Science, Computers & Technology, Health Law, Government Contracting

PODs Beware: OIG Releases Special Fraud Alert

by Matthew Murer | Polsinelli on 5/10/2013

The Office of the Inspector General (OIG) released a Special Fraud Alert on March 26, 2013 warning that physician-owned distributorships (PODs) are "inherently suspect" under the Anti-Kickback Statute (AKS). Generally...more

OIG Unveils Updated Self-Disclosure Protocol

by George Breen, Jason Christ, Anjali Downs, Jennifer Goodwin, David Matyas, Deepa Selvam, Carrie Valiant | Epstein Becker & Green, P.C. on 4/23/2013

In 1998, the Department of Health and Human Services' Office of Inspector General ("OIG") published the Self-Disclosure Protocol ("SDP"), which provides a mechanism through which health care providers may voluntarily report...more

White Collar Watch - April 2013

by Bruce D. Armon, Andrea P. Brockway, Michael Finio, Christopher R. Hall, Keith Lorenze, Nicholas J. Nastasi, Courtney L. Schultz, Brian Simons | Saul Ewing LLP on 4/23/2013

In This Issue: - Third Circuit Panel Liberalizes “Protected Activity” Immunity for Employees Claiming Whistleblower Status - Doing Time: A Requirement for White Collar Crime? - Casting a Smaller Net:...more

OIG Special Fraud Alert Labels Physician-Owned Distributorships (PODs) as “Inherently Suspect”

by Dennis Diaz, Sarah S. Fallows | Davis Wright Tremaine LLP on 4/22/2013

The U.S. Department of Health & Human Services, Office of Inspector General (the “OIG”) issued a Special Fraud Alert (“Alert”) on March 26, underscoring its heightened focus on fraud and abuse risks posed by physician-owned...more

OIG Updates Provider Self-Disclosure Protocol

by B. Scott McBride, Summer Swallow | BakerHostetler on 4/19/2013

On April 17, 2013, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a revised Provider Self-Disclosure Protocol (SDP) that clarifies the process for healthcare providers, suppliers...more

340B Drug Pricing Program: Recent Developments

by Elizabeth Elson, Anil Shankar | Foley & Lardner LLP on 4/19/2013

The 340B Drug Pricing Program (340B Program) continues to undergo a period of intense scrutiny and debate over how compliance with program rules is enforced. As previously reported in the May 30, 2012 edition of Foley’s Legal...more

Alabama Legislative Update – Week 7: Medicaid Reform Takes the Stage as the Battle for Education Continues

by Denise Killebrew, Dennis Nabors | Baker, Donelson, Bearman, Caldwell &... on 3/26/2013

As the Alabama Legislature marked the halfway point of the 2013 Regular Session, progress continued to move at a slow pace where repercussions of the Alabama Accountability Act continue to linger in the halls of the...more

CMS Focuses on Fraud Associated with Increased Use of Electronic Health Records

by Tom Crane | Mintz Levin - Health Law on 3/22/2013

Acting CMS Administrator, Marilyn Tavenner, recently reaffirmed the agency’s concern that the increased use of electronic health records (“EHRs”) has contributed to increases in fraudulent billing practices by providers. At a...more

CMS to Deny Claims When Ordering/Referring Provider Not Enrolled in Medicare

by Joan Polacheck, Monica Wallace | McDermott Will & Emery on 3/20/2013

Effective May 1, 2013, the Centers for Medicare & Medicaid Services (CMS) will begin to deny Part B Durable Medical Equipment (DME) and Part A Home Health Agency (HHA) claims for services or supplies when the...more

CMS Issues Rules On Physician Payments Sunshine Act

by Michael Volkov on 3/15/2013

People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more

Big Changes Are Happening With the 340B Drug Program

by Ellyn L. Sternfield | Mintz Levin - Health Law on 3/6/2013

Things are drastically changing for covered entities under the 340B program. In the last 18 months several factors have led the Health Resources and Services Administration (HRSA) to ramp up its oversight and auditing of...more

Health Care Enforcement in 2012: A Year in Review

by Hope Foster, Samantha Kingsbury, Tracy Miner, Jessica Sergi, Stephanie Willis | Mintz Levin - Health Law on 2/26/2013

Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more

False Press Release Leads To Exclusion From Federal Programs

by Robert Rose | Sheppard Mullin Richter & Hampton LLP on 2/20/2013

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

10 Fraud and Abuse Enforcement Trends You Can't Afford to Ignore in 2013

by Cory Fox, Gregory Saikin | BakerHostetler on 2/15/2013

To paraphrase a famous quote, "Those who do not learn from history are doomed to repeat it," and providers who ignore the significance of the federal government's healthcare fraud enforcements efforts in 2012 do so at their...more

Health Reform + Related Health Policy News Update - February 6, 2013

by Colleen M. Faddick, Bruce A. Johnson, Matthew Murer, Alan K. Parver | Polsinelli on 2/7/2013

In This Issue: - Top News ..CMS Announces Round 2 Competitive Bidding Single Payment Amounts ..CBO Lowers SGR Repeal Cost by $100 Billion ..Republicans Press HRSA on 340B Audits ..HHS Proposes...more

DOJ Recovers Up To $48 Million in False Claim Act Case Resulting From Whistleblower Report

by Sigal Mandelker, Massiel Pedreira | Proskauer - Whistleblowing & Retaliation on 1/24/2013

In yet another large recovery for the DOJ, on December 6, 2012, DFB Pharmaceuticals, and its subsidiary, Healthpoint Ltd., agreed as part of a settlement to pay up to $48 million to resolve allegations that Healthpoint caused...more

Chinese MOH Announced Centralized Procurement of High Value Medical Consumables

by Katherine Wang | Ropes & Gray LLP on 1/18/2013

On December 17, 2012, the Ministry of Health (“MOH”) issued the Tentative Guidelines for Centralized Procurement of High Value Medical Consumables (the “Guidelines”) with immediate effect, with an aim to control health care...more

CMS Seeks Comments on Hospital Readiness for EHR Hospital Inpatient Quality Data Reporting

by King & Spalding on 1/15/2013

CMS is seeking comments from hospitals, electronic health record (EHR) vendors, and other interested parties regarding whether hospitals could be ready as early as January 1, 2014, to electronically report patient-level...more

Audits, Audits And More Audits: Life In The Healthcare Industry

by Michael Volkov on 1/13/2013

Healthcare suppliers and service providers live in a regulated world. They are constantly under audit scrutiny. Sometimes federal agencies (i.e private contractors) conduct the audits; other times state agencies conduct the...more

Conflict of Interest in Research Regulations: Is Your Institution Compliant with the New Rules?

by Aaron Rabinowitz, Sarah E. Swank | Ober|Kaler on 12/20/2012

Although the Department of Health and Human Services (HHS) issued the final conflict of interest rule last year, many entities conducting research that is funded under Public Health Service (PHS) grants, cooperative...more

Health Law Alert: Federal Research Grant Recipients Face False Claims Lawsuit

by Ober|Kaler on 6/1/2012

Many of the high-profile False Claims Act (FCA) cases against the health care industry have involved allegations that false claims for payment were submitted for items or services provided to Medicare or Medicaid...more

OIG Publishes Fiscal Year 2012 Work Plan

by King & Spalding on 10/11/2011

Last week, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published its work plan for the 2012 fiscal year in which it described its primary objectives for the year. We identify below, by...more

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Science, Computers & Technology › Health Law › Government Contracting