Improving Regulatory Transparency for New Medical Therapies Act

Health IT regulation HR 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4299 - Improving Regulatory Transparency for New Medical Therapies Act HR 4494 - Regenerative Medicine Promotion Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 2126 - Regenerative Medicine Promotion Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 S 2450 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 Veterans Health Care

Client expense: $3,540,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Export-Import Bank of the United States (EXIM Bank), Federal Aviation Administration (FAA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Obesity product matters as well as FDA funding HR 4299 --Improving Regulatory Transparency for New Medical Therapies Act re: DEA scheduling of controlled substances S. 2862 - Transparency, Patient Access, and Effective Drug Enforcement Act of 2014 re: DEA scheduling of controlled substances

Client expense: Not reported · Firm income: $40,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

DEA Scheduling of Controlled Substances H.R. 4299 -- Improving Regulatory Transparency for New Medical Therapies Act S. 2862 -- Transparency, Patient Access and Effective Drug Enforcement Act of 2014

Client expense: $500,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

* Treat and Reduce Obesity Act of 2013 - HR 2415/S 1184; Medicare coverage of FDA-approved obesity medications * Improving Regulatory Transparency for New Medical Therapies Act - HR 4299; Improvement of DEA scheduling process * Commerce, Justice, Science and Related Agencies Appropriations Act of 2015 - HR 4660/S 2437; Drug Enforcement Administration (DEA) issues * Medicare Patient Access and Qulaity Improvement Act of 2013 - HR 2810

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Bioterrorism and Medical Countermeasures DNA Identification Health IT regulation HR 2085 - Diagnostic Innovation Testing and Knowledge Advancement Act of 2013HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4015 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 HR 4299 - Improving Regulatory Transparency for New Medical Therapies Act HR 4302 - Protecting Access to Medicare Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 Veterans Health Care

Client expense: $3,470,000 · Firm income: Not reported

H.R. 3742, Antibiotic Development to Advance Patient Treatment Act: Provisions related to antibiotics and drug approval H.R. 4709, Ensuring Patient Access and Effective Drug Enforcement Act: Provisions related to the Controlled Substances Act, Drug Enforcement Agency (DEA) regulation and related issues (a reintroduced version of H.R. 4069) H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act: Provisions related to DEA scheduling H.R. 5214, 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. 5657, Fair Access for Safe and Timely (FAST) Generics Act: Provisions related to DEA scheduling S. 1723, No ObamaCare Kickbacks Act of 2013: Provisions related to application of the anti-kickback statute to qualified health plans S. 2295, Patient Safety and Generic Labeling Improvement Act: Provisions relating to drug safety labeling (112th Congress) Implementation issues related to the Food and Drug Administration Safety and Innovation Act (Public Law 112-144), including user fee reauthorization and FDA reform Implementation issues related to the Drug Quality and Security Act (Public Law 113-54), including pharmacy compounding and supply chain issues Implementation issues related 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 21st Century Cures legislation and policy issues Draft legislation relating to prescription drug coverage issues Issues related to value and cost of prescription drugs Issues related to user fee reauthorization and FDA reform Patient savings program policy issues Comparative effectiveness policy issues Academic detailing policy issues General HHS, NIH, and FDA related advocacy Biopharmaceutical innovation policy issues Prescription drug abuse policy issues FDA accelerated approval policy issues Unapproved use policy issues 340B policy issues Importation policy issues Clinical trial policy issues

Health IT regulation HR 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4299 - Improving Regulatory Transparency for New Medical Therapies ActHR 4494 - Regenerative Medicine Promotion Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 2126 - Regenerative Medicine Promotion Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 S 2450 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 Veterans Health Care

Client expense: $5,320,000 · Firm income: Not reported

Education about access to therapies for children at risk of developing RSV (Respiratory Syncytial Virus), specifically with respect to guidelines by the American Academy of Pediatrics (AAP). Legislative efforts to help accelerate the discovery, development and delivery of promising new treatments to patients (21st Century Cures).H.R. 4299: Improving Regulatory Transparency for New Medical Therapies Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

DEA regulatory transparency in controlled substances scheduling person DEA regulatory transparency in issuing research licenses and quotas H.R.4299,Improving regulatory transparency for new medical therapies act S.2866,Regulatory transparency, patient access, and effective drug enforcement act

