May 2014 Manufacturer Webinar
Angela Stanley,
CMS, Division of Payment
Reconciliation
Agenda
• CGDP Data Overview
• CGDP Appeals
• Website and Portal Improvements
• An EFT Reminder
• Live Q&A
2
CGDP Data Overview
Amanda Johnson,
Director, Division of Payment
Reconciliation
Discount Eligible Beneficiary
Distribution
LICS vs Non LICS Benes Across Benefit Years
40,000,000
35,000,000
30,000,000
25,000,000
Non-LICS Bene Count
20,000,000
LICS Bene Count
15,000,000
10,000,000
5,000,000
0
2011
2012
2013
2014
4
Discount Eligible Beneficiaries in
Defined Standard Plans
Defined Standard Benefit Plan - LICS vs Non LICS Beneficiary Trend by Benefit Year
3,000,000
2,500,000
2,000,000
Non-LICS Bene Count
1,500,000
LICS Bene Count
1,000,000
500,000
2011
2012
2013
2014
5
Discount Eligible Beneficiaries in
Enhanced Alternative Plans
Enhanced Alternative Plan -LICS vs Non LICS Beneficiary Trend by Benefit Year
18,000,000
16,000,000
14,000,000
12,000,000
10,000,000
Non-LICS Bene Count
8,000,000
LICS Bene Count
6,000,000
4,000,000
2,000,000
2011
2012
2013
2014
6
Discount Eligible Beneficiaries in
Employer Group Waiver Plans
EGWP -LICS vs Non LICS Beneficiary Trend by Benefit Year
7,000,000
6,000,000
5,000,000
4,000,000
Non-LICS Bene Count
LICS Bene Count
3,000,000
2,000,000
1,000,000
2011
2012
2013
2014
7
Quarter Beneficiaries Enter the Gap
100%
90%
32.1%
29.6%
29.2%
35.0%
35.6%
80%
70%
60%
Q4
50%
36.7%
Q3
Q2
40%
Q1
30%
20%
26.8%
26.2%
6.6%
8.6%
9.1%
2011
2012
2013
24.6%
10%
0%
8
Discount Eligible Beneficiaries by
Benefit Phase, Program-wide
25,000,000
661,850
494,864
20,000,000
468,839
3,945,108
3,267,691
3,251,770
15,000,000
Catastrophic Coverage
Coverage Gap
Initial Coverage Period
10,000,000
Deductible Coverage
5,000,000
0
2011
2012
2013
9
2013 Ending Benefit Phase for EGWP
Discount Eligible Beneficiaries
2013 EGWP
Deductible
ICP
Gap
Catastrophic
3% 3%
25%
69%
10
2013 Ending Benefit Phase for EA
Discount Eligible Beneficiaries
2013 Enhanced Alternative Plan
Deductible
ICP
Gap
Catastrophic
0%
3%
14%
83%
11
2013 Ending Benefit Phase for All Other Plan
Types Discount Eligible Beneficiaries
2013 All Other Plan Types
Deductible
ICP
Gap
Catastrophic
3%
13%
23%
61%
12
Average Gap Discount Amount per
Beneficiary
Average Gap
Discount
Amount
2011
$ 603.75
2012
$ 705.56
2013
$ 910.69
13
Coverage Gap Discount
Program (CGDP) Appeals
Independent Review Entity (IRE)
for the Centers for Medicare and
Medicaid Services (CMS)
14
Independent Review Entity
for CGDP
Review appeals of denied disputes
15
CGDP Appeals
• Affirm the appeal
– (disagree with denial)
• Deny the appeal
– (agree with denial)
16
File TPA Dispute Correctly
Attachment
Summary of Dispute Submission Guidance by Reason Code
DISPUTE
REASON
CODE
DISPUTE REASON
DESCRIPTION
D01
Duplicate Invoice Item
D02
Closed Pharmacy
D03
Not PART D Covered Drug
DOCUMENTATION
COMMENTS
REQUIRED:
The SUPPORTING DETAIL
REFERENCE NUMBER field must
contain the Detail Reference Number
(DRN) of the potential duplicate.
OPTIONAL:
Supporting evidence in the
ADDITIONAL INFORMATION field.
REQUIRED:
The SUPPORTING DATE 1 field should
contain the NCPDP closed date.
OPTIONAL:
Supporting evidence in the
ADDITIONAL INFORMATION field.
REQUIRED:
The ADDITIONAL INFORMATION
field should contain supporting evidence
explaining the statutory exclusion that
applies to the drug.
Most PDEs disputed for this reason
represent adjustments to previously
invoiced items. Manufacturers should
confirm that this is not the case by
ensuring that the DRN from the disputed
PDE and the DRN entered in the
Supporting DRN field are different.
The date of service on the dispensing
event should post-date the date entered
as the NCPDP closed date.
Manufacturers should confirm that the
Service Provider ID in question does not
represent a pharmacy for disputes on the
basis that the drug is covered under Part
B.
17
Know the Guidance
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850
CENTER FOR MEDICARE
CENTER FOR MEDICARE
DATE:
March 5, 2012
TO:
Pharmaceutical Manufacturers
FROM:
Cheri Rice /s/
Director, Medicare Plan Payment Group
Medicare Coverage Gap Discount Program—Dispute Resolution
SUBJECT:
Background
As part of the Medicare Coverage Gap Discount Program (CGDP), manufacturers are required to provide
applicable beneficiaries with applicable discounts on the negotiated price of applicable drugs. Applicable
beneficiaries are Part D enrollees that do not receive income related subsidies under section 1860D-14(a)
of the Social Security Act (the Act), have reached or exceeded the initial coverage limit (ICL) under
section 1860D-2(b)(3) of the Act, and have not incurred costs for covered Part D drugs in the year equal
to the annual out-of-pocket threshold specified in 1860D-2(b)(4)(B) of the Act.
TO:
Pharmaceutical Manufacturers
FROM:
Cynthia G. Tudor, Ph.D., Director, Medicare Drug Benefit and C & D Data Group
SUBJECT:
Medicare Coverage Gap Discount Program Appeals Guidance
DATE:
May 31, 2011
This memorandum provides manufacturers with the revised guidance for appealing invoiced
discount payments under the Medicare Coverage Gap Discount Program (Discount Program).
CMS issued the draft guidance on April 7, 2011 for public comment. We reviewed all of the
timely comments received and are making a number of changes and clarifications in this
guidance. However, not all of the comments are addressed in this guidance because they were
beyond its scope. We will consider addressing other comments, such as those pertaining to our
low-volume cell policy, in future guidance or rulemaking.
• Not calculated correctly
• Not calculated with accurate data
• Explain why determination is incorrect
The Centers for Medicare & Medicaid Services (CMS) generates invoices to manufacturers for applicable
discounts based on prescription drug event (PDE) data submitted by the Part D sponsors. Manufacturers
have the right to dispute invoiced discount payments based on the “Medicare Part D Discount Information
on the Manufacturer Data Report.” Within 60 days of receipt of the information, manufacturers must
electronically submit all disputes using the “Manufacturer Dispute Submission File” format provided by
the Third Party Administrator (TPA).
The PDEs accepted from Part D plan sponsors are saved after a rigorous set of data edits are applied.
These include 15 different edits focused exclusively on the CGDP. For example, Edit 867 will reject a
PDE submission if the Food and Drug Administration (FDA) data available at the time does not designate
the drug as having a New Drug Application (NDA) or a Biologic License Application (BLA). Without
these designations the drug is ineligible for the coverage gap discount. Detailed information on PDE
submissions, including the editing process, can be obtained on the TPA's website. We specifically
recommend reviewing the "2011 PDE Participant Guide.” 1
In addition to the substantive editing process, PDEs with coverage gap amounts are subject to further data
analysis by CMS before they are used to generate invoices to the manufacturers for the CGDP.
Accordingly, we expect relatively few PDE errors that would require a dispute to correct and will
generally deny these types of disputes unless the evidence presented demonstrates a failure in the editing
and review process. Moreover, CMS will deny disputes if the discount payment is accurately calculated,
even if the dispensing event may not have been clinically appropriate. In other words, the dispute process
CMS is implementing an appeals process in accordance with section 1860D-14A(c)(1)(A)(vii) of
the Affordable Care Act of 2010 and section V of the Medicare Coverage Gap Discount Program
Agreement (the Agreement). Section 1860D-14A(c)(1)(A)(vii) of the Act requires us to provide
a reasonable mechanism to resolve manufacturer disputes involving the discounts provided under
the Discount Program and section V of the Agreement specifies the rights and obligations of
both CMS and manufacturers for resolving such disputes. A copy of the Agreement can be
found on the CMS website at:
http://www.cms.gov/PrescriptionDrugCovGenIn/05_Pharma.asp#TopOfPage.
The guidance specifies the standard that manufacturer appeals must satisfy in order for the
independent review entity (IRE) to further review and validate a disputed discount payment. This
guidance also clarifies what facts manufacturers must demonstrate, at a minimum, to satisfy this
standard. The standard is necessary to help ensure that the appeals process efficiently and
effectively addresses potential gap discount payment errors in accordance with statutory and
contractual requirements while discouraging the submission of appeals based primarily upon
unfounded bases. We will evaluate the implementation of the appeals process, and revise this
guidance in the future, if necessary, to address issues that might emerge.
1
Available online at
http://www.mcoservice.com/internet/Cssc.nsf/files/PDEParticipantGuide%20cameraready%20081811.pdf/$FIle/PD
EParticipantGuide%20cameraready%20081811.pdf
-1-
18
Reason Codes
• Duplicate Invoice Item
• Closed Pharmacy
• Not a Covered Part D Drug
19
Reason Codes
• Aberrant Quantity
• High Price of the Drug
• Last Lot Expiration
20
Reason Codes
• Marketing Category
– Not NDA
– Not BLA
• Excessive Gap Discount
– Single
– Cumulative
21
Excessive Gap Discount
Single Claim
2013 – TrOOP is $4,750 and the plan
covers 2.5% of negotiated drug costs
[($4,750÷0.975) X 0.50]
2014 – TrOOP is $4,550
2013 – Maximum discount $2,435.90
2014 – Maximum discount $2,307
22
Excessive Gap Discount
Cumulative Claims
Depends on secondary payers and their
TrOOP status
2013 - maximum discount for multiple claims
is $4,871
2014 - decreases to $4,667
23
Appeals Received
24
Appeals by Reason Codes
25
Appeal Outcomes
26
DRN Outcomes
27
Affirmed Examples
• Part D Sponsor stated the PDEs would
be adjusted
– Incorrect calculation
– Incorrect NDC
– Incorrect quantity
– Incorrect data submitted
• Exceeded maximum discount
• Not Part D Covered Drug
28
Denied Examples
• Supporting evidence absent
– Non covered drugs
– Excessive gap discount
– Inappropriate doses
– Excessive cost
• Prior Authorization present
29
Conclusion
• File your dispute correctly
• File your appeal timely
• Respond to communications received
from the IRE
CGDPAppeals@provider-resources.com
30
CGDPAppeals@
provider-resources.com
31
Website and Portal Improvements
Art Spaziano, Manager
Palmetto GBA
Medicare Part D, CGDP TPA
Website and Portal
Improvements
• TPAdministrator.com
– FAQ
– ListServ Announcement History
• Manufacturer’s Portal
– Payment Confirmation
• Support for negative amounts
– Detail reports
– Confirmation responses
• Sponsor Mailboxes
– Web based payment confirmation
33
TPAdministrator.com
FAQ
34
TPAdministrator.com
FAQ
35
TPAdministrator.com
ListServ Announcement History
36
Manufacturer’s Portal
Bi-directional Pymt Confirmation
37
Manufacturer’s Portal
Detail Reports
38
Manufacturer’s Portal
Confirmation Responses
39
EFT Reminder
Art Spaziano, Manager
Palmetto GBA
Medicare Part D, CGDP TPA
EFT Information for Manufacturers and
Sponsors
• It’s the only way you can receive what you’re owed
• No Dependency on APPS system
• Opportunity to update each quarter
• No update needed if there are no changes
• Reminders will be sent prior to each update deadline
• Full set of EFT records redistributed each quarter
• Important for Manufacturers & Sponsors to download
their respective files each quarter
• Granular description of changes issued with each
update
• EFT info for some DMs still missing!
41
Contact Information
Art Spaziano, Manager
Palmetto GBA
Medicare Part D, CGDP TPA
Contacting the TPA
• TPA website - http://tpadministrator.com
• Phone
– Help Line: 1-877-534-2772 – Option 1
– Hours: Monday thru Friday 8am to 7pm ET
• General email inquiries regarding the invoicing and payment process
should be sent to tpaoperations@tpadministrator.com
• Webinar slides will be posted to the TPA website
• Suggestions for future webinar topics should be sent to
webinar@tpadministrator.com
• Questions related to dispute files, EFT information, invoice
corrections http://tpadministrator.com – Website
• disputes@tpadministrator.com - Dispute support documentation
43
Resources
• Medicare Drug Benefit Group
• Questions related to the Manufacturers Agreement, changes of ownership,
terminations, compliance / administrative-related issues, policy
• Email address is CGDPandManufacturers@cms.hhs.gov
• Discount Program Manufacturer’s Page
• http://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovGenIn/index.html?redirect=/PrescriptionDrugCov
GenIn/
• HPMS Website
Updating CMS contact and labeler code changes
• https://gateway.cms.gov - Website
• CMS_IT_service_desk@cms.hhs.gov - Password Resets
• CMSHPMS_access@cms.hhs.gov - Non-password access assistance
• Independent Review Entity (IRE) for Discount Program appeals.
• https://cgdpappeals.provider-resources.com/Default.aspx - Website