January 14, 2024
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Key takeaways:
- Over 95% of False Claims Act cases result from a whistleblower.
- Telehealth and medically unnecessary services ordered via telehealth systems have been the number one focus of the Office of the Inspector General.
WAILEA, Hawaii — Health care law trends in 2023 were telehealth, whistleblowers, physician referrals and a more intense focus on compliance by providers and practices, according to a law expert speaking at Hawaiian Eye/Retina 2024.
“A number of the issues … that came forward to the government, came forward because the provider self-disclosed,” Allison W. Shuren, JD, MSN, said. “ … We are seeing this as a trend over time.”
Shuren said the trend may be related to the fact that physicians are more compliance-focused and the impact of whistleblowers.
“The vast majority — over 95% — of the cases that the Department of Justice brings under the False Claims Act come from whistleblowers,” she said.
You can stop the chance of a whistleblower coming forward “if you get there first” and “will more likely have a much easier time, less legal expense, less settlement expense and I think providers are taking that much more to heart,” Shuren said.
From January to June 2023, The Department of Justice reported 35 False Claims Act settlements that totaled $485 million, according to Shuren. Shuren’s law firm, Arnold and Porter, project that for 2023 there will be 255 recoveries totaling $2.7 billion, which is $500 million more than 2022. Shuren noted that the False Claims Act is the largest driver of recoveries. Areas of focus in the category of false claims include medically unnecessary services; kickbacks and bribes; billing for services not performed or products not utilized; concurrent surgeries; failure to return overpayments; and the Physician Self-Referral Law, which is often referred to as Stark Law.
“The Stark Law is what we call a per se law which means you are either compliant or you are not. The government does not have to prove intent or prove that you tried or did not try,” she said. In these cases, Shuren said, the path is easy when a whistleblower comes forward with information.
The Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services is responsible for enforcing federal fraud and abuse laws as the relate to the federal health care programs, including Medicare and Medicaid.
In 2023, the OIG reported recovery of $3 billion from audits and investigations of which the majority was investigative recovery, Shuren said.
“The OIG have been particularly interested in retina and the use of injections and the medical necessity of injections,” she said.
The OIG areas of focus were fraud involving telehealth; medical unnecessary services; failure to return overpayments; kickback and bribes; protecting nursing home residents; Medicare Advantage and Medicaid Managed Care integrity issues; and reducing prescription drug spending, Shuren said.
“Telehealth and medically unnecessary services being ordered through telehealth systems have been the number one focus. There was a national operation taskforce across the country reviewing telehealth — mainly orders for extensive genetic testing and durable medical equipment,” Shuren said, noting that $2.5 billion of the $3 billion of the OIG recovery was related to the findings of this taskforce.
“As we try to incorporate telehealth and remote monitoring and various innovations in the way we deliver care there is sort of a cloud sitting over us,” she said.
Over the course of 6 months, the 2023 OIG Hotline experienced almost 85,000 complaints that mentioned there “was something unlawful about the care they received” and of those more than 36,000 were evaluated and 21,740 were referred for action. Shuren said they have thus far closed out 14,504 of the calls and 8,000 remain open from 2023.
You can read more legal insight from Arnold & Porter here.
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Sources/Disclosures
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Source:
Shuren AW. Health care law. Presented at: Hawaiian Eye 2024; Jan. 13-19, 2024; Wailea, Hawaii.
Disclosures:
Shuren reports no relevant financial disclosures.
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