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FDA Issues Exemptions from November 27, 2024 Compliance Deadline for Updated DSCSA Requirements

On Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements.  The exemptions followed...more

Health Care Reimbursement and Payor Dispute Update Special Edition – Year End Regulatory Review

The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule - On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare...more

Changes Coming For Prescribers To The Texas Prescription Drug Monitoring Program

In response to the opioid epidemic, many states, including Texas, created prescription drug monitoring programs to monitor high-risk patients and provider behaviors. The Texas Prescription Drug Monitoring Program (“PMP”) is...more

Med-Staff Newsletter - April 2019 | VOL 2

Polsinelli is pleased to share the Med-Staff Quarterly Newsletter. This publication contains articles and insight into issues that affect the Med-Staff industry. ...more

OIG Approves Warranty Program for Bundled Products Used in Joint Replacement Surgery

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently released Advisory Opinion 18-10, which approved a proposed arrangement involving a manufacturer of medical devices and wound care...more

OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

Recently, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) issued an Advisory Opinion (17-02) that allows for waivers or reductions of cost-sharing amounts owed by financially needy...more

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