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• Preferred Drug Lists • Medicaid Dispute Resolution Program • Product Price Increase (CPI-U Penalty and Discount Best Price) • Part D Drug Benefit Effective Compliance Programs Federal Ceiling Prices TRICARE • Manufacturer, State, First Data Bank, and NCPDP MDRP responsibilities. • Effects on Best Price when dealing with disease management programs, multi-layer discounts and formularies • Internal Medicaid Drug Rebate Validation-Verification and Dispute Resolution • Medicaid Rebate Recovery Initiatives for HCPCS Codes J-Code Billing Issues • 340B and much more! In Depth Discussion And Analysis Of The Following Topics: Meet And Discuss The MDRP With Top Industry Donna Yesner McKenna, Long & Aldridge LLP Judith Waltz Partner, Foley & Lardner LLP Marci Anderson, Senior Auditor VA Office of Inspector General Don Muse, Phd. - President Muse and Associates Robert Slavkin Benny Ridout, R.PH. President, Benny Ridout Consulting Jerry Wells, Bureau Chief Medicaid Pharmacy Affairs Agency for Healthcare Administration William von Oehsen Powers Pyles Sutter & Verville PC Senior Counsel, Foley & Lardner LLP State Of Florida Larry Allen, President Coalition for Government Procurement Stephen E. Ruscus McKenna, Long & Aldridge LLP A Special Thanks To Our Sponsors: Experts Such As: Heidi A Sorensen Lena Robins Of Counsel, Foley & Lardner LLP Partner, Foley & Lardner LLP

A Special Thanks To Our Sponsor - foley.com · 3/11/2008  · Partner, Foley & Lardner LLP Marci Anderson, Senior Auditor VA Office of Inspector General Don Muse, Phd. - President

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Page 1: A Special Thanks To Our Sponsor - foley.com · 3/11/2008  · Partner, Foley & Lardner LLP Marci Anderson, Senior Auditor VA Office of Inspector General Don Muse, Phd. - President

• The 340B Program

• Preferred Drug Lists

• Medicaid Dispute Resolution Program

• Product Price Increase (CPI-U Penalty and Discount Best Price)

• Part D Drug Benefit

• Effective Compliance Programs

• Federal Ceiling Prices

• TRICARE

• Manufacturer, State, First Data Bank, and NCPDP MDRP responsibilities.

• Effects on Best Price when dealing with disease management programs, multi-layer discounts and formularies

• Internal Medicaid Drug Rebate Validation-Verification and Dispute Resolution

• Medicaid Rebate Recovery Initiatives for HCPCS Codes

• J-Code Billing Issues

• 340B and much more!

In Depth Discussion And Analysis Of The Following Topics:

Meet And Discuss The MDRP With Top Industry

Donna Yesner McKenna, Long & Aldridge LLP

Judith Waltz Partner, Foley & Lardner LLP

Marci Anderson, Senior Auditor VA Office of Inspector General

Don Muse, Phd. - PresidentMuse and Associates

Robert Slavkin

Benny Ridout, R.PH.President, Benny Ridout Consulting

Jerry Wells, Bureau Chief

Medicaid Pharmacy AffairsAgency for Healthcare Administration

William von OehsenPowers Pyles Sutter & Verville PC

Senior Counsel, Foley & Lardner LLP

State Of Florida

Larry Allen, PresidentCoalition for Government Procurement

Stephen E. RuscusMcKenna, Long & Aldridge LLP

A Special Thanks To Our Sponsors:

Experts Such As:

Heidi A Sorensen

Lena Robins

Of Counsel, Foley & Lardner LLP

Partner, Foley & Lardner LLP

Page 2: A Special Thanks To Our Sponsor - foley.com · 3/11/2008  · Partner, Foley & Lardner LLP Marci Anderson, Senior Auditor VA Office of Inspector General Don Muse, Phd. - President

Register by calling Michael Russo at 201.662.3199 or fax 718.874.8513

Day One March 11th, 2008

8:00 am Official Welcoming Thomas Scurlock DGC Business Development Director

8:05-9:05 Understanding Drug Price Reporting Program Similarities and Differences

Donna Yesner

This presentation will focus on the conceptual and legal differences between the Medicaid Rebate Program, the Veternas Health Care Act price ceiling provisions, and the Medicare Modernization Act requirement for submission of ASP. It will provide side-by-side comparisons between

climate in Washington with Democrats in charge of Congress,

definitions and treatment of specific transactions in the price calculations under these programs, such as the treatment of customary

prompt pay discounts, nominal prices, wholesaler service fees, direct

rebates, smoothing formulas, transferred and terminated drugs, and price increase penalties. Attendees will learn what the key differences are among the programs and how they need to be accommodated in drug price

reporting systems and standard operating practices.

9:05-10:05 THE FINAL AMP AND BEST PRICE RULE:

SENSE OF THE NEW REQUIREMENTSLena Robins

This session will discuss in detail CMS' final AMP and Best Price rule, which went into effect on October 1, 2007 -- including issues related to the key definitions, manufacturer reporting obligations, determination and calculation of AMP and Best Price, pharmacy reimbursement issues, fraud and abuse implications ,unresolved issues, and future issues.

10:05-10:25 Coffee Break & Networking Opportunity

10:25-11:15 J-Code Billing Issues

11:15-12:15 Understanding the Focus of Enforcers in

Healthcare Fraud Heidi A. Sorensen, Of Counsel

The session will also provide insight into the process the government uses in resolving cases. While aspects of the government’s investigativeand case resolution process are common across the healthcare industry,the session will also cover aspects of the government's investigations unique to pharmaceutical manufacturers.

Some topics that will be covered include:

* Understanding the roles of OIG, CMS, DOJ, state Medicaid Fraud Control Units, and their law enforcement partners

* Anatomy of an investigation

* DOJ’s use of parallel criminal/civil investigations and deferred

prosecution agreements

* What to do if the enforcers show up

* Case resolutions

* Question and answer session

McKenna, Long & Aldridge LLP

Partner, Foley & Lardner LLP

Safety Net Hospitals for Pharmaceutical AccessWilliam von Oehsen, President and General Counsel

* Historic exclusion of physician-administered drugs from Medicaid rebate program.

* Federal and state efforts to "crosswalk" J-Codes and NDCs to facilitate collection of rebates * Errors and complications in J-Code crosswalking process:

package size and product strength differences, generic drugs, dispute resolution

* Congressional mandate for states to collect NDCs on physician-administered drugs under the Deficit Reduction Act of 2005 (DRA)

* DRA implementation challenges and hospital opposition based on legal and operational concerns* Potential duplicate discount risk for drugs sold through the

340Bprogram and federal efforts to protect manufacturers from such risk

Foley & Lardner LLP

Get an insider's point of view as former chief in the Administration &Civil Remedies Branch of the Office of Counsel to the Inspector General focuses on understanding healthcare fraud investigations.

Page 3: A Special Thanks To Our Sponsor - foley.com · 3/11/2008  · Partner, Foley & Lardner LLP Marci Anderson, Senior Auditor VA Office of Inspector General Don Muse, Phd. - President

Register by calling Michael Russo at 201.662.3199 or fax 718.874.8513

12:15-1:15 Delegate Luncheon & Networking Opportunity 1:15-2:15 Veterans Healthcare Act

Stephen E. RuscusMcKenna, Long & Aldridge LLP

This session will contrast current NFAMP calculation requirements under the Veterans Healthcare Actwith Medicaid calculations under the DRA as well as provide some information onVHCA calculation complexities

Topics to be included are:

*Non-FAMP components

*Calculation of the Federal Ceiling Price

*The Dual Calculation versus Dual Pricing

2:15-3:15 The Pharmaceutical FSS Contract

(Schedule 65I-B, SIN 42-2A and 42-2B) Marci Anderson, Senior Auditor, VA OIG

* Background on Department of Veterans Affairs delegated authority for the pharmaceutical FSS schedule

* What drugs are included in the two SINs

* Understanding your obligations for disclosure under the FSS

* Understanding key clauses in the FSS contract including price adjustments and price reductions

* VA's audit authority

* Performing self-audits

3:30-4:30 Isn't It Time To Analyze And Forecast Your

4:30-5:30 Implementation of an effective compliance program

Judith Waltz, Partner & Robert Slavkin, Senior Counsel

program. Topics will include: Recognizing an effective compliance program: The elements of creation of a compliance program that has longevity within your organization. Discussion will include incorporation of the OIG's guidance on the

Strategies to be utilized that help to ensure a compliance program that has a positive impact on your organization. Discussion will include buy-in from 'the top,' appropriate initial and ongoing training and education, and crafting appropriate

internal auditing andmonitoring tools.Application of the OIG guidance on a Part D compliance program: Part D Marketing Guidelines, as well as Part D compliance generally,and how acompliance program can be modified to include Part D compliance.

3:15-3:30 Coffee Break & Networking Opportunity

Medicaid Exposure? Mel Walker, Imany, Inc.

price, rebate and chargeback process fall short. Ensuring that contract price is adhered to and is correctly adjudicated is the first step in managing the revenue cycle. Once these price and transaction elements are automated, companies will need to look into how they

can optimize current and future contracts to improve strategic decisions and positively impact their bottom-line. Join this session and find out how you can perform various "what if" analysis surrounding the Medicaid, supplemental and state programs, which can greatly reduce your Medicaid liability.

Office of Contract Review

Most software applications that automate the sell-side contract,

seven elements to include in a compliance program.

This session will cover the ins and outs of implementing an effective compliance

Foley & Lardner LLP

Impact of ineffective compliance programs:Identify common deficiencies found

in compliance programs and the impact these deficiencies may have on your organization.Keeping your compliance program operating effectively:

Page 4: A Special Thanks To Our Sponsor - foley.com · 3/11/2008  · Partner, Foley & Lardner LLP Marci Anderson, Senior Auditor VA Office of Inspector General Don Muse, Phd. - President

6:00 Closing Remarks

Day Two March 12th, 2008

8:00 am Welcoming Address

8:10-9:10 Covered Drug Manufacturer Obligations under VAs FSS

Marci Anderson, Senior Auditor, VA OIG

Office of Contract Review

* Overview of the Veterans Health Care Act(PL 102-585 Section 603)

* What drugs are covered( to include discussion of authorized generics)

* Who is a manufacturer

* Calculating the non-Federal Average Manufacture Price

* Dual vs Single Pricing

* The Price Reduction Clause and the FCP

9:10-10:10 Elements of an effective compliance program Benefits of an effective program

How Compliance Programs Fail- Common Defects Sidney Kaplan,Senior Vice President

How do you recognize an effective compliance program?What are the common deficiencies found in compliance programs? What do you lose with an ineffective compliance program?How do you keep your compliance program operating effectively?How should you apply the OIG's compliance guidance to Part D compliance programs?

10:10-10:30 Coffee Break & Networking Opportunity

10:30-11:30 Lary Allen, President

Coalition for Government Procurement

Register by calling Michael Russo at 201.662.3199 or fax 718.874.8513

Strategic Management Systems, Inc.

*

For many years, the Department of Defense has sought access to VA Federal Supply Schedule prices for retail pharmacypurchases. Will they finally gain access to favorable VAdiscounts? If so, when? Get the status on their latest initiativeand what it means to pharmaceutical firms, DOD, and Tricare participants.

12:15 - 1:15 Delegate Luncheon & NetworkingOpportunity

Page 5: A Special Thanks To Our Sponsor - foley.com · 3/11/2008  · Partner, Foley & Lardner LLP Marci Anderson, Senior Auditor VA Office of Inspector General Don Muse, Phd. - President

Register by calling Michael Russo at 201.662.3199 or fax 718.874.8513

1:15 - 2:15 Challenges Under the 340B Drug Discount Program William von Oehsen

Safety Net Hospitals for Pharmaceutical Access

* Basic Explanation of 340B oRequirements for manufacturers

oMedicaid requirements for double discount/rebates and billing oHow pricing is calculated

* Relationship Between 340B and Medicaid Growth of Program - The Driving Force Progress Toward Improving the 340B Database and Pricing Transparency they are dispensing.

For instance, NDC 00001-0001-01 is for a Program Shortcomings Identified by the IG and Legislative Reform Efforts

Alternative Method Demonstration Projects and Proposed Changes to 340B Contract Pharmacy Program

Medicare Part D

* We are implementing conversion factors and max units to help eliminate some erroneous billings from being invoiced. However, if a situation caused by a conversion factor is actually invoiced, then the Drug Rebate Analyst would check the claim detail

to determine if all claims are to be converted. They will also deter

-mine if all claims are to be converted. They will also determine what the correct conversion factor is. Once this is done, the correction can be made to the invoice and the manufacturer is notified.

