Issues related to pharmaceutical patents -Issues related to the Orphan Drug Tax Credit. -Issues related to the deduction of research and development expenditures. -H.R. 1350, Camerons Law. -H.R.2673, American Innovation and R&D Competitiveness Act of 2023. -Issues related to Pharmacy Benefit Managers (PBMs). -Issues related to pharmacy benefit management (PBM) reform -Issues related to implementation of the Inflation Reduction Act of 2022 (Public Law No. 117-169). -General advocacy on PBMs, IRA, inhalers -Issues related to the orphan drug exclusion of the Inflation Reduction Act. -Issues related to 340B reform. -Issues related to the 340B Drug Pricing Program -Issues related to implementation of the Inflation Reduction Act of 2022 (Public Law No. 117-169). -Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub. L. 117-169. -Issues related to low volume Diagnosis Related Groups (DRGs) and rare therapies. -Issues related to the Medicaid Drug Rebate Program -CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure. -Centers for Medicare and Medicaid Innovation (CMMI) policy issues. -Medicare patient access to rare disease therapies, Part B and Part D drugs. -Medicaid (Medicaid Drug Rebate Program) stacking issues. -Value-based payment arrangements. -Efforts to improve coding, coverage, and access for rare disease therapies. -General issues related to diagnostic reimbursement. -S. 2085, the Medicare Multi-Cancer Early Detection Screening Coverage Act -H.R. 3876 Access to Genetic Counselor Services Act of 2023. -HR 5539, Orphan Cures Act (expanding orphan drug exclusion in IRA) -Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language), Medicare negotiation and Medicare Part D reform and redesign and inflation penalties. -Issues related to the orphan drug exclusion of the Inflation Reduction Act. -Issues related to reauthorization of the Pandemics and All-Hazards Preparedness Act (PAHPRA). General issues related to rare disease and orphan drugs. -General issues related to health equity in rare disease and clinical trials. -General issues related to diagnostics for patients with rare diseases. -PBM reform -FDA modernization policy issues -FDA reform initiatives -Reauthorization of newborn screening programs. -H.R. 5539 ORPHAN Cures Act.
CPT - Copyright/Patent/Trademark TAX - Taxation/Internal Revenue Code PHA - Pharmacy MMM - Medicare/Medicaid HCR - Health Issues
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