DEBORAH WILLIAMS

H.R. 3200/S. 1796: To provide affordable, quality health care for all Americand and reduce the growth in health care spending. H.R. 3590: The Patient Protection Affordable Care Act. H.R. 4872: The Health Care and Education Reconciliation Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. 340B drug discount program Drug and device marketing and promotion Drug and biological product pricing and reimbursement Follow-on biologics Healthcare-acquired infections Health insurance reform Implementation of bundling provisions in H.R. 6331(110th Congress) Issues regarding 340B Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending. H.R. 4872: The Health Care and Education Reconciliation Act. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765: To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). S. 1796/H.R. 3200: America's Healthy Future Act, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices.

H.R. 3200/S. 1796: To provide affordable, quality health care for all Americand and reduce the growth in health care spending. H.R. 3590: The Patient Protection Affordable Care Act. H.R. 4872: The Health Care and Education Reconciliation Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. 340B drug discount program Drug and device marketing and promotion Drug and biological product pricing and reimbursement Follow-on biologics Healthcare-acquired infections Health insurance reform Implementation of bundling provisions in H.R. 6331(110th Congress) Issues regarding 340B Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending. H.R. 4872: The Health Care and Education Reconciliation Act. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765: To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). S. 1796/H.R. 3200: America's Healthy Future Act, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices.

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending. H.R. 4872: The Health Care and Education Reconciliation Act. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765: To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). S. 1796/H.R. 3200: America's Healthy Future Act, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices.

H.R. 3200/S. 1796: To provide affordable, quality health care for all Americand and reduce the growth in health care spending. H.R. 3590: The Patient Protection Affordable Care Act. H.R. 4872: The Health Care and Education Reconciliation Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. 340B drug discount program Drug and device marketing and promotion Drug and biological product pricing and reimbursement Follow-on biologics Healthcare-acquired infections Health insurance reform Implementation of bundling provisions in H.R. 6331(110th Congress) Issues regarding 340B Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200/S. 1796: To provide affordable, quality health care for all Americand and reduce the growth in health care spending. H.R. 3590: The Patient Protection Affordable Care Act. H.R. 4872: The Health Care and Education Reconciliation Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. 340B drug discount program Drug and device marketing and promotion Drug and biological product pricing and reimbursement Follow-on biologics Healthcare-acquired infections Health insurance reform Implementation of bundling provisions in H.R. 6331(110th Congress) Issues regarding 340B Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200/S. 1796: To provide affordable, quality health care for all Americand and reduce the growth in health care spending. H.R. 3590: The Patient Protection Affordable Care Act. H.R. 4872: The Health Care and Education Reconciliation Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. 340B drug discount program Drug and device marketing and promotion Drug and biological product pricing and reimbursement Follow-on biologics Healthcare-acquired infections Health insurance reform Implementation of bundling provisions in H.R. 6331(110th Congress) Issues regarding 340B Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending. H.R. 4872: The Health Care and Education Reconciliation Act. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765: To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). S. 1796/H.R. 3200: America's Healthy Future Act, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices.

H.R. 3200/S. 1796: To provide affordable, quality health care for all Americand and reduce the growth in health care spending. H.R. 3590: The Patient Protection Affordable Care Act. H.R. 4872: The Health Care and Education Reconciliation Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. 340B drug discount program Drug and device marketing and promotion Drug and biological product pricing and reimbursement Follow-on biologics Healthcare-acquired infections Health insurance reform Implementation of bundling provisions in H.R. 6331(110th Congress) Issues regarding 340B Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590: An act entitled The Patient Protection and Affordable Care Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. S. 1796, "America's Healthy Future Act," An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590: An act entitled The Patient Protection and Affordable Care Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. S. 1796, "America's Healthy Future Act," An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590: An act entitled The Patient Protection and Affordable Care Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. S. 1796, "America's Healthy Future Act," An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590: An act entitled The Patient Protection and Affordable Care Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. S. 1796, "America's Healthy Future Act," An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans. Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590: An act entitled The Patient Protection and Affordable Care Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. S. 1796, "America's Healthy Future Act," An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590: An act entitled The Patient Protection and Affordable Care Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. S. 1796, "America's Healthy Future Act," An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590: An act entitled The Patient Protection and Affordable Care Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. S. 1796, "America's Healthy Future Act," An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. 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. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. S. 301: A bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, biologicals, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. S.701: A bill to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to intravenous immune globulins (IVIG). "America's Healthy Future Act" (unnumbered Senate bill), as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. Product Payment Issues Therapy Payment Issues

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 3200: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 3590: An act entitled The Patient Protection and Affordable Care Act. H.R. 3962: To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. S. 1679: An original bill to make quality, affordable health care available to all Americans, reduce costs, improve health care quality, enhance disease prevention, and strengthen the health care workforce. S. 1796, "America's Healthy Future Act," An original bill to provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes, as it relates to Medicaid reimbursement for drugs and new fees on manufacturers of drugs and medical devices. H.R. 759, the FDA Globalization Act, as it relates to drug safety and pedigree. Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 6331 (110th Congress): To amend titles XVIII and XIX of the Social Security Act to extend expiring provisions under the Medicare Program, to improve beneficiary access to preventive and mental health services, to enhance low-income benefit programs, and to maintain access to care in rural areas, including pharmacy access, and for other purposes. In particular, execution of the kidney education and bundling provisions. H.R. 2726: To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. H.R.1: The American Recovery and Reinvestment Act (stimulus bill); Specifically focused on aspects of the bill related to comparative effectiveness research. H.R.1548 : To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. S.547 : A bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. H.R.1765 : To amend title XVIII of the Social Security Act with respect to payment for the furnishing of intravenous immune globulin (IVIG) in a patient's home for the treatment of primary immune deficiency diseases and to cover certain disposable pumps as durable medical equipment in place of non-disposable pumps under the Medicare Program. H.R.1085/S. 442: To impose a limitation on lifetime aggregate limits imposed by health plans Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Issues regarding 340B Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 1245/S. 432, Kidney Disease Educational Benefits Act of 2007 regarding Medicare and Medicaid reimbursement issues including Medicaid Rebate and Kidney Disease Education H.R. 1193/S. 691, The Kidney Care Quality and Improvement Act of 2007 regarding all issues related to Medicare coverage of pre-ESRD education H.R. 2914/S. 2990, Medicare IVIG Access Act as it relates to Medicare coverage of IVIG services H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 6331/S. 3101, Medicare Improvements for Patients and Providers Act, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 3118, Preserving Access to Medicare Act of 2008, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 558, Mental Health Parity Act of 2007, as it relates to Medicaid rebates H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007, as it relates to Medicaid rebates Drug and biological product pricing and reimbursement Durable Medical Equipment (DME) payment Product Payment Issues Therapy Payment Issues

H.R. 1245/S. 432, to amend Title XVIII of the Social Security Act to provide coverage for kidney disease education services H.R. 976, The Children's Health Insurance Program Reauthorization Act of 2007, as it relates to Medicaid Rebate issues H.R. 1193/S. 691, The Kidney Care Quality and Improvement Act of 2007 H.R. 3162, The Children's Health and Medicare Protection Act (CHAMP) and S. 2499, The Medicare, Medicaid and SCHIP Act of 2007, as they relate to Medicaid Rebate issues and Kidney Disease Education H.R. 2914, to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to immune globulins H.R. 5605/S. 2029, to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP. Drug and biological product pricing and reimbursement Durable Medical Equipment (DME) payment Product Payment Issues Therapy Payment Issues

H.R. 1245/S. 432, Kidney Disease Educational Benefits Act of 2007 regarding Medicare and Medicaid reimbursement issues including Medicaid Rebate and Kidney Disease Education H.R. 1193/S. 691, The Kidney Care Quality and Improvement Act of 2007 regarding all issues related to Medicare coverage of pre-ESRD education H.R. 2914/S. 2990, Medicare IVIG Access Act as it relates to Medicare coverage of IVIG services H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 6331/S. 3101, Medicare Improvements for Patients and Providers Act, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 3118, Preserving Access to Medicare Act of 2008, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 558, Mental Health Parity Act of 2007, as it relates to Medicaid rebates H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007, as it relates to Medicaid rebates Drug and biological product pricing and reimbursement Durable Medical Equipment (DME) payment Product Payment Issues Therapy Payment Issues

H.R. 1245/S. 432, Kidney Disease Educational Benefits Act of 2007 regarding Medicare and Medicaid reimbursement issues including Medicaid Rebate and Kidney Disease Education H.R. 1193/S. 691, The Kidney Care Quality and Improvement Act of 2007 regarding all issues related to Medicare coverage of pre-ESRD education H.R. 2914/S. 2990, Medicare IVIG Access Act as it relates to Medicare coverage of IVIG services H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 6331/S. 3101, Medicare Improvements for Patients and Providers Act, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 3118, Preserving Access to Medicare Act of 2008, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 558, Mental Health Parity Act of 2007, as it relates to Medicaid rebates H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007, as it relates to Medicaid rebates Drug and biological product pricing and reimbursement Durable Medical Equipment (DME) payment Product Payment Issues Therapy Payment Issues

H.R. 1245/S. 432, Kidney Disease Educational Benefits Act of 2007 regarding Medicare and Medicaid reimbursement issues including Medicaid Rebate and Kidney Disease Education H.R. 1193/S. 691, The Kidney Care Quality and Improvement Act of 2007 regarding all issues related to Medicare coverage of pre-ESRD education H.R. 2914/S. 2990, Medicare IVIG Access Act as it relates to Medicare coverage of IVIG services H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 6331/S. 3101, Medicare Improvements for Patients and Providers Act, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 3118, Preserving Access to Medicare Act of 2008, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 558, Mental Health Parity Act of 2007, as it relates to Medicaid rebates H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007, as it relates to Medicaid rebates Drug and biological product pricing and reimbursement Durable Medical Equipment (DME) payment Product Payment Issues Therapy Payment Issues

H.R. 1245/S. 432, to amend Title XVIII of the Social Security Act to provide coverage for kidney disease education services H.R. 976, The Children's Health Insurance Program Reauthorization Act of 2007, as it relates to Medicaid Rebate issues H.R. 1193/S. 691, The Kidney Care Quality and Improvement Act of 2007 H.R. 3162, The Children's Health and Medicare Protection Act (CHAMP) and S. 2499, The Medicare, Medicaid and SCHIP Act of 2007, as they relate to Medicaid Rebate issues and Kidney Disease Education H.R. 2914, to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to immune globulins H.R. 5605/S. 2029, to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP. Drug and biological product pricing and reimbursement Durable Medical Equipment (DME) payment Product Payment Issues Therapy Payment Issues

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products. S. 1695, to amend the public health service act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences. H.R. 5605/S. 2029, to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP. H.R. 3610, the Food and Drug Import Safety Act of 2007 Consolidated Appropriations Act of 2008 (P.L. 110 - 161) Drug and device marketing and promotion Import drug safety issues Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 S. 3408, Comparative Effectiveness Research Act of 2008 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 S. 3408, Comparative Effectiveness Research Act of 2008 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 1245/S. 432, Kidney Disease Educational Benefits Act of 2007 regarding Medicare and Medicaid reimbursement issues including Medicaid Rebate and Kidney Disease Education H.R. 1193/S. 691, The Kidney Care Quality and Improvement Act of 2007 regarding all issues related to Medicare coverage of pre-ESRD education H.R. 2914/S. 2990, Medicare IVIG Access Act as it relates to Medicare coverage of IVIG services H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 6331/S. 3101, Medicare Improvements for Patients and Providers Act, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 3118, Preserving Access to Medicare Act of 2008, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 558, Mental Health Parity Act of 2007, as it relates to Medicaid rebates H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007, as it relates to Medicaid rebates Drug and biological product pricing and reimbursement Durable Medical Equipment (DME) payment Product Payment Issues Therapy Payment Issues

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 S. 3408, Comparative Effectiveness Research Act of 2008 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 1245/S. 432, Kidney Disease Educational Benefits Act of 2007 regarding Medicare and Medicaid reimbursement issues including Medicaid Rebate and Kidney Disease Education H.R. 1193/S. 691, The Kidney Care Quality and Improvement Act of 2007 regarding all issues related to Medicare coverage of pre-ESRD education H.R. 2914/S. 2990, Medicare IVIG Access Act as it relates to Medicare coverage of IVIG services H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 6331/S. 3101, Medicare Improvements for Patients and Providers Act, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 3118, Preserving Access to Medicare Act of 2008, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 558, Mental Health Parity Act of 2007, as it relates to Medicaid rebates H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007, as it relates to Medicaid rebates Drug and biological product pricing and reimbursement Durable Medical Equipment (DME) payment Product Payment Issues Therapy Payment Issues

H.R. 1245/S. 432, to amend Title XVIII of the Social Security Act to provide coverage for kidney disease education services H.R. 976, The Children's Health Insurance Program Reauthorization Act of 2007, as it relates to Medicaid Rebate issues H.R. 1193/S. 691, The Kidney Care Quality and Improvement Act of 2007 H.R. 3162, The Children's Health and Medicare Protection Act (CHAMP) and S. 2499, The Medicare, Medicaid and SCHIP Act of 2007, as they relate to Medicaid Rebate issues and Kidney Disease Education H.R. 2914, to amend title XVIII of the Social Security Act to improve access of Medicare beneficiaries to immune globulins H.R. 5605/S. 2029, to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP. Drug and biological product pricing and reimbursement Durable Medical Equipment (DME) payment Product Payment Issues Therapy Payment Issues

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 S. 3408, Comparative Effectiveness Research Act of 2008 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2914/S. 2990, Medicare IVIG Access Act as it relates to Medicare coverage of IVIG services H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 S. 3118, Preserving Access to Medicare Act of 2008, as it relates to pre-dialysis education for certain Medicare beneficiaries S. 558, Mental Health Parity Act of 2007, as it relates to Medicaid rebates H.R. 1424, Paul Wellstone Mental Health and Addiction Equity Act of 2007, as it relates to Medicaid rebates Drug and biological product pricing and reimbursement Product Payment Issues Therapy Payment Issues

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 S. 3408, Comparative Effectiveness Research Act of 2008 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 S. 3408, Comparative Effectiveness Research Act of 2008 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008 S. 1695, Biologics Price Competition and Innovation Act of 2007 H.R. 5629, Pathway for Biosimilars Act H.R. 2914/S. 2990, Medicare IVIG Access Act of 2007 P.L. 110-85/H.R. 3580, Food and Drug Administration Amendments Act of 2007 H.R. 5605/S. 2029, Physician Payments Sunshine Act of 2007 H.R. 3610, the Food and Drug Import Safety Act of 2007 S. 3408, Comparative Effectiveness Research Act of 2008 Food and Drug Administration Globalization Act of 2008 Drug and device marketing and promotion Drug and biological product pricing and reimbursement Healthcare-acquired infections Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy

H.R. 2900/S. 1082, Prescription Drug User Fee Amendments of 2007, all issues as they relate to pedigree, anti-counterfeiting and importation of biologics, prescription drugs and medical products. S. 1695, to amend the public health service act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences. H.R. 5605/S. 2029, to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP. H.R. 3610, the Food and Drug Import Safety Act of 2007 Consolidated Appropriations Act of 2008 (P.L. 110 - 161) Drug and device marketing and promotion Import drug safety issues Lifetime caps for insurance Medical product safety Prescription drug pedigree and anti-counterfeiting policy