Compliance Update

The Government Is No Friend to Investigated Physicians Print E-mail
Written by Jeffrey Cohen, Esq.   
Thursday, 03 November 2011 08:25

Healthcare reform aside, physicians are increasingly buried under the weight of nonstop regulatory scrutiny and compliance requirements.  Even the most compliant physician will find, however, that the government is no gentleman when it comes to efforts to ferret out wrongdoing.

Physicians are most commonly confronted with the regulatory process by a phone call from an investigator or perhaps a written request for information.  Board of Medicine issues usually begin with the so called "45 day letter," which invites a physician suspected of wrongdoing to submit a written response to an allegation of wrongdoing.  EMTALA violations are reported to the Department of Health and the Office of Inspector General, both of which will initiate contact with the physician in writing.

Though physicians may think a simple explanation will convince an investigator or attorney to back off, that is seldom the case.  Physicians wrongly think that the point of such investigations is to determine the truth.  They must instead accept that, once investigators and prosecuting lawyers have contacted them, there is already a belief that wrong doing has occurred.  Physicians would do well to understand that the job of the investigator and prosecutor involves just two things:  (1)  Seeing if the physician's response is so convincing as to cause them to reevaluate their suspicion (it seldom is); and (2) to see if they think they have enough to justify a prosecution.  The investigator and prosecutor have a job, to find wrongdoing and to punish it!  They are not philosophers or social workers.  They are not counselors to have a really nice conversation with.  They are not to be trusted because their job is at odds with physicians who are the targets (or even witnesses) of their investigations.  If physicians can remember one thing, it is that they need the support of lawyers and others who know their way over this unfriendly terrain.

Innocent physicians caught in the investigative/prosecutorial process may feel impatient and frustrated.  "I've done nothing wrong, so surely if I just tell the truth everything will be ok."  It's just not that way; and it's just not that simple!  Discussions with the government will take time and will require patience.  What physicians have to keep in mind is that, though they are innocent until proven guilty, if they are targets of an investigation, the investigator and prosecutor already suspect them of wrongdoing.  It's a bit of an uphill climb!

Remarkably, even the best legal representation will not necessarily resolve matters quickly.  By the time physicians are aware they are being investigated, in many instances months have been spent working that case, and prosecutors are simply not inclined to immediately walk away from all that hard work.

Surprising still is that prosecutors will try to get a settlement, even when your lawyer tells you there is no wrongdoing.   Recall that the prosecutor has a job-find the bad guy and win the case.  If the prosecutor can get you to settle, particularly by paying money, they will call it a "win" and move on to the next case.  It is nauseating but true that sometimes it makes sense to settle, even when there is no wrongdoing, given the legal and related expenses.  But when settling is not an option because it causes a cascade of unacceptable consequences (e.g. a Board of Medicine investigation, a medical malpractice suit, becoming sanctioned by Medicare and perhaps even losing medical staff membership and managed care contracts), physicians have no option but to fight.

Probably most surprising, physicians who vigorously defend themselves may find that they never "win."  That is, they are never told by a prosecuting lawyer that the government is giving up.  Physicians who have been the targets of government investigations will find that the sound of victory is often silence.  Government prosecutors simply get quiet!  You just stop hearing from them.

The best physician defendant is one well armed with guidance to traverse an inherently adversarial environment.

With over 20 years of healthcare law experience following his position as legal counsel for the Florida Medical Association, Mr. Cohen is board certified by The Florida Bar as a specialist in healthcare law. His practice immerses him in regulatory, contract, corporate, compliance and employment related matters.  Mr. Cohen is the founder of The Florida Healthcare Law Firm. | 888-455-7702
Last Updated on Thursday, 10 November 2011 11:14
"New Start" Reviews and Activities Affecting Post-Acute Providers in OIG's 2012 Work Plan Print E-mail
Written by   
Wednesday, 26 October 2011 00:00
   The Office of Inspector General recently released its work plan for fiscal year 2012, which includes a number of "new start" reviews and activities that it plans to pursue during the next 12 months and beyond with respect to U.S. Department of Health & Human Services programs affecting post-acute providers.

Read the full article here.    Source:
Last Updated on Thursday, 27 October 2011 09:54
Ways & Means Committee Holds Hearing on Hospital Consolidation and Physician Integration Print E-mail
Written by Jeffrey Herschler   
Wednesday, 12 October 2011 00:00

One of the primary objectives of the recently enacted health reform legislation was to promote hospital and physician alignment, coordination and integration.  Unsurprisingly, hospitals and physicians have responded to these new incentives with increased merger activity and other integration strategies.  Now, in an unexpected twist, the usually business-friendly, Republican-controlled U.S. House of Representatives Committee on Ways and Means is examining consolidation activity within the health industry to determine the effect these transactions are having on efficiency and health care costs.

Read the full article here  


Last Updated on Thursday, 13 October 2011 09:57
Consignment Closets: Still a Viable Option for DME Providers Print E-mail
Written by Albert R. Meyer & Jeffrey L. Cohen   
Wednesday, 07 September 2011 16:50

In the age of heightened regulatory scrutiny, physicians and other health care providers often question whether "Consignment Closet" relationships are legal.  If properly structured these arrangements are not only legal but are of great benefit to patients needing valuable medical devices.  A properly structured relationship will, in all probability, withstand a regulatory challenge by the Office of Inspector General or from other regulatory authorities. 

Consignment Closets or "Stock and Bill" arrangements are used by many durable medical equipment, prosthetics and orthotics suppliers ("DMEPOS").  The DMEPOS supplier places inventory in space rented from a physician's office.  This allows the patient to immediately receive equipment or devices that they need as they leave the physician's office.  The DMEPOS company, not the physician, bills the patient or the patient's insurance carrier (or other third party payor) for the device.  In proper Consignment Closet models the patient should never be forced to obtain devices from the physician's office and are free to use the supplier of his/her choice.  When a patient chooses to obtain the device at the physician's office the physician's staff will instruct the patient on the use of the device or "fit" a brace or other product provided.  The DMEPOS supplier will compensate the physician's office for this service, as well as for administrative services provided by the physician's office staff for providing billing information to the DMEPOS supplier.  The DMEPOS supplier also rents from the physician the space in the physician's office where the DMEPOS supplier's inventory is stored

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Mr. Cohen and Mr. Meyer have over 45 years of combined healthcare legal experience, and have advised clients all over the United States regarding M.D./D.C. arrangements.  With an extensive background in transactional healthcare and corporate matters, particularly as they relate to physicians, the Florida Healthcare Law Firm is immersed in regulatory, contract, corporate, compliance and employment related matters of medical practices and other healthcare businesses.  Mr. Cohen and Mr. Meyer can be reached at and also by calling toll free at (888) 455-7702.   
Last Updated on Tuesday, 13 September 2011 15:56
The IOM Report on Reform of the 510(k) Device Clearance Process and Beyond Print E-mail
Written by   
Wednesday, 31 August 2011 17:39

In the second step of the Food and Drug Administration's (FDA) initiative to assess and reform the 510(k) clearance process for Class II medical devices, the Institute of Medicine released its commissioned report on July 29, 2011, recommending that the FDA replace the 510(k) clearance process with a new regulatory framework.  The IOM report should be noted by stakeholders for the significance of this recommendation and the extent to which it may impact the direction and scope of upcoming FDA changes to the medical device clearance process. 
Read the full article here.  SOURCE:
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