April 6, 2011
COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Manufacturers Webinar
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Announcements
• Quarter 1 Invoice Distribution
o April 30th, 2011
• Directions for Payment Confirmation
Overview and Overpunch Character
Mapping are posted on CSSC website.
• Manufacturer with no quarterly report
• Latest HPMS module from MDBG
released.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Webinar Schedule
• May 4th, 2011
• June 1st, 2011
• July 6th, 2011
4:00-5:00 p.m. ET
4:00-5:00 p.m. ET
4:00-5:00 p.m. ET
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Accomplishments
• Released EFT Data on March 16
• Invoice Correction Online Form
• HPMS Modules Released
o Manufactures can update labeler codes
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Agenda
• Invoice Correction Process
• FAQs
• Overview: Part D Covered Drugs and
Applicable Drugs
• Dispute Follow-up
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Invoice Correction Process
•
•
•
•
Manufacturers wishing to correct an invoice may do so only if they have been
invoiced for NDCs with labeler codes not covered by their CGDP Manufacturer
Agreements. CMS publishes the “Participating Manufacturer Labeler Codes” at
http://www.cms.gov/PrescriptionDrugCovGenIn/05_Pharma.asp#TopOfPage
which documents the current list of labeler codes covered by each Manufacturer.
Manufacturers submit their labeler codes at the time they sign the CGDP
Manufacturer Agreement and maintain current labeler codes on an ongoing
basis as described in the “Release of the Health Plan Management System
(HPMS) Drug Manufacturer Module” guidance released on March 25, 2011. This
guidance revises and supersedes the December 17th guidance for maintaining
contact and labeler code information.
CMS uses “Participating Manufacturer Labeler Codes” to create the quarterly
CGDP Invoice report. The quarterly report invoices Manufacturers for Labeler
codes assigned to them as of the first business day following the end of the
quarter.
The TPA will post the link to the Manufacturer Invoice Correction Request form at
www.csscoperations.com under the TPA/Drug Manufacturer heading before 1st
quarter invoices are distributed.
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Manufacturer Invoice Correction Request (Draft)
COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Manufacturer Steps:
1. Complete this online form within 5
calendar days of the date the TPA
distributes the CGDP Quarterly
Invoice.
2. TPA will respond within 3 business
days .
3. If the TPA confirms the invoice
correction, the manufacturer shall
not be responsible for paying NDCs
with labeler codes invoiced
incorrectly. Instead the
Manufacturer shall pay all other
labeler codes in the invoice.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Frequently Asked Question #1
Q: Will manufacturers be required to send 1099s to contracts
they have paid?
A: Yes. Manufacturers will produce 1099s for contracts to
whom they have made Coverage Gap Discount payments.
Use the 1099 name and address fields from the EFT file.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Frequently Asked Question #2
Q: How many quarterly invoices will Manufacturers receive for
2011 dates of service (DOS)
A: There will be 17 quarterly invoices for 2011 dates of
service. Generally, a quarterly invoice includes data
submitted during the invoice quarter. For example, the
invoice for Q4 of 2011 could include a PDE with a Jan 2011
DOS if the Part D sponsor submitted the PDE between Oct
1, 2011 and Dec 31, 2011. This Q & A corrects the “13
Quarter” information published during the Feb 4, 2011
webinar.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Covered Medicare Part D Drug
•
Social Security Act §§ 1927(k)(2) and 1860D-2
o
o
o
o
o
•
Dispensed only upon a prescription, including OTC insulin and supplies associated with the
injection of insulin (e.g. syringes, needles, alcohol swabs, gauze).
Approved as an Abbreviated New Drug Application (ANDA), New Drug Application (NDA), or
Biologic License Application (BLA) by the Food and Drug Administration (FDA).
Meets provisions regarding the Drug Amendments of 1962.
No payment is available under Medicare Parts A or Part B.*
Not excluded from coverage under SSA 1927(d)(2), except for smoking cessation agents.
42 CFR 423.100
o
o
o
Included in a Part D plan's formulary.
