Safe Harbors Dept. of Health and Human Services

News & Analysis as of

OIG Approves Lease of Employees to Psych Hospital

On July 28 the Office of Inspector General (OIG) of Health & Human Services gave its blessing to a health system’s lease of employees to a related psychiatric system. Under the arrangement the system would also provide...more

21st Century Cures Act – Provisions Relating to Digital Health: Interoperability and Information Blocking

On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the “bill”) by a vote of 344-77. In addition to increasing medical research funding and expediting the process of making breakthrough...more

Employee Benefits Developments - June 2015

Supreme Court: Plan Fiduciaries Have a Continuing Duty to Monitor Plan Investments. In 2007, participants and beneficiaries under a 401(k) plan sued the plan fiduciaries and the plan sponsor to recover damages for alleged...more

Obama Administration Seeks Comments on Proposed Changes to Summary of Benefits and Coverage Document and Requirements

On December 30, 2014, the Departments of Health and Human Services, Labor, and the Treasury (collectively, “Departments”) issued a proposed rule (“Proposed Rule”) regarding the summary of benefits and coverage (“SBC”) for use...more

Blog: HHS OIG Releases Annual Solicitation for New and Modified Anti-Kickback Safe Harbors and for New Special Fraud Alerts

On December 29, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released its annual solicitation (the “Solicitation”) for proposals and recommendations for developing new and modifying...more

HHS to Audit Hospital Reporting of GPO Payments: GAO Report Suggests Further Scrutiny of GPO Shareback with Hospitals

On November 24, 2014, the Government Accountability Office (“GAO”) published a report examining the contracting practices and funding structures of health care group purchasing organizations (“GPOs”) and their potential...more

Monthly Benefits Update - November 2014

U.S. Supreme Court Grants Review of ACA Case Involving Premium Subsidies Offered Through Federally Facilitated Exchanges - The Supreme Court granted review in King v. Burwell, a Fourth Circuit case that upheld an IRS...more

GPO Fees Under Scrutiny by the GAO

Last week, the Government Accountability Office (GAO) released a report examining group purchasing organization (GPO) practices. The GAO questioned whether the current structure of GPO funding through administrative fees is...more

Health Law Pulse - October 2014 # 2

In This Issue: - OIG Releases Proposed Rule Revising the Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules ..AKS Safe Harbors ..Revisions to the Civil Monetary Penalty...more

HHS Proposes New Anti-Kickback Safe Harbors

On October 3, 2013 the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) published a proposed rule (“PR”) entitled: Medicare and State Health Care Programs: Fraud and Abuse; Revisions...more

OIG Releases New Proposals on Anti-kickback Statute Safe Harbors, Exceptions to the CMP Law and the Gainsharing Prohibition

On October 3, 2014, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a long-awaited proposed rule for implementing amendments to safe harbors under the Anti-kickback Statute and...more

HHS Proposes New Safe Harbor Rules, Revises Others

Last week the Department of Health & Human Services ("HHS") issued a proposed rule amending the safe harbor regulations promulgated under the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b). The proposed rule would...more

HHS Office of Inspector General Proposes Expansions of Anti-Kickback Safe Harbors and Civil Monetary Penalties Law Exceptions

On October 3, 2014, the Office of the Inspector General (the “OIG”) of the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would amend regulations implementing the federal anti-kickback...more

Blog: OIG Releases Proposed Rule re: Beneficiary Inducements and Gainsharing Revisions

The Health and Human Services Office of Inspector General (OIG) released today a proposed rule titled, Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and...more

Monthly Benefits Update - July 2014

Two federal appeals courts issued contradictory rulings on the validity of subsidies for the purchase of health insurance under the federal marketplace established pursuant to the Affordable Care Act (ACA). On July 22, a...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

EHR Donation Exception and Safe Harbor Modified and Extended through 2021

On December 27, 2013, the Centers for Medicare & Medicaid Services and the Office of the Inspector General, both of the Department of Health and Human Services, issued closely coordinated rules (“Final Rules”) extending the...more

Final EHR Donation Rules Issued in Time for the New Year

On December 27, 2013, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) issued final rules revising the Stark exception (42 CFR...more

Health Care Law Update: Anti-Kickback Safe Harbor Rule for Electronic Health Records Extended Through 2021

The anti-kickback safe harbor concerning electronic health records (EHR) items and services, which defines certain conduct that is protected from liability under the federal anti-kickback statute (Section 1128B(b) of the...more

Texas to Launch Nation's First Privacy and Security Certification "Safe Harbor"

The Texas Health Services Authority (THSA) recently announced its selection of the Health Information Trust Alliance (HITRUST) Common Security Framework (CSF), the most widely adopted information privacy and security...more

Electronic Health Records Donations: Proposed CMS And OIG Rules Revise Stark Exception And Anti-Kickback Safe Harbor

On April 10, 2013, the Centers for Medicare & Medicaid Services (‘‘CMS'') and the Office of the Inspector General of the Department of Health and Human Services (‘‘OIG'') published twin proposed rules that amend and extend...more

Health Care Reform Implementation Update - April 26, 2013

Marilyn Tavenner received bipartisan support from members of the Senate Committee on Finance in her confirmation hearing to lead the Centers for Medicare and Medicaid Services (CMS) though a full Senate vote is being held up,...more

CMS and OIG Propose Changes to the Electronic Health Records Exception and Safe Harbor

On April 10, 2013, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of Inspector General (“OIG”) published parallel proposed rules revising, respectively, the Stark...more

HHS Extends Sunset Date for Stark Exception and Anti-Kickback Safe Harbor for EHR Donations

The Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services issued proposed rules that would extend the sunset date for the Stark Law exception and the federal Anti-Kickback Statute safe...more

CMS, OIG Propose to Extend EHR Stark Exception and Anti-Kickback Safe Harbor

On April 10, 2013, CMS and the HHS Office of Inspector General (OIG) each published proposed rules to extend the sunset dates for the Stark exception and anti-kickback statute safe harbor permitting donations of EHR software...more

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