No one likes waste. Wherever possible, doctors, clinics and hospitals should be creative in their efforts to save money. But pooling single dose drugs and then double billing is dangerous, illegal and doesn’t save taxpayers any money. Today doctors in El Paso, Texas must pay $2,929,162 to settle claims they defrauded Medicare and the State of Texas.
Dr. Robert Moreno, Cheryl Moreno, William “Bill” Collins, Accutrack Medical Claims Service, LLC, and El Paso Integrated Physicians Group, P.A. must all pay their share of the settlement to the government. The prosecution against them was made pursuant to a Civil War era whistleblower statute that allows private citizens to file claims on behalf of the government.
The case started with a whistleblower. On October 30, 2013, Sergio Garcia filed a sealed whistleblower lawsuit in federal court. Sergio claimed that the doctors “double-billed and over-billed government payors [Medicare and Medicaid] for Remicade (Infiximab), an infusion drug sold in single-use vials. Relator alleged that the Group pooled Remicade from partially used vials and used it in other patients, resulting in double-billing for the split vial, and also that it billed for Remicade not used or that was diluted. The complaint further alleged that the Group billed for drugs illegally imported from Canada and other foreign countries.”
Remicade is sold in single use vials. It is sold that way because once opened it can’t be stored since it lacks preservatives. Once opened, it has to be used immediately.
Remicade is an immune suppressant given to people who are quite ill. Because these patients already have compromised immune systems, they are more susceptible to disease and infections. Using an open vial is a recipe for disaster.
The doctors in this case combined several open and used vials in order to get additional doses. They were billing, however, as if they had purchased two individual doses. In other words, they were ripping off Medicare and Medicaid. Because of the nature of the drug, they were also jeopardizing the safety of their patients.
According to Mr. Garcia, the doctors were also importing the Remicade from non FDA approved sources. Unless the facility is inspected by the FDA, there is no way to know just how safe the drugs were when imported.
After the settlement, a Justice Department spokesperson said, “Providers who line their pockets by over-billing for medical care increase medical costs for all of us and drain critical funds from Medicare and other government health programs. The Government will continue to hold accountable medical professionals who undermine our healthcare system through fraudulent over-billing for care.”
Although the government was seemingly focused on the double billing, we are always concerned about patient safety.
Why would doctors jeopardize the safety of patients? We think the answer is simple, greed.
A single dose of Remicade costs between $1,300 to $2,500. Typically doctors don’t make a profit on drugs. The patient’s insurance reimburses the doctors’ cost of the medication. Because the price is so high, however, by stretching a single dose vial and using it twice, the doctors can bill twice and pocket the money from the second dose. Of course the patient is at risk for not having received the proper dose of medicine and from taking medication that may now be contaminated.
The Centers for Disease Control and Prevention (“CDC”) says even if a single-dose or single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use on the same patient. According to the CDC, there have been numerous outbreaks, some deadly, when attempts are made to pool single dose drugs.
The problem of reusing or pooling single use medications is so widespread that the government sponsored a One and Only campaign to raise awareness of the problem of misuse of single use drugs. [We prefer single use vials even when multiple dose vials are available. Although multi-dose vials contain an antimicrobial preservative, those typically don’t work on bloodborne diseases such as hepatitis or HIV.]
Misuse of Single Use Drugs Resulted in Prior Prosecutions
In 2016, Adventist Health System Sunbelt Healthcare Corporation (Adventist) agreed to pay the government $2.09 million after being accused of administering the remains of single-dose vials of chemotherapy drugs that were left over from administrations to prior patients.
Once again, patient safety is always present in reusing drugs once the seal on the vial has been broken. In the Adventist case, the government reported that “some patients had to be admitted for treatment after receiving injections of the pooled drugs.”
A Florida eye doctor was also charged with a similar claim of misusing of single dose vials of drugs made to be injected into the eye.
It’s not just single use drugs that are at issue. Prosecutors in Atlanta settled civil claims with Northwest ENT Surgery Center, LLC and Shatul Parikh, M.D., resolving allegations regarding Northwest ENT re-used balloon sinus dilation
devices. The FDA says only authorizes these devices for a single use. Its already bad enough that they reused these devices. Prosecutors also say the surgery center failed to adequately clean them between patient use.
Perhaps the biggest case is the pending case against McKesson. The federal government and 30 states have accused the giant drug distribution company of extracting excess chemotherapy drugs from single-use vials and then repackaging and selling the drugs as prefilled single use syringes. Because the drugs are in single use vials, they contain no preservatives. Once the seal is broken it is impossible to guarantee the sterility of either the original vial or the syringe filled with pooled product.
In 2017, the Justice Department settled a similar case with McKesson’s competitor, Amerisource Bergen for $900,000,000.00.
False Claims Act Whistleblower Rewards
These double billing / misuse of single use drugs cases were all brought under a 19th century whistleblower reward statute that allows private individuals to bring claims in the name of the government. The law is called the False Claims Act. 29 states have a similar law for state funded Medicaid.
Whistleblowers who initiate the cases are eligible for rewards of between 15% and 30% of whatever the government collects from the wrongdoer. In the AmerisourceBergen case that could be a reward of over a quarter of a billion dollars!
To qualify for the reward, you must have inside information regarding illegal pooling of single use medications or double billing associated with reusing the same medication twice. The drug must be reimbursable under Medicare or Medicaid. (Most drugs are.)
Want to learn more? Visit our Medicare fraud information page. Think you have a claim? Contact us online, by email or by phone 202-800-9791. All inquiries are kept strictly confidential. We accept cases nationwide.