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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 1650 Diagonal Road |
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City | ALEXANDRIA |
State | VA |
Zip Code | 22314 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 1386-12
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6. House ID# 321810000
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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: James C. Denneny III, MD |
Date | 1/20/2017 9:10:19 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 BUD
16. Specific lobbying issues
H.R. 1344/S. 2424, "the Early Hearing Detection and Intervention Act of 2015," all provisions.
Reauthorization of NASPER, the federal program providing support for state Prescription Drug Monitoring Programs.
Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY17.
Funding for Graduate Medical Education, in general.
Funding for NIH and medical research, in general.
Funding to the Centers for Disease Control and Prevention's (CDC) Office on Smoking and Health (OSH) for tobacco cessation intervention and preventive services.
Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA).
Funding for the Pediatric Device Consortia for 2017.
Funding for Human Temporal Bone Laboratories in the US.
Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Natl Institutes of Health (NIH), Food & Drug Administration (FDA)
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 |
Joy |
Trimmer |
JD |
Judiciary LA/Staff Counsel, Rep. Ed Pease (IN) |
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Megan |
Marcinko |
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Amelia |
Suermann |
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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
Comments to the Institute of Medicine's Committee on Accessible and Affordable Hearing Health Care for Adults regarding the delivery of hearing healthcare services in the United States.
Encourage USP to maintain current rules applicable to allergen extracts with sterile compounding.
H.R. 1741, the "Truth in Healthcare Marketing Act of 2015," all provisions.
H.R. 1859/S. 2782, the "Ensuring Childrens Access to Specialty Care Act," all provisions.
S. 2978, the Protect Continuing Physician Education and Patient Care Act," all provisions.
Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries.
Comments re:Docket No. FDA-2015-N-4602 for Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Request for Comments.
Support for provisions in the "21st Century Cures" bill relating to the exchange of clinical outcomes data between electronic health record (EHR) technologies and clinician-led clinical data registries, including provisions to promote and facilitate interoperability of clinical data and to prevent EHR vendors from blocking the transmission of such data to third parties, including clinician-led clinical data registries.
Comments re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Food & Drug Administration (FDA)
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 |
Joy |
Trimmer |
JD |
Judiciary LA/Staff Counsel, Rep. Ed Pease (IN) |
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Megan |
Marcinko |
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Amelia |
Suermann |
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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 physician payment reform, in general.
Implementation of MACRA, the Medicare Access and CHIP Reauthorization Act of 2015.
Audiology-related legislation, in general.
H.R. 1116, the "Medicare Audiology Services Enhancement Act of 2015," all provisions.
Flexibility of the Meaningful Use Program, in general.
Support for the appointment of a surgeon to the Medicare Payment Advisory Commission (MedPAC).
H.R. 2519, the "Audiology Patient Choice Act of 2015," all provisions.
Regulatory approaches that allow Qualified Clinical Data Registries to meet quality requirements under MACRA and Meaningful Use and addressing unfair data blocking policies.
Communications assessing interoperability for the Medicare Access and CHIP Reauthorization Act (MACRA), which directs the Secretary of the U.S. Department of Health and Human Services (HHS) to establish metrics to determine if and to what extent interoperability has been achieved.
Support for the inclusion of language in S.2511, the "Improving Health Information Technology Act," aimed at eliminating information blocking and enhancing data exchange between electronic health record technology and clinical data registries.
Comments re: Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.
Opposition to the provision in the Centers for Medicare and Medicaid Services (CMS) Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2017 to collect all data for all 10- and 90-day global services from all practitioners who perform these services, rather than from a representative sample of practitioners, which was required by The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Comments in support of the Centers for Medicare and Medicaid Services (CMS) restoring the Refinement Panel to serve as the relative value appeals process that was appropriately in place prior to 2011.
Comments re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017.
Comments re: CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1656-P.
Comments expressing concern about the quasi-qualified entity provisions of the final rule, Medicare Program: Expanding Uses of Medicare Data by Qualified Entities."
Comments/concerns regarding efforts to require Qualified Clinical Data Registries (QCDRs) to consolidate one or more of their proposed non-PQRS quality measures with (a) existing, traditional PQRS quality measures, (b) other non-PQRS measures proposed by other QCDRs, or (c) non-PQRS measures proposed by the QCDR.
Comments re: CMS-5517-FC - Medicare Program: Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models for use of QCDRs and certified electronic health record technology (CEHRT) for reporting measures under the Quality performance category.
Comments re: "Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models," published in the Federal Register on November 4, 2016.
Comments re: CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates CMS-1656-FC and IFC, published in the Federal Register as a final notice on November 14, 2016, addressing: 1.) Additional Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Procedures Assigned to New Technology APC Groups for CY 2017; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act for 2014 (PAMA).
Repeal of the Independent Payment Advisory Board (IPAB); in general.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS), Medicare Payment Advisory Commission (MedPAC), Government Accountability Office (GAO), 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 |
Joy |
Trimmer |
JD |
Judiciary LA/Staff Counsel, Rep. Ed Pease (IN) |
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Megan |
Marcinko |
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Amelia |
Suermann |
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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 TOB
16. Specific lobbying issues
Food and Drug Administration oversight of tobacco products, in general.
Tobacco control provisions of the Trans-Pacific Partnership (TPP) trade agreement, in general.
Pre-market review provisions of the Tobacco Control Act, in general.
Funding to the Centers for Disease Control and Prevention (CDC) for tobacco cessation intervention and preventive services.
Approval of the authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products and to oppose any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA).
Implementation of a smoke-free policy in all public housing.
H.R. 3242/S. 142, the "Child Nicotine Poisoning Prevention Act of 2015," all provisions.
Support for finalization of deeming regulations re: all tobacco products.
Opposition to policy riders in the House/Senate Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017 that would weaken FDA's authority to regulate tobacco products.
Opposition to the $110 million funding cut in the House FY 2017 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH).
Comments to the FDA re: requirement that all non-grandfathered private health insurance plans cover preventive services given an A or B rating by the U.S. Preventive Services Task Force (USPSTF), including the availability of comprehensive benefits for tobacco cessation services.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), Centers For Disease Control & Prevention (CDC), U.S. Trade Representative (USTR), Housing & Urban Development - Dept of (HUD), White House Office, 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 |
Joy |
Trimmer |
JD |
Judiciary LA/Staff Counsel, Rep. Ed Pease (IN) |
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Megan |
Marcinko |
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Amelia |
Suermann |
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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 TOR
16. Specific lobbying issues
Medical Liability Reform, in general.
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 |
Joy |
Trimmer |
JD |
Judiciary LA/Staff Counsel, Rep. Ed Pease (IN) |
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Megan |
Marcinko |
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Amelia |
Suermann |
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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
Trans-Pacific Partnership (TPP); relating to the inclusion of provisions/protections necessary to enable countries that are party to the agreement to protect the public health of their citizens from death and disease caused by tobacco products.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR)
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 |
Joy |
Trimmer |
JD |
Judiciary LA/Staff Counsel, Rep. Ed Pease (IN) |
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Megan |
Marcinko |
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Amelia |
Suermann |
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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 VET
16. Specific lobbying issues
S. 2175, the "Department of Veterans Affairs (VA) Provider Equity Act," all provisions.
H.R. 353/S. 564, the "Veterans Access to Hearing Health Act of 2015," all provisions.
H.R. 3471, the "Veterans Mobility Safety Act of 2015," provisions relating to hearing healthcare services.
Comments re: RIN 2900-AP44-Advanced Practice Registered Nurses; Proposed Rule (May 25, 2016),
the Veterans Health Administrations (VHA) Advanced Practice Registered Nurses (APRNs) Proposed Rule which, if finalized, would permit all VHA-employed APRNs to practice without the clinical supervision of physicians and without regard to state law.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Veterans Affairs - Dept of (VA)
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 |
Joy |
Trimmer |
JD |
Judiciary LA/Staff Counsel, Rep. Ed Pease (IN) |
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Megan |
Marcinko |
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Amelia |
Suermann |
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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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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:
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26. Name of each previously reported organization that is no longer affiliated with the registrant or client
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FOREIGN ENTITIES
27. Add the following foreign entities:
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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 |