It provides covered entities the ability to automatically split and track replenishment orders for eligible medications into multiple accounts (340B, GPO, WAC). e.g. New Purchasing Flexibility, But Strings Are Attached 340B hospitals that purchase through a GPO must document that they made a good faith effort to purchase the drug at Wholesale Acquisition Cost (WAC). Believes the 340B program is essential to helping providers stretch limited resources to better serve their vulnerable communities. ... (GPO) or Wholesale Acquisition Cost (WAC) purchasing requirements inherent in replenishment systems. Expected change on the 340B horizon 340B –ADAP Supplemental – Wholesaler Discount + Distribution/DF AWP Price ($100.00) Distribution and Dispensing Costs ($11.00) Wholesaler Discount ($1.00) 340B Price ($56.74) AMP Price ($82.00) Generics The “retail” (AWP or WAC) prices of a generic are typically 90% of the brand name drug. 340B Internal Audit & Best Practices The most important aspect of any Covered Entity’s 340B Program is the dedication of resources and the appropriate oversight. For the details on the full policy clarification, click on the link above. The wholesale acquisition cost (WAC) is an estimate of the manufacturer’s list price for a drug to wholesalers or direct purchasers, but does not include discounts or rebates. 340B Office of Pharmacy Affairs Information System GPO Prohibition. 2. Supports eliminating the orphan drug exclusion for certain 340B hospitals. This session reviews the definition and reason for the WAC account and how to recognize good WAC spend vs. unnecessary WAC spend. The Centers for Medicare & Medicaid Services (CMS) yesterday released the calendar year (CY) 2021 outpatient prospective payment system (…, The Centers for Medicare & Medicaid Services (CMS) Nov. 20 released an interim final rule implementing the Most Favored Nation (MFN) Model, a new payment…, The AHA on Friday sent a letter to the Health Resources and Services Administration’s Office of Pharmacy Affairs urging the agency to order drug manufacturers…. as clients, negotiates group discounts on drugs and other items. After initial purchases, data is fed into the 340B accumulator for 340B eligible patients and replenished when a full package size has been accumulated. The program requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. The only inventory carried by the outpatient infusion center would be 340B inventory, with the exception of crash-cart medications that would be purchased at the wholesale acquisition cost (WAC). You will need to maintain a spreadsheet as discussed above, or have a similar report writing capability from your Hospital Information System. Without this program, these individuals would find more difficulty in finding ready access to care and medications. During the first twenty years of the program, HRSA applied a commonsense understanding of the GPO limitation that allowed hospitals subject to the GPO limitation to use two-inventory systems. 3. Supports voluntary program integrity efforts already underway to ensure this vital program remains available to safety-net providers. 86 0 obj <> endobj To be fair, some sites have better anesthesia … We are the leading advocate and resource for those hospitals who serve their communities through participation in 340B. The 340B Drug Pricing Program is a federal program created in 1992 for section 340B(a)(4) of the Public Health Service Act (PHSA). Therefore, a hospital subject to the GPO prohibition cannot use a GPO for covered outpatient drugs, even if the drugs Despite increased oversight from HRSA and the program’s proven record of decreasing government spending and expanding access to patient care, some want to scale it back or significantly reduce the benefits that eligible hospitals and their patients receive from the program. For covered entities using replenishment models, the Notice specifies that hospitals may not tally 340B-ineligible outpatient use for drug orders on a GPO account. Once they are actively enrolled in 340B, hospitals subject to the GPO prohibition must initially purchase drugs at non-340B, non-GPO prices (e.g., WAC). 340B hospitals subject to the group purchasing organization (GPO) prohibition typically have 3 separate accounts on which to purchase medications: 340B, GPO, and WAC. 10272, 10277 (March 5, 2010)). The Centers for Medicare and Medicaid Services has stated that SNHPA says the exceptions would spare 340B hospitals the expense of buying drugs at their more expensive wholesale acquisition cost (WAC) when the drugs cannot be bought at a 340B price. WAC, GPO and 340B) and to replenish inventory in the mixed-use inventory setting. But several respondents cite software limitations as a problem. AHA does not claim ownership of any content, including content incorporated by permission into AHA produced materials, created by any third party and cannot grant permission to use, distribute or otherwise reproduce such third party content. in the 340B Program subject to the GPO prohibition and listed on the OPA 340B database may not use a GPO for covered outpatient drugs at any point in time. If it is also unable to purchase the product at WAC due to shortages, a hospital may use a GPO (or GPO private label products). Ninety-one percent of these larger hospitals indicate that they use a split billing software solution to manage GPO (inpatient), 340B and WAC purchases. GPO vs. WAC pricing for oncology products: Oncology products may not have a beneficial GPO price, so if these drugs have to be purchased on WAC there might not be that great of difference. This will require routine consult with the pharmacy purchasing staff and the pharmacy drug wholesaler to ensure accurate pricing and purchase unit configuration in all related electronic billing systems. Narrowed patient definition, 340B eligibility or even a changed business relationship with a key group of providers can influence the 340B/non-340B patient mix. (For more information, see the Health Resources Supports eliminating the orphan drug exclusion for certain 340B hospitals. If they are also unable to purchase the product at WAC, entities may use a GPO only if they then immediately notify OPA detailing the covered outpatient drug(s) involved, the