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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 1001 Connecticut Ave. NW |
Address2 | Suite 925 |
City | Washington |
State | DC |
Zip Code | 20036 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 323477-12
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6. House ID# 397100000
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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: Mark Lenker |
Date | 10/20/2016 4:32:56 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 PHA
16. Specific lobbying issues
ADHD awareness
Drug Values
Comprehensive Addiction and Recovery Act S. 524 and HR 953
Binge Eating Disorder awareness
Newborn Screening
DEA processes and re-exportation
FDA funding
Medicaid line extension rebates
Medicaid rare disease patient access to therapy
Orphan drug tax credit
Orphan Drug Act regulations
H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations
Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016
Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Congressional Budget Office (CBO)
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 |
Edward |
Buckley |
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Mark |
Lenker |
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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
S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015
Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs.
Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims.
Medicare coverage and reimbursement
Medicare Part B drug payment model demonstration
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 |
Engel |
Burns |
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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. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.
340B Drug Discount Program
Orphan Drug Act
Biosimilars
Gene Therapy
Drug Pricing
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Titles: S.2689 - 114th Congress (2015-2016)
Short Titles:
Short Titles - Senate
Short Titles as Introduced:
REGROW Act
Reliable and Effective Growth for Regenerative Health Options that Improve Wellness
Official Titles:
Official Titles - Senate
Official Titles as Introduced:
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies.
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 |
Engel |
Burns |
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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
Orphan drug tax credit
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 |
Engle |
Burns |
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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 FOR
16. Specific lobbying issues
Article 29 Working Party on the Protection of Individuals ("WP29") statement regarding the landmark CJEU ruling invalidating Safe Harbor as a mechanism of establishing adequacy supporting EU-US data transfers.
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 |
Engel |
Burns |
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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 |