Medical Device Guardians Act of 2016

Support for a national reporting database of medical errors related to the delivery of radiation therapy. Support for the development of an appropriate medical event definition. Support to ensure that patient care advances in biomedical research impacting patient care are not compromised by any policies imposed on the medical use and research applications of cesium chloride. FDA review process of medical devices; The Medical Device Guardians Act of 2016 (H.R. 5404) Support for NRC Commissioner nominee to have medical background. Support patient choice in treatment options by closing the in-office ancillary services exception to the Stark Law for radiation oncology services; Protecting Integrity in Medicare Act (H.R. 5088) Oppose Non-Burning Sunshine Report Language Oppose HR 2698, Tanning Tax Repeal Act of 2015 Support HR 239, To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes Radiation Oncology reimbursement Radiation Oncology safety Cancer Moonshot Initiative H.R. 5721 Local Coverage Determination Clarification Act of 2016

Client expense: $169,918 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Nuclear Regulatory Commission (NRC), Office of Management & Budget (OMB), SENATE

Support for a national reporting database of medical errors related to the delivery of radiation therapy. Support for the development of an appropriate medical event definition. Support to ensure that patient care advances in biomedical research impacting patient care are not compromised by any policies imposed on the medical use and research applications of cesium chloride. FDA review process of medical devices; The Medical Device Guardians Act of 2016 (H.R. 5404) Support for NRC Commissioner nominee to have medical background. Support patient choice in treatment options by closing the in-office ancillary services exception to the Stark Law for radiation oncology services; Protecting Integrity in Medicare Act (H.R. 5088) Oppose HR 2698, Tanning Tax Repeal Act of 2015 Support HR 239, To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes Radiation Oncology reimbursement Radiation Oncology safety Cancer Moonshot Initiative H.R. 5721 Local Coverage Determination Clarification Act of 2016

Client expense: $124,957 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Nuclear Regulatory Commission (NRC), Office of Management & Budget (OMB), SENATE

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

Client expense: $700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE