Drug Shortage Prevention Act of 2012

Monitor implementation of the Patient Protection and Affordable Care Act. (P.L. 111-148) S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments. S. 2196, Congressional Health Care for Seniors Act of 2012. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. H.R. 5, Protecting Access to Healthcare Act. H.R. 452, Medicare Decisions Accountability Act of 2011. H.R. 3839, Drug Shortage Prevention Act of 2012. H.R. 4209, Patients' Access to Treatments Act of 2012. H.R. 451, Healthcare Truth and Transparency Act of 2011. H.R. 5707, Medicare Physician Payment Innovation Act of 2012. H.R. 6142, Assuring Medicare Stability and Access for Seniors Act of 2012. H.R. 6352, Resident Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act. H.R. 6482, To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings. H.R. 6562, Resident Physician Shortage Reduction Act of 2012. HJRes 117, Continuing Appropriations Resolution, 2013. (P.L. 112-175) Ryans Fy2013 Budget: A Path to Prosperity: A Blueprint for American Renewal Monitor federal issues and legislation associated with health care policy.

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

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

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

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)

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

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

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)

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

S.3187 - Food and Drug Administration and Safety and Innovation Act and Related Conference Report PL 112-144 (drug shortage provisions). S.296/H.R.2245 - Preserving Access to Life-Saving Medications Act (drug shortage provisions). S.319 - Pharmaceutical Market Access and Drug Safety Act (drug shortages provisions). H.R.5651 - Food and Drug Administration Reform Act (drug shortage provisions). H.R.3839 - Drug Shortage Prevention Act (drug shortage provisions). Medicare physician fee schedule fix (issue only). Medicare hospital wage index (issue only). Inpatient Prospective Payment system final proposed regulation (coding offset). H.R.3519 - To exempt the Medicare program from fallback sequestration under the Budget Control Act of 2011, (entire bill). S.2620/H.R.5943 - Rural Hospital Access Act, (entire bill). H.R.2224 - Improving Physician Access to Teaching Hospitals Act, (entire bill). S.1627/H.R.6562 - Resident Physician Shortage Reduction Act (entire bill). H.R.452 - Medicare Decisions Accountability Act (IPAB repeal). S.668 - Health Care Bureaucrats Elimination Act. Resident Physician Shortage Reduction and Graduate Medical Education Accountability Act, H.R.6352 (entire bill).

Client expense: $209,000 · Firm income: Not reported

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

H.R.2245 - Preserving Access to Life-Saving Medications Act of 2011. H.R.3849 - Rural Hospital and Provide Equity (R-HoPE) Act. H.R.3839 - Drug Shortage Prevention Act. S.2257 - Excellence in Mental Health Act. S.296 - Preserving Access to Life-Saving Medications Act. S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011. H.R.3630 - Middle Class Tax Relief and Job Creation Act of 2012; Related Conference Report 112-399 H.R.3519 - To exempt the Medicare Program from fallback sequestration under the Budget Control Act of 2011. H.R.2500 - The Equal Access and Parity for Multi-Campus Hospitals Act. H.R. 2224 - Improving Physician Access to Teaching Hospitals. S.1627 - Resident Physician Shortage Reduction Act. H.R.452 - Medicare Decisions Accountability Act of 2011. S.668 - Health Care Bureaucrats Elimination Act. S.218/H.R.5 - Help Efficient, Accessible, Low-Cost, Timely Healthcare (Health) Act of 2011. Medicare Physician Fee Schedule Fix. Medicare Hospital Wage Index.

Client expense: $238,000 · Firm income: Not reported

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

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 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: $487,850 · 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

H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) 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 consumer HR 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 S. Amend. t.2107 and related legislative proposals regarding prescription drug importation

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

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

H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 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 S. Amend. t.2107 and related legislative proposals regarding prescription drug importation

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

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

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: $3,550,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office

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 consumer HR 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: $980,000 · Firm income: Not reported

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

H.R. 3026, S. 1882 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 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 H.R. 6160 - issues related to drug safety, including tamper resistent packaging

Client expense: $980,000 · Firm income: Not reported

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

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: $235,393 · Firm income: Not reported

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

H.R. 5 Protecting Access to Healthcare Act; H.R. 2245 / S. 296 Preserving Access to Life-Saving Medications Act; H.R. 3839 Drug Shortage Prevention Act; H.R. 4209 Patients' Access to Treatments Act; H.R. 6352 Resident Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act; H.R. 6482 To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health services; H.R. 6562 Resident Physician Shortage Reduction Act

Client expense: $120,000 · Firm income: Not reported

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

"S. 3187, Food and Drug Administration Safety and Innovation Act (drug shortages in hospitals) and Related Conference Report PL 112-144 "S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act (drug shortages in hospitals) "S. 319, Pharmaceutical Market Access and Drug Safety Act (drug shortages in hospitals) H.R. 5651, Food and Drug Administration Reform Act (drug shortages in hospitals) H.R. 3839, Drug Shortage Prevention Act (drug shortages in hospitals) Medicaid provider taxes Medicare and Medicaid Payment reductions, including Graduate Medical Education, bad debt payments, post-acute care payments, CAH payments, IPPS coding offset, rural hospital payments, section 508 wage index reclassification, Medicare Dependent Hospital authorization, inpatient coding offset, small rural clinical hold harmless, Sole Community Hospital (SCH) outpatient department hold harmless, outpatient therapy cap moratorium, and hospital outpatient department (HOPD) evaluation and management (E/M) service. Medicare physician fee schedule fix Medicare hospital wage index H.R. 3519, To exempt the Medicare program from fallback sequestration under the Budget Control Act of 2011 S. 2620/H.R. 5943, Rural Hospital Access Act (MDH/LV Adjustment 1-year extension) S. 1680/H.R. 3859, Craig Thomas Rural Hospital and Provider Equity (R-HoPE) Act H.R. 2224, Improving Physician Access to Teaching Hospitals Act (Medicare residency slots) S.1627/H.R. 6562, Resident Physician Shortage Reduction Act (Medicare residency slots) H.R. 452, Medicare Decisions Accountability Act of 2011 (IPAB repeal) Medicare and Medicaid Programs; Electronic Health Record Incentive ProgramStage 2; Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology; Final Rules (CMS and ONC Medicare and Medicaid EHR Meaningful Use Incentive Program Stage 2 final rules) New York State 1115 Medicaid Waiver Application to CMS Medicare and Medicaid Recovery Audit Contractor (RAC) Programs

Client expense: Not reported · Firm income: Not reported

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

Issues relating to R&D funding for rare disease products; drug shortages; DEA quotas for controlled substances; manufacturing, distribution and dispensing process for ADHD medication; extension of enantiomer exclusivity program; fast track and accelerated approvals; voucher program to incentivize development of products for rate pediatric cancer; end stage renal disease Prospective Payment System (ESRD PPS); drug importation; tax reform; prescription drug user fees; H.R. 2245, Preserving Access to Life Saving Medications Act; H.R. 3839, Drug Shortage Prevention Act of 2012; H.R. 5651, Food and Drug Administration Reform Act of 2012; S. 296, Preserving Access to Life Saving Medications Act; S. 3187, Food and Drug Administration Safety and Innovation Act

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

- S.3187, Food and Drug Administraton Safety and Innovation Act (drug shortages in hospitals) and Related Conference Report P.L.112-144. - S.296/H.R.2245, Preserving Access to Life-Saving Medications Act (drug shortages in hospitals). - H.R.3839, Drug Shortage Prevention Act (drug shortages in hospitals) - S.319, Pharmaceutical Market Access and Drug Safety Act (drug shortages in hospitals). - H.R.5651, Food and Drug Administration Reform Act (drug shortages in hospitals). - Medicaid provider taxes. - Medicare and Medicaid Payment reductions, including Graduate Medical Education, bad debt payments, post-acute care payments, CAH payments, IPPS coding offset, rural hospital payments, section 508 wage index reclassification, Medicare Dependent Hospital authorization, inpatient coding offset, small rural clinical hold harmless, Sole Community Hospital (SCH) outpatient department hold harmless, outpatient therapy cap moratorium, and hospital outpatient department (HOPD) evaluation and management (E/M) service. - Medicare physician fee schedule fix. - Medicare hospital wage index. - H.R.3519, To exempt the Medicare program from fallback sequestration under the Budget Control Act of 2011. - S.2620/H.R.5943, Rural Hospital Access Act (MDH/LV Adjustment 1-year extension). - S.1680/H.R.3859, Craig Thomas Rural Hospital and Provider Equity (R-HoPE) Act. - H.R.2500, The Equal Access and Parity for Multi-Campus Hospitals Act (Electronic Health Record multi-campus incentive bill). - H.R.2224, Improving Physician Access to Teaching Hospitals Act (Medicare residency slots). - S.1627/H.R.6562, Resident Physician Shortage Reduction Act (Medicare residency slots). - H.R.452, Medicare Decisions Accountability Act of 2011 (IPAB repeal). - S.668, Health Care Bureaucrats Elimination Act (IPAB repeal). - Medicare and Medicaid Programs; Electronic Health Record Incentive ProgramStage 2; Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology; Final Rules (CMS and ONC Medicare and Medicaid EHR Meaningful Use Incentive Program Stage 2 final rules). - New York State 1115 Medicaid Waiver Application to CMS. - H.R.6118, Taking Essential Steps for Testing (TEST) Act (unintentional proficiency testing laboratory referrals). - Medicare and Medicaid Recovery Audit Contractor (RAC) Programs.

