Dextromethorphan Distribution Act of 2009

H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA

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

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA

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

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

H.R. 1259, Dextromethorphan Distribution Act of 2009; S. 1383, Dextromethorphan Abuse Reduction Act of 2009

Client expense: Not reported · Firm income: $45,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Importation H.R. 759 - The Food, drug and Cosmetic Globalization Act, 1/09 H.R. 1259 - Dextromethorphan Distribution Act 4/09 S. 1383 - Dextromethorphan Abuse Reduction Act 6/09 H.R. 573 - Act to Prohibit the Marketing of Authorized Generic Drugs, 1/09

Client expense: $2,590,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)

HR 1259 & S 1383 - Dextromethorphan Abuse S 256 & HR 2923 - Methamphetamine Abuse Issues related to methamphetamine precursor chemicals

Client expense: $715,571 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Office of Natl Drug Control Policy (NDCP), SENATE, Treasury, Dept of

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "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. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "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. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions. - Issues relating to the McNeil recall of over the counter medications. - H.R. 2923, "A bill to Enhance the ability to combat Methamphetamine", regarding all provisions. - H.R. 5786, "Safe Cosmetics Act of 2010", regarding all provisions.

Client expense: $850,000 · Firm income: Not reported

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

H.R.1259, Dextromethorphan Distribution Act of 2009; S.1383, Dextromethorphan Abuse Reduction Act of 2009; Issues related to preventing the abuse of prescription and nonprescription drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.1259 Dextromethorphan Distribution Act of 2009; S. 1383 Dextromethorphan Abuse Reduction Act of 2009

Client expense: $980,915 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

HR 2751 - FDA Food Safety Modernization Act (Sections on dietary supplements, establishment of foreign FDA offices; and the establishment of voluntary food allergy and anaphylaxis management guidelines) Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) and the Institute of Medicine of National Academies HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demonstration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program (ACOs); national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal... medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0950-AA06) Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Interim Final Rule (Docket Number: 75FR65495) National Institutes for Health; Interagency Pain Research Coordinating Committee; Call for Nominations (Docket Number: 2010-28041) Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (Docket Number: CMS-0009-N) Health Insurance Reform; Announcement of Maintenance Changes to Electronic Data Transaction Standards Adopted Under the Health Insurance Portability and Accountability Act of 1996 (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (Docket Number: 75FR65359)AHRQ Common Formats for Patient Safety Data Collection and Event Reporting; Notice of availability NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS Request for Comment on the Development of the National Health Care Quality Strategy and Plan IRS Notice (2010-59) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 - Cafeteria Plans, Section 220 Archer MSAs, Section 223 Health Savings Accounts (P.L. 111-148, Section 9003) IRS Revised Notice (2011-5) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 Cafeteria Plans (P.L. 111-148, Section 9003) HHS National Health Care Quality Strategy and Plan IOM Study on the Determination of Essential Health Benefits in P.L. 111-148 Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions

Client expense: $240,240 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Natl Institutes of Health (NIH), SENATE, White House Office

HR 1259, Dextromethorphan Distribution Act, restrictions on distribution of bulk Dextromethorphan. S. 1383, Dextromethorphan Abuse Reduction Act of 2009; Amendment to Controlled Substances Act to prevent abuse of Dextromethorphan and to impose age restrictions. Electronic tracking for pseudoephedrine - No bills.

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

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1259, Dextromethorphan Distribution Act of 2009; S. 1383, Dextromethorphan Abuse Reduction Act of 2009

Client expense: Not reported · Firm income: $45,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Importation H.R. 759 - The Food, drug and Cosmetic Globalization Act, 1/09 H.R. 1259 - Dextromethorphan Distribution Act 4/09 S. 1383 - Dextromethorphan Abuse Reduction Act 6/09 H.R. 573 - Act to Prohibit the Marketing of Authorized Generic Drugs, 1/09

Client expense: $4,150,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS)

H.R. 1359 Secure and Responsible Drug Disposal Act of 2009; H.R. 1191 Safe Drug Disposal Act of 2009; H.R.1259 Dextromethorphan Distribution Act of 2009; S. 1383 Dextromethorphan Abuse Reduction Act of 2009

Client expense: $1,030,211 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "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. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "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. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions. - Issues relating to the McNeil recall of over the counter medications. - H.R. 2923, "A bill to Enhance the ability to combat Methamphetimine", regarding all provisions. - H.R. 5786, "Safe Cosmetics Act of 2010", regarding all provisions.

Client expense: $2,410,000 · Firm income: Not reported

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

HR 1259 & S 1383 - Dextromethorphan Abuse S 256 & HR 2923 - Methamphetamine Abuse Issues related to methamphetamine precursor chemicals

Client expense: $736,734 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), Office of Natl Drug Control Policy (NDCP), SENATE

H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA

Client expense: $1,842,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

HR 6012 - To direct the Secretary of Health and Human Services to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purposes. HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 Drug Safety Discussion Draft Bill (builds on the Food and Drug Globalization Act - HR 759) - Amends the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes. (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute; and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information (RIN 0991AB57) Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act (Docket Number: FDA-2010-D-0431) Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability (Docket Number: FDA-2010-N-0449) Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products; Public Workshop; Request for Comments FDA Draft Guidance for Industry Tobacco Retailer Training Programs NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS National Health Care Quality Strategy and Plan Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions

Client expense: $212,859 · Firm income: Not reported

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

H.R.1259, Dextromethorphan Distribution Act of 2009; S.1383, Dextromethorphan Abuse Reduction Act of 2009; Issues related to preventing the abuse of prescription and nonprescription drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1259, Dextromethorphan Distribution Act, restrictions on distribution of bulk Dextromethorphan. S. 1383, Dextromethorphan Abuse Reduction Act of 2009; Amendment to Controlled Substances Act to prevent abuse of Dextromethorphan and to impose age restrictions. Electronic tracking for pseudoephedrine - No bills.

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

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

S.80 - Pharmaceutical Market Access Act, 1/09 S. 501 - Fair prescription Drug Competition Act, 3/09 S. 882 - Drug and Device Accountability Act H.R. 573 - act to prohibit the marketing of authorized generic drugs, 1/09 H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicines Act, 3/09 H.R. 1548 - Pathway for Biosimilars Act, 3/09 H.R. 759 - The Food, drug and Cosmetic Globalization Act, 1/09 H.R. 1259 - Dextromethorphan Distribution Act 4/09 S. 1383 - Dextromethorphan Abuse Reduction Act 6/09

Client expense: $2,250,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "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. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "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. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346/ S. 540, "Medical Device Safety Act of 2009", regarding all provisions. - Issues relating to the McNeil recall of over the counter medications.

Client expense: $1,150,000 · Firm income: Not reported

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

H.R. 1359 Secure and Responsible Drug Disposal Act of 2009; H.R. 1191 Safe Drug Disposal Act of 2009; H.R.1259 Dextromethorphan Distribution Act of 2009; S. 1383 Dextromethorphan Abuse Reduction Act of 2009; S. 256 Combat Methamphetamine Enhancement Act of 2009

Client expense: $1,079,067 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA

Client expense: $1,616,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information HHS Draft Healthy People 2020 Objectives HHS Strategic Framework on Multiple Chronic Conditions Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Pharmacist Clinical Services Provisions in Health Care Reform

Client expense: $151,510 · Firm income: Not reported

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

HR 1259 & S 1383 - Dextromethorphan Abuse S. 256 & HR 2923 - Methamphetamine Abuse Issues related to methamphetamine precursor chemicals

Client expense: $1,687,444 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE

H.R.1259, Dextromethorphan Distribution Act of 2009; S.1383, Dextromethorphan Abuse Reduction Act of 2009; Issues related to preventing the abuse of prescription and nonprescription drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1259, Dextromethorphan Distribution Act, restrictions on distribution of bulk Dextromethorphan. S. 1383, Dextromethorphan Abuse Reduction Act of 2009; Amendment to Controlled Substances Act to prevent abuse of Dextromethorphan and to impose age restrictions. Electronic tracking for pseudoephedrine - No bills.

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

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE

HR 1259 the Dextromethorphan Distribution Act of 2009 all provisions of the bill; regarding amending the federal food, drug, and cosmetic act to limit the distribution and abuse of DXM. HR. 759 the Food and Drug Administration Globalization Act of 2009 Title II Drug Safety provisions relating to country of origin labeling for drugs and devices. S. 1383 the Dextromethorphan Abuse Reduction Act of 2009 all provisions; regarding amending the Controlled Substances Act to prevent the abuse of dextromethorphan.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "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. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "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. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions.

Client expense: $2,110,000 · Firm income: Not reported

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

S.80 - Pharmaceutical Market Access Act, 1/09 S. 501 - Fair prescription Drug Competition Act, 3/09 S. 882 - Drug and Device Accountability Act H.R. 573 - act to prohibit the marketing of authorized generic drugs, 1/09 H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicines Act, 3/09 H.R. 1548 - Pathway for Biosimilars Act, 3/09 H.R. 759 - The Food, drug and Cosmetic Globalization Act, 1/09 H.R. 1259 - Dextromethorphan Distribution Act 4/09 S. 1383 - Dextromethorphan Abuse Reduction Act 6/09

Client expense: $4,340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Veterans Affairs, Dept of (VA)

H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

Client expense: $149,615 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

HR 1259 & S 1383 - Dextromethorphan Abuse S. 256 & HR 2923 - Methamphetamine Abuse

Client expense: $423,644 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE

H.R.3200 America's Affordable Health Choices Act of 2009 S.1796 America's Healthy Future Act of 2009 H.R.3962 Affordable Health Care for America Act H.R.3590 Patient Protection and Affordable Care Act H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 4705 HR 4993, S 2466 - Vaccines for the uninsured Adult Act of 2008 HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 HR 1038, S623 - Access to Life-Saving Medicine Act HR 1548 Pathway for Biosimilars Act HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act S 726 - Promoting Innovation and Access to Life-Saving Medicine Act S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Personalized Medicine Public Health Service Act Drug Importation Gene Therapy PDUFA

Client expense: $2,040,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

H.R. 1359 Secure and Responsible Drug Disposal Act of 2009; H.R. 1191 Safe Drug Disposal Act of 2009; H.R.1259 Dextromethorphan Distribution Act of 2009; S. 1383 Dextromethorphan Abuse Reduction Act of 2009; S. 256 Combat Methamphetamine Enhancement Act of 2009

Client expense: $1,046,127 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

**see addendum page Importation of prescription drugs (S. 525/H.R. 1298) RX Pedigree Import Safety (H.R. 759) Counterfeit Drugs (H.R. 1450) Methamphetamine / Pseudoephedrine Regulation (S. 256) Dextromethorphan Regulation (H.R. 1259) Pharmacy Benefit Management Issues (H.R. 4489)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1259, Dextromethorphan Distribution Act, restrictions on distribution of bulk Dextromethorphan. S. 1383, Dextromethorphan Abuse Reduction Act of 2009; Amendment to Controlled Substances Act to prevent abuse of Dextromethorphan and to impose age restrictions. Electronic tracking for pseudoephedrine - No bills.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.80 - Pharmaceutical Market Access Act, 1/09 S. 501 - Fair prescription Drug Competition Act, 3/09 S. 767 - Independent Drug Education and Outreach Act, 4/09 S. 882 - Drug and Device Accountability Act H.R. 163 - The Prescription Drug Affordability Act, 1/09 H.R. 91 - Shipment of Prescription Drugs between the States and the Virgin Islands, 1/09 H.R. 573 - act to prohibit the marketing of authorized generic drugs, 1/09 H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicines Act, 3/09 H.R. 1548 - Pathway for Biosimilars Act, 3/09 H.R. 759 - The Food, drug and Cosmetic Globalization Act, 1/09 H.R. 1256 - Family Smoking Prevention: Tobacco Control Act H.R. 1259 - Dextromethorphan Distribution Act 4/09 S. 1383 - Dextromethorphan Abuse Reduction Act 6/09

Client expense: $6,200,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

S.80 - Pharmaceutical Market Access Act, 1/09 S. 501 - Fair prescription Drug Competition Act, 3/09 S. 767 - Independent Drug Education and Outreach Act, 4/09 S. 882 - Drug and Device Accountability Act H.R. 163 - The Prescription Drug Affordability Act, 1/09 H.R. 91 - Shipment of Prescription Drugs between the States and the Virgin Islands, 1/09 H.R. 573 - act to prohibit the marketing of authorized generic drugs, 1/09 H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicines Act, 3/09 H.R. 1548 - Pathway for Biosimilars Act, 3/09 H.R. 759 - The Food, drug and Cosmetic Globalization Act, 1/09 H.R. 1256 - Family Smoking Prevention: Tobacco Control Act H.R. 1259 - Dextromethorphan Distribution Act 4/09 S. 1383 - Dextromethorphan Abuse Reduction Act 6/09

Client expense: $5,590,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

S.80 - Pharmaceutical Market Access Act, 1/09 S. 501 - Fair prescription Drug Competition Act, 3/09 S. 767 - Independent Drug Education and Outreach Act, 4/09 S. 882 - Drug and Device Accountability Act H.R. 163 - The Prescription Drug Affordability Act, 1/09 H.R. 91 - Shipment of Prescription Drugs between the States and the Virgin Islands, 1/09 H.R. 573 - act to prohibit the marketing of authorized generic drugs, 1/09 H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicines Act, 3/09 H.R. 1548 - Pathway for Biosimilars Act, 3/09 H.R. 759 - The Food, drug and Cosmetic Globalization Act, 1/09 H.R. 1256 - Family Smoking Prevention: Tobacco Control Act H.R. 1259 - Dextromethorphan Distribution Act 4/09 S. 1383 - Dextromethorphan Abuse Reduction Act 6/09

Client expense: $5,590,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, Veterans Affairs, Dept of (VA)

HR 1259 the Dextromethorphan Distribution Act of 2009 all provisions of the bill; regarding amending the federal food, drug, and cosmetic act to limit the distribution and abuse of DXM. HR. 759 the Food and Drug Administration Globalization Act of 2009 Title II Drug Safety provisions relating to country of origin labeling for drugs and devices. HR. 1548 the Pathway for Biosimilars Act all provisions; regarding establishing a pathway at the Food and Drug Administration for the approval of generic versions of biotech pharmaceuticals. S. 726/HR. 1427 the Promoting Innovation and Access to Life-Saving Medicine Act - all provisions; regarding establishing a pathway at the Food and Drug Administration for the approval of generic versions of biotech pharmaceuticals. HR. 1815 the Consumer Product Safety Solutions Act Section 2 provision relating to lead limits and third party testing requirements, Section 3 provisions relating to phthalates prohibition, Section 4 provisions relating to clarification of testing methodologies, Section 5 provisions relating to the exclusion of certain materials from lead content limit, Section 6 provision relating to the waiver of third party testing requirements for certain component parts, Section 7 provisions relating to exemptions from tracing label requirements, Section 8- provisions relating to the general application and exemptive authority of the Consumer Product Safety Commission. S. 882 the Drug and Device Accountability Act of 2009 Title I Ensuing the safety and quality of medical products and their components all provisions relating to this title on drug and device safety. S. 1383 the Dextromethorphan Abuse Reduction Act of 2009 all provisions; regarding amending the Controlled Substances Act to prevent the abuse of dextromethorphan.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "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. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "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. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions.

Client expense: $1,640,000 · Firm income: Not reported

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

- H.R. 1259, "To amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan, and for other purposes", regarding all provisions. - H.R. 1346 / S. 540, "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. - S. 1142, "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising", regarding all provisions. - H.R. 2502, "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. 882, "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes", regarding all provisions. - S. 1383, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes", regarding all provisions.

Client expense: Not reported · Firm income: Not reported

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

HR 1259 & S 1383 - Dextromethorphan Abuse S 256 & HR 2923 - Methamphetamine Abuse

Client expense: $422,034 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE

S 750 - Caring for an Aging America Act HR 2891 - Access to Frontline Health Care Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR 1259 - Dextromethorphan Distribution Act of 2009 HR 1256 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 S 1679 Affordable Health Choices Act [Sections on: ensuring quality of care; affordable choices of health benefit plans; seeking the best medical advice; spending for Federally Qualified Health Centers; national strategy; presentation of drug information; center for health outcomes research and evaluation; administrative simplification; right choices program; grants to establish community health teams to support a medical home model; grants to implement medication therapy management services in treatment of chronic disease; national health care workforce commission; funding for National Health Service Corps; geriatric education and training, career awards, comprehensive geriatric education; nurse education, practice, and retention grants; increasing Access to clinical preventive services, and increase prevention and wellness provisions.] HR 3200 - America's Affordable Health Choices Act of 2009 [Sections on: ensuring adequacy of provider networks; essential benefits package defined; Health Benefits Advisory Committee; outreach and enrollment of exchange-eligible individuals and employers in Exchange-participating health benefits plan; payment rates for items and services; reducing potentially preventable hospital readmissions; post acute care services payment reform plan; requiring drug manufacturers to provide drug rebates for certain, full premium subsidy eligible individuals; phasedin elimination of coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out of pocket threshold under part D; permitting mid-year changes in enrollment; telehealth expansion and enhancements; intelligent assignment in enrollment; ensuring effective communication in Medicare; Accountable Care Organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; comparative effectiveness research; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; distribution of unused residency positions; require providers and suppliers to adopt programs to reduce waste, fraud, and abuse; payments to pharmacists (AMP); Task Force on Clinical Preventive Services; fully integrated dual eligible special needs plans; public health and workforce development; prevention and wellness; preventive cost sharing services; amendments to establish a medication therapy management grant program, pharmacy benefit manager transparency; and allowing direct price negotiations in Medicare Part D.] S 1796 - America's Healthy Future Act of 2009 [Sections on: health care coverage, including sections on the Health Benefits Advisory Committee, making coverage affordable, Medicaid coverage for the lowest income populations, Medicaid prescription drug coverage, changes to Medicaid payment for prescription drugs (AMP); Medicaid quality; promoting disease prevention and wellness including sections on Medicare (annual wellness visit, study on beneficiary access to immunizations, removing barriers to preventive services, and incentives for healthy lifestyles) and Medicaid (improving access to preventive services for eligible adults, incentives for healthy lifestyles, and Medicaid state plan option promoting health homes and integrated care); improving the quality and efficiency of health care including sections on physician value-based purchasing, quality infrastructure, Accountable Care Organizations, and CMS Innovation Center; strengthening primary care and other workforce improvements; Medicare Part D improvements including sections improving coverage in the Part D coverage gap, facilitation of reassignments of beneficiaries in low-income subsidy plans, strengthening formularies with respect to certain categories or classes of drugs, and limitation on removal or change of coverage of covered Part D drugs under a formulary; Medicare Advantage including section on Medicare Advantage payment; home health payment changes including section on durable medical equipment; improving Medicare for patients and providers, including sections on Medicare diabetes self-management training, and revisions to demonstration project on community health integration models in certain rural counties; administrative simplification including section on changes to HIPAA; ensuring Medicare sustainability including section on Medicare Commission; transparency and program integrity including sections on physician payment sunshine and prescription drug samples; fraud, waste, and abuse including sections on provider screening, provider compliance and penalties; revenue items including sections on employer health insurance reporting, and annual fee on clinical laboratories; the inclusion of PBM transparency and the medications therapy management grant program in section 213 of S1679; and changes to long-term care pharmacy utilization management provisions.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medial residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; institute of medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; and Indian Health Care Improvement.] HR 3590 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Amendments: Improvements in Medicare Part D MTM programs in Freshman Amendments; Modernize Americas health care system provide for a performance-based pharmacy reimbursement program under Medicare part D (S.A. 3119); Pharmaceutical Market Access and Drug Safety Act of 2009 (S.A. 2793) Provide for establishment and maintenance of chronic care pharmacy program (S.A. 3109).] Public Law 111-3 - Reauthorization of Childrens Health Insurance Plans on pharmacist appointment to MEDPAC [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement (Docket No. FDA-2009-N-0247) FDA Transparency Task Force; Request for Comments (Docket Number FDA2009N0441) Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Docket Number DEA321a) Identification of Institution-based Individual Practitioners (Docket No. FDA2009N0294) Regulation of Tobacco Products; Request for Comments AHRQ Proposed Collection Project: Health IT Community Tracking Study 2009 HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in 2009 H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

Client expense: $117,517 · Firm income: Not reported

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

H.R. 1359 Secure and Responsible Drug Disposal Act of 2009; H.R. 1191 Safe Drug Disposal Act of 2009; H.R. 1427/S. 726 Promoting Innovation and Access to Life-Saving Medicine Act of 2009; H.R. 1548 Pathway for Biosimilars Act of 2009; H.R.1259 Dextromethorphan Distribution Act of 2009; S. 1383 Dextromethorphan Abuse Reduction Act of 2009; S. 256 Combat Methamphetamine Enhancement Act of 2009

Client expense: $824,821 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)