Since the inception of the Coverage Gap Discount Program (CGDP), Manufacturers have been presented with challenges in managing the CGDP. There are operational, financial, compliance and legal challenges that fall across the organization.
This webcast will highlight those challenges and provide insight into practical solutions Manufacturers have employed to help mitigate these challenges.
What you can expect to learn from the webcast:
- High-Level Process Requirements needed to efficiently manage CGDP
- Practical Solutions that have been applied to mitigate challenges and risks
- How to manage the Negative Balance Solution
- Tips for preparing for the Dispute Resolution Process
- How to maximize data for Financial Analytics
2. Shannon
Bermudez
Principal Consultant,
Life Sciences
http://www.linkedin.com/pub/shannon-bermudez/b/541/695
sbermudez@consultparagon.com
3. Coverage Gap Discount Program History
The Affordable Care Act stipulated that the Coverage Gap or
Donut Hole will be closed by 2020.
• In 2010, CMS provided a $250 rebate to all Part D
beneficiaries who entered the Coverage Gap.
• As of January 1 2011, Part D beneficiaries who reached the
Coverage Gap received a 50% discount on brand name
drugs provided by the brand name drug manufacturers while
in the Coverage Gap. This program is known as the
Coverage Gap Discount Program (“CDGP”).
• Through 2020, CMS will gradually phase in additional
subsidies for generic and brand name drugs which will
reduce Medicare Part D beneficiaries’ co-insurance rate in
the “donut hole” from 100% to 25%.
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4. Closing the “Donut Hole” 2011 - 2020
By 2020, the “donut hole” will be
effectively eliminated and Medicare Part
D beneficiaries will pay only a 25%
cost-sharing for all drugs until reaching
the Catastrophic Coverage threshold.
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Benefit Year Beneficiary Part D Plan Manufacturer
2011 50% - 50%
2012 50% - 50%
2013 47.50% 2.50% 50%
2014 47.50% 2.50% 50%
2015 45% 5% 50%
2016 45% 5% 50%
2017 40% 10% 50%
2018 35% 15% 50%
2019 30% 20% 50%
2020 25% 25% 50%
5. Coverage Gap Discount
The Affordable Care Act mandated that manufacturers of Branded
Drugs, Biologics and Authorized Generics provide Part D beneficiaries
50% discounts of the “negotiated price” of such drugs dispensed in the
Coverage Gap (“Donut Hole”) in order for such drugs to be covered
under Medicare Part D.
• Based on “negotiated price,” minus dispensing fees and vaccine
administrative fees.
• Does not apply to Low Income Subsidy Beneficiary utilization, whose
Donut Hole costs are paid by CMS.
• Paid after a Part D Plan’s supplemental benefits
• CMS can waive this requirement in its discretion
• The product must be on the Part D Plan’s formulary, or approved
under an exception.
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6. Prominent Differences between CGDP & MDRP
CGDP Pay and chase
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Not a guarantee of coverage
Hundreds of plans vs. 50 states
Rigid appeals process
Payment level detail only available on audit
No challenges for duplicate rebates (e.g.,
commercial, 340B)
No price reporting
No CPI-U inflation consideration
8. Who’s impacted by CGDP in your organization?
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Cross Functional Impact
Contract
Operations
Responsible
for overall
CGDP
admin.
Finance
Forecasting
accruals
and liability
Managed
Markets
Negotiation
of standard
Part D
agreements
Potential
terms
around
duplicate
discounts
Product
Management
Interest on
cost to
determine
effects on
product
specific
profitability
Accounts
Payable
Sending EFT
payments
Maintenance
of EFT
information
Accounts
Receivable
Track
receipt of
EFT
payments
for negative
invoices
from Plan
Sponsors
Information
Technology
Infrastructure
to support
CGDP
admin.
9. CGDP High-Level Process Requirements
The figure to the right illustrates
the minimum high level
requirements Manufacturers
should have in place to support
the administration & processing
of CGDP payments.
