Tag: 2019 News

This summer, the Sackler family, founders and owners of Purdue Pharma, announced they would pay at least $3 billion of a proposed $12 billion settlement of more than 2000 cases filed by cities, states and local government for its part in the opioid epidemic.  The Sackler portion of the settlement money would be obtained by the family selling off Mundipharma, a separate global pharmaceutical company they own.

So this announcement may raise questions about the little known Mudipharma company reportedly owned by the Sacklers.  A story just published in the Guardian sheds some light on what the Sacklers might be up to with Mundipharma.

After decades of stringent narcotics laws, borne of debilitating opium epidemics of centuries past, India is a country ready to salve its pain. For-profit pain clinics are opening by the score across Mumbai, Kolkata, Bangalore and other cities in this nation of 1.3 billion people.

And American pharmaceutical companies – architects of the opioid crisis in the United States and avid hunters of new markets – stand at the ready to fuel that demand.

Most large Indian hospitals have added pain management as a specialty in recent years. At the insistence of the professional societies that accredit hospitals in India, nurses and doctors now are required to assess pain as a fifth vital sign, along with pulse, temperature, breathing and blood pressure.

The pharmaceutical industry has kept pace. Twenty years ago only a few pharmaceutical companies marketed pain medicines in India, Today, almost every company is having pain management as a separate division.  A salesman for Sun Pharma, India’s largest drugmaker by sales, echoed the point during an interview in Chandigarh, the capital of Punjab and Haryana.

For Indian cancer patients who once writhed in agony, there are fentanyl patches from a subsidiary of Johnson & Johnson.  For the country’s vast army of middle-class office workers wracked with back and neck pain, there is buprenorphine from Mundipharma, a network of companies controlled by the Sackler family, the owners of Connecticut-based Purdue Pharma.

And for the hundreds of millions of aging Indians with aching joints and knees, there are shots of tramadol from Abbott Laboratories.

Palliative care advocates, who recount stories of patients enduring excruciating cancer pain or dying in agony, have persuaded reluctant government officials to allow high-powered opioid painkillers into doctors’ offices and on to chemists’ shelves.

But what began as a populist movement to bring inexpensive, Indian-made morphine to the ill has given rise to a pain management industry that promises countless new customers to American pharmaceutical companies facing a government crackdown and mounting lawsuits back home.

The lure of a pain-free life is a revelation in a country where incomes are rising for many city dwellers and 300 million to 400 million people are approaching the middle-class. Newly-minted pain doctors promise aspiring Indians that life has more to offer in a body free from pain.

As major pharmaceutical companies look to capitalize on the opportunity, the playbook unfolding in India seems familiar. Earnest advocates share heartbreaking stories of suffering patients; physicians and pharmaceutical companies champion pain relief for cancer patients and persuade regulators to grant greater access to powerful opioids; well-meaning pain doctors open clinics; shady pain clinics follow; and a spigot of prescription opioids opens – first addressing legitimate medical uses but soon spilling into the streets and onto the black market.

A looming deluge of addictive painkillers terrifies some Indian medical professionals, who are keenly aware that despite government regulations most drugs are available for petty cash at local chemist shops.

The maker of OxyContin, Purdue Pharma, and its owners, the Sackler family, are offering to settle more than 2,000 lawsuits against the company for $10 billion to $12 billion. The potential deal reported by NBC News was part of confidential conversations and discussed by Purdue’s lawyers at a meeting in Cleveland last Tuesday, Aug. 20, according to two people familiar with the mediation.

At least 10 state attorneys general and the plaintiffs’ attorneys gathered in Cleveland, where David Sackler represented the Sackler family, according to two people familiar with the meeting. David Sackler, who was a board member of the company, has recently been the de facto family spokesperson.

In a statement to NBC News, the company said, “While Purdue Pharma is prepared to defend itself vigorously in the opioid litigation, the company has made clear that it sees little good coming from years of wasteful litigation and appeals.”

At the Cleveland meeting, the company presented a plan for Purdue to declare Chapter 11 bankruptcy and then restructure into a for-profit “public benefit trust,” according to the summary term sheet that was read to NBC News and another source who is familiar with the potential deal.

The Purdue lawyers claim the value of the trust to plaintiffs would include more than $4 billion in drugs that would be provided to cities, counties and states, the people familiar with the matter said. Some of the drugs are used to rescue people from overdoses.

The in-kind drugs, combined with profits from the sale of drugs, would add up to a total Purdue settlement of $7 billion to $8 billion, according to two people familiar with the offer.

The trust would exist for at least 10 years. Three “well-recognized expert” trustees would be independently appointed by a bankruptcy court, according to the terms of the potential deal. Those trustees would in turn choose a board of directors to run the trust, according to the term sheet.

Any profits from the sale of Purdue’s drugs such as OxyContin or Nalmefene, a drug that has been fast-tracked by the FDA and would be used for emergency treatment of opioid overdoses, would go to the cities, counties and states if they agree to the settlement.

The Sackler family would give up ownership of the company and would no longer be involved, according to two people familiar with the matter.

For their part, the Sackler family, which has faced an increasingly hostile activist movement, would pay at least $3 billion. Forbes ranks the family as the 19th richest in America, with a fortune of at least $13 billion shared by an estimated 20 family members.

The Sackler money would be obtained by the family selling off Mundipharma, a separate global pharmaceutical company they own, according to a person briefed on the potential settlement deal. An additional $1.5 billion may be tacked onto the $3 billion if the sale of Mundipharma exceeds $3 billion.

Mundipharma describes itself on its website as a privately owned network of “independent associated companies” with “a presence in over 120 countries.” Mundipharma is controlled by the Sackler family.

A 2016 Los Angeles Times investigation of Mundipharma described how the global venture offered a new international pipeline for Purdue’s opioids.

An Oklahoma judge found Johnson & Johnson and Janssen Pharmaceutical Companies liable for stoking the opioid crisis in the state and said the company must pay $572 million, far less the $17 billion that the state was seeking.

Judge Thad Balkman, of Cleveland County District Court in Norman, Oklahoma, is the first judge to rule in the opioid cases brought to trial by thousands of state and local governments against opioid manufacturers and distributors.

His precedent-setting ruling was being closely watched as 2,000 other pending suits await to be heard before a federal judge in Ohio in October.

J&J said it plans to appeal Balkman’s ruling and that the decision was “flawed.”

“Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome,” said Michael Ullmann, Executive Vice President, General Counsel, Johnson & Johnson. “We recognize the opioid crisis is a tremendously complex public health issue and we have deep sympathy for everyone affected. We are working with partners to find ways to help those in need” according to a company statement.

Oklahoma Attorney General Mike Hunter brought the case to trial for seven weeks, arguing the pharmaceutical company executed an intensive marketing campaign that overwhelmed the market and mislead consumers about the addictive risks of the drug.

Oklahoma lawyers dubbed J&J an opioid “kingpin” and alluded to its marketing tactics as a public health nuisance, under law. However, J&J absolves itself of any misconduct and presented research that said its painkillers, Duragesic and Nucynta, comprised a fraction of opioids prescribed in the state.

Oklahoma escalated the trial after resolving claims against OxyContin maker Purdue Pharma LP in March for $270 million and against Teva Pharmaceutical Industries Ltd in May for $85 million, with only J&J remaining as a defendant.

Plaintiffs’ lawyers have compared the opioid cases to litigation against the tobacco industry that led to the landmark $246 billion settlement in 1998. The city and county lawyers hope this decision could provide a model for future resolutions in public health issues Opens a New Window. like firearms and climate change and pollution.

A report in Property Casualty 360 makes the case that the utilization review process for workers’ compensation claims is ripe for automation. The practice of determining whether healthcare is medically necessary for an injured worker has remained relatively unchanged for decades.  Requests for authorization are submitted, a nurse compares the requested care against evidence-based medical guidelines, and a determination is issued.

The determination is a tool for the treating provider, the claims examiner, and the claimant. Applying the determination during the actual delivery of care is traditionally accomplished by a person, typically a claim examiner or adjuster, or by a medical bill reviewer or auditor, but rarely is it done through technology-enabled automation.

Automation can have many touchpoints in the utilization review workstream. One of the first is the request intake process. Unlike bill review, the Request for Authorization (RFA) form is not standardized across the United States. Some states have very specific requirements for submitting the RFA, whereas other states offer little or no guidance on form submittal, which leads to a very manual process for data entry into a utilization review system.

This is changing with new UR platforms that combine optical character recognition tools and automated intelligence or AI. The faster and more effectively that requests can be submitted for review, the sooner claimants can receive appropriate care.

The next step that is ideal for automation is the application of the appropriate evidence-based medical guideline. This includes identifying the correct criteria set, as well as the correct guideline itself. The hallmark of a good utilization review program is consistency. This includes consistency in meeting turnaround times, consistency in applying guidelines, and consistency in outcomes. Rules-based technology increases guideline accuracy. In situations where an exact match cannot be found, algorithms can serve up best matches.

Automation can also relieve delays when a treatment request is denied. Instead of waiting for the provider to submit an appeal, the noncertified case can be instantly routed to a peer reviewer for assessment. Using a peer reviewer can improve clients’ outcomes when the peer reviewer is in the same specialty, has state licensure in the state where the claimant resides and has a clear understanding of the process’ goals. Automating the referral process to peer review gets the case into the right hands quickly, allowing time for an effective peer-to-peer discussion.

The dissemination of the determination is critical to communication and essential for timely management of the referral. Automating distribution is a time saver for all levels of the case. However, the biggest jump in value is achieved by tightly integrating utilization review with medical bill review.

Today, the workers’ compensation industry relies on claims examiners or bill review auditors to make a visual comparison of the approved or denied treatment to actual care rendered. The flaws in this approach are obvious, and mistakes are unavoidable.

A more intelligent approach is through automation. To accomplish this, the bill review and utilization review platforms need to speak the same language. Utilization review is regularly completed as a narrative and bill review reads in code. The solution is to create the request and the outcome using a medical code set that the bill review system can understand, such as CPT®, a medical code set maintained by the American Medical Association.

The Ventura County District Attorney announced that Oxnard resident Ernestina Rodriguez, was placed on formal probation for a period of 36 months after having pled guilty to a felony violation of lnsurance Code section 1871.4(a)(l), making a false or fraudulent statement of a material fact for the purpose of obtaining workers’ compensation benefits.

She had previously made restitution in full to the victim, Zenith Insurance Company, in the amount of $9,333.50 and will serve 150 days in the Ventura County jail as a condition of probation.

Rodriguez was employed as a field worker in Oxnard and filed a workers’ compensation claim for injuries to her back, neck, and knees on February 14, 2015.

She was placed off work and began receiving medical treatment and temporary total disability benefits provided by Zenith Insurance.

During the time she received treatment, she denied to her treating physicians, a Qualified Medical Examiner, and at a deposition that she had ever filed any prior workers’ compensation claims involving the same body parts as she was claiming in February 2015.

In fact, the defendant had filed and settled two prior workers’ compensation claims for the same body parts in 2002 and 2010.

Her material misrepresentations affected the way her claim was apportioned and caused Zenith Insurance to pay her $9,333.50 in benefits that she was not entitled to receive.