Legal Summary

From Page 23 causes mental anxiety and a loss of reputation. Therefore, health care providers should avoid the possibility of a lawsuit.

Avoiding a lawsuit

Because the Government or relator must prove that the health care provider knew that the claim was false or was deliberately ignorant of the truth or recklessly disregarded the truth, health care providers must document their decision-making process relating to statements or claims submitted to government agencies such as CMS. If there is clear guidance from the government agency on a particular regulation then the health care provider should document the guidance. For those ambiguous situations where there is little or no guidance, providers should document how they interpreted the regulations and attach any supporting documents. Providers may request written clarification from CMS or pertinent government agency, which, as a practical matter is often impossible. But even if CMS fails to respond, the fact that the provider sought clarification is a strong indicator that the provider intended to comply. Providers may also request legal advice. However, any communication seeking legal advice from an attorney is privileged and confidential. This means that if the provider decides to disclose the privileged communications to the Government and/or relators, he/she would have to waive the attorney-client privilege. Therefore, attorney-client communications should be drafted knowing that its disclosure to the Government and/or relator is a strong possibility. If the defendant sought legal advice giving the lawyer truthful and complete information so that the lawyer can give a valid opinion as to theambiguous regulation, and the provider complies with the advice, the provider may assert that he/she relied on the legal advice which will significantly weaken the government or relator’s proof of scienter. In addition, having a strong and effective compliance plan fortifies the defense.

These steps build a strong wall against FCA attacks by the Government and/or relator. If these walls are raised, it will be an uphill battle for the Government or relator to successfully prove the provider’s scienter as required by the FCA.

DISCLAIMER: This article is for information only and should not be considered legal advice. To obtain legal advice on this matter, please contact an attorney experienced in this area of law.

Lourdes Sanchez Ridge practices law at Pietragallo Gordon Alfano Bosick & Raspanti LLP. She focuses on white-collar criminal defense. She is licensed in Pennsylvania, Washington, D.C. and Florida. Her bio can be found at https://www.pietragallo.com/lawyers.

i 31 U.S.C. §§ 3729 – 3733

ii 598 U. S. ____ (2023). The Supreme Court consolidated two cases: United States ex rel. Schutte v. SuperValu Inc., No. 21-1326, and United States ex rel. Proctor v. Safeway, Inc., No. 22-111.

Pittsburgh Ophthalmology Society announces new President Pamela P. Rath, MD

Pamela P. Rath, MD, was installed as president of the Pittsburgh Ophthalmology Society (POS) during the annual banquet held March 9, 2023 at the Hotel Monaco in Pittsburgh, PA. She has been an active member of the POS since 2006, serving as a Board member since 2016 and Course Director of the Ophthalmic Personnel Meeting from 2016 through 2023. Dr. Rath will serve a two-year term, which ends March 2025.

Dr. Rath is a Pittsburgh native who received her medical degree from the State University of New York at Buffalo where she was elected to Alpha Omega Alpha honor medical society. She completed her residency at the University of Minnesota where she received multiple awards including for research, teaching and patient care and compassion. She completed a fellowship in medical retina, inherited retinal diseases, electrophysiology as well as ocular oncology at Moorfields Eye Hospital in London, England.

Board certified by the American Board of Ophthalmology, she is a retina specialist at Everett and Hurite Ophthalmic Association. She has 20 years of experience specializing in the treatment of medical retinal diseases. She is also trained in the diagnosis and treatment of intraocular tumors and hereditary diseases of the retina.

She looks forward to working with the POS board of directors to continue the tradition of excellence in offering high level educational programming to POS members for both the monthly meeting series and the annual meeting.

The Society would also like to congratulate Laurie A. Roba, MD who was elected as President-Elect.

Dr. Roba will serve a two-year term and succeed Dr. Rath as President in 2025.