News & Analysis as of

340B Drug Pricing Program Update: Hospital Recertification and Recent Audit Activity

As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more

HRSA Clarifies 340B Orphan Drug Exception But 340B Audit Enforcement Remains Murky

Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on...more

DOL Audits Of Employer-Sponsored Group Health Plans Now Include Healthcare Reform Compliance

The U.S. Department of Labor (the "DOL") has recently enhanced its enforcement activities with respect to group health plans by significantly increasing the number of audits it is conducting. In addition, the DOL's audit...more

Investigations/Audits Of Employers By DOL Increase And Expand In Scope

The Department of Labor (DOL) routinely investigates and audits employers to ensure compliance with a variety of important labor and employment laws. Historically, wage and hour (overtime) compliance under the Fair Labor...more

DOL Audit Letters Requesting Proof of Compliance with Health Care Reform Requirements

The U.S. Department of Labor (DOL) audits already evaluate a company’s compliance on a spectrum of laws, statutes and regulations. However, the DOL has updated and revamped its audit letter to now also capture compliance...more

CMS Publishes Annual Update On Recovery Audit Activity, Says Program Returned Nearly $490 Million to Medicare Trust Fund in 2011

On February 5, 2013, CMS sent Congress a report summarizing developments related to its Medicare recovery audit program for fiscal year (FY) 2011. According to the report (titled Recovery Auditing in the Medicare and...more

Are You Ready? HIPAA Audits Are Here.

As part of health care reform, the federal government mandated that a pilot HIPAA audit program (the “HIPAA Audit Program”) be developed to ensure compliance with HIPAA’s privacy and security rules and its breach notification...more

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