340B Program Improvement Act

Health and Human Services Appropriations - In support of increased funding for the Department of Health and Human Services including National Institutes of Health research programs and Title VII and Title VIII funding; Poison Control Centers and programs for teaching and research at academic medical centers. In opposition to cuts to GME/IME. In support of 340B Improvement Act of 2011 (HR 2674). In support of extension for 340B Program. In opposition to 2% medicare cut and NIH funding cuts as a result of sequestration. In support of CHGME funding.

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

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

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act 340B Issues Drug Shortage Issues Drug Supply Chain Security AHRQ Report on Enzyme Replacement Therapy for Lysosomal Storage Diseases H.R. 2674, 340B Program Improvement Act

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

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

HR 452 Medicare Decisions Accountability Act of 2011, to repeal the provisions of the Patient Protection and Affordable Care Act providing for the Independent Payment Advisory Board; HR 541 Pay for all your Undocumented Procedures (PAY UP!) Act of 2011, amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to make permanent the program of federal reimbursement of emergency health services furnished to undocumented aliens. Requires a re-allotment of unspent program funds in a fiscal year among eligible providers in full expenditure states according to a specified ratio. Requires addition of such funds to the aggregate amount available for allotment for the succeeding fiscal year in the event there is no full expenditure state; HR 876 and S 58 The Registered Nurse Safe Staffing Act of 2011, to amend title XVIII of the Social Security Act to provide for patient protection by establishing safe nurse staffing levels at certain Medicare providers; HR 1159, to repeal certain provisions of the Patient Protection and Affordable Care Act relating to the limitation on the Medicare exception to the prohibition on certain physician referrals for hospitals and to transparency reports and reporting of physician ownership or investment interests; HR 1186, a bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals; S 374 and HR 2783 Medicare Mental Health Inpatient Equity Act, a bill to amend title XVIII of the Social Security Act to eliminate the 190-day lifetime limit on inpatient psychiatric hospital services under the Medicare program; HR 1398 Rural Hospital Protection Act, legislation which would amend the Social Security Act to ensure that the full cost of certain provider taxes are considered allowable costs for purposes of Medicare reimbursements to CAHs; S 1486 Long-Term Care Hospital Improvement Act of 201, a bill to amend title XVIII of the Social Security Act to clarify and expand on criteria applicable to patient admission to and care furnished in long-term care hospitals participating in the Medicare program; Raising concerns about CMS flawed methodology that overstates the effect of the documentation and coding changes to PPS payments, ensuring that CMS does not go beyond its charge of ensuring budget-neutral implementation of MS-DRGs; Working with CMS to clarify requirements and ensure that the systems to register for the meaningful use incentives and attest to meeting the requirements are useable, including ensuring that hospitals can, with permission, help their physicians sign up for the program and attest to meeting the requirements; Worked with ONC to modify the certification requirements for EHRs to allow the flexibility promised in the rules for meaningful use; Worked to get legislative fix introduced for ACA provision related to readmission policy to eliminate a computation error and ensure that unrelated and planned readmissions are excluded from the policy; Worked to improve the regulation to implement ACOs; Urging CMS to update, streamline, and modernize the Medicare conditions of participation; HR 1852/ S 950 Children's Hospital GME Support Reauthorization Act of 2011, the current CHGME authorization expired in September 2011, and the bills would reauthorize the CHGME program for an additional five years, through fiscal year (FY) 2016, at the current authorization level of up to $330 million a year; HR 1683/ S 868 Medicaid MOE, strikes provisions of ACA related to maintaining Medicaid eligibility levels; HR 1543 Improving Access to Medicare Coverage Act of 2011, to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital requirement for coverage of skilled nursing facility services under Medicare; S 1251Medicare and Medicaid FAST Act, a bill to amend titles XVIII and XIX of the Social Security Act to curb waste, fraud, and abuse in the Medicare and Medicaid programs; HR 2500 Equal Access and Parity for Multi-Campus Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to clarify the application of EHR payment incentives in cases of multi-campus hospitals; HR 2674 340B Program Improvement Act, a bill to amend section 340B of the Public Health Service Act to improve the provision of discounts on drug purchases for certain safety net providers; HR 3630 Temporary Payroll Tax Cut Continuation Act of 2011 or Middle Class Tax Relief and Job Creation Act of 2011, a bill that cuts hospitals to pay for the doc fix, it contains the Social Security payroll tax cut and the Unemployment Insurance extension; HR 3519 a bill to amend and exempt the Medicare program from fallback sequestration under the Budget Control Act of 2011; S. 1680 Craig Thomas Rural Hospital and Provider Equity (R-HoPE) Act of 2011, a bill to amend title XVIII of the Social Security Act to protect and preserve access of Medicare beneficiaries in rural areas to health care providers under the Medicare program; Letter to Rehberg and DeLauro in support of the CHGME program that was circulated by Reps. Capps and Bilbray; Wyden/Crapo letter to CMS to actively oppose a Senate Dear Colleague letter to CMS in support of updating Medicare payments to ambulatory surgery centers (ASCs). The letter did not request a payment update for ASCs. Rather, the letter advocated against the Medicare payment rate for services provided in hospital outpatient department settings; HR 2954 and S 2474 Health Equity and Accountability Act of 2011, Comprehensive bill focused on eliminating racial and ethnic disparities in health care through improved data collection and reporting, culturally and linguistically-appropriate health care, workforce diversity, health information technology, and other actions; Discussions with the Administration (CMS) on applying the therapy cap to hospital outpatient departments; Worked to change CMS definition of allowed EHR costs for CAH Meaningful Use incentive payments to include capital lease purchases of EHRs; HR 3859 Rural Hospital and Provider Equity (R-HOPE) Act of 2012, to amend title XVIII of the SSA to protect and preserve access of Medicare beneficiaries in rural areas to health care providers under the Medicare program; HR 4245 Veterans Co-Pay Fairness Act, to amend title 38, United States Code, to require the Secretary of Veterans Affairs to reimburse eligible veterans who are entitled to Medicare benefits for Medicare deductibles and other expenses that are owed by the veterans for emergency medical treatment provided in non-Department of Veterans affairs facilities; S 2620 and HR 5943 Rural Hospital Access Act of 2012, a bill to amend title XVIII of the Social Security Act to provide for an extension of the Medicare-dependent hospital (MDH) program and the increased payments under the Medicare low-volume hospital program; S 3187 and HR 5651Prescription Drug User Fee Amendments of 2012, a bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars; H.R.6575 Medicare Audit Improvement Act of 2012 to amend title XVIII of the Social Security Act to improve operations of recovery auditors under the Medicare integrity program, to increase transparency and accuracy in audits conducted by contractors; Urging HHS and OIG to examine error rates of RAC as part of its Workplan for 2013 studies of RAC effectiveness.

