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

Medicare/Medicaid MMM

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.

Contacted: Food & Drug Administration (FDA); SENATE; Natl Institutes of Health (NIH); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS)

Health Issues HCR

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.

Contacted: Natl Institutes of Health (NIH); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; SENATE; Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS)

Bills named: S. 560 (116th), H.Res. 242 (116th), S.Res. 90 (116th), H.R. 1010 (116th), H.R. 2279 (116th), H.Res. 161 (116th), H.R. 1379 (116th), H.R. 1884 (116th)

Budget/Appropriations BUD

Appropriations for patients with rare diseases. Food and Drug Administration Appropriations. Emergency Medical Services for Children (EMSC) program appropriations.

Contacted: HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Natl Institutes of Health (NIH); Food & Drug Administration (FDA); SENATE; Centers For Medicare and Medicaid Services (CMS)

Pharmacy PHA

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.

Contacted: Natl Institutes of Health (NIH); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); SENATE; Health & Human Services, Dept of (HHS)

Bills named: S. 340 (116th), H.R. 965 (116th), H.R. 1332 (116th)