standard Operating ProceduresSelf-Reporting Non-ComplianceSelf-Audit Tool
23340B U attendance prior to audit No 340B U attendance prior to audit FY 2012 Audits and 340B U Attendance and Sanction/Finding Rate (In Entities with Sanctions/Findings)340B U attendance prior to auditNo 340B U attendance prior to auditSanction Rate0%100%Finding Rate3%97%340B U attendance prior to an audit had a 0% sanction rate and a very low finding rate. There could be a confounder that some behavior other than 340B University attendance was causing these low rates of sanctions/findings (for example, entities that are already more compliance-focused attend 340B U). So we are not saying the 340B U caused the low rates, but attendance was definitely associated with it. Who wouldn’t want to associate with the types of entities that attend 340B U and end up with stellar audit findings?
24340B Contract Pharmacy - Overview HRSA guidance permits entities to partner with outside pharmacies to provide eligible patients with 340B medicationsIdentification via shared patient and provider dataInventory via "Bill To - Ship To” wholesale arrangementsEntity-Contract Pharmacy relationship types :Direct Contracting with PharmacyContracting through 340B vendor with Pharmacy
25340B Contract Pharmacy Process Contract Pharmacy dispenses drug (non-340B inventory) to 340B entity’s eligible patientWhen a full package size of the Rx is reached, the pharmacy or vendor orders a 340B drug to replace itReplacement 340B drugs are “billed to” the entity and “shipped to” the contract pharmacyEntity pays contract pharmacy for its servicesThis slide covers the highest level overview of 340B contract pharmacy—there are a few players missing, but this helps to convey the big picture.Covered Entity purchases product (bill to ship to) and contracts with administrator.Administrator determines eligibility and proportional billing by contract with pharmacy and entity.Administrator gets a processing fee for eligibility, program management (including contracting), virtual inventory and record keeping. It is the program of the covered entity that is responsible for the outcomes.Pharmacy bills third party and receives payment from third party with whom they have a separate network contract, they can do a “pay to” to the administrator for ease of funds allocation if desired.Covered entity receives a cost for product and a proportion of total funds received from third party as determined by contract and consistent with value of the services provided.Pharmacy dispenses the product to patient.Pharmacy uses in house inventory and replenishes product from orders through covered entity wholesaler account.Bills third party payer (MCO or Medicaid) at contracted rate set by network contract between pharmacy and third party payer .Payment is made to pharmacy through provider agreement, may be “pay to” administrator if desired.Pharmacy is liable for the professional dispensing activity, the inventory (especially if product is a controlled substance), and the conduct related to the contract with the third party and the separate contract with the covered entity.Periodic true-upIf the pharmacy is not able to use an entire container of product over a quarter because the product utilization did not consume the total units of use (bottle of bills), then the covered entity pays the pharmacy the cost of the partial package at regular wholesaler cost.
26What is a 340B Vendor?A company providing 340B contract pharmacy program implementation and management servicesNot a HRSA requirementMinimizes impact on retail pharmacy workflowCollects data from retail pharmacy at the switchProvides the interface to identify eligible claims (matches entity data and pharmacy data)Manages inventory replenishmentEstablishes contracts with pharmaciesProvides reports and transparency for auditing
27Contract Negotiation, Summary Entity pays flat fee per claimStop-loss function (prevents 3rd party transmission if loss to entity)Entity does not pay fees on claim reversals (net paid claims)Entity pays lowest of U&C, MAC, and 340BEntity has access to ALL data (including prescriptions presented vs. filled with 340B)High complexity data management systemsHL7 interfaceEntity pays fees based on % of revenue or drug costEntity does not keep 3rd party reimbursementVendor recruits patients to its mail order pharmacyEarly cancellation feesEntity not permitted to select wholesalerEntity may end up purchasing partial bottles at high rates due to non-replenishmentEntity not permitted to contract with other 340b vendors
28Split Billing or Contract Pharmacy Vendors - Buyer Beware Not two vendors are the sameRules applied can varyVarious levels of sophistication and and experienceWhat if HRSA reported vendors associated with all covered entity audit findings?Responsibility for 340B program compliance cannot be delegated to a 3rd party. Read the fine print of the agreements.Some Vendors do not feel it is their obligation to support 340B compliance (and offer non-compliant alternatives)Apexus is developing new tools to assist covered entities evaluate and select vendors
30Contract Pharmacy OIG Report Contract Pharmacy Arrangements in the 340B Program (OEI ) released Feb. 5, 2014Contract pharmacy arrangements create complications in preventing diversion and duplicate discounts, and covered entities addressed the complications in different ways.Some covered entities in the study offer the 340B discount to uninsured patients at the contract pharmacy and others do not.Most covered entities in the study do not conduct all of the HRSA-recommended oversight activities.OIG Issues 340B Contract Pharmacy Memorandum ReportThe OIG Released a report Contract Pharmacy Arrangements in the 340B Program (OEI ) in final form on February 5, This Memorandum Report was released in final form and there were no recommendations. The report had the following conclusions:Contract pharmacy arrangements create complications in preventing diversion and duplicate discounts, and covered entities addressed the complications in different ways.Some covered entities in the study offer the 340B discount to uninsured patients at the contract pharmacy and others do not.Most covered entities in the study do not conduct all of the HRSA-recommended oversight activities.This report was the first of three expected OIG reports regarding the 340B program slated in its 2014 work plan. The OIG recently announced that 2014 will include the OIG:Examining the extent to which HRSA and 340B covered entities oversee compliance by 340B contract pharmacies;Examining the extent to which HRSA has implemented prior OIG recommendations regarding 340B covered entities’ access to 340B ceiling prices; andExamining whether changes in practice or procedure might allow Medicare Part B to receive the benefit of 340B discounts when reimbursing for 340B drugs.
33Wholesaler Account Setup -DSH/PED/CAN with GPO Prohibition InpatientGPOGPO ContractDSH Inpatient GPO Contracts (DSH only)GPO or Wholesaler Generic Source ProgramIndividual Hospital AgreementOutpatient(not 340B eligible)Non-GPO/WACWAC PricingPVP Sub-WAC(if enrolled in PVP)Apexus Generic Portfolio (AGP) (if enrolled in PVP)Individual Hospital Agreement (single entity only)Outpatient(340B eligible)340BPHS/340BPVP Sub-340B(if enrolled in PVP)Apexus Generic portfolio (AGP) (if enrolled in PVP)Individual Hospital Agreement (single entity only)There is an inpatient account (where you can use a GPO), and 2 outpatient accounts (non-GPO/WAC and the 340B account). This middle account was created to give hospitals an alternative to paying WAC. Apexus has been actively contracting in this space for its members with its PVP Sub-WAC contracts. One primary difference between the two outpatient accounts is shown in orange vs. red, as the PVP sub-340B contracts and the PHS/340B contracts are loaded only to the 340B account. The other major difference between these accounts is that WAC prices are in the non-GPO/WAC, and 340B prices appear ONLY in the 340B eligible account. Making sure this account set-up is correct is critical for GPO Prohibition compliance.PVP Non-340B/WAC account is THE area of focus.The two Apexus contract portfolios are now named:PVP 340B = which is the 340B sub ceiling priced pharmacy itemsPVP Non-340B = which is everything elseAccount #1Account #3Account #2