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). 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. 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. endstream
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... (WAC). 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. 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. The program guidance in this policy release will affect certain hospitals participating in 340B that are required to abide by the GPO prohibition. WAC “When I founded Sentry, I was intent upon providing our clients the best BI Platform that could manage all pharmacy/supply chain procurement from any contract, including WAC, GPO or 340B, while ensuring compliance to each of their respective criteria,” said Travis Leonardi, President and CEO of Sentry. purchased through a GPO. Ninety-one percent of these larger hospitals indicate that they use a split billing software solution to manage GPO (inpatient), 340B and WAC purchases. 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. 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%. Drugs purchased outside of 340B program and dispensed by 340B contact pharmacies are not covered. However, if the covered entity is unable to purchase an item at 340B or wholesale acquisition cost (WAC) due to drug shortages, only then may it purchase on GPO. (WAC purchasing would apply for first purchases on all drugs when DSH and items ineligible due to carve out.) Hospitals subject to the GPO prohibition or the Orphan Drug Exclusion should also pay attention to the financial implications of maintaining a compliant 340B program. h��Vmk�0�+�}iي�,ˆ�K���lp-5$v�ݭ����_�d^���ad�tw���;q�F8SDp
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Expected change on the 340B horizon In many cases, the difference between the WAC price and the … 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. WAC: Wholesaler Acquisition Cost - a published purchase price from a wholesaler with no additional discounts ... 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, etc.) Nominal Price = No more than AAC for the drug. Review GPO purchase history to ensure that drugs being purchased on GPO accounts are used for inpatient usage only consist with the GPO Prohibition Statute. These covered entity types may not use a GPO for purchasing covered outpatient drugs; however, HRSA notes that if a hospital is unable to purchase a covered outpatient drug at the 340B price, it should try to obtain the drug at wholesale acquisition cost (WAC). e.g. Introduction. 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. Changes in supply and demand influence market price, and thena price change influences consumer decisions to purchase. It provides covered entities the ability to automatically split and track replenishment orders for eligible medications into multiple accounts (340B, GPO, WAC). 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…. According to HRSA, all initial purchases of covered outpatient drugs by hospitals subject to the GPO prohibition must be made using a wholesale acquisition cost (WAC) account or other non-340B, non-GPO account. Section 1903(a) of the Act provides for federal financial participation (FFP) in state expenditures for these drugs. The Centers for Medicare and Medicaid Services has stated that The program requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. FSS = No more than the AAC for the cost of the drug. Supports eliminating the orphan drug exclusion for certain 340B hospitals. (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 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 ... (GPO) or Wholesale Acquisition Cost (WAC) purchasing requirements inherent in replenishment systems. 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. The 340B program stretches resources for care to indigent and at-risk populations. I. For brand-name drugs, WAC and 340B price values had a similar inflation trend, and both inflation rates were higher than the general inflation rate, except for the years 2009, 2012, and 2014. Basic microeconomics explains therelationship of supply and demand with the pricing of goods andservices. 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. UTMB ensures compliance with Group Purchasing Organization (GPO) prohibition. At A Glance 340B Health is a nonprofit membership organization of more than 1,400 public and private non-profit hospitals and health systems throughout the U.S. that participate in the 340B drug pricing program. The 340B-SMART system optimizes accumulation into 340B, GPO and WAC accounts, expedites purchase orders, tracks fulfillment and provides detailed compliance reports and documentation on … The Health Resources and Services Administration (HRSA) Dec. 10 released its long-awaited final rule implementing an Affordable Care Act (ACA)…, At A Glance 340B policies and procedures must include telehealth and non-traditional health care delivery if utilized at your facility. The 340B Drug Pricing Program is a federal program created in 1992 for section 340B(a)(4) of the Public Health Service Act (PHSA). Hospitals that are subject to the GPO prohibition include disproportionate share hospitals, children’s hospitals, and freestanding cancer hospitals. Outpatient Clinic Sites and Areas of the Hospital where GPO Prohibition Applies OPA advises that a hospital subject to the GPO prohibition may not purchase covered outpatient drugs through a GPO for any of its clinics/departments within the four walls of the hospital (i.e., same … 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. If it isn’t available at WAC, the hospital can then use a GPO, but it must keep a record of the transaction. “To reach this goal we developed a BI platform and Enterprise Data Warehouse. 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. This session reviews the definition and reason for the WAC account and how to recognize good WAC spend vs. unnecessary WAC spend. In a letter to Senator Lamar Alexander and Representative Greg Walden, AHA expresses strong support for the 340B Drug Pricing Program. 340B program) and 340B cost (WAC – GPO) for WAC purchases: Difference between WAC cost and GPO cost (or next best available pricing w/o the 340B program) No, reporting savings is not currently required by HRSA. 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 more information, see the Health Resources Supports efforts to rescind the Centers for Medicare & Medicaid Services’ (CMS) drastic payment cuts for many hospitals in the 340B program and expand drug manufacturer transparency. Capture eligible ingredient medications: Map compound drugs for precise capture of each ingredient.
purchase the drug at the 340B price and the WAC price prior to purchasing the drug through a GPO. Your Free Source for 340B News and Commentary; Connect … …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). 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). 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). 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. For more than 25 years, the 340B Drug Pricing Program has provided financial help to hospitals serving vulnerable communities to manage rising prescription drug costs. If it isn’t available at WAC, the hospital can then use a GPO, but it must keep a record of the transaction. Believes the 340B program is essential to helping providers stretch limited resources to better serve their vulnerable communities. Such situations arise, they say, when drugs or therapeutic products are in short supply, perhaps most notably intravenous immunoglobulin (IVIG). Contract Pharmacy.. Assess Infrastructure Needs In situations where a product is unavailable at 340B or WAC… 340B Compliance Playbook: Internal Audit and Best Practices. The complexity of managing WAC/340B/GPO accounts, and the potential loss of 340B eligibility via violation of the GPO Prohibition makes managing 340B, without split billing software, in one of these three account types, very risky. 86 0 obj
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A compliant 340B program contains strong policies and procedures, processes, internal controls and a leadership team that ensures they are being followed. 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 …