Protect Medical Innovation Act of 2015

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Tele-health services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: $11,560 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Tele-health services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: Not reported · Firm income: $10,368

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Tele-health services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Tele-health services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies.

Client expense: $16,214 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.160, Protect Medical Innovation Act of 2015, Issues related to medical device tax Issues related to corporate tax

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. H.R. 160, Protect Medical Innovation Act of 2015. S. 149, Medical Device Access and Innovation Protection Act. S. 440, Veterinary Medicine Loan Repayment Program Enhancement Act.

Client expense: $1,880,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. H.R. 160, Protect Medical Innovation Act of 2015. S. 149, Medical Device Access and Innovation Protection Act. S. 440, Veterinary Medicine Loan Repayment Program Enhancement Act.

Client expense: $2,260,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Monitor legislative and federal activity related to tax reform. H.R. 160, Protect Medical Innovation Act of 2015. S. 149, Medical Device Access and Innovation Protection Act. S. 440, Veterinary Medicine Loan Repayment Program Enhancement Act.

Client expense: $2,130,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Implementation of the Patient Protection and Affordable Care Act (PL 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated complications, healthcare associated infections,readmission, payment bundling, potentially preventable events and outcomes, and value based purchasing. Comparative effectiveness research and policies Accountable Care Organizations (ACO) Policy Competitive Bidding Policy Regulations and legislation related to the Adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) User Fee Program H.R.160 - Protect Medical Innovation Act S.149 - Medical Device Access and Innovation Protection Act H.R.2 - Medicare Access - CHIP Reauthorization Act H.R.1470 - SGR Repeal & Medicare Provider Payment Modernization Act S.1695, FY2016 Labor/Health and Human Services and Education Appropriations Bill H.R. 3422 VA Vendor Verification Act H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts HR 5273 Helping Hospitals Improve Patient Care Act Medicaid waiver policy Access to dental coverage H.R. 6274, The Hospital Outcomes Act

Client expense: $540,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Implementation of the Patient Protection and Affordable Care Act (PL 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated complications, healthcare associated infections,readmission, payment bundling, potentially preventable events and outcomes, and value based purchasing. Comparative effectiveness research and policies Accountable Care Organizations (ACO) Policy Competitive Bidding Policy Regulations and legislation related to the Adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) User Fee Program H.R.160 - Protect Medical Innovation Act S.149 - Medical Device Access and Innovation Protection Act H.R.2 - Medicare Access - CHIP Reauthorization Act H.R.1470 - SGR Repeal & Medicare Provider Payment Modernization Act S.1695, FY2016 Labor/Health and Human Services and Education Appropriations Bill H.R. 3422 VA Vendor Verification Act H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts HR 5273 Helping Hospitals Improve Patient Care Act Medicaid waiver policy Access to dental coverage

Client expense: $610,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Implementation of the Patient Protection and Affordable Care Act (PL 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated complications, healthcare associated infections,readmission, payment bundling, and potentially preventable events and outcomes. Comparative effectiveness research and policies Accountable Care Organizations (ACO) Policy Competitive Bidding Policy Regulations and legislation related to the Adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) User Fee Program H.R.160 - Protect Medical Innovation Act S.149 - Medical Device Access and Innovation Protection Act H.R.2 - Medicare Access - CHIP Reauthorization Act H.R.1470 - SGR Repeal & Medicare Provider Payment Modernization Act S.1695, FY2016 Labor/Health and Human Services and Education Appropriations Bill H.R. 3422 VA Vendor Verification Act H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts

Client expense: $1,120,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R. 160 - Protect Medical Innovation Act of 2015 (Medical Device Tax) H.R. 636 - Americas Small Business Tax Relief Act (Sec. 179) H.R. 1185 - Responsible Additions and Increases to Sustain Employee (RAISE) Health Benefits Act of 2015 (Flexible Spending Accounts) H.R. 1842 - Indian Health Service Health Professions Tax Fairness Act of 2015 (Student Loan Tax Deduction) H.R. 2029 - Consolidated Appropriations Act, 2016 (Dietary Guidelines; tobacco rider; dental research programs; child nutrition programs; appropriations for IHS, AHRQ, CDC, CMS, HHS, HRSA, NIH/NIDCR, other dental-related agencies) H.R. 2911 - Small Business Healthcare Relief Act (HRAs) H.R. 5447 - Small Business Health Care Relief Act of 2016 (HRAs) S. 149 - Medical Device Access and Innovation Protection Act (Medical Device Tax) S. 536 - Indian Health Service Health Professions Tax Fairness Act of 2015 (Student Loan Tax Deduction) S. 1697 - Small Business Healthcare Relief Act (HRAs) S. 1827 - Small Business Tax Compliance Relief Act of 2015 (Cash accounting) S. 1946 - Tax Relief Extension Act of 2015 (Section 179 tax deduction) S. 3060 - Small Business Health Care Relief Act of 2016 (HRAs) Business Tax Reform

Client expense: $470,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Education, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Internal Revenue Service (IRS), Natl Institutes of Health (NIH), Occupational Safety & Health Administration (OSHA), SENATE, Small Business Administration (SBA), Veterans Affairs, Dept of (VA)

Issues regarding reimbursement and Medicare program issues regarding long term care and post acute care vendors, suppliers, and providers including cuts to portable x-ray providers and including the following: HR 6 21st Century Cures Initiative, Medicare Tele Health Parity Act of 2015 H.R. 2948, improving information technology interoperability, electronic prescribing, S. 1349/H.R. 876, Improving Access to Medicare Coverage Act of 2015 S.843/H.R.1571, Medicare Post-Acute Care Value-Based Purchasing H.R. 3298,Protecting Seniors Access to Medicare Act of 2015 H.R. 1190, Medical Device Tax Repeal Bill H.R. 160, Audit and Appeals Fairness, Integrity, and Reforms in Medicare (AFIRM) Act of 2015, Consolidated Appropriations Act.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 2646 - Helping Families in Mental Health Crisis Act of 2015 H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 6 - 21st Century Cures Act S. 711 - Mental Health First Act of 2015 S. 599 - Improving Access to Emergency Psychiatric Care Act S. 149 - Medical Device Access and Innovation Protection Act H.R. 160 - Protect Medical Innovation Act of 2015 H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015 S. 141 - Protecting Seniors Access to Medicare Act of 2015 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 S. 1945 - Mental Health Reform Act of 2015 S. 2680 - Mental Health Reform Act of 2016 S. 524 - Comprehensive Addiction and Recovery Act (CARA)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R. 2646 - Helping Families in Mental Health Crisis Act of 2015 H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 6 - 21st Century Cures Act S. 711 - Mental Health First Act of 2015 S. 599 - Improving Access to Emergency Psychiatric Care Act S. 149 - Medical Device Access and Innovation Protection Act H.R. 160 - Protect Medical Innovation Act of 2015 H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015 S. 141 - Protecting Seniors Access to Medicare Act of 2015 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 S. 1945 - Mental Health Reform Act of 2015 S. 2680 - Mental Health Reform Act of 2016 S. 524 - Comprehensive Addiction and Recovery Act (CARA)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 6 - 21st Century Cures Act S. 995 - Bipartisan Congressional Trade Priorities and Accountability Act of 2015 H.R. 2581 - Preservation of Access for Seniors in Medicare Advantage Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act H.R. 160 - Protect Medical Innovation Act of 2015 H.R. 2156 - Medicare Audit Improvement Act of 2015 S. 1268 - Trade Adjustment Assistance Reauthorization Act of 2015 H.R. 1295 - Trade Preferences Extension Act of 2015 H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015 S. 141 - Protecting Seniors Access to Medicare Act of 2015 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 S.754 - Cybersecurity Information Sharing Act of 2015

Client expense: Not reported · Firm income: $40,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

H.R. 2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R. 6 - 21st Century Cures Act S. 995 - Bipartisan Congressional Trade Priorities and Accountability Act of 2015 H.R. 2581 - Preservation of Access for Seniors in Medicare Advantage Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act H.R. 160 - Protect Medical Innovation Act of 2015 H.R. 2156 - Medicare Audit Improvement Act of 2015 S. 1268 - Trade Adjustment Assistance Reauthorization Act of 2015 H.R. 1295 - Trade Preferences Extension Act of 2015 H.R. 1190 - Protecting Seniors' Access to Medicare Act of 2015 S. 141 - Protecting Seniors Access to Medicare Act of 2015 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 S.754 - Cybersecurity Information Sharing Act of 2015

Client expense: Not reported · Firm income: $40,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to dietary supplements. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148. Monitor legislative and administrative action related to FDAs Priority Review Voucher Program. S. 149, Medical Device Access and Innovation Protection Act. H.R. 34, 21st Century CURES Act. (P.L. 114-255) H.R. 160, Protect Medical Innovation Act of 2015. H.R. 1537, Advancing Hope Act of 2015.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.160, Protect Medical Innovation Act of 2015, Issues related to medical device tax Issues related to corporate tax

Client expense: $440,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 34, the 21st Century Cures Act, specifically those sections relating to regulatory and reimbursement policies affecting the medical technology industry. H.R. 1078, the Food and Drug Administration Safety Over Sequestration Act. H.R. 160, the Protect Medical Innovation Act. S. 149, the Medical Device Access and Innovation Protection Act. S. 1077, the Advancing Breakthrough Devices for Patients Act. S. 1622, the FDA Device Accountability Act. S. 2737, the Improving Medical Device Innovation Act. Public Law No. 112-144, the Food and Drug Administration Safety and Innovation Act, specifically those sections relating to implementation of the Medical Device User Fee program. Public Law No. 111-148, the Patient Protection and Affordable Care Act, specifically implementation issues regarding the medical device tax, accountable care organizations and the Sunshine Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 30, Save American Workers Act of 2015 H.R. 160, Protect Medical Innovation Act of 2015 H.R. 248, American Job Protection Act H.R. 879, Ax the Tax on Middle Class Americans' Health Plans Act H.R. 928, To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act H.R. 1189/S. 620, Preserving Employee Wellness Programs Act H.R. 1196, Health Savings Act of 2015 H.R. 1270/S. 709, Restoring Access to Medication Act of 2015 H.R. 2050, Middle Class Health Benefits Tax Repeal Act of 2015 H.R. 2712, Commonsense Reporting and Verification Act of 2015 H.R. 2911, Small Business Healthcare Relief Act H.R. 4469/S.2499, Health Savings Act of 2016 H.R. 5445, Health Care Security Act of 2016 H.R. 5447/S.3060, Small Business Health Care Relief Act of 2016 S. 30, Forty Hours Is Full Time Act of 2015 S. 149, Medical Device Access and Innovation Protection Act S. 183, Jobs and Premium Protection Act S. 305, American Job Protection Act S. 1099, Protecting Affordable Coverage for Employees (PACE) Act S. 1697, Small Business Healthcare Relief Act S. 1996, Commonsense Reporting Act of 2015 S. 2045, Middle Class Health Benefits Tax Repeal Act of 2015 S. 2075, American Worker Health Care Tax Relief Act of 2015 Proposed Regulation on Shared Responsibility for Employers Regarding Health Coverage (78 Fed. Reg. 218-253, January 2, 2013) (to be codified at 26 C.F.R. pts. 1, 54, 301) Proposed Regulation on Information Reporting by Applicable Large Employers on Health Insurance Coverage Offered Under Employer-Sponsored Plans (78 Fed. Reg. 54,996-55,013, September 9, 2013) (to be codified at 26 C.F.R. pt. 301) Proposed Regulation on Information Reporting of Minimum Essential Coverage (78 Fed. Reg. 54,986-54,996, September 9, 2013) (to be codified at 26 C.F.R. pts. 1, 301) Proposed Rule on HHS Notice of Benefit and Payment Parameters for 2017 (80 Fed. Reg. 75,488-75,588, December 2, 2015) (to be codified at 45 C.F.R. pts. 144, 146, 147 et al.) Proposed rule on Nondiscrimination in Health Programs and Activities (80 Fed. Reg. 54,172-54,221, September 8, 2015) (to be codified at 45 C.F.R. pt. 92) Proposed rule on Expatriate Health Plans, Expatriate Health Plan Issuers, and Qualified Expatriates; Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance (81 Fed. Reg. 38,020-38,048, June 10, 2016) IRS Notice on Section 4980I - Excise Tax on High Cost Employer-Sponsored Health Coverage (Notice 2015-16, February 23, 2015) Various issues relating to the Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings accounts (HSAs), health reimbursement accounts (HRAs), and flexible spending accounts (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; House Republican Taskforce on Health Care report, 'A Better Way to Fix Health Care'

Client expense: $18,590,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Industry and Security (BIS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Bureau of Investigation (FBI), Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Fish & Wildlife Service (USFWS), U.S. Geological Survey (USGS), U.S. Trade Representative (USTR), White House Office

H.R. 160 - Protect Medical Innovation Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act device tax repeal

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

Protect Medical Innovation Act of 2015 (HR 160); issues related to tax policy.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Tele-health services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: Not reported · Firm income: $11,560

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Issues relating to incentives for life sciences research. H.R. 160: Protect Medical Innovation Act of 2015. Tax treatment of inverted companies. Tax issues in mergers and acquisitions of US firms.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES

RetireSafe worked as a leader, along with other patient advocate groups, to oppose any new cuts to the Medicare Advantage payment rates for 2016. RetireSafe worked with the Medicare Access for Patients Rx Coalition (MAPRx) to raise concerns regarding the Advance Notice of Methodological Changes for Calendar Year 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter to express concerns related to: the Exceptions and Appeals Process, Star Ratings and the Dual-Eligibles, Formulary Oversight, Drug Utilization Review Controls, Tier Labeling and Composition, Specialty Tiers, and the Use of Multiple Tiers with Coinsurance Cost-Sharing Rates. RetireSafe joined with the Medicare Rights Center and other patient advocates to urge numerous changes to the Medicare Part D Program to make the Exceptions and Appeals Processes More Accessible for Beneficiaries. RetireSafe joined with the Healthcare Leadership Council and others to support the Protecting Seniors Access to Medicare Act, (H.R. 1190 and S. 141) to repeal the Independent Payment Advisory Board (IPAB), authorized under the Patient Protection and Affordable Care Act. Support H.R. 2624 and S. 1488, the Part D Beneficiary Appeals Fairness Act. Support the passage of H.R. 160 to repeal the 2.3% Medical Device Tax. Support the passage of H.R. 1190 to repeal the Independent Payment Advisory Board (IPAB). Joined with the MAPRx coalition to urge Congress to build on the success of Medicare Part D to ensure robust formularies, coverage for the six-protected classes, strong oversight, and transparency for consumers, as well as add improvements to the process for notice of non-coverage, appeals and exceptions. Also, urged Part D remedies to correct gaps in coverage, onerous cost-shifting created by specialty tiers, and restrictive utilization management tools that severely reduce patient benefits. Support "340B" Medicaid program reform to end widespread abuse of the drug discount program that ultimately harms patients. Joined with other patient advocate groups to comment on proposed rule: CMS-2390-P-Medicaid and Childrens Health Insurance Programs (CHIP); Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability. We supported the proposed rules intent to strengthen program integrity safeguards, and ensure beneficiary protections in areas of provider networks, coverage standards, and the treatment of appeals. We agree with the other groups that a modernized Medicaid managed care regulatory structure is essential to facilitate necessary system reform initiatives, and advance the delivery of health care for millions of people, and we supported rule changes to achieve those goals. RetireSafe joined with other patient advocates to comment on proposed rule: CMS-1631-P-Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY2016. In commenting we supported various measures for improving accuracy for primary care and care management services; providing appropriate advanced care planning services; providing better Medicare Telehealth services; providing better Chronic Care Management services for Rural Health Clinics and Qualified Health Centers; providing a useful Physicians Compare Website with data in proper context; and providing physician payment, efficiency, and quality improvements linked to a physician quality reporting system. RetireSafe joined with numerous patient groups to oppose a new CMS plan to cut the payment rate (from Average Sales Price plus 6%) for Medicare Part B Drugs administered by physicians in large parts of the U.S. because this Center for Medicare & Medicaid initiative focuses on costs rather than patients needs and health care quality. This new Part B Drug Plan will adversely impact Medicare patients with complex conditions such as cancer, macular degeneration, hypertension, rheumatoid arthritis, and primary immunodeficiency diseases. Along with many other patient advocates in the MAPRx Coalition, we strongly opposed a recent MedPAC effort to place Medicare cost savings ahead of the best interests of Medicare patients. Specifically, we urged MedPAC to reject proposals to make changes to true out-of-pocket costs (TrOOP); increase copays for low-income subsidy (LIS) beneficiaries; and eliminate any of the protected classes. RetireSafe joined with numerous patient groups to comment on the CMS Advance Notice and Draft Call Letter issued on February 19, 2016. The comments focused on better patient access to Medicare Part D Prescription Drugs and related specifically to: Specialty Tier Thresholds, Tier Labeling and Composition, Generic Tier $0 Copay Plans, Formulary Oversight, Drug Utilization Review Controls, Coverage Determination Timelines, and Access to Preferred Cost-sharing Pharmacies. RetireSafe has continued to work with a large number of patient groups (on several occasions) to strongly oppose the Centers for Medicare Services (CMS) Centers for Medicare and Medicaid Innovation (CMMI) March 8, 2016 proposed rule that would implement substantial changes to the Medicare Part B payment program. As we have stated in several joint letters to Members of Congress and to CMS, we believe the proposed changes which have been proposed as a demonstration project would impact some 75 percent of Medicare population and could limit access to the full range of available treatments under Part B to treat serious illnesses and medical treatments such as cancer, multiple sclerosis, primary immune deficiency, macular degeneration and schizophrenia. Unfortunately, the proposed program will be, in fact, mandatory for many physicians and their patients, and will cause patients to switch from the most appropriate treatment to less effective therapies or to forego treatment altogether because of transportation hurdles created by the new rule. RetireSafe also objects to the lack of sufficient stakeholder input from the beginning of this rule-making process, which has now created one-size-fits-all government payment policies that ignore patient differences and completely undermines the goal of patient-centered Medicare.

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.34, 21st Century Cures Act S.149, Medical Device Access and Innovation Protection Act H.R. 160, Protect Medical Innovation Act of 2015

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 149, Medical Device Access and Innovation Protection Act H.R. 160, Protect Medical Innovation Act of 2015

