Ariel Grace's Law

H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B

Client expense: Not reported · Firm income: Not reported

H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. proposals related to Medicare Parts A & B

Client expense: Not reported · Firm income: Not reported

Lobbying with regard to the implementation of the SMART Act (Public Law 112-242), generally. Lobbying with regard to the Medicare Secondary Payer Program, generally. S. 1514/H.R. 2649 (Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2015); provides for the application of Medicare secondary payer rules to certain workers' compensation settlement agreements and qualified Medicare set-aside provisions. Lobbying with regard to the Medicaid Third Party Liability Program, generally. S. 884/H.R. 836 (Health Care Safety Net Enhancement Act of 2015); improves access to emergency medical services, and for other purposes. H.R. 1021 (Protecting the Integrity of Medicare Act); amends Title XVIII of the Social Security Act to improve the integrity of the Medicare program, and for other purposes. H.R. 1376 (Patient Choice Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast-track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. H.R. 2300 (Empowering Patients First Act of 2015); provides for incentives to encourage health insurance coverage. H.R. 2653 (American Health Care Reform Act of 2015); repeals the Patient Protection and Affordable Care Act and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines. S. 2204 (End of Suffering Act of 2015); respects the Constitutional entitlement to liberty by recognizing the right of an individual to have personal control over the medical assistance and treatment necessary to avoid intolerable physical suffering. H.R.__/S.__ (Behavioral Health Information Technology Act); draft legislation amending the Public Health Service Act to include as a health care provider behavioral and mental health professionals, substance abuse professionals, psychiatric hospitals, certain community mental health centers (including one operated by a county behavioral health agency), and residential or outpatient mental health or substance abuse treatment facilities. H.R. 5403 (Ariel Grace's Law); to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. S. 2912 (Trickett Wendler Right to Try Act of 2016); to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes. H.R. 6 (21st Century Cures Act); establishing and appropriating funds, and reforming Medicaid, Medicare, and other reforms.

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries and legislation to improve the use of clinical data registries HR. 6 the "21st Century Cures Act" Issues related to the Medical Device User Fee Agreement Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to WHO administration of diagnostics access program Issues related to the regulation of mobile medical technology Issues related to promoting innovation in the med tech industry and improving FDA regulating procedures for devices Issues related to cybersecurity for medical technology Issues related to the regulation of transporting lithium batteries for medical devices by air Issues related to credentialing for industry representatives in VA health care facilities Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of contact lenses Issues related to De-Identified Bio-specimens and Diagnostics Development Issues related to the regulation of and access to cancer diagnostics, imaging, and radiation therapies Issues relating to USDA import policies S.1077 Advancing Breakthrough Devices for Patients Act of 2015 S.1622 FDA Device Accountability Act of 2015 S. 1101 MEDTECH Act S. 2188 The Rare Disease Innovation Act S. 2187 The FDA Regulatory Efficiency Act S. 1767 Combination Product Regulatory Fairness Act S. 2737 the Improving Medical Device Innovation Act H.R. 636/S. 2658 the FAA Re-authorization Act H.R. 5403 Ariel Graces Law H.R. 5404 Medical Device Guardians Act H.R. 3422, the VA Vendor Verification Act

H.R. 6 21st Century Cures Act Innovation for Healthier Americans House and Senate Agriculture Appropriations bills S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S.1622, FDA Device Accountability Act of 2015 S.2737, Improving Medical Device Innovation Act Issues related to lab developed tests H.R. 5403, To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE