Medicare Advanced Laboratory Diagnostics Act of 2007

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

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, Preemption gift disclosure

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

Government targets: Executive Office of the President (EOP), 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 Gift Disclosure

Client expense: $270,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

H.R. 2/S. 275 Children's Health Insurance Program Reauthorization Act of 2009; H.R. 15 National Health Insurance Act of 2009; H.R. 109 America's Affordable Health Care Act of 2009; H.R. 193 AmeriCare Health Care Act of 2009; H.R. 462 Medicaid SCHIP Dental Benefits Improvement Act of 2009; H.R. 544 Flexible Health Savings Act of 2009; H.R. 1321 Healthy Americans Act of 2009; S. 4 Comprehensive Health Reform Act of 2009; S. 391 Healthy Americans Act of 2009

Client expense: $1,131,806 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), 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)

H.R. 1321/S. 2404 Medicare Advanced Laboratory Diagnostics Act of 2007 S. 2029 Physician Payments Sunshine Act of 2007; H.R. 5605, Physician Payments Sunshine Act of 2008 H.R. 3162, Child Health and Medicare Protection Act Diagnostic Imaging Payments, Diabetes Testing payments, Computed Tomographic Angiography payments H.R. 6331, The Medicare Improvements for Patients and Providers Act of 2008 House Resolution for Medicare Reimbursement - Prostate Exams

Client expense: $1,154,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Energy Regulatory Commission (FERC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

HR.1321, Medicare Advanced Laboratory Diagnostics Act of 2007 Issues related to payments for kidney dialysis patients S.3101, Medicare Improvements for Patients and Providers Act of 2008 HR.6331, Medicare Improvements for Patients and Providers Act of 2008 S.3118, Preserving Access to Medicare Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3453, Community Clinical Laboratory Fairness in Competition Act of 2007 Reimbursement for clinical lab services under Medicare H.R. 1321 "Medicare Advanced Laboratory Diagnostics Act"; S.2404 "The Medicare Advanced Laboratory Diagnostic Act of 2007" S.976 "Genomics & Personalized Medicine Act of 2007" Competitive bidding for lab tests S.736, "The Laboratory Test Improvement Act"

Client expense: $658,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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 noninterference 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 provision Comparative Effectiveness S. 2099 "Preserving Access to Laboratory Services Act of 2007" Repeal of Competitive bidding demo ESRD "bundling issues" and ESRD drug reimbursement issues Medicare prescription drug benefit H.R. 1321 "Medicare Advanced Laboratory Diagnostic Act of 2007" S. 691/H.R. 1193 The Kidney Care Quality and Education Act CPT Coding decisions and HCPCS coding decisions Reimbursement for Part B Drugs administered in hospital out patient departments, dialysis centers and physician officers Physicians fee schedule payment rates for lab tests. Medicaid rebates H.R. 2184, The Enhanced health Care Value for All Act H.R. 6331 "Medicare Improvements for Patients and Providers Act of 2008" S. 3101, "Medicare Improvements for Patients and Providers Act of 2008" MIPPA Technical Connections H.R. 1472 Emergency Economic Stabilization Act of 2008

Client expense: $658,000 · Firm income: Not reported

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

HR 1321/S 2404 - Medicare Advanced Laboratory Diagnostics Act of 2007 - a bill to improve payments under the Medicare clinical laboratory fee schedule. [Julie Cohen, Elizabeth Pika Sharp] S. 2029/HR 5605 - 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. [Julie Cohen, Brett Loper, Elizabeth Kegler] S. 2221 - Transparency in Medical Device Pricing Act of 2007 - a bill to provide for the reporting of sales prices data for implantable medical devices [Brett Loper, Elizabeth Kegler] HR 5765 - Medicare Remote Monitoring Access Act of 2008 - to amend Title XVIII of the Social Security Act to cover remote patient management services for certain chronic health conditions under the Medicare Program. [Julie Cohen, Elizabeth Kegler] HR 6761 - to require the Secretary of Health and Human Services to enter into negotiated rulemaking to modernize the Medicare Part B fee schedule for clinical diagnostic laboratory tests. [Elizabeth Pika Sharp] 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. [Julie Cohen, Elizabeth Kegler, Brett Loper] H.R. 6163 - To improve the provision of telehealth services under the Medicare Program, to provide grants for the development of telehealth networks,, and for other purposes. [Julie Cohen, Elizabeth Pika Sharp] * Gainshairing - No specific bill - a provision in the proposed 2009 Physician Fee Schedule regulation [Julie Cohen, Elizabeth Kegler, Brett Loper]

Client expense: $335,662 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE

H.R.1321/S.2404 Medicare Advanced Laboratory Diagnostics Act of 2007 H.R.6331/S.3101 - Medicare Improvements for Patients and Providers Act of 2008, implementation of sections 153, 154 Medicaid Implementation and Rebates

Client expense: $940,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1321, Medicare Advanced Laboratory Diagnostics Act of 2007; H.R. 5765, to amend title XVIII of the Social Security Act to cover remote patient management services for certain chronic health conditions under the Medicare Program; address the consequences of the inappropriate applications of comparative effectiveness research when used simply as a cost containment mechanism.

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2404, Medicare Advanced Laboratory Diagnostics Act of 2007, To provide appropriate levels of reimbursement for diagnostic tests H.R. 1321, Medicare Advanced Laboratory Diagnostics Act of 2007, To provide appropriate levels of reimbursement for diagnostic tests H.R.6331, PL 110-275, Medicare Improvements for Patients and Providers Act of 2008, Issues relating to provisions for patient access to medical devices and diagnostics S.3101, PL 110-275, Medicare Improvements for Patients and Providers Act of 2008, Issues relating to provisions for patient access to medical devices and diagnostics H.R.6212, PL 110-275, Medicare Efficiency and Development of Improvement of Care and Services Act (MEDICS Act) of 2008, Issues relating to provisions for patient access to medical devices and diagnostics

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

Government targets: HOUSE OF REPRESENTATIVES, 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.2099, Preserving Access to Laboratory Services Act of 2007 H.R.6761, Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008 H.R.6331, Medicare Improvements for Patients and Providers Act of 2008 S.3101, Medicare Improvements for Patients and Providers Act of 2008; Medicare: Date of Service S.3118, Preserving Access to Medicare Act of 2008 H.R.3162, Children's Health and Medicare Protection Act of 2007 S.1893, Children's Health and Medicare Protection Act of 2007 H.R.1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S.2404, Medicare Advanced Laboratory Diagnostics Act of 2007 H.R.3453, Community Clinical Laboratory Fairness in Competition Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2099, Preserving Access to Laboratory Services Act of 2007 H.R.6761, Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008 H.R.6331, Medicare Improvements for Patients and Providers Act of 2008 S.3101, Medicare Improvements for Patients and Providers Act of 2008 S.3118, Preserving Access to Medicare Act of 2008 H.R.3162, Children's Health and Medicare Protection Act of 2007 S.1893, Children's Health and Medicare Protection Act of 2007 H.R.1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S.2404, Medicare Advanced Laboratory Diagnostics Act of 2007 H.R.3453, Community Clinical Laboratory Fairness in Competition Act

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

Government targets: HOUSE OF REPRESENTATIVES, 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 H.R. 6381, Medical Device Safety Act

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

Government targets: HOUSE OF REPRESENTATIVES, 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 HR 1293 / S 1338, Access to Medical Imaging Act of 2007 S 2029, Physician Payment Sunshine Act of 2007

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page Medicare Physician Reimbursement; Reimbursement for Imaging and Technology; value based purchasing, remote monitoring H.R. 1321/S. 2404 - Medicare Advanced Laboratory Diagnostics Act of 2007 S. 631 - Remote Monitoring Accessing Act of 2007 *** no specific bill(s), gainsharing

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

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

H.R. 1321 & S. 2404, Medicare Advanced Laboratory Diagnostics Act of 2007; H.R. 5765, Medicare Remote Monitoring Access Act of 2008; S. 631 Remote Monitoring Act of 2007; S. 2221, Transparency in Medical Device Pricing Act of 2007; H.R. 6331, Medicare Improvements for Patients & Providers Act of 2008; H.R. 3162, Childrens Health & Medicare Protection Act of 2007; S. 2029, Physician Payment Sunshine Act; H.R. 3023, Drug & Medical Device Company Gift Disclosure Act S. 1893, Children's Health Insurance Program Reauthorization Act of 2007; Legislation addressing Comparative Effectiveness including S. 3408, Comparative Effectiveness Research Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare coverage of and reimbursement for pharmaceuticals in Parts B&D, including oncology, rheumatoid arthritis and ESRD; Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S.2404, the Medicare Advance Laboratory Dianostics Act of 2007; H.R. 3453/S.2099 (to repeal the Medicare competitive bidding project for clinical; laboratory services); comparative effectiveness policies, including provisions in H.R. 3162 the Children's Health and Medicare Protection Act of 2007; Medicare coverage policy for blood glucose monitors and test strips; Medicare payments for diagnostic tests; Emergency preparedness for influenza pandemic; DACC/ Competitive Bidding; lobbied activities of the PST Coalition. The PST Coalition lobbied Cngress and CMS on matters related to reimbursement for and coverage of home prothrombin time testing.

Client expense: $1,332,417 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6331/S.3101 - Medicare Improvements for Patients and Providers Act of 2008, Section 153, 154 S.3118 - Preserving Access to Medicare Act of 2008, Section 152 H.R. 6252/S. 3144 Medicare DMEPOS Competitive Acquisition Reform Act of 2008 Protection of private sector delivery H.R. 1321 - Medicare Advanced Laboratory Diagnostics Act of 2007 Proposal to repeal CMS's Least Costly Alternative reimbursement policy for selected medicines H.R. 638/S. 3398 - Medicaid Device Safety Act of 2008 H.R.3162 - Children's Health and Medicare Protection Act of 2007 H.R.4854 - False Claims Act Correction Act of 2007 HR 3326 - Early Treatment for HIV Act of 2007

Client expense: $1,780,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

**see addendum page Medicare Physician Reimbursement Package; Reimbursement for Imaging and Technology; value based purchasing, remote monitoring H.R. 6331/S. 3101 - the Medicare Improvements for Patients and Providers Act of 2008 S. 3118 - Preserving Access to Medicare Act of 2008 H.R. 1321/S. 2404 - Medicare Advanced Laboratory Diagnostics Act of 2007 S. 631 - Remote Monitoring Accessing Act of 2007 *** no specific bill(s), gainsharing

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

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

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 noninterference 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 provision Comparative Effectiveness S. 2099 "Preserving Access to Laboratory Services Act of 2007" Repeal of Competitive bidding demo ESRD "bundling issues" and ESRD drug reimbursement issues Medicare prescription drug benefit H.R. 1321 "Medicare Advanced Laboratory Diagnostic Act of 2007" S. 691/H.R. 1193 The Kidney Care Quality and Education Act CPT Coding decisions and HCPCS coding decisions Reimbursement for Part B Drugs administered in hospital out patient departments, dialysis centers and physician officers Physicians fee schedule payment rates for lab tests. Medicaid rebates H.R. 2184, The Enhanced health Care Value for All Act H.R. 6331 "Medicare Improvements for Patients and Providers Act of 2008" S. 3101, "Medicare Improvements for Patients and Providers Act of 2008" MIPPA Technical Connections H.R. 1472 Emergency Economic Stabilization Act of 2008

Client expense: $770,000 · Firm income: Not reported

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

H.R. 3453, Community Clinical Laboratory Fairness in Competition Act of 2007 Reimbursement for clinical lab services under Medicare H.R. 1321 "Medicare Advanced Laboratory Diagnostics Act"; S.2404 "The Medicare Advanced Laboratory Diagnostic Act of 2007" S.976 "Genomics & Personalized Medicine Act of 2007" Competitive bidding for lab tests S.736, "The Laboratory Test Improvement Act"

Client expense: $770,000 · Firm income: Not reported

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

S. 631 - Remote Monitoring Access Act of 2007 - a bill to provide for coverage of remote patient management services for chronic healthcare conditions under the Medicare program. [Julie Cohen] HR 1321/S 2404 - Medicare Advanced Laboratory Diagnostics Act of 2007 - a bill to improve payments under the Medicare clinical laboratory fee schedule. [Julie Cohen, Elizabeth Pika Sharp] 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] S. 2029/HR 5605 - 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. [Julie Cohen, Brett Loper] S. 2221 - Transparency in Medical Device Pricing Act of 2007 - a bill to provide for the reporting of sales prices data for implantable medical devices [Brett Loper, Julie Cohen] 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 disclose certain gifts provided in connection with detailing, promotional, or other marketing activities. [Julie Cohen] S. 3101/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] HR 2184 - Enhanced Health Care Value for All Act of 2007 - bill to amend the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to expand comparative effectiveness research and to increase funding for such research to improve the value of health care. [Julie Cohen, Brett Loper] HR 5765 - Medicare Remote Monitoring Acess Act of 2008 - to amend Title XVIII of the Social Security Act to cover remote patient management services for certain chronic health conditions under the Medicare Program. [Julie Cohen] HR 6761 - to require the Secretary of Health and Human Services to enter into negotiated rulemaking to modernize the Medicare Part B fee schedule for clinical diagnostic laboratory tests. [Elizabeth Pika Sharp] * Shared savings programs betwen hospitals and physicians - No specific bill - [Julie Cohen, Elizabeth Kegler, Brett Loper]

Client expense: $484,537 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA)

S. 2404, Medicare Advanced Laboratory Diagnostics Act of 2007, To provide appropriate levels of reimbursement for diagnostic tests H.R. 1321, Medicare Advanced Laboratory Diagnostics Act of 2007, To provide appropriate levels of reimbursement for diagnostic tests H.R.6331, PL 110-275, Medicare Improvements for Patients and Providers Act of 2008, Issues relating to provisions for patient access to medical devices and diagnostics S.3101, PL 110-275, Medicare Improvements for Patients and Providers Act of 2008, Issues relating to provisions for patient access to medical devices and diagnostics H.R.6212, PL 110-275, Medicare Efficiency and Development of Improvement of Care and Services Act (MEDICS Act) of 2008, Issues relating to provisions for patient access to medical devices and diagnostics

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1321 & S. 2404, Medicare Advanced Laboratory Diagnostics Act of 2007; H.R. 5765, Medicare Remote Monitoring Access Act of 2008; S. 631 Remote Monitoring Act of 2007; S. 2221, Transparency in Medical Device Pricing Act of 2007; H.R. 6331, Medicare Improvements for Patients & Providers Act of 2008; H.R. 3162, Childrens Health & Medicare Protection Act of 2007; S. 2029, Physician Payment Sunshine Act; H.R. 3023, Drug & Medical Device Company Gift Disclosure Act S. 1893, Children's Health Insurance Program Reauthorization Act of 2007; Legislation addressing Comparative Effectiveness including S. 3408, Comparative Effectiveness Research Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, 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: $1,500,000 · 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. 1321, Medicare Advanced Laboratory Diagnostics Act of 2007. H.R. 5765, to amend title XVIII of the Social Security Act to cover remote patient management services for certain chronic health conditions under the Medicare Program; address the consequences of the inappropriate applications of comparative effectiveness research when used simply as a cost containment mechanism.

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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 H.R. 6381, Medical Device Safety Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1321- All provisions CMS- 1404-P

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

Government targets: HOUSE OF REPRESENTATIVES

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 HR 1293 / S 1338, Access to Medical Imaging Act of 2007 S 2029, Physician Payment Sunshine Act of 2007

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR.1321, Medicare Advanced Laboratory Diagnostics Act of 2007 Issues related to payments for kidney dialysis patients S.3101, Medicare Improvements for Patients and Providers Act of 2008 HR.6331, Medicare Improvements for Patients and Providers Act of 2008 S.3118, Preserving Access to Medicare Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1321/S. 2404 Medicare Advanced Laboratory Diagnostics Act of 2007 S. 2029 Physician Payments Sunshine Act of 2007; H.R. 5605, Physician Payments Sunshine Act of 2008 H.R. 3162, Child Health and Medicare Protection Act Diagnostic Imaging Payments, Diabetes Testing payments, Computed Tomographic Angiography payments H.R. 6331, The Medicare Improvements for Patients and Providers Act of 2008 House Resolution for Medicare Reimbursement - Prostate Exams

Client expense: $1,350,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Aviation Administration (FAA), Federal Energy Regulatory Commission (FERC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

S.2099, Preserving Access to Laboratory Services Act of 2007 H.R.6761, Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008 H.R.6331, Medicare Improvements for Patients and Providers Act of 2008 S.3101, Medicare Improvements for Patients and Providers Act of 2008 S.3118, Preserving Access to Medicare Act of 2008 H.R.3162, Children's Health and Medicare Protection Act of 2007 S.1893, Children's Health and Medicare Protection Act of 2007 H.R.1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S.2404, Medicare Advanced Laboratory Diagnostics Act of 2007 H.R.3453, Community Clinical Laboratory Fairness in Competition Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2099, Preserving Access to Laboratory Services Act of 2007 H.R.6761, Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008 H.R.6331, Medicare Improvements for Patients and Providers Act of 2008 S.3101, Medicare Improvements for Patients and Providers Act of 2008 S.3118, Preserving Access to Medicare Act of 2008 H.R.3162, Children's Health and Medicare Protection Act of 2007 S.1893, Children's Health and Medicare Protection Act of 2007 H.R.1321, Medicare Advanced Laboratory Diagnostics Act of 2007 S.2404, Medicare Advanced Laboratory Diagnostics Act of 2007 H.R.3453, Community Clinical Laboratory Fairness in Competition Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6331/S.3101 - Medicare Improvements for Patients and Providers Act of 2008, Section 154 S.3118 - Preserving Access to Medicare Act of 2008, Section 152 H.R. 6252/S. 3144 Medicare DMEPOS Competitive Acquisition Reform Act of 2008 S. 1951/H.R. 3700: Fair Medicaid Drug Payment Act of 2007 H.R. 1321 - Medicare Advanced Laboratory Diagnostics Act of 2007 Proposal to repeal CMS's Least Costly Alternative reimbursement policy for selected medicines

Client expense: $1,040,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

H.R. 2184, "Enhanced Health Care Value for All Act of 2007," all provisions. S. 631, "Remote Monitoring Access Act of 2007," all provisions. H.R. 1321/S.2404, "Medicare Advanced Laboratory Diagnostics Act of 2007," all provisions. H.R. 6331, "Medicare Improvements for Patients and Providers Act of 2008," Sec. 154 S. 3101, "Medicare Improvements for Patients and Providers Act of 2008." S. 3118, "Preserving Access to Medicare Act of 2008." S. 2029, "Physician Payments Sunshine Act of 2007," all provisions. Implementation of the DME/POS competitive bidding program.

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

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 noninterference provisions H.R. 5480m 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 provision Comparative Effectiveness S. 2099 "Preserving Access to Laboratory Services Act of 2007" Repeal of competitive bidding demo ESRD "bundling issues" and ESRD drug reimbursement issues Medicare prescription drug benefit H.R. 1321 "Medicare Advanced Laboratory Diagnostic Act of 2007" S.2404 "The Medicare Advanced Laboratory Diagnostic Act of 2007" S. 691/H.R. 1193 The Kidney Care Quality and Education Act CPT Coding decisions and HCPCS coding decisions Reimbursement for Part B Drugs administered in hospital outpatient departments, dialysis centers and physician officers Physicians fee schedule payment rates for lab tests. Medicaid rebates H.R. 2184, the Enhanced health Care Value for All Act H.R. 6331 "Medicare Improvements for Patients and Providers Act of 2008" S.3101, "Medicare Improvements for Patients and Providers Act of 2008"

Client expense: $668,115 · 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

H.R. 3453, Community Clinical Laboratory Fairness in Competition Act of 2007 Reimbursement for clinical lab services under Medicare H.R. 1321 "Medicare Advanced Laboratory Diagnostics Act"; S.2404 "The Medicare Advanced Laboratory Diagnostic Act of 2007" S.976 "Genomics & Personalized Medicine Act of 2007" Competitive bidding for lab tests S.736, "The Laboratory Test Improvement Act"

Client expense: $668,115 · 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

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

S. 2404, Medicare Advanced Laboratory Diagnostics Act of 2007, To provide appropriate levels of reimbursement for diagnostic tests H.R. 1321, Medicare Advanced Laboratory Diagnostics Act of 2007, To provide appropriate levels of reimbursement for diagnostic tests H.R.6331, Medicare Improvements for Patients and Providers Act of 2008, Issues relating to provisions for patient access to medical devices and diagnostics S.3101, Medicare Improvements for Patients and Providers Act of 2008, Issues relating to provisions for patient access to medical devices and diagnostics H.R.6212, Medicare Efficiency and Development of Improvement of Care and Services Act (MEDICS Act) of 2008, Issues relating to provisions for patient access to medical devices and diagnostics

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR.1321, Medicare Advanced Laboratory Diagnostics Act of 2007 Issues related to payments for kidney dialysis patients S.3101, Medicare Improvements for Patients and Providers Act of 2008 HR.6331, Medicare Improvements for Patients and Providers Act of 2008 S.3118, Preserving Access to Medicare Act of 2008

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare durable medical equipment reimbursement and policy Medicare laboratory reimbursement and policy, including provisions in: H.R. 1321/S. 2404, the Medicare Advanced Laboratory Diagnostics Act of 2007 H.R. 3453/S. 2099 (to repeal the Medicare competitive bidding project for clinical laboratory services)

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE