Physician Payments Sunshine Act of 2007

HR 6331 Medicare Improvements for Patients and Providers Act of 2008, implementation of the Medicare Part D Program; S 3101 Medicare Improvements or Patients and Providers Act of 2008; Part D, Electronic Prescribing, Medicaid Pharmacy Reimbursement. S 3118, Preserving Access to Medicare Act of 2008. HR 4, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues; HR 758, Price Disclosure Regarding Treatment of Breast Cancer; S 3330 The Medicare Prescription Drug Savings and Choice Act 2009:HR 5605, Physician Payments Sunshine Act of 2008: transparency issues; HR 6884, Medicare Prescription Drug Cost Equalization Act: Part D issues; S 3, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues; S 2029, Physician Payments Sunshine Act of 2007: transparency issues; S 2041, False Claims Act Correction Act of 2007: liability issues; S 3118, Preserving Access to Medicare Act of 2008: electronic prescribing, Part D data disclosure, and other issues; S 3396, The Independent Drug Education and Outreach Act of 2008: direct to physician marketing; S 3408, Comparative Effectiveness Research Act of 2008: comparative effectiveness

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 2029/HR 5605 Physician Payments Sunshine Act, Comparative Effectiveness Research Act (S. 3408), American Recovery and Reinvestment Act of 2009 (with focus on health IT and comparative effectiveness provisions), Health Reform draft legislation.

Client expense: $100,000 · Firm income: Not reported

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

Provisions of the FY 2010 Budget and Budget Resolution (S Con Res 13 and H C Res 85) regarding health care reform, funding for the Centers for Medicare and Medicaid Services (CMS) for implementation of the Medicare program and Medicare Advantage Programs, the provision of Medicare and Medicaid services and benefits to patients, incentives to promote electronic health records for all Americans, value based purchasing and geographic fairness in Medicare reimbursement, a freeze in Medicare reimbursement updates for physician services, and comparative effectiveness research at the Agency for Health Research and Quality (AHRQ). Value Index Rewarding Value in the Reimbursement System Congress must introduce a value index into Medicare Parts A and B, to reward physicians and hospitals who provide safe, high quality care with excellent service to Medicare patients at a reasonable cost. The value index can be constructed for many types of payment models, including hospital DRG payments, physician fees, payment updates, and other payment formulas. We recommend that the geographic adjustment of physician work should be eliminated as recommended in legislation introduced by Senator Feingold (S 712) and Senator Grassley (S 318), and replaced with a quality/efficiency based coefficient for physician work as soon as possible. Legislation that we strongly support and would accomplish this objective, has been introduced by Iowa Rep. Bruce Braley and Wisconsin Rep. Ron Kind in the House and by Minnesota Senator Amy Klobuchar and Wisconsin Senators Feingold and Kohl in the Senate. The Medicare Payment Improvement Act (HR 2844, S 1249) seeks to reform the Medicare system to one that rewards the value of care over quantity of procedures, improving quality and lowering the total cost of care over time. The bills outcome-based approach creates the incentive for physicians and hospitals to work together to improve quality and use resources efficiently. Value Based Purchasing In the traditional fee-for-service system Medicare currently reimburses for units of service, in a manner that promotes service utilization without regard to quality. This has had the effect of economically stimulating growth in the numbers of supply-sensitive services provided by physicians. According to a recent report by the Congressional Budget Office spending in high-spending regions could be reduced without producing worse outcomes, on average, or reductions in the quality of care. (CBO February 2008) Alternatives: Medicare must capture the data on performance measures utilizing available claims-based data, and/or data recoverable through enhanced IT functions, and validate performance improvement. Implement quality/efficiency based payments for physician services as soon as possible. Implement bundled payments for episodes of care. Implement FFS reimbursement for the value added through care management and coordination of services. Improve reimbursement for primary care services. Improve access to care in rural areas. The Medicare Advantage program provides a capitated reimbursement to health plans for all Medicare benefits provided to enrolled beneficiaries. Corresponding mechanisms for rewarding value in the Medicare Advantage program should offer incentives for those plans that demonstrate superior patient care performance. Performance bonuses should be provided for plans that: Achieve predetermined quality performance targets; Adopt health information technology; Meet standards for care coordination; and Provide data on comparative effectiveness. Medicare Advantage Program Marshfield Clinic has concerns about payment projections and policy changes outlined by the Centers for Medicare and Medicaid Services in its Advance Notice of Methodological Changes for Calendar Year 2010 for Medicare Advantage Capitation Rate and Part C and Part D Payment Policies, dated February 20, 2009. Our first concern is that the national per capita growth rate projected in CMSs Advance Notice deviates significantly from the growth rate health plans are experiencing. CMSs projection is based in large part on an unrealistic assumption that Medicare fee-for-service payments for physician services will be cut by 21% this year. However, since 2003, previously scheduled fee reductions have been overridden by Congress. Secondly, an across-the-board 3.74% reduction for risk score coding patterns for all health plans appears quite large. Adequate Funding for CMS The problems facing the Medicare program stem from the nations earliest attempts to make health care services broadly available nationwide without disturbing the economic incentives that were then in place. The federal government developed formulas to evaluate the cost of providing services in different practice settings and in different geographic locations. Those formulas measure resource inputs that have changed over the +40 year life of the program. To ensure affordable access to Medicare services throughout the country Medicare must take steps to refine its measures of the cost of providing services so that Medicares overwhelming financial dominance does not interfere with affordable access in markets that have changed very much since the program began. Congress must ensure that CMS has adequate funding to provide oversight of its many programs, including its measurement of resource and input costs. Information Technology Under current law the capital and operating expenses of installing and maintaining electronic medical records (EMRs) are assumed to be part of the overhead expense of a medical practice. Since no more than 5 10% of the physician population has installed EMRs, CMS now obsolete measurement of physician practice expenses reflect minimal average expense associated with IT. Alternatives: Congress should provide incentives for EMR adoption, and/or utilization, and Establish standards to facilitate the sharing and exchange of data. CMS must update its mechanism for evaluating the cost of medical practice. Payment Equity for Physician Work Before MMA 03, Medicares payments were geographically adjusted based upon erroneous assumptions about the cost of hiring and retaining physicians. Congress established a floor payment mechanism for the physician work component of Medicare payment for 04 06 to assure that physicians in low payment localities were compensated for their work at least at the national average payment amount. The payment floor provision expired in 06, but has been extended in federal legislation every year since then. Alternatives: The payment floor should be extended indefinitely; Geographic adjustment of work should be eliminated entirely; and replaced with a coefficient of quality and efficiency. Support Senator Feingolds bill, the Rural Medicare Equity Act, S 712. Payment Fairness for Practice Costs The formulas by which Medicares payments are calculated are widely variable throughout Medicare localities, and are based upon outdated data assumptions regarding the cost and organization of medical practice. Alternatives: Congress should require CMS to administratively revise its measurement of cost of practice to assure the validity and fairness of payments; A payment floor could be established for practice expense. Practice Expense Payment Floor Congress must require the Centers for Medicare & Medicaid Services (CMS) to administratively revise its measurement of the cost of practice to assure the validity and fairness of payment. However, in the interim, a payment floor must be established for practice expense to stem the inequities of the current methodology as proposed by Reps. Braley and Kind in HR 2201, the Medicare Equity and Accessibility Act of 2009. Extreme variation induced by errors in the payment methodology may also be reduced without compromising the relativity of payment by establishing a geographic practice expense index that limits to the difference between relative wages and rents between fee schedule areas and the national average as proposed by Senator Grassley in S 318. Comparative Effectiveness/Evidence Based Medical Informatics Research Evidence-based medicine relies upon the judicious use of current best evidence in making decisions about the care of individual patients. Key to effective implementation of value-based purchasing initiatives is the systematic development of data that links the health of populations to the medical services the population receives. The application of health information technology and genomic information in population- and community-based health care delivery systems coupled with the development of wellness programs has the potential to substantially improve health and personalized health care on a national basis. The Physician Payment Sunshine Act, S. 2029, introduced by Senator Kohl with Senator Grassley in the 110th Congress to create accountability among physicians and the manufacturers of drugs and devices that physicians utilize and prescribe for their patients. This legislation would require manufacturers of pharmaceutical drugs, medical devices, and biologics to disclose the amount of money they give to doctors through payments, gifts, honoraria, travel and other means. The Medicare Rural Health Access Improvement Act, S 2786, introduced by Senator Grassley 110th Congress to mitigate current inequities in Medicare reimbursement, improve access to health services in rural and underserved areas, and will begin to close the gap between Medicare reimbursement and the cost of providing services in predominantly rural areas. The legislation establishes a 1.0 floor for physician work and practice expense adjustments. It also revises the work and practice expense formulas to reduce payment differences and more accurately compensate physicians in rural areas for their true practice costs. The bill also extends the five percent incentive payments for primary care and specialty physicians in scarcity areas. Marshfield Clinic nominated Dr. Douglas Reding for an open position on the Medicare Payment Advisory Commission, and sought the endorsement of the Wisconsin delegation, and other Senators and Representatives that serve on the Committees with jurisdiction over the Medicare program. Support for Rep. Ron Kinds concept of a not yet introduced MEDICARE EFFICIENCY BILL that would amend the CHAMP Act (H.R. 3162) 304 in whole, by establishing that the 5% bonus payment would be expanded to the top 10% of efficient counties; and a corresponding 5% efficiency penalty for physicians in the bottom 10% of efficient counties. CMS Physician Group Practice Demonstration On September 27, 2002 the Centers for Medicare and Medicaid Services published a notice in the Federal Register informing interested parties of an opportunity to submit proposals for participation in the Medicare Physician Group Practice Demonstration (PGP) project to test a hybrid payment methodology that combines Medicare fee-for-service payments with a bonus pool derived from savings achieved by improvements in patient care management. Marshfield Clinic submitted a proposal for this demonstration and was selected by CMS to participate in the demonstration program, effective April 1, 2005. Marshfield Clinic supported CMS determination to extend this program, beyond its initial 3-year term. Also supports efforts to eliminate the 2% threshold for payments and the 5% limitation on payments.

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

regulatory and reimbursement issues for medical devices in Medicare S. 2029 Physician Payments Sunshine Act transparency medical device pricing issues relating to disclosure of payments to physicians and gift bans issues relating to comparative effectiveness research

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 1 The American Recovery & Reinvestment Act of 2009: Comparative Effectiveness; HR 6331 Medicare Improvements for Patients and Providers Act of 2008, implementation of the Medicare Part D Program; HR 3162 Children's Health and Medicare Protection Act of 2007; S 3101 Medicare Improvements or Patients and Providers Act of 2008; Part D, Electronic Prescribing, Medicaid Pharmacy Reimbursement. S 3118, Preserving Access to Medicare Act of 2008. HR 4, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues; HR 758, Price Disclosure Regarding Treatment of Breast Cancer; S 3330 The Medicare Prescription Drug Savings and Choice Act 2009:HR 5605, Physician Payments Sunshine Act of 2008: transparency issues; HR 6884, Medicare Prescription Drug Cost Equalization Act: Part D issues; S 3, Medicare Prescription Drug Price Negotiation Act of 2007: Part D issues; S 2029, Physician Payments Sunshine Act of 2007: transparency issues; S 2041, False Claims Act Correction Act of 2007: liability issues; S 3118, Preserving Access to Medicare Act of 2008: electronic prescribing, Part D data disclosure, and other issues; S 3396, The Independent Drug Education and Outreach ACt of 2008: direct to physician marketing; S 3408, Comparative Effectiveness Research Act of 2008: comparative effectiveness

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

regulatory and reimbursement issues for medical devices in Medicare S. 2029 Physician Payments Sunshine Act transparency medical device pricing issues relating to disclosure of payments to physicians and gift bans issues relating to comparative effectiveness research

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

General Medicare and Medicaid issues, including, but not limited to, coverage and reimbursement; Physician Gifts: Physician Payments Sunshine Act (S. 2029); Drug and Medical Device Company Gift Disclosure Act (H.R. 3023); False Claims Act Correction Act (H.R. 4854/S.2041); Medicare Part D: Non-interference; Medicare Prescription Drugs and Modernization Act (Public Law 108-173)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 2029 - Physician Payments Sunshine Act of 2007 HR 6111 - Tax Relief and Healthcare Act (Medicare) Access to Life Saving Medicines Act Medicare Part B and Part D - Part D: Non-Interference/Part B: Prompt Pay Removal from Average Sales Price Calculation HR 6331 - Medicare Improvements for Patients and Providers Act of 2008 HR 2184 - Enhanced Health Care Value for all Act of 2007 HR 3023 Drug and Medical Device Company Gift Disclosure Act HR 3963 Children's Health Insurance Program Reauthorization Act of 2007 S 2041, HR 4854 - False Claims Act of Correction Act of 2007 HR 3610 - Food and Drug Import Safety Act of 2007 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation

Client expense: $1,347,134 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)

Provisions of the FY 2010 Budget and Budget Resolution (S Con Res 13 and H C Res 85) regarding health care reform, funding for the Centers for Medicare and Medicaid Services (CMS) for implementation of the Medicare program and Medicare Advantage Programs, the provision of Medicare and Medicaid services and benefits to patients, incentives to promote electronic health records for all Americans, value based purchasing and geographic fairness in Medicare reimbursement, and comparative effectiveness research at the Agency for Health Research and Quality (AHRQ). General Issue Area Code MMM (Medicare and Medicaid) Provisions of the FY 2010 Budget and Budget Resolution (S Con Res 13 and H C Res 85) regarding health care reform, funding for the Centers for Medicare and Medicaid Services (CMS) for implementation of the Medicare program and Medicare Advantage Programs, the provision of Medicare and Medicaid services and benefits to patients, incentives to promote electronic health records for all Americans, value based purchasing and geographic fairness in Medicare reimbursement, a freeze in Medicare reimbursement updates for physician services, and comparative effectiveness research at the Agency for Health Research and Quality (AHRQ). Value Based Purchasing In the traditional fee-for-service system Medicare currently reimburses for units of service, in a manner that promotes service utilization without regard to quality. This has had the effect of economically stimulating growth in the numbers of supply-sensitive services provided by physicians. According to a recent report by the Congressional Budget Office spending in high-spending regions could be reduced without producing worse outcomes, on average, or reductions in the quality of care. (CBO February 2008) Alternatives: Medicare must capture the data on performance measures utilizing available claims-based data, and/or data recoverable through enhanced IT functions, and validate performance improvement. Implement quality/efficiency based payments for physician services as soon as possible. Implement bundled payments for episodes of care. Implement FFS reimbursement for the value added through care management and coordination of services. Improve reimbursement for primary care services. Improve access to care in rural areas. The Medicare Advantage program provides a capitated reimbursement to health plans for all Medicare benefits provided to enrolled beneficiaries. Corresponding mechanisms for rewarding value in the Medicare Advantage program should offer incentives for those plans that demonstrate superior patient care performance. Performance bonuses should be provided for plans that: Achieve predetermined quality performance targets; Adopt health information technology; Meet standards for care coordination; and Provide data on comparative effectiveness. Medicare Advantage Program Marshfield Clinic has concerns about payment projections and policy changes outlined by the Centers for Medicare and Medicaid Services in its Advance Notice of Methodological Changes for Calendar Year 2010 for Medicare Advantage Capitation Rate and Part C and Part D Payment Policies, dated February 20, 2009. Our first concern is that the national per capita growth rate projected in CMSs Advance Notice deviates significantly from the growth rate health plans are experiencing. CMSs projection is based in large part on an unrealistic assumption that Medicare fee-for-service payments for physician services will be cut by 21% this year. However, since 2003, previously scheduled fee reductions have been overridden by Congress. Secondly, an across-the-board 3.74% reduction for risk score coding patterns for all health plans appears quite large. Adequate Funding for CMS The problems facing the Medicare program stem from the nations earliest attempts to make health care services broadly available nationwide without disturbing the economic incentives that were then in place. The federal government developed formulas to evaluate the cost of providing services in different practice settings and in different geographic locations. Those formulas measure resource inputs that have changed over the +40 year life of the program. To ensure affordable access to Medicare services throughout the country Medicare must take steps to refine its measures of the cost of providing services so that Medicares overwhelming financial dominance does not interfere with affordable access in markets that have changed very much since the program began. Congress must ensure that CMS has adequate funding to provide oversight of its many programs, including its measurement of resource and input costs. Information Technology Under current law the capital and operating expenses of installing and maintaining electronic medical records (EMRs) are assumed to be part of the overhead expense of a medical practice. Since no more than 5 10% of the physician population has installed EMRs, CMS now obsolete measurement of physician practice expenses reflect minimal average expense associated with IT. Alternatives: Congress should provide incentives for EMR adoption, and/or utilization, and Establish standards to facilitate the sharing and exchange of data. CMS must update its mechanism for evaluating the cost of medical practice. Payment Equity for Physician Work Before MMA 03, Medicares payments were geographically adjusted based upon erroneous assumptions about the cost of hiring and retaining physicians. Congress established a floor payment mechanism for the physician work component of Medicare payment for 04 06 to assure that physicians in low payment localities were compensated for their work at least at the national average payment amount. The payment floor provision expired in 06, but has been extended in federal legislation every year since then. Alternatives: The payment floor should be extended indefinitely; Geographic adjustment of work should be eliminated entirely; and replaced with a coefficient of quality and efficiency. Support Senator Feingolds bill, the Rural Medicare Equity Act, S 712. Payment Fairness for Practice Costs The formulas by which Medicares payments are calculated are widely variable throughout Medicare localities, and are based upon outdated data assumptions regarding the cost and organization of medical practice. Alternatives: Congress should require CMS to administratively revise its measurement of cost of practice to assure the validity and fairness of payments; A payment floor could be established for practice expense; or Comparative Effectiveness/Evidence Based Medical Informatics Research Evidence-based medicine relies upon the judicious use of current best evidence in making decisions about the care of individual patients. Key to effective implementation of value-based purchasing initiatives is the systematic development of data that links the health of populations to the medical services the population receives. The application of health information technology and genomic information in population- and community-based health care delivery systems coupled with the development of wellness programs has the potential to substantially improve health and personalized health care on a national basis. The Physician Payment Sunshine Act, S. 2029, introduced by Senator Kohl with Senator Grassley in the 110th Congress to create accountability among physicians and the manufacturers of drugs and devices that physicians utilize and prescribe for their patients. This legislation would require manufacturers of pharmaceutical drugs, medical devices, and biologics to disclose the amount of money they give to doctors through payments, gifts, honoraria, travel and other means. The Medicare Rural Health Access Improvement Act, S 2786, introduced by Senator Grassley 110th Congress to mitigate current inequities in Medicare reimbursement, improve access to health services in rural and underserved areas, and will begin to close the gap between Medicare reimbursement and the cost of providing services in predominantly rural areas. The legislation establishes a 1.0 floor for physician work and practice expense adjustments. It also revises the work and practice expense formulas to reduce payment differences and more accurately compensate physicians in rural areas for their true practice costs. The bill also extends the five percent incentive payments for primary care and specialty physicians in scarcity areas. Marshfield Clinic nominated Dr. Douglas Reding for an open position on the Medicare Payment Advisory Commission, and sought the endorsement of the Wisconsin delegation, and other Senators and Representatives that serve on the Committees with jurisdiction over the Medicare program. Support for Rep. Ron Kinds concept of a not yet introduced MEDICARE EFFICIENCY BILL that would amend the CHAMP Act (H.R. 3162) 304 in whole, by establishing that the 5% bonus payment would be expanded to the top 10% of efficient counties; and a corresponding 5% efficiency penalty for physicians in the bottom 10% of efficient counties. CMS Physician Group Practice Demonstration On September 27, 2002 the Centers for Medicare and Medicaid Services published a notice in the Federal Register informing interested parties of an opportunity to submit proposals for participation in the Medicare Physician Group Practice Demonstration (PGP) project to test a hybrid payment methodology that combines Medicare fee-for-service payments with a bonus pool derived from savings achieved by improvements in patient care management. Marshfield Clinic submitted a proposal for this demonstration and was selected by CMS to participate in the demonstration program, effective April 1, 2005. Marshfield Clinic supported CMS determination to extend this program, beyond its initial 3-year term. Also supports efforts to eliminate the 2% threshold for payments and the 5% limitation on payments.

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

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

-H.R. 1190, "Community Cancer Care Preservation Act of 2007," regarding amending title XVIII of the Social Security Act to preserve access to community cancer care by Medicare beneficiaries; -Proposed Rule (CMS-1404-P), "CY 2009 Outpatient Prospective Payment System Rules". -H.R. 1321,Medicare Advanced Laboratory Diagnostics Act of 2007, regarding amending title XVIII of the Social Security Act to improve payments under the Medicare clinical laboratory fee schedule; -H.R. 1663, Medicare Mental Health Modernization Act of 2007, regarding amending title XVIII of the Social Security Act to expand and improve coverage of mental health services under the Medicare Program; -H.R. 1845 / S 1428, Medicare Durable Medical Equipment Access Act of 2007, regarding amending part B of title XVIII of the Social Security Act to assure access to durable medical equipment under the Medicare Program; -H.R. 2770, To amend title XVIII of the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price, all provisions; -H.R. 3011, To amend title XVIII of the Social Security Act to ensure adequate payment amounts for drugs and biologicals under part B of the Medicare Program, regarding all provisions; -H.R. 3061, Medicare Part D Drug Class Protection Act of 2007, regarding amending title XVIII of the Social Security Act to require that Medicare prescription drug plans using formularies cover all drugs included in 6 specified therapeutic categories and to establish protective requirements for coverage determinations; -H.R. 4 / S 3, Medicare Prescription Drug Price Negotiation Act of 2007, regarding amending part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate lower covered part D drug prices on behalf of Medicare beneficiaries; -H.R. 976 / S 1893, Children's Health Insurance Program Reauthorization Act of 2007; -H.R. 3162, Children's Health and Medicare Protection Act of 2007, regarding improving enrollment and retention of eligible children; -S. 1887, Medicare Access to Critical Medications Act of 2007, regarding amending title XVIII of the Social Security Act in order to ensure access to critical medications under the Medicare part D prescription drug program; -S. 631, Remote Monitoring Access Act of 2007, regarding amending title XVIII of the Social Security Act to provide for coverage of remote patient management services for chronic health care conditions under the Medicare Program; -S. 860, Early Treatment for HIV Act of 2007, regarding amending title XIX of the Social Security Act to permit States the option to provide Medicaid coverage for low-income individuals infected with HIV; -CMS-1270-F, Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) and Other Issues, regarding a final rule establishing competitive bidding programs for certain Medicare Part B covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act; issues regarding competitive bidding, demonstrations for clinical lab services and competitive Medicare payments for lab services; issues regarding Medicare national coverage determination for the use of erythropoiesis stimulating agents in cancer and related neoplastic conditions; -CMS-2238-FC, regarding the Medicaid program, and prescription drugs; -S. 2499, "Medicare, Medicaid, and SCHIP Extension Act of 2007," all provisions. -S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP; -H.R. 5765 / S. 631, "Medicare Remote Monitoring Access Act of 2008," regarding amending title XVIII of the Social Security Act to cover remote patient management services for certain chronic health conditions under the Medicare Program; -H.R. 6252, "Medicare DMEPOS Competitive Acquisition Reform Act of 2008", To amend part B of title XVIII of the Social Security Act to delay and reform the Medicare competitive acquisition program for purchase of durable medical equipment, prosthetics, orthotics, and supplies, regarding all provisions; -S. 2404, "Medicare Advanced Laboratory Diagnostics Act of 2007", A bill to amend title XVIII of the Social Security Act to improve payments under the Medicare clinical laboratory fee schedule, regarding all provisions; -H.R. 6331/ S. 3101, "Medicare Improvements for Patients and Providers Act of 2008", A bill to amend titles XVIII and XI 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, regarding all provisions; -H.R. 2770, "To amend title XVIII of the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price", regarding all provisions.

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

-H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; -H.R. 1494 / S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediatric medical devices; -H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; -H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; -H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; -H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; -H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; -H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; -S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; -S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; -S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; -S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; -S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; -S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; -H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; -H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; -H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; -S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; -H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; -H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; -H.R. 5839, "Safeguarding America's Pharmaceuticals Act of 2008", To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, regarding all provisions; -S. 334, "Healthy Americans Act", A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away, regarding all provisions; -H.R. 6381, "Medical Device Safety Act of 2008", To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions; -S. 438, "Fair Prescription Drug Competition Act", A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs, regarding all provisions; -S.2274, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan", and for other purposes, regarding all provisions. -S.3409 "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration", and for other purposes; regarding all provisions. -S.1378 "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan", and for other purposes; regarding all provisions. -S. 3408, "Comparative Effectiveness Research Act of 2008", A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes, regarding all provisions; -S. 1276, "Methamphetamine Production Prevention Act of 2008", A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions. -Proposed Rule (CMS-1403-P), Regarding revisions to Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; -S.2424, "A bill to ensure that all Americans have basic health literacy skills to function effectively as patients and health care consumers", regarding all provisions.

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

-H.R. 1424, "Paul Wellstone Mental Health and Addiction Equity Act of 2007," regarding amending section 712 of the Employee Retirement Income Security Act of 1974, section 2705 of the Public Health Service Act, and section 9812 of the Internal Revenue Code of 1986 to require equity in the provision of mental health and substance-related disorder benefits under group health plans; -H.R. 1494 / S. 830, "Pediatric Medical Device Safety and Improvement Act of 2007," regarding improving the process for the development of needed pediatric medical devices; -H.R. 1956, "Patient Protection and Innovative Biologic Medicines Act of 2007," regarding amending the public Health Service Act to provide for the approval of similar biological products; -H.R. 2193, "Animal Protection Accountability Improvement Act," regarding amending the Animal Welfare Act to increase the penalties for violations of such Act to prohibit the use of animals for marketing medical devices; -H.R. 2349/ S. 1413, "Uterine Fibroid Research and Education Act of 2007," regarding providing for research and education with respect to uterine fibroids; -H.R. 3333 / S. 1576, "Minority Health Improvement and Health Disparity Elimination Act," regarding amending the Public Health Services Act to improve the health and healthcare of racial and ethnic minority groups; -H.R. 788 / S. 468, "Food and Drug Administration Safety Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act with respect to drug safety; -H.R. 2900, "Food and Drug Administration Amendments Act of 2007," regarding amending the Federal Food, Drug, and Cosmetic Act to revise and extend the use-fee programs for prescription drugs and for medical devices and to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs; -S. 1082, "Food and Drug Administration Revitalization Act," regarding amending the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products; -S. 1695, "Biologics Price Competition and Innovation Act of 2007," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosilimar products to promote innovation in the life sciences; -S. 467, "Fair Access to Clinical Trials Act of 2007 or the 'FACT Act'," regarding amending the Public Health Services Act to expand clinical trials drug data bank; -S. 558, "Mental Health Parity Act of 2007," regarding all provisions ; -S. 628, "Critical Access to Health Information Technology Act of 2007," regarding improving grants for rural health information technology development activities; -S. 993, "Pediatric Research Improvement Act," regarding improving pediatric research; issues regarding Acetemorphine and Phenelyperine; -H.R. 3580, "Food and Drug Administration Amendments Act of 2007," regarding fees related to prescription drugs, medical devices, and food safety; -H.R. 2419 / S. 2302, "Food and Energy Security Act of 2007," regarding marketing and financial assistance related to farming and food production; -H.R. 5606 / S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending Title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP; -S. 2221, "Transparency in Medical Device Pricing Act of 2007," regarding amending Title XVIII of the Social Security Act to provide for the reporting of sales price data for implantable devices; -H.R. 3043, "Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008," regarding appropriations for the Department of Health and Human Services; -H.R. 5629, "Pathway for Biosimilar Act," regarding amending the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products; -H.R. 5839, "Safeguarding America's Pharmaceuticals Act of 2008", To Amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, regarding all provisions; -S. 334, "Healthy Americans Act", A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away, regarding all provisions; -H.R. 6381, "Medical Device Safety Act of 2008", To amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions; -S. 438, "Fair Prescription Drug Competition Act", A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs, regarding all provisions; -S.2274, "A bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan", and for other purposes, regarding all provisions. -S.3409 "A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration", and for other purposes; regarding all provisions. -S.1378 "A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the distribution of the drug dextromethorphan", and for other purposes; regarding all provisions. -S. 3408, "Comparative Effectiveness Research Act of 2008", A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research and to amend the Internal Revenue Code of 1986 to establish a Comparative Effectiveness Research Trust Fund, and for other purposes, regarding all provisions; -S. 1276, "Methamphetamine Production Prevention Act of 2008", A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices, regarding all provisions. -Proposed Rule (CMS-1403-P), Regarding revisions to Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; -S.2424, "A bill to ensure that all Americans have basic health literacy skills to function effectively as patients and health care consumers", regarding all provisions.

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

-H.R. 1190, "Community Cancer Care Preservation Act of 2007," regarding amending title XVIII of the Social Security Act to preserve access to community cancer care by Medicare beneficiaries; -Proposed Rule (CMS-1404-P), "CY 2009 Outpatient Prospective Payment System Rules". -H.R. 1321,Medicare Advanced Laboratory Diagnostics Act of 2007, regarding amending title XVIII of the Social Security Act to improve payments under the Medicare clinical laboratory fee schedule; -H.R. 1663, Medicare Mental Health Modernization Act of 2007, regarding amending title XVIII of the Social Security Act to expand and improve coverage of mental health services under the Medicare Program; -H.R. 1845 / S 1428, Medicare Durable Medical Equipment Access Act of 2007, regarding amending part B of title XVIII of the Social Security Act to assure access to durable medical equipment under the Medicare Program; -H.R. 2770, To amend title XVIII of the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price, all provisions; -H.R. 3011, To amend title XVIII of the Social Security Act to ensure adequate payment amounts for drugs and biologicals under part B of the Medicare Program, regarding all provisions; -H.R. 3061, Medicare Part D Drug Class Protection Act of 2007, regarding amending title XVIII of the Social Security Act to require that Medicare prescription drug plans using formularies cover all drugs included in 6 specified therapeutic categories and to establish protective requirements for coverage determinations; -H.R. 4 / S 3, Medicare Prescription Drug Price Negotiation Act of 2007, regarding amending part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate lower covered part D drug prices on behalf of Medicare beneficiaries; -H.R. 976 / S 1893, Children's Health Insurance Program Reauthorization Act of 2007; -H.R. 3162, Children's Health and Medicare Protection Act of 2007, regarding improving enrollment and retention of eligible children; -S. 1887, Medicare Access to Critical Medications Act of 2007, regarding amending title XVIII of the Social Security Act in order to ensure access to critical medications under the Medicare part D prescription drug program; -S. 631, Remote Monitoring Access Act of 2007, regarding amending title XVIII of the Social Security Act to provide for coverage of remote patient management services for chronic health care conditions under the Medicare Program; -S. 860, Early Treatment for HIV Act of 2007, regarding amending title XIX of the Social Security Act to permit States the option to provide Medicaid coverage for low-income individuals infected with HIV; -CMS-1270-F, Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) and Other Issues, regarding a final rule establishing competitive bidding programs for certain Medicare Part B covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act; issues regarding competitive bidding, demonstrations for clinical lab services and competitive Medicare payments for lab services; issues regarding Medicare national coverage determination for the use of erythropoiesis stimulating agents in cancer and related neoplastic conditions; -CMS-2238-FC, regarding the Medicaid program, and prescription drugs; -S. 2499, "Medicare, Medicaid, and SCHIP Extension Act of 2007," all provisions. -S. 2029, "Physician Payments Sunshine Act of 2007," regarding amending title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid or SCHIP; -H.R. 5765 / S. 631, "Medicare Remote Monitoring Access Act of 2008," regarding amending title XVIII of the Social Security Act to cover remote patient management services for certain chronic health conditions under the Medicare Program; -H.R. 6252, "Medicare DMEPOS Competitive Acquisition Reform Act of 2008", To amend part B of title XVIII of the Social Security Act to delay and reform the Medicare competitive acquisition program for purchase of durable medical equipment, prosthetics, orthotics, and supplies, regarding all provisions; -S. 2404, "Medicare Advanced Laboratory Diagnostics Act of 2007", A bill to amend title XVIII of the Social Security Act to improve payments under the Medicare clinical laboratory fee schedule, regarding all provisions; -H.R. 6331/ S. 3101, "Medicare Improvements for Patients and Providers Act of 2008", A bill to amend titles XVIII and XI 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, regarding all provisions; -H.R. 2770, "To amend title XVIII of the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price", regarding all provisions.

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

S.2029-Physician Payments Sunshine Act of 2007 H.R.5613-Protecting the Medicaid Safety Net Act H.R.3610-Food & Drug Import Safety Act H.R.4-Medicare Prescription Drug Price Negotiation Act of 2007 Comparative Effectiveness in H.R.3162

Client expense: $441,146 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institute on Alcohol Abuse & Alcoholism (NIAA), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA)

Sunshine Act (S 2029, HR 5605)

Client expense: $2,860,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Sunshine Act (S 2029, HR 5605)

Client expense: $2,860,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R.477 Stroke Treatment & Ongoing Prevention Act H.R.583 Consistency, Accuracy, Responsibility, & Excellence (CARE) in Medical Imaging & Radiation Therapy Act of 2007 H.R.882 Access to Emergency Medical Services Act of 2007 H.R.1093 Resident Physician Shortage Reduction Act of 2007 H.R.1233 Mitigating the Impact of Uncompensated Services & Time Act of 2007 H.R.1418 Reauthorizations of the Traumatic Brain Injury Act H.R.1424 Paul Wellstone Mental Health & Addiction Equity Act of 2007 H.R.2050 Medicaid Emergency Psychiatric Care Act of 2007 H.R.2164 Medicare Ambulance Payment Extension Act H.R. 2406 Healthcare Information Technology Enterprise Integration Act H.R.2464 Wakefield Act H.R.2580 Help Efficient, Accessible, Low Cost, Timely Healthcare (HEALTH) Act of 2007 H.R.2583 Physician Workforce & Graduate Medical Education Enhancement Act of 2007 H.R.2584 High-need Physician Workforce Incentives Act of 2007 H.R.2626 Comprehensive Health Coverage and Reform Enhancement (CARE) Act of 2007 H.R.2749 Voluntary Medicare Quality Reporting Act H.R.3163 Healthy Americans Act H.R.3173 Improving Emergency Medical Care & Response Act of 2007 H.R.3344 Treat Physicians Fairly Act of 2007 H.R.3495 - Kids in Disasters Well-Being, Safety & Health Act of 2007 H.R.3533 Public and Teaching Hospital Preservation Act H.R.3963 Childrens Health Insurance Program Reauthorization Act of 2007 H.R.4736 To amend Part B of Title XVIII of the Social Security Act to repeal limiting charges under the Medicare Program for non-participating physicians and to preempt State laws that prohibit balance billing H.R.5445 To amend Part B of Title XVIII of the Social Security Act to increase Medicare payments for physicians services through December 31, 2009 H.R.5613 Protecting the Medicaid Safety Net Act of 2008 S.60 Wakefield Act S.243 Medical Care Access Protection (MCAP) Act of 2007 S.334 Healthy Americans Act S.558 Mental Health Parity Act of 2007 S.588 Resident Physician Shortage Reduction Act of 2007 S.793 Reauthorizations of the Traumatic Brain Injury Act S.999 Stroke Treatment & Ongoing Prevention Act S.1003 Access to Emergency Medical Services Act of 2007 S.1042 Consistency, Accuracy, Responsibility, & Excellence (CARE) in Medical Imaging & Radiation Therapy Act of 2007 S.1310 Medicare Ambulance Payment Extension Act S.1408 Health Information Technology Act of 2007 S.1519 Voluntary Medicare Quality Reporting Act S.1693 Wired for Health Care Quality Act S.1873 Improving Emergency Medical Care & Response Act of 2007 S.1947 Continuing the Advancement of Quality Improvement Act of 2007 S.1970 Kids in Disasters Well-Being, Safety & Health Act of 2007 S.2029 Physician Payments Sunshine Act of 2007 S.2319 National Trauma Center Stabilization Act of 2007 S.2406 Medicaid Emergency Psychiatric Care Act of 2007 S.2729 Ensuring the Future Physician Workforce Act of 2008 S.2785 Save Medicare Act of 2008 S.2819 Economic Recovery in Health Care Act of 2008

Client expense: $762,281 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H. R. 2606, 340B Program Improvement and Integrity Act of 2007, 340B drug price expansion H. R. 3162, Children's Health and Medicare Protection Act of 2007 H. R. 4, Medicare Prescription Drug Price Negotiation Act, Medicare "non-interference" provisions H. R. 5480, Medicare Funding Warning Response Act of 2008 S. 1376, 340B Program Improvement and Integrity Act of 2007, 340B drug price expansion S. 2029, Physician Payments Sunshine Act of 2007 S. 2662, Medicare Funding Warning Response Act of 2008 S. 3, Medicare Prescription Drug Price Negotiation Act, Medicare noninterference provisions Comparative Effectiveness 2008 Medicare Bill H.R. 1424, Emergency Economic Stabilization Act of 2008

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

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

S. 877, Controlling the Abuse of Prescriptions Act of 2007 Drug importation H. R. 1038, Access to Life-Saving Medicine Act, follow-on biologics H. R. 1956, Patient Protection and Innovative Biologic Medicines Act of 2007, follow-on biologics H. R. 5629, Pathway for Biosimilars Act S. 1505, Affordable Biologics for Consumers Act of 2007, follow-on biologics S. 1695, Biologics Price Competition and Innovation Act of 2007, follow-on biologics S. 2029, Physician Payments Sunshine Act of 2007 S. 623, Access to Life-Saving Medicine Act, follow-on biologics

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

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

S. 251, Pharmaceutical Market Access Act of 2007; S. 242/H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007; S. 2029/H.R. 5605, Physician Payment Sunshine Act of 2008; S. 558, Mental Health Parity Act of 2007; H.R. 1424, Paul Wellstone Health and Addiction Equity Act of 2007; S. 2723/H.R. 5549, Deamonte Driver Dental Access Act of 2008; H.R. 3580 - Food and Drug Administration Amendments Act of 2007

Client expense: $733,000 · Firm income: Not reported

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

S 631 - Remote Monitoring Access Act of 2007 - a bill to provide for coverage of remote patient management services for chronic health care conditions under the Medicare program. [Julie Cohen, Seth Radus, Brett Loper, Madeleine Smith] HR 1321/S 2404 - Medicaid Advanced Laboratory Diagnostics Act of 2007 - a bill to improve payments under the Medicare clinical laboratory fee schedule [Julie Cohen, Seth Radus, Brett Loper] S 736 - Laboratory Test Improvement Act [David Nexon] HR 1293/S 1338- Access to Medicare Imaging Act - a bill to provide for a 2-year moratorium on certain Medicare physician payment reductions for advanced diagnostic imaging service [Seth Radus, Madeleine Smith] HR 3162 - Children's Health and Medicare Protection Act of 2007 - a bill to extend and improve the children's health insurance program, to improve beneficiary protections under the Medicare, Medicaid, and the CHIP program. [Julie Cohen, Seth Radus, David Nexon] S 2029- Physician Payments Sunshine Act of 2007 - a bill to provide transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP. [Seth Radus, Julie Cohen, Brett Loper, David Nexon] HR 5605 - Physician Payments Sunshine Act of 2008 - A bill to amendment 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, and for other purposes [Julie Cohen, Seth Radus, David Nexon] S 2221 - Transparency in Medical Device Pricing Act of 2007 - a bill to provide for the reporting of sales price data for implantable medical devices [ Seth Radus, Julie Cohen, David Nexon, Brett Loper, Madeleine Smith, David Nexon] HR 3023 - Drug and Medical Device Company Gift Disclosure Act - a bill to require the manufacturers, and distributors of prescription drugs and medical devices to disclosre certain gifts provided in connection with detailing, promotional, or other marketing activities. [Seth Radus, Julie Cohen, David Nexon] HR 6381 - to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. [Seth Radus, Julie Cohen] S. 3010/HR 6331 - Medicare Improvements for Patients and Providers Act of 2008. A bill to amend title XVIII (medicare) of the Social Security Act (SSA) to provide for coverage of additional preventive services [Julie Cohen, Brett Loper, Seth Radus, David Nexon] HR 6252 - Medicare DMEPOS Competitive Acquisition Reform Act. A bill to amend part B of title XVIII of the Social Security Act to delay and reform the Medicare competitive acquisition program for purchase of durable medical equipment, prosthtics, orthotics, and supplies [Julie Cohen, David Nexon, Madeleine Smith]

Client expense: $924,074 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), White House Office

Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Drug Safety Cont... Heparin Contamination Counterfeit Drugs FDA Globalization Act of 2008 H.R. 5839 Safeguarding America's Pharmaceuticals Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Stem Cell Research Medicaid Rebates H.R. 1424 H.R. 6331 H.R. 3162 H.R. 1367 S.3101 Medicaid/Medicare Packages Dual Proportionality Medicaid Rebates in Hospital Outpatient Setting CMS AMP Regulations Human Growth Hormone Regulation S.877 H.R. 4911 Follow-on Biologics H.R. 1038 H.R. 1956 H.R. 5629 S. 1695 FDA Regulatory Processes for First-Time Filers Funding for Biomedical Advanced Research & Development Authority (BARDA) Departments of Labor, Health and Human Services and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Vaccine Financing National Vaccine Advisory Committee Draft Recommendations Vaccines for Children Program National Vaccine Advisory Committee Draft Recommendations Influenza Vaccine Supply and Immunization Recommendations Barriers and Incentives Related to Personalized Medicine Outpatient Prospective Patient Services S. 3101: Medicare Improvements for Patients and Providers Act of 2008 In Vitro Diagnostics Regulatory Oversight Comparative Effectiveness Program Initiatives H.R. 6331 S. 3101 Medicare/Medicaid Packages International Market Access for U.S. Healthcare Products Healthcare Sector Advocacy/Free Trade Agreements Alliance for Healthcare Competitiveness Funding for National Institutes of Health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Bioterrorism and Emergency Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for Pandemic Influenza Preparedness Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642) Funding for the Food and Drug Administration Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 (Human Drug, Biologics, Food Safety, Critical Path, Regan-Udall Foundation, Center for Veterinary Medicine) FY 2008 Supplemental Appropriations Bill (H.R. 2642) Access to Investigation Drugs for Seriously Ill Patents The Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (S.1956) Physician Payments Sunshine Act S.2029 Access to Drug Pricing Data H.R. 5683 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FDA Debarment H.R. 6378: The Strengthening of FDA Integrity Act Intellectual Property and Access to Medicines for Neglected Diseases and Diseases of Developing World U.S. Government Positions in WTO, WHO Negotiations

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Genetically Engineered (GE) Animals U.S. Government Policy Position for Codex Guidelines on Food Safety Risk Assessment for rDNA Animals FDA and USDA Draft Regulation of GE Animals H. R. 6432 Drug Safety Implementation of Food & Drug Administration Amendments Act of 2007 Clinical Trial Registry and Results Databases Risk Management Plans Heparin Contamination Counterfeit Drugs H.R. 5839: Safeguarding America's Pharmaceuticals Act of 2008 FDA Globalization Act of 2008 H.R. 3610: The Food and Drug Import Safety Act of 2007 Drug Importation Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act for FY 2009 Department of Homeland Security Appropriations Act for FY 2009 (S.3181) Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 Adventitious Presence (Low Level Presence) U.S. Government Policy Position for Codex Guidelines on Adventitious Presence Korea Trade Negotiations EU Trade Meetings Physician Payments Sunshine Act S.2029 Livestock Cloning/Product Labeling FDA Risk Assessment on Cloning USDA Marketing and Regulatory Programs, Cloning Transition Period USDA Economic Report on Impact of Cloning on US Agriculture and Food Production USDA National Organic Program, Advance Notice of Proposed Rulemaking Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 H.R. 3161 S. 1859 H.R. 992 S. 414 H.R. 1396 S. 536 H.R. 4855 H.R. 2419 S.2663 Access to Drug Pricing Data H.R. 5683 Funding for Food Safety at the Food and Drug Administration Departments of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for FY 2009 FY 2008 Supplemental Appropriations Bill (H.R. 2642)

Client expense: $1,920,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

S. 2029 - The Physician Payments Sunshine Act of 2007 H.R. 3023 - The Drug and Medical Device Company Gift Disclosure Act of 2007 S. 2662 / H.R. 5480 - The Medicare Funding Warning Response Act of 2008 H.R. 3162 - The Children's Health and Medicare Protection Act of 2007 S. 2313 / H.R. 3697 - The Strategies to address Antimicrobial Resistance Act of 2007 Medicare Reform Implementation Medicare Technology Reimbursement ICD-10 Implementation H.R. 6252 and S. 3144 - The Medicare DMEPOS Competitive Acquisition Reform Act of 2008 H.R. 6331 - The Medicare Improvements for Patients and Providers Act of 2008 CE bill (Baucus and Allen) - S. 3408 - Comparative Effectiveness Research Act; H.R. 2184 - Enhanced Health Care Value For All Act Wydam bill - S. 334 and H.R. 3163 - Healthy Americans Act and new chron care bill, S. 3613 - Independence At Home Act Ryan Tax / Health bill - H.R. 6110 - Roadmap For America's Future Act

Client expense: $870,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Federal Communications Commission (FCC), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

S. 2029 - The Physician Payments Sunshine Act of 2007 H.R. 3023 - The Drug and Medical Device Company Gift Disclosure Act of 2007 S. 2313 / H.R. 3697 - The Strategies to Address Antimicrobial Resistance Act of 2007 S. 628 - The Critical Access to Health Information Technology Act of 2007 S. 2351 / H.R. 4200 - A bill to amend the Internal Revenue Code of 1986 to provide a tax credit for medical research related to developing qualified infectious disease products H.R. 3610 - Food and Drug Import Safety Act of 2007 H.R. 3839 - Safeguarding America's Pharmaceuticals Act of 2008 E-Records Patient Safety ERISA Preservation CE bill (Baucus and Allen) - S. 3408 - Comparative Effectiveness Research Act; H.R. 2184 - Enhanced Health Care Value For All Act Wydan bill - S. 334 and H.R. 3163 - Healthy Americans Act and new chron care bill, S. 3613 - Independence At home Act Ryan Tax/Health bill - H.R. 6110 - Roadmap For America's Future Act

Client expense: $870,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Federal Communications Commission (FCC), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

H.R. 1065, H.R. 1682, H.R. 2549, H.R. 2762, H.R. 3121, H.R. 3200, H.R. 330, H.R. 3926, H.R. 3959, H.R. 4050, H.R. 4299, H.R. 4461, H.R. 4721, H.R. 5611, H.R. 5633, H.R. 5792, H.R. 5840, H.R. 5961, H.R. 6062, H.R. 6078, H.R. 6213, H.R. 6285, H.R. 6424, H.R. 91, H.R. 920, H.R. 921, H.R. 922, H.R. 957, S. 1061, S. 1890, S. 1938, S. 2029, S. 2151, S. 2251, S. 2284, S. 2285, S. 2458, S. 2499, S. 2621, S. 3483, S. 396, S. 30, S. 929

Client expense: $454,203 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Federal Emergency Management Agency (FEMA), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

HR91, HR330, HR920, HR921, HR922, HR957, HR1049, HR1065, HR1289, HR1682, HR2549, HR2638, HR2761, HR3121, HR3200, HR3926, HR3959, HR4050, HR4299, HR4461, HR 4721, HR5611, HR5633, HR5792, HR5840, HR5961, HR6062, HR6078, HR6213, HR6285, HR6308, HR6755, S40, S396, S1061, S1890, S1938, S2029, S2040, S2151, S2251, S2284, S2285, S2458, S2499, S2621

Client expense: $433,208 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE, Treasury, Dept of

HR 1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S. 631, Remote Monitoring Access Act of 2007 S. 2221, Transparency in Medical Device pricing Act of 2007 H.R. 6381, Medical Device Safety Act S. 2029 Gift Disclosure

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

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

HR 1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S. 631, Remote Monitoring Access Act of 2007 S. 2221, Transparency in Medical Device pricing Act of 2007; price transparency H.R. 6381, Medical Device Safety Act, S. 3398 S. 2029 gift disclosure

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

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

S. 242 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 4854 False Claims Act Correction Act of 2007 S. 2029 False Claims Act Correction Act of 2007 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccines Supply Act H.R. 3944 National Hepatitis B Act H.R. 5884 Sunshine in Litigation Act of 2008 S. 2449 Sunshine in Litigation Act of 2007 H.R. 5605 Physician Payments Sunshine Act of 2008 S. 2029 Physician Payments Sunshine Act of 2007 H.R. 3610 Food and Drug Import Safety Act of 2007 S. 3409 Drug and Device Accountability Act of 2008 H.R. 6381 Medical Device Safety Act of 2008 S. 3398 Medical Device Safety Act of 2008

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

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

S. 2029, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. H.R. 5605, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME.

Client expense: $755,699 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE

P.L. 110-204, Federal programs to screen for heritable disorders in newborn children, Public awareness, training to offer quality care for infants. S. 1695, Follow-on Biologics, Determine AAFP position. S. 2029, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. H.R. 5605, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. H.R. 6357, Health Information Technology, To subsidize HIT for small and medium sized physician practices. H.R. 7192, Preserving Patient Access to Primary Care Act, To provide support for medical training for primary care and for primary care physician practices. No Bill, Health Care reforms to improve access to health care, To introduce AAFP views on health reform to Senate HELP Committee. No Bill, Health Professions Shortage Areas, To ensure fairness in the designation process. No Bill, Increase appropriations for Rural Health programs in FY 2009, Adequate funding for HHS Rural Health and programs. No Bill, Increase appropriations for Title VII health professions grants in FY 2009, Adequate funding for AHRQ. No Bill, Prevents cuts to the National Health Services Corps in FY 2009, Adequate funding for NHSC to relieve student debt. No Bill, Racial and Ethnic Disparities, To reduce disparities in health care.

Client expense: $755,699 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE

P.L. 110-329 (H.R. 2638), Increased funding for Agency for Healthcare Research and Quality (AHRQ) FY 2009 Appropriations, Adequate funding for Health Information Technology and Comparable Effectiveness Research. P.L. 110-329 (H.R. 2638), Increased funding for Rural Health Programs in FY 2009 Appropriations, Adequate funding for HHS Rural Health Programs. P.L. 110-329 (H.R. 2638), Increased funding for Title VII Health Professions Grants for Primary Care Medicine Training FY 2009 Appropriations, Adequate funding for HRSA's Title VII grants. P.L. 110-329 (H.R. 2638), Prevent cuts in funding to National Health Service Corps in FY 2009 Appropriations, Adequate funding for NHSC. S. 2029, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. S. 2408, Health Information Technology, To subsidize HIT for small and medium sized physician practices. H.R. 3800, Health Information Technology, To subsidize HIT for small and medium sized physician practices. H.R. 4296, Health Information Technology, To subsidize HIT for small and medium sized physician practices. H.R. 5442, Health Information Technology, To subsidize HIT for small and medium sized physician practices. H.R. 5605, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. H.R. 6357, Health Information Technology, To subsidize HIT for small and medium sized physician practices. H.R. 6983, Mental Health Parity, To require health plans to cover mental health services on a par with how they cover physical health. No Bill, Health care reforms to improve access to health care, To introduce AAFP views on health reform to Senate HELP Committee. No Bill, Health Professions Shortage Areas, To ensure fairness in the designation process. No Bill, Promoting the US health delivery system reform to a Patient Centered Medical Home model of care, Promoting health care reform base on the PCMH model of care. No Bill, Racial and Ethnic Disparities, To reduce and eventually eliminate disparities in health care.

Client expense: $755,146 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE

S. 2029, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. H.R. 5605, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME.

Client expense: $755,146 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE

S. 2029, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. H.R. 5605, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. No Bill, Out of pocket costs for health care, To make sure out-of-pocket costs for health care (especially drugs) does not prevent patients' access to health care.

Client expense: $934,646 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE

S.Con.Res. 70, Increase Discretionary Health Spending under F. 550 of the House and Senate Budget Resolutions, Adequate funding for HHS agencies: HRSA, AHRQ, Rural Health, NIH. S. 1858 (PL 110-204), Supporting Newborn Screening Saves Lives Act of 2008, Promote public awareness, trained workers to offer quality care for newborns. S. 2029, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. H.R. Con. Res. 312, Increase Discretionary Health Spending under F. 550 of the House and Senate Budget Resolutions, Adequate funding for HHS agencies: HRSA, AHRQ, Rural Health, NIH. H.R. Con. Res. 3825 (PL 110-204), Supporting Newborn Screening Saves Lives Act of 2008, Promote public awareness, trained workers to offer quality care for newborns. H.R. 5605, Physician Payments Sunshine Act, To discourage requiring pharmaceutical companies from having to report unrestricted grants for CME. No Bill, Health care reforms to improve access to health care, To introduce AAFP views on health reform to Senate HELP Committees and to promote additional support. No Bill, Health Professions Shortage Areas, To ensure fairness in the designation process. No Bill, Increased funding for Rural Health Programs in FY 2009 Appropriations, Adequate funding for HHS Rural Health programs. No Bill, Increased funding for Title VII Health Professions Grants for Primary Care Medicine Training FY 2009 Appropriations, Adequate funding for HRSA's Title VII grants. No Bill, Out of pocket costs for health care, To make sure out-of-pocket costs for health care (especially drugs) does not prevent patients' access to health care. No Bill, Prevent cuts in funding to National Health Service Corps in FY 2009 Appropriations, Adequate funding for NHSC. No Bill, Racial and Ethnic Disparities, To reduce and eventually eliminate disparities in health care.

Client expense: $934,646 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), SENATE

S. 242 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 380 Pharmaceutical Market Access and Drug Safety Act of 2007 H.R. 4854 False Claims Act Correction Act of 2007 S. 2029 False Claims Act Correction Act of 2007 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccines Supply Act H.R. 3944 National Hepatitis B Act H.R. 5884 Sunshine in Litigation Act of 2008 S. 2449 Sunshine in Litigation Act of 2007 H.R. 5605 Physician Payments Sunshine Act of 2008 S. 2029 Physician Payments Sunshine Act of 2007 H.R. 3610 Food and Drug Import Safety Act of 2007 S. 3409 Drug and Device Accountability Act of 2008 H.R. 6381 Medical Device Safety Act of 2008 S. 3398 Medical Device Safety Act of 2008

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

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

Health Information Technology, S. 1693/H.R. 3800, Wired for Health Care Quality Act, H.R. 1952, National Health Information Incentive Act, HR 5442, TRUST in Health Information Act, Regulation of Tobacco, HR 1108, Family Smoking Prevention and Tobacco Control Act, Physician Workforce Shortages, Disparities in Health Care, HR 6357, Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008, S. 2029, Physician Payments Sunshine Act, HR 6898, the Health-e Information Technology Act of 2008

Client expense: $750,000 · Firm income: Not reported

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

E-Prescribing, S. 2408/HR 4296 Medicare Electronic Medication and Safety Protection Act, Physician Disclosure, HR 5605/ S 2029 - Physician Payments Sunshine Act, Physician Reimbursement/Medicare Physician Fee Schedule, HR 3162, Children's Health and Medicare Protection Act, S. 2785, Save Medicare Act, HR 5545/S.2729 Ensuring the Future Physician Workforce, HR 5445 - to increase Medicare payments for physicians' services, Imaging, HR 1293/S1338, Access to Medicare Imaging Act, Health Information Technology S 1042/HR 583 - Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act Appropriateness Criteria and Accreditation National Coverage Decision on CTA (CMS) National Coverage Decision on Percutaneous Transluminal Angioplasty concurrent w/Stenting (CMS) Quality Improvement (PQRI) Specialty Hospitals Comparative Effectiveness HR 6331, Medicare Improvements for Patients and Providers Act of 2008 S. 3101, the Medicare Improvements for Patients and Providers Act of 2008 S. 3118, Preserving Access to Medicare Act of 2008 Cardiac Magnetic Resonance Services Coverage for Carotid Stenting IDTF and Anti-markip rules in Physician Fee Schedule

Client expense: $750,000 · Firm income: Not reported

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

Sunshine Act (S 2029, HR 5605)

Client expense: $2,895,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Security Agency (NSA), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S 1338, The Access to Medical Imaging Act of 2007 HR 1293, The Access to Medical Imaging Act of 2007 S 1693, Wired for Health Care Quality Act of 2007 HR 6331, Medicare Improvement for Patients and Providers Act of 2008 S 2029, Physician Sunshine Act S 1695, Wired for HC Act HR 6898, Health-e Technology Act of 2008 MIPPA implementation HR 6357, Pro(TECH)t Act HR 6331, Medicare Improvements for Patients and Providers Act HR 3610, FDA Globalization Act of 2008 S334, Healthy Americans Act Bioterrorism Health Information Technology

Client expense: $4,260,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Natl Aeronautics & Space Administration (NASA), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Physician Payment Sunshine Act S. 2029 Patent Settlements H.R. 1432 S. 316

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

Patent Reform H.R. 1908, Import Safety Act H.R. 2100 Patent Settlements H.R. 1432 S. 316 Generic Biologics S 1685 H.R. 5629 Physician Payment Sunshine Act S. 2029

Client expense: Not reported · Firm income: $102,000

Patent Reform H.R. 1908, Import Safety Act H.R. 2100 Patent Settlements H.R. 1432 S. 316 Generic Biologics S 1685 H.R. 5629 Physician Payment Sunshine Act S. 2029

Client expense: Not reported · Firm income: $102,000