Affordability Is Access Act

Teen Pregnancy Prevention (TPP) Program and Title X Family Planning Program in Continuing Resolution (H.R. 5325) Funding to address Zika virus in continuing resolution (H.R. 5325) Teen Pregnancy Prevention (TPP) Program and Title X Family Planning Program in any future FY 2017 appropriations legislation Over-The-Counter Contraceptives Act of 2016 (H.R. 5138) Allowing Greater Access to Safe and Effective Contraception Act (S. 1438) Affordability is Access Act (S. 1532/H.R. 3163) Possible future legislation to improve contraceptive access Possible future legislation to improve contraceptive coverage and access for military veterans

Client expense: $44,311 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Substance Use Disorder (general); HIV Screening (general); Gynecologic Cancer (general); Gynecologic devices (general); Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality and Morbidity (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); Healthy Start (general); H.R.4695/S. 466, Quality Care for Moms and Babies Act; H.R. 3865/S.2542, Cradle Act;; H.R. 865/S. 3101, Good Samaritan Health Professionals Act; H.R. 4774, Training Tomorrows Doctors Today Act; H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016; H.R. 1209/S.628 Improving Access to Maternity Care Act; Implementation of H.R. 1462/S. 799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; Fetal Tissue Research (General); H.R. 3706/S.1911, Reach Every Mother and Child Act of 2016; H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; S. 304, Conscience Protection Act; H.R. 3504, Born-Alive Abortion Survivors Protection Act; Hyde Amendment (General); Senate Biomedical Innovations Packages (general); S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S.2742, Promoting Biomedical Research and Public Health for Patients Act; H.R. 6, 21st Century Cures Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 5746, Birth Control Privacy Act; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3235/S. 2311, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act; H.R. 5369, Healthy Start Reauthorization Act; S. 3070, Hygiene Assistance for Families of Infants and Toddlers Act of 2016; H.R. 5219 Safe Medications for Moms and Babies Act of 2016; H.R. 953/S. 524, Comprehensive Addiction and Recovery Act; H.R. 2646, Helping Families in Mental Health Crisis Act; S. 2680, Mental Health Reform Act; H.R. 3537, Synthetic Drug Control Act; H.R. 4499/S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act; H.R. 4874, Prevent Abuse by Using Interstate Exchange Act; H.R. 2805/S. 1134, Heroin and Prescription Opioid Abuse, Prevention, Education, and Enforcement Act; H.R. 2654/S. 1512, Pregnant Workers Fairness Act; H.R. 1706/S.2765, Real Education for Healthy Youth Act; H.R. 5065/ S. 3299 Bottles and Breastfeeding Equipment Screening Act; H.R. 6010, Zika Pregnancy and Infant Registry Act.

Pseudoephedrine Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number). Extended Producer Responsibility/Pharmaceutical Stewardship (Drug Take-Back) H.R. 4931 - Pharmaceutical Stewardship Act of 2016. Requires the Drug Enforcement Administration to establish and implement a national pharmaceutical stewardship program to collect and dispose of prescription medications; all sections. H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 (COARA). Amends the Omnibus Crime Control and Safe Streets Act of 1968 to authorize the Attorney General to make grants to assist State and local governments in addressing the national epidemic of opioid abuse, and for other purposes (all sections). S. 524 - Comprehensive Addiction and Recovery Act of 2016 (CARA; became P.L. 114-198 on 7/22/2016). Authorizes the Attorney General and Secretary of Health and Human Services to award grants to address the national epidemics of prescription opioid abuse and heroin use, and to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes (Section 201 - expands eligible uses of grant funds to include drug take-back efforts; Section 203 requires coordination among multiple government agencies to develop a prescription drug take-back program). Oral Contraceptives H.R. 5138 - Over-the-Counter Contraceptives Act of 2016. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. S. 1438 - Allowing Greater Access to Safe and Effective Contraception Act. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. H.R. 3163/S. 1532 - Affordability is Access Act. Clarifies that all oral contraceptive products be covered by insurance and provided to consumers without cost, regardless of prescription/nonprescription (over-the-counter) status; all sections. Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

H.R. 30, Save American Workers Act (Young) - definition of full-time employee H.R. 117, Reclaiming Individual Liberty Act (Garrett) - ACA individual mandate H.R. 221, ACA Taxpayer Bailout Prevention Act (Harris) - risk corridors program H.R. 371, Care for All Act (Fortenberry) - catastrophic plans H.R. 494, Competitive Health Insurance Reform Act (Gosar) - antitrust policy H.R. 543, Health Care Choice Act (Blackburn) - national marketplace for individual health insurance H.R. 724, Taxpayer Bailout Protection Act (Lance) - risk corridors program H.R. 815, Access to Independent Health Insurance Advisors Act (Long-Schrader) - treatment of broker compensation in MLR calculation H.R. 1770, Data Security and Breach Notification Act (Blackburn-Welch) - data security H.R. 2205, Data Security Act (Neugebauer) - data security H.R. 2739, Cancer Drug Coverage Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 2868, Small Business Health Fairness Act (Johnson) - association health plans H.R. 3323, Dental and Optometric Care Access Act (Carter) - dental and vision benefits H.R. 3727, Health Insurance Rate Review Act (Schakowsky) - rate review H.R. 4299, Patient Opportunity Protection Act (Blum) - HIPAA excepted benefits H.R. 5410, Health Coverage State Flexibility Act (Flores) - grace period for recipients of advanced premium tax credits H.R. 5485, Financial Services and General Government Appropriations Act (Crenshaw) - risk corridors amendment H.R. 5589, Plan Verification and Fairness Act (Blackburn) - pre-enrollment verification process Draft Bill on Age Variation in Health Insurance Premium Rates (Brooks) S. 30, Forty Hours Is Full Time Act (Collins) - definition of full-time employee S. 123, ACA Taxpayer Bailout Prevention Act (Rubio) - risk corridors program S. 158, Employee Health Care Protection Act (Cassidy) - grandfathering of health coverage S. 359, Taxpayer Bailout Protection Act (Cassidy) - risk corridors program S. 1099, Protecting Affordable Coverage for Employees Act (Scott-Shaheen) - ACA definition of small employer S. 1532, Affordability is Access Act (Murray) - coverage of OTC birth control S. 1566, Cancer Drug Coverage Parity Act (Kirk) - coverage of oral anti-cancer drugs S. 1661, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - treatment of broker compensation in MLR calculation S. 2172, Health Insurance Rate Review Act (Feinstein) - rate review S. 2803, Taxpayers Before Insurers Act (Sasse) - ACA reinsurance program Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; dependent coverage; treatment of expatriate plans; compliance with the transitional reinsurance program; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues related to implementation of the Telephone Consumer Protection Act; and other issues relating to health care reform implementation.

Teen Pregnancy Prevention (TPP) Program and Title X Family Planning Program in Senate FY 2017 Labor, Health and Human Services and Education Appropriations Bill (S.3040) Teen Pregnancy Prevention (TPP) Program and Title X Family Planning Program in House FY 2017 Labor, Health and Human Services and Education Appropriations Bill Over-The-Counter Contraceptives Act of 2016 (H.R. 5138) Allowing Greater Access to Safe and Effective Contraception Act (S. 1438) Affordability is Access Act (S. 1532/H.R. 3163)

Client expense: $57,392 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecologic Cancer (general); Gynecologic devices (general); Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality and Morbidity (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); Meaningful Use Stage 3; H.R. 3940, Meaningful Use Hardship Relief Act; H.R.4695/S. 466, Quality Care for Moms and Babies Act; H.R. 3865/S.2542, Cradle Act; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 865, Good Samaritan Health Professionals Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; H.R. 4774, Training Tomorrows Doctors Today Act; H.R. 3658/S. 84, GEDI Act; H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016; H.R. 1209/S.628 Improving Access to Maternity Care Act; Implementation of H.R. 1462/S. 799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; Fetal Tissue Research (General); H.R. 3706/S.1911, Reach Every Mother and Child Act of 2016; H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; H.R. 4924/S.48, Prenatal Nondiscrimination Act (PRENDA) of 2016; Senate Biomedical Innovations Packages (general); S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S.2742, Promoting Biomedical Research and Public Health for Patients Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3235/S. 2311, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act; H.R. 5369, Healthy Start Reauthorization Act; S. 3070, Hygiene Assistance for Families of Infants and Toddlers Act of 2016; H.R. 5219 Safe Medications for Moms and Babies Act of 2016; H.R. 953/S. 524, Comprehensive Addiction and Recovery Act; H.R. 2646, Helping Families in Mental Health Crisis Act; S. 2680, Mental Health Reform Act; H.R. 3537, Synthetic Drug Control Act; H.R. 4499/S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act; H.R. 4874, Prevent Abuse by Using Interstate Exchange Act; H.R. 2805/S. 1134, Heroin and Prescription Opioid Abuse, Prevention, Education, and Enforcement Act; H.R. 2654/S. 1512, Pregnant Workers Fairness Act; H.R. 1706/S.2765, Real Education for Healthy Youth Act.

Pseudoephedrine Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number). Extended Producer Responsibility/Pharmaceutical Stewardship (Drug Take-Back) H.R. 4931 - Pharmaceutical Stewardship Act of 2016. Requires the Drug Enforcement Administration to establish and implement a national pharmaceutical stewardship program to collect and dispose of prescription medications; all sections. H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 (COARA). Amends the Omnibus Crime Control and Safe Streets Act of 1968 to authorize the Attorney General to make grants to assist State and local governments in addressing the national epidemic of opioid abuse, and for other purposes (all sections). S. 524 - Comprehensive Addiction and Recovery Act of 2016 (CARA). Authorizes the Attorney General and Secretary of Health and Human Services to award grants to address the national epidemics of prescription opioid abuse and heroin use, and to provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes (Section 201 - expands eligible uses of grant funds to include drug take-back efforts; Section 203 requires coordination among multiple government agencies to develop a prescription drug take-back program). Oral Contraceptives H.R. 5138 - Over-the-Counter Contraceptives Act of 2016. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. S. 1438 - Allowing Greater Access to Safe and Effective Contraception Act. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections. H.R. 3163/S. 1532 - Affordability is Access Act. Clarifies that all oral contraceptive products be covered by insurance and provided to consumers without cost, regardless of prescription/nonprescription (over-the-counter) status; all sections. Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

Affordability Is Access Act (H.R. 3163/S. 1532 Advancing NIH Strategic Planning and Representation in Medical Research Act (S. 2745) Zika Supplemental (Not yet introduced) The Youth Access to Sexual Health Serivices Act (H.R. 4475) The Real Education for Healthy Youth Act (S. 2765) Labor, Health and Human Services Appropriations for FY2017 (Not yet introduced) Restoring Americans' Healthcare Freedom Reconciliation Act (H.R. 3762) Reducing Unexpected Deaths in Infants and Children Act (H.R. 4571) Senate Regulatory Package Mental Health Reform Act (S. 2680) HEAL Act (H.R. 931) House Budget Resolution (H. Con. Res. 125)

Client expense: $49,129 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID)

H.R. 30, Save American Workers Act (Young) - definition of full-time employee H.R. 117, Reclaiming Individual Liberty Act (Garrett) - ACA individual mandate H.R. 221, ACA Taxpayer Bailout Prevention Act (Harris) - risk corridors program H.R. 371, Care for All Act (Fortenberry) - catastrophic plans H.R. 494, Competitive Health Insurance Reform Act (Gosar) - antitrust policy H.R. 543, Health Care Choice Act (Blackburn) - national marketplace for individual health insurance H.R. 724, Taxpayer Bailout Protection Act (Lance) - risk corridors program H.R. 815, Access to Independent Health Insurance Advisors Act (Long-Schrader) - treatment of broker compensation in MLR calculation H.R. 1624, Protecting Affordable Coverage for Employees Act (Guthrie-Cardenas) - ACA definition of small employer H.R. 1770, Data Security and Breach Notification Act (Blackburn-Welch) - data security H.R. 2205, Data Security Act (Neugebauer) - data security H.R. 2739, Cancer Drug Coverage Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 2868, Small Business Health Fairness Act (Johnson) - association health plans H.R. 3323, Dental and Optometric Care Access Act (Carter) - dental and vision benefits H.R. 3727, Health Insurance Rate Review Act (Schakowsky) - rate review H.R. 3762, Restoring Americans' Healthcare Freedom Reconciliation Act (Price) - ACA premium stabilization programs, individual mandate H.R. 4299, Patient Opportunity Protection Act (Blum) - HIPAA excepted benefits S. 30, Forty Hours Is Full Time Act (Collins) - definition of full-time employee S. 123, ACA Taxpayer Bailout Prevention Act (Rubio) - risk corridors program S. 158, Employee Health Care Protection Act (Cassidy) - grandfathering of health coverage S. 359, Taxpayer Bailout Protection Act (Cassidy) - risk corridors program S. 1099, Protecting Affordable Coverage for Employees Act (Scott-Shaheen) - ACA definition of small employer S. 1532, Affordability is Access Act (Murray) - coverage of OTC birth control S. 1566, Cancer Drug Coverage Parity Act (Kirk) - coverage of oral anti-cancer drugs S. 1661, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - treatment of broker compensation in MLR calculation S. 2172, Health Insurance Rate Review Act (Feinstein) - rate review Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; dependent coverage; treatment of expatriate plans; compliance with the transitional reinsurance program; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues related to implementation of the Telephone Consumer Protection Act; and other issues relating to health care reform implementation.

Pseudoephedrine Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number). Oral Contraceptives S. 1438 - Allowing Greater Access to Safe and Effective Contraception Act. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections (and potential House companion bill). H.R. 3163/S. 1532 - Affordability is Access Act. Clarifies that all oral contraceptive products be covered by insurance and provided to consumers without cost, regardless of prescription/nonprescription (over-the-counter) status; all sections. Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

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

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecologic Cancer (general); Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality and Morbidity (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); Meaningful Use Stage 3; H.R. 3940, Meaningful Use Hardship Relief Act; H.R.4695/S. 466, Quality Care for Moms and Babies Act; H.R. 3865/S.2542, Cradle Act; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 865, Good Samaritan Health Professionals Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; H.R. 4774, Training Tomorrows Doctors Today Act; H.R. 3658/S. 84, GEDI Act; H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016; H.R. 1209/S.628 Improving Access to Maternity Care Act; Implementation of H.R. 1462/S. 799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act; H.R. 3504/S. 1603, Born-Alive Abortion Survivors Protection Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; Fetal Tissue Research (General); H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; Senate Biomedical Innovations Packages (general); S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S.2742, Promoting Biomedical Research and Public Health for Patients Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 2191/S. 1170, Breast Cancer Research Stamp Reauthorization Act of 2015; H.R. 1925, To award a Congressional Gold Medal to Dr. Ernie Bodai; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3235/S. 2311, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act.

H.R. 30, Save American Workers Act (Young) - definition of full-time employee H.R. 117, Reclaiming Individual Liberty Act (Garrett) - ACA individual mandate H.R. 221, ACA Taxpayer Bailout Prevention Act (Harris) - risk corridors program H.R. 371, Care for All Act (Fortenberry) - catastrophic plans H.R. 494, Competitive Health Insurance Reform Act (Gosar) - antitrust policy H.R. 543, Health Care Choice Act (Blackburn) - national marketplace for individual health insurance H.R. 724, Taxpayer Bailout Protection Act (Lance) - risk corridors program H.R. 815, Access to Independent Health Insurance Advisors Act (Long-Schrader) - treatment of broker compensation in MLR calculation H.R. 1560, Protecting Cyber Networks Act (Nunes) - cybersecurity H.R. 1624, Protecting Affordable Coverage for Employees Act (Guthrie-Cardenas) - ACA definition of small employer H.R. 1731, National Cybersecurity Protection Advancement Act (McCaul) - cybersecurity H.R. 1770, Data Security and Breach Notification Act (Blackburn-Welch) - data security H.R. 2739, Cancer Drug Coverage Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 2868, Small Business Health Fairness Act (Johnson) - association health plans H.R. 3020, Labor-HHS-Education Appropriations Bill (Cole) - ACA risk corridors provision, HHS appropriations S. 30, Forty Hours Is Full Time Act (Collins) - definition of full-time employee S. 123, ACA Taxpayer Bailout Prevention Act (Rubio) - risk corridors program S. 158, Employee Health Care Protection Act (Cassidy) - grandfathering of health coverage S. 359, Taxpayer Bailout Protection Act (Cassidy) - risk corridors program S. 754, Cybersecurity Information Sharing Act (Burr) - cybersecurity S. 1099, Protecting Affordable Coverage for Employees Act (Scott-Shaheen) - ACA definition of small employer S. 1532, Affordability is Access Act (Murray) - coverage of OTC birth control S. 1566, Cancer Drug Coverage Parity Act (Kirk) - coverage of oral anti-cancer drugs S. 1661, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - treatment of broker compensation in MLR calculation S. 1695, Labor-HHS-Education Appropriations Bill (Blunt) - ACA risk corridors provision, HHS appropriations S. 2132, Labor-HHS-Education Appropriations Bill (Cochran) - ACA risk corridors provision, HHS appropriations Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; dependent coverage; treatment of expatriate plans; compliance with the transitional reinsurance program; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues related to implementation of the Telephone Consumer Protection Act; and other issues relating to health care reform implementation.

HR 770 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010: entire bill HR 132/S 339 - ObamaCare Repeal Act: entire bill Public Law No. 111-148- Patient Protection and Affordable Care Act: entire law Public Law No. 111-152- Health Care and Education Reconciliation Act of 2010: entire law S 1438 - Allowing Greater Access to Safe and Effective Contraception Act: entire bill HR 3163/S 1532 - Affordability Is Access Act: entire bill HR 3443 - Women's Health Accountability Act

Client expense: $10,700 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID)

