JED PERRY

ADHD Awareness *Drug Values -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -Expanded Access -Rare Disease awareness -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Newborn Screening

HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing

HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing

HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing

HR 4170: Disclosing Foreign Influence Act

HR 4170: Disclosing Foreign Influence Act

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - HR 4724: Medicare IVIG Access Enhancement Act - Medicare Part D

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - HR 4724: Medicare IVIG Access Enhancement Act - Medicare Part D

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - HR 4724: Medicare IVIG Access Enhancement Act - Medicare Part D

HR 5340/S1390: Stronger Patents Act

HR 5340/S1390: Stronger Patents Act

HR 5340/S1390: Stronger Patents Act

HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing

HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing

HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing

ADHD Awareness *Drug Values -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -Expanded Access -Rare Disease awareness -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Newborn Screening

ADHD Awareness *Drug Values -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -Expanded Access -Rare Disease awareness -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Newborn Screening

ADHD Awareness *Drug Values -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -Expanded Access -Rare Disease awareness -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Newborn Screening

HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing

HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing

HR 2587/S1194: Medical Nutrition Equity Act of 2017 HR6: Support for Patients and Communities Act 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing

HR 5340/S1390: Stronger Patents Act

HR 5340/S1390: Stronger Patents Act

HR 5340/S1390: Stronger Patents Act

ADHD Awareness *Drug Values -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -Expanded Access -Rare Disease awareness -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Newborn Screening

ADHD Awareness *Drug Values -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -Expanded Access -Rare Disease awareness -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Newborn Screening

ADHD Awareness *Drug Values -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -Expanded Access -Rare Disease awareness -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Newborn Screening

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - HR 4724: Medicare IVIG Access Enhancement Act - Medicare Part D

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - Bipartisan Budget Act - HR 1892 - Medicare Part D

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - HR 4724: Medicare IVIG Access Enhancement Act - Medicare Part D

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - HR 4724: Medicare IVIG Access Enhancement Act - Medicare Part D

Orphan drug tax credit HR 1: An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (Tax Cuts and Jobs Act)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 -PDUFA Reauthorization

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - Affordable Care Act Medicaid Expansion - Medicare IVIG Access Act Reauthorization HR 3172 - Medicare Part D

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - Affordable Care Act Medicaid Expansion - Medicare IVIG Access Act Reauthorization HR 3172 - Medicare Part D

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - Affordable Care Act Medicaid Expansion - Medicare IVIG Access Act Reauthorization HR 3172 - Medicare Part D

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan drug tax credit -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Trickett Wendler Right to Try Act of 2017 (S.204) and Right to Try Act (H.R. 878 and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703)

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - Affordable Care Act Medicaid Expansion - Medicare IVIG Access Act Reauthorization HR 3172 - Medicare Part D

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - Affordable Care Act Medicaid Expansion - Medicare IVIG Access Act Reauthorization HR 3172 - Medicare Part D

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - Affordable Care Act Medicaid Expansion

- Home Infusion technical change to H.R.6 21st Century Cures to move wrap around training and monitoring services benefit forward from 2021 to 2018 implementation. - Medicare coverage and reimbursement - Medicare Part B drug payment model demonstration - Affordable Care Act Medicaid Expansion - Medicare IVIG Access Act Reauthorization HR 3172 - Medicare Part D

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing ____________________________________ Titles: S.2689 - 114th Congress (2015-2016) Short Titles: Short Titles - Senate Short Titles as Introduced: REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Official Titles: Official Titles - Senate Official Titles as Introduced: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies.

S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement Medicare Part B drug payment model demonstration

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

ADHD awareness Drug Values Comprehensive Addiction and Recovery Act S. 524 and HR 953 Binge Eating Disorder awareness DEA processes and re-exportation FDA funding Medicaid rare disease patient access to therapy Orphan drug tax credit Orphan Drug Act regulations H.R. 6, 21st Century Cures Act, including expanded access, rare pediatric disease priority review vouchers re-authorization, DEA re-exports, OPEN Act, NIH funding, and exclusion of authorized generics from AMP calculations Expanded Access, including H.R. 909, Andrea Sloan Compassionate Use Reform and Enhancement Act ad S. 2912, Trickett Wendler Right to Try Act of 2016 Advancing Hope Act of 2015 (S. 1878, H.R. 1537) ; related to rare pediatric disease priority review vouchers Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (H.R. 971, S. 1421)

H.R. 6, the 21st Century Cures Act: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. 340B Drug Discount Program Orphan Drug Act Gene Therapy Drug Pricing ____________________________________ Titles: S.2689 - 114th Congress (2015-2016) Short Titles: Short Titles - Senate Short Titles as Introduced: REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness Official Titles: Official Titles - Senate Official Titles as Introduced: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies.

S. 275/HR. 605: Medicare Home Infusion Site of Care Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to authorize Medicare coverage of home infusion therapy and home infusion drugs. Directs the Secretary of Health and Human Services to implement the Medicare home infusion therapy benefit in a manner that ensures that: (1) Medicare beneficiaries have timely and appropriate access to infusion therapy in their homes, and (2) there is rapid and seamless coordination between drug coverage under Medicare part D (Voluntary Prescription Drug Benefit Program) and home infusion therapy services coverage under Medicare part B (Supplemental Security Income) (SSI) to avoid the filing of duplicative or otherwise improper claims. Medicare coverage and reimbursement Medicare Part B drug payment model demonstration