340B Drug Program Key Terms

Transcription

1 340B Drug Program Key Term 340B Covered Entity (CE) Only nonprofit health care organization that have certain Federal deignation or receive funding from pecific Federal program are eligible organization (covered entitie) that can regiter, be enrolled and purchae dicounted drug through the 340B Program. Thee include Federally Qualified Health Center, Ryan White HIV/AIDS Program grantee, and certain type of hopital and pecialized clinic. Eligible covered entitie can be found in the HRSA 340B databae. Note: Covered entitie mut recertify their eligibility every year and provide notification to the Office of Pharmacy Affair if a change in eligibility occur. 340B Covered Outpatient Drug (COD) 340B Drug Pricing Program Drug purchaed through the 340B Program mut be limited to outpatient ue and provided to eligible patient. Generally, the 340B Program cover the following outpatient drug: FDA-approved precription drug; Over-the-counter (OTC) drug written on a precription; Biological product that can be dipened only by a precription (other than vaccine); FDA-approved inulin The 340B Drug Pricing Program require drug manufacturer who opt-into the program, to provide outpatient drug to eligible health care organization/covered entitie at ignificantly reduced price. The intent of thi Federal program i that it enable covered entitie to tretch carce Federal reource a far a poible, reaching more eligible patient and providing more comprehenive ervice. 340B Eligible Patient To be eligible to receive 340B-purchaed drug, patient mut receive health care ervice other than drug from the 340B covered entity. The only exception i patient of State-operated or funded AIDS drug purchaing aitance program. To tay current on patient eligibility, check at 340B ID HRSA provide a unique identification number to identify a 340B-eligible entity on the 340B Databae. Thi unique identifier i ued to purchae 340B drug.

2 340B Prime Vendor Program (PVP The 340B tatue require HRSA to etablih a prime vendor program whoe reponibilitie include ecuring ub-ceiling dicount on outpatient drug a well a other pharmacy-related product and ervice on behalf of participating entitie. The current PVP i managed by Apexu. More information pecific to their ervice can be found at Accountable Care Organization (ACO) An accountable care organization (ACO) i a healthcare organization characterized by a payment and care delivery model that eek to tie provider reimburement to quality metric and reduction in the total cot of care for an aigned population of patient. According to the Center for Medicare and Medicaid Service (CMS), an ACO i an organization of health care provider that agree to be accountable for the quality, cot, and overall care of Medicare beneficiarie who are enrolled in the traditional fee-for-ervice program who are aigned to it. Actual Acquiition Cot (AAC) The total price a pharmacy pay for the product it dipene which may vary according to whether it i purchaed direct veru wholeale, the volume of purchae made, incentive or pecial deal offered and the type of pharmacy. Average Manufacturer Price (AMP) Average manufacturer price (AMP) mean the average price paid by wholealer to manufacturer for drug ditributed to retail pharmacy cla of trade. AMP help in determining Medicaid drug rebate liabilitie. Average Wholeale Price (AWP) In the United State the Average Wholeale Price (AWP) i a precription drug term referring to the average price at which drug are purchaed at the wholeale level. The term wa originally intended to convey real pricing information to third-party payor, including government precription drug program. Bet Price (BP) The lowet price available to any wholealer, retailer, provider, health maintenance organization (HMO), nonprofit entity, or the government. BP exclude price to the Indian Health Service (IHS), Department of Veteran Affair (DVA), Department of Defene (DoD), the Public Health Service (PHS), 340B covered entitie, Federal Supply Schedule (FSS) and State pharmaceutical aitance program, depot price, and nominal pricing. BP include cah dicount, free good that are contingent upon purchae, volume dicount, and rebate. Big 4 The four larget purchaer of pharmaceutical within the Federal government include: Department of Veteran Affair (VA), Department of Defene (DoD), Public Health Service (PHS), and Coat Guard. Thee four Federal agencie have the right to purchae their pharmaceutical from the Federal Supply Schedule (FSS) like every other Federal agency.

3 Comprehenive Hemophilia Treatment Center (HTC) Thi i an example of non-hopital covered entitie that participate in the 340B program. HTC are pecialized treatment center that receive funding from the Center for Dieae Control and Prevention to provide complete hemophilia ervice through multidiciplinary team that focu on preventing complication of the dieae. Contract Pharmacy An arrangement through which a covered entity may contract with an outide pharmacy to provide comprehenive pharmacy ervice utilizing medication purchaed under 340B. Critical Acce Hopital (CAH) I a deignated limited-ervice hopital located in a rural area. Medicare pay CAH for inpatient and outpatient ervice on the bai of their current Medicare-allowable cot or cot-baed reimburement. Specific 340B eligibility criteria mut be met to participate in the program, including accepting the orphan drug prohibition. Dipening Fee The dipening fee repreent the charge for the profeional ervice provided by the pharmacit when dipening a precription (including overhead expene and profit). Medicaid and mot direct pay inured precription program ue dipening fee to etablih pharmacy payment for precription. Dipening fee do not include any payment for the drug being dipened. Under the new Medicare Law, pharmacy dipening fee paid by Medicare under Part B are expected to grow depending on the complexity of the drug adminitration ervice involved. Diproportionate Share Hopital (DSH) A hopital with a diproportionately large hare of low-income patient. Under Medicaid, State augment payment to thee hopital. Medicare inpatient hopital payment are alo adjuted for thi added burden. Federal Ceiling Price (FCP): The maximum price manufacturer can charge for FSS-lited brand name drug to the Big 4: Veteran Affair, Department of Defene, Public Health Service, and the Coat Guard. Group Purchaing Organization (GPO) A healthcare group purchaing organization (GPO) ait in promoting quality healthcare relief and ait divere provider in effectively managing expene. A GPO aggregate the purchaing volume of it member for variou good and ervice and develop contract with upplier through which member may buy at group price and term if they chooe to. GPO typically provide contracted dicount on medical upplie, nutrition, pharmacy and laboratory.

4 GPO Prohibition The GPO prohibition i a tatutory requirement that applie to diproportionate hare hopital (DSH), children hopital (PED), and free-tanding cancer hopital (CAN). Upon regitration for the 340B Program, thee covered entity type mut acknowledge that they undertand the retriction with uing a GPO for covered outpatient drug, and during the 340B annual recertification proce, they mut attet to compliance with the GPO prohibition. Health Inurance Portability and Accountability Act (HIPAA) HIPAA (Health Inurance Portability and Accountability Act of 1996) i United State legilation that provide data privacy and ecurity proviion for afeguarding medical information. Health Reource and Service Adminitration (HRSA) HRSA i an agency within the Department of Health and Human Service. It miion i to improve and expand acce to quality health care for all. HRSA aure the availability of quality health care to low income, uninured, iolated, vulnerable and pecial need population and meet their unique health care need. HRSA i organized into everal Office and five Bureau (the Healthcare Sytem Bureau, the Bureau of Primary Health Care, the Bureau of Health Profeion, the HIV/AIDS Bureau, and the Maternal and Child Health Bureau). HRSA 340B Databae Once a covered equity i enrolled in the 340B Program and included in the covered entitie databae, it i the covered entity reponibility to inform wholealer and manufacturer of enrollment in order to purchae drug at the 340B dicounted price. In-houe Pharmacy An in-houe Pharmacy, i where the covered entity own drug, pharmacy and licene; purchae drug; i fically reponible for the pharmacy; and pay pharmacy taff. Manufacturer Manufacturer who participate in Medicaid are required under the 340B tatute to enter into an agreement with the Secretary under which the manufacturer mut agree to charge a price that will not exceed the amount determined under tatute (ceiling price) when elling covered outpatient drug to 340B covered entitie. Thi agreement, known a the Pharmaceutical Pricing Agreement (PPA), mut be igned by a manufacturer a a condition for participating in Medicaid. Signing the PPA doe not prohibit a manufacturer from charging a price for a covered outpatient drug that i lower than the 340B ceiling price. A manufacturer may not condition the offer of 340B dicount upon a covered entity aurance of compliance with ection 340B Program requirement.

5 Medicaid Carve-in The term carve-in i ued to decribe a covered entity deciion to ue 340B dicounted drug for it Medicaid patient that meet the 340B program patient definition tet. Medicaid Carve-out The term carve-out i ued to decribe a covered entity deciion not to ue 340B dicounted drug for any of it Medicaid patient. Covered entitie that chooe to carve out fee-for-ervice Medicaid patient mut inform OPA of thi deciion. A covered entity that chooe the carveout option mut purchae all covered outpatient drug ubject to Medicaid rebate outide the 340B program. Medicaid Excluion File The Office of Pharmacy Affair (OPA) created and maintain a databae to enure that manufacturer do not pay a rebate and a 340B dicount on the ame drug given to fee-for-ervice Medicaid patient. When a covered entity enroll in the 340B program, they mut inform OPA how they will adminiter or dipene drug purchaed at 340B price to it fee-for-ervice Medicaid beneficiarie Mixed Ue Setting Thi refer to a hopital area that erve both outpatient and inpatient. Example of mixed-ue etting include emergency room, infuion center, urgery center and cardiac catheterization lab. Office of Pharmacy Affair (OPA) The Office of Pharmacy Affair (OPA) i the ection within the Health Reource and Service Adminitration (HRSA) that adminiter the 340B Drug Pricing Program. Outpatient Clinic In order to purchae, adminiter or dipene 340B drug, a hopital outpatient clinic mut be an integral part of a 340B eligible hopital, have patient that meet the 340B patient definition guideline, be lited on the HRSA 340B Databae a eligible, ubmit to HRSA the mot recently filed cot report to verify clinic eligibility and be deignated a a reimburable clinic above line 96 on Workheet A of the cot report. Pharmacy Benefit Manager (PBM) An organization that provide adminitrative ervice in proceing and analyzing precription claim for pharmacy benefit and coverage program. PBM ervice can include contracting with a network of pharmacie; etablihing payment level for provider pharmacie; negotiating rebate arrangement; etting and managing formularie, preferred drug lit, and prior authorization program; maintaining patient compliance program; performing drug utilization review; and operating dieae management program. Many PBM alo operate mail order pharmacie or have arrangement to include precription availability through mail order pharmacie. PBM are expected to play a key role in managing pharmacy benefit plan in the Medicare drug program.

6 Recertification A a participant in the 340B program, entitie mut review and update their information maintained in the 340B Databae on an annual bai. Part of thi recertification include tatement related to compliance. Termination Date The date in the OPA databae on which a provider participation in the 340B program i terminated. Provider/entitie can no longer purchae 340B drug once a termination date ha been etablihed. OPA update termination date on a quarterly bai. Wholeale Acquiition Cot (WAC) Thi refer to the price paid by a wholealer for drug purchaed from the wholealer upplier, typically the manufacturer of the drug. On financial tatement, the total of thee amount equal the wholealer cot of good old. Dicloed in publihed compendia, lited WAC amount may not reflect all available dicount. A few tate ue markup of WAC in etting Medicaid reimburement. Wholealer A wholealer i an enterprie that purchae drug from a upplier, typically through a manufacturer, for the purpoe of ditributing the drug to pharmacie, hopital, phyician and other purchaer that dipene and/or adminiter drug to patient. Wellpartner: Who We Are A your trategic partner, we re committed to providing a complete 340B ervice uite that create value, and get it right. Wellpartner i the authority in 340B program management offering innovative technology and the broadet et of 340B ervice. By taying ahead of indutry change, Wellpartner provide a eamle, eay-to-ue olution for covered entitie currently or conidering participating in the 340B Drug Program. Our experience i your advantage. Our procee are finely-tuned toward achieving the bet reult for our cutomer, whether it i contracting, providing our fully accredited pecialty pharmacy ervice, enuring program compliance, aligning pecialty network acce, maximizing claim capture, or driving program value. Wellpartner i focued on excelling at thee tak, ince we hare the ame goal a our covered entity cutomer to preerve reource, in order to erve thoe who need it mot. Wellpartner When it matter mot Copyright Wellpartner All right reerved. Thi material or any portion thereof may not be reproduced or ued in any manner whatoever without the expre written permiion of the publiher.