From: CMS RxDRUGPolicy To: Schaefer, Kathy A Cc: Coster, John M.
(CMS/CMCS); Blatt, Ruth (CMS/CMCS) Subject: H.P. Acthar gel Date:
Tuesday, March 12, 2019 9:55:34 AM Attachments: TEMPLATE FOR BASE
AMP CHANGE REQUEST - (S & I Drugs).xlsx
acthar March 2019.doc.pdf
Ms. Schaefer, Please find attached an advance copy of a letter that
you will be receiving by U.S. Mail. Thank you, CMS Rx Drug Policy
(04) The information in this response is limited to and based upon
the facts described in this email and any attachments provided and
our understanding of the facts as described in the emails and
attachments submitted. If a subsequent review by CMS, by the Office
of Inspector General, or another authorized government agency
determines or reveals that additional adjustments or revisions are
necessary, the manufacturer is responsible for complying with that
determination. This response cannot be considered an advisory
opinion under section 1128D(b) of the Social Security Act, since
only the Inspector General of the U.S. Department of Health and
Human Services has been authorized to issue advisory opinions
relating to health care fraud and abuse under that section. This
response should not be interpreted as acquiescence by the
Government to the arrangements described herein. Further, this
response is not a release of any liability. NOTICE: The contents of
this message and any attachments may be privileged and
confidential. If you are not an intended recipient, or have
received this message in error, please delete it without reading it
and please do not print, copy, forward, disseminate, or otherwise
use the information. Also, please notify the sender that you have
received this communication in error. Your receipt of this message
is not intended to waive any applicable privilege.
HHS - 000012
Sheet1
TEMPLATE FOR BASE AMP CHANGE REQUEST (S and I Drugs only)
1. Date of Request:
4. Labeler Code
5. Product Code
6. Product Name
7a. COD Status
7b. FDA Application No. (NDA/ANDA)/OTC Mongraph
8. Does this NDC have a reference NDC, such as did you acquire this
product from another company? If yes, please provide the old
company's NDC. Or if your product is an Authorized Generic, please
provide the NDC of the Brand Product.
9. If product is acquired from another company as provided in #8,
then please provide the Product Purchased Date (PPD).
10. OBRA ’90 Base AMP Quarter
11. Current OBRA '90 Base AMP
12a. Revised OBRA '90 Base AMP
12b. If no PPD provided in #9, please provide BP value
13. OBRA ’93 Base AMP Quarter
14. Current OBRA '93 Base AMP
15a. Revised OBRA '93 Base AMP
15b. If no PPD provided in #9, please provide BP value
16. Esimated Amount Due to States from Labeler
17. Estimated Amount Due to Labeler from States
If there is NO AMOUNT DUE either to States from Labeler or to
Labeler from States, please provide the reason why no amount is due
in the reason box.
20. Labeler’s Reason to Request for a Change (please provide as
much detail as possible):
Updated September 2017
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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare
& Medicaid Services 7500 Security Boulevard, Mail Stop S2-14-26
Baltimore, Maryland 21244-1850 Disabled and Elderly Health Programs
Group March 12, 2019 Kathy A. Schaefer Senior Vice President,
Finance and Corporate Controller Mallinckrodt Pharmaceuticals 1425
U.S. Route 206 Bedminster, New Jersey 07921 Dear Ms. Schaefer: We
thank Mallinckrodt Pharmaceuticals (Mallinckrodt) for meeting with
us on March 7, 2019 to present its position regarding the base date
Average Manufacturer Price (AMP) of H.P. Acthar Gel. As we have
said in our prior communications of April 13, 2016, June 2, 2016,
and March 20, 2017, and as we reiterated at the March 7th meeting,
the base date AMP of H.P. Acthar Gel should reflect the base date
AMP for the drug that was first produced or distributed under new
drug application (NDA) 008372. Because H.P. Acthar gel is
currently, and always has been, produced or distributed under NDA
008372, the base date AMP Mallinckrodt is reporting to the Drug
Data Reporting for Medicaid (DDR) system does not reflect the
appropriate base date AMP, and Mallinckrodt has been underpaying
Medicaid rebates for H.P. Acthar Gel.
We are enclosing a template for you to complete and return to
[email protected] in order for Mallinckrodt to report the
correct baseline information to the Medicaid Drug Rebate Program.
Sincerely, /s/
John M. Coster, Ph.D, RPh Director, Division of Pharmacy
cc: Alice Valder Curran
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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare
& Medicaid Services 7500 Security Boulevard, Mail Stop S2-14-26
Baltimore, Maryland 21244-1850 Disabled and Elderly Health Programs
Group March 12, 2019 Kathy A. Schaefer Senior Vice President,
Finance and Corporate Controller Mallinckrodt Pharmaceuticals 1425
U.S. Route 206 Bedminster, New Jersey 07921 Dear Ms. Schaefer: We
thank Mallinckrodt Pharmaceuticals (Mallinckrodt) for meeting with
us on March 7, 2019 to present its position regarding the base date
Average Manufacturer Price (AMP) of H.P. Acthar Gel. As we have
said in our prior communications of April 13, 2016, June 2, 2016,
and March 20, 2017, and as we reiterated at the March 7th meeting,
the base date AMP of H.P. Acthar Gel should reflect the base date
AMP for the drug that was first produced or distributed under new
drug application (NDA) 008372. Because H.P. Acthar gel is
currently, and always has been, produced or distributed under NDA
008372, the base date AMP Mallinckrodt is reporting to the Drug
Data Reporting for Medicaid (DDR) system does not reflect the
appropriate base date AMP, and Mallinckrodt has been underpaying
Medicaid rebates for H.P. Acthar Gel.
We are enclosing a template for you to complete and return to in
order for Mallinckrodt to report the correct baseline information
to the Medicaid Drug Rebate Program. Sincerely, /s/
John M. Coster, Ph.D, RPh Director, Division of Pharmacy
cc: Alice Valder Curran
7b. FDA Application No. (NDA/ANDA)/OT
C Mongraph
Quarter
12b. If no PPD provided in #9, please provide BP
value
Quarter
15a. Revised
15b. If no PPD provided in #9, please provide BP
value
States from Labeler
States
20. Labeler’s Reason to Request for a Change (please provide as
much detail as possible):
TEMPLATE FOR BASE AMP CHANGE REQUEST (S and I Drugs only)
1. Date of Request:
3. Labeler Technical Contact (Name & Phone #):
If there is NO AMOUNT DUE either to States from Labeler or to
Labeler from States, please provide the reason why no amount is due
in the reason box.
8. Does this NDC have a reference NDC, such as
did you acquire this product from another
company? If yes, please provide the old
company's NDC. Or if your product is an
Authorized Generic, please provide the NDC of
the Brand Product.
then please provide the
Product Purchased Date (PPD).