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Reported covered position: Senior Policy Analyst, Food and Drug Administration; Senior FDA Counsel, Energy and Commerce Committee; FDA Counsel, U.S. Representative Henry Waxman
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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.
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 Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
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)
2020 · second_quarter · Q2
Health issues impacting patients with rare diseases. International Classification of Diseases (ICD-10). FDA Clinical Trials Step Therapy. Gene Therapy. Biosimilars. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. HHS/OCR Anti discrimination. Health Care Access Affordability. Surprise Medical Billing. Value Based Purchasing. Paid Leave. COVID-19 Related Issues. COVID-19 Related Home Infusion Issues. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
Source: Senate LDA
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) 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 Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) 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. Importation Issues. FDA-2019-D-5743: Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability. H.R.5497/S.3133: Conditional Approval Act.
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 Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
Conditional Approval 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. Importation Issues. FDA-2019-D-5743: Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability. H.R.5497/S.3133: Conditional Approval 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. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. 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. International Classification of Diseases (ICD-10). FDA Clinical Trials Step Therapy. Gene Therapy. Biosimilars. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. HHS/OCR Anti discrimination. Health Care Access Affordability. Surprise Medical Billing. Value Based Purchasing. Paid Leave. COVID-19 Related Issues. COVID-19 Related Home Infusion Issues. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) 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 Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) 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.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. 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. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
Conditional Approval 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. Importation Issues. FDA-2019-D-5743: Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability. H.R.5497/S.3133: Conditional Approval 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. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. 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. International Classification of Diseases (ICD-10). FDA Clinical Trials Step Therapy. Gene Therapy. Biosimilars. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. HHS/OCR Anti discrimination. Health Care Access Affordability. Surprise Medical Billing. Value Based Purchasing. Paid Leave. COVID-19 Related Issues. COVID-19 Related Home Infusion Issues. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) 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 Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. 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.
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). H.Res.161/S.Res.90: Expressing support for the designation of the last day of February each year as "Rare Disease Day". 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. Newborn Screening Saves Lives Act Reauthorization (Legislation not yet introduced). H.R.1379/S.560: Ensuring Lasting Smiles Act. CMS-9923-NC: Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). Medical Nutrition Equity Act (Legislation not yet introduced). H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
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. 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. 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.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: 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.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). H.Res.161/S.Res.90: Expressing support for the designation of the last day of February each year as "Rare Disease Day". 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. Newborn Screening Saves Lives Act Reauthorization (Legislation not yet introduced). H.R.1379/S.560: Ensuring Lasting Smiles Act. CMS-9923-NC: Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). Medical Nutrition Equity Act (Legislation not yet introduced). H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
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). H.Res.161/S.Res.90: Expressing support for the designation of the last day of February each year as "Rare Disease Day". 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. Newborn Screening Saves Lives Act Reauthorization (Legislation not yet introduced). H.R.1379/S.560: Ensuring Lasting Smiles Act. CMS-9923-NC: Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). Medical Nutrition Equity Act (Legislation not yet introduced). H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
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/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.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). H.Res.161/S.Res.90: Expressing support for the designation of the last day of February each year as "Rare Disease Day". 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. Newborn Screening Saves Lives Act Reauthorization (Legislation not yet introduced). H.R.1379/S.560: Ensuring Lasting Smiles Act. CMS-9923-NC: Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). Medical Nutrition Equity Act (Legislation not yet introduced). H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
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: 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.
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.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.
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.
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: 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.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.
STRONGER Patents Act of 2019
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Patent issues impacting patients with rare diseases. Section 101 of the Patent Act. H.R.3666: STRONGER Patents 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.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.
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.
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.
Expressing support for the designation of the last day of February each year as "Rare Disease Day".
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). H.Res.161/S.Res.90: Expressing support for the designation of the last day of February each year as "Rare Disease Day". 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. Newborn Screening Saves Lives Act Reauthorization (Legislation not yet introduced). H.R.1379/S.560: Ensuring Lasting Smiles Act. CMS-9923-NC: Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). Medical Nutrition Equity Act (Legislation not yet introduced). H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
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). H.Res.161/S.Res.90: Expressing support for the designation of the last day of February each year as "Rare Disease Day". 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. Newborn Screening Saves Lives Act Reauthorization (Legislation not yet introduced). H.R.1379/S.560: Ensuring Lasting Smiles Act. CMS-9923-NC: Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). Medical Nutrition Equity Act (Legislation not yet introduced). H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
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.
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.
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.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.
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.
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.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.
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.
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.
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). H.Res.161/S.Res.90: Expressing support for the designation of the last day of February each year as "Rare Disease Day". 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. Newborn Screening Saves Lives Act Reauthorization (Legislation not yet introduced). H.R.1379/S.560: Ensuring Lasting Smiles Act. CMS-9923-NC: Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). Medical Nutrition Equity Act (Legislation not yet introduced). H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
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.
A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers".
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Medicare issues impacting patients with rare diseases. Medicare Part D Program. Section 1115 Waivers. Section 1332: State Innovation Waivers. CMS-2406-P2/RIN: 0938-AT41: Methods for Assuring Access to Covered Medicaid Services - Rescission. CMS-9936-NC2: Request for Information Regarding State Relief and Empowerment Waivers. S.J.Res.52: A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers".
A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers".
Client: NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) · Firm: NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
Medicare issues impacting patients with rare diseases. Medicare Part D Program. Section 1115 Waivers. Section 1332: State Innovation Waivers. CMS-2019-0100-0562: Medicare and Medicaid Programs: CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements. S.J.Res.52: A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers".
A resolution designating February 28, 2019, as "Rare Disease Day".
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). H.Res.161/S.Res.90: Expressing support for the designation of the last day of February each year as "Rare Disease Day". 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. Newborn Screening Saves Lives Act Reauthorization (Legislation not yet introduced). H.R.1379/S.560: Ensuring Lasting Smiles Act. CMS-9923-NC: Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). Medical Nutrition Equity Act (Legislation not yet introduced). H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Drug Pricing. Pediatric Priority Review Vouchers.
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 · first_quarter · Q1
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. Importation Issues. FDA-2019-D-5743: Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability. H.R.5497/S.3133: Conditional Approval Act.
Health issues impacting patients with rare diseases. H.R.4228: Rare disease Advancement, Surveillance Research, and Education (RARE) Act of 2019. Rare Disease Day Resolution. NIH Rare Disease Day. FDA Rare Disease Day. 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. Individualized Therapies. Genetic Testing. Gene Therapy. Medical Foods. Public Law No: 111-148: The Patient Protection and Affordable Care Act. CMS-9916-P: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans. S.1895: Lower Health Care Costs Act. Surprise Medical Billing. COVID-19 Related Issues. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
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, Social Security Administration (SSA)
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.
Medicare issues impacting patients with rare diseases. Medicare Part D Program. Section 1115 Waivers. Section 1332: State Innovation Waivers. CMS-2019-0100-0562: Medicare and Medicaid Programs: CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements. S.J.Res.52: A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers".
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.
Medicare issues impacting patients with rare diseases. Medicare Part D Program. Section 1115 Waivers. Section 1332: State Innovation Waivers. CMS-2406-P2/RIN: 0938-AT41: Methods for Assuring Access to Covered Medicaid Services - Rescission. CMS-9936-NC2: Request for Information Regarding State Relief and Empowerment Waivers. S.J.Res.52: A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Secretary of the Treasury and the Secretary of Health and Human Services relating to "State Relief and Empowerment Waivers".
Patent issues impacting patients with rare diseases. Section 101 of the Patent Act. H.R.3666: STRONGER Patents 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.
Appropriations for patients with rare diseases. Food and Drug Administration Appropriations.
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
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2019 · second_quarter · Q2
Medicare issues impacting patients with rare diseases. Medicare Part D Program. Section 1115 Waivers. CMS Rebate Rule. CMS-9926-P: Proposed HHS Notice of Benefit and Payment Parameters for 2020. Fiscal Year 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS). CMS-1716-P: FY 2020 LTCH PPS Proposed Rule.
Appropriations for patients with rare diseases. Food and Drug Administration Appropriations. Emergency Medical Services for Children (EMSC) program appropriations. Pediatric Device Consortia (PDC) Grant Program.
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.
Section 101 of the Patent Act.
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.
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
NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD) via NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD)
2019 · first_quarter · Q1
Health issues impacting patients with rare diseases. H.R.2279: Safe Step Act. Rare Disease Advancement, Research, and Education Act (Legislation not yet introduced). H.Res.161/S.Res.90: Expressing support for the designation of the last day of February each year as "Rare Disease Day". 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. Newborn Screening Saves Lives Act Reauthorization (Legislation not yet introduced). H.R.1379/S.560: Ensuring Lasting Smiles Act. CMS-9923-NC: Request for Information Regarding Grandfathered Group Health Plans and Grandfathered Group Health Insurance Coverage. H.R.1884: Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. The Patient-Centered Outcomes Research Institute (PCORI) Reauthorization (Legislation not yet introduced). Medical Nutrition Equity Act (Legislation not yet introduced). H.R.1010: To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect.
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.
Medicare issues impacting patients with rare diseases. Medicare Part D Program. Section 1115 Waivers. CMS-9922-P: Exchange Program Integrity Proposed Rule. CMS-9926-P: Proposed HHS Notice of Benefit and Payment Parameters for 2020.
Appropriations for patients with rare diseases. Food and Drug Administration Appropriations. Emergency Medical Services for Children (EMSC) program appropriations.
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