Author: WorkCompAcademy

Reuters reports that Israeli pharmaceuticals company PainReform has received approval from the U.S. Food and Drug Administration (FDA) to begin late-stage clinical studies for a pain relief drug that is a departure from opiate-based narcotics, it said on Tuesday.

Many patients today dealing with pain after surgery are prescribed opioids, which can be highly addictive and are at the heart of a costly health crisis in the United States.

PainReform said the FDA had given it a green light to carry out two Phase 3 trials on its product PRF-110, which prolongs the action of a local analgesic, or painkiller, called ropivacaine. The studies will focus on post-operative pain relief in soft and hard tissue.

The drug is administered during surgery, before the wound is sutured. An earlier study showed PRF-110 was able to relieve pain for up to 72 hours – 10 times longer than the current standard of care, PainReform said.

This is a crucial period when pain is maximal and opioids are often given, said Chief Executive Eli Hazum.

“This kind of drug can help delay or prevent the prescription of opiates,” he told Reuters.

PainReform estimates the market potential for such treatment at $5 billion.

FDA Commissioner Scott Gottlieb said in a statement on Monday the agency “remains focused on striking the right balance between reducing the rate of new addiction by decreasing exposure to opioids and rationalizing prescribing, while still enabling appropriate access to those patients who have legitimate medical need for these medicines”.

Should PainReform’s treatment pass its trials, results for which Hazum estimated could come within a year after they start, it would compete with other non-opiate drugs like Heron Therapeutics’ HTX-011, which just finished Phase 3 studies.

“This market will not depend on a single drug,” Hazum said.

The company has raised $12 million and is looking for an additional $15 million before beginning the trials, which focus on bunion and hernia operations.

It would consider an initial public offering in New York after the trials are finished, or even at the time of interim results, which could be after about six months, Hazum said.

Last month the Insurance Journal reported that the Workers’ Compensation Insurance Rating Bureau in California is looking into using blockchain technology as a better, safer, way to get the workers’ comp carriers and agents and brokers access to the massive amount of data the WCIRB collects. And this may just be the start of blockchain implementation in insurance claims processing.

Insurance experts expect blockchain will touch a number of areas: underwriting, customer on-boarding, travel and life insurance, personal accident insurance, surety insurance, peer-to-peer insurance and claims processing. In healthcare, for example, a doctor could submit a claim to the insurer’s blockchain – this action starts a smart contract, which is programmed inside business rules, revises the claim and defines a total sum to be paid.

According to the Institute of Medicine, about 30 cents of every healthcare dollar is wasted on needless administrative fees, medical fraud, excessive paperwork and other waste. Blockchain may not be the elixir for age-old problems, but it has great potential to save billions by optimizing current workflow and business processes.

And now details are emerging from technology startups, and carriers who are developing insurance claim blockchain applications. And a handful of headlines from the past three months have made it clear that insurers are moving forward with novel technologies in mind.

Of note, a partnership of five healthcare organizations including insurers UnitedHealthcare and Humana, Optum, Quest Diagnostics, and MultiPlan announced plans to launch a blockchain pilot to help payers tackle mandated provider directories. The program will apply blockchain technology to improve the quality of data and reduce the administrative costs associated with insurers getting up-to-date healthcare provider demographic data.

The pilot will start in late spring through the summer with results expected this fall. “I think the alliance is one of the first, if not the first, national blockchain alliances for healthcare,” Mike Jacobs, a senior distinguished engineer at Optum, who has been working on the test program for two years, said.

It takes quite a lot of time and money for insurers to reach out to providers each 90-day cycle, Jacobs said. Sometimes it takes half-a-dozen times to reach a provider through calls, emails or even through faxed information.

Managed care organizations, health systems, physicians, diagnostic information service providers and other healthcare stakeholders typically maintain separate copies of healthcare provider data, which can result in time-intensive and expensive reconciliation processes when differences arise, Optum said.

An estimated $2.1 billion is spent annually across the healthcare system chasing and maintaining provider data.

The pilot will use blockchain technology for the five members of the alliance to share the curated information.

“So when one payer does the curation work, it could be potentially shared with the other payers,” he said. “This works for payers that have an overlapping provider population.”

Optum also seems to have been keeping an eye on other up-and-coming technologies, namely AI and neural networks. In a sold-out discussion hosted at Optum’s Boston office and organized by the Design Museum Foundation, Sanji Fernando, vice president and head of OptumLabs’ Center for Applied Data Science, explained at length how ongoing difficulties researchers face in explaining the decision-making process of these networks is limiting their role in healthcare.

A psychiatrist who practices at a Santa Ana clinic has been arrested on federal charges that allege he issued prescriptions for dangerous and addictive narcotics, such as the opioid oxycodone, without a medical purpose.

Dr. Robert Tinoco Perez, 56, of Westminster, was arrested Friday by special agents with the Drug Enforcement Administration.

Perez was named in a 14-count indictment returned by a federal grand jury on June 27. The indictment charges Perez with selling prescriptions to drug customers, as well as to brokers who sold the drugs obtained from filling the prescriptions and split the profits with Perez.

Perez wrote prescriptions for “patients” he had never met or examined, including an undercover officer, according to the indictment. Perez and his co-conspirators allegedly created fictitious medical records for drug customers to provide justification for their prescriptions.

The drugs alleged to have been prescribed illegally by Perez included oxycodone and hydrocodone (both opioid pain medications), amphetamine salts (sold primarily under the brand name Adderall), and alprazolam (sold primarily under the brand name Xanax).

Perez is also charged with possession with intent to distribute nearly one ounce of methamphetamine.

Perez pleaded not guilty and was ordered to stand trial on August 21.

Perez’s license to practice had been placed on probation for 35 months last December, due to his ill treatment of patients, family members, an Orange County judge and a Medical Board of California investigator, according to state officials.

The order for Dr. Robert T. Perez went into effect on Dec. 8. That was after Perez and his Santa Ana attorney Lee J. Retros had signed a letter in September accepting the medical board’s allegations and punishment against the psychiatrist, which includes seeing a psychiatrist. State records cited Perez’s behavior toward numerous people and care and treatment of a patient identified as M.M..

Perez had additional proceeding filed against him by the Medical Board in May 2018. It alleges three causes of discipline – sexual exploitation, sexual misconduct and unprofessional conduct – because Perez had sex with a patient he went on to marry. The Board also claims he failed to adhere to terms of his December 2018 probation. He failed to complete the educational courses required by the probation.

A second defendant charged in the federal criminal indictment – William Jason Plumley, 40, of Huntington Beach – is alleged to have sold both prescriptions written by Perez and the drugs filled from his prescriptions. Plumley already is in federal custody on a previous indictment alleging that he sold methamphetamine.

In the escalating battle over U.S. prescription drug prices, Reuters Health reports that major pharmaceutical companies are scrambling to limit the economic damage from a new U.S. insurer tactic that coaxes patients away from expensive drugs.

In recent years, insurers have tried to guide patients toward less expensive treatments by making them pay a higher portion of a drug’s costs. Drugmakers responded by dramatically raising the financial aid they offer, in the form of “copay assistance” cards – similar to a debit card – that reduce what consumers need to pay when they place their pharmacy order.

Express Scripts Holding Co and CVS Health, which manage prescription drug coverage for large U.S. employers, say these payments shield consumers from drug costs, making it easier for manufacturers to raise those prices. Insurers have to make up the difference.

This year, Express Scripts and others introduced a new “copay accumulator” approach for its corporate customers. The programs prevent copay card funds from counting toward a patient’s required out-of-pocket spending before insurance kicks in on expensive specialty drugs, such as arthritis and HIV treatments.

As an example, a patient whose medicine costs $1,000 per month might be required to pay that amount until they reach a deductible of $2,000 set by their insurer. A copay card from the drugmaker would cover most, or all, of those costs for the patient and it would count towards the deductible.  When the deductible is reached, the insurance begins to pay.

But if the insurance plan is using an accumulator, the patient could still have to pay the $2,000 out of pocket when their copay card expires or runs out of money. Some more aggressive accumulator programs will also draw more money than a drugmaker expected to pay off a copay card when the card is detected.

These tactics could force the drugmaker to keep paying the out of pocket costs. Otherwise the patient could move to an equivalent drug if one is available or abandon their prescription because it is too expensive.

Drugmakers are working on ways to counter copay accumulator programs, fearing that more employer health plans will adopt them in 2019.  

They include new payment options to evade detection by the pharmacy benefits managers (PBMs) so that a patient still benefits from the financial aid, said Matthew Turner, who is working with drugmakers as director of patient affordability at TrialCard, which operates copay cards for companies. He would not provide details of how those arrangements work.

Drugmakers are also taking a tougher stance when negotiating prices or new discounts for payers, according to insurance industry executives and pharmaceutical consultants.

They have reason for concern. A survey by the National Business Group on Health (NBGH), which represents large corporate employers, showed that 17 percent of respondents said they were currently using a copay accumulator program. Another 18 percent of respondents are considering using one next year or in 2020.

Savings can be substantial for employers when accumulators coax patients to switch to a drug for which they receive the highest rebate. For instance, rebates to PBMs for Humira and Enbrel can differ by as much as $1,000 per prescription, according to Michael Rea, CEO of Rx Savings Solutions.

Insurance Commissioner Jones announced he has issued an order that every insurer licensed to write workers’ compensation insurance in the State of California must report their federal income tax savings annually through a rate filing in light of the new tax law.

The recent revision to the Federal Tax Schedule for 2018 reduced the corporate tax rate from 35 percent to 21 percent. Jones says “That means that nationally insurers will now be able to retain even more of policyholder premiums as profit.”

He is referring to the “Tax Jobs and Cuts Act of 2017” signed into law by President Trump on December 22, 2017.

“Any savings to insurers should be passed along to California businesses,” said Commissioner Jones.

Thus, Jones’ order will require each insurer to submit a rate filing to report the dollar amount of their tax savings by December 31, 2018, and on a yearly basis through December 31, 2020.  Insurers will need to provide details about how those savings impact their rates.

The insurer must also provide a detailed explanation if they have determined that there is no rate impact, stating why the reduction in the federal corporate tax rate does not affect their rates.

The Order is broadly written to include tax savings from earnings having nothing to do with workers’ compensation lines of insurance in California. It pertains to profits from any line of insurance, or an business enterprise of an insurance company, as though that would pertain to setting a premium for workers’ compensation insurance risk in the California marketplace.

Nonetheless, Jones maintains that “This order will allow my department to examine workers’ compensation insurers’ savings and rates and provide transparency to the public. I urge insurers to pass these savings along to policyholders.”

Jones has no rate making authority over worker’s compensation insurance pricing in California. Thus it would seem that the outcome of this study would lead to no particular regulatory action other than “transparency” which is already available for most insurance companies that are publicly held. All publicly held corporations are required to file regular certified financial statements with the Securities and Exchange Commission that provide detailed financial and tax information. The Commissioner – and the public – can review this historical and current information at any time.