Ensuring Access to Clinical Trials Act of 2015

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues and increased funding for the NIH. H.R. 209/S. 139, Expanding Access to Clinical Trials Act of 2015 (P.L. 114-63); H.R. 6, 21st Century Cures; Innovation for Healthier Americans initiative; H.R. 1516/S. 1013, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015; S. 1597, Patient-Focused Impact Assessment Act of 2015; and S. 2425, the Patient Access and Medicare Protection Act (P.L. 114-115)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 114 - 20 - the Medicare Access and Chip Reauthorization Act - SGR repeal, CHIP reauthorization, Community Health Center Reauthorization - comments on regulations re: quality measurements, technical support for small businesses, MIPS, APMS HR 293 - the Protect Continuing Physician Education Act and Patient Care Act - regulations implementing the Sunshine Act HR 6 - 21st Century Cures - provisions impacting Sunshine Act S 320 - Medical Innovation Act - NIH funding Opioid Addiction issues S. 1455 - TREAT ACT, Recovery Enhancement for Addiction Act S. 1641 - The Jason Simcakoski Memorial Opioid Safety Act s. 480 - Reauthorization of NASPER - The National All Schedules Prescription Electronic Reporting Act - No specific bill S. 1392 Safer Prescribing of Controlled Substances Act HR 2085/S. 1134 - Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 HR 1462/S 799 - Protecting our Infants Act of 2015 - PL 114-91 Partial Fill legislation - no specific bill Funding for demonstration projects for access to pain specialists - no specific bill DEA - change/classification of regulations regarding partial fill of prescriptions E Prescribing - no specific bill S. 524 - Comprehensive Addiction and Recovery Act of 2015 S. 1134 - Heroin and Prescription Opioid Abuse Education and Enforcement Act Draft CDC Guideline for Prescribing Opioids for Chronic Pain Prescriber Education on the VA System draft legislation Prescription Drug Pricing - no specific bill Direct to Consumer Advertising - no specific bill Negotiating Prescription Drug Prices for Medicare and Medicaid - no specific bill Access to medically tailored food for low income people - no specific bill S 139/HR 209 - the Ensuring Access to Clinical Trials Act of 2015 - PL 114-63 Meaningful Use and Electronic Medical Records - HR 3309 - Future Flexibility on HIT Reporting and Advancing Interoperability Act Opposition to Meaningful Use Stage III Rules HR 3940 - Meaningful Use Hardship Relief Act - PL 114-115 HR 2568 - Fair Medical Audits Act of 2015 DEA Reclassification of marijuana to allow scientific research and study

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

PL 114 - 20 - the Medicare Access and Chip Reauthorization Act - SGR repeal, CHIP reauthorization, Community Health Center Reauthorization - comments on regulations re: quality measurements, technical support for small businesses, MIPS, APMS HR 293 - the Protect Continuing Physician Education Act and Patient Care Act - regulations implementing the Sunshine Act HR 6 - 21st Century Cures - provisions impacting Sunshine Act Meaningful Use and Electronic Medical Records - HR 3309 - Future Flexibility on HIT Reporting and Advancing Interoperability Act Opposition to Meaningful Use Stage III Rules HR 3940 - Meaningful Use Hardship Relief Act - PL 114-115 HR 2568 - Fair Medical Audits Act of 2015 Prescription Drug Pricing - negotiating drug prices for Medicare and Medicaid - no specific bill HR 2568 - Fair Medical Audits HR 209/S. 1391 - Ensuring Access to Clinical Trials Act of 2015 - PL 114-63

