How to Survive a HRSA Audit & Take Corrective Action. William von Oehsen, Principal Powers Pyles Sutter & Verville, PC
|
|
- Damian Ferguson
- 6 years ago
- Views:
Transcription
1 How to Survive a HRSA Audit & Take Corrective Action William von Oehsen, Principal Powers Pyles Sutter & Verville, PC
2 Statement of Conflicts of Interest William von Oehsen represents 340B providers and 340B provider groups This presentation is not to be construed or relied upon as legal advice 2
3 Today s Agenda HRSA audit program Typical findings, sanctions and areas of improvement Corrective action plans (CAPs) When to self-disclose and assessing materiality Elements of a CAP Manufacturer repayment issues Closing out a CAP Manufacturer inquiries 3
4 CE Question True or False: A covered entity is only required to initiate corrective action if the non-compliance is material? 4
5 HRSA Audit Program Health Resources and Services Administration (HRSA) began auditing covered entities (CEs) in 2012 As of last month, HRSA audit reports posted: 51 audits for FY audits for FY audits for FY audits for FY audits for FY 2016 Another audits expected in 2017 To date, HRSA has completed six manufacturer audits 5
6 HRSA Audit Program (cont d) Audit Process Engagement Letter Teleconference with auditor Data request Onsite audit Audit report Post-Audit Process Appeal? Notice of Disagreement filed Final audit report Audit findings posted on OPA website CAP submitted CAP approval CAP Implementation CAP initiated Periodic CAP implementation updates CE attests CAP is completed HRSA closes out audit 6
7 Typical Findings and Sanctions Database errors Finding GPO prohibition violations after 8/7/13 Diversion Duplicate discounts and Medicaid billing violations Failure to replenish at NDC 11 level in virtual inventory systems Inadequate oversight of contract pharmacies Sanction Improved policies and procedures (P&Ps) CE termination if violation is ongoing and manufacturer repayment Manufacturer repayment Manufacturer repayment Manufacturer repayment? Termination of contract pharmacies Inauditable records CE termination if violation is ongoing and repayment 7
8 Typical Areas of Improvement CE needs comprehensive P&Ps CE should review and update its database record Contract pharmacy P&Ps need to be strengthened CE should remove inactive contract pharmacy registrations from OPA database CE should develop policies for notifying HRSA when it must purchase covered outpatient drugs through a group purchasing organization in the absence of 340B pricing availability 8
9 Two Kinds of CAPs CEs must initiate correction action in two situations: As a result of an adverse audit by HRSA or manufacturer As a result of discovering a use of the 340B program that is noncompliant There are both differences and similarities between these two kinds of CAPs 9
10 HRSA Audit CAP CAP is generally due within 60 days of either an uncontested adverse audit report or any unsuccessful appeal, called a Notice of Disagreement HRSA is generally willing to grant one extension Audit results are posted on the website of the Office of Pharmacy Affairs (OPA) and manufacturers are invited to contact the CE if they believe they are owed repayment 10
11 HRSA Audit CAP (cont d) In January 2016, OPA provided an update on its website announcing changes to the audit process Discontinuance of public letter requirement Electronic submission of audit documents using address CAPs remain open until settlements have been finalized and CE submits letter attesting that corrective action is complete CEs must receive written confirmation from state Medicaid agencies that manufacturers were not subject to duplicate discounts 11
12 HRSA Audit CAP (cont d) HRSA has developed a CAP template CAP preparation simply involves filling in the boxes in the template chart The template appears to have fewer elements for example, it does not seek information about performing targeted self-audits to validate that the non-compliance will not reoccur Question is HRSA seeking less information? We have found use of the template to be awkward because it does not provide sufficient room to describe a CAP fully A detailed CAP can provide protection against future allegations that the CE failed to take adequate corrective action 12
13 Self-Audit CAP Pursuant to the annual recertification process, the CE s Authorizing Official must certify, among other things, the CE s responsibility to: Self-disclose to HRSA as soon as possible if there is any change in eligibility and/or breach of program requirements Take corrective action which may include repayment to manufacturers, payment of interest and/or removal from the program Corrective action is always required even if self-disclosure is not 13
14 Self-Audit CAP (cont d) HRSA does not require a specific format, including use of the new CAP template, for describing its proposed corrective action Nonetheless, CEs would be well advised to address all of the CAP elements required by HRSA in response to a HRSA audit HRSA expects CAP implementation updates and notification when a CAP is complete, but again the process if less formal Results of a self-disclosure, in contrast to a HRSA audit, are not posted on the OPA website CEs are always better off addressing compliance issues through the selfdisclosure process than waiting for a HRSA audit Self-disclosures made after a CE receives its audit notice are typically included in the audit report as a finding 14
