QI Program Supplemental Funding Act of 2008

Issues related to: Medicare coverage of immunosuppressants, Medicare Part D's six classes of clinical concern, Medicaid payment for hospital-acquired conditions; The Medicare Improvements for Patients and Providers Act Technical Corrections Act; , Amending Title XVIII of the SSA to ensure access to critical medications under Medicare Part D; S. 1951 and H.R. 3700, the Fair Medicaid Drug Payment Act, S. 2320 and H.R. 3282 , the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2007 Issues related to implementation of Section 5001(c) of the Deficit Reduction Act of 2005; S. 3560, QI Program Supplemental Funding Act of 2008 -- the QI bill included language to protect critical medications under Part D originally in H.R. 6331/S. 1887.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to: Antibiotic exclusivity and Infectious disease control; H.R. 6432, S. 2313 and H.R. 3697, the Strategies to Address Antimicrobial Resistance (STAAR Act); S. 3560, QI Program Supplemental Funding Act of 2008; S Res 454 and H Res 988, designating March 2008 as MRSA Awareness Month

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to: Antibiotic exclusivity and Infectious disease control; H.R. 6432, Animal Drug User Fee Amendments Act of 2008; S. 2313 and H.R. 3697, the Strategies to Address Antimicrobial Resistance (STAAR Act); S. 3560, QI Program Supplemental Funding Act of 2008; S Res 454 and H Res 988, designating March 2008 as MRSA Awareness Month

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2945 - Medicare Advantage Truth in Advertising Act; HR 2642 - Supplemental Appropriations for FY 2008; HR 4296 - Medicare Electronic Medication and Safety Protection Act; HR 5613 - Protecting the Medicaid Safety Net Act; HR 6331 - Medicare Improvements for Patients and Providers Act of 2008; HR 6365 - Medicare Special Needs Plans Extension and Amendments Act of 2008; S 1507 - Access to Medicare Data Act; S 1544 - Medicare Quality Enhancement Act; S 1954 - Pharmacy Access Improvement Act; S 2408 - Medicare Electronic Medication and Safety Protection Act; S 3101 - Medicare Improvements for Patients and Providers Act of 2008; S 3560 - QI Program Supplemental Funding Act of 2008; HR 2638 - Consolidated Security, Disaster Assistance and Continuing Appropriations Act; S 3236 - The Medicare and Medicaid Extensions Act of 2008; HR 2 - Children's Health Insurance Program Reauthorization Act of 2008

Client expense: $840,000 · Firm income: Not reported

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

MMM (Legislative Issues): H.R. 4: Medicare Prescription Drug Price Negotiation Act (Dingell); H.R. 976: Childrens Health Insurance Program Reauthorization Act (Rangel) (continued) H.R. 1990: Medicare Cost Contract Extension and Refinement Act (Pomeroy); H.R. 2945: Medicare Advantage Truth in Advertising Act (Stark); H.R. 3025: Medicare Prescription Drug Savings for Our Seniors Act (Doggett); H.R. 3061: Medicare Part D Drug Class Protection Act (Doggett); H.R. 3162: Childrens Health and Medicare Protection Act (Dingell); H.R. 3932: Medicare Prescription Drug Savings and Choice Act (Berry); H.R. 3963: Childrens Health Insurance Program Reauthorization Act (Dingell); H.R. 4296: Medicare Electronic Medication and Safety Protection Act (Schwartz); H.R. 5268: Medicaid FMAP (Pallone); H.R. 5480: Medicare Funding Warning Response Act (Hoyer-Boehner); H.R. 5613: Protecting the Medicaid Safety Net Act (Dingell); H.R. 5683: GAO Act (provisions relating to access to Medicare part C/part D data) (Davis); H.R. 5998: Protecting Children's Health Coverage Act (Pallone); H.R. 6331: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, and electronic prescribing) (Rangel-Dingell); H.R. 6388: GAO Improvement Act (provisions relating to access to Medicare part C/part D data) (Waxman); H.R. 6359: Medicare Beneficiary Protection Act (Biggert); H.R. 6365: Medicare Special Needs Plans Extension and Amendments Act (Kind); H.R. 7077: QI Program Supplemental Funding Act (Dingell) (provisions relating to cost sharing assistance for low-income Medicare beneficiaries); H.R. 7197: Medicare Advantage Funding (Gonzalez) (provisions relating to limiting increases in Medicare Advantage payment rates); H.Res. 1368 (provisions relating to Medicare Funding Warning); S. 3: Medicare Prescription Drug Price Negotiation Act (Reid); S. 130: Medicare Cost Contract Extension and Refinement Act (Allard); S. 706: Medicare Advantage Stabilization Fund (Feingold); S. 799: Community Choice Act (Harkin); S. 1102: Part D Equity for Low-Income Seniors Act (Bingaman); S. 1103: Helping Fill the Medicare Rx Gap Act (Bingaman); S. 1107: Home and Community Services Copayment Equity Act (Smith); S. 1108: Medicare Part D Outreach and Enrollment Enhancement Act (Smith); S. 1200: Indian Health Care Improvement Act (includes Medicaid/MA provisions); S. 1507: Access to Medicare Data Act (Grassley); S. 1544: Medicare Quality Enhancement Act (Gregg); S. 1589: Drug Rebate Equalization Act (Bingaman) (provisions relating to Medicaid drug rebates); S. 1827: Pharmacist Access and Recognition in Medicare Act (Cochran); S. 1893: Childrens Health Insurance Program Reauthorization Act (Baucus); S. 1954: Pharmacy Access Improvement Act (Baucus); S. 2219: Medicare Prescription Drug Savings and Choice Act (Durbin); S. 2408: Medicare Electronic Medication and Safety Protection Act (Kerry); S. 2620: Medicaid FMAP (Rockefeller); S. 2662: Medicare Funding Warning Response Act (Baucus-Gregg); S. 2795: Small Business Health Options Program Act (Durbin-Snowe); S. 2819: Economic Recovery in Health Care Act (provisions relating to Medicaid funding) (Rockefeller); S. 3101: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, electronic prescribing) (Baucus); S. 3560: QI Program Supplemental Funding Act (Baucus) (provisions relating to cost sharing assistance for low-income Medicare beneficiaries); S. 3604: Emergency Supplemental Appropriations Act (provisions relating to Medicaid FMAP); S. 3656: Preserving Access to Healthcare Act (Schumer) (provisions relating to Medicare and Medicaid regulation); S. 3869: Economic Stimulus (Reid) (provisions relating to Medicaid FMAP and Medicaidd MCO provider taxes); S. 3710: Medicare Early Access Act (Rockefeller) (provisions relating to Medicare "buy-in" option); and S.J.Res. 44 (provisions relating to blocking implementation of SCHIP requirements). MMM (Regulatory Issues) Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology and data issues, (including audit and encounter data issues), bidding and payment issues (including MA coding intensity, Part D reinsurance, low income subsidies, application process, and audits), application process, audits to evaluate compliance with MA and Part D program rules, benefit design rules, SSA and CMS premium withhold processing issues, enrollment rules, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff, measurement and oversight of plan performance including Special Needs Plans (SNPs); quality meaasures, grievance and appeals processes, compliance/fraud and abuse training, and Medicare/Medicaid integration issues for Special Needs Plans (SNPs); Federal premption of State authority over MA and Part D plans, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, and other operational issues; Medicare creditable drug coverage reporting requirements; implementation issues for the Medicare Retiree Drug Subsidy program; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education program; ongoing implementation issues for the Medicare cost plan program including enrollment, marketing materials review and approval and other operational issues, MA and Part D systems issues affecting enrollment and disenrollment processing and payment and other operational issues; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting inititiative; issues relating to Medicare coverage policy and national coverage decisions; Medicare clinical trials; Medicaid managed care regulations and policies, including the Medicaid managed care actuarial soundness standard, quality oversight, grievance and appeals processes, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost/rebate issues affecting Medicaid health plans; health plan-related State Childrens Health Insurance Program (SCHIP) issues, including eligibility and outreach issues; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including documentation of citizenship requirements, state benefit flexibility options, and Medicaid managed care organization provider tax issues; standards for electronic prescribing; and health information technology standards and policies.

Client expense: $2,240,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Personnel Management (OPM), SENATE, Social Security Administration (SSA), Treasury, Dept of

Supported all provisions unless otherwise indicated: BOTH SENATE AND HOUSE S.2620, H.R. 5268, To provide a temporary increase of the Federal medical assistance percentage (FMAP) under the Medicaid program and for other purposes Supported all provisions unless otherwise indicated: BOTH SENATE AND HOUSE: S. 3101, H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008 S. 2102, H.R. 154, Ending the Medicare Disability Waiting Period Act of 2007 S. 3560, QI [Qualified Individuals] Program Supplemental Funding Act of 2008 H.R. 7110, Job Creation and Unemployment Relief Act of 2008 - supported provisions related to temporary FMAP increase SENATE ONLY: S. 2586, State Fiscal Relief Act of 2008, provisions relating to providing a temporary FMAP increase, freezing the Medicaid regulations and for other purposes S. 2819, Economic Recovery in Health Care Act of 2008 HOUSE ONLY: H.R. 5613, Protecting the Medicaid Safety Net Act of 2008 H.R. 6684, Medicare Prescription Drug Cost Equalization Act

Client expense: $7,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: 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. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: Direct-to-consumer drug advertising H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs

Client expense: $6,170,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Medical Research Antibiotic Resistance issues H. R. 1174, Healthy Hospitals Act H. R. 3697, Strategies to Address Antimicrobial Resistance Act H. R. 4352, Antimicrobial Task Force in public schools H. R. 4451, MRSA Research and Study Act H.R. 1424, Emergency Economic Stabilization Act of 2008 H Res. 988, Designating the month of March 2008 as `MRSA Awareness Month' S. 2278, Community and Healthcare Associated Infections Reduction Act S. 2313, Strategies to Address Antimicrobial Resistance Act S. 2525, MRSA Infection Prevention and Patient Protection Act S. 2526, Worker Infection Protection Act S. 3560 QI Program Supplemental Funding Act of 2008 (Antibiotic Provision) S Res. 454, Designating the month of March 2008 as `MRSA Awareness Month'

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

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, Veterans Affairs, Dept of (VA)

Medical Research Prescription drug/Federal Drug Admin/Center for Disease Control/Health and Human Service issues Antibiotic Resistance issues H. R. 1174, Healthy Hospitals Act H. R. 3697, Strategies to Address Antimicrobial Resistance Act H. R. 4352, Antimicrobial Task Force in public schools H. R. 4451, MRSA Research and Study Act S. 2278, Community and Healthcare Associated Infections Reduction Act S. 2313, Strategies to Address Antimicrobial Resistance Act S. 2525, MRSA Infection Prevention and Patient Protection Act S. 2526, Worker Infection Protection Act S. 3560 QI Program Supplemental Funding Act of 2008 (Antibiotic Provision)

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

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, Veterans Affairs, Dept of (VA)

S. 3560, QI Program Supplemental Funding Act of 2008, Amending Title XVIII of the SSA to ensure access to critical medications under Medicare Part D; S. 1951 and H.R. 3700, the Fair Medicaid Drug Payment Act; S. 2320 and H.R. 3282, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2007; Issues related to implementation of Section 5001 (c) of the Deficit Reduction Act of 2005; Issues related to Medicare coverage of immunosuppressants; Issues related to Medicare Part Ds six classes of clinical concern; Issues related to Medicaid payment for hospital-acquired conditions.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2945 - Medicare Advantage Truth in Advertising Act; HR 2642 - Supplemental Appropriations for FY 2008; HR 4296 - Medicare Electronic Medication and Safety Protection Act; HR 5613 - Protecting the Medicaid Safety Net Act; HR 6331 - Medicare Improvements for Patients and Providers Act of 2008; HR 6365 - Medicare Special Needs Plans Extension and Amendments Act of 2008; S 1507 - Access to Medicare Data Act; S 1544 - Medicare Quality Enhancement Act; S 1954 - Pharmacy Access Improvement Act; S 2408 - Medicare Electronic Medication and Safety Protection Act; S 3101 - Medicare Improvements for Patients and Providers Act of 2008; S 3560 - QI Program Supplemental Funding Act of 2008; HR 2638 - Consolidated Security, Disaster Assistance and Continuing Appropriations Act; S 3236 - The Medicare and Medicaid Extensions Act of 2008; HR 2 - Children's Health Insurance Program Reauthorization Act of 2008

Client expense: $800,000 · Firm income: Not reported

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

Medicare Advantage program - Proposed legislation concerning this issue. Medicare/Medicaid issues - HR 4, Medicare Prescription Drug Price Negotiation Act of 2007; S 3, Medicare Prescription Drug Price Negotiation Act of 2007; S 1102, Part D Equity for Low-Income Seniors Act of 2007; S 1103, Helping Fill the Medicare Rx Gap Act of 2007; S 1107, Home and Community Services Copayment Equity Act of 2007; S 1108, Medicare Part D Outreach and Enrollment Enhancement Act of 2007; HR 2945, Medicare Advantage Truth in Advertising Act of 2007; S 799, Community Choice Act of 2007; S 1544, Medicare Quality Enhancement Act of 2007; S 1507, Access to Medicare Data Act of 2007; S 1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; HR 3025, Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2007; HR 3061, Medicare Part D Drug Class Protection Act of 2007; HR 3162, Children's Health and Medicare Protection Act of 2007; HR 976, Children's Health Insurance Program Reauthorization Act of 2007; S 1893, Children's Health Insurance Program Reauthorization Act of 2007; S 1954, Pharmacy Access Improvement (PhAIm) Act of 2007; HR 3963, Children's Health Insurance Program Reauthorization Act of 2007; S 2219, Medicare Prescription Drug Savings and Choice Act of 2007; HR 3932, Medicare Prescription Drug Savings and Choice Act of 2007; S 2408, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; HR 4296, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; S 1200, Indian Health Care Improvement Act Amendments of 2008; HR 5480, Medicare Funding Warning Response Act of 2008; S 2662, Medicare Funding Warning Response Act of 2008; HR 5268, To provide for a temporary increase of the Federal medical assistance percentage under the Medicaid Program; HR 6388, Government Accountability Office Improvement Act of 2008; HR 5998, Fair and Justifiable Credit Card Interest Rate Act of 2008; S 2819, Economic Recovery in Health Care Act of 2008; HR 6359, Medicare Beneficiary Protection Act of 2008; HR 6365, Medicare Special Needs Plans Extension and Amendments Act of 2008; HR 5613, Protecting the Medicaid Safety Net Act of 2008; S 2620, To provide for a temporary increase of the Federal medical assistance percentage under the Medicaid program; HR 5683, Government Accountability Office Act of 2008; HR 7110, Job Creation and Unemployment Relief Act of 2008; S 3560, QI Program Supplemental Funding Act of 2008; HR 7077, QI Program Supplemental Funding Act of 2008; S 3604, Emergency Supplemental; HR 7197, To amend part C of title XVIII of the Social Security Act to limit increases in Medicare Advantage payment rates; S 3656, Preserving Access to Healthcare (PATH) Act of 2008; S 3689, Economic Stimulus; S 3710, Medicare Early Access Act of 2008; S 3101, Medicare Improvements for Patients and Providers Act of 2008.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to: Antibiotic exclusivity and Infectious disease control; H.R. 6432, S. 2313 and H.R. 3697, the Strategies to Address Antimicrobial Resistance (STAAR Act); S. 3560, QI Program Supplemental Funding Act of 2008; S Res 454 and H Res 988, designating March 2008 as MRSA Awareness Month

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to: Medicare coverage of immunosuppressants, Medicare Part D's six classes of clinical concern, Medicaid payment for hospital-acquired conditions; The Medicare Improvements for Patients and Providers Act Technical Corrections Act; , Amending Title XVIII of the SSA to ensure access to critical medications under Medicare Part D; S. 1951 and H.R. 3700, the Fair Medicaid Drug Payment Act, S. 2320 and H.R. 3282 , the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2007 Issues related to implementation of Section 5001(c) of the Deficit Reduction Act of 2005; S. 3560, QI Program Supplemental Funding Act of 2008 -- the QI bill included language to protect critical medications under Part D originally in H.R. 6331/S. 1887.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2313 and H.R. 3697, The Strategies to Address Antimicrobial Resistyance (STAAR Act); S. 2278, The Community and Healthcare Associated Infections (CHAI) Reduction Act; H. Res. 988 and S. Res. 454 MRSA Awareness Month. S. 3560, Q1 Program Suplemental Funding Act of 2008, provisions regarding antibiotics.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent Reform, including but not limited to: S.1145, S.3600, and H.R.1908 Patent Settlements/Reverse Payments, including but not limited to: S.316, H.R.1432, and H.R.1902 Special 301 Report International Intellectual Property Issues Patent Process Issues, including but not limited to: S.3560, H.R.1778, and H.R.6344 Any other matter that relates to acess to generic drugs

Client expense: $539,634 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 6898 Health-e Information Technology Act H.R. 7067 Quality FIRST Act S. 3560 QI Program Supplemental Funding Act of 2008

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

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

Issues related to: Antibiotic exclusivity and Infectious disease control; H.R. 6432, S. 2313 and H.R. 3697, the Strategies to Address Antimicrobial Resistance (STAAR Act); S. 3560, QI Program Supplemental Funding Act of 2008; S Res 454 and H Res 988, designating March 2008 as MRSA Awareness Month

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 380, Pharmaceutical Market Access and Drug Safety Act of 2007: importation H.R. 1014, Heart Disease Education, Analysis Research, and Treatment for Women Act: reporting and analysis of patient data 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. 3610, Food and Drug Import Safety Act of 2007: import safety H.R. 5501, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health H.R. 5629, Pathway for Biosimilars Act: follow-on biologics H.R. 5683, The Government Accountability Office Act: disclosure of data H.R. 5839, Safeguarding America's Pharmaceuticals Act of 2008: anti-counterfeiting H.R. 6151, Responsibility in Drug and Device Advertising Act of 2008: direct-to-consumer drug advertising H.R. 6353, Ryan Haight Online Pharmacy Consumer Protection Act of 2008: on-line pharmacy issues H.R. 6378, Strengthening of FDA Integrity Act of 2008: debarment H.R. 6381, Medical Device Safety Act of 2008: preemption issues H.R. 6388 The Government Accountability Office Improvement Act of 2008: disclosure of data H.R. 6432, Animal Drug User Fee Amendments of 2008: technical corrections to FDAAA H.R. 6820, Water Assessment and Treatment Evaluation Research Study Act of 2008: pharmaceuticals in drinking water and human health S. 242, Pharmaceutical Market Access and Drug Safety Act of 2007: importation S. 334, Healthy Americans Act: non-interference S. 623, Access to Life-Saving Medicine Act: follow-on biologics S. 1693, Wired for Health Care Quality Act: health information technology and health care quality and costs S. 1695, Biologics Price Competition and Innovation Act of 2007: follow-on biologics S. 2663, CPSC Reform Act: importation S. 2731, Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008: public health S. 3046, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act): access to investigational drugs and related issues S. 3398, Medical Device Safety Act of 2008: preemption issues S. 3409, Drug and Device Accountability Act of 2008: import safety S. 3560, QI Program Supplemental Funding Act of 2008: antibiotic exclusivity provisions S. 3633, Transparency in Drug Labeling Act: country of origin labeling for drugs

Client expense: $5,420,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Medicare Advantage - HR 6331, Medicare Improvements for Patients and Providers Act of 2008; Proposed legislation re this issue. Medigap insurance market issues - Proposed legislation re these issues. Medicare/Medicaid issues - S 706, To amend title XVIII of the Social Security Act to repeal the MA Regional Plan Stabilization Fund; S 130, Medicare Cost Contract Extension and Refinement Act of 2007; HR 1990, Medicare Cost Contract Extension and Refinement Act of 2007; HR 4, Medicare Prescription Drug Price Negotiation Act of 2007; S 3, Medicare Prescription Drug Price Negotiation Act of 2007; S 1102, Part D Equity for Low-Income Seniors Act of 2007; S 1103, Helping Fill the Medicare Rx Gap Act of 2007; S 1107, Home and Community Services Copayment Equity Act of 2007; S 1108, Medicare Part D Outreach and Enrollment Enhancement Act of 2007; HR 2945, Medicare Advantage Truth in Advertising Act of 2007; S 799, Community Choice Act of 2007; S 1544, Medicare Quality Enhancement Act of 2007; S 1507, Access to Medicare Data Act of 2007; S 1827, Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007; HR 3025, Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2007; HR 3061, Medicare Part D Drug Class Protection Act of 2007; HR 3162, Children's Health and Medicare Protection Act of 2007; HR 976, Children's Health Insurance Program Reauthorization Act of 2007; S 1893, Children's Health Insurance Program Reauthorization Act of 2007; S 1954, Pharmacy Access Improvement (PhAIm) Act of 2007; HR 3963, Children's Health Insurance Program Reauthorization Act of 2007; S 2219, Medicare Prescription Drug Savings and Choice Act of 2007; HR 3932, Medicare Prescription Drug Savings and Choice Act of 2007; S 2408, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; HR 4296, Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007; S 1200, Indian Health Care Improvement Act Amendments of 2008; HR 5480, Medicare Funding Warning Response Act of 2008; S 2662, Medicare Funding Warning Response Act of 2008; HR 5268, To provide for a temporary increase of the Federal medical assistance percentage under the Medicaid Program; HR 6388, Government Accountability Office Improvement Act of 2008; HR 5998, Fair and Justifiable Credit Card Interest Rate Act of 2008; S 2819, Economic Recovery in Health Care Act of 2008; HR 6359, Medicare Beneficiary Protection Act of 2008; HR 6365, Medicare Special Needs Plans Extension and Amendments Act of 2008; HR 5613, Protecting the Medicaid Safety Net Act of 2008; S 2620, To provide for a temporary increase of the Federal medical assistance percentage under the Medicaid program; S 3101, Medicare Improvements for Patients and Providers Act of 2008; HR 5683, Government Accountability Office Act of 2008; HR 7110, Job Creation and Unemployment Relief Act of 2008; S 3560, QI Program Supplemental Funding Act of 2008; HR 7077, QI Program Supplemental Funding Act of 2008; SJRes 44, blocking implementation of SCHIP; HRes 1368, Resolved, That section 803 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 shall not apply during the remainder of the 110th Congress; S 3604, Emergency Supplemental.

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

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

Medical Research Antibiotic Resistance issues H. R. 1174, Healthy Hospitals Act H. R. 3697, Strategies to Address Antimicrobial Resistance Act H. R. 4352, Antimicrobial Task Force in public schools H. R. 4451, MRSA Research and Study Act H.R. 1424, Emergency Economic Stabilization Act of 2008 H Res. 988, Designating the month of March 2008 as `MRSA Awareness Month' S. 2278, Community and Healthcare Associated Infections Reduction Act S. 2313, Strategies to Address Antimicrobial Resistance Act S. 2525, MRSA Infection Prevention and Patient Protection Act S. 2526, Worker Infection Protection Act S. 3560 QI Program Supplemental Funding Act of 2008 (Antibiotic Provision) S Res. 454, Designating the month of March 2008 as `MRSA Awareness Month'

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

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, Veterans Affairs, Dept of (VA)

Medical Research Prescription drug/Federal Drug Admin/Center for Disease Control/Health and Human Service issues Antibiotic Resistance issues H. R. 1174, Healthy Hospitals Act H. R. 3697, Strategies to Address Antimicrobial Resistance Act H. R. 4352, Antimicrobial Task Force in public schools H. R. 4451, MRSA Research and Study Act S. 2278, Community and Healthcare Associated Infections Reduction Act S. 2313, Strategies to Address Antimicrobial Resistance Act S. 2525, MRSA Infection Prevention and Patient Protection Act S. 2526, Worker Infection Protection Act S. 3560 QI Program Supplemental Funding Act of 2008 (Antibiotic Provision)

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

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, Veterans Affairs, Dept of (VA)

Patent Reform, including but not limited to: S.1145, S.3600, and H.R.1908 Patent Settlements/Reverse Payments, including but not limited to: S.316, H.R.1432, and H.R.1902 Special 301 Report International Intellectual Property Issues Patent Process Issues, including but not limited to: S.3560, H.R.1778 and H.R.6344 Any other matter that relates to access to generic drugs

Client expense: $506,976 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

HR 2945 - Medicare Advantage Truth in Advertising Act; HR 2642 - Supplemental Appropriations for FY 2008; HR 4296 - Medicare Electronic Medication and Safety Protection Act; HR 5613 - Protecting the Medicaid Safety Net Act; HR 6331 - Medicare Improvements for Patients and Providers Act of 2008; HR 6365 - Medicare Special Needs Plans Extension and Amendments Act of 2008; S 1507 - Access to Medicare Data Act; S 1544 - Medicare Quality Enhancement Act; S 1954 - Pharmacy Access Improvement Act; S 2408 - Medicare Electronic Medication and Safety Protection Act; S 3101 - Medicare Improvements for Patients and Providers Act of 2008; S 3560 - QI Program Supplemental Funding Act of 2008; HR 2638 - Consolidated Security, Disaster Assistance and Continuing Appropriations Act

Client expense: $970,000 · Firm income: Not reported

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

MMM (Legislative Issues): H.R. 4: Medicare Prescription Drug Price Negotiation Act (Dingell); H.R. 976: Childrens Health Insurance Program Reauthorization Act (Rangel) (continued) H.R. 1990: Medicare Cost Contract Extension and Refinement Act (Pomeroy); H.R. 2945: Medicare Advantage Truth in Advertising Act (Stark); H.R. 3025: Medicare Prescription Drug Savings for Our Seniors Act (Doggett); H.R. 3061: Medicare Part D Drug Class Protection Act (Doggett); H.R. 3162: Childrens Health and Medicare Protection Act (Dingell); H.R. 3932: Medicare Prescription Drug Savings and Choice Act (Berry); H.R. 3963: Childrens Health Insurance Program Reauthorization Act (Dingell); H.R. 4296: Medicare Electronic Medication and Safety Protection Act (Schwartz); H.R. 5268: Medicaid FMAP (Pallone); H.R. 5480: Medicare Funding Warning Response Act (Hoyer-Boehner); H.R. 5613: Protecting the Medicaid Safety Net Act (Dingell); H.R. 5683: GAO Act (provisions relating to access to Medicare part C/part D data) (Davis); H.R. 5998: Protecting Children's Health Coverage Act (Pallone); H.R. 6331: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, and electronic prescribing) (Rangel-Dingell); H.R. 6388: GAO Improvement Act (provisions relating to access to Medicare part C/part D data) (Waxman); H.R. 6359: Medicare Beneficiary Protection Act (Biggert); H.R. 6365: Medicare Special Needs Plans Extension and Amendments Act (Kind); H.R. 7077: QI Program Supplemental Funding Act (Dingell) (provisions relating to cost sharing assistance for low-income Medicare beneficiaries); H.Res. 1368 (provisions relating to Medicare Funding Warning); S. 3: Medicare Prescription Drug Price Negotiation Act (Reid); S. 130: Medicare Cost Contract Extension and Refinement Act (Allard); S. 706: Medicare Advantage Stabilization Fund (Feingold); S. 799: Community Choice Act (Harkin); S. 1102: Part D Equity for Low-Income Seniors Act (Bingaman); S. 1103: Helping Fill the Medicare Rx Gap Act (Bingaman); S. 1107: Home and Community Services Copayment Equity Act (Smith); S. 1108: Medicare Part D Outreach and Enrollment Enhancement Act (Smith); S. 1200: Indian Health Care Improvement Act (includes Medicaid/MA provisions); S. 1507: Access to Medicare Data Act (Grassley); S. 1544: Medicare Quality Enhancement Act (Gregg); S. 1827: Pharmacist Access and Recognition in Medicare Act (Cochran); S. 1893: Childrens Health Insurance Program Reauthorization Act (Baucus); S. 1954: Pharmacy Access Improvement Act (Baucus); S. 2219: Medicare Prescription Drug Savings and Choice Act (Durbin); S. 2408: Medicare Electronic Medication and Safety Protection Act (Kerry); S. 2620: Medicaid FMAP (Rockefeller); S. 2662: Medicare Funding Warning Response Act (Baucus-Gregg); S. 2795: Small Business Health Options Program Act (Durbin-Snowe); S. 2819: Economic Recovery in Health Care Act (provisions relating to Medicaid funding) (Rockefeller); S. 3101: Medicare Improvements for Patients and Providers Act (provisions relating to Medicare Advantage, Medicare Part D, Medigap, Medicaid, health care disparities, electronic prescribing) (Baucus); S. 3560: QI Program Supplemental Funding Act (Baucus) (provisions relating to cost sharing assistance for low-income Medicare beneficiaries); S. 3604: Emergency Supplemental Appropriations Act (provisions relating to Medicaid FMAP); and S.J.Res. 44 (provisions relating to blocking implementation of SCHIP requirements). MMM (Regulatory Issues) Ongoing implementation issues for the Medicare Advantage (MA) and Medicare Part D prescription drug programs, including risk adjustment methodology and data issues, (including audit and encounter data issues) bidding and payment issues (including MA coding intensity, Part D reinsurance, low income subsidies, application process, and audits), application process, and audits, benefit design rules, SSA and CMS premium withhold processing issues, systems issues affecting enrollment and disenrollment processing, enrollment rules, marketing materials review and approval, marketing activities, including conduct and compensation of brokers and agents and plan sponsor marketing staff, measurement and oversight of plan performance including Special Needs Plans (SNPs); grievance and appeals processes, compliance/fraud and abuse training, and Medicare/Medicaid integration issues for Special Needs Plans (SNPs); Federal premption of State authority over MA and Part D plans, Part D prescription drug event data reporting, Part D formulary rules, Part D pharmacy access standards, and other operational issues; Medicare creditable drug coverage reporting requirements; implementation issues for the Medicare Retiree Drug Subsidy program; functionality of the Medicare Personal Plan Finder and Drug Plan Finder; National Medicare Education program; ongoing implementation issues for the Medicare cost plan program including enrollment, marketing materials review and approval, systems issues affecting enrollment and disenrollment processing, payment and other operational issues; Medicare demonstration program on performance-based payments for physician groups; physician quality reporting inititiative; issues relating to Medicare coverage policy and national coverage decisions; Medicare clinical trials; Medicaid managed care regulations and policies, including the Medicaid managed care actuarial soundness standard, quality oversight, grievance and appeals processes, beneficiary information requirements, treatment of Medicaid health plan member hospital days in the upper payment limit calculation; policies affecting State Medicaid funding, including intergovernmental transfers (IGTs); coordination of benefits with state Medicaid programs; Medicaid prescription drug cost/rebate issues affecting Medicaid health plans; health plan-related State Childrens Health Insurance Program (SCHIP) issues, including eligibility and outreach issues; implementation of Medicaid changes made in Deficit Reduction Act of 2005, including documentation of citizenship requirements, state benefit flexibility options, and Medicaid managed care organization provider tax issues; standards for electronic prescribing; and health information technology standards and policies.

Client expense: $1,630,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Personnel Management (OPM), SENATE, Social Security Administration (SSA), Treasury, Dept of

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.1108 - Family Smoking Prevention and Tobacco Control Act H.R.1233 - Mitigating the Impact of Uncompensated Services & Time Act of 2007 H.R.1343 - Health Centers Renewal Act of 2008 H.R.1424 - Paul Wellstone Mental Health & Addiction Equity Act of 2007 H.R.1553 - Caroline Pryce Walker Conquer Childhood Cancer Act of 2008 H.R.2164 - Medicare Ambulance Payment Extension Act H.R.2464 - Wakefield Act H.R.2583 - Physician Workforce & Guidance Medical Education Enhancement Act of 2007 H.R.2584 - High-Need Physician Workforce Incentives Act of 2007 H.R.2638 - Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 H.R.2749 - Voluntary Medicare Quality Reporting Act H.R.2851 - Michelle's Law 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.3403 - 911 Modernization and Public Safety Act H.R.3495 - Kids in Disasters Well-Being, Safety & Health Act of 2007 H.R.3800 - Promoting Health Information Technology (PHIT) Act H.R.4321 - Enhancing Safety in Medicine Utilizing Leading Advanced Simulation Technologies to Improve Outcomes Now 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.5545 - Ensuring the Future Physician Workforce Act of 2008 H.R.5605 - Physician Payments Sunshine Act of 2008 H.R.5613 - Protecting the Medicaid Safety Net Act of 2008 H.R.5669 - Poison Center Support, Enhancement & Awareness Act of 2008 H.R.5942 - National Trauma Center Stabilization Act of 2008 H.R.6091 - Save Medicare Act of 2008 H.R.6331 - Medicare Improvements for Patients & Providers Act (MIPPA) of 2008 H.R.6357 - Protecting Records, Optimizing Treatment, and Easing Communication Through Healthcare Technology Act of 2008 H.R.6898 - Health-e Information Technology Act of 2008 P.L.110-252 - Supplemental Appropriations Act of 2008 S.60 - Wakefield Act S.334 - Healthy Americans Act S.558 - Mental Health Parity Act of 2007 S.625 - Family Smoking Prevention and Tobacco Control Act S.901 - Health Care Safety net Act of 2007 S.911 - Conquer Childhood Cancer Act of 2007 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.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.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 S.2932 - Poison Center Support, Enhancement & Awareness Act of 2008 S.3101 - Medicare Improvements for Patients & Providers Act (MIPPA) of 2008 S.3560 - QI Program Supplemental Funding Act of 2008

Client expense: $528,537 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to: Antibiotic exclusivity and Infectious disease control; H.R. 6432, Animal Drug User Fee Amendments Act of 2008; S. 2313 and H.R. 3697, the Strategies to Address Antimicrobial Resistance (STAAR Act); S. 3560, QI Program Supplemental Funding Act of 2008; S Res 454 and H Res 988, designating March 2008 as MRSA Awareness Month

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2313 and H.R. 3697, The Strategies to Address Antimicrobial Resistyance (STAAR Act); S. 2278, The Community and Healthcare Associated Infections (CHAI) Reduction Act; H. Res. 988 and S. Res. 454 MRSA Awareness Month. H. R. 6432, Animal Drug User Fee Amendments of 2008; S. 3560, Q1 Program Suplemental Funding Act of 2008, provisions regarding antibiotics.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Supported all provisions unless otherwise indicated: BOTH SENATE AND HOUSE: S. 2620, H.R. 5268, To provide a temporary increase of the Federal medical assistance percentage (FMAP) under the Medicaid program and for other purposes Supported all provisions unless otherwise indicated: BOTH SENATE AND HOUSE: S. 3101, H.R. 6331, Medicare Improvements for Patients and Providers Act of 2008 S. 2102, H.R. 154, Ending the Medicare Disabaility Waiting Period Act of 2007 S. 3560, QI [Qualified Individuals] Program Supplemental Funding Act of 2008 H.R. 7110, Job Creation and Unemployment Relief Act of 2008 - supported provisions related to temporary FMAP increase SENATE ONLY: S. 2586, State Fiscal Relief Act of 2008, provisions relating to providing a temporary FMAP increase, freezing the Medicaid regulations and for other purposes S. 2819, Economic Recovery in Health Care Act of 2008 S.J. Res. 44, A Joint Resolution for Congressional Disapproval of the Rule Set Forth as Requirements Contained in the August 17, 2007, Letter to State Health Officials from the Director of the Center for Medicaid and State Operations ... HOUSE ONLY: H.R. 5613, Protecting the Medicaid Safety Net Act of 2008

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6432, Animal Drug User Fee Amendments Act of 2008; S. 2313 and H.R. 3697, the Strategies to Address Antimicrobial Resistance (STAAR Act); S. 2278, the Community and Healthcare Associated Infections (CHAI) Reduction Act; S. 3560, QI Program Supplemental Funding Act of 2008; S. Res. 454 and H. Res. 988, designating March 2008 as MRSA Awareness Month; Issues related to antibiotics and infectious dissease control.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE