White gift box wrapped with vibrant red bow and ribbon isolatedOn Dec. 7, 2016, the U.S. Department of Health & Human Services Office of Inspector General (OIG) released an update to its 2000 policy regarding gifts of nominal value given to a Medicare or Medicaid beneficiary. The update increases the nominal value of gifts given to a Medicare or Medicaid beneficiary to $15 per occurrence and $75 in the aggregate for a year (the previous limit was $10 per occurrence and $50 in the aggregate). If a gift complies with these limits, the arrangement does not need to fit within a “safe harbor” to 42 U.S.C. §1320a-7b(b) (the federal anti-kickback statute).
Continue Reading OIG updates policy regarding gifts of nominal value

Due diligence is often perceived as a mundane part of the mergers & acquisitions (M&A) process, but its importance in healthcare transactions is critical. Due diligence is one of the first steps of any transaction and involves a buyer undertaking an in-depth examination of the target to evaluate the business and uncover potential issues or liabilities. In the healthcare industry, diligence is especially important considering the heavy regulation of the industry, the unique areas of risk, and the significant liabilities that could be imposed upon a buyer if issues and liabilities are not identified before the transaction closes.
Continue Reading Unique Considerations in Healthcare M&A Part 1 – Due Diligence

Under HIPAA rules, covered entities are required to report breaches of unsecured protected health information (PHI) to the Secretary of the Office of Civil Rights (OCR). The deadline for reporting breaches of PHI discovered during 2014 that affected fewer than 500 individuals is March 1, 2015.
Continue Reading Deadline for HIPAA breach notification approaching

The jury in the Tuomey case (U.S. ex rel. Drakeford v. Tuomey Healthcare Systems, Inc.) returned a verdict in favor of the government yesterday, May 8, 2013.  As is well known, this is the re-trial of a case centered on a series of employment agreements that Tuomey Healthcare entered to allegedly capture referrals

On April 17, 2013, the Office of Inspector General (OIG) updated the OIG’s self-disclosure protocol (SDP).  This update significantly revises the SDP first published in 1998, and supersedes the OIG’s related open letters to providers from 2006, 2008 and 2009. To date, the OIG has processed 235 settlements and monetary recoveries in excess of $280

In its Semi-Annual Report to Congress, OIG announced that expected recoveries for FY 2012 are $6.9 billion.  The $6.9 billion consists of $923.8 million in audit receivables and $6 billion in investigative receivables.  The investigative receivables include criminal restitution, settlements pursuant to False Claims Act (FCA) cases and Civil Monetary Penalty (CMP) actions, and

On September 25, 2012, two members of the Husch Blackwell Healthcare team, Brian Bewley and David Pursell, presented a webinar discussing:

  • An overview of Stark
  • Stark overpayment reporting requirements
  • Steps to take after discovering a potential Stark violation

As former Senior Counsel in the Office of Inspector General for Health and Human Services and

On June 18, 2012, the Office of Inspector General for the Department of Health and Human Services (OIG) published a notice in the Federal Register seeking comments and recommendations on how best to revise its self-disclosure protocol to make it more useful in today’s health care regulatory environment. This should come as welcome news to the healthcare provider community because OIG’s protocol was first established in 1998, when the healthcare fraud enforcement landscape was much different. Specifically, the government’s investigation and pursuit of health care fraud has substantially increased over the last 14 years. 1998’s total recoveries from health care fraud of under $500 million compared to last year’s total recoveries of $4.1 billion are good evidence of that change.

The Federal Register notice mentions that since 1998, OIG has resolved over 800 disclosures and recovered over $280 million to the Federal health care programs. These high numbers are likely due in large part to the benefits health care providers and practitioners derive from self-disclosing, namely a lower multiplier on damages (approximately 1.5) and no requirement for a Corporate Integrity Agreement (CIA) in exchange for OIG’s highly sought after exclusion release. For cases settled after an affirmative investigation by the government – rather than a voluntary disclosure – healthcare providers should expect OIG, usually in conjunction with the Department of Justice (DOJ), to demand at least a 2.0 multiplier on the single damages (overpayment) amount. As an example, if the government determines that you received $500,000 in reimbursement that you were not entitled to, OIG would likely settle the self-disclosed matter for a 1.5 multiplier, or $750,000.  However, if the settlement is pursuant to an affirmative investigation and not a voluntary disclosure, OIG and DOJ would likely demand at least “double damages,” or $1 million.Continue Reading OIG-HHS Seeking to Improve Self-Disclosure Protocol

Another major drug company agreed to settle with the Department of Justice (DOJ). GlaxoSmithKline LLC (GSK) agreed to pay a historic $3 billion and plead guilty to resolve its alleged criminal and civil liability arising from the company’s promotion of certain prescription drugs, failure to report certain safety data, and its civil liability for alleged