The Complete Guide to the CGDP Dispute Process
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Register for the free on-demand webinar here: http://hubs.ly/y0mdl90 As part of the Medicare Part D Coverage Gap Discount Program (CGDP), pharmaceutical manufacturers may dispute invoiced coverage gap discount payments the manufacturer feels are inaccurately calculated. Many manufacturers find the mandated dispute process complex and burdensome, and simply pay their CGDP payments without determining whether filing a dispute is warranted. There are instances, however, where it is in the organization’s best interest to pursue a dispute and recoup the lost revenue that is at stake. View this presentation and register for the corresponding webinar today, where Paragon Solutions' Shannon Bermudez will break down the CGDP Dispute Process, providing a simplified view in its entirety. What you can expect to learn: - What is the dispute process timeline - What are the dispute reason codes and their supporting required documents - How to determine if it’s worthwhile to submit a dispute - What to expect if you chose to dispute - What to expect if a dispute is accepted or denied - Tips for developing an internal CGDP dispute process
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The Complete Guide to the CGDP Dispute Process
- 1. The Complete Guide to the CGDP Dispute Process
- 2. Missed the Live Webcast? Paragon Solutions, Inc. Proprietary and Confidential 2 Click to Watch the Recorded Webcast
- 3. Paragon Solutions – Value Envisioned. Value Delivered. Paragon is a professional services firm providing a full spectrum of consulting services from advisory through solution design and implementation for tighter alignment between business and IT. Paragon Solutions, Inc. Proprietary and Confidential 3 Leverages a proprietary set of methodologies and approaches to develop a pragmatic path to reaching business objectives. Visit us: http://www.consultparagon.com Provides application architecture and development, project management, and implementation integration services. Quick Facts: • 550 Employees • Global Clients • NJ Headquarters • 5 US Offices & 2 overseas • Dual-shore Development capability • Privately owned, 32-year history Advisory Consulting Systems Integration Services
- 4. Shannon Bermudez Principal Consultant, Life Sciences http://www.linkedin.com/pub/shannon-bermudez/b/541/695 sbermudez@consultparagon.com Paragon Solutions, Inc. Proprietary and Confidential 4
- 5. • Identifying records to Dispute • Generating the Dispute Submission File • Compiling & Preparing Dispute Supporting Evidence • Submitting & Confirming Acceptance of Dispute Submission File • 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 Paragon Solutions, Inc. Proprietary and Confidential 5 Agenda • Initiating CGDP Disputes • Resolving CGDP Disputes Visit us: http://www.consultparagon.com
- 6. Paragon Solutions, Inc. Proprietary and Confidential 6 Initiating Disputes Identifying records to Dispute Visit us: http://www.consultparagon.com Generating the Dispute Submission File Compiling & sending Dispute Supporting Evidence Submitting Dispute Submission File & Confirming Acceptance
- 7. 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 Paragon Solutions, Inc. Proprietary and Confidential 7 Visit us: http://www.consultparagon.com 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
- 8. 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 Paragon Solutions, Inc. Proprietary and Confidential 8 Visit us: http://www.consultparagon.com
- 9. 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. Paragon Solutions, Inc. Proprietary and Confidential 9 Visit us: http://www.consultparagon.com
- 10. Submitting & Confirming Acceptance of Dispute Submission • Manu submits Dispute Submission Files to the TPA via secure Paragon Solutions, Inc. Proprietary and Confidential 10 Visit us: http://www.consultparagon.com 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.
- 11. Dispute Submission Validations Paragon Solutions, Inc. Proprietary and Confidential 11 Validations performed on Dispute Submission Visit us: http://www.consultparagon.com Syntax 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
- 12. Correction of Rejected Dispute Submission Files 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. Updates & corrections for rejections found during the Syntax & Content validation phases must be submitted within the original 60 day dispute submission deadline. Paragon Solutions, Inc. Proprietary and Confidential 12 Visit us: http://www.consultparagon.com 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.
- 13. Paragon Solutions, Inc. Proprietary and Confidential 13 Resolving Disputes Tracking & Receiving Dispute Resolution Visit us: http://www.consultparagon.com Interpreting the Dispute Resolution File Process for Upheld Disputes Process for Denied Disputes & Appeals
- 14. • Once disputes have been accepted the TPA has 60 days to • 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. Paragon Solutions, Inc. Proprietary and Confidential 14 Tracking Disputes resolve the dispute. Visit us: http://www.consultparagon.com
- 15. 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 • Dispute Resolution Code – contains a unique resolution code for • Dispute Resolution Text – an explanation of why the dispute is • Evaluate each dispute and corresponding resolution status to determine if an appeal is justified. Paragon Solutions, Inc. Proprietary and Confidential 15 the dispute. the dispute. upheld or denied. Visit us: http://www.consultparagon.com
- 16. Process for Upheld Disputes • The invoice adjustment for upheld disputes will be made on a • 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 ‒ The Reported Gap Discount amount may or may not change due to an • Invoice adjustment will be submitted to the Manufacturer within one to two invoice cycles after the discovery date. Paragon Solutions, Inc. Proprietary and Confidential 16 future invoice. disputed data. upheld dispute. Visit us: http://www.consultparagon.com
- 17. Process for Denied Disputes & Appeals If Manufacturer determines an Appeal is warranted for Paragon Solutions, Inc. Proprietary and Confidential 17 Visit us: http://www.consultparagon.com 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
- 18. CGDP Dispute Reason Codes & Descriptions Paragon Solutions, Inc. Proprietary and Confidential 18 Dispute Reason Code Visit us: http://www.consultparagon.com 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
- 19. Dispute Considerations by Reason Code Code Description Dispute Considerations D01 Duplicate Invoice Item PDE records undergo frequent adjustments. Paragon Solutions, Inc. Proprietary and Confidential 19 D01 – Duplicate Invoice Item Visit us: http://www.consultparagon.com 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.
- 20. Dispute Considerations by Reason Code Code Description Dispute Considerations D02 Closed Pharmacy Upon initial review of PDE records, CMS’ PDE editing systems allow Paragon Solutions, Inc. Proprietary and Confidential 20 D02 – Closed Pharmacy Visit us: http://www.consultparagon.com 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.
- 21. Dispute Considerations by Reason Code Code Description Dispute Considerations D03 Not Part D Covered Drug Drug should not be covered under Part D in any circumstances Paragon Solutions, Inc. Proprietary and Confidential 21 D03 – Not Part D Covered Drug Visit us: http://www.consultparagon.com Incorrect disputes for Medicare Part B vs. Medicare Part D drug
- 22. Dispute Considerations by Reason Code Code Description Dispute Considerations D04 Excessive Quantity Quantity not supported as being a clinically inappropriate per product Paragon Solutions, Inc. Proprietary and Confidential 22 D04 – Excessive Quantity Visit us: http://www.consultparagon.com 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.
- 23. Dispute Considerations by Reason Code Code Description Dispute Considerations D06 High Price of the Drug The Coverage Gap Discount is based on the Medicare Part D Paragon Solutions, Inc. Proprietary and Confidential 23 D06 – High Price of the Drug Visit us: http://www.consultparagon.com 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.
- 24. Dispute Considerations by Reason Code D09 - Marketing Category is Not NDA or BLA Code Description Dispute Considerations D09 Marketing Category is Not NDA or BLA PDE invoice based on the actual FDA NDC directory e-listing Paragon Solutions, Inc. Proprietary and Confidential 24 Visit us: http://www.consultparagon.com 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.
- 25. Dispute Considerations by Reason Code D99 - Other (D99) ex. 340B Pharmacy Disputes, Maximum Gap Discount Code Description Dispute Considerations Maximum Gap Discount Disputes (Single or Cumulative) Paragon Solutions, Inc. Proprietary and Confidential 25 D99 Other (D99) ex. 340B Pharmacy Disputes Visit us: http://www.consultparagon.com 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.
- 26. Developing an Internal CGDP Dispute Process Paragon Solutions, Inc. Proprietary and Confidential 26 Tip # 1 Know the Dispute Guidance Visit us: http://www.consultparagon.com Tip #2 Implement method to validate & dispute CGDP data Tip # 3 Establish Tracking & Communication Plan
- 27. Paragon Solutions, Inc. Proprietary and Confidential 27 Tip # 1 Know the Dispute Guidance Visit us: http://www.consultparagon.com Dispute reason codes & descriptions Dispute Submission File requirements Required supporting evidence - documentation & explanation Dispute Timeline Audit Rights
- 28. Implement Method to validate & dispute CGDP Paragon Solutions, Inc. Proprietary and Confidential 28 Tip # 2 data Visit us: http://www.consultparagon.com 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
- 29. Communication Paragon Solutions, Inc. Proprietary and Confidential 29 Tip # 3 Establish Tracking & Plan Visit us: http://www.consultparagon.com 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
- 30. CGDP Invoice & Dispute Process Timeline Paragon Solutions, Inc. Proprietary and Confidential 30 Visit us: http://www.consultparagon.com Click to Download the Infographic: http://hubs.ly/y0mdl90
- 31. For more information, download our whitepaper: Key Considerations for Effective Processing of the CGDP s b e rmu d e z@c o n s u l t p a r a g o n . c om Paragon Solutions, Inc. Proprietary and Confidential 31
Editor's Notes
- Opening - Thank you Erik. Thank you to everyone on the call for taking the time to join me today. Today we will walk through the CGDP dispute process breaking down the cycle into major components. If you had the opportunity to attend the MDRP event in Sept 2014 I presented on CGDP Practical Solutions manufacturers can use to manage Coverage Gap. We had a lengthy discussion on disputes as a group, but due to timing had to end the discussion short. I realized after that engaging discussion that CGDP disputes is an area of unchartered territory for many. Some manufacturers aren’t really sure of the cost-benefit given the pay and chase concept mandated by CMS. Others are only checking their data for certain reason codes and others are just paying and not even evaluating the detail level data for reasonability let alone dispute. The goal of this webinar is for you to walk away with a full understanding the processing and the CMS guidance around the dispute process so that you can make a reasonable determination if disputes are something your company would want to pursue. So let’s take a look at the agenda….
- We will start by delving into how to initiating a dispute. I’ve broken this into 4 major areas as I see it. Over the next few slides we will walk through each of these areas and highlight what you need to know and consider in these areas to initiate a dispute effectively. Invoice corrections for incorrect labeler billings can be submitted within 5 days of receipt of invoices. All other disputes items are pay & chase. Disputing CGDP claims will present many difficulties due to the stringent dispute guidelines and resolution process established by CMS. The guidelines set by CMS for disputes under the CGDP follow a “Pay and Chase” concept.
- I’m going into this with some assumptions that you have a process in place to identify disputes whether it be custom/internal, outsourced or in a third party software system. Later in the presentation we will go over some tips for developing an internal dispute process, but for the time being we will assume one exists. In order to get the most out of that solution you need to know the CGDP dispute reason codes, know the guidance and your product data. If you understand and examine these area first this will help you determine what dispute reason codes will be most worth your value to pursue and help you identify those disputes. For instance, if you have products in your portfolio that aren’t your traditional pill products and may have a known issue around variability in how they are entered at the pharmacy and billed you would want to consider evaluating excessive quantity.
- Once you’ve identified disputes you’ll need to generate the dispute submission file. If you have a system you’ll need to know this first to make sure your system is configured to support this format. To generate a the dispute submission file you need to know what the file layout and data format is as defined by CMS. As you know with many file layouts related to the CGDP. These are defined by CMS as are non-negotiable. Dispute file layout and instructions available on the TPA website. Copy and rename the quarterly detail file as follows R.#######.RPT.MANUF_DISPUTE The ####### is a sequential number the you received on your Manufacturers Data Report
- Make sure that all of the relevant documentation is included at the initial level. Be very distinct in your explanations as to how the documents and supporting evidence support the dispute. Explain why the PDE records and determination of CG discount is incorrect After the dispute line item has been accepted during the content validation phase, drug manufacturers can send supporting documentation and attachments to disputes@tpadministrator.com.
- Completed once file passes Syntax Validation Phase CMS Data Level Edits checks content using Drug Data Processing System (DPPS) Make notes here on edits performed per edit document TPA performs Syntax - Syntax Validations are file level edits performed by the TPA on the dispute submission file. The TPA runs these edits twice daily at 8:45am & 3:45 PM EST standard time. TPA file level edits Run twice daily 8:45 a.m. & 3:45 p.m. ET TPA sends response reports to MFR secure mailbox –TPA sends validation response reports around the Syntax validation phase to the MFR approx. 45 mins after the validation phase. The response reports are sent twice daily as applicable so they would transmit at 9:30am or 4:30pm. MFR needs to have process in place to check mailbox twice per day for response reports to confirm dispute file submission file was accepted or to take action to correct as needed. Transmitted by 9:30 a.m. and 4:30 p.m. ET MFR checks mailbox twice per day for response reports & takes action as needed TPA performs Content Validation – Completed once file passes Syntax Validations CMS Data Level Edits - Checks content using DPPS Runs once daily in the evening TPA submits Content response reports to MFR secure mailbox Transmitted by 9:30 a.m. the following morning Important Note: Allow time within the 60 day dispute submission deadline for the Syntax & Content validation phases. Updates & corrections for rejections found during the Syntax & Content validation phases must be submitted within the original 60 day dispute submission deadline.
- The Sponsor is obligated to fix the incorrect data that caused the dispute and can adjust financial and/or non-financial fields to correct the disputed data. In other words, the Reported Gap Discount amount may or may not change due to an upheld dispute.
- The IRE may send request for additional information or documentation during this timeframe. Be sure you are monitoring your secure mailbox and respond to communications received from the IRE. The IRE – Provider Resources reported on the May 2014 TPA webinar that: 10% of appeals submitted had been affirmed – meaning the IRE disagrees with the original dispute denial 44% had been partially affirmed – meaning they IRE partially disagrees perhaps more information is needed to make a final determination in these cases 44% of appeals had been denied –meaning the IRE agreed with the original dispute denial 2% of appeals were withdrawn by the Manufacturer after submitting High Price of Drug/Excessive Gap Discount – represents 36% of appeals by reason code Excessive/Abherrent Qty – represents 32% of appeals by reason code Not a Part D Drug or Not NDA/BLA – represents 20% of appeals by reason code Remaining 12% of appeals represented by various reason codes
- CMS’s Position on Disputes Due to the thorough set of 150 fundamental PDE data edits, which include 15 additional edits solely focused on CGDP and additional data analysis performed by CMS prior to generating CGDP invoices to manufacturers; CMS expects very few PDE errors that would require a dispute to correct and will generally deny CGDP disputes unless evidence is presented by the Manufacturer that reveals a failure in the editing and review process. PDEs submitted by Part D Plan Sponsors are only saved after a rigorous set of data edits are applied. These edits include 15 edits solely focused on the CGDP. On top of the fundamental PDE edits, PDES with Coverage Gap Amts CMS Dispute Guidance Disputes should be based on Medicare Part D policy – received disputes based on other government program policies, which are not relevant to Part D & CGDP. Become familiar with Part D Prescription Drug Benefit Manual CMS generally upholds disputes that are based on PDES not calculated correctly or calculated with accurate data CMS generally denies disputes due to 0verall lack of supporting of required documentation & supporting evidence
- Supporting Evidence Required for this Dispute The Detail Reference Number (DRN) of the potential duplicate invoice should be provided in the supporting detail reference number field in the Dispute Submission file. Supporting Evidence in the Additional Information field is optional Distinctly explain how the item is a duplicate of another invoice. Considerations when determining to dispute for this reason code CMS suggest that you confirm this is not an adjustment to a previously invoiced PDE record by verifying that the DRN for the disputed PDE and the DRN entered in the Supporting DRN field are different. Check for duplicates using multiple data elements (PRODUCT SERVICE ID, PRESCRIPTION SERVICE REFERENCE NO, FILL NUMBER, DATE OF SERVICE (DOS), SERVICE PROVIDER ID). Once you identify potential duplicates then validate that the DRN is not the same for the potential duplicate.
