News & Analysis as of

How the Kirtsaeng Decision Could Ruin the U.S. Branded Drug Industry

The Constitution gives Congress the power to grant copyright and patent protection in the same part of Article I, specifically in Section 8, Clause 8...more

Health Care Update - November 2014 #3

In This Issue: - 21st Century Cures Remains Top Bi-Partisan Priority for 2015 - Senate Passes Critical Access Hospital Direct Supervision Bill - Implementation of the Affordable Care Act - Other...more

Blog: DOJ’s Record Year for FCA Recoveries Includes $2.3 Billion for Health Care Fraud

The Department of Justice (DOJ) announced this week that it recovered a record $5.69 billion in civil False Claims Act (FCA) settlements during fiscal year 2014. This recovery included $2.3 billion for FCA cases involving...more

Eleventh Circuit Limits Scope of FCA Whistleblower Suit

Late last month, a three-judge panel of the Eleventh Circuit Court of Appeals reinstated portions of a former executive’s False Claims Act (“FCA”) whistleblower action against Health Management Associates Inc. (“HMA”),...more

Meaningful Use Attestations - Be Careful of What You Attest To

Under the American Recovery and Reinvestment Act of 2009, eligible health providers who demonstrate “meaningful use” of certified electronic health record (EHR) technology can qualify for incentive payments under the Medicare...more

Government turns up the heat with the False Claims Act – 5 action steps for healthcare providers

Forbes magazine has dubbed 2014 “The Year of the Whistleblower.” For healthcare providers, this designation has translated into millions of dollars in fines and penalties and the initiation of criminal investigations. ...more

DOJ Criminal Division Renews Efforts to Investigate Whistleblower Allegations

The Department of Justice (DOJ) has signaled a heightened effort to bring criminal prosecutors into the loop regarding False Claims Act referrals and other whistleblower complaints. In recent remarks at a conference comprised...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

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

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

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

Deadline Approaching to Secure Health Plan Identifier (“HPID”)

Certain group health plans are required to obtain a 10-digit Health Plan Identifier ("HPID") from the Center for Medicare and Medicaid Services ("CMS") by November 5, 2014. Currently various users of the health care system...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

Seventh Circuit Reaffirms Worthlessness of Worthless Services Cases

In August the Seventh Circuit expressed its view that so-called “worthless services” cases don’t state a claim under the False Claims Act. Last Friday the court reaffirmed its view by refusing to rehear the case en banc....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

CMS to Modernize Home Health Regulations - Proposed rule targets quality of care, more flexible procedures

On October 9, 2014, the Centers for Medicare and Medicaid Services (CMS) issued a Proposed Rule revising current conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the...more

Whistleblower Goes It Alone to Secure $5 Million Settlement under False Claims Act

The potential success of a whistleblower lawsuit filed under the False Claims Act (FCA) is significantly reduced when the government fails to intervene because such cases are often assumed to lack merit. However, a plaintiff...more

Sometimes the Government is Here to Help: OIG Proposes More Flexibility in Rules Governing Local Transportation, Beneficiary...

The U.S. Department of Health & Human Services, Office of Inspector General ("OIG") just released a proposed rule (“Proposed Rule”) that provides long awaited guidance on patient transportation services, relaxes the...more

Medicaid ACOs: States’ Answer to Escalating Costs?

States increasingly are experimenting with the use of Accountable Care Organizations (ACOs) in their Medicaid programs as a possible avenue to curb the escalating costs of providing care to expanding Medicaid populations....more

CMS Announces Launch of Open Payments Database: $3.5 Billion Paid to Physicians and Teaching Hospitals

The Open Payments database (the “Database”) is now live, and the first round of data is available to the public on the Centers for Medicare and Medicaid Services (“CMS”) website. This first round of data reflects “nearly 4.4...more

Amid the Sunshine, Controversy Lingers: The Release of CMS's "Open Payments" System

In a March 2013 post on the Insider blog, we noted the issuance by the Centers for Medicare and Medicaid Services (CMS) of a long-awaited final rule mandating the collection of information regarding payments that drug and...more

Health Reform + Related Health Policy News - September 2014, Issue 1

In This Issue: - Top News ..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections ..Physician Supervision Requirement for Small and Rural Hospitals ..CMS Offers Hospitals...more

CMS Releases MSSP and Pioneer ACO Data on Shared Savings and Losses – Where Do We Go From Here?

On September 16, 2014, the Centers for Medicare & Medicaid Services (CMS) announced key shared savings and losses results of Accountable Care Organizations (ACOs) that began participating in the Medicare Shared Savings...more

Corridors Fall 2014 - News for NC Hospitals

In this issue: - North Carolina’s Medicaid RAC Program – Don’t Let Your Guard Down - A Primer on Medicare Requirements for Physician Supervision of “Incident to” Services - Hospital Options for Unused...more

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