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

H.R. 1190, Protecting Seniors' Access to Medicare Act of 2015 H.R. 1314, the Bipartisan Budget Act of 2015 H.R. 1427/S. 804 Medicare CGM Access Act H.R. 1624/S. 1099, the Protecting Affordable Coverage for Employees Act (PACE Act). H.R. 1686, the Preventing Diabetes in Medicare Act H.R. 1726/S. 1345, the Access to Quality Diabetes Education Act H.R. 2029, Consolidated Appropriations Act, 2016 H.R. 2050/S. 2045, the Middle Class Health Benefits Tax Repeal Act of 2015 H.R. 2061, the Equitable Access to Care and Health (EACH) Act H.R. 209/S. 139, the Ensuring Access to Clinical Trials Act H.R. 2102/S. 1131, the Medicare Diabetes Prevention Act H.R. 2205, the Data Security Act of 2015 H.R. 2404/S.1509, The Treat and Reduce Obesity Act H.R. 2446, To amend title XIX of the Social Security Act to require the use of electronic visit verification for personal care services furnished under the Medicaid program, and for other purposes. H.R. 2646, the Helping Families in Mental Health Crisis Act H.R. 2878/ S. 1461, to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015. H.R. 2911/S. 1697, the Small Business Healthcare Relief Act H.R. 292/S. 2260, the Long-Term Studies of Comprehensive Outcomes and Returns for the Economy Act (Long-Term SCORE Act) H.R. 3081/S.1778 - TELEmedicine for MEDicare (TELE-MED) Act H.R. 3539, the Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act H.R. 3660, the Preventive Health Savings Act H.R. 3716, the Ensuring Terminated Providers are Removed from Medicaid and CHIP Act H.R. 3762, the Restoring Americans Healthcare Freedom Reconciliation Act H.R. 3821, the Medicaid Directory of Caregivers Act H.R. 4155/S. 2343, the Telehealth Innovation and Improvement Act H.R. 4227/S.2392, the Medicare Advantage Bill of Rights Act H.R. 592/S. 314, Pharmacy and Medically Underserved Areas Enhancement Act H.R. 6, 21st Century Cures Act S. 139, Ensuring Access to Clinical Trials Act of 2015 S. 1945, Mental Health Reform Act of 2015 S. 2023, the Prescription Drug Affordability Act S. 2030, the Advancing Targeted Therapies for Rare Diseases Act S. 2104, A bill to amend title XVIII of the Social Security Act to provide relief to Medicare Advantage plans with a significant number of dually eligible or low-income subsidy beneficiaries and to prevent the termination of two star plans. S. 2141, TRUST IT Act S. 2153, the Provider Payment Sunshine Act, S. 2187, the FDA Regulatory Efficiency Act S. 2425, the Patient Access and Medicare Protection Act S. 754, the Cybersecurity Information Sharing Act (CISA)

Renewable Fuels Standard Maintenance; FY16 Interior and Environment Appropriations Act (H.R.2822 & S.1645) Omnibus Appropriations Act (H.R.209)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 6 - The 21st Century Cures Act Orphan Drug Tax Credit H.R. 1537/S. 1878 - Advancing Hope Act of 2015 H.R. 209/S. 139 - Ensuring Access to Clinical Trials Act S. 2188 - Rare Disease Innovation Act H.R. 3731 - RAD Fund Act H.R. 3678 - Preserving Access to Orphan Drug Act S. 2030 - Advancing Targeted Therapies for Rare Diseases Act H.R. 2624 - Part D Beneficiaries Appeals Fairness Act S. 1421 - OPEN Act

Client expense: Not reported · Firm income: Not reported

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

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues and increased funding for the NIH. H.R. 209/S. 139, Expanding Access to Clinical Trials Act of 2015; H.R. 6, 21st Century Cures and Innovation for Healthier Americans initiatives; S. 1604, Transition to Independence Act; H.R. 1516/S. 1013, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015; S. 1597, Patient-Focused Impact Assessment Act of 2015; S. 2030, Advancing Targeted Therapies for Rare Diseases Act; and HR 3229, Enforce the Medicare Improvements for Patients and Providers Act of 2015

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues and increased funding for the NIH. H.R. 209/S. 139, Expanding Access to Clinical Trials Act of 2015; H.R. 6, 21st Century Cures and Innovation for Healthier Americans initiatives; S. 1604, Transition to Independence Act; H.R. 1516/S. 1013, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015; S. 1597, Patient-Focused Impact Assessment Act of 2015; S. 2030, Advancing Targeted Therapies for Rare Diseases Act; and HR 3229, Enforce the Medicare Improvements for Patients and Providers Act of 2015

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

HR 209/ S. 139: Ensuring Access to Clinical Trials Act of 2015; all provisions of the bill Bill Not Yet Introduced: Discussions related to Innovation for Healthier Americans legislation; provisions related to Food and Drug Administration & National Institutes of Health funding, laboratory developed tests, pathways for approval of drugs, clinical trial design, & biomedical research

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Social Security Administration (SSA), White House Office

HR 209/S. 139: Ensuring Access to Clinical Trials Act of 2015; all provisions of the bill S. 139: Ensuring Access to Clinical Trials Act of 2015; all provisions of the bill Bill Not Yet Introduced: Discussions related to Innovation for Healthier Americans legislation; provisions related to Food and Drug Administration & National Institutes of Health funding, laboratory developed tests, pathways for approval of drugs, clinical trial design, & biomedical research Bill Not Yet Introduced: Discussions related to Prescription Drug User Fee Act (PDUFA) VI; provisions related to rare diseases, pathways for drugs, expertise in review of rare treatments Bill Not Yet Introduced: Discussions related to Hawaii Cystic Fibrosis Care Center; provisions related to access

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Social Security Administration (SSA), White House Office

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. 6 The 21st Century Care Act (all provisions); Issues related to the Senate "Innovation for Healthier Americans" Report (no specific bills); H.R. 209/S.139 Ensuring Access to Clinical Trials Act (all provisions); S. 2030 Advancing Targeted Therapies for Rare Disease Act of 2015.

