Scrutiny of anti-VEGF treatment protocols intensifies
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WAILEA, Hawaii — “For those of you in retina or have retina in your practice I am sure this is a topic of conversation – the government is coming after anti-VEGF therapy from all directions,” said an expert in healthcare law.
“They are coming from the OIG. The Office of the Inspector General is auditing individual physicians right now looking at their use of anti-VEGF therapy and services provided on the same day,” Allison W. Shuren, JD, MSN, who is a partner at Arnold & Porter and co-chairs the Life Sciences and Healthcare Regulatory practice said. “The first report was posted on the OIG website about 3 weeks ago.”
Shuren said the OIG took 100 records from the physician and brought OIG agents into the practice to take the records; took 6 months’ worth from the date of service they were going to audit 6 months in advance and 1 month after “in order to see what the treatment protocol was that was being delivered to those patients.”
The OIG also on the investigator arm has started to issue subpoenas to practices looking at anti-VEGF therapy and clinical decision making in drug choice, Shuren said. “I think we can assume the question really is – brand over Avastin.”
The Department of Justice has several cases that are open including one in Boston, Shuren said. The Boston US Attorney’s office “based on the subpoenas that have been issued it appears that the government is looking at the purchasing of anti-VEGF drugs, rebates, discounts and how those are being offered and how they are being reported,” Shuren said.
There is also an uptick in physicians self-reporting themselves, in particular the use of CPT code modifier 25 and office visits, she said.
“This is an area that is not going away, and I expect that we are going to be talking about this for quite a while, and the environment here for those in retina is disconcerting right now to have this much attention,” Shuren said.
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Shuren AW. Healthcare Law in the New Normal: What Just Happened? Telehealth View, Human Resources Post-COVID-19, Physician Contracting and How Salary Addendums were Handled. Presented at: Hawaiian Eye; May 8-14, 2021; Wailea, Hawaii.
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