cms, medicaid drug rebate, program, release no. 148

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services
January 28, 2008
MEDICAID DRUG REBATE PROGRAM
Release No. 148
NEWS For State Medicaid Directors


APPROVAL OF ORTHO-McNEIL PHARMACEUTICALS/HALDOL
RECALCULATION

Ortho-McNeil Pharmaceuticals (formerly McNeil Pharmaceuticals, labeler 00045) recalculated
Base Date AMPs for Haldol Tablets and Concentrate. These recalculated Base Date AMPs will
result in revised quarterly unit rebate amounts, which was included with 3rd quarter 2007 rebate
data provided to the States. As a result, additional rebates may be due the states for first quarter
1994 through the current quarter. Ortho-McNeil intends to pay these additional rebates and
applicable interest along with payment of 3rd quarter 2007 invoices. Ortho-McNeil indicated to
CMS that they have previously manually calculated and paid rebates to states for earlier
quarters (1991-1993) as a result of the Haldol recalculation. (See Medicaid Drug Rebate
Program Releases 73 & 75 to State Medicaid Directors.)
If you have any questions on this particular issue, please contact Kim Howell at (410) 786-6762
or

NEW LABELERS

REINSTATED LABELERS

67857

Contact information for new and reinstated labelers is attached for your convenience.

TERMINATED LABELERS

The following labeler code is being terminated effective 10/01/2007:
F. Dohman (aka Healthcare America (HCA))
The following labeler codes are being terminated effective 01/01/2008: Elan The following labeler codes are being terminated effective 04/01/2008: Glaxosmithkline Oncology Therapeutics Network Joint Vent.
NOTE: The termination of Laser Pharmaceuticals, LLC, Labeler Code 68134, effective
October 1, 2007 has been rescinded.
VOLUNTARILY TERMINATED LABELERS

The following labelers have requested voluntary termination effective 01/01/2008:
FEI Products LLC


The following labeler has requested voluntary termination effective 04/01/2008:
Zila Pharmaceuticals, Inc. Labeler Code 51284 Johnson & Johnson Health Care Systems Labeler Code 00501 McNeil-PPC, Inc. Labeler Code 08004 Johnson & Johnson Merck Consumer Labeler Code 16837
McNeil Consumer Healthcare Labeler Code 50580
Personal Products Company Labeler Code 62341
PRODUCT DELETIONS FROM MDR
As part of our continuing effort to remove non-rebate-eligible data from the Medicaid Drug
Rebate (MDR) system, the following products have been deleted from the MDR master file of
covered outpatient drugs:
00074
VI-DAYLIN/IRON DRP MULTIVITAMIN WITH IRON OYSTER SHELL CALCIUM 500+ D CHEWABLE TABS
CHANGE IN DRUG COVERAGE STATUS/DESI CODE CHANGE
The following drug was reported by the labeler as DESI Code 2 (i.e., Safe and Effective or non-
DESI drug). The FDA has determined that the drug is DESI Code 5 (i.e., Less-than-
Effective/IRS Drug) (DESI FR Notice 6514, 02/09/1973). Please be aware that this drug is not
rebate eligible.
51991-0513 Quartuss
The following drug was reported by the labeler as DESI Code 2 (i.e., Safe and Effective or non-DESI drug). The FDA has determined that the drug is DESI Code 5 (i.e., Less-than-Effective/IRS Drug) (FR Notice 20495, 05/06/1983). Please be aware that this drug is not rebate eligible. 68032-0256 Servira The following products were reported by the labelers as DESI Code 5 (i.e., Less-than-Effective/IRS drug for all indications); however, the FDA has informed us that the drugs are DESI Code 2 (i.e., Safe and effective or non-DESI drug). 68462-0105 Ondansetron Hydrochloride Tablets 4mg 30’s 68462-0106 Ondansetron Hydrochloride Tablets 8mg 68462-0162
68462-0178 Naproxen Sodium Tablets 275mg
68462-0179 Naproxen Sodium Tablets 550mg
STATE ROLE IN DESI PROCESS

Labelers that market new drugs during a rebate period should report the relevant product data,
including DESI code, to CMS within thirty days from the end of the rebate period. Each
quarter, CMS compiles the report of approximately 1,000 to 2,000 new NDCs to send to the
FDA for their review and comment. As part of this review, the FDA ensures that the new
NDCs reflect the correct DESI code. In those instances where the review determines that an
incorrect DESI code was reported by the labeler, CMS notifies states via fax and the reporting
labeler via letter of the error and correction. CMS subsequently publishes any DESI code
corrections in a program release.
Prior to CMS’s notification of DESI changes/errors to states, some State Medicaid Agency
pharmacists have identified potential DESI errors and have notified CMS before the FDA’s
review has been completed. In many cases CMS is then able to confirm the DESI status with
the FDA on an individual NDC basis and to subsequently alert states within twenty-four to
forty-eight hours from the state’s initial notification.

We appreciate state input on these DESI issues and encourage all states to continue notifying
CMS when they are aware of or suspect other potential DESI corrections. In the interest of the
Medicaid beneficiaries, CMS and states will continue to work closely to detect and correct
DESI code errors as expeditiously as possible. Please send your DESI issues and concerns to
the rebate operations email resource box, .

CHANGE IN METHOD OF SENDING STATE NOTIFICATIONS
Future State Program Releases and other state notifications (e.g., new labeler agreements and
NDC status changes/corrections) will be shared with states via email rather than mail or fax.
Emails will be sent to each state’s Technical Contact (TC). As a result, states should review
their contact information (including the TC’s email address) at
to ensure that it is
correct. If you need to update your state contact information, please use the MDR Program State
Agency Contact Form (form 368) located at
. All
changes should be either emas soon as possible. Although the method of sending these updates is changing, it is important
for states to keep all contact information on the form 368 current (including fax numbers,
mailing addresses, etc.).

OTHER ATTACHMENTS

A copy of the current listing of the 91-day treasury bill auction rates beginning with the period
May 1, 2006, is attached.
Please rememb
enters and is maintained in the
2 Attachments cc: All State Drug Rebate Technical Contacts All Regional Administrators WEEKLY U.S. T-BILL INVESTMENT RATE
Weekly 91-day Treasury Bill Auction Rates of Invest.
MDRI Detailed Manufacturer Contact Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 1
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 1
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 1
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 1
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
200 SOMEREST CORPORATE BOULEVARD 3600 ARCO CORPORATE DRIVE Effective Date:
Transmission Option: 1
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
Effective Date:
Transmission Option: 2
Termination Date:

Legal Information Invoice
Information Technical
Information
TOPICAL INDEX - STATE MEDICAID RELEASES 1 - 148
TOPIC
RELEASE #
Adjustment Code for Forms CMS-304 & CMS-304a Monthly AMP Methodology (Manufacturer Assumptions) Best Price Effect of Sales to HMOs, etc. Betaseron - Coverage & Reimbursement Bulk Transfer/Buy-Out of Major Pharm. Assets Dataset Name Changes on Quarterly Rebate Tapes Drug Efficacy Study & Implementation (DESI): Change Effective Date TOPICAL INDEX - STATE MEDICAID RELEASES 1 - 148
TOPIC
RELEASE #
Duplicate Discount/Rebate Mechanism Implementation Failure of Manufacturers to Notify States of Disputes or Pay Rebates Heparin/Saline Flush Syringes & Other Non-Drug Products Improper Rebate Withholding/Interest Implications TOPICAL INDEX - STATE MEDICAID RELEASES 1 - 148
TOPIC
RELEASE #
New Address for Shipping (Effective 6/1/95) Manufacturer Information Record Specification Manufacturer Name & Address Contact Info Diskette Medicaid Drug Rebate Data Guide for States Multiple Package Size-Pricing Inconsistency 137, 138, 139, 140, 142, 143, 144, 145, 146, 148 Point-of-Sale System (POS) in Pharmacies Prior Period Adjustments - Eli Lilly & Company Prior Quarter Adjustment Statement (PQAS) Approval Proposed Discount Equal Access Legislation Publication of Drug Rebate Regulations CMS-2175-FC Publication of Drug Rebate Regulations MB-46-P Rebate Agreements: Start Date Procedures TOPICAL INDEX - STATE MEDICAID RELEASES 1 - 148
TOPIC
RELEASE #
Reconciliation of State Invoice (ROSI) Approval Rejection of State Records Matching LTE Drugs Rescission of Termination for Novopharm USA S-TAG (Systems Technical Advisory Group) Separate Rebate Agreements with Manufacturers Special Study – Anti-Load Viral/AIDS Drugs State Invoices Containing Universal Product Codes State Pharmacy Assistance Programs Exemption From Medicaid Best Price State Quarterly URA Tape Labeler Contact Information Timely Receipt of Tapes/Notices of Mailing Tolerance Threshold Clarification For Interest TOPICAL INDEX - STATE MEDICAID RELEASES 1 - 148
TOPIC
RELEASE #
Change for Boehringer Ingelheim Product Unit Rebate Amount (URA): Additional Amounts in 3/1998 File Unit Type: Changes and Prior Period Adjustments Utilization Adjustments for Prior Calendar Quarters Transmitting Corrections/Adjustments to CMS Warrick Pharmaceuticals (Sodium Chloride Solution)

Source: http://www.dhs.state.or.us/policy/healthplan/guides/pharmacy/cms_releases/cms_rel148.pdf