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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Fairness in Orphan Drug Exclusivity Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Drug Pricing and Orphan Drug Act. Accelerated Approval Pathway. Orphan Drug Tax Credit. H.R.1629 - Fairness in Orphan Drug Exclusivity Act. Cures 2.0.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2021 · third_quarter · Q3
Pharmaceutical issues impacting patients with rare diseases. Drug Pricing and Orphan Drug Act. Accelerated Approval Pathway. Orphan Drug Tax Credit. H.R.1629 - Fairness in Orphan Drug Exclusivity Act. Cures 2.0.
Health issues impacting patients with rare diseases. Rare disease initiatives. Telehealth. Step Therapy. User Fee Negotiations. Newborn screening. Affordable Care Act (ACA) issues. Affordable Care Act (ACA) enhancements. COVID-19 Related Issues. Medical Nutrition. Paid Medical and Family Leave
Source: Senate LDA
Health issues impacting patients with rare diseases. Rare disease initiatives. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn screening. Genetic testing. Health equity. Affordable Care Act (ACA) issues. Affordable Care Act (ACA) enhancements. Drug Pricing and Orphan Drug Act. COVID-19 Related Issues. Medical Nutrition.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. Rare disease initiatives. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Clinical trials. Newborn screening. User Fee Negotiations. Value Based Purchasing. Affordable Care Act (ACA) issues. Affordable Care Act (ACA) enhancements. COVID-19 Related Issues.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. Rare disease initiatives. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn screening. Genetic testing. Health equity. Affordable Care Act (ACA) issues. Affordable Care Act (ACA) enhancements. Drug Pricing and Orphan Drug Act. COVID-19 Related Issues. Medical Nutrition.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. Rare disease initiatives. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Clinical trials. Newborn screening. User Fee Negotiations. Value Based Purchasing. Affordable Care Act (ACA) issues. Affordable Care Act (ACA) enhancements. COVID-19 Related Issues.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Notice of Benefit Payment Parameters. Surprise Medical Billing. Pre-Existing Conditions. User Fee Negotiations. Physician Fee Schedule. Value Based Purchasing. Integrated Review Panel. Regulation and Guidance Reform. Affordable Care Act. COVID-19 Related Issues.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. Telehealth. Medical Foods. Step Therapy. H.R.2279/S.2546: Safe Step Act. Surprise Medical Billing. Physician Fee Schedule. Value Based Purchasing. Grandfathered Plans - Affordable Care Act. COVID-19 Related Issues. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
CARES Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. Telehealth. Medical Foods. Step Therapy. H.R.2279/S.2546: Safe Step Act. Surprise Medical Billing. Physician Fee Schedule. Value Based Purchasing. Grandfathered Plans - Affordable Care Act. COVID-19 Related Issues. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Notice of Benefit Payment Parameters. Surprise Medical Billing. Pre-Existing Conditions. User Fee Negotiations. Physician Fee Schedule. Value Based Purchasing. Integrated Review Panel. Regulation and Guidance Reform. Affordable Care Act. COVID-19 Related Issues.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. Telehealth. Medical Foods. Step Therapy. H.R.2279/S.2546: Safe Step Act. Surprise Medical Billing. Physician Fee Schedule. Value Based Purchasing. Grandfathered Plans - Affordable Care Act. COVID-19 Related Issues. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
CARES Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. Telehealth. Medical Foods. Step Therapy. H.R.2279/S.2546: Safe Step Act. Surprise Medical Billing. Physician Fee Schedule. Value Based Purchasing. Grandfathered Plans - Affordable Care Act. COVID-19 Related Issues. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
To provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect.
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Fair Care Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. FDA-2018-N-4171: Patient Engagement in Medical Device Clinical Trials. Docket No. FDA-2018-D-4455-0001: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. FR Document: 2019-01026 Citation: 84 FR 2340: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.
Fair Care Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. H.R.2296: FAIR Drug Pricing Act of 2019. H.R.987: Strengthening Health Care and Lowering Prescription Drug Costs Act. S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019. Rebate Rule Comments. FDA Natural History Studies for Drug Development. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. Prescription Drug User Fee Act (PDUFA) Reauthorization.
Fair Care Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. Drug Pricing. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.3: Lower Drug Costs Now Act of 2019.
Ensuring Lasting Smiles Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Ensuring Lasting Smiles Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
Ensuring Lasting Smiles Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
ENROLL Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
To amend the Internal Revenue Code of 1986 to permanently extend the 7.5 percent adjusted gross income floor for the medical expense deduction.
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
More Efficient Tools to Realize Information for Consumers Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. H.R.2296: FAIR Drug Pricing Act of 2019. H.R.987: Strengthening Health Care and Lowering Prescription Drug Costs Act. S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019. Rebate Rule Comments. FDA Natural History Studies for Drug Development. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. Prescription Drug User Fee Act (PDUFA) Reauthorization.
Medical Nutrition Equity Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
Medical Nutrition Equity Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Medical Nutrition Equity Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
Newborn Screening Saves Lives Reauthorization Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
VACCINES Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Elijah E. Cummings Lower Drug Costs Now Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Drug Pricing. H.R.3: Elijah E. Cummings Lower Drug Costs Now Act. FDA Patient-Focused Drug Development (PFDD) Draft Guidance. H.R.4712: Fairness in Orphan Drug Exclusivity Act.
Elijah E. Cummings Lower Drug Costs Now Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. Drug Pricing. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.3: Lower Drug Costs Now Act of 2019.
RARE Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
RARE Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
Creating Hope Reauthorization Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
Fairness in Orphan Drug Exclusivity Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Drug Pricing. H.R.3: Elijah E. Cummings Lower Drug Costs Now Act. FDA Patient-Focused Drug Development (PFDD) Draft Guidance. H.R.4712: Fairness in Orphan Drug Exclusivity Act.
Emergency Medical Services for Children Program Reauthorization Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
CREATES Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. FDA-2018-N-4171: Patient Engagement in Medical Device Clinical Trials. Docket No. FDA-2018-D-4455-0001: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. FR Document: 2019-01026 Citation: 84 FR 2340: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.
CREATES Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. H.R.2296: FAIR Drug Pricing Act of 2019. H.R.987: Strengthening Health Care and Lowering Prescription Drug Costs Act. S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019. Rebate Rule Comments. FDA Natural History Studies for Drug Development. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. Prescription Drug User Fee Act (PDUFA) Reauthorization.
Protecting Americans with Preexisting Conditions Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Strengthening Health Care and Lowering Prescription Drug Costs Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. H.R.2296: FAIR Drug Pricing Act of 2019. H.R.987: Strengthening Health Care and Lowering Prescription Drug Costs Act. S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019. Rebate Rule Comments. FDA Natural History Studies for Drug Development. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. Prescription Drug User Fee Act (PDUFA) Reauthorization.
Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases.
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases.
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Medical Expense Savings Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Protect Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Emergency Medical Services for Children Program Reauthorization Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Lower Health Care Costs Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
ENROLL Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
The Newborn Screening Saves Lives Reauthorization Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
The Newborn Screening Saves Lives Reauthorization Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
Prescription Drug Pricing Reduction Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. Drug Pricing. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.3: Lower Drug Costs Now Act of 2019.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
Safe Step Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. H.R.2296: FAIR Drug Pricing Act of 2019. H.R.987: Strengthening Health Care and Lowering Prescription Drug Costs Act. S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019. Rebate Rule Comments. FDA Natural History Studies for Drug Development. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. Prescription Drug User Fee Act (PDUFA) Reauthorization.
A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. FDA-2018-N-4171: Patient Engagement in Medical Device Clinical Trials. Docket No. FDA-2018-D-4455-0001: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. FR Document: 2019-01026 Citation: 84 FR 2340: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.
Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. H.R.2296: FAIR Drug Pricing Act of 2019. H.R.987: Strengthening Health Care and Lowering Prescription Drug Costs Act. S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019. Rebate Rule Comments. FDA Natural History Studies for Drug Development. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. Prescription Drug User Fee Act (PDUFA) Reauthorization.
Ensuring Lasting Smiles Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
Ensuring Lasting Smiles Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
Ensuring Lasting Smiles Act
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
Medicare / Medicaid issues impacting patients with rare diseases. Medicare Part D Program. Prescription Drug Pricing. Accelerated Approval. Medicare issues related to medical nutrition.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2021 · second_quarter · Q2
Medicare / Medicaid issues impacting patients with rare diseases. Medicare Part D Program. Section 1115 Medicaid Waivers. Medicaid Drug Rebates. Prescription Drug Pricing.
Health issues impacting patients with rare diseases. Rare disease initiatives. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn screening. Genetic testing. Health equity. Affordable Care Act (ACA) issues. Affordable Care Act (ACA) enhancements. Drug Pricing and Orphan Drug Act. COVID-19 Related Issues. Medical Nutrition.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2021 · first_quarter · Q1
Medicaid issues impacting patients with rare diseases. Section 1115 Medicaid Waivers. Medicaid Drug Rebates.
Health issues impacting patients with rare diseases. Rare disease initiatives. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Clinical trials. Newborn screening. User Fee Negotiations. Value Based Purchasing. Affordable Care Act (ACA) issues. Affordable Care Act (ACA) enhancements. COVID-19 Related Issues.
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2020 · fourth_quarter · Q4
Health issues impacting patients with rare diseases. Telehealth. Step Therapy. H.R.2279/S.2546: Safe Step Act. Notice of Benefit Payment Parameters. Surprise Medical Billing. Pre-Existing Conditions. User Fee Negotiations. Physician Fee Schedule. Value Based Purchasing. Integrated Review Panel. Regulation and Guidance Reform. Affordable Care Act. COVID-19 Related Issues.
Medicare issues impacting patients with rare diseases. Medicaid issues impacting patients with rare diseases. Medicare Part D Program. Section 1115 Medicaid Waivers. Medicaid Drug Rebates. Medicaid Expansion. Value-Based Payments. Prior Authorization.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2020 · third_quarter · Q3
Health issues impacting patients with rare diseases. Telehealth. Medical Foods. Step Therapy. H.R.2279/S.2546: Safe Step Act. Surprise Medical Billing. Physician Fee Schedule. Value Based Purchasing. Grandfathered Plans - Affordable Care Act. COVID-19 Related Issues. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2019 · fourth_quarter · Q4
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Cancer. Step Therapy. H.R.2279/S.2546: Safe Step Act. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. Pediatric Research Equity Act (PREA). Biosimilars. Genetic Testing. Clinical Trials. Institutional Review Boards. Medical Devices. Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Public Law No: 111-148: The Patient Protection and Affordable Care Act. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. Dr. Hahn's Confirmation.
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Drug Pricing. H.R.3: Elijah E. Cummings Lower Drug Costs Now Act. FDA Patient-Focused Drug Development (PFDD) Draft Guidance. H.R.4712: Fairness in Orphan Drug Exclusivity Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2019 · third_quarter · Q3
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. Drug Pricing. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.3: Lower Drug Costs Now Act of 2019.
Health issues impacting patients with rare diseases. H.R.2279/S.2546: Safe Step Act. H.R.4228: Rare disease Advancement, surveillance Research, and Education (RARE) Act of 2019. H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Docket No. FDA-2019-D-1264: Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability. Newborn Screening. H.R.2507/S.2158: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.4439: Creating Hope Reauthorization Act. Biosimilars. Genetic Testing. FDA User Fee Reauthorization (Legislation Not Yet Introduced). Medical Foods. H.R.2501: Medical Nutrition Equity Act of 2019. Section 1557 of the Patient Protection and Affordable Care Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance. Enrollment Practices. Copay Accumulator Adjustment Programs (CAAPs). CMS-2406-P/RIN 0938-AT41/: Methods for Assuring Access to Care; Exceptions for High Managed Care Penetration and Rate Reduction Threshold. Docket No. HHS-OCR-2019-0007: Nondiscrimination in Health and Health Education Programs or Activities. Docket No. FDA-2019-N-1619: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments.
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2019 · second_quarter · Q2
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. H.R.2296: FAIR Drug Pricing Act of 2019. H.R.987: Strengthening Health Care and Lowering Prescription Drug Costs Act. S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019. Rebate Rule Comments. FDA Natural History Studies for Drug Development. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. Prescription Drug User Fee Act (PDUFA) Reauthorization.
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). Advancing Access to Targeted Therapies Act (Legislation not yet introduced). H.Res.242: Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved since its creation, and recognizing the need to continue supporting research and development for rare diseases. Pediatric subspecialty loan repayment reauthorization. H.R.2507: Newborn Screening Saves Lives Reauthorization Act of 2019. H.R. 776/S.1173: Emergency Medical Services for Children Program Reauthorization Act of 2019. H.R.1379/S.560: Ensuring Lasting Smiles Act. H.R.2862: VACCINES Act of 2019. Copay Accumulator Adjustment Programs (CAAPs). The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). H.R.2501: Medical Nutrition Equity Act. H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.986: Protecting Americans with Preexisting Conditions Act of 2019. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. S.1125: Protect Act. RIN 0938-ZB45: Patient Protection and Affordable Care Act; Increasing Consumer Choice Through the Sale of Individual Health Insurance Coverage Across State Lines Through Health Care Choice Compacts. H.R.1386/S.1905: ENROLL Act of 2019. H.R.2073/S.110: Medical Expense Savings Act. Guidance on Compliance with the Congressional Review Act.
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2019 · first_quarter · Q1
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Orphan Drug Tax Credit. H.R.1332: Fair Care Act of 2019. FDA-2018-N-4171: Patient Engagement in Medical Device Clinical Trials. Docket No. FDA-2018-D-4455-0001: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders. Docket No. FDA-2015-D-2818: Rare Diseases: Common Issues in Drug Development, Guidance For Industry; Draft Guidance. H.R.965/S.340: CREATES Act of 2019. FR Document: 2019-01026 Citation: 84 FR 2340: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
Filing targets: Bureau of Citizenship & Immigration Services (BCIS), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE