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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 |
Address2 |
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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 | 2016 |
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: Juan Carlos Scott |
Date | 1/19/2017 12:00:35 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 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. 1253 Patient Access to Disposable Medical Technology Act of 2015
S. 2343, H.R. 4155 Telehealth Innovation and Improvement Act
H.R. 4714 the Removing Barriers to Clinical Research Act of 2016
S. 2736 Patient Access to Durable Medical Equipment Act
H.R. 5009, S. 2998 Ensuring Access to Critical Breakthrough Products Act
H.R. 5721, S. 3392 Local Coverage Determination Clarification Act of 2016
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 use of device registries and legislation to improve the use of clinical data registries
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 the regulation of blood glucose meters
HR. 6 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.
Issues related to the regulation of combination products
Issues related to FDA inspection of foreign and domestic manufacturing facilities
Issues related to diagnostics regulation
Issues related to WHO administration of diagnostics access program
Issues related to the regulation of mobile medical technology
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 the regulation of transporting lithium batteries for medical devices by air
Issues related to credentialing for industry representatives in VA health care facilities
Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies
Issues related to the regulation of contact lenses
Issues related to De-Identified Bio-specimens and Diagnostics Development
Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies
Issues relating to USDA import policies
S.1077 Advancing Breakthrough Devices for Patients Act of 2015
S.1622 FDA Device Accountability Act of 2015
S. 1101 MEDTECH Act
S. 2188 The Rare Disease Innovation Act
S. 2187 The FDA Regulatory Efficiency Act
S. 1767 Combination Product Regulatory Fairness Act
S. 2737 the Improving Medical Device Innovation Act
H.R. 636/S. 2658 the FAA Re-authorization Act
H.R. 5403 Ariel Graces Law
H.R. 5404 Medical Device Guardians Act
H.R. 3422, the VA Vendor Verification Act
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
H.R. 1078 Food and Drug Administration Safety Over Sequestration Act of 2015
HR 2029 the Consolidated Appropriations Act of 2016
House and Senate agriculture and FDA appropriations acts
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 TAX
16. Specific lobbying issues
H.R. 160, S. 149, S. 588 bills related to the Medical Device Excise Tax
Issues related to the reform of the tax code
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 Transpacific Partnership
Issues related to regulatory issues 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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JC |
Scott |
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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 |