Remoxy ER (oxycodone) Extended-Release Capsules CII, based on Pain Therapeutics’ ORADUR technology, is a long-acting formulation of oxycodone designed to discourage most methods of tampering linked to opioid abuse.

However, a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to the FDA voted 14 to 3 against approving the drug. And the FDA agreed and argued that the benefits of the drug did not outweigh the risks.

The company reacted badly.

“This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction,” said Remi Barbier, Pain Therapeutics’ president and chief executive officer, in a statement. “We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin. We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would. Instead, I believe Remoxy received an ideological judgment call that is vague in nature but conclusive in its damaging effects.”

This is the companies fourth rejection on Remoxy. Seemingly in response to the rejection, Pain Therapeutics has launched a strategic reorganization. It plans to shift its focus from tamper-resistant opioid formulations to Alzheimer’s disease. Details are expected to be released in the upcoming weeks.

The FDA has perhaps changed direction on approval of opioid pain management strategies. They have announced “we must also take steps to help those with acute and chronic pain who need access to medicines, including opioids, get improved treatment alternatives.”

“Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit. While these innovative formulations are designed to make it harder for people to manipulate the opioid drug so they can’t be abused, it’s important that prescribers and patients understand that these drugs are not ‘abuse-proof,’ and they do not prevent addiction, overdose, or death.”

“In addition, part of our ongoing work is ensuring that drug approval and removal decisions are made within a benefit/risk framework that evaluates not only the outcomes of opioids when used a prescribed, but also the public health effects of inappropriate use of these drugs. We are continually re-evaluating the safety of approved opioid products based on both post-market data the FDA has required from sponsors and additional sources of information as part of our safety surveillance.”

Both the announced policy and the FDA current opioid rejection history seem to indicate a trend away from opioid drugs toward “alternatives,” whatever that might be.

Prime Healthcare Services, Inc.; Prime Healthcare Foundation, Inc.; Prime Healthcare Management, Inc.; and Prime’s Founder and chief executive officer, Dr. Prem Reddy, have agreed to pay the United States $65 million to settle allegations that 14 Prime hospitals in California knowingly submitted false claims to Medicare by admitting patients who required only less costly, outpatient care and by billing for more expensive patient diagnoses than the patients had (a practice known as “up-coding”).

Under the settlement agreement, Reddy will pay $3.25 million and Prime will pay $61.75 million.

Headquartered in Ontario, California, Prime Healthcare Services and the not-for-profit Prime Healthcare Foundation constitute one of the largest hospital systems in the nation, with 45 acute-care hospitals located in 14 states.

The following 10 hospital defendants owned by Prime Healthcare Services are parties to the settlement agreement: Alvarado Hospital Medical Center, Garden Grove Medical Center, La Palma Intercommunity Hospital, Desert Valley Hospital, Chino Valley Medical Center, Paradise Valley Hospital, San Dimas Community Hospital, Shasta Regional Medical Center, West Anaheim Medical Center and Centinela Hospital Medical Center.

Four other hospital defendants owned by Prime Healthcare Foundation are also parties to the settlement agreement: Sherman Oaks Hospital, Montclair Hospital Medical Center, Huntington Beach Hospital and Encino Hospital Medical Center. Prime Healthcare Management, a subsidiary of Prime Healthcare Services, provides management, consulting and support services to hospitals owned and operated by Prime.

The settlement resolves allegations that, from 2006 through 2013, Prime engaged in a deliberate, corporate-driven scheme to increase inpatient admissions of Medicare beneficiaries who originally presented to the Emergency Departments at the 14 Prime hospitals in California.

The government claimed that the inpatient admission of these beneficiaries was not medically necessary because their symptoms and treatment needs should have been managed in a less-costly outpatient or observation setting. Hospitals generally receive significantly higher payments from Medicare for inpatient admissions as opposed to outpatient treatment; therefore, the admission of beneficiaries who do not need inpatient care, as alleged here, can result in substantial financial harm to the Medicare program.

The settlement also resolves allegations that, from 2006 through 2014, Prime engaged in up-coding by falsifying information concerning patient diagnoses, including complications and comorbidities, in order to increase Medicare reimbursement.

This settlement resolves a False Claims Act (FCA) lawsuit filed in federal court in Los Angeles by Karin Berntsen, the former director of performance improvement at Alvarado Hospital Medical Center in San Diego. Under the qui tam, or whistleblower, provisions of the FCA, private citizens are permitted to bring lawsuits on behalf of the United States and obtain a portion of the government’s recovery. The FCA also permits the government to intervene and take over the lawsuit, as it did in this case as to some of Ms. Berntsen’s allegations. Ms. Berntsen will receive $17,225,000 as her portion of the settlement amount.

The case is United States ex rel. Karin Berntsen v. Prime Healthcare Services, Inc., et al., CV11-08214-PJW (C.D. Cal.). The claims resolved by this settlement are allegations only and there has been no determination of liability.

Fitch Ratings reports that the U.S. workers’ compensation insurance market reported strong underwriting performance for the third consecutive year in 2017, with an industry statutory combined ratio of approximately 92 percent..

However, a steady decline in premium rates from increased competition will ultimately lead to weaker underwriting results.

According to the summary prepared by the Insurance Journal, Fitch believes that while the industry may still generate underwriting profits this year, workers’ compensation results will move toward break-even in 2019, with low visibility of longer term projected results due to historical performance volatility.

Positive performance drivers include underwriting exposure growth, continued falling claims frequency rates and conservative reserve levels.

Past underwriting and pricing actions and relatively stable loss trends have positively influenced recent market performance. Recognition of greater reserve redundancies in 2017 also partly drove results, which totaled ~12 percent of market earned premiums. Fitch says favorable loss reserve redundancies will materialize for the next few years but to a lessening degree than in 2017.

Factors that can negatively affect future industry performance include premium rate pressure, increasing medical loss severity and erosion of past reform benefits in key states.

Market direct written premium volume in 2017 declined by 30 bps from the prior year to $56 billion, representing the first year of lower market premiums since 2010.

Net written premiums fell by 1.3 percent during the same time, mainly due to larger reinsurance cessions. Premium revenue weakness, along with greater technology-related spending, has led to higher expense ratios, which have risen two points since 2014 for the industry.

Workers’ compensation premium growth will continue to lag other commercial lines segments due largely to divergent pricing trends. According to the Council of Insurance Agents & Brokers’ quarterly Commercial Property/Casualty Market Index Survey, renewal rates in the workers’ compensation segment declined in each of the past 13 consecutive quarters.

Shifts in loss cost trends, particularly claims severity, represent a source for future workers’ compensation performance deterioration that bears further monitoring. Both indemnity and medical claims cost severity were relatively stable compared with historical norms for nearly a decade but ticked up recently.

The National Council on Compensation Insurance’s latest State of the Line presentation notes an increase in workers’ compensation indemnity and medical cost claims severity of 4 percent each in 2017.

The August online issue of the British Medical Journal reports that the use of prescription opioids remains high in the U.S., despite public health efforts and growing awareness of risks for abuse and overdose.

Over a decade, the proportion of adults being prescribed opioid medications has changed little, but dosages have continued to rise and are especially high among patients with permanent disability, researchers report in The BMJ.

Reuters Health reports that it was surprising to study leader Molly Moore Jeffery of the Mayo Clinic in Rochester, Minnesota. “You expect to see them using more, but it was bigger than I expected,” she said.

Also concerning were the number of patients with prescriptions for both opioids and benzodiazepines, because the combination can raise the risk of death, Jeffery said.

The U.S. has the highest per capita rate of opioid use in the world – nearly double that of second-ranked Germany and seven times higher than the UK, the researchers note. On average, 40 people die in the U.S. daily from prescription opioid overdoses, a four-fold increase since 1999, they add.

Jeffery’s team analyzed a national database of medical and pharmacy claims to examine trends in opioid use among 48 million people with health insurance between 2007 and 2016. They included working-age adults with commercial insurance, as well as Medicare beneficiaries eligible for coverage either because they were over age 65 or younger but disabled.

Overall, 14 percent of commercially insured patients and 26 percent of older Medicare beneficiaries used opioids during the study period. The rate was 52 percent among disabled Medicare beneficiaries.

To allow comparisons between different opioid medications, the researchers converted all prescription doses into so-called milligram morphine equivalents (MME).

Like other recent studies, this one showed that opioid use and average dose leveled off after peaking in 2012-2013. But the MME dose in all groups of patients was still higher in 2016 than it was in 2007.

“All reports are showing that opioid prescribing still occurs too frequently and (is) far higher than in the 1990s in the U.S.,” said Dr. John Mafi of the David Geffen School of Medicine at the University of California, Los Angeles, who wasn’t involved in the study.

“This is a cause for alarm and we need rapid and effective policy changes to decrease overprescribing and reduce opioid-related deaths. Specifically, we need to improve access and coverage of evidence-based non-opioid pain alternatives, such as topical non-steroidal anti-inflammatory medications for acute musculoskeletal pain or physical therapy for chronic low back pain.”

In a case where the parties made five panel requests to the Medical Unit, four panel lists failed to yield a physician capable of offering a regulation-compliant appointment window, the WCJ abandoned the PQME process and directly appointed a “Regular Physician” who was available to evaluate the applicant.

In this case, Tyree Foster claimed to have injured his back on November 29, 2016, while working for Express Employment.Professionals. His claim was denied.

An MSC was set regarding a “panel dispute” and indicating that the parties were in need of a replacement panel of QMEs. Defendants objected, averring that a hearing would be moot or premature because the Medical Unit had recently issued a new replacement panel list.

The applicant made the initial QME panel request on April 11, 2017; After the remaining QME from the original panel (Dr. Shen) turned out to be unavailable, the parties submitted a replacement panel request on May 22, 2017; The remaining doctor from the first replacement panel (Dr. Herny) was scheduling in 2018, so the parties sought another replacement panel; From the second replacement panel, the remaining QME was Dr. Grant, whose earliest available appointment was seven months out, so another replacement panel was requested; The remaining doctor from the third replacement panel (Dr. Cheng) was not available sooner than April 2018, leading the parties to submit yet another replacement panel request on November 21, 2017. As of the time of this MSC, that request was pending at the Medical Unit.

Attorneys for Mr. Foster asked the WCJ for help moving the case forward, claiming he had lost his job and was without benefits “due to the difficulty of being unable to obtain a medical evaluation.” No medical reports were filed at the time of the MSC.

The WCJ found that the record was not sufficiently developed to allow adjudication of AOE/COE. And that the parties have been diligent in pursuing medical-legal discovery, but have been unsuccessful for reasons that are beyond their control (and beyond his comprehension).

In the interest of expediting resolution of compensability in this case, as well as potentially other medical questions the WCJ ordered that applicant to be examined by Dr. Joel Renbaum for all medical-legal purposes in this case. The parties were ordered to communicate with Dr. Renbaum in the same manner as they would if he were appointed as a Qualified Medical Evaluator. The Order was pursuant to the authority of Labor Code Section 5701.

The employer Petitioned for Removal and asked that the order be rescinded. They assert that the order exceeds the lawful bounds of the WCJ discretion.The WCAB denied Removal in the case of Foster v Express Employment Professionals.

LC 5701 provides that “The appeals board may also from time to time direct any employee claiming compensation to be examined by a regular physician.” Contrary to defendants’ contention, the Labor Code does not grant them an unconditional right to participate in the panel QME selection protocol. The statute limits litigants’ options for obtaining medical-legal evidence, but it does not require or entitle them to select a QME.