Client expense: $405,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies related to: Physician/nurse practitioner reimbursement Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Adoption of recommendations of the Institute of Medicine report, The Future of Nursing: Leading Change, Advancing Health Medicare Shared Savings Program beneficiary assignment requirements Medicare-Medicaid hospital conditions of participation Evaluation of the Medicare Graduate Nurse Education demonstration Medicare-Medicaid Program Integrity policies Medicaid maintenance of effort requirements Medicaid eligibility expansion and state options Medicaid waiver application procedures Medicaid per capita cap policy options Medicare-Medicaid dual eligible coverage and demonstration Draft Hospital Improvement for Payment (HIP) Act HHS study on the comparability of CHIP coverage and benefits with those of marketplace health plans Medicare provisions of H.R. 1892, the Trade Adjustment Assistance Act H.R. 2 - Medicare Access and CHIP Reauthorization Act H.R. 160/S. 149 - Protect Medical Innovation Act H.R. 546/S. 298 - Advancing Care for Exceptional Kids (ACE Kids) Act H.R. 700 - Stabilize Medicaid and CHIP Coverage Act H.R. 818/S. 861 - Preventing and Reducing Improper Medicare and Medicaid Expenditures (PRIME) Act H.R. 876 - Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act H.R. 919 - CHIP Extension and Improvement Act H.R. 1021 - Protecting Integrity of Medicare Act (PIMA) H.R. 1190/S. 141 - Protecting Seniors Access to Medicare Act H.R. 1362 - Medicaid Requiring Expenditures for Public Objectives to be Reflective of Total Spending (Medicaid REPORTS) Act H.R. 1458 - Bundling and Coordinating Post-Acute Care (BACPAC) Act H.R. 1470 - SGR Repeal and Medicare Provider Payment Modernization Act H.R. 2339 - To amend title XIX of the Social Security Act to clarify the treatment of lottery winnings and other lump sum income for purposes of income eligibility under the Medicaid program H.R. 3014 - Medical Controlled Substances Transportation Act H.R. 3134 - Defund Planned Parenthood Act of 2015 H.R. 3292 - Medicare IME Pool Act H.R. 3298 - Medicare Post-Acute Care Value-Based Purchasing Act H.R. 3716 - Ensuring Terminated Providers Are Removed From Medicaid and CHIP Act H.R. 3821/S. 2618 - Medicaid Directory of Caregivers (Medicaid DOC) Act H.R. 4588 - Incentivizing Medicaid Expansion Act of 2016 H.R. 4725 - Common Sense Savings Act of 2016 H.R. 5164 - Rural Hospital Regulatory Relief Act H.R. 5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act H.R. 5273 - Helping Hospitals Improve Patient Care Act of 2016 H.R. 5613/S. 3129 - Continuing Access to Hospitals Act of 2016 S. 257/H.R. 1611 - Protecting Access to Rural Therapy Services Act S. 578/H.R. 1342 - Home Health Care Planning Improvement Act S. 737/H.R. 2253 - Ensuring Access to Primary Care for Women & Children Act S. 1349 - Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act S. 1456 - Rural ACO Improvement Act S. 1461 - Extending a moratorium on enforcement of direct physician supervision of outpatient therapeutic services in critical access and small rural hospitals through 2015 S. 2425 - Patient Access and Medicare Protection Act S. 2787 - States Achieve Medicaid Expansion (SAME) Act S. 3130 - Independence at Home Act of 2016

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Issues relating to incentives for life sciences research. H.R. 160 - Protect Medical Innovation Act of 2015. Tax treatment of inverted companies. Tax issues in mergers and acquisitions of US firms.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Department of Health & Human Services: Implementation of Health insurance exchanges; Implementation of Qualified Health Plans; Delivery system reform. HR 34 - 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures. Upton (R-MI) HR 160 & S 149 - Protect Medical Innovation Act of 2015: A bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices. Paulsen (R-MN) and Hatch (R-UT) HR 248 - American Job Protection Act - repeal the ACA's employer responsibility requirements. Boustany (R-LA) HR 954 - CO-OP Consumer Protection Act of 2016: To amend the Internal Revenue Code of 1986 to exempt from the individual mandate certain individuals who had coverage under a terminated qualified health plan funded through the Consumer Operated and Oriented Plan (CO-OP) program. Smith (R-NE) HR 2028 - Further Continuing and Security Assistance Appropriations Act, 2017: Provides continuing appropriations for most federal agencies through the earlier of April 28, 2017, or the enactment of the applicable appropriations legislation. Simpson (R-ID) HR 2050 - Middle Class Health Benefits Tax Repeal Act of 2015: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Courtney (D-CT) HR 5447 - Small Business Health Care Relief Act of 2016: To provide an exception from certain group health plan requirements for qualified small employer health reimbursement arrangements. Boustany (R-LA) S 123 & HR 221- To repeal the ACA risk corridor program. Rubio (R-FL) & Harris (R-MD) S 157 - To repeal the ACA's Individual mandate, employer responsibility requirements and medical device excise tax. Cassidy (R-LA) S 305 - To repeal the ACA's employer responsibility requirements. Hatch (R-UT) and Alexander (R-TN) S Res 561 - A resolution supporting efforts to increase competition and accountability in the health insurance marketplace, and to extend accessible, quality, affordable health care coverage to every American through the choice of a public insurance plan. Merkley (D-OR) S 2680 - Mental Health Reform Act of 2016: To amend the Public Health Service Act to provide comprehensive mental health reform, and for other purposes. Alexander (R-TN) S 3056 - Creating and Restoring Equal Access to Equivalent Samples Act of 2016: To provide for certain causes of action relating to delays of generic drugs and biosimilar biological products. Leahy (D-VT) S 3297 - Relief from Obamacare Mandate Act of 2016: To amend the Internal Revenue Code of 1986 to provide an exemption to the individual mandate to maintain health coverage for certain individuals whose premium has increased by more than 10 percent, and for other purposes. Cotton (R-AR) S 3326 - State Flexibility to Provide Affordable Health Options Act: To give States the authority to provide temporary access to affordable private health insurance options outside of Obamacare exchanges. Alexander (R-TN)

Client expense: $1,450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Implementation of the Patient Protection and Affordable Care Act (PL 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated complications, healthcare associated infections,readmission, payment bundling, potentially preventable events and outcomes, and value based purchasing. Comparative effectiveness research and policies Accountable Care Organizations (ACO) Policy Competitive Bidding Policy Regulations and legislation related to the Adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) User Fee Program H.R.160 - Protect Medical Innovation Act S.149 - Medical Device Access and Innovation Protection Act H.R.2 - Medicare Access - CHIP Reauthorization Act H.R.1470 - SGR Repeal & Medicare Provider Payment Modernization Act S.1695, FY2016 Labor/Health and Human Services and Education Appropriations Bill H.R. 3422 VA Vendor Verification Act H.R. 2029, The Consolidated Appropriations Act of 2015 HR 1185 Responsible Additions and Increases to Sustain Employee Health Benefits Act HR 4469 Health Savings Act S 2499 Health Savings Act Health Savings Accounts; Flexible Spending Accounts HR 5273 Helping Hospitals Improve Patient Care Act Medicaid waiver policy Access to dental coverage H.R. 6274, The Hospital Outcomes Act

Client expense: $610,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R.34, 21st Century Cures Act (P.L.114-255). H.R.160, Protect Medical Innovation Act of 2015. S.149, Medical Device Access and Innovation Protection Act. Affordable Care Act (P.L.111-148) implementation. Oversight and regulation of medical devices.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.160 - Protect Medical Innovation Act of 2015 & S.149 - Medical Device Access and Innovation Protection Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor legislative and federal activity related to tax reform. Monitor legislative and federal activity related to Treasury Regulations proposed under section 385 of the Internal Revenue Code. H.R. 160, Protect Medical Innovation Act of 2015. S. 149, Medical Device Access and Innovation Protection Act. S. 440, Veterinary Medicine Loan Repayment Program Enhancement Act.

Client expense: $1,870,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Issues relating to incentives for life sciences research; H.R. 160 - Protect Medical Innovation Act of 2015; tax treatment of inverted companies; tax issues in mergers and acquisitions of U.S. firms.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 160, S. 149, S. 588 bills related to the Medical Device Excise Tax Issues related to the reform of the tax code

Client expense: $650,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to incentives for life sciences research; H.R. 160- Protect Medical Innovation Act of 2015; tax treatment of inverted companies; tax issues in mergers and acquisitions of US firms.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Patient Protection and Affordable Care Act (H.R. 3590/Pub. L. 111-148); telemedicine and connected care; remote patient monitoring; Health Care and Education Reconciliation Act (H.R. 4872/Pub. L. 111-152); Protect Medical Innovation Act of 2015 (H.R. 160/S. 149); The Medicare Access and CHIP Reauthorization Act (H.R. 2); Medicare Telehealth Parity Act (H.R. 2948); CONNECT for Health Act (S 2484/HR 4442); Diabetic Eye Disease Prevention Act (H.R. 4642); safe patient handling, FDA reform.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Technology research; telemedicine and connected care; remote patient monitoring; implementation of Patient Protection and Affordable Care Act (H.R. 3590/P.L. 111-148); Health Care and Education Reconciliation Act (H.R. 4872/P.L. 111-152); the Protect Medical Innovation Act (H.R. 160/S. 149); 21st Century Cures Act (H.R. 6/HR 34); The Medicare Access and CHIP Reauthorization Act (H.R. 2); Medicare Telehealth Parity Act (H.R. 2948); CONNECT for Health Act (S 2484/HR 4442); Diabetic Eye Disease Prevention Act (H.R. 4642); safe patient handling, FDA reform.

Client expense: Not reported · Firm income: $70,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation H.R. 160 - Protect Medical Innovation Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act

Client expense: Not reported · Firm income: $80,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 160 - Protect Medical Innovation Act of 2015 S. 149 - Medical Device Access and Innovation Protection Act

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R.160, Protect Medical Innovation Act of 2015; S.149, Medical Device Access and Innovation Protection Act. Tax reform; international tax issues; the repeal of the medical device excise tax; manufacturing and taxes.

Client expense: $430,000 · Firm income: Not reported

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

PL 109-442: Lifespan Respite Care Act; PL 109-365: Older Americans Act Amendments of 2006; PL 111148: The Patient Protection and Affordable Care Act; PL 111-152: Affordable Health Care for America Act; PHS 42 USC 254C-8: Healthy Start Reauthorization of 2007; PL 111-192: Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act; PL 111-152, 124 Stat. 1029: Health Care & Education Reconciliation Act; HR 1190: Protecting Seniors Access to Medicare; S 810: Repeal Outpatient Rehab Caps; HR 928/S 408: Medicare Prescription Drug Savings & Choice Act; HR 132: ObamaCare Repeal Act; S 1034/HR 1960: National Defense Authorization Act 2014; S 737/HR 1516: Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013; S 2449/HR 4631: Autism CARES (Collaboration, Accountability, Research, Education and Support) Act of 2014; S 192: Older Americans Act Reauthorization Act of 2015; HR 30: Save American Workers Act; HR 2: Medicare Access & CHIP Reauthorization Act; S 157: No Obama Mandate Act; HR 1271: Concussion Awareness & Education Act; HR 1470: SGR Repeal & Medicare Provider Payment Modernization Act; HR 160: Protecting Medical Innovations Act; S 539/HR 775: Medicare Access to Rehabilitation Services Act; HR 2646: Helping Families in Mental Health Crisis: HR 5003: Improving Child Nutrition and Education Act of 2016; HR 5243: Zika Response Appropriation Act of 2016; HR 1859: Ensuring Children's Access to Specialty Care Act of 2015; and HR 5325: Continuing Appropriations and Military Construction, Veterans Affairs Act of 2017 and Zika Response and Preparedness Act.

Client expense: $41,529 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Defense, Dept of (DOD), Education, Dept of, Equal Employment Opportunity Commission (EEOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Council on Disability, SENATE, Transportation, Dept of (DOT), U.S. Architectural & Transportation Barriers Compliance Board (ACCESS), Veterans Affairs, Dept of (VA), White House Office