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Harris Poll: Patients “Clueless” About Antibiotic Abuse

Antibiotics and similar drugs, together called antimicrobial agents, have been used for the last 70 years to treat patients who have infectious diseases. Since the 1940s, these drugs have greatly reduced illness and death from these infectious diseases.

However, these drugs have been used so widely and for so long that the infectious organisms the antibiotics are designed to kill have adapted to them, making the drugs less effective.

Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections.

But a new HealthDay/Harris Poll shows most Americans are clueless about the dangers, More than two-thirds of U.S. adults know “little” or “nothing” about so-called superbugs — bacterial infections that are resistant to many or all antibiotics. And around half believe, incorrectly, that antibiotics work against viruses.

That’s a concern because improper antibiotic use is considered the major driver of the superbug problem — a problem with deadly consequences.

“This poll shows that public ignorance is a huge part of the problem,” said Humphrey Taylor, chairman emeritus of The Harris Poll. “Millions of patients continue to believe that antibiotics will help them recover from colds, flu and other viral infections,” Taylor said, “and they can be upset with their doctors if they will not prescribe them.”

According to the agency, some of the most dangerous infections include: Clostridium difficile, a gut infection that often arises after someone has been on a long course of antibiotics for a different infection; and antibiotic-resistant strains of gonorrhea, pneumonia and Staphylococcus aureus — which can infect the skin, lungs or bloodstream.

In the new poll, 69 percent of Americans said they know little to nothing about the superbug problem. Meanwhile, 53 percent said that antibiotics are effective against viral infections, 40 percent said they fight the common cold, and 48 percent said they battle the flu.

Wrong on all counts.

The typical American may not be well-versed in infectious disease, but even a little knowledge can be enough, said Dr. Brad Spellberg, a spokesman for the Infectious Diseases Society of America.

“Most people have probably heard the term ‘superbug,’ and know they should be afraid of them,” said Spellberg, who is also a professor of clinical medicine at the University of Southern California’s Keck School of Medicine.

And he had some advice for what the public can do: “Don’t pressure your doctor for an antibiotic,” he said. “And when your doctor does prescribe one, ask whether it’s really necessary. We need to flip the script.”

Spellberg also pointed to a less obvious tactic. “Choose to buy antibiotic-free meat. Companies respond to what the public buys.”   That’s important because in the United States, antibiotics are commonly given to food-producing animals to promote their growth. That practice, the CDC says, can cause animals to develop drug-resistant bacteria, which can then be transmitted to humans.

Sleep Clinic Whistleblower Gets Half Million

Bay Sleep Clinic, its related businesses – Qualium Corporation and Amerimed Corporation – and their owners and operators, Anooshiravan Mostowfipour and Tara Nader have agreed to pay $2.6 million to settle allegations that they fraudulently billed the Medicare program. The allegations against the Defendants were set out in an amended False Claims Act complaint filed by the United States on August 8, 2016.

According to the complaint, Saratoga, Calif., residents Mostowfipour, 58, and Nader, 58, own Amerimed Corporation (that was doing business as Amerimed Sleep Diagnostics and Amerimed CPAP Specialists) and Qualium Corporation, which operated twenty sleep clinics doing business as Bay Sleep Clinic.

The government alleged that as early as April 2002, Mostowfipour, Nader, and their businesses fraudulently billed Medicare for sleep tests performed by technicians lacking the licenses or certifications required by Medicare payment rules.

In addition, the Defendants billed Medicare for sleep tests that allegedly were conducted at unenrolled and unapproved locations. Specifically, the government alleged that defendants regularly falsified documents to make it appear that a sleep test had been given at one of the defendants’ two locations which had been approved by Medicare, when, in fact, the test had been conducted at another, unapproved facility.

Additionally, the government alleged the Defendants fraudulently billed Medicare for medical devices in violation of Medicare rules and regulations that prohibit providers of diagnostic sleep tests from supplying medical devices and from sharing a sleep laboratory location with a durable medical equipment supplier.

The whistleblower action, captioned United States ex rel. Dresser v. Qualium Corp., et al., Civil Action No. 12-1745 (N.D. Cal.), was filed under the qui tam provisions of the False Claims Act. The False Claims Act allows for private persons, such as Elma F. Dresser in this case, to file actions to provide the government information about wrongdoing and then obtain a portion of the government’s recovery. Dresser will receive approximately $545,000.

As is permitted by the statute, the United States intervened in the action in May 2015 and filed its initial complaint in intervention in September 2015.

As part of the agreement, the defendants have voluntarily terminated their two existing Medicare enrollments and agreed not to re-enroll as providers or suppliers in the Medicare program for a period of three years.

Assistant U.S. Attorneys Erica Blachman Hitchings, Robin Wall, Kimberly Friday, and Tom Green handled the case with assistance from Jacqueline Hollar, Tina Louie, Bonny Wong, and Stefania Chin. The investigation was conducted by the U.S. Attorney’s Office for the Northern District of California and HHS-OIG.

The claims resolved by this settlement are allegations only and there has been no determination of liability.

OSIP Releases New Self Insured Forms

The Office of Self-Insurance Plans (OSIP) has released new application forms for private stand-alone and group insurers as it continues to modernize and simplify steps for employers. The forms were revised to remove unneeded information and language that no longer applies, which significantly reduced the total number of pages required for submission.

The forms can be downloaded for free from the OSIP website and are found under Forms, Publications, and Reports.

Private stand-alone applications:

Form A-1 (1-2016) Application for a Private Entity Certificate of Consent to Self-Insure
Form A-2 (1-2016) Application for a Public Agency Certificate of Consent to Self-Insure
Form A-3A (1-2016) Private Affiliate Interim Application
Form A-3B (1-2016) Application for a Permanent Certificate of Consent to Self-Insure by an Interim Self-Insurer
Form A-4 (1-2016) Guaranty of Workers’ Compensation Liabilities
Form A4-50 Application for a Certificate to Administer Workers’ Compensation Claims
Form A-5 (1-2016) Corporate Resolution Authorizing Application
Form A-6 (1-2016) Agreement and Undertaking for Security Deposit

Group applications:

Form S-1 (1-2016) Group Master Application for Certificate of Consent to Self-insure
Form S-2A (1-2016) Group Affiliate Member Interim Application
Form S-2B (1-2016) Application for Affiliate Certificate of Consent to Self-insure as a Member of a Group Self-insurer
Form S-3 (1-2016) Corporate Resolution
Form S-4 (1-2016) Indemnity Agreement and Power of Attorney
Form S-5 (1-2016) Agreement of Assumption and Guarantee of Workers’ Compensation Liabilities for Group and Affiliate Members
Form S-6 (1-2016) Agreement and Undertaking for Security Deposit

For more information regarding the application forms contact OSIP at (916) 464-7000.

The Office of Self-Insurance Plans (OSIP) is a program within the director’s office of the Department of Industrial Relations (DIR) responsible for the oversight and regulation of workers’ compensation self-insurance within California. OSIP is also responsible for establishing and insuring that required security deposits are posted by self-insurers in amounts sufficient to collateralize against potential defaults by self-insured employers and groups.

Are CT Claims This Years Battleground?

Last year Assemblyman Adam Gray, D-Merced, introduced and successfully passed Assembly Bill 1244 to crack down on medical providers who defraud the system. AB 1244 provides that If a vendor is convicted of fraud, then they are automatically suspended from treating in workers’ compensation, and the Administrative Director is to create a list of all names of suspended vendors on their website.

Last week, the Department of Industrial Relations, using new powers from Gray’s bill, announced that seven Southern California medical providers had been suspended from treating workers’ compensation payments for fraudulent billings.

As AB 1244 was moving through the process last year, Gray inserted and then quickly removed other language that seemingly relieved employers and insurers of responsibility for some small claims for “cumulative trauma” – injuries that accumulate over months or years, rather than stem from one incident.

This year he has introduced Assembly Bill 221, a new Gray bill that’s similar in thrust to last year’s abandoned language. The proposed law, if passed, will add the following language to Labor Code section 4600 that defines medical care.

(i) For claims of occupational disease or cumulative injury filed on or after January 1, 2018, the employee shall have no liability for payment for medical treatment and the employer shall have no liability for payment for medical treatment unless one or more of the following has occurred:
(1) The treatment was authorized by the employer.
(2) The injury to the body part or body parts for which the treatment was provided has been accepted by the employer.
(3) The appeals board, after an evidentiary hearing or stipulation of the parties, finds the injury to the body part or body parts for which the treatment was provided was compensable.
(4) The employee has undergone an evaluation by a qualified medical examiner, pursuant to Section 4600, or an agreed medical examiner and the evaluating physician has determined that the claimed occupational disease or cumulative injury was caused, in whole or in part, by the employment.

According to the Sacramento Bee, Gray’s office says it’s just another effort to crack down on fraud, but lobbyists who work the issue believe there are other motives.

Companies that represent medical providers in seeking workers’ compensation payments for patients’ bills have labeled it a maneuver by employers and/or insurers to shed liability.

Another theory is that it’s an indirect slap by workers’ compensation lawyers against labor unions for their 2012 deal with employers. The California Applicants Attorneys Association, however, denies paternity.

Labor killed last year’s language and will probably kill AB 221. Whatever its origin or fate, it indicates that in the next round of “reform,” cumulative trauma may be on the table.

Cumulative trauma claims have been increasing rapidly and employers and insurers see them as fraught with fraud, while unions are leery of any changes that could deny legitimate claims.m

Study Says Ultrasound No Help for Fractures

New evidence suggests that receiving low intensity pulsed ultrasound (LIPUS) to speed up bone healing after fracture has little or no impact on pain or recovery time, say a panel of international experts in The BMJ.

According to the story in Medical News Today, they say LIPUS does not represent an efficient use of health resources and recommend that it should be stopped.

Their advice is part of The BMJ’s ‘Rapid Recommendations’ initiative – to produce rapid and trustworthy guidance based on new evidence to help doctors make better decisions with their patients. Both the new evidence and the guidance are published by The BMJ.

Every year around 4 in 100 people of all ages have a fracture – and up to 10% of these experience slow or complicated healing. As such, fractures have been a target for numerous interventions to aid recovery.

LIPUS was approved for fracture healing by the US Food and Drug Administration (FDA) in 1994 and is also supported by the UK National Institute for Health and Care Excellence (NICE).

Each device costs between US$1300 and $5000 and data suggest it is commonly used in clinical practice. But some studies have shown that the potential benefits of LIPUS on bone healing are highly uncertain.

So The BMJ’s guideline panel – made up of bone surgeons, physiotherapists, clinicians and patients with experience of fractures – carried out a detailed analysis of the latest evidence.

They judged, with moderate to high certainty, that LIPUS has little or no impact on time to return to work, time to full weight bearing, pain, the number of subsequent operations, or time to healing assessed with radiographs (known as radiographic healing).

As such, they unanimously recommend against LIPUS for patients with any bone fractures or osteotomy (the surgical cutting of a bone to allow realignment).

“We have moderate to high certainty of a lack of benefit for outcomes important to patients, and, combined with the high costs of treatment, LIPUS represents an inefficient use of limited healthcare resources,” they write.

It is unlikely that new trials will alter the evidence, they add. And they suggest that future research “should focus on other interventions that have a greater probability to speed up healing.”

Former Deputy Sheriff Guilty in “CrossFit” Fraud Case

A former Orange County Sheriff’s Department (OCSD) deputy was convicted and sentenced to six months in Orange County jail and three years informal probation on charges for committing insurance fraud by failing to disclose his true physical abilities and activities to his health care providers.

36 year old Nicholas Zappas who lives in Laguna Niguel, pleaded guilty to six misdemeanor counts of insurance fraud.

In addition to his jail time and probation, Zappas was ordered to pay $34,838.97 in restitution to the County and $1,000 to the Worker’s Compensation Fraud Assessment Fund. The defendant is also required to dismiss his 2011 and 2015 worker’s compensation claims with prejudice as a condition of his probation.

At the time of the crimes, Zappas was employed as an OCSD deputy for approximately 14 years.

On April 2, 2015, while working Harbor Patrol and engaged in a boat rescue, Zappas tripped over a fire hose and fell on his back. He filed a workers’ compensation insurance claim for injuries to his left shoulder, left side of his neck, and lower back.

Zappas was placed on work restrictions of no lifting, pushing, or pulling greater than 10 pounds by a medical doctor due to the defendant’s complaint of pain. OCSD accommodated the work restrictions and Zappas was assigned to dispatch.

Between May 2015 and November 2015, Zappas engaged in CrossFit, which is a high-impact exercise with varied functional movements. The defendant appeared on video while engaging in CrossFit, including lifting substantial weights in excess of 200 pounds, performing box jumps, burpees, squats, and other activities that were contrary to the limitations imposed by the doctor based on the defendant’s description of his pain, symptoms, and limitations. Zappas failed to disclose that he was participating in CrossFit to his medical physicians.

On Dec. 1, 2015, while under oath during his deposition, Zappas denied lifting anything over 20 pounds since the date of his injury and claimed that he could not lift anything heavy, could not do squats, and could not run.

Between January 2016 and May 2016, Zappas continued to engage in CrossFit and did not disclose his abilities to his medical physicians.

Deputy District Attorney Pamela Leitao of the Insurance Fraud Unit prosecuted this case.

FDA Rejects New Naloxone Intranasal Injector

After coming under fire from angry lawmakers in the wake of its recent decision to more than double the price of its opioid intervention drug naloxone, Amphastar says that the FDA has handed it a rejection for an intranasal version of the treatment.

The Rancho Cucamonga, California based biotech company did not spell out all the reasons for the rejection or go into much detail in its statement, but the company cited the agency’s questions about a “user human factors study, device evaluation, and other items.”

CRLs, though, aren’t public, so there’s no way to check on exactly what regulators are objecting to.

Naloxone is a medication used to block the effects of opioids, especially in overdose. When given intravenously, it works within two minutes, and when injected into a muscle, it works within five minutes. The medication may also be used in the nose. The effects of naloxone last about half an hour to an hour

Naloxone was patented in 1961 and approved for opioid overdose by the Food and Drug Administration in 1971. It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system. Naloxone is available as a generic medication.

A pair of US senators, Susan Collins and Claire McCaskill, on the Special Committee on Aging, took Amphastar, Pfizer, Mylan, Adapt Pharma and Kaleo to task last summer for hiking the price of naloxone as opioid abuse ran rampant in the country.

Amphastar raised its price of naloxone in early 2015 from $19 a dose to $41 and lawmakers have criticized the players in the field for a ten-fold increase in recent years, right alongside a national opioid addiction crisis.

Amphastar’s CEO, Dr. Jack Zhang, stated: “While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA to address their concerns in the CRL and hope to bring Intranasal Naloxone to the market as soon as possible.”

Amphastar already sells naloxone in pre-filled syringes, as does privately held Kaleo Pharmaceuticals, which came under fire earlier this year for raising the price of its naloxone device Evzio by 550 percent to $4,500.

Adapt Pharma Ltd already has two naloxone nasal spray formulations approved by the U.S. FDA.

Convicted Chiropractor Attacks New Law

California lawmakers passed new law last year to limit lien claims by medical providers who are charged with or convicted of fraud related crimes.

SB 1160 provides that in the event a lien filer is charged with workers’ compensation fraud, Medi-Cal fraud, or Medicare fraud, all liens are stayed pending resolution of the charges. And AB 1244 provides that If a vendor is convicted of fraud, then they are automatically suspended from treating in workers’ compensation, and the Administrative Director is to create a list of all names of suspended vendors on their website.

Last Friday, the DWC announced the suspension of seven medical providers from participating in California’s workers’ compensation system. The providers have been convicted of workers’ comp fraud or have been suspended from the Medicare or Medicaid programs for medical fraud. The suspended providers have filed more than 8,500 liens in California’s workers’ compensation system, with a total of claim value of at least $59 million.

But one convicted chiropractor has fought back, challenging the constitutionality of the two new laws.

The Department of Justice announced that Chiropractor Michael E. Barri, 48, of San Clemente, who owned and operated the Santa Ana companies Tri-Star Medical Group and Jojaso Management Company, pleaded guilty on March 11, 2016 to a conspiracy count and admitted that he received illegal kickbacks for referrals to Pacific Hospital of Long Beach. During a nine-month period that ended in 2013, Barri admitted receiving $158,555 in illegal kickbacks after referring a dozen patients to Pacific Hospital, where they had back surgeries. As a result of his referrals, Pacific Hospital billed insurance carriers approximately $3.9 million for spinal surgeries.

Barri has also been indicted by an Orange County Grand Jury in 2014 with charges of kickbacks and related offenses involving compounded medications, along with Kareem Ahmed the owner of Landmark Medical, and 13 other named providers. Much of that case was dismissed by the Court of Appeal in 2016. However some of the charges have been re-filed by the Orange County District Attorney, and it is not clear how much of the original indictment will proceed, and what defendants will be involved.

Nonetheless, Chiropractor Barri filed case A150549 with the California First District Court of Appeal  on February 15, seeking to have SB 1160 and AB 1244 declared to be unconstitutional, so that he and his company Tri-Start Medical Group can continue to collect workers’ compensation liens. Among other theories, Barri alleged “The Lien Stay Provision Violates Petitioners’ Right to Due Process Under the California and United States Constitutions.”

He further claimed that “Prompt action is essential. The new provisions took effect on January 1, 2017. Dr. Barri and Tristar, along with similarly situated lien claimants, will suffer irreparable injury if the Court does not immediately grant the requested relief. California already has applied the Lien Stay Provision to Dr. Barri’s liens, and approximately 200,000 other liens valued at over one billion dollars” and “Absent immediate relief, under the Lien Stay Provision, Dr. Barri will be deprived of his constitutional right to secure counsel of his choice in the criminal proceeding pending against him. Without the income provided by untainted liens, Dr. Barri simply cannot afford capable counsel” and “The liens that will be stayed provide Dr. Barri with his sole source of income, and a stay will make it impossible for Dr. Barri to pay his defense attorneys’ fees and his living expenses.” His attorneys concede that Barri “resides in Dana Point, Orange County, California” no doubt a very expensive place to live.

He did not get very far with his newly filed case.

Court records reflect that on February 17, the Court of Appeal issued the following order. “The petition for peremptory and/or alternative writs of mandate, prohibition, or other appropriate relief is denied as premature, given that a hearing on the suspension under Labor Code section 139.21 is scheduled for February 24, 2017 before a hearing officer of the Division of Workers’ Compensation, and the suspension is stayed pending the outcome of that hearing. The court also questions whether this is the proper appellate district to file this petition, given that none of the petitioners reside or have their principal place of business in this appellate district. The request for a stay is denied. (Ruvolo, P.J., Reardon, A.P.J., and Rivera, J. participated in the decision.)”

Oakland Comp Attorney Pleads Guilty

Marc Terbeek, an East Bay workers’ compensation attorney who also represents marijuana dispensary operators appeared in federal court this month and admitted to counts one (29 U.S.C. § 186(a)(2)-Making A Payment To A Union Employee) and two (12 U.S.C. § 1956- Willful Violation of Anti-Structuring Regulation) of the Information filed in federal court case 4:17-cr-00087-HSG.

According to court documents, between 2010 and 2015, Terbeek paid money to “D.R.” in exchange for having business improperly steered to him. The initials refer to Daniel Rush, who was at the time the organizing coordinator of the cannabis division of the United Food and Commercial Workers union.

Rush was charged in 2015 in federal court with honest-services fraud and accepting payments in violation of the Taft-Hartley Act, which restricts the activities and power of labor unions. Rush’s trial is set to begin in March.

Terbeek was allegedly involved in the massive corruption case filed by the FBI’s Public Corruption and Civil Rights Squad. The FBI and IRS raided Terbeek’s office in January 2015 and since then he has been cooperating with investigators.

Daniel Rush was an official with the United Food and Commercial Workers Union that had established a “Cannabis Division” to organize dispensary employees. He was also closely involved in Measure D, the process to regulate medical marijuana dispensaries in Los Angeles, and also connected to legalization’s most prominent pitchman: Lt. Gov. Gavin Newsom.

According to the allegations of paragraph 31 of the Affidavit , Tarbeek admitted to the FBI that he had been paying “kickbacks” to Rush for sending Terbeek legal work since 2004. Rush “encouraged” Terbeek to acquire a workers compensation law practice to litigate cases referred by the Insitutio Laboral de la Raza. In exchange Tarbeek gave Rush a credit card associated with Terbeek’s law firm and Terbeek paid it off routinely. Text messages confirmed this practice continued as late as February 2015. From 2010 to 2015, Rush spent $110,000 on Terbeek’s card, about $2,000 per month, for mostly personal expenses.

Also, Terbeek allegedly agreed to share legal fees with Rush derived from Terbeek’s clients seeking permits to operate dispensaries in California, Nevada, and beyond (Affidavit paragraph 34). After creation of this arrangement, Terbeek paid Rush $5000 as his “share” of the medical marijuana legal fees.

Terbeek’s attorney, Ed Swanson said, “Mr. Terbeek has been fully cooperative with the government’s investigation of this case. He regrets his actions and accepts full responsibility for his conduct.” The case was continued to May 22, 2017 at 2:00 p.m. for sentencing.

California State Bar records reflect that there is no public record of discipline or administrative actions against Mr. Terbeek, and he remains an active member of the State Bar.

Drug Monitoring Databases Cut Doctor Shopping 80%

A new study published in the International Journal of Addictive Behaviors found that state programs that require physicians to check drug registries before writing prescriptions appeared to slash the odds of doctor-shopping for opioid pain relievers.

According to the report by Reuters Health, the study “shows that prescription-drug monitoring programs are a promising component of a multifaceted strategy to address the opioid epidemic,” Ryan Mutter, one of the study authors, said in a phone interview. He is a health economist at the Substance Abuse and Mental Health Service Administration in Rockville, Maryland.

Mutter and other researchers analyzed annual nationwide surveys of drug use and health from 2004 until 2014, when 36 states implemented prescription-drug monitoring programs, or PDMPs.

PDMPs are state-run electronic databases designed to track prescribing of controlled substances and to identify people at high risk of using opioids for nonmedical purposes. Every state except Missouri now has a drug-monitoring program. Some states have mandatory programs requiring physicians to participate, and other states have voluntary programs.

California is one of many states that maintain a drug registry. CURES 2.0 (Controlled Substance Utilization Review and Evaluation System) is a database of Schedule II, III and IV controlled substance prescriptions dispensed in California serving the public health, regulatory oversight agencies, and law enforcement. CURES 2.0 is committed to the reduction of prescription drug abuse and diversion without affecting legitimate medical practice or patient care.

The study found that in states where physicians were required to check an electronic database before writing an opioid prescription, the odds that two or more doctors would be giving pain relievers for nonmedical purposes to a single patient were reduced by 80 percent. States that implemented voluntary monitoring programs showed a 56 percent reduction in the odds of doctor-shopping.

States with mandatory prescription-drug monitoring programs reduced the use of painkillers for nonmedical purposes by an average of 20 days a year, the study found. States with voluntary prescription-drug monitoring program reduced the use of painkillers for nonmedical purposes by an average of 10 days a year.

“Overall, this, as well as other studies, suggests there’s promise for prescription-drug monitoring programs,” Dr. Stephen W. Patrick said in a phone interview. “But they aren’t a panacea.”

The number of PDMPs has expanded rapidly across states since 2000, but prior studies have shown mixed results about their effectiveness, the study authors write.

One previous study found that drug-monitoring programs help prevent 10 opioid-overdose deaths a day in the U.S., yet improvements could save another two people a day. States with the most robust programs – ones that tracked a greater number of potentially addictive medications and updated their databases at least weekly – saw the biggest drops in overdose deaths, the previous study showed.

Public health advocates worry that an unintended consequence of drug-monitoring programs could be that opioid users would seek drugs illegally and turn to heroin, the authors write. But the current study found that PDMPs did not lead to an increase in people starting to use heroin.

Lead author Mir M. Ali said in a phone interview he found it “reassuring” that drug-monitoring programs were not responsible for opioid users substituting heroin. Ali is a health economist at the Substance Abuse and Mental Health Services Administration.