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Legal Update
By Fulbright & Jaworski, of counsel to THA
CMS Withdraws Request to Send Mandatory Financial Disclosure Survey. On April 10, the Centers for Medicare & Medicaid Services formally withdrew from the Office of Management and Budget its request to send a new mandatory survey, entitled the Disclosure of Financial Relationships Report, to 500 selected hospitals. The hospital industry had challenged CMS' estimates that it would take hospitals approximately six hours to complete the forms. The new disclosure report was a product of a CMS updated regulatory notice issued in September 2007 that stated that CMS was conducting a review of investment/ownership and compensation arrangements between physicians and hospitals to determine whether they were in compliance with the physician self-referral statute and implementing regulations. CMS was required to obtain OMB's approval before sending out the forms. OMB's delay in issuing a decision on CMS' request was seen widely as an indication that OMB had serious doubts about the estimates presented by CMS. View CMS' notice of withdrawal.
OIG Issues New Guidance on Self-Disclosure Protocol. On April 15, the Office of Inspector General for the U.S. Department and Health and Human Services posted an open letter to health care providers “refining” the requirements of the OIG Provider Self-Disclosure Protocol. With the initial implementation of the 1998 Self-Disclosure Program, the OIG sought to encourage providers to self-report evidence of potential fraud by stating that providers that complied with the requirements of the SDP would pay lower civil damages and face lessened ongoing compliance obligations. In its letter of April 15, the OIG establishes four additional submission requirements which must be included in the initial report, including (1) a complete description of the conduct being disclosed; (2) a description of the provider's internal investigation or a commitment regarding when it will be completed; (3) an estimate of the damages to the federal health care programs and the methodology used to calculate that figure or a commitment when the provider will complete such an estimate; and (4) a statement of the laws potentially violated by the conduct. In addition, the OIG states that the provider must be in a position to complete the investigation and damages assessment within three months after acceptance into the self-disclosure program. The letter also states that providers that disclose in good faith, fully cooperate with OIG, and provide requested information in a timely manner, generally will not be required to enter into Corporate Integrity or Certification of Compliance Agreements with OIG.
Court Rejects Suit Alleging Academic Medical Center Violated Stark Law. A federal trial court ruled April 8 that a qui tam relator pursuing a False Claims Act lawsuit against an academic medical center in Kentucky failed to show that the defendants did not qualify for the AMC exception under the Stark Law. The case is believed to be the first instance that a court has examined the Stark Law's exception for AMCs. The litigation involved a challenge to the financial arrangement between Norton Hospitals Inc. d/b/a Kosair Children's Hospital, the University of Louisville Medical School Fund Inc., the University of Louisville Research Foundation Inc., and four members of the medical school faculty and their practice groups. The court concluded that the indirect flow of funds from Kosair to the faculty members did not violate the Stark Law, finding that the AMC exception applied because: (1) the named physicians were faculty members; (2) the named physicians received reasonable compensation unrelated to the amount of their referrals; and (3) there was no evidence of illegal kickbacks.The court dismissed the contention that the named defendants were not “faculty” covered by the exemption, noting that they had faculty appointments and provided “substantial” amounts of clinical and academic services. It also rejected the notion that the defendants were required to adopt a rigid timekeeping methodology to document the amount of time they spent on faculty-related matters, and found the compensation paid to the physicians was reasonable, did not vary in relation to referrals and was set at fair market value. Claims that the relationship violated the anti-kickback law and, therefore, brought the arrangement outside the safe harbor, also failed. The citation for the court's opinion is United States ex rel. Villafane v. Solinger, No. 3:03-cv-519, (W.D. Ky. Apr. 8, 2008).
Texas Appeals Court Allows Nurse to Pursue Negligent Misrepresentation Claim against Hospital Employer. A Texas appeals court held on April 10 that a nurse was entitled to pursue her negligent misrepresentation claim against her health system employer after she was investigated and ultimately reassigned for following the system's alleged unwritten policy allowing physicians to delegate certain duties to nurses. According to the nurse, the hospital's unwritten policy permitted nurses, without the presence of a physician, to sedate patients, and with the assistance of a technician, observe the insertion of a colonoscope.
On Jan. 17, 2002, the nurse in charge of a colonoscopy and following a physician's orders via telephone, sedated a patient and observed a technician insert a colonoscope and remove a polyp. The entire procedure was performed without a physician's presence or supervision. Subsequently, the nurse was placed on administrative leave, reviewed by the nursing board and reassigned to a different position.
The nurse sued the hospital system alleging fraud, negligent misrepresentation, violation of procedural due process rights and intentional infliction of emotional distress. The hospital system was granted summary judgment and the nurse appealed. The appellate court upheld the trial court's summary judgment for the health system on the nurse's fraud, procedural due process rights and intentional infliction of emotional distress claims. However, the appeals court found evidence “that the [hospital] was aware that some physicians were ordering nurses to start procedures without the physician being present, knew there were no clear and precise policies and procedures within the unit as to what duties could be delegated, and did not attempt to clarify the delegation policy until after it began investigating the incident.” The appeals court held, “the evidence raises a fact issue regarding whether the [hospital] negligently communicated its delegation policy because there was no clear policy.”
Fulbright & Jaworski, LLP, and the Texas Hospital Association make no warranties or representations of any sort with respect to this update, including any warranties or representations as to the accuracy or completeness of any of the information, facts or opinions contained herein. The information does not constitute the delivery of legal advice, and does not, by itself, establish an attorney-client relationship. The Texas Hospital Association is not liable for the accuracy of the information presented here, and this information does not imply endorsement of any kind.
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