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45 States Sue 18 Drug Companies for Price Fixing

A large group of U.S. states accused key players in the generic drug industry of a broad price-fixing conspiracy, moving on to widen an earlier lawsuit to add many more drugmakers and medicines.

According to the Reuters Health report, the lawsuit, brought by the attorneys general of 45 states and the District of Columbia, accused 18 companies and subsidiaries and named 15 medicines. It also targeted two individual executives: Rajiv Malik, president and executive director of Mylan NV, and Satish Mehta, CEO and managing director of India’s Emcure Pharmaceuticals.

The states said the drugmakers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market. The companies sometimes agreed on price increases in advance, the states added.

The states said Malik and Mehta spoke directly to one another to agree on their companies’ shares of the market for a delayed-release version of a common antibiotic, doxycycline hyclate.

“It is our belief that price-fixing is systematic, it is pervasive, and that a culture of collusion exists in the industry,” Connecticut Attorney General George Jepsen, who is leading the case, told a news conference in Hartford.

Mylan said in a statement it had found no evidence of price-fixing by the company or any of its employees, and vowed to defend itself vigorously. Malik, the company’s second-ranking official, has received more than $50 million in compensation over the past three years, last year making more than CEO Heather Bresch. “Mylan has deep faith in the integrity of its president, Rajiv Malik, and stands behind him fully,” the company said.

Two former executives of Emcure’s subsidiary Heritage Pharmaceuticals pleaded guilty in January to federal charges of conspiring to fix prices and divide up the market for doxycycline and the diabetes drug glyburide. The two men, former Heritage president Jason Malek and former chairman and chief executive Jeffrey Glazer, reached a deal with 41 states and territories in which they each agreed to pay $25,000 and cooperate with the state probe.

The original complaint, filed in December, targeted Mylan, Heritage, Aurobindo Pharma USA Inc, Citron Pharma LLC, Mayne Pharma USA Inc and Teva Pharmaceuticals USA Inc.

The states are pressing a new complaint that would add Novartis AG’s unit Sandoz, India-based Sun Pharmaceutical Industries Ltd, Endo International PLC’s unit Par Pharmaceutical, Dr. Reddy’s Laboratories, Apotex Corp, Glenmark Generics Ltd, Lannett Company Inc, Alkem Laboratories Ltd’s unit Ascend Laboratories and Cadila Healthcare Ltd’s unit Zydus Pharmaceuticals Inc.

Teva spokeswoman Denise Bradley said the company denied the allegations. Endo spokeswoman Heather Lubeski said the company would vigorously defend itself against the claims. Other companies did not immediately respond to requests for comment.

The original lawsuit centered on just two medicines, delayed-release doxycycline and glyburide. The price of doxycycline rose from $20 for 500 tablets to $1,849 between October 2013 and May 2014, according to U.S. Senator Amy Klobuchar, a Minnesota Democrat who had been pressing for action on high drug prices.The amended complaint would expand the number of drugs to include glipizide-metformin and glyburide-metformin, which are among the most commonly used diabetes treatments.

Others include: acetazolamide, which is used to treat glaucoma and epilepsy; the antibiotic doxycycline monohydrate; the blood pressure medicine fosinopril; the anti-anxiety medicine meprobamate; and the calcium channel blocking agent nimodipine.

Billionaire Drugmaker Arrested in Fentanyl Kickback Case

The billionaire founder of Insys Therapeutics Inc, John Kapoor, has resigned from the company’s board of directors, Insys said in a statement on Sunday after he was arrested on Thursday on charges he participated in a scheme to bribe doctors to prescribe a fentanyl-based cancer pain drug, marking a step by authorities to fight the opioid epidemic.

The founder and majority owner of Insys Therapeutics Inc., was arrested and charged with leading a nationwide conspiracy to profit by using bribes and fraud to cause the illegal distribution of a Fentanyl spray intended for cancer patients experiencing breakthrough pain.

John N. Kapoor, 74, of Phoenix, Ariz., a former member of the Board of Directors of Insys, was arrested in Arizona and charged with RICO conspiracy, as well as other felonies, including conspiracy to commit mail and wire fraud and conspiracy to violate the Anti-Kickback Law.

The superseding indictment also includes additional allegations against several former Insys executives and managers who were initially indicted in December 2016.

The superseding indictment charges that Kapoor and other company officials conspired to bribe practitioners in various states, many of whom operated pain clinics, in order to get them to prescribe a fentanyl-based pain medication.

The medication, called “Subsys,” is a powerful narcotic intended to treat cancer patients suffering intense breakthrough pain. Prosecutors allege that the practitioners wrote large numbers of prescriptions for the patients, most of whom were not diagnosed with cancer, In exchange for bribes and kickbacks,

The indictment also alleges that Kapoor and the six former executives conspired to mislead and defraud health insurance providers who were reluctant to approve payment for the drug when it was prescribed for non-cancer patients. They achieved this goal by setting up the “reimbursement unit,” which was dedicated to obtaining prior authorization directly from insurers and pharmacy benefit managers.

“As alleged, these executives created a corporate culture at Insys that utilized deception and bribery as an acceptable business practice, deceiving patients, and conspiring with doctors and insurers,” said Harold H. Shaw, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division.

The charges of conspiracy to commit RICO and conspiracy to commit mail and wire fraud each provide for a sentence of no greater than 20 years in prison, three years of supervised release and a fine of $250,000, or twice the amount of pecuniary gain or loss.  The charges of conspiracy to violate the Anti-Kickback Law provide for a sentence of no greater than five years in prison, three years of supervised release and a $25,000 fine. Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and other statutory factors.

Aetna Considers Merger with CVS Health

The proposed merger between U.S. pharmacy operator CVS Health Corp and No. 3 health insurer Aetna Inc represents a $66 billion bet that insurers can drive down high U.S. drug prices by cutting out the middleman.

The move is the most expensive effort to date that would enable a national health insurer to take back full control of prescription medicines for their customers by negotiating prices with pharmaceutical manufacturers and setting customer out-of-pocket costs for each drug.

Reuters Health reports that CVS, one of the largest U.S. pharmacy benefits managers, has offered to buy No. 3 health insurer Aetna for more than $200 per share. It could take at least several weeks for any deal to materialize.

If the deal happens, it would likely pressure rival insurers, drugmakers, pharmaceutical benefits managers, and retail pharmacies to also consider mergers or switching partners to try to keep up with the potential healthcare cost savings or increase in profit margins.

“It’s an alternate model at this point. It’s not clear that it’s definitely a better one,” BMO Capital Markets analyst Matt Borsch said. “More consolidation could lead to pressure on some of the brand-name drug prices and a better counterweight to the big pharma companies.”

For years, insurers paid drug benefits managers like CVS and Express Scripts Holdings Co to negotiate down drug prices, with both parties taking a share of any discount by the time a medicine was paid for by consumers.

But outrage over the high costs of drugs has grown as consumers have picked up a larger portion of the tab for drug costs and it is threatening profit margins all along the drug supply chain, from manufacturers to distributors, insurers and pharmacies.

UnitedHealth Group Inc and Humana Inc currently have in-house pharmacy benefits businesses, and say that it has helped them keep medical costs down.

Anthem Inc recently decided to go down that same path. It cut ties with Express Scripts during a $3 billion legal fight, and said it would use CVS to build its own pharmacy benefits business in the next few years. That tie-up could now be at risk if CVS reaches a deal to buy Aetna.

CVS also provides management services for Aetna rival Cigna Corp. If CVS buys Aetna, that could revive Cigna’s interest in buying Humana, analyst Christine Arnold of investment bank Cowen & Co said in a research note.

Aetna earlier this year closed the door on a deal with rival insurer Humana Inc after antitrust regulators said that combination and a rival deal between Anthem Inc and Cigna Corp were anti-competitive.

Over the past decade, health insurers have diverged on the value of the pharmacy benefits business.

Anthem sold its pharmacy benefit manager to Express Scripts and outsourced almost all of the business in 2010.

UnitedHealth took the opposite approach when it decided in 2011 to bring its pharmacy benefits management in house, then bought an even bigger standalone benefits manager, Catamaran, in 2015.

Humana operates its own pharmacy benefit manager and Cigna and Aetna have hybrid approaches where they manage some parts in house and outsource others.  

Another potential lure of a deal for Aetna would be to capitalize on the growing number of simple health services offered in a CVS store, from flu shots to blood pressure checks. Reimbursing such patient care outside of a doctor’s office or hospital could cut healthcare costs, Gupta said.

CDI Lowers Advisory Comp Rates by 17.1%

Insurance Commissioner Dave Jones adopted and issued a revised advisory pure premium rate, lowering the benchmark to $1.94 per $100 of payroll for workers’ compensation insurance, effective January 1, 2018.

This is 17.1 percent less than the average pure premium rate of $2.34 California insurers filed as of July 1, 2017.

This decision results in an advisory pure premium rate that is slightly below the $1.96 average rate recommended by the Workers’ Compensation Insurance Rating Bureau (WCIRB) in its filing. Jones issued the advisory pure premium rate three weeks after a public hearing and careful review of the testimony and evidence submitted.

His adoption is only advisory, as the commissioner has no rate authority over workers’ compensation insurers.

“The continued decreases in costs to insurers should be passed along to employers through lower rates,” said Insurance Commissioner Dave Jones. “Workers’ compensation reform legislation should require that system cost savings be passed onto employers in the form of lower rates– the law does not require this currently.”

The WCIRB’s pure premium advisory rate filing demonstrated continued decreases in costs in California’s workers’ compensation insurance market.

The pure premium advisory rate reduction is based on insurers’ cost data through June 30 of this year. Insurers’ net costs in the workers’ compensation system continue to decline as a result of SB 863, SB 1160, and AB 1244 enacted by the Legislature and Governor Brown.

The WCIRB notes continued favorable medical loss development including acceleration in claim settlement.

The WCIRB will evaluate workers’ compensation insurance costs again in the summer and fall of next year when it files its pure premium rate benchmark recommendation with the Department of Insurance. That filing will provide an opportunity to assess whether medical costs continue to be lower and what changes, if any, there are in other costs in the system.

The purpose of the pure premium benchmark rate process is to review costs in the workers’ compensation insurance system and to confirm that rates filed by insurance companies are adequate to cover benefits for injured workers.

Suspended Provider List Grows to 52 Vendors

The Division of Workers’ Compensation (DWC) has suspended three more medical providers from participating in California’s workers’ compensation system, bringing the total number of providers suspended this year to 52.

DWC Administrative Director George Parisotto issued Orders of Suspension against the following providers:

1) Byong Chun “David” Min of Irvine pled guilty on April 20, 2016 to health care fraud and illegal kickbacks. Min, co-owner and operator of Glory Rehab Team, Inc., which also operated as Dream Hospital and Daesung Clinic in Orange County, was involved in an illegal kickback scheme referring Medicare beneficiaries to co-schemers Marlon Songco, Joseff Sales and Danniel Goyena, knowing that they would bill Medicare for services that were never provided.

2) Sujan Thyagaraj of Roswell, New Mexico, a physician whose medical license was summarily suspended in New Mexico in March 2016 after criminal charges were filed against him for sexual assault on a patient. The Medical Board of California revoked his physician and surgeon’s license on September 23, 2016. Thyagaraj was suspended from the Medi-Cal program on August 29, 2017.

3) Rhonda Singleton of Los Angeles, owner of substance abuse treatment facility Singleton Housing Project, pled no contest in Los Angeles County Superior Court on January 25, 2017 to grand theft of the California Health Care Deposit Fund. Singleton was suspended from Medi-Cal on August 15, 2017.

AB 1244 (Gray and Daly), which went into effect January 1, introduced new changes to the workers’ compensation system and requires the division’s Administrative Director to suspend any medical provider, physician or practitioner from participating in the workers’ compensation system under certain circumstances.

Stakeholders Challenge TD Awarded After 5 Year Limit

Kyle Pike was employed by the County of San Diego as a Deputy Sheriff Detention on July 31, 2010. He sustained an industrial injury to his right shoulder and received a combination of Labor Code section 4850 salary continuation benefits and permanent disability benefits between October 27, 2010 and November 15, 2011 and April 30, 2015 through June 19, 2015.

Pike received a Stipulated Award of 12% permanent disability on May 31, 2011, and filed a timely Petition to Reopen on May 26, 2015 as he claimed an entitlement to Labor Code section 4850 benefits for the period September 15, 12 2015 through March 28, 2016, and temporary total disability benefits from March 29, 2016 through August 18,2016 which was beyond the five year time limit from the date of his injury.

The County paid all temporary disability and 4850 benefits through the period ending five years from the date of injury. The issue to be determined was whether applicant could receive additional benefits for periods of temporary disability that extended more than five years from his July 31, 2010 date of injury. The parties submitted the issue on the record without testimony.

The WCJ concluded that when acting upon a timely petition to reopen, the Appeals Board may award temporary disability benefits more than five years from the date of injury, provided that applicant is limited to an aggregate of 104 weeks of benefits. A split panel decision denied reconsideration in the case of Pike v County of San Diego.

Labor Code section 4656( c )(2) provides that “Aggregate disability payments for a single injury occurring on or after January 1, 2008, causing temporary disability shall not extend for more than 104 compensable weeks within a period of five years from the date of injury.”

The majority held that because “the statutory language does not provide that no temporary disability benefits may be paid more than five years from the date of injury, the WCJ concluded that the legislature did not intend to prohibit otherwise temporarily disabled injured workers from receiving the full 104 weeks of benefits where such temporary disability occurs within five years from the date of injury.” The majority cited some panel decisions that have agreed with this view.

Commissioner Razo dissented. “I believe our ability to award temporary disability indemnity is constrained by the statutory language in Labor Code section 4656( c )(2), which expressly limits such an award to five years from the date of injury for injuries on or after January 1, 2008.” He cited several panel decisions that agreed with his view and against the majority.

In August the County filed a Petition for Writ of Review with the Court of Appeal. At the end of September the Court issued a writ and agreed to hear the case. On October 23 the CWCI was grated permission to file an amicus brief in the case, and it is expected that the CAAA, and other stakeholders will soon weigh in as well.

Among the several theories presented by the County and CWCI, they claim “the decision below relies upon an improper use of Labor Code Section 3202. As noted by our Supreme Court in Nickelsberg v. Workers’ Comp. Appeals Bd. (1991) 54 Cal.3d 288, 298 the rule of liberal construction stated in section 3202 should not be used to defeat the overall statutory framework and fundamental rules of statutory construction.

En Banc WCAB Moves 1200 Lien Cases to Hearing

Numerous lien claimants by and through their sole representative Maximum Medical filed over 1,200 Petitions for Reconsideration,challenging an administrative action which prevented them from filing in their cases because they had allegedly failed to timely file required declarations.

Thereafter, to secure uniformity of decision in the future, the Chair of the Appeals Board, upon unanimous vote of its members, assigned these cases to the Appeals Board as a whole for an en banc decision. The cases at issue are defined as: “The Cases Involving a Labor Code section 4903.05(c) Declaration filed after 5:00 p.m. on Friday, June 30, 2017 through 5:00 p.m. on Monday, July 3, 2017 where a Petition for Reconsideration was filed on the issue of timeliness of the filing” and are designated as The Lien Cases.

The Lien Cases were consolidated on motion of the Appeals Board for the limited purpose of making the orders herein, including designating Rodriguez v. Garden Plating Co. (ADJ8588344) as the master case and designating service of this decision to lien claimants’ representative, Maximum Medical.

The providers in the Lien Cases contend that since July 1, 2017 fell on a Saturday, the required declarations were timely filed because the declarations were filed no later than the close of business on Monday, July 3, 2017 so that the notation placed in EAMS by DWC was improper.

However, on October 3, 2017, DWC issued a Newsline stating in pertinent part that: [DWC] will lift the notation in its Electronic Adjudication Management System (EAMS) that indicates all liens with Labor Code section 4903.05(c) declarations filed on July 2 and July 3 were dismissed.

The DWC has now removed the notation as to dismissal. Accordingly, lien claimants are not aggrieved (Lab. Code, §§ 5900, 5903) and their Petitions for Reconsideration are moot. Thus, the WCAB ruled that the Petitions must be dismissed. As set forth above in the Newsline and as discussed below, the issue of timeliness must be adjudicated in each case in the first instance at the trial level. Accordingly, the WCAB made no opinion on the merits of the issue of whether the declarations were timely filed.

Given that the Petitions for Reconsideration are nearly identical and given the limited resources of the Appeals Board, consolidation of the cases for the narrow purpose of addressing the Petitions for Reconsideration was appropriate. The en banc decision shall apply to any case in which a Labor Code section 4903.05(c) Declaration was filed by a lien claimant after the close of business at 5:00 p.m. on Friday, June 30, 2017 through the close of business at 5:00 p.m. on Monday, July 3, 2017, whether or not the case number is identified in this decision.

Whether declarations filed after the close of business at 5:00 p.m. on Friday, June 30, 2017 through the close of business at 5:00 p.m. on Monday July 3, 2017 were timely filed is not presently at issue, and we make no determination as to the timeliness of filing of such declarations. Once such a determination has been made, any aggrieved person may seek review of such determination. (Lab. Code, §§ 5900, 5903.)

Purdue Pharma Faces Criminal OxyContin Probe

Purdue Pharma confirmed on Wednesday that it has become the subject of a U.S. criminal investigation related to its painkiller OxyContin as the drugmaker battles a series lawsuits seeking to hold it responsible for its role in the nation’s opioid epidemic.

U.S. Attorney Deirdre Daly is gathering documents about Purdue’s claim that OxyContin provides 12 hours of pain relief. A Los Angeles Times investigation, published last year, found that Purdue ignored evidence showing the drug’s effects failed to last that long in some patients, increasing the risk of withdrawal, abuse and addiction.

“Purdue is committed to being part of the solution to our nation’s opioid crisis and has been cooperating with the U.S. Attorney’s investigation,” company spokesman Robert Josephson said in an email. “We will continue to do so until this matter is resolved.”

Purdue is cast as the main villain in a wave of government lawsuits seeking to hold opioid makers and distributors responsible for an epidemic now killing thousands of people and costing the U.S. economy billions of dollars annually. Ten states and dozens of cities and counties have sued companies including Purdue, Endo International Plc, and Johnson & Johnson’s Janssen Pharmaceuticals, alleging that they triggered the epidemic by minimizing the addiction and overdose risks of painkillers such as OxyContin and Percocet.

Stamford, Connecticut-based Purdue invented many of the aggressive marketing techniques that made OxyContin a blockbuster drug and which government lawsuits now seek to frame as unlawful.

Purdue resolved a federal criminal prosecution in 2007. The company and three of its top executives pleaded guilty to “misbranding” OxyContin and collectively agreed to pay more than $630 million in civil and criminal penalties in one of the largest pharmaceutical settlements in U.S. history. The company specifically acknowledged that it trained its sales representatives to mislead physicians about opioid risks.

Purdue promoted the synthetic morphine substitute as a low-risk painkiller, according to court papers, although the drug is a habit-forming narcotic derived from the opium poppy.

The executives, former CEO Michael Friedman, General Counsel Howard Udell and Chief Medical Officer Paul Goldenheim, served no prison time and were sentenced to community service in drug rehabilitation centers.

Purdue has faced a wave of lawsuits by Louisiana, Washington, New Mexico, Oklahoma, Mississippi, Ohio, Missouri, New Hampshire and South Carolina, as well as several cities and counties. Many of those cases target other drugmakers as well.

The lawsuits have generally accused Stamford, Connecticut Purdue of deceptive marketing of OxyContin and convincing doctors and the public that its drugs had a low-risk of addiction and were effective for treating chronic pain.

Purdue is closely held and doesn’t release financial information, but the brokerage Sanford C. Bernstein & Co. estimates OxyContin alone generated sales of $1.3 billion in 2016. Purdue is also the focus of a Congressional investigation led by Senator Claire McCaskill, a Missouri Democrat, who’s demanding documents and information related to the sales, marketing and education strategies that opioid manufacturers used to promote their painkillers.

DEA’s Prescription Drug Take-Back Day Is Saturday

Unused or expired prescription medications are a public safety issue, leading to potential accidental poisoning, misuse, and overdose. Proper disposal of unused drugs saves lives and protects the environment.

The Drug Enforcement Administration first launched its “Take-Back” day more than six years ago and since then has collected more than 8.1 million pounds of prescription drugs from the public.

After collecting and destroying 900,000 pounds – 450 tons – of unused prescription drugs last April, the U.S. Drug Enforcement Administration is continuing its efforts to take back unused, unwanted and expired prescription medications.

The DEA invites the public to bring their potentially dangerous, unwanted medicines to one of nearly 5,000 collection sites around the country that are manned by more than 4,000 of DEA’s tribal and local law enforcement partners.

The public can find a nearby collection site by visiting www.DEATakeBack.com or by calling 800-882-9539. This service is free of charge, with no questions asked.

“The abuse of opioids and prescription drugs is at an all-time high in our country, and the effect is devastating, not only on the users, but on their families, friends, and communities,” U.S. Attorney Talbert stated. “Young people are particularly at risk, as they can gain easy access to unused and addictive prescription drugs inside the home. I strongly encourage everyone to take advantage of this safe and easy way to dispose of unused prescription drugs.”

“America is in the midst of a prescription drug crisis and the home medicine cabinet is a major source. Let’s work together to help put an end to this epidemic by cleaning out that cabinet and disposing of unwanted medication at a take back location,” stated DEA Special Agent in Charge John J. Martin.

Overdoses from prescription opioids are the driving factor in the 15-year increase in opioid overdose deaths. The removal from homes of unwanted prescription pills that can be abused, stolen or resold is an easy way to help fight the epidemic of substance abuse and addiction.

More Controversy Over Vegas Shooting Comp Claims

Orange County rejected workers’ compensation claims from four sheriff’s deputies injured in the shooting, paving the way for a court battle that could force appellate judges to eventually decide an untested issue touching several counties and cities in Southern California.

Los Angeles County is considering whether to grant claims from two of its deputies shot Oct. 1 at the Route 91 Harvest festival. Officials acknowledged they have no policy on how to handle such requests and said they expect the issue will result in litigation.

Several other officers from Southern California law enforcement departments also plan to file claims in the near future, according to police unions, potentially forcing as many seven other municipalities – including San Bernardino and Riverside counties  -to soon consider similar questions.

If the claims are approved, it could put taxpayers on the hook for years of medical expenses, allow officers to retire early on disability and guarantee injured officers paid time off in the short term. If officers begin to claim injuries related to PTSD suffered during the shooting – as two deputies in Orange County did – it also could open the door for scores of additional filings.

In San Bernardino County, which employs 11 deputies who attended the festival, including Sgt. Brad Powers, who was shot in the leg in Las Vegas, the deputies’ union has initiated talks with the sheriff’s department to advocate that Powers be treated as an on-duty injury.

Steve Nyblom, a manager in Los Angeles County’s risk management branch, which is weighing claims from local two deputies shot in Las Vegas, said legislative intervention may be needed to clarify the labor code in light of the looming disputes. “There is that vague issue, subject to interpretation, and issues relating to legislative intent should be clarified by the legislature,” Nyblom said.

Had all those officers been shot and injured while responding to a mass-killing in California, they likely would be taken care of without dispute. But because they were shot in Nevada instead, their life-saving efforts could cost them dearly.

California’s labor code states that public agencies are required to pay benefits to off-duty police officers injured while engaging in “protection or preservation of life or property, or the preservation of the peace anywhere in this state,” even if the officer “is not at the time acting under the immediate direction of his employer.” Out-of-state events are not mentioned, spurring multiple interpretations of the law.

“The statute does not allow counties to cover off-duty conduct outside of states,” Orange County Supervisor Todd Spitzer said, expressing a view shared by county lawyers. “These police officers went into their instinctive training mode – and I don’t think they should be punished because they trusted their instincts. But it requires a legislative fix to the statute to extend workers’ benefits for out-of-state conduct.”

However, local workers’ compensation attorneys disagree with Orange County’s interpretation of state law. And the union representing Orange County’s sheriff’s deputies has said that if the county denied its members’ claims, the agency would be abandoning officers who were acting in accordance with their department’s training.

“The sheriff’s department has an expectation of its sworn members to take whatever actions are necessary to preserve life wherever they’re at,” said Tom Dominguez, president of the Association of Orange County Deputy Sheriffs. “If they deny the claims, then the message that they’re sending to their peace officers is not to take action when it is certainly warranted.” “Everybody’s watching what happens with these cases,” Dominguez added.