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340B Program Omnibus Guidance Withdrawn

The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The...more

OIG Rings in the New Year With New Anti-Kickback Statute Safe Harbors

Just in time for the New Year, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued final regulations (Final Regulations) that revised two existing Anti-Kickback Statute safe...more

California’s End of Life Option Act: Key Requirements and Considerations

On June 9, 2016, California’s End of Life Option Act (the “Act”) will go into effect. The Act authorizes an adult who is suffering from a terminal disease and meets other qualifications to request an aid-in-dying drug that...more

Recent EHR Meaningful Use Program Updates

As we enter the sixth year of the Medicare and Medicaid Electronic Health Records Incentive Programs (commonly referred to as the “Meaningful Use Programs”), the Centers for Medicare & Medicaid Services (CMS) continues to...more

OIG Releases Compliance Guidance for Health Care Governing Boards

The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released new compliance guidance for health care governing boards, attorneys, compliance officers and internal auditors on...more

CMS Releases Stage 3 Meaningful Use Proposed Rule

The Centers for Medicare & Medicaid Services (“CMS”) released the Stage 3 proposed rule to the Medicare and Medicaid Electronic Health Records Incentive Programs (“Proposed Rule”) on March 20, 2015. To provide context,...more

How to Prepare Your Hospital or Medical Practice for a Meaningful Use Audit

For the past several years, the Centers for Medicare and Medicaid Services (“CMS”) has incentivized hospitals and eligible professionals to adopt and make “meaningful use” of certified electronic health records (“EHR”)...more

GAO Issues Report on Post-Payment Claims Reviews by CMS Contractors

The U.S. Government Accountability Office (GAO) recently issued a report entitled “Medicare Program Integrity: Increased Oversight and Guidance Could Improve Effectiveness and Efficiency of Post-Payment Claims Reviews,” which...more

CMS and OIG Issue Final Regulations to Extend the Stark Exception and Anti-Kickback Statute Safe Harbor for EHR Donations

On December 27, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of Inspector General (OIG) finalized amendments to the Physician Self-Referral Law (Stark) and...more

CMS and OIG Issue Proposed Rules Modifying the Stark Exception and Anti-Kickback Safe Harbor for Donation of EHR

On April 10, 2013, the Centers for Medicare and Medicaid Services (CMS) and the Office of the Inspector General of the U.S. Department of Health and Human Services (OIG) each published proposed rules in the Federal Register...more

First-Ever HIPAA Settlement Involving Fewer Than 500 Patients Announced

On January 2, 2013, the U.S. Department of Health and Human Services (HHS) announced a settlement with the Hospice of North Idaho (HONI) for potential HIPAA violations....more

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