340B Advocacy Continues – DSH Adjustments. WAC. A hospital subject to the GPO prohibition may not purchas… . Can our hospital, subject to the GPO prohibition, voluntarily opt out of participating in 340B purchasing for some of its clinics, and use a GPO in those clinics? Our mixed-use area has only inpatients or 340B eligible outpatients. If you’re new, plan ahead and have your split billing software ready to roll on day one! A 340B covered entity subject to the GPO prohibition should purchase using a non-GPO account and only replenish with 340B drugs once 340B patient eligibility is confirmed and can be Click on this linkto see the entire text of the February 7, 2013 Program Notice. 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When I first understood this rule, I was flustered. These hospitals must use a non-GPO/WAC account for purchases for outpatients who are ineligible for 340B. Yes, unless they have a method that they can use that they are confident will demonstrate appropriate use of GPO pricing for inpatients (rare). Then the CE has to prove compliance before they can be reapproved for 340B purchases. The 2010 amendment to the 340B statute added rural referral centers and critical access, sole community, and free-standing cancer hospitals to the list of 340B-eligible entity types. The only real solution that I can see for my 400 bed hospital, The Triple Split!!! 340B prescriptions must originate from a healthcare service provided at a registered facility. However, HRSA will not require hospitals to contact manufacturers or report purchases from GPOs through the Apexus form during the public health emergency. So. 2011 To adhere to this requirement, a covered entity is responsible for the tracking and accountability of its 340B drugs to ensure that diversion has not occurred. covered entity compliance with the GPO Prohibition. Section 340B(a)(5)(A)(i) of the Public Health Service Act prohibits duplicate discounts—that is, a covered entity purchasing a drug at a 340B price and a manufacturer paying a Medicaid rebate on that same drug. These four criteria are critical to allowing use of GPO pricing in place of WAC for these clinics. No - this is not about the Volstead Act, which was enacted to enforce the 18th amendment (more commonly known as Prohibition). If the HTC is an off-site outpatient facility of a hospital subject to the GPO prohibition, but is not registered for the 340B Program (as a child site of the hospital) and meets all of the following, if may use a GPO for covered outpatient drugs: 1. If you decide that’s just not going to fly, HRSA does allow for a CE to re-class 340B drugs, IF the CE first notifies manufacturers, and ensures all processes are transparent and auditable. Web Design by Speak Creative. Access 340B: Vol. How do they resolve it. created by the GPO Prohibition and demonstrate HRSA's flexibility in interpreting the GPO Prohibition in ways that benefit both patients and providers. A few eager readers thought this meant HRSA was ‘releasing’ the GPO prohibition. Because hospitals are making changes to care delivery, including increasing the number of inpatient beds and shifting non-COVID-19 patients to outpatient setting, the crisis may temporarily change payor mix and reduce DSH percentage, potentially threatening 340B eligibility. No, according to HRSA. Posted: Comprehensive Pharmacy Services, Inc. All Rights Reserved. The new policy should provide 340B hospitals with greater flexibility in sourcing drugs during the public health emergency, but it is not a wholesale removal of the GPO prohibition. There are specific situations where GPO instead of WAC is appropriate for outpatient use. 2013-1, Statutory Prohibition on Group Purchasing Organization Participation states, “Organizations that are not part of the 340B covered entity are not subject to the GPO prohibition; however, the 340B covered entity is still prohibited from having organizations purchase covered outpatient drugs through a GPO on its behalf or otherwise receive … HRSA is increasing scrutiny of the GPO policy, leading to more audits of CE. May also address GPO prohibition and/or orphan drug adherence, dependent on entity type (GPO Prohibition and Orphan Drug Exclusion) Can be used in virtual and physical inventory settings, and should incorporate all pharmacies – in-house retail, mixed use, contract pharmacies, etc. He said Magic Valley previously participated in the 340B program as a disproportionate share hospital (DSH) but had to drop out when the hospital no longer met the criteria for that designation. 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%. Which means if you’re scheduled to ‘go-live’ on April 1st, your last GPO purchase for any OP area should be no later than March 31st. Sources say lawmakers feared that small rural hospitals, which rely heavily on GPOs, would have shunned 340B if the prohibition remained in place. Under normal circumstances, 340B hospitals are completely prohibited from purchasing drugs through a group purchasing organization, with very limited exceptions. You just need to know how the GPO Prohibition rules work to be certain you use it appropriately. Some have even suggested that any violations of the Prohibition, whether by error or intent, invalidates all 340B-purchases during the time of the violation (s). Cahoon said the hospital can still get a "pretty good discount" on orphan-designated drugs from its group purchasing organization (GPO), but the cost will be higher than the 340B price. An older and well managed 340B CE was supplying non-registered off-site clinics with GPO pricing, but did not meet all the required criteria, creating a prohibition violation issue. 340B GPO Prohibition There is a statutory prohibition against obtaining covered outpatient drugs through a group purchasing organization (GPO) or other group purchasing arrangement for disproportionate share hospitals (DSH), children’s … Section 340B of the PHSA prohibits diversion – the resale or other transfer of a 340B drug to ineligible patients. The GPO prohibition only applies to 340B-enrolled disproportionate share hospitals, children's hospitals, and free-standing cancer hospitals. One CAH buyer thought it meant they could buy 340B or GPO for inpatients as well as outpatients. In an audit, a Parent organization owned a clinic that met three of the four criteria. MacroHelix Irving, TX (Sept 2017-present) Product Support Analyst • Assisted with a diversity of support requests involving 340B split-billing software; topics ranged from 340B Accumulation, 340B Qualification, Charge Code/NDC Crosswalk, GPO Prohibition, Orphan Drug Exclusions, Medicaid-related Exclusions, EDI-based Purchasing, HL7/ADT Data Just to be clear, and For the Record:  The GPO Prohibition applies to Disproportionate Share Hospitals, Children’s Hospitals, and Free-Standing Cancer Hospitals. 340B Patient Definition The 340B statute prohibits covered entities from transferring or reselling a 340B-acquired drug to an individual who is not a patient of the covered entity. A lot of new CE’s don’t have any TPA or split billing software in place when they ‘go-live’ with 340B. All others may choose GPO or 340B, whichever is most cost favorable, for outpatient use. Two questions prompted this post, which pertains to DSH, Children’s Hospitals, and Free Standing Cancer Hospitals. The GPO prohibition rule specifically states: However, certain off-site outpatient facilities of the hospital may use a GPO for covered outpatient drugs if those off-site outpatient facilities meet all of the following criteria: OK, so what does this mean for you, the DSH, Children’s Hospital, or Free Standing Cancer Center manager? He said Magic Valley previously participated in the 340B program as a disproportionate share hospital (DSH) but had to drop out when the hospital no longer met the criteria for that designation. HRSA, PVP and Drug Firms Were Opposed. Purpose: The purpose of this tool is to share strategies to help minimize unnecessary WAC exposure in 340B hospitals subject to the GPO Prohibition (DSH, PEDs CAN). • Group Purchasing Organization (GPO) Prohibition – Applicable hospitals must agree not to purchase any covered outpatient drugs for outpatient use through a GPO. Drug ordering process is efficient and automated with wholesalers and distributors. Does this include inpatient usage? Existing HRSA guidance addresses who is a 340B-eligible patient. 340B hospitals subject to the group purchasing organization (GPO) prohibition typically have 3 separate accounts on which to purchase medications: 340B, GPO, and WAC. If a covered entity violates the GPO prohibition, it will be removed from the 340B Program as it will no longer be eligible for participation. Section 340B (a) (5) (B) of the Public Health Service Act prohibits covered entities from reselling or otherwise transferring a 340B covered outpatient drug to a person who is not a patient of the entity. Reducing DSH percentage based on time-limited COVID-19 emergency measures would unfairly penalize hospitals by threatening access to the 340B program when hospitals can least afford it. Purchasing compliance (GPO prohibition) Per 340B Program rules, DSHs, PEDs, and CANs participating in the 340B Program cannot obtain covered outpatient drugs through a group purchasing organization (GPO) or other group purchasing arrangement. Obtain purchase detail for all 340B accounts When a brand new CE goes live – what do they do if they don’t have split billing software in place – can they continue using GPO if they don’t buy 340B until the split billing software is in place? Before September 2017, these covered entity types had a parent-child relationship. Prescriptions to patients seen in a physician’s private practice are not eligible. Three months later the split billing software is implemented. Statement: Vaccines Save Lives: What Is Driving Preventable Disease Outbreaks? Cahoon said the hospital can still get a "pretty good discount" on orphan-designated drugs from its group purchasing organization (GPO), but the cost will be higher than the 340B price. Prescriptions to patients seen in a physician’s private practice are not eligible. By Access 340B Editorial Staff Access 340B: Vol. 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). ” Now it is time to get to work. Following the recent release of new Program Notices regarding the Group Purchase Organization (GPO) prohibition and Medicaid Exclusion File, 340B participating entities should review their 340B program policies and procedures to ensure compliance with new and clarified guidance regarding GPO purchasing and dispensing of 340B drugs to Medicaid patients. At that time, all participating 340B hospitals must attest that they are in compliance with all 340B program requirements, including compliance with the GPO prohibition as detailed in Policy Release 2013-1 (PDF – 227 KB). We are the leading advocate and resource for those hospitals who serve their communities through participation in 340B. the GPO prohibition. Hospitals subject to the GPO prohibition and their off-site outpatient clinic sites that are registered on the OPA 340B database as participating in the 340B Program are subject to the GPO prohibition and cannot purchase any covered outpatient drugs through a GPO or other group purchasing arrangement. Not warned, removed. Your Free Source for 340B News and Commentary; Connect … If you have 340B-related questions or concerns, please email Jillanne Schulte Wall at [email protected], Joint Pharmacy Comments on the Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine, ASHP and State Affiliates Letter to Congress Requesting Increased Funding for Medicaid, ASHP Comments on Center for Medicare and Medicaid Innovation, ASHP Comments on Proposed Changes by CMS to Drug Utilization Review and Quality Measures under Medicare Part D, CMS Releases a future LCD for Pharmacogenomics Testing, ASHP Issue Brief: COVID-19 Diagnostic Testing and Immunization, ASHP Issue Brief: The Bipartisan Budget Act of 2018 Analysis of Health Provisions, ASHP Responds to Surgeon General’s Call to Action: Community Health and Prosperity. Under normal circumstances, 340B eligibility requirements prohibit certain hospitals from using a GPO to purchase covered outpatient drugs. In fact, HRSA prohibits loading Private Label drugs in the 340B accounts as well as the WAC account (Link). Under the 340B program, disproportionate share hospitals (DSH), children’s hospitals, and free-standing cancer hospitals that are registered on the Office of Pharmacy Affairs (OPA) database as participating in the program, are subject to a Group Purchasing Organization (GPO) prohibition and cannot purchase any outpatient 340B covered drugs through a GPO or a group purchasing arrangement. Tags: This amendment included the Orphan Drug Exclusion, which specifies that orphan drugs are not considered covered outpatient drugs for those entity types added. The new policy should provide 340B hospitals with greater flexibility in sourcing drugs during the public health emergency, but it is not a wholesale removal of the GPO prohibition. • Group Purchasing Organization (GPO) Prohibition – Applicable hospitals must agree not to purchase any covered outpatient drugs for outpatient use through a GPO. Hospitals subject to the 340B Drug Pricing Program (340B Program) Group Purchasing Organization (GPO) prohibition now have an additional four months, until August 7, 2013, to comply with 340B Program guidance issued February 7, 2013, regarding GPO use and inventory replenishment models. 2012-2 Clarification of Covered Entity Eligibility within Accountable Care Organizations (PDF - 37 KB) 05/23/2012 2012-1.1 Clarification of HRSA Audits of 340B Covered Entities (PDF - 36 KB) 02/08/2013 replaces 2012-1. By Nelson Pratt, Access 340B Senior Editor. Specifically, we are requesting that CMS cease disproportionate share hospital (DSH) percentage adjustments for 340B hospitals for the duration of the declared public health emergency. By Nelson Pratt, Access 340B Senior Editor. 2012. Not quite as exciting as Prohibition, unless you’re the pharmacy manager who violates it. But this is about the 340B GPO Prohibition. Compliance, Is located at a different physical address than the parent; 2. Covered entities participating in the 340B Program are responsible for requesting 340B pricing at the time of the original purchase.”. For hospitals subject to the GPO Prohibition or entity-owned retail pharmacies subject to the GPO Prohibition: Step 1: Calculate 340B savings by reviewing the purchase history report from the 340B account and identify the unit price for each NDC when purchasing those NDCs at 340B price and GPO price. Further, hospitals should clearly document inability to obtain a drug at WAC and retain records of purchases, because HRSA will have the authority to audit GPO purchasing practices when the COVID-19 crisis subsides. Associated site “ Associated site”is used by HRSA’s 340B OPAIS to indicate sites that share grant numbers (CHCs) or a designation number (federally qualified health center look-alikes). 2012-2 Clarification of Covered Entity Eligibility within Accountable Care Organizations (PDF - 37 KB) 05/23/2012 2012-1.1 Clarification of HRSA Audits of 340B Covered Entities (PDF - 36 KB) 02/08/2013 replaces 2012-1. Prescribing provider either must be employed by the CE or an independent contractor such that the entity may bill for services on behalf of the provider. 340B savings will be equal to the GPO total minus the 340B total. Resolution: The Apexus Answers specialist responded that a GPO could not be used for covered outpatient drugs. New Purchasing Flexibility, But Strings Are Attached. By August 7, 2013, affected covered entities must ensure their drug replenishment practices comply with HRSA policy, or risk being removed from the program. So now they go retro-active and re-class drugs to WAC, 340B and GPO, right? Woodrow Wilson vetoed the Volstead act, but both Congress and the senate over-rode his veto. A COVID-19 340B Update: OPA Updates Its GPO Prohibition Guidance and Other Outstanding 340B Program Issues Hall Render Killian Heath & Lyman PC USA March 25 … Note that HRSA categorizes Wholesaler Private Label Drugs as GPO, and as such, exclude them from any outpatient use. The reform law, however, did lift the GPO prohibition for the new categories of rural hospitals that have been allowed to join the 340B program. This is known as the Group Purchasing Organization (GPO) Prohibition. If the HTC is an off-site outpatient facility of a hospital subject to the GPO prohibition, but is not registered for the 340B Program (as a child site of the hospital) and meets all of the following, if may use a GPO for covered outpatient drugs: 1. A lot of them figure that they just won’t start buying 340B until they get the software in place, and that makes it OK for staying with GPO purchases. Each hospital type is subject to specific requirements according to the 340B program statute. Some have even suggested that any violations of the Prohibition, whether by error or intent, invalidates all 340B-purchases during the time of the violation (s). The sole criteria they did not meet was number three – use a separate wholesaler account. You must ensure that 340B entities are not on your GPO Roster. Hospitals subject include : … 340B Patient Definition The 340B statute prohibits covered entities from transferring or reselling a 340B-acquired drug to an individual who is not a patient of the covered entity. It can be done, and it is not that difficult, but we’re now seeing Wholesalers ask the CE to gain permission from the manufacturer before they even attempt a ‘credit/rebill’ for 340B. ASHP will continue to advocate aggressively to safeguard the 340B program and to seek program flexibility during COVID-19 response. Hospitals subject to the 340B Drug Pricing Program (340B Program) Group Purchasing Organization (GPO) prohibition now have an additional four months, until August 7, 2013, to comply with 340B Program guidance issued February 7, 2013, regarding GPO use and inventory replenishment models. Remember that little disclaimer about Outpatients. On March 23, 2020, the Health Resources & Services Administration (“HRSA”) launched a new webpage providing COVID-19 information related to the 340B drug discount program (“340B Program”), including responses to frequently asked questions related to COVID … Obtain purchase detail for all 340B accounts We do not have any 340B ineligible patients. Tool Requisition When new tools or equipment are required, personnel should fill out a requisition order, which should include an item number, a description of the desired tool, the cost of the tool, the size of the tool and the weight of the tool. No 340B, no GPO. Notice the four (4) criteria above – NOT located at the same address as the Parent, NOT registered on the OPA database, use a SEPARATE wholesaler account, and maintain records. 340B, Section 340B of the PHSA prohibits diversion – the resale or other transfer of a 340B drug to ineligible patients. For all other violations of the GPO prohibition, if HRSA determines that a violation has occurred, HRSA will apply the sanctions as described in the GPO policy release. Effective immediately, the Health Resources Services Administration (HRSA) Office of Pharmacy Affairs (OPA) has loosened the 340B group purchasing organization (GPO) prohibition for the duration of the COVID-19 public health emergency. Not. Temporarily Waives the Group Purchasing Organization (GPO) Prohibition. As a teaser: This blog will explain when and where you can use GPO in place of WAC for outpatients, and remain `100% compliant with 340B rules and regulations. Prohibition, Following the recent release of new Program Notices regarding the Group Purchase Organization (GPO) prohibition and Medicaid Exclusion File, 340B participating entities should review their 340B program policies and procedures to ensure compliance with new and clarified guidance regarding GPO purchasing and dispensing of 340B drugs to Medicaid patients. 42), ASHP and National Center for Frontier Communities Letter of Support for New Mexico H.B. Purpose:The purpose of this tool is to provide an example 340B Program policy and procedure (P&P) manual that exhibits high program integrity to assist participating GPO Prohibition Hospital (DSH/PED/CAN) leaders in the preparation of their own unique, site-specific P&P manual that supports placing compliant policy into practice. Friday, June 5, 2020, Ambulatory & Specialty Pharmacy Solutions. 2013-1 Statutory Prohibition on Group Purchasing Organization Participation (PDF - 227 KB) 02/07/2013. 42, Letter of Support for West Virginia Senate Bill 787, ASHP Statement on the Medicare Program Part D, ASHP Offers Input on Prescription Drug-Use Software, ASHP and State Affiliates Send Letter to USPS Inspector General Regarding Medication Delivery, Issue Brief: HHS Upends FDA’s Oversight of Laboratory Developed Tests (LDTs), United States Postal Service (USPS) Slowdowns and Mail-Order Medication Delivery Delays, Breaking News: COVID-19 Vaccine Distribution Plan Released, Administration Announces Health Plan, Finalizes Drug Importation, and Takes Action on Insulin and Injectable Epinephrine, ASHP Submits Comments to CMS on Electronic Prescribing of Controlled Substances, HHS Authorizes Pharmacy Technician and Pharmacy Intern Administration of COVID-19 Tests and Vaccines, ASHP Submits Comments to FDA on COVID-19 Vaccine Principles, CMS Releases Payment Information for COVID-19 Vaccines and Treatments, ASHP Comments on HHS’s Request for Information on Vaccines National Strategic Plan. When placing a replenishment order, GPO Prohibition hospitals may be able to choose to first use 340B account accumulations, then GPO accumulations, with any remaining non-accumulated drugs being purchased from the non-GPO/WAC account. Under the 340B program, disproportionate share hospitals (DSH), children’s hospitals, and free-standing cancer hospitals that are registered on the Office of Pharmacy Affairs (OPA) database as participating in the program, are subject to a Group Purchasing Organization (GPO) prohibition and cannot purchase any outpatient 340B covered drugs through a GPO or a group purchasing arrangement. Our mixed-use area has only inpatients or 340B eligible outpatients. 3 Issue 11. We do not have any 340B ineligible patients. (paraphrased, of course). Duplicate Discounts, Contract Pharmacy, Mega Guidance... 340B prescriptions must originate from a healthcare service provided at a registered facility. © Copyright 2000-2018-2019. The GPO prohibition is specific, and HRSA even states they expect CE’s to stop buyinmg GPO for outpatient before they go live with 340B. The 2013 HRSA 340B Drug Pricing Program Notice Release No. 3 Issue 8 Less than two months remain until HRSA’s (extended) deadline for compliance with the GPO Prohibition for 340B covered entities. 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 (same physical address) under any circumstance. The new policy should provide 340B hospitals with greater flexibility in sourcing drugs during the public health emergency, but it is not a wholesale removal of the GPO prohibition. Please note that this information in this blog pertains to Covered Entities subject to the GPO prohibition. To adhere to this requirement, a covered entity is responsible for the tracking and accountability of its 340B drugs to ensure that diversion has not occurred. Here discuss 340B GPO Prohibition. A GPO is an organization that utilizes the collective buying power of the members of the organization to negotiate discounts from vendors; therefore, a GPO price is a negotiated price whereas the 340B price is a calculated price, based on a formula specified in the 340B law. What happens if a Covered Entity violates the GPO prohibition? GPO, This applies to Disproportionate Share Hospitals (DSH), Children’s Hospitals (PED) and Free Standing Cancer Hospitals (CAN), who are all subject to the GPO Prohibition. In our June 19 issue, we shared observations from a few Access 340B readers about the expected financial and administrative impact full compliance with the GPO Prohibition would have on their hospitals. 340B hospitals subject to the group purchasing organization (GPO) prohibition typically have 3 separate accounts on which to purchase medications: 340B, GPO, and WAC. HRSA is increasing scrutiny of the GPO policy, leading to more audits of CE. The GPO prohibition only applies to 340B-enrolled disproportionate share hospitals, children's hospitals, and free-standing cancer hospitals. They used their local pharmacy’s GPO account to supply the clinic, and this violated the GPO prohibition. Not all off-site clinics show up on the Medicaid Cost Report and as such do not qualify as 340B eligible child sites. We also had a number of DSH facilities asked for clarification as to when Group Purchasing Organization (GPO) purchases can be made for outpatients. If a covered entity violates GPO prohibition, it … White Papers, Covered entities must have mechanisms in place to prevent duplicate discounts. This brings us back to the Brand New CE:  the brand new CE must purchase all drugs on WAC until their split billing software is in place. The 2013 HRSA 340B Drug Pricing Program Notice Release No. . Statute: GPO Prohibition • A condition of 340B eligibility for: – Disproportionate Share – Children's Hospitals – Free Standing Cancer Hospitals • 340B Statute states the hospital: – “…does not obtain covered outpatient drugs through a group purchasing organization or … The actual wording of the GPO Prohibition is: Hospitals and their off-site outpatient clinic sites that are registered on the OPA 340B database as participating in the 340B Program are subject to the GPO prohibition and cannot purchase any covered outpatient drugs … HRSA, PVP and Drug Firms Were Opposed. Access 340B: Vol. OPA expects that hospitals will have policies and procedures in place to address the use of GPOs, even during the public health emergency. In short, the statute states these three types of facilities can use GPO for inpatients and non-covered outpatient drugs, but otherwise must use 340B or WAC exclusively for outpatients. Sentry Data Systems, Inc. is reaching out to the 340B community to address concerns regarding Covered Entities (CEs) meeting the requirements stated in the Health Resources and Services Administration’s (HRSA’s) recently released GPO Prohibition Policy guidance. OK, so they buy everything on WAC. This means that when a hospital subject to this provision acquires an outpatient covered drug that does not qualify for 340B, it must be purchased at WAC pricing. 340B Informed . Sentry Releases FAQs on GPO Prohibition Policy. If it isn’t available at WAC, the hospital can then use a GPO, but it must keep a record of the transaction. 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. Not quite as exciting, unless you’re the pharmacy manager who violates it.
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