Preserving Access to Life-Saving Medications Act of 2011

H.R. 2245/S. 296 - Preserving Access to Life-Saving Medications Act of 2011 H.R. 3839 - Drug Shortage Prevention Act of 2012 Drug Shortage Provisions of the Prescription Drug User Fee Reauthorization Act

Client expense: $221,011 · Firm income: Not reported

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

HR 2182, S1734, and S2187 (as passed in Pub. L. No. 112-144) issues related to the development of antibiotics H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumerHR 1483 - issues related to drug safety, supply chain, and facility inspections H.R. 2245, S.296, H.R. 3839 (Prescribing Access to Lifesaving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages, including notifications and public reporting H.R. 3668 issues related to increased penalties for counterfeiting drugs HR 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to 340B program amendments and implementation of statutory changes. HR 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to definition of essential health benefits and health insurance exchanges. HR 6160 - issues related to drug safety issues, including tamper resistent packaging HR 1513 - issues related to animal research HR 6502 - issues related to development of medicines for life-threatening illnesses HR 3497 - issues related to incentives for developing and improving diagnostic tests and related treatments HR 6272 - issues related to the expansion of clinical trial data banks and increase government reporting of same HR 6163 - issues related to incentives for increased research into pediatric treatments

Client expense: $900,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality.NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation. Labor, HHS Appropriations. Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program.

Client expense: $560,000 · Firm income: Not reported

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

H.R. 5: All provisions of the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011; H.R. 1409: All provisions of the Quality Health Care Coalition Act of 2011; H.R. 891/S. 274: All provisions of the Medication Therapy Management Benefits Act of 2011; H.R. 905 /S. 733: All provisions of the legislation to exclude customary prompt pay discounts from manufacturers to wholesalers from the average sales price for drugs and biologicals under Medicare; H.R. 979 - All provisions of the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 4 /S.18 / S.72 - All provisions of the Small Business Paperwork Mandate Elimination Act H.R. 605 / S. 312 - All provisions of the Patients Freedom to Choose Act S. 27 - All provisions of the Preserve Access to Affordable Generics Act S. 31 - All provisions of the Prescription Drug and Health Improvement Act of 2011 S. 44 - All provisions of the Medicare Prescription Drug Price Negotiation Act of 2011 H.R. 999 / S. 560 - All provisions of the Medicare Prescription Drug Savings and Choice Act of 2011 H.R. 1839 - All provisions of the Community Pharmacy Fairness Act of 2011; H.R. 1946 - All provisions of the Preserving or Hometown Independent Pharmacies Act of 2011; H.R. 1971 / S. 1058 - All provisions of the Pharmacy Competition and Consumer Choice Act of 2011 Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio) Regulatory and proposed legislative changes to Medicare part D including EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs Regulatory Implementation of the HITECH Act FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs), implementation of approval pathway for generic biologic drugs 340b program H.R. 2245/S. 296 - All provisions of the Preserving Access to Life-Saving Medications Act of 2011

Client expense: $559,998 · Firm income: Not reported

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

H.R. 6482 To amend the Congressional Budget Act of 1974 respecting the scoring of preventative health savings; H.R. 4209 Patients' Access to Treatments Act; H.R. 451 Healthcare, Truth and Transparency Act; H.R. 6352 Resident Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act; H.R. 6562 Resident Physician Shortage Reduction Act; H.R. 5 Protecting Access to Healthcare Act; H.R. 2245 / S. 296 Preserving Access to Life-Saving Medications Act

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

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

H.R. 1483, H.R. 3026, & S. 1584 - Pharmaceutical pedigree anti-counterfeiting; H.R. 2245, S. 296. - drug shortages

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the quality of cancer care [Preserving Access to Life-Saving Medications Act (S. 296, H.R. 2245) -- all provisions]; Health reform implementation issues pertaining to the regulation and coverage of cancer care and treatments; Issues pertaining to average sales price

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

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

S.296, H.R. 2245 Preserving Access to Life-Saving Medications Acts; 340B Drug Discount; H.R. 1483 , Drug Safety Enhancement Act; Devise Tax; AdvaMed Competitiveness Agenda; 510(k) Clearance Reforms; FDA Regulatory Environment. Raise awareness with legislators about the benefits of home dialysis and try to increase awareness in the veteran population. HELP and Energy and Commerce Drug shortage draft legislation. S. 3187, Food and Drug Administration Safety and Innovation Act. MDUFA, PDUFA, BSUFA, GDUFA. Traceability and drug supply chain reforms. Medical device reforms. Medical Gases Safety Act. Raise Awareness with legislators about survey and certification issues as it relates to home dialysis. Seeking appropriate reimbursement and access for an investigational indication of our product, GammaGard, to treat Alzheimers Disease.

