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Compliance Update
7 Essential Elements for Compliance Print E-mail
Written by Todd Demel, MBA   
Thursday, 26 May 2011 16:55

Establishment of Compliance Standards and Procedures:

Develop and distribute written standards of conduct, policies and procedures.


Designation of a Compliance Officer or Committee:

Specific individual(s) in high level positions within the organization should be assigned overall responsibility for compliance development, implementation, oversight, and enforcement.


Employee Education and Compliance Training:

Effectively communicate standards and procedures to all employees through development and implementation of ongoing program


Ongoing Monitoring and Reporting Systems:

Use audits and/ or evaluation techniques to monitor compliance and assist in the reduction of identified problem areas.


Corrective Actions:

Once an offense is detected, the organization should take all reasonable steps to respond appropriately.


Disciplinary Actions:

Compliance standards should be consistently enforced by the organization, including the use of appropriate disciplinary mechanisms.


Lines of Communication:

Mechanisms should be in place for raising questions or alerting the company of potential violations. Employees should be allowed to make complaints anonymously and confidentially as well as being assured of non-retaliation for complaints raised in good faith.  

Source:  MF Healthcare Solutions:  Developing a Compliance Plan


Last Updated on Wednesday, 29 June 2011 16:59
Be Mindful of the Medicare Incident-To Rules Print E-mail
Written by Todd Rodriguez   
Thursday, 12 May 2011 16:30

Although many Medicare billing rules can present challenges for physicians, the incident-to billing rules consistently confound many physicians. The incident-to rules permit a physician to bill for the services of non-physician mid-level providers and auxiliary personnel as if the physician performed those services himself. To be covered on an incident-to basis, the services and supplies must be:

· An integral, although incidental, part of the physician's professional service. The Centers for Medicare and Medicaid Services (CMS) has interpreted this to mean that there must have been a physician's service rendered to which the auxiliary personnel services are incidental. However, according to CMS, this does not mean that a physician's service must precede every single incident-to service. Rather, there must have been a physician's service which initiates the course of treatment during which incident-to services will be rendered.

· Commonly rendered without charge or included in the physician's bill.

· Of a type that are commonly furnished in physician offices or clinics. If auxiliary personnel perform services outside of the office setting, such as in a patient's home or an institution (other than a hospital or skilled nursing facility), their services may be covered under the incident-to rules only if there is direct supervision by the physician. In a non-office setting, direct supervision would require that the physician be in the immediate presence of the auxiliary personnel while the services are being rendered.

· Furnished by the physician or by auxiliary personnel under the physician's direct supervision. This means the physician must be present in the office suite where the services are being rendered, at all times while the services are being rendered, and must be able to immediately respond if needed. CMS has not provided any clear guidance on what constitutes an "office suite," and presently this is within the discretion of each Medicare Area Contractor.

All of the incident-to rule technical requirements must be met as a condition of Medicare reimbursement. This means that if even one of the requirements is not met, the services may not be billable to Medicare and you may be receiving overpayments (which must be repaid within 60 days of discovery). Accordingly, it is advisable to adopt policies and procedures to ensure ongoing incident-to compliance.

 ABOUT THE AUTHOR:  Todd Rodriguez  is a partner with Fox Rothschild, LLP.   To learn more click HERE.

Florida Physician Strikes Out in Challenging Hospital Re-Appointment Denial Print E-mail
Written by Jeff Cohen, JD   
Wednesday, 06 April 2011 14:22

In January, a Florida appellate court upheld the denial of a physician's request to halt a hospital's intention to deny reappointment to the medical staff.  The physician involved in the case was a member of the medical staff and was recredentialed pursuant to the hospital's recredentialling cycle.    The doctor asked the trial court to stop the hospital from implementing the denial until the trial court fully considered the case; which request the court granted.  The appellate court, however, decided the trial court was wrong and overturned the decision.

The basis of the doctor's claim was that the hospital didn't follow the medical staff bylaws and that, therefore, the hospital's decision shouldn't be implemented, at least not until the court could have a trial-like hearing on the issue, which might take many months to schedule.  The appellate court relied on a state law granting immunity to the hospital for the denial and stated that the doctor didn't make the proper argument that would have justified the trial court granting his request to delay implementing the decision. 

Specifically, Florida law grants medical staffs the authority for reviewing applications, but is clear that the final decision rests with the hospital governing body.  Most medical staff bylaws codify the very same principle, though there is room to create more of a collaborative relationship between governing bodies and medical staffs on the issue.  Medical staffs ought to be vigilant about the wording of their medical staff bylaws, since they are considered to be a contract between them and the hospital.       

In the present case, however, the doctor was ultimately denied the right to delay the hospital's decision because he did not argue that the hospital decision involved fraud.  The case is yet another example of why medical staffs have to take a very pro active role in creating medical staff bylaws, which is no easy feat, since most physicians consider medical staff bylaw creation to be only slightly more exciting than paint drying contests.

With over 20 years of healthcare law experience following his experience as legal counsel for the Florida Medical Association, Mr. Cohen is board certified by The Florida Bar as a specialist in healthcare law. With a strong background and expertise in transactional healthcare and corporate matters, particularly as they relate to physicians, Mr. Cohen's practice immerses him in regulatory, contract, corporate, compliance and employment related matters. He is the Founder of The Florida Healthcare Law Firm. 

Last Updated on Thursday, 14 April 2011 09:36
The Stark Law Self-disclosure Protocol: Apply With Care Print E-mail
Written by Chris M. Morrison, Esq.   
Saturday, 05 February 2011 15:06

On September 23, 2010, the Centers for Medicare and Medicaid Services ("CMS") posted the Voluntary Self-referral Disclosure Protocol ("Protocol") on its website.  The Protocol allows providers and suppliers ("disclosing parties") to self-disclose actual or potential violations of the federal physician self-referral statute (42 U.S.C. §1395nn, commonly known as the Stark Law) and possibly settle their financial liability for such violations for less than the full amount due.  The Secretary of HHS (the "Secretary") was required to establish a self-disclosure protocol under the Patient Protection and Affordable Care Act ("PPACA").  PPACA also authorized the Secretary of HHS to reduce the amount due and owing for Stark Law violations.   

This article discusses generally some of the main provisions of the Protocol, as well as some of the risks and drawbacks that a disclosing party should consider before deciding to use the Protocol.  This article is not exhaustive of all aspects of the Protocol.

General Disclosure Requirements

A disclosure under the Protocol must contain three things:  a description of the actual or potential violation or violations; a financial analysis setting forth the total amounts believed to be due and owing; and a certification by the disclosing party that the information provided is truthful and based on a good faith effort to resolve the matter at hand.  The disclosure must be provided electronically and in hard copy to the addresses specified in the Protocol.   

The description must contain detailed factual disclosures and legal analysis regarding the actual or potential violation.  A summary of the required content is as follows:

  • Identifying information, including organizational relationships if the disclosing party is owned, controlled, or otherwise part of a system or network, and affected corporate divisions, departments or branches.
  • A description of the matter being disclosed, including the financial relationships and parties involved; the time periods of the violation and when the conduct was cured, if at all; the type of transaction or other conduct involved; and the names of the entities and individuals believed to be implicated and an explanation of their roles.
  • A statement regarding why the disclosing party believes a violation of the Stark Law may have occurred, including a complete legal analysis of the Stark Law's application to the conduct, any Stark Law exceptions that apply and/or that the disclosing party attempted to use, and which elements of the applicable exception(s) were and were not met.  It should also describe the potential causes of the violation, such as intentional conduct, lack of internal controls, or circumvention of corporate procedures or government regulations.
  • The circumstances of discovering the violation, and the measures taken both to address it and to prevent future abuses.
  • A statement of whether the disclosing party has a history of similar conduct or has any prior criminal, civil, and regulatory enforcement actions against it.
  • A description of the existence and adequacy of a pre-existing compliance program and efforts to prevent recurrence of the incident, including measures to restructure the non-compliant arrangement or relationship.
  • A description of notices provided to other government agencies in connection with the disclosed matter.
  • An indication of whether the disclosing party has knowledge that the matter is under current investigation or inquiry by a government agency or contractor.

The disclosing party is expected to conduct a financial analysis and furnish its findings to CMS as part of its initial submission.  The analysis should provide a total amount, itemized by year, that is actually or potentially due and owing for the period during which the disclosing party may have been out of compliance with the Stark Law.  The disclosing party must also describe the methodology it used to determine these amounts.

Finally, the disclosing party must provide a signed certification stating that, to the best of the individual's knowledge, the information provided contains truthful information and is based on a good faith effort to bring the matter to CMS' attention for the purpose of resolving any potential liabilities under the Stark Law.  This certification may be provided by the disclosing party's CEO, CFO or other authorized representative.   

Coordination with Other Agencies

CMS will coordinate with the Office of the Inspector General ("OIG") and the Department of Justice ("DOJ"), and may also refer the disclosed matter to law enforcement.  CMS may use the disclosure to prepare recommendations to OIG and DOJ for resolution of False Claims Act, civil monetary penalty, or other liability.  Thus, a disclosure under the Protocol may result in contact from other government agencies. 

Investigation Phase

After CMS receives the disclosure it will begin verifying the information provided.  During this process, CMS expects to receive documents and information from the disclosing party without having to use "compulsory methods," and to have access to all financial statements and other supporting documents without the assertion of privileges.  Any matters discovered during this process which are not part of disclosure will be treated as being outside the Protocol.   

CMS states that in the "normal course of verification" it will not ask disclosing parties to produce written communications subject to attorney-client privilege.  CMS might more aggressively seek documentation covered by attorney work product, but is "prepared to discuss" ways to get the underlying information without a waiver of privilege.  Assertion of privilege should be made advisedly, as the disclosing party's cooperation with CMS during the investigation process is a factor considered in reducing the disclosing party's financial liability, and failing to fully cooperate may result in removal from the Protocol.

To finish article, click here.

Chris M. Morrison is Of Counsel to GrayRobinson, P.A.'s Orlando office, and is board certified in health law by The Florida Bar.  Mr. Morrison can be contacted at (407) 843-8880 or by email at

Last Updated on Saturday, 05 March 2011 15:35
OIG Soliciting Proposals and Recommendations Print E-mail
Written by Sandra P. Greenblatt, Esq.   
Thursday, 27 January 2011 15:53


On December 28, 2010, the Office of Inspector General (OIG) issued a proposed rule in the Federal Register (75 FR 81556) soliciting proposals and recommendations for developing new and modifying existing Safe Harbor regulations under the Federal Anti-Kickback Statute (Soc. Sec. Act §1128(b)) and for developing new OIG Special Fraud Alerts to provide guidance to the health care industry. The proposed rule states the OIG will consider the following factors in reviewing proposals for new or modified safe harbor provisions: (1) access to health care services, (2) quality of services, (3) patient freedom of choice among health care providers, (4) competition among health care providers, (5) cost to Federal health care programs, (6) potential over-utilization of health care services, (7) ability of health care facilities to provide services in medically underserved areas or populations, and (8) other factors, including the existence of potential financial benefit to health care providers that may take into account their decisions to order a health care item or service.

In determining whether to issue additional Special Fraud Alerts, the OIG will consider whether, and to what extent, the proposed practices may result in any of the above consequences related to the proposed Safe Harbor regulations, as well as the volume and frequency of the conduct that would be identified in the Special Fraud Alert. Comments must be delivered by February 28, 2011.

Sandra P. Greenblatt is a Board Certified Health Lawyer with 25 years of experience representing health care professionals and businesses in complying with the Federal and Florida fraud and abuse laws and regulatory, contractual and transactional health law matters.  If you are interested in submitting comments on the proposed rule to the OIG, she may be reached at (305) 577-9995 or

Last Updated on Saturday, 12 February 2011 14:47
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