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Category: Daily News

FDA Strengthens NSAID Label Warning

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An aggravation of a medical condition as a result of treatment for an industrial injury can become a compensable consequence claim. Industrial injuries resulting in pain and inflammation are commonly treated with NSAID pain medications. But now the U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke.

“Based on our comprehensive review of new safety information, we are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. We will also request updates to the OTC non-aspirin NSAID Drug Facts labels.”

NSAIDs are widely used to treat pain and inflammation. NSAIDs are available by prescription and OTC. Examples of commonly used over-the-counter NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve); celecoxib (Celebrex), diclofenac (Cataflam, Voltaren) are prescription NSAIDs. Aspirin is also an NSAID, but it does not pose a risk of heart attack or stroke and is not covered by this new warning.

The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, the FDA has reviewed a variety of new safety information on prescription and OTC NSAIDs. However, the FDA was not able to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID

The risk of heart attack and stroke achieved special notoriety with rofecoxib (Vioxx), a type of NSAID called a COX-2 inhibitor. It caused as many as 140,000 heart attacks in the U.S. during the five years it was on the market (Vioxx was removed from the market in 2004). The regrettable experience with Vioxx raised awareness about the cardiovascular risk of NSAIDs, and led to further studies showing that the risk is not limited to Vioxx but is associated with all NSAIDs.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied. There is also an increased risk of heart failure with NSAID use.

This new FDA warding joins a list of two of the more common potential risks and complications of NSAIDs. Kidney damage and stomach problems. Most types of NSAIDs have a variety of other potential risks and complications associated with them. While most side effects are rare, some can be serious and even potentially fatal, so it is important for patients to remain aware of them and under supervision by a health professional.

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Feds Want More Pills – Faster

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The U.S. House of Representatives on Friday passed a sweeping bill to speed new drugs to the market after lawmakers defeated last-minute amendments that threatened to derail it. According to the report in Reuters Health, the House voted 344 to 77 in favor of the 21st Century Cures Act, which would require the FDA to streamline its drug approval process, consider more flexible forms of clinical trials and incorporate patient experience into its decision-making process.

The bill was developed by the House Energy and Commerce Committee and spearheaded by Republican Fred Upton and Democrat Diana DeGette. A similar bill in the Senate is expected to be voted on before the end of the year. The program would be paid for with the sale of 80 million barrels of crude oil from the Strategic Petroleum Reserve (SPR) over eight years.

“The strong bipartisan support for the Cures Act in the House, together with broad support from the Obama Administration, are strong indications that the Senate will approve the Cures Act with small changes,” said Ross Muken, an analyst at Evercore ISI, in a research note.

One challenge may come from Republican Senator Lisa Murkowski, head of the Senate Energy Committee, who has said she opposes the use of SPR sales to fund anything other than national energy security.

The House bill would increase funding to the National Institutes of Health by nearly $8.75 billion over five years and increase funding to the Food and Drug Administration by $550 million over the same period.

The bill would overhaul the FDA’s regulatory framework for approving drugs. It would create incentives for companies to develop drugs for rare diseases. It would allow certain antibiotics to be approved based more limited testing and establish other measures to shorten the drug development time.

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DWC Proposes Changes to WCIS Regs

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The Division of Workers’ Compensation has posted on its rulemaking forum proposed revisions to the Workers’ Compensation Information System (WCIS) Regulations and the two California EDI (electronic data exchange) Implementation Guides published by DWC. The guides are the EDI Implementation Guide for First and Subsequent Reports of Injury (FROI/SROI) and the EDI Implementation Guide for Medical Bill Payment Records, Version 2.0.

Electronic Data Interchange (EDI) is the computer-to-computer exchange of data or information in a standardized format. In workers’ compensation, EDI refers to the electronic transmission of claims information from claims administrators (insurers, self-insured employers, and third party administrators) to a State Workers’ Compensation Agency.

Data are transmitted in a format standardized by the International Association of Industrial Accident Boards and Commissions (IAIABC). The IAIABC is a professional association of workers’ compensation specialists from the public and private sectors and has spearheaded the introduction of EDI in workers’ compensation. All collected data elements are reviewed for valid and standardized business definitions and formats.

The FROI/SROI Guide has not been updated since 2010 and is being revised to improve reporting efficiencies in response to feedback from trading partners and to increase the usefulness of the FROI/SROI data received by WCIS.

The EDI Implementation Guide for Medical Bill Payment Records, Version 2.0, was updated earlier this year but requires additional revisions to comply with reporting standards set forth in the IAIABC Workers’ Compensation Medical Bill Reporting Implementation Guide, Release 2.0, February 1, 2015 Publication. Compliance with this newer standard is essential to enable WCIS to collect data regarding compound and repackaged drugs. The proposed regulations and the draft revised Guides will be available on the DWC Forum for public comment until July 20, 2015.

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Pot Dispensary Owner Arrested for Comp Fraud

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A contingent of local and state law enforcement raided a San Jose marijuana dispensary last Thursday and arrested its owner and manager, based on allegations of illegal marijuana sales and workers’ compensation fraud, authorities said.

According to the report in the San Jose Mercury News, police and investigators from the Santa Clara County District Attorney’s Office led the operation at San Jose Organics, on Tully Road east of Monterey Road, aided by agents from the state Board of Equalization and the Employment Development Department.

Deputy District Attorney Edward Liang said the search of the club stemmed from an investigation into illicit marijuana trafficking and possible tax and workers’ compensation fraud. He declined to provide additional details about the scope of, or what spurred the probe, only that it involved violations including operating in an unlawful location and outside of prescribed regulations.

Authorities arrested on site the business’s manager, Brian Wong, a San Francisco resident. The owner, Ben Lew, was arrested in San Francisco. Both were booked on suspicion of possessing marijuana for sale, selling marijuana and maintaining a place to unlawfully sell marijuana, Liang said.

Agents carried boxes of evidence out of the storefront shop. Liang said the investigation continues, and that additional charges could be considered.

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Minnesota Approves Marijuana for Use in Workers’ Comp Claims

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Medical marijuana poses challenges for the workers compensation industry, but some experts and recent research say it could be an alterative to long-term opioid use. There’s a growing consensus among workers comp payers and doctors that any treatment that could reduce opioid dependency is something to look into, or something to keep an eye on.

Business Insurance reports that the Minnesota Department of Labor and Industry adopted a rule establishing criteria for long-term opioid treatment that also said medical marijuana is not an “illegal substance” for injured workers under state law. It remains illegal under federal law, however.

The U.S. Food and Drug Administration has not approved marijuana for any medical condition, so it’s difficult to compare its effects with other drugs used in workers comp, such as opioids, said Dr. Damon Raskin, a Pacific Palisades, California, internist who specializes in treating addiction and substance abuse. However, “the risk of death and other severe addiction issues with opiates make looking at (medical marijuana) more palatable,” he said. “Until I see good scientific evidence that this is something that works (for pain), it’s going to be hard to endorse,” Dr. Raskin said. “But if there’s a choice between opiates vs. medical marijuana, I will still pick medical marijuana if that helps the patient’s pain – If we can do anything except for opiates for pain, that’s ideal.”

But in a report published in a June issue of the Journal of the American Medical Association, Dr. Amy E. Thompson says “so far, evidence suggests that marijuana may be an effective treatment for chronic pain, neuropathic (nerve) pain and muscle spasms due to multiple sclerosis or paraplegia.”

In New Mexico, the state Court of Appeals has ruled three times since last year that medical marijuana is “reasonable and necessary” for injured workers and that it should be covered under workers comp. In each New Mexico case, physicians supported the use of medical marijuana when opioids and other medications failed to relieve injured workers’ chronic pain. In the most recent case, Sandra Lewis v. American General Media and Gallagher Bassett, Ms. Lewis’ health care provider opined that the “benefits of medical marijuana outweigh the risk of hyper doses of narcotic medications.”

Though medical marijuana is now considered a legal substance in Minnesota for workers comp, it won’t “be reasonable and necessary in all circumstances that it’s recommended,” Mr. Atchison said. “It provides a little guidance as to whether or not it’s still an illegal substance for the purpose of the law, but it doesn’t change the analysis that payers, insurers and employers have to go through when determining if treatment is compensable.”

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Work Comp Doctors Arrested by Feds for Fraud

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Following arrests made earlier today, a federal indictment was unsealed charging three southern California defendants with conspiracy to commit health care fraud and 15 counts of health care fraud.

Chiropractor Bahar Gharib-Danesh, 38, of Woodland Hills, was arrested in Los Angeles; Chiropractor Na Young Eoh, 41, of Bakersfield, was arrested in Bakersfield; and clinical psychologist John Terrence, 72, of Marina Del Rey, is expected to voluntarily appear before the U.S. District Court in Fresno within the next 30 days.

According to the indictment returned on July 2, 2015, Gharib-Danesh was a chiropractor and the manager of Pain Relief Health Centers (PRHC). PRHC was headquartered in Los Angeles, and had clinics in Bakersfield, Visalia and Fresno, as well as in Los Angeles County. Eoh was also a chiropractor, and was the treating physician for PRHC’s Kern County workers’ compensation claims. Terrence was a clinical psychologist who saw patients from the Bakersfield clinic.

According to the indictment, PRHC recruited patients who were workers claiming to have an injury. In treating the patients, Gharib instructed her staff to add as many injured body parts for treatment as possible to generate higher billings. The treatment plan generally included shock wave therapy, electro stimulation therapy, myo-facial release/massage, physical therapy, chiropractic manipulation, compound creams, and psychological evaluation. Nearly every patient was scheduled for the same treatments, and the maximum amount of treatments allowed by law was generally billed to the insurance company. Eoh operated out of the Bakersfield Clinic, the Visalia Clinic, and the Fresno Clinic and would sign the treatment plans and referral forms.

If the claim of injury was denied by the insurance company, a lien would be filed, and the claims would either be litigated before the California Workers’ Compensation Appeals Board or be settled by negotiations through the parties. Lien settlements for less than the full amount of the claim were acceptable because of the high volume of patients recruited and by the large amount of medical fees generated.

The indictment further alleges that Gharib directed Eoh to refer all patients who came into the clinic to Terrence for a psychological evaluation, regardless of the injury the patient reported. Terrence submitted bills and reports for each patient that were virtually identical. He also allegedly fraudulently billed for patients at a rate higher than legally allowed. According to the indictment, Terrence provided each patient with approximately 20.8 hours of psychological evaluations in a single day. On one day, Terrence billed a total of 291.2 hours for treating 14 patients. In one period of two weeks, Terrence billed over a thousand hours treating patients and writing reports. Between 2005 and 2012, Terrence submitted claims for psychological services in workers’ compensation cases totaling in excess of $5.6 million.

If convicted, each defendant faces a maximum statutory penalty of 20 years in prison and a $250,000 fine on each count of the indictment.

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DWC Posts 2014 Annual WCJ Ethics Report

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The Division of Workers’ Compensation has posted the 2014 ethics advisory committee’s (EAC) annual report on its website. The committee is a state committee independent of the Division of Workers’ Compensation. The EAC is charged with reviewing and monitoring complaints of misconduct filed against workers’ compensation administrative law judges (WCALJs, or judges). The committee is required to make a public report each year summarizing activities in the previous calendar year. The 2014 annual report may be viewed or downloaded at the DWC website.

As civil servants, the WCALJs are not subject to review by the California Commission on Judicial Performance, the agency which is responsible for investigating misconduct complaints directed at judges serving on the Supreme, Superior and Appellate courts. The EAC’s authority and duties are set forth in the California Code of Regulations, title 8, sections 9722 through 9723.

Any person may file a complaint with the EAC. Complaints must be presented in writing and the EAC will accept anonymous complaints. The EAC considered a total of 39 of the 45 new complaints it received in the calendar year of 2014, in addition to 3 complaints pending from 2013. The complaints set forth a wide variety of grievances. A substantial portion of the complaints alleged legal error not involving judicial misconduct or expressed dissatisfaction with a judge’s decision.

