Patients' Access to Treatments Act of 2013

"Accessing Medicare Therapies Act" - H.R.1239 "To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care" - H.R.5214 "The Value-Based Insurance Design (VBID) for Better Care Act of 2014" - H.R.5183 "Patients' Access to Treatment" - H.R.460 "FDA Safety Over Sequestration Act" - H.R.2725/S 1413 "Preserving Access to Orphan Act" - S.1128/H.R. 2315 "Medical Foods for Inborn Errors of Metabolism"

Client expense: Not reported · Firm income: Not reported

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

"Accessing Medicare Therapies Act" - H.R.1239 "To require the Secretary of Health and Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care" - H.R.5214 "The Value-Based Insurance Design (VBID) for Better Care Act of 2014" - H.R.5183 "Patients' Access to Treatment" - H.R.460 "FDA Safety Over Sequestration Act" - H.R.2725/S 1413 "Preserving Access to Orphan Act" - S.1128/H.R. 2315 "Medical Foods for Inborn Errors of Metabolism"

Client expense: Not reported · Firm income: Not reported

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

H.R. 460: Patients' Access to Treatments Act H.R. 1098/ S. 2539: Traumatic Brain Injury Reauthorization Act Coverage and appropriate use of telemedicine, VA Epilepsy Centers of Excellence, NIH

Client expense: Not reported · Firm income: $173,880

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 460 The Patients' Access to Treatment Act - states that an insurance company cannot charge more for drug placed on specialty tier than drug placed in non-preferred brand tier; HR 2827, the Part D Beneficiaries Appeals Fairness Act which provides for an appeals process in Medicare Part D for drugs that are placed on specialty tiers; Restor funding for the National Center for Birth Defects and Developmental Disorders

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access to rare and orphan disease therapeutics under the enactment of the ACA; FDA regulatory pathways for pharmaceuticals; HR 460 the Patients Access to Treatment Act of 2013; Awareness of Cystic Fibrosis

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 460 Patients' Access to Treatments Act HR 1827 Pediatric Subspecialty and Mental Health Workforce Reauthorization Act of 2013 21st Century Cures Biosimilars guidance, oversight

Client expense: $65,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Newborn Screening Saves Lives Reauthorization Act - H.R.1281 Andrea Sloan CURE Act - H.R.5805 ABLE Act - H.R.647 Patients' Access to Treatment- H.R.460

Client expense: Not reported · Firm income: Not reported

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

-Urge Congress to support efforts that increase access to care for people with psoriasis and psoriatic arthritis by supporting the following bill: efforts: -H.R.460: Patients' Access to Treatments Act of 2013: Support efforts to reduce impediments to treatment for individuals with moderate to severe psoriasis. The National Psoriasis Foundation supports the Patients' Access to Treatments Act of 2013 (introduced in the House as H.R.460), which limits copayments, coinsurance, and other cost-sharing and out-of-pocket expenses for so-called specialty tier drugs. This bill will help ensure that people with psoriasis and other chronic conditions have access to the therapy that their health care provider determines is most appropriate for them. -Engagement with the Food and Drug Administration (FDA) on the patient focused drug development initiative in the form of submitted comments. Additional engagement with FDA dermatology staff on the latest in psoriasis research, the NPFs current focus and drug therapy development views from the patient community.

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

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

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. S. 77, Prescription Drug and Health Improvement Act S. 557, Medication Therapy Management Empowerment Act H.R. 460, Patients Access to Treatments Act H.R. 1188, Preserving Our Hometown Independent Pharmacies Act H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 1024, Medication Therapy Management Empowerment Act HR4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid, Pharmacy; and Health Care General

Client expense: $788,488 · Firm income: Not reported

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

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. Issues related to the compounding of certain drugs. S. 77, Prescription Drug and Health Improvement Act S. 557, Medication Therapy Management Empowerment Act H.R. 460, Patients Access to Treatments Act H.R. 1188, Preserving Our Hometown Independent Pharmacies Act H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 1024, Medication Therapy Management Empowerment Act S. 867, Medicare Prescription Drug Program Integrity and Transparency Act H.R. 2960, Medicare Prescription Drug Integrity Act of 2013 H.R., Keep the Promise to Seniors Act H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid, Pharmacy; and Health Care General H.R. 4418, Expanding the Availability of Medicare Data to Medicare/Medicaid

Client expense: $788,488 · Firm income: Not reported

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

issues surrounding oral parity and specialty tiers (H.R. 460 and H.R. 1801); issues surrounding potential new incentives for research into unmet medical needs (H.R. 3116)

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. S. 77, Prescription Drug and Health Improvement Act S. 557, Medication Therapy Management Empowerment Act H.R. 460, Patients Access to Treatments Act H.R. 1188, Preserving Our Hometown Independent Pharmacies Act H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 1024, Medication Therapy Management Empowerment Act HR4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid, Pharmacy; and Health Care General

Client expense: $788,488 · Firm income: Not reported

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

Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, closing the Part D coverage gap Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, grandfathering, value-based insurance design, e-prescribing, PBM disclosure requirements, and medical loss ratio). Regulatory and proposed legislative changes to Medicare part D including pharmacy networks, classes of clinical concern, mail-service pharmacy, EGWP waivers, MTM expansion, long term care short-term fills, recovery audit contractors. Implementation of changes to the definition of Average Manufacturer Price in Medicaid Issues related to the management of Medicaid prescription drug benefits Legislation to promote generic drugs. Regulatory Implementation of the HITECH Act. FDA issues related to the Prescription Drug User Fee Act (PDUFA) (generic user fees, pedigree, REMs); implementation of approval pathway for generic biologic drugs, 340B program. Issues related to the compounding of certain drugs. S. 77, Prescription Drug and Health Improvement Act S. 557, Medication Therapy Management Empowerment Act H.R. 460, Patients Access to Treatments Act H.R. 1188, Preserving Our Hometown Independent Pharmacies Act H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act H.R. 1024, Medication Therapy Management Empowerment Act S. 867, Medicare Prescription Drug Program Integrity and Transparency Act H.R. 2960, Medicare Prescription Drug Integrity Act of 2013 H.R., Keep the Promise to Seniors Act H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014 to Medicare/Medicaid, Pharmacy; and Health Care General H.R. 4418, Expanding the Availability of Medicare Data to Medicare/Medicaid

Client expense: $788,488 · Firm income: Not reported

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

Monitor federal issues and legislation related to healthcare policy; Monitor implementation, P.L. 111-148; H.R. 460, Patients Access to Treatment Act of 2013; Extension, Section 3111, P.L. 111-148; H.R. 1701 / S. 972, Cutting Costly Codes Act; H.R. 1429 Scleroderma Research and Awareness Act; H.R. 2663 / S. 1422, To Amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings; H.R. 1827, Pediatric Subspecialty and Mental Health Workforce Reauthorization Act of 2013; H.R. 4282, Creating Access to Residency Education Act of 2014; H.R. 5481, To continue the use of a 3-month quarter EHR reporting period for health care providers to demonstrate meaningful use for 2015 under EHR incentive payment programs

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

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

Advocate on behalf of provisions for inclusion in the 21st Century Cures Initiative. Advocate for improved access to specialty drugs for patients with chronic conditions (H.R. 460, Patients' Access to Treatments Act of 2013). Advocate for truth in advertising for health care providers (H.R. 1427, Truth in Healthcare Marketing Act of 2013). Lobby Members of Congress to join the Congressional Skin Cancer Caucus. Lobby Congress to protect and preserve the in-office use of compounded pharmaceuticals without a patient prescription (H.R. 3204, Drug Quality and Security Act/Public Law No: 113-54). Lobby Congress on legislation to remove non-discrimination requirements relating to health care providers. (H.R. 2817, Protect Patient Access to Quality Health Professionals Act of 2013). Advocate for legislation that would allow for Flexible Spending Accounts (FSAs) to be used to cover over-the-counter (OTC) drugs (S. 1647, H.R. 2835, Restoring Access to Medication Act). Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Lobby Congress on legislation to create a transparent and predictable review process for sunscreen ingredients (S. 2141/H.R. 4250 Sunscreen Innovation Act/ Public Law No: 113-195). Advocate on use and availability of health care data. Support legislation to exempt independent medical educational programs and materials from reporting under the Physician Payments Sunshine Act (Sunshine Act) (H.R. 5539)

