Ms. Schaefer, Please find attached an advance copy of a ...
3
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
Transcript of Ms. Schaefer, Please find attached an advance copy of a ...
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
1 | P a g e
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
1 | P a g e
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).
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
1 | P a g e
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
1 | P a g e
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).
