Stopping Medication Abuse and Protecting Seniors Act of 2015

Medicare Advantage Policy and Reimbursement Part D Policy and Reimbursement Medicaid and Dual Eligible Issues Pharmacy Reimbursement Issues Medicare Access and CHIP Reauthorization Act (MACRA) Implementation Chronic Care Working Group Issues H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act H.R. 2507, Increasing Regulatory Fairness Act H.R. 2582, Seniors' Health Care Plan Protection Act H.R. 3831, Securing Fairness in Regulatory Timing Act H.R. 4275, Medicare Advantage Quality Payment Relief Act S. 1913, Stopping Medication Abuse and Protecting Seniors Act S. 524/H.R. 953, Comprehensive Addiction and Recovery Act Opioid and Drug Abuse Issues H.R. 5659, ESRD Choice Act

Client expense: $670,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R. 34, 21st Century Cures Act (Upton) - Medicare Advantage and Medicaid issues H.R. 546, ACE Kids Act (Barton) - Medicaid Childrens Care Coordination Program H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model H.R. 3718, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 3716, Ensuring Access to Quality Medicaid Providers Act (Bucshon) - oversight of terminated Medicaid providers H.R. 4275, Medicare Advantage Quality Payment Relief Act (Kelly) - calculation of MA benchmark cap H.R. 4442, CONNECT for Health Act (Black-Welch) - telehealth, remote patient monitoring services H.R. 4589, Excellence in Medicare Act (MacArthur) - MA payment cap H.R. 5273, Helping Hospitals Improve Patient Care Act (Tiberi) - MA issues, site-neutral payments H.R. 5506, Dialysis PATIENT Demonstration Act (Young) - demonstration program for Medicare beneficiaries with ESRD H.R. 5659, ESRD Choice Act (Smith) - option for ESRD patients to enroll in MA plans H.R. 5942, Dialysis PATIENTS Demonstration Act (Young) - demonstration program for Medicare beneficiaries with ESRD H.R. 6265, Medigap Reforms (McDermott) S. 298, ACE Kids Act (Grassley) - Medicaid Childrens Care Coordination Program S. 524, Comprehensive Addiction and Recovery Act (Whitehouse) - Medicare Part D lock-in programs S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1347, Electronic Health Fairness Act - preventing certain MA plan terminations, annual reporting of MA enrollment data S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S. 1913, Stopping Medication Abuse and Protecting Seniors Act (Toomey) - Medicare Part D lock-in programs S. 2104, Preserving Medicare Advantage for all Medicare Beneficiaries Act (Portman-Casey) - preventing certain MA plan terminations, MA demonstration program S. 2349, Medicare Advantage Coverage Transparency Act (Heller) - MA enrollment data S. 2484, CONNECT for Health Act (Schatz-Wicker) - telehealth, remote patient monitoring services S. 2864, RxCAP Act (Wyden) - Medicare Part D cost-sharing S. 3090, Dialysis PATIENT Demonstration Act (Heller) - demonstration program for Medicare beneficiaries with ESRD S. 3504, Chronic Care Act (Hatch-Wyden-Isakson-Warner) - chronic care reforms, Medicare Advantage provisions Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS' proposed substantial revisions to the managed care regulations, new mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation. *Add MACPAC to Agency List.

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

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

Pharmacy Act; Drug Pricing; Generic Brand Settlement; Generic Dispensing; Generic Biologics; Specialty Drug Issues; S. 1413, RX Abuse and Prevention; and S.1913, Pharmacy Lock-In

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4499, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, provisions relating to payment and delivery reform S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, provisions relating to payment and delivery reform S. 3130, Independence at Home Act of 2016, all provisions H.R. 3220, Medicare Common Access Card Act of 2015, all provisions S. 3504, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2016, all provisions H.R.6333, To amend title XVIII of the Social Security Act with respect to the accreditation of osteopathic residency training programs for purposes of graduate medical education payments under the Medicare program, all provisions H.R. 976, Patient Access to Higher Quality Health Care Act of 2015, all provisions H.R. 2, Medicare Access and CHIP Reauthorization Act of 2015, provisions relating to payment and delivery reform H.R. 1470, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions relating to payment and delivery reform S. 810, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions relating to payment and delivery reform H.R. 1190, Protecting Seniors' Access to Medicare Act of 2015, all provisions S.141, Protecting Seniors' Access to Medicare Act of 2015, all provisions H.R. 4442, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, provisions relating to telehealth S. 2484, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, provisions relating to telehealth S. 1131, Medicare Diabetes Prevention Act of 2015, all provisions H.R. 2646, Helping Families in Mental Health Crisis Act of 2016, all provisions S. 1945, Mental Health Reform Act of 2015, all provisions S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 2015, all provisions Medicare program: MACRA Implementation Medicare program: PAMA implementation Medicare program: ACO Improvement Act Medicare program: The Center for Medicare and Medicaid Innovation (CMMI) Medicare program: Repeal of the Independent Payment Advisory Board (IPAB) Medicare program: Medicare Part B Drug Demonstration Medicare program: Regulatory Relief Medicare program: CY 2017 Medicare Physician Fee Schedule Medicare program: In-Office Ancillary Services Exception (IOASE) Medicare program: Merit-Based Incentive Payment System (MIPS) Medicare program: Value-Based Payment Modifier (VPM) Medicare program: Physician Compare Medicare program: Alternate Payment Models Medicare program: Physician Quality Reporting System (PQRS) Medicare program: Graduate Medical Education (GME) Medicare program: Electronic Health Records/Meaningful Use (EHR/MU) Medicare program: Quality Reporting Medicare program: ICD-10 Medicare program: Prescription Drug Diversion Medicare program: Physician data Medicare program: Telemedicine Medicare program: Patient Relationship Codes Medicare program: Social Security Number Removal Initiative Medicaid program: Amendment to New York's section 1115 demonstration waiver

Client expense: $3,990,000 · Firm income: Not reported

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

Medical liability reform (H.R. 836/S. 884, H.R. 4771) Mental health & opioid abuse policy (H.R. 2646, H.R. 4435, S. 1893, S. 1913, S. 524, S. 2680, S. 480, S. 2687, H.R. 4843, H.R. 4499/S. 2758, H.R. 3680, H.R. 3691, H.R. 4599, H.R. 4651, H.R. 4976, H.R. 4978, H.R. 4982, H.R. 4969, H.R. 34 - 21st Century Cures Act) 340B discount drug program Chronic care policy Nurse education policy (H.R. 977/H.R. 1784/S. 629, H.R. 2713) Trauma (H.R. 4365) Cybersecurity policy

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmacy Lock-in (s.1913, S.524), Pharmacy provider status (H.R. 592/S.314),

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

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

Medicare Advantage Policy and Reimbursement. Part D Policy and Reimbursement. Medicaid and Dual Eligible issues. Pharmacy Reimbursement Issues. MACRA Implementation. H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors. H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act. H.R. 2507, Increasing Regulatory Fairness Act. H.R. 2582, Seniors' Health Care Plan Protection Act. H.R. 3831, Securing Fairness and Regulatory Timing. H.R. 4275, Medicare Advantage Quality Payment Relief Act. S. 1913, Stopping Medication Abuse and Protecting Seniors ACt. S. 524 and H.R. 953, Comprehensive Addiction and Recovery Act. Opioid and Drug Abuse Issues. H.R. 5659, ESRD Choice Act. H.R. 6, 21st Century Cures Act.

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

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

H.R. 6 - 21st Century Cures Act; Senate HELP Innovation Initiative: How to Get Medical Devices, Drugs, Treatments From Discovery to the Medicine Cabinet S. 1913 - Stopping Medication Abuse and Protecting Seniors Act of 2015

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

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 512: The DISARM Act of 2015 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model Medicaid and Childrens Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Final rule [CMS-2390-F] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Other: - Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation - Medicare Part B Average Sales Price (ASP) policy issues - Medicare Part D rebates policy issues - Drug cost and pricing policy issues - Transparency policy issues - Medication adherence policy issues - Alternative payment models policy issues - Value-based arrangements policy issues - Coding and reimbursement policy issues including for biologics - Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues - MedPAC June Report - Part B and D policy issues - Medicaid rebates/reformulations policy issues - Non-interference policy issues - Prescription drug abuse policy issues

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.

Medicare Advantage Policy and Reimbursement Part D Policy and Reimbursement Medicaid and Dual Eligible Issues Pharmacy Reimbursement Issues Medicare Access and CHIP Reauthorization Act (MACRA) Implementation Chronic Care Working Group Issues H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act H.R. 2507, Increasing Regulatory Fairness Act H.R. 2582, Seniors' Health Care Plan Protection Act H.R. 3831, Securing Fairness in Regulatory Timing Act H.R. 4275, Medicare Advantage Quality Payment Relief Act S. 1913, Stopping Medication Abuse and Protecting Seniors Act S. 524/H.R. 953, Comprehensive Addiction and Recovery Act Opioid and Drug Abuse Issues H.R. 5659, ESRD Choice Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R. 546, ACE Kids Act (Barton) - Medicaid Childrens Care Coordination Program H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model H.R. 3718, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 3716, Ensuring Access to Quality Medicaid Providers Act (Bucshon) - oversight of terminated Medicaid providers H.R. 4275, Medicare Advantage Quality Payment Relief Act (Kelly) - calculation of MA benchmark cap H.R. 4442, CONNECT for Health Act (Black-Welch) - telehealth, remote patient monitoring services H.R. 4589, Excellence in Medicare Act (MacArthur) - MA payment cap H.R. 5273, Helping Hospitals Improve Patient Care Act (Tiberi) - MA issues, site-neutral payments H.R. 5506, Dialysis PATIENT Demonstration Act (Young) - demonstration program for Medicare beneficiaries with ESRD H.R. 5659, ESRD Choice Act (Smith) - option for ESRD patients to enroll in MA plans H.R. 5942, Dialysis PATIENTS Demonstration Act (Young) - demonstration program for Medicare beneficiaries with ESRD H.R. 6265, Medigap Reforms (McDermott) S. 298, ACE Kids Act (Grassley) - Medicaid Childrens Care Coordination Program S. 524, Comprehensive Addiction and Recovery Act (Whitehouse) - Medicare Part D lock-in programs S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1347, Electronic Health Fairness Act - preventing certain MA plan terminations, annual reporting of MA enrollment data S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S. 1913, Stopping Medication Abuse and Protecting Seniors Act (Toomey) - Medicare Part D lock-in programs S. 2104, Preserving Medicare Advantage for all Medicare Beneficiaries Act (Portman-Casey) - preventing certain MA plan terminations, MA demonstration program S. 2349, Medicare Advantage Coverage Transparency Act (Heller) - MA enrollment data S. 2484, CONNECT for Health Act (Schatz-Wicker) - telehealth, remote patient monitoring services S. 2864, RxCAP Act (Wyden) - Medicare Part D cost-sharing S. 3090, Dialysis PATIENT Demonstration Act (Heller) - demonstration program for Medicare beneficiaries with ESRD Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS' proposed substantial revisions to the managed care regulations, new mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; issues relating to enrollment of beneficiaries with ESRD into MA plans; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation.

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

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

Medical liability reform (H.R. 836/S. 884, H.R. 4771) Mental health & opioid abuse policy (H.R. 2646, H.R. 4435, S. 1893, S. 1913, S. 524, S. 2680, S. 480, S. 2687, H.R. 4843, H.R. 4499/S. 2758, H.R. 3680, H.R. 3691, H.R. 4599, H.R. 4651, H.R. 4976, H.R. 4978, H.R. 4982, H.R. 4969) 340B discount drug program Chronic care policy Nurse education policy (H.R. 977/H.R. 1784/S. 629, H.R. 2713) Trauma (H.R. 4365) Cybersecurity policy

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model H.R. 5273: Helping Hospitals Improve Patient Care Act of 2016 - Provisions related to exemption of hospitals that had off-site facilities under development Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Final rule [CMS-2390-F] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference policy issues

Client expense: $4,550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Pharmacy Lock-in (s.1913, S.524), Pharmacy provider status (H.R. 592/S.314),

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

Government targets: Centers For Medicare and Medicaid Services (CMS), 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

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

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model Medicaid and Childrens Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Final rule [CMS-2390-F] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Prescription drug abuse policy issues Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference policy issues

Client expense: $4,130,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S. 3130, Independence at Home Act of 2016, all provisions S. 3220, Medicare Common Access Card Act of 2015, all provisions H.R. 3355, To amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs, all provisions S. 488, A bill to amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs, all provisions S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 2015, all provisions H.R. 4442, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 2484, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 2141, Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) Act of 2015, all provisions S. 1131, Medicare Diabetes Prevention Act of 2015, all provisions H.R. 976, Patient Access to Higher Quality Health Care Act of 2015, all provisions H.R. 2568, Fair Medical Audits Act of 2015, all provisions H.R. 4499, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions Medicare program: ACO Improvement Act of 2016 Medicare program: Medicare Access and CHIP Reauthorization Act (MACRA) implementation Medicare program: Merit-Based Incentive Payment System (MIPS) Medicare program: Part B Drug Demonstration Medicare program: Outpatient Prospective Payment - site of service, pain measures Medicare program: Advancing Care Information (ACI) Medicare program: Clinical Practice Improvement Activities (CPIA) Medicare program: Resource use Medicare program: Physician Fee Schedule Medicare program: Independent Payment Advisory Board (IPAB) Medicare program: Center for Medicare and Medicaid Innovation (CMMI) Medicare program: Global surgical codes Medicare program: Mobility payment add-on Medicare program: Episode groups Medicare program: Patient relationship codes Medicare program: Composite scoring and performance adjustments Medicare program: Feedback reports Medicare program: Alternative payment models (APMs) Medicare program: Relative Value Scale Update Committee (RUC) Medicare program: Health Insurance Portability and Accountability Act (HIPAA) Medicare program: Electronic health record (EHR) interoperability Medicare program: EHR/Meaningful Use Medicare program: EHR Certification Medicare program: ICD-10 Medicare program: Medicare appeals Medicare program: Medicare Pre-Diabetes Program Medicare program: Unique Device Identifier Medicare program: CPT Medicare program: Social Security Number Removal Initiative Medicare program: Telehealth Medicare program: In-office Ancillary Services Exception Medicare program: Value-based Payment Modifier Medicare program: Graduate Medical Education Medicare program: Physician Quality Reporting System (PQRS) Medicare program: Prescription drug diversion Medicare program: Physician data Medicare program: Physician-owned hospital moratorium Medicare program: Smart Card technology Medicare program: PECOS/Medicare Enrollment Medicare program: Diabetes Prevention Program fees

Client expense: $3,870,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Veterans Affairs, Dept of (VA), White House Office

Medicare Advantage Policy and Reimbursement. Part D Policy and Reimbursement. Medicaid and Dual Eligible issues. Pharmacy Reimbursement Issues. MACRA Implementation. H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors. H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act. H.R. 2507, Increasing Regulatory Fairness Act. H.R. 2582, Seniors' Health Care Plan Protection Act. H.R. 3831, Securing Fairness and Regulatory Timing. H.R. 4275, Medicare Advantage Quality Payment Relief Act. S. 1913, Stopping Medication Abuse and Protecting Seniors ACt. S. 524 and H.R. 953, Comprehensive Addiction and Recovery Act. Opioid and Drug Abuse Issues. H.R. 5659, ESRD Choice Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmacy Act; Drug Pricing; Generic Brand Settlement; Generic Dispensing; Generic Biologics; Specialty Drug Issues; S. 1413, RX Abuse and Prevention; and S.1913, Pharmacy Lock-In

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

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

H.R. 6 - 21st Century Cures Act; Senate HELP Innovation Initiative: How to Get Medical Devices, Drugs, Treatments From Discovery to the Medicine Cabinet S. 1913 - Stopping Medication Abuse and Protecting Seniors Act of 2015

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

21st century cures (HR 6), Medicare Part D pharmacy drug management programs for at-risk beneficiaries (S. 1913),Biosimilar naming, Medicare Part D, AMCP draft legislation - "Medicare Prescription Drug Anti-Fraud Act", Medicare Part B reimbursement of biosimilars, Medicare Part B Drug Demonstration Projects, Senate Innovations Initiative and Medication Therapy Management (MTM)

Client expense: $168,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

H.R.471-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3865-Cradle Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 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. H.R.4697-Prevevent Drug Addiction Act of 2016 S.36-Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.483-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.954-FDA Accountability for Public Safety Act S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1327-Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1654-Overdose Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2687-Plan of Safe Care Improvement Act

Client expense: $512,329 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6-21st Century Cures Act H.R.33-Protecting Volunteer Firefighters and Emergency Responders Act H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.293-To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. H.R.398-Trafficking Awareness Training for Health Care Act H.R.639-Improving Regulatory Transparency for New Medical Therapies Act H.R.647-Access to Life-Saving Trauma Care for All Americans Act H.R.648-Trauma Systems and Regionalization of Emergency Care Reauthorization Act H.R.836-Health Care Safety Net Enhancement Act H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1818-Veteran Emergency Medical Technician Support Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.1854-Comprehensive Justice and Mental Health Act of 2015 H.R.1877-Mental Health First Aid Act of 2015 H.R.2050-Middle Class Health Benefits Tax Repeal Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2366-Field EMS Modernization and Innovation Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2603-Saving Lives, Saving Costs Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3299-Strengthening Public Health Emergency Response Act H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3681-Improving Access to Emergency Psychiatric Care Act H.R.3682-Reducing Employer Burdens, Unleashing Innovation, and Labor Development Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.3865-Cradle Act H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4150-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act H.R.4365-Protecting Patient Access to Emergency Medications Act of 2016 H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 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. H.R.4697-Prevevent Drug Addiction Act of 2016 H.R.4771-Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R.4732-Advancing Medical Resident Training in Community Hospitals Act of 2016 H.R.5243-Zika Response Appropriations Act H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 S.141-Protecting Seniors Access to Medicare Act of 2015 S.425-Homeless Veterans' Reintegration Programs Reauthorization Act of 2015 S.453-Veteran Emergency Medical Technician Support Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.711-Mental Health First Act of 2015 S.763-Trauma Systems and Regionalization of Emergency Care Reauthorization Act S.884-Health Care Safety Net Enhancement Act S.843-Improving Access to Medicare Coverage Act of 2015 S.954-FDA Accountability for Public Safety Act S.993-Comprehensive Justice and Mental Health Act of 2015 S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1446-SOAR to Health and Wellness Act of 2015 S.1450-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act S.1452-Veterans Emergency Health Safety Net Expansion Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1475-Saving Lives, Saving Costs Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1654-Overdose Prevention Act S.1693-To amend title 38, United States Code, to expand eligibility for reimbursement for emergency medical treatment to certain veterans that were unable to receive care from the Department of Veterans Affairs in the 24-month period preceding the furnishing of such emergency treatment, and for other purposes. S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1893-Mental Health Awareness and Improvement Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.1945-Mental Health Reform Act of 2015 S.2002-Mental Health and Safe Communities Act of 2015 S.2045-Middle Class Health Benefits Tax Repeal Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2597-Medicare Mental Health Access Act S.2671-Advancing Medical Resident Training in Community Hospitals Act of 2016 S.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act S.2932-Protecting Patient Access to Emergency Medications Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016 P.L.114-10-Medicare Access and CHIP Reauthorization Act of 2015

Client expense: $512,329 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015

Client expense: $512,329 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3288-Strengthening DSH and Medicare Through Subsidy Recapture and Payment Reform Act of 2015 H.R.3291-Medicare Crosswalk Hospital Code Development Act of 2015 H.R.3292-Medicare IME Pool Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 S.141-Protecting Seniors Access to Medicare Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.843-Improving Access to Medicare Coverage Act of 2015 S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2680-Mental Health Reform Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016 P.L.114-10-Medicare Access and CHIP Reauthorization Act of 2015

Client expense: $512,329 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug abuse, preferred pharmacy networks, pharmacist provider status, drug pricing and Tricare. Issues related to biosimilars, FDA repackaging and drug disposal. HR 1600 :A bill to amend title XXVII of the Public Health Service Act to limit co-payment, coinsurance, or other cost-sharing requirements applicable to prescription drugs in a specialty drug tier to the dollar amount (or its equivalent) of such requirements applicable to prescription drugs in a non-preferred brand drug tier, and for other purposes. HR 592 - Pharmacy and Medically Underserved Areas Enhancement Act S 314 - Pharmacy and Medically Underserved Areas Enhancement Act HR 244 - MAC Transparency Act S 776 - Medication Therapy Management Empowerment Act of 2015 HR 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 HR 6-Stopping Medication Abuse and Protecting Seniors Act of 2015 S 1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 HR 1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S 480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S. 524-Comprehensive Addiction and Recovery Act HR 4909-National Defense Authorization Act S 2943--National Defense Authorization Act

Client expense: $1,158,247 · Firm income: Not reported

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

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model H.R. 5273: Helping Hospitals Improve Patient Care Act of 2016 - Provisions related to exemption of hospitals that had off-site facilities under development Other: - Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] - Provisions related to Medicaid - Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) - Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) - Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation - Medicare Part B Average Sales Price (ASP) policy issues - Medicare Part D rebates policy issues - Drug cost and pricing policy issues - Transparency policy issues - Medication adherence policy issues - Alternative payment models policy issues - Value-based arrangements policy issues - Coding and reimbursement policy issues including for biologics - Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues - MedPAC June Report - Part B and D policy issues - Medicaid rebates/reformulations policy issues - Non-interference policy issues

Client expense: $1,070,000 · Firm income: Not reported

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

H.R. 546, ACE Kids Act (Barton) - Medicaid Childrens Care Coordination Program H.R. 588, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA enrollment opportunities H.R. 818, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 1021, Protecting the Integrity of Medicare Act (Brady) - reducing fraud H.R. 2488, Medicare Beneficiary Preservation of Choice Act (Rothfus-Schrader) - MA open enrollment period H.R. 2505, Increasing Access to Data in Medicare Advantage Act (Kelly) - annual reporting of MA enrollment data H.R. 2506, Preventing Unnecessary Plan Terminations Act (Buchanan) - preventing certain MA plan terminations H.R. 2507, Increasing Regulatory Fairness Act (Brady) - schedule for MA rates H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors Act (Black) - Value-Based Insurance Design demonstration H.R. 2579, Securing Care for Seniors Act (Black) - MA risk adjustment model H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act (Brady) - Value-Based Insurance Design demonstration and MA open enrollment period H.R. 2582, Seniors Health Care Plan Protection Act (Buchanan) - preventing certain MA plan terminations, MA risk adjustment model H.R. 3718, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Roskam-Carney) - reducing fraud H.R. 3716, Ensuring Access to Quality Medicaid Providers Act (Bucshon) - oversight of terminated Medicaid providers H.R. 4275, Medicare Advantage Quality Payment Relief Act (Kelly) - calculation of MA benchmark cap H.R. 4442, CONNECT for Health Act (Black-Welch) - telehealth, remote patient monitoring services H.R. 4589, Excellence in Medicare Act (MacArthur) - MA payment cap H.R. 5273, Helping Hospitals Improve Patient Care Act (Tiberi) - MA issues, site-neutral payments H.R. 5506, Dialysis PATIENT Demonstration Act (Young) - demonstration program for Medicare beneficiaries with ESRD Draft Bill on Option for ESRD Patients to Enroll in MA Plans (Ways and Means Committee) H.Con.Res. 125, Budget Resolution (Price) - Medicare, Medicaid issues S. 298, ACE Kids Act (Grassley) - Medicaid Childrens Care Coordination Program S. 524, Comprehensive Addiction and Recovery Act (Whitehouse) - Medicare Part D lock-in programs S. 861, Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (Carper-Enzi) - reducing fraud S. 1347, Electronic Health Fairness Act - preventing certain MA plan terminations, annual reporting of MA enrollment data S. 1396, Value-Based Insurance Design Seniors Copayment Reduction Act (Thune-Stabenow) - VBID demonstration S. 1549, Care Planning Act (Warner) - advanced illness care coordination for Medicare beneficiaries S. 1913, Stopping Medication Abuse and Protecting Seniors Act (Toomey) - Medicare Part D lock-in programs S. 2104, Preserving Medicare Advantage for all Medicare Beneficiaries Act (Portman-Casey) - preventing certain MA plan terminations, MA demonstration program S. 2349, Medicare Advantage Coverage Transparency Act (Heller) - MA enrollment data S. 2484, CONNECT for Health Act (Schatz-Wicker) - telehealth, remote patient monitoring services S. 2864, RxCAP Act (Wyden) - Medicare Part D cost-sharing S. 3090, Dialysis PATIENT Demonstration Act (Heller) - demonstration program for Medicare beneficiaries with ESRD Regulatory Issues: Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology, network adequacy and provider directories, encounter data and other data-related issues, and audit issues; bidding and payment issues (including MA rate assumptions, MA coding intensity, MA Secondary Payer issues, Part D reinsurance, Part D low income subsidies, Part D direct and indirect remuneration (DIR), and audits); in-home health risk assessments; Medicare Medical Loss Ratio issues; implementation of sequestration under the Medicare Advantage and Part D programs; implications of the health insurer fee for MA and Part D plans; application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, enrollment rules, requirements for notice and denial forms, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff; measurement and oversight of plan performance including Special Needs Plans (SNPs); quality measures, grievance and appeals processes, fraud and abuse compliance including training; contracting issues for Dual Eligible SNPs; Federal preemption of State authority under MA and Part D programs, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, Part D coverage gap discount program, including employer group waiver plan (EGWP) issues, and other operational issues; issues raised by Part D coverage of new specialty drugs, the Part D non-interference policy and related issues (e.g., preferred pharmacy and any willing pharmacy requirements, standards for network pharmacy reimbursement, and policies regarding sponsor negotiation of pharmacy price concessions); CMS's proposed Part B drug demonstration program; Medication Therapy Management Program requirements and the Center for Medicare and Medicaid Innovation (CMMI) Demonstration; MA EGWP issues; CMMI's value-based insurance design (VBID) demonstration; Part D requirements for offering basic and enhanced alternative plans; MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; issues relating to MA and Part D Star Rating system including measures, the methodology for calculating ratings, and the role of the ratings for payment purposes; implementation of the Affordable Care Act (ACA) changes to the Part D coverage gap; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education Program; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting initiative; issues relating to Medicare coverage policy and national coverage decisions; new payment system for physicians under MACRA, including implications for MA and Part D plans; Medicare clinical trials; Medicare/Medicaid integration for dual eligibles, including implementation of the Capitated Financial Alignment Demonstration and related issues (e.g., quality ratings); Medicaid managed care regulations and policies, including CMS' proposed substantial revisions to the managed care regulations, new mental health parity rules, the Medicaid managed care actuarial soundness standard, quality oversight, Medicaid and CHIP Payment and Access Commission (MACPAC), grievance and appeals processes, fraud and abuse compliance, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including block grants, the calculation of the federal medical assistance (federal matching) percentage (FMAP), and intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost issues affecting Medicaid health plans including issues raised by Medicaid coverage of new specialty drugs; health plan-related Childrens Health Insurance Program (CHIP) issues, including eligibility and outreach issues and CHIP reauthorization; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including Medicaid managed care organization provider tax issues; standards for electronic prescribing; implementation of Medicaid changes of interest to Medicaid health plans made in the ACA including Medicaid expansion, the managed care organization (MCO) prescription drug rebate provisions, minimum payments to primary care providers (PCPs), interactions between the Medicaid program and health insurance exchanges, and Medicaid and CHIP maintenance of effort (MOE) requirements; implications of the health insurer fee for Medicaid health plans; issues related to Medicaid Managed long-term care including home and community-based waiver services (HCBS); expanding the availability of Medicare Advantage and Medicaid health plan telemedicine programs; implications of the new non-discrimination rules for health plans participating in public programs; issues related to Medigap coverage; issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); cybersecurity; provider directories; value-based insurance design models; Part D prescriber enrollment requirements; Part D recovery audit contractor programs; socioeconomic status impacts on star ratings related to MA and Part D programs; and other issues relating to health care reform implementation. *Add MACPAC to Agency List.

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

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

H.R. 6 - 21st Century Cures Act; Senate HELP Innovation Initiative: How to Get Medical Devices, Drugs, Treatments From Discovery to the Medicine Cabinet S. 1913 - Stopping Medication Abuse and Protecting Seniors Act of 2015

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

H.R.471-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3865-Cradle Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 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. H.R.4697-Prevevent Drug Addiction Act of 2016 S.36-Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.483-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.954-FDA Accountability for Public Safety Act S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1327-Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1654-Overdose Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2687-Plan of Safe Care Improvement Act

Client expense: $217,135 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015

Client expense: $217,135 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3288-Strengthening DSH and Medicare Through Subsidy Recapture and Payment Reform Act of 2015 H.R.3291-Medicare Crosswalk Hospital Code Development Act of 2015 H.R.3292-Medicare IME Pool Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 S.141-Protecting Seniors Access to Medicare Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.843-Improving Access to Medicare Coverage Act of 2015 S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2680-Mental Health Reform Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016

Client expense: $217,135 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6-21st Century Cures Act H.R.33-Protecting Volunteer Firefighters and Emergency Responders Act H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.293-To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. H.R.398-Trafficking Awareness Training for Health Care Act H.R.639-Improving Regulatory Transparency for New Medical Therapies Act H.R.647-Access to Life-Saving Trauma Care for All Americans Act H.R.648-Trauma Systems and Regionalization of Emergency Care Reauthorization Act H.R.836-Health Care Safety Net Enhancement Act H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1818-Veteran Emergency Medical Technician Support Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.1854-Comprehensive Justice and Mental Health Act of 2015 H.R.1877-Mental Health First Aid Act of 2015 H.R.2050-Middle Class Health Benefits Tax Repeal Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2366-Field EMS Modernization and Innovation Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2603-Saving Lives, Saving Costs Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3299-Strengthening Public Health Emergency Response Act H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3681-Improving Access to Emergency Psychiatric Care Act H.R.3682-Reducing Employer Burdens, Unleashing Innovation, and Labor Development Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.3865-Cradle Act H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4150-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act H.R.4365-Protecting Patient Access to Emergency Medications Act of 2016 H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 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. H.R.4697-Prevevent Drug Addiction Act of 2016 H.R.4771-Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R.4732-Advancing Medical Resident Training in Community Hospitals Act of 2016 H.R.5243-Zika Response Appropriations Act H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 S.141-Protecting Seniors Access to Medicare Act of 2015 S.425-Homeless Veterans' Reintegration Programs Reauthorization Act of 2015 S.453-Veteran Emergency Medical Technician Support Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.711-Mental Health First Act of 2015 S.763-Trauma Systems and Regionalization of Emergency Care Reauthorization Act S.884-Health Care Safety Net Enhancement Act S.843-Improving Access to Medicare Coverage Act of 2015 S.954-FDA Accountability for Public Safety Act S.993-Comprehensive Justice and Mental Health Act of 2015 S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1446-SOAR to Health and Wellness Act of 2015 S.1450-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act S.1452-Veterans Emergency Health Safety Net Expansion Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1475-Saving Lives, Saving Costs Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1654-Overdose Prevention Act S.1693-To amend title 38, United States Code, to expand eligibility for reimbursement for emergency medical treatment to certain veterans that were unable to receive care from the Department of Veterans Affairs in the 24-month period preceding the furnishing of such emergency treatment, and for other purposes. S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1893-Mental Health Awareness and Improvement Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.1945-Mental Health Reform Act of 2015 S.2002-Mental Health and Safe Communities Act of 2015 S.2045-Middle Class Health Benefits Tax Repeal Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2597-Medicare Mental Health Access Act S.2671-Advancing Medical Resident Training in Community Hospitals Act of 2016 S.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act S.2932-Protecting Patient Access to Emergency Medications Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016

Client expense: $217,135 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmacy Act; Drug Pricing; Generic Brand Settlement; Generic Dispensing; Generic Biologics; Specialty Drug Issues; S. 1413, RX Abuse and Prevention; and S.1913, Pharmacy Lock-In

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Program; Part B Drug Payment Model, Proposed rule, CMS-1670-P (March 11, 2016) - Provisions related to the Medicare Part B Drug Payment Model Medicaid Program: Covered Outpatient Drugs (CMS-2345-FC) - Provisions related to line extension drug definition, effective date and other issues S. 31: Medicare Prescription Drug Price Negotiation Act of 2015 - Provisions related to Secretary negotiation authority in Part D program S. 141: Protecting Seniors' Access to Medicare Act of 2015 - Provisions related to Independent Payment Advisory Board (IPAB) repeal S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 648: Medicare Formulary Improvement Act of 2015 - Provisions related to codification of six protected classes in Part D program S. 1083: Medicare Drug Savings Act of 2015 - Provisions related to drug rebates in Medicare Part D S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 - Provisions related to programs to prevent prescription drug abuse under the Medicare program S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures S. 2646: Veterans Choice Improvement Act of 2016 - Provisions related to TRICARE drug pricing S. 2981: A bill to amend title XIX of the Social Security Act to add standards for drug compendia for physician use for purposes of Medicaid payment for certain drugs, and for other purposes H.R. 22: FAST Act - Medicare related offsets to the biopharmaceutical industry H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 - Provisions related to IPAB repeal H.R. 2005: Medicare Drug Savings Act of 2015 - Provisions related to changes to Part D rebates H.R. 2298: Medicare Patient Safety and Drug Abuse Prevention Act - Provisions related to the design of a Part D Lock-in program H.R. 3513: Prescription Drug Affordability Act of 2015 - Provisions related to Secretary negotiation authority in Part D program, Medicare and Medicaid rebates, resolution of government enforcement actions, and reporting of certain drug manufacturer expenditures H.R. 5122: To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models - Suspending the Part B Drug Payment Model H.R. 5273: Helping Hospitals Improve Patient Care Act of 2016 - Provisions related to exemption of hospitals that had off-site facilities under development Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Final rule [CMS-2390-F] - Provisions related to Medicaid Proposed Medicare hospital outpatient prospective payment system (OPPS) rule for 2016 (CMS-1633-P) Proposed Medicare physician fee schedule (MPFS) rule for 2016 (CMS-1631-P) Department of Health and Human Services (HHS) delivery system reform issues and regulatory barriers to innovation Medicare Part B Average Sales Price (ASP) policy issues Medicare Part D rebates policy issues Drug cost and pricing policy issues Transparency policy issues Medication adherence policy issues Alternative payment models policy issues Value-based arrangements policy issues Coding and reimbursement policy issues including for biologics Center for Medicare and Medicaid Innovation (CMMI) transparency policy issues MedPAC June Report - Part B and D policy issues Medicaid rebates/reformulations policy issues Non-interference policy issues

Client expense: $5,820,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 4499, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act of 2016, all provisions H.R. 976, Patient Access to Higher Quality Health Care Act of 2015, all provisions H.R. 5273, Helping Hospitals Improve Patient Care Act of 2016, all provisions H.R. 2977, Furthering Access to Stroke Telemedicine (FAST) Act, all provisions H.R. 21102, Medicare Diabetes Prevention Act of 2015, all provisions S. 1131, Medicare Diabetes Prevention Act of 2015, all provisions H.R. 1470, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions relating to delivery and payment reform S. 810, SGR Repeal and Medicare Provider Payment Modernization Act of 2015, provisions relating to delivery and payment reform H.R. 1190, Protecting Seniors' Access to Medicare Act of 2015, all provisions H.R. 4442, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 2484, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, all provisions S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 2015, all provisions H.R. 1608, Lymphedema Treatment Act, all provisions S. 2373, Lymphedema Treatment Act, all provisions S. 2943, National Defense Authorization Act for Fiscal Year 2017, provisions relating to Telemedicine and licensure Medicare program: Diabetes prevention Medicare program: IPAB Repeal Medicare program: Medicare Access and CHIP Reauthorization Act (MACRA) Implementation Medicare program: MACRA physician compliance flexibility Medicare program: Quality Payment Program (QPP) Medicare program: Protecting Access to Medicare Act (PAMA) implementation Medicare program: Merit-Based Incentive Payment System (MIPS) Medicare program: Value-Based Modifier (VBM) Medicare program: Advancing Care Information (ACI) score Medicare program: Clinical Practice Improvement Activities (CPIAs) Medicare program: Resource Use Medicare program: Alternative Payment Models (APMs) Medicare program: Physician Quality Reporting System (PQRS) Medicare program: Graduate Medical Education (GME) Medicare program: Prescription Drug Diversion/Opioid abuse Medicare program: Physician data Medicare program: Adding unique device identifier to billing form Medicare program: Physician-owned hospital moratorium Medicare program: Physician Office-based Labs (POLS) Medicare program: EHR/Meaningful Use Medicare program: Sunshine Act Medicare program: Part B Drug Demonstration/Reimbursement Medicare program: In-Office Ancillary Services Exception Medicare program: Provider networks adequacy and balance billing Medicare program: AHIP-CMS Core Measure activity Medicare program: Comprehensive joint replacement Medicare program: Chronic care Medicare program: Home health prior authorization Medicare program: Telehealth Medicare program: Clinical Trials - insurance coverage improvements Medicare program: Coverage policy Medicare program: Program Integrity/Provider Enrollment Medicare and Medicaid programs: EHR interoperability/digital health Medicaid program: State Medicaid cuts

Client expense: $4,310,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Indian Health Service, Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Veterans Affairs, Dept of (VA), 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

Medicare Advantage Policy and Reimbursement Part D Policy and Reimbursement Medicaid and Dual Eligible Issues Pharmacy Reimbursement Issues Medicare Access and CHIP Reauthorization Act (MACRA) Implementation Chronic Care Working Group Issues H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors H.R. 2581, Preservation of Access for Seniors in Medicare Advantage Act H.R. 2507, Increasing Regulatory Fairness Act H.R. 2582, Seniors' Health Care Plan Protection Act H.R. 3831, Securing Fairness in Regulatory Timing Act H.R. 4275, Medicare Advantage Quality Payment Relief Act S. 1913, Stopping Medication Abuse and Protecting Seniors Act S. 524/H.R. 953, Comprehensive Addiction and Recovery Act Opioid and Drug Abuse Issues

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office