HR 770 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010: entire bill HR 132/S 339 - ObamaCare Repeal Act: entire bill Public Law No. 111-148- Patient Protection and Affordable Care Act: entire law Public Law No. 111-152- Health Care and Education Reconciliation Act of 2010: entire law HR 2 - Medicare Access and CHIP Reauthorization Act SGR Repeal and Medicare Beneficiary Access Act: amendments and provisions related to and affecting reproductive health and family planning HR 1101 - Viral Hepatitis Testing Act: entire bill HR 1502 - Medicare Parity Act: entire bill S 737 - Ensuring Access to Primary Care for Women & Children Act: entire bill HR 117 - Reclaiming Individual Liberty Act: entire bill S 77 - Patient Choice Restoration Act: entire bill S 221 - Pregnancy Assistance Fund Expansion Act: entire bill HR 22 - Hire More Heroes Act: entire bill HR 1356/S 471 - Women Veterans Access to Quality Care Act: entire bill S 469 - Women Veterans and Families Health Services Act: entire bill HR 691 - Telehealth Modernization Act : entire bill HR 768 - Stop AIDS in Prison Act: entire bill HR 45 - Triple-Negative Breast Cancer Research and Education Act: entire bill HR 716/S 370 - Breast Density and Mammography Reporting Act: entire bill HR 1197 - Accelerating the End of Breast Cancer Act: entire bill S 697 - Frank R. Lautenberg Chemical Safety for the 21st Century Act: entire bill S 1016 - Preserving Freedom and Choice in Health Care Act: entire bill HR 2054 - To amend title 38, United States Code, to provide for increased access to Department of Veterans Affairs medical care for women veterans: entire bill HR 2300 - Empowering Patients First Act: entire bill S 1438 - Allowing Greater Access to Safe and Effective Contraception Act: entire bill S Res 193 - A resolution celebrating the 50th anniversary of the historic Griswold v. Connecticut decision of the Supreme Court of the United States and expressing the sense of the Senate that the case was an important step forward in helping ensure that all people of the United States are able to use contraceptives to plan pregnancies and have healthier babies.: entire resolution HR 2653 - American Health Care Reform Act: entire bill HR 3163/S 1532 - Affordability Is Access Act: entire bill HR 2866 - To amend title XXVII of the Public Health Service Act to provide for a special enrollment period for pregnant women, and for other purposes: entire bill HR 6 - 21st Century Cures Act: entire bill HR 2066 - Telehealth Enhancement Act: entire bill HR 1345 - Health IT Modernization for Underserved Communities Act: entire bill HR 270 - Flexibility in Health IT Reporting (Flex-IT) Act: entire bill HR 2646 - Helping Families in Mental Health Crisis Act: entire bill HR 2725 - 21st Century Care for Military and Veterans Act: entire bill HR 2355 - Women's Preventive Health Awareness Campaign: entire bill HR 2820 - Stem Cell Therapeutic and Research Reauthorization Act: entire bill HR 2866/S 2220 - the Healthy MOM Act S 1299/HR 938 - Garrett Lee Smith Memorial Act Reauthorization HR 3171 - To amend the Public Health Service Act to prohibit certain research on the transplantation of human fetal tissue obtained pursuant to an abortion. S 1919 - A bill to amend the Patient Protection and Affordable Care Act to protect rights of conscience with regard to requirements for coverage of specific items and services, to amend the Public Health Service Act to prohibit certain abortion-related discrimination in governmental activities, and for other purposes. HR 3443 - Women's Health Accountability Act HR 2972 - Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act HR 3498 - Human Cloning Prohibition Act S 1917 - A bill to prohibit the provision of Federal funds to an entity that receives compensation for facilitating the donation of fetal tissue derived from an abortion. H Res 558/S Res 327 - A resolution condemning violence that targets healthcare for women. Reducing Unexpected Deaths in Infants and Children Act of 2015

H.R. 30, Save American Workers Act (Young) - definition of full-time employee H.R. 117, Reclaiming Individual Liberty Act (Garrett) - ACA individual mandate H.R. 221, ACA Taxpayer Bailout Prevention Act (Harris) - risk corridors program H.R. 371, Care for All Act (Fortenberry) - catastrophic plans H.R. 494, Competitive Health Insurance Reform Act (Gosar) - antitrust policy H.R. 543, Health Care Choice Act (Blackburn) - national marketplace for individual health insurance H.R. 724, Taxpayer Bailout Protection Act (Lance) - risk corridors program H.R. 815, Access to Independent Health Insurance Advisors Act (Long-Schrader) - treatment of broker compensation in MLR calculation H.R. 1314, Bipartisan Budget Act - SSDI and disability issues, auto-enrollment requirement for large employers H.R. 1560, Protecting Cyber Networks Act (Nunes) - cybersecurity H.R. 1624, Protecting Affordable Coverage for Employees Act (Guthrie-Cardenas) - ACA definition of small employer H.R. 1731, National Cybersecurity Protection Advancement Act (McCaul) - cybersecurity H.R. 1770, Data Security and Breach Notification Act (Blackburn-Welch) - data security H.R. 2029, Consolidated Appropriations Act - ACA risk corridors program, cybersecurity H.R. 2205, Data Security Act (Neugebauer) - data security H.R. 2739, Cancer Drug Coverage Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 2868, Small Business Health Fairness Act (Johnson) - association health plans H.R. 3020, Labor-HHS-Education Appropriations Bill (Cole) - ACA risk corridors provision, HHS appropriations H.R. 3727, Health Insurance Rate Review Act (Schakowsky) - rate review H.R. 3762, Restoring Americans' Healthcare Freedom Reconciliation Act (Price) - ACA premium stabilization programs, individual mandate H.R. 4299, Patient Opportunity Protection Act (Blum) - HIPAA excepted benefits S. 30, Forty Hours Is Full Time Act (Collins) - definition of full-time employee S. 123, ACA Taxpayer Bailout Prevention Act (Rubio) - risk corridors program S. 158, Employee Health Care Protection Act (Cassidy) - grandfathering of health coverage S. 359, Taxpayer Bailout Protection Act (Cassidy) - risk corridors program S. 754, Cybersecurity Information Sharing Act (Burr) - cybersecurity S. 1099, Protecting Affordable Coverage for Employees Act (Scott-Shaheen) - ACA definition of small employer S. 1532, Affordability is Access Act (Murray) - coverage of OTC birth control S. 1566, Cancer Drug Coverage Parity Act (Kirk) - coverage of oral anti-cancer drugs S. 1661, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - treatment of broker compensation in MLR calculation S. 1695, Labor-HHS-Education Appropriations Bill (Blunt) - ACA risk corridors provision, HHS appropriations S. 2132, Labor-HHS-Education Appropriations Bill (Cochran) - ACA risk corridors provision, HHS appropriations S. 2172, Health Insurance Rate Review Act (Feinstein) - rate review Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; dependent coverage; treatment of expatriate plans; compliance with the transitional reinsurance program; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues related to implementation of the Telephone Consumer Protection Act; and other issues relating to health care reform implementation.

Pseudoephedrine Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number). Oral Contraceptives S. 1438 - Allowing Greater Access to Safe and Effective Contraception Act. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections S. 1532 - Affordability is Access Act. Clarifies that all oral contraceptive products be covered by insurance and provided to consumers without cost, regardless of prescription/nonprescription (over-the-counter) status; all sections. Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

Client expense: $315,000 · Firm income: Not reported

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecologic Cancer; Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); H.R. 2866, Healthy MOM Act; CMS Health IT Incentive Program, Meaningful Use Stage 3; H.R. 3940, Meaningful Use Hardship Relief Act; S. 466, Quality Care for Moms and Babies Act; S. 1427, Quality Measure Alignment Act of 2015; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 865, Good Samaritan Health Professionals Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; H.R. 3658/S. 84, GEDI Act; Pregnancy Discrimination (general); H.R. 2654/S. 1512, Pregnant Workers Fairness Act; H.R. 1209/S.628 Improving Access to Maternity Care Act; H.R. 1462/S.799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R.36/S. 1553, Pain-Capable Unborn Child Protection Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 3134/S. 764, Defund Planned Parenthood Act; H.R. 3504/S. 1603, Born-Alive Abortion Survivors Protection Act; H.R. 3495, Womens Public Health and Safety Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; H.R. 6, 21st Century Cures Act; Innovation for Healthier Americans; H.R. 1375/S. 142, Child Nicotine Poisoning Prevention Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 2191/S. 1170, Breast Cancer Research Stamp Reauthorization Act of 2015; H.R. 1925, To award a Congressional Gold Medal to Dr. Ernie Bodai; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3339/S. 1926, Protecting Access to Lifesaving Screenings Act; H.R. 3235, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act.

HR 770 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010: entire bill HR 132/S 339 - ObamaCare Repeal Act: entire bill Public Law No. 111-148- Patient Protection and Affordable Care Act: entire law Public Law No. 111-152- Health Care and Education Reconciliation Act of 2010: entire law S 1438 - Allowing Greater Access to Safe and Effective Contraception Act: entire bill HR 3163/S 1532 - Affordability Is Access Act: entire bill HR 3443 - Women's Health Accountability Act

Client expense: $329,241 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID)

HR 770 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010: entire bill HR 132/S 339 - ObamaCare Repeal Act: entire bill Public Law No. 111-148- Patient Protection and Affordable Care Act: entire law Public Law No. 111-152- Health Care and Education Reconciliation Act of 2010: entire law HR 2 - Medicare Access and CHIP Reauthorization Act SGR Repeal and Medicare Beneficiary Access Act: amendments and provisions related to and affecting reproductive health and family planning HR 1101 - Viral Hepatitis Testing Act: entire bill HR 1502 - Medicare Parity Act: entire bill S 737 - Ensuring Access to Primary Care for Women & Children Act: entire bill HR 117 - Reclaiming Individual Liberty Act: entire bill S 77 - Patient Choice Restoration Act: entire bill S 221 - Pregnancy Assistance Fund Expansion Act: entire bill HR 22 - Hire More Heroes Act: entire bill HR 1356/S 471 - Women Veterans Access to Quality Care Act: entire bill S 469 - Women Veterans and Families Health Services Act: entire bill HR 691 - Telehealth Modernization Act : entire bill HR 768 - Stop AIDS in Prison Act: entire bill HR 45 - Triple-Negative Breast Cancer Research and Education Act: entire bill HR 716/S 370 - Breast Density and Mammography Reporting Act: entire bill HR 1197 - Accelerating the End of Breast Cancer Act: entire bill S 697 - Frank R. Lautenberg Chemical Safety for the 21st Century Act: entire bill S 1016 - Preserving Freedom and Choice in Health Care Act: entire bill HR 2054 - To amend title 38, United States Code, to provide for increased access to Department of Veterans Affairs medical care for women veterans: entire bill HR 2300 - Empowering Patients First Act: entire bill S 1438 - Allowing Greater Access to Safe and Effective Contraception Act: entire bill S Res 193 - A resolution celebrating the 50th anniversary of the historic Griswold v. Connecticut decision of the Supreme Court of the United States and expressing the sense of the Senate that the case was an important step forward in helping ensure that all people of the United States are able to use contraceptives to plan pregnancies and have healthier babies.: entire resolution HR 2653 - American Health Care Reform Act: entire bill HR 3163/S 1532 - Affordability Is Access Act: entire bill HR 2866 - To amend title XXVII of the Public Health Service Act to provide for a special enrollment period for pregnant women, and for other purposes: entire bill HR 6 - 21st Century Cures Act: entire bill HR 2066 - Telehealth Enhancement Act: entire bill HR 1345 - Health IT Modernization for Underserved Communities Act: entire bill HR 270 - Flexibility in Health IT Reporting (Flex-IT) Act: entire bill HR 2646 - Helping Families in Mental Health Crisis Act: entire bill HR 2725 - 21st Century Care for Military and Veterans Act: entire bill HR 2355 - Women's Preventive Health Awareness Campaign: entire bill HR 2820 - Stem Cell Therapeutic and Research Reauthorization Act: entire bill HR 2866 - the Healthy MOM Act S 1299/HR 938 - Garrett Lee Smith Memorial Act Reauthorization HR 3171 - To amend the Public Health Service Act to prohibit certain research on the transplantation of human fetal tissue obtained pursuant to an abortion. S 1919 - A bill to amend the Patient Protection and Affordable Care Act to protect rights of conscience with regard to requirements for coverage of specific items and services, to amend the Public Health Service Act to prohibit certain abortion-related discrimination in governmental activities, and for other purposes. HR 3443 - Women's Health Accountability Act HR 2972 - Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act HR 3498 - Human Cloning Prohibition Act S 1917 - A bill to prohibit the provision of Federal funds to an entity that receives compensation for facilitating the donation of fetal tissue derived from an abortion.

H.R. 30, Save American Workers Act (Young) - definition of full-time employee H.R. 117, Reclaiming Individual Liberty Act (Garrett) - ACA individual mandate H.R. 221, ACA Taxpayer Bailout Prevention Act (Harris) - risk corridors program H.R. 371, Care for All Act (Fortenberry) - catastrophic plans H.R. 494, Competitive Health Insurance Reform Act (Gosar) - antitrust policy H.R. 543, Health Care Choice Act (Blackburn) - national marketplace for individual health insurance H.R. 724, Taxpayer Bailout Protection Act (Lance) - risk corridors program H.R. 815, Access to Independent Health Insurance Advisors Act (Long-Schrader) - treatment of broker compensation in MLR calculation H.R. 1560, Protecting Cyber Networks Act (Nunes) - cybersecurity H.R. 1624, Protecting Affordable Coverage for Employees Act (Guthrie-Cardenas) - ACA definition of small employer H.R. 1731, National Cybersecurity Protection Advancement Act (McCaul) - cybersecurity H.R. 1770, Data Security and Breach Notification Act (Blackburn-Welch) - data security H.R. 2739, Cancer Drug Coverage Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 2868, Small Business Health Fairness Act (Johnson) - association health plans H.R. 3020, Labor-HHS-Education Appropriations Bill (Cole) - ACA risk corridors provision, HHS appropriations S. 30, Forty Hours Is Full Time Act (Collins) - definition of full-time employee S. 123, ACA Taxpayer Bailout Prevention Act (Rubio) - risk corridors program S. 158, Employee Health Care Protection Act (Cassidy) - grandfathering of health coverage S. 359, Taxpayer Bailout Protection Act (Cassidy) - risk corridors program S. 754, Cybersecurity Information Sharing Act (Burr) - cybersecurity S. 1099, Protecting Affordable Coverage for Employees Act (Scott-Shaheen) - ACA definition of small employer S. 1532, Affordability is Access Act (Murray) - coverage of OTC birth control S. 1566, Cancer Drug Coverage Parity Act (Kirk) - coverage of oral anti-cancer drugs S. 1661, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - treatment of broker compensation in MLR calculation S. 1695, Labor-HHS-Education Appropriations Bill (Blunt) - ACA risk corridors provision, HHS appropriations S. 2132, Labor-HHS-Education Appropriations Bill (Cochran) - ACA risk corridors provision, HHS appropriations Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; dependent coverage; treatment of expatriate plans; compliance with the transitional reinsurance program; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues related to implementation of the Telephone Consumer Protection Act; and other issues relating to health care reform implementation.

HR 1462 - Protecting our Infants Act: Authorizing AHRQ research on treatment and prevention of prenatal opioid abuse. HR 3020 - Labor/HHS Appropriations Bill: Preserving funding for AHRQ and Title VII in HRSA. S. 1532 Affordability is Access Act: Supporting making over the counter contraceptives covered by insurance health plans.

Client expense: $750,939 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Justice, Dept of (DOJ), Office of Administration, Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Veterans Affairs, Dept of (VA), White House Office

HR 2-Reauthorize Teaching Health Center GME Program Funding: maintain the sustainability of the THCGME program to US. HR 758- Lawsuit Abuse Reduction Act - Reducing frivolous lawsuits. HR 1725-National All Schedules Prescription Electronic Reporting (NASPER) Reauthorization Act: Supporting prescription drug monitoring. HR 2709-Brfing on Professional's Access to Health Workforce Integration Act: Pathway to licensure for health professionals immigrating to US. HR 3020/S. 1695 - FY 2016 appropriations increases for AHRQ, HRSA Title VII medicine training grants, NHSC: Federal spending priorities to support workforce, research. HR 3099/S. 1719: Recognize, Assist, Include, Support and Engage (RAISE) Family Caregivers Act: Creating and advisory board at HHS to develop a strategy to support family caregivers. HR 3309: Further Flexibility in HIT Reporting and Advancing Interoperability (FLEX-IT 2) Act: Recasting the meaningful use of HIT program to emphasize interoperability and vendor responsibility. HR 3656/S 2100-Tobacco to 21 Act: Raising the minimum age for buying tobacco to 21. S. 1532-Affordability is Access Act: Supporting making over-the-counter contraceptives covered by insurance health plans. S. 1893 - Mental Health Improvement Awareness Act: Removing barriers to improved mental health services in primary care settings. S. 1989: Primary Care Enhancement Act: Removing impediments to broader use of Direct Primary Care. No Bill No. - Chronic Care Management: advocate for introduction of bill to eliminate the Part B coinsurance. No Bill No.- Health IT: Lobby to raise awareness of hardships created by implementation of Meaningful Use program; advocate for a pause on Stage 3, etc. No Bill No.-Graduate Medical Education: Advocate for introduction of a bill to require CMS to report data on residency positions; raise awareness if AAFP's policy proposals on GME; support the GAO transparency letter. No Bill No. - Health Resources and Services Administration HRSA FY 16 & 17 Budget: Primary care practice-based research, patient safety, HIT. No Bill No. - Substance use disorders on youth athletes: Appropriate pain management, preventing opioid abuse. No Bill No.-Primary care forum: Achieving the triple aim in health care. No Bill No.-Advisory Committee on Training in Primary Care Medicine and Dentistry: Federal support for family medicine education and training. No Bill No.-Innovative practices in Medication Assisted Treatment and Primary Care Coordination: Appropriate pain management, preventing opioid abuse. No Bill No.-Oppose House draft FY16 bill to eliminate AHRQ: primary care practice-based research, patient safety, HIT. No Bill No.-Reestablish annual appropriations for NHSC to address Health Professional Shortage Areas: Physician workforce shortages, Medical student debt. No Bill No.-Robust investment in HRSA Title VII primary care physician training: primary care workforce. No Bill No.-Title X, Family Planning Grants: access to women's health care. No Bill No.-CMS Innovation Center: support health care delivery reforms for the triple aim. No Bill No. - FP's as specialists for inpatient settings: Asking for changes so that FPs can consult with other FPs in inpatient settings. No Bill No. - Health Insurer Mergers-Concern over mergers. No Bill No.-Improving the Meaningful Use Program - Asking for interoperability and other changes to the Meaningful Use/HIT program. No Bill No.-Tobacco Control: nicotine warning labels and child resistant packaging. No Bill No.-HRSA Childhood vaccines: Nominated and FP to serve on a committee. No Bill No.-EHRs: 2015 CEHRT proposal. No Bill No.-Vaccines: Urge coverage of shingles and Tdap. No Bill No.-Insulin Pen Availability: Insulin pens at same formulary level as injectable insulin. No Bill No.-2016 proposed Medicare fee schedule: Commented on CMS proposed policy change for 2016; appropriate physician payment rules. No Bill No.-Advance Care Planning: Support for advance care planning code. No Bill No.-Medicaid Managed Care Policies: Commented on proposed changes to Medicaid managed care. No Bill No.-Agricultural Appropriations Bill: retaining the Feb. 2007 date for FDA authority over tobacco products. No Bill No. Trade Preferences Extension Act: opposing the use of reduction in Medicare provider payments to offset the cost of the bill. No Bill No.-Chronic Disease Management reforms: Improving ways policies for Medicare beneficiaries with multiple chronic conditions. No Bill No.-Repeal of the Affordable Care Act's Independent Advisory Board: Supporting the reform of the IPAB. No Bill No.-Advanced Care Planning: Supporting CMS proposed rule to pay for advanced care planning. No Bill No.-Consolidation of Health Insurance Plans: Expressing caution about proposed mergers of major insurance providers. No Bill No.-Prescription Drug Abuse: Prioritizing prevention of prescription drug abuse. No Bill No. - Tobacco Advertising: Asking for enforcement action against tobacco company that advertises "all Natural" cigarettes. No Bill No.-Liquid Nicotine Packaging: Recommending FDA require child-proof packaging for liquid nicotine packages. No Bill No.-Mental Health Reform: Advocated to eliminate insurance mental health carve outs. No Bill No.-Health IT: Urged support for the FLEX-IT2 Act; stage 3 delay and Meaningful Use flexibility. No Bill No.-Chronic Care Management Codes: Lobbying for potential legislation to eliminate patient co-pays associates with the CCMC. No Bill No.-Health Insurance Marketplace Issues & Provider Involvement with Patient Enrollment: Network Adequacy, Patient Enrollment in Marketplaces. No Bill No. - Children's Health Insurance - CHIP Program. No Bill No. - Health Market Consolidation - Health Insurance consolidation, provider consolidation, hospital consolidation.

H.Con.Res.79, resolution to prohibit funding for Planned Parenthood; H.R.3495, Women's Public Health and Safety Act; H.J.Res.61, resolution to prohibit funding for Planned Parenthood for one year; H.R.3504, Born-Alive Abortion Survivors Protection Act; H.R.36 Pain-Capable Unborn Child Protection Act; H.R.3134, Defund Planned Parenthood Act; S.1881, bill to prohibit federal funding for Planned Parenthood; H.R.3378, Stop Deceptive Advertising for Womens Services Act; FY'16 Financial Services and General Government appropriations bill: DC abortion ban, Abortion coverage under the FEHBP, D.C. non-discrimination laws, Prohibition on insurance coverage of abortion; S.1532 and H.R.3163, Affordability is Access Act; FY'16 Homeland Security Appropriations Bill, Abortion care for women detained by U.S. Immigration and Customs Enforcement; H.R.6, Lee amendment to remove abortion restriction language; H.R.2972, EACH Woman Act; FY'16 State and Foreign Operations Appropriations Bill, global gag rule, international family planning funding, UNFPA funding.

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

Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecological Cancer; Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); H.R. 2866, Healthy MOM Act; CMS Health IT Incentive Program, Meaningful Use Stage 3; H.R. 1974, HEAL for Immigrant Women and Families Act of 2015; S. 466, Quality Care for Moms and Babies Act; S. 1427, Quality Measure Alignment Act of 2015; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 3658/S. 84, GEDI Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; Pregnancy Discrimination (general); S. 821, BPA in Food Packaging Right to Know Act; H.R. 1209/S.628 Improving Access to Maternity Care Act; H.R. 1462/S.799, Protecting our Infants Act; H.R. 6, 21st Century Cures Act; Innovation for Healthier Americans; Health Equity and Accountability Act; H.R. 293 Exempt certain transfers of value from reporting requirements under Sunshine Act; H.R. 1375/S. 142, Child Nicotine Poisoning Prevention Act; H.R. 3652/S. 674, 21st Century Womens Health Act; H.R.7/S. 582, No Taxpayer Funding for Abortion and Abortion Insurance Full Disclosure Act of 2015; H.R.36/S. 1553, Pain-Capable Unborn Child Protection Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 865, Good Samaritan Health Professionals Act of 2015; H.R. 2654/S. 1512, Pregnant Workers Fairness Act; S. 1532, Affordability is Access Act; H.R. 2191/S. 1170, Breast Cancer Research Stamp Reauthorization Act of 2015; H.R. 1925, To award a Congressional Gold Medal to Dr. Ernie Bodai; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3339/S. 1926, Protecting Access to Lifesaving Screenings Act; H.R. 3235, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); H.R. 3134/S. 764, Defund Planned Parenthood Act; H.R. 3504/S. 1603, Born-Alive Abortion Survivors Protection Act; H.R. 3495, Womens Public Health and Safety Act; H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation; H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act; H.R. 2407, School Milk Nutrition Act of 2015.

Pseudoephedrine Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number). Oral Contraceptives S. 1438 - Allowing Greater Access to Safe and Effective Contraception Act. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections S. 1532 - Affordability is Access Act. Clarifies that all oral contraceptive products be covered by insurance and provided to consumers without cost, regardless of prescription/nonprescription (over-the-counter) status; all sections. Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

Client expense: $260,000 · Firm income: Not reported

H.R. 30, Save American Workers Act (Young) - definition of full-time employee H.R. 99, Health Insurance Industry Antitrust Enforcement Act (Conyers) - antitrust policy H.R. 117, Reclaiming Individual Liberty Act (Garrett) - ACA individual mandate H.R. 221, ACA Taxpayer Bailout Prevention Act (Harris) - risk corridors program H.R. 371, Care for All Act (Fortenberry) - catastrophic plans H.R. 494, Competitive Health Insurance Reform Act (Gosar) - antitrust policy H.R. 543, Health Care Choice Act (Blackburn) - national marketplace for individual health insurance H.R. 724, Taxpayer Bailout Protection Act (Lance) - risk corridors program H.R. 815, Access to Independent Health Insurance Advisors Act (Long-Schrader) - treatment of broker compensation in MLR calculation H.R. 1560, Protecting Cyber Networks Act (Nunes) - cybersecurity H.R. 1624, Protecting Affordable Coverage for Employees Act (Guthrie-Cardenas) - ACA definition of small employer H.R. 1731, National Cybersecurity Protection Advancement Act (McCaul) - cybersecurity H.R. 1770, Data Security and Breach Notification Act (Blackburn-Welch) - data security H.R. 2462, Health Insurance Industry Fair Competition Act (DeFazio) - antitrust policy H.R. 2739, Cancer Drug Coverage Parity Act (Lance) - coverage of oral anti-cancer drugs H.R. 2868, Small Business Health Fairness Act (Johnson) - association health plans H.R. 3020, Labor-HHS-Education Appropriations Bill (Cole) - ACA risk corridors provision, HHS appropriations S. 30, Forty Hours Is Full Time Act (Collins) - definition of full-time employee S. 123, ACA Taxpayer Bailout Prevention Act (Rubio) - risk corridors program S. 158, Employee Health Care Protection Act (Cassidy) - grandfathering of health coverage S. 359, Taxpayer Bailout Protection Act (Cassidy) - risk corridors program S. 531, Removing Limitations on Insurance Effectiveness and Flexibility Act (Flake) - catastrophic plans S. 647, Health Care Choice Act (Cruz) - national marketplace for individual health insurance S. 754, Cybersecurity Information Sharing Act (Burr) - cybersecurity S. 1099, Protecting Affordable Coverage for Employees Act (Scott-Shaheen) - ACA definition of small employer S. 1532, Affordability is Access Act (Murray) - coverage of OTC birth control S. 1566, Cancer Drug Coverage Parity Act (Kirk) - coverage of oral anti-cancer drugs S. 1661, Access to Independent Health Insurance Advisors Act (Isakson-Coons) - treatment of broker compensation in MLR calculation S. 1695, Labor-HHS-Education Appropriations Bill (Blunt) - ACA risk corridors provision, HHS appropriations Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to the continuation of reporting requirements for state LTCI partnership programs; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; summary of benefits and coverage disclosures; pre-existing condition insurance plans; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; dependent coverage; treatment of expatriate plans; compliance with the transitional reinsurance program; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; application of fiduciary standards to group health plans, issues related to supplemental products, and other issues relating to health care reform implementation.

HR 770 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010: entire bill HR 132/S 339 - ObamaCare Repeal Act: entire bill Public Law No. 111-148- Patient Protection and Affordable Care Act: entire law Public Law No. 111-152- Health Care and Education Reconciliation Act of 2010: entire law S 1438 - Allowing Greater Access to Safe and Effective Contraception Act: entire bill S 1532 - Affordability Is Access Act: entire bill

Client expense: $11,569 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID)

HR 770 - To repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010: entire bill HR 132/S 339 - ObamaCare Repeal Act: entire bill Public Law No. 111-148- Patient Protection and Affordable Care Act: entire law Public Law No. 111-152- Health Care and Education Reconciliation Act of 2010: entire law HR 2 - Medicare Access and CHIP Reauthorization Act SGR Repeal and Medicare Beneficiary Access Act: amendments and provisions related to and affecting reproductive health and family planning HR 1101 - Viral Hepatitis Testing Act: entire bill HR 1502 - Medicare Parity Act: entire bill S 737 - Ensuring Access to Primary Care for Women & Children Act: entire bill HR 117 - Reclaiming Individual Liberty Act: entire bill S 77 - Patient Choice Restoration Act: entire bill S 221 - Pregnancy Assistance Fund Expansion Act: entire bill HR 22 - Hire More Heroes Act: entire bill HR 1356/S 471 - Women Veterans Access to Quality Care Act: entire bill S 469 - Women Veterans and Families Health Services Act: entire bill HR 691 - Telehealth Modernization Act : entire bill HR 768 - Stop AIDS in Prison Act: entire bill HR 45 - Triple-Negative Breast Cancer Research and Education Act: entire bill HR 716/S 370 - Breast Density and Mammography Reporting Act: entire bill HR 1197 - Accelerating the End of Breast Cancer Act: entire bill S 697 - Frank R. Lautenberg Chemical Safety for the 21st Century Act: entire bill S 1016 - Preserving Freedom and Choice in Health Care Act: entire bill HR 2054 - To amend title 38, United States Code, to provide for increased access to Department of Veterans Affairs medical care for women veterans: entire bill HR 2300 - Empowering Patients First Act: entire bill S 1438 - Allowing Greater Access to Safe and Effective Contraception Act: entire bill S Res 193 - A resolution celebrating the 50th anniversary of the historic Griswold v. Connecticut decision of the Supreme Court of the United States and expressing the sense of the Senate that the case was an important step forward in helping ensure that all people of the United States are able to use contraceptives to plan pregnancies and have healthier babies.: entire resolution HR 2653 - American Health Care Reform Act: entire bill S 1532 - Affordability Is Access Act: entire bill HR 2866 - To amend title XXVII of the Public Health Service Act to provide for a special enrollment period for pregnant women, and for other purposes: entire bill HR 6 - 21st Century Cures Act: entire bill HR 2066 - Telehealth Enhancement Act: entire bill HR 1345 - Health IT Modernization for Underserved Communities Act: entire bill HR 270 - Flexibility in Health IT Reporting (Flex-IT) Act: entire bill HR 2646 - Helping Families in Mental Health Crisis Act: entire bill HR 2725 - 21st Century Care for Military and Veterans Act: entire bill HR 2355 - Women's Preventive Health Awareness Campaign: entire bill HR 2820 - Stem Cell Therapeutic and Research Reauthorization Act: entire bill S 1299/HR 938 - Garrett Lee Smith Memorial Act Reauthorization

H.R.2, Medicare Access and CHIP Reauthorization Act: Hyde amendment restrictions; S.178, Justice for Victims of Human Trafficking Act: Hyde amendment restrictions; H.J.Res. 43, resolution of disapproval of District of Columbia non-discrimination measure; Affordable Care Act contraceptive coverage policy; H.R.36, 20-week abortion ban; S.1438, Allowing Greater Access to Safe and Effective Contraception Act; H.R.1735, National Defense Authorization Act: Shaheen amendment to lift ban on privately funded abortion services for military women, Shaheen amendment to improve servicewomen's access to contraception; H.R.2738, Global Democracy Promotion Act; S.1532, Affordability Is Access Act; S.1725, H.R.2772, Department of State, Foreign Operations, and Related Programs Appropriations Act: global gag rule, international family-planning funding, United Nations Population Fund; H.R.2995, Financial Services and General Government Appropriations Act: D.C. abortion funding ban rider, abortion coverage under the FEHBP, DC non-discrimination Laws, restrictions on insurance coverage of abortion; H.R.2646, Helping Families in Mental Health Crisis Act; H.R.3020, S.1695, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act: Hyde amendment restrictions; funding for family-planning programs, insurance coverage for abortion in Affordable Care Act plans, funding for sex-ed and abstinence-only programs; H.R.2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act of 2015.

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

Advocate against resolution disapproving D.C. law A joint resolution disapproving the action of the District of Columbia Council in approving the Reproductive Health Non-Discrimination Amendment Act of 2014. (S. J. Res 10)(H. J. Res 43) Advocate for bill improving access to reproductive health care and counseling for women in the military and their dependents Access to Contraception for Women Servicemembers and Dependents Act of 2015 (S. 358/H.R. 742) Advocate for provisions improving access to contraception for women servicemembers National Defense Authorization Act for Fiscal Year 2016 (H.R. 1735) Advocate against provisions that would harm womens health and in support of amendments that would improve womens health Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016 (H.R. 3020/S. 1695) Advocate against amendments that would harm women in D.C. Financial Services and General Government Appropriations Act, 2016 (H.R. 2995) Advocate for protection from using religion to discriminate (no bill introduced) Advocate in support of D.C. bill that would require 12 month dispensing of birth control (no bill introduced) Advocate for improved reproductive health care access for women veterans (no bill introduced) A joint resolution disapproving the action of the District of Columbia Council in approving the Human Rights Amendment Act of 2014 (S.J. Res. 11)(H.J. Res. 44) Advocate against resolutions disapproving of DCs bill, Human Rights Amendment Act of 2014 Advocate for improving access to contraception Affordability Is Access Act (S. 1532) Advocate against provision in bill that is harmful to womens reproductive health 21st Century Women's Cures Act 2015 (H.R. 6) Advocate for provision that improves access to reproductive health care for Peace Corps volunteers Department of State, Foreign Operations, and Related Programs Appropriations Act, 2016 (S. 1725/H.R. 2772) Advocating against administration policy that is harmful to womens reproductive health. Global Democracy Promotion Act (H.R.2740)

Pseudoephedrine Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient, common in popular cold and allergy medications (no bill number) and oppose prescription requirement (no bill number). Oral Contraceptives - S. 1438 - Allowing Greater Access to Safe and Effective Contraception Act. Grants priority review of applications to switch oral contraceptive drugs from prescription to nonprescription (over-the-counter) status; all sections S. 1532 - Affordability is Access Act. Clarifies that all oral contraceptive products be covered by insurance and provided to consumers without cost, regardless of prescription/nonprescription (over-the-counter) status; all sections. Over-the-counter (OTC) medicines; Manufacturing and importation of OTC drugs; Mandatory recall authority of the FDA; Rx-to-OTC Switch Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

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