Category: Daily News

The U.S. Drug Enforcement Administration said on Tuesday it had changed a regulation to allow more healthcare professionals to prescribe a medication used to treat opioid addiction, opening up access in rural America where there are few doctors.

Prior to 2000, only physicians could treat those with opioid addiction and had to register with the DEA as both physicians and operators of narcotic treatment programs. The latest change is part of a 2016 law that added categories of practitioners who may prescribe the narcotic drug buprenorphine for maintenance or detoxification treatment, the DEA said in a statement.

Buprenorphine, sold under the brand name Subutex, among others, is an opioid used to treat opioid addiction, acute pain, and chronic pain. It can be used under the tongue, by injection, as a skin patch, or as an implant. When used for opioid addiction it is recommended that a health care provider observe the person while they take the medication. For longer term treatment of addiction a combination formulation of buprenorphine/naloxone is usually recommended. Maximum pain relief is generally within an hour with effects up to 24 hours.

Buprenorphine was approved for medical use in the United States in 1981.In 2012, 9.3 million prescription for the medication were written in the United States. Buprenorphine may also be used recreationally by injection or in the nose for the high it produces. Some use it as a substitute for heroin. In the United States it is a Schedule III controlled substance.

A 2017 study published by the National Rural Health Association found that 53 percent of rural counties had no physician able to prescribe medication to those addicted to opioids, the DEA said. About 90 percent of physicians allowed to prescribe such medication live in urban counties, and 30 million people live in areas where treatment is unavailable.

About 5,000 mid-level practitioners can now prescribe the medication, and nearly 43,000 practitioners may qualify to do so, the DEA said.

Rural America has more drug overdose deaths than urban areas, a 2017 study by the Centers for Disease Control and Prevention showed. Prescription drug abuse is a leading cause of death, with opioids killing more than 42,000 people in 2016, the highest U.S. death toll of any year on record, CDC said.

“This action reflects this work and the ongoing need to further expand access to the most effective treatment for opioid use disorder,” said David Fiellin, professor of medicine, emergency medicine and public health at Yale School of Medicine, in an email to Reuters, who published the story.

In 2001, Alexander Zaks M.D. formed several businesses in California’s Central Valley that focused on providing medical treatment to the region’s agricultural workers. Zaks, along with David Holmes D.C. and Daniel Reyes D.C., formed Accident Help Line Medical Group (AHL) at that time. The entities focused on patients with chronic work-related injuries. Zaks also established Millcreek Surgery Center and Alta Surgery Center. Zaks and a partner also owned Reliable Medical Supply, which provided medical equipment. In 2003 Zaks and partners also created Valley Interpreting, a translation service for patients who spoke limited or no English.

Dr. Khan and Dr. Zaks engaged in some cross marketing of their respective services to attorneys representing clients with workers’ compensation issues.

Bruce Roth, then a senior attorney with State Fund, was assigned to defend State Fund against the Zaks Entities’ WCAB liens. Suspecting possible fraud, Roth led an investigation of the Zaks Entities. In January 2006, Roth filed a petition with the WCAB to consolidate the Khan Entities’ and Zaks Entities’ 1,200+ liens against State Fund.

In October 2009, after losing on several issues before the WCAB, Roth settled the consolidated case with the Zaks Defendants without first gaining the approval of his manager at State Fund or State Fund’s claims department. Once Roth’s superiors learned of the settlement they removed Roth from the case, contacted the Zaks Entities, and disavowed the settlement on the basis that Roth lacked authority to enter into it. They forced Roth to resign and referred the case to other attorneys.

State Fund then entered into superseding settlement agreements with the Zaks Entities for substantially the same amount of money as provided for in the 2009 Settlement Memorandum negotiated by Roth. State Fund asserts that it did so in large part out of concern that the WCAB might have enforced the original 2009 Settlement Memorandum between Roth and the Zaks Entities based on Roth’s ostensible authority to bind State Fund. The newer 2010 Settlement Agreement between State Fund and the Zaks Entities released both State Fund and the Zaks Entities from all claims they had against each other up until the time of that agreement.

The State Fund then filed a federal suit for violation of the federal Racketeering and Corrupt Organizations Act (RICO) statute against defendants Alexander Zaks, M.D., Sana Khan, M.D., David Holmes, D.C., and Daniel Reyes, D.C.; their various companies and State Fund’s own former employee, attorney Bruce Roth.

After three years of litigation and extensive discovery, the Zaks Defendants, the Khan Defendants, and Roth filed three separate motions for summary judgment which were granted in March 2016. SCIF appealed the summary judgment to the 9th Circuit Court of Appeal which just affirmed the trial court in the unpublished case of SCIF v Kahn, Zaks et.al.

State Fund’s claims against these Defendants-Appellees were precluded by the broad liability releases contained in the 2010 Settlement Agreements. The district court correctly determined that the releases protected all of these Defendants-Appellees because even State Fund’s claims against the Individual Zaks Defendants were premised on acts within the scope of their agency relationships with lien claimants, such that liability was precluded by the releases’ plain terms.

The court also correctly held that there were no grounds for rescinding the 2010 Settlement Agreements. For fraud to justify rescission, however, it must be extrinsic. Here, there was no extrinsic fraud to justify rescission.

For years, hospital executives have expressed frustration when essential drugs like heart medicines have become scarce, or when prices have skyrocketed because investors manipulated the market.

Now, some of the country’s largest hospital systems are taking an aggressive step to combat the problem: They plan to go into the drug business themselves, in a move that appears to be the first on this scale.

Intermountain Healthcare is a not-for-profit health system based in Salt Lake City, Utah, with 22 hospitals, a broad range of clinics and services, about 1,400 employed primary care and secondary care physicians at more than 185 clinics in the Intermountain Medical Group, and health insurance plans from SelectHealth.

The organization just announced a bold initiative to establish a not-for-profit generic drug company aimed at ending shortages and reducing prices. Intermountain Healthcare is leading a collaboration with Ascension, SSM Health, and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form the company. The five organizations represent more than 450 hospitals around the U.S. The press release made clear price and availability are the key issues.

The story on Forbes says the new company intends to be an FDA approved manufacturer and will either directly manufacture generic drugs or sub-contract manufacturing to reputable contract manufacturing organizations, providing patients an affordable alternative to products from generic drug companies whose capricious and unfair pricing practices are damaging the generic drug market and hurting consumers.

The company will also seek to stabilize the supply of essential generic medications administered in hospitals, many of which have fallen into chronic shortage. The new initiative will result in lower costs and more predictable supplies of essential generic medicines, helping ensure that patients and their needs come first in the generic drug marketplace.

Several major hospital systems, including Ascension, a Catholic system that is the nation’s largest nonprofit hospital group, plan to participate the new nonprofit company, that will provide a number of generic drugs to the hospitals. The Department of Veterans Affairs is also expressing interest in participating. Other hospitals are expected to join.

“This is a shot across the bow of the bad guys,” said Dr. Marc Harrison, the chief executive of Intermountain Healthcare, the nonprofit that is spearheading the effort. “We are not going to lay down. We are going to go ahead and try and fix it.”

Dr. Carolyn Clancy, the executive in charge of the Veterans Health Administration, said its pharmacy experts have consulted with the other systems about the project and is now working out the details of its possible involvement. “Our strong interest here is minimizing the impact of any shortages of generic drugs,” she said. While she said the agency is able to negotiate good prices for veterans, “we don’t necessarily control supply” and have experienced many of the same shortages, including the recent lack of saline fluids, as the other health groups.

Dr. Kevin A. Schulman, a professor of medicine at the Duke University School of Medicine who has studied the generic drug market and is advising the effort, said: “If they all agree to buy enough to sustain this effort, you will have a huge threat to people that are trying to manipulate the generic drug market. They will want to think twice.”

According to federal prosecutors, Philip Sobol, an orthopedic surgeon, agreed with Michael Drobot to receive kickbacks in exchange for performing surgeries at Pacific Hospital of Long Beach or referring spinal surgery patients to physicians who would perform the spinal surgeries at Pacific Hospital.

Sobol and Drobot concealed the kickbacks through a series of sham agreements including a management agreement and option agreement. Sobol received approximately $5.2 million dollars in kickbacks.

On November 24, 2015, Sobol entered into an agreement to plead guilty to a two-count information that charged him with Conspiracy in violation of 18 U.S.C. § 371, and Interstate Travel in Aid of a Racketeering Enterprise in violation of 18 U.S.C. § 1952.

Sobol further agreed to forfeit the sum of $5,200,000.00 which he admitted represented proceeds he obtained as a result of the offenses to which he entered the guilty plea.

In furtherance of this stipulation, on January 16, 2018, Federal Judge Josephine L. Stanton ordered a money judgment in the amount of $2,000,000.00 in favor of the United States of America and against Defendant Philip A. Sobol.

She furthered ordered that “This Money Judgment is part of the sentence imposed on Defendant Sobol in this case.” He remains to be sentenced in February.

Prosecutors filed a Sentencing Report in his criminal case on December 5. On February 24, 2017, the United States Probation Office reported that his sentencing range was 46-57 months’ imprisonment. The report noted that Sobol had agreed to pay restitution but “did not identify any victims from the harm.”

But prosecutors say the Court should apply an additional two level increase because the offense involved more than ten victims.

Prosecutors reported that “it is difficult to determine exactly how many surgeries defendant referred where he received a kickback because the kickbacks were paid through sham management and option agreements that were designed to approximate the number of surgeries referred or performed at Pacific Hospital, Drobot admitted in his plea agreement that he paid between $10,000 and $15,000 per surgery performed.”

His Sentencing Hearing is currently set for February 16, 2018 at 8:30 a.m.

A Brea physician, who is being prosecuted in a baby’s death and for being part of an alleged $100 million workers compensation fraud scam, recently had his medical license restricted pending the outcome of criminal proceedings filed in Orange County.

The interim suspension order agreed to by Dr. Andrew Robert Jarminski, his attorney Peter R. Osinoff and counsel for the Medical Board of California went into effect on Dec. 22.

Jaminski’s legal problems date back to criminal proceedings commenced in 2014 by an Orange County grand jury indictment of Kareem Ahmed of Landmark Medical Management in Ontario and 15 people including Jarminski.

The OCWeekly recent case summary notes that the original indictment specifically cast Ahmed as the ringleader, accusing him of: hiring pharmacists to produce compounded transdermal creams and  paying kickbacks to several physicians and chiropractors, including Dr. Jarminski, for prescribing the cream to their workers’ compensation patients.

Ahmed’s attorneys managed to get most of the counts against their client tossed in March 2016. But the OCDA refiled charges against Ahmed and others that pushed the number of defendants up to 21 people and the alleged fraud ballooned to $100 million. Hearings in the case are set for Feb. 9 and 26 in Orange County Superior Court. Jarminski, had offices in Long Beach and Lawndale when he was first accused of having received $1.9 million in Landmark kickbacks.

As a result of events alleged in the OCDA criminal prosecution, the California Medical Board issued an Accusation against Jarminski in June, 2017 seeking to revoke his license. They claim he commenced treating Priscilla Lujan, an injured worker, in 2011. During the course of her treatment she gave birth to a child who was breastfeeding. The child died after ingesting residue from the compounded transdermal medication he prescribed for her. The ODCA pursued manslaughter charges against Jarminski, and others, for this death.

Attorneys for the defendants have vehemently denied the charges against them. As for Jarminski’s medical license, his lawyers argued that staying a suspension is appropriate because he is presumed innocent until proven guilty, and if he is convicted his license will be revoked by the medical board anyway.

Late last month, Administrative Law Judge Susan L. Formaker agreed that the public can be protected through the restrictions of the interim suspension order, which stipulates that Jarminski cannot dispense or prescribe non-FDA approved compounded medications before the matters before the criminal court and medical board are resolved.