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Ensuring Patient Access to Critical Breakthrough Products Act of 2016
Legislative Progress
Introduced
April 20, 2016
Latest Action
May 5, 2016
Primary Sponsor
Charles W. Boustany Jr.Republican(LA)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
53pct
15d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
Ensuring Patient Access to Critical Breakthrough Products Act of 2016 This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to modify provisions related to coverage and payment for certain breakthrough medical devices under the Medicare and Medicaid programs. Specifically, with respect to such devices, the bill: (1) provides for transitional coverage; (2) establishes accelerated processes for determining regular coverage and payment; and (3) modifies provisions related to specified payment adjustments, cost thresholds, and classification.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (12)
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Congress.gov source codes: H11100, H11100-A
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2018 · third_quarter · Medicare/Medicaid
H.R.5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals related to the prevention of Anti-Microbial Resistant Bacteria. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).
Client expense: $730,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2018 · third_quarter · Medicare/Medicaid
H.R.5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals related to the prevention of Anti-Microbial Resistant Bacteria. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).
Client expense: $700,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2018 · second_quarter · Medicare/Medicaid
H.R.5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule. Proposals to ensure Medicare coverage for emerging medical device technology. Proposals for Medicare reimbursement for diagnostic patient self-testing. Proposals related to the prevention of Anti-Microbial Resistant Bacteria. Proposals to reform the FDA regulatory pathway for approval of diagnostic tests including Laboratory Developed Tests (LDTs).
Client expense: $770,000 · Firm income: Not reported
2016 · fourth_quarter · Health Issues
S. 1622 FDA Device Accountability Act of 2015. S. 586 National Diabetes Clinical Care Commission Act. H.R. 6 21st Century CURES Act/Senate Innovation Package. H.R. 1192 National Diabetes Clinical Care Commission Act. H.R. 5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals related to Affordable Care Act improvements/repeal and replace. Proposals to modify requirements for diabetes testing supplies. Proposals regarding payments across healthcare sites of service.
Client expense: $820,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Medicare/Medicaid
Support efforts to clarify Medicare authority regarding local coverage determinations. Support HR 5009, Ensuring Patient Access to Critical Breakthrough Products Act of 2016.
Client expense: $250,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
| Republican |
| FL |
| Jared Polis | Democratic | CO |
| Juan Vargas | Democratic | CA |
| Kyrsten Sinema | Independent | AZ |
| Leonard Lance | Republican | NJ |
| Pete Aguilar | Democratic | CA |
| Raul Ruiz | Democratic | CA |
| Richard E. Neal | Democratic | MA |
| Scott H. Peters | Democratic | CA |
| Seth Moulton | Democratic | MA |
| Tony Cárdenas | Democratic | CA |
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
S. 1622 FDA Device Accountability Act of 2015. S. 586 National Diabetes Clinical Care Commission Act. H.R. 6 21st Century CURES Act/Senate Innovation Package. H.R. 1192 National Diabetes Clinical Care Commission Act. H.R. 5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals related to Affordable Care Act improvements/repeal and replace. Proposals to modify requirements for diabetes testing supplies. Proposals regarding payments across healthcare sites of service.
Client expense: $790,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Medicare/Medicaid
PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation ***, no specific bill(s), diagnostics, Medicare Physician Reimbursement; reimbursement for imaging and technology; value based purchasing, Accountable Care Organizations, Sunshine Act, bundling, PODs, Cost centers, ICD-10, Stark H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 1470/S. 810 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015 H.R. 1021 - Protecting the Integrity of Medicare Act of 2015 S. 2425 - Patient Access and Medicare Protection Act H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act H.R. 5009/S. 2998 - Ensuring Access to Critical Breakthrough Products Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act H.R. 34 - 21st Century Cures Act
Client expense: Not reported · Firm income: $70,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Medicare/Medicaid
CMS Coverage Policies for Medical Devices H.R. 6 21st Century Cures Initiative Senate "Innovation for Healthier Americans" Initiative CMS Payment Policies For Medical Devices Coverage and reimbursement policy for medical devices/THV H.R. 5009 / S. 2998, Ensuring Patient Access to Critical Breakthrough Products Act of 2016
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R.6 - 21st Century Cures Act - provisions related to medical innovation, technology and medical device regulatory reforms. S. 2187 - FDA Regulatory Efficiency Act, Efforts - provisions in support of third-party quality system programs. S. 1622 - The FDA Device Accountability Act of 2015 - provisions in support for centralized IRBs. S. 1767 - The Combination Product Regulatory Fairness Act - provisions related to combination product issues. S. 2737 - Improving Medical Device Innovation Act - provisions related to medical device innovation. S. 2998/H.R. 5009 - Ensuring Patient Access to Critical Breakthrough Products Act of 2016. H.R. 34 - 21st Century Cures Act - provisions related to medical innovation, technology and medical devices. S. 3504 - Chronic Care Act of 2017 - provisions related to teleheath and diabetes. S. 2873 - Echo Act - provisions related to telehealth. H.R. 2020 - Short Term Continuing Resolution - provisions related to federal funding of the government through April 28, 2017. Issues related to VA procurement and devices.
Client expense: $540,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R.6/H.R. 34- 21st Century Cures Act- provisions related to medical innovation, technology and medical device regulatory reforms. S.2998/H.R.5009- Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Issues related to Pandemic Preparedness. S.1767- The Combination Product Regulatory Fairness Act- Provisions related to combination products.
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Medicare/Medicaid
Issues related to physician owned distributors of devices Issues related to deficit reduction and Medicare Issues related to Medicare program integrity , including changes to the Stark laws and Anti-Kickback Statute Issues relating to payment reform, ACOs and Bundling Issues related to the CMS program for durable medical equipment Issues related to the development of Medicare payments for telehealth and remote monitoring services Issues related to applying the unique device identifier to Medicare claims forms S. 1253 Patient Access to Disposable Medical Technology Act of 2015 S. 2343, H.R. 4155 Telehealth Innovation and Improvement Act H.R. 4714 the Removing Barriers to Clinical Research Act of 2016 S. 2736 Patient Access to Durable Medical Equipment Act H.R. 5009, S. 2998 Ensuring Access to Critical Breakthrough Products Act H.R. 5721, S. 3392 Local Coverage Determination Clarification Act of 2016
Client expense: $650,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Issues related to H. R. 6, 21st Century Cures the Senate Innovation for Healthier Americans Initiative as it relates to the discovery and development of breakthrough products. Issues related to the role of medical devices and diagnostics including the regulation of lab developed tests, durable medical equipment, coverage and reimbursement for devices. Issues related to breakthrough pathways for the approval and coverage of medical devices. Issues related to the Vice President's Cancer Moonshot Initiative. H.R. 5009, Ensuring Patient Access to Critical Breakthrough Products Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Medicare/Medicaid
Issues related to H.R.6, 21st Century Cures, the Senate Innovation for Healthier Americans Initiative. Issues related to coverage and reimbursement for medical devices. Issues related to breakthrough pathways for the approval and coverage of medical devices, including H. R. 5009, Ensuring Patient Access to Critical Breakthrough Products Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Medicare/Medicaid
CMS Coverage Policies For Medical Devices H.R. 6, 21st Century Cures Act Senate "Innovation for Healthier Americans" Initiative CMS Payment Policies for Medical Devices Coverage and reimbursement policy for medical devices/THV HR 5009, Ensuring Patient Access to Critical Breakthrough Products Act of 2016 S.2998, Ensuring Patient Access to Critical Breakthrough Products Act of 2016
Client expense: $180,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Medicare/Medicaid
CMS Coverage Policies For Medical Devices H.R. 6, 21st Century Cures Act Senate "Innovation for Healthier Americans" Initiative CMS Payment Policies for Medical Devices Coverage and reimbursement policy for medical devices/THV HR 5009, Ensuring Patient Access to Critical Breakthrough Products Act of 2016 S.2998, Ensuring Patient Access to Critical Breakthrough Products Act of 2016
Client expense: $180,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Public Law 112-144 - Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule H.R. 6 - 21st Century Cures Initiative - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies Innovation for Healthier Americans (Senate, companion) - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies FDA/CMS Breakthrough Pathway - H.R. 5009 - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction Implementation of Comprehensive Addiction & Recovery Act (CARA) - Bill to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 4641 - Pain Best Practices
Client expense: $420,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medicare/Medicaid
CMS Coverage Policies for Medical Devices H.R. 6 21st Century Cures Initiative Senate "Innovation for Healthier Americans" Initiative CMS Payment Policies For Medical Devices Coverage and reimbursement policy for medical devices/THV H.R. 5009 / S. 2998, Ensuring Patient Access to Critical Breakthrough Products Act of 2016
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
H.R.6- 21st Century Cures Act- provisions related to medical innovation, technology and medical device regulatory reforms. S.2998/H.R.5009- Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Issues related to Pandemic Preparedness. S.1767- The Combination Product Regulatory Fairness Act- Provisions related to combination products. Education about FDA regulation of hysteroscopic morcellators.
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
H.R.6 - 21st Century Cures Act - provisions related to medical innovation, technology and medical device regulatory reforms. H.R. 4155/S.2343 - Telehealth Innovation and Improvement Act of 2015 - provisions related to remote patient management and telehealth. S. 2187 - FDA Regulatory Efficiency Act, Efforts - provisions in support of third-party quality system programs. S. 1622 - The FDA Device Accountability Act of 2015 - provisions in support for centralized IRBs. S. 849 - Neurological Disease Act - provisions promoting research and aggregation of data on neurological diseases. S. 1767 - The Combination Product Regulatory Fairness Act - provisions related to combination product issues. S. 2737 - Improving Medical Device Innovation Act - provisions related to medical device innovation. S. 524 - Comprehensive Addiction and Recovery Act of 2016 - provisions related to pain management. S. 2998/H.R. 5009 - Ensuring Patient Access to Critical Breakthrough Products Act of 2016. S. Res. 438 - Designating September 2016 as "National Brain Aneurysm Awareness Month." H.R. 5325 - Short-Term Continuing Resolution - provisions related to opioid funding. Issues related to VA procurement and devices.
Client expense: $940,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medicare/Medicaid
CMS Coverage Policies For Medical Devices H.R. 6, 21st Century Cures Act Senate "Innovation for Healthier Americans" Initiative CMS Payment Policies for Medical Devices Coverage and reimbursement policy for medical devices/THV HR 5009, Ensuring Patient Access to Critical Breakthrough Products Act of 2016 S. 2998, Ensuring Patient Access to Critical Breakthrough Products Act of 2016
Client expense: $220,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
S. 1622 FDA Device Accountability Act of 2015. S. 586 National Diabetes Clinical Care Commission Act. H.R. 6 21st Century CURES Act/Senate Innovation Package. H.R. 1192 National Diabetes Clinical Care Commission Act. H.R. 5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Proposals regarding payments across healthcare sites of service.
Client expense: $670,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · third_quarter · Medicare/Medicaid
Issues related to physician owned distributors of devices Issues related to deficit reduction and Medicare Issues related to Medicare program integrity Issues relating to payment reform, ACOs and Bundling Issues related to the CMS program for durable medical equipment Issues related to the development of Medicare payments for telehealth and remote monitoring services Issues related to applying the unique device identifier to Medicare claims forms S. 1253 Patient Access to Disposable Medical Technology Act of 2015 S. 2343, H.R. 4155 Telehealth Innovation and Improvement Act H.R. 4714 the Removing Barriers to Clinical Research Act of 2016 S. 2736 Patient Access to Durable Medical Equipment Act H.R. 5009, S. 2998 Ensuring Access to Critical Breakthrough Products Act H.R. 5721, S. 3392 Local Coverage Determination Clarification Act of 2016
Client expense: $700,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Issues related to H. R. 6, 21st Century Cures the Senate Innovation for Healthier Americans Initiative as it relates to the discovery and development of breakthrough products. Issues related to the role of medical devices and diagnostics including the regulation of lab developed tests, durable medical equipment, coverage and reimbursement for devices. Issues related to breakthrough pathways for the approval and coverage of medical devices. Issues related to the Vice President's Cancer Moonshot Initiative. H.R. 5009, Ensuring Patient Access to Critical Breakthrough Products Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medicare/Medicaid
Issues related to H.R.6, 21st Century Cures, the Senate Innovation for Healthier Americans Initiative. Issues related to coverage and reimbursement for medical devices. Issues related to breakthrough pathways for the approval and coverage of medical devices, including H. R. 5009, Ensuring Patient Access to Critical Breakthrough Products Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Medicare/Medicaid
PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation ***, no specific bill(s), diagnostics, Medicare Physician Reimbursement; reimbursement for imaging and technology; value based purchasing, Accountable Care Organizations, Sunshine Act, bundling, PODs, Cost centers, ICD-10, Stark H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 1470/S. 810 - SGR Repeal and Medicare Provider Payment Modernization Act of 2015 H.R. 1021 - Protecting the Integrity of Medicare Act of 2015 S. 2425 - Patient Access and Medicare Protection Act H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act H.R. 5009/S. 2998 - Ensuring Access to Critical Breakthrough Products Act S. 2343/H.R. 4155 - Telehealth Innovation and Improvement Act
Client expense: Not reported · Firm income: $70,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · third_quarter · Health Issues
Public Law 112-144 - Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule H.R. 6 - 21st Century Cures Initiative - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies Innovation for Healthier Americans (Senate, companion) - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies FDA/CMS Breakthrough Pathway - H.R. 5009 - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction S. 524 - H.R. 943 - Comprehensive Addiction & Recovery Act (CARA) - Bill to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 4641 - Pain Best Practices
Client expense: $420,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Labor Issues/Antitrust/Workplace
Project Labor Agreements - Working to ensure proper guidance and implementation of Executive Order 13502, encouraging the use of project labor agreements in connection with large-scale construction projects in order to promote economy and efficiency in federal procurement. No bill. Davis-Bacon Prevailing Wage - General education unrelated to a specific bill concerning the social benefits of Davis-Bacon, sub chapter IV of Chapter 31 or Title 40, United States Code, to provide prevailing wages to federally funded projects. No bill. Registered Apprenticeships and Workforce Development - Lobbied to promote the use of apprenticeship and training programs in workforce development, as well as general education of apprenticeship and training programs. No bill. S. 2945 - Effective Apprenticeships to Rebuild National Skills (EARNS) Act - A bill to promote effective registered apprenticeships, for skills, credentials, and employment. Entire bill. S. 3341 - American Apprenticeship Act - A bill to establish and strengthen projects that defray the cost of related instruction associated with pre-apprenticeship and apprenticeship programs. Entire bill. H.R. 5009 - Ensuring Patient Access to Critical Breakthrough Products Act of 2016 - To amend titles XVIII and XIX of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare and Medicaid program. Lobbied to establish a pilot program on partnership agreements to construct new facilities for the Department of Veterans Affairs.
Client expense: $290,000 · Firm income: Not reported
Government targets: Energy, Dept of, HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, White House Office
2016 · second_quarter · Health Issues
Issues related to H. R. 6, 21st Century Cures the Senate Innovation for Healthier Americans Initiative as it relates to the discovery and development of breakthrough products. Issues related to the role of medical devices and diagnostics including the regulation of lab developed tests, durable medical equipment, coverage and reimbursement for devices. Issues related to breakthrough pathways for the approval and coverage of medical devices. Issues related to medical research and innovation including the "Common Rule" relating to bio-specimens. Issues related to the Vice President's Cancer Moonshot Initiative. H.R. 5009, Ensuring Patient Access to Critical Breakthrough Products Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S., White House Office
2016 · second_quarter · Medicare/Medicaid
Issues related to H.R.6, 21st Century Cures, the Senate Innovation for Healthier Americans Initiative. Issues related to coverage and reimbursement for medical devices. Issues related to breakthrough pathways for the approval and coverage of medical devices, including H. R. 5009, Ensuring Patient Access to Critical Breakthrough Products Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S., White House Office
2016 · second_quarter · Medicare/Medicaid
CMS Coverage Policies For Medical Devices H.R. 6, 21st Century Cures Act Senate "Innovation for Healthier Americans" Initiative CMS Payment Policies for Medical Devices Coverage and reimbursement policy for medical devices/THV HR 5009, Ensuring Patient Access to Critical Breakthrough Products Act of 2016 S. 2998, Ensuring Patient Access to Critical Breakthrough Products Act of 2016
Client expense: $230,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S. 1622 FDA Device Accountability Act of 2015. H.R. 5009 Ensuring Patient Access to Critical Breakthrough Products Act of 2016. H.R. 771 Protecting Access to Diabetes Supplies Act of 2015. Proposals regarding payments across healthcare sites of service. Proposals to provide Diagnostic Regulatory Reform.
Client expense: $360,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
2016 · second_quarter · Health Issues
H.R.6 - 21st Century Cures Act - provisions related to medical innovation, technology and medical device regulatory reforms. H.R. 4155/S.2343 - Telehealth Innovation and Improvement Act of 2015 - provisions related to remote patient management and telehealth. S. 2187 - FDA Regulatory Efficiency Act, Efforts - provisions in support of third-party quality system programs. S. 1622 - The FDA Device Accountability Act of 2015 - provisions in support for centralized IRBs. S. 849 - Neurological Disease Act - provisions promoting research and aggregation of data on neurological diseases. S. 1767 - The Combination Product Regulatory Fairness Act - provisions related to combination product issues. S. 2737 - Improving Medical Device Innovation Act - provisions related to medical device innovation. S. 524 - Comprehensive Addiction and Recovery Act of 2016 - provisions related to pain management. S. 2998/H.R. 5009 - Ensuring Patient Access to Critical Breakthrough Products Act of 2016. S. Res. 438 - Designating September 2016 as "National Brain Aneurysm Awareness Month."
Client expense: $920,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Medicare/Medicaid
Issues related to physician owned distributors of devices Issues related to deficit reduction and Medicare Issues related to Medicare program integrity Issues relating to payment reform, ACOs and Bundling Issues related to the CMS program for durable medical equipment Issues related to the development of Medicare payments for telehealth and remote monitoring services Issues related to applying the unique device identifier to Medicare claims forms Issues relating to improving the local coverage determination process S. 1253 Patient Access to Disposable Medical Technology Act of 2015 S. 2343, H.R. 4155 Telehealth Innovation and Improvement Act H.R. 4714 the Removing Barriers to Clinical Research Act of 2016 S. 2736 Patient Access to Durable Medical Equipment Act H.R. 5009, S. 2998 Ensuring Access to Critical Breakthrough Products Act
Client expense: $680,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
United Spinal supports H.R. 292/S.849 - Advancing Research for Neurological Diseases Act of 2015. This bill will mandate that the Centers for Disease Control and Prevention track the incidence and prevalence of neurological diseases. United Spinal supports S. 800/H.R. 1631 - Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act which better coordinates rehabilitation and disability research at the NIH. S. 2689 REGROW Act: Met and worked with Sen. Mark Kirks office on language edits to this bill. Participated in a roundtable discussion with Sen. Kirks office along with several other organizations regarding the REGROW Act which sets up an expedited process to get therapies to market. United Spinal, along with the Disability Research and Rehabilitation Coalition, have identified some gaps in the Interagency Committee on Disability Research (ICDR), defining the need for a comprehensive government wide strategic plan for disability, independent living, and rehabilitation research and has shared these comments with appropriate government officials at NIH (including the NIH Research Plan on Rehabilitation) and NIDILRR. As a member of Patients for Biologics Safety and Access, United Spinal is working to educate Congress on the needs for patient protections on pharmaceuticals and better guidance from the Food and Drug Administration on patient use of biosimilars. HR 5009 - Ensuring Patient Access to Critical Breakthrough Products Act of 2016 United Spinal endorses this legislation and signed on to a Congressional House letter in support. This bill provides prompt access to breakthrough diagnostics and treatments. United Spinal Association submitted comments to FDA regarding biologics license application 761024, for ABP 501 (Humira).
Client expense: Not reported · Firm income: $150,000
Government targets: Defense, Dept of (DOD), Education, Dept of, Equal Employment Opportunity Commission (EEOC), Federal Aviation Administration (FAA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Transportation, Dept of (DOT), Veterans Affairs, Dept of (VA), White House Office
2016 · second_quarter · Medicare/Medicaid
CMS Coverage Policies for Medical Devices H.R. 6 21st Century Cures Initiative Senate "Innovation for Healthier Americans" Initiative CMS Payment Policies For Medical Devices Coverage and reimbursement policy for medical devices/THV H.R. 5009 / S. 2998, Ensuring Patient Access to Critical Breakthrough Products Act of 2016
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R.6- 21st Century Cures Act- provisions related to medical innovation, technology and medical device regulatory reforms. Issues related to Brain Aneurysm Awareness and Funding. S.Res 438- Designating September 2016 as "National Brain Aneurysm Awareness Month." S.2998/H.R.5009- Ensuring Patient Access to Critical Breakthrough Products Act of 2016. Issues related to Pandemic Preparedness.
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Public Law 112-144 - Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule H.R. 6 - 21st Century Cures Initiative - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies Innovation for Healthier Americans (Senate, companion) - Legislation to accelerate the pace of biomedical innovation and cures by modernizing federal research and regulatory agencies FDA/CMS Breakthrough Pathway - H.R. 5009 - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction S. 524 - H.R. 943 - Comprehensive Addiction & Recovery Act (CARA) - Bill to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 4641 - Pain Best Practices
Client expense: $420,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE