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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1779 Massachusetts Avenue, NW |
Address2 | Suite 500 |
| City | Washington |
State | DC |
Zip Code | 20036 |
Country | USA |
3. Principal place of business (if different than line 2)
| City | Danbury |
State | CT |
Zip Code | 06810 |
Country | USA |
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5. Senate ID# 28264-12
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6. House ID# 306890000
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| TYPE OF REPORT | 8. Year | 2019 |
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: Beth Anne Cole |
Date | 7/22/2019 7:30:20 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 HCR
16. Specific lobbying issues
Health issues impacting patients with rare diseases.
H.R.2279: Safe Step Act.
Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced).
Advancing Access to Targeted Therapies Act (Legislation not yet introduced).
H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases.
Pediatric subspecialty loan repayment reauthorization.
H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019.
H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019.
H.R.1379/S.560: Ensuring Lasting Smiles Act.
H.R.2862: VACCINES Act of 2019.
Copay Accumulator Adjustment Programs (CAAPs).
The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced).
H.R.2501: Medical Nutrition Equity Act.
H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
H.R.986: Protecting Americans with Preexisting Conditions Act of 2019.
H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019.
S.1125: Protect Act.
RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts.
H.R.1386/S.1905: ENROLL Act of 2019.
H.R.2073/S.110: Medical Expense Savings Act.
Guidance on Compliance with the Congressional Review Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH)
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 |
Rose |
Avellino |
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Timothy |
Boyd |
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Melanie |
Buzzelli |
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Paul |
Melmeyer |
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Rachel |
Sher |
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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
Medicare issues impacting patients with rare diseases.
Medicare Part D Program.
Section 1115 Waivers.
CMS Rebate Rule.
CMS-9926-P: Proposed HHS Notice of Benefit and Payment Parameters for 2020.
Fiscal Year 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS).
CMS-1716-P: FY 2020 LTCH PPS Proposed Rule.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), 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 |
Melanie |
Buzzelli |
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Paul |
Melmeyer |
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Rachel |
Sher |
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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 PHA
16. Specific lobbying issues
Pharmaceutical issues impacting patients with rare diseases.
Orphan Drug Act.
Orphan Drug Tax Credit.
H.R.1332: Fair Care Act of 2019.
H.R.2296: FAIR Drug Pricing Act of 2019.
H.R.987: Strengthening Health Care and Lowering Prescription Drug Costs Act.
S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019.
Rebate Rule Comments.
FDA Natural History Studies for Drug Development.
Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance.
H.R.965/S.340: CREATES Act of 2019.
Prescription Drug User Fee Act (PDUFA) Reauthorization.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH)
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 |
Rose |
Avellino |
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Timothy |
Boyd |
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Melanie |
Buzzelli |
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Paul |
Melmeyer |
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Peter |
Saltonstall |
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Rachel |
Sher |
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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
Appropriations for patients with rare diseases.
Food and Drug Administration Appropriations.
Emergency Medical Services for Children (EMSC) program appropriations.
Pediatric Device Consortia (PDC) Grant Program.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, 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 |
Melanie |
Buzzelli |
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Paul |
Melmeyer |
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Rachel |
Sher |
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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
Section 101 of the Patent Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Melanie |
Buzzelli |
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Paul |
Melmeyer |
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Rachel |
Sher |
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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 |
CONVICTIONS DISCLOSURE
29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery,
extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
| Lobbyist Name | Description of Offense(s) |