- CMS Pharmacy Source CMS uses the NCPDP pharmacy data Used to build a source history file that is updated monthly System uses reported service ID to determine store open and close dates per data view as of the day the PDE was submitted The system allows a 6 month grace period from the date of service to account for variability and timing delays of pharmacy data. This is mainly related to the store close date when the pharmacy appears closed on one file, but the next file update it shows they were open the entire time. This is commonly due to a timing issue. Thus, CMS allows the grace period in initial processing of PDE claims. Regardless, through additional edits CMS believes they reject most PDEs that were submitted not operating as of the DOS. But does state that there is a small chance that some of these PDES will be saved to their system. And thus believes this is a reasonable dispute for a manufacturer to pursue if they identify a PDE invoice dispute for this reason. Supporting Evidence Required for this Dispute The NCPDP close date for the pharmacy should be provided in the supporting date 1 field in the Dispute Submission file. During dispute review CMS will review the NCPDP historical data to determine if the pharmacy was open or closed on the DOS. This will be based on the information on file as of the time of the dispute review. CMS does not include lag time in store closing dates when assessing disputes. Considerations when determining to dispute for this reason code Because of the grace period allowed by the CMS’ PDE editing systems PDE CDGP invoice records may pass through incorrectly if the pharmacy was truly closed.
- Supporting Evidence Required for this Dispute The Additional Information field in the dispute submission file should contain supporting evidence explaining the statutory exclusion that applies to the drug. Distinctly explain how the item is not a part d covered drug Considerations when determining to dispute for this reason code This dispute code should be used when the CGDP invoiced drug would not be covered under Part D in any circumstances. Part D vs. Part B drug differentiations are largely based on indication or patient setting i.e. physician administered products that can not be dispensed at a retail pharmacy for patient pick up. If the service provider ID on the invoiced CGDP PDE record does not represent a pharmacy ID. This type of dispute could potentially be upheld by CMS for this record. If the drug can be covered through Part D or Part B and it is dispensed through the pharmacy and the service provider ID is a pharmacy entity CMS will assume that the patient setting and indication supports being billed under Part D.
- Supporting Evidence Required for this Dispute The Additional Information field in the dispute submission file should contain supporting evidence to show the following: Qty is inconsistent with product labeling/packaging Qty is questionable in the Medicare population – goes back to my point about knowing your product data and the prescribing patters for certain market segments Gap discount is based on an incorrect calculation and/or Gap discount based on incorrect data that does not represent the dispensing event as it occurred The proprietary threshold used to determine excessive or aberrant quantities must also be provided. Considerations when determining to dispute for this reason code When the PI contains a maximum daily dose CMS will generally not uphold disputes that represent doses 3 times the maximum. Quantity represented is potentially related to dispensing errors and is not clinically appropriate in any circumstances – incorrect uom used i.e. mainly effects non pill products, CII products, products with maximum daily dose, products not available through mail order, but contain an 90 day DOS.
- Supporting Evidence Required for this Dispute The Additional Information field in the dispute submission file should contain supporting evidence to show that The per unit price is excessive related to the per unit price commonly paid under the Part D program. CMS will analyze the per unit price of the disputed PDE comparative to all PDEs accepted for the same NDC. If price falls within an acceptable comparative range the dispute is denied. However, CMS has stated that they have seen that an excessive high price of drug is attributed to days of supply. However, that does not necessarily mean they will uphold the dispute in these cases since this will not solely change the quantity dispense, the drug cost or the reported gap discount amount on the PDE. Considerations when determining to dispute for this reason code The Coverage Gap Discount is based on the Medicare Part D negotiated prices determined via private negotiations between the plan sponsor and the pharmacy. Negotiated prices are not determined by a statutory formulary and may differ by plan. Medicare Part D based on negotiated price not other non-Part D pricing standards such as: WAC, AWP AMP or ASP. Disputes for this reason code should not be submitted solely on deviations from these pricing standards. Use Prescription Drug Plan Formulary, Pharmacy Network and Pricing information files to help assess pricing outliers. Considering determining an average negotiated price seen in Part D plans and develops models using this to assess potentially excessive prices. Consider enhancing validations to use this data as well.
- Dispute is intended to represent disputes for PDEs for products that are ineligible for the Coverage Gap based on the marketing Category not being an NDA (New Drug Application or a BLA (Biologic License Application) as of the date of service Supporting Evidence Required for this Dispute The DATE THE FDA DIRECT WAS UPDATED should be provided in the supporting date 1 field in the Dispute Submission file. Supporting Evidence in the Additional Information field is optional Supporting documents however are required and should demonstrate The FDA was notified of the change or error in the FDA NDC Directory/NSDE and/or That updates to the FDA NDC Directory/NDSE were made prior to the DOS and processing date of the PDE. CMS will not take into consideration retroactive listing changes made after the PDES were invoiced for the applicable DOS. Considerations when determining to dispute for this reason code Dispute is evaluated based on the FDA elisting as of the date of service. Retroactive changes will not impact PDEs invoiced based on the FDA listing as of the DOS. Identify who is responsible for submitting directory updates to the FDA Ensure your products are properly listed on the FDA NDC directory and are updated on a frequent and proactive basis to ensure you are not paying CGDP discounts due to administrative delays. Maintain documentation to show communication with FDA and monitor directory to ensure accuracy.
- 340B Supporting Evidence Required for this Dispute The Additional Information field in the dispute submission file should describe the basis of the dispute and include any supporting dates or detail reference numbers. Considerations when determining to dispute for this reason code Part D sponsors are required to establish a pharmacy network that ensures access to covered Part D drugs for their enrollees. Part D sponsors are permitted to count 340B pharmacies toward their retail pharmacy network requirement The SSA does not require a specific contractual relationship between the 340B acquisition cost and the price the Part D sponsor has negotiated with the pharmacy Thus disputes would not be upheld if filed solely on the difference between these two prices Maximum Gap Discount Supporting Evidence Required for this Dispute The Additional Information field in the dispute submission file should describe the basis of the dispute and include any supporting dates or detail reference numbers. Considerations when determining to dispute for this reason code CMS states disputes should not be filed merely bc the invoice differs from the defined standard benefit design and the specific plans benefit design should be taken into consideration. However, the plan information is not provided in the detail report so there’s no way of knowing what the plans benefit design. If you evaluate this item for dispute and determine if outlies the standard it may be worth submitting for additional dispute evaluation by CMS since they have access to this information. Most Part D plans deviate from the standard coverage/benefit but frequently provide benefits that are in the end equivalent to defined standard coverage or enhanced with lower deductibles, fixed copays instead of 25% of coverage before the initial ICL (initial coverage limit) In some cases part d plans have a lower than standard ACL as a result beneficiaries may incur different levels of out of pocket expense when the reach the ICL dependent upon their specific plan parameters.
- Buy or Build – do you have a scrubbing system already? You will need to most likely enhance it to support the processing of CGDP disputes, or you can choose to outsource Implement a process to review invoices for initial verification, i.e. appropriate labeler codes were billed. Invoice matches detail Invoice disputes related to incorrect labeler code billings are submitted via defined CMS process within five days of receipt of the invoice. CMS utilizes FDA National Drug Code Directory to determine labeler codes and corresponding NDCS that will be billed under CGDP. Manufacturers are responsible for the accuracy of this Directory.
- This slide will give you a full visual picture of the CGDP Invoice & Dispute Process Timeline