NATIONAL ORGANIZATION FOR RARE DISORDERS, INC. (NORD) for NATIONAL ORGANIZATION FOR RARE DISORDERS INC (NORD)

Budget/Appropriations BUD

Appropriations for patients with rare diseases. Food and Drug Administration Appropriations.

Contacted: HOUSE OF REPRESENTATIVES; Bureau of Citizenship & Immigration Services (BCIS); SENATE; Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); Homeland Security, Dept of (DHS); Natl Institutes of Health (NIH); Food & Drug Administration (FDA)

Immigration IMM

Deferred Action.

Contacted: Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Natl Institutes of Health (NIH); Homeland Security, Dept of (DHS); SENATE; Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Bureau of Citizenship & Immigration Services (BCIS)

Copyright/Patent/Trademark CPT

Patent issues impacting patients with rare diseases. Section 101 of the Patent Act. H.R.3666: STRONGER Patents Act of 2019.

Contacted: Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Homeland Security, Dept of (DHS); SENATE; Office of Management & Budget (OMB); Natl Institutes of Health (NIH); Bureau of Citizenship & Immigration Services (BCIS); Food & Drug Administration (FDA)

Bills named: H.R. 3666 (116th)

Health Issues HCR

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Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Draft Guidance for Industry; Availability.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.

Contacted: Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; SENATE; Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); Bureau of Citizenship & Immigration Services (BCIS); Homeland Security, Dept of (DHS); Natl Institutes of Health (NIH); Food & Drug Administration (FDA)

Bills named: H.R. 2507 (116th), H.R. 2501 (116th), H.Res. 242 (116th), H.R. 2279 (116th), H.R. 4228 (116th), H.R. 1379 (116th), H.R. 4439 (116th), S. 2546 (116th), S. 2158 (116th), S. 560 (116th)

Medicare/Medicaid MMM

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".

Contacted: HOUSE OF REPRESENTATIVES; Bureau of Citizenship & Immigration Services (BCIS); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Office of Management & Budget (OMB); SENATE; Natl Institutes of Health (NIH); Homeland Security, Dept of (DHS); Health & Human Services, Dept of (HHS)

Bills named: S.J.Res. 52 (116th)

Pharmacy PHA

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.

Contacted: Homeland Security, Dept of (DHS); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Bureau of Citizenship & Immigration Services (BCIS); Natl Institutes of Health (NIH); Health & Human Services, Dept of (HHS); SENATE; Centers For Medicare and Medicaid Services (CMS)

Bills named: S. 2543 (116th), H.R. 3 (116th), H.R. 1332 (116th)