* The most difficult dispute to work is when products are generically available. In most cases, it is not possible to get on a telephone and call every provider who was paid a claim and ask what was dispensed on a particular date of service. We have found that it is better to write a letter to the the provider and ask for them to write on a copy of the claim, the correct drug NDC that was dispensed and the doctor's orders regarding

the claim. In some cases, we contact them again and ask that they fax a copy of the script to the office for the file. We have also asked for the doctor's information so that contact can be made with that office if a question has occured about the quantity written for the recipient.

2:15 - 2:30 Coffee Break & Networking Opportunity

2:30 - 3:30 The Deficit Reduction Act of 2005 (DRA) President, Benny Ridout Consulting

Benny Ridout, R.PH.

During this session we will look at the changes that were required of thepharmaceutical manufacturers and the State Medicaid Programs. We will discuss the changes and their effect on providers, drug manufacturers and the states.

Below is a list of some of the topics that will be covered:

* Federal Upper Limits (FUL) * Pharmacy dispensing fees

* Changes in definition and calculation of AMP

* Authorized generic drugs

* Limitation on sales at a nominal price * Determination of best price

* Bona fide service fee.

3:30 Closing Remarks And End Of Conference

* Bundles Sales* Manufacturer coupons* New requirements for manufacturers* Flexibilty for States to increase cost sharing* Physician-administered drugs

Page 6: A Special Thanks To Our Sponsor - foley.com · 3/11/2008  · Partner, Foley & Lardner LLP Marci Anderson, Senior Auditor VA Office of Inspector General Don Muse, Phd. - President

Conference 2008 Medicaid Drug Rebate Program Date: March 11th/12th,

Venue: The Radisson Hotel Miami, FL

Hotel Reservation: 305.374.0000 CONFERENCE PRICING Pharmaceutical Industry Pre-Conference $1395 Pre- Conference ends Jan. 30th, 2008 Standard Registration $1895 To Register, Please Contact Michael Russo Phone: 201.662.3199 Fax: 718.874.8513 Mail: DGC NYC Incorporated 237 75th Street, Suite 3 North Bergen NJ, 07047 DGC NYC Inc. Tax ID Number- 432022621 PLEASE REGISTER US TO ATTEND AS DETAILED BELOW: Company:

Address: Telephone:

Fax: Email:

Delegate(s): Title: Registration # Amount $ 1. 2. 3. 4. Total:

Method of Payment: [ ] AMEX [ ] Check

Card No.: Expiration Date: Cardholder Name: Signature:

DGC CANCELLATION, POSTPONMENT & SUBSTITUTION POLICY Payment is due prior to the conference and includes Lunches, Refreshments & all meeting materials available on site. While every effort is made on the part of DGC to secure speaker materials for inclusion in the delegate welcoming package, speakers reserve the right not to have their materials distributed or included. DGC does not provide refunds for cancellations. For cancellations received in writing less than seven (7) days prior to the conference delegate will receive a 100% credit to be used at another DGC conference for up to one year. For cancellations received less than seven (7) days prior to the conference no credits will be issued. In the event DGC cancels a conference, delegate payments at the date of cancellation will be credited to a future DGC event. If a registered delegate does not cancel or fails to attend the conference, this will be treated as a cancellation and no credit will be issued. If the delegate is unable to attend the rescheduled event, the delegate will receive will receive a 100% credit representing payments made towards a future DGC conference. This credit will be available for up to one year from the date of issuance. DGC is not responsible for any loss or damage as a result of substitution, alteration, cancellation or postponement due to a fortuitous event, act of God, unforeseen occurrence or any other event that renders performance of this conference impracticable or impossible. For purposes of this clause, a fortuitous event shall include, but not be limited to: war, fire, labor strike, extreme weather or other emergency. Please note that speakers and topics were confirmed at the time of publishing, however, circumstances beyond the control of the organizers may necessitate substitutions, alterations or cancellations of the speakers and/or topics. As such, DGC reserves the right to alter or modify the advertised speakers and/or topics if necessary.

2008