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

Section 340B of the Public Health Service Act, Section 1927 of the Social Security Act and issues related to (1) administration of the 340B Drug Discount Program, (2) implementation of 340B-related provisions in the Patient Protection and Affordable Care Act of 2010, (3) funding of the Health Resources and Services Administration (HRSA) under the Labor Health & Human Services & Education appropriations bills, and (4) enactment of the 340B Program Improvement Act of 2011 (H.R. 2674).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

H.R.1316, Stop Oxy Abuse Act of 2011: To limit the approval of any drug containing controlled-release oxycodone hydrochloride H.R. 1513, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing H.R. 2674, 340B Program Improvement Act: Provisions related to 340B 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. 4209, Patients Access to Treatments Act: To limit cost-sharing requirements applicable to prescription drugs in a specialty drug tier 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. 6288, Patient Choice Act: To permit provisional approval of fast track products H.R. 6342, Compassionate Freedom of Choice Act: Provisions related to access to investigational drugs or devices for terminally ill patients H.R. 6584, Verifying Authority and Legality In Drug Compounding Act: Provisions relating to drug compounding H.R. 6611, Patient Access to Drugs in Shortage Act of 2012: Promote public notification and provide incentives to reduce drug shortages 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. 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 Implementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including PPACA; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking Vaccine-related policy issues Comparative effectiveness policy issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues Pharmaceutical supply chain security issues

