Healthcare Fraud

August 20, 2017

Mylan Agrees to Settle FCA Lawsuit Regarding EpiPen

lukasz-szmigiel-413-copy-300x169 Pharmaceutical companies Mylan Inc. and Mylan Specialty L.P. agree to pay $465 million to settle a lawsuit brought under the False Claims Act (FCA). According to the FCA-based suit brought by a whistleblower, Mylan intentionally misclassified EpiPen as a generic drug – knowing it was a brand name drug – in order to not have to pay higher rebates to Medicaid. EpiPen is a brand name drug because there is no therapeutically equivalent drug provided by other manufacturers. Mylan is the single source of EpiPen. By willfully and incorrectly deeming it a generic drug, Mylan was not required by law to pay a higher rebate to Medicaid, thereby retaining a greater amount of money and increasing their profits.

More on Mylan’s Actions

The purpose of the Medicaid Drug Rebate Program is to ensure state Medicaid programs were not injured to price gouging by manufacturers that were the only source of a drug, like EpiPen. When a drug manufacturer is a single course for a medication, there is no market competition to balance the price of the drug. Instead, that manufacturer can continually raise the price and there will always be a demand for the drug out of necessity.

August 11, 2017

The DOJ Continues to Root Out Healthcare Fraud

by Gregory J. Brod

aidan-bartos-313782-copy-300x200 On August 10, the Department of Justice (DOJ) announced victory in another healthcare fraud case. A federal jury convicted registered nurse, Evelyn Mokwuah, 52, of criminal involvement in a $20-million Medicare fraud scheme. Mokwuah owned two home health companies based out of Houston, Beechwood Home Health and Criseven Health Management Corporation. She and these companies were convicted of making fraudulent claims to Medicare for home health services.

Healthcare Fraud Trial Ends Well for Government

There was a four-day trial regarding Mokwuah’s fraudulent activities. She was convicted of four counts of health care fraud and one count of conspiracy to commit health care fraud. Evidence at trial was based on claims made to Medicare by the two companies between 2008 and 2016. Fraudulent claims were made for home health services that were either not provided or were provided when not medically necessary.

August 4, 2017

Qui Tam Cases Remain Under Seal for Years

by Gregory J. Brod

When qui tam cases under the False Claims Act (FCA) are first filed, they are to remain under seal for 60 days. During this time, the case is secret. The defendant is not even served yet, so it likely does not know there is a suit filed against it unless there are quiet rumblings or leaks. During this 60-day period, the government is given an opportunity to investigate the allegations and decide whether to join the suit or not. Once the government makes its decision, the case is unsealed. In certain instances, this is when the defendant is served. However, in many cases, the seal is partially lifted and the defendant is served prior to the whistleblower case being made public.

The truth of the matter, though, is that a qui tam case is never under seal for just 60 days. The FCA, the government can ask for extensions of the seal period if they can show it is for good cause. This happens regularly and continuously to the point where many qui tam cases remain confidential for years.

How Long Do Qui Tam Cases Remain Under Seal?

July 28, 2017

Pharmaceutical Manufacturer Celgene to Pay $280 Million for Fraud Allegations

by Gregory J. Brod

andres-de-armas-103880-copy-300x200 On July 24, the U.S. Attorney’s Office for the Central District of California announced that Celgene Corp., a pharmaceutical manufacturer headquartered in New Jersey, will pay $280 million to numerous states and the federal government to settle claims that it submitted false claims to the federal government and state health programs. From the settlement, $259.3 million will go to the federal government, $20.7 million will be divided among 28 states and the District of Columbia. California is set to receive more than any other state at $4.7 million.

U.S. ex rel. Brown v. Celgene Corp.

The settlement is the result of a whistleblower lawsuit filed by Beverly Brown under the qui tam provision of the False Claims Act. Brown, who was a sales manager at Celgene, brought a lawsuit on behalf of the federal and state governments. She provided evidence that Celgene promoted two cancer drugs, Thalomid and Revlimid, for uses that were not approved by the U.S. Food and Drug Administration and therefore not covered by federal healthcare programs.

July 21, 2017

DOJ Announces Largest Health Care Fraud Enforcement in Department History

by Gregory J. Brod

david-everett-strickler-196946-copy-300x195 On July 13, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Tom Price, M.D., announced the Department of Justice’s largest ever health care fraud enforcement action. The work of the Medicare Fraud Strike Force, established in 2007, led to 412 defendants being charged with health care fraud offenses based on information they all participated in fraudulent schemes to obtain about $1.3 billion in false billings to Medicare, Medicaid, and TRICARE. Additionally, HHS has begun the suspension process against 295 health care providers’ licenses.

Hundreds of Individuals Charged With Health Care Fraud

Of the 412 defendants, 115 are physicians, nurses, and other licensed medical professionals. Many of these defendants were charged with federal crimes for prescribing medically unnecessary drugs and compound medications, many of which were not actually distributed to the patients or purchased. Providers could then bill for these unnecessary or unpurchased medications and receive a greater amount of reimbursements from state and federal health services.

July 14, 2017

Wal-Mart Pays $1.65 Million Due to False Claims

by Gregory J. Brod

The Department of Justice (DOJ) for the Eastern District of California announced on July 7 that Wal-Mart Stores, Inc. (Walmart) paid $1.65 million to resolve accusations related to unlawful medical claims. This is an important suit as it demonstrates that the federal and state governments will go after large retailers for false claims. Pursuing whistleblower suits and securing government funds that were unlawfully obtained remains a top property for the DOJ.

Walmart’s False Claims

Through a qui tam suit brought by a former Walmart pharmacist in the Sacramento area, the California government learned that Walmart was allegedly submitting false claims to the state’s Medi-Cal program in order to increase reimbursements. Supposedly, Walmart would knowingly submit claims that were not supported by a proper and relevant diagnosis or documentation. More specifically, Walmart would submit reimbursement claims for Code 1 drugs that were not based on proper and pre-approved diagnoses. Medi-Cal only reimburses for Code 1 drugs if they were prescribed for approved diagnoses. If a Walmart pharmacy wanted reimbursement for a Code 1 drug for something else, it would need to submit a specific request with the reasoning for a non-approved use. Walmart pharmacists intentionally submitted claims without confirming the approved diagnosis and obtaining the necessary documentation or for non-approved uses.

July 7, 2017

DOJ Cases Against Major Insurer United Health Group Continue

by Gregory J. Brod

There are currently two False Claims Act (FCA) qui tam cases against United Health Group (UHG) pending in the Central District of California. The cases are: U.S. ex rel. Benjamin Poehling v. UnitedHealth Group, Inc. and U.S. ex rel. Swoben v. Secure Horizons, et al. The cases were brought by James Swoben, who was previously an employee of Senior Care Action Network Health Plan and a consultant within the risk adjustment industry, and Benjamin Poehling, who was the former finance director of a UHG group that managed the insurer’s Medicare Advantage Plans.

The Qui Tam Cases Against UHG

On May 2, the U.S. intervened in the Swoben False Claims Act suit against UHG based on the allegations the insurer overcharged Medicare Advantage and prescription drug programs. In the DOJ’s complaint, it alleges the insurer knowingly ignored patients’ medical conditions to increase payments it received from Medicare and funded chart reviews to increase the risk adjustment payments it reviewed. However, any information the reviews uncovered regarding misdiagnoses were disregarded to avoid repaying Medicare.

June 30, 2017

Los Angeles Hospital Pays $42 Million to Settle Qui Tam Suit

by Gregory J. Brod

The U.S. Department of Justice announced on June 28 that PAMC Ltd. and Pacific Alliance Medical Center Inc. have agreed to pay $42 million to settle allegations that they violated provisions of the False Claims Act. The two companies, which operate together as Pacific Alliance Medical Center in Los Angeles, allegedly had unlawful financial relationships with doctors.

Qui Tam Suit Against Pacific Alliance Medical Center

The qui tam lawsuit against the defendants was filed by Paul Chan, who was a manager with one of the defendant businesses. A qui tam suit is a civil lawsuit brought by a private citizen on behalf of the government. The private citizen, known as the relator during the suit, provides information regarding the claims that is not available to the public. If the government receives a settlement or jury award in relation to the relator’s allegations, then he receives part of the monetary recovery. In this case, Chan is set to receive more than $9.2 million.

May 26, 2017

CareCore National, LLC to pay $54 Million for Fraudulently Overbilling

by Gregory J. Brod

CareCore National, LLC and the U.S. Department of Justice entered into a settlement agreement, according to a May announcement. CareCore will pay $54 million to resolve a False Claims Act suit based on allegations it fraudulently billed government insurance programs. The business provides pre-authorization/pre-certification services to managed care plans. It determines whether diagnostic testing is medically reasonable and necessary for patients and should be paid for by health insurers. However, the allegations brought by a previous employee stated that CareCore did not follow its protocol and directed nurses to move forward with medical services that were not reviewed or medically necessary. This caused hundreds of thousands of inappropriate and unnecessary diagnostic tests to be approved and billed to Medicare and Medicaid.

Why the Whistleblower Came Forward

CareCore’s previous employee, John Miller, a licensed practical nurse, filed the qui tam suit against the business on behalf of the government. Miller acted as a clinical reviewer for the company and was required to assess whether a medical procedure met certain criteria for being approved. If the service was necessary and appropriate, it would be submitted to the insurance company for payment. Due to the high demand for its services, CareCore could not keep up. In response to the demand, it created the program known as Process As Directed (PAD). Through this program, clinical reviewers like Miller automatically approved prior authorization requests without a physician performing an independent review. This enabled CareCore to return more pre-authorization requests in a shorter period of time. PAD ultimately led to more than 200,000 deceptive authorizations between 2005 and 2013. Medicare and Medicaid paid for many of these unnecessary and fraudulently approved tests.

May 19, 2017

Omnicare to Pay $8 Million FCA Settlement

by Gregory J. Brod

The U.S. Department of Justice and CVS Health Corp.’s Omnicare Inc. have settled a suit based on the federal False Claims Act for $8 million. Omnicare is the country’s largest nursing home pharmacy. It was formed in 1981 and acquired by CVS Health in 2015. Prior to this takeover, the U.S. Federal Trade Commission blocked Omnicare’s hostile takeover of competitor PharMerica. Had Omnicare purchased the business, it would have had 57% of the market share for long-term-care pharmacies. The most recent FCA settlement with the federal government is one in a long line of settlements based on fraudulent and unlawful claims to federal programs.

Omnicare’s Most Recent FCA Settlement

In a qui tam brought by Elizabeth Corsi and Christopher Ezzie in February 2014, it was alleged that Omnicare created and implemented an automated label verification system, which utilized a less specific drug code, “MEDID,” during the automated Stage II pharmacist verification process instead of a more specific National Drug Code (NDC). The result of this system was that the company submitted claims to Medicare and Medicaid for generic drugs different than those actually dispensed to patients. This created false claims to the federal government. The patient’s medication labels also had incorrect manufacturer or NDC information. Because of these issues, Omnicare could not properly track medication information or, if necessary, conduct a patient-level recall on drugs, putting patient safety at risk.