logo - Liles Parker PLLC
(202) 298-8750 (800) 475-1906
Washington, DC | Houston, TX
Baton Rouge, LA

We Defend Healthcare Providers Nationwide in Audits & Investigations.

Exclusion Screening-OIG Screening: The New “Seventh Element” of Compliance.

Download PDF

 Exclusion Screening-OIG Screening(May 17, 2017): Exclusion screening-OIG screening duties are now more important than ever before!  The recently issued Resource Guide for Measuring Compliance Program Effectiveness,” a product of Office of Inspector General staff and compliance professionals roundtable discussions, reconfigures the traditional “Seven Elements of an Effective Compliance Program” by making the “Screening and Evaluation of Employees, Physicians, Vendors and other Agents” an element unto itself – or the new Seventh Element of Compliance! The Resource Guide, prepared under the auspices of the Health Care Compliance Association (HCCA), serves to once again underscore the critical role of exclusion screening-OIG screening, and background checks in compliance.

Paul Weidenfeld, co-Counsel with Liles Parker, has recently assessed this important change and provided an overview of the impact this change for the folks at Exclusion Screening.  For a detailed discussion of the statutory requirements of screening, the potential damages that may be assessed in the event of a violation AND your obligations as a provider participating in Medicare or Medicaid, we recommend you see the article on Exclusion Screening’s website.  This article may be accessed by clicking here.

Paul Weidenfeld is co-counsel with  Liles Parker, Attorneys & Counselors at Law.  Our attorneys are experienced and knowledgeable of your obligations under the law to conduct periodic “Exclusion Screening-OIG Screening” duties.  For a free consultation, please call: 1 (800) 475-1906.-

OIG And DOJ Issue Important New Compliance Guidance

Download PDF

Compliance Guidance

(April 14, 2017) Recently, the Office of Inspector General of the United States Department of Health and Human Services (OIG) and the Criminal Division of the Fraud Section at the United States Department of Justice (DOJ) have issued guidance on measuring the effectiveness of corporate compliance programs.  In February, DOJ placed on its website a document entitled “Evaluation of Corporate Compliance Programs.”  That document lists 119 sample questions that DOJ’s Fraud Section has in the past found relevant in its evaluation of the effectiveness of corporate compliance programs for the purpose of deciding whether to prosecute cases, and in recommending sentences for criminal violations.  These questions are separated into eleven (11) topic areas: analysis and remediation of underlying conduct, senior and middle management, autonomy and resources, policies and procedures, risk assessment, training and communication, confidential reporting and investigation, incentives and disciplinary measures, continuous improvement, periodic testing and review, third-party management, and mergers and acquisitions.  While not specifically addressing health care organizations, per se, the guidance is highly relevant to organizations and practices since they are questions that Federal prosecutors will be asking when evaluating compliance programs in any criminal investigation.  The guidance can be reviewed in its entirety at https://www.justice.gov/criminal-fraud/page/file/937501/download.

Even more recently, on March 27 of this year, OIG published a parallel and more inclusive document focused specifically on the health care industry, “Measuring Compliance Program Utilization – A Resource Guide.” The Guide, which is 52 pages in length, sets out a checklist of questions broken down into seven standards based on the standard seven elements of an effective compliance programs, and further broken down into various subcategories under each element.  The guidance is the product of a round table on January 2017 that brought together a group of compliance professionals and staff from OIG “to discuss ways to measure the effectiveness of compliance programs.”  While the guidance is clear that it is not a “one size fits all,” it provides a number of ideas of “what to measure” and “how to measure” these programs, and should be mandatory reading for all compliance officers in organizations, whether a small physician’s office or a large hospital system or health care organization.  The guidance can be accessed at https://oig.hhs.gov/compliance/101/files/HCCA-OIG-Resource-Guide.pdf.

Liles Parker attorneys, and frankly any knowledgeable attorney who specializes in health care, have for many years advised clients that is essential to establish a compliance program that is implemented effectively.  Among other things, an effective compliance program establishes the culture of compliance for an organization in following the law, that should demonstrate an ethos from the top down through every employee and professional.  It also provides management with the opportunity to detect and correct problems and potential issues before they either emerge or become widespread. Many, if not most, whistleblower lawsuits are the result of employees feeling that their concerns, when reported internally, were not investigated.

Moreover, Congress has mandated compliance plans for skilled nursing facilities and the revised requirements of participation require them for both nursing and skilled nursing facilities so that the effectiveness of these programs will become part of the survey process.  And, if an investigation arises, the conversation with enforcement agencies is dramatically different when an organization can demonstrate that it has an effective program as opposed to no program, or one that sits on a shelf.

One of the criteria that OIG has had for determining whether a compliance program is effective is whether the organization measures the effectiveness of its program, itself.  At a minimum, every organization should do this once per year.

Finally, in September 2015, DOJ issued a memorandum entitled “The Individual Accountability for Corporate Wrongdoing.”  Among other things, the memorandum, referred to as the Yates Memo,” instructs prosecutors and investigators to hold highly placed individuals within an organization accountable for the organization’s misconduct.  Prior to the issuance of the Yates memo, those of us involved as defense counsel in investigations were frequently able to obtain releases for individual members of an organization in settlements of civil and administrative investigations.  Since the issuance of the Memo, releases of individuals now occur on only the rarest of occasions.


For all of these reasons, it is imperative that every health care provider establish an effective compliance program and that it periodically measure the effectiveness of that program.  These guidances provide important and helpful information in how to accomplish that result.

Compliance GuidanceLiles Parker attorneys have extensive experience in developing compliance programs, providing compliance guidance, and working with clients in investigations.  Clients having questions related to these issues should contact Michael Cook at (202) 298-8750, mcook@lilesparker.com


Under Health Care Reform Legislation, Stark Law Whole Hospital and Rural Provider Exceptions are Changing

Download PDF

Stark Law Whole Hospital Exception(October 22, 2010):  It’s not exactly breaking news to anyone in the hospital industry that the U.S. Congress and the regulators at the Center for Medicare and Medicaid Services seem bent on preventing or eliminating physician referrals to hospitals in which they invest. With the passage of health reform legislation in March of this year, Congress approved yet another round of sweeping measures designed to eliminate or prevent the growth of physician investment in hospitals to which they refer by drastically changing both the rural provider and whole hospital ownership exceptions to the Stark Law. Here are a few key points to be aware of if you invest or work in a physician-owned hospital and you rely on the Stark Law rural provider or whole hospital exceptions to protect physician-investor referrals to the facility:

1. No new physician-owned hospitals after December 31, 2010 – The new law imposes a total moratorium on Medicare certification of new physician-owned hospitals that would rely on either of these exceptions to protect investor referrals unless they have a provider agreement in place as of December 31, 2010.

2. Cap on Total Physician Ownership Percentage – Health reform legislation capped total physician investment in existing Medicare-certified facilities at whatever total percentage physician ownership a facility had on March 23, 2010, the date the law was passed. Physician owners can still buy and sell their interests, but total physician ownership may not exceed the capped amount. If your physician investors have increased their total ownership percentage since March 23, 2010, they will have 18 months from that date to take action to comply with the new law.

3.  No Bed Increases Without An Exception from CMS – The legislation also froze the number of beds a physician owned, Medicare-certified hospital may have unless it is granted an exception by CMS to increase its capacity. The new law defines the basic criteria for an exception, but CMS has until December 31, 2012 to promulgate regulations implementing the exception process. You may not put new beds into service and continue to have physician investors refer to your facility until your hospital has been granted an exception.

4. New Disclosure and Reporting Requirements – There were a host of new disclosure and reporting requirements added by the legislation, including mandatory disclosures to patients referred or treated by an investor, public disclosures on hospital websites and in public advertising about physician ownership, and an annual report to the Secretary of the Dept. of Health & Human Services that identifies all physician and non-physician owners or investors in a hospital, as well as the nature and extent of their ownership and investment interests. Also, the law includes a mandate for the Secretary of HHS to post on its website all investment information reported pursuant to these new requirements.

5. New Patient Safety Requirements – Finally, there are new patient safety requirements that mandate a disclosure to, and written acknowledgement from, all patients regarding whether a physician is available on-site, 24-hours a day, as well as a requirement that the hospital provide assessment and initial treatment for all patients and the capacity to refer and transfer patients to hospitals with the capability to treat the needs of each patient that can’t be appropriately treated on-site.

CMS recently proposed regulations implementing most of the above described legislative changes.

Healthcare LawyerJennifer Papapanagiotou, J.D., is a Partner at Liles Parker, Attorneys & Counselors at Law.  She is an experienced health care attorney with more than a decade of experience assisting providers with structuring or re-structuring their businesses and contractual relationships to comply with Federal and State health care fraud and abuse laws, including the Stark Law. Should you have questions regarding the Stark Law, the Anti-Kickback Statute, or the myriad other health care fraud and abuse laws and regulations, please give us a call at 1 (800) 475-1906.

Identity Theft — Red Flags Rule — Treating Doctors Like Banks Is Delayed Once Again

Download PDF

Has Your Practice Implemented the Red Flags Rule?(July 5, 2010): The Federal Trade Commission (FTC) has agreed to once again delay enforcement of its illogical and onerous identity theft Red Flags rule with respect to physicians. The Red Flags rule arose under the Fair and Accurate Credit Transactions Act of 2003 and requires “financial institutions” and “other creditors” to develop written plans to detect identify theft in their day-to-day operations.  Under the FTC’s interpretation of the rule, physicians who permit patients to pay after they have rendered medical service are transformed into “creditors.”Extension of the rule to physicians has been delayed several times as the extent of the burden on health care providers has become clear.  As recently as May 28, the FTC made note of the concerns:

“At the request of several Members of Congress, the [FTC] is further delaying enforcement of the ‘Red Flags’ Rule through December 21, 2010, while Congress considers legislation that would affect the scope of entities covered by the Rule….The Commission urges Congress to act quickly to pass legislation that will resolve any questions as to which entities are covered by the Rule and obviate the need for further enforcement delays.”

The June 25th agreement arises in connection with a suit filed against the FTC last month by the American Medical Association (AMA) and others seeking to prevent enforcement of the Red Flags rule and alleging that the FTC overreached its bounds in seeking to enforce the rule against physicians.   A similar complaint by the American Bar Association (ABA) is currently making its way through the appeals process after the U.S. District Court for the District of Columbia enjoined enforcement of the rule against lawyers.  Until a ruling is issued in the ABA case, the AMA case will be held in abeyance and physicians will be safe from the Red Flags rule.

Health Care AttorneyShould you have any questions regarding these issues, don’t hesitate to contact us.  For a complementary consultation, you may call Robert W. Liles or one of our other attorneys at 1 (800) 475-1906.