On July 31, 2014, the Food and Drug Administration (“FDA”) announced that it would begin regulating laboratory developed tests (LDTs). According to the FDA, LDTs are designed, manufactured, and used within a single lab, and include some genetic tests and tests that are used by various health care professionals. These tests are developed by hospitals, academic, and clinical laboratories in response to unmet clinical needs to ensure patients receive the best possible care. The FDA considers these tests to be medical devices.
Author Archives: Jeffrey Sherrin
O’Connell & Aronowitz attorneys, Jeffrey Sherrin, Kurt Bratten, and Charles Dunham, spoke at a national meeting of clinical laboratories in Las Vegas on May 19, on the complicated issue of referrals to and billing by out- of-network (OON) clinical laboratories, and the waiver of patient responsibility. Waivers of copays, deductibles and balance billing have been used increasingly by OON labs to compete for the business of patients who have OON benefits. Labs may be shut out of networks because of exclusive provide agreements or closed panel, or they may find that reimbursement is actually greater as an OON lab and choose not to seek to participate with individual plans. Many OON labs market that patients will be treated no differently than if they went in-network labs, meaning usually that they will not be billed for any patient responsibility for balance billing or other costs that they would not have if their specimens were tested by an in-network lab.
These billing practices have come under tremendous and aggressive scrutiny by federal and state prosecutors, state regulatory agencies, third-party payers with their special investigations units, and competitors. Our attorneys presented a comprehensive review of all activities going on around the country, including criminal investigations or prosecutions, litigation brought by third-party payers, the most active being Aetna Health, and litigation and complaints between competitor labs. They also explained the respective interests of all involved parties to the debate over the legality of waivers or limitations of patient responsibility — those of patients, in-network labs, out-of-network labs, third-party payers, and state governments — as well as a review of key states’s laws that come into play. Continue reading
A Virginia physician has become the first person criminally indicted under the Health Insurance Portability and Accountability Act (HIPAA) for communicating with a former patient’s employer.
According to the United States Attorney for the Eastern District of Virginia, Dr. Richard Kaye, the former Medical Director of the Psychiatric Care Center at Sentara Obici Hospital in Suffolk, Virginia, revealed protected health information on three separate occasions when he contacted a former patient’s employer and expressed his view that the former patient posed “a serious and imminent threat to the safety of the public.” Dr. Kaye’s three alleged criminal violations occurred in February 2008. Dr. Kaye discharged the patient in September 2007 because, according to his discharge summary, the patient was stable and posed no threat. Continue reading
On May 16, 2011 the US Supreme Court resolved a split among federal circuits and ruled in Schindler Elevator Corp. v. United States ex rel. Kirk that a federal agency’s response to a Freedom of Information Act (FOIA) request amounts to a “report” within the False Claims Act’s (FCA) pre-PPACA public disclosure bar and therefore cannot form the independent basis of an FCA claim. Continue reading
Several years ago, O’Connell and Aronowitz formed a Healthcare Fraud and Abuse Unit as an adjunct to its well-established health law practice. The Healthcare Fraud and Abuse Unit focuses on all fraud and abuse issues, both civil and criminal, that impact health care providers. Recently, the unit was expanded with the addition of Richard A. Harrow, Esq. Mr. Harrow was a prosecutor for 27 years in the New York State Attorney General’s Medicaid Fraud Control Unit, where his positions included serving as Regional Director of the New York City and Albany offices. The work of this unit includes representation in federal and state criminal investigations and prosecutions, private payer investigations, and all payor overpayment and fraud audits and litigation, including Office of Medicaid Inspector General audits. Continue reading
O’Connell and Aronowitz continues its rapid growth to its health care and criminal law practices with the addition of Richard S. Harrow, Esq. Mr. Harrow was a prosecutor in the New York State Attorney General’s Medicaid Fraud Control Unit for 27 years, where his positions included serving as Regional Director for the NYC Region and as Regional Director in the Albany office. Mr. Harrow has investigated and prosecuted hundreds of Medicaid fraud and patient abuse cases, including “Operation Home Alone,” where he was the lead prosecutor for then Attorney General Andrew Cuomo’s top to bottom investigation of the homecare industry. His work resulted in over 100 criminal convictions of home health aides, licensed health care agencies, schools, nurses, and $40 million in restitution. Mr. Harrow’s recoveries for New York State are among the largest in U.S. history. Continue reading