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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 |
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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 | 2017 |
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 | 1/19/2018 10:11:40 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
Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA).
H.R. 1539/S. 652, the "Early Hearing Detection and Intervention Act of 2017," all provisions.
Agency for Healthcare Research and Quality (AHRQ) funding request(s) for FY2017.
Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill.
Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA).
Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products.
Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products.
For FY18, opposition to the inclusion of either of two policy riders originally included in the House Appropriations Committees Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill that would weaken FDAs authority to oversee tobacco products.
Opposition to the House Appropriations Committees proposed 25% cut to the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH).
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), Health Resources & Services Administration (HRSA), 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 HCR
16. Specific lobbying issues
Comments to HHS' Office for Human Research Protections on finalization of the rule on the Federal Policy for the Protection for Human Subjects; including: single IRB review mandate, revisions to the Common Rules informed consent requirements, and numerous other modifications.
Comments to the Food and Drug Administration (FDA) Re: Docket Number FDA-2016-D-3466; Immediately in Effect Guidance Document: Conditions for Sale for Air Conduction Hearing Aids.
Federal "Truth-in-Advertising" legislation; in general.
Issues pertaining to scope of practice; in general.
Repeal of the Affordable Care Act; in general.
Comments to the Food and Drug Administration re: Docket No. FDA-2016-D-2268 for Insanitary Conditions at Compounding Facilities
Comments to the Food and Drug Administration re: Docket 2014-D-1525-0358; Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry.
H.R.1652/S. 670, the "Over-the-Counter Hearing Aid Act of 2017," all provisions.
H.R. 2430, the "FDA Reauthorization Act of 2017," provisions relating to the over-the-counter sale of hearing aids.
Comments to the Federal Trade Commission Re: Notice of Workshop and Requesting Public Comments; Hearing Health and Technology - Workshop, Project No. P171200.
Concerns regarding the potential impact of a revised United States Pharmacopeia (USP) Chapter 797 on physician practices and patient access to critical sterile drug products.
H.R.1628 - American Health Care Act of 2017; in general.
The "Better Care Reconciliation Act"; in general.
Support for the nomination and confirmation of Jerome Adams, MD, to serve as the United States Surgeon General.
H.R.3928, the "Truth in Healthcare Marketing Act of 2017;" all provisions.
17. House(s) of Congress and Federal agencies Check if None
Health & Human Services - Dept of (HHS), Labor - Dept of (DOL), U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), Federal Trade Commission (FTC)
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 |
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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 and implementation of the Medicare Access and CHIP Reauthorization Act of 2015, in general.
Comments to CMS requesting a deferment from implementing 2015 Edition certified electronic health record technology (CEHRT) until such technology is widely available, and, in no event, sooner than January 2019.
Comments re: Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter (Call Letter).
H.R.1156, the "Patient Access to Higher Quality Health Care Act of 2017," all provisions.
H.R.849/S. 260, the "Protecting Seniors' Access to Medicare Act of 2017," all provisions.
S.251, the "Protecting Medicare from Executive Action Act of 2017," all provisions.
Comments requesting relief from 2018 penalties to be imposed on physicians pursuant to the Value Modifier (VM), Meaningful Use (MU) and Physician Quality Reporting System (PQRS) programs.
Comments Final Rule re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Topics included: 1.) Practice Expense; 2.) Potentially Misvalued Services under the Fee Schedule; 3.) Improving Valuation of the Global Surgical Package; 4.) Reducing Administrative Burden and Improving Payment Accuracy for Chronic Care Management Services; 5.) Valuation of Specific Codes; 6.) Appropriate Use Criteria for Advanced Imaging Screening; 7.) Accountable Care Organizations (ACO) Participants Who Report Physician Quality Reporting System (PQRS) Quality Measures Separately; and 8.) Value-Based Payment Modifier and Physician Feedback Program.
Issues pertaining to scope of practice; in general.
Comments re: Collecting Data on Resources Used in Furnishing Global Services per the calendar year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule.
Comments re: the Centers for Medicare & Medicaid Services (CMS) planned enactment of the Social Security Number Removal Initiative (SSNRI).
Comments re: relief from the administrative burdens and significant financial penalties slated to be imposed on physicians in 2018 as part of the Medicare physician fee schedule.
H.R. 2276, the "Audiology Patient Choice Act," all provisions.
Comments re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rate.
Support for allowing eligible clinicians utilizing an electronic health record to participate in a qualified clinical data registry to qualify them as fully achieving all points for the Advancing Care Information category of the Quality Payment Programs Merit Based Incentive Payment System.
Concerns regarding the difficulty Qualified Clinical Data Registries (QCDRs) have experienced with the QCDR measure review and self-nomination process under the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Support for efforts to improve the transparency regarding Medicare Advantage (MA) plan prior authorization requirements.
Support for the implementation of the Unique Device Identifier (UDI) through electronic health records (EHRs) and clinical registries in order to achieve the congressional intent of promoting patient safety by ensuring all patients and their healthcare providers as well as public health officials and researchers have accurate and complete information on medical devices.
Comments re: "Medicare Program; CY 2018 Updates to the Quality Payment Program (QPP)," published in the Federal Register on June 30, 2017. Topics included: changes in reporting requirements, classification of measures, ACI performance category credit, APMs, and the use of QCDRs and certified EHR technology (CEHRT) for reporting measures under the Quality performance category of the Merit-Based Incentive Payment System (MIPS).
Comments on the "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program," published in the Federal Register on July 21, 2017. Topics included: 1.) Practice Expense; 2.) Crosswalking PLI for Non-Physicians; 3.) Potentially Misvalued Services under the Fee Schedule; 4.) Valuation of Specific Codes; 5.) Appropriate Use Criteria for Advanced Imaging Screening; 6.) Physician Quality Reporting System Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment; 7.) Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Records (EHR) Incentive Program for 2016; 8.) Value-Based Payment Modifier and Physician Feedback Program; and 9.) MACRA Patient Relationship Categories and Codes.
Comments re: FY 2018 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Prospective Payment System Final Rule, published in the Federal Register as a proposed rule on August 2, 2017.
Comments re: the CY 2018 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, published in the Federal Register as a proposed rule. Topics included: 1.) CY 2018 Comprehensive Ambulatory Payment Classifications (C-APCs); 2.) Imaging APCs; and 3.) Changes for Computed Tomography (CT) under the Protecting Access to Medicare Act of 2014 (PAMA); and 4.) New Bundled Sinus Codes Payment in the Ambulatory Surgical Center (ASC).
Concerns with new methodology for updating malpractice (MP) relative value units (RVUs) as discussed in the calendar year (CY) 2018 Medicare Physician Fee Schedule (PFS) proposed
rule.
Comments to the House Ways & Means Committee in response to its "Medicare Red Tape Relief Project." Topics included: scope of practice, the Quality Payment Program (QPP) and clinical data registries.
Support for statutory changes to MACRA that will allow CMS to provide an additional three years of flexibility as necessary program elements are put in place.
Comments outlining concerns re: the commercial misuse of quality measures developed for the Merit-based Incentive Payment System (MIPS), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), and requests that CMS issue sub-regulatory guidance about the ownership and licensing of MIPS measures as it has issued for QCDR measures.
Opposition to the inclusion of Medicare cuts (in general) in the tax bill, an end of year spending package, or other legislation, that could threaten patient access to quality care.
Comments via the Physician Clinical Registry Coalition re: CMS-5522-FC - Medicare Programs: CY 2018 Updates to the Quality Payment Program.
Comments to CMS re: the Innovation Center New Direction Request for Information, posted on the CMS Innovation Center website on September 20, 2017. The AAO-HNS urged CMMI to adopt several strategies to design and implement new APMs consistent with the guiding principles, including support for physician-driven approaches to APM models.
Comments to CMS re: Medicare; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year.
Comments to MedPAC highlighting the significant benefits of clinical data registries and the role they should play in achieving the goals of the Quality Payment Program (QPP).
Opposition to current methodologies used to survey and assess values associated with Global Surgical Services.
17. House(s) of Congress and Federal agencies Check if None
Centers For Medicare and Medicaid Services (CMS), Health & Human Services - Dept of (HHS), U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), Medicare Payment Advisory Commission (MedPAC)
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
Opposition to H.R. 564 and any appropriations policy riders that would exempt some cigars, including flavored cigars, from regulation under the Family Smoking Prevention and Tobacco Control Act (TCA).
Support for legislation and/or regulation requiring all non-grandfathered private health insurance plans to cover preventative services given an "A" or "B" rating by the U.S. Preventative Services Task Force (USPSTF), especially provisions relating to comprehensive benefits for tobacco cessation services.
Opposition to H.R. 1136, the "FDA Deeming Authority Clarification Act of 2017," all provisions.
Comments to the Department of Housing and Urban Development re: Reducing Regulatory Burden; Enforcing the Regulatory Reform Agenda Under Executive Order 13777; Docket No. FR-6030-N-01.
Support for funding for the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH) in the FY 2018 Labor, Health and Human Services, Education, and Related Agencies Appropriations bill.
Comments re: Docket No. USTR-2017-0006; provisions relating to public health measures to protect citizens from the death and disease caused by tobacco products.
Support for authorized level of user fees for the Food and Drug Administrations (FDA) oversight of tobacco products in the FY 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, and opposition to any effort to limit the authority that Congress granted the FDA under the Family Smoking Prevention and Tobacco Control Act (TCA).
Opposition to Sections 752 and 753 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for FY 2018. These sections weaken the Food and Drug Administrations (FDA) May 2016 final rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products.
Comments in support of Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products, Docket No. FDA-2016-N-2527.
Opposition to Rep. James Comers amendment (amendment #9) to Division B of H.R. 3354, the Make America Secure and Prosperous Appropriations Act, which would prohibit the Food and Drug Administration (FDA) from finalizing a product standard to reduce N-Nitrosonornicotine (or NNN), a carcinogen in smokeless tobacco products.
For FY18, opposition to the inclusion of either of two policy riders originally included in the House Appropriations Committees Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill that would weaken FDAs authority to oversee tobacco products.
Opposition to the House Appropriations Committees proposed 25% cut to the Centers for Disease Control and Preventions (CDC) Office on Smoking and Health (OSH).
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA), Labor - Dept of (DOL), Health & Human Services - Dept of (HHS), Treasury - Dept of, Housing & Urban Development - Dept of (HUD), Centers For Disease Control & Prevention (CDC), 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 TOR
16. Specific lobbying issues
H.R. 1215, the "Protecting Access to Care Act," all provisions.
H.R. 1704, the "Accessible Care by Curbing Excessive lawSuitS (ACCESS) Act," all provisions.
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
Comments re: Docket No. USTR-2017-0006; provisions relating to public health measures to protect citizens from the death and disease caused by tobacco products.
17. House(s) of Congress and Federal agencies Check if None
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
Information Update Page - Complete ONLY where registration information has changed.
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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)
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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:
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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 |