Regenerative Medicine Promotion Act of 2014

Health IT regulation HR 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4299 - Improving Regulatory Transparency for New Medical Therapies Act HR 4494 - Regenerative Medicine Promotion Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 2126 - Regenerative Medicine Promotion Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 S 2450 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 Veterans Health Care

Client expense: $3,540,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Medicare Reforms: Medicare A & B; Delivery System Reforms, Benefit Restructuring; Medigap first-dollar coverage; Quality Initiatives/SGR Reform, HIPAA Code Adoption Process, Medicare Advantage Risk Delay Part D Cuts, HR 2810 Introduced by Burgess (R-TX) on July 31, 2013 HR 3392 Introduced October 13, 2013 by Gus Bilirakis (R-FL) To amend title XVIII of the Social Security Act to provide for a PDP safety program to prevent fraud and abuse in the dispensing of controlled substances under Part D of the Medicare program, and for other purposes. Multi-State Plan Programs, Medicare Patient Access and Quality Improvement Act of 2013, Medicare Prescription Drug Integrity. Medicare fraud; Provider terminations in Medicare Advantage; CHIP (Children's Health Insurance Program) reauthorization HR 4160 Introduced March 6, 2014 by Renee Ellmers (R-NC) Keep the Promise to Seniors Act of 2014 - Prohibits the Secretary of Health and Human Services (HHS) from taking any action (through promulgation of a final or interim final regulation, issuance of regulatory or program guidance, use of federal payment audit procedures, or other enforcement or administrative action, policy, or practice) to implement any provision of the proposed regulation (relating to policy and technical changes to the MedicareAdvantage and part D programs under Medicare) published in the Federal Register on January 10, 2014, insofar as that regulation relates to part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), including its application to MedicareAdvantage-Prescription Drug (MA-PD) plans under part C (Medicare+Choice Program). HR 4577 Introduced May 6, 2014 by H. Griffith (R-VA) Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII(Medicare) of the Social Security Act with respect to a prescription drug plan that has, in its network of pharmacies, one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs dispensed through them. Declares that such a plan shall extend to any pharmacy located in that area or among that population the option to be an in-network pharmacy with respect to such plan under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population. HR 2960 Introduced August 1, 2013 by Frank Pallone (D-NJ) Medicare Prescription Drug Integrity Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require a prescription drug plan (PDP) sponsor to have in place procedures designed to prevent fraud and abuse in PDPs. HR 5083 Introduced July 11, 2014 by Renee Ellmers (R-NC) Medicare DMEPOS Audit Improvement and Reform (AIR) Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to establish a Medicare Administrative Contractor Payment Outreach and Education Program for DMEPOS (durable medical equipment, prosthetics, orthotics, and supplies) suppliers. HR 5460 Introduced September 11, 2014 by Greg Walden (R-OR) to amend title XVIII of the Social Security Act to increase access to ambulance services under the Medicare program and to reform payments for such services under such program as introduced. HR 5547 Introduced September 18, 2014 by Matthew Cartwright (D-PA) to ensure that Medicaid beneficiaries have the opportunity to receive care in a home and community-based setting. HR 5558 Introduced September 18, 2014 by Diane Black (R-TN) to amend Title XVIII of the Social Security Act to improve the Medicare accountable care organization (ACO) program, and for other purposes. HR 4494 Introduced June 26, 2014 by Dave Camp (R-MI) Improving Medicare Post-Acute Care Transformation Act of 2014 or the IMPACT Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to provide for standardized post-acute care assessment data for quality, payment, and discharge planning, and for other purposes. HR 2925 Introduced August 1, 2013 by Kevin Brady (R-TX) Strengthening Medicare Anti-Fraud Measures Act of 2013 - Amends title XI of the Social Security Act to authorize the Secretary of HHS to exclude from participation in any federal care program entities affiliated with a sanctioned entity, as well as any officer or managing employee of an affiliated entity (currently, only individuals with an ownership or control interest in a sanctioned entity), if the affiliated entity was so affiliated at the time of any of the conduct forming the basis for the conviction or exclusion of the sanctioned entity. HR 645 - /ABLE Act Introduced February 13, 2013 by Ander Crenshaw (R-FL) Achieving a Better Life Experience Act of 2014 or the ABLE Act of 2014 - Title I: Qualified ABLE Programs - (Sec. 101) States as the purposes of this title to: (1) encourage and assist individuals and families in saving private funds for the purpose of supporting individuals with disabilities to maintain health, independence, and quality of life; and (2) provide secure funding for disability-related expenses of beneficiaries with disabilities that will supplement, but not supplant, benefits provided through private insurance, title XVI (Supplemental Security Income) and title XIX (Medicaid) of the Social SEcurity Act, the beneficiary's employment, and other sources. HR 4994 Introduced June 26, 2014 by Dave Camp (R-MI) Title XVIII amendments of Social Security Act. Other Medicare/Medicaid Issues: Delivery reform and network design; Qualified Health Plan Survey; CHIP Reauthorization; Medicare co-pay limits

Advocate for creation of national strategy for regenerative medicine. Lobbied in support of H.R. 4494, S.2126, the Representative Medicare Promotion Act of 2014. Also worked with White House on "Grand Challenge." Also lobbied regarding H.R. 4800/S.2389, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015.

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

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

Medicare Reforms: Medicare A & B; Delivery System Reforms, Benefit Restructuring ; Quality Initiatives/SGR Reform, HIPAA Code Adoption Process, Medicare Advantage Risk Delay Part D Cuts, HR 2810 Introduced by Burgess (R-TX) on July 31, 2013 See addendum on additional Medicare/Medicaid issues...Addtional Medicare/Medicaid Issues: HR 3392 Introduced October 13, 2013 by Gus Bilirakis (R-FL) To amend title XVIII of the Social Security Act to provide for a PDP safety program to prevent fraud and abuse in the dispensing of controlled substances under part D of the Medicare program, and for other purposes. Multi-State Plan Programs, Medicare Patient Access and Quality Improvement Act of 2013, Medicare Prescription Drug Integrity. Medicare fraud; Provider terminations in Medicare Advantage; CHIP (Children's Health Insurance Program) reauthorization HR 4160 Introduced March 6, 2014 by Renee Ellmers (R-NC) Keep the Promise to Seniors Act of 2014 - Prohibits the Secretary of Health and Human Services (HHS) from taking any action (through promulgation of a final or interim final regulation, issuance of regulatory or program guidance, use of federal payment audit procedures, or other enforcement or administrative action, policy, or practice) to implement any provision of the proposed regulation (relating to policy and technical changes to the MedicareAdvantage and part D programs under Medicare) published in the Federal Register on January 10, 2014, insofar as that regulation relates to part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), including its application to MedicareAdvantage- Prescription Drug (MA-PD) plans under part C (Medicare+Choice Program). HR 4577 Introduced May 6, 2014 by H. Griffith (R-VA) Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act with respect to a prescription drug plan that has, in its network of pharmacies, one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs dispensed through them. Declares that such a plan shall extend to any pharmacy located in that area or among that population the option to be an in-network pharmacy with respect to such plan under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population. HR 2960 Introduced August 1, 2013 by Frank Pallone (D-NJ) Medicare Prescription Drug Integrity Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require a prescription drug plan (PDP) sponsor to have in place procedures designed to prevent fraud and abuse in PDPs. HR 5547 Introduced September 18, 2014 by Matthew Cartwright (D-PA) To ensure that Medicaid beneficiaries have the opportunity to receive care in a home and community-based setting HR 5558 Introduced September 18, 2014 by Diane Black (R-TN) To amend title XVIII of the Social Security Act to improve the Medicare accountable care organization (ACO) program, and for other purposes HR 4494 Introduced June 26, 2014 by Dave Camp (R-MI) Improving Medicare Post-Acute Care Transformation Act of 2014 or the IMPACT Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to provide for standardized post-acute care assessment data for quality, payment, and discharge planning, and for other purposes. HR 2925 Introduced August 1, 2013 by Kevin Brady (R-TX) Strengthening Medicare Anti-Fraud Measures Act of 2013 - Amends title XI of the Social Security Act to authorize the Secretary of Health and Human Services (HHS) to exclude from participation in any federal health care program entities affiliated with a sanctioned entity, as well as any officer or managing employee of an affiliated entity (currently, only individuals with an ownership or control interest in a sanctioned entity), if the affiliated entity was so affiliated at the time of any of the conduct forming the basis for the conviction or exclusion of the sanctioned entity.

Medicare Reforms: Medicare A & B; Delivery System Reforms, Benefit Restructuring ; Medigap first-dollar coverage; Quality Initiatives/SGR Reform, HIPAA Code Adoption Process, Medicare Advantage Risk Delay Part D Cuts, HR 2810 Introduced by Burgess (R-TX) on July 31, 2013 See addendum on additional Medicare/Medicaid issues...Addtional Medicare/Medicaid Issues: HR 3392 Introduced October 13, 2013 by Gus Bilirakis (R-FL) To amend title XVIII of the Social Security Act to provide for a PDP safety program to prevent fraud and abuse in the dispensing of controlled substances under part D of the Medicare program, and for other purposes. Multi-State Plan Programs, Medicare Patient Access and Quality Improvement Act of 2013, Medicare Prescription Drug Integrity. Medicare fraud; Provider terminations in Medicare Advantage; CHIP (Children's Health Insurance Program) reauthorization HR 4160 Introduced March 6, 2014 by Renee Ellmers (R-NC) Keep the Promise to Seniors Act of 2014 - Prohibits the Secretary of Health and Human Services (HHS) from taking any action (through promulgation of a final or interim final regulation, issuance of regulatory or program guidance, use of federal payment audit procedures, or other enforcement or administrative action, policy, or practice) to implement any provision of the proposed regulation (relating to policy and technical changes to the MedicareAdvantage and part D programs under Medicare) published in the Federal Register on January 10, 2014, insofar as that regulation relates to part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), including its application to MedicareAdvantage- Prescription Drug (MA-PD) plans under part C (Medicare+Choice Program). HR 4930 Introduced June 20, 2014 by Joe Barton (R-TX) Advancing Care for Exceptional Kids Act of 2014 or the ACE Kids Act of 2014 - Amends titles XIX (Medicaid) and XXI (Children's Health Insurance) (CHIP) of the Social Security Act to extend medical assistance to payment for items and services furnished under a Medicaid Children's Care Coordination (MCCC) Program which the state may elect to provide to eligible children with complex medical conditions HR 4577 Introduced May 6, 2014 by H. Griffith (R-VA) Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act with respect to a prescription drug plan that has, in its network of pharmacies, one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs dispensed through them. Declares that such a plan shall extend to any pharmacy located in that area or among that population the option to be an in-network pharmacy with respect to such plan under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population. HR 2960 Introduced August 1, 2013 by Frank Pallone (D-NJ) Medicare Prescription Drug Integrity Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require a prescription drug plan (PDP) sponsor to have in place procedures designed to prevent fraud and abuse in PDPs. HR 5083 Introduced July 11, 2014 by Renee Ellmers (R-NC) Medicare DMEPOS Audit Improvement and Reform (AIR) Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to establish a Medicare Administrative Contractor Payment Outreach and Education Program for DMEPOS (durable medical equipment, prosthetics, orthotics, and supplies) suppliers HR 5010 Introduced June 26, 2014 by Jackie Speier (D-CA) To provide greater clarity in the regulation of electronic nicotine delivery systems, including electronic cigarettes, cigars, cigarillos, pipes, and hookahs, and for other purposes. as introduced. HR 5460 Introduced September 11, 2014 by Greg Walden (R-OR) To amend title XVIII of the Social Security Act to increase access to ambulance services under the Medicare program and to reform payments for such services under such program. as introduced. (See following page on additional Medicare/Medicaid issues...)HR 5547 Introduced September 18, 2014 by Matthew Cartwright (D-PA) To ensure that Medicaid beneficiaries have the opportunity to receive care in a home and community-based setting HR 5558 Introduced September 18, 2014 by Diane Black (R-TN) To amend title XVIII of the Social Security Act to improve the Medicare accountable care organization (ACO) program, and for other purposes HR 4494 Introduced June 26, 2014 by Dave Camp (R-MI) Improving Medicare Post-Acute Care Transformation Act of 2014 or the IMPACT Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to provide for standardized post-acute care assessment data for quality, payment, and discharge planning, and for other purposes. HR 2925 Introduced August 1, 2013 by Kevin Brady (R-TX) Strengthening Medicare Anti-Fraud Measures Act of 2013 - Amends title XI of the Social Security Act to authorize the Secretary of Health and Human Services (HHS) to exclude from participation in any federal health care program entities affiliated with a sanctioned entity, as well as any officer or managing employee of an affiliated entity (currently, only individuals with an ownership or control interest in a sanctioned entity), if the affiliated entity was so affiliated at the time of any of the conduct forming the basis for the conviction or exclusion of the sanctioned entity.

1. H.R. 4494 Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) 2. CMS-1067-P, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2015 Rates; Proposed Rule (Vol. 79, No. 94), May 15, 2014

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

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