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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1700 K Street, NW |
Address2 | Suite 740 |
| City | Washington |
State | DC |
Zip Code | 20006 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 401010854-12
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6. House ID# 421710000
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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: Ryne Carney |
Date | 1/23/2020 9:41:05 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 HCR
16. Specific lobbying issues
-The Alliance for Aging Research submitted a letter in support of Dr. Stephen Hahn as Commissioner of the U.S. Food and Drug Administration (FDA).
-The Alliance for Aging Research submitted a letter to the House of Representatives on our recommendations for policies to be included in a proposed "21st Century Cures 2.0." The letter recommended harmonization of CMS coverage, coding, and payment processes for FDA-approved digital health products to avoid coverage gaps for digital technologies, CMS layout milestones and targeted end dates for Coverage with Evidence Development, CMS/CMMI should develop models to encourage treatments choices that coincide with clinical outcomes/patient-centered outcomes, and total cost of care system, CMS should be accepted FDA approved clinical trials, unfettered access to registry data, public reporting of site-specific health outcomes that are collected by specialty societies as part of the CED process.
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 |
Ryne |
Carney |
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Intern Rep. Ed Perlmutter |
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Ellen |
Jenkins |
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Special Assistant to the Speaker, Office of Speaker Newton L. Gingrich
Assistant to the Senate Minority Whip, Office of Senate Minority Leader Alan K. Simpson
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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 MED
16. Specific lobbying issues
-Signed a letter in support of H.R. 3584, The Laboratory Access for Beneficiaries (LAB) Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, White House Office, 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 |
Ryne |
Carney |
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Intern. Rep. Ed Perlmutter |
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Ellen |
Jenkins |
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Special Assistant to the Speaker, Office of Speaker Newton L. Gingrich
Assistant to the Senate Minority Whip, Office of Senate Minority Leader Alan K. Simpson
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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
-The Alliance for Aging Research wrote and submitted a letter to the House of Representatives and Senate in support of adding an annual out-of-pocket limit in Medicare Part D, a "smoothing" mechanism for out-of-pocket costs to fix the seasonality issue in Medicare Part D, an expansion of the low-income subsidy for Medicare Part D, to fix a coverage glitch for colorectal cancer screening, expanded patient protections and benefit redesign, expanded Medicare coverage for dental/vision/and hearing services, and sharing Part D rebates at point of sale with enrollees.
-Signed on to a letter urging Congress to address the issue of delayed patient access to generic medicines in Medicare Part D.
-Signed a letter supporting the inclusion of several important Medicare and Medicaid provisions in the "Extenders" legislative package. The letter urged to address the scheduled increase in Medicare prescription drug costs, making permanent programs that help Medicaid enrollees remain in their communities, continuing Medicare low-income outreach and enrollment assistance, improving the Part B enrollment process, and extending Medicaid funding in US territories.
-Signed on to a MAPRx letter in support of a "smoothing" policy be included future drug pricing legislation.
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 |
Ryne |
Carney |
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Intern Rep. Ed Perlmutter |
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
-Signed an Ad Hoc Group for Medical Research letter calling for the House and Senate Appropriations Committees to prioritize funding for the National Institutes of Health.
-Signed letter to House and Senate regarding 2020 funding legislation for domestic and global programs to address antimicrobial resistance. Below are the funding requests in the letter.
Centers for Disease Control and Prevention
Our organizations are deeply appreciative of funding at the Centers for Disease Control and Prevention (CDC) to address AMR. We strongly support $186 million in funding for the Antibiotic Resistance Solutions Initiative as appropriated in the House LHHS bill to reduce the emergence and spread of AMR pathogens and to improve appropriate antibiotic use through antimicrobial stewardship. A report released in April 2018 by CDC demonstrated that AMR is an increasingly dangerous threat, but that CDC containment strategies are effective in preventing its spread. For example, the report found 221 instances of unusual resistance genes in just one of the most-deadly bacteria (carbapenem-resistant Enterobacteriaceae or CRE) in the US in 2017. CDC further estimated that its aggressive containment strategy could prevent 1600 cases of CRE in a single state in a three-year period. We also advocate for $12 million for funding for the CDC Healthcare-Associated Infections (HAIs) activities, $22.75 million for the National Healthcare Safety Network, and $32.5 million for the Advanced Molecular Detection Initiative (AMD) as provided in the House LHHS bill. The NHSN increase will be essential to help more hospitals report data on antibiotic use and resistance, to help the CDC and other scientists evaluate our efforts to combat AMR and track emerging threats. The additional funding for the AMD Initiative will allow CDC to more rapidly determine where emerging diseases come from, whether microbes are resistant to antibiotics, and how microbes are moving through a population. Each of these steps is essential to the prevention of patient morbidity and mortality.
Our organizations urge funding of $595.84 million for the agencys Global Health Program including $208.2 million for the CDC Center for Global Health global public health protection program as provided in the Senate LHHS bill. The CDC is a key implementor of the Global Health Security Agenda (GHSA), which includes preventing AMR as its first action package. GHSA focuses on improving surveillance and laboratory capacity and promoting judicious use of antibiotics. Without sustained funding for activities to prevent, detect and respond to AMR threats globally, Americans will be left more vulnerable.
Assistant Secretary for Preparedness and Response (ASPR)
We call for $567 million in funding for BARDA, as provided in the House LHHS bill to further help the federal effort to combat antibiotic‐resistant bacteria. The BARDA Broad Spectrum Antimicrobials Program leverages partnerships with public and private partners to develop products that directly support the government‐wide National Action Plan for Combating Antibiotic‐Resistant Bacteria. CARB-X, supported by BARDA, NIH, and other partners, supports the worlds largest pre-clinical and early development pipeline of antibiotics and other therapeutics, diagnostics, and vaccines to prevent, diagnose and treat resistant infections. Despite progress in the development of new products, antibiotic research and development continue to face steep economic hurdles. While the first BARDA-supported new antibiotic secured FDA approval in 2017, one of the few small antibiotics companies went bankrupt in 2019 and two others laid-off significant numbers of staff. If more companies are allowed to go bankrupt, the antibiotic pipeline will collapse, depriving patients of lifesaving new antibiotics and putting modern medicine and national security at risk. More, not stagnant, investment in antibiotic research and development through BARDA is essential.
National Institutes of Health
The National Institute of Allergy and Infectious Diseases (NIAID) is a world leader on research related to AMR. We recommend funding of $5.937 billion as provided in the Senate LHHS bill to support this work, including $600 million in funding to address AMR. Funding at this level enables NIAID to continue its role as a lead funder of research to discover novel antimicrobials, diagnostics and vaccines that are urgently needed to address multi-drug resistant organisms. This funding also supports the Antibacterial Resistance Leadership Group (ARLG), a scientific team that manages and implements a strategic research agenda by building transformational trials that will change clinical practice and reduce the burden of AMR. Current ARLG efforts aim to support the research and development of urgently needed new diagnostics and antibiotics, assess the impact of stewardship interventions, and optimize dosing of existing antibiotics to maximize effectiveness and limit the development of resistance
Agriculture and Related Agencies Antibiotics in Agriculture
Experts agree that a One Health approach, addressing both human and animal health, is essential for combating antimicrobial resistance. We urge robust FY2020 funding to enable the Center for Veterinary Medicine (CVM) at the US Food and Drug Administration (FDA) to continue to make progress on the Agencys five-year Action Plan for Antibiotic Stewardship in Animal Agriculture. FDA recently announced its proposed Guidance for Industry (GFI) 263 to incorporate veterinary oversight for all remaining medically important antimicrobial drugs administered to animals, but additional funding is needed to enable FDA to advance these and other important priorities identified in the Action Plan, including updating labels for medically important antimicrobials that lack targeted durations of use, the finalization of a biomass adjustment methodology to enhance sales data reporting, updating FDAs list of medically important antimicrobials associated with GFI 152, as well as FDAs commitment to develop a functional and efficient system for collecting antimicrobial use data in food animals. Funding these activities will help ensure that animal antibiotic drug labels reflect judicious use principles and veterinary stewardship while enhancing the quality and granularity of antibiotic data available to producers, veterinarians and public health stakeholders interested in promoting antibiotic stewardship in agriculture.
