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CMS Proposes Regulations Implementing the Mandatory 60-Day Overpayment Disclosure Requirement Print E-mail
Written by Lester Perling   
Sunday, 22 April 2012 00:00

On February 16, 2012, the Centers for Medicare & Medicaid Services ("CMS") released a proposed regulation regarding Medicare provider obligations to report and return overpayments (the "Proposed Regulation"). Under the Proposed Regulation, providers are required to report and return an "overpayment" within the later of (a) 60 days after the overpayment is "identified," or (b) the date any corresponding cost report is due, if applicable. An "overpayment" is defined as any funds a person received or retains under Medicare or Medicaid to which the person, after "applicable reconciliation," is not entitled. An improperly retained overpayment constitutes an "obligation" under the federal civil False Claims Act, which imposes liability upon any person who knowingly conceals or knowingly and improperly avoids or decreases an obligation to the government. Each unpaid obligation under the False Claims Act could result in a civil penalty of anywhere between $5,000 and $10,000 per obligation (adjusted by inflation) and three times the damages suffered by the United States. Providers who fail to comply with the 60-day rule may also be subject to Medicare and Medicaid exclusion and civil monetary penalties under the federal Civil Monetary Penalty statute.

Read More.

Last Updated on Monday, 23 April 2012 07:13
WHAT IS TELEMEDICINE? Federal & Florida State Law Implications Print E-mail
Written by Troy A. Kishbaugh and Sarah L. Mancebo   
Friday, 13 April 2012 16:35

Telemedicine, generally, is the use of information technologies to transmit and exchange medical information between individuals via electronic means to provide health care services. Essentially, telemedicine brings technology to medicine for the treatment of individuals when the individual and the health care practitioner are not in the same physical location.

Incorporating technology into medicine can improve health care by maximizing resources, efficiency and expertise in the field. Common examples of telemedicine technologies include real-time videoconferencing with a physician located at a remote site, exchanging and transmitting still medical images via computers, remote monitoring of vital signs and the exchange of e-mail. Telemedicine is cutting edge because it oftentimes eliminates the traditional in-person patient visit with a physician and requires the health care provider to rely on a patient history report and/or audio/video information to treat an individual instead of a physical examination. Therefore, prior to engaging in telemedicine, health care providers must be aware of the legal restrictions and implications that arise.

The Centers for Medicare & Medicaid Services ("CMS") use the term "telehealth" for telemedicine. Telemedicine for CMS means "multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. Telephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system."

States across the country also define telemedicine. Florida, however, does not define telemedicine in its statutes. Despite the absence of a statutory definition, the State of Florida Board of Medicine has taken the position that to engage in telemedicine, the physician and the patient must first have an in-person, face-to-face encounter prior to any telemedicine services being provided. Further, there are certain regulatory rules in Florida that address telemedicine prescribing requirements and patient medical record documentation.

Specifically, physicians and physician assistants, when providing treatment recommendations, including the issuance of prescriptions via electronic means, must meet the following requirements:
  • A documented patient evaluation, including history and physical examination to establish the diagnosis for which any legend drug is prescribed.
  • Discussion between the physician and the patient regarding treatment options and the risks and benefits of treatment.
  • Maintenance of contemporaneous medical records that meet the requirements of Florida law.

For more information on telemedicine under federal and state law, please contact Troy A. Kishbaugh and Sarah L. Mancebo with GrayRobinson's Health Law Team.

Last Updated on Friday, 20 April 2012 10:43
Navigating the Evolving Regulation and Commercialization of Stem Cell Research Print E-mail
Written by   
Monday, 09 April 2012 09:30

Interested parties that can successfully navigate the evolving regulation of stem cell research stand to gain significant scientific and commercial advantage. Given that in the fall of 2011 the Court of Justice of the European Union issued a highly anticipated ruling regarding the patentability of human embryonic stem cells (hESCs) and many await the outcome to an appeal challenging the U.S. National Institutes of Health's ability to fund hESC research, interested parties are encouraged to conduct a thorough assessment of their intellectual property portfolios and evaluate their current funding sources.

Read the full article here
IFPMA Releases Revised Code for Interactions with Health Care Professionals and Other Stakeholders Print E-mail
Written by   
Friday, 30 March 2012 10:37

On March 1, 2012, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) issued a Code of Practice relating to interactions with the health care community, which replaces and expands upon its 2006 Code of Pharmaceutical Marketing Practices. In this newsletter, we summarize some of the key changes between the new IFPMA code and its 2006 predecessor, and discuss certain implications of these revisions for pharmaceutical companies, including those with significant operations in the United States.

Read the full article here.
The Impact of Medical Device Fraud on Physicians' Practices Print E-mail
Written by Dave Restaino   
Friday, 16 March 2012 08:53
A recent U.S. Department of Justice (DOJ) settlement with a medical device manufacturer highlights the need for physicians to pay close attention to their dealings with medical device companies. The settlement, announced in December, calls for the payment of $23.5 million to resolve allegations that a medical device manufacturer was manipulating post-market studies to improve the results and to encourage doctors to increase usage of the company's products.  

Click HERE to see DOJ Press Release.

Click HERE to see Medtronic Press Release.

Specifically, the company was allegedly paying per-patient kickbacks of $1,000 to $2,000 to doctors in order to encourage the use of company medical devices in lieu of competitors' devices. Because the fees were payable only when the company's devices were used, the DOJ was concerned that the ultimate goal was to discourage the use of other devices.

Because the law imposes criminal liability upon both sides of a situation involving illegal kickbacks [See Section 1128B of the Social Security Act, 42 U.S.C.1320a-7b], the consequences are enormous, and can include:

-A felony conviction;
-Criminal fines and civil penalties;
-Prison; and
-Exclusion from federal health care programs.

Although there are regulatory "safe harbors" that specify certain acceptable situations, it is nevertheless imperative that medical professionals monitor their practice to ensure that all physicians avoid situations where the use of medical devices is essentially conducted on a "pay-to-play" basis.

Finally, keep in mind that the DOJ investigation was triggered by company whistleblowers, which serves as an ever-present reminder that internal compliance programs are an essential tool in the fight against fraud.

 Dave Restaino is a partner at Fox Rothschild, LLP in Princeton, NJ.
Last Updated on Monday, 19 March 2012 08:06
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