The U.S. Department of Justice (DoJ) has filed a complaint against a South Dakota neurosurgeon and two physician-owned distributorships for alleged kickbacks paid to the neurosurgeon. DoJ said Wilson Asfora received payments in the hundreds of thousands of dollars from Medical Design LLC and Sicage LLC in relation to devices he used in spinal surgeries. Asfora owns both the companies and continued the practice "despite numerous warnings that he was performing medically unnecessary procedures" with the devices in question. DoJ said it previously had resolved related civil claims against "several Sanford Health entities" in October. The case, which was a qui tam at its inception, is titled, U.S. ex rel. Bechtold, et al. v. Asfora, et al.
DoJ also said physician Temp Ray Patterson was sentenced to seven months in prison for receipt and delivery of breast implants shipped from China. The DoJ statement said Patterson took receipt of nine pairs of implants that were not approved by the U.S. FDA. Patterson then used pictures of FDA-approved implants in e-mails to deceive a patient into believing she was receiving legitimate implants. Patterson also allegedly altered the patient's medical record to indicate that she received an implant of different size than was actually implanted. Patterson will serve a year of supervised release, pay restitution of $8,200 and fines of $10,000.
Novitas Solutions Inc., of Mechanicsburg, Pa., said it will cover the 4Kscore test for prostate-specific antigen (PSA) and other markers for men aged 45 and older. Novitas said the test will be covered prior to an initial biopsy or following a negative biopsy assuming the patient has been diagnosed with moderately elevated PSA, although patients with less than 10 years of life expectancy are not covered. Among the other stipulations for coverage are that digital rectal exam does not suggest the patient is cancerous and that multiparametric MRI does not suggest cancer. Opko Health Inc., of Miami, said in a Nov. 15 statement that the local coverage determination (LCD) for the 4Kscore test is in force as of Dec. 30, and that the National Comprehensive Cancer Network has included the test in its guidelines since 2015. Jon Cohen, CEO of Opko subsidiary Bioreference Laboratories Inc., of Elmwood Park, N.J., said the LCD "is expected to significantly improve" access to the test.
Edwards Lifesciences Corp., of Irvine, Calif., said it issued a recall of two guide sheaths used with the Pascal transcatheter valve repair system due to potential for damage to the inner lining of the sheath. Edwards said the issue is related to a manufacturing problem and that while there are no reports of injuries or fatalities in connection with the flaw, embolization is a potential consequence. Analysts with Wells Fargo Inc., of San Francisco, wrote that Edwards indicated that the problem was discovered during an inspection of the facility that manufactures the sheath, which is manufactured by a third party. The note added that the problem may incur "a brief pause" in Pascal implants in the fourth quarter, and that two physicians had advised Wells Fargo that "it is a very minor issue."