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Data
Management
Requirements
Data Receipt
Invoice Data
Management
Detail Data
Management
EFT File
Management
Payment
Requirements
Maintain EFT
banking info for
600+ contracts
38 day processing
deadline
Send EFT
payments for
600+ contracts
Reporting
Requirements
Payment
Confirmation
report
Operational
Reports
Financial & Trend
Reports
Retain data for 17
quarters
Negative
Balance
Solution
Negative Invoice
Reconciliation
Report
Maintain EFT info
for receipt of
Negative Invoice
payments
Receive EFT
payments
(Negative
Invoices)
Confirm receipt of
negative invoice
payments
Dispute
Resolution
Mechanism to
scrub & validate
detail claims data
Determine data
elements to
dispute
Develop Dispute
internal
guidelines &
polices
10. Operational Challenges
Practical Solutions
• Dedicate resources to specially manage CGDP
operations
• Define detailed process & timeline from receipt of
data to payment due date
• Automate processes as much as possible
• Promote Cross functional Awareness,
Involvement & Collaboration
• Data storage & data repository
• Build operational reporting capabilities
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Operational
• Strict Mandated
timelines
• Resource Constraints
• Maintenance of EFT
information
• Mgmt. of Negative
Invoices
11. Financial Challenges
Practical Solutions
• Adhere to detailed process timeline to avoid payment
penalty
• Data storage & data repository
– Build financial reporting capabilities to support
financial analysis
– Negotiate with Part D Plans to limit double dipping
concerns
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Financial
• 25% late payment
penalty
• Cash Flow
• Forecasting limitations
• Potential for double
dipping
12. Compliance Challenges
Practical Solutions
• Define business rules, processes, and SOPs with
control points for the overall operational process
• Develop Dispute Business Rules & Process
• Perform reasonability checks on data to support
payment justification & additional financial analysis.
• Monitor compliance with business rules, processes,
and SOPs
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Compliance
• Dispute process is pay
and chase
• Lack of data visibility
• Challenge verifying CG
Discount invoiced is correct
• Strict Audit Guidelines
13. Legal Challenges
Practical Solutions
• Exhibit C of the Manufacturer Agreement with CMS restricts
the use of claims-level data.
• Permitted use- financial statement forecasting and
accounting purposes.
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Legal
• Restrictions on use
of data
• HIPAA Confidentially
• Appeal Process
14. CGDP Risks to Manufacturer
Operational
• Strict Mandated
timelines
• Resource Constraints
• Maintenance of EFT
information
• Mgmt. of Negative
Invoices
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Financial
• 25% late payment
penalty
• Cash Flow
• Forecasting limitations
• Potential for double
dipping
Compliance
• Dispute process is pay
and chase
• Lack of data visibility
• Strict Audit Guidelines
Legal
• Restrictions on use
of data
• HIPAA Confidentially
• Appeal Process
Risks across the organization
15. CGDP Primary Pain Points
• Negative Balance Solution
• Pay & Chase Dispute Resolution Process
• Negotiating with Part D Plans to limit double dipping
• Financial Forecasting & Predictive Analytics
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17. Negative Balance Solution Impact on Business Process
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• Multiple reports
• Manual Updates
• Confirming payments
in and out
• Additional Processing
• Same 38 day
timeframe
• Tracking Funds
coming in
• Tracking funds going
out
• Phase 1 &
Phase2/Qtrly Invoice
Process
• Phase 2 & Standard
Qtrly Invoice Process
Processing
Overlap
EFT Funds
Tracking
Payment
Confirmation
Reports
Resource &
Time
Constraints
18. How to manage the Negative Balance Solution
Implement process to receive & translate Negative Balance Reports
Evaluate file formats Determine process and/or system changes Implement applicable changes
Implement process to receive funds
Set–up account to receive funds from
Provide applicable EFT banking
information to TPA
Ensure A/R system is equipped to receive
EFT funds for CGDP payments
Implement A/R process to track receipt of funds
Sponsors via EFT
Identify & allocate A/R resources Create reports to support tracking
Define overall A/R process, process
timeline & SLA to track receipt of funds
Implement process to Confirm receipt of funds
Confirm payments received for negative
invoices
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Confirm payments not received for
negative invoices
Confirm payments made for positive
invoices
Implement Reconciliation Process
Funds expected vs. actual funds received Internal tracking vs. TPA tracking Summarize & report variances
20. Tips for Preparing for the Dispute Resolution Process
• Must have mechanism to scrub & validate data for
disputes
• Determine data elements & validations to dispute
• Develop Dispute internal guidelines & polices
• Ability to prepare dispute report in CMS defined format
• Understand Dispute Process Timeline & Audit Rights
• Time exercise of audit right to maximize chances of
success during appeal
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21. Data Items Eligible for Dispute per CMS
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Pay & Chase Dispute Items
• Duplicate Invoice Item (D01)
• Closed Pharmacy (D02)
• Not Part D Covered Drug (D03)
• Excessive Quantity (D04)
• Days’ Supply (D05)
• High Price of the Drug (D06)
• Last Lot Expiration Date (D07)
• Early Fill (D08)
• Marketing Category is Not NDA or BLA (D09)
• Date of Service Prior to 1/1/2011 (D10)
• PDE Improperly Invoiced Beyond Manufacturer
Agreement Invoice Period (D11)
• Invalid Prescription Service Reference Number (D12)
• Other (D99)
340B Pharmacy Disputes
Maximum Gap Discount Disputes
Employer Group Waiver Plans (EGWPs)
Invoice corrections for incorrect
labeler billings can be submitted
within 5 days of receipt of invoices. All
other disputes items are pay & chase.
22. Dispute Resolution Timeline
Extensive Dispute Resolution Timeline in upwards of 210
days.
• Disputes must be submitted to the TPA in writing within
60 days of receipt of the applicable invoice.
• The TPA must use its best efforts to work with the
Manufacturer to resolve these disputes within 60 days
of the notice.
• If the TPA and the manufacturer fail to resolve the
dispute within 60 days of the notice, CMS will specify
an entity to perform an independent review of the
dispute.
• This review will be completed within 90 days of receipt
of request by manufacturer for an independent review.
• Upon an unfavorable decision, manufacturer may
request CMS Administrator review w/I 30 days after
receipt of such determination.
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23. Manufacturer Audit Rights
Manufacturer can audit TPA’s data annually.
• Audit commenced on 60 days notice.
Must include:
• Reasonable basis for the audit; and
• Description of the information required for the audit.
• Review limited to a “statistically significant sample size of
PDEs.”
• No audit of CMS records.
• Records are confidential and reviewed on-site.
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Data elements subject to audit are:
• Contract Number
• Plan Benefit Package Identifier
• Ingredient Cost Paid
• Dispensing Fee Paid
• Total Amount Attributed to Sales Tax
• Low-Income Cost Sharing Amount
• Non-covered Plan Paid Amount
• Vaccine Administration Fee
• Total Gross Covered Drug Cost Accumulator
• True Out-of-Pocket Accumulator
25. Limit Double Dipping by Negotiating with Part D Plans
Data Requirements
• Consider a clause requiring Part D Plan cooperation in
gathering information that could be useful in a dispute
(subject to HIPAA limitations).
• Require Benefit Stage Qualifier of NCPDP standard be
valued in standard Part D rebate submissions.
Terms
• Pursue terms to carve out double rebates, but Part D
Plans not required to agree.
• Negotiate terms that will allow for the scrubbing out of
claims that are identified as falling in the Coverage Gap
Benefit Stage.
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27. Maximizing CGDP Data for Financial Analytics
What’s my total CGDP
liability overtime
qtr/qtr & yr/yr ?
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What’s my CGDP
liability by product &
how’s it trending?
How are Part D lives
growing?
What am I owed for
negative invoices?
28. Maximizing CGDP Data for Financial Analytics
How to get there?
• Understand all aspects of Coverage Gap data
you are receiving
• Create data repository for data storage for
reporting & trend analysis overtime.
• Build Operational & Financial Reporting
capabilities
• Build Scrubbing capabilities
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29. Maximizing CGDP Data for Financial Analytics
What to look for?
• Perform validation checks and review data for
applicable disputes acceptable by CMS.
• Use detail data to report by NDC to provide visibility to
finance for forecasting, accruals ,GTN purposes and
breakout of U.S. vs. Puerto Rico.
• Perform additional analysis on detail data using
calculation algorithms to evaluate for reasonableness.
• Innovative approaches to evaluating data that is
available to do more advanced analysis.
• Link data between EFT file and invoice file to
summarize estimate by plan sponsor and region.
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30. CGDP Business & Technical Process Flow
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31. For information, visit:
http://www.consultparagon.com
s b e rmu d e z@c o n s u l t p a r a g o n . c om
Hinweis der Redaktion
Speaker: Jim Kane
This slide covers all the pieces of SharePoint. SharePoint exists on premises as well as in the cloud. Regardless of the path you choose these functions are available in either scenario.
**Change Slide**
Speaker: Robert Heiden
In order to properly put your arms around your projects, programs or portfolio there are three key pillars which need to be addressed right out of the gate. These pillars function as the basic girders by which you will build future success. That is not to say that these items will not change and evolve as your organization matures, they will.
These pillars address the following:
Why are we working on this? – strong business case to obtain agreement on what you are doing
How are we doing? – Status Reporting to track progress
What are we doing? – The ability to manage change against the agreed upon scope
All of the features, improvements and functionality we find in SharePoint 2013 will be mapped back to supporting these pillars.
**Change Slide**
Speaker: Robert Heiden
There is an evolution and we can use SharePoint to start off with. As you mature with your project management techniques you can use a lot of different tools, but basic SharePoint can help you frame out how to effectively manage your projects, if properly constructed. It is our expertise as a company to help you make those simple choices to ensure that you set yourself up for a successful future.
During the course of this webinar we will be discussing how you can use Microsoft SharePoint 2013 to effectively manage your projects. SharePoint 2013 offers many new options and improvements to increase adoption and allow for a streamlined setup. Most importantly the platform is presented in a way that allows you to mature and grow without throwing away previous work. A simple task list can expand into a fully functional PPM solution.
Some simple analysis is needed to identify key data points. Begin with the end in mind. If you have a project code, for example, that code should be replicated across all of your lists and libraries using a site level custom field. This should be the basis of your taxonomy. As you build out the taxonomy and layer that into the built in SharePoint lists, you start to build out the consistency that is required.
**Change Slide**
Speaker: Robert Heiden
You can manage your documents with versioning, check out, check in. This can function as a central repository for all the documents that manage the business case (i.e., financial calculations). You can leverage content types that represent a standardized business case.
Depending on what schema you use, and this is where the flexibility comes in, you can have one library for all projects or one per project. The security model previously defined would drive your decisions here. SharePoint can be expanded by the scale of your organization and you can take this framework and apply it to the other lists we will discuss in this presentation.
**Change Slide**
Transition slide
Speaker: Robert Heiden
Team members can be notified of task assignments via email, which removes the burden from the Project Manager to notify assignments. Alerts (i.e., notifications) of item changes can let team members know when their assignments have been altered. Also alerts can be used for team broadcasts sending daily or weekly summaries to the entire team of altered tasks.
Animation 1- Task Indentation – now provides a hierarchal view of task relationships
Animation 2- Mark complete with checkbox – quickly enables team members to update status
Animation 3- Strikethrough – provides an “at a glance” view showing anything that is completed
Animation 4- Lync Integration – facilitates communication to quickly gain the latest updates
Animation 5- Date Formatting – offers dates in a friendlier format for end users
The platform is dynamic yet simple enabling users to rapidly add tasks.
**Change Slide**
Speaker: Robert Heiden
The new Project Summary web part flips between the Timeline view and Overdue tasks.
Animation 1- The Project Summary web part shows a carousel easily switching between upcoming/late tasks and the overall project timeline. This can be added to different pages of your SharePoint site
**Change Slide**
Speaker: Robert Heiden
To improve the adoption rate for such a change there are multiple ways to interact with team members. In order to buffer end users from MS Project (which we all know and love) multiple methods exist for communicating task status. Including SharePoint task lists, Outlook, and Excel. This integration can be done without any programming or specialized IT skills. This increases the likelihood of individuals providing the project managers with their task updates since they do not need to interact with Microsoft Project.
**Change Slide**
Speaker: Robert Heiden
So now lets talk about pulling these things together. The taxonomy defined earlier provides us with the framework for grouping or associating the various SharePoint list items with the projects that they are associated with.
Scenario 1 – a single registry for multiple projects we can group a list by project ID and you can see all the risks or issues or changes associated with that particular project
Scenario 2 – an individual registry for a project and group items by priority to view all high priority item, group by assigned to resource.
The foundation is now established for continuous improvement. These lists are now searchable for future projects facilitating lessons learned.
**Change Slide**
Speaker: Robert Heiden
One of the most powerful aspects here is the ability to sort and group in the views creating reports that align to the steps of your processes (i.e., creation, status, reporting and lessons learned)
**Change Slide**
Speaker: Robert Heiden
Increase the transparency and insight into the organization is easily done via these views. All of this information can be shared with team members, executives and stakeholders in a manner that they require.
This is the first iteration of the single truth, now you are establishing consistency across the platform that is scalable in that it can easily manage as many projects as you require.
Animation 1- There are a number of different ways to view your data within SharePoint 2013. Whether you are looking at a calendar, single item view, a gantt chart or a timeline the information can be presented to your end users in a meaningful way.
**Change Slide**
Speaker: Robert Heiden
**Animations on this slide are timed with a single click**
Thanks Stephen…
The examples we have shown you throughout this presentation are applicable, to varying degrees, to all stages of your PMO evolution.
An alternative scenario may be to have your project task lists separate but keep your documents, risk issues and changes consolidated. This scenario would allow project managers to sync projects with Microsoft Project Professional to have more robust project schedules.
As you expand or depending on your current size you may want to consider a site per program or a site per business unit. In this scenario you can leverage the foundation described today across these sites. You can then leverage web parts and other techniques to bring that information back together in a single place for reporting. In future webinars we will show you how you can quickly and easily report on tagged items across sites. An example being a view of all high priority lists.
Finally as you move into a more robust scenario you would want to consider a PPM tool such as project server or leverage the foundation to simply have separate project sites. Reporting across those sites and maintaining consistency via list, library and site templates.
**Change Slide**
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Transition slide
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Transition slide
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Transition slide
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Transition slide
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**
Speaker: Robert Heiden
Here we see how this approach ties into Microsoft’s PPM journey. We have focused on the task management and project collaboration area. In future webinars we will move along this curve and describe how you can eventually leverage Project Server without your teams keeping the SharePoint front end. In Project Server 2013 you have the ability to import the same SharePoint task list we just demonstrated into the enterprise for visibility in PPM reporting.
**Change Slide**