Client expense: $554,400 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Natl Institute on Alcohol Abuse & Alcoholism (NIAA), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

Obesity product matters as well as FDA funding HR 4299 --Improving Regulatory Transparency for New Medical Therapies Act re: DEA scheduling of controlled substances

Client expense: Not reported · Firm income: $40,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4709 - Ensuring Patient Access and Effective Drug Enforcement Act; S. 2862-The Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act of 2014; H.R. 4299 - Improving Regulatory Transparency for New Medical Therapies Act; Implementation of P.L. 113 - 54 (Drug Quality and Security Act)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 487, Primary Care Workforce Access Improvement Act, Urge House to cosponsor bill that would create GME pilot project to train primary care doctors, urge Senate offices to sponsor bill, GME reform increase primary care physician training, Pilot test alternatives to GME payment in order to increase primary care physician training.HR 2415, Treat and Reduce Obsity, Seeking House and Senate cosponsors for obesity legislation. HR 3306, Telehealth Enhancement Act, Defining the home base for telehealth reimbursement to incluse family medicine offices. HR 4299, Improving Regulatory Transparency for New Medical Therapies Act, Improving DEA's process for scheduling new drugs approved by the FDA. HR 4709, Ensuring Patient Access and Effective Drug Enforcement Act, Allowing supply chain stakeholders for prescription drugs to collaborate. HR 4810, VA Health Reform, Improve access for veterans to primary care services, both inside the VA and outside. S. 1184, Treat and Reduce Obsity, Seeking House and Senate cosponsors for obesity legislation. S. 1759, Teaching Health Center Reauthorization Act, Reauthorize the Teaching Health Centers Graduate Medical Education program. S. 1994, TRICARE Moms Improvement Act, Supporting TRICARE payment for breastfeeding support and supplies and counseling. S. 1978, Increasing Primary Care Access Act, Family physician workforce, Teaching Health Center Reauthorization Act, Reauthorize the Teaching Health Centers Graduate Medical Education program, increase family physician workforce. S. 2229, Expanding Primary Care Access and Workforce Act, Reauthorizing Title VII primary care programs, Teaching Health Centers and the NHSC, Reauthorizing Teaching Health Center GME program, Teaching Health Centers Graduate Medical Education, Reauthorizing Title VII primary care programs, Teaching Health Centers and the NHSC. S. 2450, VA Health Reform, Improve access for veterans to primary care services, both inside the VA and outside No Bill Number, Extend Medicare/Medicare parity for primary care services, Extend Medicaid pay increase to Medicare levels beyond 2015. H. Con. Res. 96, House Budget Resolution, Protecting access to primary care in Medicaid. No Bill Number, Children's Health, Advocate for reauthorization of CHIP and children's mental health issues via coalition group meetings. No Bill Number, First Friday & Health Care Provider Meetings, Provider outreach groups for ACA, provider, and open enrollment issues. No Bill Number, SGR Repeal and Replacement process, Advocate for SGR repeal and new physician payment system that pays for value and primary care. No Bill Number, Medicaid Primary Care Bonus, Advocate for extension of the Medicaid bonus which expires at the end of 2014; advocate for members to mention at E&C hearing. No Bill Number, Medicare Primary Care Incentive Payment, Urge Ways and Means members to discuss at annual MedPac hearing. No Bill Number, Telemedicine,advocate for AAFP policies to be included in a potential bipartisan telehealth bill. No Bill Number, Teaching Health Centers, advocate for introduction of bipartisan bill to reauthorize the program. No Bill Number, FY funding increses in AHRQ, Title VII 747, NHSC, Teaching Health Center planning grants, Federal spending priorities to support workforce, research. No Bill Number, Veterans Health Care, advocate for inclusion of policies in final bill that allow family doctors to easily contract with the VA; advocate for primary-care GME slots in the VA. No Bill Number, FDA regulation of tobacco products, Oppose any limits or amendments that would limit FDA ability to regulate cigars. No Bill Number, E-Cigarettes impact on public health; Support FDA regulation of e-cigarettes, still urging FDA to regulate all tobacco. No Bill Number, National Health Service Corps trust fund reauthorization, appropriation, NHSC provides scholarships & debt relief as well as physicians for underserved communities.No Bill Number, Rural workforce, Comments on FQHC final rule. No Bill Number, VA committee on Woman Veterans, Nominated to FPs to the VA committee. No Bill Number, HHS Appropriations, Funding for health professions training grants, AHRQ research, and National Health Service Corps (NHSC). No Bill Number, Enhanced Medicaid payment for primary care, Extending the enhanced Medicaid payment for primary care. No Bill Number, Site-neutral payment for medical services, Support site-neutral payment by CMS for medical services. No Bill Number, White House's Health Kids and Save Sports Concussion Summit, Providing family physicians with latest information about sports concussions. No Bill Number, Veterans Health Administration, Allowing community physicians to charge VA for services to Vets. No Bill Number, Direct Primary Care, Primary care model of retainer-based practice. No Bill Number, Medicare physician payment reform of the Sustainable Growth Rate, 2014 conversion factor. No Bill Number, Graduate Medical Education, comments on 2015 proposed IPPS. No Bill Number, Health IT, asking CMS to delay MU2. No Bill Number, Non-discrimination, Advocate for correct use of non-discrimination clause in Affordable Care Act. No Bill Number, Extend Medicare/Medicare parity for primary services, extend Medicaid pay increase to Medicare levels beyond 2015. No Bill Number, First Fridays Meetings, Provider outreach group for Affordable Care Act, provider and open enrollment issues.

HR 487, Primary Care Workforce Access Improvement Act, Urge House to cosponsor bill that would create GME pilot project to train primary care doctors, urge Senate offices to sponsor bill, GME reform increase primary care physician training, Pilot test alternatives to GME payment in order to increase primary care physician training.HR 2415, Treat and Reduce Obsity, Seeking House and Senate cosponsors for obesity legislation. HR 3306, Telehealth Enhancement Act, Defining the home base for telehealth reimbursement to incluse family medicine offices. HR 4299, Improving Regulatory Transparency for New Medical Therapies Act, Improving DEA's process for scheduling new drugs approved by the FDA. HR 4709, Ensuring Patient Access and Effective Drug Enforcement Act, Allowing supply chain stakeholders for prescription drugs to collaborate. HR 4810, VA Health Reform, Improve access for veterans to primary care services, both inside the VA and outside. S. 1184, Treat and Reduce Obsity, Seeking House and Senate cosponsors for obesity legislation. S. 1759, Teaching Health Center Reauthorization Act, Reauthorize the Teaching Health Centers Graduate Medical Education program. S. 1994, TRICARE Moms Improvement Act, Supporting TRICARE payment for breastfeeding support and supplies and counseling. S. 1978, Increasing Primary Care Access Act, Family physician workforce, Teaching Health Center Reauthorization Act, Reauthorize the Teaching Health Centers Graduate Medical Education program, increase family physician workforce. S. 2229, Expanding Primary Care Access and Workforce Act, Reauthorizing Title VII primary care programs, Teaching Health Centers and the NHSC, Reauthorizing Teaching Health Center GME program, Teaching Health Centers Graduate Medical Education, Reauthorizing Title VII primary care programs, Teaching Health Centers and the NHSC. S. 2450, VA Health Reform, Improve access for veterans to primary care services, both inside the VA and outside No Bill Number, Extend Medicare/Medicare parity for primary care services, Extend Medicaid pay increase to Medicare levels beyond 2015. H. Con. Res. 96, House Budget Resolution, Protecting access to primary care in Medicaid. No Bill Number, Children's Health, Advocate for reauthorization of CHIP and children's mental health issues via coalition group meetings. No Bill Number, First Friday & Health Care Provider Meetings, Provider outreach groups for ACA, provider, and open enrollment issues. No Bill Number, SGR Repeal and Replacement process, Advocate for SGR repeal and new physician payment system that pays for value and primary care. No Bill Number, Medicaid Primary Care Bonus, Advocate for extension of the Medicaid bonus which expires at the end of 2014; advocate for members to mention at E&C hearing. No Bill Number, Medicare Primary Care Incentive Payment, Urge Ways and Means members to discuss at annual MedPac hearing. No Bill Number, Telemedicine,advocate for AAFP policies to be included in a potential bipartisan telehealth bill. No Bill Number, Teaching Health Centers, advocate for introduction of bipartisan bill to reauthorize the program. No Bill Number, FY funding increses in AHRQ, Title VII 747, NHSC, Teaching Health Center planning grants, Federal spending priorities to support workforce, research. No Bill Number, Veterans Health Care, advocate for inclusion of policies in final bill that allow family doctors to easily contract with the VA; advocate for primary-care GME slots in the VA. No Bill Number, FDA regulation of tobacco products, Oppose any limits or amendments that would limit FDA ability to regulate cigars. No Bill Number, E-Cigarettes impact on public health; Support FDA regulation of e-cigarettes, still urging FDA to regulate all tobacco. No Bill Number, National Health Service Corps trust fund reauthorization, appropriation, NHSC provides scholarships & debt relief as well as physicians for underserved communities.No Bill Number, Rural workforce, Comments on FQHC final rule. No Bill Number, VA committee on Woman Veterans, Nominated to FPs to the VA committee. No Bill Number, HHS Appropriations, Funding for health professions training grants, AHRQ research, and National Health Service Corps (NHSC). No Bill Number, Enhanced Medicaid payment for primary care, Extending the enhanced Medicaid payment for primary care. No Bill Number, Site-neutral payment for medical services, Support site-neutral payment by CMS for medical services. No Bill Number, White House's Health Kids and Save Sports Concussion Summit, Providing family physicians with latest information about sports concussions. No Bill Number, Veterans Health Administration, Allowing community physicians to charge VA for services to Vets. No Bill Number, Direct Primary Care, Primary care model of retainer-based practice. No Bill Number, Medicare physician payment reform of the Sustainable Growth Rate, 2014 conversion factor. No Bill Number, Graduate Medical Education, comments on 2015 proposed IPPS. No Bill Number, Health IT, asking CMS to delay MU2. No Bill Number, Non-discrimination, Advocate for correct use of non-discrimination clause in Affordable Care Act. No Bill Number, Extend Medicare/Medicare parity for primary services, extend Medicaid pay increase to Medicare levels beyond 2015. No Bill Number, First Fridays Meetings, Provider outreach group for Affordable Care Act, provider and open enrollment issues.

Health IT regulation HR 3230 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4299 - Improving Regulatory Transparency for New Medical Therapies ActHR 4494 - Regenerative Medicine Promotion Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 2126 - Regenerative Medicine Promotion Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 S 2450 - Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 Veterans Health Care

Client expense: $2,840,000 · Firm income: Not reported

Obesity product matters as well as FDA funding HR 4299 --Improving Regulatory Transparency for New Medical Therapies Act re: DEA scheduling of controlled substances

Client expense: Not reported · Firm income: $40,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2415/S 1184 - Treat and Reduce Obesity Act of 2013 - Medicare coverage of obesity medications HR 4299 - Improving Regulatory Transparency for New MEdical Therapies Act -- DEA scheduling process HR 4660/S 2437 - Commerce, Justice, Science, and Related Agencies Appropriations Act of 2015; Drug Enforcement Administration (DEA) issues HR 2810 - Medicare Patient Access and Quality Improvement Act of 2013

Client expense: $450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4299, The Improving Regulatory Transparency for New Medical Therapies Act.

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

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

Obesity product matters as well as FDA funding HR 4299 --Improving Regulatory Transparency for New Medical Therapies Act re: DEA scheduling of controlled substances

Client expense: Not reported · Firm income: $40,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Bioterrorism and Medical Countermeasures DNA Identification Health IT regulation HR 2085 - Diagnostic Innovation Testing and Knowledge Advancement Act of 2013HR 3303 - Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 HR 4015 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 HR 4299 - Improving Regulatory Transparency for New Medical Therapies Act HR 4302 - Protecting Access to Medicare Act of 2014 HR 523 - Protect Medical Innovation Act of 2013 S 2000 - SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S 2007 - Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S 232 - Medical Device Access and Innovation Act of 2013 Veterans Health Care

Client expense: $3,360,000 · Firm income: Not reported

H.R. 4299, Improving Regulatory Transparency for New Medical Therapies Act DEA regulatory transparency in controlled substances scheduling process DEA regulatory transparency in issuing research licenses and quotas

Client expense: $570,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)