Child Protection Improvements Act of 2008

HR 1424 Paul Wellstone Mental Health and Addiction Equity Act, sec 105, provisions related to Medicaid Drug Rebate; HR 5606 Physicians Payments Sunshine Act of 2008; S 2029 Physician Payments Sunshine Act of 2007; HR 6631 Medicare Improvements for Patients and Providers Act; S 3101 Medicare Improvements for Patients and Providers Act of 2008/S 3118 Preserving Access to Medicare Act 2008 HR 5765 Medicare Remote Monitoring Access Act of 2008; S 3144/HR 6252, Medicare DMEPOS Competitive Acquisition Reform Act 2008; S 2221 Transparency in Medical Device Pricing Act; Issues related to oxygen provisions, competitive bidding and bariatric surgery.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

1. Physician payment - H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008 and S. 2029/H.R. 5606, Physician Payment Sunshine Act of 2007/2008 2. Prevention - expansion of abdominal aortic aneurysm screening 3. Imaging - H.R. 1293/S. 1338 - The Access to Medicare Imaging Act, exemption of vascular ultrasound from DRA cuts and S. 3343/H.R. 6821, Medicare Imaging Disclosure Sunshine Act 4. Quality - Physician Quality Reporting Initiative and use of registries for reporting quality measures 5. Health care reform

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

-H.R.1165, "Swift Approval, Full Evaluation Drug Act or the 'SAFE Drug Act," regarding amending the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs and to establish whistleblower protections for certain individuals; -H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; -H.R. 1494 / S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediatric medical devices; -H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; -H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; -H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; -H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; -H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; -H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; -S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; -S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; -S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; -S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; -S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; -S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; -H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; -H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; -H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; -S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; -H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; -H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; -H.R. 5839, "Safeguarding America's Pharmaceuticals Act of 2008", To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, regarding all provisions; -S. 334, "Healthy Americans Act", A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away, regarding all provisions; -H.R. 6381, "Medical Device Safety Act of 2008", To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions; -S. 438, "Fair Prescription Drug Competition Act", A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs, regarding all provisions; -S. 3408, "Comparative Effectiveness Research Act of 2008", A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes, regarding all provisions; -S. 1276, "Methamphetamine Production Prevention Act of 2008", A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions. -Proposed Rule (CMS-1403-P), Regarding revisions to Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions;

Improving the criminal background check system for youth-serving organizations (HR5606/S2756) Extending the Child Safety Pilot (S3605) Commerce-Justice-Science appropriations for "Youth mentoring grants"

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

Government targets: Corporation for Natl & Community Service, Federal Bureau of Investigation (FBI), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE

1. Physician payment - H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008 and S. 2029/H.R. 5606, Physicians Payment Sunshine Act of 2007/2008 2. Prevention - S.2115, Medicare Prevention Services Coverage Act of 2007 and expansion of abdominal aortic aneurysm screening 3. Imaging - H.R. 1293/S. 1338 - The Access to Medicare Imaging Act, exemption of vascular ultrasound from DRA cuts and S. 3343/H.R. 6821, Medicare Imaging Disclosure Sunshine Act 4. Quality - Physician Quality Reporting Initiative and use of registries for reporting quality measures 5. Competitive Bidding - H.R. 4935, Medicare Wound Therapy Patient Protection Act 6. Health care reform

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Improving the criminal background check system for youth-serving organizations (HR5606/S2756) Extending the Child Safety Pilot (S. 3218) Commerce-Justice-Science appropriations for "Youth mentoring grants"

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

Government targets: Corporation for Natl & Community Service, Education, Dept of, Federal Bureau of Investigation (FBI), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE

H.R.1165, "Swift Approval, Full Evaluation Drug Act or the 'SAFE Drug Act," regarding amending the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs and to establish whistleblower protections for certain individuals; H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision o mental health and substance-related disorder benefits under group health plans; H.R. 1494 / S. 830, "Pediactric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediactric medical devices; H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; H.R. 5839, "To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs", regarding all provisions; S. 334, "A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away", regarding all provisions; H.R. 6381, "To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices", regarding all provisions; S. 438, "A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs", regarding all provisions.

1. Physician payment - H.R. 6331 - Medicare Improvements for Patients and Providers Act of 2008 and S. 2029/H.R. 5606 - Physicians Payments Sunshine Act of 2007/2008 2. Prevention - S. 2115 - Medicare Prevention Services Coverage Act of 2007 and expansion of abdominal aortic aneurysm screening 3. Imaging - H.R. 1293/S. 1338 - The Access to Medicare Imaging Act and exemption of vascular ultrasound from DRA cuts 4. Quality - Physician Quality Reporting Initiative and use of registries for reporting quality measures 5. Competitive Bidding - H.R. 4935 - Medicare Wound Therapy Patient Protection Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R.1165, "Swift Approval, Full Evaluation Drug Act or the 'SAFE Drug Act," regarding amending the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs and to establish whistleblower protections for certain individuals; H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision o mental health and substance-related disorder benefits under group health plans; H.R. 1494 / S. 830, "Pediactric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediactric medical devices; H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products.

Improving the criminal background check system for youth-serving organizations (HR 5606/S 2756) Commerce-Justice-Science appropriations for "Youth Mentoring Grants"

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

Government targets: Corporation for Natl & Community Service, Education, Dept of, Federal Bureau of Investigation (FBI), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE