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$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Posted in Fraud & Abuse, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP).  Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to submit accurate ASP data to CMS. ASP reporting was adopted in large part to create a mechanism whereby government drug reimbursement rates for biologics… Continue Reading

Mintz Levin’s Health Care Qui Tam Update

Posted in Fraud & Abuse, Long-term Care/Skilled Nursing Facilities, Payors & PBMs, State & Federal Audits, Investigations & Litigation, Uncategorized

Mintz Levin’s Health Care Enforcement Defense Practice has published its most recent Qui Tam Update, highlighting two qui tam cases unsealed in November and December of 2014 and giving an overview of the other 17 cases unsealed during the same time period. Mintz Levin’s analysis of the 19 total unsealed cases revealed that almost half… Continue Reading

Reported Compliance Problems: The Six Stages of Corporate Grief

Posted in Fraud & Abuse, Home Health & Hospice, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

Last week, I had the honor of participating in a panel discussion about how health care entities deal with reported compliance concerns at the ABA’s 16th Annual Conference on Emerging Issues in Healthcare Law. The panel was made up of experienced health care attorneys with broad and long-standing health care experience: Richard Westling, current First… Continue Reading

GAO Report Highlights Improper Medicare/Medicaid Payments

Posted in Fraud & Abuse, Payors & PBMs, Physicians, State & Federal Audits, Investigations & Litigation

Despite the efforts of the Department of Health and Human Services (HHS) to combat fraud and contain costs in federal healthcare programs, Medicare’s fee-for-service program (Parts A and B)  and Medicaid were two of the top three culprits for the billions reported to have been improperly paid by the federal government in fiscal year 2014. … Continue Reading

MA Risk Adjustment in the 2016 Call Letter and … in Health Care Fraud Charges

Posted in Fraud & Abuse, Health Care Reform, Payors & PBMs, Physicians, Reimbursement, State & Federal Audits, Investigations & Litigation

In past Call Letters, CMS has proposed and finalized significant changes to the Medicare Advantage risk adjustment system including, recalibrations, deletions and additions of diagnoses codes, and questioning of the value of in-house health risk assessments. This year’s Call Letter did not include any major changes to risk adjustment, but nevertheless the Call Letter  includes important risk adjustment information… Continue Reading

In Case You Missed It: Health Care Enforcement in 2015 Webinar

Posted in Fraud & Abuse, Hospitals & Health Systems, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, State & Federal Audits, Investigations & Litigation

Earlier this month, Mintz Levin’s Hope Foster and Bridget Rohde hosted a webinar entitled “Health Care Enforcement in 2015: A Look Back on 2014 and Forecasting the Year Ahead.” A video recording of the webinar, along with an accompanying PDF, can be found below. The webinar provides a detailed look back on the health care enforcement… Continue Reading

Device Manufacturer Settles False Claims Act Allegations with DOJ for $1.25 Million

Posted in Fraud & Abuse, Hospitals & Health Systems, Payors & PBMs, Reimbursement, State & Federal Audits, Investigations & Litigation

The Department of Justice (DOJ) recently announced that ev3 Inc. (which acquired Fox Hollow Technologies, Inc. (“Fox Hollow”), a medical device manufacturer, in late 2007) agreed to pay $1.25 million to resolve allegations that Fox Hollow violated the False Claims Act (FCA) by causing certain hospital clients to submit false claims to the Medicare program…. Continue Reading

7th Circuit Court of Appeals Creates Expansive Definition of “Referral” Under the Anti-Kickback Statute

Posted in Fraud & Abuse, Home Health & Hospice, Physicians, State & Federal Audits, Investigations & Litigation

On February 10, 2015, in United States v. Patel (Case No. 14-2607), the Seventh Circuit Court of Appeals ruled that a physician makes a “referral” within the meaning of the federal health care programs Anti-Kickback Statute (AKS) when the physician makes a certification and recertification for Medicare-reimbursed home health services even without playing any role… Continue Reading

Health Care Enforcement in 2015: A Look Back at 2014 and Forecasting the Year Ahead

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Written by: Bridgette A. Wiley The US Department of Justice (DOJ), the Department of Health and Human Services’ Office of Inspector General (OIG), and other federal and state agencies continued to focus on health care enforcement as a top priority in 2014.  Companies in the health care industry were subject to steep monetary penalties and… Continue Reading

OIG Defends Its Hospital Compliance Reviews in Response to AHA Criticism

Posted in Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

Written by: Daria Niewenhous and Sarah Beth Smith The Office of the Inspector General for the Department of Health and Human Services(“OIG”) responded to concerns expressed by the American Hospital Association (“AHA”) regarding the OIG’s hospital compliance reviews, particularly regarding Medicare Part A.  In a letter released publicly on January 22, 2015, the OIG defended its… Continue Reading

Pharmacy Qui Tam Based On U&C Price Billing Survives Motion to Dismiss

Posted in Fraud & Abuse, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Reimbursement, State & Federal Audits, Investigations & Litigation

Written by: Ellyn L. Sternfield Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D billings resulted in falsely inflated claims to those programs. And once… Continue Reading

You’re Invited: Tips for Surviving a HIPAA Audit

Posted in Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation

Written by: Samantha P. Kingsbury On Wednesday January 28th, my colleague Dianne Bourque (a member in Mintz Levin’s Health Law practice), will be presenting a webinar on how to survive a HIPAA audit.  As luck would have it, January 28th is also international Data Privacy Day. With the New Year in full swing, the HHS… Continue Reading

Mintz Levin Attorneys Discuss Top Health Care Fraud Issues to Watch in 2015

Posted in Fraud & Abuse, Home Health & Hospice, Hospitals & Health Systems, Pharma & Medical Devices, State & Federal Audits, Investigations & Litigation

Bloomberg BNA recently published a Health Care Fraud Report entitled Outlook 2015: Uptick Expected in Stark, Anti-Kickback FCA Cases, Self-Disclosures, which examines the top issues for health care providers and suppliers to watch in 2015.   My colleagues Tom Crane and Larry Freedman were quoted extensively in the article, and they discussed a broad range of… Continue Reading

Missed the Webinar Covering the Attorney-Client Privilege? Here’s a Link.

Posted in Clinical Laboratories, Fraud & Abuse, Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, Pharma & Medical Devices, State & Federal Audits, Investigations & Litigation

My colleagues Susan Berson, Karen Lovitch, and I hosted a webinar on December 16, 2014 entitled “Practical Tips for Health Care and Life Sciences Companies to Protect the Attorney-Client Privilege.”  A link to the recorded presentation can be found here. In the webinar, we: Provided an overview of attorney-client privilege considerations particular to the health care and life… Continue Reading

Provider Beware: HIPAA and State Privacy Laws May Inform Negligence Suits

Posted in Physicians, Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation

Written by:  Stephanie D. Willis A recent opinion from the Connecticut Supreme Court illustrates that HIPAA is not the only law that covered entities and business associates must worry about if an unauthorized disclosure of protected health information (PHI) happens on their watch. In Emily Byrne v. Avery Center For Obstetrics and Gynecology PC (Docket… Continue Reading

Federal Judge Awards Attorneys’ Fees to Defendant in Dismissed Qui Tam Case, Calls Whistleblower a “Serial Relator”

Posted in Fraud & Abuse, Pharmacies, State & Federal Audits, Investigations & Litigation

Written by: Ellyn L. Sternfield and Samantha P. Kingsbury In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor.  Fox filed one of those cases against OmniCare, Inc.,… Continue Reading

Health Care Enforcement Defense Practice Publishes Most Recent Qui Tam Update

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Our Health Care Enforcement Defense Practice has published its most recent Qui Tam Update analyzing 68 recently unsealed health care related whistleblower cases. In this issue, the team analyzes overall trends in the 68 cases, and looks more closely at three notable cases. First we review a settlement that resulted in Arizona’s largest-ever False Claims Act recovery – the… Continue Reading

Hospital Executive Pleads Guilty to False Meaningful Use Attestation for EHR Incentive Payments

Posted in State & Federal Audits, Investigations & Litigation

Written by: Sarah Beth Smith and Laurence J. Freedman The former CFO of Shelby Regional Medical Center, Joe White, pleaded guilty to knowingly making a false statement related to the hospital’s meaningful use of electronic health records (“EHR”).  Shelby Regional had received $785,655 in meaningful use incentive payments from Medicare for fiscal year 2012. White faces sentencing of… Continue Reading

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & Litigation

Written by: Laurence J. Freedman and Samantha P. Kingsbury Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food and Drug Administration (FDA); and (2) conspiring to defraud… Continue Reading

Hospital Alliance Deemed a Single Entity, Incapable of Conspiring

Posted in Antitrust, Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

On October 21, 2014, the U.S. District Court for the Southern District of Ohio granted Defendants’ motion for summary judgment, holding that Premier Health Partners and its affiliate hospitals, Atrium Health Systems, Catholic Health Initiatives, MedAmerica Health Systems, Samaritan Health Partners, and Upper Valley Medical Center, operating under a joint operating agreement, constituted a single… Continue Reading

Managing Antitrust Risks in Pre-Transaction Planning

Posted in Health Care Reform, Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, Payors & PBMs, Pharma & Medical Devices, Physicians, State & Federal Audits, Investigations & Litigation

Dynamic changes in the nation’s health care delivery systems have been prompted, in part, by the implementation of the Patient Protection and Affordable Care Act (“ACA”).  In the wake of the ACA, hospitals and other health care industry participants have been undergoing significant consolidation.  Health care antitrust enforcers continue to closely scrutinize health care transactions… Continue Reading

Fraud and Abuse Waivers for MSSP ACOs Extended Another Year

Posted in Accountable Care Organizations, Fraud & Abuse, Physicians, State & Federal Audits, Investigations & Litigation

Written by:  Stephanie D. Willis 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 regarding applicable fraud and abuse law waivers for ACOs participating in the Medicare Shared… Continue Reading

Mintz Levin’s Health Care Qui Tam Update

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Written by: Kimberly J. Gold Mintz Levin’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides a broad overview of 65 recently unsealed health care–related qui tam cases, with an in-depth look at six cases. The six featured cases are: United States ex rel. Fox Rx, Inc. v. Managed Health Care… Continue Reading

Supreme Court Examines Boundaries of Antitrust Immunity

Posted in Antitrust, State & Federal Audits, Investigations & Litigation

On October 14, 2014, the US Supreme Court heard oral arguments in North Carolina State Board of Dental Examiners v. FTC, a Fourth Circuit decision upholding an FTC finding that the North Carolina State Board of Dental Examiners did not qualify for antitrust immunity after excluding non-dentists from providing teeth-whitening services. The question under consideration… Continue Reading