Patient Access to Disposable Medical Technology Act of 2015

H.R. 1018/S. 1253, the "Patient Access to Disposable Medical Technology Act of 2015" H.R. 1516/S. 1013, the "Ensuring Access to Quality Complex Rehabilitation Technology Act" H.R. 2646, the "Helping Families in Mental Health Crisis Act" The "Community Choice Act" Implementation of P.L. 111-148, the "Patient Protection and Affordable Care Act" HHS Appropriations: "Lifespan Respite" funding

Client expense: $66,363 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 8, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues Chronic Care Working Group - Medicare policy affecting drugs

Client expense: $1,490,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 8, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues Chronic Care Working Group - Medicare policy affecting drugs

Client expense: $5,950,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.

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 price transparency for medical devices 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

Client expense: $1,140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1018/ S. 1253, the Patient Access to Disposable Medical Technology Act of 2015 H.R. 1516/ S. 1013, the Ensuring Access to Quality Complex Rehabilitation Technology Act H.R. 2646, the Helping Families in Mental Health Crisis Act The Community Choice Act Implementation of P.L. 111-148, the Patient Protection and Affordable Care Act HHS Appropriations: Lifespan Respite funding

Client expense: $68,250 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

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 scope of the HHS inspector generals authority to exclude individuals and companies from the Medicare program Issues related to price transparency for medical devices 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

Client expense: $980,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 3819: Surface Transportation Extension Act of 2015 - Medicare related offsets to the biopharmaceutical industry H.R. __, S. __: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to Hospital Outpatient Department (HOPD) reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Proposed Rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Chronic Care Working Group - Medicare policy affecting drugs HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014

Client expense: $380,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Lobbying related to Medicare Part D drug rebate proposals. Patient Access to Disposable Medical Technology Act (H.R. 1018; S. 1253) and similar provision contained in the 21st Century Cures Act (H.R. 6) and in the Consolidated Appropriations Act, 2016 (H.R. 2029).

Client expense: $410,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Disposable medical technologies; H.R. 6, 21st Century Cures Act; S. 1253, Patient Access to Disposable Medical Technology Act of 2015; Proposed 2016 Hospital Outpatient Payment Rule

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Assist client with work on H.R. 1018 and S. 1253, Patient Access to Disposable Medical Technology Act of 2015, H.R. 6, 21st Century Cures Act and H.R. 2029, Consolidated Appropriations Act of 2016

Client expense: Not reported · Firm income: Not reported

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 scope of the HHS inspector generals authority to exclude individuals and companies from the Medicare program Issues related to price transparency for medical devices 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

Client expense: $910,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 275: Medicare Home Infusion Site of Care Act of 2015 - Provisions related to Medicare coverage S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2409: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 3819: Surface Transportation Extension Act of 2015 - Medicare related offsets to the biopharmaceutical industry H.R. 4273: Medicare and Medicaid Improvements and Adjustments Act of 2015 - Provisions related to outpatient reimbursement rates Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Proposed rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Chronic Care Working Group - Medicare policy affecting drugs

Client expense: $3,820,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Issues related to disposable medical technologies and H.R. 1018, the Patient Access to Technology Act of 2015; issues related to S.1253, The Patient Access to Disposable Medical Technology Act of 2015.

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R 1018: Patient Access to Disposable Medical Technology Act H.R. 1600: Patients Access to Treatments Act H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency Act for Seniors of 2015 S. 1253: Patient Access to Disposable Medical Technology Act

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.605/S.275, Medicare Home Infusion Site of Care Act of 2015, H.R.1018/S.1253, Patient Access to Disposable Medical Technology Act of 2015, H.R.6, 21st Century Cures Act; issues related to patient infusion therapy.

Client expense: $510,000 · Firm income: Not reported

Government targets: Army, Dept of (Other), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Natl Guard, SENATE, Transportation Security Administration (TSA), U.S. Customs & Border Protection

H.R. 1018/S. 1253, Patient Access to Disposable Medical Technology.

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

Government targets: HOUSE OF REPRESENTATIVES

S.1253, H.R. 1018, Patient Access to Disposable Medical Technology Act of 2015; 21st Century Cures Act.

