letters & comments

Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making; Public Workshop

02/03/2020 Read More

Health and Human Services’ Transparency in Coverage Proposed Rule

01/30/2020 Read More

Medicare and State Healthcare Programs: Fraud and Abuse; Revisions To Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

12/31/2019 Read More

Centers for Medicare & Medicaid Services’ (CMS’) Proposed Medicare Program Rule; Modernizing and Clarifying the Physician Self-Referral Regulations

12/31/2019 Read More

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

12/18/2019 Read More

Congressional Efforts to Address Drug Pricing – Prescription Drug Pricing Reduction Act (PDPRA)

12/17/2019 Read More

Letter to Representatives DeGette & Upton on the “Cures 2.0” Initiative

12/16/2019 Read More

2020 Proposed Changes to Institute for Clinical and Economic Review’s (ICER) Framework

10/18/2019 Read More

2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies

09/27/2019 Read More
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