manufacturer, and the communication between the parties as to why the product was not available at 340B or WAC, by submitting the HRSA Template Notification Tool: Unavailable 340B Price (DOC - 60 KB). A 340B covered entity purchases and maintains title to the drugs, not a contract pharmacy (see 75 Fed. Perform manual uploads of 340B, GPO, WAC invoices not EDI-capable: Daily: 340B Program manager (or similar role) Charge master (CDM) mapping: Mapping of Charge Data Masters to correct payor billing ratios and remain up-to-date with new CDMs and changes to billing units: Weekly: Purchasing agent, 340B specialist (or similar role) NDC mapping: Mapping of purchased NDC to charge data master … wholesale acquisition cost (WAC) or prices individually negotiated between the hospital and manufacturer. Describes the processes that a covered entity may use to verify 340B pricing, including comparison of prices among different 340B accounts, comparing with WAC and GPO pricing, comparison among wholesalers via the Apexus secure website, contacting Apexus Answers for assistance, verifying the 340B ceiling price directly with the manufacturer, and contacting HRSA, if necessary. It then describes the issues that state Medicaid programs face in coordinating prescription drug benefits with 340B. the 340B Program, ForwardHealth will use calculated 340B ceiling prices to determine a maximum ingredient cost of drugs purchased through the 340B Program, including specialty drugs purchased through the 340B Program, and to comply with the 340B AAC requirements in the rule. (3) With the exception of claim types identified in subsection (4) of this section, all 340B purchased drugs must be billed to the medicaid agency at the 340B actual acquisition cost (340B AAC). 340B participating hospitals subject to the GPO exclusion should review their current operations and policies and procedures to evaluate compliance with the guidance released in … a) Non-GPO (WAC) account is the terminal account used to purchase drugs for non-340B eligible outpatients, to increase inventory due to a new NDC being purchased, when products are not available (e.g., drug shortages) such than an 11-digit NDC match is not available, or when adequate accumulations are lacking. A compliant 340B program contains strong policies and procedures, processes, internal controls and a leadership team that ensures they are being followed. WAC: Wholesaler Acquisition Cost - a published purchase price from a wholesaler with no additional discounts (beyond volume) or contracts applied • 340B: Provides mandated discounts of 30-50% off the WAC cost of the drug • GPO: Group Purchasing Organization, for -profit company with independent purchasers (like hospitals, pharmacies, The concern is that their system may be unable to differentiate inpatient vs. outpatient drugs dispensed from a mixed use pharmacy. Hospitals running a compliant program may see additional cost through purchasing of 340B-excluded drugs at WAC or other non-340B price. Annual Recertification. wholesale distributor provide a report that includes GPO pricing for all 340B drugs purchased. Changes in supply and demand influence market price, and thena price change influences consumer decisions to purchase. Basic microeconomics explains therelationship of supply and demand with the pricing of goods andservices. 340B Compliance: For the C­Suite 340B and Medicaid HRSA Recertification Attestation Language Minimize WAC Exposure GPO Prohibition and Wholesaler Non­GPO Account Load Options DSH Comprehensive 340B Policy and Procedure Manual DSH 340B Compliance Self­Assessment Policy DSH 340B Compliance Self­Assessment Data and Transactions ... Review purchases made on the WAC account on a regular basis to research and analyze for areas of improvement in hospital drug-spend. 340B(a)(4)(L)(iii) • For hospitals that use replenishment-based virtual inventory systems, initial purchases of an NDC must be on a non-340B, non-GPO account, typically at wholesale acquisition cost (WAC), and replenishment under the hospital’s 340B and GPO accounts must be for the same NDC (including package size) as for the drugs dispensed Your Free Source for 340B News and Commentary; Connect … Medi-Span drug pricing data provides a variety of pricing concepts including AWP, WAC and other trusted pricing attributes to help you confidently make decisions. …if a hospital is unable to purchase a covered outpatient drug at the 340B ceiling price, the covered entity should first try to obtain the drug at wholesale acquisition cost (WAC). The Health Resources and Services Administration (HRSA) Dec. 10 released its long-awaited final rule implementing an Affordable Care Act (ACA)…, At A Glance See WAC 182-530-7500 for information on the drug rebate program. FSS = No more than the AAC for the cost of the drug. GPO Prohibition HRSA has stated it won’t waive the group purchasing organization (GPO) prohibition. 340B hospitals that purchase through a GPO must document that they made a good faith effort to purchase the drug at Wholesale Acquisition Cost (WAC). Assess Infrastructure Needs When using WAC as the comparator, 340B-priced drugs are typically discounted about 25% to 50% (Figure), and GPO-priced drugs are typically discounted about 15% to 20%. Opposes efforts to scale back, significantly reduce the benefits of, or expand the regulatory burden of the 340B program, including proposals to dramatically expand reporting requirements on certain 340B hospitals and impose a moratorium on new entrants into the program. PADs submitted under the medical benefit will be reimbursed 100% of ASP. UTMB ensures compliance with Group Purchasing Organization (GPO) prohibition. If it isn’t available at WAC, the hospital can then use a GPO, but it must keep a record of the transaction. Introduction. 0 If it isn’t available at WAC, the hospital can then use a GPO, but it must keep a record of the transaction. These organizations include community health centers, children’s hospitals, hemophilia treatment centers, critical access hospitals (CAHs), sole community hospitals (SCHs), rural referral centers (RRCs), and public and nonprofit disproportionate share hospitals (DSH) that serve low-income and indigent populations.
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