TIPS ON THE STARK SELF DISCLOSURE PROTOCOL

Although not frequently used, the amended and revised STARK SDP continues to be attractive in some situations.  A few practical tips:

1.   First determine if there is a STARK violation.  The determination of the STARK violation must be made outside of the disclosure protocol, usually by provider’s counsel.

2.   If the STARK disclosure involves relatively small amounts of money, the costs of the SDP may indicate that submitting repayment directly to the Medicare contractor may be less expensive.

3.   It is unlikely that CMS will engage in any significant compromise negotiations over a settlement amount under the SDP.  This means that if you do not think that CMS’ proposal for resolving the matter is reasonable, you may have disclosed a STARK violation to CMS, and then notified them that you refuse to continue under the self-disclosure protocol.  You should assume that SDP filings will become public.

4.   If the STARK SDP disclosure also could give rise to a claim under federal Anti-Kickback Statutes, you may wish to review other options.

5.   If you do decide to use the SDP, then be complete in your disclosure, be clear what you are disclosing, avoid admissions, relaying on factual disclosures only, and make an element by element legal analysis in your disclosure submission.  Finally, should you have multiple disclosures to make, each disclosure should be made separately in your submission, rather than grouped.  This allows for a fuller and clearer analysis, particularly when discussing future compliance plans which may be burdensome.

WELLNESS PROGRAMS MAY BE DYING

On May 29^th, the IRS issued final rules that generally limit wellness programs as part of the necessary minimum coverage for employees.  Labor unions and others have protested that employers could circumvent minimum health care coverage by including wellness programs.  They claimed the wellness programs discriminate, and put sick or unhealthy workers at a disadvantage.  Under the new rules, wellness program limits are imposed.  The EEOC is reviewing these programs for ADA issues.

EMTLA CLAIM FAILS

A US District Court granted a hospital’s motion for summary judgment as plaintiffs failed to show that the hospital violated the Emergency Medical Treatment and Labor Act.

A patient suffered severe injuries in an ATV accident.  Upon arrival at the hospital’s ER, the doctor determined the patient suffered acute trauma, and a serious medical condition.  Doctors and nurses performed medical assessment, administered medications, ordered and performed tests, labs x-rays, and blood transfusions.   The treating physician then ordered the patients transfer to a trauma center despite the fact that the patient was not stable.  The doctor determined the benefits of transfer outweighed the potential risk of transfer.  The trauma center accepted the transfer and the patient’s mother authorized it.  The patient died before the transfer could be completed.

In the suit, plaintiffs alleged that the hospital failed to provide necessary medical screening that was immediate, prompt and appropriate.  The court disagreed stating EMTLA’s medical screening requirements existed so a determination could be made about whether an emergency medical condition exists, and that the screening must only be within the hospital emergency department’s capabilities.  Here it was uncontested that the hospital and physician ordered and performed a series of tests, and found the patient had suffered acute trauma, and was in a serious medical condition.  The plaintiffs failed to tell the court what test and treatments were allegedly needed by the patient, were within the hospitals capability but omitted.  Regarding EMTLA’s stabilization requirement, plaintiffs allege the hospital failed to stabilize the patient’s serious medical condition.  When coupled with the plaintiff’s claim that the hospital had failed to timely transfer the patient, and that this resulted in the patient’s death, the court also disagreed.  The Court indicated that the decision to transfer or not to transfer might trigger state law medical malpractice liability, but would not otherwise constitute an EMTLA violation.  EMTLA merely restricts the conditions under which a hospital may transfer an unstable, critical patient.

We continue to see EMTLA claims which do not appear appropriate under the legislation, or the legislation’s purpose.  Where hospitals assess the patient’s condition under emergency conditions, and then make a medically sound decision to transfer during the process of stabilization and transfer to an appropriate facility, it does not appear that EMTLA claims will succeed.  Maldonado-Rodriguez v. St. Luke’s Med. Hosp., No. 10-1362 (PG) (D.P.R. Apr. 22, 2013).

This newsletter is edited by Paul Wallace of Jones • Wallace, LLC, a member of the American Bar Association Healthcare Law Section and the American Health Lawyers Association who has been representing physicians and healthcare practices for over 25 years.  Mr. Wallace assists physicians in health practices in contract items, federal legal compliance, creation of practice entities, estate and wealth planning and similar issues.  Please feel free to call if you have any questions about this newsletter or any other matter at (812) 402-1600 or pwallace@joneswallace.com.