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HHS/OCR Audits are Coming: What are Covered Entities Doing to Prepare? Print E-mail
Written by David Restaino, Esq.   
Wednesday, 30 November 2011 17:38

Those entities subject to both the HIPAA privacy and security rules should pay close attention to recent action taken by the U.S. Department of Health and Human Services ("HHS") Office for Civil Rights ("OCR"), which will increase the frequency and depth of government audits for HIPAA/HITECH compliance over the next year. This initiative may be in direct response to some critics that OCR was not doing sufficient monitoring of compliance with HIPAA/HITECH.

Preliminary Audit Procedures. Specifically, OCR awarded a contract worth over $9 million to KPMG, LLP for administration of the audits, which will begin shortly. The audits are required by the American Recovery and Reinvestment Act of 2009 (ARRA), which states at Section 13411, "The Secretary shall provide for periodic audits to ensure that covered entities and business associates that are subject to the requirements ... comply with such requirements."   Details are sketchy regarding the process to identify the entities that will be audited. However, this much is known:

● The first step will be creation of audit protocols, followed by an undertaking of the actual audits.

● OCR will base its decision to audit upon risk.

● Audits will not be based upon complaints or actual reported privacy or security breaches. 

● KPMG will assist OCR in establishing the program to audit covered entities and business associates, and their compliance with the privacy and security rules.

● HHS staff will guide KPMG's conduct during the audits.

● The audits will include site visits, interviews with leadership, documentation, an examination of operations, and an assessment of the consistency with which process is married to policy.

● Each audit will be followed by a report that will, among other things, address compliance efforts and corrective actions taken. 

Who Will Be Audited?  HHS reports that every covered entity and business associate is eligible to be audited. The initial round of recipients is expected to provide a broad assessment of a complex and diverse health care industry. Thus, the audit process is designed to have OCR audit as wide a range of types and sizes of covered entities as possible; covered individual and organizational providers of health services, health plans of all sizes and functions, and health care clearinghouses may all be considered. OCR has also made it explicitly clear that covered entities must fully cooperate with the auditors - as obligated under the HIPAA "enforcement rule." Finally, HHS reports that business associates will be included in future audits.

What can covered entities do now to be ready? For starters, they can make sure that all policies and procedures are in place now. For example, the HHS website states that covered entities will have only ten (10) days to produce documents; this is not much time if policies and procedures are not already in good order. 

Based on the above, the best way to get prepared is to make sure that compliance protocols are in place, and being followed, today. Stated differently, all covered entities and business associates should assess their compliance efforts, ensure that timely corrective actions are taken when necessary, and remain on their guard.  Documentation of the proactive assessment and corrective measures should also assist in demonstrating that the compliance efforts are effective.

David Restaino, a partner at Fox Rothschild LLP in its Princeton, NJ office, has more than 20 years of experience representing clients in regulatory compliance and complex commercial litigation matters, including environmental and health care disputes, before multiple federal and state courts and agencies.

Last Updated on Wednesday, 07 December 2011 12:46
 
CMS Issues One Final and Two Proposed Rules in Effort to Reduce Health Care Delivery Costs by Streamlining Regulations Print E-mail
Written by MWE.com   
Thursday, 10 November 2011 11:11

CMS issued the rules on October 18, 2011, in response to President Obama's Executive Order 13563, "Improving Regulation and Regulatory Review," and consistent with the U.S. Department of Health and Human Services' Plan for Retrospective Review of Existing Rules.  Overall, the final rule and two proposed rules appear to make significant progress in eliminating duplicative and unnecessary requirements, while providing hospitals and other providers with greater control over how to best achieve patient health care objectives.  

Read the full article here..     SOURCE: MWE.com
Last Updated on Sunday, 13 November 2011 13:05
 
Another Proposed Physician Joint Venture Bites the Dust Print E-mail
Written by Todd Rodriguez   
Thursday, 10 November 2011 11:06

Physicians are feeling the economic burn of the down economy perhaps more than the average American. Not surprisingly, creative physician joint ventures are proliferating in the healthcare industry as a means of stabilizing revenue streams and referral patterns. Unfortunately, many of these arrangements may raise questions under applicable fraud and abuse laws. One such proposed arrangement was the subject of the most recent (and negative) Advisory Opinion issued by the Office of Inspector General (OIG) of the Department of Health and Human Services.

The arrangement involved a proposed management services agreement for pathology services pursuant to which a physician-owned management company would provide pathology laboratory management services to a pathology lab. Under the management services agreement, the management company would provide all pathology services, utilities, furniture, fixtures, space and laboratory equipment. In addition, the management company would provide both marketing and billing services. For all of these services, the pathology lab would pay the management company a "usage" fee based on a percentage of the lab's revenue. Moreover, the management company would offer ownership interests to physicians in a position to refer to the pathology lab.

Noting that the arrangement could not meet any of the available safe harbors under the federal anti-kickback statute and citing the fact that the management fee would fluctuate with the volume or value of services performed by the pathology lab, the OIG found that the arrangement would pose a substantial risk of fraud and abuse and, therefore, refused to bless it.

When revenue is flat and costs are increasing, it is hard to blame physicians for at least considering potentially lucrative joint venture proposals. Of course, many such arrangements may be perfectly legal and may even be eligible for safe harbor protection under the various healthcare laws. That being said, physicians must always be mindful that penalties for violating federal and state laws can be catastrophic. For example, violation of the federal anti-kickback statute is a felony a felony, punishable by a fine of up to $25,000, up to five years in jail, or both as well as potential false claims liability. Therefore, when it comes to joint venture arrangements, the best course is to proceed with caution.

Mr. Rodriguez serves as Co-Chair of the Health Law Practice at Fox Rothschild, LLP. He is a regulatory and transactional health care attorney. To learn more click HERE.

Last Updated on Wednesday, 16 November 2011 12:23
 
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.

ABOUT THE AUTHOR
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. www.floridahealthcarelawfirm.com | 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 MWE.com   
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: MWE.com
Last Updated on Thursday, 27 October 2011 09:54
 
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