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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 950 F Street, NW |
Address2 | Suite 300 |
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# 31350-12
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6. House ID# 306540000
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TYPE OF REPORT | 8. Year | 2014 |
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. | ||||||||
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 |
Signature | Digitally Signed By: PAUL J. LARSEN |
Date | 1/20/2015 12:14:52 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
H.R. 83, Making consolidated appropriations for the fiscal year ending September 30, 2015, and for other purposes: Provisions related to Food and Drug Administration (FDA) funding and oversight, 340B Drug Pricing Program, and other issues
H.R. 3230, Veterans Access to Care through Choice, Accountability, and Transparency Act of 2014: Provisions related to TRICARE health care program
H.R. 4486, Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2015: Provisions related to TRICARE health care program
H.R. 4660, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2015: Provisions related to United State Trade Representative (USTR) and Patent and Trademark Office (PTO)
H.R. 4800, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015: Provisions related to FDA funding and oversight
H.R. 4870, Department of Defense Appropriations Act, 2015: Provisions related to defense health programs and bio-defense
H.R. 4903, Department of Homeland Security Appropriations Act, 2015: Provisions related to Customs and Border security
H.R. 5464, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2015: Provisions related to 340B program, National Institutes of Health (NIH), Independent Payment Advisory Board (IPAB), and Agency for Healthcare Research & Quality (AHQR)
Preparation for the FY 2016 budget
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 |
Maya |
Bermingham |
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Randy |
Burkholder |
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John |
Castellani |
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Charles |
Clapton |
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Jeffrey |
Francer |
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Colleen |
Maloney |
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Cara |
Moon |
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Lori |
Reilly |
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Jennifer |
Romans |
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Nick |
Shipley |
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Matt |
Sulkala |
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Sarah |
Spurgeon |
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Pamela |
Smith |
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Senate HELP Committee: Staff Director, Deputy Staff Director |
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Pamela |
Smith |
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Sen. Tom Harkin: Legislative Director |
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Pamela |
Smith |
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Dept. of Justice: Counselor to Asst. AG, Civil Division |
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Pamela |
Smith |
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Dept. of Justice: Special Counsel, Office of Leg. Affairs |
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Pamela |
Smith |
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Sen. Carol Moseley-Braun: Counsel and Legislative Asst. |
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Chester (Chip) |
Davis |
Jr |
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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. 845, Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the SHIELD Act): Provisions related to patent litigation
H.R. 2024, End Anonymous Patents Act: Patent owner information provisions
H.R. 2582, PATENT Jobs Act: Provisions related to patent user fees
H.R. 2639, Patent Litigation and Innovation Act: Patent litigation provisions
H.R. 2766, STOP Act: Provisions related to business method patents
H.R. 2985, Combination Drug Development Incentive Act of 2013: Provisions related to exclusivity
H.R. 3116, MODDERN Cures Act of 2013: Provisions related to exclusivity
H.R. 3309, Innovation Act: Provisions related to patent litigation reform
H.R. 3349, Innovation Protection Act: PTO Fee Diversion
H.R. 3540, Demand Letter Transparency Act: Provisions related to patent demand letters
H.R. 3709, Protecting Consumer Access to Generic Drugs: Provisions related to patent settlements
H.R. 4287, Independent Innovator and Repurposing Act: Provisions related to patent term restoration
H.R. 4763, Trade Protection not Troll Protection Act: Patent and trade provisions
H.R. 5233, Trade Secrets Protection Act of 2014: Provisions related to trade secrets
H.R. 5750, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014: Provisions related to targeted IP incentives for new indications for rare diseases or conditions
S. 214, Preserve Access to Affordable Generics Act: Provisions related to patent settlements
S. 504, Fair and Immediate Release of Generic Drugs Act: Provisions related to patent settlements
S. 627, Medical Innovation Prize Fund Act: Medical prize provisions
S. 712, Patents for Humanity Program Improvement Act of 2013: Transferability of PTO vouchers provisions
S. 866, Patent Quality Improvement Act of 2013: Business methods patents provisions
S. 1013, Patent Abuse Reduction Act of 2013: Patent litigation provisions
S. 1612, Patent Litigation Integrity Act: Patent litigation provisions including bonding
S. 1720, Patent Transparency and Improvements Act: Patent litigation provisions
S. 2049, Transparency in Assertion of Patents Act: Provisions related to patent demand letters
S. 2150, Independent Innovator and Repurposing Act: Provisions related to patent term restoration
S. 2196, Patent Fee Integrity Act: Patent fee diversion prohibition
S. 2267, Defend Trade Secrets Act of 2014: Provisions related to trade secrets
S. 3004, Dormant Therapies Act of 2014: Provisions related to incentives to develop biopharmaceutical products
Biopharmaceutical innovation and patent policy issues
Biologics data protection issues
Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act
Issues related to biopharmaceutical economic incentives and intellectual property
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Commerce - Dept of (DOC), Patent & Trademark Office (PTO), U.S. Trade Representative (USTR)
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 |
John |
Castellani |
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Charles |
Clapton |
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Peter |
Fotos |
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Sascha |
Haverfield-Gross |
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David |
Korn |
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Colleen |
Maloney |
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Cara |
Moon |
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Anne |
Pritchett |
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Lori |
Reilly |
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James M. (Mit) |
Spears |
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Matt |
Sulkala |
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Sarah |
Spurgeon |
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Pamela |
Smith |
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Senate HELP Committee: Staff Director, Deputy Staff Director |
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Pamela |
Smith |
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Sen. Tom Harkin: Legislative Director |
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Pamela |
Smith |
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Dept. of Justice: Counselor to Asst. AG, Civil Division |
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Pamela |
Smith |
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Dept. of Justice: Special Counsel, Office of Leg. Affairs |
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Pamela |
Smith |
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Sen. Carol Moseley-Braun: Counsel and Legislative Asst. |
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Kristin |
Van Goor |
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Chester (Chip) |
Davis |
Jr |
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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. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval
H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069)
H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling
H.R. 5214, To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care
H.R. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to Risk Evaluation and Mitigation Strategies (REMS)
H.R. 5805, Andrea Sloan Compassionate Use Reform and Enhancement Act: Provisions related to expanded access and compassionate use
S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans
S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions related to drug safety labeling (112th Congress)
S. 2917, Adding Ebola to the FDA Priority Review Voucher Program: Provisions related to new proposed voucher program; Public Law No. 113-233
Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform
Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues
Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges
Branded Prescription Drug Fee policy issues (79 Fed. Reg. 43631 (July 28, 2014))
21st Century Cures legislation and policy issues
R&D tax credit renewal as part of H.R. 5771, Tax Increase Prevention Act of 2014
Draft legislation relating to prescription drug coverage issues
Issues related to value and cost of prescription drugs
Issues related to user fee reauthorization and FDA reform
Patient savings program policy issues
Comparative effectiveness policy issues
Academic detailing policy issues
General HHS, NIH, and FDA related advocacy
Biopharmaceutical innovation policy issues
Prescription drug abuse policy issues
FDA expedited drug approval policy issues
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products [Docket No. FDA-2013-N-0500]: Patient labeling
Issues relating to communications about prescription drugs
340B program policy issues
Importation policy issues
Clinical trial policy issues
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), Food & Drug Administration (FDA), Government Accountability Office (GAO), Treasury - Dept of, Internal Revenue Service (IRS)
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 |
Maya |
Bermingham |
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Jennifer |
Bryant |
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Randy |
Burkholder |
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John |
Castellani |
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Charles |
Clapton |
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Peter |
Fotos |
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Jeffrey |
Francer |
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Sascha |
Haverfield-Gross |
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Lisa |
Joldersma |
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David |
Korn |
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Colleen |
Maloney |
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Cara |
Moon |
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Anne |
Pritchett |
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Lori |
Reilly |
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Jennifer |
Romans |
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Nick |
Shipley |
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James M. (Mit) |
Spears |
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Matt |
Sulkala |
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Sarah |
Spurgeon |
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Pamela |
Smith |
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Senate HELP Comm.: Staff Director, Deputy Staff Director |
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Pamela |
Smith |
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Sen. Tom Harkin: Legislative Director |
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Pamela |
Smith |
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Dept. of Justice: Counselor to Asst. AG, Civil Division |
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Pamela |
Smith |
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Dept. of Justice: Special Counsel, Office of Leg. Affairs |
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Pamela |
Smith |
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Sen. Carol Moseley-Braun: Counsel and Legislative Asst. |
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Kristin |
Van Goor |
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Chester (Chip) |
Davis |
Jr |
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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 MMM
16. Specific lobbying issues
H.R. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board
H.R. 460, Patients Access to Treatments Act: Provisions related to cost sharing in the specialty tier
H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues
H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part D
H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference
H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues
H.R. 2753 Securing Care for Seniors Act: Provisions related to Value Based Insurance Design
H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform
H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies
H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to Office of Inspector General (OIG) enforcement of fraud and abuse laws
H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs
H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models
H.R. 3890 Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease
H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to sustainable growth rate (SGR) and Medicare provider payment reform
H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues
H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry
H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014: Provisions related to Part D preferred pharmacy networks
H.R. 5183, Value Based Insurance Design for Better Care Act of 2014: Provisions related to valued base insurance design demonstration program
H.R. 5558 ACO Improvement Act: Provisions related to alternate payment models
H.R. 5780, Protecting Integrity in Medicare Act of 2014: Provisions related to addressing fraud and prescription drug abuse
S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference
S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board
S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues
S. 557, Medication Therapy Management Empowerment Act of 2013: Provisions related to Part D and medication therapy management
S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues
Deficit reduction policy issues
S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress)
S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D
S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments
S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease
S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform
S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform
Hospital Improvements for Payment (HIP) Act of 2014: Provisions related to Medicare reform (no bill number)
Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number)
Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D
Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy
Medicaid Program, Covered Outpatient Drugs rulemaking
Medicare sustainable growth rate policy issues
Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Issues related to better use of medicine and adherence
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), Medicare Payment Advisory Commission (MedPAC)
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 |
Maya |
Bermingham |
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Jennifer |
Bryant |
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Randy |
Burkholder |
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John |
Castellani |
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Charles |
Clapton |
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Lisa |
Joldersma |
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Colleen |
Maloney |
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Cara |
Moon |
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Anne |
Pritchett |
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Lori |
Reilly |
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Jennifer |
Romans |
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Nick |
Shipley |
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James M. (Mit) |
Spears |
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Matt |
Sulkala |
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Sarah |
Spurgeon |
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Pamela |
Smith |
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Senate HELP Comm.: Staff Director, Deputy Staff Director |
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Pamela |
Smith |
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Sen. Tom Harkin: Legislative Director |
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Pamela |
Smith |
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Dept. of Justice: Counselor to Asst. AG, Civil Division |
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Pamela |
Smith |
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Dept. of Justice: Special Counsel, Office of Leg. Affairs |
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Pamela |
Smith |
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Sen. Carol Moseley-Braun: Counsel and Legislative Asst. |
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Chester (Chip) |
Davis |
Jr |
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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
H.R. 3803, Bipartisan Congressional Trade Priorities Act of 2014: Provisions related to trade agreements
S. 1900, Bipartisan Congressional Trade Priorities Act of 2014: Trade promotion authority issues
Korea Free Trade Agreement: Implementation issues related to intellectual property, market access and public health
Trans-Pacific Partnership (TPP): Provisions related to intellectual property, market access and public health issues
Mexico and Canada IP and market access issues
Turkey Market Access Issues
India innovation, IP and market access issues
Transatlantic Trade and Investment Partnership (TTIP): Market access, intellectual property, regulatory and other issues
Issues related to Special 301 and National Trade Estimate (NTE) submissions including intellectual property and market access issues
China intellectual property and market access issues
International market access and intellectual property issues
Biopharmaceutical innovation policy issues
Trade Promotion Authority policy issues
Colombia biosimilars policy issues
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), Commerce - Dept of (DOC)
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 |
John |
Castellani |
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Jeffrey |
Francer |
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David |
Korn |
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Colleen |
Maloney |
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James M. (Mit) |
Spears |
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Matt |
Sulkala |
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Chester (Chip) |
Davis |
Jr |
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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: http://www.phrma.org/about/member-companies
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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 |