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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 975 F Street NW Suite 500 |
Address2 |
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| City | Washington |
State | DC |
Zip Code | 20004 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 40032282-75
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6. House ID# 399140003
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| TYPE OF REPORT | 8. Year | 2015 |
Q1 (1/1 - 3/31) | Q2 (4/1 - 6/30) | Q3 (7/1 - 9/30) | Q4 (10/1 - 12/31) |
9. Check if this filing amends a previously filed version of this report
| 10. Check if this is a Termination Report | Termination Date | 12/31/2015 |
11. No Lobbying Issue Activity |
| INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13 | |||||||||
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| 12. Lobbying | 13. Organizations | ||||||||
| INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
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| Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). | 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options. | ||||||||
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Method A.
Reporting amounts using LDA definitions only
Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code Method C. Reporting amounts under section 162(e) of the Internal Revenue Code |
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| Signature | Digitally Signed By: Richard J Tarplin |
Date | 1/24/2016 4:50:15 PM |
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code HCR
16. Specific lobbying issues
Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow-on biologics.
Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit.
Meetings with Administration and congressional staff on coverage/payment issues related to cancer biotherapeutics, 340B program.
Meetings with Administration staff concerning the President's precision medicine initiative.
Public Law 114-113, Consolidated Appropriations Act, 2016, provisions relating to HHS and FDA appropriations and program authority.
Public Law 114-74, Bipartisan Budget Act of 2015, provisions relating to HHS and FDA funding, including changes to sequestration levels, possible changes to Medicare Part B payments.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Health & Human Services - Dept of (HHS)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Richard |
Tarplin |
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Assistant Secretary for Legislation/HHS; Principal Deputy Assistant Secretary for Legislation/HHS; Staff Director, Senate Subcommittee on Children and Families |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code MMM
16. Specific lobbying issues
Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics
Public Law 114-10, the Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform and CHIP extension, payment for Part B drugs.
Public Law 114-113, Consolidated Appropriations Act, 2016, provisions relating to HHS and FDA appropriations and program authority, possible changes to Medicare program.
Public Law 114-74, Bipartisan Budget Act of 2015, provisions relating to HHS and FDA funding, including changes to sequestration levels, possible changes to Medicare Part B payments.
Meetings with executive branch officials regarding innovative Part B reimbursement plans for bio pharmaceuticals.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Office of Management & Budget (OMB)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Richard |
Tarplin |
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Assistant Secretary for Legislation/HHS; Principal Deputy Assistant Secretary for Legislation/HHS; Staff Director, Senate Subcommittee on Children and Families |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code PHA
16. Specific lobbying issues
Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to FDA approval of follow-on biologics and length of data exclusivity period, 340B drug pricing program, structure of the Medicare prescription drug benefit.
Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid reimbursement, fees assessed on the pharmaceutical industry, design and structure of the Medicare prescription.
Public Law 112-144, the Food and Drug Administration Safety and Innovation Act - legislation related to reauthorization of user fees for prescription drug, medical device, and bilogics approval.
General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis.
Held discussions with Administration staff about 340B program requirements on participating pharmaceutical manufacturers.
H.R.6, 21st Century Cures Act, all provisions
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Executive Office of the President (EOP), Centers For Disease Control & Prevention (CDC), Health & Human Services - Dept of (HHS), Health Resources & Services Administration (HRSA)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Richard |
Tarplin |
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Assistant Secretary for Legislation/HHS; Principal Deputy Assistant Secretary for Legislation/HHS; Staff Director, Senate Subcommittee on Children and Families |
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Information Update Page - Complete ONLY where registration information has changed.
20. Client new address
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21. Client new principal place of business (if different than line 20)
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22. New General description of client’s business or activities
LOBBYIST UPDATE
23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client
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ISSUE UPDATE
24. General lobbying issue that no longer pertains
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AFFILIATED ORGANIZATIONS
25. Add the following affiliated organization(s)
Internet Address:
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Principal Place of Business (city and state or country) |
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26. Name of each previously reported organization that is no longer affiliated with the registrant or client
| 1 | 2 | 3 |
FOREIGN ENTITIES
27. Add the following foreign entities:
| Name | Address |
Principal place of business (city and state or country) |
Amount of contribution for lobbying activities | Ownership percentage in client | ||||||||||
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28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization
| 1 | 3 | 5 |
| 2 | 4 | 6 |