Client expense: Not reported · Firm income: $20,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1018/ S. 1253, the Patient Access to Disposable Medical Technology Act of 2015 H.R. 1516/ S. 1013, the Ensuring Access to Quality Complex Rehabilitation Technology Act H.R. 2646, the Helping Families in Mental Health Crisis Act The Community Choice Act Implementation of P.L. 111-148, the Patient Protection and Affordable Care Act HHS Appropriations: Lifespan Respite funding

Client expense: $62,998 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

Supports 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. Also support the companion bill, HR 292 (which was included in the 21st Century Cures Initiative). United Spinal supports the Patient Access to Disposable Medical Technology Act of 2015, S.1253/H.R. 1018 - portable medical equipment that can be used outside of the hospital. United Spinal joined a coalition, led by the Center for Responsible Science, to file an FDA petition to broaden testing options in drug development and to update regulations that govern preclinical drug and device development. As a member of the Patients for Biologics Safety and Access, United Spinal is engaged in an advocacy campaign with Congress to ensure that Congress hold an oversight hearing with the Food and Drug Administration to ask for expedited publication of guidances on consumer safety and clinical testing for biological pharmaceuticals. A Senate HELP hearing with the FDA CDRH Director, Janet Woodcock testifying took place in September. United Spinal Association signed on to a letter spearheaded by the Advanced Medical Technology Association (AdvaMed) in support of repealing the tax on medical device manufacturers. Research shows that innovations in medical technology have greatly improved outcomes of individuals with disabilities. We are concerned that the medical device tax will curtail investments in future innovation, thereby reducing consumer access to innovative medicine and hampering their quality of life.

Client expense: Not reported · Firm income: $75,000

Government targets: Defense, Dept of (DOD), Education, Dept of, Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Transportation, Dept of (DOT), Veterans Affairs, Dept of (VA), White House Office

Provisions related to disposable medical technologies in the 21st Century Cures Act (H.R. 6) and the Patient Access to Disposable Medical Technology Act of 2015 (S. 1253); proposed 2016 Hospital Outpatient Payment Rule

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, White House Office

Issues related to disposable medical technologies and H.R. 1018, the Patient Access to Technology Act of 2015; issues related to S.1253, The Patient Access to Disposable Medical Technology Act of 2015.

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Supports 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. Also support the companion bill, HR 292 (which was included in the 21st Century Cures Initiative). United Spinal supports the Patient Access to Disposable Medical Technology Act of 2015, S.1253/H.R. 1018 - portable medical equipment that can be used outside of the hospital. United Spinal joined a coalition, led by the Center for Responsible Science, to file an FDA petition to broaden testing options in drug development and to update regulations that govern preclinical drug and device development. As a member of the Patients for Biologics Safety and Access, United Spinal is engaged in an advocacy campaign with Congress to ensure that Congress hold an oversight hearing with the Food and Drug Administration to ask for expedited publication of guidances on consumer safety and clinical testing for biological pharmaceuticals. A Senate HELP hearing with the FDA CDRH Director, Janet Woodcock testifying took place in September. United Spinal Association signed on to a letter spearheaded by the Advanced Medical Technology Association (AdvaMed) in support of repealing the tax on medical device manufacturers. Research shows that innovations in medical technology have greatly improved outcomes of individuals with disabilities. We are concerned that the medical device tax will curtail investments in future innovation, thereby reducing consumer access to innovative medicine and hampering their quality of life.

Client expense: Not reported · Firm income: $75,000

Government targets: Defense, Dept of (DOD), Education, Dept of, Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Transportation, Dept of (DOT), Veterans Affairs, Dept of (VA), White House Office

HR 1600: Patients' Access to Treatments Act S 1253: Patients' Access to Disposable Medical Technologies Act HR 1018: Patients' Access to Disposable Medical Technologies Act HR 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act of 2015

Client expense: $90,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Supports 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. Also support the companion bill, HR 292 (which was included in the 21st Century Cures Initiative). United Spinal supports the Patient Access to Disposable Medical Technology Act of 2015, S.1253/H.R. 1018 - portable medical equipment that can be used outside of the hospital. United Spinal joined a coalition, led by the Center for Responsible Science, to file an FDA petition to broaden testing options in drug development and to update regulations that govern preclinical drug and device development. As a member of the Patients for Biologics Safety and Access, United Spinal is engaged in an advocacy campaign with Congress to ensure that Congress hold an oversight hearing with the Food and Drug Administration to ask for expedited publication of guidances on consumer safety and clinical testing for biological pharmaceuticals. A Senate HELP hearing with the FDA CDRH Director, Janet Woodcock testifying took place in September. United Spinal Association signed on to a letter spearheaded by the Advanced Medical Technology Association (AdvaMed) in support of repealing the tax on medical device manufacturers. Research shows that innovations in medical technology have greatly improved outcomes of individuals with disabilities. We are concerned that the medical device tax will curtail investments in future innovation, thereby reducing consumer access to innovative medicine and hampering their quality of life.

Client expense: Not reported · Firm income: $75,000

Government targets: Defense, Dept of (DOD), Education, Dept of, Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, Transportation, Dept of (DOT), Veterans Affairs, Dept of (VA), White House Office

Assist client with work on H.R. 1018 and S. 1253, Patient Access to Disposable Medical Technology Act of 2015, and H.R. 6, 21st Century Cures Act

Client expense: Not reported · Firm income: Not reported

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program S. 1884: Medicare Prescription Drug Savings and Choice Act of 2015 - Provisions related to the Medicare Operated Prescription Drug Plan Option S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 3244: Providing Innovative Care for Complex Cases Demonstration Act of 2015 - Provisions relating to changes to the Part D benefit Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] - Provisions related to Medicaid Medicaid Program; Covered Outpatient Drugs; Final Rule [CMS-2345-F] - Provisions related to calculating Average Manufacturer Price (AMP) Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare Part D rebates issues Drug cost and pricing issues Medication adherence policy issues Alternative payment models policy issues

Client expense: $4,240,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

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 scope of the HHS inspector generals authority to exclude individuals and companies from the Medicare program Issues related to price transparency for medical devices 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

Client expense: $480,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobbying related to Medicare Part D drug rebate proposals. Patient Access to Disposable Medical Technology Act (H.R. 1018; S. 1253) and similar provision contained in the 21st Century Cures Act (H.R. 6). CY 2016 Medicare Hospital Outpatient Proposed Rule.

Client expense: $360,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, White House Office

H.R.160, Protect Medical Innovation Act of 2015, S.149, Medical Device Access and Innovation Protection Act, H.R.605/S.275, Medicare Home Infusion Site of Care Act of 2015, H.R.1018/S.1253, Patient Access to Disposable Medical Technology Act of 2015, H.R.6, 21st Century Cures Act; issues related to patient infusion therapy.

Client expense: $580,000 · Firm income: Not reported

Government targets: Army, Dept of (Other), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Natl Guard, SENATE, Transportation Security Administration (TSA), U.S. Customs & Border Protection

H.R. 1600: Patient's Access to Treatments Act H.R 1018: Patient Access to Disposable Medical Technology Act S. 1253: Patient Access to Disposable Medical Technology Act

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare coverage and payment for durable medical equipment; H.R. 1018/S. 1253, Patient Access to Disposable Medical Technology; H.R. 6, 21st Century Cures, provision related to disposable medical technology.

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

Government targets: HOUSE OF REPRESENTATIVES

S.1253, H.R. 1018, Patient Access to Disposable Medical Technology Act of 2015; 21st Century Cures Act.

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

S.1253, H.R. 1018, Patient Access to Disposable Medical Technology Act of 2015; 21st Century Cures Act.

Client expense: Not reported · Firm income: Not reported

Lobbying related to Medicare policies that promote bundled payments. Lobbying related to implementation of the ICD-10 coding system. Lobbying related to Medicare Part D drug rebate proposals. Patient Access to Disposable Medical Technology Act (H.R. 1018; S. 1253) and similar provision contained in the 21st Century Cures Act (H.R. 6).

Client expense: $380,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 6: 21st Century Cures Act HR 1600: Patients' Access to Treatments Act S 1253: Patients' Access to Disposable Medical Technologies Act HR 1018: Patients' Access to Disposable Medical Technologies Act

Client expense: $100,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Provisions related to disposable medical technologies in the 21st Century Cures Act (H.R. 6) and the Patient Access to Disposable Medical Technology Act of 2015 (S. 1253)

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to disposable medical technologies and H.R. 1018, the Patient Access to Technology Act of 2015; issues related to S.1253, The Patient Access to Disposable Medical Technology Act of 2015.

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1253: Patient Access to Disposable Medical Technology Act of 2015 - Provisions related to capitated payments for disposable medical technology S. 1396: Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 1725: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions relating to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 2570: Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 - Provisions related to changes to the Medicare Advantage Program H.R. 2581: Preservation of Access for Seniors in Medicare Advantage Act of 2015 - Provisions related to changes to the Medicare Advantage Program H.R.__: To amend title XVIII of the Social Security Act to establish a program to improve care for the highest cost Medicare fee-for-service beneficiaries, and for other purposes - Provisions relating to changes to the Part D benefit S.___: Stopping Medicare Abuse and Protecting Seniors Act of 2015 - Provisions related to Part D Lock-in program Hospital Improvements for Payment Act (discussion draft) - Provisions related to Medicare Parts A and B reform Cancer Care Payment Reform Act (discussion draft) - Provisions related to oncology medical home demonstration Fighting Medicare Fraud Act (discussion draft) - Provisions related to exclusion from federal healthcare programs Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) issues Medicare exclusion issues Medicare Part D rebates issues Drug cost and pricing policy issues

Client expense: $4,820,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Issues related to disposable medical technologies and H.R. 1018, the Patient Access to Technology Act of 2015; issues related to S.1253, The Patient Access to Disposable Medical Technology Act of 2015.

Client expense: Not reported · Firm income: $54,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare coverage and payment for durable medical equipment; H.R. 1018/S. 1253, Patient Access to Disposable Medical Technology; H.R. 6, 21st Century Cures, provision related to disposable medical technology.

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

Government targets: HOUSE OF REPRESENTATIVES

H.R.160, Protect Medical Innovation Act of 2015, S.149, Medical Device Access and Innovation Protection Act, H.R.605/S.275, Medicare Home Infusion Site of Care Act of 2015, H.R.1018/S.1253, Patient Access to Disposable Medical Technology Act of 2015, H.R.6, 21st Century Cures Act; issues related to patient infusion therapy.

Client expense: $520,000 · Firm income: Not reported

Government targets: Army, Dept of (Other), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Natl Guard, SENATE, Transportation Security Administration (TSA), U.S. Customs & Border Protection

Supports H.R. 1516/S. 1013 - ENsuring Access to Quality Compex Rehabiliation Technology Act - to ensure Medicare beneficiaries' access to customized wheelchairs. United Spinal advocated distributed a Congressional Dear Colleague letter urging that CRT accessories (specialty controls such as head-rests) are not set at competitive bidding pricing the same as standard wheelchairs due to their highly customized nature for a small population living with significant disabilities. United Spinal highlighted our concern with CRT Accessories, described above and with our concerns with access to durable medical equipment for wheelchair users under the competitive acquisition program. United Spinal signed on to a letter to US Health and Human Services Secretary Burwell and CMS officials regarding a pending case, Davis v. Shah, in the U.S. Second Circuit Court of Appeals - a challenge to New York Medicaid's attempt to limit coverage of compression stockings and orthopedic shoes only to Medicaid recipients with specific diagnoses. Supports the Steve Gleason Act which lifts caps on access to speech-generating devices. (HR 1919, H.R. 629, S, 768, S. 984. United Spinal supported Congressional testimony on behalf of the Coalition to Preserve Rehabilitation Steering Committee highlighting the need to eliminate site-neutral payments under Medicare and also advocated for additional signatories to a Dear Colleague letter stating the same issue. United Spinal supports expanded state participation in Medicaid programs that increase funding for HCBS such as the Community First Choice Option, Money Follows the Person, and the Balancing Incentive Program; and oppose restructuring of Medicaid funding through block grants, State Flexibility Funds, or per capita caps. United Spinal signed on to a letter to the Centers for Medicare and Medicaid Services in support of an improved mechanism for the reimbursement of Lemtrada to ensure speedier access to this therapy for individuals with multiple sclerosis. United Spinal signed onto three comment letters to the Centers for Medicare and Medicaid Services in support of improved rehab policy, namely: on in-patient rehabilitative facilities and on skilled nursing facilities to allow for improved quality reporting and on acute care hospitals and payment issues to ensure that bundled payments of services does not hinder coverage of episodes of care for individuals with multiple needs. United Spinal signed onto a MapRx letter to urge the Senate Finance Committee to include, in their discussion of chronic care, robust formularies, coverage of the six-protected classes of drugs, strong oversight, and transparency for consumers are among the design principles essential to meet the needs of Medicare beneficiaries. In addition, a process for notice of non-coverage, appeals and exceptions is critical to providing access to needed drug therapies. United Spinal supports S.1253, the Patient Access to Disposable Medical Technology Act of 2015.The legislation amends title XVIII (Medicare) of the Social Security Act to cover disposable medical technology in addition to equipment traditionally described as durable medical equipment. This legislation was introduced by Senators Burr (R-NC) and Bennet (D-CO) this spring and is identical to its House counterpart, H.R. 1018, which United Spinal has also supported. United Spinal supports the Protect Medical Innovation Act of 2015, HR 160, introduced by Rep. Eric Paulsen of Minnesota, which repeals the medical device tax on medical device manufacturers and importers. United Spinal signed on to a letter to Congress to convey support for the goals of the final Home and Community Based Settings (HCBS) rule issued by the Centers for Medicare & Medicaid Services (CMS) in January 2014. This rule is the first time CMS has defined community for Medicaid-funded HCBS programs. The letter also urges Congress to: protect cuts to funding; support the requested additional $2.8m in CMS funding for HCBS; and defend against policies or changes to the rule that would hinder the goal of providing supports through HCBS so that people with disabilities can live meaningful lives.

Client expense: Not reported · Firm income: $120,000

Government targets: Defense, Dept of (DOD), Education, Dept of, Federal Communications Commission (FCC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Transportation, Dept of (DOT), U.S. Architectural & Transportation Barriers Compliance Board (ACCESS), U.S. Coast Guard (USCG), Veterans Affairs, Dept of (VA), White House Office

H.R. 1600: Patient's Access to Treatments Act H.R 1018: Patient Access to Disposable Medical Technology Act S. 1253: Patient Access to Disposable Medical Technology Act

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE