National Organ Transplant Act Amendments of 2018

Adequacy of health care workforce associated with expansion of health care coverage; Reauthorization of the Childrens Health Insurance Program (CHIP); issues related to health care coverage; H.R. 2257, Guard and Reservists Education Improvement Act; H.R.3, Spending Cuts to Expired and Unnecessary Programs Act; Graduate Medical Education Issues; H.R. 5385/S. 2597, Children's Hospital GME Support Reauthorization Act of 2018; S. 3014, Rural Physician Workforce Production Act of 2018; H.R. 5818/S. 2843, Opioid Workforce Act of 2018; S. 3014, Rural Physician Workforce Production Act of 2018; Nicotine regulation issues; S. 2446, Safe Staffing for Nurse and Patient Safety Act; POLST issues; H.R. 6458 NOTA Amendments Bill of 2019; Issues related to allocation of Livers.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 111-148 and P.L. 111-152 Affordable Care Act. All provisions related to implementation of health care reform including the Medicare and Medicaid programs, tax and insurance policies, graduate medical education, biomedical research, public and preventative health measures, and other policies concerning hospitals, physicians, health plans, employers and individuals. P.L. 115-120 Making Further Appropriations for Fiscal Year Ending September 30, 2018 and for other purposes. All provisions related to the Children's Health Insurance Program and Medicare Rural Hospital payments. H.R. 1892 Bipartisan Budget Act of 2018. All provisions related to the Children's Health Insurance Program, Medicare, Medicaid disproportionate share hospital payments, biomedical research and medical education. H.R. 1625 Consolidated Appropriations Act of 2018. All provisions related to the Children's Health Insurance Program, Medicare, Medicaid disproportionate share hospital payments, biomedical research and medical education. H.R. 6 Support for Patients and Communities Act. All provisions related to Opioids. H.R. 5818 The Opioid Workforce Act of 2018. All provisions. S. 2843 The Opioid Workforce Act of 2018. All provisions. H.R. 6458 National Organ Transplant Amendments of 2018. All provisions. Digital Medicine/Health Programs Deputy Secretary's (HHS) Innovation and Investment Summit Nomination Health Resources and Services Administration Remote Pregnancy Monitoring Program Liver Allocation and Transplantation Policy

Client expense: $140,000 · Firm income: Not reported

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

H.R. 6 SUPPORT for Patients and Communities Act H.R. 6458 National Organ Transplant Act Amendments of 2018 H.R. 6517 Fairness in Liver Allocation Act of 2018 H.R. 6157 Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 H.R. 6470 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Q3 Submitted Letters SUBJECT: CMS-1695-P, Medicare Program; Proposed Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Requests for Information on Promoting Interoperability and Electronic Health Care Information, Price Transparency, and Leveraging Authority for the Competitive Acquisition Program for Part B Drugs and Biologicals for a Potential CMS Innovation Center Model, Proposed Rule, Federal Register (Vol. 83, No, 147), July 31, 2018 SUBJECT: DEA-488P, Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2019, Notice, Federal Register (Vol. 83, No, 161), August 20, 2018 SUBJECT: CMS-1693-P, Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program Proposed Rule, Federal Register (Vol. 83, No. 145), July 27, 2018 SUBJECT: CMS-1691-P, Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS, Proposed Rule, Federal Register (Vol. 83, No, 139), July 19, 2018 SUBJECT: CMS 1689-P, Medicare and Medicaid Programs: CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements: Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements; Home Infusion Therapy; and Training Requirements, Proposed Rule, Federal Register (Vol. 83, No. 134), July 12, 2018 SUBJECT: CMS-1720-NC, Request for Information Regarding the Physician Self-Referral Law; Federal Register (Vol. 83, No. 122), June 25, 2018

implementation of health care reform generally pertaining to pediatric health care and autism services Medicaid program reforms, including hospital outpatient department regulations Section 340B Drug Pricing Program, including H.R. 4710 (340B PAUSE Act), All provisions, and H.R. 5598 (340B Optimization Act), all provisions and H.R. 6240 (drug Discount accountability act), all provisions H.R. 5385 (Dr. Benjy Frances Brooks Children's Hospital GME Support Reauthorization Act of 2018), all provisions S. 2597 (Children's Hospital GME Support Reauthorization act of 2018), all provisions Sickle Cell Disease Research funding generally Drug pricing reforms generally Department of Justice implementation of grant program for missing individuals with autism and developmental disabilities H.R. 6560 (ChiPACC Act of 2018), all provisions Department of Homeland Security rulemaking regarding public charge rule and Medicaid program implications S. 3429 (Neonatal Abstinence Intervention Act), all provisions H.R. 2410 (Sickle Cell Disease research, Surveillance, prevention and treatment act of 2017), all provisions S. 2465 (Sickle cell disease and other heritable blood disorders research, surveillance, Prevention and treatment act of 2018), all provisions H.R. 6 (support for patients and Communities Act), section 1004 regarding Medicaid drug review and utilization H.R. 6458 (National Organ Transplant Act Amendments of 2018), all provisions H.R. 3325 (ACE kids Act), all provisions S. 428 (Ace Kids Act of 2017), all provisions

Client expense: $137,852 · Firm income: Not reported

Organ allocation issues Public Law 111-148, Patient Protection and Affordable Care Act, Implementation issues NIH grant related issues Public health and CDC related issues H.R.6, SUPPORT for Patients and Communities Act, Opioid related issues Biomedical research and FDA reform CMS Hospital Payment issues 340B issues H.R.3, Spending Cuts to Expired and Unnecessary Programs Act, Children's Health Insurance Program (CHIP) Disproportionate Share Hospital (DSH) Payments H.R.6458, National Organ Transplant Act Amendments of 2018, Entirety

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6458, National Organ Transplant Act Amendments of 2018, Organ allocation issues 340B issues Academic Medical Centers related issues Teaching Hospitals related issues H.R.6, SUPPORT for Patients and Communities Act, Opioid related issues

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of health care reform generally pertaining to pediatric health care and autism services Medicaid program reforms, including hospital outpatient department regulations Section 340B Drug Pricing Program, including H.R. 4710 (340B PAUSE Act), all provisions, H.R. 5598 (340B Optimization Act), all provisions, and H.R. 6240 (Drug Discount Accountability Act), all provisions H.R. 5385 (Dr. Benjy Frances Brooks Children's Hospital GME Support Reauthorization Act of 2018), all provisions S. 2597 (Children's Hospital GME Support Reauthorization Act of 2018), all provisions Sickle cell disease research funding generally Drug pricing reforms generally Department of Justice implementation of grant program for missing individuals with autism and developmental disabilities H.R. 6560 (ChiPACC Act of 2018), all provisions Department of Homeland Security rulemaking regarding public charge rule and Medicaid program implications S. 3429 (Neonatal Abstinence Intervention Act), all provisions H.R. 2410 (Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017), all provisions S. 2465 (Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018), all provisions H.R. 6 (SUPPORT for Patients and Communities Act), Section 1004 regarding Medicaid drug review and utilization H.R. 6458 (National Organ Transplant Act Amendments of 2018), all provisions H.R. 3325 (ACE Kids Act), all provisions S. 428 (ACE Kids Act of 2017), all provisions

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

P.L. 111-148 and P.L. 111-152 Affordable Care Act. All provisions related to implementation of health care reform including the Medicare and Medicaid programs, tax and insurance policies, graduate medical education, biomedical research, public and preventative health measures, and other policies concerning hospitals, physicians, health plans, employers and individuals. P.L. 115-120 Making Further Appropriations for Fiscal Year Ending September 30, 2018 and for other purposes. All provisions related to the Children's Health Insurance Program and Medicare Rural Hospital payments. H.R. 1892 Bipartisan Budget Act of 2018. All provisions related to the Children's Health Insurance Program, Medicare, Medicaid disproportionate share hospital payments, biomedical research and medical education. H.R. 1625 Consolidated Appropriations Act of 2018. All provisions related to the Children's Health Insurance Program, Medicare, Medicaid disproportionate share hospital payments, biomedical research and medical education. H.R. 6 Support for Patients and Communities Act. All provisions related to Opioids. H.R. 5818 The Opioid Workforce Act of 2018. All provisions. S. 2843 The Opioid Workforce Act of 2018. All provisions. H.R. 6458 National Organ Transplant Amendments of 2018. All provisions.

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

Adequacy of health care workforce associated with expansion of health care coverage; Reauthorization of the Childrens Health Insurance Program (CHIP); issues related to health care coverage; H.R. 2257, Guard and Reservists Education Improvement Act; H.R.3, Spending Cuts to Expired and Unnecessary Programs Act; Graduate Medical Education Issues; H.R. 5385/S. 2597, Children's Hospital GME Support Reauthorization Act of 2018; S. 3014, Rural Physician Workforce Production Act of 2018; H.R. 5818/S. 2843, Opioid Workforce Act of 2018; S. 3014, Rural Physician Workforce Production Act of 2018; Nicotine regulation issues; S. 2446, Safe Staffing for Nurse and Patient Safety Act; POLST issues; H.R. 6458 NOTA Amendments Bill of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Hospital and Medicaid issues related to repeal and replace of the Affordable Care Act (ACA), including opposition to The American Health Care Act (House), the Better Care Reconciliation Act (Senate) (H.R. 1628), the Graham-Cassidy-Heller-Johnson bill, and the Trump Administration's FY 2019 budget proposal. Organ donation issues, including the liver transplant allocation system and in support of new proposed UNOS system. Discussions with HHS and DHS regarding cybersecurity issues. Advocated for individual marketplace stabilization measures, including the funding of ACA cost sharing reduction payments in standalone legislation and in FY 2018 funding legislation. Graduate Medical Education (GME) issues, including the Resident Physician Shortage Reduction Act of 2017 (support) (H.R. 2267/S. 1301), the Opioid Workforce Act of 2018 (support) (H.R. 5818/S. 2843), and the cuts and changes to Medicare and Medicaid GME programs in President Trumps FY 2019 budget proposal (oppose). Support the inclusion of legislation to increase GME funding, the Opioid Workforce Act of 2018 (support) (H.R. 5818/S. 2843), in the SUPPORT for Patients and Communities Act (support) (H.R. 6) and the Opioid Crisis Response Act of 2018 (support) (S. 2680). Support legislation to repeal the Medicaid IMD exclusion, the Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act (support) (H.R. 5797), and support the inclusion of the legislation in the SUPPORT for Patients and Communities Act (support) (H.R. 6) and the Opioid Crisis Response Act of 2018 (support) (S. 2680). Support legislation to align 42 CFR Part 2 regulations with the Health Insurance Portability and Accountability Act (HIPAA), The Overdose Prevention and Patient Safety Act (support) (H.R. 6082), and support the inclusion of the legislation in the SUPPORT for Patients and Communities Act (support) (H.R. 6) and the Opioid Crisis Response Act of 2018 (support) (S. 2680). Support the SUPPORT for Patients and Communities Act (support) (H.R. 6). Support the Opioid Crisis Response Act of 2018 (support) (S. 2680). Lobby HHS, HRSA, OPTN and UNOS on liver allocation reforms. Support liver allocation reforms, including the Fairness in Liver Allocation Act (support) (H.R. 6517). Oppose legislation to amend the National Organ Transplant Act, the National Organ Transplant Act Amendments of 2018 (oppose) (H.R. 6458), and the inclusion of language that would amend the National Organ Transplant Act in the Labor-HHS appropriations bill (H.R. 6157). Oppose 340B provisions and site-neutral provisions in the CMS OPPS proposed rule for 2019.