Ensuring Seniors Access to Local Pharmacies Act of 2015

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 Provisions related to the 21st Century Cures Initiative (Energy and Commerce) and Innovations for Healthier Americans (HELP Committee). Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, biosimilars. 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 S.2700: The FDA and NIH Workforce Authorization Modernization Act - Provisions related to biologic drugs H.R.2841: The FAST Generics Act S.3056: The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 H.R. 4784/S.2651: The Increasing Competition in Pharmaceuticals Act H.R. 5573/S.3094 The Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act

Client expense: $755,506 · 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

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

Regulatory design and coverage of pharmacy benefits in health reform Exchanges and the commercial market, including: EHB, grandfathering, Rx quality, eRx, PBM disclosure, MLR, specialty pharmacy tiering restrictions. Regulatory implementation of a pathway for the approval of biosimilars. REMs. 340b program reform. policies placing restrictions on pharmacy benefit design. Issues regarding making prescription drugs more affordable, including: generic user fees, pedigree, biosimilars, REMs. General issues dealing with prescription drug abuse, including Medicare lock-in programs. General issues dealing with regulating pharmacy drug compounding. HR 1600; S 1190/ HR793.

Client expense: $650,000 · 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), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office

HR 793 & S. 1190 - Ensuring Seniors Access to Local Pharmacies Act; H.R. 244 -The MAC Transparency Act; HR 34 - Century Cures Act

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

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

Issues related to CARA Act; Issues related to Pharmacy Regulation; Issues related to HR 592, Pharmacy and Medically Underserved Areas Enhancement Act; Issues related to HR 793/ S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015; Issues related to 21st Century Cures; Issues related to HR 244, MAC Transparency Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to CARA Act; Issues related to Pharmacy Regulation; Issues related to HR 592, Pharmacy and Medically Underserved Areas Enhancement Act; Issues related to HR 793/ S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015; Issues related to 21st Century Cures; Issues related to HR 244, MAC Transparency Act.

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

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: $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

Reducing the costs of pharmaceuticals, medical devices, and supplies for consumers and health care providers, including implementation of the Drug Quality and Security Act (P.L.113-54) and P.L.112-144; support medical device pricing transparency and prohibition on medical device price "gag clauses"; preserving access to group purchasing organizations (GPOs) and protecting the GPO safe harbor; educating policymakers on hospital drug shortages and significant drug price increases and support draft reform legislation; pharmaceutical labeling of generic drugs (FDA-2013-N-0500); legislation to create a comprehensive Medicare home infusion benefit (H.R.605/S.275) - support; support reforming the durable medical equipment competitive bidding program; supporting "any willing pharmacy" legislation; promoting access to biosimilars (labeling/interchangeability); 21st Century Cures Act (H.R.6) - general support for overall bill, support final pharmacy lock-in policy, oppose PPSA weakening of existing requirements, oppose Section 4004 treatment of infusion drugs furnished through durable medical equipment, oppose use of savings from home infusion payment reform for purposes other than creating a Medicare home infusion benefit; Ensuring Seniors Access to Local Pharmacies Act (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 Empowerment Act (S.776) - support; Strengthening Medicare Advantage Through Innovation and Transparency for Seniors - oppose; FDA-2014-D-1524-0002 - comments, Administration and Capitol Hill meetings on draft guidance on repackaging of certain human drug products by pharmacies and outsourcing facilities; FDA-2014-N-1459 - comments and Capitol Hill meetings on draft MOU addressing certain distributions of compounded human drug products between states and the FDA; proposed changes to the 340B prescription drug program - oppose; 21st Century Cures Act (H.R.6, now P.L.114-255) - support, but with serious concerns about the misalignment of implementation dates for two home infusion provisions - oppose implementation of Section 5004 (a) without aligning the start date of the new Medicare home infusion service benefit in Section 5012; proposed amendments to 340b program (not ultimately included in H.R.6) - oppose; provide comments on proposed 340b omnibus guidance (RIN 0906 AB08); Stopping Medication Abuse and Protecting Seniors Act of 2015 (S.1913)- support (with some concerns about pharmacy lock-in policy); submitted comments on Management Standards for Hazardous Waste Pharmaceuticals (EPA-HQ-RCRA-2007-0932); meeting with DEA on Controlled Substances Act (21 USC 802); proposed changes to regulation of Laboratory Developed Tests (FDA-2011-D-0360-Draft Guidance for Industry, Food and Drug Administration Staff and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests) - oppose; Comprehensive Addiction and Recovery Act of 2016 ((S.524), monitoring for pharmacy lock-in policy, which includes exemption for LTC) - support; Increasing Competition in Pharmaceuticals Act (S.2615/H.R.4784) - support; CREATES Act addressing REMS abuses (S.3056) - support; submitted comments in response to HRSA proposed rule establishing an Administrative Dispute Resolution (ADR) Process for the 340B Drug Purchasing Program (81 Fed. Reg. 53,381).

Client expense: $400,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

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.

Client expense: $400,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

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

H.R. 592/S. 314, Pharmacy and Medically Underserved Areas Enhancement Act, all provisions. H.R. 4909, FY 2017 National Defense Authorization Act, provisions related to TRICARE and pharmacy access. H.R. 953/S. 524, Comprehensive Addition and Recovery Act, provisions related to state prescription drug monitoring programs. H.R. 793/S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015, all provisions. H.R. 3250, DXM Abuse Prevention Act, provisions related to retail pharmacy.

Client expense: $220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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

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

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

Client expense: $580,000 · 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. 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

HR 793 & S. 1190 - Ensuring Seniors Access to Local Pharmacies Act; H.R. 244 -The MAC Transparency Act; HR 4981 -The Opioid Use Disorder Treatment Expansion and Modernization Act; HR 4599 - Reducing Unused Medications Act of 2016; S. 2256 - Co-Prescribing Saves Lives; HR 3680 - Co-Prescribing to Reduce Overdoses Act of 2016; S. 524 Comprehensive Addiction and Recovery Act (CARA)

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

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

Issues related to CARA Act; issues Related to Pharmacy Regulation; issues Related to HR 592, Pharmacy and Medically Underserved Areas Enhancement Act; issues related to HR 793/ S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015; issue related to 21st Century Cures; issues related to HR 244, MAC Transparency Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to CARA Act; issues Related to Pharmacy Regulation; issues Related to HR 592, Pharmacy and Medically Underserved Areas Enhancement Act; issues related to HR 793/ S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015; issue related to 21st Century Cures; issues related to HR 244, MAC Transparency Act.

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

Government targets: 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.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 Provisions related to the 21st Century Cures Initiative (Energy and Commerce) and Innovations for Healthier Americans (HELP Committee). Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, biosimilars. 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 S.2700: The FDA and NIH Workforce Authorization Modernization Act - Provisions related to biologic drugs H.R.2841: The FAST Generics Act S.3056: The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 H.R. 4784/S.2651: The Increasing Competition in Pharmaceuticals Act H.R. 5573/S.3094 The Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED 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. 592/S. 314, Pharmacy and Medically Underserved Areas Enhancement Act, all provisions. H.R. 4909, FY 2017 National Defense Authorization Act, provisions related to TRICARE and pharmacy access. H.R. 953/S. 524, Comprehensive Addition and Recovery Act, provisions related to state prescription drug monitoring programs. H.R. 793/S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015, all provisions. H.R. 3250, DXM Abuse Prevention Act, provisions related to retail pharmacy.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

Reducing the costs of pharmaceuticals, medical devices, and supplies for consumers and health care providers, including implementation of the Drug Quality and Security Act (P.L.113-54) and P.L.112-144; support medical device pricing transparency and prohibition on medical device price "gag clauses"; preserving access to group purchasing organizations (GPOs) and protecting the GPO safe harbor; educating policymakers on hospital drug shortages and significant drug price increases and support draft reform legislation; pharmaceutical labeling of generic drugs (FDA-2013-N-0500); legislation to create a comprehensive Medicare home infusion benefit (H.R.605/S.275) - support; support reforming the durable medical equipment competitive bidding program; supporting "any willing pharmacy" legislation; promoting access to biosimilars (labeling/interchangeability); 21st Century Cures Act (H.R.6) - general support for overall bill, support final pharmacy lock-in policy, oppose PPSA weakening of existing requirements, oppose Section 4004 treatment of infusion drugs furnished through durable medical equipment, oppose use of savings from home infusion payment reform for purposes other than creating a Medicare home infusion benefit; Ensuring Seniors Access to Local Pharmacies Act (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 Empowerment Act (S.776) - support; Strengthening Medicare Advantage Through Innovation and Transparency for Seniors - oppose; FDA-2014-D-1524-0002 - comments, Administration and Capitol Hill meetings on draft guidance on repackaging of certain human drug products by pharmacies and outsourcing facilities; FDA-2014-N-1459 - comments and Capitol Hill meetings on draft MOU addressing certain distributions of compounded human drug products between states and the FDA; proposed changes to the 340B prescription drug program - oppose; 21st Century Cures Act (H.R.6) - support; proposed amendments to 340b program (not ultimately included in H.R.6) - oppose; provide comments on proposed 340b omnibus guidance (RIN 0906 AB08); Stopping Medication Abuse and Protecting Seniors Act of 2015 (S.1913)- support (with some concerns about pharmacy lock-in policy); submitted comments on Management Standards for Hazardous Waste Pharmaceuticals (EPA-HQ-RCRA-2007-0932); meeting with DEA on Controlled Substances Act (21 USC 802); proposed changes to regulation of Laboratory Developed Tests (FDA-2011-D-0360-Draft Guidance for Industry, Food and Drug Administration Staff and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests) - oppose; Comprehensive Addiction and Recovery Act of 2016 ((S.524), monitoring for pharmacy lock-in policy, which includes exemption for LTC) - support; Increasing Competition in Pharmaceuticals Act (S.2615/H.R.4784) - support; CREATES Act addressing REMS abuses (S.3056) - support.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

Regulatory design and coverage of pharmacy benefits in health reform Exchanges and the commercial market, including: EHB, grandfathering, Rx quality, eRx, PBM disclosure, MLR, specialty pharmacy tiering restrictions. Regulatory implementation of a pathway for the approval of biosimilars. REMs. 340b program reform. policies placing restrictions on pharmacy benefit design. Issues regarding making prescription drugs more affordable, including: generic user fees, pedigree, biosimilars, REMs. General issues dealing with prescription drug abuse, including Medicare lock-in programs. General issues dealing with regulating pharmacy drug compounding. HR 1600; S 1190/ HR793.

Client expense: $690,000 · 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), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office

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;

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.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

Client expense: $280,000 · Firm income: Not reported

Government targets: 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;

Client expense: $390,000 · 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

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 Provisions related to the 21st Century Cures Initiative (Energy and Commerce) and Innovations for Healthier Americans (HELP Committee). Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, biosimilars. 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 S.2700: The FDA and NIH Workforce Authorization Modernization Act - Provisions related to biologic drugs H.R.2841: The FAST Generics Act S.3056: The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 H.R. 4784/S.2651: The Increasing Competition in Pharmaceuticals Act H.R. 5573/S.3094 The Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act

Client expense: $632,600 · 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.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 HR953/S524: 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

Client expense: $632,600 · 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

Issues related to CARA Act; Issues Related to Pharmacy Regulation, Issues Related to HR 592, Issues related to HR 793/ S. 1190; issue related to 21st Century Cures; issues related to HR 244.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to CARA Act; Issues Related to Pharmacy Regulation, Issues Related to HR 592, Issues related to HR 793/ S. 1190; issue related to 21st Century Cures; issues related to HR 244.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory design and coverage of pharmacy benefits in health reform Exchanges and the commercial market, including: EHB, grandfathering, Rx quality, eRx, PBM disclosure, MLR, specialty pharmacy tiering restrictions. Regulatory implementation of a pathway for the approval of biosimilars. REMs. 340b program reform. policies placing restrictions on pharmacy benefit design. Issues regarding making prescription drugs more affordable, including: generic user fees, pedigree, biosimilars, REMs. General issues dealing with prescription drug abuse, including Medicare lock-in programs. General issues dealing with regulating pharmacy drug compounding. HR 1600; S 1190/ HR793.

Client expense: $693,000 · 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), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office

Reducing the costs of pharmaceuticals, medical devices, and supplies for consumers and health care providers, including implementation of the Drug Quality and Security Act (P.L.113-54) and P.L.112-144; support medical device pricing transparency and prohibition on medical device price "gag clauses"; preserving access to group purchasing organizations (GPOs) and protecting the GPO safe harbor; educating policymakers on hospital drug shortages and significant drug price increases and support draft reform legislation; pharmaceutical labeling of generic drugs (FDA-2013-N-0500); legislation to create a comprehensive Medicare home infusion benefit (H.R.605/S.275) - support; support reforming the durable medical equipment competitive bidding program; supporting "any willing pharmacy" legislation; promoting access to biosimilars (labeling/interchangeability); 21st Century Cures Act (H.R.6) - general support for overall bill, support final pharmacy lock-in policy, oppose PPSA weakening of existing requirements, oppose Section 4004 treatment of infusion drugs furnished through durable medical equipment; Ensuring Seniors Access to Local Pharmacies Act (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 Empowerment Act (S.776) - support; Strengthening Medicare Advantage Through Innovation and Transparency for Seniors - oppose; FDA-2014-D-1524-0002 - comments, Administration and Capitol Hill meetings on draft guidance on repackaging of certain human drug products by pharmacies and outsourcing facilities; FDA-2014-N-1459 - comments and Capitol Hill meetings on draft MOU addressing certain distributions of compounded human drug products between states and the FDA; proposed changes to the 340B prescription drug program - oppose; 21st Century Cures Act (H.R.6) - support; proposed amendments to 340b program (not ultimately included in H.R.6) - oppose; provide comments on proposed 340b omnibus guidance (RIN 0906 AB08); Stopping Medication Abuse and Protecting Seniors Act of 2015 (S.1913)- support (with some concerns about pharmacy lock-in policy); submitted comments on Management Standards for Hazardous Waste Pharmaceuticals (EPA-HQ-RCRA-2007-0932); meeting with DEA on Controlled Substances Act (21 USC 802); proposed changes to regulation of Laboratory Developed Tests (FDA-2011-D-0360-Draft Guidance for Industry, Food and Drug Administration Staff and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests) - oppose; Comprehensive Addiction and Recovery Act of 2016 ((S.524),monitoring for pharmacy lock-in policy, which includes exemption for LTC)- support; Increasing Competition in Pharmaceuticals Act (S.2615)- support.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

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).

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

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.

Client expense: $180,000 · Firm income: Not reported

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

HR 793 & S. 1190 - Ensuring Seniors Access to Local Pharmacies Act; H.R. 244 -The MAC Transparency Act; HR 4981 -The Opioid Use Disorder Treatment Expansion and Modernization Act; HR 4599 - Reducing Unused Medications Act of 2016; S. 2256 - Co-Prescribing Saves Lives; HR 3680 - Co-Prescribing to Reduce Overdoses Act of 2016; S. 524 Comprehensive Addiction and Recovery Act (CARA)

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.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 592/S. 314, Pharmacy and Underserved Areas Enhancement Act, all provisions. H.R. 4909, FY 2017 National Defense Authorization Act, provisions related to TRICARE and pharmacy access. H.R. 953/S. 524, Comprehensive Addition and Recovery Act, provisions related to state prescription drug monitoring programs. H.R. 793/S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015, all provisions. H.R. 3250, DXM Abuse Prevention Act, provisions related to retail pharmacy.

Client expense: $150,000 · 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

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

H.R. 592/S. 314 -- Pharmacy and Underserved Areas Enhancement Act, all provisions. Draft Proposal: Preserve Access to Community Pharmacies in TRICARE, all provisions. H.R. 953 -- Comprehensive Addiction and Recovery Act, provisions related to state prescription drug monitoring programs. H.R. 793/S. 1190 -- Ensuring Seniors Access to Local Pharmacies Act of 2015, all provisions.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to CARA Act; Issues Related to Pharmacy Regulation, Issues Related to HR 592, Issues related to HR 793/ S. 1190; issue related to 21st Century Cures; issues related to HR 244.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to CARA Act; Issues Related to Pharmacy Regulation, Issues Related to HR 592, Issues related to HR 793/ S. 1190; issue related to 21st Century Cures; issues related to HR 244

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE