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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 701 PENNSYLVANIA AVENUE, N.W., SUITE 800 |
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| City | WASHINGTON |
State | DC |
Zip Code | 20004-2654 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 17831-12
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6. House ID# 310010000
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| TYPE OF REPORT | 8. Year | 2017 |
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: Juan Carlos Scott |
Date | 10/20/2017 1:45:49 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 MMM
16. Specific lobbying issues
Issues related to physician owned distributors of devices
Issues related to deficit reduction and Medicare
Issues related to value-based healthcare and Medicare program integrity, including changes to the Stark laws and Anti-Kickback Statute
Issues relating to payment reform, ACOs and Bundling
Issues related to the CMS program for durable medical equipment
Issues related to the development of Medicare payments for telehealth and remote monitoring services
Issues related to applying the unique device identifier to Medicare claims forms
S. 787 Telehealth Innovation and Improvement Act
Issues related to Ensuring Access to Critical Breakthrough Products Act
H.R. 3635, S. 794 Local Coverage Determination Clarification Act of 2016
Issues related to Patient Access to Medicare Protection Act ID
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 |
Elizabeth |
Sharp |
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Riley |
Swinehart |
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Duane |
Wright |
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JC |
Scott |
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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
Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act
Issues related to the regulation and publication of clinical trials for medical devices
Issues related to FDA public communications regarding emerging signals
Issues related to implementation of the 21st Century Cures Act
Issues related to the Medical Device User Fee Agreement
Issues related to the competitiveness of the medical technology industry and the impact of Federal policies
H.R. 2430 and S. "934" The FDA Reauthorization Act
H.R. 2474 Medical Product Review Harmonization Act
H.R. 2144 and SS. 1070 related to the classification of medical device accessories
H.R. 2483 and S. 1183 related to modifications to medical devices
S. 1069 related to postmarket regulation of medical devices
H.RR. 2164 related to medical device preemption protection
H.R. 2163 related to medical device reporting
H.R. 2118 related to third party servicing of medical devices
H.R. 1703 related to medical product communications
H.R. 2026 related to medical product communications
S.404 and H.R. 1736 bills to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications
Issues related to diagnostics regulation
Issues related to diagnostics payment reform
Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices
Issues related to cybersecurity for medical technology
Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies
Issues related to the regulation of, reimbursement for, and access to cancer diagnostics, imaging, and radiation therapies
Issues related to federal regulation of the distribution and supply chain for medical devices
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 |
Elizabeth |
Sharp |
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Riley |
Swinehart |
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Duane |
Wright |
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JC |
Scott |
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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 BUD
16. Specific lobbying issues
Issues related to funding for the Food and Drug Administration
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 |
Elizabeth |
Sharp |
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Riley |
Swinehart |
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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 TAX
16. Specific lobbying issues
H.R. 184, S. 108 bills related to the Medical Device Excise Tax
Issues related to the reform of the tax code and tax credits for investors in pre-revenue and start-up medical technology companies
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 |
Elizabeth |
Sharp |
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Riley |
Swinehart |
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Duane |
Wright |
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JC |
Scott |
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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
Issues related to the price caps for medical technology in India
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 |
Duane |
Wright |
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Riley |
Swinehart |
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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 TRA
16. Specific lobbying issues
S. 1405 and H.R. 2997 Issues related to the air transport of lithium batteries
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 |
Elizabeth |
Sharp |
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Riley |
Swinehart |
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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 |