Federal and Florida laws require that translators be used where patient do not have language skills need to understand their care. In most circumstances, the translator does not need to be certified. However, Florida Rule of Judicial Administration 2.560 requires the appointment of a certified translator absent exigent circumstances in cases where a fundamental interest is at stake. As such, in a situation where the hospital is contemplating involuntary commitment, a certified translator is required. See Pullen v. State, 802 So. 2d 1113 (Fla. 2001). If the patient is indigent and not represented by the Public Defender, the Hospital will need to incur these expenses for the convenience of the Court.

The Affordable Care Act (“ACA”) has upped the ante. The ACA extends previous mandates and explicitly requires insurers and healthcare institutions to provide written translation and interpreting services for limited English proficiency individuals of qualifying language groups.

The Affordable Care Act mandates that all health insurers and group health plans provide a Summary of Benefits and Coverage (SBC) to all clients and consumers.

The US Government has designed a template for insurance companies to use to disclose benefit and coverage information to maintain consistency across all insurance plans. This template helps people compare insurance plan information.

Probably the biggest impact of the changes that come with the ACA is that minor children, family members, and friends cannot serve as interpreters. Additionally, bilingual staff without formal training as medical interpreters cannot serve as interpreters. Interpreters must be “qualified,” which is defined as:

  • An individual who adheres to interpreter ethics and client confidentiality requirements, and who via a remote interpreting service or in-person appearance and
  • Has demonstrated language proficiency and the ability to interpret effectively, accurately, and impartially including specialized medical terminology.

The truth is that communication is critical to patient care. Slate reported on two examples of life changing consequences as result of poor translation:

  • After staff misunderstood intoxicado (Spanish for “poisoned”) as “drunk,” Florida teen Willie Ramirez received the wrong care and ended up paralyzed.
  • In Oregon, Elidiana Valdez-Lemus died after 911 misinterpreted her address.

Because of the serious consequences of failing to properly communicate with patients, healthcare providers must take note and provide patients with qualified interpreters. The ACA also provides for penalties for failure to follow this mandate, which includes fines, referral to DOJ for legal proceedings, and termination of Federal financial assistance.

Gazelle Craig, a licensed physician, and Shane Faithful, a clinic owner, were charged in a four count indictment.  The Indictment charged four counts – Conspiracy to Unlawfully Distribute and Dispense Controlled Substances and three counts of Unlawfully Distributing and Dispensing Controlled Substances and Aiding and Abetting.  Craig was an employed physician at Gulfton Community Health Center (“Gulfton Clinic”).  Gulfton Clinic was owned and operated by Faithful.  Gulfton Clinic was an unregistered pain clinic, but the Government alleged it was operating as a pain mill.

The government alleged that the scheme involved recruiters that would bring patients to the clinic.  The patients would line up outside the clinic to get prescriptions from Craig.  It was further alleged that Craig would see patients for minutes and in exchange for $300 would prescribe Hydrocodone and Carisoprodol, a muscle relaxer.

At trial, the government introduced surveillance video and video captured by cooperating patient witnesses.  The government also introduced ledgers and practitioner prescribing history data for Craig.

Craig and Faithful were convicted after a nine day trial and Attorney General Jeff Sessions commented on the convictions in a Department of Justice Press Release:

“Our great country is currently in the midst of the deadliest drug crisis in our history,” said Attorney General Sessions. “Sadly, even some trusted medical professionals like doctors, nurses and pharmacists have chosen to violate their oaths and exploit this crisis for cash.  The consequences have been devastating. In this case, tens of thousands of pills flooded our streets because of the defendants’ actions. We will never know for certain the scale of the damage done. We do know that justice has been served, and so I want to thank everyone who helped secure this conviction, including the DEA and Department of Justice Trial Attorneys Scott Armstrong and Devon Helfmeyer. This conviction will not only help stop the diversion of prescription drugs, it will send a message to every would-be fraudster in America.”

https://www.justice.gov/opa/pr/houston-physician-and-pain-management-clinic-owner-convicted-running-pill-mill-provided

Interestingly, the DOJ Press Release did not mention that the conviction came after a hung jury. The initial trial took place a little over thirty days before the second trial.  After multiple notes from the jury that they could not reach a unanimous verdict, the court declared a mistrial and ordered the parties back for a second trial.  The hung trial is an indication that the facts were not as clear cut as presented by the government.

Litigation over release of data in the opioid litigation gives a glimpse at the volumes of information available to the Department of Justice in health care fraud cases.

Judge Dan Aaron Polster of the Northern District of Ohio is presiding over a multidistrict litigation involving more than 400 federal lawsuits brought by cities, counties, and Native American tribes against makers of prescription painkillers, companies that distribute the painkillers, and pharmacy chains that sell the painkillers. Judge Polster was picked to preside over the litigation for several reasons, including that Ohio has been hard hit by the opioid crisis and that Judge Polster has extensive experience with multidistrict litigation.

In that litigation, the local governments suing the drug companies sought extensive documentation kept by the United States Drug Enforcement Administration (“DEA”) regarding data on painkiller sales. Status reports filed by the parties revealed that the DEA was worried the release of the information would reveal trade secrets.  The DEA also wanted to limit the amount of information provided and wanted a broad protective order to shield the information from release to the media.  The DEA finally relented and agreed to provide some information.

The New York Times has been covering the story, including outlining what data will be released.  A portion of the NYT article and a link to read more is below.

 

CLEVELAND — The U.S. Department of Justice has shared some federal data about prescription painkiller sales to help with settlement talks between local governments and drug companies targeted in hundreds of lawsuits over the opioid epidemic.

The department previously agreed to release certain data on the grounds it not be circulated publicly and be returned or destroyed when the litigation is finished. The information includes a year-by-year, state-by-state breakdown of companies that made and distributed most of the opioids in each state between 2006 and 2014. It also includes how many pills were sold annually in each state and each drug company’s market share.

DOJ Will Share Rx Painkiller Data For Opioid Lawsuit Talks – WOUB Digital

Interestingly, it seems that the DEA can track sales of opioids to the smallest detail, including state sold, year sold, and even manufacturer.  The DEA’s concerns regarding the trade secret nature of its data gives insight into the value of this information to the Government. In fact, data mining is steering prosecutions, but this data is not only valuable to the Government.  Defense attorneys may find value in this same data when defending health care fraud prosecutions.  Defense attorneys are well served demanding that the Government turn over all documents reflecting data mining resulting in the prosecution of the defendant, including cost reports.

Last week, I attended the American Bar Association National Institute on White Collar Crime in San Diego. I had the opportunity to speak on a panel with a great group of lawyers, which included Laura B. Angelini, Laura G. Hoey, Joseph G. Petrosinelli, and Gregg Shapiro.

The panel discussed the Government’s recent focus on donations by pharmaceutical companies to charity organizations that subsidize copays on expensive drugs. These charity programs are referred to as Patient Assistance Programs (“PAP”). The Department of Justice, led by a team of prosecutors, primarily out of the U.S. Attorney’s Office in Boston, is investigating whether these donations violate the AKS.

It has been widely reported that more than a dozen companies have received subpoenas, the charity organizations are wondering whether they will need to shut down, and patients are growing concerned about their access to these drugs.

Even though the OIG issued guidance in 2005 on how to structure these PAPs to avoid any issue with the Anti-Kickback Statute, today, the Government seems concerned that the charitable organizations are merely a conduit of the pharmaceutical companies to funnel money to patients. It seems the Government is also concerned that the pharmaceutical companies are simply trying to push their own products.

The panel surmised that the Government is most concerned with PAPs that are sharing extensive data with the pharmaceutical company donors, with PAPs that are asking companies to donate a certain amount, situations where the PAPs are working on behalf of donors, and situations where assistance is only provided for donor drugs and not all drugs.

The panel also discussed how the government versus everyone else views co-pays. It appears that the Government views co-pays as a way to give consumers a cost-effective option. The insurance industry uses co-pays for cost sharing among insurance providers.

Defense attorneys on the panel noted that it will be very difficult for the Government to establish “inducement” as required by the AKS because the pharmaceutical company never touched the patient.

While the panel could not agree on how to resolve the problem of access to drugs for patients without a violation of the AKS, some best practices were discussed, which included: (1) pharmaceutical company should wall off the charity from the rest of the company and definitely no one from the commercial team should be involved; (2) budget donations; (3) know what the pharmaceutical company is getting from the charitable organizations; and (4) get a legal opinion.

 

The U.S. Attorney’s Office in Eastern District of New York has unsealed an indictment and arrested three New York diagnostic testing facility owners in alleged multi-million dollar health care fraud scheme. The Indictment alleges a kickback scheme and an unnecessary services scheme. The Department of Justice press release states:

 

According to the indictment, beginning in approximately January 2014 and continuing through at least December 2016, Kaganovich, Mitaishvili and Iskanderova executed a scheme in which they submitted fraudulent claims to Medicare, Medicaid managed care plans and other health care benefit programs for diagnostic testing services.  As part of the scheme, the defendants allegedly paid kickbacks for the referral of beneficiaries who submitted themselves to diagnostic testing and other purported medical services.  The indictment also alleges that the beneficiaries themselves received kickbacks as part of the scheme.  The defendants allegedly submitted and caused to be submitted claims to Medicare, Medicaid managed care plans and other health care benefit programs for services that misrepresented which diagnostic testing company purportedly performed the services.  The indictment further alleges that the defendants disguised their illicit payments by moving the proceeds of this illegal activity through shell companies and engaged in financial transactions greater than $10,000 involving the proceeds of unlawful activity.  Kaganovich and Mitaishviliare are alleged to have falsely reported to the IRS that the illegal payments made to co-conspirators were legitimate business expenses, which caused relevant tax forms to falsely under-report business income and claim deductions.  In addition, the indictment alleges that Iskanderova, on two separate occasions, lied to federal agents about her role in the alleged fraud scheme. Here is the entire story. DOJ Press Release.

 

Given this prosecution, it seems like the Government’s interest in prosecuting diagnostic companies has not waned.

Experts are key in defending the recent wave of prosecutions alleging the fraudulent provision of medically unnecessary services. However, the defense must first survive the Daubert challenge.

Dr. Rajashakher P. Reddy was able to convince the Eleventh Circuit that his defense expert survived Daubert.

Dr. Reddy was named in a thirty-seven count Indictment alleging wire fraud, mail fraud, health care fraud, and falsifying records in a federal investigation. Dr. Reddy was a licensed and board-certified radiologist and the owner of Reddy Solutions, Inc. (“RSI”). RSI was a teleradiology business in Atlanta, Georgia. The charges stem from Dr. Reddy’s operation of RSI.

The Indictment alleged that Dr. Reddy perpetuated an eighteen-month health care fraud scheme, whereby Dr. Reddy fraudulently signed and submitted radiology reports electronically and through the U.S. Mail for “tens of thousands of patients … in cases where neither he nor any other RSI physician had ever reviewed or analyzed the film.”

The jury convicted Dr. Reddy of all offenses, except for five wire fraud counts. Dr. Reddy appealed arguing that the trial court committed reversible error by excluding the proposed defense expert testimony of Dr. Benjamin Sacks pursuant to Daubert.

The defense theory at trial was that Dr. Reddy performed the services as represented, but that remote access and other indicia that he did the work were not adequately reflected by RSI systems and records. Dr. Reddy’s proposed expert, Dr. Benjamin Sacks, was to provide testimony summarizing his “peer review” of a sampling of images which Dr. Reddy had purportedly examined and diagnosed. Dr. Sacks’s substantive findings were that Dr. Reddy’s work as a radiologist was “spot on” and Dr. Sacks concurred with Dr. Reddy’s conclusions in 1053 out of the original 1060 reports reviewed.

The Government moved to exclude the testimony of Dr. Sacks based upon its claim that the entire peer review study was unreliable for various reasons, and that the testimony would not assist the jury. The district court agreed that the proposed peer review testimony failed all three aspects of the Daubert analysis.

The Eleventh Circuit determined that the exclusion of the defense expert was an abuse of discretion and vacated Dr. Reddy’s convictions and remanded for further proceedings on the issue. Particularly, the court found that Dr. Reddy’s defense was that he “did the work”. The court further found that the purpose of the peer review performed by Dr. Sacks was to give the jury some sense of the accuracy of the work that was being generated by Dr. Reddy as indicative of the actual attention he must have paid to the images on which he reported. The court stated that the jury could infer from Dr. Sacks’s peer review and attendant results that a radiologist and not a lesser trained staff member had undertaken a review of the image. The court agreed that this was a “powerful defense evidence.”

The Eleventh Circuit appeared impressed that the defense expert had hired a statistical expert to identify how to conduct the peer review. Additionally, the statistical expert had suggested that Dr. Sacks review a minimum of 287 images to achieve a greater level of confidence with the peer review. Dr. Sacks exceeded this number in reviewing 1060 images. The court also noted that Dr. Sacks had the proper credentials. He was a graduate of Cornell University, obtained his medical degree from UCLA, had completed a four-year residency in diagnostic radiology at Emory University, and was board-certified.

The takeaways from this case are:

  • Pick an expert with solid credentials and highlight these at the hearing;
  • Confirm all the information in your expert’s CV before the hearing;
  • Conduct a thorough review of all authoritative literature;
  • Ensure your expert has done more than the minimum in reaching his opinion;
  • Illustrate the reliability of your expert’s testimony; and
  • Ensure the review or analysis is independent.

 

Saloman Melgen sentenced to 17 years today.  A win for the defense, but tantamount to a life sentence for the 63 year old physician.

Melgen was charged in a 76 count indictment.  The case was brought after data mining by the OIG determined Melgen was the highest billing ophthalmologist to Medicare in the entire country. The Government alleged that Melgen was performing unnecessary eye injections and laser procedures and that Melgen was illegally dividing vials of the drug Lucentis into multiple doses.

The Government claimed this was one of the biggest health care fraud cases in the nation and claimed that Melgen robbed Medicare of $105 million.  The Government’s experts at trial testified that Melgen used antiquated tests, which were poorly done, to diagnose patients with wet macular degeneration.  The experts testified that most of Melgen’s patients didn’t even have the disease.  One expert referred to melgen’s practices as “abusive” and “horrifying.”

The defense presented the testimony of Melgen’s family and staff, who said he was a good doctor that cared about his patients.

The jury believed the Government and convicted Melgen of 64 counts.  Judge Marra tossed 9 of the 76 counts before the case went to the jury.

There was much litigation in advance of sentencing, including four days of hearings over two months focused on the loss at issue.  The Government argued that the loss to Medicare was $136 million.  The defense argued the loss was $64,000.  Judge Marra largely sided with the Government and set the loss figure at $73.4.

In two ultimately hollow victories for Melgen, the judge agreed that his treatment didn’t pose potentially fatal risks to his patients and that he didn’t target vulnerable people.

“(Melgen) was not able to perpetrate his fraud because his patients were vulnerable. He was able to do so because he was a trained physician in whom his patients place their trust,” Marra wrote. “The mere fact that the patients were elderly puts them in no different position than a patient of any age who trusts that his or her doctor is acting in their best interest.”

PalmBeachPost

Going into sentencing Melgen was facing 19 to 25 years in prison.  Melgen’s attorneys have vowed to appeal.