Medicare Home Infusion Site of Care Act of 2015

Patient access to disposable infusion pumps. Medicare Home Infusion Site of Care Act (S.275/H.R.605)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to implementation of Section 1557 of ACA HR 793 - Ensuring Seniors Access to Local Pharmacies Act HR 2570-Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 HR 605-Medicare Home Infusion Site of Care Act S 275-Medicare Home Infusion Site of Care Act

Client expense: $2,080,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Issues regarding comprehensive coverage of home infusion therapy; the Medicare Home Infusion Site of Care Act of 2015 (S. 276, H.R. 605); Medicare reform issues regarding home care; infusion therapy demo project & similar demo projects; Medicare Part B competitive bidding;issues regarding drug compounding regulations

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement Medicare Part B drug payment model demonstration

Client expense: $350,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

Medicare coverage of home infusion drugs and biologics, including payment for durable medical equipment drugs and biologics. S. 275 and H.R. 605 - Medicare Home Infusion Site of Care Act of 2015. H.R. 6 - 21st Century Cures (P.L. 114-255): Sec. 5012 - Medicare Coverage of Home Infusion Therapy.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 605/S 275 - The Medicare Home Infusion Site of Care Act - Lobbied in support of passage of the legislation to ensure Medicare beneficiaries have access to home infusion. IVIG Coverage Demonstration - Worked with CMS to ensure the IVIG Demonstration is carried out in a manner that is beneficial to Medicare beneficiaries. Medicare Audits and ALJ Hearings - Continued efforts supporting reforms to the Medicare Audits system. Competitive bidding of DMEPOS - worked to ensure competitive bidding does not adversely affect the home infusion industry's ability to provide infusion services. HR 6 / HR 2581 / HR 2570 / S 2409 / HR 4273 / HR 34 - lobbied House and Senate against ASP infusion drug pricing without inclusion of a services payment for home infusion pharmacies under the Medicare DME Program. Lobbied for inclusion of services payment under the legislation. Medicare Program; Part B Drug Payment Model - lobbied House and Senate regarding the effects of the Medicare Program; Part B Drug Payment Model demonstration project released on Friday, March 11, 2016 (81 FR 13229). MLN Learning Matters SE- 1609 and DME MAC Billing Guidance-Billing for External Infusion Pumps and Drugs When Treatment Was Initiated Somewhere Other Than the Beneficiary Home - Lobbied for delay in MLN Learning Matters and a moratorium on the Billing Guidance.

Client expense: $125,000 · Firm income: Not reported

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

Medicare Part B Drug Payment Model Proposal S. 275 / H.R. 605 - Medicare Home Infusion Site of Care Act H.R. 1600, Patients Access to Treatments Act 21st Century Cures Act Zika Virus / Public Health Preparedness

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 34, The 21st Century Cures Act; S. 275 / H.R. 605, The Medicare Home Infusion Site of Care Act of 2015 and issues related to reimbursement for infused drugs administered through DME. Issues related to pharmaceutical prices, including the Part B Demonstration; H.R. 2028, Further Continuing and Security Assistance Appropriations Act of 2017.

Client expense: Not reported · Firm income: $52,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2425 - Patient Access and Medicare Protection Act H.R. 605/S. 275 - Medicare Home Infusion Site of Care Act H.R. 4273 - Medicare and Medicaid Improvements and Adjustments Act, ASP H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act H.R. 34 - 21st Century Cures Act **no specific bills; ASP, competitive bidding, Part B demonstration, MLN Learning Matters Billing Guidance H.R. 5122 - Part B demonstration

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

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

H.R.605/S.275, Medicare Home Infusion Site of Care Act of 2015; P.L.114-255, 21st Century Cures Act; issues related to patient infusion therapy. Regulations related to Medical Device User Fee Amendments (MDUFA). Issues related to Medicare reimbursements for tracheotomy tubes. Issues related to inspection process of medical device facilities.

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

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

Medicare Part B Drug Payment Model Proposal S. 275 & H.R. 605: Medicare Home Infusion Site of Care Act H.R. 1600: Patients Access to Treatments Act CURES Zika Virus/Public Health Preparedness

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

Government targets: 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. 546: ACE KIDS ACT OF 2015; PROVISIONS RELATED TO MEDICAID ACCESS TO THERAPY H.R. 605: MEDICARE HOME INFUSION SITE OF CARE ACT OF 2015; PROVISIONS RELATED TO MEDICARE ACCESS TO THERAPY S 298: ACE KIDS ACT OF 2015; PROVISIONS RELATED TO MEDICAID ACCESS TO THERAPY S 275: MEDICARE HOME INFUSION SITE OF CARE ACT OF 2015; PROVISIONS RELATED TO MEDICARE ACCESS TO THERAPY

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 546: Advancing Care for Exceptional (ACE) Kids Act of 2015; all provisions of the bill HR 605: Medicare Home Infusion Site of Care Act of 2015; all provisions of the bill S. 275: Medicare Home Infusion Site of Care Act of 2015; all provisions of the bill

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Patient access to disposable infusion pumps. Medicare Home Infusion Site of Care Act (S.275/H.R.605)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

Medicare Part B Drug Payment Model Proposal S. 275 / H.R. 605 - Medicare Home Infusion Site of Care Act H.R. 1600, Patients Access to Treatments Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement Medicare Part B drug payment model demonstration

Client expense: $570,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, SENATE

H.R.605/S.275, Medicare Home Infusion Site of Care Act of 2015; H.R.6, 21st Century Cures Act; issues related to patient infusion therapy. Regulations related to Medical Device User Fee Amendments (MDUFA). Issues related to Medicare reimbursements for tracheotomy tubes. Issues related to inspection process of medical device facilities.

Client expense: $600,000 · Firm income: Not reported

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

H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors; S. 275 / H.R. 605, The Medicare Home Infusion Site of Care Act of 2015 and issues related to reimbursement for infused drugs administered through DME. Issues related to pharmaceutical prices, including the Part B Demonstration.

Client expense: Not reported · Firm income: $52,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 605/S 275 - The Medicare Home Infusion Site of Care Act - Lobbied in support of passage of the legislation to ensure Medicare beneficiaries have access to home infusion. IVIG Coverage Demonstration - Worked with CMS to ensure the IVIG Demonstration is carried out in a manner that is beneficial to Medicare beneficiaries. Medicare Audits and ALJ Hearings - Continued efforts supporting reforms to the Medicare Audits system. Competitive bidding of DMEPOS - worked to ensure competitive bidding does not adversely affect the home infusion industry's ability to provide infusion services. HR 6 / HR 2581 / HR 2570 / S 2409 / HR 4273 - lobbied House and Senate against ASP infusion drug pricing without inclusion of a services payment for home infusion pharmacies under the Medicare DME Program. Medicare Program; Part B Drug Payment Model - lobbied House and Senate regarding the effects of the Medicare Program; Part B Drug Payment Model demonstration project released on Friday, March 11, 2016 (81 FR 13229). MLN Learning Matters SE- 1609 and DME MAC Billing Guidance-Billing for External Infusion Pumps and Drugs When Treatment Was Initiated Somewhere Other Than the Beneficiary Home - Lobbied for delay in MLN Learning Matters and a moratorium on the Billing Guidance.

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

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

S. 2425 - Patient Access and Medicare Protection Act H.R. 605/S. 275 - Medicare Home Infusion Site of Care Act H.R. 4273 - Medicare and Medicaid Improvements and Adjustments Act, ASP H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act **no specific bills; ASP, competitive bidding, Part B demonstration, MLN Learning Matters Billing Guidance H.R. 5122 - Part B demonstration

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

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

Medicare coverage of home infusion drugs and bioloigcals; payment for durable medical equipment drugs and biologicals. S. 275: Medicare Home Infusion Site of Care Act of 2015. H.R. 605: Medicare Home Infusion Site of Care Act of 2015.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part B Drug Payment Model Proposal S. 275 & H.R. 605: Medicare Home Infusion Site of Care Act H.R. 1600: Patients Access to Treatments Act

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

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

Issues regarding comprehensive coverage of home infusion therapy; the Medicare Home Infusion Site of Care Act of 2015 (S. 276, H.R. 605); Medicare reform issues regarding home care; infusion therapy demo project & similar demo projects; Medicare Part B competitive bidding;issues regarding drug compounding regulations

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement Medicare Part B drug payment model demonstration

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patient access to disposable infusion pumps. Medicare Home Infusion Site of Care Act (S.275/H.R.605)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to smoking cessation, Medicare Part D and anti-PBM legislation. Other issues include health care delivery system reforms including telehealth, chronic care, Innovation Initiative & health IT, cost containment and medication adherence. HR 793 - Ensuring Seniors Access to Local Pharmacies Act HR 2570-Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015 HR 605-Medicare Home Infusion Site of Care Act S 275-Medicare Home Infusion Site of Care Act HR 2029-Consolidated Appropriations Act of 2016 S 2141-Transparent Ratings on Usability & Security to Transform Information Technology H.R. 2712,Commonsense Reporting and Verification Act of 2015 S. 1996, Commonsense Reporting Act of 2015

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)

HR 546: ACE Kids Act of 2015; all provisions of the bill HR 605: Medicare Home Infusion Site of Care Act of 2015; all provisions of the bill S. 275: Medicare Home Infusion Site of Care Act of 2015; all provisions of the bill

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement Medicare Part B drug payment model demonstration

Client expense: $290,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors; S. 275 / H.R. 605, the Medicare Home Infusion Site of Care Act of 2015 and issues related to reimbursement for infused drugs administered through DME. Issues related to pharmaceutical prices, including the Part B Demonstration.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2425 - Patient Access and Medicare Protection Act H.R. 605/S. 275 - Medicare Home Infusion Site of Care Act H.R. 4273 - Medicare and Medicaid Improvements and Adjustments Act, ASP H.R. 5210/S. 2736 - Patient Access to Durable Medical Equipment Act **no specific bills; ASP, competitive bidding, Part B demonstration H.R. 5122 - Part B demonstration

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2570, Strengthening Medicare Advantage through Innovation and Transparency for Seniors; S. 275 / H.R. 605, the Medicare Home Infusion Site of Care Act of 2015 and issues related to reimbursement for infused drugs administered through DME. Issues related to pharmaceutical prices, including the Part B Demonstration.

Client expense: Not reported · Firm income: $52,500

Government targets: 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; 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 Part B Drug Payment Model Proposal S. 275 / H.R. 605 - Medicare Home Infusion Site of Care Act H.R. 1600, Patients Access to Treatments Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part B Drug Payment Model Proposal S. 275 / H.R. 605 - Medicare Home Infusion Site of Care Act H.R. 1600, Patients Access to Treatments Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 605/S 275 - The Medicare Home Infusion Site of Care Act - Lobbied in support of passage of the legislation to ensure Medicare beneficiaries have access to home infusion. IVIG Coverage Demonstration - Worked with CMS to ensure the IVIG Demonstration is carried out in a manner that is beneficial to Medicare beneficiaries. Medicare Audits and ALJ Hearings - Continued efforts supporting reforms to the Medicare Audits system. Competitive bidding of DMEPOS - worked to ensure competitive bidding does not adversely affect the home infusion industry's ability to provide infusion services. HR 6 / HR 2581 / HR 2570 / S 2409 / HR 4273 - lobbied House and Senate against ASP infusion drug pricing without inclusion of a services payment for home infusion pharmacies under the Medicare DME Program. Medicare Program; Part B Drug Payment Model - lobbied House and Senate regarding the effects of the Medicare Program; Part B Drug Payment Model demonstration project released on Friday, March 11, 2016 (81 FR 13229). MLN Learning Matters SE- 1609 and DME MAC Billing Guidance-Billing for External Infusion Pumps and Drugs When Treatment Was Initiated Somewhere Other Than the Beneficiary Home - Lobbied for delay in MLN Learning Matters and a moratorium on the Billing Guidance.

Client expense: $160,000 · Firm income: Not reported

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

Issues regarding comprehensive coverage of home infusion therapy; the Medicare Home Infusion Site of Care Act of 2015 (S. 276, H.R. 605); Medicare reform issues regarding home care; infusion therapy demo project & similar demo projects; Medicare Part B competitive bidding;issues regarding drug compounding regulations

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.605/S.275, Medicare Home Infusion Site of Care Act of 2015; H.R.6, 21st Century Cures Act; issues related to patient infusion therapy. Regulations related to Medical Device User Fee Amendments (MDUFA). Issues related to Medicare reimbursements for tracheotomy tubes.

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

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

Medicare coverage of home infusion drugs and bioloigcals; payment for durable medical equipment drugs and biologicals. S. 275: Medicare Home Infusion Site of Care Act of 2015. H.R. 605: Medicare Home Infusion Site of Care Act of 2015.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE