XXXXXXXFUNDAMENTALS An Essential Guide for Health System Executive Management

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "XXXXXXXFUNDAMENTALS An Essential Guide for Health System Executive Management"

Transcription

1 340B XXXXXXXFUNDAMENTALS An Essential Guide for Health System Executive Management

2

3 Table of Contents 340B Fundamentals for Health System Executive Management...1 What is the 340B Program?... 2 Participation Requirements... 3 Hospital Eligibility...4 Key Program Requirements Contract Pharmacy Arrangements... 7 Key Considerations for Executive Leadership...8 Wellpartner and the tri-heart logo are trademarks of Wellpartner, Inc by Wellpartner, Inc. This document is intended to inform the reader about the federal 340B Program. Wellpartner has taken reasonable care in the description and presentation of material contained in this paper. However, it is not intended, nor should it be used as a comprehensive information source. This paper is provided with no warranty, expressed or implied regarding the suitability of the information contained herein for any specific purpose and any such warranties are hereby disclaimed.

4 340B Fundamentals for Health System Executive Management Introduction This brief provides a detailed overview of the 340B Drug Pricing Program. It is designed to give the executive management of qualified safety net health care provider organizations a firm grasp on the program s construct, benefits and requirements. An investment in understanding program basics and ensuring integrity helps protect the opportunities afforded by this important federal discount program. Key Takeaways The 340B Program can provide great savings, but the rules of participation are complex. Discounts on qualified prescription drugs can be as much as 50% below the market price. However, capturing these savings requires that Covered Entities adhere to strict compliance guidelines. Organizations that do not meet these regulations can be required to repay 340B savings to manufacturers and may be dropped from the program altogether. Proper implementation and operation is not just the responsibility of the pharmacy department. Because of the complexity of the 340B program, executive management should coordinate the efforts of several departments in addition to pharmacy including, but not necessarily limited to: finance, purchasing, billing, patient services, and compliance. The 340B Program faces unprecedented scrutiny. The 340B Program was created through statute in 1992, but is experiencing heightened attention from HRSA and pharmaceutical manufacturers today due to health care reform and program growth. This increased scrutiny forces compliance efforts to the forefront. Covered Entities must prevent diversion of 340B prescriptions to ineligible patients. Best practice is to have a clear patient definition incorporated into the organization s 340B policies and procedures documentation. 1 Wellpartner 340B FUNDAMENTALS

5 What is the 340B Program? The 340B Drug Pricing Program is federally administered and allows certain qualified safety net health care provider organizations (referred to as covered entities in the regulation) to purchase outpatient medications at or below a defined discount price, known as the 340B ceiling price. Congress intention is to assist covered entities in stretching their limited federal funds to better serve the pharmaceutical needs of uninsured patients and other vulnerable populations. The 340B Discount The discount available through the 340B ceiling price is determined based on a statutorily defined formula. In general, the discount is equal to the average price reduced by a minimum rebate percentage, which varies by drug type. In addition to the minimum rebate percentage, manufacturers must provide additional discounts on brand name drugs given certain predefined marketplace dynamics. A full review of the 340B discount formula and methodology can be found at According to HRSA estimates, the 340B ceiling price is an estimated 20 to 50 percent lower than typical retail cost. Protection from Price Increases A unique aspect of the 340B Program is the protection against price increase for brand name drugs. When the average price of a brand name drug increases the 340B discount increases. As a result, the 340B price can decrease as commercial prices rise. 340B program administration The Health Resources and Services Administration s Office of Pharmacy Affairs (HRSA/OPA) administers the 340B Program. OPA contracts with an organization called Apexus to serve as the program s single preferred purchasing agent that specializes in price negotiation and drug distribution responsibilities on behalf of participating entities. An Essential Guide 2

6 Participation Requirements The full range of safety net health care providers includes everything from small community health clinics to multi-site community hospitals and health systems. Regardless of organization size or type, participating 340b covered entities must ensure that they: Meet eligibility thresholds and maintain the accuracy of registration Only provide 340B drugs to eligible patients Develop systems for preventing duplicate discounts with the Medicaid Drug Rebate program Institute self-auditing and audit preparedness Organization Eligibility Requirements In general, 340B eligible entities can be divided into two categories: grantees and hospitals. Grantees must meet the conditions of the various Health and Human Services (HHS) programs under which they are funded. Example grantees are community health centers, hemophilia treatment centers, and family planning clinics. For hospitals, there are four main eligibility requirements: 1. Hospital Classification: The hospital must be either: a) owned or operated by a unit of the State or local government, b) a public or private non-profit corporation which is formally granted governmental powers by a unit of the State or local government or c) a public or private non-profit corporation which has a contract to provide health care services to low income individuals not eligible for Medicare or Medicaid. 2. Disproportionate Share Adjustment Percentage: For hospitals, eligibility for 340B is not based on the traditional benchmarks of other public insurance programs, like poverty level, demographics, or health status. Instead, eligibility is based on meeting a threshold DSH percentage, which varies based on the hospital type. 3. GPO Prohibition: Certain hospitals types cannot obtain covered outpatient drugs through a group purchasing organization. The GPO prohibition applies specifically to DSH, children s and free-standing cancer hospitals. 4. Orphan Drug Exclusion: Certain hospital types cannot purchase orphan drugs using 340B when those drugs are used for their orphan indications. The orphan drug exclusion applies specifically to critical access hospitals, sole community hospitals, rural referral centers and free-standing cancer hospitals. 3 Wellpartner 340B FUNDAMENTALS

7 Hospital Eligibility Eligibility Requirements for 340B Hospitals Hospital Type DHS Threshold GPO Prohibition Disproportionate Share Hospitals (DSH) Orphan Drug Exclusion 11.75% YES NO Children s Hospital (PED) 11.75% YES NO Critical ACcess Hospital (CAH) N/A NO YES Free Standing Cancer Hospital (CAN) 11.75% YES YES Rural Referral Center (RRC) 8% NO Sole Community Hospital (SCH) 8% NO YES Exhibit 1 Hospitals and larger Federally Qualified Health Centers (FQHC) may also elect to register certain outpatient facilities as child sites of the main facility. To be eligible, the outpatient child facility must be listed as reimbursable on the hospital s most recently filed Medicare cost report. Covered Entity Registration Registration for the 340B Program for both Covered Entities and contract pharmacies occurs on a quarterly basis as follows: Exhibit 2 Registration Window Start Date January 1 January 15 April 1 April 1 April 15 July 1 July 1 July 15 October 1 October 1 October 15 January 1 When registering for the 340B program, entities should refer to the HRSA website to make sure they have required documentation readily available, understand how to respond to the questions, and appoint an appropriate authorizing official to sign off on registration. An Essential Guide 4

8 Key Program Requirements In general, covered entities must to comply with three statutory requirements: Patient Eligibility Duplicate discount prohibition Maintenance of auditable records 1. Patient Eligibility Requirements A basic concept underpinning the 340B Program is the definition of an eligible patient. While there are no income requirements as with most assistance programs, the entity must be able to demonstrate that the patient is theirs. Conceptually, this means having the documentation that the patient received care at your facility, by one of your physicians, and, for grantees, that the drug administered is appropriate given the scope of grant received. Practically, there are many issues with tracking eligible patients as well as regulatory gaps and divergent interpretations of eligibility. The formal HRSA/OPA patient definition is: Current Patient Definition Guidelines For 340B eligibility purposes, an individual is considered a patient of a covered entity only if: The covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual s health care; and The individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity; and The individual receives a health care service or range of services from the covered entity which is consistent with the service or range of services for which grant funding or Federally Qualified Health Center Look-Alike status has been provided to the entity. Disproportionate share hospitals are exempt from this requirement. Statute prohibits the resale of drugs purchased under 340B to any person who is not an eligible patient of the Covered Entity. The 340B guidelines refer to such distribution as diversion and this violation can result in disqualification from the program. It is therefore critical that Covered Entities pay strict attention to patient definition guidelines and implement procedures to ensure the guidelines are met. Common Issues with Meeting Patient Definition Ensuring that patients receive health care services from the covered entity: Patient definition guidelines specifically state that an individual is not considered a patient of the entity for the purposes of 340B if the only health care service received by the individual is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting. Eligible Providers: While admitting privileges may qualify a prescriber when they are providing care in an integral part of the entity, relying only on privileges is not sufficient to establish the relationship with a 340B entity. Employees: Employees can meet HRSA S definition of a patient, but they may not receive 340B drugs simply by virtue of being employed by the entity. 5 Wellpartner 340B FUNDAMENTALS

9 Key Program Requirements (cont d) 2. Duplicate Discount Prohibition Federal law created two drug discount programs: the Medicaid Drug Rebate Program and the 340B Program. Because entities using the 340B Program dispense drugs to a large number of Medicaid beneficiaries, there is a potential for a manufacturer s product to be discounted twice. A covered entity can receive a discount through the 340B program or the State Medicaid Agency can receive a mandatory (OBRA 90) rebate, but both discounts may not occur for the same drug. To assist with the identification of 340B claims, HRSA created the Medicaid Exclusion File. The Medicaid Exclusion File lists the Medicaid provider numbers and National Provider Identifiers (NPI) of covered entities that provide 340B drugs to Medicaid beneficiaries. In addition, covered entities are required to follow any State specific guidance regarding the billing or identification of 340b drugs. For instance, many States require covered entities to bill the State at actual acquisition cost plus a dispensing fee. Entities are also required to adhere to State Medicaid guidelines for 340B billing, be correctly listed in the online HRSA Medicaid Exclusion File, and work with their billing departments to prevent duplicate discounts. Preventing duplicate discounts Duplicate discounts are statutorily prohibited. The penalties range from the required repayment to manufacturers to disqualification from the 340B Program altogether. Common Issues with Preventing Duplicate Discounts Incorrect Listing on Exclusion File Limitations of the Exclusion File Billing of Physician-Administered Drugs Lack of Clarity on Medicaid Managed Care Requirements Maintenance of Auditable Records Requirements 3. Maintenance of Auditable Records Requirements Entities may be audited by HRSA or by manufacturers. HRSA s audit protocols are uniform across entity type and broadly cover program operations and 340B purchases. Since 2012, HRSA has published the findings from a significant number of audits on its web site. Manufacturer audit protocols must be approved by HRSA per program guidelines and are product-specific. According to HRSA, six (6) manufacturers have been approved to conduct audits as of April, Covered entities must maintain information sufficient to demonstrate compliance and should have written policies and procedures in place. The OPA published detailed audit and compliance expectations in 2010 (75 fed eg 10272). An Essential Guide 6

10 Key Program Requirements (cont d) Maintaining auditable records Entities should be prepared to demonstrate to auditors that 340B drugs are not subject to duplicate discounts nor resold or transferred to persons who are not patients of the entity. Many covered entities choose to conduct periodic self-audits to ensure they meet this standard. Others go further and arrange for an annual independent audit. In either case, preparing for an audit can help covered entities identify gaps in compliance and to efficiently manage resources over time. Common Issue with Maintaining Auditable Records Maintaining comprehensive and documented policies and procedures. Covered entities should have written policies and procedures. These policies and procedures should be comprehensive, covering all key areas of 340B Program compliance, including patient definition, prevention of duplicate discounts, compliance with eligibility requirements and maintenance of auditable records. Using 340B for prescriptions written by referral providers, without adequate documentation/ auditable records. It is important to note that a patient who is referred by a covered entity to an outside provider is still considered a patient of the entity. The patient is still eligible to receive 340B medications, as long as responsibility for the patient s care remains with the original covered entity. Contract Pharmacy Arrangements Covered Entities may choose to dispense 340B drugs to qualified patients using contract pharmacies. This is an arrangement whereby retail and/or mail order pharmacies are contracted to fill 340B-eligible prescriptions for covered entity patients. This arrangement helps facilitate patient participation for covered entities that do not have appropriate in-house pharmacy services or want to supplement these services. By creating a 340B contract pharmacy network, the covered entity can significantly increase patient access to 340B drugs. In a typical 340B contract pharmacy arrangement, a retail pharmacy will allow a covered entity to track and identify 340B-eligible prescriptions dispensed to its patients. This can be done manually, but more commonly the Covered Entity is given access to the pharmacy s adjudication switch feed, so claims data is captured and analyzed electronically. In return for a pre-negotiated service fee, the pharmacy will remit funds collected for 340B claims to the covered entity and then receive replenishment inventory for the drugs dispensed. Since inventory used to fill 340B prescriptions is replaced by the covered entity, the contract pharmacy is inventory-neutral with respect to 340B drugs over time. New 340B contract pharmacies must be registered with the OPA by the covered entity. Registration windows are scheduled quarterly (see Exhibit 2 on page 4). 7 Wellpartner 340B FUNDAMENTALS

11 Key Considerations for Executive Leadership Be aware of registration deadlines. OPA uses a quarterly registration processes. If you miss the registration period, you must wait until the next open registration period to register a new site or add new outpatient facilities or contract pharmacy arrangements. Regularly review eligibility. OPA requires covered entities to recertify annually. This should include a review of the accuracy of the OPA data base and covered entity eligibility. For hospitals, this should include discussions with the individuals responsible for submitting the Medicare Cost Report. Any changes in the Medicare Cost Report must be accurately reflected in the OPA registration. Keep your record in the OPA database up to date. Make sure addresses are correct and authorizing official/contact is correct. Several of HRSA s recent negative audit findings have cited inaccuracies in program registration, so descriptions of this process to executives is essential. Ensure an accurate listing in the Medicaid Exclusion File. Review your entry in HRSA s Medicaid Exclusion File, verify practices and appropriateness of Medicaid billing procedures for both pharmacy-dispensed and physician-administered drugs, and assess steps for adherence to State billing policies for 340B drugs. Establish strong patient definition controls. Although some covered entities may feel that all patients should be considered eligible for 340B or that the hospital, health system and affiliated physician practices are one entity, for 340B, only individuals meeting current patient definition guidelines are eligible for 340B. Entities should have a defensible and documented position on qualified patients that is rooted in the guidelines. Invest in 340B Program integrity. This means ensuring that all 340B Program requirements are met, including ordering, inventory management, dispensing and billing of 340B drugs. Covered entities should regularly conduct self-audits and review their written policies and procedures. Determine appropriate use of contract pharmacies for your organization. This includes the number, type and location of contract pharmacies in your service area and inclusion of a mail order option. Covered Entities must ensure that procedures are in place to prevent diversion of 340B prescriptions to ineligible patients. Best practices suggest that patient definition be part of a Covered Entity s documented policies and procedures. An Essential Guide 8

12 Wellpartner is nationally recognized as the leading provider of strategic 340B administration and specialty pharmacy services. We serve a diverse range of 340B Covered Entities including safety net Hospitals & Health Systems, FQHCs, Blood Centers and HIV/AIDS Clinics. All of our clients have a common goal: improved community health through increased access to high-quality care. Wellpartner shares this commitment and works hard every day to help our clients achieve it. For more information, visit wellpartner.com or call

340B Drug Discount Program Improving Compliance to Protect Savings and Be Audit Ready. Suzanne Herzog Founding Director Rx X Consulting

340B Drug Discount Program Improving Compliance to Protect Savings and Be Audit Ready. Suzanne Herzog Founding Director Rx X Consulting 340B Drug Discount Program Improving Compliance to Protect Savings and Be Audit Ready Suzanne Herzog Founding Director Rx X Consulting What is 340B? 340B Overview A drug discount program that allows covered

More information

340B Drug Pricing Program

340B Drug Pricing Program 340B Drug Pricing Program Chad E. Gay Director of Contract Compliance Agenda Discuss the 340B drug pricing program How the program is defined Who is eligible Enrollment Dates to be aware of Source Documentation

More information

Speakers. Recent Developments in 340B Drug Pricing Program Compliance and Enforcement. Elizabeth S. Elson, Esq. Anil Shankar, Esq.

Speakers. Recent Developments in 340B Drug Pricing Program Compliance and Enforcement. Elizabeth S. Elson, Esq. Anil Shankar, Esq. 1 Recent Developments in 340B Drug Pricing Program Compliance and Enforcement Elizabeth S. Elson, Esq. Anil Shankar, Esq. October 18, 2012 2 Speakers Elizabeth Elson Of Counsel Foley & Lardner LLP Los

More information

Federal 340B Drug Pricing Program

Federal 340B Drug Pricing Program 2015 CliftonLarsonAllen LLP Federal 340B Drug Pricing Program March 6, 2015 Continuous learning in action Learning Objectives Explain the intent of the Federal 340B Drug Pricing Program List the eligibility

More information

340B Drug Discount Program Overview and Emerging Issues

340B Drug Discount Program Overview and Emerging Issues 340B Drug Discount Program Overview and Emerging Issues I. APPLICABLE STATUTE AND OTHER LEGAL AUTHORITIES Section 340B of the Public Health Service Act (42 U.S.C. 256b) requires pharmaceutical manufacturers,

More information

340B Integrity Audit: Is Your Hospital Ready for a HRSA Audit? February 4, 2013

340B Integrity Audit: Is Your Hospital Ready for a HRSA Audit? February 4, 2013 340B Integrity Audit: Is Your Hospital Ready for a HRSA Audit? February 4, 2013 1 Agenda 340B Program Overview Why HRSA Audits? What will HRSA Audits Cover? Verification of Eligibility: Covered Entity,

More information

Finally... maybe? The Long Awaited 340B Mega Guidance. Georgia Healthcare Financial Management Association. October 2015

Finally... maybe? The Long Awaited 340B Mega Guidance. Georgia Healthcare Financial Management Association. October 2015 Finally... maybe? The Long Awaited 340B Mega Guidance Georgia Healthcare Financial Management Association October 2015 Disclaimer This webinar assumes the participant is familiar with the basic operations

More information

340B Drug Pricing Program. A Survey of the Program s Past, Present, and Future

340B Drug Pricing Program. A Survey of the Program s Past, Present, and Future 340B Drug Pricing Program A Survey of the Program s Past, Present, and Future Presented by: Daniel Soldato Wyatt, Tarrant & Combs LLP dsoldato@wyattfirm.com (859) 288-7631 Disclaimer The views expressed

More information

Disclosure. Overview. Safety Net Hospitals for Pharmaceutical Access

Disclosure. Overview. Safety Net Hospitals for Pharmaceutical Access 340B: Issues and Opportunities in Pharmacy Automation Safety Net Hospitals for Pharmaceutical Access Executive Director, SNHPA Editor in Chief, Drug Discount Monitor American Society for Automation in

More information

340B Drug Pricing Program: Recent Developments and Compliance Update

340B Drug Pricing Program: Recent Developments and Compliance Update 340B Drug Pricing Program: Recent Developments and Compliance Update Elizabeth S. Elson, Esq. Anil Shankar, Esq. November 19, 2015 Attorney Advertising Prior results do not guarantee a similar outcome

More information

CPAs and ADVISORS. experience access // 340B QUALIFICATIONS, BENEFITS AND CURRENT FOCUS

CPAs and ADVISORS. experience access // 340B QUALIFICATIONS, BENEFITS AND CURRENT FOCUS CPAs and ADVISORS experience access // 340B QUALIFICATIONS, BENEFITS AND CURRENT FOCUS BRIAN M. BELL BRAD K. BROTHERTON DIRECTOR PARTNER MATERIALS COVERED TODAY 340B Program Evolution, Purpose & Benefits

More information

ASHP Regulatory Alert

ASHP Regulatory Alert Proposed Guidance: 340B Drug Discount Program Introduction On Friday, August 28, 2015, the Health Resources and Services Administration (HRSA) published the long awaited proposed omnibus guidance for the

More information

340B Drug Pricing Program: Overview and Recent Developments

340B Drug Pricing Program: Overview and Recent Developments 340B Drug Pricing Program: Overview and Recent Developments November 12, 2015 Kirstin B. Ives Partner and Chair of Healthcare Litigation Group Williams Montgomery & John Ltd. 233 S. Wacker Drive, Suite

More information

The Pharmacy 340B Program- Compliance & Internal Audit Strategies. for Covered Entities. Matthew D. Vogelien Huron Healthcare

The Pharmacy 340B Program- Compliance & Internal Audit Strategies. for Covered Entities. Matthew D. Vogelien Huron Healthcare The Pharmacy 340B Program- Compliance & Internal Audit Strategies Matthew D. Vogelien Huron Healthcare for Covered Entities 340B Drug Discount Program (340B Program) Discussion Outline Topics for Discussion:

More information

340B Drug Discount Program 2013 March 15, 2013 1 Agenda 340B Program Overview Covered Entities Covered Drugs Covered Patients Why HRSA Audits How to Prepare for HRSA Audit Questions/Answers 2 340 DRUG

More information

340B Drug Pricing Program January 15, 2015

340B Drug Pricing Program January 15, 2015 340B Drug Pricing Program January 15, 2015 340B Basics - Gary Merchant. MBA, BSPharm 340B Audit - Robert Theriault, MBA, BSPharm Declarations Neither Gary Merchant nor Robert Theriault have no actual or

More information

340B Compliance & Risk Assessment. Kathe Hoots

340B Compliance & Risk Assessment. Kathe Hoots 340B Compliance & Risk Assessment Kathe Hoots 0 340B Program Background Congress implemented the 340B Drug Pricing Program via the Veterans Health Care Act Statutorily requires pharmaceutical manufacturers

More information

The 340B Drug Pricing Program: The Basics

The 340B Drug Pricing Program: The Basics The 340B Drug Pricing Program: The Basics Paul Shank, MBA Health & Human Services Consultant, Health Resources and Services Administration Healthcare Systems Bureau, Office of Pharmacy Affairs July 14,

More information

Keep Your Savings: 340B Audits and Ensuring Compliance

Keep Your Savings: 340B Audits and Ensuring Compliance Keep Your Savings: 340B Audits and Ensuring Compliance Disclosure This presentation reflects experience with the topics at hand and does not constitute legal advice, and does not reflect interpretation

More information

4/3/2015 WHAT IS 340B? DISCLOSURE. No conflicts of interest to disclose

4/3/2015 WHAT IS 340B? DISCLOSURE. No conflicts of interest to disclose WHAT IS 340B? S C O T T M I L N E R P H AR M D, M B A DISCLOSURE No conflicts of interest to disclose 1 OBJECTIVES At the end of this presentation we should be able to: Describe the origin of the 340b

More information

The 340B Drug Pricing Program. Ariel Winter and Daniel Zabinski November 6, 2014

The 340B Drug Pricing Program. Ariel Winter and Daniel Zabinski November 6, 2014 The 340B Drug Pricing Program Ariel Winter and Daniel Zabinski November 6, 2014 Outline Background on 340B program Program has grown substantially 340B statute does not define key terms, allows many providers

More information

340B Drug Discount Program Identifying risks and internal audit focus areas

340B Drug Discount Program Identifying risks and internal audit focus areas 340B Drug Discount Program Identifying risks and internal audit focus areas Introduction The 340B Drug Discount Program is administered by the Health Resources and Services Administration (HRSA) Office

More information

The 340B Drug Discount Program Overview, Compliance Issues and Interplay with Medicare and Medicaid

The 340B Drug Discount Program Overview, Compliance Issues and Interplay with Medicare and Medicaid The Drug Discount Program Overview, Compliance Issues and Interplay with Medicare and Medicaid Barbara Straub Williams Powers Pyles Sutter & Verville PC American Health Lawyers Association 2014 Institute

More information

10/1/2013. Objectives. 340B Drug Pricing Program; Transitioning from Access to Integrity. 340B Stats, Arkansas. 340B Participating Entities, AR

10/1/2013. Objectives. 340B Drug Pricing Program; Transitioning from Access to Integrity. 340B Stats, Arkansas. 340B Participating Entities, AR Objectives Drug Pricing Program; Transitioning from Access to Integrity Arkansas Association of Health-system Pharmacists 47 th Annual Fall Seminar October 3 & 4, 2013 Chris Hatwig RPh, MS, FASHP President,

More information

The 3 Keys to Success in Your 340B Program. Rob Nahoopii, PharmD, MS, BCPS CEO Turnkey Pharmacy Solutions A 340B Management Company

The 3 Keys to Success in Your 340B Program. Rob Nahoopii, PharmD, MS, BCPS CEO Turnkey Pharmacy Solutions A 340B Management Company The 3 Keys to Success in Your 340B Program Rob Nahoopii, PharmD, MS, BCPS CEO Turnkey Pharmacy Solutions A 340B Management Company Objectives Provide a description and overview of the 340B program Discuss

More information

The 340B Program: New Developments and New Opportunities for CAHs and Others. Todd Nova Hall Render

The 340B Program: New Developments and New Opportunities for CAHs and Others. Todd Nova Hall Render The 340B Program: New Developments and New Opportunities for CAHs and Others Todd Nova Hall Render Wisconsin Office of Rural Health Hospital Finance Workshop August 30, 2011 What We Will Cover 2 340B Program

More information

340B: ARE WE MONITORING COMPLIANCE EFFECTIVELY AND EFFICIENTLY

340B: ARE WE MONITORING COMPLIANCE EFFECTIVELY AND EFFICIENTLY CPAs & ADVISORS experience clarity // 340B: ARE WE MONITORING COMPLIANCE EFFECTIVELY AND EFFICIENTLY September 17, 2014 Michael Earls, CPA, Senior Manager September 17, 2014 OVERVIEW OF TODAY S PRESENTATION

More information

340B Compliance: I sure wish I d known that!

340B Compliance: I sure wish I d known that! 340B Compliance: I sure wish I d known that! Aaron K. Lott Pharm. D. Executive Director of Pharmacy Services June 2015 Disclosures The presenter has no significant financial or commercial interests to

More information

Overview of the 340B Drug Pricing Program

Overview of the 340B Drug Pricing Program M a y 2 0 1 5 Report to the Congress Overview of the 340B Drug Pricing Program M a y 2 0 1 5 Report to the Congress Overview of the 340B Drug Pricing Program 425 I Street, NW Suite 701 Washington, DC 20001

More information

Legal Alert. Long-Awaited 340B Program Guidance Now Available for Comments: What Stakeholders Need to Know. Authors

Legal Alert. Long-Awaited 340B Program Guidance Now Available for Comments: What Stakeholders Need to Know. Authors September 10, 2015 1 Legal Alert Authors Stephanie Trunk Partner stephanie.trunk@arentfox.com Erin E. Atkins Associate erin.atkins@arentfox.com Long-Awaited 340B Program Guidance Now Available for Comments:

More information

Mega Guidance Is Here!

Mega Guidance Is Here! Mega Guidance Is Here! David Pointer has no actual or potential conflict of interest in relation to this presentation. 1 Introduction Where are we today? Brief Overview of HRSA Audit Findings Where are

More information

Mega Guidance Is Here!

Mega Guidance Is Here! Mega Guidance Is Here! David Pointer has no actual or potential conflict of interest in relation to this presentation. Introduction Where are we today? Brief Overview of HRSA Audit Findings Where are we

More information

SUMMARY: The Health Resources and Services Administration (HRSA) administers section

SUMMARY: The Health Resources and Services Administration (HRSA) administers section This document is scheduled to be published in the Federal Register on 08/28/2015 and available online at http://federalregister.gov/a/2015-21246, and on FDsys.gov Billing Code: 4165-15 DEPARTMENT OF HEALTH

More information

GAO DRUG PRICING. Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement

GAO DRUG PRICING. Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement GAO United States Government Accountability Office Report to Congressional Committees September 2011 DRUG PRICING Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs

More information

The 340B Drug Pricing Program: The Basics INTEGRITY ACCESS VALUE 1

The 340B Drug Pricing Program: The Basics INTEGRITY ACCESS VALUE 1 The 340B Drug Pricing Program: The Basics INTEGRITY ACCESS VALUE 1 Learning Objectives 1 2 3 Intent of the program 340B Pricing determination Entity eligibility 4 5 6 Program requirements and prohibitions

More information

HHS Releases Long-Awaited 340B Proposed Guidance

HHS Releases Long-Awaited 340B Proposed Guidance AUGUST 31, 2015 HHS Releases Long-Awaited 340B Proposed Guidance David Ivill, Emily Cook and Joseph Parise On August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited

More information

October 27, 2015. Attention: RIN 0906-AB08. RE: 340B Drug Pricing Program Omnibus Guidance. Dear Captain Pedley:

October 27, 2015. Attention: RIN 0906-AB08. RE: 340B Drug Pricing Program Omnibus Guidance. Dear Captain Pedley: Captain Krista Pedley, Director Office of Pharmacy Affairs Health Resources and Services Administration 5600 Fishers Lane Mail Stop 08W05A Rockville, MD 20857 Attention: RIN 0906-AB08 RE: 340B Drug Pricing

More information

MEDICARE PART B DRUGS. Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals

MEDICARE PART B DRUGS. Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals United States Government Accountability Office Report to Congressional Requesters June 2015 MEDICARE PART B DRUGS Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals

More information

TEXAS VENDOR DRUG PROGRAM PHARMACY PROVIDER PROCEDURE MANUAL

TEXAS VENDOR DRUG PROGRAM PHARMACY PROVIDER PROCEDURE MANUAL 1 OF 10 DOCUMENT HISTORY LOG STATUS REVISION EFFECTIVE DESCRIPTION Revision 1.1 Sep. 1, 2015 Baseline 1.0 Feb. 1, 2015 3.1 Eligible Entity 5 CAD Claim Submission o Instruction update and email address.

More information

Date: September 3, 2014

Date: September 3, 2014 Date: September 3, 2014 Subject: Background on Sections 401 and 403 of the Indian Health Care Improvement Act: Disregarding Certain Payments in Determining Appropriations and Reporting Requirements Note:

More information

A fter much-anticipation, the Health Resources and

A fter much-anticipation, the Health Resources and BNA s Health Care Policy Report Reproduced with permission from BNA s Health Care Policy Report, 23 HCPR 1420, 09/21/2015. Copyright 2015 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com

More information

C. Covered 340B drugs, as found in section 1927 (k)(2) of the Social Security Act, include the following outpatient drugs:

C. Covered 340B drugs, as found in section 1927 (k)(2) of the Social Security Act, include the following outpatient drugs: Title 23: Medicaid Part 200: General Provider Information Part 200 Chapter 4: Provider Enrollment Rule 4.10: 340B Providers A. The Division of Medicaid defines a 340B provider as a nonprofit healthcare

More information

The 340B Drug Pricing Program: The Basics

The 340B Drug Pricing Program: The Basics The 340B Drug Pricing Program: The Basics Todd Lemke, Pharm.D CDE Paynesville Area Health Care System Pharmacist HRSA APhA Pharmacy Services Support Center Consultant 1 Intent of the 340B Program Safety

More information

340B Compliance Self-Assessment: Self-Audit Process Page 1 A Sample Self-Audit Process for Community Health Centers

340B Compliance Self-Assessment: Self-Audit Process Page 1 A Sample Self-Audit Process for Community Health Centers 340B Compliance Self-Assessment: Self-Audit Process Page 1 Purpose: The purpose of this tool is to provide a sample internal audit process to assist participating community health center (CHC) leaders

More information

O n Aug. 28, the Department of Health and Human

O n Aug. 28, the Department of Health and Human BNA s Health Law Reporter Reproduced with permission from BNA s Health Law Reporter, 24 HLR 1202, 9/17/15. Copyright 2015 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com HRSA

More information

Structuring 340B Contract Pharmacy Arrangements: Meeting Legal and Regulatory Requirements

Structuring 340B Contract Pharmacy Arrangements: Meeting Legal and Regulatory Requirements Presenting a live 90-minute webinar with interactive Q&A Structuring 340B Contract Pharmacy Arrangements: Meeting Legal and Regulatory Requirements THURSDAY, JUNE 4, 2015 1pm Eastern 12pm Central 11am

More information

340B Policy Landscape

340B Policy Landscape 340B Policy Landscape Providence 2015 340B Summit Presented by Steve Brennan, Director, Public Policy Providence Health & Services Sept. 28, 2015 1 Today s topics Backdrop of debate over 340B program Legislative

More information

340B Mega Guidance: Implications for Essential Hospitals Sarah Mutinsky and Barbara Eyman Washington Counsel, America s Essential Hospitals Eyman

340B Mega Guidance: Implications for Essential Hospitals Sarah Mutinsky and Barbara Eyman Washington Counsel, America s Essential Hospitals Eyman 340B Mega Guidance: Implications for Essential Hospitals Sarah Mutinsky and Barbara Eyman Washington Counsel, America s Essential Hospitals Eyman Associates September 10, 2015 TODAY S AGENDA Background

More information

2015-340B & Prime Vendor Program Update

2015-340B & Prime Vendor Program Update 2015-340B & Prime Vendor Program Update Christopher A. Hatwig, R.Ph., MS, FASHP President, Apexus 340B Sales by Entity Types Percentage of Total Apexus Participant Sales 90.00% 80.00% 70.00% 60.00% 50.00%

More information

340B DRUG DISCOUNT PROGRAM OMNIBUS GUIDANCE. Presented by the American Bar Association Health Law Section and Center for Professional Development

340B DRUG DISCOUNT PROGRAM OMNIBUS GUIDANCE. Presented by the American Bar Association Health Law Section and Center for Professional Development 340B DRUG DISCOUNT PROGRAM OMNIBUS GUIDANCE Presented by the American Bar Association Health Law Section and Center for Professional Development American Bar Association Center for Professional Development

More information

Expanding 340B Participation: The Provider-Based Challenge

Expanding 340B Participation: The Provider-Based Challenge Expanding 340B Participation: The Provider-Based Challenge Presentation by Karen Smith, Esq. & David Johnston, Esq. Bricker & Eckler LLP www.bricker.com Columbus l Cleveland l Cincinnati-Dayton I Marietta

More information

Statement of the Biotechnology Industry Organization Before the Advisory Panel on Ambulatory Payment Classification Groups August 23-24, 2010

Statement of the Biotechnology Industry Organization Before the Advisory Panel on Ambulatory Payment Classification Groups August 23-24, 2010 Statement of the Biotechnology Industry Organization Before the Advisory Panel on Ambulatory Payment Classification Groups August 23-24, 2010 Laurel Todd Director, Reimbursement and Health Policy Biotechnology

More information

SUMMARY OF HRSA PROPOSED OMNIBUS GUIDANCE ON THE 340B DRUG DISCOUNT PROGRAM

SUMMARY OF HRSA PROPOSED OMNIBUS GUIDANCE ON THE 340B DRUG DISCOUNT PROGRAM L A W O F F I C E S HYMAN, PHELPS & MCNAMARA, P.C. 7 0 0 T H I R T E E N T H S T R E E T, N. W. S U I T E 1 2 0 0 W A S H I N G T O N, D. C. 2 0 0 0 5-5 9 2 9 ( 2 0 2 ) 7 3 7-5 6 0 0 F A C S I M I L E

More information

OPA DATABASE GUIDE PUBLIC USERS - RECERTIFICATION FOR AUGUST 2013 VERSION 5.2.1

OPA DATABASE GUIDE PUBLIC USERS - RECERTIFICATION FOR AUGUST 2013 VERSION 5.2.1 OPA DATABASE GUIDE FOR PUBLIC USERS - RECERTIFICATION AUGUST 2013 VERSION 5.2.1 CERTIFICATION 1 Authorizing Official (AO) Advance Notification 1 340B Recertification Email 2 AO Logging In 3 Navigating

More information

340B Program New Developments and Increasing Scrutiny

340B Program New Developments and Increasing Scrutiny 340B Program New Developments and Increasing Scrutiny Todd Nova Hall Render tnova@hallrender.com Wisconsin Office of Rural Health Hospital Finance Workshop August 24, 2012 What We Will Cover 2 340B Program

More information

340B PROGRAM. Scrutiny & Uncertainty Increase the Need for Compliance

340B PROGRAM. Scrutiny & Uncertainty Increase the Need for Compliance 340B PROGRAM Scrutiny & Uncertainty Increase the Need for Compliance Uncertainty will always be part of the taking charge process. Harold S. Geneen For many years, drug manufacturers and Covered Entities

More information

University of Kentucky / UK HealthCare Policy and Procedure. Policy # A14-070

University of Kentucky / UK HealthCare Policy and Procedure. Policy # A14-070 University of Kentucky / UK HealthCare Policy and Procedure Policy # A14-070 Title/Description: 340B Drug Discount Program Purpose: This policy describes UK HealthCare s 340B Drug Discount Program and

More information

7/16/2010. 14 th Annual 340B Coalition Conference July 19, 2010 Washington, DC. Safety Net Hospitals for Pharmaceutical Access

7/16/2010. 14 th Annual 340B Coalition Conference July 19, 2010 Washington, DC. Safety Net Hospitals for Pharmaceutical Access Safety Net Hospitals for Pharmaceutical Access The Story From Washington, D.C. Ted Slafsky Executive Director, SNHPA Editor in Chief, Drug Discount Monitor (202)552-58605860 ted.slafsky@snhpa.org 14 th

More information

340B University Page 1 340B Manager and Coordinator Job Description Template

340B University Page 1 340B Manager and Coordinator Job Description Template 340B University Page 1 Purpose: The purpose of this tool is to provide a list of activities commonly assigned to the role of 340B Manager or Coordinator. This list is not exhaustive, rather a compilation

More information

340B Drug Pricing Program 340B Contract Pharmacy

340B Drug Pricing Program 340B Contract Pharmacy 340B Drug Pricing Program 340B Contract Pharmacy LTJG Enudio Mercado-Gonzalez, USPHS Program Management Officer U.S. Department of Health and Human Services Health Resources and Services Administration

More information

The Federal 340B Drug Discount Program: A Primer

The Federal 340B Drug Discount Program: A Primer The Federal 340B Drug Discount Program: A Primer Andrea G. Cohen Manatt, Phelps & Phillips, LLP Presentation to the National Medicaid Congress June 4, 2006 Preview 340B Program Overview What is it Who

More information

340B Omnibus Guidance Would Significantly Narrow the Pool of Eligible Patients

340B Omnibus Guidance Would Significantly Narrow the Pool of Eligible Patients White Paper August 31, 2015 340B Omnibus Guidance Would Significantly Narrow the Pool of Eligible Patients By Kristi V. Kung This client alert also was published as a bylined article on Law360 on September

More information

Sec. 340B PUBLIC HEALTH SERVICE ACT

Sec. 340B PUBLIC HEALTH SERVICE ACT Sec. 340B PUBLIC HEALTH SERVICE ACT LIMITATION ON PRICES OF DRUGS PURCHASED BY COVERED ENTITIES (a) REQUIREMENTS FOR AGREEMENT WITH SECRETARY. (1) IN GENERAL. The Secretary shall enter into an agreement

More information

340B DISCOUNT DRUG PROGRAM OVERVIEW

340B DISCOUNT DRUG PROGRAM OVERVIEW 340B DISCOUNT DRUG PROGRAM OVERVIEW March 2014 Investment banking services are provided by Harris Williams LLC, a registered broker-dealer and member of FINRA and SIPC, and Harris Williams & Co. Ltd, which

More information

Printed copies are for reference only. Please refer to the electronic copy of this policy for the latest version.

Printed copies are for reference only. Please refer to the electronic copy of this policy for the latest version. 340B Pharmacy Audit Policy Version: 1.4 Date Created: 01/05/2015 Date Approved: 02/18/2015 Printed copies are for reference only. Please refer to the electronic copy of this policy for the latest version.

More information

(RIN) 0906-AB08; 340-B

(RIN) 0906-AB08; 340-B October, 2015 Ms. Krista Pedley Director, Office of Pharmacy Affairs (OPA) Health Resources and Services Administration (HRSA) 5600 Fishers Lane, Mail Stop 08W05A Rockville, Maryland 20857 Re: Regulatory

More information

PHARMACY CARE ----- FQHCs AND 340B PROGRAM

PHARMACY CARE ----- FQHCs AND 340B PROGRAM PHARMACY CARE ----- FQHCs AND 340B PROGRAM HISTORY OF 340B PROGRAM Initiated during Clinton administration Who can participate? FQHC, Family Planning, Ryan White, Black Lung, Hemophilia, Urban Indian,

More information

HRSA Pharmacy Services Support Center: The 340B Access Resource

HRSA Pharmacy Services Support Center: The 340B Access Resource HRSA Pharmacy Services Support Center: The 340B Access Resource Lisa Scholz PharmD, MBA Vice President, APhA HRSA Pharmacy Services Support Center Office of Population Affairs Webinar 9/16 INTEGRITY ACCESS

More information

DSH Litigation and 340B Program Update: What Participating Hospitals Need to Know and What They Should Be Doing

DSH Litigation and 340B Program Update: What Participating Hospitals Need to Know and What They Should Be Doing DSH Litigation and 340B Program Update: What Participating Hospitals Need to Know and What They Should Be Doing Presented by: Joe Metro, Partner Sal Rotella, Partner Agenda Disproportionate Share Hospital

More information

Is your organization 340B equipped? Understanding Contract Pharmacy arrangements

Is your organization 340B equipped? Understanding Contract Pharmacy arrangements Is your organization 340B equipped? Understanding Contract Pharmacy arrangements In today s era of healthcare reform that emphasizes enhanced accessibility and cost reductions, the 340B program remains

More information

October 27, 2015. Krista Pedley, Director Office of Pharmacy Affairs Health Resources and Services Administration.

October 27, 2015. Krista Pedley, Director Office of Pharmacy Affairs Health Resources and Services Administration. 1015 15 th Street, N.W., Suite 950 Washington, DC 20005 Tel. 202.204.7508 Fax 202.204.7517 www.communityplans.net John Lovelace, Chairman Margaret A. Murray, Chief Executive Officer October 27, 2015 Krista

More information

GROWTH OF THE 340B PROGRAM: PAST TRENDS, FUTURE PROJECTIONS

GROWTH OF THE 340B PROGRAM: PAST TRENDS, FUTURE PROJECTIONS : PAST TRENDS, FUTURE PROJECTIONS Healthcare WHITE PAPER NOVEMBER 2014 Prepared By: Aaron Vandervelde avandervelde@thinkbrg.com 202.480.2661 Copyright 2014 by Berkeley Research Group, LLC. Except as may

More information

NAMD WORKING PAPER SERIES. Medicaid and the 340B Program: Alignment and Modernization Opportunities

NAMD WORKING PAPER SERIES. Medicaid and the 340B Program: Alignment and Modernization Opportunities NAMD WORKING PAPER SERIES Medicaid and the 340B Program: Alignment and Modernization Opportunities May 2015 444 North Capitol Street, Suite 524 Washington, DC 20001 Phone: 202.403.8620 www.medicaiddirectors.org

More information

340B GROWTH AND THE IMPACT ON THE ONCOLOGY MARKETPLACE

340B GROWTH AND THE IMPACT ON THE ONCOLOGY MARKETPLACE 340B GROWTH AND THE IMPACT ON THE ONCOLOGY MARKETPLACE Healthcare WHITE PAPER SEPTEMBER 2015 Prepared By: Aaron Vandervelde avanvervelde@thinkbrg.com 202.480.2661 Copyright 2015 by Berkeley Research Group,

More information

The 340B Drug Discount Program

The 340B Drug Discount Program The 340B Drug Discount Program Ponaman Healthcare Consulting Ralph V. Moreno Jr. Presented: August 11, 2011 Table of Contents...1 THE 340B DRUG DISCOUNT PROGRAM 1.1 340B Overview......2 1.2 340B Eligibility.......

More information

Fast Track to 340B FEATURE: ROBERT F. GRICIUS AND DOUGLAS WONG

Fast Track to 340B FEATURE: ROBERT F. GRICIUS AND DOUGLAS WONG HFM MAGAZINE:JANUARY 2016 Fast Track to 340B FEATURE: ROBERT F. GRICIUS AND DOUGLAS WONG MANY HOSPITALS AND HEALTH SYSTEMS HAVE A PROFOUND NEW OPPORTUNITY TO OBTAIN SAVINGS ON OUTPATIENT PHARMACEUTICALS

More information

Medicaid Drug Rebate Program Summit Podcast. Chris Hatwig, Vice President, Apexus

Medicaid Drug Rebate Program Summit Podcast. Chris Hatwig, Vice President, Apexus Medicaid Drug Rebate Program Summit Podcast My first question is, Chris, tell us how the 340B Program was affected by the Supreme Court s ruling at the end of June? Chris: I think that s hard to say at

More information

UPDATES ON 340B 2011. Where do we go from here?

UPDATES ON 340B 2011. Where do we go from here? UPDATES ON 340B 2011 Where do we go from here? Brief Review of 340B Initiated during Clinton administration Who can participate? (FQHC, Family Planning, Ryan White, Black lung, Hemophilia, Urban Indian,

More information

STATEMENT OF DIANA ESPINOSA DEPUTY ADMINISTRATOR, HEALTH RESOURCES AND SERVICES ADMINISTRATION BEFORE THE

STATEMENT OF DIANA ESPINOSA DEPUTY ADMINISTRATOR, HEALTH RESOURCES AND SERVICES ADMINISTRATION BEFORE THE STATEMENT OF DIANA ESPINOSA DEPUTY ADMINISTRATOR, HEALTH RESOURCES AND SERVICES ADMINISTRATION BEFORE THE U.S. HOUSE ENERGY AND COMMERCE COMMITTEE SUBCOMMITEE ON HEALTH WASHINGTON, D.C. MARCH 5, 2015 Good

More information

340B program presents opportunities and challenges

340B program presents opportunities and challenges NOVEMBER 2009 healthcare financial management MEDICARE/MEDICAID Christopher L. Keough Stephanie A. Webster 340B program presents opportunities and challenges AT A GLANCE > The 340B program provides an

More information

The PHS 340B Drug Pricing Program

The PHS 340B Drug Pricing Program 340B DRUG PRICING PROGRAM: Improving access to affordable medications. Harry P. Hagel, RPh, MS Senior Director HRSA Pharmacy Services Support Center American Pharmacists Association August 16, 2006 The

More information

The Federal 340B Drug Discount Program: A Primer

The Federal 340B Drug Discount Program: A Primer The Federal 340B Drug Discount Program: A Primer Andrea G. Cohen Manatt, Phelps & Phillips, LLP Presentation to the National Medicaid Congress June 13, 2007 Preview 340B Program Overview What is it Who

More information

The 340B Program: Today and Beyond

The 340B Program: Today and Beyond FL Regional Education Session - Tampa The 340B Program: Today and Beyond May 19, 2015 2:15-3:15 PM ET 2015 Safety Net Hospitals for Pharmaceutical Access 1 Disclaimer This presentation is not to be construed

More information

OIG Responses to Additional Questions from Chairman Pitts Regarding the 340B Program May 4, 2015

OIG Responses to Additional Questions from Chairman Pitts Regarding the 340B Program May 4, 2015 OIG Responses to Additional Questions from Chairman Pitts Regarding the 340B Program May 4, 2015 1. HRSA had been preparing a regulation to address the definition of a patient and hospital eligibility,

More information

THE 340B DRUG DISCOUNT PROGRAM A Review and Analysis of the 340B Program

THE 340B DRUG DISCOUNT PROGRAM A Review and Analysis of the 340B Program THE 340B DRUG DISCOUNT PROGRAM A Review and Analysis of the 340B Program WINTER 2013 A publication of the following organizations: the Biotechnology Industry Organization (BIO), the Community Oncology

More information

Eligibility of Rural Hospitals for the 340B Drug Discount Program

Eligibility of Rural Hospitals for the 340B Drug Discount Program Public Hospital Pharmacy Coalition www.phpcrx.org (A Coalition of the National Association of Public Hospitals and Health Systems) Eligibility of Rural Hospitals for the 340B Drug Discount Program Prepared

More information

Alabama Department of Public Health Drug Purchasing Programs: 340B and MMCAP. Alabama Department of Public Health 8/20/2012

Alabama Department of Public Health Drug Purchasing Programs: 340B and MMCAP. Alabama Department of Public Health 8/20/2012 Alabama Department of Public Health Drug Purchasing Programs: 340B and MMCAP Satellite Conference and Live Webcast Thursday, August 23, 2012 2:00 4:00 p.m. Central Time Produced by the Alabama Department

More information

Maximizing the 340B Drug Discount Program: A Webinar for Finance Executives in 340B Hospitals Webinar

Maximizing the 340B Drug Discount Program: A Webinar for Finance Executives in 340B Hospitals Webinar Maximizing the 340B Drug Discount Program: A Webinar for Finance Executives in 340B Hospitals Webinar January 20, 2010 The Webinar Will Begin Momentarily National Association of Public Hospitals and Health

More information

RE: 340B Drug Pricing Program Omnibus Guidance HRSA RIN 0906-AB08, (Vol. 80, No. 167, August 28, 2015)

RE: 340B Drug Pricing Program Omnibus Guidance HRSA RIN 0906-AB08, (Vol. 80, No. 167, August 28, 2015) October 26, 2015 Krista Pedley, PharmD, MS Captain, USPHS Director, Office of Pharmacy Affairs Health Resources and Services Administration 5600 Fishers Lane, Mail Stop 08W05A Rockville, MD 20857 Via Email:

More information

340B Drug Pricing Program Results of a Survey of Eligible but Non-Participating Rural Hospitals

340B Drug Pricing Program Results of a Survey of Eligible but Non-Participating Rural Hospitals 340B Drug Pricing Program Results of a Survey of Eligible but Non-Participating Rural Hospitals A Joint Publication of The North Carolina Rural Health Research & Policy Analysis Center (1) Working Paper

More information

THE 340B DRUG DISCOUNT PROGRAM A Review and Analysis of the 340B Program

THE 340B DRUG DISCOUNT PROGRAM A Review and Analysis of the 340B Program THE 340B DRUG DISCOUNT PROGRAM A Review and Analysis of the 340B Program WINTER 2013 A publication of the following organizations: the Biotechnology Industry Organization (BIO), the Community Oncology

More information

October 9, 2015. RIN 0906-AB08 340B Drug Pricing Program Omnibus Guidance. Dear Director Pedley:

October 9, 2015. RIN 0906-AB08 340B Drug Pricing Program Omnibus Guidance. Dear Director Pedley: October 9, 2015 Krista Pedley Director, Office of Pharmacy Affairs Health Resources and Services Administration 5600 Fishers Lane Mail Stop 08W05A Rockville, Maryland 20857 Re: RIN 0906-AB08 340B Drug

More information

Safety Net Hospitals for Pharmaceutical Access

Safety Net Hospitals for Pharmaceutical Access Safety Net Hospitals for Pharmaceutical Access December 24, 2008 Ms. Alberta J. Dwivedi Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1404-FC Mail Stop

More information

IHS TRIBAL SELF-GOVERNANCE ADVISORY COMMITTEE

IHS TRIBAL SELF-GOVERNANCE ADVISORY COMMITTEE IHS TRIBAL SELF-GOVERNANCE ADVISORY COMMITTEE c/o Self-Governance Communication and Education P.O. Box 1734, McAlester, OK 74501 Telephone (918) 302-0252 ~ Facsimile (918) 423-7639 ~ Website: www.tribalselfgov.org

More information

HRSA Issues 340B Program Omnibus Guidance

HRSA Issues 340B Program Omnibus Guidance 3 September 2015 Practice Groups: Healthcare FDA HRSA Issues 340B Program Omnibus Guidance By Gina L. Bertolini, Richard P. Church, Leah D'Aurora Richardson On August 28, 2015, the Health Resources and

More information

340B UNIVERSITY Las Vegas Edition. May 31, 2014

340B UNIVERSITY Las Vegas Edition. May 31, 2014 340B UNIVERSITY Las Vegas Edition May 31, 2014 SESSION 1: THE TOP 5: 340B BASICS FOR HOSPITALS Mike Benedict Objectives 1. Define the intent of the 340B Program 2. Describe the major 340B stakeholders

More information

Implementing a System-wide 340B Program

Implementing a System-wide 340B Program Implementing a System-wide 340B Program An Overview Steve Pitzer System Executive, Supply Chain Management CHRISTUS Health Sam Colletti, RPh Director of Enterprise Accounts- CHRISTUS Health Broadlane Objectives

More information

Medical Care Advisory Committee. Andy Vasquez, Deputy Director, Medicaid/CHIP Vendor Drug Program Health and Human Services Commission

Medical Care Advisory Committee. Andy Vasquez, Deputy Director, Medicaid/CHIP Vendor Drug Program Health and Human Services Commission TO: Medical Care Advisory Committee DATE: November 8, 2013 FROM: Andy Vasquez, Deputy Director, Medicaid/CHIP Vendor Drug Program Health and Human Services Commission Agenda Item No.: 7 SUBJECT: Fee-for-Service

More information

Challenges and Opportunities

Challenges and Opportunities The Future of the 340B Drug Pricing Program: Challenges and Opportunities Jeffrey R. Lewis jeffreyrobertlewis@gmail.com Mr. Lewis is the former President of PS2 Health Care and now serves as the Chief

More information

RE: File Code CMS 2345 P: Medicaid Program; Covered Outpatient Drugs

RE: File Code CMS 2345 P: Medicaid Program; Covered Outpatient Drugs April 2, 2012 Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS 2345 P Mail Stop C4-26-05 7500 Security Boulevard Baltimore, MD 21244 1850 RE: File Code CMS

More information