the complete guide to the cgdp dispute process

The Complete Guide

to the CGDP Dispute Process

Paragon Solutions, Inc. Proprietary and Confidential

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Shannon

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Life Sciences

http://www.linkedin.com/pub/shannon-bermudez/b/541/695

[email protected]

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mailto:[email protected]



Agenda

• Initiating CGDP Disputes

• Identifying records to Dispute

• Generating the Dispute Submission File

• Compiling & Preparing Dispute Supporting Evidence

• Submitting & Confirming Acceptance of Dispute Submission File

• Resolving CGDP Disputes

• Tracking Disputes

• Receiving & interpreting the Dispute Resolution File

• Process for Upheld Disputes

• Process for Denied Disputes & Appeals

• Dispute Considerations by Reason Code

• Tips for Developing an Internal CGDP Dispute Process

• CGDP Invoice & Dispute Process Timeline

• Q&A




Initiating Disputes

Identifying records to Dispute

Generating the Dispute Submission

File

Compiling & sending Dispute

Supporting Evidence

Submitting Dispute

Submission File &

Confirming Acceptance




Identifying Records to Dispute

What you need to know?

• Know the CGDP Dispute Reason Codes and Descriptions

• Know the dispute guidance and required documentation

• Know your product data & standard Part D prescribing patterns for

your product data

What you need to determine & validate?

• Determine what disputes you want to identify

• Determine thresholds and configure system for validation

accordingly ex. Excessive Quantities, Days Supply, Gap Discount

• Validate detail level data per defined threshold's

• Summarize data that was flagged by validations

• Review & evaluate error & warning records flagged by validations

• Initiate disputes accordingly




Generating the Dispute Submission File

File Layout & Format

• Non-negotiable & defined by CMS

• Fixed Width & Signed Overpunch code

• Consists of header records, detail records (PDE level) and

trailer records as defined by CMS

• Naming convention defined by CMS

File Contents

• File should only include records that are being disputed

• Must include all defined data fields including data provided on

the applicable qtrly Manu Data Detail Report

• All disputes must be submitted in the defined file format & layout




Compiling Dispute Supporting Evidence

Dispute Documentation & Explanations

• Ensure all required documentation is initially included to support the dispute

upon submission.

• Ensure dispute explanation is included with required documentation.

• Explanation should emphasize how the documents prove the dispute is

warranted.

• Refer to CMS Dispute Submission Guidance for documentation required by

reason code.

Dispute Attachments

• Should be in PDF format

• Should Include P-Number, Invoice Qtr, Dispute Reason Code, Detail

Reference Number at the top page of each attachment.

Submit supporting evidence to TPA the same day you submit the Dispute

Submission File.




Submitting & Confirming Acceptance of Dispute Submission

• Manu submits Dispute Submission Files to the TPA via secure

FTP site.

• TPA receives Disputes Dispute Submission Files via secure FTP

site.

• TPA/CMS perform two validation phases on Disputes Submission

• Syntax Validation

• Content Validation

• Allow time within the 60 day dispute submission deadline for the

validation phases & potential file corrections.




Dispute Submission Validations

Validations performed on

Dispute SubmissionSyntax Validations Content Validations

Accepted Dispute

Submission

• Performed by TPA

• File level edits

• Run twice daily - 8:45

a.m. & 3:45 p.m.

• Response reports to

transmitted twice daily -

9:30 a.m.& 4:30 p.m.

• Performed by CMS

• Data level edits - line

by line

• Runs once daily in the

evening

• Response report

transmitted by 9:30

a.m. the following

morning




Correction of Rejected Dispute Submission Files

Updates & corrections for rejections found during the Syntax & Content validation

phases must be submitted within the original 60 day dispute submission deadline.

Syntax Validation Rejections

• Multiple dispute submissions are allowed on a daily basis until the file has passed the syntax validation phase.

• Still only one dispute submission can be accepted, per day, per P#, and sent off to DDPS for the content validation phase.

Content Validation Rejections

• DDPS Rejections performed line by line.

• If DDPS accepts at least one dispute record, it will be reviewed by CMS for dispute resolution.

• Manufacturer may correct data and resubmit records rejected by DDPS by the original submission deadline.




Resolving Disputes

Tracking & Receiving Dispute

Resolution

Interpreting the Dispute Resolution

File

Process for Upheld

Disputes

Process for Denied

Disputes & Appeals




Tracking Disputes

• Once disputes have been accepted the TPA has 60 days to resolve the dispute.

• Maintain communication with TPA during 60 days.

• TPA submits the Dispute Resolution File to the Manufacturer

within 60 days of Dispute Submission File deadline.

• The date the Dispute Resolution report is distributed by the TPA

is considered the discovery date.




Receiving & Interpreting Dispute Resolution File

• Dispute Resolution File includes the following fields to help you

determine the status of disputes:

• Dispute Disposition – contains a status code of upheld or denied for

the dispute.

• Dispute Resolution Code – contains a unique resolution code for

the dispute.

• Dispute Resolution Text – an explanation of why the dispute is

upheld or denied.

• Evaluate each dispute and corresponding resolution status to

determine if an appeal is justified.




Process for Upheld Disputes

• The invoice adjustment for upheld disputes will be made on a

future invoice.

• Plan Sponsors have 90 days from the discovery date to submit

a corrected PDE to CMS. ‒ The Sponsor is obligated to fix the incorrect data that caused the dispute.

‒ The Sponsor will adjust financial and/or non-financial fields to correct the

disputed data.

‒ The Reported Gap Discount amount may or may not change due to an

upheld dispute.

• Invoice adjustment will be submitted to the Manufacturer within

one to two invoice cycles after the discovery date.




Process for Denied Disputes & Appeals

If Manufacturer determines an Appeal is warranted for a Denied Dispute:

Manufacturers can submit an appeal to

the Independent Review Entity (IRE)

• Provider Resources is the IRE for CGDP.

• Appeals are to be submitted through the IRE portal.

Appeals must be submitted within the

earlier of:

• 30 days of receiving the dispute denial

• 60 days after filing the dispute if no dispute resolution has been determined.

The IRE either Affirms or Denies the appeal

within 90 days of receipt

• Affirm = IRE disagrees with original dispute denial

• Denies = IRE agrees with original dispute denial

If the IRE denies the appeal, Manufacturers

have the right to appeal to the CMS

administrator

• Must make request within 30 calendar days of receipt of denial notification

• CMS Administrator decision is final and binding

• No judicial review




CGDP Dispute Reason Codes & Descriptions

Dispute Reason

Code

Dispute Reason Description Commonly filed

Dispute

D01 Duplicate Invoice Item

D02 Closed Pharmacy

D03 Not Part D Covered Drug

D04 Excessive Quantity

D05 Days’ Supply

D06 High Price of the Drug

D07 Last Lot Expiration Date

D08 Early Fill

D09 Marketing Category is Not NDA or BLA

D10 Date of Service Prior to 1/1/2011

D11 PDE Improperly Invoiced Beyond Manufacturer Agreement Invoice Period

D12 Invalid Prescription Service Reference Number

D99 Other (D99) (ex. 340B Pharmacy Disputes, Maximum Gap Discount Disputes

Employer Group Waiver Plans (EGWPs))

* Bold text denotes Dispute Reasons commonly submitted




Dispute Considerations by Reason Code

D01 – Duplicate Invoice Item

Code Description Dispute Considerations

D01 Duplicate Invoice Item PDE records undergo frequent adjustments.

Evaluate varies data elements to determine if this dispute for

a true duplicate PDE record or if it is related to an adjustment

to a previously invoiced PDE record.





D02 – Closed Pharmacy


D02 Closed Pharmacy Upon initial review of PDE records, CMS’ PDE editing systems allow

for a 6 month grace period from fill date/date of service to account for

variability of pharmacy data sources & timing delays.

CMS does not include lag time in store closing dates when assessing

dispute items.





D03 – Not Part D Covered Drug


D03 Not Part D Covered Drug Drug should not be covered under Part D in any circumstances

Incorrect disputes for Medicare Part B vs. Medicare Part D drug





D04 – Excessive Quantity


D04 Excessive Quantity Quantity not supported as being a clinically inappropriate per product

labeling & prescribing guide and may represent a threat to the

Medicare beneficiary.

CMS allowance for products with max daily dose = 3 times

maximum daily dose

Represent quantity that is potentially related to dispensing errors

and is not clinically appropriate in any circumstances.





D06 – High Price of the Drug


D06 High Price of the Drug The Coverage Gap Discount is based on the Medicare Part D

negotiated prices determined via sponsors private negotiations.

Negotiated prices are not determined by a statutory algorithm and

may differ by plan.

Use Prescription Drug Plan Formulary, Pharmacy Network and

Pricing information files to help assess potential excessive prices.





D09 - Marketing Category is Not NDA or BLA


D09 Marketing Category is Not NDA or BLA PDE invoice based on the actual FDA NDC directory e-

listing as of the date of service.

Retroactive changes to the FDA NDC directory e-listing will

not be taken into consideration if the PDE was invoiced

before the changes were made.





D99 - Other (D99) ex. 340B Pharmacy Disputes, Maximum Gap Discount


D99 Other (D99) ex.

340B Pharmacy Disputes

Maximum Gap Discount Disputes (Single or Cumulative)

340B pharmacies may be included in

the Part D sponsors network. This does

not necessarily mean that the Part D

negotiated price is the 340B pharmacy

acquisition cost.

Plans deviate slightly from the standard

defined benefit design.




Developing an Internal CGDP Dispute Process

Tip # 1

Know the Dispute Guidance

Tip #2 Implement method to validate &

dispute CGDP data

Tip # 3

Establish Tracking & Communication Plan




Tip # 1

Know the Dispute

Guidance

Dispute reason codes & descriptions

Dispute Submission File requirements

Required supporting evidence -documentation & explanation

Dispute Timeline

Audit Rights




Tip # 2

Implement Method to validate &

dispute CGDP data

Buy or Build?

Define Dispute Business Process & Business Rules

Implement system to load, translate, & validate detail data

Determine data elements, thresholds & validations to dispute

Ability to generate Dispute Submission File




Tip # 3

Establish Tracking &

Communication Plan

Do it right the first time, you don’t get a second chance.

Allow time for validation rejections from the TPA

Track communications with TPA to ensure timely

response between deadlines




CGDP Invoice & Dispute Process Timeline

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the complete guide to the cgdp dispute process

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