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Ensuring Patient Access to Critical Breakthrough Products Act of 2016
Legislative Progress
Momentum (last 30 days)
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vs 3,548 other S bills in the 114th — cohort avg 43d
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 (6)
2016 · fourth_quarter · Medicare/Medicaid
Read twice and referred to the Committee on Finance.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
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 · 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 · 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
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 · 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
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
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
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
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
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
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE