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Tag: 2017 News

New Back Pain Guidelines Shun Medications

People should try non-drug treatment options like massage or stretching for most cases of chronic low back pain before choosing treatment with over-the-counter or prescription drugs, according to new treatment guidelines promulgated by the American College of Physicians.

The report in Reuters Health says that if the pain began recently, the guidelines recommend superficial heat, massage, acupuncture or spinal manipulation. If patients wish to take medication, they should use nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or skeletal muscle relaxants prescribed by a doctor. Acetaminophen and steroids are not recommended for low back pain, according to the guidelines.

But for chronic low back pain – defined as pain that’s lasted more than 12 weeks – the American College of Physicians (ACP) recommends people hold off on medications.

The new guidelines apply to low back pain that does not radiate to other parts of the body like the legs, said Dr. Nitin Damle of the Alpert Medical School of Brown University in Providence, Rhode Island, who is president of the ACP.

Patients with low back pain that radiates to other parts of the body need further evaluation, he told Reuters Health.

“Most back pain is self-limited,” said Damle. “It’s common, will go away given enough time and patients can help themselves initially by trying some heat and stretching before going to see a physician.”

The new guidelines are based on a review of studies that looked at the use of drug and non-drug therapies for low back pain. The review did not look at creams or injections, however.

Based on the review, the ACP recommends that people who have been suffering with chronic low back pain try non-drug therapies such as exercise, acupuncture, mindfulness-based stress reduction, tai chi, yoga, biofeedback, cognitive behavioral therapy or spinal manipulation.

If those methods don’t work, the guidelines say the next step should be NSAIDs or the pain medications duloxetine, which is marketed as Cymbalta, or tramadol, which is marketed as Ultram.

Opioids should only be considered as last resorts, and only prescribed after doctors discuss their risks and benefits with patients.

“If you’re going to have to use opioids, use them in the smallest dose possible with the least frequency and smallest prescription,” said Damle.

The new recommendations are very reasonable, said Dr. Joel Press, who is physiatrist-in-chief at the Hospital for Special Surgery in New York City.

“Anything you can do with these non-pharmaceuticals that can get you moving faster is going to get you better in the end,” said Press, who was not involved in crafting the new guidelines.

“I hope this reinforces to physicians and patients that a lot of these non-pharmaceutical treatments can have a lot of success,” he told Reuters Health.

15 Arrested in Unlicensed Contractor Sting

The Yolo County District Attorney’s Office Workers’ Compensation Fraud Unit recently coordinated a joint unlicensed contractor sting operation in Woodland, California with the Contractors State License Board, the Sutter County District Attorney’s Office, and the Woodland Police Department.

The goal was to hold unlicensed contractors accountable for violations of contractor’s law and workers’ compensation fraud. The team was specifically looking for individuals who were posting false advertisements as well as those who were providing a contractor’s bid without being properly licensed.

During the two-day operation there were a total of 15 arrests made for violations including contracting without a license, posting false advertisements, and not having workers’ compensation insurance. Those arrested were processed and provided information on how to become a licensed contractor.

According to California law all individuals performing work regulated by the Contractor’s State License Board at $500 or greater must have a valid contractor’s license. If they have any employees working for them they must provide their employees with proper workers’ compensation insurance as well.

Homeowners can be held liable for any medical treatment stemming from injuries sustained by the employee of an unlicensed contractor if the injury occurred while working on the homeowner’s property.

District Attorney Jeff Reisig emphasized the incredible liability homeowners face when hiring uninsured employers or unlicensed contractors, saying “If the employee was injured or killed while working on the homeowner’s property, the homeowner could be personally liable for all of the medical bills. Most homeowner’s insurance policies will not cover these types of injuries, resulting in the homeowner owing hundreds of thousands of dollars and potentially losing their home and life savings to pay for these bills. It is critical that homeowners ensure the contractors they hire are licensed by the Contractor’s State License Board and have proper workers’ compensation insurance for their employees. We are committed to combating this type of fraud in our community.”

Kaiser Permanente Pharmacy Fined for CSA Violations

U.S. Attorney Phillip A. Talbert announced that Kaiser Foundation Health System Inc. has paid $850,000 to settle allegations that a Kaiser Permanente pharmacy at 3800 Dale Road in Modesto violated the Controlled Substances Act (CSA) by improperly filling defective prescriptions and by failing to maintain accurate records.

An investigation into a theft of controlled substances at the pharmacy in December 2013 resulted in prosecution of a Kaiser employee on a grand theft charge. It also led to closer scrutiny of the pharmacy by investigators with the Drug Enforcement Administration diversion control unit in Fresno.

The settlement resolves allegations that a large percentage of prescriptions that the pharmacy filled were incomplete, lacking the patient and dosage information required by the CSA’s implementing regulations.

Additionally, the settlement resolves allegations that the pharmacy failed to maintain accurate documentation of incoming and outgoing controlled substances. The investigation identified discrepancies in comparing the pharmacy’s purchase and dispensing records with the actual controlled substances on hand at the pharmacy.

“One purpose of the CSA is to ensure that pharmacies maintain accurate records to minimize the chance of diversion of powerful and potentially addictive drugs, which wreak havoc on our communities and destroy lives,” U.S. Attorney Talbert said. “Large pharmacy chains and health care conglomerates like Kaiser dispense a high volume of controlled substances to customers and members. Strict compliance with the CSA’s recordkeeping provisions by these entities is imperative.”

“Health care providers and pharmacies that don’t fully comply with the CSA give the public the short end of the stick. DEA will hold entities dispensing controlled substances accountable for their actions to protect public health and safety,” stated DEA Special Agent in Charge John J. Martin.

There was no evidence the violations caused harm to patients. Kaiser cooperated with the investigation and has agreed to implement protocols to minimize the chance of future violations.

In a statement Kaiser Permanente said tracking and management of controlled substances is taken seriously at its pharmacies. “Since bringing this matter to the attention of the Department of Justice, we have reviewed the Modesto pharmacy’s documentation and record-keeping of controlled substances, and have taken a number of steps, including instituting additional security controls.”

This case was the product of an investigation by the Fresno DEA Diversion Group. Assistant U.S. Attorney Vincente A. Tennerelli represented the United States in this matter.

Officials Note Increase in Pharmacy Burglaries

The Ventura County Star reports that in 2015, law enforcement agencies had six pharmacy burglaries in Ventura County. The following year, these burglaries numbered 64, resulting in an average of more than five burglaries per month and leaving law enforcement officials scrambling for answers. Capt. Garo Kuredjian, of the Ventura County Sheriff’s Office, described the 58-burglary increase as a “statistically significant ” change in criminal behavior.

Detective Chip Buttell, of the Oxnard Police Department’s property crimes unit, said most of the burglaries had specific targets, such as opioid-based narcotics, with little variation. The burglars generally have not tried to take everything of value, such as computers or patient information, from a location, officials said.

“It was obvious the criminals were seeking high-priced drugs such as oxycodone,” said Mary Jarvis, a public affairs representative for Kaiser Permanente, whose Oxnard pharmacy was burglarized twice in 2016.

Thieves can potentially make hundreds of dollars from the illicit sale of such opioid drugs on the black market. “Typically, the opioid-based drugs are selling for about 50 cents per milligram,” Kuredjian said. “So it’s $7 to $18 for a 15-milligram pill and $15 to $36 for a 30-milligram pill.”

Indications of the spike began showing up early last year when the Ventura County Sheriff’s Office alerted the public to a string of burglaries in Thousand Oaks and Camarillo. Between January and March, six pharmacies had been burglarized, with the thieves forcing entry into small, independent pharmacies during non-operating hours. They primarily took opioid-based medications, then fled. As the year drew on, the county’s cities – large and small – were plagued by pharmacy break-ins.

In total for 2016, Ventura saw 14 break-ins and Camarillo had 12, while both Oxnard and Thousand Oaks finished the year with 10. Santa Paula reported five and Simi Valley had six pharmacy burglaries. Newbury Park saw two.

Law enforcement officials stressed that the problem is not confined to Ventura County. Regions such as Santa Barbara County, which was unaffected in 2015, reported multiple instances last year, according to the Santa Barbara County Sheriff’s Office. Five pharmacy burglaries were reported in 2016, four in Santa Barbara and one in Montecito.

While law enforcement officials have noted the likely financial motive for the burglaries, there are challenges in alleviating the issue. Authorities are unsure precisely why Ventura County and other parts of Southern California have seen a sudden surge in incidents.

Most of the burglaries have occurred at smaller, independent pharmacies, not chain stores such as CVS or Rite Aid where traffic is higher and security is more prevalent.  A Kaiser Permanente representative confirmed that measures had been taken at its Oxnard location to avoid further incidents, although specifics were not shared.

The decreased supply of legitimate drugs has increased the demand from illicit sources, according to authorities. Burglars are only too happy to fill the void left behind by a decline in prescriptions.

FS&K Announces 7th Annual Employment Law Conference

Floyd, Skeren & Kelly’s “Annual Employment Law Conference” now enters its 7th year. This year the firm has another stellar group of employment law and workers’ compensation experts to present a comprehensive learning experience for employers, human resource administrators, risk managers and claims adjusters on important topics impacting the workplace.

Kevin Kish, Director of the Department of Fair Employment and Housing (DFEH) will be the keynote speaker during an important year for employers as we transition to a new President and federal administration, along with the inevitable changes in employment law and regulations that will follow.

Tina Walker, Regional Administrator for the DFEH will be joining Mr. Kish to provide her valuable input on the topics covered.

Mark ‘RX Professor’ Pew from PRIUM, will cover recent developments impacting employer policies on marijuana in the workplace and to address the many questions that have arisen since the passage of Proposition 64.

This years conference sessions will include:

1) Expanded Employee Protections: Key Developments on Conducting Lawful Background Checks, Transgender Protections, and Discrimination, Harassment and Retaliation Policies
2) New Laws Impacting Work Place Drug Testing- The Good, the Bad and the Unknown
3) HR Compliance is Complicated – 2017 Update Includes New Legislation, Cases and Key Trends Impacting the Workplace
4) Reducing the Risk of Costly Disability Discrimination Claims – Recommendations for Employer Best Practices (Legislative and Case Law Update Included)
5) Workers’ Compensation Case Law Update
6) Employer’s Fraud Task Force Update
7) Post Brinker-Costly Class Actions For Meal And Rest Period Violations Continue- Key Strategies For Avoiding Liability
8) Is My Employee Drunk, Sick or Simply Sleeping- Training Managers on ‘Reasonable Suspicion’ Based Drug Testing
9) Defending Good Faith Personnel Actions and Post-Termination Workers’ Compensation Claims
10) 2017 Hot Topics in Workers’ Compensation

Please see our Complete Agenda for more details.

The Conference is set for April 28, 2017 from 8:00 am to 5:00 pm at the Disneyland Hotel, 1150 Magic Way in Anaheim. Our conference is in the approval process for MCLE, CE, SPHR, HRCI and Credits for ARPM, CPDM and CCMP.

Employers Must Post Annual Injury and Illness Summaries

Cal/OSHA is reminding employers in California with more than 10 employees to post their 2016 annual summaries of work-related injuries and illnesses. These employers must post the annual summary no later than February 1 of the year following the year covered by the records and keep the posting in place until April 30.

“This important posting requirement increases awareness of health and safety hazards in the workplace and helps employers and employees understand how to reduce risks,” said Cal/OSHA Chief Juliann Sum.

Employers’ requirements to record occupational fatalities, injuries, and illnesses are in the California Code of Regulations, Title 8, Sections 14300 through 14300.48. Section 14300.32 describes the annual posting requirement. Section 14300.2 lists exempted industries.

To satisfy this requirements, at the end of each calendar year, employers must:

(1) Review the Cal/OSHA Form 300 to verify that the entries are complete and accurate, and correct any deficiencies identified;
(2) Create an annual summary of injuries and illnesses recorded on the Cal/OSHA Form 300 using the Cal/OSHA Form 300A Annual Summary of Work-related Injuries and Illnesses;
(3) Certify the annual summary; and
(4) Post the annual summary.

The employer must review the entries as extensively as necessary to make sure that they are complete and correct. A company executive (as defined) must certify that he or she has examined the Cal/OSHA Form 300 and that he or she reasonably believes, based on his or her knowledge of the process by which the information was recorded, that the annual summary is correct and complete.

The employer must then post a copy of the annual summary in each establishment in a conspicuous place or places where notices to employees are customarily posted. The employer must ensure that the posted annual summary is not altered, defaced or covered by other material.

Instructions and form templates can be downloaded for free on Cal/OSHA’s Record Keeping Overview. The overview includes the summary template, Form 300A, which is the required workplace posting that must be placed in a visible, easily accessible location at each worksite. Current and former employees, including employee representatives, have the right to review the summary in its entirety.

Senators Probe Overdose Antidote 550% Price Surge

First came Martin Shkreli, the brash young pharmaceutical entrepreneur who raised the price for an AIDS treatment by 5,000 percent. Then, Heather Bresch, the CEO of Mylan, who oversaw the price hike for its signature Epi-Pen to more than $600 for a twin-pack, though its active ingredient costs pennies by comparison.

Now a small Virginia company called Kaleo is joining their ranks. It makes an injector device that is suddenly in demand because of the nation’s epidemic use of opioids, a class of drugs that includes heavy painkillers and heroin.

Called Evzio, it is used to deliver naloxone, a life-saving antidote to overdoses of opioids. And as demand for Kaleo’s product has grown, the privately held firm has raised its twin-pack price to $4,500, from $690 in 2014. Founded by twin brothers Eric and Evan Edwards, 36, the company first sought to develop an Epi-Pen competitor, thanks to their own food allergies. Now, they’ve taken that model and marketed it for a major public health crisis. It’s another auto-injector that delivers an inexpensive medicine.

And the cost of generic, injectable naloxone – which has been on the market since 1971 – has been climbing. A 10-mililiter vial sold by one of the dominant vendors costs close to $150, more than double its price from even a few years ago, and far beyond the production costs of the naloxone chemical, researchers say. The other common injectable, which comes in a smaller but more potent dose, costs closer to $40, still about double its 2009 cost.

U.S. Senator Claire McCaskill on Thursday asked Kaleo Pharmaceuticals to justify the more than 550 percent surge in the price of its device to treat painkiller overdoses, becoming the second senator to question Evzio’s $4,500 price tag.  Senator Amy Klobuchar sent Kaleo a letter earlier this month, voicing similar concerns.

Evzio contains the overdose-reversing drug naloxone and can be used in emergencies by people without medical training. Privately held Kaleo has raised the price of a twin-pack to $4,500, from $690 in 2014, according to a Kaiser Health News report.

The concerns over Evzio’s price comes at a time when pharmaceutical companies are facing intense scrutiny over “price-gouging”, and as lawmakers struggle with the epidemic of opioid abuse.

“At a time when Congress has worked to expand access to naloxone products and to assist state and local communities to equip first responders with this life-saving drug, this startling price hike is very concerning,” McCaskill said in a letter to Kaleo Chief Executive Spencer Williamson. The letter, which was signed by 30 U.S. senators, asked Kaleo for information on Evzio’s price structure and why the company chose to adjust prices.

“We received the letter from the Senators and are in communication with them to ensure all questions are addressed,” Williamson told Reuters in an e-mailed statement.

“There’s absolutely nothing that warrants them charging what they’re charging,” said Leo Beletsky, an associate professor of law and health sciences at Northeastern University in Boston.

Opioid Drugmaker Lobbying Ramps Up

A leading drugmaker ramped up its lobbying in Canada fivefold last year, urging government officials to enact a rule that would give it an effective monopoly on long-acting narcotic painkillers.

Purdue Pharma’s efforts came as the government pledged a new attack on the county’s deadly opioid crisis. The privately owned maker of the blockbuster OxyContin pushed for a requirement that all long-acting narcotic painkillers, known as opioids, be made tamper resistant. The company, which sells the only tamper-resistant, long-acting opioids in Canada, met with 40 officeholders last year, up from eight in 2015 and three in 2014, records show.

The rule it proposed could edge out companies that don’t sell tamper-resistant opioids, including Novartis’, Sandoz AG , Johnson & Johnson’s Janssen, Teva, Pharmascience and Apotex SA <Apotex SA> and others.

Health Canada issued a statement last April saying it had no plans to require tamper resistance. Purdue sent lobbyists on four occasions to Health Canada officials last year, including a May meeting seeking an explanation for the government’s stance, department spokesperson Anna Maddison said in an email.

Conservative Member of Parliament Kevin Sorenson revived the idea in September with a bill to require all controlled substances be tamper resistant. Records show Sorenson met with Purdue representatives six days before he introduced the bill and spoke with them again two days before it went to second reading in November.

Purdue’s lobbying illustrates the stakes for drugmakers in efforts to curb what policymakers have called North America’s biggest public health crisis.  Canada’s $881-million annual opioid sales are dwarfed by the U.S. market, the biggest in the world. Any action by Canada is likely to attract interest south of the border.

Purdue said it was pushing for the rule to improve safety. Canadian officials have passed on that proposal and instead are looking at measures that could hurt sales of long-acting opioids, including Purdue’s best-selling painkillers.

Long-acting opioids contain high doses of narcotics designed to be released over time. If crushed pills are snorted or injected, they release their full dose all at once, which makes them dangerous and valuable among addicts.  In 2012, Purdue replaced OxyContin with tamper-resistant OxyNEO in Canada and now wants that standard mandated for all long-acting opioids.

Many experts and public health officials see the research differently. They said there’s little evidence tamper resistance reduces addiction or death and that it may even prompt doctors to more readily prescribe opioids. Research shows opioids are most often abused not by crushing but by swallowing pills whole, said David Juurlink, a drug-safety researcher at Toronto’s Sunnybrook Health Sciences Centre.  “It’s very easy to get the sense that this push in favor of tamper-resistant opioids is rooted more in financial considerations than in the public interest,” he said.

Generics manufacturers said they do not view tamper resistance as the answer. “We believe that efforts should be made to address the main root cause of opioid abuse and misuse, which appears to be over-prescribing,” Jeff Connell, Canadian Generic Pharmaceutical Association Vice-President, said in an email.

“There is no evidence that tamper-resistant formulations are effective in reducing the level of abuse of opioids,” a Sandoz spokesperson wrote in an email. Sandoz sells a long-acting, crushable oxycodone painkiller.

Judge Blocks Anthem – Cigna Merger

A federal judge has blocked the proposed $54 billion merger of two major health insurance companies, Anthem and Cigna, after the Justice Department concluded that the deal would reduce competition in the health insurance market and raise prices.

Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia made the ruling.

Anthem is determined to ensure Wednesday’s decision isn’t the final word on the issue. The company said in a statement Thursday that it “promptly intends to file a notice of appeal and request an expedited hearing.”

The Justice Department announced last summer that it would oppose both the Anthem-Cigna merger and one by Aetna and Humana, These are four of the major five insurers in the nation.

Both mergers have now been blocked in separate federal court cases citing adverse effects on competition and pricing.

Then-Attorney General Loretta Lynch said: “If allowed to proceed, these mergers would fundamentally reshape the health insurance industry. They would leave much of the multi-trillion dollar health insurance industry in the hands of three mammoth insurance companies, drastically constricting competition in a number of key markets that tens of millions of Americans rely on to receive health care. … If these mergers were to take place, the competition among these insurers that has pushed them to provide lower premiums, higher quality care and better benefits would be eliminated.”

The California Insurance Commissioner said “Today’s federal court decision to block the merger of two of the nation’s largest health insurers is a significant win for consumers who need more choice, not less, in an already highly concentrated health insurance market. Bigger was definitely not better when it comes to the Anthem-Cigna merger.”

“Last year I held an extensive public hearing on the proposed merger. After reviewing all the evidence, I concluded the Anthem-Cigna merger was bad for consumers and businesses, and bad for health insurance and health care markets. I issued detailed findings of fact and law and urged the U.S. Department of Justice to sue to block this merger because it is anti-competitive and would harm California consumers, businesses, and the California health insurance market.”

The commissioner concluded that “Allowing a merger between two of the largest health insurers in the country would have increased the price of health insurance, and decreased choice and the quality of healthcare for consumers and businesses. I am very pleased the federal district court entered a decision consistent with my findings and legal conclusions that the Anthem-Cigna merger is anti-competitive.”

Sacramento Chiropractor Arraigned in Fraud Case

A California chiropractor was arraigned in Sacramento Superior Court on eight felony counts of insurance fraud for his alleged role in a fraud scheme billing health and auto insurers for treatment services never provided.

The chiropractor is William Guenther, 69, of Granite Bay and former owner of Fort Sutter Chiropractic. Former in-house biller Pam Rivas, 58, of Cameron Park, and office managers Cristen Jones-Hassanali, 37, of Sacramento and Stacey Fellows, 37, also of Sacramento, face seven counts of felony insurance charges.

An investigation by department of insurance detectives revealed Guenther and his staff billed several insurers for mechanical traction treatments for 50 to 70 patients per day between 2012 and 2015, when no mechanical traction units were in the office.

Insurers reportedly paid $150,325 to Fort Sutter Chiropractic in fraudulent claims.

Guenther was released on $150,000 bail. Rivas, Jones-Hassanali, and Fellows were scheduled to appear in court at a later date.

This case is being prosecuted by the Sacramento County District Attorney’s Office.

Fort Sutter Chiropractic is under new ownership and Guenther is no longer affiliated with the practice.