News & Analysis as of

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

OIG Proposes Amendments to the Electronic Health Records Safe Harbor

The Office of the Inspector General (OIG) for the Department of Health and Human Services announced and solicited comments to proposed rule changes to the Electronic Health Records Safe Harbor (EHRSH) under the federal...more

CMS and OIG Propose Extension of Federal Stark Exception and Anti-Kickback Safe Harbor for Electronic Health Record Donations

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

IRS Issues Proposed Regulations for Employer-Shared Responsibility under ACA

On December 28, 2012, the IRS issued proposed regulations with respect to employer-shared responsibility regarding health coverage under the Affordable Care Act of 2010 (ACA). Employers are permitted to rely on these proposed...more

The Affordable Care Act’s “Play Or Pay” Mandate: How It Works

The Affordable Care Act added the so-called “Play or Pay” mandate or “Employer Shared Responsibility” provisions to the Internal Revenue Code (the Code). Starting in 2014, certain employers may be subject to a penalty tax,...more

IRS Releases Proposed Regulations on the Affordable Care Act's Play or Pay Mandate

On January 2, 2013, the Department of Treasury and Internal Revenue Service (collectively “IRS") published proposed regulations ("Proposed Regulations") on the Affordable Care Act's employer shared responsibility provisions,...more

Wellness Programs: Keeping Up With the Times

On November 20, 2012, the IRS, DOL and HHS jointly issued proposed regulations under the Affordable Care Act building on existing HIPAA regulations of wellness programs. The new proposed regulations provide clearer guidance...more

OCR Releases De-Identification Guidance

The HHS Office of Civil Rights (OCR) recently released guidance intended to assist covered entities in understanding what de-identification is, the general process by which de-identified information can be created, and the...more

OCR Issues Guidance On HIPAA Privacy Rule’s De-Identification Standard

On November 26, 2012, the Department of Health and Human Services Office for Civil Rights (“OCR”) published a thirty-two page document titled “Guidance Regarding Methods for De-identification of Protected Health Information...more

Office of Civil Rights Releases Guidance on De-Identification of PHI Under HIPAA Privacy Rule

On November 26, 2012, the Department of Health and Human Services Office for Civil Rights (OCR) released long-overdue guidance on how covered entities subject to the Health Insurance Portability and Accountability Act (HIPAA)...more

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