IdealNet and iContracts GP Presentation
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Transcript of IdealNet and iContracts GP Presentation
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
July 2010
Government Pricing How IdealNet, Inc. and iContracts, Inc. can help you to ensure full compliance
© 2010 IdealNet, Inc.Page 2
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 2
Taking Your Business to the Next Level™
Agenda
• Government Pricing Program Discussion
• Government Pricing Compliance Infrastructure Requirements
• Government Pricing Program Best Practices
• Government Audit Initiatives
• iContracts/Government Pricing
• How IdealNet and iContracts can help
• Questions & Discussion
© 2010 IdealNet, Inc.Page 3
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 3
Taking Your Business to the Next Level™
What is Government Contracting?
The contracting landscape for a manufacturer is segmented into two different end customers – commercial customers and government customers. Contracting with each customer segment demands different pricing strategies and compliance responsibilities.
– contracting landscape –
GPO
PBM
WHLSR
HOSP
HMO
PHARMACYMAIL ORDER
commercial government
MEDICAIDPROGRAM
STATES
VA PRIME VENDOR
PHSENTITIES
DSHENTITIES
FSS ENTITIES
• Pricing discounts range between 5% - 20% as driven by competition
• Contract compliance is required by Terms and Conditions or incentive structures
• Pricing is lower than commercial and reflects the largest discounts• Compliance is required by legislation and may carry severe monetary
penalties and criminal charges if violated
© 2010 IdealNet, Inc.Page 4
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 4
Taking Your Business to the Next Level™
What does it mean to contract with the Government?
Government Sector
Manufacturer
CMS(Centers for Medicare &
Medicaid Services)
VA(Veteran Affairs)
DOD(Department of Defense)
PHSEntities
(Public Health Service)
+
MedicaidAgreement
Federal Supply
Schedule Agreement
PricingAgreement
Other Programs(State or Assistance
Programs)+
If a pharmaceutical company elects to contract with the Government sector, it will enter into several agency agreements making its products available to all government entities.
Selective contracting is not allowed in the government sector (e.g., participate in Medicaid but not in PHS pricing is not allowed).
A manufacturer can elect to contract with the government sector to position their product in the Medicaid Drug Rebate Program as well as make its products eligible for purchase by all Federal entities.
© 2010 IdealNet, Inc.Page 5
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 5
Taking Your Business to the Next Level™
How is Government Contracting administered?
CMS &State Agencies
CMS &State Agencies
ManufacturerManufacturerManaged Care Entities
Managed Care Entities
Pharmacy / Retail
Pharmacy / Retail
Medicaid
Rebates
Chargebacks
PrescriptionClaims
PrescriptionClaims
Rebate ($)
Rebate ($)
Rebate Contract
ProductShipment
ProductShipment
Product Shipment
Purchase Product
Bid Contract
Utilization DataUtilization Data
Rebate Agreement
WholesalerWholesaler
1
2
3
VA contracting
PHS pricing
GPO, Hospitals, Government,
Other
GPO, Hospitals, Government,
Other
As part of the overall contract administration process, specific administration of government contracting is focused in three areas – Medicaid pricing & claims, VA contracting and PHS pricing.
© 2010 IdealNet, Inc.Page 6
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 6
Taking Your Business to the Next Level™
Government Pricing Programs
• The Medicaid Drug Rebate Program, Veterans Health Care Act and Federal Supply Schedule reporting and compliance requirements create an interconnected Web of obligations for healthcare manufacturers:– Each program requires various submissions and reporting to government
agencies– All three programs use the same data as the basis for required reports
and submissions– All three programs allow the government to audit related submissions for
compliance– All three programs can expose a manufacturer to significant penalties for
non-compliance
© 2010 IdealNet, Inc.Page 7
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 7
Taking Your Business to the Next Level™
Government Pricing Programs
• A company’s ability to remain compliant with each program is reliant upon its ability to access, manage and analyze transaction level sales and pricing data
• A strong compliance program must also provide the ability to recreate and reconcile pricing submissions at some future point to support an audit or other Government inquiry
• The Government expects program participants to employ a consistent, re-creatable compliance process, driven by strong standard operating procedures and policies
© 2010 IdealNet, Inc.Page 8
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 8
Taking Your Business to the Next Level™
Infrastructure Requirements Government Pricing Compliance
• Policies– Clearly defined interpretations for each program
• Standard Operating Procedures (S.O.P.’s)– Documented method for administering each aspect of the program, including price
calculations
• People– Trained in each Government pricing program– Understanding of commercial business as it relates to each pricing program
• Systems– Automated processes to enforce a consistent approach to: data access; pricing
calculations; securing each policy; calculating rebate payments; and deliver against audit requests
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
Government Pricing Program Best Practices
© 2010 IdealNet, Inc.Page 10
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 10
Taking Your Business to the Next Level™
Best PracticesGovernment Pricing Compliance
• Data Integrity
• Consistent Implementation of Government Pricing Policies
• Preserving and Protecting Government Pricing Compliance Methodologies
• FSS Tracking Customer Creation and Monitoring
• Government Audit Response Capability
© 2010 IdealNet, Inc.Page 11
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 11
Taking Your Business to the Next Level™
Best PracticesGovernment Pricing Compliance
• Data Integrity– Properly classifying transaction level data for use in Government Pricing
calculations– Employ a consistent process for accessing ERP, contract management
and legacy data – Data “cleansing” – ensure the data is accurate and valid– Data storage – store and secure all transaction level data used in
calculations
© 2010 IdealNet, Inc.Page 12
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 12
Taking Your Business to the Next Level™
Best PracticesGovernment Pricing Compliance
• Consistent Implementation of Government Pricing Policies– Maintain a formal written Government compliance policy and procedure
document– The ability to apply a consistent set of Government pricing policies that
reflect corporate S.O.P.’s– Need to provide the capability to take the transactions and calculation
logic and apply them on a consistent Qtr to Qtr basis– The ability to filter transactions, classes of trade, customers, etc., when
building policies
© 2010 IdealNet, Inc.Page 13
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 13
Taking Your Business to the Next Level™
Best PracticesGovernment Pricing Compliance
• Preserving and Protecting Government Pricing Compliance Methodologies– The ability to secure your Government Pricing compliance methodologies
to eliminate risks of:• Lost documents• Pricing policy documents becoming outdated / inaccurate
– Deal with the “loss of corporate memory” when key people leave the company
– The ability to properly handle business changes, and reflect those changes within Government pricing policies and submissions
© 2010 IdealNet, Inc.Page 14
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 14
Taking Your Business to the Next Level™
Best PracticesGovernment Pricing Compliance
• FSS Tracking Customer Creation and Monitoring– Historical transaction analysis to identify “like” customers and comply with
CSP requirements– Employ a monitoring process that effectively analyzes all tracking
customer related activity:• Research and understand price violations• Resolve and document violations
– When tracking customer price violations occur, properly recalculate and monitor the new tracking price
– Disclosing all FSS tracking customer price violations within the mandated window of time
© 2010 IdealNet, Inc.Page 15
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 15
Taking Your Business to the Next Level™
Best PracticesGovernment Pricing Compliance
• Government Audit Response Capability– The ability to quickly and accurately respond to government audits and
information requests – Deliver the exact set of transactions, calculations and pricing data
previously submitted to the Government– Reach back in time to properly articulate
the company’s policies and interpretations– Manage the cost, stress and business disruption that can occur during a
Government audit
© 2010 IdealNet, Inc.Page 16
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 16
Taking Your Business to the Next Level™
Government Audit Initiatives
• Certain companies targeted each year based on their turn in queue
• Others based on past issues and performance
• Can be requested by contracting officers and other officials
• Voluntary Disclosures generally result in some sort of review by the government
• How can the risks associated with potential adverse findings be mitigated?
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
Application Overview
iContracts/Government Pricing
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
How IdealNet and iContracts can help
© 2010 IdealNet, Inc.Page 19
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 19
Taking Your Business to the Next Level™
Assessment of current policies, procedures, controls and systems
• Medicare Part B – Average Sales Price
• Medicaid Drug Rebate Program (Average Manufacturer Price, Best Price, Unit Rebate Amount, nominal price and prompt pay discount pricing)
• Public Health Service – 340B price offering and membership eligibility
• Federal Supply Schedule – Non-Federal Average Manufacturer Price (Non-FAMP) and Federal Ceiling
• Price (FCP)
• Medicare Part D
• 2010 Healthcare Reform Legislation
• Various other governmental agency price reporting requirements
© 2010 IdealNet, Inc.Page 20
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 20
Taking Your Business to the Next Level™
Implementation of updated policies, procedures, controls and systems
• Practical recommendations and solutions that take into consideration the needs and reporting environment of the manufacturer
• Develop calculation methodology policy and standard operating procedures (SOPs)
• Develop and present training materials to all levels of management and operations
• Expert testimony and assist counsel related to:– Qui Tam Allegations– Whistleblower Allegations– DOJ inquiries and investigations– Anti-Kickback Statute and False Claims Act Violations
• Corporate Integrity Agreement (CIA) preparation and negotiation
• Independent Review Organization (IRO) as required under the CIA
© 2010 IdealNet, Inc.Page 21
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 21
Taking Your Business to the Next Level™
Support iContracts implementation
• Document all required calculations– Generate detailed formulas for each specific calculation– Create corresponding documents which detail and facilitate
implementation of the formulas within the iContracts environment
• Create detailed data flow/integration functional and technical specifications for all required interfaces to and from the iContracts environment– Based on other existing manufacturer systems to be interfaced– Can also supplement iContracts technical personal with interface
designers and coders
• As needed, provide targeted business expertise to iContracts technical staff during the implementation
• Generate and execute manufacturer specific test scenarios in partnership with iContracts
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
Questions & Discussion
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
IdealNet, Inc. Overview
© 2010 IdealNet, Inc.Page 24
Taking Your Business to the Next Level™
© 2010 IdealNet, Inc.Page 24
Taking Your Business to the Next Level™
IdealNet, Inc. Overview
• Expert business and technical consulting firm to the Life Sciences industry since 1994
• Domain expertise:– 16+ years focused on optimizing contract management processes across multiple industries– Design, development and deployment of leading industry solutions including SOP’s, training
materials, filing guidelines, and GP software package implementation– Only employs seasoned staff with relevant expertise
• Business strength:– Track record of successful commercial and government pricing projects with many Tier 1
Pharmaceutical manufacturers as well as Biotech and Medical Device manufacturers
• Industry leading Medicaid and Government Pricing compliance support services:– Production of complete Policy and Procedure frameworks required to maintain compliance with
the Medicaid Drug Rebate, Veteran’s Healthcare Act and Federal Supply Schedule laws
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
2933 West Germantown PikeBuilding 2, Suite 204Fairview Village, Pa 19409USA
Toll Free : 800 618-0836Fax : 610 666-1006Email : [email protected]
Learn how iContract’s Government Pricing solution can help your organization in conjunction with IdealNet’s expert Government Pricing services
Contact Todd Venetianer at [email protected]
Contact Christopher C. Biddle at [email protected]
Thank You
Visit us online at www.idealnetinc.com