Improving Transparency and Accuracy in Medicare Part D Spending Act

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: $180,000 · 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

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.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: $100,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

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

S 560/HR 1057, PARTS Act (Promoting Automotive Repair, Trade, and Sales Act of 2015) S 685/HR 2892, Autocycle Safety Act HR 2864, Prohibits EPA from extending the RFS past 2022 if the Administrator waives applicable volume requirements in prior years. HR 3994, Security and Privacy in Your Car Study Act of 2015 HR 4630, Compensating Losses to the Environment from Automobiles with Noxious Undisclosed Pollution Act of 2016 S 2659/HR 4715, Recognizing the Protection of Motorsports Act of 2016 (RPM Act) HR 5024, Clean Air and Vehicle Technology Accountability Act of 2016 S 3308, National Historic Vehicle Register Act of 2016

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

Government targets: Bureau of Land Management (BLM), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Highway Traffic Safety Administration (NHTSA), SENATE, U.S. Forest Service

Graduate Medical Education (GME) issues (including Resident Physician Shortage Reduction Act (H.R.2124/S.1148) - support); provided comments to Congress in response to Energy and Commerce Committee request for input on GME; amendments to the Medicare hospital re-admissions penalty program methodology (providing SES adjustments, fixing the formula flaw), H.R.1343/S.688 - support; proposals to amend the 2 midnight policy - support; hospital issues included in President Obama's FY 16 budget - oppose; hospital issues included in H.R.2, the Medicare Access and CHIP Re-authorization Act of 2015 - support; legislation to create a comprehensive Medicare home infusion benefit (H.R.605/S.275) - support; Strengthening Medicare Advantage through Innovation and Transparency for Seniors (H.R.2570) - oppose; Medicare Inpatient Prospective Payment System FY 2016 proposed rule (CMS 1632-P) - detailed comment letter; legislation to improve the recovery audit contractor program (H.R.2156); Audit and Appeal Fairness, Integrity and Reforms in Medicare Act (AFIRM) - provided comments to the Senate Finance Committee; Ensuring Seniors Access to Local Pharmacies Act of 2015 (H.R.793/S.1190) - support; Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.314) - support; MAC Transparency Act (H.R.244) - support; Medication Therapy Management Act (S.776) - support; CMS-4159-F2 - comments on daily dispensing fees; Medicare Independence at Home Medical Practice Demonstration Improvement Act of 2015 (P.L.114-39) - support; provided comments on the proposed Medicare outpatient prospective payment system rule (CMS-1633-P); Medicare IME Pool Act of 2015 (H.R.3292) - oppose; Strengthening DSH and Medicare through Subsidy Recapture and Payment Reform Act (H.R.3288) - oppose; Medicare Crosswalk Hospital Code Development Act (H.R. 3291) - oppose; sign-on letter to CMS urging it to reconsider negative update for CY 2016 (CMS-1633-P) - support; proposed Medicare and Medicaid cuts as offsets to pay for budget increases, raising the debt ceiling, etc. - oppose; site neutral hospital outpatient cuts and other hospital related provisions included in the Bipartisan Budget Act of 2015 (H.R. 1314) - oppose; legislative proposals (H.R. 5273)and Congressional letters to amend the Bipartisan Budget Acts site neutral hospital outpatient payment cut to grandfather sites under development as well as other legislative changes (support) - advocated for their inclusion in the Consolidated Appropriations Act of 2016 (Omnibus legislation/Senate amendment to H.R. 2029); provided comments to Congress regarding provisions in the Mental Health Reform Act of 2015 (S. 1945), that would reform how health care information for substance abuse patients is shared; met with HHS officials on Medicare and Medicaid issues of importance to the Commonwealth of Puerto Rico and Puerto Rican health care providers; submitted comments on Medicare and Medicaid Programs: Reform of Requirements for Long-Term Care Facilities (CMS-3260-P); Stopping Medication Abuse and Protecting Seniors Act of 2015 (S.1913) - support (with some concerns about pharmacy lock-in policy); hospital issues included in House FY 17 budget - oppose; hosptial issues included in President Obama's FY 17 budget proposal - oppose; provided comments in response to Energy and Commerce Committee request for input on hospital site-neutral issues; Medicaid provisions included in the Common Sense Savings Act of 2016 (H.R.4725) - oppose; provided comments to CMS and Congress regarding the Hospital Compare Star Ratings for hospitals - support for delay and fixing measures; The Fair Medicare Hospital Payments Act of 2016 (H.R. 4428) - oppose; provided comments to CMS on hospital site-neutral proposals - argued for flexibility in the anticipated OPPS proposed rule; provided comments to CMS on the FY 17 IPPS proposed rule (CMS-1655-P) with a focus on opposition to the proposed Medicare DSH policy and provided input to Capitol Hill and the Administration;submitted comments on Medicaid Program,Covered Outpatient Drugs (CMS-2345-FC); asked Congressional members to urge CMS to finalize its 2014 proposed guidance to Part D drug plans and PBMs regarding consistent reporting of Direct and Indirect Remuneration (DIR); Improving Transparency & Accuracy in Medicare Part D Spending (S.3308/H.R.5957) - support; testified at House Ways and Means Health Subcommittee hearing entitled "Incentivizing Quality Outcomes in Medicare Part A" in support of streamlining hospital measures and reporting; provided comments regarding the Medicare OPPS CY2017 proposed rule (81 FR 45603), in particular in opposition to implementation of site-neutral proposals; provided comments on Merit Based Incentive Payment System (MIPS)and Alternative Payment Models (APMs) under MACRA 2015 (81 FR 28161); discussions with CMS regarding priority categories for redistribution of Medicare-funded residency slots; discussions with CMS to encourage consistency in hospital surveys; submitted comments on the Part B Drug Payment Model proposed rule (CMS-1670-P) - serious concerns; submitted comments on the SNF PPS proposed rule (CMS-1645-P) - serious concerns; Texas proposed Medicaid State Plan Amendment (15-005) in response to the CMS Covered Outpatient Drug Rule (CMS-2345-FC) - concerns; submitted comments to CMS about its proposal to expand testing of mandatory, risk-based bundled payments for acute episodes of care - oppose; 21st Century Cures Act (H.R. 34, now P.L.114-255) provisions that apply to site neutral, readmissions, and other hospital reimbursement issue - support.

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

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

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.

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 560/HR 1057, PARTS Act (Promoting Automotive Repair, Trade, and Sales Act of 2015) S 685/HR 2892, Autocycle Safety Act HR 2864, Prohibits EPA from extending the RFS past 2022 if the Administrator waives applicable volume requirements in prior years. HR 3994, Security and Privacy in Your Car Study Act of 2015 HR 4630, Compensating Losses to the Environment from Automobiles with Noxious Undisclosed Pollution Act of 2016 S 2659/HR 4715, Recognizing the Protection of Motorsports Act of 2016 (RPM Act) HR 5024, Clean Air and Vehicle Technology Accountability Act of 2016 S 3308, National Historic Vehicle Register Act of 2016

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

Government targets: Bureau of Land Management (BLM), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Natl Highway Traffic Safety Administration (NHTSA), SENATE, U.S. Forest Service

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

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

Graduate Medical Education (GME) issues (including Resident Physician Shortage Reduction Act (H.R.2124/S.1148) - support); provided comments to Congress in response to Energy and Commerce Committee request for input on GME; amendments to the Medicare hospital re-admissions penalty program methodology (providing SES adjustments, fixing the formula flaw), H.R.1343/S.688 - support; proposals to amend the 2 midnight policy - support; hospital issues included in President Obama's FY 16 budget - oppose; hospital issues included in H.R.2, the Medicare Access and CHIP Re-authorization Act of 2015 - support; legislation to create a comprehensive Medicare home infusion benefit (H.R.605/S.275) - support; Strengthening Medicare Advantage through Innovation and Transparency for Seniors (H.R.2570) - oppose; Medicare Inpatient Prospective Payment System FY 2016 proposed rule (CMS 1632-P) - detailed comment letter; legislation to improve the recovery audit contractor program (H.R.2156); Audit and Appeal Fairness, Integrity and Reforms in Medicare Act (AFIRM) - provided comments to the Senate Finance Committee; Ensuring Seniors Access to Local Pharmacies Act of 2015 (H.R.793/S.1190) - support; Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592/S.314) - support; MAC Transparency Act (H.R.244) - support; Medication Therapy Management Act (S.776) - support; CMS-4159-F2 - comments on daily dispensing fees; Medicare Independence at Home Medical Practice Demonstration Improvement Act of 2015 (P.L.114-39) - support; provided comments on the proposed Medicare outpatient prospective payment system rule (CMS-1633-P); Medicare IME Pool Act of 2015 (H.R.3292) - oppose; Strengthening DSH and Medicare through Subsidy Recapture and Payment Reform Act (H.R.3288) - oppose; Medicare Crosswalk Hospital Code Development Act (H.R. 3291) - oppose; sign-on letter to CMS urging it to reconsider negative update for CY 2016 (CMS-1633-P) - support; proposed Medicare and Medicaid cuts as offsets to pay for budget increases, raising the debt ceiling, etc. - oppose; site neutral hospital outpatient cuts and other hospital related provisions included in the Bipartisan Budget Act of 2015 (H.R. 1314) - oppose; legislative proposals (H.R. 5273)and Congressional letters to amend the Bipartisan Budget Acts site neutral hospital outpatient payment cut to grandfather sites under development as well as other legislative changes (support) - advocated for their inclusion in the Consolidated Appropriations Act of 2016 (Omnibus legislation/Senate amendment to H.R. 2029); provided comments to Congress regarding provisions in the Mental Health Reform Act of 2015 (S. 1945), that would reform how health care information for substance abuse patients is shared; met with HHS officials on Medicare and Medicaid issues of importance to the Commonwealth of Puerto Rico and Puerto Rican health care providers; submitted comments on Medicare and Medicaid Programs: Reform of Requirements for Long-Term Care Facilities (CMS-3260-P); Stopping Medication Abuse and Protecting Seniors Act of 2015 (S.1913) - support (with some concerns about pharmacy lock-in policy); hospital issues included in House FY 17 budget - oppose; hosptial issues included in President Obama's FY 17 budget proposal - oppose; provided comments in response to Energy and Commerce Committee request for input on hospital site-neutral issues; Medicaid provisions included in the Common Sense Savings Act of 2016 (H.R.4725) - oppose; provided comments to CMS and Congress regarding the Hospital Compare Star Ratings for hospitals - support for delay and fixing measures; The Fair Medicare Hospital Payments Act of 2016 (H.R. 4428) - oppose; provided comments to CMS on hospital site-neutral proposals - argued for flexibility in the anticipated OPPS proposed rule; provided comments to CMS on the FY 17 IPPS proposed rule (CMS-1655-P) with a focus on opposition to the proposed Medicare DSH policy and provided input to Capitol Hill and the Administration;submitted comments on Medicaid Program,Covered Outpatient Drugs (CMS-2345-FC); asked Congressional members to urge CMS to finalize its 2014 proposed guidance to Part D drug plans and PBMs regarding consistent reporting of Direct and Indirect Remuneration (DIR); Improving Transparency & Accuracy in Medicare Part D Spending (S.3308/H.R.5957) - support; testified at House Ways and Means Health Subcommittee hearing entitled "Incentivizing Quality Outcomes in Medicare Part A" in support of streamlining hospital measures and reporting; provided comments regarding the Medicare OPPS CY2017 proposed rule (81 FR 45603), in particular in opposition to implementation of site-neutral proposals; provided comments on Merit Based Incentive Payment System (MIPS)and Alternative Payment Models (APMs) under MACRA 2015 (81 FR 28161); discussions with CMS regarding priority categories for redistribution of Medicare-funded residency slots; discussions with CMS to encourage consistency in hospital surveys; submitted comments on the Part B Drug Payment Model proposed rule (CMS-1670-P) - serious concerns; submitted comments on the SNF PPS proposed rule (CMS-1645-P) - serious concerns; Texas proposed Medicaid State Plan Amendment (15-005) in response to the CMS Covered Outpatient Drug Rule (CMS-2345-FC) - concerns.

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)