15 When Are Self-Disclosures Required? Question are there some instances of non-compliance that still do not need to be reported if, for example, they are minor in nature and/or easily corrected? Although HRSA eliminated the materiality language in the recertification statement, a materiality threshold for self-reporting is still referenced on the OPA website and in Apexus materials We recommend that CEs establish a materiality threshold in their 340B policies and procedures 15
16 Assessing Materiality Apexus tool suggests three steps: 1. Establish threshold (may vary by setting) 2. Determine how and by whom materiality will be assessed 3. Maintain records of materiality assessments Threshold examples: % of total 340B purchases (or by manufacturer) Fixed dollar amount for all non-compliant purchases (or by manufacturer) % of total 340B inventory (units) % of audit sample 16
17 Elements of a CAP Manufacturer repayment (if necessary) Strengthened policies and procedures Targeted self-audits with description of audit process, sampling, frequency, etc. Ongoing compliance oversight activities Implementation dates Responsible individuals Internal communication and education strategy 17
18 Manufacturer Repayment - Statute 42 U.S.C. 256b(a)(5)(D) If the Secretary finds, after audit as described in subparagraph (C) and after notice and hearing, that a covered entity is in violation of the anti-diversion or duplicate discount requirements, the covered entity shall be liable to the manufacturer of the covered outpatient drug that is the subject of the violation in an amount equal to the reduction in the price of the drug
19 Manufacturer Repayment Statute (cont d) Enhanced sanctions under 42 U.S.C. 256b(d)(2)(B)(v): If covered entity knowingly and intentionally diverts 340B drugs, the HRSA may impose an interest penalty on the amount of the discount to be repaid If the diversion is also systematic and egregious, HRSA may remove the covered entity from the 340B program These sanctions are NOT exclusive HRSA could also refer a covered entity to other authorities if it suspects that the covered entity has violated other provisions, like the False Claims Act, anti-kickback statute, or Prescription Drug Marketing Act 19
20 Manufacturer Repayment - Remedies Credit and rebill Offer refund check If repayment is due as a result of over-purchasing 340B drugs: Return to supplier Keep separate from non-340b inventory and only use for 340B eligible patient Destroy If using a replenishment-based virtual inventory system, adjust accumulator (i.e., under-purchase NDC to negate over-purchases), but need manufacturer transparency and/or permission 20
21 Repayment Challenges Quantifying the amount to refund The 340B price changes over time, as does the non-340b price For hospitals subject to GPO prohibition, consider using Apexus wholesale acquisition cost (WAC) file because historical WAC is difficult to retrieve Contract pharmacies often refuse to reveal what they pay for drugs so CE will have to estimate non-340b price consider using the NADAC price file Ask manufacturer to calculate repayment amount? Contacting manufacturer who is proper contact person? How to handle unresponsive manufacturers? 21
22 Repayment Tips 1. Give manufacturers different options for repayment credit-and-rebill, refund check, or accumulator adjustment 2. Be transparent with OPA and manufacturers show how repayment amount was calculated 3. Do not just mail out checks or initiate credit-and-rebills or accumulator adjustments 4. Set a deadline for manufacturer responses 5. Specify default remedy if manufacturer fails to respond and send closeout letter when corrective action completed 6. Cooperate with manufacturers that have questions or take issue with the proposed remedy 22
23 Other CE Corrective Actions Updating 340B policies and procedures; Updating 340B inventory management systems; Increasing the frequency of CE self-audits; Implementing 340B compliance training programs; Correcting/updating database entries and Medicaid Exclusion File; Working with state Medicaid agencies; and Improving internal controls in mixed-use areas. 23
24 Closing Out a CAP To close out the CAP, HRSA expects an attestation letter stating that the CAP is fully implemented, settlements have been finalized and CE is willing to work towards repayment with unresponsive manufacturers Spreadsheet identifying repayments made are typically included Question how long must a CE be willing to work towards repayment for unresponsive manufacturers? A three-year repayment obligation is defensible in light of the manufacturer audit guidelines and HRSA s dispute resolution regulation 24
25 Manufacturer Inquiries CE should be cooperative Failure to cooperate could lead to formal manufacturer audit and serve as reasonable cause that violation occurred CE must balance its own interests Compliance with federal and state privacy laws No fishing expeditions need specific NDCs, time period, general explanation of why data is being requested Issues Old data is difficult to retrieve retrieval fees, wholesalers change, manual processes often involved, etc. Evolving HRSA guidance cannot apply current standards to past practices Attorney-client privilege 25
26 CE Question True or False: A covered entity is only required to initiate corrective action if the non-compliance is material? 26
27 CE Question & Answer True or False: A covered entity is only required to initiate corrective action if the non-compliance is material? Answer: False 27
28 Additional Questions? Bill von Oehsen Principal Powers Pyles Sutter & Verville, PC 1501 M Street, NW 7 th Floor Washington, DC Phone: William.vonOehsen@PowersLaw.com 28
Following this presentation, attendees should be able to: Identify key events in 340B landscape that occurred in 2015 and 2016.
Following this presentation, attendees should be able to: Identify key events in 340B landscape that occurred in 2015 and 2016. Identify critical components of a compliance plan. List the different types
More informationThe Federal 340B Drug Discount Program. Compliance and Lessons Learned. Jason Reddish September 24, 2014
The Federal 340B Drug Discount Program Compliance and Lessons Learned Jason Reddish September 24, 2014 About Me Jason Reddish Attorney Powers Pyles Sutter & Verville PC 1501 M Street NW, 7 th Floor Washington,
More informationTable of Contents. Executive Resources, LLC 2015, v. 2
2 Table of Contents I. Introduction II. Overview III. Contract Pharmacy and Arrangements IV. HRSA and 340B Data Base V. Software, Internal Control Systems and Management of Inventory VI. External Relationships
More informationThe 340B Program: Challenges and Opportunities
The 340B Program: Challenges and Opportunities March 2015 Thomas Barker Igor Gorlach Foley Hoag LLP Overview Overview and History of the 340B Program ACA s Changes to the 340B Program Recent Developments
More information6/11/2013. South Carolina Primary Health Care Association. Overview. 340B Essentials. Disclaimer. 340B Essentials. 340B Essentials
South Carolina Primary Health Care Association 2013 Clinical Network Retreat June 9, 2013 Preparing for and Surviving a 340B Audit presented by: Michael B. Glomb, Partner of Overview Key features of the
More information340B Program Contract Pharmacy Self-Audit Tool: Diversion
Page 1 Purpose: The purpose of the Contract Pharmacy Self-Audit Tools is to improve contract pharmacies compliance with the 340B Program requirements. Covered entities remain responsible for the 340B drugs
More informationWebinar Schedule. I. A Guide to the 340B Omnibus Guidance 340B Background Guide to the Guidance
Webinar Schedule I. A Guide to the 340B Omnibus Guidance 340B Background Guide to the Guidance II. Stakeholder Response to the 340B Ceiling Price and Manufacturer CMP Proposed Rule Thursday, Oct. 8, 2005
More information340B Program Update & Recommendations for Monitoring Program Compliance October
340B Program Update & Recommendations for Monitoring Program Compliance October 2 2014 Speaker Biography Ray Albertina Director Deloitte & Touche LLP +1 (314) 342 4984 ralbertina@deloitte.com Ray is a
More information2/25/2016. Today s Objectives. Disclaimer WHAT S NEW IN THE WORLD OF 340B?
WHAT S NEW IN THE WORLD OF 340B? Jim Donnelly Vice President of Pharmacy Services Hudson Headwaters Health Network Jennifer Bolster Partner Hancock Estabrook, LLP. Friday, February 26 th Today s Objectives
More informationRenee Gravalin, Partner
Experience the Eide Bailly Difference 340B Drug Program Renee Gravalin, Partner rgravalin@eidebailly.com 701.799.5449 Agenda Proposed Changes 1 Experience the Eide Bailly Difference Created in 1992 to
More informationTHE 340B DRUG DISCOUNT PROGRAM AND INTERPLAY WITH MEDICARE AND MEDICAID REIMBURSEMENT PRINCIPLES. Barbara Straub Williams.
THE 340B DRUG DISCOUNT PROGRAM AND INTERPLAY WITH MEDICARE AND MEDICAID REIMBURSEMENT PRINCIPLES I. History and Purpose of 340B Program Barbara Straub Williams March 2015 Section 340B of the Public Health
More informationCOMPLIANCE IN THE 340B DRUG PRICING PROGRAM
COMPLIANCE IN THE 340B DRUG PRICING PROGRAM Jason Atlas RPh MBA Manager, Education and Compliance Support Apexus Education and Compliance Support Team Apexus Education and Compliance Support Team 1 Objectives
More informationMATERIAL COVERED TODAY
MATERIAL COVERED TODAY This presentation has been designed to discuss compliance needs, proposed changes and best practices for covered entities in the 340B Drug Pricing Program This presentation should
More informationThis training will begin at 12:00pm ET. WebEx Technical Support: Or us at
This training will begin at 12:00pm ET WebEx Technical Support: 1-866-229-3239 Or e-mail us at nationalhivcenter@fenwayhealth.org Works with HIV/AIDS service organizations and community-based organizations
More information340B Drug Pricing: Don t Become an HRSA Statistic. Wipfli LLP 1
340B Drug Pricing: Don t Become an HRSA Statistic October 13, 2017 Wipfli LLP 1 Today s Agenda 340B Drug Pricing Program Overview Program Benefit Eligibility Program in Operation Contract Pharmacy Regulatory
More information1/16/2014. David Pointer President, SolutionsRx
David Pointer President, SolutionsRx 417.679.2203 david@pointerlaw.com 1 340B Program Overview Physician-Administered Drugs Contract Pharmacies 340B Compliance Expanding 340B Utilization 2 Federally mandated
More information10/2/2015. CPAs and ADVISORS 340B: COMPLIANCE MATTERS AND HERE S WHY MICHAEL R. EARLS, CPA DIRECTOR. experience access // 2 // experience access
CPAs and ADVISORS experience access // 340B: COMPLIANCE MATTERS AND HERE S WHY MICHAEL R. EARLS, CPA DIRECTOR MATERIALS COVERED TODAY 340B Program Evolution, Purpose & Benefits HRSA & Manufacturer Audits
More information340B Drug Pricing Program: Participation, Eligibility and Program Integrity HOSPITALS June 26 th, 2014
340B Drug Pricing Program: Participation, Eligibility and Program Integrity HOSPITALS June 26 th, 2014 LCDR Joshua E. Hardin MBA, RN/BSN, MLT U.S. Department of Health and Human Services Health Resources
More informationIntroduction. The Basics of the 340B Program. 340B Drug Discount Program Compliance, Audit & Enforcement Activity. Wesley R.
340B Drug Discount Program Compliance, Audit & Enforcement Activity Wesley R. Butler Wes.Butler@BBB-Law.com Introduction Caveat This presentation is intended as an overview of a complex area of law and
More information340B Program: Mega Guidance, Mega Change Pershing Yoakley & Associates, PC (PYA).
340B Program: Mega Guidance, Mega Change No portion of this white paper may be used or duplicated by any person or entity for any purpose without the express written permission of PYA. For many years,
More informationStructuring 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 WEDNESDAY, MARCH 19, 2014 1pm Eastern 12pm Central 11am
More information340B Compliance, Audits & Opportunities
340B Compliance, Audits & Opportunities NW Ohio HFMA February 15, 2018 David Layne, CPA Manager HRSA Audits Bizzell Group-Silver Spring, Maryland Prior Hospital experience Many are pharmacists Experienced
More informationCompliance Risk Areas for Health Centers: A Financial Perspective. Marcie H. Zakheim Partner
Compliance Risk Areas for Health Centers: A Financial Perspective Marcie H. Zakheim Partner DISCLAIMER This training has been prepared by the attorneys of Feldesman Tucker Leifer Fidell LLP. The opinions
More information340B 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 1 340B Program
More informationStatement of Conflicts of Interest
Part 1 - Overview Debra A. Muscio, MBA, CHC, CCE, CFE SVP, Chief Audit, Ethics & Officer Community Medical Centers Karolyn Woo-Miles Senior Manager Deloitte & Touche LLP April 22, 2015 Statement of Conflicts
More informationIt s Here: The Final 60 Day Overpayment Rule
It s Here: The Final 60 Day Overpayment Rule (What it means for you and your clients) Hillary M. Stemple, Esq. Associate Arent Fox LLP Washington, DC 20006 hillary.stemple@arentfox.com December 5, 2017
More information340B Guardian Model Overview
340B Guardian Model Overview Why monitor 340B program compliance? The 340B program has grown from less than $2B in total sales in 2002 to over $8B in sales in 2012. Currently, approximately 30,000 covered
More information340B Pharmacy Program Compliance insight. ideas Kentucky Primary Care Association attention
340B Pharmacy Program Compliance Kentucky Primary Care Association Presented by: Scott Gold, CPA, Partner October 16, 2012 Brief Overview History of 340B Drug Program Discounted Pharmaceuticals Growing
More information340B Drug Program Compliance: Focus on Disproportionate Hospitals
340B Drug Program Compliance: Focus on Disproportionate Hospitals Part II: 340B Drug Program Compliance: Pharmacy Operations and the DSH January 29, 2014 1 Faculty Stephen J. Weiser, JD, LLM Director 312-403-4284
More informationContract Pharmacy Relationships
Contract Pharmacy Relationships What is a contract pharmacy? 1 What is a contract pharmacy? Dispenses drugs to FQHC patients on behalf of FQHC Contract between FQHC and pharmacy Typically pharmacy not
More informationSteve Zielinski Regional Director SUNRx, LLC April 16, 2010
Steve Zielinski Regional Director SUNRx, LLC April 16, 2010 Mississippi Primary Care Association 340B Program Overview Contracted Pharmacy Model New Multiple Contract Pharmacy Elements Maintaining 340B
More information340B: WHAT ATTORNEYS NEED TO KNOW TODAY, TOMORROW AND IN THE FUTURE. March 3, 2016 ABA Emerging Issues in Healthcare Conference San Diego, CA
340B: WHAT ATTORNEYS NEED TO KNOW TODAY, TOMORROW AND IN THE FUTURE March 3, 2016 ABA Emerging Issues in Healthcare Conference San Diego, CA 2 Presentation Outline What you need to know Today 340B Program
More information340B Pharmacy Program Best Practices
340B Pharmacy Program Best Practices December 8, 2015 Agenda 1. The Program and the Requirements 2. Program Compliance and Integrity (Best Practices) Internal Controls Policies and Procedures OPA Database
More information340B Compliance: Overcoming Challenges with Diversion, Duplicate Discounts, and Orphan Drug Restrictions
Presenting a live 90-minute webinar with interactive Q&A 340B Compliance: Overcoming Challenges with Diversion, Duplicate Discounts, and Orphan Drug Restrictions WEDNESDAY, JANUARY 15, 2014 1pm Eastern
More informationAaron Vandervelde Managing Director Berkeley Research Group
Aaron Vandervelde Managing Director Berkeley Research Group Statement re Interests Aaron Vandervelde provides services as an independent consultant concerning 340B matters to pharmaceutical manufacturers
More informationChapter 9 Medicaid and 340B
Chapter 9 Medicaid and 340B A. Introduction UPDATED 1. The complex intersection of Medicaid and 340B The intersection of 340B and Medicaid is one of the most complex and significant areas within any health
More informationCertifying Employee Training Navicent Health s Corporate Integrity Agreement Year Two
Certifying Employee Training Navicent Health s Corporate Integrity Agreement Year Two Corporate Integrity Agreement Effective 4/23/2015 Term of five years Basic Requirement: Maintain a Compliance Program
More informationBKD NATIONAL HEALTH CARE GROUP
BKD NATIONAL HEALTH CARE GROUP PRESCRIPTION FOR 340B SUCCESS IN 2018 February 14, 2018 BRIAN BELL DIRECTOR BBELL@BKD.COM TO RECEIVE CPE CREDIT Participate in entire webinar Answer polls when they are provided
More informationWhat is the 340B Program?
Emily Cook, Partner, McDermott Will & Emery Anne S. Daly, Senior Director of Compliance, Banner Health Karolyn Woo Miles, Principal, Deloitte & Touche LLP 1 What is the 340B Program? Federal drug discount
More informationDEPARTMENT OF HEALTH AND HUMAN SERVICES. Office of Inspector General s Use of Agreements to Protect the Integrity of Federal Health Care Programs
United States Government Accountability Office Report to Congressional Requesters April 2018 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General s Use of Agreements to Protect the Integrity
More informationD E B R A S C H U C H E R T, C O M P L I A N C E O F F I C E R
D E B R A S C H U C H E R T, C O M P L I A N C E O F F I C E R INTEGRATED CARE ALLIANCE, LLC CORPORATE COMPLIANCE PROGRAM It is the policy of Integrated Care Alliance to comply with all laws governing
More informationSTATE OF NEW JERSEY. SENATE, No th LEGISLATURE. Sponsored by: Senator NIA H. GILL District 34 (Essex and Passaic)
SENATE, No. STATE OF NEW JERSEY th LEGISLATURE INTRODUCED FEBRUARY, 00 Sponsored by: Senator NIA H. GILL District (Essex and Passaic) SYNOPSIS Regulates pharmacy benefits management companies. CURRENT
More informationReporting and Returning Overpayments. The 60-Day Repayment Window
Reporting and Returning Overpayments The 60-Day Repayment Window James A. Robertson, Esq. jrobertson@mdmc-law.com John W. Kaveney, Esq. jkaveney@mdmc-law.com Affordable Care Act requires: A person Who
More informationThe 340B Drug Pricing Program
The 340B Drug Pricing Program Presentation at Alliance of Community Health Plans Medical Directors and Pharmacy Directors Meeting October 2012 Avalere Health LLC Avalere Health LLC The intersection of
More informationPharmaceutical Summit on Business and Compliance Issues in Managed Markets
Pharmaceutical Summit on Business and Compliance Issues in Managed Markets TRACK A: 340B PROGRAM CONSIDERATIONS A Panel Discussion By: Agenda Panel Introductions Overview of 340B Program Compliance Considerations
More informationATTN: Comments on 340B Drug Pricing Program Omnibus Guidance
October 27, 2015 Krista Pedley Director, Office of Pharmacy Affairs Health Resources and Services Administration 5600 Fishers Lane Rockville, MD 20857 ATTN: Comments on 340B Drug Pricing Program Omnibus
More informationStark Self-Disclosure. Thomas S. Crane 1/ Mintz Levin Cohn Ferris Glovsky and Popeo, PC
Stark Self-Disclosure Thomas S. Crane 1/ Mintz Levin Cohn Ferris Glovsky and Popeo, PC A. Background 1. Stark Law The Physician Self-Referral Statute (or the Stark Law ) prohibits a physician from referring
More informationCompliance and Fraud, Waste, and Abuse Awareness Training. First Tier, Downstream, and Related Entities
Compliance and Fraud, Waste, and Abuse Awareness Training First Tier, Downstream, and Related Entities 1 Course Outline Overview Purpose of training Effective Compliance program Definition of Fraud, Waste,
More informationANTI-FRAUD PLAN INTRODUCTION
ANTI-FRAUD PLAN INTRODUCTION We recognize the importance of preventing, detecting and investigating fraud, abuse and waste, and are committed to protecting and preserving the integrity and availability
More informationBest Practices for 340B Internal Audits and Key Takeaways from the Winter 340B Coalition Conference
Best Practices for 340B Internal Audits and Key Takeaways from the Winter 340B Coalition Conference February 9, 2017 1 Webinar Panelists! The Panel! Tammy Zukowski, MBA! Douglas E. Miller, Pharm.D.! William
More informationA Pharmacy s Guide to 340B Contract Pharmacy Services Best Practices
A Pharmacy s Guide to 340B Contract Pharmacy Services Best Prepared by: Date: September 1, 2014 Table of Contents Overview... 1 Introduction to the 340B program... 3 340B Covered Entity Eligibility...
More informationTX Health and Human Services Commission Proposed Rule: 340B Program Reimbursement
January 31, 2014 VIA ELECTRONIC SUBMISSION Vendor Drug Program Medicaid/CHIP Division 4900 N. Lamar Austin, Texas 78751 RE: TX Health and Human Services Commission Proposed Rule: 340B Program Reimbursement
More informationDisclaimer. The materials and views expressed in this presentation are the views of the presenters and not necessarily the views of Northwell Health
Helpful Tips for Value Based Payment (VBP) Compliance Programs Greg Radinsky Vice President & Chief Corporate Compliance Officer Aaron Lund Director of Corporate Compliance & Privacy Officer Disclaimer
More informationRx Office Hours: IMPORTANT
Rx Office Hours: IMPORTANT To ensure a high quality audio experience for all, please: Dial in using your phone (NOT your computer.) Enter your personal Attendee ID (located in the left hand box, below
More informationANCILLARY services: How to Stay Out of Trouble. The neurosurgical minefield Informed consent
ANCILLARY services: How to Stay Out of Trouble Richard N.W. Wohns, M.D. JD, MBA NeoSpine, Puget Sound Region, Washington The neurosurgical minefield 2013 Informed consent HIPAA ARRA and HITECH Anti-Kickback
More informationRecent Developments In Voluntary Disclosure Stark Law
HCCA Compliance Institute 2010 Legal & Regulatory W6, Part1 April 21, 2010 Recent Developments In Voluntary Disclosure Stark Law Jeffrey Fitzgerald Faegre & Benson LLP jfitgerald@faegre.com 303.607.3740
More informationSUPPLEMENTAL REBATE AGREEMENT Company Name
Department Log # SUPPLEMENTAL REBATE AGREEMENT Company Name This Supplemental Rebate Agreement ( Agreement ) is dated as of this 1 st day of January, by and between the State of Utah Department of Health,
More informationA. As Currently Implemented, the Recovery Purchasing Program Is Not Truly Voluntary for FSS Contractors Under Schedule 65, Part I, Section B.
April 2, 2007 Ms. Laurieann Duarte General Services Administration Regulatory Secretariat (VIR) 1800 F Street, NW Room 4035 Washington, D.C. 20405 Dear Ms. Duarte: Re: Amendment 2007-01, GSAR Case 2006-G522;
More informationAnti-Kickback Statute and False Claims Act Enforcement
Anti-Kickback Statute and False Claims Act Enforcement Nicholas Gachassin, III, Esq. Gachassin Law Firm, LLC Nick3@gachassin.com Press Conference on Health Care Fraud and the Affordable Care Act May 13,
More informationChapter 13 Section 6. Provider Exclusions, Suspensions, And Terminations
Program Integrity Chapter 13 Section 6 1.0 SCOPE AND PURPOSE 1.1 This section specifies which individuals and entities may, or in some cases must, be excluded from the TRICARE program. It outlines the
More informationREIMBURSEMENT: GETTING PHYSICIANS PAID
REIMBURSEMENT: GETTING PHYSICIANS PAID Andrew H. Selesnick Current State of Affairs The last few years have been a tumultuous financial time for Physicians: Slashed Medicaid programs Each year, Congress
More information340B MEGA GUIDANCE WHAT NOW? HFMA REGION 6 DECEMBER 16, 2015
340B MEGA GUIDANCE WHAT NOW? HFMA REGION 6 DECEMBER 16, 2015 Brian Bell Director bbell@bkd.com Claire Torrella Manager ctorrella@bkd.com MATERIAL COVERED TODAY The Health Resources and Services Administration
More informationH e a l t h C a r e Compliance Adviser
March 2001 Volume 5 Number 1 H e a l t h C a r e Compliance Adviser OIG Issues New Advisory Opinion on Gainsharing Reversing July 1999 Special Advisory Bulletin In a welcome departure from its former position,
More informationCMS Opens its Doors by Creating the Stark Voluntary Self-Referral Disclosure Protocol But Enter at Your Own Risk
A BNA s HEALTH LAW REPORTER! Reproduced with permission from BNA s Health Law Reporter, hlr, 10/07/2010. Copyright 2010 by The Bureau of National Affairs, Inc. (800-372-1033) http:// www.bna.com CMS Opens
More informationWYOMING MEDICAID SUPPLEMENTAL DRUG REBATE AGREEMENT
SSDC WYOMING MEDICAID SUPPLEMENTAL DRUG REBATE AGREEMENT 1. PARTIES/PERIOD This Agreement is made and entered into this 1 st day of January, 2012, by and between the State of Wyoming (State), represented
More informationGERALD (JERRY) LEWANDOWSKI. BERKELEY RESEARCH GROUP, LLC 1800 M Street NW, Second Floor Washington, DC 20036
Curriculum Vitae GERALD (JERRY) LEWANDOWSKI BERKELEY RESEARCH GROUP, LLC 1800 M Street NW, Second Floor Washington, DC 20036 Direct: 202.480.2643 Mobile: 202.258.2669 jlewandowski@thinkbrg.com Jerry Lewandowski
More information340B Drug Discount Program: Expansion Issues, Diversion Concerns, and Implications for Price Reporting and Compliance
BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK PALO ALTO SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. 340B Drug Discount Program: Expansion Issues,
More informationWeb Seminar. Physician Payments in the "Sunshine": Implications of CMS Regulations for Business and the Future of American Health Care.
Web Seminar Physician Payments in the "Sunshine": Implications of CMS Regulations for Business and the Future of American Health Care Featuring James C. Stansel Sidley Austin LLP Meenakshi Datta Sidley
More informationSOAH DOCKET NO C TDI CASE NO Argus Health Systems, Inc. Administrative Hearings. First Amended Notice of Hearing
SOAH DOCKET NO. 454-15-4787.C TDI CASE NO. 6438 Texas Department of Insurance, Petitioner Before the State Office V. of Argus Health Systems, Inc. Respondent Administrative Hearings First Amended The Texas
More informationCROSS-BORDER PRIVACY RULES SYSTEM JOINT OVERSIGHT PANEL RECOMMENDATION REPORT ON THE CONTINUED APEC RECOGNITION OF TRUSTe
CROSS-BORDER PRIVACY RULES SYSTEM JOINT OVERSIGHT PANEL 2015 RECOMMENDATION REPORT ON THE CONTINUED APEC RECOGNITION OF TRUSTe Submitted To: Mr. Ted Dean Chair, APEC Electronic Commerce Steering Group
More informationHRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment
Alert Life Sciences Health Industry If you have questions or would like additional information on the material covered in this Alert, please contact one of the attorneys listed below: Joseph W. Metro Partner,
More informationAmerica s Voice for Community Health Care
America s Voice for Community Health Care The National Association of Community Health Centers (NACHC) represents Community and Migrant Health Centers, as well as Health Care for the Homeless and Public
More informationDEFENSE FINANCE AND ACCOUNTING SERVICE U.S. Military Retired Pay 8899 E 56 th Street Indianapolis, IN
DEFENSE FINANCE AND ACCOUNTING SERVICE U.S. Military Retired Pay 8899 E 56 th Street Indianapolis, IN 46249-1200 www.dfas.mil/retiredmilitary.html, (Ret) Month XX, 20XX Dear : This letter addresses your
More informationPrivacy Rule - Complaint Investigations
Update on Enforcement of the HIPAA Privacy and Security Rules Marilou King, JD Office for Civil Rights U.S. Department of Heath and Human Services www.hcca-info.org 888-580-8373 Privacy Rule - Complaint
More informationFAR GOVERNMENT CONTRACT PROVISIONS
PAGE 1 OF 10 INCORPORATION OF FAR CLAUSES The following terms and conditions apply for purchase orders, subcontracts, or other applicable agreements issued in support of a US Government contract, in addition
More information11/5/2015 A&A PERSPECTIVE. HFMA Region 9 Conference November 15, Tracy Young, CPA, Partner Brian Bell, Director
340B MEGA GUIDANCE FROM AN A&A PERSPECTIVE HFMA Region 9 Conference November 15, 2015 Tracy Young, CPA, Partner Brian Bell, Director 1 MATERIAL COVERED TODAY The Health Resources and Services Administration
More information503 SURVIVING A HIPAA BREACH INVESTIGATION
503 SURVIVING A HIPAA BREACH INVESTIGATION Presented by Nicole Hughes Waid, Esq. Mark J. Swearingen, Esq. Celeste H. Davis, Esq. Regional Manager 1 Surviving a HIPAA Breach Investigation: Enforcement Presented
More informationThe 340B Drug Pricing Program: Opportunities for Community Pharmacists
The 340B Drug Pricing Program: Opportunities for Community Pharmacists by Marsha K. Millonig, MBA, RPh President,Catalyst Enterprises, LLC Goals: After completing this program, participants will be able
More informationCommitment to Compliance
Introduction Commitment to Compliance SelectHealth has a compliance oversight program which supports compliant behavior by its employees and any of its contracted business partners, including first -tier,
More information340B Contract Pharmacy Arrangements: What Does the Future Hold?
Presenting a live 90-minute webinar with interactive Q&A 340B Contract Pharmacy Arrangements: What Does the Future Hold? Structuring Arrangements, Meeting Legal and Regulatory Requirements THURSDAY, DECEMBER
More informationTRICARE Pharmacy Voluntary Agreement for Retail Refunds (Additional Refund) for Uniform Formulary Placement (UF-VARR)
TRICARE Pharmacy Voluntary Agreement for Retail Refunds (Additional Refund) for Uniform Formulary Placement (UF-VARR) CAVEATS: The parties acknowledge that 32 C.F.R. 199.21(q), effective May 26, 2009 provides
More informationGENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2017 H 2 HOUSE BILL 156 Senate Health Care Committee Substitute Adopted 6/22/17
GENERAL ASSEMBLY OF NORTH CAROLINA SESSION H HOUSE BILL Senate Health Care Committee Substitute Adopted // Short Title: Medicaid PHP Licensure/Food Svcs State Bldgs. (Public) Sponsors: Referred to: February,
More informationElectricity Concession Contract
Electricity Concession Contract ELECTRICITY CONCESSION CONTRACT TABLE OF CONTENTS 1 SCOPE OF CONCESSION... 1 1.1 Concession... 1 1.2 Back up generation... 1 1.3 Self generation... 1 2 SERVICE COVERAGE
More informationAgenda. Strategic Considerations in Resolving Voluntary Government Disclosures
Strategic Considerations in Resolving Voluntary Government Disclosures Health Care Compliance Association Annual Compliance Institute Patrick Garcia Hall, Render, Killian, Heath, & Lyman, P.C. Kenneth
More information2/24/2017. Agenda. Determine Potential Liability. Strategic Considerations in Resolving Voluntary Government Disclosures. Relevant legal authorities:
Strategic Considerations in Resolving Voluntary Government Disclosures Health Care Compliance Association Annual Compliance Institute Patrick Garcia Hall, Render, Killian, Heath, & Lyman, P.C. Kenneth
More information2013 HIPAA Omnibus Regulations: New Rules for Healthcare Providers and Collections Partners
2013 HIPAA Omnibus Regulations: New Rules for Healthcare Providers and Collections Partners Providers, and Partners 2 Editor s Foreword What follows are excerpts from the U.S. Department of Health and
More informationRE: 340B Civil Monetary Penalties for Manufacturers and Ceiling Price Regulations (RIN AA89)
Office of Pharmacy Affairs Healthcare Systems Bureau Health Resources and Services Administration 5600 Fishers Lane Mail Stop 08W05A Rockville, MD 20857 Submitted via www.regulations.gov RE: 340B Civil
More informationChapter 13 Section 2. Controls, Education, and Conflicts of Interest
Program Integrity Chapter 13 Section 2 Revision: 1.0 CONTROLS 1.1 Controls for the Prevention And Detection Of Fraudulent Or Abusive Practices The contractor shall establish procedures and utilize controls
More informationVaries by State from 17% to 23%.
The table immediately below is provided for illustrative purposes only and the consumer will receive a table with their specific terms prior to the first transactions on the account. Interest Rate and
More informationFundamentals and Practicalities of Identifying and Returning Overpayments
Fundamentals and Practicalities of Identifying and Returning Overpayments American Health Lawyers Association Physicians and Physician Organizations Law Institute Hospitals and Health Systems Law Institute
More informationVisa Health Savings Debit Card Agreement and Disclosure
Visa Health Savings Debit Card Agreement and Disclosure P.O. Box 45085 Jacksonville, FL 32232-5085 www.vystarcu.org (904) 908-2329 1-866-897-8272 VYSTAR CREDIT UNION VISA HEALTH SAVINGS DEBIT CARD AGREEMENT
More informationDEFICIT REDUCTION ACT AND FALSE CLAIMS POLICY INFORMATION FOR All MASSACHUSETTS WORKFORCE MEMBERS
DEFICIT REDUCTION ACT AND FALSE CLAIMS POLICY INFORMATION FOR All MASSACHUSETTS WORKFORCE MEMBERS The Company is committed to preventing health care fraud, waste and abuse and complying with applicable
More informationMedicare Parts C & D General Compliance Training
Medicare Parts C & D General Compliance Training Developed by the Centers for Medicare & Medicaid Services Issued: February, 2013 Part 2: Medicare Parts C & D Compliance Training Developed by the Centers
More information340B MEGA GUIDANCE WHAT NOW? KENTUCKY HFMA WINTER INSTITUTE JANUARY 21, 2016
340B MEGA GUIDANCE WHAT NOW? KENTUCKY HFMA WINTER INSTITUTE JANUARY 21, 2016 Brian Bell Director bbell@bkd.com Brenda Christman Managing Director bchristman@bkd.com MATERIAL COVERED TODAY The Health Resources
More informationCHAPTER 2 Section 10, pages 3 through 6 Section 10, pages 3 through 7
CHANGE 13 6010.59-M DECEMBER 12, 2017 REMOVE PAGE(S) INSERT PAGE(S) CHAPTER 2 Section 10, pages 3 through 6 Section 10, pages 3 through 7 CHAPTER 10 Section 4, pages 5, 6, and 19 through 21 Section 4,
More informationDEFICIT REDUCTION ACT AND FALSE CLAIMS POLICY INFORMATION FOR All NEW YORK WORKFORCE MEMBERS
DEFICIT REDUCTION ACT AND FALSE CLAIMS POLICY INFORMATION FOR All NEW YORK WORKFORCE MEMBERS The Company is committed to preventing health care fraud, waste and abuse and complying with applicable state
More informationFlorida Agency for Health Care Administration AG Federal Awards Audit (Report# ) Six-Month Status Report as of September 30, 2014
Six-Month Status Report Finding# 2013-001 Recommendation Management Response The FAHCA Bureau of Finance and Accounting (Bureau) did not appropriately record in the correct funds the receivables resulting
More informationCompliance Program. Health First Health Plans Medicare Parts C & D Training
Compliance Program Health First Health Plans Medicare Parts C & D Training Compliance Training Objectives Meeting regulatory requirements Defining an effective compliance program Communicating the obligation
More informationRETAIL INSTALMENT CREDIT AGREEMENT ( RETAIL CHARGE)
RETAIL INSTALMENT CREDIT AGREEMENT ( RETAIL CHARGE) Luther Credit Terms & Conditions 1. PROMISE TO PAY: You (meaning each applicant and co-applicant for credit identified on the application which is incorporated
More information340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties. AGENCY: Health Resources and Services Administration, HHS.
This document is scheduled to be published in the Federal Register on 06/05/2018 and available online at https://federalregister.gov/d/2018-12103, and on FDsys.gov Billing Code: 4165-15 DEPARTMENT OF HEALTH
More information