Archive for March 2021
OIG Opinion: Drug Maker Can Provide Free Medication
On March 23, the Department of Health and Human Services Office of the Inspector General issued a favorable ruling to a drug manufacturer looking to provide a free medication to patients in need of a one-time treatment made from their own cells. The drug maker (Requestor) makes the FDA-approved drug for two indications that is…
Read MoreProviders Beware: Ensure That Diagnostic Tests are Medically Necessary!
A fundamental principle of providing healthcare services to Medicare beneficiaries is that the services must be “medically necessary,†which means that they must be “reasonable and necessary for the diagnosis or treatment of illness or injury.†42 U.S.C. § 1395y(a)(1)(A). This requirement also imposes an obligation on healthcare providers to ensure that health services ordered…
Read MoreIf You’re Not Complying with Medical Record Requests, it Will Cost You
It was a little more than a year ago that we first wrote about how the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services had begun to vigorously enforce HIPAA Privacy Rule’s right of access. It requires providers to give patients access to their health records upon request and…
Read MorePaying a Marketing Company for Referrals? Beware!
If you pay independent contractors to market your healthcare services, read on. The United States Court of Appeals for the Fourth Circuit recently upheld a verdict against the former owner of a blood testing lab and two marketers who were found to have violated the False Claims Act by paying physicians for drawing patients’ blood…
Read MoreEleventh Circuit Upholds Convictions for Patient Recruiter in Home Health Kickback Conspiracy
The Eleventh Circuit Court of Appeals recently upheld convictions for a South Florida patient recruiter for conspiring to defraud the United States and receiving illegal kickbacks for referring patients to a Medicare provider. The case involved Yamilet Diaz who was accused of sending Medicare beneficiaries to a home health agency in exchange for $2,000 per…
Read MoreTelemedicine in OIG’s Crosshairs as Fraud Mounts
When the pandemic hit and a public health emergency was declared, the government began to issue waivers designed to give providers more flexibility in how they could treat patients. One area that saw restrictions lifted considerably has been telemedicine, an industry that has been gaining traction in recent years. As we wrote about, the use…
Read MoreSCOTUS Declines to Review FCA Objective Falsity Standard
The United States Supreme Court recently declined to take up two cases relating to whether a False Claims Act can go forward if the only evidence proving medical necessity are conflicting medical opinions. The plaintiffs in both cases were hoping to settle the question since courts around the country have been split on the issue.…
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