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What Pharmacies Need to Know About the “Know the Lowest Price Act” and the “Patients’ Right to Know Drug Prices Act”

Two recently enacted federal laws important to pharmacies, the "Know the Lowest Price Act" and the "Patients' Right to Know Drug Prices Act" were recently signed into law. The laws are designed to remove vagueness in pharmaceutical pricing and to eliminate gag clauses in provider agreements between pharmacy benefit managers (PBMs) and pharmacies. Such gag clauses would prevent a pharmacist from disclosing to the patient that the copayment exceeded the cash price of...

How Hospitals Can Prepare for S-10 Audits

As of October 1st, Disproportionate Share Hospital (DSH) eligible hospitals must now submit patient-level records for encounters that result in uncompensated charity care reported on their S-10 worksheets. Worksheet S-10 compliance is critical as the Centers for Medicare and Medicaid Services (CMS) has reiterated that there is no better proxy for the costs of hospitals for treating individuals who are uninsured despite stakeholder concerns over "inconsistent reporting" and "inadequate and unreliable...

OIG Issues Final Rule Revising and Introducing New Safe Harbors Under the Anti-Kickback Statute

In 2014, the Department of Health and Human Services' (HHS) Office of Inspector General (OIG) first announced modifications to existing federal Anti-Kickback Statute (AKS) safe harbors and the beneficiary inducement prohibition in the Civil Monetary Penalty rules (CMP Law). The OIG published a final rule on December 7, 2016. The Final Rule becomes effective on January 6, 2017. Revisions to Anti-Kickback Statute Safe Harbors The modifications would codify statutory changes...

Hospital HIPAA Breach Highlights the Value of a Thorough Risk Assessment

Recently, a university hospital reached a settlement of potential violations of the Health Insurance Portability and Accountability Act (HIPAA) following an investigation of a breach of unsecured Protected Health Information (PHI). PHI of nearly 1,700 individuals was impermissibly disclosed when the hospital's network was attacked by a malware virus; the hospital did not have an acceptable firewall in place. In accordance with HIPAA regulations, the hospital disclosed the breach in...