Improving Transparency and Accuracy in Medicare Part D Spending Act

H.R. 9, Innovation Act (Goodlatte) - changes to inter partes review process H.R. 1600, Patients' Access to Treatments Act (McKinley-Capps) - specialty drug tiers H.R. 4599, Reducing Unused Medications Act (Clark) - partial fillings of prescriptions H.R. 4784, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug issues H.R. 5122, Medicare Part B Prescription Drug Demonstration (Bucshon) H.R. 5951, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - Medicare Part D pharmacy payments H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act (Schakowsky) - reporting requirements for prescription drug price increases S. 1137, PATENT Act (Grassley) - changes to inter partes review process S. 2019, Preserve Access to Affordable Generics Act (Klobuchar-Grassley) - pay-for-delay settlements S. 2023, Prescription Drug Affordability Act (Sanders) - pharmaceutical issues S. 2578, Reducing Unused Medications Act (Warren) - partial fillings of prescriptions S. 2615, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug issues S. 2689, REGROW Act (Kirk) - stem cell /regenerative medicines S. 3056, CREATES Act (Leahy) - challenging anti-competitive practices of brand name drug manufacturers S. 3308, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - Medicare Part D pharmacy payments S. 3335, Fair Accountability and Innovative Research Drug Pricing Act (Baldwin) - reporting requirements for prescription drug price increases Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Treasury, Dept of, White House Office

H.R. 471 & S. 483 legislation to prevent and reduce prescription drug abuse. H.R. 592 & S. 314, Provide for coverage under Medicare program of pharmacist services. Medication Therapy Management, including S. 776 The Medication Therapy Management Empowerment Act of 2015. H.R.5951 and S. 3308, legislation to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies. Pharmaceutical compounding and the implementation of the Drug Quality Security Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to biosimilars and Part D preferred pharmacy networks; CMS Proposed Guidance on Direct and Indirect Remuneration (DIR) and Pharmacy Price Concessions; H.R.4062 - Protecting Seniors Access to Proper Care Act of 2015; HR 5951-Improving Transparency and Accuracy in Medicare Part D Spending Act.

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

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

S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 592 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 1270 - Restoring Access to Medication Act of 2015 S. 709 - Restoring Access to Medication Act of 2015 S.776 - Medication Therapy Management Empowerment Act of 2015 H.R. 793 - Ensuring Seniors Access to Pharmacies Act of 2015 H.R. 1021, the Protecting the Integrity of Medicare Act (PIMA) of 2015 H.R.2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R.6 - 21st Century Cures Act S.1190 - Ensuring Seniors Access to Local Pharmacies Act of 2015 S. 1913 - Stopping Medication Abuse and Protecting Seniors Act of 2015 H.R.4878 - Better Care, Lower Cost Act S. 3094 - Price Relief, Innovation, and Competition for Essential Drugs Act HR 5573 - Price Relief, Innovation and Competition for Essential Drugs Act H. R. 4641 -To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. HR 5210-Patient Access to Durable Medical Equipment Act S 2736-Patient Access to Durable Medical Equipment Act of 2016 H.R. 1192 - National Diabetes Clinical Care Commission Act S. 3056 - Creating and Restoring Equal Access to Equivalent Samples Act H.R. 5951- Improving Transparency and Accuracy in Medicare Part B Spending

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

S. 776 - Medication Therapy Empowerment Act of 2015; H.R. 1021 - Protecting the Management Integrity of Medicare Act of 2015; H.R. 1270 - Restoring Access to Medication Act of 2015; S. 709- Restoring Access to Medication Act of 2015; H.R. 2- Medicare Access and Chip Reauthorization Act of 2015; H.R. 793 - Ensuring Seniors Access to Local Pharmacies Act of 2015; S. 1190 -Ensuring Seniors Access to Local Pharmacies Act of 2015; S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 592 - Pharmacy and Medically Underserved Areas Enhancement Act; H.R. 5951/S. 3308 - Improving Transparency and Accuracy in Medicare Part D Spending Act

Client expense: $245,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE

Potential future guidance on DIR: Direct and Indirect Renumeration for Pharmacies. S.2256: Co-Prescribing Saves Lives Act of 2016. H.R.244: "MAC Transparency Act," educating on how MAC pricing helps control costs for consumers. H.R.793/S.1190: "Ensuring Seniors Access to Local Pharmacies Act of 2015," importance of pharmacy networks in reducing costs. H.R.1600: "The Patients' Access to Treatment Act," educating on the importance of step therapy to ensuring optimal therapy access and cost control. Drug pricing in general. H.R.5951 and S.3308, Improving Transparency and Accuracy in Medicare Part D Spending Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 776, Medication Therapy Management Empowerment Act of 2015. H.R. 592/S. 314, Pharmacy and Medically Underserved Areas Enhancement Act. H.R. 793/S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015. H.R. 244, MAC Transparency Act. H.R. 5951/S. 3308, Improving Transparency and Accuracy in Medicare Part D Spending Act.

