|
LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 801 PENNSYLVANIA AVENUE, NW, #700 |
Address2 |
|
| City | WASHINGTON |
State | DC |
Zip Code | 20004 |
Country | USA |
3. Principal place of business (if different than line 2)
| City |
|
State |
|
Zip Code |
|
Country |
|
|
5. Senate ID# 9204-12
|
||||||||
|
6. House ID# 335890000
|
||||||||
| 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 |
|
11. No Lobbying Issue Activity |
| INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 12. Lobbying | 13. Organizations | ||||||||
| INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
|
|
||||||||
|
|
||||||||
| 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: Daniel Casserly |
Date | 10/22/2018 11:18:08 AM |
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.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018
Cell & Gene Therapy, including reimbursement
Personalized Medicine
Section 9008 of Patient Protection and Affordable Care Act
FSA/HSA - Support reinstating coverage of OTC products
340B Drug Discount Program
Dual Eligibles Program
DQSA Implementation (Track & Trace)
Certified Importer Program
Drug Importation
Reimbursement for medical devices
GMP related to manufacturing sites
Biosimilars
Low-income Subsidy in Part D
REMS
Creates Act
FCLCA
Value of Medicines
Drug Cost/Pricing
Biosimilars Reimbursement
Generic Drugs
Medicaid
FDA Regulations of Lab Developed Tests (LDT)
Reimbursement for LDTs
IPAB
Generic Drug Labeling
Outcomes-based Contracting
PREA/BPCA
Truthful, Non-Misleading Drug Information
Part D Non-interference
S.469 - Affordable and Safe Prescription Drug Importation Act
Orphan Drugs
Drug Pricing Transparency
S.456 - RACE for Children Act
S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation
Drug Compounding
CMMI
H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017
Clinical Trials
H.R.2430 - FDA Reauthorization Act of 2017
H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Virtual Clinical Trials
S2465 - Sickle Cell Disease
Part D
Donut Hole
PAUSE Act
DQSA Implementation
Omnibus bill
CR
PAHPA Reauthorizing
Biosimilar Pass Through Payments
Value Based Pricing
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), White House Office, 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 |
Daniel |
Casserly |
|
|
|
Shawn |
O'Neail |
|
|
|
Leo |
Farber |
|
|
|
Sarah |
Haller |
|
|
|
Joseph |
McGowan |
|
|
|
Taylor |
Booth |
|
|
|
Nora |
Connors |
|
|
|
Shelly |
Mui-Lipnik |
|
|
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
Free Trade Agreements:
- Intellectual Property and Transparency Provisions - Free Trade Agreements
Access to Medicines Issues
Global Health Issues
India, China and Canada IP and market Access Issues
Sub-standards Medicines
Quality of Medicines
International Market Access and Intellectual Property Issues
Biopharmaceutical Innovation Policies
Colombia Intellectual Property
Regulatory Cooperation
The North American Free Trade Agreement - NAFTA Re-negotiation
USTR Special 301 Report/National Trade Estimate
Trade Policy
KORUS
Tariffs
CFIUS
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), State - Dept of (DOS), U.S. Agency for International Development (USAID), 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 |
Sarah |
Haller |
|
|
|
Leo |
Farber |
|
|
|
Shawn |
O'Neail |
|
|
|
Joseph |
McGowan |
|
|
|
Shelly |
Mui-Lipnik |
|
|
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
FDA Appropriations funding for Generic Drugs
Certified Importer Program (CIP)
FY 2018 Labor HHS Appropriations Bill
Reconciliation
Gx Drug Labeling
Biosimilars
2018 Agriculture Appropriations Bill
Importation Drug Pricing Value of Meds
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 |
Casserly |
|
|
|
Shawn |
O'Neail |
|
|
|
Leo |
Farber |
|
|
|
Joseph |
McGowan |
|
|
|
Shelly |
Mui-Lipnik |
|
|
|
Nora |
Connors |
|
|
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
Biosimilars
Medicare Part D
Drug Pricing
Part B
Outcomes Based Contracts
Generics
Innovative Pharmaceuticals
Cell and Gene Therapy
Medicaid
Alternative Payment Models
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 |
Casserly |
|
|
|
Shawn |
O'Neail |
|
|
|
Leo |
Farber |
|
|
|
Joseph |
McGowan |
|
|
|
Shelly |
Mui-Lipnik |
|
|
|
Taylor |
Booth |
|
|
|
Nora |
Connors |
|
|
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
ACA Pharmaceutical Industry Fee Exclusions
Anti-Inversion Tax
Medical Device Tax Repeal & Suspension
Section 385 Tax Regulation
Tax Reform
Orphan Drug Tax
Tax Reform Border Adjustment Tax
Mobile Workforce
Thin Capitalization Rules 163(j)
Base Erosion Surtax
Interest Deduction
Debt Equity Regulations
Tax Cuts & Jobs Act Implementation
Innovation Box
Expanded FDII
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 |
Casserly |
|
|
|
Shawn |
O'Neail |
|
|
|
Leo |
Farber |
|
|
|
Joseph |
McGowan |
|
|
|
Shelly |
Mui-Lipnik |
|
|
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
Data Exclusivity
Trade Secrets
Intellectual Property
Biopharmaceutical Innovation Policy Issues
Biologics Data Protection Issues
Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO
Neonates
BPCIA
Hatch-Waxman
Patents
Inter Partes Review at PTO
Biosimilars
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 |
Casserly |
|
|
|
Shawn |
O'Neail |
|
|
|
Leo |
Farber |
|
|
|
Joseph |
McGowan |
|
|
|
Shelly |
Mui-Lipnik |
|
|
|
Taylor |
Booth |
|
|
|
Nora |
Connors |
|
|
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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 FOR
16. Specific lobbying issues
Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA)
CFIUS Reform
Foreign Agents Registration Act (FARA) Reform
Treasury
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 |
Shawn |
O'Neail |
|
|
|
Leo |
Farber |
|
|
|
Shelly |
Mui-Lipnik |
|
|
|
Joseph |
McGowan |
|
|
19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
Information Update Page - Complete ONLY where registration information has changed.
20. Client new address
| Address |
|
||||||
| City |
|
State |
|
Zip Code |
|
Country |
|
21. Client new principal place of business (if different than line 20)
| City |
|
State |
|
Zip Code |
|
Country |
|
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
|
|
||||||||
| 1 |
|
3 |
|
||||||
| 2 |
|
4 |
|
ISSUE UPDATE
24. General lobbying issue that no longer pertains
|
|
|
|
|
|
|
|
|
AFFILIATED ORGANIZATIONS
25. Add the following affiliated organization(s)
Internet Address:
| Name | Address |
Principal Place of Business (city and state or country) |
||||||||||||
| ||||||||||||||
|
||||||||||||||
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 | ||||||||||
| ||||||||||||||
|
% | |||||||||||||
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 |