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Another Generic Drugmaker Targeted by DOJ Investigation

Reuters Health reports that Taro Pharmaceutical Industries Ltd and two of its senior officers received grand jury subpoenas last week in connection with a federal antitrust investigation into generic drug pricing. The company said in an SEC filing late on Friday it received subpoenas on Thursday from the U.S. Justice Department’s Antitrust Division.

The SEC filing discloses that “On September 8, 2016, Taro Pharmaceuticals, U.S.A., Inc. (“Taro”), as well as two senior officers in its commercial team, received grand jury subpoenas from the United States Department of Justice, Antitrust Division, seeking documents relating to corporate and employee records, generic pharmaceutical products
and pricing, communications with competitors and others regarding the sale of generic pharmaceutical products, and certain other related matters.”

“Taro intends to respond to the subpoena and otherwise cooperate with the Department of Justice investigation.”

Taro is the maker of many popular generic over-the-counter ointments, including antibiotic pain relief and Hydrocortisone creams used to relieve itching and minor skin rashes.

It also manufacturers prescription creams such as Clobetasol, which treats a variety of skin disorders including eczema and psoriasis.

A story published by the Boston Globe last year highlighted concerns about the rising prices of some generic drugs, including Clobetasol, which is made by several companies. The newspaper reported that the price of Clobetasol rose to $4.15 a gram in 2015 from $0.26 in 2013.

It was not clear from Friday’s filing whether Clobetasol is among the products being reviewed by the Justice Department.

The rising cost of prescription medications has become a high-profile issue over the past year, with various companies coming under scrutiny for drastically raising the prices of their drugs and devices.

Companies including Valeant Pharmaceuticals and Turing Pharmaceuticals were both targets of congressional investigations earlier this year for hiking the price of life-saving drugs, with Turing also facing antitrust probes by the Federal Trade Commission and the New York attorney general.

Separately, Valeant faces investigations by federal prosecutors into its pricing and distribution.

More recently, Mylan NV has come under fire for raising the price of its allergy auto-injector Epipen. The New York attorney general disclosed earlier this month he had launched an antitrust probe into the company’s contracts to provide Epipens to schools. The company is also facing congressional probes.

The issue has also resonated on the campaign trail, with Democratic presidential nominee Hillary Clinton saying that if elected in November, she would create an oversight panel to protect U.S. consumers from large price hikes on long-available life-saving drugs.

Allstate Wins Second L.A. Fraud Civil Judgment

Los Angeles County Superior Court ruled in favor of Allstate Insurance Company and the State of California in a lawsuit topping more than $2.3 million that ends the illegal ownership, kickbacks and fraudulent operation of two medical clinics in Los Angeles.

In its lawsuit, Allstate alleged chiropractor Byum Suk Kim violated the state’s Insurance Frauds Prevention Act when he submitted to Allstate more than 90 claims for treatment of patients at the two clinics that were illegally owned in violation of California’s Moscone Knox Professional Corporation Act. In its complaint, Allstate alleged the two clinics, Wilshire Spinal Disc Clinic, Inc. and Allied Medical, Inc. were held out to the public as legitimate medical clinics incorporated in the State of California, but were actually owned and operated by Byum Suk Kim, D.C. in violation of the Moscone Knox Professional Corporation Act and Business & Professions Code sections 2052, and 2400, commonly referred to as the “corporate practice of medicine bar.” Both clinics are no longer operating.

Judge Terry A. Green agreed with Allstate and ordered Kim to pay $1.8 million in penalties, plus over $582,000 in assessments and fees – a $2.3 million judgment.

“Submitting even one false insurance claim is more than just a bad idea; it’s fraud, and insurance fraud is a crime,” said Allstate’s California Field Senior Vice President Phil Telgenhoff. “Fraud drives up the cost we all pay for insurance by stealing millions of dollars from insurers. This cannot and will not be tolerated in California or anywhere. Allstate will fight fraud to help protect our customers and keep insurance costs down.”

Allstate’s suit identified Kim as a chiropractor owning and operating the two medical clinics. The judgment was based on evidence submitted by Allstate showing Kim engaged in clinical and billing fraud in connection with claims that were submitted to Allstate, which included hundreds of individual violations of California Penal Code section 550. Specifically, the evidence showed Kim was responsible for the preparation of 91 separate reports for patients allegedly treated by him at Wilshire and Allied, each of which contained misrepresentations in violation of section 550 regarding the level and type of treatment purportedly provided.

Additionally, the billing records for the treatment allegedly provided were likewise fraudulent, as the evidence presented by Allstate showed there was illegal “up-coding” for services. The judgment was based on Allstate proving the medical records, narrative reports, and bills of patients purportedly treated by Kim amounted to billing and clinical frauds perpetrated and carried out by Kim on a systematic basis at both Wilshire Spinal Disc Clinic, Inc. and Allied Medical, Inc.

This is the second multimillion-dollar ruling against insurance fraud that Allstate has successfully argued in Los Angeles County Superior Court in 2016.

WCIRB Thinks Proposed Law Means Lower Comp Rates

The Insurance Journal reports that the governing committee of California’s Workers’ Compensation Insurance Rating Bureau on Wednesday approved an amended, and reduced, rate filing for Jan. 1, 2017 workers’ compensation rates. It did so based on the hope that California Gov. Jerry Brown signs two bills into law, and that those bills end up producing a cost savings in the state’s massive workers’ comp system.

All bets are off if Brown doesn’t sign them.

“Nothing set in stone for sure unless the governor signs both of those bills,” said Jerry Azevedo with the Workers’ Compensation Action Network, a group that represents the interests of employers.

The committee on Wednesday recommended a 4.3 percent reduction. Just a month earlier it had recommended a 2.6 percent reduction, which it sent to the California Department of Insurance. The move by the WCIRB committee was surprising for some.

“I’m kind of surprised that the two new bills that are likely to be signed would work into any immediate savings,” said John Norwood, a lobbyist and managing partner of Sacramento-based Norwood and Associates.

The bills WCIRB is pinning its hopes on are Senate Bill 1160 and Assembly Bill 1244.

AB 1244 is designed to remove from the workers’ comp system doctors found to have committed a felony or misdemeanor involving fraud or abuse of the Medi-Cal program, Medicare or the workers’ comp system itself. The bill would also keep those doctors from filing liens.

According to the Department of Workers’ Compensation, 10 percent of liens filed between 2011 and 2015 were filed by providers with fraud indictments or convictions.

The other bill, SB 1160, places limitations on the utilization review (UR) process, and also would stay any physician or provider lien upon the filing of criminal charges against them for specified offenses involving medical fraud.

Impact projections from the WCIRB shows an estimated reduction in UR costs from SB 1160 but an increase in medical costs.

Uber Wins Next Round in Classification Battle

Uber won a courtroom victory on Wednesday when an appeals court ruled that drivers are subject to individual arbitration in a lawsuit over background checks, a ruling that might help the ride-hailing company fend off another costly class action lawsuit filed by its drivers.

While the Ninth U.S. Circuit Court of Appeals found that agreements signed by two former drivers for the service over background checks “clearly and unmistakably” require legal disputes be settled by a private arbiter, the reasoning may be applied to another class action lawsuit filed by drivers over the company’s employment classifications.

Uber agreed to settle that classification lawsuit earlier this year — an agreement that was rejected by a federal judge last month. Arbitration is a method frequently used by companies for resolving legal conflicts outside of the court system.

Uber Technologies Inc.’s message to the judge who was asked to approve its $100 million settlement with drivers last month was clear: take it or leave it. Bloomberg reports there is an escalating game of courtroom brinkmanship, Uber has hit what was an impasse with U.S. District Judge Edward Chen who presides over the federal class action suit pending in San Francisco, its demand that, as part of the deal, he erase his own order intended to protect the ride-hailing company’s drivers.

And indeed Judge Chen rejected the proposed settlement in August. Uber drivers contended in the lawsuit they should be deemed employees and reimbursed for expenses such as gasoline and vehicle maintenance. Those expenses are now borne by the drivers. The proposed settlement would have kept drivers classified as independent contractors. Several drivers who were part of the class filed objections with the court, particularly because the proposed amount was well below the total potential damages in the case of roughly $850 million.

In an order handed down last August in San Francisco, US District Judge Edward Chen said that, despite changes to its policies that Uber was ready to enact, the proposed settlement on the whole “is not fair, adequate, and reasonable.” Had it been approved, the agreement would have impacted about 385,000 Uber drivers California and Massachusetts involved in the class-action suit.

The U.S. 9th Circuit Court of Appeals in San Francisco said with Wednesday in the published case of Mohamed v Uber Technologies that drivers who signed up with Uber in 2013 and 2014 must go to arbitration, not the courts, to resolve disputes with the company. Judge Chen previously ruled in the companion classification case that the arbitration agreements were unenforceable and unconscionable. But the appeals panel said Chen lacked the authority to make that call because the contracts require an arbiter to decide “all matters.”

The ruling on Wednesday applies directly to two drivers’ challenge of Uber’s background-check practices in a proposed class-action lawsuit. But it could have an effect on dozens of lawsuits across the nation. Uber drivers have used the threat of a class-action lawsuit to extract concessions from the San Francisco company. Having to go to arbitration largely takes the specter of mass litigation off the table.

Now, Uber could drop the settlement talks altogether in the classification case because the appeals court could go on to unwind Chen’s certification of a class of drivers, forcing most of the drivers to individual arbitration. One-one-one fights typically result in smaller benefits for complainants. The class currently includes some 240,000 drivers from California and Massachusetts. If the arbitration agreements are enforced, the class could be reduced to 8,000 people – those who had rejected the arbitration agreements when they joined Uber’s driver roster.

DWC Posts Adjustments to OMFS

The Division of Workers’ Compensation (DWC) has posted an order adjusting the Official Medical Fee Schedule (OMFS) to conform to changes in the Medicare payment system as required by Labor Code section 5307.1.

The Physician and Non-Physician Practitioner Fee Schedule update Order adopts the following Medicare changes:

– CMS Medicare National Physician Fee Schedule Relative Value File RVU16D October 1, 2016 quarterly update
– National Correct Coding Initiative Physician/Practitioner Services CCI Edits October 1, 2016 quarterly update
– National Correct Coding Initiative Medically Unlikely Edits October 1, 2016 quarterly update

The order adopting the OMFS adjustments is effective for services rendered on or after October 1, 2016.

Berkshire Hathaway Stipulates to EquityComp Cease and Desist Order

The California Insurance Commissioner approved an order agreed to by California Insurance Company (CIC) and Applied Underwriters Captive Risk Assurance Company, Inc. (AUCRA), under which they will stop selling workers’ compensation policies that the two Berkshire Hathaway companies used without filing key addendums to the policies (called EquityComp) with the Department of Insurance for the commissioner’s review and approval, and will work with the department’s actuaries to agree upon fair terms for calculating future claims that would apply to existing EquityComp policies.

The agreement to submit to a cease and desist order was in response to the commissioner’s June 28, 2016 notice that a hearing would be held to decide whether CIC and AUCRA should be ordered to cease and desist from issuing new unapproved EquityComp policies.

The order halts the issuance of new EquityComp policies unless and until the commissioner approves them. The order also provides substantial relief under existing EquityComp policies, which includes eliminating punitive requirements for posting collateral, and specifying new, appropriate loss development factors. The order does not affect the ability of any employer to challenge the legality of the EquityComp policies.

Commissioner Jones’ action stemmed from his precedential decision that a complex insurance scheme in the Shasta Linen case circumvented regulatory review and cannot be sold in California unless it is filed and approved. Shasta Linen, a small employer, purchased an EquityComp policy from CIC and AUCRA. Shasta Linen brought a case before the commissioner, challenging the legality of the policies.

The commissioner found that the insurance companies issued the policies and rates without his approval, as is required by law. The commissioner also ruled that the companies designed the unusual and complex program with the intent of avoiding the review of insurance regulators.

Among the most troubling features of the EquityComp policy was the imposition of unexpected and greatly excessive collateral requirements upon termination of the employers’ policies. The collateral requirements had serious and unexpected consequences for many employers.

The policies also forced an employer who disputed the insurers’ decisions to arbitrate their disputes in Tortola, British Virgin Islands, or in other locations outside of California. The expense of a remote arbitration made it unreasonably difficult for employers to challenge the insurers’ decisions. The commissioner’s order requires CIC/AUCRA to arbitrate disputes with the policyholders in California.

“Insurance companies are required to file rates and terms so we can make sure they are complying with the law,” said Commissioner Jones. “These filing requirements were put in place to protect businesses from insurers seeking to take advantage of their market power – for example, the unfiled insurance scheme sold to small business Shasta Linen shifted the risk back to Shasta Linen, had prohibitively expensive renewal and cancellation penalties, and required disputes to be arbitrated in the British Virgin Islands.”

New Indictment Involves Executive Director of Surgical Center

A Rancho Mirage woman who was the executive director of a cosmetic surgery center has been named in a superseding indictment that adds new fraud and identity theft charges to a case in which she is accused of participating in a scheme that billed insurance companies $50 million for cosmetic surgeries that were falsely claimed to be “medically necessary.”

Linda Morrow, 64, was named in a 31-count superseding indictment that was returned on August 31 by a federal grand jury. Morrow and her husband, who pleaded guilty earlier this year, were initially charged a year ago with participating in a scheme to defraud health insurance companies by submitting bills for more than $50 million for procedures that were claimed as “medically necessary” – but in fact were cosmetic procedures such as “tummy tucks,”and  “nose jobs.”

The superseding indictment adds nine new charges against Morrow – three new mail fraud charges, three counts of identity theft and three counts of aggravated identity theft charges. The new indictment expands on forfeiture allegations in the original indictment that would require Morrow, if she is convicted, to forfeit all of the ill-gotten gains obtained from the scheme, a figure that may exceed $20 million.

The superseding indictment outlines a scheme in which patients were lured to The Morrow Institute (TMI) in Rancho Mirage, where Morrow was the executive director, with promises that cosmetic procedures would be paid for by their union or PPO health insurance plans. TMI allegedly submitted bills to insurance companies seeking as much as $100,000 for individual surgeries, and as much as $700,000 for multiple surgeries. The indictment further alleges that some patients who underwent multiple surgeries at TMI suffered severe medical complications from the procedures.

“As part of the scheme charged in this indictment, the defendant allegedly used the names and signatures of patients without their knowledge to obtain payments for procedures that were not covered by insurance,” said United States Attorney Eileen M. Decker. “Health care fraud schemes that defraud insurance companies in this manner victimize both the insurers and the insured who are forced to pay higher premiums. This case seeks both to punish the defendants and to deprive them of their illegal profits.”

In March, Morrow’s husband – Dr. David M. Morrow, 71, of Rancho Mirage, a cosmetic surgeon and dermatologist who was the owner of TMI – pleaded guilty to conspiracy to commit mail fraud and filing a false tax return. Dr. Morrow agreed to pay more than $1 million in restitution to victims. When he pleaded guilty, Dr. Morrow admitted that he had altered a medical record by handwriting “hernias” over the original text in the document, which had correctly listed the cosmetic procedure of “abdominoplasty” (tummy tuck).

The victim health insurance companies included Anthem Blue Cross, Blue Cross/Blue Shield of California, Blue Cross/Blue Shield of Massachusetts, Regional Employer/Employee Partnership for Benefits, formerly known as Riverside Employer/Employee Partnership (REEP) and Cigna.

The superseding indictment further alleges that after the FBI executed a federal search warrant at TMI in March 2011, Morrow went to the home of a TMI employee and asked whether the employee had been “the mole” who had reported TMI to the FBI.

Dr. Morrow is scheduled to be sentenced by Judge Staton on December 2, at which time he will face a statutory maximum sentence of 23 years in federal prison.

California Claimants Lose RICO Case Against TPAs

The Racketeer Influenced and Corrupt Organizations Act, commonly referred to as the RICO Act or simply RICO, is a United States federal law that provides for extended criminal penalties and a civil cause of action for acts performed as part of an ongoing criminal organization.In order to prevail in a RICO action, a plaintiff must prove a “predicate offense” one of which is fraud. In addition to the predicate offense, a plaintiff must also prove a “pattern of racketeering activity” which requires a showing of at least two acts of racketeering activity. This second requirement opens the doors to fairly broad discovery rights covering practically any history of a target defendant that might prove a pattern of racketeering, an open ended discovery process. Federal RICO allows a successful plaintiff to recover treble damages, plus attorney fees.

The plaintiffs bar has sought to apply RICO laws as a penalty in workers’ compensation claims for at least a decade with mixed results. Conceptually they allege that an employer, carrier or third party administrator concocts a fraudulent scheme that is used over and over to prevent workers from obtaining just benefits.

Plaintiff efforts to succeed at RICO in the federal 6th Circuit (Kentucky, Michigan, Ohio, and Tennessee) ultimately ended in failure. In one the the last tries, a Michigan claimant alleged that employer/carrier defrauded him with “false” medical testimony, and filed federal Racketeer Influenced and Corrupt Organizations Act RICO case, In that case, Brown v. Ajax Paving Industries, 752 F.3d 656 (2014), the United States Court of Appeals for the Sixth Circuit followed the prior ruling in Jackson v. Sedgwick Claims Management Services, a carbon copy of this case, 731 F.3d 556, 558 (6th Cir.2013) (en banc). Essentially in the 6th Circuit, RICO cannot be based on an underlying workers’ compensation claim because the court held that “loss or diminution of benefits the plaintiff expects to receive under a workers’ compensation scheme does not constitute an injury to ‘business or property’ under RICO.”

The effort to win comp related RICO cases then moved to the 9th Circuit (nine western states including California and Arizona) arguably the most liberal Circuit in the federal system. In Laurie Miller et al. v. York Risk Services Group, nine plaintiffs worked as firefighters or engineers for the Phoenix fire department, and York adjusted the department’s workers comp claims. The plaintiffs alleged, in part, that York worked with the City of Phoenix to wrongfully deny or delay their workers comp benefits in violation of the federal RICO Act. York moved to dismiss based partly on the en banc decision from the 6th U.S. Circuit Court of Appeals, which dismissed similar RICO claims against Sedgwick Claims Management Services Inc. That defense did not work in Arizona. Judge Sedwick ruled in 2013 that the employees “possess a property right in their workers compensation benefits under Arizona law,” which allows them to have a property interest under RICO law and the case was allowed to proceed. Before the case went to trial, it was settled at the end of 2015. Thus the ruling was not tested in the 9th Circuit Court of Appeals.

Now they have lost another 9th Circuit RICO case this time filed in California.

John Black, and a group of police officers and fire fighters assert a RICO claim in their fourth amended complaint involving the City of Rialto and the City of Stockton, CorVel Enterprises, York Risk Services Group and others. These plaintiffs allege “York, CorVel, and Rialto engaged in a pattern of fraudulently denying and delaying legitimate claims in order to lower the liability of the city, while at the same time maximizing the TPA’s revenues (and allowing the TPA to maintain and obtain contracts with other public entities based on their ‘outstanding’ financial performance at the expense of public servants)”

At the end of April, the Federal Judge granted the defendant’s motion to dismiss the third amended complaint, but gave the plaintiffs leave to amend for the fourth time.  And on August 25, the federal judge reviewed the 4th amended complaint and dismissed the case without leave to amend. The decision was based in part upon a determination that a workers’ compensation benefit is not a property right subject to RICO, a ruling consistent with the 6th Circuit.

Plaintiffs now have an opportunity to appeal the decision in the 9th Circuit Court of Appeals. Assuming a defense result in that tribunal, this would likely end the effort in the 6th and 9th Circuits, and these plaintiffs will have to go elsewhere.

It will be important to monitor the City of Rialto case until it reaches its ultimate conclusion.

FDA Sets Long Awaited Hearing on Off Label Medication Use

After years of anticipation, the US Food and Drug Administration will hold a public, two-day meeting in November to review the extent to which so-called off-label information about medicines may be disseminated to physicians.

Off-label information is regulatory parlance for materials that describe unapproved uses of a drug. Doctors are, in fact, allowed to prescribe a medicine for an unapproved use, but drug makers have long chafed at restrictions on their ability to distribute such information – reprints of medical studies, for example – and have lobbied Congress and the FDA to loosen regulations.

Despite such efforts, the FDA has taken a firm stance toward the issue. A key concern is that public health could be jeopardized if a company were to distribute information about an unapproved use that had not been proven to be safe and effective, a standard for regulatory approval.

The issue became highly contentious, however, after a 2012 ruling by a federal appeals court that overturned the criminal conviction of a Jazz Pharmaceutical sales rep, who was prosecuted for encouraging doctors to prescribe a drug for unapproved uses. The court ruled his speech was protected, since the information was truthful and not misleading.

Since then, drug makers have argued that conveying certain types of information is protected by the First Amendment. The debate accelerated last year when Amarin filed a lawsuit arguing it had the right to off-label marketing, so long as the information provided to doctors is truthful and not misleading. A federal judge agreed with the company and the FDA recently reached a settlement with Amarin.

Throughout these events, the FDA indicated it would issue regulations on off-label marketing and hold a public meeting to review the myriad issues.

However, drug makers and their supporters have grown impatient and fear that various court rulings might become a de facto standard. Last winter, an independent review panel was floated as a way to address the issue. Last May, two lawmakers accused the US Department of Health and Human Services of delaying new rules and issued a draft bill that would allow companies to market products for unapproved uses.

The upcoming meeting, which will be held on Nov. 9 and 10 at FDA offices in Silver Spring, Md., is supposed to give the public a long-awaited chance to convey their opinions and debate the issue. In a notice published Wednesday in the Federal Register, the agency poses several potential questions for which it hopes to receive responses about the pros and cons of off-label marketing.

It’s not clear how long it will take the FDA to issue new regulations.

El Cajon Pain Physician Arrested for Illegal Prescribing

Physician Naga Raja Thota, a board certified anesthesiologist who works as a pain-control specialist with an office in El Cajon, was arrested and charged with distributing oxycodone and other highly addictive drugs without any legitimate medical purpose in exchange for sex acts. He has been licensed to practice in California since 1994.

The doctor was taken into custody by San Diego Drug Enforcement Administration agents at his place of work.

The criminal complaint said at least two young women received prescriptions for opioids without a legitimate medical purpose on numerous occasions in exchange for sex acts. The complaint also shows a pattern in which sexually-explicit texts are exchanged by the doctor and the women, followed by prescriptions written for them by Thota.

According to the complaint, one victim said she met Thota when she was hospitalized for withdrawal symptoms for Hydrocodone and Alprazolam. Thota agreed to treat her but documented that his treatment was for pain even though this victim did not suffer from any medical condition that caused chronic or ongoing pain. This victim also stated that Thota kept increasing the dosage.

This victim, who was twenty years old when she met Thota, said she felt that if she did not submit to sexual acts with Thota he would not have provided her with additional opioid prescriptions. After being exposed to greater dosage levels of opioids by Thota, the young woman started using an even stronger opioid – heroin.

About a dozen potential new victims have come forward following the arrest according to Amy Roderick of the U.S. Drug Enforcement Administration. Roderick said she could provide no details on those individuals or their allegations

Thota’s arrest came at the conclusion of a several-year investigation Officials said he is accused of prescribing the alleged victims, ranging in age from early 20s to early 30s, various narcotics, including hydrocodone, methadone and oxycodone, and using his access to the narcotics a way to pressure them into sex acts.

During his arraignment, Assistant U.S. Attorney Orlando Gutierrez said a 20-year-old patient of Thota’s reported that the doctor upped the dosage of a prescription she was taking without telling her and that she felt she couldn’t get more of it unless she had sex with the defendant.

Another woman threatened to take allegations of abuse to the DEA, and Thota paid her money not to do so, the prosecutor alleged.

And this is not his first run-in with authorities. In 2014 the California Medical Board accusation claimed that he committed gross negligence in his care and treatment of patients. The specific allegations say he prescribed increasing doses of opiates to patients without any clear positive response. In November 2015 Thota entered into a stipulated settlement and disciplinary order which provided for the revocation of his license, however the revocation was stayed and he was placed on seven years probation with restrictions. He was therefore on probation when this current arrest was made.

“Prescription drug abuse and overdoses have reached alarming levels,” said U.S. Attorney Laura Duffy. “We are going after doctors who abuse their power to prescribe and exploit the desperation of addicts for their own gratification.”

“Doctors who exploit patients are the worst kind of predators.” said DEA San Diego Special Agent in Charge William Sherman. “DEA recognizes the trust the citizens of San Diego place in their doctors. We will continue to ensure that physicians who are abusing that trust by bartering sex for prescriptions will be arrested and prosecuted.”

If anyone has information regarding other victims or if you believe you were victimized by Dr. Thota, we urge you to contact DEA at (858) 616-4100 and ask for the Diversion Duty Agent.

Under Title 21, United States Code, Section 841, and Title 21, United States Code of Federal Regulations, Section 1306.04(a), a medical doctor may not prescribe a controlled substance unless there is a legitimate medical purpose.