Tag Archives: anti-kickback statute

OIG blesses digital health substance use disorder treatment program paid for by providers and suppliers

The Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued a favorable advisory opinion to a digital health company that offers direct monetary incentives to patients as part of a technology-enabled contingency management program for patients with substance use disorders. Contingency management, also known as motivational incentives, is a treatment approach … Continue Reading

OIG approves arrangement encouraging device study enrollment for economically disadvantaged Medicare beneficiaries

In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical device manufacturer to pay Medicare-reimbursable costs for subjects enrolled in a clinical trial sponsored by the manufacturer and involving the manufacturer’s therapy. The OIG indicated it would not impose administrative sanctions, despite the fact … Continue Reading

AdvaMed announces revisions to code of ethics for interactions with health care professionals

On March 18, 2022, the Advanced Medical Technology Association (AdvaMed) – the world’s largest trade organization representing medical technology manufacturers – announced revisions to its Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code). The effective date of the revised AdvaMed Code is June 1, 2022. The AdvaMed Code was updated to address … Continue Reading

OIG permits home health agency to pay nurse aide certification tuition costs

In its February 14, 2022 advisory opinion the Department of Health and Human Services Office of Inspector General (OIG) allowed a Home Health Agency (HHA), that predominantly serves Medicaid eligible children, to pay the nurse certification program tuition costs for new employees seeking to work as certified nurse aides (CNAs). According to OIG, the tuition … Continue Reading

OIG approves arrangement involving a testamentary gift to a nonprofit hospital to reduce costs for pediatric patients

On February 4, 2022, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a favorable advisory opinion on a proposal by a nonprofit children’s hospital to enter into an arrangement with two individual donors, who intend on making a testamentary gift to the hospital that would be used to reduce and … Continue Reading

Pending investigations/cases no longer prevent OIG advisory opinions

The Department of Health and Human Services’ Office of Inspector General (OIG) will be lifting its long-standing refusal to accept requests for advisory opinions if the request describes a course of action that is “the same or substantially the same” as a course of action that is either under investigation by OIG, or is the … Continue Reading

Future of discount safe harbor for prescription drugs remains uncertain

In November 2020, four months after the Trump Administration issued a series of Executive Orders reiterating its policy goals on reducing the costs to consumers for prescription drugs and directing the Department of Health and Human Services, Office of Inspector General (“HHS-OIG”) to implement those policy objectives, HHS-OIG issued a Final Rule to amend certain … Continue Reading

HHS-OIG approves uniform chiropractic discount program for federal beneficiaries

Andrew and Quynh are law clerks at the firm and their work is supervised by licensed attorneys. Their admission to – respectively – the Washington, D.C. and California bar is pending. On October 4, 2021, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposal … Continue Reading

Health Care Provisions in the Infrastructure Investment and Jobs Act

On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684.  The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021.  The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the … Continue Reading

Final Rules Modernizing Stark Law and Anti-Kickback Statute Released

The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute. As we wrote when the proposed rules were released last autumn (see client alerts here and here), the … Continue Reading

OIG Accepting Recommendations for New Anti-kickback Safe Harbors and Fraud Alerts

The HHS Office of Inspector General (OIG) has issued its annual solicitation of recommendations for new or revised Anti-kickback Statute (AKS) safe harbors and new Special Fraud Alerts.  In reviewing proposed safe harbor changes, the OIG will consider the extent to which the proposals would increase or decrease: Access to health care services Quality of health … Continue Reading

OIG, CMS Propose Changes to Stark, Anti-Kickback Rules to Promote Value-Based Arrangements:  Reed Smith Analysis

As previously reported, the Department of Health and Human Services has published highly anticipated proposed changes to align the regulations under the Physician Self-Referral Law, the federal Anti-Kickback Statute, and the Civil Monetary Penalties Law with value-based health care arrangements.  Reed Smith is providing a series of client alerts and teleseminars that analyze key aspects … Continue Reading

Proposed Rules to Modernize Stark Law and Anti-Kickback Statute Released Today

Today, the Department of Health and Human Services (HHS) announced proposed changes to modernize the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the Federal Anti-Kickback Statute. In a press release, HHS states these proposed rules are intended to “provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated … Continue Reading

HHS OIG Pulls CMP, Safe Harbor Proposed Regs Pending for More Than a Decade

Seeking to “eliminate any confusion,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has formally withdrawn proposed civil money penalty (CMP) and anti-kickback (AKS) safe harbor regulations that it no longer intends to finalize.  Specifically, the OIG is withdrawing: A 1994 proposed rule that would have codified the … Continue Reading

HHS Scraps Pending Rule to Remove Anti-Kickback Safe Harbor Protection for Drug Rebates to Health Plans, PBMs

The Trump Administration has decided against finalizing a controversial proposed Office of Inspector General (OIG) regulation that would have modified Federal Anti-Kickback Statute safe harbor protection for certain prescription drug rebates to health plans and pharmacy benefit managers (PBMs).  As we previously reported, the proposed rule would have (i) removed safe harbor protection for drug … Continue Reading

OMB Reviewing OIG Proposed Rule Amending Federal Anti-kickback and Beneficiary Inducement Policies to Promote Value-Based Care

The White House Office of Management and Budget (OMB) is reviewing a long-awaited Trump Administration proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute to better support coordinated care.  The proposed rule presumably builds on the related request … Continue Reading

OIG’s Proposed Drug Pricing Safe Harbor Amendments: “Hot Takes”

Late yesterday, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a proposed rule to amend the anti-kickback safe harbors[1] in response to perceived risks that rebates paid by pharmaceutical manufacturers to payors and pharmacy benefit managers (PBMs) may contribute to pharmaceutical list price inflation and not benefit … Continue Reading

OIG Invites Comments on Potential Changes to Federal Anti-kickback and Beneficiary Inducement Policies to Promote Value-Based Care

The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) has issued a request for information (RFI) on ways to amend or add new safe harbors to the Anti-Kickback Statute and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty statute, in order to foster arrangements that promote care … Continue Reading

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
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