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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1399 New York Avenue NW |
Address2 | Suite 600 |
| City | Washington |
State | DC |
Zip Code | 20005 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 401049961-12
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6. House ID# 422720000
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| TYPE OF REPORT | 8. Year | 2018 |
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 |
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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: Paul Ehrlich |
Date | 7/20/2018 12:10:04 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 BUD
16. Specific lobbying issues
S. 3158: Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
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 |
Daniel |
Bachner |
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Stephen |
Scango |
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Courtney |
Piron |
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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 CPT
16. Specific lobbying issues
H.R. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent Settlements
H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms
S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements
S. 974 Amendment: Hatch-Waxman Integrity Act of 2018 - Provisions related to inter partes review process
S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms
S. 2601: BIG Data for IP Act - Provisions related to fee-setting authority
Biopharmaceutical innovation and patent policy issues
Patent litigation reform issues and issues related to post-grant proceeding at the PTO
Draft legislation related to notification of agreements to the FTC and DOJ
Bayh-Dole march-in rights policy issues
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
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 |
Daniel |
Bachner |
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Stephen |
Scango |
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Courtney |
Piron |
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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 HCR
16. Specific lobbying issues
H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program
H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness
H.R. 5353; Leonard Lance, Eliminating Opioid Infectious Diseases Act of 2018
H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program
H.R. 5687: SOUND Disposal and Packaging Act - To require improved packaging and disposal methods with respect to certain drugs
H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program
H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste
S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness
S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems
S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pri
S. 2312: HELP Act - Provisions related to 340B progr
S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B prog
S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding
Drug cost and pricing policy issues
Transparency policy issues
Drug importation and counterfeiting policy issues
Prescription drug take back and secure disposal policy issues
Policy issues related to prescription drug abuse and opioids
Expanded access policy issues
Generic drug approval process policy issues
Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors
Risk Evaluation and Mitigation Strategy (REMS) policy issues
Limited distribution systems in the pharmaceutical supply chain policy issues
FDA modernization policy issues
340B drug discount program policy issues
21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency
Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy
Patient assistance program policy issues
Biosimilar approval and reimbursement policy issues
Cancer drug vial size policy issue
Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Council of Economic Advisers (CEA), Vice President of the U.S.
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 |
Stephen |
Scango |
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Daniel |
Bachner |
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Courtney |
Piron |
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Hayden Rhudy |
Kennedy |
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Sen Orrin Hatch, 1/2011-9/2013 Senior Health Policy Advisor: Sen Mike Enzi, Senate HELP Cmt. 11/2007-1/2011 Research Asst, Prof Staff Member; Sen Issakson, 3/2005-11/2007; Staff Asst, Asst Sched; Health LC |
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
S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit manag
S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs
Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues
Part D policy issues including non-interference and rebates policy issues
Part B reform including MedPAC recommendations and other policy issues
Drug cost and pricing policy issues
Transparency policy issues
Alternative payment models policy issues
Value-based purchasing arrangements policy issues
Anti-Kickback Statute policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Medicaid rebates and waiver policy issues
Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018
Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
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 |
Stephen |
Scango |
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Daniel |
Bachner |
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Courtney |
Piron |
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Hayden Rhudy |
Kennedy |
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Sen Orrin Hatch, 1/2011-9/2013 Senior Health Policy Advisor: Sen Mike Enzi, Senate HELP Cmt. 11/2007-1/2011 Research Asst, Prof Staff Member; Sen Issakson, 3/2005-11/2007; Staff Asst, Asst Sched; Health LC |
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 TAX
16. Specific lobbying issues
HImplementation of H.R. 1, Bill to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (bill formerly known as the Tax Cuts and Jobs Act)
Draft legislation relating to economic activity in Puerto Rico
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
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 |
Daniel |
Bachner |
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Stephen |
Scango |
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Courtney |
Piron |
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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 TRD
16. Specific lobbying issues
Trade Agreements and related policy issue
International intellectual property and market access policy issues
Pricing and reimbursement policy issues
Canada intellectual property and market access policy issues
NAFTA policy issues
Korea Trade Agreement (KORUS) policy issues
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
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 |
Stephen |
Scango |
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Courtney |
Piron |
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Daniel |
Bachner |
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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:
| Name | Address |
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 |