Pharmaceutical Quality, Security, and Accountability Act

HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Senate Health, Education, Labor, & Pensions (HELP) Committee Pharmaceutical Compounding Quality and Accountability Act (S. 959), the House Energy and Commerce Committee Compounding Pharmacies, and the Pharmaceutical Quality, Security and Accountability Act (S.959).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Senate Health, Education, Labor, & Pensions (HELP) Committee Pharmaceutical Compounding Quality and Accountability Act (S. 959), the House Energy and Commerce Committee Compounding Pharmacies, and the Pharmaceutical Quality, Security and Accountability Act (S.959).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Senate Health, Education, Labor, & Pensions (HELP) Committee Pharmaceutical Compounding Quality and Accountability Act (S. 959), the House Energy and Commerce Committee Compounding Pharmacies, and the Pharmaceutical Quality, Security and Accountability Act (S.959).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 800 & S. 806 (Medicare Prompt Pay discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Caner Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding Legislation pertaining to drug manufacturing shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent Terms, Pandemic Preparedness, Tamiflu Stockpile, Appropriations; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", HR 1919 "Safeguarding America's Pharmaceuticals Act", Implementation issues related to the Pharmaceutical Quality, Security and Accountability Act (P.L. 113-54), Pharma supply chain issues, Issues related to 340b program; Ongoing issues related to the implementation of the Affordable Care Act of 2010; Drug pricing under 340B program

Client expense: $1,310,600 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The Senate Health, Education, Labor, & Pensions (HELP) Committee Pharmaceutical Compounding Quality and Accountability Act (S. 959), the House Energy and Commerce Committee Compounding Pharmacies, and the Pharmaceutical Quality, Security and Accountability Act (S.959).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2467 National Defense Authorization Act Army Medical Army Medical Specialty Corps (AMSC) S. 907/ H.R. 1915 Gestational Diabetes (GEDI) Act S. 539 National Diabetes Clinical Care Commission Act H.R. 1074 National Diabetes Clinical Care Commission Act H.R. 2663/ S. 1422 Preventative Health Savings Act S. 959 Pharmaceutical Compounding Quality and Accountability Act Affordable Care Act - Preventative Services H.R. 6543 Older Americans Act

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

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

S.959, Pharmaceutical Quality, Security, and Accountability Act Issues Related to Biosimilar Regulation, Labeling, E-Labeling and Access Issues Related to the newly-formed Affordable Medicine Caucus

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR), White House Office

Monitor and lobby legislation and regulations related to compound pharmacies. Bills include: H.R. 3204, S.959, and H.R. 3089.

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

Government targets: Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions and prescription drug abuse. 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Delivering Antimicrobial Transparency in Animals Act of 2013 (H.R. 820) 7.Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 8.Healthier Lifestyles and Prevention America Act (S. 39) 9.Promoting Health as Youth Skills in Classrooms and Life Act (S. 392/H.R. 2160) 10.Medicare Diabetes Prevention Act (S. 452/H.R. 962) 11.Personal Health Investment Today Act (H.R. 956) 12.A bill to provide for a sequester replacement (S. 16/S. 799) 13.American Family Economic Protection Act of 2013 (S. 388) 14.Consolidated and Further Continuing Appropriations Act, 2013 (H.R. 933/Public Law 113-6) 15.Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 16.National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539) 17.Physical Activity Guidelines for Americans Act (S. 531/H.R. 2179) 18.Firearm Safety and Public Health Research Act (H.R. 321) 19.Energy Consumers Relief Act (S. 1363/H.R. 1582) 20.Common Sense Nutrition Disclosure Act (H.R. 1249/S. 1756) 21.Improve Nutrition Program Integrity and Deficit Reduction Act (S. 458/H.R. 1510) 22.A bill to amend the Food and Nutrition Act of 2008 to improve the supplemental nutrition assistance program (S. 762/H.R. 1657) 23.Agriculture Reform, Food, and Jobs Act (S. 954/H.R. 2498) 24.Federal Agriculture Reform and Risk Management Act (H.R. 1947) 25.FIT Kids Act (S. 1033/H.R. 2178) 26.Strengthening Americas Schools Act (S. 1094) 27.Access to Quality Diabetes Education Act (S. 945/H.R. 1274) 28.Fit to Serve Act (S. 976) 29.Climate Change Health Protection and Promotion Act (H.R. 2023/S. 2864) 30.Treat and Reduce Obesity Act (S. 1184 / H.R. 2415) 31.Student Success Act (H.R. 5) 32.To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act (H.R. 45) 33.Medicare Better Health Rewards Program Act (S. 1228/H.R. 2524) 34.Senate FY14 Labor, Health and Human Services, and Education Bill (S. 1284) 35.House of Representatives FY14 Labor, Health and Human Services, and Education Bill 36.Pharmacy Compounding Quality and Accountability Act (S. 959) 37.Safeguarding Americas Pharmaceuticals Act (H.R. 1919) 38.Implementation of Drug Supply Chain Security Act (P.L. 113-54) 39.Preservation of Antibiotics for Medical Treatment Act (H.R. 1150)/Preventing Antibiotic Resistance Act of 2013 (S. 1256) 40.Healthy Families Act (H.R. 1286/S. 631) 41.FY2014 Continuing Resolution (H.J. Res. 59) 42.Pharmaceutical Quality, Security and Accountability Act (S. 959) 43.Energy Consumers Relief Act (S. 1363/H.R. 1582) 44.Increasing the Safety of Prescription Drug Use Act (S. 1657) 45.National Energy Tax Repeal Act (S. 1324) 46.Saving Coal Jobs Act of 2013 (S. 1514/H.R. 5077) 47.Community Parks Revitalization Act (H.R. 2424) 48.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (S. 1422/H.R. 2663) 49.School-based Health Centers Program Reauthorization Act of 2013 (H.R. 2632) 50.Nutrition Reform and Work Opportunity Act (H.R. 3102) 51.Health Equity and Accountability Act (H.R. 5294) 52.Secure America for Education (SAFE) in Our Schools Act of 2013 (H.R. 3158) 53.Continuing Appropriations Resolution, 2014 (H.J. Res 59) 54.Continuing Resolution FY 2014 (HR 2775, PL 113-46) 55.A bill to amend title 23, United States Code, with respect to the establishment of performance measures for the highway safety improvement program, and for other purposes. (H.R. 3493/S. 1708) 56.The Farm Bill (S. (S. 954/H.R. 2498; H.R. 1947, and H.R. 3102, Public Law 113-79) 57.Better Care, Lower Cost Act (S. 1932/H.R. 3890) 58.Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742) 59.The Consolidated Appropriations Act of 2014 (H.R. 3547/Public Law 113-76 60.Strategies to Address Antimicrobial Resistance (STAAR) Act (S. 2236/H.R. 2285) 61.New Opportunities for Bicycling and Pedestrian Infrastructure Financing Act of 2014 (H.R. 3978) 62.Eliminating Disparities in Diabetes Prevention, Access, and Care Act (H.R. 3322) 63.Electricity Security and Affordability Act (S. 1905/H.R. 3826) 64.Stop Overdose Stat Act (HR 4169) 65.Overdose Prevention Act (S 2755) 66.Opioid Overdose Reduction Act (S. 2092/H.R. 4288) 67.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 (DISARM Act) (H.R. 4187) 68.Child Care and Development Block Grant Act of 2014 (S. 1086) 69.Departments of Labor, Health and Human Services and Education And Related Agencies Fiscal Year 2015 Appropriations Bill (including H.R. 5464) 70.Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389 / H.R. 4800) 71.Department of the Interior, Environment, and Related Agencies appropriations legislation, 2015 (including H.R. 5171) 72.MAP-21 Reauthorization Act (S. 2322) 73.Stop Subsidizing Childhood Obesity Act (S. 2342/H.R. 2831) 74.ENRICH Act (H.R. 4427) 75.Healthy Kids Outdoors Act of 2014 (S. 2367/H.R. 4706) 76.Summer Meals Act of 2014 (S. 2527/HR. 5012) 77.Long-Term SCORE Act (H.R. 4444) 78.American Cures Act (S. 2115/H.R. 4384) 79.A joint resolution to disapprove a rule of the Environmental Protection Agency relating to greenhouse gas emissions from electric utility generating units. (S.J. Res 30) 80.Fit for Life Act of 2014 (H.R.4765) 81.School Food Modernization Act (S. 2210/H.R. 1783) 82.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 2014/H.R. 4325) 83.Pedestrian Safety Act of 2014 (S. 2284) 84.Safe Streets Act of 2014 (S. 2004/H.R. 2468) 85.Time for Recovery Enhancement for Addiction Treatment Act (S. 2645) 86.FY 2015 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (including H.R. 5016) 87.Vector-Borne Disease Research Accountability and Transparency Act (H.R. 4701) 88.Highway and Transportation Funding Act of 2014 (H.R. 5021/Public Law 113-159) 89.Full-Service Community Schools Act of 2014 (H.R. 5168) 90.PREPARE Act of 2014 (H.R. 5314) 91.Waters of the United States Regulatory Overreach Protection Act of 2014 (S. 2496/H.R. 5078) 92.American Energy Solutions for Lower Costs and More American Jobs Act (H.R. 2) 93.FY2015 Omnibus; Consolidated and Further Continuing Appropriations Act (H.R. 83/Public Law 113-234) 94.Promise for Antibiotics and Therapeutics for Health Act (PATH Act, S. 2996) 95.Infectious Disease Hospital Hubs Act (S. 2942)

Client expense: $39,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

Monitor and lobby legislation and regulations related to compound pharmacies. Bills include: H.R. 3204, S.959, and H.R. 3089.

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

Government targets: Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

Commented to the Secretary of Health and Human Services on the Proposed Rule "Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit plans, Eligibility Notices Appeals and Other provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing." Support language that states must cover all drugs by companies that participate in the Medicaid drug rebate program. Oppose language that allows states toplace "limitations on amount, duration, and scope" and "adopt prior authorization other utilization control measures, as well as policies that promote the use of generic drugs," as open-ended limitations that can greatly impact access and violate the non-discrimination requirements included in the ACA. Urged at least 60 days for the public to review and comment on the respective state plans and subsequent plan changes. Support requiring all Alternative Benefit Plans to cover all preventive service that plans in the marketplace must cover, and oppose cost sharing for the Medicaid expansion population. Urge HHS to ensure that "medically frail" beneficiaries are not forced into a plan that provides fewer benefits than the ABP or the traditional Medicaid package. Urge the strongest possible non-discrimination rule across plans. Oppose copays for the very poor, or in the alternative, support monthly caps on copays. Oppose discriminatory copays and cost-sharing for non-preferred drugs. Oppose the use of "cost-effectiveness standards" which may compromise care. Support preferred cost-sharing on non-preferred drugs where the prescribing physician determines that the preferred drug would not be as effective or would have adverse effects for the patient. Urge clear and understandable notices and an easily understood, fully accessible, and speedy appeals process. Oppose sequestration budget cuts that negatively impact the Alzheimer's disease patient community including cuts to basic and translational Alzheimer's research at NIH, funding for FDA, and funding for federal programs that support individuals with dementia, family and paid caregivers at the Administration on Aging (AOA), the Health Resources and Services Administration (HRSA) and other agencies authorized under the Older Americans Act (OAA). Supported all of the Leaders Engaged on Alzheimer's Disease (LEAD) Coalition's recommendations to improve the implementation of the National Plan to Address Alzheimer's Disease, as submitted by letter to the HHS Secretary. Support FDA draft industry guidance regarding the development of drugs and biomarkers for the safe and effective early stage treatment of Alzheimer's Disease. Urged the HHS Secretary to appoint a new Agency for Healthcare Research and Quality (AHRQ) Director who is not only well-qualified, but also demonstrates "a commitment to recognizing the diversity, perspective, and participation of patients in every decision the agency makes." Urged the Dept. of Labor to revise the Affordable Care Act (ACA) exception regarding the coordinated annual limitation on out-of-pocket maximums put forth in the February 2013 "Frequently Asked Questions about the ACA" that indicates a major disparity in annual out-of-pocket limits between patients. This is unfair and could cause major hardships for patients dealing with chronic health conditions where out-of-pocket spending can total thousands of dollars each year. Supported the National Institutes of Health (NIH) creation of the National Center for Advancing Translation Sciences' (NCATS) "Discovering New Therapeutic Uses for Existing Molecules Initiative," especially as it applies to the enhanced development of new treatments for Alzheimer's Disease. Support the US Preventative Services Task Force (USPSTF) Transparency and Accountability Act of 2013, H.R. 2143. Support the Drug Supply Chain Security Act, S. 959, and H.R. 3204, the Drug Quality and Security Act. Support the Orphan Drug Tax Credit (ODTC). Support House and Senate efforts to require HHS to adopt standards ensuring electronic health record systems are interoperable by 2017 or another date certain, as well as provisions to prevent the blocking of information necessary to treat a patient. RetireSafe also supports strong privacy protections in this regard. Support a "safety first" unique naming policy for any and all biosimilar drugs pending market approval. Urged the FTC and the FDA to place patient safety and consumer protection above all other considerations regarding biosimilar drugs. Support the "I Am (Still) Essential" patient coalition effort to ensure that enrollees with chronic health conditions are able to realize full and equal benefits from their Qualified Health Plans (QHPs). To that end, these enrollees must overcome numerous barriers to care now, including: 1) Limited Benefits and Restricted Access to Care; 2) High Cost-Sharing and Out-of Pocket Costs; and 3) Unacceptable Plan Transparency and Uniformity, all of which need immediate remedial action.Support the I AM (Still) ESSENTIAL December coaltion letter to HHS regarding proposed changes to define essential health benefits for Qualified Health Plans in the future under the Affordable Care Act. Joined numerous other organizations in urging Congress to pass legislation under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to provide clarity and certainty for appropriate risk-based oversight of health information technology. This includes legislation that protects patients, ensures safe and effective care, and fosters continued innovation in a rapidly growing health IT field. Support S. 232, the Medical Device and Innovation Protection Act, and H.R 523, the Protect Medical Innovation Act.