Client expense: $190,000 · 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

Monitor implementation of the Patient Protection and Affordable Care Act. (P.L. 111-148) S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments. S. 2196, Congressional Health Care for Seniors Act of 2012. S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. H.R. 5, Protecting Access to Healthcare Act. H.R. 452, Medicare Decisions Accountability Act of 2011. H.R. 3839, Drug Shortage Prevention Act of 2012. H.R. 4209, Patients' Access to Treatments Act of 2012. H.R. 451, Healthcare Truth and Transparency Act of 2011. H.R. 5707, Medicare Physician Payment Innovation Act of 2012. H.R. 6142, Assuring Medicare Stability and Access for Seniors Act of 2012. H.R. 6352, Resident Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act. H.R. 6482, To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings. H.R. 6562, Resident Physician Shortage Reduction Act of 2012. HJRes 117, Continuing Appropriations Resolution, 2013. (P.L. 112-175) Ryans Fy2013 Budget: A Path to Prosperity: A Blueprint for American Renewal Monitor federal issues and legislation associated with health care policy.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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/S.3187/H.R. 5853/H.R. 5651) Rx Pedigree (H.R. 3026/S. 3187) Cargo/Product Theft (S. 1002/H.R. 4223) Prescription Drug Monitoring Program (H.R. 2254/H.R. 4292/S. 3187) Counterfeit Drugs (S. 1886/H.R. 3668/S. 3187) ***, 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. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend 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 of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies 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 of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

Client expense: $4,140,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

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.2219, Department of Defense Appropriations Act, 2012, primarily matters related to appropriations for Congressional Directed Medical Research Programs. Pub. Law No. 112-74, Consolidated Appropriations Act, 2012, primarily matters related to appropriations for cancer research, cancer screening programs and Congressional directed medical research programs. S.3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013, primarily matters related to funding of cancer research and CDC cancer prevention and control programs. 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.3067, Accelerating the End of Breast Cancer 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. H.R. 6157, Patient Centered Quality Care for Life Act of 2012

Client expense: $25,001 · 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

S. 3187, Food and Drug Administration and Safety and Innovation Act and Related Conference Report PL 112-144 (drug shortage provisions) S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act (drug shortage provisions) S. 319, Pharmaceutical Market Access and Drug Safety Act (drug shortages provisions) H.R. 5651, Food and Drug Administration Reform Act (drug shortage provisions) H.R. 3839, Drug Shortage Prevention Act (drug shortage provisions) Medicare physician fee schedule fix (issue only) Medicare hospital wage index (issue only) Inpatient Prospective Payment system final proposed regulation (coding offset) H.R. 3519, To exempt the Medicare program from fallback sequestration under the Budget Control Act of 2011, (entire bill) S. 2620/H.R. 5943, Rural Hospital Access Act, (entire bill) H.R. 2224, Improving Physician Access to Teaching Hospitals Act, (entire bill) S.1627/H.R. 6562, Resident Physician Shortage Reduction Act (entire bill) H.R. 452, Medicare Decisions Accountability Act (IPAB repeal) S. 668, Health Care Bureaucrats Elimination Act Resident Physician Shortage Reduction and Graduate Medical Education Accountability Act, H.R. 6352 (entire bill)

Client expense: $628,940 · 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), Medicare Payment Advisory Commission (MedPAC), 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: $120,000 · 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

S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters 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" 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.4156, 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.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program 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 H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, 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.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

Client expense: $890,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Rx Pedigree (H.R. 3026/S. 3187); NASPER Reauthorization (H.R. 866); Prescription Drug Monitoring Programs (S. 2254/H.R. 4292/S.3187); 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/S. 3187/H.R. 5853/H.R. 5651); Cargo/Product Theft (S. 1002/H.R. 4223); Counterfeit Drugs (S. 1886/H.R. 3668/S. 3187)

Client expense: $222,819 · Firm income: Not reported

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

H.R. 733 & S. 362: Pancreatic Cancer Research & Education Act H.R. 2239: Functional Gastrointestinal & Motility Disorders (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

Appropriations for Patient Protection and Affordable Care Act (ACA) Behavioral Health Information Technology Act (S. 539) (HR 6043) State Flexibility Act (HR1683) The BPCA and PREA Reauthorization Act (HR4274) Preserving Access to Life Saving Medication Act (S. 296) (HR2245) Drug Shortage Prevention Act (HR3839) Food and Drug Administration Safety and Innovation Act (S. 3187) (HR 5651) Synthetic Drug Abuse Prevention Act (S. 3190) (HR 1254) Synthetics are Dangerous Act (HR 4205) Department of Labor, Health and Human Services and Education and Related Agencies Appropriations Act 2013 (S. 3295) (HR 3070)

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)

Drug Shortages; H.R. 3839 - Drug Shortage Prevention Act of 2012; Oral Chemotherapy.

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

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

S. 3187, Food and Drug Administration Safety and Innovation Act and Related Conference Report PL 112-144 (drug shortage provisions) S. 296/H.R. 2245, Preserving Access to Life-Saving Medications Act (drug shortage provisions) S. 319, Pharmaceutical Market Access and Drug Safety Act (drug shortages provisions) H.R. 5651, Food and Drug Administration Reform Act (drug shortage provisions) H.R. 3839, Drug Shortage Prevention Act (drug shortage provisions)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug shortages. S.296/HR2245 Preserving Access to Life Saving Medications Act, HR3839 Drug Shortage Prevention Act; S.3187, FDA Safety and Innovation Act.

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), 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

Client expense: $600,000 · 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)

HR 2/S192, Repealing the Job-Killing Health Care Law Ac; HR5, S218 Help Efficient, Accessible, Low Cost Timely Health Care Act of 2011; HR 570 Dental Emergency responder Act; HR 2405/S1855, Pandemic and All Hazards Preparedness Act of 2001; S296/HR2245, Preserving Access to Life-saving Medications Act; HR 3839, Drug Shortage Prevention Act of 2012; Food and Drug Safety and Innovation Act.

Client expense: Not reported · Firm income: $15,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug shortage legislation: Preserving Access to Life-Saving Medications Act (H.R. 2245 and S. 296); Drug Shortage Prevention Act of 2012 (H.R. 3839) to be sure companies in compliance with FDA/DEA rules were not penalized; legislative provisions concerning DEA quotas for controlled substances; manufacturing and distribution process regarding Adderall; dispensing of Adderall products. Lobbied for inclusion of provisions in S. 3187, the Food & Drug Administration Safety & Innovation Act and HR 5651, the Food & Drug Administration Reform Act of 2012. Also worked on provisions in those billes that: provide for accelerated approval, modify FDA Advisory Committee Rules, create a voucher program to incentivize companies to develop products for rare pediatric cancer, and extend enantiomer exclusivity program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3590, S 1790 (as enacted into PL 111-148 and PL 111-152) issues related to Medicare and Medicaid reform, including possible changes to Part D and changes to Medicaid price reporting requirements H.R. 2245, S. 296, H.R. 3839(Preserving Access to Life-Saving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages including notification and public reporting H.R. 2182, S. 1734 GAIN (Generating Antibiotic Incentives Now Act of 2011) - issues related to the development of antibiotics H.R. 452 IPAB (Independent Payment Advisory Board) Medicare Decisions Accountability Act of 2011 S.1882, H.R. 3026 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer; HR 1483 - issues related to drug safety, supply chain, and facility inspections HR 3468 - issues related to increased penalties for counterfeiting drugs Discussions regarding use of psychotropic drugs by children in foster care HR 1254 (Synthetic Drug Control Act) - issues related to propsed controlled substance amendments S 2113 (Transforming Regulatory Environment to Accelerate Access to Treatments Act) - issues related to acceleration of innovation and approvals of medical treatments

Client expense: $1,110,000 · Firm income: Not reported

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

H.R. 2245, S. 296, H.R. 3839 (Preserving Access to Life-Saving Medications Act of 2011) and related legislative proposals regarding issues surrounding potential drug shortages including notification and public reporting S.1882, H.R. 3026 and related legislative proposals regarding establishment/implementation of pharmaceutical pedigrees and tracking/tracing of pharmaceuticals from manufacturer to consumer HR 1483 - issues related to drug safety, supply chain, and facility inspections

Client expense: $1,110,000 · Firm income: Not reported

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

H.R. 4209 Patients' Access to Treatments Act; H.R. 5 Protecting Access to Healthcare Act; S. 296 / H.R. 2245 Preserving Access to Life-Saving Medications Act; S. 2069 / H.R. 3891 Spending Reductions through Innovations in Therapies Agenda Act; H.R. 3839 Drug Shortage Prevention Act; S. 2113 Transforming the Regulatory Environment to Accelerate Access to Treatments; S. 2516 Food and Drug Administration Safety and Innovation Act; H.R. 5849 Charity Care Tax Deduction for Physicians Act of 2012

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

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