Client expense: $4,120,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 8, American Taxpayer Relief Act of 2012, entire bill with focus on Title VI and Title X. H.R. 6575, Medicare Audit Improvement Act, entire bill. H.R. 6611, Patient Access to Drugs in Shortage Act of 2012, entire bill. H.R. 1543 and S. 818, Improving Access to Medicare Coverage Act of 2011, entire bill. H.R. 6684, Spending Reduction Act of 2012, entire bill with focus on Title II and Title VII. H.R. 4872, Health Care & Education Affordability Reconciliation Act of 2010: provisions relating to hospitals and physicians, including: Section 1106: physician-owned hospitals and self-referral; Section 2302: 340B program; Section 1104 and Section 1203: Medicare and Medicaid DSH Payments; Sections 1108 and 1109 involving geographic disparities in Medicare payment; Section 1105: Market basket updates; Section 1201: Federal funding for States; Section 1202: Payments to primary care physicians. H.R. 3590, Patient Protection and Affordable Care Act, provisions relating to hospitals, hospice and physicians including: Section 3001: hospital value-based purchasing; Section 3125: low-volume hospital payment; Section 3401: productivity adjustments; Section 6001: physician-owned hospital and self-referral; Section 3121: outpatient hold harmless for hospitals; Sections 7101-7103: 340B Program; Section 3401: Independent Payment Advisory Board; Section 3015: hospital readmissions program; Section 3124: Extension of Medicare Dependent Hospital program; Section 3137: Section 508 Reclassification; Section 9007: non-profit hospital provision; Section 3105: ambulance services; Section 3008 and Section 2702: payment adjustment for hospital acquired conditions; Section 3133: Medicare DSH; Section 2551: Disproportionate Share Hospitals; Section 5501: Primary Care Provisions; Section 5503: Graduate Medical Education; Sections 2001-2081: Expansion of Medicaid, CHIP; Sections 1311-1343: CO-OPs and Exchanges; Section 3022: Accountable Care Organizations; Section 3023: Hospital Bundling Provision; Section 6401-6402: Program Integrity Provisions; Section 6501-6503, 6505, 6508: Medicaid Program Integrity Provisions; Section 3141: Changes to the Rural Floor of the Hospital Wage Index. H.R. 2674, 340B Program Improvement Act, entire bill. S. 722 and H.R. 3506, Hospice Evaluation and Legitimate Payment Act, entire bills. S. 778, Protecting Access to Rural Therapy Services (PARTS) Act, entire bill. H.R. 3859 and S. 1680, Rural Hospital and Provider Equity (R-HOPE) Act of 2012, entire bills. H.R. 5943 and S. 2620, Rural Hospital Access Act of 2012, entire bills. H.R. 3630, Middle Class Tax Relief and Job Creation Act of 2011, Title II, Subtitle C--Medicare Extensions; Other Health Provisions, Part 1--Medicare extensions, Section 2201, Physician payment update. Section 2202: Ambulance Add-ons; Section 2203: Medicare payment for outpatient therapy services; Section 2204: Work geographic Adjustment; Part 3--Offsets, Section 2223: Parity in Medicare payments for hospital outpatient department evaluation and management office visit services; Section 2224, Reduction of bad debt treated as an allowable cost; Section 2225, Rebasing of State DSH allotments for FY 2021. Part 2 of Subtitle C--Other Health Provisions, Section 2213: Modification to requirements for qualifying for exception to Medicare prohibition on certain physician referrals for hospitals. H.R. 3630, Middle Class Tax Relief and Job Creation Act of 2012, entire bill. Other issues: 2013 Outpatient Prospective Payment System rule, entire rule. 2013 Inpatient Prospective Payment System rule, entire rule. 2013 Physician Fee Schedule rule, entire rule. Proposals surrounding the Sustainable Growth Rate (SGR) and deficit/debt reduction as related to hospitals and physicians. Accountable Care Organizations and the Innovation Center's demonstration programs. Medicare and Medicaid Recovery Audit Contractor programs. Geographic Variation in Medicare spending, IOM studies on high value and Medicare geographic adjusters. Medical Liability Reform. Medicare and Medicaid Electronic Health Record Payment Incentive Programs. Hospital wage index reform, including Section 3137(b) of the Affordable Care Act. Implementation of the state health insurance exchanges. 2013 Inpatient Rehab rule, entire rule. 2013 LTCH rule, entire rule Hospice Quality Reporting Program. 2013 Home Health rule, entire rule. Dual Eligible Demonstration Programs.

Client expense: $53,327 · Firm income: Not reported

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

Issues pertaining to implementation of the Affordable Care Act, particularly Medicaid expansion HR 2674, 340B Program Improvement Act, all provisions H.R. 5 HEALTH Act, all provisions S. 1855 Pandemic and all Hazards Preparedness Act, all provisions H.R. 6611 Patient Access to Drugs in Shortage Act Issues related to 340B program integrity, oversight, program intent, contract pharmacies H.R. 8, the American Taxpayer Relief Act of 2012

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

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

Health and Human Services Appropriations - Increased funding for the Department of Health and Human Services including National Institutes of Health research programs and Title VII and Title VIII funding; Poison Control Centers and programs for teaching and research at academic medical centers. In opposition to cuts to GME/IME. In support of 340B Improvement Act of 2011 (HR 2674). In support of extension for 340B Program. In opposition of sequestration, SGR, GME, ACA. In opposition of Great Ape Protection and Cost Savings Act. In opposition to cuts to Hospital Outpatient Department.

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

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

H.R. 2674 Supprotive of any language that amends section 340B of the Public Health Service Act to revise and expand the drug discount program under that section to improve the provision of discounts on drug purchases for certain safety net providers by expanding 340 B discoutns to inpatient settings.

Client expense: $12,856 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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

Medicare Physician Payment/Sustainable Growth Rate Graduate Medical Education H.R. 3765, the Temporary Payroll Tax Cut Continuation Act of 2011 H.R. 3630, Middle Class Tax Relief & Job Creation Act Disproportionate Share Hospital payments H.R. 2674 - The 340B Program Improvement and Integrity Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Healthcare issues and the 340B Drug Discount Program; including extension to inpatient drugs, HR 2674, and removal of orphan drug exemption, including development of similar legislation for introduction in the Senate; legislative efforts regarding drug shortage issue under development in the House and Senate; address questions related to 340B program operatives and potential improvements

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care reform implementation; 340B drug discount program (H.R. 2674); Medicaid funding for public hospitals; Medicaid/Medicare deficit reduction proposals.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Care, HR.2674- 340B Program Improvement Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HConRes 34 (Health Related Issues Only); Debt Ceiling Debate (Medicare/Medicaid proposed changes and cuts); S365; HR2674 the 340B Improvement Act of 2011; HR3630 extenders legislation; HConRes 112 (Health Related Issues Only); HR 2500; HR452 the Medicare Decisions Accountability Act; H.R.8, the American Taxpayer Relief Act of 2012

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Hospital Group Purchasing - Engaged in education and outreach efforts to promote the value of hospital group purchasing organizations for America's hospitals. Responded to inquiries about hospital utilization of compounding pharmacies and relation to group purchasing contracts. Tracked legislative efforts to expand FDA's authority to regulate large compounding pharmacies (H.R. 6584). Unique Device Identification - tracked the release of regulations from the FDA to establish a unique device identification system as required under the Food and Drug Administration Amendments Act of 2007. Urged a more aggressive timeline for implementation of a UDI system. 340 B of the Public Health Service Act Drug Discount Program - tracked legislative proposals to expand the 340B drug discount program to inpatient providers (H.R. 2674).

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

Government targets: HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), SENATE

HR 452 Medicare Decisions Accountability Act of 2011, to repeal the provisions of the Patient Protection and Affordable Care Act providing for the Independent Payment Advisory Board; HR 541 Pay for all your Undocumented Procedures (PAY UP!) Act of 2011, amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to make permanent the program of federal reimbursement of emergency health services furnished to undocumented aliens. Requires a re-allotment of unspent program funds in a fiscal year among eligible providers in full expenditure states according to a specified ratio. Requires addition of such funds to the aggregate amount available for allotment for the succeeding fiscal year in the event there is no full expenditure state; HR 876 and S 58 The Registered Nurse Safe Staffing Act of 2011, to amend title XVIII of the Social Security Act to provide for patient protection by establishing safe nurse staffing levels at certain Medicare providers; HR 1159, to repeal certain provisions of the Patient Protection and Affordable Care Act relating to the limitation on the Medicare exception to the prohibition on certain physician referrals for hospitals and to transparency reports and reporting of physician ownership or investment interests; HR 1186, a bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals; S 374 and HR 2783 Medicare Mental Health Inpatient Equity Act, a bill to amend title XVIII of the Social Security Act to eliminate the 190-day lifetime limit on inpatient psychiatric hospital services under the Medicare program; HR 1398 Rural Hospital Protection Act, legislation which would amend the Social Security Act to ensure that the full cost of certain provider taxes are considered allowable costs for purposes of Medicare reimbursements to CAHs; S 1486 Long-Term Care Hospital Improvement Act of 201, a bill to amend title XVIII of the Social Security Act to clarify and expand on criteria applicable to patient admission to and care furnished in long-term care hospitals participating in the Medicare program; Raising concerns about CMS flawed methodology that overstates the effect of the documentation and coding changes to PPS payments, ensuring that CMS does not go beyond its charge of ensuring budget-neutral implementation of MS-DRGs; Working with CMS to clarify requirements and ensure that the systems to register for the meaningful use incentives and attest to meeting the requirements are useable, including ensuring that hospitals can, with permission, help their physicians sign up for the program and attest to meeting the requirements; Worked with ONC to modify the certification requirements for EHRs to allow the flexibility promised in the rules for meaningful use; Worked to get legislative fix introduced for ACA provision related to readmission policy to eliminate a computation error and ensure that unrelated and planned readmissions are excluded from the policy; Worked to improve the regulation to implement ACOs; Urging CMS to update, streamline, and modernize the Medicare conditions of participation; HR 1852/ S 950 Children's Hospital GME Support Reauthorization Act of 2011, the current CHGME authorization expired in September 2011, and the bills would reauthorize the CHGME program for an additional five years, through fiscal year (FY) 2016, at the current authorization level of up to $330 million a year; HR 1683/ S 868 Medicaid MOE, strikes provisions of ACA related to maintaining Medicaid eligibility levels; HR 1543 Improving Access to Medicare Coverage Act of 2011, to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital requirement for coverage of skilled nursing facility services under Medicare; S 1251Medicare and Medicaid FAST Act, a bill to amend titles XVIII and XIX of the Social Security Act to curb waste, fraud, and abuse in the Medicare and Medicaid programs; HR 2500 Equal Access and Parity for Multi-Campus Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to clarify the application of EHR payment incentives in cases of multi-campus hospitals; HR 2674 340B Program Improvement Act, a bill to amend section 340B of the Public Health Service Act to improve the provision of discounts on drug purchases for certain safety net providers; HR 3630 Temporary Payroll Tax Cut Continuation Act of 2011 or Middle Class Tax Relief and Job Creation Act of 2011, a bill that cuts hospitals to pay for the doc fix, it contains the Social Security payroll tax cut and the Unemployment Insurance extension; HR 3519 a bill to amend and exempt the Medicare program from fallback sequestration under the Budget Control Act of 2011; S. 1680 Craig Thomas Rural Hospital and Provider Equity (R-HoPE) Act of 2011, a bill to amend title XVIII of the Social Security Act to protect and preserve access of Medicare beneficiaries in rural areas to health care providers under the Medicare program; Letter to Rehberg and DeLauro in support of the CHGME program that was circulated by Reps. Capps and Bilbray; Wyden/Crapo letter to CMS to actively oppose a Senate Dear Colleague letter to CMS in support of updating Medicare payments to ambulatory surgery centers (ASCs). The letter did not request a payment update for ASCs. Rather, the letter advocated against the Medicare payment rate for services provided in hospital outpatient department settings; HR 2954 and S 2474 Health Equity and Accountability Act of 2011, Comprehensive bill focused on eliminating racial and ethnic disparities in health care through improved data collection and reporting, culturally and linguistically-appropriate health care, workforce diversity, health information technology, and other actions; Discussions with the Administration (CMS) on applying the therapy cap to hospital outpatient departments; Worked to change CMS definition of allowed EHR costs for CAH Meaningful Use incentive payments to include capital lease purchases of EHRs; HR 3859 Rural Hospital and Provider Equity (R-HOPE) Act of 2012, to amend title XVIII of the SSA to protect and preserve access of Medicare beneficiaries in rural areas to health care providers under the Medicare program; HR 4245 Veterans Co-Pay Fairness Act, to amend title 38, United States Code, to require the Secretary of Veterans Affairs to reimburse eligible veterans who are entitled to Medicare benefits for Medicare deductibles and other expenses that are owed by the veterans for emergency medical treatment provided in non-Department of Veterans affairs facilities; S 2620 and HR 5943 Rural Hospital Access Act of 2012, a bill to amend title XVIII of the Social Security Act to provide for an extension of the Medicare-dependent hospital (MDH) program and the increased payments under the Medicare low-volume hospital program; S 3187 and HR 5651Prescription Drug User Fee Amendments of 2012, a bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars.

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

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act 340B Issues Drug Shortage Issues Drug Supply Chain Security AHRQ Report on Enzyme Replacement Therapy for Lysosomal Storage Diseases H.R. 2674, 340B Program Improvement Act

Client expense: $400,000 · Firm income: Not reported

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

Health and Human Services Appropriations - Increased funding for the Department of Health and Human Services including National Institutes of Health research programs and Title VII and Title VIII funding; Poison Control Centers and programs for teaching and research at academic medical centers. In opposition to cuts to GME/IME. In support of 340B Improvement Act of 2011 (HR 2674). In support of extension for 340B Program. In support of retaining cap of NIH Salary Cap, Executive Level 1. In support of Community Transformation Small Communities Grant Application.

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

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

Section 340B of the Public Health Service Act, Section 1927 of the Social Security Act and issues related to (1) administration of the 340B Drug Discount Program, (2) implementation of 340B-related provisions in the Patient Protection and Affordable Care Act of 2010, (3) funding of the Health Resources and Services Administration (HRSA) under the Labor Health & Human Services & Education appropriations bills, and (4) enactment of the 340B Program Improvement Act of 2011 (H.R. 2674).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), 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

Issues pertaining to health implementation of the Affordable Care Act, particularly Medicaid expansion Safety Net Financing Issues HR. 2674, 340B Program Improvement Act - all provisions H.R. 5 - HEALTH Act, all provisions Issues pertaining to pharmaceutical shortages S.1855 -Pandemic and all Hazards Preparedness Act, all provisions S.339 - Taking Essential Steps for Testing Act of 2012 Issues related to 340B program integrity, oversight, program intent, contract pharmacies

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

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

H.R. 1543 and S. 818, Improving Access to Medicare Coverage Act of 2011, entire bill. H.R. 6365, the National Security and Job Protection Act of 2011, entire bill. H.R. 4872, the Health Care & Education Affordability Reconciliation Act of 2010: provisions relating to hospitals and physicians, including: Section 1106: physician-owned hospitals and self-referral; Section 2302: 340B program; Section 1104 and Section 1203: Medicare and Medicaid DSH Payments; Sections 1108 and 1109 involving geographic disparities in Medicare payment; Section 1105: Market basket updates; Section 1201: Federal funding for States; Section 1202: Payments to primary care physicians. H.R. 3590, the Patient Protection and Affordable Care Act, provisions relating to hospitals, hospice and physicians including: Section 3001: hospital value-based purchasing; Section 3125: low-volume hospital payment; Section 3401: productivity adjustments; Section 6001: physician-owned hospital and self-referral; Section 3121: outpatient hold harmless for hospitals; Sections 7101-7103: 340B Program; Section 3401: Independent Payment Advisory Board; Section 3015: hospital readmissions program; Section 3124: Extension of Medicare Dependent Hospital program; Section 3137: Section 508 Reclassification; Section 9007: non-profit hospital provision; Section 3105: ambulance services; Section 3008 and Section 2702: payment adjustment for hospital acquired conditions; Section 3133: Medicare DSH; Section 2551: Disproportionate Share Hospitals; Section 5501: Primary Care Provisions; Section 5503: Graduate Medical Education; Sections 2001-2081: Expansion of Medicaid, CHIP; Sections 1311-1343: CO-OPs and Exchanges; Section 3022: Accountable Care Organizations; Section 3023: Hospital Bundling Provision; Section 6401-6402: Program Integrity Provisions; Section 6501-6503, 6505, 6508: Medicaid Program Integrity Provisions. H.R. 2674, 340B Program Improvement Act, entire bill. S. 722 and H.R. 3506, Hospice Evaluation and Legitimate Payment Act, entire bills. S. 778, Protecting Access to Rural Therapy Services (PARTS) Act, entire bill. H.R. 3285, Medicare Equity Extension Act, entire bill. H.R. 3630, Middle Class Tax Relief and Job Creation Act of 2011, Title II, Subtitle C--Medicare Extensions; Other Health Provisions, Part 1--Medicare extensions, Section 2201, Physician payment update. Section 2202: Ambulance Add-ons; Section 2203: Medicare payment for outpatient therapy services; Section 2204: Work geographic Adjustment; Part 3--Offsets, Section 2223: Parity in Medicare payments for hospital outpatient department evaluation and management office visit services; Section 2224, Reduction of bad debt treated as an allowable cost; Section 2225, Rebasing of State DSH allotments for FY 2021. Part 2 of Subtitle C--Other Health Provisions, Section 2213: Modification to requirements for qualifying for exception to Medicare prohibition on certain physician referrals for hospitals. H.R. 3859 and S. 1680, The Rural Hospital and Provider Equity (R-HOPE) Act of 2012, entire bills. H.R. 3630, The Middle Class Tax Relief and Job Creation Act of 2012, entire bill. H.R. 5943 and S. 2620, the Rural Hospital Access Act of 2012, entire bills. H.R. 2461, Physician Pathology Services Continuity Act of 2011, entire bill. H.R. 2104, Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2011, entire bill. 2013 Outpatient Prospective Payment System proposed rule, entire rule. 2013 Inpatient Prospective Payment System final rule, entire rule. 2013 Physician Fee Schedule proposed rule, entire rule. Other issues: Proposals surrounding the Sustainable Growth Rate (SGR) and deficit/debt reduction as related to hospitals and physicians. Accountable Care Organizations and the Innovation Center's demonstration programs. Medicare and Medicaid Recovery Audit Contractor programs. Geographic Variation in Medicare spending, IOM studies on high value and Medicare geographic adjusters. Medical Liability Reform. Medicare and Medicaid Electronic Health Record Payment Incentive Programs. Hospital wage index reform, including Section 3137(b) of the Affordable Care Act. Implementation of the state health insurance exchanges. 2013 Inpatient Rehab rule, entire rule. 2013 LTCH rule, entire rule Hospice Quality Reporting Program. 2013 Home Health rule, entire rule. Dual Eligible Demonstration Programs.

Client expense: $50,463 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), 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

HConRes34 (Health Related Issues Only); Debt Ceiling Debate (Medicare/Medicaid proposed changes and cuts); S365; HR2674 the 340B Improvement Act of 2011; HR3630 Extenders Legislation; HConRes112 (Health Related Issues Only); HR2500; HR452 The Medicare Decisions Accountability Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.2674, the 340 B Improvement Act. CDC Tuberculosis funding formula (FY'13 Labor/HHS Appropriations). Medicaid

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3765, the Temporary Payroll Tax Cut Continuation Act of 2011 H.R. 3630, Middle Class Tax Relief & Job Creation Act Medicare Physician Payment/Sustainable Growth Rate Graduate Medical Education Disproportionate Share Hospital payments H.R. 2674 - The 340B Program Improvement and Integrity Act Medicare Wage Index Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Proposed Regulation Bad debt/charity care

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Care, HR.2674- 340B Program Improvement Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Hospital Group Purchasing - Engaged in outreach and education efforts to demonstrate the value that GPOs offer to hospitals. Budget Control Act - Advocated for changes to the Budget control act to prevent a 2.0% cut in Medicare payments for hospitals. Physician Payment Sunshine Act - tracked implementation of the Medicare physician payment sunshine requirements from the Affordable Care Act. 340 B (of the Public Health Services Act ) Drug Discount Program - tracked Congressional investigations of the 340B program and monitored legislative efforts (H.R. 2674) to expand the program to inpatient providers. Health IT - followed the continued implementation of the HITECH Act, and the health IT incentive program for meaningful users of electronic health records. Shortage of prescription drugs - monitored ongoing federal efforts to combat the shortage of prescription drugs. Advocated for proposals that would help ease the shortage in the Food and Drug Administration Safety and Innovation Act which was signed into law on July 9. Unique Device Identification - supported inclusion of provisions in the Food and Drug Administration Safety and Innovation Act requiring the FDA to implement a unique device identification system for medical devices by a set date.

Client expense: $25,000 · Firm income: Not reported

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

H.R. 2674 Supportive of any language that amends section 340B of the Public Health Service Act to revise and expand the drug discount program under that section to improve the provision of discounts on drug purchases for certain safety net providers by expanding 340B discounts to impatient settings.

Client expense: $114,551 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Healthcare issues and the 340B Drug Discount Program; including extension to inpatient drugs, HR 2674, and removal of orphan drug exemption, including development of similar legislation for introduction in the Senate; legislative efforts regarding drug shortage issue under development in the House and Senate; address questions related to 340B program operatives and potential improvements

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care reform implementation; 340B drug discount program (H.R. 2674); Medicaid funding for public hospitals; Medicaid/Medicare deficit reduction proposals.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2674: 340B Improvement Act of 2011 H.R. 1217: To Repeal the Prevention and Public Health Fund H.R. 1398: Rural Hospital Protection Act S. 668: Health Care Bureaucrats Elimination Act

Client expense: Not reported · Firm income: Not reported

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

Issues pertaining to health reform implementation Safety Net Financing Issues HR. 2674, 340B Program Improvement Act - all provisions H.R. 5 - HEALTH Act, all provisions Issues pertaining to pharmaceutical shortages

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

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

Discussing the importance of the 340B drug discount pogram and improving program oversight. Advocating for the enactment of H.R. 2674.

Client expense: $194,429 · Firm income: Not reported

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

HR 452 Medicare Decisions Accountability Act of 2011, to repeal the provisions of the Patient Protection and Affordable Care Act providing for the Independent Payment Advisory Board; HR 541 Pay for all your Undocumented Procedures (PAY UP!) Act of 2011, amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to make permanent the program of federal reimbursement of emergency health services furnished to undocumented aliens. Requires a re-allotment of unspent program funds in a fiscal year among eligible providers in full expenditure states according to a specified ratio. Requires addition of such funds to the aggregate amount available for allotment for the succeeding fiscal year in the event there is no full expenditure state; HR 876 and S 58 The Registered Nurse Safe Staffing Act of 2011, to amend title XVIII of the Social Security Act to provide for patient protection by establishing safe nurse staffing levels at certain Medicare providers; HR 1159, to repeal certain provisions of the Patient Protection and Affordable Care Act relating to the limitation on the Medicare exception to the prohibition on certain physician referrals for hospitals and to transparency reports and reporting of physician ownership or investment interests; HR 1186, a bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals; S 374 and HR 2783 Medicare Mental Health Inpatient Equity Act, a bill to amend title XVIII of the Social Security Act to eliminate the 190-day lifetime limit on inpatient psychiatric hospital services under the Medicare program; HR 1398 Rural Hospital Protection Act, legislation which would amend the Social Security Act to ensure that the full cost of certain provider taxes are considered allowable costs for purposes of Medicare reimbursements to CAHs; S 1486 Long-Term Care Hospital Improvement Act of 201, a bill to amend title XVIII of the Social Security Act to clarify and expand on criteria applicable to patient admission to and care furnished in long-term care hospitals participating in the Medicare program; Raising concerns about CMS flawed methodology that overstates the effect of the documentation and coding changes to PPS payments, ensuring that CMS does not go beyond its charge of ensuring budget-neutral implementation of MS-DRGs; Working with CMS to clarify requirements and ensure that the systems to register for the meaningful use incentives and attest to meeting the requirements are useable, including ensuring that hospitals can, with permission, help their physicians sign up for the program and attest to meeting the requirements; Worked with ONC to modify the certification requirements for EHRs to allow the flexibility promised in the rules for meaningful use; Worked to get legislative fix introduced for ACA provision related to readmission policy to eliminate a computation error and ensure that unrelated and planned readmissions are excluded from the policy; Worked to improve the regulation to implement ACOs; Urging CMS to update, streamline, and modernize the Medicare conditions of participation; HR 1852/ S 950 Children's Hospital GME Support Reauthorization Act of 2011, the current CHGME authorization expired in September 2011, and the bills would reauthorize the CHGME program for an additional five years, through fiscal year (FY) 2016, at the current authorization level of up to $330 million a year; HR 1683/ S 868 Medicaid MOE, strikes provisions of ACA related to maintaining Medicaid eligibility levels; HR 1543 Improving Access to Medicare Coverage Act of 2011, to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital requirement for coverage of skilled nursing facility services under Medicare; S 1251Medicare and Medicaid FAST Act, a bill to amend titles XVIII and XIX of the Social Security Act to curb waste, fraud, and abuse in the Medicare and Medicaid programs; HR 2500 Equal Access and Parity for Multi-Campus Hospitals Act, a bill to amend titles XVIII and XIX of the Social Security Act to clarify the application of EHR payment incentives in cases of multi-campus hospitals; HR 2674 340B Program Improvement Act, a bill to amend section 340B of the Public Health Service Act to improve the provision of discounts on drug purchases for certain safety net providers; HR 3630 Temporary Payroll Tax Cut Continuation Act of 2011 or Middle Class Tax Relief and Job Creation Act of 2011, a bill that cuts hospitals to pay for the doc fix, it contains the Social Security payroll tax cut and the Unemployment Insurance extension; HR 3519 a bill to amend and exempt the Medicare program from fallback sequestration under the Budget Control Act of 2011; S. 1680 Craig Thomas Rural Hospital and Provider Equity (R-HoPE) Act of 2011, a bill to amend title XVIII of the Social Security Act to protect and preserve access of Medicare beneficiaries in rural areas to health care providers under the Medicare program; Letter to Rehberg and DeLauro in support of the CHGME program that was circulated by Reps. Capps and Bilbray; Wyden/Crapo letter to CMS to actively oppose a Senate Dear Colleague letter to CMS in support of updating Medicare payments to ambulatory surgery centers (ASCs). The letter did not request a payment update for ASCs. Rather, the letter advocated against the Medicare payment rate for services provided in hospital outpatient department settings; HR 2954 Health Equity and Accountability Act of 2011, Comprehensive bill focused on eliminating racial and ethnic disparities in health care through improved data collection and reporting, culturally and linguistically-appropriate health care, workforce diversity, health information technology, and other actions; Discussions with the Administration (CMS) on applying the therapy cap to hospital outpatient departments; Worked to change CMS definition of allowed EHR costs for CAH Meaningful Use incentive payments to include capital lease purchases of EHRs; HR 3859 Rural Hospital and Provider Equity (R-HOPE) Act of 2012, to amend title XVIII of the SSA to protect and preserve access of Medicare beneficiaries in rural areas to health care providers under the Medicare program. HR 4245 Veterans Co-Pay Fairness Act, to amend title 38, United States Code, to require the Secretary of Veterans Affairs to reimburse eligible veterans who are entitled to Medicare benefits for Medicare deductibles and other expenses that are owed by the veterans for emergency medical treatment provided in non-Department of Veterans Affairs facilities; S 2620 and HR 5943 Rural Hospital Access Act of 2012, a bill to amend title XVIII of the Social Security Act to provide for an extension of the Medicare-dependent hospital (MDH) program and the increased payments under the Medicare low-volume hospital program; S 3187 and HR 5651Prescription Drug User Fee Amendments of 2012, a bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars.

Client expense: $4,150,000 · 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

Health and Human Services Appropriations - Increased funding for the Department of Health and Human Services including National Institutes of Health research programs and Title VII and Title VIII funding; Poison Control Centers and programs for teaching and research at academic medical centers. In opposition to cuts to GME/IME. In support of Children's Hospital GME letter. In support of 340B Improvement Act of 2011 (HR 2674). In support of extension for 340B Program. In support of retaining cap of NIH Salary Cap, Executive Level 1.

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

Government targets: 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. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting 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. 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. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting 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: $4,840,000 · Firm income: Not reported

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

Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act 340B Issues Drug Shortage Issues Drug Supply Chain Security AHRQ Report on Enzyme Replacement Therapy for Lysosomal Storage Diseases H.R. 2674, 340B Program Improvement Act

Client expense: $360,000 · Firm income: Not reported

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

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 The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - 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 HR 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 HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 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 HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 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 HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 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 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 S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Care, HR.2674- 340B Program Improvement Act;

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

Government targets: HOUSE OF REPRESENTATIVES, 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. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration 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 S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation 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 Rug 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 No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. 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: $1,220,000 · Firm income: Not reported

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

Healthcare issues and the 340B Drug Discount Program; including extension to inpatient drugs, HR 2674, and removal of orphan drug exemption, including development of similar legislation for introduction in the Senate; legislative efforts regarding drug shortage issue under development in the House and Senate

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HConRes34 (Health Related Issues Only); Debt Ceiling Debate (Medicare/Medicaid proposed changes and cuts); S365; HR2674 the 340B Improvement Act of 2011; HR3630 Extenders legislation; HConRes112 (Health Related Issues Only); HR2500; HR452 The Medicare Decisions Accountability Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Section 340B of the Public Health Service Act, Section 1927 of the Social Security Act and issues related to (1) administration of the 340B Drug Discount Program, (2) implementation of 340B-related provisions in the Patient Protection and Affordable Care Act of 2010, (3) funding of the Health Resources and Services Administration (HRSA) under the FY2012 Labor Health & Human Services & Education appropriations bills, and (4) enactment of the 340B Program Improvement Act of 2011 (H.R. 2674).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE