Tag Archives: safe harbors

OIG Moving Ahead on Changes to Anti-Kickback Safe Harbor Protection for Drug Rebates to Plans, PBMs

On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB) for regulatory review a proposed rule entitled “Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor … Continue Reading

OIG Invites Anti-kickback Safe Harbor, Fraud Alert Recommendations

The HHS Office of Inspector General (OIG) has published its annual solicitation of recommendations for new or revised anti-kickback statute safe harbors and new Special Fraud Alerts. The OIG states that in considering any recommendations, it will seek to determine potential financial benefits to health care providers in ordering or referring health care services. The … Continue Reading

OIG Issues Annual Solicitation of Suggestions for New Fraud Alerts, Anti-Kickback Safe Harbors

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) is inviting public recommendations for new or modified safe harbor provisions under the federal anti-kickback statute.  The OIG also invites suggestions for new OIG Special Fraud Alerts to provide guidance to health care providers regarding “practices OIG finds potentially fraudulent … Continue Reading

OIG Issues CMP, Anti-kickback Safe Harbor Final Rules

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS (Final Rule). … Continue Reading

HHS OIG Invites Suggestions for New Fraud Alerts, Anti-Kickback Safe Harbors

On December 23, 2015, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published its annual notice soliciting recommendations for new or modified, safe harbor provisions under the federal anti-kickback statute. The notice also invites suggestions for new OIG Special Fraud Alerts.  The OIG will accept proposals until February … Continue Reading

OIG Issues Fall 2015 Semiannual Report to Congress

The HHS Office of Inspector General (OIG) has issued its Semiannual Report to Congress covering April 1 – September 30, 2015. The report summarizes significant OIG audits, investigations, and enforcement activities during this period and includes key accomplishments for the full fiscal year (FY) 2015. According to the report, the OIG expects recoveries of about … Continue Reading

HHS OIG “Reminder” about Information Blocking & the Federal Anti-Kickback Statute

The HHS Office of Inspector General (OIG) recently released a “Policy Reminder” on how “information blocking” — defined by HHS as knowingly and unreasonably interfering with the exchange or use of electronic health information — may affect protection under the regulatory electronic health records (EHR) safe harbor to the federal anti-kickback statute (AKS).… Continue Reading

Annual OIG Solicitation of Anti-Kickback Safe Harbor, Fraud-Alert Topic Proposals

Today the HHS Office of Inspector General (OIG) published its annual solicitation of recommendations for new or modified safe harbor provisions under the federal anti-kickback statute, as well as potential topics for new OIG Special Fraud Alerts. Comments will be accepted until March 2, 2015. In a separate report, the OIG discusses three safe harbor proposals … Continue Reading

Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS. Reed Smith has prepared a Client Alert analyzing the proposed rule, highlighting areas where the OIG is seeking public comment. Overall, the OIG appears to recognize that new health care delivery mechanisms demand a more flexible approach to fraud and abuse enforcement than has been the case in the past, as discussed in our analysis.… Continue Reading

OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing

The OIG has just released a major proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rule to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the anti-kickback statute.  In particular, with regard to the AKS, the OIG proposes: a technical … Continue Reading

OMB Clears OIG Proposed Rule on Anti-Kickback Safe Harbors, CMPs for Beneficiary Inducements & Gainsharing

The Office of Management and Budget (OMB) has cleared an HHS Office of Inspector General (OIG) proposed rule that would expand the OIG’s Medicare and state health care program fraud and abuse authorities. Specifically, on September 4, 2014, the OMB gave final regulatory clearance to an OIG proposed rule that would add new anti-kickback safe … Continue Reading

Reed Smith Client Alert: CMS/OIG Extend Protections for Electronic Health Record Donations

As previously reported, the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) published final rules in December amending Anti-Kickback Statute (AKS) and Stark Law regulations permitting certain arrangements involving the donation of interoperable electronic health record (EHR) software or information technology and training services.  Reed Smith has prepared a … Continue Reading

OIG Seeks Anti-Kickback Safe Harbor, Fraud-Alert Topic Proposals

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published its annual solicitation of recommendations for new or modified safe harbor provisions under the federal anti-kickback statute, as well as potential topics for new OIG Special Fraud Alerts.  Comments will be accepted until February 25, 2014. For a … Continue Reading

Final Rules Issued Extending Protections of Electronic Health Record Donations

On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements related to the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. Among these amended regulations was the extension of protections of the Stark law exception and the Anti-Kickback safe harbor from December 31, 2013 to December 31, 2021 (the "sunset" provisions).… Continue Reading

Obama Administration’s Regulatory Agenda Points to Busy 2013 for HHS

On January 8, 2013, the Obama Administration published its latest semiannual regulatory agenda, outlining planned regulatory initiatives in a number of policy areas. The Federal Register version of the agenda includes only a portion of the regulations in the pipeline, however; the full agenda has been posted on the Office of Management and Budget (OMB) web … Continue Reading
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