Client expense: $307,164 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to health disparities, health care reform, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including H.R.1666 & S.2800, the Patient Centered Quality Care for Life Act, and, H.R.1339 & S.641, the Palliative Care and Hospice Education and Training Act; S.621 and H.R.2607 & S.1251, the Caroline Pryce Walker Conquer Childhood Cancer Act; H.R.2058 & S.1247 the Childhood Cancer Survivors Quality of Life Act; H.R.2019, the Kids First Research Act; and H.R.460, the Patients' Access to Treatments Act; H.R.5145 & S.2622, the Breast Density & Mammography Reporting Act, H.R.4250 and S.2141, the Sunscreen Innovation Act, and regulations relating to tanning beds. In addition, regulatory issues before the F.D.A relating to laboratory developed tests, colorectal cancer screening tests, electronic medical devices, and issues relating to the 21st Century Cures Initiative of the House Energy & Commerce Committee.

Client expense: $1,340,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), 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 Health Technology Assessment of Orphan DrugsH.R. 1281, Newborn Screening Saves Lives Reauthorization Act of 2013 S. 1417, Newborn Screening Saves Lives Reauthorization Act of 2013 Sequestration of FDA User Fees H.R. 2315, Preserving Access to Orphan Drugs Act of 2013 S. 1128, Preserving Access to Orphan Drugs Act of 2013 H.R. 2090, Patient Choice Act of 2013 H.R. 4475, Compassionate Freedom of Choice Act of 2014 H.R. 1239, Accessing Medicare Therapies Act of 2013 H.R. 460, Patients' Access to Treatments Act of 2013 21st Century Cures Initiatives H.R. 3805, Andrea Sloan CURE Act H.R. 3116, MODDERN Cures Act of 2013 S. 3004, Dormant Therapies Act of 2014 H.R. 5771, To amend the Internal Revenue Code of 1986 to extend certain expiring provisions and make technical corrections, to amend the Internal Revenue Code of 1986 to provide for the tax treatment of ABLE accounts established under State programs for the care of family members with disabilities, and for other purposes. H.R. 5750, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014

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

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

Improve prescription drug access: H.R. 460: Patients Access to Treatments Act of 2013, S867. Medicare Prescription Drug Program Integrity and Transparency Act of 2013; provisions related to improving prescription drug access. Issues related to the high cost of specialty drugs; H.R. 4577 about pharmacy access and quality

Client expense: $550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

HR 460: Patients' Access to Treatments Act HR 2315/S 1128: Preserving Access to Orphan Drugs Act of 2013 Medicare Reimbursement for Neurological Diagnostic Testing Sickle Cell Disease Legislation

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Policies related to FEHBP's pharmacy benefit (HR 1367). Regulatory design and coverage of pharmacy benefits in health reform Exchanges and the commercial market, including: EHB, grandfathering, Rx quality, eRx, PBM disclosure, MLR. Specialty pharmacy tiering restrictions (HR 460). Regulatory implementation of a pathway for the approal of biosimilars. REMs. 340b program reform. Policies placing restrictions on pharmcy benefit design. Issues regarding making prescription drugs more affordable, including: generic user fees, pedigree, biosimilars, REMs. General issues dealing with prescription drug abuse (HR 3392) including Medicare Lock-in programs. General issues dealing with regulating pharmacy drug compounding (PDSQ Act). S. 867, HR 4437, HR 4577.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), 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), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office

Regulatory policies related to the health reform law: structure, drug benefits, disclosure. Regulatory implementation of HITECH/Accounting of Disclosures Issues regarding making prescription drugs more affordable (generic user fees, pedigree, pathway for biosimilars, REMs). Restrictions on specialty tiering. HR 460.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), 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), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office

H.R. 460, Patients' Access to Treatments Act (McKinley) - cost sharing in a specialty drug tier H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs H.R. 3116, MODDERN Cures Act (Lance) - innovations in diagnostics, drug exclusivity H.R. 3742, Antibiotic Development to Advance Patient Treatment Act (Gingrey) - treatments for serious or life-threatening diseases S. 214, Preserve Access to Affordable Generics Act (Klobuchar) - access to generic drugs Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,230,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), 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), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension & Welfare Benefits Administration, SENATE, Treasury, Dept of, White House Office

H.R. 460: Patients' Access to Treatments Act H.R. 1098/ S. 2539: Traumatic Brain Injury Reauthorization Act Coverage and appropriate use of telemedicine, VA Epilepsy Centers of Excellence, NIH

Client expense: $173,880 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 460, Patients' Access to Treatments Act (McKinley) - cost sharing in a specialty drug tier. H.R. 1367, FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (Lynch) - FEHBP prescription drugs. H.R. 3116, MODDERN Cures Act (Lance) - innovations in diagnostics, drug exclusivity. H.R. 3742, Antibiotic Development to Advance Patient Treatment Act (Gingrey) - treatments for serious or life-threatening diseases. S. 214, Preserve Access to Affordable Generics Act (Klobuchar) - access to generic drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical Distribution Supply Chain Security (H.R. 1919 / S. 957 / S. 959); Electronic distribution of prescribing information; School Access to Emergency Epinephrine (H.R. 2094); Biosimilars; H.R. 8; H.R. 486 - the Stop Tampering of Prescription Pills (STOPP) Act; S.504 - Fair and Immediate Release of Generic Drugs Act; S.621 - The Safe Prescribing Act of 2013 /H.R.1285 H.R.460 - Patients Access to Treatments Act of 2013; House Energy & Commerce Committee's 21st Century Cures initiative

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitored Implementation of Track & Trace Monitored the Patients' Access & Treatments Act, H.R. 460 Monitored Federal Oncology programs/Monitored 340B program Monitored Federal Dialysis programs

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures; HR 460, Patients' Access to Treatments Act; PPACA Marketplace Plan Network Adequacy Rules; HR 1801, Cancer Drug Coverage Parity Act; S 1879, Cancer Treatment Parity Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Health Reform Legislation/Patient Protection and Affordable Care Act (P.L. 111-148) Hematology and Oncology Drug Research and Approval Issues Implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144) Clinical Trials Regulations and Coverage Cancer Drug Coverage Parity Act (H.R. 1801) Cancer Treatment Parity Act (S. 1879) Patients' Access to Treatments Act (H.R. 460)

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. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to the Independent Payment Advisory Board H.R. 460, Patients Access to Treatments Act: Provisions related to cost sharing in the specialty tier H.R. 928, Medicare Prescription Drug Savings and Choice Act of 2013: Provisions related to Part D issues H.R. 1024, Medication Therapy Management Empowerment Act of 2013: Provisions related to medication therapy management in Part D H.R. 1102, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference H.R. 1588, Medicare Drug Savings Act of 2013: Provisions related to Part D issues H.R. 2753 Securing Care for Seniors Act: Provisions related to Value Based Insurance Design H.R. 2810, Medicare Patient Access and Quality Improvement Act: Provisions related to SGR reform H.R. 2827, To amend title XVIII of the Social Security Act to allow for fair application of the exceptions process for drugs in tiers in formularies in prescription drug plans under Medicare part D: Provisions related to Medicare Part D Drug Tier Formularies H.R. 2925, Strengthening Medicare Anti-Fraud Measures Act of 2013: Provisions related to Office of Inspector General (OIG) enforcement of fraud and abuse laws H.R. 3392, Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013: Provisions related to lock-in programs H.R. 3796, Comprehensive Care Payment Innovation Act: Provisions related to alternative payment models H.R. 3890 Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease H.R. 4015, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to sustainable growth rate (SGR) and Medicare provider payment reform H.R. 4160, Keep the Promise to Seniors Act of 2014: Provisions related to Part D issues H.R. 4302, Protecting Access to Medicare Act of 2014: Provisions related to the biopharmaceutical industry H.R. 4577, Ensuring Seniors Access to Local Pharmacies Act of 2014: Provisions related to Part D preferred pharmacy networks H.R. 5183, Value Based Insurance Design for Better Care Act of 2014: Provisions related to valued base insurance design demonstration program H.R. 5558 ACO Improvement Act: Provisions related to alternate payment models H.R. 5780, Protecting Integrity in Medicare Act of 2014: Provisions related to addressing fraud and prescription drug abuse S. 117, Medicare Prescription Drug Price Negotiation Act of 2013: Provisions related to Part D issues and non-interference S. 351, Protecting Seniors Access to Medicare Act of 2013: Provisions related to Independent Payment Advisory Board S. 408, Medicare Prescription Drug Savings and Choice Act of 2013: Provision related to Part D issues S. 557, Medication Therapy Management Empowerment Act of 2013: Provisions related to Part D and medication therapy management S. 740, Medicare Drug Savings Act of 2013: Provisions related to Part D issues Deficit reduction policy issues S. 882, Stop Trafficking of Pills (STOP) Act: Provisions related to lock-in programs (112th Congress) S. 1365, Part D Beneficiary Appeals Fairness Act: Provisions related to the specialty tier in Part D S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013: Provisions related to reforming Medicare physician payments S. 1932, Better Care, Lower Cost Act: Provisions related to Part D, value-based insurance design, and chronic disease S. 2000, SGR Repeal and Medicare Provider Payment Modernization Act of 2014: Provisions related to SGR reform S. 2110, Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014: Provisions related to SGR reform Hospital Improvements for Payment (HIP) Act of 2014: Provisions related to Medicare reform (no bill number) Medicare Prescription Drug Diversion and Abuse Prevention Act: Provisions related to diversion and abuse (no bill number) Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefits Programs: Provisions related to Part D Proposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy Medicaid Program, Covered Outpatient Drugs rulemaking Medicare sustainable growth rate policy issues Implementation issues relating to the Physician Payment Sunshine Act, including Medicare, Medicaid, Childrens Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking Issues related to better use of medicine and adherence

Client expense: $3,960,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 4299, The Improving Regulatory Transparency for New Medical Therapies Act; H.R. 3077, TELE-MED Act of 2013; H.R. 460, Patient Access to Treatments Act; S. 2862, The Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act; S.3004 The Dormant Therapies Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to quality of care for blood cancers [Patients Access to Treatment Act, H.R. 460 - all provisions; Cancer Drug Coverage Parity Act, H.R. 1801 - all provisions; Kids First Research Act, H.R. 2019 - all provisions; Medicare exceptions process within prescription drug plans, H.R. 2827 - all provisions]

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE

H.R. 460: Patient's Access to Treatments Act Medicare Reimbursement for Neurological Diagnostic Testing H.R. 2315 & S. 1128: Preserving Access to Orphan Drugs Act of 2013 Sickle Cell Legislation

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor implementation of the Patient Protection and Affordable Care Act. (P.L. 111-148). Monitor federal issues and legislation associated with health care policy. Monitor passage and implementation of Consolidated and Further Continuing Appropriations Act, 2015 (P.L. 113-235). H.R. 460, Patients Access to Treatment Act of 2013. H.R. 1416, Cancer Patient Protection Act of 2013. H.R. 1429, Scleroderma Research and Awareness Act of 2013. H.R. 1827, Pediatric Subspecialty and Mental Health Workforce Reauthorization Act of 2013. H.R. 2663, to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings. S. 1422, A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings. H.R. 2810, Medicare Patient Access and Quality Improvement Act of 2013. H.R. 4282, Creating Access to Residency Education Act of 2014. H.R. 4302, Protecting Access to Medicare Act. H.R. 5481, To continue the use of a 3-month quarter HER reporting period for health care providers to demonstrate meaningful use for 2015 under the Medicare and Medicaid HER incentive payment programs, and for other purposes. S. 2658, Accelerating Biomedical Research Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor implementation of the Patient Protection and Affordable Care Act. (P.L. 111-148). Monitor federal issues and legislation associated with health care policy. Monitor passage and implementation of Consolidated and Further Continuing Appropriations Act, 2015 (P.L. 113-235). H.R. 460, Patients Access to Treatment Act of 2013. H.R. 1416, Cancer Patient Protection Act of 2013. H.R. 1429, Scleroderma Research and Awareness Act of 2013. H.R. 1827, Pediatric Subspecialty and Mental Health Workforce Reauthorization Act of 2013. H.R. 2663, to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings. S. 1422, A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings. H.R. 2810, Medicare Patient Access and Quality Improvement Act of 2013. H.R. 4282, Creating Access to Residency Education Act of 2014. H.R. 4302, Protecting Access to Medicare Act. H.R. 5481, To continue the use of a 3-month quarter HER reporting period for health care providers to demonstrate meaningful use for 2015 under the Medicare and Medicaid HER incentive payment programs, and for other purposes. S. 2658, Accelerating Biomedical Research Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Abuse. Support of the Alliance to Prevent the Abuse of Medicines legislative priorities including minimum requirements for state databases, pharmacy lock-in programs, and abuse deterrent technology. Biosimilars - concerns regarding naming (shared names with reference product vs. original names); specialty drug cost trends HR 4577 Ensuring Seniors Access to Local Pharmacies Act - opposed HR 460 Patients Access to Treatment Act - opposed HR 4437 Medication Therapy Empowerment Act - oppose expanding to one condition

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Prescription Drug Abuse. Support of the Alliance to Prevent the Abuse of Medicines legislative priorities including minimum requirements for state databases, pharmacy lock-in programs, and abuse deterrent technology. Biosimilars - concerns regarding naming (shared names with reference product vs. original names); specialty drug cost trends HR 4577 Ensuring Seniors Access to Local Pharmacies Act - opposed HR 460 Patients Access to Treatment Act - opposed HR 4437 Medication Therapy Empowerment Act - oppose expanding to one condition

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Issues related to access to rare and orphan disease therapeutics under the enactment of ACA (no specific bills); Issues related to FDA regulatory pathways for pharmaceuticals (no specific bills); H.R. 460 The Patients' Access to Treatments Act of 2013 (all provisions); H.R. 2725 FDA Safety Over Sequestration (SOS) Act (all provisions)

Client expense: $210,000 · Firm income: Not reported

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

Issues relating to implementation of PL 111-148 "Patient Protection and Affordable Care Act of 2010," all provisions. HR 460 "Patients' Access to Treatment Act of 2013," all provisions. Issues relating to patient access to treatments and orphan drug incentives.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to prescription drugs in health care bills; orphan drug and rare disease bill; Cancer Drug Coverage Parity Act of 2013 (H.R. 1801); Patients' Access to Treatment of 2013 (H.R. 460); MODDERN Cures Act (H.R. 3116); H.R. 5657, the FAST Generics Act of 2014; tax extenders package; 21st Century Cures; H.R. 5780, the Protecting the Integrity of Medicare Act.

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

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

Issues related to hemophilia treatments, specialty pharmacies and the 340B drug purchasing program. HR 460 Patients Access to Treatment Act

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

HR 460, Patient Access to Treatment Act; HR 1801 Cancer Drug Coverage Parity Act/S. 1989 Cancer Treatment Parity Act.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

Cancer Drug Coverage Parity Act (H.R. 1801); Cancer Treatment parity Act of 2013 (S. 1879); and Patients Access to Treatment Act (H.R. 460).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Marfan Syndrome Research activities at NIH Marfan Syndrome Education & Awareness activities at CDC H.R. 460: Patients Access to Treatments Act H.R. 3114: MODDERN Cures Act

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

H.R. 460: Patient's Access to Treatments Act GBS/CIDP research at NIH Third Party Premium Assistance

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

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

House Scleroderma Research & Awareness Act (H.R. 1429/S. 1239) H.R. 3114: MODDERN Cures Act H.R. 460, Patients Access to Treatments Act

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

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