Regenerative Medicine Promotion Act of 2011

H.R. 1862, Regenerative Medicine Promotion Act of 2011 H.R. 2787/S. 1468, Medicare Diabetes Self-Management Training Act S. 2236, Advancing Breakthrough Therapies for Patients Act H.R. 2969/S. 1454 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011 H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3187 Food and Drug Administration Safety & Innovation Act H.R. 6309, To amend the Public Health Service Act to reauthorize the special diabetes programs for Type I diabetes and Indians under that Act. H.R. 2960/S. 3430 National Diabetes Clinical Care Commission Act H.R. 3150/S. 725 Medicare Safe Needle Disposal Coverage Act of 2011

Client expense: $370,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013, NIH funding. H.R.1862, Regenerative Medicine Promotion Act of 2011, Regenerative medicine funding.

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

Government targets: Energy, Dept of, HOUSE OF REPRESENTATIVES, SENATE

Advocate for creation of national strategy for regenerative medicine. Advocate for new/modified regulations regarding FDA approval of regenerative medicine products. Spoke with FDA officials about same. Lobbied in support of HR 1862, The Regenerative Medicine Promotion Act of 2011. Lobbied Congress to have provisions inserted in HR 5651 & S. 3187 Patient Centered Outcomes Research Institute (PCORI). Lobbied for FDA appropriation increase. FDA appropriations eventually included in HR 2112 and S. 2375 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. Lobbied for accelerated approval of regenerative medicine products for serious or life threatening conditions. These became part of HR 5651 the FDA Reform Act of 2012 and S. 3187 the FDA Safety and Innoviation Act. Reimbursement policies for regenerative medicine prodcuts; comparative effectiveness research studies related to regenerative medicine products. Drafted and submitted comments on proposed "methodology report" regarding comparative effectiveness research from the Patient Centered Outcome Research Institute.

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

Medicare payment for biologics; Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Delivery reforms) H.R. 1862 Regenerative Medicine Promotion Act of 2011; Budget Control Act of 2011(P.L. 112-25) (Part B payment for drugs and biologics)

Client expense: Not reported · Firm income: $24,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare payment for biologics; Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Delivery reforms) H.R. 1862 Regenerative Medicine Promotion Act of 2011; Budget Control Act of 2011(P.L. 112-25) (Part B payment for drugs and biologics)

Client expense: Not reported · Firm income: $36,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare payment for biologics; Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Delivery reforms) H.R. 1862 Regenerative Medicine Promotion Act of 2011; Budget Control Act of 2011(P.L. 112-25) (Part B payment for drugs and biologics)

Client expense: Not reported · Firm income: $24,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare payment for biologics; Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Delivery reforms) H.R. 1862 Regenerative Medicine Promotion Act of 2011; Budget Control Act of 2011(P.L. 112-25) (Part B payment for drugs and biologics)

Client expense: Not reported · Firm income: $24,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1862, Regenerative Medicine Promotion Act of 2011 H.R. 2787/S. 1468, Medicare Diabetes Self-Management Training Act H.R. 2960, National Diabetes Clinical Care Commission Act S. 2236, Advancing Breakthrough Therapies for Patients Act H.R. 2969/S. 1454 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011 H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3187 Food and Drug Administration Safety & Innovation Act S. 725, Medicare Safe Needle Disposal Coverage Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1862, Regenerative Medicine Promotion Act of 2011 H.R. 2787/S. 1468, Medicare Diabetes Self-Management Training Act H.R. 2960, National Diabetes Clinical Care Commission Act S. 2236, Advancing Breakthrough Therapies for Patients Act H.R. 2969/S. 1454 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011 H.R. 5651, Food and Drug Administration Reform Act of 2012 S. 3187 Food and Drug Administration Safety & Innovation Act S. 725, Medicare Safe Needle Disposal Coverage Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013, NIH funding. H.R.1862, Regenerative Medicine Promotion Act of 2011, Regenerative medicine funding.

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

Government targets: Energy, Dept of, HOUSE OF REPRESENTATIVES, SENATE

Advocate for creation of national strategy for regenerative medicine. Met with OSTP officals regarding same; Advocate for new/modified regulations regarding FDA approval of regenerative medicine products. Spoke with FDA officials about same. Lobbied in support of HR 1862, The Regenerative Medicine Promotion Act of 2011. Lobbied Congress to have provisions inserted in PDUFA reauthorization Energy & Commerce Committee draft legislation. Lobbied for FDA appropriation increase. FDA appropriations eventually included in HR 2112 and S. 2375 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. Lobbied for accelerated approval of regenerative medicine products for serious or life threatening conditions. These became part of HR 5651 and FDA Reform Act of 2012 and S. 3187 the FDA Safety and Innoviation Act. Reimbursement policies for regenerative medicine prodcuts; comparative effectiveness research studies related to regenerative medicine products.

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

Voiced support for HR 2182, The Generativng Antibiotic Incentives Now ("GAIN") Act. The legislation provides incentives for the development of infectious disease products. Voiced opposition to HR 3699, the Research Works Act. Voiced support for HR 1862, the Regenerative Medicine Promotion Act. The legislation encourages private investment in R&D, and it enables accelerated approval for regenerative medicine products. Voiced opposition to HR 3433, the Grant Reform and New Transparency Act of 2011 (GRANT ACT). The legislation requires certain standards in the award of federal grants, and for other purposes. Voiced opposition over the IPAB. Voiced opposition over proposed cuts to Medicare Part D, which provides seniors with a drug benefit, and Part B, which provides onology products for administration in physicians offices.

Client expense: $52,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1862, Regenerative Medicine Promotion Act of 2011 H.R. 2787/S. 1468, Medicare Diabetes Self-Management Training Act H.R. 2960, National Diabetes Clinical Care Commission Act S. 2236, Advancing Breakthrough Therapies for Patients Act H.R. 2969/S. 1454 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare payment for biologics; Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Delivery reforms) H.R. 1862 Regenerative Medicine Promotion Act of 2011; Budget Control Act of 2011(P.L. 112-25) (Part B payment for drugs and biologics)

Client expense: Not reported · Firm income: $36,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013, NIH funding. H.R.1862, Regenerative Medicine Promotion Act of 2011, Regenerative medicine funding.

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

Government targets: Energy, Dept of, HOUSE OF REPRESENTATIVES, SENATE, Transportation, Dept of (DOT)

Advocate for creation of federal coordinating entity for regenerative medicine. Met with NIH officals regarding same; Advocate for new/modified regulations regarding FDA approval of regenerative medicine products. Spoke with FDA officials about same. Lobbied in support of HR 1862, The Regenerative Medicine Promotion Act of 2011. Lobbied Congress to have provisions inserted in PDUFA reauthorization Energy & Commerce Committee draft legislation.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Medicare payment for biologics; Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Delivery reforms) H.R. 1862 Regenerative Medicine Promotion Act of 2011; Budget Control Act of 2011(P.L. 112-25) (Part B payment for drugs and biologics)

Client expense: Not reported · Firm income: $36,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1862, Regenerative Medicine Promotion Act of 2011 H.R. 2787/S. 1468, Medicare Diabetes Self-Management Training Act H.R. 2376, Stem Cell Research Advancement Act of 2011 H.R. 2960, National Diabetes Clinical Care Commission Act H.R. 2969/S. 1454, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocate for funding for regenerative medicine companies; NIH funding for regenerative medicine research; funding for FDA to perform regulatory research and creation of federal coordinating entity for regenerative medicine. Advocate for new/modified regulations re: FDA aprroval of regenerative medicine products. Met with FDA officials about same. Work with NIST to explore collaborations re: manfacturing standards; Lobbied in support of HR 1862, The Regenerative Medicine Promotion Act of 2011.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), SENATE

Support for HR 1862, the Regenerative Medicine Promotion Act.

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

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

Medicare payment for biologics; Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Delivery reforms) H.R. 1862 Regenerative Medicine Promotion Act of 2011; Budget Control Act of 2011(P.L. 112-25) (Part B payment)

Client expense: Not reported · Firm income: $36,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2376 Stem Cell Research Advancement Act of 2011 H.R. 1862 Regenerative Medicine Promotion Act of 2011 H.R. 2969/S.1454 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

See next page. Have continued to advocate against the repeal of the 2010 Affordable Care Act. Have met with Congressional staff and signed letters of support for the ACA and full enactment of its various provisions. Participated in discussion with DHHS of data development on health disparities and capturing information on people with disabilities as a disparity population criteria. Continued to reinforce with the DHHS Secretary and the Quality Measures Workgroup of the Health Information Technology Policy Committee better ways to address the health care needs of people with disabilities within the new clinical quality measures to be developed to leverage the evolving health IT infrastructure and decrease disability health disparities. Supported HR 1862 the National Regenerative Medicine Strategy legislation. Supported HR 2376 the Stem Cell Research Advancement Act. Participated in meetings of FDA-sponsored MDUFA III Stakeholders Group. Endorsed group letter to FDA Center for Devices and Radiological Health to comment on the Institute of Medicine (IOM) report on "Medical Devices and the Public Health" and recommend ways to strengthen the 510 (k) new device review process. Joined with 70 other organizations in a letter to the Senate HELP Committee urging reauthorization of the Lifespan Respite Care program. Participated in letters from the NDLA and CCD to the President urging implementation of the CLASS long-term services an supports insurance program. Participated in briefing with Centers for Disease Control and Prevention (CDC) officials on Year One progress the CDC Disability and Health Work Group. See Budget/Appropriation, Medicaid, and Medicare.

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

Advocate for funding for regenerative medicine companies and researchers in universities; Advocate for NIH funding for regenerative medicine research. Advocate for funding for the FDA. Lobbied in support of HR 1862, The Regenerative Medicine Promotion Act of 2011.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), SENATE

Advocate for funding for regenerative medicine companies; NIH funding for regenerative medicine research; funding for FDA to perform regulatory research and creation of federal coordinating entity for regenerative medicine. Advocate for new/modified regulations re: FDA aprroval of regenerative medicine products. Work with NIST to explore collaborations re: manfacturing standards; Lobbied in support of HR 1862, The Regenerative Medicine Promotion Act of 2011.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), SENATE

Support HR 1862, the Regenerative Medicine Promotion Act. Support NIH funding.

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

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

H.R. 2376 Stem Cell Research Advancement Act of 2011 H.R. 1862 Regenerative Medicine Promotion Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1862 The Regenerative Medicine Promotion Act H.R. 1666 Breaking Barriers to Oral Health H.R. 1852/S 958 To reauthorize Children's Hospitals Graduate Medical Education program FY 2012 Labor, HHS, Education and Related Agencies appropriations

Client expense: $126,163 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Education, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

H.R.1862, Regenerative Medicine Promotion Act of 2011

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

See following page. Have continued to advocate against the repeal of the 2010 Affordable Care Act. Have met with Congressional staff and signed letters of support for the ACA and full enactment of provisions included in it. Participated in HHS discussion of data development on health disparities. Recommended to the DHHS Secretary and the Quality Measures Workgroup of the Health Information Technology Policy Committee ways to address the health care needs of people with disabilities within the new clinical quality measures to be developed to leverage the evolving health IT infrastructure and decrease disability health disparities. Supported HR 1862 the National Regenerative Medicine Strategy legislation. Supported HR 2376 the Stem Cell Research Advancement Act.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Social Security Administration (SSA), State, Dept of (DOS), Veterans Affairs, Dept of (VA), White House Office

Advocate for funding for regenerative medicine companies; NIH funding for regenerative medicine research; funding for FDA to perform regulatory research and creation of federal coordinating entity for regenerative medicine. Advocate for new/modified regulations re: FDA aprroval of regenerative medicine products. Met with NIST to explore collaborations re: manfacturing standards; Lobbied in support of HR 1862, The Regenerative Medicine Promotion Act of 2011

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), SENATE

Advocate for funding for regenerative medicine companies and researchers in universities; Advocate for NIH funding for regenerative medicine research. Advocate for funding for the FDA. Lobbied in support of HR 1862, The Regenerative Medicine Promotion Act of 2011.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), SENATE