Client expense: $330,000 · Firm income: Not reported

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

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues and increased funding for the NIH. H.R. 209/S. 139, Expanding Access to Clinical Trials Act of 2015 H.R. 6, 21st Century Cures and Innovation for Healthier Americans initiatives H.R. 1516/S. 1013, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 S. 1597, Patient-Focused Impact Assessment Act of 2015

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PL 114 - 20 - the Medicare Access and Chip Reauthorization Act - SGR repeal, CHIP reauthorization, Community Health Center Reauthorization - preparation for regulations re: quality measurements, technical support, MIPS, APMS HR 293 - the Protect Continuing Physician Education Act and Patient Care Act - regulations implementing the Sunshine Act HR 6 - 21st Century Cures - provisions impacting Sunshine Act S 320 - Medical Innovation Act - NIH funding Opioid Addiction issues S. 1455 - TREAT ACT, Recovery Enhancement for Addiction Act S. 1641 - The Jason Simcakoski Memorial Opioid Safety Act s. 480 - Reauthorization of NASPER - The National All Schedules Prescription Electronic Reporting Act - No specific bill S. 1392 Safer Prescribing of Controlled Substances Act HR 2085/S. 1134 - Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 HR 1462/S 799 - Protecting our Infants Act of 2015 Partial Fill legislation - no specific bill Funding for demonstration projects for access to pain specialists - no specific bill DEA - change/classification of regulations regarding partial fill of prescriptions E Prescribing - no specific bill S. 524 - Comprehensive Addiction and Recovery Act of 2015 S. 1134 - Heroin and Prescription Opioid Abuse Education and Enforcement Act Draft CDC Guideline for Prescribing Opioids for Chronic Pain Prescription Drug Pricing - no specific bill Access to medically tailored food for low income people - no specific bill HR 2519 - Audiology Patient Choice Act of 2015 S 139/HR 209 - the Ensuring Access to Clinical Trials Act of 2015 ICD 10 issues - no specific bill Meaningful Use and Electronic Medical Records - HR 3309 - Future Flexibility on HIT Reporting and Advancing Interoperability Act Stage 3 Final Rules - CMS 42 CFR - Part 412 - 495 - no specific bill HR 2568 - Fair Medical Audits Act of 2015 DEA Reclassification of marijuana to allow scientific research and study

Electrodiagnostic Accreditation and reimbursement - creating mandatory standards for electrodiagnostic testing (needle EMG and nerve conduction studies) NIH funding of at least $32 billion for federal medical research Ensuring Access to Clinical Trials Act (S. 139/H.R. 209) - This legislation passed the Senate and needs to be passed by the House before financial incentives for patients to participate in rare disease clinical trials lapse later this year Patients Access to Treatments Act (H.R. 1600) - Some conditions diagnosed through EDX testing are progressive and treatment needs to begin as quickly as possible. Restrictive coinsurance requirements on innovative therapies create significant barriers for patients in need of life-changing therapies.

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

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

General education about policies impacting pharmaceutical development, approval, and reimbursement; 21st Century Cures Initiative, H.R. 6 (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee), including efforts to advance precision medicine. H.R. 209/S. 139 Ensuring Access to Clinical Trial Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education about policies impacting pharmaceutical development, approval, and reimbursement; 21st Century Cures Initiative, H.R. 6 (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee), including efforts to advance precision medicine. H.R. 209/S. 139 Ensuring Access to Clinical Trial Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues and increased funding for the NIH. H.R. 209/S. 139, Expanding Access to Clinical Trials Act of 2015; H.R. 6, 21st Century Cures and Innovation for Healthier Americans initiatives; S. 1604, Transition to Independence Act; and H.R. 1516/S. 1013, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues and increased funding for the NIH. H.R. 209/S. 139, Expanding Access to Clinical Trials Act of 2015 H.R. 6, 21st Century Cures and Innovation for Healthier Americans initiatives H.R. 1516/S. 1013, Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 209: Ensuring Access to Clinical Trials Act of 2015; provisions related to access S. 139: Ensuring Access to Clinical Trials Act of 2015; provisions related to access Docket No: FDA-2014-N-2187: Identifying Potential Biomarkers of Qualifications and Describing Contexts of Use to Address Areas Important to Drug Development; provided regulatory comments on issue

Client expense: $150,000 · Firm income: Not reported

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

HR 6: 21st Century Cures Act; provisions on drug development and disease research HR 209: Ensuring Access to Clinical Trials Act of 2015; provisions related to access Not Yet Introduced: Discussions related to HELP Innovation for Healthier Americans legislation; provisions on drug development and disease research Not Yet Introduced: Discussions related to Hawaii Cystic Fibrosis Care Center; provisions related to access to military health care center for civilians with Cystic Fibrosis

Client expense: $150,000 · Firm income: Not reported

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

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. 6 The 21st Century Care Act (all provisions); Issues related to the "Innovation for Healthier Americans" Report (no specific bills); H.R. 209/S.139 Ensuring Access to Clinical Trials Act (all provisions)

Client expense: $300,000 · Firm income: Not reported

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

H.R.6 - The 21st Century Cures Act Orphan Drug Tax Credit H.R.1537 - Advancing Hope Act of 2015 H.R.209/S.139 - Ensuring Access to Clinical Trials Act H.R.1600 - Patients' Access to Treatments Act Trade Promotion Authority H.R.1859 - Childrens Access to Specialty Care Act of 2015

Client expense: Not reported · Firm income: Not reported

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

PL 114 - 20 - the Medicare Access and Chip Reauthorization Act - SGR repeal, CHIP reauthorization, Community Health Center Reauthorization HR 293 - the Protect Continuing Physician Education Act and Patient Care Act - regulations implementing the Sunshine Act HR 6 - 21st Century Cures - provisions impacting Sunshine Act S 320 - Medical Innovation Act - NIH funding Opioid Addiction issues S. 1455 - TREAT ACT, Recovery Enhancement for Addiction Act S. 1641 - The Jason Simcakoski Memorial Opioid Safety Act Reauthorization of NASPER - The National All Schedules Prescription Electronic Reporting Act - No specific bill S. 1392 Safer Prescribing of Controlled Substances Act HR 2085/S. 1134 - Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 HR 1462/S 799 - Protecting our Infants Act of 2015 HR 2519 - Audiology Patient Choice Act of 2015 S 139/HR 209 - the Ensuring Access to Clinical Trials Act of 2015 ICD 10 issues, letter to CMS - no specific bill Meaningful Use and Electronic Medical Records - no specific bill HR 2568 - Fair Medical Audits Act of 2015

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues. H.R. 209/S. 139, Expanding Access to Clinical Trials Act of 2015 21st Century Cures and Innovation for Healthier Americans initiatives

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care issues affecting individuals with neuromuscular disease, including transitional health care issues. H.R. 209/S. 139, Expanding Access to Clinical Trials Act of 2015 21st Century Cures and Innovation for Healthier Americans initiatives

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

All provisions of the Ensuring Access to Clinical Trials Act of 2015 (S. 139, H.R. 209) Funding for the Food and Drug Administration (FDA) Funding for the National Institutes of Health (NIH) Funding for the Centers for Disease Control (CDC) Funding for the Health Resources and Services Administration (HRSA) Funding for the Center for Medicare and Medicaid Innovation (CMMI) General discussions regarding Childrens Health Insurance Program (CHIP) Reauthorization General discussions regarding 21st Century Cures Initiative General discussions regarding Innovation for Healthier Americans Initiative

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Ensuring Access to Clinical Trials Act of 2015 (S. 139, H.R. 209) Funding for the Food and Drug Administration (FDA) Funding for the National Institutes of Health (NIH) Funding for the Centers for Disease Control (CDC) Funding for the Health Resources and Services Administration (HRSA) Funding for the Center for Medicare and Medicaid Innovation (CMMI) General discussions regarding Childrens Health Insurance Program (CHIP) Reauthorization 21st Century Cures Initiative Innovation for Healthier Americans Initiative

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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); Issues related to the "21st Century Cures Act" Discussion Draft (no specific bills); Issues related to the "Innovation for Healthier Americans" Report (no specific bills); H.R. 209/S.139 Ensuring Access to Clinical Trials Act (all provisions)

Client expense: $380,000 · Firm income: Not reported

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

HR 2 - the Medicare Access and Chip Reauthorization Act - SGR repeal, CHIP reauthorization, Community Health Center Reauthorization HR 293 - the Protect Continuing Physician Education Act and Patient Care Act - regulations implementing the Sunshine Act 21st Century Cures draft - provisions impacting Sunshine Act S 320 - Medical Innovation Act - NIH funding Opioid Addiction issues HR 1462/S 799 - Protecting our Infants Act of 2015 S 139/HR 209 - the Ensuring Access to Clinical Trials Act of 2015 ICD 10 issues, letter to CMS, no specific bill Meaningful Use and Electronic Medical Records

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE