Florida law takes on clinical laboratory self referral and kickbacks

This is great news that Florida is going after fraudulent clinical laboratory practices!  It will be interesting to follow how this affects Florida’s health care spending situation.  Obviously I hope this can be used as an example for other states to crack down on these abuses nationwide.

SAN DIEGO, March 10, 2012 – Millennium’s vigorous support of legislation helps move state closer to cleaning up abusive practices in lab industry; flagrant violators are “out of options and must comply”

SAN DIEGO, March 10, 2012 /PRNewswire-USNewswire/ – Millennium Laboratories praised theFlorida legislature for sending SB 1292 to Governor Rick Scott for signature after it passed with overwhelming margins in both Houses.  The law addresses a comprehensive list of issues related to the Florida Agency for Health Care Administration (AHCA), which, among other responsibilities, regulates clinical laboratories operating in the state.  A critical component of this legislation is that it puts the full force of government behind the effort to stop certain laboratories from misusing health care dollars and putting physicians and their patients at risk.

The primary relevant provisions of the new legislation are:

  • Converting an often-abused AHCA regulation into broad statutory language outlawing the placement of laboratory personnel in physician offices under any circumstances.
  • Rooting out another common kickback scheme by aligning Florida’s statutes with  Federal Stark and anti-kickback laws and prohibiting a clinical laboratory from leasing space in a physician’s office or otherwise paying “rent” to the physician in return for better access to patients and office staff.
  • Authorizing fines of $5,000 for each separate violation and/or revocation of the laboratory’s state license upon two violations.
  • Referring unlicensed laboratories operating in the state to local law enforcement as a second degree misdemeanor and fines in an amount not to exceed $5,000 per day.

“This legislation sends a clear message: whether you are based in Nashville TN, Baltimore MD or Woburn MA, when you conduct business in Florida, you must play by the rules,” said Howard Appel, President of Millennium Laboratories.  “With this passage, flagrant violators are out of optionsNo longer will reckless laboratories be able to use these particular tactics in Florida to mislead unsuspecting physicians and put honest doctors and their patients at risk.”

Passage of this new legislation was motivated by the practices of several clinical laboratories, which include the placement of laboratory employees inside physician offices to induce those physicians to exclusively refer testing services to them.  This practice is especially prevalent in the pain medication monitoring industry, and is of major concern to the Legislature.  Some laboratories further flaunted existing regulations by paying “rent” to physicians and claiming that the portion of the office where laboratory employees worked was “leased” and therefore not  technically in the physician’s office.  When AHCA issued multiple warnings, regulatory clarifications, and cease and desist letters to curtail this illegal behavior, these practices continued.  One laboratory even filed a lawsuit against AHCA to prevent enforcement of its own regulations.  Senior lawmakers recognized that a swift and powerful legislative solution was in order.

“States like Florida are increasingly taking bold steps to stem the proliferation of kickbacks and inducements that put physicians at risk, harm patient care, and waste heath care dollars.  While we applaud Florida’s actions today, practices such as leasing space in physician offices and similar blatant kickbacks are of national concern. The U.S. OIG and responsible members of Congress are taking note and beginning to take action,” said Appel. “We will continue this fight until all laboratories play by the same set of ethical rules.”

Millennium’s vigorous support for the passage of this legislation is reflective of a broader initiative to highlight ethics and compliance in the industry.  On February 2nd, the company called on all clinical diagnostic laboratories to immediately adopt OIG guidelines for clinical laboratories, and announced a grant to Dr. Richard Payne, Professor of Medicine and Divinity, Duke University to chair a stakeholder’s summit to establish clear and specific standards to which each laboratory can be held accountable.  Millennium’s Commitment to Compliance policy is publicly available on the company website at www.millenniumlabs.com.

http://www.sacbee.com/2012/03/09/4326555/millennium-laboratories-applauds.html

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  1. Breaking–Millennium Labs sold to LabCorp–Triangle Business Journal | The Pathology Blawg says:

    [...] it is official:  LabCorp bought Millennium Laboratories.  I have posted about Millennium before (here and here and here).  In addition, I have a post written but not yet published about a court case [...]

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