Treated as being included in a Part D plan's formulary as a result of a coverage determination
or appeal (includes transition and emergency fills).
Obtained at a network pharmacy or an out-of-network pharmacy.
* Part D plans use prior authorizations to determine Part B versus Part D coverage on drugs
such as injectables. Note, claims for non-Part-B-covered injectables whether usually selfadministered or not, when dispensed and submitted by pharmacists could be covered
under Part D.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Applicable Drugs
Applicable Drug
• The definition of an applicable drug can be found
under SSA §1860D-14A(g)(2).
o Meets the definition of a covered Medicare Part D drug.
o Approved by the FDA under an NDA or BLA.
• Applicable drugs may be covered under Part D only
if the manufacturer has a signed agreement, unless
through an exception under SSA 1860D-43(c).
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Resources to Identify
Applicable Drugs
FDA National Drug Code (NDC) Directory
•
•
FDA NDC Directory at
http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange
Book)
New NDC Directory
•
FDA has scheduled for June 1, 2011. See:
http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm
•
The new NDC Directory (FDA Online Label Repository) is expected to have
downloadable data files that are efficient for plans and CMS to identify NDC
marketing categories.
•
Currently, NDCs that are electronically listed show on the FDA Online Label
Repository and eventually the NDC Directory.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
MEDICARE COVERAGE GAP DISCOUNT
PROGRAM (CGDP) AGREEMENT
Manufacturers agree to:
“To electronically list and maintain an up-to-date
electronic FDA listing of all NDCs of the Manufacturer,
including the timely removal of discontinued NDCs
from the FDA NDC Directory, so that CMS and Part D
sponsors can accurately identify applicable drugs (as
defined in section I (c) of this Agreement).”
“To list NDCs with the FDA in advance of commercial
distribution of the drug product.”
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Electronically Listing NDCs
Manufacturers are responsible for listing and maintaining
listings of NDCs of drug products that are on the market,
including drug products:
1. In commercial distribution.
2. With discontinued applications , but unexpired drug product may be
on wholesaler/distributor or pharmacy shelves.
3. Commercial distribution has halted, but unexpired drug product
may be on wholesaler/distributor or pharmacy shelves.
4. Acquired through manufacturer acquisition.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
In Commercial Distribution
• If a drug product is being distributed on the
market, whether the manufacturer anticipates
stopping distribution or not, the manufacturer
needs to electronically list the NDC with the FDA.
• Manufacturers need to look over their inventory
and make sure that all marketed NDCs, including
NDCs that could potentially be on the market are
electronically listed with the FDA.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Discontinued Applications
• Application discontinued for reasons other than
safety.
• NDC was not recalled from the market.
• Unexpired drug product may be on pharmacy
shelves.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Commercial Distribution has Halted
• NDC of a drug product not listed with the FDA.
• Marketing has discontinued.
• Unexpired drug product may be on pharmacy shelves.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
NDC Changes
• Manufacturer acquisition.
• Includes NDCs no longer distributed on the market.
• Includes NDCs where new manufacturer changed NDC.
• Unexpired drug product may be on pharmacy shelves.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Important Notes
• NDCs need to be listed for plans to identify
applicable drugs.
• Include the marketing start dates and end dates
on Structured Product Labeling (SPL).
• For NDC acquisitions, use the original marketing
start date for that NDC, not the date acquired
from another manufacturer.
• The Marketing End Date is the expiration date of
the last lot released to the marketplace.
• NDCs should only be listed once with the correct
application number.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Periodic Review of NDCs
• FDA NDC Directory at
http://www.accessdata.fda.gov/scripts/cder/n
dc/default.cfm .
• New NDC Directory (FDA Online Label
Repository) at http://labels.fda.gov/
• Corrections and updates should promptly be
made by electronically listing or contacting the
FDA at eDRLS@fda.hhs.gov .
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Timely Removal of
NDCs not on Market
• NDCs listed only through Form 2657 (paper),
contact FDA at eDRLS@fda.hhs.gov .
• NDCs listed by SPL, update SPL using the same set
id and new id root and version.
• Inform the FDA prior to the last lot expiration date
to allow ample time to update the FDA website.
• The CGDP does not look at data submitted to the
Drug Date Reporting for Medicaid (DDR) System.
CMS will verify that the date the NDC no longer
displays on the NDC Directory is not after the last
lot expiration date.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Dispute Follow Up
Updates to simplify dispute submission:
• increase detail record length to 1024
• expand “Additional Information” field to 800+ characters
• remove comment record cross-reference in detail record
• eliminate additional comment detail record
Approach for automating dispute processing: specify required
fields for individual dispute reason codes
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Dispute Reasons (part 1 of 2)
COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Dispute
Reason Dispute
code
Reason
D01
SUPPORTING DETAIL
REFERENCE NUMBER
SUPPORTING SUPPORTING
DATE 1
DATE 2
ADDITIONAL INFORMATION
Duplicate Invoice Reference Number of
Item
duplicate record
Provide additional supporting
evidence (optional)
NCPDP closed
date
Provide additional supporting
evidence (optional)
D02
Closed Pharmacy
D03
Not PART D
Covered Drug
Explain statutory exclusion for
the drug (required)
D04
Excessive
Quantity
Excessive quantity on
individual invoice item. Provide
proprietary benchmark used to
identify excessive quantity.
(required)
D05
Invalid Days
Supply
Provide additional supporting
information (Required)
D06
High Price of the
drug
Provide additional supporting
information (Required)
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Dispute Reasons (part 2 of 2)
COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Dispute
Reason
Dispute Reason
code
D07
Early Fill
D09
Marketing category is not
NDA or BLA
D11
Invalid Date of Service
(prior to 01/01/2011)
Invalid Date of Service
(invoiced after 17th quarter
for the benefit year)
D12
Invalid Prescription Service
Reference Number
D99
Other
SUPPORTING SUPPORTING
DATE 1
DATE 2
NDC directory Last lot
drop date
expiration date
Last Lot Expiration Date
D08
D10
SUPPORTING
DETAIL
REFERENCE
NUMBER
Reference number
for early fill
disputed
FDA update
date
ADDITIONAL
INFORMATION
Provide additional
supporting information
(optional)
Provide additional
supporting information
(Required)
Provide additional
supporting information
(optional)
Provide additional
supporting information
(optional)
Provide additional
supporting information
(optional)
Provide additional
supporting information
(optional)
Provide additional
supporting information
(required)
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Detail Dispute Record
COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Fields 1-16: Detail record (DETCG) from Data report
Fields 17–22: Information to support dispute; completed by manufacturer
FIELD
NO FIELD NAME
17
DISPUTE REASON CODE
POSITION
PICTURE
LENGTH
149 - 151
X(3)
3
SUPPORTING DETAIL
Draft
format
posted152on
18 REFERENCE
NUMBER
- 171CSSC
X(20) website
20
19
SUPPORTING DATE 1
172 - 179
9(8)
8
20
SUPPORTING DATE 2
180 - 187
9(8)
8
21
ADDITIONAL INFORMATION
188 - 1024
X(837)
836
DEFINITION / VALUES
The reason for the manufacturers to dispute GAP
discount amount.
D01 - Duplicate Invoice Item
D02 - Closed Pharmacy
D03 - Not PART D Covered Drug
D04 - Excessive Quantity
D05 - Invalid 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 - invalid date of service (prior to 01/01/2011)
D11 - Invalid Date of Service (invoiced after 17th
quarter for the benefit year)
D12 - Invalid Prescription Service Reference
Number
D99 - Other
Expected supporting detail reference number for
related records. ( i.e. Duplicate PDEs, Early fill). If
there is more than one reference number, then
note them in the dispute explanation field.
Expected ‘CCYYMMDD’, if the dispute reason
requires two dates, Use this date column as
Primary for reporting the date.
Expected ‘CCYYMMDD’, if the dispute reason
requires two dates, use this date column as
secondary for reporting the date.
Detailed explanation of the dispute.
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COVERAGE GAP DISCOUNT PROGRAM – USER GROUP
Question and Answer
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