In yet another healthcare fraud settlement, Tennessee-based Ageless Men’s Health has been targeted by the Department of Health and Human Services, as well as the Department of Justice, for fraudulently billing Medicare and TRICARE for medically unnecessary male hormone therapy services.
When treating patients enrolled in government healthcare programs, certain patient criteria must be met for a medical procedure to be considered medically necessary. Within the context of male hormone replacement therapy, government regulations require evidence that the patient is suffering from a medical condition resulting in the reduction of the production of testosterone, including primary hypogonadism, injury, tumors, trauma, radiation, or the late onset of puberty. Government reimbursement is only available for treatment in men, and certain contraindications may also affect eligibility, including men with prostate cancer, gynecomastia, or male breast cancer.
In sum, there are very strict and limited criteria applicable to reimbursement for testosterone replacement therapy, and Ageless Men’s Health is accused of seeking reimbursement on behalf of patients who did not meet these eligibility criteria.
Details of the Case Against Ageless Men’s Health
The False Claims Act lawsuit was commenced by two whistleblowers who are former employees of Ageless Men’s Health. According to the allegations, Ageless Men’s Health operates 22 testosterone replacement clinics across the United States.
At Ageless, candidates for testosterone replacement arrive at their first appointment, are given a finger-stick blood test to measure testosterone levels, and are administered their first testosterone shot that day, provided the results of the blood test reveal a testosterone level below 350. No testing is performed for the covered medical conditions, and no screening for oncological contraindications is conducted.
The clinic is also set up to require patients to receive one shot per week, for one year, resulting in 52 office visits. Alarmingly, relators assert that at each clinic “there were no stethoscopes, thermometers, blood pressure cuffs, otoscopes, or similar diagnostic devices in treatment rooms. There was one of each of these devices in a supply closet in the back of the office.”
According to one relator, who is a former billing specialist for Ageless Men’s Health, the clinics record approximately 182,000 office visits per year. Ten percent of its client base is covered by Medicare, which reimburses the clinic approximately $40 per visit. As such, relators assert that Ageless Men’s Health has received more than $700,000 annually in Medicare reimbursements that did not meet the eligibility criteria described above and were medically unnecessary and, thus, false claims.
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