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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1050 K STREET, NW, #800 |
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| City | WASHINGTON |
State | DC |
Zip Code | 20001 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 16293-12
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6. House ID# 314610000
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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: William J. Schuyler |
Date | 1/22/2019 6:06:32 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. 1892 Bipartisan Budget Act of 2018
H.R. 5961: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs
H.R.6157: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act,2019
S. 2976: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019 - FDA provisions related to prescription drugs
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, 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 |
William |
Schuyler |
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Kimberly |
Williams |
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Jonathan |
Causey |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Sen. Mike Enzi (R-WY), Intern: August 2013 - Dec 2013; Staff Assistant: Dec 2013 - March 2014; Sen. HELP Committee, Subcommittee on Primary Health and Retirement Security, Research Asst : March 2014 - Sept 2017
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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. 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
H.R. 7251: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings
S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements
S. 3738: Hatch-Waxman Integrity Act of 2018 - Provisions related to PTAB proceedings
Biopharmaceutical innovation and patent policy issues
Patent litigation reform issues and issues related to post-grant proceeding at the PTO
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 |
William |
Schuyler |
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Kimberly |
Williams |
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Jonathan |
Causey |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Sen. Mike Enzi (R-WY), Intern: August 2013 - Dec 2013; Staff Assistant: Dec 2013 - March 2014; Sen. HELP Committee, Subcommittee on Primary Health and Retirement Security, Research Asst : March 2014 - Sept 2017 |
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. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals
H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation
H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation
H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms
H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing
H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems
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. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal
H.R. 5228: SCREEN Act - Provisions related to drug recall authority
H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act
H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program
H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing
HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018
S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act
HR 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
HR 394/S85 - Restoring Access to Medication Ac
HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018
Medicare Doughnjt hole -House/Senate Labor HHS AppropriationsHouse/Senate DoD AppropriationsDoggett bill
Trump Administration IPI proposal, Trump Administration proposed changes to six protected classes.
HR6378, Pandemic and All Hazards Preparedness and Advancing Innovation Act;
HR4993/S3253, Vaccine Access Improvement Act;
HR 4297/S2103, Protecting Seniors Through Immunization Act;
H.R.4710 - 340B PAUSE ActH.R.4297 - Protecting Seniors Through Immunization Act of 2017
S. 3477 - Protecting Seniors through Immunization Act
S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation
S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation
S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation
S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing
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 pricing
S. 2312: HELP Act - Provisions related to 340B program
S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program
S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing
S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees -Know the Lowest Price Act of 2018Medicare Part D Six Protected Classes
HHS Proposal on Medicare Part B International Pricing Index (IPI)340B Drug Discount Program
S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling
S. 3775: Affordable Drug Manufacturing Act of 2018
Drug cost and pricing policy issues
Transparency policy issues
Drug importation and counterfeiting policy issues
Prescription drug take back and secure disposal policy issues
Expanded access policy issues
Generic drug approval process policy issues
High deductible health plans/HSA policy issues
Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors
Risk Evaluation and Mitigation Strategy (REMS) policy issues
Compulsory licensing policy issues
Foreign reference pricing policy issues
340B drug discount program policy issues
Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions
Biosimilar approval and reimbursement policy issues
Drug compounding policy issues including federal oversight of compounded drugs
Cancer drug vial size policy issues
TRICARE pharmacy pilot program
Drug shortages policy issues
Reauthorization of the Pandemic and All-Hazards Preparedness Act
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), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), 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 |
William |
Schuyler |
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Kimberly |
Williams |
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Jonathan |
Causey |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alex |
Hinojosa |
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Sen. Mike Enzi (R-WY), Intern: August 2013 - Dec 2013; Staff Assistant: Dec 2013 - March 2014; Sen. HELP Committee, Subcommittee on Primary Health and Retirement Security, Research Asst : March 2014 - Sept 2017 |
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. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation
H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies
HR 1892 - Bipartisan Budget Act of 2018, provision related to Medicare Part D Doughnut Hole
H.R. 3192: CHIP Mental Health Parity Act
H.R. 4005: Medicaid Reentry Act
H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs
H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries.
H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act
H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act
H.R. 5801: Medicaid PARTNERSHIP Act
H.R. 5808: Medicaid Pharmaceutical Home Act of 2018
H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 - Drug pricing
H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs
H.R. 7217: Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act or IMPROVE Act
S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation
S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D
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 managers
S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care
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
S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions
Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues
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 and local coverage decisions
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
False Claims Act policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Medicaid rebates and waiver policy issues
Prescription drug abuse policy issues
ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM)
Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P)
Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P)
Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018)
Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)
Final Rule; Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System changes for 2019 (CMS-1695-FC)
Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing Proposed Rule (CMS-4180-P)
Medicare Part D/Medicare Part B
Medicaid Protected Classes
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), Centers For Medicare and Medicaid Services (CMS), 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 |
William |
Schuyler |
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Kimberly |
Williams |
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Jonathan |
Causey |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Sen. Mike Enzi (R-WY), Intern: August 2013 - Dec 2013; Staff Assistant: Dec 2013 - March 2014; Sen. HELP Committee, Subcommittee on Primary Health and Retirement Security, Research Asst : March 2014 - Sept 2017 |
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 including NAFTA, USMCA and related policy issues
Biopharmaceutical innovation policy issues
International intellectual property and market access policy issues
Pricing and reimbursement policy issues
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, U.S. Trade Representative (USTR), 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 |
William |
Schuyler |
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Kimberly |
Williams |
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Shira |
Kilcoyne |
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Jonathan |
Causey |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Sen. Mike Enzi (R-WY), Intern: August 2013 - Dec 2013; Staff Assistant: Dec 2013 - March 2014; Sen. HELP Committee, Subcommittee on Primary Health and Retirement Security, Research Asst : March 2014 - Sept 2017 |
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:
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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 |