We also urge full funding for AMR activities at the US Department of Agriculture (USDA). Funding for the Departments AMR activities would provide continued support for important research in the area of antimicrobials in agriculture, the emergence of resistance and the search for effective antibiotic alternatives. Additional funding would strengthen USDA efforts to promote antibiotic stewardship and support voluntary, on-farm surveillance through the USDAs Animal and Plant Health Inspection Service (APHIS) (we acknowledge and support the increase reflected in the House bill for this work), and essential intramural and extramural research activities underway at the Agricultural Research Service (ARS) and the National Institute of Food and Agriculture (NIFA), as well as training and technical assistance on good stewardship practices provided through USDAs Cooperative Extension Service.
State and Foreign Operations Appropriations
US Agency for International Development
We urge funding of $1.56 billion for the Global Fund to Fight AIDS, Tuberculosis, and Malaria, as provided in the House and Senate bills. Further, we recommend funding $310 million for the tuberculosis program through the US Agency for International Development as proposed in the House and Senate bills. Support for the Global Fund and USAIDs TB program will drive reductions in the growth of drug-resistant forms of this disease. Funding for these efforts would support high-quality screening, diagnosis and treatment services for patients affected by multidrug-resistant TB. USAID also leads efforts to expand treatment to more patients infected with MDR-TB in the 10 highest-burden countries, strengthen diagnostic and surveillance capacities globally, and accelerate basic and applied research and development to combat MDR-TB.
Additionally, we call on Congress to sustain adequate funding for USAID implementation of the Global Health Security Agenda (GHSA). Between 2014 and 2019, USAID has supported GHSA global AMR activities, including training health providers to prevent healthcare-associated infections - which are often resistant to antibiotics - and expanding surveillance of drug-resistant bacteria.
Department of Defense (DoD)
We urge funding of $33.495 billion provided for the DoDs Defense Health Program in the Senate FY2020 DoD Appropriations bill. The Defense Health Program and the Research, Development, Test & Evaluation (RDT&E) budgets support R&D to address key medical challenges to the military including antibiotic resistance. For example, in recent years, projects have been supported to develop strategies to prevent, mitigate, and treat antibiotic-resistant bacteria in wounds. The Defense Health Program also supports a Multi-Drug Resistant Surveillance Network (MRSN) program that includes development projects for Army service level support. Specifically, the MRSN is the Enterprise effort to collect and characterize bacterial isolates to inform best practice, such as patient management and antibiotic selection
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 |
Ryne |
Carney |
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Intern, Rep. Ed Perlmutter |
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Missy |
Jenkins |
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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
-Submitted letters to the Committee on Ways and Means hearing, "Caring for Aging Americans" and the Center for Medicare and Medicaid Services. The letters expressed concern about the unmet medical need in long-term care (LTC) settings for the diagnosis and management of neuropsychiatric symptoms (NPS) in dementia. The letter recommended CMS:
1.CMS should expand recognition of FDA-approved uses for psychotropic and antipsychotic medications for the treatment of neuropsychiatric disorders in late-life.
2.CMS should establish a mechanism for the inclusion of new FDA-approved medications with indications for the treatment of NPS.
3.CMS should remove the requirement to count residents in skilled nursing facilities who are prescribed antipsychotics for FDA-approved indications used appropriately, as defined by FDA indication or evidence-based research.
4.CMS should better integrate diagnostic criteria and clinical practice guidelines in training for nursing home operators, medical directors, nurses, and surveyors.
5.CMS should sponsor population health studies with the goal of creating evidence-based clinical practice. guidelines on the use of psychotropic and antipsychotic medications for the treatment of NPS.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS)
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 |
Ryne |
Carney |
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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 RET
16. Specific lobbying issues
The Alliance for Aging Research signed a letter in support of the House-proposed Dignity in Aging Act (HR 4334) to reauthorize the Older Americans 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 |
Ryne |
Carney |
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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
-Signed a letter supporting H.R. 2073, legislation to make the 7.5 percent threshold for medical expense deduction permanent.
17. House(s) of Congress and Federal agencies Check if None
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 |
Ryne |
Carney |
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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 ENV
16. Specific lobbying issues
-Signed a letter to the Committee on Science, Space, and Technology issuing our concern over the proposed "strengthing transparency in regulatory science" proposed rule.
17. House(s) of Congress and Federal agencies Check if None
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 |
Ryne |
Carney |
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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:
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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
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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) |