News & Analysis as of

CMS Releases Final Rule That Increases Difficulty of Medicare Enrollment

In early December, CMS released a final rule that implements certain provider (i.e., Hospitals, SNFs, physicians, etc.) and supplier (i.e., DME companies, etc.) enrollment requirements (“Rule”). The goal of CMS’...more

CMS Final Rule Adds More Arrows but also Demonstrates Restraint

CMS reconsiders $10 million bounties for reporting of regulatory violations. On December 5, the Centers for Medicare & Medicaid Services (CMS) finalized a rule (the Final Rule) that expands its program integrity and...more

With a New Year Rolls in a New OIG Work Plan

Recently, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released its Work Plan for Fiscal Year 2015 (“Work Plan”). The OIG protects the integrity of HHS programs by identifying...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

OIG Again Approves Medicap Insurer's Contract with Preferred Hospital Network

On October 21, 2014, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 14-10, approving a Medigap insurer’s proposed contract with a preferred hospital network. Similar to...more

OIG Identifies Top 10 Management Challenges for HHS in Fiscal Year 2014

On November 18, 2014, the HHS OIG released its annual list of the top 10 management and performance challenges faced by HHS and the OIG during the current fiscal year, and the new and emerging issues that the OIG anticipates...more

Is Provider-Based Reimbursement Going Away?

We get this question every year: will Medicare, Medicaid or other payors continue to recognize hospital-level facility fee reimbursement for hospital outpatient departments meeting the provider-based designation criteria at...more

SRDP No Longer New Wine

More than four years after the Centers for Medicare & Medicaid Services' (CMS) issuance of the Stark Self-Referral Disclosure Protocol (SRDP), it's time to assess the results. The SRDP was designed by Congress to resolve...more

HHS OIG Announces Information Security Initiatives in 2015 Work Plan

The 2015 Work Plan of the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted on Friday, October 31, 2014, includes initiatives focused on testing information security controls related to...more

OIG Releases Its Workplan for 2015

HHS’s Office of Inspector General (OIG) released on Friday its Work Plan for fiscal year (FY) 2015. The 94-page work plan summarizes the new and ongoing reviews and activities that OIG plans to pursue across the full spectrum...more

Key Takeaways from OIG’s 2015 Work Plan

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to...more

Another Halloween Treat: the OIG’s 2015 Work Plan

On Halloween the Office of Inspector General (OIG) of Health & Human Services released its “Work Plan Fiscal 2015.” The 90-page document is meant to tell the public, and especially health care providers paid by Medicare and...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

Blog: HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more

Fraud and Abuse Waivers for MSSP ACOs Extended Another Year

Fridays are for fraud and abuse news-related releases, yet again. Last Friday, the HHS Office of the Inspector General (OIG) released a notice (Notice) informing the public that it has delayed the release of a final rule...more

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more

Hospital Settles Provider-Based Compliance Investigation for $3.3 Million

A New York State hospital has agreed to pay the U.S. Department of Justice more than $3.3 million to resolve an investigation conducted by the HHS-OIG and U.S. Attorney’s Office for the Northern District of New York into...more

Health Law Alert: OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors and Civil Monetary Penalty Rules

The Department of Health and Human Services Office of Inspector General (OIG) recently released a proposed rule that revises safe harbors under the Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) rules regarding...more

Blurring the Lines between False Claims Act Litigation and Putative Federal Malpractice Law: The DOJ Quietly Invokes “Worthless...

On October 10, 2014, the United States Department of Justice (“DOJ”) announced a civil settlement agreement (the “Settlement”) with Extendicare Heath Services, Inc. and its subsidiary Progress Step Corporation (collectively,...more

Medicare Shared Saving Program Interim Final Rule Extended

On October 17, 2014, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services, Office of Inspector General (OIG) published in the Federal Register (79 FR 62356 et seq) a notice...more

OIG Announces Proposed AKS and CMP Regulations

On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly...more

OIG Proposed Anti-Kickback Safe Harbors and CMP Regulations: The End of Frustration or Just the Beginning?

On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...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

OIG Releases Proposed Rule Adding New Safe Harbors to the Anti-Kickback Statute

Last week, the HHS OIG released a proposed rule published in the October 3 Federal Register that would add new safe harbors to the Anti-Kickback Statute and expand the list of conduct exempt from civil monetary penalties...more

FDA Regulatory and Compliance Monthly Recap - September 2014

In This Issue: - FDA sends warning letters to companies that made claims on social media that their products treat, cure Ebola, marking the first time the agency singles out Pinterest - OIG issues special...more

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