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.

HR 5214 Requires the Secretary of Health and Human Services (HHS) to consult with clinical experts and make recommendations for the use of clinical data registries to improve patient care. S 1879/HR 1801 Cancer Treatment Parity Act of 2013. HR 3033 The SOFTWARE Act.

Client expense: $10,098 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

P.L. 111-375 National Alzheimer's Project Act, All sections S709/HR1507 Health Outcomes, Planning and Education for Alzheimer's Act, All sections S.1119 Positive Aging Act of 2013, All Sections S.1028 Older American's Act Amendments of 2013 S.219/H.R.4351 - Alzheimer's Accountability Act of 2014 P.L. 111-148/111-152 Patient Protection and Affordable Car Act - All Sections related to care coordination, transitional care, long term care services and supports access to affordable insurance, establishment of a national voluntary disability insurance program, provisions related to individuals with Alzheimer's disease and caregivers and provisions related to research including the Cures Acceleration Network. H.R. 2976 Missing Alzheimer's Disease Patient Alert Program Reauthorization All sections H.R. 2975 Alzheimer's Caregiver Support Act. All Sections S.1914 National Silver Alert Act of 2013 H. Res. 396 - A resolution supporting the goals of the National Alzheimer's Disease Awareness month S.1365/H.R. 2827 Part D Beneficiary appeals S. Res. 301 - A resolution recognizing and supporting the goals and implementation of the national Alzheimer's Project Act and the National Plan to Address Alzheimer's Disease. S. Res 303 - A resolution declaring that achieving the primary goal of the National Plan to Address Alzheimer's Disease of the Department of Health and Human Services to prevent and effectively treat Alzheimer's disease by 2025 is an urgent national priority H.R. 3836/S. 1910 Pat Summitt Congressional Gold Medal Act H. Res. 489 - A resolution expressing the need to facilitate a robust response to the looming global crisis of Alzheimer's and other forms of dementia. H.R. 4484 - Strengthening Healthcare Options for Vulnerable Populations Act. H.R.4543 - PACE Pilot Act of 2014 H.R. 647/S.313 - ABLE Act H.R. 4145 - Elder Care Tax Credit Act H.R. 5633/S.5633 - In Home Caregiver Assessment Reources and Education Act H.R. 5024 - Social Security Caregiver Credit Act H.R. 5214 - Olson Registry Bill S.1562 Older Americans Act Reauthorization Act of 2013 21st Century Cures

Client expense: $136,000 · Firm income: Not reported

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries, including H.R. 5214, legislation to improve the use of clinical data registries Issues related to unique device identifier Issues related to FDA regulation of blood glucose meters Issues related to the competitiveness of the medical technology industry and the impact of Federal policies Issues related to the regulation of combination products Issues related to diagnostics regulation Issues related to the CMS program for durable medical equipment Issues related to the VA credentialing system for health care industry representatives Issues related to the regulation of mobile medical technology, including H.R. 3303 SOFTWARE Act of 2013 S. 2007 Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 S. 2977 Medical Electronic Data Technology Enhancement for Consumers Health Act or the MEDTECH Act Issues related to VA contracts with medical device companies and direct shipment to consumers

Client expense: $550,000 · 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 Risk Evaluation and Mitigation Strategies (REMS) H.R. 5805, Andrea Sloan Compassionate Use Reform and Enhancement Act: Provisions related to expanded access and compassionate use 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 related to drug safety labeling (112th Congress) S. 2917, Adding Ebola to the FDA Priority Review Voucher Program: Provisions related to new proposed voucher program; Public Law No. 113-233 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 health insurance exchanges Branded Prescription Drug Fee policy issues (79 Fed. Reg. 43631 (July 28, 2014)) 21st Century Cures legislation and policy issues R&D tax credit renewal as part of H.R. 5771, Tax Increase Prevention Act of 2014 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 expedited drug approval policy issues Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products [Docket No. FDA-2013-N-0500]: Patient labeling Issues relating to communications about prescription drugs 340B program policy issues Importation policy issues Clinical trial policy issues

See attached addendum for General Lobbying Issue Area: HCR - HealthcareAffordable Private Health Care: Effect of the Health Insurance Tax, defined Essential Health Benefits, and Age Rating on premiums; Healthcare Delivery System Reforms State-based regulation: State Oversight of Rates; Properly designed state based health insurance exchanges to improve competition and maximize choice; federal exchanges; Multi-State Health Plans; Centralized All-Payer Database Medical Loss Ratios: Level Playing Field for MLRs; Consistent reporting requirements for all insurers; MLR Broker Fees: Health Care Quality: Delivery System Incentives to Promote Better Care; Payment Reforms; Patient-centered Primary Care/Medical Home; Evidence Based Care; Wellness; Chronic Care Management Federal Employee Health Benefit Program (FEHBP) regarding proposals to allow additional types of carriers including regional PPOs to be included in the coverage options offered by OPM FEHBP Modernization Act circulation draft President's budget, regional PPOs, government contributions HR 2667 Introduced by Griffin (R-AR) on July 11, 2013 Authority for Mandate Delay Act HR 2668 Introduced by Young (R-IN) on July 17, 2013 Fairness for Families Act Bailouts for Insurance Companies, S. 1726, H.R. 3541, 3812, 3851. 4406 HR 2328 Introduced in House June 12, 2013 Rep. Rogers, Mike J. (R-MI) Access to Professional Health Insurance Advisors Act of 2013 - Amends the Public Health Service Act to exclude remuneration paid for licensed independent insurance producers from administrative cost calculations for purposes of calculating the medical-loss ratio of a health insurance plan. HR 3541 introduced by Tim Griffin November 19,2013 Obamacare Taxpayer Bailout Prevention Act - Repeals the provision of the Patient Protection and Affordable Care Act that directs the Secretary of Health and Human Services (HHS) to establish and administer a program of risk corridors for calendar years 2014, 2015, and 2016 under which a qualified health plan offered in the individual or small group market is required to participate in a payment adjustment system based on the ratio of the allowable costs of the plan to the plan's aggregate premiums. Other general Affordable Care Act topics related to multiple parts of legislation: ACA Implementation and back-end issues; Multi-State Plan Program Implementation; Risk Corridors and Risk Mitigation; Reinsurance; Small Business Health Options Program (SHOP) implementation; Third-party payment of premiums; Electronic Health Records (EHRs); Health IT Roadmap; Contraception Rule; Expatriate Legislation. See following page on Health Care Reform issuesS. 1486 Introduced August 1, 2013 by Sen. Carper, Thomas R. (D-DE) Postal Reform Act of 2013 - Amends provisions of federal law relating to the funding of the U.S. Postal Service (USPS) retirement and health care systems, operations, revenue, and governance.. Section 104 Substitute Amendment. HR 3362 Introduced October 29, 2013 by Rep. Terry, Lee (R-NE) Exchange Information Disclosure Act - Amends the Patient Protection and Affordable Care Act to expand reporting requirements related to health care exchanges. Requires the Secretary of Health and Human Services (HHS) to publish reports weekly through March 31, 2015, on: (1) consumer interactions with healthcare.gov or subsequent sites and any efforts undertaken to remedy problems that impact taxpayers and consumers, (2) calls to the federal customer service call center, including the number of calls received by the call center, problems identified by users, and referrals of those calls; (3) all navigators and certified application counselors that have been trained and certified by health care exchanges; and (4) all agents and brokers who have been trained and certified by the federal health care exchange. HR 762 Introduced in House February 15, 2013 by Rep. Blackburn, Marsha (R-TN) Health Care Choice Act of 2013 - Repeals the health insurance and health coverage expansion requirements of the Patient Protection and Affordable Care Act and related requirements of the Health Care and Education Reconciliation Act of 2010. Restores provisions of law amended or repealed by such provisions. HR 1701 Introduced April 24, 2013 by Ted Poe (R-TX) Cutting Costly Codes Act of 2013 - Prohibits the Secretary of Health and Human Services (HHS) from implementing, administering, or enforcing specified regulations insofar as they would replace International Classification of Diseases (ICD)-9 with ICD-10 as a standard for code sets for appropriate data elements for financial and administrative transactions involving the electronic exchange of health information. HR 3985 Introduced February 3, 2014 by Lynn Westmoreland (R-GA) Prohibits health insurance issuers and third-party administrators, for any period after December 31, 2014, from being required to make payments under the Patient Protection and Affordable Care Act (PPACA) for a transitional reinsurance program for the individual health insurance market in each state. Allows payments to issuers, as limited by this Act, only to the extent of available funds. Limits to 2014 the applicability of the program of risk corridors, under which a qualified health plan offered in the individual or small group market shall participate in a payment adjustment system based on the ratio of the allowable costs of the plan to the plan's aggregate premiums . HR 4496 Introduced April 28, 2014 by Cory Gardner (R-CO) Covering People With Pre-Existing Conditions Act of 2014 - Requires each state to mitigate the health costs of high risk individuals in the state through a state reinsurance program or a state high risk pool HR 4777 Introduced May 30, 2014 by Michael Burgess (R-TX) To amend the Internal Revenue Code of 1986 to modify rules relating to health savings accounts. HR 3522 Introduced November 18, 2013 by Bill Cassidy (R-LA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes. HR 5214 Introduced July 28, 2014 by Pete Olsen (R-TX) 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. See following page on Health Care Reform issuesHR 3750 Introduced December 12, 2013 by Donna Matsui (D-CA) Telehealth Modernization Act of 2013 - Calls for states to authorize health care professionals to deliver health care to individuals through telehealth and to consider adopting conditions under which such a professional should: have access to the individual's medical history. HR 4633 Introduced May 9, 2014 by H. Griffith (R-VA) Insurance Rate Transparency Act - Amends the Public Health Service Act to require that specific health insurance premium increase information submitted to the Secretary of Health and Human Services (HHS) be disclosed to Congress no later than 30 days after receipt of the information. HR 5453 Introduced September 11, 2014 by Bruce Braley (D-IA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes.

Affordable Private Health Care: Effect of the Health Insurance Tax, defined Essential Health Benefits, and Age Rating on premiums; Healthcare Delivery System Reforms State-based regulation: State Oversight of Rates; Properly designed state based health insurance exchanges to improve competition and maximize choice; federal exchanges; Multi-State Health Plans; Centralized All-Payer Database Medical Loss Ratios: Level Playing Field for MLRs; Consistent reporting requirements for all insurers; MLR Broker Fees: Health Care Quality: Delivery System Incentives to Promote Better Care; Payment Reforms; Patient-centered Primary Care/Medical Home; Evidence Based Care; Wellness; Chronic Care Management Federal Employee Health Benefit Program (FEHBP) regarding proposals to allow additional types of carriers including regional PPOs to be included in the coverage options offered by OPM. FEHBP Modernization Act circulation draft President's budget, regional PPOs, government contributions HR 2667 Introduced by Griffin (R-AR) on July 11, 2013 Authority for Mandate Delay Act HR 2668 Introduced by Young (R-IN) on July 17, 2013 Fairness for Families Act Bailouts for Insurance Companies, S. 1726, H.R. 3541, 3812, 3851, 4406 HR 2328 Introduced in House June 12, 2013 Rep. Rogers, Mike J. (R-MI) Access to Professional Health Insurance Advisors Act of 2013 - Amends the Public Health Service Act to exclude remuneration paid for licensed independent insurance producers from administrative cost calculations for purposes of calculating the medical-loss ratio of a health insurance plan. HR 3541 introduced by Tim Griffin November 19, 2013 Obamacare Taxpayer Bailout Prevention Act - Repeals the provision of the Patient Protection and Affordable Care Act that directs the Secretary of Health and Human Services (HHS) to establish and administer a program of risk corridors for calendar years 2014, 2015, and 2016 under which a qualified health plan offered in the individual or small group market is required to participate in a payment adjustment system based on the ration of the allowable costs of the plan to the plan's aggregate premiums. Other general Affordable Care Act topics related to multiple parts of legislation: ACA Implementation and back-end issues; Multi-State Plan Program Implementation; Risk Corridors and Risk Mitigation; Reinsurance; Small Business Health Options Program (SHOP) implementation; Third-Party payment of premiums; Electronic Health Records (EHRs); Health IT Roadmap; Contraception Rule; Expatriate Legislation. S. 1486 Introduced August 1, 2013 by Sen. Carper,Thomas R. (D-DE) Postal Reform Act of 2013 - Amends provisions of federal law relating to the funding of the U.S.Postal Service (USPS) retirement and health care systems, operations, revenue, and governance. Section 104 Substitute Amendment. HR 3362 Introduced October 29, 2013 by Rep. Terry, Lee (R-NE) Exchange Information Disclosure Act - Amends the Patient Protection and Affordable Care Act to expand reporting requirements related to health care exchanges. Requires the Secretary of Health and Human Services (HHS) to publish reports weekly through March 31, 2015, on: (1) consumer interactions with healthcare.gov or subsequent sites and any efforts undertaken to remedy problems that impact taxpayers and consumers, (2) calls to the federal customer service call center, including the number of calls received by the call center, problems identified by users, and referrals of those calls; (3) all navigators and certified application counselors that have been trained and certified by health care exchanges; and (4) all agents and brokers who have been trained and certified by the federal health care exchange. HR 762 Introduced in House February 15, 2013 by Rep. Blackburn, Marsha (R-TN) Health Care Choice Act of 2013 - Prohibits the Secretary of Health and Human Services (HHS) from implementing, administering, or enforcing specified regulations insofar as they would replace International Classification of Diseases (ICD-9) with ICD-10 as a standard for code sets for appropriate data elements for financial and administrative transactions involving the electronic exchange of health information. HR 3985 Introduced February 3, 2014 by Lynn Westmoreland (R-GA) Prohibits health insurance issuers and third-party administrators, or any period after December 31, 2014, from being requirement to make payments under the Patient Protection and Affordable Care Act (PPACA) for a transitional reinsurance program for the individual health insurance market in each state. Allows payments to issuers, as limited by this Act, only to the extent of available funds. Limits to 2014 the applicability of the program of risk corridors, under which a qualified health plan offered in the individual or small group market shall participate in a payment adjustment system based on the ratio of the allowable costs of the plan to the plan's aggregate premiums. HR 4496 Introduced April 28, 2014 by Cory Gardner (R-CO) Covering People With Pre-Existing Conditions Act of 2014 - Requires each state to mitigate the health costs of high risk individuals in the state through a state reinsurance program or a state high risk pool. HR 4777 Introduced May 30, 2014 by Michael Burgess (R-TX) To amend the Internal Revenue Code of 1986 to modify rules relating to health savings accounts. HR 3522 Introduced November 18, 2013 by Bill Cassidy (R-LA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes. HR 5214 Introduced July 28, 2014 by Pete Olsen (R-TX) 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. HR 3750 Introduced December 12, 2013 by Donna Matsui (D-CA) Telehealth Modernization Act of 2013 - Calls for states to authorize health care professionals to deliver health care to individuals through telehealth and to consider adopting conditions under which such a professional should have access to the individual's medical history. HR 4633 Introduced May 9, 2014 by H. Griffith (R-VA) Insurance Rate Transparency Act - Amends the Public Health Service Act to require that specific health insurance premium increase information submitted to the Secretary of Health and Human Services (HHS) be disclosed to Congress no later than 30 days after receipt of the information. HR 5453 Introduced September 11, 2014 by Bruce Braley (D-IA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes.

HR 83 - Consolidated and Further Continuing Appropriations Act, 2015. HR 416 - Health Insurance Rate Review Act:A bill to amend the Public Health Service Act to provide protection for consumers against excessive, unjustified or unfairly discriminatory increases in premium rates. HR 979 - FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: To amend chapter of title 5, United States Code to ensure program integrity, transparency and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program. HR 1370 - To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act. HR 2577 - SAFE Data Act: A bill to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information and to provide for nationwide notice in the event of a security breach. HR 2676 - Small Business Health Relief Act of 2011: To lower health premiums and increase choice for small business. HR 3350 - Keep your Health Plan Act of 2013: To authorize health insurance issuers to continue to offer for sale current individual health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes. HR 3522 - Employee Health Care Protection Act of 2013: To authorize health insurance issuers to continue to offer for sale current individual health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement and for other purposes. HR 3541 - Obamacare Taxpayer Bailout Prevention Act: To prevent a taxpayer bailout of health insurance issuers. HR 4805 - No subsidies Without Verification Process Act of 2014: To delay the provision of the Affordable Care Act premium and cost-sharing subsidies until the eligibility verification process for such subsidies is complete and for other purposes. HR 5214 - Clinical Data Registries: To require the Secretary of Health & Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care. HR 5364 - CHIP Extension & Improvement Act of 2014: To amend title XXI of the Social Security Act to extend and improve Childrens Health Insurance Program and for other purposes. S 24 - Small Business Health Relief Act of 2013: To lower health premiums and increase choice for small business. S 40 - American Liberty Restoration Act: To restore Americans individual liberty by striking the federal mandate to purchase insurance. S 482 - Health Insurance Rate Review Act: To amend the Public Health Service to provide protections for consumers against excessive, unjustified or unfairly discriminatory increases in premium rates. S 1726 - Obamacare Taxpayer Bailout Prevention Act: To prevent a taxpayer bailout of health insurance issuers. S 1729 - Expanded Consumer Choice Act: To amend the Patient Protection and Affordable Care Act to provide further options with respect to levels of coverage under qualified health plans. S 1880 - Jobs and Premium Protection Act: To repeal the annual fee on health care laws job-killing health insurance tax. S 2174 - Commonsense Competition and Access to Health Insurance Act: To amend the Patient Protection and Affordable Care Act to provide greater flexibility in offering health insurance coverage across state lines. S 2461 - CHIP Extension Act of 2014: Amend title XXI of the Social Security Act to extend & improve the Childrens Health Insurance Program and for other purposes. Department of Health & Human Services Implementation of Medical Loss Ratio arrangements; Implementation of health insurance exchanges; Implementation of Qualified Health Plans, Implementation Essential Health Benefits.

H.R. 5214: "To require HHS to provide recommendations for clinical data registries". Legislative efforts to help accelerate the discovery, development and delivery of promising new treatments to patients (21st Century Cures).

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

Government targets: HOUSE OF REPRESENTATIVES

Affordable Private Health Care: Effect of the Health Insurance Tax, defined Essential Health Benefits, and Age Rating on premiums; Healthcare Delivery System Reforms State-based regulation: State Oversight of Rates; Properly designed state based health insurance exchanges to improve competition and maximize choice; federal exchanges; Multi-State Health Plans; Centralized All-Payer Database Medical Loss Ratios: Level Playing Field for MLRs; Consistent reporting requirements for all insurers; MLR Broker Fees: Health Care Quality: Delivery System Incentives to Promote Better Care; Payment Reforms; Patient-centered Primary Care/Medical Home; Evidence Based Care; Wellness; Chronic Care Management Federal Employee Health Benefit Program (FEHBP) regarding proposals to allow additional types of carriers including regional PPOs to be included in the coverage options offered by OPM FEHBP Modernization Act circulation draft President's budget, regional PPOs, government contributions HR 2667 Introduced by Griffin (R-AR) on July 11, 2013 Authority for Mandate Delay Act HR 2668 Introduced by Young (R-IN) on July 17, 2013 Fairness for Families Act Bailouts for Insurance Companies, S. 1726, H.R. 3541, 3812, 3851. 4406 HR 3541 introduced by Tim Griffin November 19,2013 Obamacare Taxpayer Bailout Prevention Act - Repeals the provision of the Patient Protection and Affordable Care Act that directs the Secretary of Health and Human Services (HHS) to establish and administer a program of risk corridors for calendar years 2014, 2015, and 2016 under which a qualified health plan offered in the individual or small group market is required to participate in a payment adjustment system based on the ratio of the allowable costs of the plan to the plan's aggregate premiums. Other general Affordable Care Act topics related to multiple parts of legislation: ACA Implementation and back-end issues; Multi-State Plan Program Implementation; Risk Corridors and Risk Mitigation; Reinsurance; Small Business Health Options Program (SHOP) implementation; Third-party payment of premiums; Electronic Health Records (EHRs); Health IT Roadmap;Contraception Rule; Expatriate Legislation. S. 1486 Introduced August 1, 2013 by Sen. Carper, Thomas R. (D-DE) Postal Reform Act of 2013 - Amends provisions of federal law relating to the funding of the U.S. Postal Service (USPS) retirement and health care systems, operations, revenue, and governance.. Section 104 Substitute Amendment. HR 4777 Introduced May 30, 2014 by Michael Burgess (R-TX) To amend the Internal Revenue Code of 1986 to modify rules relating to health savings accounts. HR 3522 Introduced November 18, 2013 by Bill Cassidy (R-LA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement,and for other purposes. HR 5214 Introduced July 28, 2014 by Pete Olsen (R-TX) 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. HR 5453 Introduced September 11, 2014 by Bruce Braley (D-IA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes.

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

Client expense: Not reported · Firm income: Not reported

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

P.L. 111-375 National Alzheimer's Project Act, All sections S709/HR1507 Health Outcomes, Planning and Education for Alzheimer's Act, All sections S.1119 Positive Aging Act of 2013, All Sections S.1028 Older American's Act Amendments of 2013 S.219/H.R.4351 - Alzheimer's Accountability Act of 2014 P.L. 111-148/111-152 Patient Protection and Affordable Car Act - All Sections related to care coordination, transitional care, long term care services and supports access to affordable insurance, establishment of a national voluntary disability insurance program, provisions related to individuals with Alzheimer's disease and caregivers and provisions related to research including the Cures Acceleration Network. H.R. 2976 Missing Alzheimer's Disease Patient Alert Program Reauthorization All sections H.R. 2975 Alzheimer's Caregiver Support Act. All Sections S.1914 National Silver Alert Act of 2013 H. Res. 396 - A resolution supporting the goals of the National Alzheimer's Disease Awareness month S.1365/H.R. 2827 Part D Beneficiary appeals S. Res. 301 - A resolution recognizing and supporting the goals and implementation of the national Alzheimer's Project Act and the National Plan to Address Alzheimer's Disease. S. Res 303 - A resolution declaring that achieving the primary goal of the National Plan to Address Alzheimer's Disease of the Department of Health and Human Services to prevent and effectively treat Alzheimer's disease by 2025 is an urgent national priority H.R. 3836/S. 1910 Pat Summitt Congressional Gold Medal Act H. Res. 489 - A resolution expressing the need to facilitate a robust response to the looming global crisis of Alzheimer's and other forms of dementia. H.R. 4484 - Strengthening Healthcare Options for Vulnerable Populations Act. H.R.4543 - PACE Pilot Act of 2014 H.R. 647/S.313 - ABLE Act H.R. 4145 - Elder Care Tax Credit Act H.R. 5633/S.5633 - In Home Caregiver Assessment Reources and Education Act H.R. 5024 - Social Security Caregiver Credit Act H.R. 5214 - Olson Registry Bill

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

HR 5214 Requires the Secretary of Health and Human Services (HHS) to consult with clinical experts and make recommendations for the use of clinical data registries to improve patient care. S 1879/HR 1801 Cancer Treatment Parity Act of 2013. HR 3033 The SOFTWARE Act.

Client expense: $36,316 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to the use of device registries, including H.R. 5214, legislation to improve the use of clinical data registries Issues related to unique device identifier Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. Issues related to the regulation of combination products Issues related to FDA regulation of blood glucose meters Issues related to diagnostics regulation Issues related to the CMS program for durable medical equipment Issues related to the VA credentialing system for health care industry representatives Issues related to the regulation of mobile medical technology, including H.R. 3303 SOFTWARE Act of 2013 S. 2007 Preventing Regulatory Overreach To Enhance Care Technology Act of 2014

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

See attached addendum for General Lobbying Issue Area: HCR - HealthcareState-based regulation: State Oversight of Rates; Properly designed state based health insurance exchanges to improve competition and maximize choice; federal exchanges; Multi-State Health Plans; Centralized All-Payer Database Medical Loss Ratios: Level Playing Field for MLRs; Consistent reporting requirements for all insurers; MLR Broker Fees: Health Care Quality: Delivery System Incentives to Promote Better Care; Payment Reforms; Patient-centered Primary Care/Medical Home; Evidence Based Care; Wellness; Chronic Care Management Federal Employee Health Benefit Program (FEHBP) regarding proposals to allow additional types of carriers including regional PPOs to be included in the coverage options offered by OPM FEHBP Modernization Act circulation draft President's budget, regional PPOs, government contributions Bailouts for Insurance Companies, S. 1726, H.R. 3541, 3812, 3851. 4406 HR 2328 Introduced in House June 12, 2013 Rep. Rogers, Mike J. (R-MI) Access to Professional Health Insurance Advisors Act of 2013 - Amends the Public Health Service Act to exclude remuneration paid for licensed independent insurance producers from administrative cost calculations for purposes of calculating the medical-loss ratio of a health insurance plan. HR 3541 introduced by Tim Griffin November 19,2013 Obamacare Taxpayer Bailout Prevention Act - Repeals the provision of the Patient Protection and Affordable Care Act that directs the Secretary of Health and Human Services (HHS) to establish and administer a program of risk corridors for calendar years 2014, 2015, and 2016 under which a qualified health plan offered in the individual or small group market is required to participate in a payment adjustment system based on the ratio of the allowable costs of the plan to the plan's aggregate premiums. Other general Affordable Care Act topics related to multiple parts of legislation: ACA Implementation and back-end issues; Multi-State Plan Program Implementation; Risk Corridors and Risk Mitigation; Reinsurance; Small Business Health Options Program (SHOP) implementation; Third-party payment of premiums; Electronic Health Records (EHRs); Health IT Roadmap; Contraception Rule; Expatriate Legislation. S. 1486 Introduced August 1, 2013 by Sen. Carper, Thomas R. (D-DE) Postal Reform Act of 2013 - Amends provisions of federal law relating to the funding of the U.S. Postal Service (USPS) retirement and health care systems, operations, revenue, and governance.. Section 104 Substitute Amendment. HR 3362 Introduced October 29, 2013 by Rep. Terry, Lee (R-NE) Exchange Information Disclosure Act - Amends the Patient Protection and Affordable Care Act to expand reporting requirements related to health care exchanges. Requires the Secretary of Health and Human Services (HHS) to publish reports weekly through March 31, 2015, on: (1) consumer interactions with healthcare.gov or subsequent sites and any efforts undertaken to remedy problems that impact taxpayers and consumers, (2) calls to the federal customer service call center, including the number of calls received by the call center, problems identified by users, and referrals of those calls; (3) all navigators and certified application counselors that have been trained and certified by health care exchanges; and (4) all agents and brokers who have been trained and certified by the federal health care exchange. HR 1701 Introduced April 24, 2013 by Ted Poe (R-TX) Cutting Costly Codes Act of 2013 - Prohibits the Secretary of Health and Human Services (HHS) from implementing, administering, or enforcing specified regulations insofar as they would replace International Classification of Diseases (ICD)-9 with ICD-10 as a standard for code sets for appropriate data elements for financial and administrative transactions involving the electronic exchange of health information. See following page on Health Care Reform issuesHR 3985 Introduced February 3, 2014 by Lynn Westmoreland (R-GA) Prohibits health insurance issuers and third-party administrators, for any period after December 31, 2014, from being required to make payments under the Patient Protection and Affordable Care Act (PPACA) for a transitional reinsurance program for the individual health insurance market in each state. Allows payments to issuers, as limited by this Act, only to the extent of available funds. Limits to 2014 the applicability of the program of risk corridors, under which a qualified health plan offered in the individual or small group market shall participate in a payment adjustment system based on the ratio of the allowable costs of the plan to the plan's aggregate premiums . HR 4496 Introduced April 28, 2014 by Cory Gardner (R-CO) Covering People With Pre-Existing Conditions Act of 2014 - Requires each state to mitigate the health costs of high risk individuals in the state through a state reinsurance program or a state high risk pool HR 4777 Introduced May 30, 2014 by Michael Burgess (R-TX) To amend the Internal Revenue Code of 1986 to modify rules relating to health savings accounts. HR 3522 Introduced November 18, 2013 by Bill Cassidy (R-LA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes. HR 5214 Introduced July 28, 2014 by Pete Olsen (R-TX) 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. HR 3750 Introduced December 12, 2013 by Donna Matsui (D-CA) Telehealth Modernization Act of 2013 - Calls for states to authorize health care professionals to deliver health care to individuals through telehealth and to consider adopting conditions under which such a professional should: have access to the individual's medical history. HR 4633 Introduced May 9, 2014 by H. Griffith (R-VA) Insurance Rate Transparency Act - Amends the Public Health Service Act to require that specific health insurance premium increase information submitted to the Secretary of Health and Human Services (HHS) be disclosed to Congress no later than 30 days after receipt of the information. HR 5453 Introduced September 11, 2014 by Bruce Braley (D-IA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes.

See attached addendum for General Lobbying Issue Area: HCR - HealthcareAffordable Private Health Care: Effect of the Health Insurance Tax, defined Essential Health Benefits, and Age Rating on premiums; Healthcare Delivery System Reforms State-based regulation: State Oversight of Rates; Properly designed state based health insurance exchanges to improve competition and maximize choice; federal exchanges; Multi-State Health Plans; Centralized All-Payer Database Medical Loss Ratios: Level Playing Field for MLRs; Consistent reporting requirements for all insurers; MLR Broker Fees: Health Care Quality: Delivery System Incentives to Promote Better Care; Payment Reforms; Patient-centered Primary Care/Medical Home; Evidence Based Care; Wellness; Chronic Care Management Federal Employee Health Benefit Program (FEHBP) regarding proposals to allow additional types of carriers including regional PPOs to be included in the coverage options offered by OPM FEHBP Modernization Act circulation draft President's budget, regional PPOs, government contributions HR 2667 Introduced by Griffin (R-AR) on July 11, 2013 Authority for Mandate Delay Act HR 2668 Introduced by Young (R-IN) on July 17, 2013 Fairness for Families Act Bailouts for Insurance Companies, S. 1726, H.R. 3541, 3812, 3851. 4406 HR 2328 Introduced in House June 12, 2013 Rep. Rogers, Mike J. (R-MI) Access to Professional Health Insurance Advisors Act of 2013 - Amends the Public Health Service Act to exclude remuneration paid for licensed independent insurance producers from administrative cost calculations for purposes of calculating the medical-loss ratio of a health insurance plan. HR 3541 introduced by Tim Griffin November 19,2013 Obamacare Taxpayer Bailout Prevention Act - Repeals the provision of the Patient Protection and Affordable Care Act that directs the Secretary of Health and Human Services (HHS) to establish and administer a program of risk corridors for calendar years 2014, 2015, and 2016 under which a qualified health plan offered in the individual or small group market is required to participate in a payment adjustment system based on the ratio of the allowable costs of the plan to the plan's aggregate premiums. Other general Affordable Care Act topics related to multiple parts of legislation: ACA Implementation and back-end issues; Multi-State Plan Program Implementation; Risk Corridors and Risk Mitigation; Reinsurance; Small Business Health Options Program (SHOP) implementation; Third-party payment of premiums; Electronic Health Records (EHRs); Health IT Roadmap; Contraception Rule; Expatriate Legislation. See following page on Health Care Reform issuesS. 1486 Introduced August 1, 2013 by Sen. Carper, Thomas R. (D-DE) Postal Reform Act of 2013 - Amends provisions of federal law relating to the funding of the U.S. Postal Service (USPS) retirement and health care systems, operations, revenue, and governance.. Section 104 Substitute Amendment. HR 3362 Introduced October 29, 2013 by Rep. Terry, Lee (R-NE) Exchange Information Disclosure Act - Amends the Patient Protection and Affordable Care Act to expand reporting requirements related to health care exchanges. Requires the Secretary of Health and Human Services (HHS) to publish reports weekly through March 31, 2015, on: (1) consumer interactions with healthcare.gov or subsequent sites and any efforts undertaken to remedy problems that impact taxpayers and consumers, (2) calls to the federal customer service call center, including the number of calls received by the call center, problems identified by users, and referrals of those calls; (3) all navigators and certified application counselors that have been trained and certified by health care exchanges; and (4) all agents and brokers who have been trained and certified by the federal health care exchange. HR 762 Introduced in House February 15, 2013 by Rep. Blackburn, Marsha (R-TN) Health Care Choice Act of 2013 - Repeals the health insurance and health coverage expansion requirements of the Patient Protection and Affordable Care Act and related requirements of the Health Care and Education Reconciliation Act of 2010. Restores provisions of law amended or repealed by such provisions. HR 1701 Introduced April 24, 2013 by Ted Poe (R-TX) Cutting Costly Codes Act of 2013 - Prohibits the Secretary of Health and Human Services (HHS) from implementing, administering, or enforcing specified regulations insofar as they would replace International Classification of Diseases (ICD)-9 with ICD-10 as a standard for code sets for appropriate data elements for financial and administrative transactions involving the electronic exchange of health information. HR 3985 Introduced February 3, 2014 by Lynn Westmoreland (R-GA) Prohibits health insurance issuers and third-party administrators, for any period after December 31, 2014, from being required to make payments under the Patient Protection and Affordable Care Act (PPACA) for a transitional reinsurance program for the individual health insurance market in each state. Allows payments to issuers, as limited by this Act, only to the extent of available funds. Limits to 2014 the applicability of the program of risk corridors, under which a qualified health plan offered in the individual or small group market shall participate in a payment adjustment system based on the ratio of the allowable costs of the plan to the plan's aggregate premiums . HR 4496 Introduced April 28, 2014 by Cory Gardner (R-CO) Covering People With Pre-Existing Conditions Act of 2014 - Requires each state to mitigate the health costs of high risk individuals in the state through a state reinsurance program or a state high risk pool HR 4777 Introduced May 30, 2014 by Michael Burgess (R-TX) To amend the Internal Revenue Code of 1986 to modify rules relating to health savings accounts. HR 3522 Introduced November 18, 2013 by Bill Cassidy (R-LA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes. HR 5214 Introduced July 28, 2014 by Pete Olsen (R-TX) 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. See following page on Health Care Reform issuesHR 3750 Introduced December 12, 2013 by Donna Matsui (D-CA) Telehealth Modernization Act of 2013 - Calls for states to authorize health care professionals to deliver health care to individuals through telehealth and to consider adopting conditions under which such a professional should: have access to the individual's medical history. HR 4633 Introduced May 9, 2014 by H. Griffith (R-VA) Insurance Rate Transparency Act - Amends the Public Health Service Act to require that specific health insurance premium increase information submitted to the Secretary of Health and Human Services (HHS) be disclosed to Congress no later than 30 days after receipt of the information. HR 5453 Introduced September 11, 2014 by Bruce Braley (D-IA) To authorize health insurance issuers to continue to offer for sale current group health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes.

HR 416 - Health Insurance Rate Review Act:A bill to amend the Public Health Service Act to provide protection for consumers against excessive, unjustified or unfairly discriminatory increases in premium rates. HR 979 - FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act: To amend chapter of title 5, United States Code to ensure program integrity, transparency and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program. HR 1370 - To repeal the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act. HR 2577 - SAFE Data Act: A bill to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information and to provide for nationwide notice in the event of a security breach. HR 2676 - Small Business Health Relief Act of 2011: To lower health premiums and increase choice for small business. HR 3350 - Keep your Health Plan Act of 2013: To authorize health insurance issuers to continue to offer for sale current individual health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement, and for other purposes. HR 3522 - Employee Health Care Protection Act of 2013: To authorize health insurance issuers to continue to offer for sale current individual health insurance coverage in satisfaction of the minimum essential health insurance coverage requirement and for other purposes. HR 3541 - Obamacare Taxpayer Bailout Prevention Act: To prevent a taxpayer bailout of health insurance issuers. HR 4805 - No subsidies Without Verification Process Act of 2014:To delay the provision of the Affordable Care Act premium and cost-sharing subsidies until the eligibility verification process for such subsidies is complete and for other purposes. HR 5214 - Clinical Data Registries: To require the Secretary of Health & Human Services to provide for recommendations for the development and use of clinical data registries for the improvement of patient care. HR 5364 - CHIP Extension & Improvement Act of 2014: To amend title XXI of the Social Security Act to extend and improve Childrens Health Insurance Program and for other purposes. S 24 - Small Business Health Relief Act of 2013: To lower health premiums and increase choice for small business. S 40 - American Liberty Restoration Act: To restore Americans individual liberty by striking the federal mandate to purchase insurance. S 482 - Health Insurance Rate Review Act: To amend the Public Health Service to provide protections for consumers against excessive, unjustified or unfairly discriminatory increases in premium rates. S 1726 - Obamacare Taxpayer Bailout Prevention Act: To prevent a taxpayer bailout of health insurance issuers. S 1729 - Expanded Consumer Choice Act:To amend the Patient Protection and Affordable Care Act to provide further options with respect to levels of coverage under qualified health plans. S 1880 - Jobs and Premium Protection Act: To repeal the annual fee on health care laws job-killing health insurance tax. S 2174 - Commonsense Competition and Access to Health Insurance Act: To amend the Patient Protection and Affordable Care Act to provide greater flexibility in offering health insurance coverage across state lines. S 2461 - CHIP Extension Act of 2014: Amend title XXI of the Social Security Act to extend & improve the Childrens Health Insurance Program and for other purposes. Department of Health & Human Services Implementation of Medical Loss Ratio arrangements; Implementation of health insurance exchanges; Implementation of Qualified Health Plans, Implementation Essential Health Benefits.