Client expense: $190,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 793 - Ensuring Seniors Access to Local Pharmacies Act HR 4062 - Protecting Seniors Access to Proper Care Act of 2015 HR 2570-Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 HR 605-Medicare Home Infusion Site of Care Act S 275-Medicare Home Infusion Site of Care Act H.R. 5951-Improving Transparency and Accuracy in Medicare Part D Spending Act

Client expense: $1,320,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

H.R. 9, Innovation Act (Goodlatte) - changes to inter partes review process H.R. 1600, Patients' Access to Treatments Act (McKinley-Capps) - specialty drug tiers H.R. 4599, Reducing Unused Medications Act (Clark) - partial fillings of prescriptions H.R. 4784, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug issues H.R. 5122, Medicare Part B Prescription Drug Demonstration (Bucshon) H.R. 5951, Improving Transparency and Accuracy in Medicare Part D Spending Act (Griffith) - Medicare Part D pharmacy payments H.R. 6043, Fair Accountability and Innovative Research Drug Pricing Act (Schakowsky) - reporting requirements for prescription drug price increases S. 1137, PATENT Act (Grassley) - changes to inter partes review process S. 2019, Preserve Access to Affordable Generics Act (Klobuchar-Grassley) - pay-for-delay settlements S. 2023, Prescription Drug Affordability Act (Sanders) - pharmaceutical issues S. 2578, Reducing Unused Medications Act (Warren) - partial fillings of prescriptions S. 2615, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug issues S. 2689, REGROW Act (Kirk) - stem cell /regenerative medicines S. 3056, CREATES Act (Leahy) - challenging anti-competitive practices of brand name drug manufacturers S. 3308, Improving Transparency and Accuracy in Medicare Part D Spending Act (Capito) - Medicare Part D pharmacy payments S. 3335, Fair Accountability and Innovative Research Drug Pricing Act (Baldwin) - reporting requirements for prescription drug price increases Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,710,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R.3250/S. 2994 - DXM Abuse Prevention Act of 2015 H.R. 1270 / S. 620 - Restore Access to Medication Act H.R. 592 / S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 2029 - Consolidated Appropriations Act, House Amendments 1 and 2 to Senate Amendment published as Rules Committee Prints 114-39 and 114-40 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R. 793/S. 1190 - the Ensuring Seniors Access to Local Pharmacies Act Health Savings Act of 2016 - H.R.4469/S.2499 H.R. 5951/S. 3308 - Improving Transparency and Accuracy in Medicare Part D Spending Act

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 471 & S. 483 legislation to prevent and reduce prescription drug abuse. H.R. 592 & S. 314, Provide for coverage under Medicare program of pharmacist services. Medication Therapy Management, including S. 776 The Medication Therapy Management Empowerment Act of 2015. H.R.5951 and S. 3308, legislation to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies. Pharmaceutical compounding and the implementation of the Drug Quality Security Act.

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 592 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 1270 - Restoring Access to Medication Act of 2015 S. 709 - Restoring Access to Medication Act of 2015 S.776 - Medication Therapy Management Empowerment Act of 2015 H.R. 793 - Ensuring Seniors Access to Pharmacies Act of 2015 H.R. 1021, the Protecting the Integrity of Medicare Act (PIMA) of 2015 H.R.2 - Medicare Access and CHIP Reauthorization Act of 2015 H.R.6 - 21st Century Cures Act S.1190 - Ensuring Seniors Access to Local Pharmacies Act of 2015 S. 1913 - Stopping Medication Abuse and Protecting Seniors Act of 2015 H.R.4878 - Better Care, Lower Cost Act S. 3094 - Price Relief, Innovation, and Competition for Essential Drugs Act HR 5573 - Price Relief, Innovation and Competition for Essential Drugs Act H. R. 4641 -To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. HR 5210-Patient Access to Durable Medical Equipment Act S 2736-Patient Access to Durable Medical Equipment Act of 2016 H.R. 1192 - National Diabetes Clinical Care Commission Act S. 3056 - Creating and Restoring Equal Access to Equivalent Samples Act H.R. 5951- Improving Transparency and Accuracy in Medicare Part B Spending

Client expense: $920,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Issues relating to biosimilars and Part D preferred pharmacy networks; CMS Proposed Guidance on Direct and Indirect Remuneration (DIR) and Pharmacy Price Concessions; H.R.4062 - Protecting Seniors Access to Proper Care Act of 2015; HR 5951-Improving Transparency and Accuracy in Medicare Part D Spending Act.

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

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

Potential future guidance on DIR: Direct and Indirect Renumeration for Pharmacies. S.524: "Comprehensive Addiction and Recovery Act," focused on Prescription Drug Management Plans (PDMPs). S.480/H.R.1725: "National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015," educating on the importance of PDMPs and the need for federal funding. H.R.4981: The Opioid Use Disorder Treatment Expansion and Modernization Act. H.R.4599/S.2578: Reducing Unused Medications Act of 2016. H.R.3680: Co-Prescribing to Reduce Overdoses Act of 2016. S.2256: Co-Prescribing Saves Lives Act of 2016. H.R.244: "MAC Transparency Act," educating on how MAC pricing helps control costs for consumers. H.R.793/S.1190: "Ensuring Seniors Access to Local Pharmacies Act of 2015," importance of pharmacy networks in reducing costs. H.R.1600: "The Patients' Access to Treatment Act," educating on the importance of step therapy to ensuring optimal therapy access and cost control. Drug pricing in general. H.R.5951 and S.3308, Improving Transparency and Accuracy in Medicare Part D Spending Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including non-interference, pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care pharmacy, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Issues related to prescription drug abuse in Medicare. H.R.2: Medicare Access and CHIP Reauthorization Act of 2015 - provisions related to the expansion of availability of Medicare data H.R.244: The MAC Transparency Act H.R.793/S1190: The Ensuring Seniors Access to Local Pharmacies Act H.R. 1021: The Protecting the Integrity of Medicare Act H.R. 1600: The Patient Access to Treatments Act H.R. 804: The Access to Medicare Data Act H.R. 2298: The Medicare Drug Abuse Prevention Act H.R. 953/S.524: The Comprehensive Addiction and Recovery Act - Provisions related to the establishment of a Medicare patient review and restriction lock-in program to prevent prescription opioid abuse. H.R. 2646: The Helping Families in Crisis Act - Provisions related to prescription drug coverage S.2680: Mental Health Reform Act - Provisions related to prescription drug coverage H.R.6: 21st Century Cures H.R.4062: Protecting Seniors Access to Proper Care Act H.R.5951/S.3308: Improving Transparency and Accuracy in Medicare Part D Spending Act

Client expense: $643,584 · Firm income: Not reported

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

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including non-interference, pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care pharmacy, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Issues related to prescription drug abuse in Medicare. H.R.2: Medicare Access and CHIP Reauthorization Act of 2015 - provisions related to the expansion of availability of Medicare data H.R.244: The MAC Transparency Act H.R.793S1190: The Ensuring Seniors Access to Local Pharmacies Act H.R.1021: The Protecting the Integrity of Medicare Act H.R.1600: The Patient Access to Treatments Act H.R.804: The Access to Medicare Data Act H.R.2298: The Medicare Drug Abuse Prevention Act H.R.6: 21st Century Cures Act H.R. 1735/S.1376: The National Defense Authorization Act - Provisions related to TRICARE pharmacy H.R. 4062: Protecting Seniors Access to Proper Care Act H.R. 5951/ S.3308: Improving Transparency and Accuracy in Medicare Part D Spending Act

Client expense: $643,584 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), 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. 244 - MAC Transparency Act of 2015; Congressional Oversight of 340 B Program; S. 1406 - Saving Access to Compounding Medications for Special Needs Patients Act; Issues related to FDA implementation of The Drug Quality and Security Act related to compounding; Issues Related to Direct and Indirect Renumeration (DIR) Fees; H.R. 5951/S. 3308 - Improving Transparency and Accuracy in Medicare Part D Spending Act

Client expense: $335,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE

H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015; S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015; Implementation of Public Law 114-198; S.524 - Comprehensive Addiction and Recovery Act of 2016; H.R.953 - Comprehensive Addiction and Recovery Act of 2015; H.R. 3250 - DXM Abuse Prevention Act; H.R. 5951/S. 3308 - Improving Transparency and Accuracy in Medicare Part D Spending Act

Client expense: $335,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE

Reimbursement of Pharmacist Services - HR592/S314 Transitions of Care Risk Evaluation and Mitigation Services Track and Trace/Supply cChain Health Information Technology Immunizations Compounding Tele-Medicine Quality Rating AMP FULs/MAC P ricing Biosimiliars/Biologic Products (S 2700) Drug Importation Generics Labeling Pharmacy Benefit Managers Preferred Pharmacy Network (HR793) Electronic Labeling 21st Century Cures/Innovation Bills (HR6, HR 350) Drug Disposal/Management Drug Prices Direct and Indirect Remuneration Fees (HR 5951, S3308) Lab Developed Tests

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Reimbursement of Pharmacist Services (HR592, S314) Transitions of Care Risk Evaluation and Mitigation Services Track and Trace/Supply Chain Health Information Technology Immunizations Compounding Tele-medicine Quality Rating AMP FULs/MAC Pricing Biosimiliars/Biologic Products (S 2700) Drug Importation Generics Labeling Pharmacy Benefit Managers Preferred Pharmacy Network (HR793) Electronic Labeling 21st Century Cures (HR6, HR 350) Drug Disposal/Management Drug Prices Direct and Indirect Remuneration Fees (HR 5951, S 3308) Cody Miller Act (S 2214) Lab Developed Tests

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)