Client expense: $820,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to health disparities, health care reform, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, and wellness, including the following legislation: S. 494 and H.R. 912, Colorectal Cancer Prevention, Early Detection & Treatment Act; H.R. 1213, Repeal mandatory funding provided to states in PPACA to establish American Health Benefit Exchanges; H.R. 1217, Repeal Prevention and Public Health Fund; H.R. 1740 and H.R. 5560, the Quality Cancer Care for Life Act of 2010; H.R.2941 and S.3493; H.R.3974, Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009; H.R.4662, the Lymphedema Diagnosis and Treatment Cost Savings Act of 2010; the implementation of P.L. 111-148, the Patient Proection and Affordable Care Act of 2010; S.1064, the Sun Act; S.965, the Family Act; H.R.2954, Health Equity and Accountability Act of 2011; and H.R.2077, the MLR Repeal Act; H.R.2245 and S.296 Preserving Access to Life-Saving Medications Act, issues related to the reauthorization of the prescription drug user fee, S.3187, the FDA Safety and Innovation Act and the House Companion legislation, and issues relating to the ongoing national shortage of cancer drugs, Amendment relating to S.1813, the Moving Ahead for Progress in the 21st Century Act, and H.R.4274, reauthorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Issues relating to global health including S.2515, the Clean Cookstoves Support Act of 2012; H.R.6155 & S.3047, the Palliative Care and Hospice Education & Training Act; and H.R.6157, the Patient Centered Quality of Care Act.

Client expense: $810,000 · 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), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), White House Office

Implementation of the Patient Protection and Affordable Care Act (P.L. 111-148); Medical Malpractice; H.R. 2245/S. 296 - Preserving Access to Life-Saving Medications Act of 2011; Drug Shortages; H.R. 5 - Protecting Access to Healthcare Act; Impact of Sequestration on Health Care Programs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1 Full Year Continuing Appropriations Act 2011, making appropriations for the Department of Defense and the other departments and agencies of the Government for the fiscal year ending September 30, 2011; HR 2 Repealing the Job-Killing Health Care Law Act, to repeal the job-killing health care law and health care-related provisions in the Health Care and Education Reconciliation Act of 2010; HR 4 Small Business Paperwork Mandate Elimination Act of 2011, offsets the cost of 1099 repeal by increasing the maximum amount of tax subsidy to be repaid if a persons (or familys) income exceeds 400% of poverty; HR 5, S 218, HR 105 and S 1099 Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, to improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system; HRes 9 Instructing four committees to produce legislation to replace the health reform law and to include a permanent fix to the SGR; S 296 and HR 2245 Preserving Access to Life-Saving Medications Act of 2011, to amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages; HR 705 The Comprehensive 1099 Taxpayer Protection and Repayment of Exchange Subsidy Overpayments Act of 2011, to amend the Internal Revenue Code of 1986 to repeal the expansion of information reporting requirements to payments made to corporations, payments for property and other gross proceeds, and rental property expense payments; HR 1213 To repeal mandatory funding provided to States in the Patient Protection and Affordable Care Act to establish American Health Benefit Exchanges; HR 1217 to repeal the Prevention and Public Health Fund; S 539 Behavioral Health Information Technology Act of 2011, a bill to amend the Public Health Services Act and the Social Security Act to extend health information technology assistance eligibility to behavioral health, mental health, and substance abuse professionals and facilities; S 668 Health Care Bureaucrats Elimination Act, a bill to remove unelected, unaccountable bureaucrats from seniors' personal health decisions by repealing the Independent Payment Advisory Board; Allow hospitals to claim the full cost of provider taxes as allowable costs; Ensure CAHs are paid at least 101 percent of costs by Medicare Advantage plans; Ensure that the Centers for Medicare & Medicaid Services (CMS) appropriately addresses the issue of direct supervision for outpatient therapeutic services for rural hospitals and CAHs; Ensure rural hospitals and CAHs have adequate reimbursement for certified registered nurse anesthetist and stand-by services; Exempt CAHs from the Independent Payment Advisory Board; Extend expiring provisions; Provide small, rural hospitals with cost-based reimbursement for outpatient laboratory services and ambulance services; Provide CAHs bed size flexibility; Reinstate CAH necessary provider status; Remove unreasonable restrictions on CAHs ability to rebuild; Discussions on a bill to credit some observation status days to 3 day inpatient hospital stays; Worked with HHS on establishing the Partnership for Patients Program to improve patient safety activities in hospitals; HR 1929 Emergency Nursing Relief Act, provides for 20,000 additional immigrant visas (green cards) for Registered Nurses, and their immediate family members. Visas issued to the family members would not count against the 20,000 quota. The Secretary of State would not be permitted to issue more visas than this set quota. Employers are charged $1,500 for these visas which would support funding US nursing programs; HR 1933, to amend the Immigration and Nationality Act to modify the requirements for admission of nonimmigrant nurses in health professional shortage areas and calls for a limited revival of the H-1C program; S 778 Protecting Access to Rural Therapy Services (PARTS) Act, a bill to amend title XVIII of the Social Security Act with respect to physician supervision of therapeutic hospital outpatient services; HR 1363 Department of Defense and Further Additional Continuing Appropriations Act, 2011; Letter to oppose Cuts to the funding of the Hospital Preparedness Program; HR 1214 a bill to repeal mandatory funding for school-based health center construction, it amends the Patient Protection and Affordable Care Act to repeal the program requiring the Secretary of Health and Human Services (HHS) to award grants to school-based health centers or their sponsoring facilities to support the operation of such health centers. Rescinds unobligated appropriations for the program. Urging that final Accounting of Disclosures rule not include the proposal to require provision of an access report to patients; HR 1540 National Defense Authorization Act of 2012, a bill to establish a working group within the Department of Defense to comprehensively review all TRICARE policies and practices related to pediatric care and to develop recommendations that specifically address the health care needs of children of military families; S 1854 Medical Surge Capacity Act, a bill to enhance medical surge capacity which uses lessons learned from previous disasters to make critical changes when responding to a natural or manmade disaster; HR 2405 and S 1855 Pandemic and All-Hazards Preparedness Act Reauthorization of 2011, a bill to amend the Public Health Service Act to reauthorize various programs under the Pandemic and All-Hazards Preparedness Act; S. 1979 Conrad State 30 Improvement Act (Immigration) , a bill to help streamline J-1 visa waiver process for hospitals to hire international physicians to practice in rural and medically underserved communities; Critical Access Hospital (CAH) Letter from Rep. Ron Kind and Rep. Jo Ann Emerson to the supercommittee to protect CAH from potential cuts or other detrimental policy changes; Urging the Super Committee to reject cuts to inpatient rehabilitation facilities (IRFs); Extender's letter to supercommittee with a list of hospital specific issues that need to be addressed; HR 3586 Good Samaratin Health Professionals Act, a bill to amend the PHSA to limit the liability of healthcare professionals who volunteer to provide healthcare services in response to disaster; HR 3839 Drug Shortage Prevention Act of 2012, to address critical drug shortage; S 2193 Ensuring Safe Medical Devices for Patients, a bill to require the Food and Drug Administration to include devices in the postmarket risk identification and analysis system, to expedite the implementation of the unique device identification system for medical devices; HR 4246 VA Enrollment Act, to amend title 38, United States Code, to provide for the expansion of eligibility for veteran reimbursement for emergency treatment provided in non-Department of Veterans Affairs facilities; HR 5800 Health Care Price Transparency Promotion Act of 2012, to amend title XIX of the Social Security Act to provide for increased price transparency of hospital information and to provide for additional research on consumer information on charges and out-of-pocket costs; H.R.6118 and S.3391 Taking Essential Steps for Testing Act of 2012. to amend the Public Health Service Act to revise sanctions for laboratories that intentionally refer proficiency testing samples required for certification to another laboratory for analysis by: (1) giving the Secretary of Health and Human Services (HHS) discretion to substitute intermediate sanctions for such violations instead of the two-year prohibition against ownership or operation which would otherwise apply, and (2) making the one-year certificate revocation for such a laboratory optional rather than mandatory. Which gives CMS more discretion in enforcing the Clinical Laboratory Improvement Amendments to preserve patient access to lab services.

Client expense: $5,350,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 905 and S. 733 (Medicare Prompt Pay Discount Exclusion), legislation to ensure more appropriate general payment amount 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. H.R. 1483, Drug Safety Enhancement Act of 2011, provisions related to pharmaceutical pedigree, wholesale transaction documentation, and electronic tracking. H.R. 3026, Safeguarding America's Pharmaceuticals Act, provisions related to pharmaceutical pedigree anti-counterfeiting. S. 1584, Drug Safety and Accountability Act of 2011, provisions related to pharmaceutical pedigree anti-counterfeiting. Preserving Access to Life-Saving Medications Act (H.R. 2245, S. 296), provisions related to drug shortages.

Client expense: $390,000 · Firm income: Not reported

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

Issues relating to implementation of the Patient Protection & Affordable Care Act (PL111-148) including implementation of health insurance reform measures in the comprehensive health reform to provide coverage of the uninsured and annual and lifetime benefit limits; Medicare's Sustainable Growth Rate (SGR) reimbursements for physicians; drug shortage related legislation including: H.R.2245-Preserving Access to Life-Saving Medications Act, H.R.3839-Drug Shortage Prevention Act, S.296-Preserving Access to Life-Saving Medications Act, S.3187-Food and Drug Administration Safety and Innovation Act and policy issues related to medical imaging and radiation therapy reimbursement policy and H.R.4209, The Patient Access to Treatment Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 319, Pharmaceutical Market Access and Drug Safety Act - Lobbied against passage of legislation to allow for the importation of unsafe prescription drugs. S. 752, Lung Cancer Mortality Reduction Act of 2011 - Lobbied for passage of bill to reduce lung cancer mortality. NO BILL, Health Care Reform Implementation - Lobbied on implementation of provisions in the health care reform bill regarding biosimilars, the Independent Payment Advisory Board and the Annual Fee. S. 296 and H.R. 2245, Preserving Access to Life-Savings Medications Act - Lobbied to improve provisions in the drug shortage legislation. H.R. 1483, Drug Safety Enhancement Act of 2011 - Lobbied to pass meaningful drug safety legislation. S. 3187, the "Food and Drug Administration Safety and Innovation Act - Lobbied for passage of PDUFA legislation. S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments - Lobbied to pass meaningful FDA reform legislation. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012 - Lobbied to pass meaningful FDA reform legislation. H.R. 4274, BCPA and PREA Reauthorization Act of 2012 - Lobbied for permanence of BCPA and PREA. H.R. 3497, MODERN Cures Act of 2011 - Lobbied for incentives for development of pharmacodiagnostics and dormant therapies. H.R. 3737, Unlocking Lifesaving Treatments for Rare-Diseases Act - Lobbied to pass meaningful FDA reform legislation. H.R. 4132, Faster Access to Specialized Treatments Act - Lobbied to pass meaningful FDA reform legislation. Labor, HHS Appropriations. Lobbied for increased access to HIV/AIDS drugs in the AIDS Drug Assistance Program. NO BILL, Supply chain draft legislation - Lobbied for passage of legisaltion to increase security of the drug distribution supply chain.

Client expense: $1,280,000 · Firm income: Not reported

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

Implementation of the Patient Protection and Affordable Care Act (P.L. 111-148); Medical Malpractice; H.R. 2245/S.296 - Preserving Access to Life-Saving Medications Act of 2011; Drug Shortages; H.R. 5 - Protecting Access to Healthcare Act; Impact of sequestration on Health Care programs

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug User Fee Act; legislation related to drug shortages (S.296, H.R.2245); FDA Safety & Innovation Act; H.R.733 Recalcitrant Cancer Research Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to implementation of the Patient Protection & Affordable Care Act (PL111-148) including implementation of health insurance reform measures in the comprehensive health reform to provide coverage of the uninsured and annual and lifetime benefit limits; Medicare's Sustainable Growth Rate (SGR) reimbursements for physicians; drug shortage related legislation including: H.R.2245-Preserving Access to Life-Saving Medications Act, H.R.3839-Drug Shortage Prevention Act, S.296-Preserving Access to Life-Saving Medications Act, S.3187-Food and Drug Administration Safety and Innovation Act and policy issues related to medical imaging and radiation therapy reimbursement policy and H.R.4209, The Patient Access to Treatment Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Appropriations for Patient Protection and Affordable Care Act (ACA) Behavioral Health Information Technology Act (S. 539) (HR 6043) State Flexibility Act (HR 1683) The BPCA and PREA Reauthorization Act (HR 4274) Preserving Access to Life Saving Medication Act (S 296) (HR 2245) Drug Shortage Prevention Act (HR 3839) Department of Labor, Health and Human Services and Education Related Agencies Appropriations Act 2013 (S 3295) (HR 3070) Protect our Kids Act of 2012 (S 3705) (HR 6655)

Client expense: Not reported · Firm income: Not reported

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

- Issues regarding tax reform. - HR 605, "The Patients' Freedom to Choose Act", regarding all provisions. - HR 436, "Protect Medical Innovation Act of 2011", regarding all provisions. - HR 488, "Save Our Medical Devices Act of 2011", regarding all provisions. - HR 734, "To amend the Internal Revenue Code of 1986 to repeal the medical device tax, and for other purposes", regarding all provisions. - S 17, "Medical Device Access and Innovation Protection Act", regarding all provisions. - S 262, "A bill to repeal the excise tax on medical device manufacturers", regarding all provisions. - HR 942, "American Research and Competitiveness Act of 2011", regarding all provisions - Issues related to tax legislation. - Issues related to the President's proposed "Job Bill" (2011) - S 1368/ HR 2529, "Restoring Access to Medication Act", regarding all provisions. - S 1584, "Drug Safety and Accountability Act of 2011", regarding all provisions. - HR 2245, "Preserving Access to Life-Saving Medication Act", regarding all provisions. - Issues related to Ways and Means tax reform discussion draft. - HR 2735, "To amend the Internal Revenue Code of 1986 to make permanent the look-through treatment of payments between related controlled foreign corporations", regarding all provisions. - S 1577, "Greater Research Opportunities With Tax Help Act", regarding all provisions. - PL 112-96, "Middle Class Tax Relief and Job Creation Act of 2012", provisions regarding Medicare clinical laboratory services. - HR 1864, "Mobile Workforce State Income Tax Simplification Act of 2011", regarding all provisions. - S 2091, "United States Job Creation and International Tax Reform Act of 2012", regarding all provisions.

Client expense: $880,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (PREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program S.1855, HR 2405 Pandemic and All-Hazards Preparedness Act Reauthorization of 2011

Client expense: $1,212,000 · Firm income: Not reported

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

H.R.905 and S.733, legislation to ensure more appropriate general payment amount 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. H.R. 1483, H.R.3026 and S.1584, pharmaceutical pedigree anti-counterfeiting legislation. H.R.2245 and S.296, legislation pertaining to drug manufacturing shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Patient Protection and Affordable Care Act (P.L. 111-148); Medical Malpractice; H.R. 2245/S. 296 - Preserving Access to Life-Saving Medications Act of 2011; Drug Shortages; H.R. Protecting Access to Healthcare Act; Impact of Sequestration on Health Care Programs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 296 Preserving Access to Life Saving Medication At, Drug Shortage in hospitals HR 2245, Preserving Access to Life Saving Medication At, Drug Shortage in hospitals

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative proposals related to pharmaceutical pedigree anti-counterfeiting, wholesale transaction documentation, and electronic tracking, including H.R. 1483, H.R. 3026, and S. 1584; legislative proposals related to drug shortages, including H.R. 2245 and S. 296.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare payment issues. Health reform issues. H.R.2245/S.296, the Preserving Access to Life-Saving Medications Act, Drug shortage related issues. Sequestration and fiscal cliff issues, generally.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2013, Medical Center related initiatives S.296/H.R.2245, Preserving Access to Life-Saving Medications Act, Drug shortage issues Public Law 112-144, Food & Drug Administration Safety and Innovation Act, Drug Shortage issues Reauthorization of the Traumatic Brain Injury Act, Traumatic brain injury issues generally. S.1465/H.R.2751, Joining Forces for Military Mental Health Act, Traumatic brain injury issues. S.362/H.R.733, Recalcitrant Cancer Research Act of 2012, Cancer research issues. H.R.4310/S.3254, National Defense Authorization Act for Fiscal Year 2013, Cancer research and Traumatic brain injury issues.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

The Prescription Drug Marketing Act and issues relating to anti-counterfeiting/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse; H.R. 1316, Stop Oxy Abuse Act; H.R. 1065, Pill Mill Crackdown Act; Patient Protection and Affordable Care Act; H.R. 1483, Drug Safety Enhancement Act; Drug shortages; Preserving Access to Life-Saving Medications Act (S. 296); H.R.2245,Preserving Access to Life-Saving Medications Act of 2011

Client expense: $510,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

The Prescription Drug Marketing Act and issues relating to anti-counterfeiting/pedigree issues Drug importation issues; Drug safety and inspection of drug manufacturing facilities; Prescription Drug Abuse; H.R. 1316, Stop Oxy Abuse Act; H.R. 1065, Pill Mill Crackdown Act; Patient Protection and Affordable Care Act; H.R. 1483, Drug Safety Enhancement Act; Drug shortages; Preserving Access to Life-Saving Medications Act (S. 296); H.R.2245,Preserving Access to Life-Saving Medications Act of 2011

Client expense: $510,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Supply chain safety (H.R. 5651; S. 3187); pharmaceutical shortages (H.R. 2245; S. 296;H.R. 5651; S. 3187; H.R. 3381)

Client expense: $1,190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page S. 660 - PATIENTS Act of 2011, comparative effectiveness S. 296/H.R. 2245 - Preserving Access to Life Saving Medications Act Health care reform, drug importation, 340b, biosimilars PL 111-148 - The Patient Protection and Affordable Care Act, PL 111-152 - The Reconciliation Act of 2010, implementation PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation ***no specific bills, importation, Prescription Drug User Fee Act Renewal and associated policies, supply chain integrity

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

HR 5 HEALTH Act/Protecting Access to Healthcare Act; HR 451, Healthcare Truth & Transparency Act; HR 1044, Medicare Access to Rural Anesthesiology Act; HR 452 Medicare Decisions Accountability Act of 2011; HR 2104 Consistency Accuracy Responsibility & Excellence in Medical Imaging & Radiation Therapy Act of 2011; S 296/HR 2245 Preserving Access to Life-Saving Medications Act of 2011; HR 6611 Patient Access to Drugs in Shortage Act; Health reform implementation.

Client expense: $230,000 · 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 Resources & Services Administration (HRSA), SENATE

H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines

Client expense: $1,370,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

FY 2014 Budget, FY 2013 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, drug shortages, prescription drug abuse and generic drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011 H.R. 3839 - Drug Shortage Prevention Act of 2012 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 H.R.6160 - Stop Tampering of Prescription Pills Act of 2012 H.R. 6433 - FDA User Fee Corrections Act of 2012 H.R.6584 - Verifying Authority and Legality In Drug Compounding Act of 2012 H.R.6611 - Patient Access to Drugs in Shortage Act of 2012 H.R.6638 - S.A.F.E. Compounded Drugs Act of 2012 S. 44 Medicare Prescription Drug Negotiation Act S. 296 and H.R.2245 Preserving Access to Life-Saving Medication Act S. 373 Fair Prescription Drug Competition Act S. 1584 - Drug Safety and Accountability Act of 2011 S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 2295 - Patient Safety and Generic Labeling Improvement Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act S.1855 - Pandemic and All-Hazards Preparedness Act Reauthorization of 2011

Client expense: $486,262 · 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

the Patients' Freedom to Choose Act (H.R. 605/S. 312) the HEALTH Act of 2011 (H.R. 5/S. 1099) the Protect Medical Innovation Act of 2011 (H.R. 436) the Preserving Access to Life-Saving Medications Act (S. 296/H.R. 2245)

Client expense: $30,430 · 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), Internal Revenue Service (IRS), Office of Natl Drug Control Policy (NDCP), SENATE

Legislation to address drug shortages (H.R. 2245, S. 296). State and Federal regulation of air medical services (S. 2376, H.R. 1117). Medicare reimbursement for air medical services.

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

Government targets: Federal Aviation Administration (FAA), HOUSE OF REPRESENTATIVES, Natl Transportation Safety Board (NTSB), SENATE, Transportation, Dept of (DOT)

Implementation of Pub. Law No. 111-148, the Patient Protection and Affordable Care Act, primarily patient protection provisions and provisions on breast health education, research and clinical trials. (Continued on Addendum) H.R.2245/S.296, Preserving Access to Life-Saving Medications Act of 2011, primarily matters related to establishing notification requirements to mitigate drug shortages. H.R. 3839, Drug Shortage Prevention Act of 2012. H.R.2499, Lymphedema Diagnosis and Treatment Cost-Saving Act of 2011. H.R.3102, Breast Density and Mammography Reporting Act of 2011. H.R.3705, Comprehensive Cancer Care Improvement Act of 2011. H.R.2746, Cancer Drug Coverage Parity Act of 2011. H.R.1483, Drug Safety Enhancement Act of 2011, primarily matters related to ensuring the safety and quality of the drug supply chain. H.R.3699, Research Works Act, primarily matters related to opposing it in order to protect the NIH Public Access Policy. S.2113, Transforming the Regulatory Environment to Accelerate Access to Treatments, primarily matters related to codifying and clarifying FDA authority to expedite approval of new treatments for life-threatening conditions. S.2236, Advancing Breakthrough Therapies for Patients Act of 2012. Pub. Law No. 112-144, Food and Drug Administration Safety and Innovation Act of 2012, primarily matters related to drug shortages, drug approval and patient access. H.R. 4209, Patients' Access to Treatments Act of 2012. H.R. 5937, Breast Cancer Patient Education Act of 2012. Pub. Law No. 112-240, American Taxpayer Relief Act of 2012, primarily matters related to funding for the National Breast and Cervical Cancer Early Detection Program and the National Institutes of Health.

Client expense: $30,000 · 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), Natl Institutes of Health (NIH), SENATE

H.R. 451, Healthcare Truth and Transparency Act: Healthcare Provider Transparency, Healthcare Provider Misrepresentation H.R. 866, National All Schedules Prescription Electronic Reporting Reauthorization Act S. 296/H.R. 2245, Preserving Access to Life-saving Medications Act, drug shortages S. 507, Prescription Drug Abuse Prevention and Treatment Act of 2011 H.R. 2119, Ryan Creedon Act of 2011 Medical Liability Reform; H.R. 5, HEALTH Act of 2011 H.R. 3839, Drug Shortage Prevention Act of 2012 H.R. 2245, Preserving Access to Life-saving Medications Act of 2011 P.L. 112-144, The Food and Drug Administration Safety and Innovation Act Drug Shortages - FDA, DEA, HHS, CMS, GAO, House Energy and Commerce Committee, Senate HELP Committee PPACA Nondiscrimination language regarding paraprofessionals - repeal DEA Scheduling Propofol Comparative Effectiveness Research HITECH Implementation, Electronic Health Records, Final and Proposed Rules, HIT Meaningful Use HHS/OIG Anesthesia Practice Arrangements, Company Model FDA Risk Evaluation and Mitigation Strategies FDA Safe Use Initiative Pain Management Individual Mandate- PPACA Proposed Federal CME requirements by ONDCP FTC Letters to States regarding Interventional Pain Medicine and Advanced Practice Nurses Scope of Practice FDA Operating Room Fires Prescription Drug User Fee Act State Exchanges pursuant to PPACA FDA SEDASYS FDA Patient Prescriber working group FDA Sedation Initiative FDA Naloxone workshop FDA Patient Prescriber Agreement workshop FDA Anesthesia Trials workshop FDA Opioid Efficacy workshop ICD-10-CM/PCS and proposed delay of implementation date

Client expense: $230,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE

**see addendum page Importation of prescription drugs (S.319/H.R. 147) NASPER reauthorization (H.R. 866) Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297) Drug Abuse (S. 507) Drug Shortages (S. 296/H.R. 2245/H.R. 3839/PL 112-144/H.R. 5853/H.R. 5651) Rx Pedigree (H.R. 3026/PL 112-144) Cargo/Product Theft (S. 1002/H.R. 4223) Prescription Drug Monitoring Program (H.R. 2254/H.R. 4292/PL 112-144) Counterfeit Drugs (S. 1886/H.R. 3668/PL 112-144) ***, no specific bills, supply chain integrity, prescription drug abuse

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

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

H.R. 733 & S. 362: Pancreatic Cancer Research & Education Act H.R. 2239: Functional Gastrointestinal & Motility Disorder (FGIMD) Research Enhancement Act H.R. 2108 & S. 1173: Ambulatory Surgical Center Quality & Access Act H.R. 2195 & S. 1203: Medicare Home Infusion Therapy Coverage H.R. 3839: Drug shortage legislation including: The Drug Shortage Prevention Act H.R. 2245 & S. 296: The Preserving Access to Life Saving Medications Act H.R. 3381 & S. 1809: Viral Hepatitis Testing Act H.R. 3198: Supporting Colorectal Examination & Education Now (SCREEN) Act H.R. 912 & S. 494: Colorectal Cancer Prevention, Early Detection, and Treatment Act H.R. 3211 & S. 1865: Patient Access to Medical Innovation Act: humanitarian Device Reform Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 606, Creating Hope Act of 2011, S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act, The Food and Drug Administration Safety and Innovation Act (PL 112-144) and amendments considered, including the Faster Access to Specialized Treatments Act (H.R. 4132) and the Transforming the Regulatory Environment to Accelerate Access to Treatment (TREAT) Act (S. 2113). Assess potential impact of sequestration on public health/food and drug programs (HR 8/PL 112-240).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

proposed legislative provisions and related inquiries into Group Purchasing Organizations Implementation of PL 111-148 - The Patient Protection and Affordable Care Act S 296 - Preserving Access to Life Saving Medications Act HR 2245 - The Preserving Access to Life Saving Medications Act Monitoring of other legislative proposals regarding drug shortages S. 3187 - Food and Drug Administration Safety and Innovation Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 525Veterinary Public Health Amendments Act All Provisions S. 518 Veterinary Medicine Loan Repayment Program Enhancement Act All Provisions S.3187Food and Drug Administration Safety and Innovation Act Provisions related to drug shortages H.R.2245/S.296The Preserving Access to Lifesaving Medications Act Provisions related to drug shortages CMS-1588-PCenters for Medicare & Medicaid Services Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to oral-health and dental practice in the following bills: H.R. 2/S. 192, Repealing the Job-Killing Health Care Law Act; H.R. 5/S. 218, S. 1099, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011; H.R. 38, A bill to rescind funds appropriated to the Health Insurance Reform Implementation Fund under the Health Care and Education Reconciliation Act of 2010; HR105, Empowering Patients First Act; HR157, Health Care Safety Net Enhancement Act of 2011; HR165, Informed Choice Act; H.R. 969, the Medical Practice Freedom Act of 2011; H.R. 314, Medical Liability Procedural Reform Act of 2011; H.R. 570, Dental Emergency Responder Act; H.R. 1578/S. 1765, Violence Against Women Health Initiative Act of 2011; H.R. 2119, Ryan Creedon Act of 2011; H.R. 2405/S. 1855, Pandemic and All Hazards Preparedness Act of 2011; H.R. 3586, Good Samaritan Health Professionals Act of 2011; S. 197, Medical Care Access Protection (MCAP) Act of 2011; S. 312/H.R. 605, Patients Freedom to Choose Act; S. 966, Bone Health Promotion and Research Act of 2011; S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act; S. 1878/H.R. 4091, Coordination of Pro Bono Medically Recommended Dental Care Act; S. 1925, Violence Against Women Reauthorization Act of 2011; H.R. 3765, Temporary Payroll Tax Cut Continuation Act of 2011; H.R. 3839, Drug Shortage Prevention Act of 2012; S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act; S. 3187 [H.R. 5651] - Prescription Drug User Fee Act. H.R. 5909 - Comprehensive Dental Reform Act of 2012 H.R. 5979 - Medicaid Accountability and Care Act of 2012 S. 3272 - Comprehensive Dental Reform Act of 2012 Community water fluoridation Medicaid and CHIP Payment and Access Commission: -Center for Consumer Information and Insurance Oversight; -Center for Medicaid, CHIP and Survey and Certification; Implementation of P.L. 111-148; 111-152, Patient Protection and Affordable Care Act; Oral-health issues within Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020, Healthy People 2020; Comments on planning and establishment of state level exchanges; Office of the Assistant Secretary for Preparedness and Response, National Health Security Strategy (biennial implementation plan), National Disaster Medical System (disaster medical assistance team) regarding issues related to utlization of dental professionals in the event of a disaster; Office of Global Health (United Nations high-level meeting on non-communicable diseases); Division of Oral Health Reorganization; CMS Limited English Proficiency Guidelines; Advisory Committee on Training in Primary Care Medicine and Dentistry Nominations, Ninth Report to Congress; National Advisory Dental and Craniofacial Research Council Nominations; Center for Substance Abuse Treatment, National Recovery Month; United Nations Summit on Non-Communicable Diseases; National Drug Control Strategy / Prescription Drug Abuse Prevention Plan; DEA National Prescription Drug Take Back Campaign; FDA Center for Drug Evaluation and Research regarding dry mouth labeling; Medical/Dental Coding Issues; Comparative Effectiveness regarding Dental Quality Alliance; Health Information Technology (HIT) Regulations; Health care issues before the Joint Select Committee on Deficit Reduction. United Nations General Assembly's High-level Meeting on Non-communicable Diseases CMS proposed rule on reporting and returning Medicare overpayments Food and Drug Administration Sedation Product Guidance Centers for Disease Control and Prevention recommendations for identification of persons with Hepatitis C (HCV) chronic infection H.R. 5711 - Access to Substance Abuse Treatment Act of 2012 Department of Health and Human Services media campaign to educate the public about the dangers of tobacco use SAMHSA National Recovery Month Food and Drug Administration clinical development and use of sedation products Surgeon General report on sugar-sweetened beverages S. 3562, Older Americans Act Amendments of 2012 HR 436, Protect Medical Innovation Act of 2011 (Medical Device Tax) HR 488, Save Our Medical Devices Act of 2011 (Medical Device Tax) S 17, Medical Device Access and Innovation Protection Act (Medical Device Tax) S 262, To repeal the excise tax on medical device manufacturers (Medical Device Tax)

Client expense: $620,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Air Force, Dept of, Army, Dept of (Other), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Indian Health Service, Natl Institutes of Health (NIH), Navy, Dept of, Occupational Safety & Health Administration (OSHA), Office of Natl Drug Control Policy (NDCP), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA)

H.R.866-National All Schedules Prescription Electronic Reporting (NASPER) Reauthorization Act of 2011 H.R.1065- Pill Mill Crackdown Act of 2011 H.R.1254-Synthetic Drug Control Act of 2011 H.R.1571-Combating Dangerous Synthetic Stimulants Act of 2011 H.R.2245-Preserving Access to Life-Saving Medications Act of 2011 H.R.3668-Counterfeit Drug Penalty Enhancement Act of 2012 H.R.5651-Food and Drug Administration Safety and Innovation Act S.296-Preserving Access to Life-Saving Medications Act S.409-Combating Dangerous Synthetic Stimulants Act of 2011 S.605-Dangerous Synthetic Drug Control Act of 2011 S.839-Combating Designer Drugs Act of 2011 S.1760-Pill Mill Crackdown Act of 2011 S.2516-Food and Drug Administration Safety and Innovation Act S.3187-Food and Drug Administration Safety and Innovation Act

Client expense: $695,377 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Rx Pedigree (H.R. 3026/PL 112-144); NASPER Reauthorization (H.R. 866); Prescription Drug Monitoring Programs (S. 2254/H.R. 4292/PL 112-144); Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297); Drug Abuse (S. 507); Drug Shortages (S. 296/HR 2245/HR 3839/ PL 112-144/HR 5853/HR 5651); Cargo/Product Theft (S. 1002/H.R. 4223; PL 112-204); Counterfeit Drugs (S. 1886/H.R. 3668/PL 112-144)

Client expense: $228,000 · Firm income: Not reported

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