Client expense: $25,533 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), President of the U.S., SENATE

S. 959, Pharmaceutical Compounding Quality and Accountability Act-Animal health drug compounding; H.R. 1150, Preservation of Antibiotics for Medical Treatment Act; H.R. 820, Delivering Antimicrobial Transparency in Animals Act; S. 1256, Preventing Antibiotic Resistance Act; S. 895, Antimicrobial Data Collection Act; H.R. 2285, Strategies to Address Antimicrobial Resistance Act; S. 1171, H.R. 1528, Veterinary Medicine Mobility Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.644, Preventing Abuse of Cough Treatments Act of 2013 S. 621, Safe Prescribing Act of 2013 H.R. 1285, Safe Prescribing Act of 2013 H.R. 1919 Safeguarding America's Pharmaceuticals Act of 2013 S 959, Pharmaceutical Compounding Quality and Accountability Act S 1277, Combating Prescription Drug Abuse Act S.957, Drug Supply Chain Security Act H.R.3204 - Drug Quality and Security Act H.R. 4437 - Generic Drug Pricing Fairness Act

Client expense: $460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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

Prescription Drug Abuse, STOPP Act HR486; S.Con.Res.8 (FY 2014 Budget) (provisions relating to healthcare and pharmeceuticals); Drug labeling, electronic labeling proposals; counterfeit drugs; HR 1919, Safeguarding America's Pharmaceuticals Act, and S.959, Pharmaceutical Quality, Security and Accountability Act; H. 3717 Helping Families in Mental Health Crisis Act of 2013; HR4800, FY15 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies;HR 2985, Combinaation Drug Development Incentive Act of 2013; and "21st Century Cures."

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

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

Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow-on biologics; Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit; Regulatory and legislative activities regarding 340B program; Issues relating to biologics; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; Issues related to the implementation of the Affordable Care Act of 2010; issues related to biosimilars; Issues concerning clinical trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act. Federal Drug. Drug pricing under 340B program; Medical reimbursement - advocacy on behalf of maintaining ASP+6%, 340B Drug Discounting Program - education of Congress on unintended growth of program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.

Client expense: $1,090,200 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1919 - Safeguarding America's Pharmaceuticals Act of 2013 S. 959 Pharmaceutical Quality, Security, and Accountability Act S. 957 Drug Supply Chain Security Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to Physician Payment Sunshine provisions. - Issues related to regulation and reimbursement of diagnostics.- Issues related to health care reform, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 1074, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 539, "National Diabetes Clinical Care Commission Act", regarding all provisions. - S 452, "Medicare Diabetes Prevention Act of 2013", regarding all provisions. - Issues related to personalized medicine incentives and regulation. - Issues related to Moddern Cures initiative. - Issues related to modernizing laboratory test standards. - Issues related to diagnostic payments. - PL 111-148, "Patient Protection and Affordable Care Act", issues related to vision care coverage. - PL 112-144, "Food and Drug Administration Safety and Innovation Act", regarding Medical Device User Fee Act provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - Issues related to hepatitis C testing and treatment guidelines. - PL 101-381, "Ryan White Comprehensive AIDS Resources Emergency (CARE) Act" and issues related to state ADAP funding. - Issues related to drug resistant tuberculosis. - Issues related to legislation that would establish drug importation. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to medical device reprocessing. - Issues related to health care pricing transparency. - HR 3303, "Mobile Medical Application", regarding all provisions. - Issues related to health care associated inflation policy. - HR 2663/ S 1422, "Preventative Health Savings Act", regarding all provisions. - HR 3204, "Drug Quality and Security Act", regarding all provisions. - Issues related to neglected tropical diseases. - Issues related to transferable market exclusivity. - Issues related to health care associated infections. - S 959, "Pharmaceutical Quality Security and Accountability Act", regarding all provisions. - Issues related to FDA regulation of custom medical devices. - Issues related to Tricare coverage of Total Disc Arthroplasty. - Issues related to VA requirements for vendor access and credentialing. - Issues related to 21st Century Cures. - Issues related to Medicare beneficiary access. - Issues related to mobile medical applications and digital healthcare. - Issues related to FDA draft guidances on blood glucose meters. - HR 4895/ S 2902, "The Microbead Free Waters Act of 2014", regarding all provisions. - Issues related to the expanded use of unapproved drugs. - Issues related to combination products. - Issues related to the PROTECT Act (bill number pending), specifically medical mobile applications. - Issues related to Government Health Care Exclusion/ Debarment (bill number pending) - S 2977, "MEDTECH Act", regarding provisions related to medical mobile applications. - S 2917, "Adding Ebola to the FDA Priority Review Voucher Program Act", regarding all provisions.

Client expense: $1,400,000 · Firm income: Not reported

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

H.R.800 & S.806 Medicare Prompt Pay Discount Exclusion (H.R.800 & S.806), legislation to ensure more appropriate general payment amount for drugs & biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. Cancer Patient Protection Act of 2013 (H.R.1416), legislation to exclude cancer drugs from sequestration cuts. Prescription Drug Abuse Legislation (H.R.1919, H.R.3204, S.957 & S.959)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 800 & S. 806 (Medicare Prompt Pay Discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. H.R. 1416 Cancer Patient Protection Act of 2013) legislation to exclude cancer drugs from sequestration cuts.H.R. 1919, H.R. 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding. Legislation pertaining to drug manufacturing shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: FDA Drug Safety and Risk Management Advisory Committee January 25 recommendation to reschedule hydrocodone as a Schedule II controlled substance H.R. 1285 - To amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug H.R. 1919 - Safeguarding Americas Pharmaceuticals Act S. 621 - Safe Prescribing Act S. 959 - Pharmaceutical Compounding Quality and Accountability Act H.R. 3089 - Compounding Clarity Act H.R. 3204 - Drug Quality and Security Act (Public Law 113-54) H.R 4069 - Ensuring Patient Access and Effective Drug Enforcement Act

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Pharmaceutical Compounding and Accountability Act S.959 The Compound Clarity Act H.R.3089 The Drug Quality and Security Act H.R.3204 Issues related to implementation of the Compounding Quality Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical Compounding and Accountability Act S.959 The Compound Clarity Act H.R.3089 The Drug Quality and Security Act H.R.3204 2015 National Defense Authorization Act Issues related to implementation of the Compounding Quality Act

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

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

S. 959, "Pharmaceutical Compounding Quality and Accounting Act" H.R. 1416, "Cancer Patient Protection Act of 2013" S. 957, "Drug Supply Chain Security" H.R. 1919, " Safeguarding America's Pharmaceuticals Act"

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 959, "Pharmaceutical Compounding Quality and Accounting Act" H.R. 1416, "Cancer Patient Protection Act of 2013" S. 957, "Drug Supply Chain Security" H.R. 1919, " Safeguarding America's Pharmaceuticals Act"

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Commented to the Secretary of Health and Human Services on the Proposed Rule "Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit plans, Eligibility Notices Appeals and Other provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing." Support language that states must cover all drugs by companies that participate in the Medicaid drug rebate program. Oppose language that allows states toplace "limitations on amount, duration, and scope" and "adopt prior authorization other utilization control measures, as well as policies that promote the use of generic drugs," as open-ended limitations that can greatly impact access and violate the non-discrimination requirements included in the ACA. Urged at least 60 days for the public to review and comment on the respective state plans and subsequent plan changes. Support requiring all Alternative Benefit Plans to cover all preventive service that plans in the marketplace must cover, and oppose cost sharing for the Medicaid expansion population. Urge HHS to ensure that "medically frail" beneficiaries are not forced into a plan that provides fewer benefits than the ABP or the traditional Medicaid package. Urge the strongest possible non-discrimination rule across plans. Oppose copays for the very poor, or in the alternative, support monthly caps on copays. Oppose discriminatory copays and cost-sharing for non-preferred drugs. Oppose the use of "cost-effectiveness standards" which may compromise care. Support preferred cost-sharing on non-preferred drugs where the prescribing physician determines that the preferred drug would not be as effective or would have adverse effects for the patient. Urge clear and understandable notices and an easily understood, fully accessible, and speedy appeals process. Oppose sequestration budget cuts that negatively impact the Alzheimer's disease patient community including cuts to basic and translational Alzheimer's research at NIH, funding for FDA, and funding for federal programs that support individuals with dementia, family and paid caregivers at the Administration on Aging (AOA), the Health Resources and Services Administration (HRSA) and other agencies authorized under the Older Americans Act (OAA). Supported all of the Leaders Engaged on Alzheimer's Disease (LEAD) Coalition's recommendations to improve the implementation of the National Plan to Address Alzheimer's Disease, as submitted by letter to the HHS Secretary. Support FDA draft industry guidance regarding the development of drugs and biomarkers for the safe and effective early stage treatment of Alzheimer's Disease. Urged the HHS Secretary to appoint a new Agency for Healthcare Research and Quality (AHRQ) Director who is not only well-qualified, but also demonstrates "a commitment to recognizing the diversity, perspective, and participation of patients in every decision the agency makes." Urged the Dept. of Labor to revise the Affordable Care Act (ACA) exception regarding the coordinated annual limitation on out-of-pocket maximums put forth in the February 2013 "Frequently Asked Questions about the ACA" that indicates a major disparity in annual out-of-pocket limits between patients. This is unfair and could cause major hardships for patients dealing with chronic health conditions where out-of-pocket spending can total thousands of dollars each year. Supported the National Institutes of Health (NIH) creation of the National Center for Advancing Translation Sciences' (NCATS) "Discovering New Therapeutic Uses for Existing Molecules Initiative," especially as it applies to the enhanced development of new treatments for Alzheimer's Disease. Support the US Preventative Services Task Force (USPSTF) Transparency and Accountability Act of 2013, H.R. 2143. Support the Drug Supply Chain Security Act, S. 959, and H.R. 3204, the Drug Quality and Security Act. Support the Orphan Drug Tax Credit (ODTC). Support House and Senate efforts to require HHS to adopt standards ensuring electronic health record systems are interoperable by 2017 or another date certain, as well as provisions to prevent the blocking of information necessary to treat a patient. RetireSafe also supports strong privacy protections in this regard. Support a "safety first" unique naming policy for any and all biosimilar drugs pending market approval. Urged the FTC and the FDA to place patient safety and consumer protection above all other considerations regarding biosimilar drugs. Support the "I Am (Still) Essential" patient coalition effort to ensure that enrollees with chronic health conditions are able to realize full and equal benefits from their Qualified Health Plans (QHPs). To that end, these enrollees must overcome numerous barriers to care now, including: 1) Limited Benefits and Restricted Access to Care; 2) High Cost-Sharing and Out-of Pocket Costs; and 3) Unacceptable Plan Transparency and Uniformity, all of which need immediate remedial action.Support the I AM (Still) ESSENTIAL December coaltion letter to HHS regarding proposed changes to define essential health benefits for Qualified Health Plans in the future under the Affordable Care Act. Joined numerous other organizations in urging Congress to pass legislation under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to provide clarity and certainty for appropriate risk-based oversight of health information technology. This includes legislation that protects patients, ensures safe and effective care, and fosters continued innovation in a rapidly growing health IT field. Support S. 232, the Medical Device and Innovation Protection Act, and H.R 523, the Protect Medical Innovation Act.

Client expense: Not reported · Firm income: $7,838

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), President of the U.S., SENATE

Drug safety and drug counterfeiting; Rebates for Medicare Part D; Federal preemption for prescription drugs; drug importation; and drug shortages; track and trace; H.R. 3204; S. 959; 21st Century Cures Initiative.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3204, S. 959 Drug Quality and Security Act (track and trace supply chain provisions); issues regarding biosimilars; 340B

Client expense: $280,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

The Senate Health, Education, Labor, & Pensions (HELP) Committee Pharmaceutical Compounding Quality and Accountability Act (S. 959), the House Energy and Commerce Committee Compounding Pharmacies, and the Pharmaceutical Quality, Security and Accountability Act (S.959).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: FDA Drug Safety and Risk Management Advisory Committee January 25 recommendation to reschedule hydrocodone as a Schedule II controlled substance H.R. 1285 - To amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug H.R. 1919 - Safeguarding Americas Pharmaceuticals Act S. 621 - Safe Prescribing Act S. 959 - Pharmaceutical Compounding Quality and Accountability Act H.R. 3089 - Compounding Clarity Act H.R. 3204 - Drug Quality and Security Act (Public Law 113-54) H.R 4069 - Ensuring Patient Access and Effective Drug Enforcement Act

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Monitor and lobby legislation and regulation relating to compounding pharmacies. Bills include: H.R. 3204, S. 959, and H.R. 3089.

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

Government targets: Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)

HR 800 & S. 806 (Medicare Prompt Pay Discount Exclusion), legislation to ensure more appropriate general payment amount for drugs and biological under Part B of the Medicare Program by excluding customary prompt-pay discounts extended to wholesalers from the manufacturer's average sales price. HR 1416 Cancer Patient Protection Act of 2013, legislation to exclude cancer drugs from sequestration cuts. HR 1919, HR 3204, S. 957 & S. 959, Pharmaceutical pedigree anti-counterfeiting legislation and provisions affecting pharmaceutical compounding. Legislation pertaining to drug manufacturing shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; and community-based public health interventions and prescription drug abuse. 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148)2.Implementation of the FDA Food Safety Modernization Act (Public Law 111-353) 3.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act (Public Law 113-5) 4.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 5.Implementation of the Budget Control Act of 2011 (Public Law 112-25) 6.Delivering Antimicrobial Transparency in Animals Act of 2013 (H.R. 820) 7.Animal Drug and Animal Generic Drug User Fee Act (Public Law 113-14) 8.Healthier Lifestyles and Prevention America Act (S. 39) 9.Promoting Health as Youth Skills in Classrooms and Life Act (S. 392/H.R. 2160) 10.Medicare Diabetes Prevention Act (S. 452/H.R. 962) 11.Personal Health Investment Today Act (H.R. 956) 12.A bill to provide for a sequester replacement (S. 16/S. 799) 13.American Family Economic Protection Act of 2013 (S. 388) 14.Consolidated and Further Continuing Appropriations Act, 2013 (H.R. 933/Public Law 113-6) 15.Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Public Law 113-5) 16.National Diabetes Clinical Care Commission Act (H.R. 1074/S. 539) 17.Physical Activity Guidelines for Americans Act (S. 531/H.R. 2179) 18.Firearm Safety and Public Health Research Act (H.R. 321) 19.Energy Consumers Relief Act (S. 1363/H.R. 1582) 20.Common Sense Nutrition Disclosure Act (H.R. 1249/S. 1756) 21.Improve Nutrition Program Integrity and Deficit Reduction Act (S. 458/H.R. 1510) 22.A bill to amend the Food and Nutrition Act of 2008 to improve the supplemental nutrition assistance program (S. 762/H.R. 1657) 23.Agriculture Reform, Food, and Jobs Act (S. 954/H.R. 2498) 24.Federal Agriculture Reform and Risk Management Act (H.R. 1947) 25.FIT Kids Act (S. 1033/H.R. 2178) 26.Strengthening Americas Schools Act (S. 1094) 27.Access to Quality Diabetes Education Act (S. 945/H.R. 1274) 28.Fit to Serve Act (S. 976) 29.Climate Change Health Protection and Promotion Act (H.R. 2023/S. 2864) 30.Treat and Reduce Obesity Act (S. 1184 / H.R. 2415) 31.Student Success Act (H.R. 5) 32.To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act (H.R. 45) 33.Medicare Better Health Rewards Program Act (S. 1228/H.R. 2524) 34.Senate FY14 Labor, Health and Human Services, and Education Bill (S. 1284) 35.House of Representatives FY14 Labor, Health and Human Services, and Education Bill 36.Pharmacy Compounding Quality and Accountability Act (S. 959) 37.Safeguarding Americas Pharmaceuticals Act (H.R. 1919) 38.Implementation of Drug Supply Chain Security Act (P.L. 113-54) 39.Preservation of Antibiotics for Medical Treatment Act (H.R. 1150)/Preventing Antibiotic Resistance Act of 2013 (S. 1256) 40.Healthy Families Act (H.R. 1286/S. 631) 41.FY2014 Continuing Resolution (H.J. Res. 59) 42.Pharmaceutical Quality, Security and Accountability Act (S. 959) 43.Energy Consumers Relief Act (S. 1363/H.R. 1582) 44.Increasing the Safety of Prescription Drug Use Act (S. 1657) 45.National Energy Tax Repeal Act (S. 1324) 46.Saving Coal Jobs Act of 2013 (S. 1514/H.R. 5077) 47.Community Parks Revitalization Act (H.R. 2424) 48.A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings (S. 1422/H.R. 2663) 49.School-based Health Centers Program Reauthorization Act of 2013 (H.R. 2632) 50.Nutrition Reform and Work Opportunity Act (H.R. 3102) 51.Health Equity and Accountability Act (H.R. 5294) 52.Secure America for Education (SAFE) in Our Schools Act of 2013 (H.R. 3158) 53.Continuing Appropriations Resolution, 2014 (H.J. Res 59) 54.Continuing Resolution FY 2014 (HR 2775, PL 113-46) 55.A bill to amend title 23, United States Code, with respect to the establishment of performance measures for the highway safety improvement program, and for other purposes. (H.R. 3493/S. 1708) 56.The Farm Bill (S. (S. 954/H.R. 2498; H.R. 1947, and H.R. 3102, Public Law 113-79) 57.Better Care, Lower Cost Act (S. 1932/H.R. 3890) 58.Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742) 59.The Consolidated Appropriations Act of 2014 (H.R. 3547/Public Law 113-76 60.Strategies to Address Antimicrobial Resistance (STAAR) Act (S. 2236/H.R. 2285) 61.New Opportunities for Bicycling and Pedestrian Infrastructure Financing Act of 2014 (H.R. 3978) 62.Eliminating Disparities in Diabetes Prevention, Access, and Care Act (H.R. 3322) 63.Electricity Security and Affordability Act (S. 1905/H.R. 3826) 64.Stop Overdose Stat Act (HR 4169) 65.Overdose Prevention Act (S 2755) 66.Opioid Overdose Reduction Act (S. 2092/H.R. 4288) 67.Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 (DISARM Act) (H.R. 4187) 68.Child Care and Development Block Grant Act of 2014 (S. 1086) 69.Departments of Labor, Health and Human Services and Education And Related Agencies Fiscal Year 2015 Appropriations Bill (including H.R. 5464) 70.Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389 / H.R. 4800) 71.Department of the Interior, Environment, and Related Agencies appropriations legislation, 2015 (including H.R. 5171) 72.MAP-21 Reauthorization Act (S. 2322) 73.Stop Subsidizing Childhood Obesity Act (S. 2342/H.R. 2831) 74.ENRICH Act (H.R. 4427) 75.Healthy Kids Outdoors Act of 2014 (S. 2367/H.R. 4706) 76.Summer Meals Act of 2014 (S. 2527/HR. 5012) 77.Long-Term SCORE Act (H.R. 4444) 78.American Cures Act (S. 2115/H.R. 4384) 79.A joint resolution to disapprove a rule of the Environmental Protection Agency relating to greenhouse gas emissions from electric utility generating units. (S.J. Res 30) 80.Fit for Life Act of 2014 (H.R.4765) 81.School Food Modernization Act (S. 2210/H.R. 1783) 82.Protecting Children from Electronic Cigarette Advertising Act of 2014 (S. 2014/H.R. 4325) 83.Pedestrian Safety Act of 2014 (S. 2284) 84.Safe Streets Act of 2014 (S. 2004/H.R. 2468) 85.The Recovery Enhancement for Addiction Treatment Act (S. 2645) 86.FY 2015 Financial Services and General Government Appropriations bill, in support of an appropriation for the National Alliance for Model State Drug Laws (including H.R. 5016) 87.Vector-Borne Disease Research Accountability and Transparency Act (H.R. 4701) 88.Highway and Transportation Funding Act of 2014 (H.R. 5021/Public Law 113-520) 89.Full-Service Community Schools Act of 2014 (H.R. 5168) 90.PREPARE Act of 2014 (H.R. 5314) 91.Waters of the United States Regulatory Overreach Protection Act of 2014 (S. 2496/H.R. 5078) 92.American Energy Solutions for Lower Costs and More American Jobs Act (H.R.

Client expense: $38,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to Medicare's 2011 guidance on servicing hospital equipment, including medical imaging equipment. Monitor legislative and administrative action related to drug safety and drug counterfeiting (track and trace). Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to federal preemption for prescription drugs. Monitor legislative and administrative action related to point-of-care instruments. Monitor legislative and administrative action related to streamlined pathways to market for breakthrough technologies. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administration action related to Tropical Disease Priority Review Voucher Program. Monitor activities related to House Energy and Commerce Committees 21st Century Cures Initiative. H.R. 1150, Preservation of Antibiotics for Medical Treatment Act of 2013. Title II and general provisions in the bill. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013. HR 3204, Drug Quality and Security Act. Provisions related to drug distribution. H.R. 4302, Protecting Access to Medicare Act. Provisions related to imaging and Sec. 213. S. 959, Pharmaceutical Quality, Security, and Accountability Act. Provisions related to drug distribution. S. 1256, Preventing Antibiotic Resistance Act of 2013. S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013. H.R. 1528, Veterinary Medicine Mobility Act of 2014. H.R. 4771, Designer Anabolic Steroid Control Act of 2014. S. 2012, Designer Anabolic Steroid Control Act of 2014. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148. H.R. 1295, Medical Device Tax Elimination Act.

Client expense: $1,450,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

HR 3204, Drug Quality and Security Act. Provisions related to drug distribution. S. 959, Pharmaceutical Quality, Security, and Accountability Act. Provisions related to drug distribution. Monitored legislative and federal activity related to drug distribution and safety and pharmacy drug compounding.

Client expense: $1,450,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

HR 3204, Drug Quality and Security Act. Provisions related to drug distribution. S. 959, Pharmaceutical Quality, Security, and Accountability Act. Provisions related to drug distribution. Monitored legislative and federal activity related to drug distribution and safety and pharmacy drug compounding.

Client expense: $1,360,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to sustainable growth rate and SGR repeal. Issues of tranparency on the CMS preventative maintenance directive for medical equipment. Monitor legislative and administrative action related to Medicare's 2011 guidance on servicing hospital equipment, including medical imaging equipment. Monitor legislative and administrative action related to drug safety and drug counterfeiting (track and trace). Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to federal preemption for prescription drugs. H.R. 1150, Preservation of Antibiotics for Medical Treatment Act of 2013. Title II and general provisions in the bill. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013. HR 3204, Drug Quality and Security Act. Provisions related to drug distribution. H.R. 4302, Protecting Access to Medicare Act. Provisions related to imaging and Sec. 213. S. 959, Pharmaceutical Quality, Security, and Accountability Act. Provisions related to drug distribution. S. 1256, Preventing Antibiotic Resistance Act of 2013. S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013. H.R. 1528, Veterinary Medicine Mobility Act of 2014. H.R. 4771, Designer Anabolic Steroid Control Act of 2014. S. 2012, Designer Anabolic Steroid Control Act of 2014. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148. H.R. 1295, Medical Device Tax Elimination Act.

Client expense: $1,360,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug user fees. Monitor legislative and administrative action related to sustainable growth rate and SGR repeal. Issues of transparency on the CMS preventative maintenance directive for medical equipment. Monitor legislative and administrative action related to Medicare's 2011 guidance on servicing hospital equipment, including medical imaging equipment. Monitor legislative and administrative action related to drug safety and drug counterfeiting (track and trace). Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. oMonitor legislative and administrative action related to federal preemption for prescription drugs. H.R. 1150, Preservation of Antibiotics for Medical Treatment Act of 2013. Title II and general provisions in the bill. H.R. 2725, Food and Drug Administration Safety Over Sequestration Act of 2013. HR 3204, Drug Quality and Security Act. Provisions related to drug distribution. H.R. 4302, Protecting Access to Medicare Act. Provisions related to imaging and Sec. 213. S. 959, Pharmaceutical Quality, Security, and Accountability Act. Provisions related to drug distribution. S. 1256, Preventing Antibiotic Resistance Act of 2013. S. 1871, SGR Repeal and Medicare Beneficiary Access Act of 2013. Monitor the implementation of the Patient Protection and Affordable Care Act, P.L. 111-148.

Client expense: $2,080,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3204, Drug Quality and Security Act. Provisions related to drug distribution. S. 959, Pharmaceutical Quality, Security, and Accountability Act. Provisions related to drug distribution. Monitored legislative and federal activity related to drug distribution and safety and pharmacy drug compounding.

Client expense: $2,080,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Abuse, STOPP Act HR486; S.Con.Res.8 (FY 2014 Budget) (provisions relating to healthcare and pharmeceuticals); Drug labeling, electronic labeling proposals; counterfeit drugs; HR 1919, Safeguarding America's Pharmaceuticals Act, and S.959, Pharmaceutical Quality, Security and Accountability Act; H. 3717 Helping Families in Mental Health Crisis Act of 2013; HR4800, FY15 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies;HR 2985, Combinaation Drug Development Incentive Act of 2013; and "21st Century Cures."

Client expense: $880,000 · Firm income: Not reported

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