A federal court in Utah recently dismissed a qui tam
False Claims Act case alleging that surgical procedures performed
by a cardiologist were medically unnecessary and subsequent
Medicare and Medicaid reimbursement for the procedures amounted to
false claims as a result.
In United States ex rel. Polukoff v. St. Mark's Hospital
et al., U.S. District Court Judge Jill N. Parrish noted that
the the relator, Dr. Gerald Polukoff did not allege that Dr.
Sherman Sorenson and two hospitals, Intermountain Medical Center
and St. Mark's Hospital, did not bill the government "for
phantom services that were never provided—i.e. a
'factually false' claim" but rather that the
"defendant's claims for payment were legally false"
on the grounds that the procedures were not medically reasonable or
necessary." Polukoff based his claims on guidelines published
in 2006 by the American Heart Association/American Stroke
Association (AHA/ASA) regarding the surgical procedure. It is
critical to note, however, that Medicare has not issued a National
Coverage Determination on the procedure.
Citing an unpublished opinion from the Tenth Circuit, however,
Judge Parrish held that "liability 'must be predicated on
an objectively verifiable fact.'" Judge Parrish further
cited a 2016 case from the Northern District of Alabama, United
States v. AseraCare Inc., which noted that a "mere
difference of opinion between physicians, without more, is
not enough to show falsity."
The court dismissed the complaint concluding that even if the
relator "could show that Dr. Sorensen did not comply with the
relevant AHA/ASA standards, this does not support a claim that Dr.
Sorensen's certification that the PFO closures were medically
necessary was objectively false." Judge Parrish also
characterized Dr. Polukoff's equation of the AHA/ASA standards
with Medicare's medical necessity standard "a false
A March 2 article in Bloomberg BNA's Privacy Law Watch and other publications, "Privacy and Security Audits May Be Moving From Education to Enforcement," reported that the Department of Health and Human Services' Office for Civil Rights' (OCR's) ongoing HIPAA privacy and security audits may be shifting focus from provider education to enforcement.
It's been a couple of months since the dust has settled from FDA's October 26, 2016 approval of Mylan Pharmaceuticals Inc.'s ANDA 078276 for a generic version of Daiichi Sankyo Inc.'s BENICAR Tablets...
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