An illustrative case is item eleven in the report which pertains to a defense attorneys complaint about a WCJ who “alleged that the judge harassed the parties and exceeded the scope of the judge’s authority.” In this case the judge refused to approve a Compromise and Release with the represented applicant. The “harassment” allegedly occurred when “the judge wrote to the parties a total of five letters regarding the status of the case. The parties were not on calendar, however, the judge continued to write. Complainant complained that on the judge’s own motion, the judge set a status conference for March of 2014 as parties did not respond to the judge’s letters.”

Following its review of the investigation, the Committee recommended further action. The report does not specify what that action was.

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CWCI Says No Reduction in IMR Volume

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A new analysis of 2015 independent medical review (IMR) outcomes shows there was no significant reduction in IMR volume in the first quarter of this year, even though the independent medical reviewers continue to concur with the utilization review (UR) physician’s denial or modification of treatment in about 90 percent of the cases.

The CWCI analysis compares data from 33,909 IMR determination letters issued in the first three months of this year in response to applications submitted to the state after a utilization review (UR) physician modified or denied a requested medical service to similar data from the 137,781 IMR decisions issued in 2014.

State legislators who enacted IMR expected the volume of requests would decline following an initial learning curve as doctors, attorneys and others involved in the process became familiar with the types of treatment that would meet the evidence-based medicine standards and be approved through UR and IMR, but the new data indicate that after more than 2 years, IMR volume has yet to subside.

A review of the IMR decisions issued in the first quarter shows that after reviewing the patient’s records and any additional information provided in support of the request, the IMR physicians upheld the UR doctor’s modification or denial of the service 89 percent of the time, nearly matching the 91 percent uphold rate from 2014.

The mix of services submitted for IMR also showed little change, as prescription drugs again topped the list, accounting for 48 percent of the first quarter IMR decisions (vs. 45 percent in 2014), with the UR denial or modification upheld in 92 percent of those cases. Requests for prescription drugs, physical therapy, durable medical equipment, injections and diagnostic tests and measurements together accounted for ¾ of all services submitted for IMR in the first quarter, though requests for surgery, which accounted for 4.4 percent of the IMR cases (vs. 4.7 percent in 2014) surpassed diagnostic tests and measurements as the fifth most common type of service submitted for IMR, even though the uphold rate for modifications or denials of surgical requests held steady at 89 percent.

The first quarter IMR results also show that a relatively small number of physicians continue to account for the majority of the disputed medical services, as the top 10 percent of physicians named in IMR decision letters (516 providers) accounted for 70 percent of the IMR requests, though that was down from 83 percent last year, while the top 1 percent of physicians (52 providers) accounted for 28 percent of the disputed service requests in the first quarter, down from 44 percent last year.

In addition, the study documents continued geographic variation, with 38 percent of the first quarter IMR decision letters addressed to Los Angeles County recipients – 1.5 times the proportion of claims that come from that region, whereas in all other regions of the state the percentage of IMR decisions was either in line with or disproportionately low relative to the percentage of claims from the region.

CWCI has published more details on the first quarter IMR outcomes in a Spotlight Report, “California Workers’ Compensation Independent Medical Review: 1st Quarter 2015 Outcomes,” which CWCI members and subscribers can access in the research section of the Institute’s website.

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CDC Says Heroin Deaths Quadrupled – 96% Abuse Prescription Drugs

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Heroin overdose deaths in the United States nearly quadrupled between 2002 and 2013, fueled by lower costs as well as increased abuse of prescription opiate painkillers, U.S. health officials said on Tuesday. The report found that heroin use increased by 63 percent from 2002 to 2013. In 2013, roughly 517,000 people reported that they had used heroin in the last year, a 150 percent increase from 2007. As many as 8,200 people died from heroin overdoses in 2013 alone.

Such medicines, which include Vicodin, OxyContin and Percocet, increase individuals’ susceptibility to heroin addiction, Dr. Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention, told Reuters.

“Everything we see points to more accessible, less-expensive heroin all over the country,” Frieden said of the joint report by the CDC and the U.S. Food and Drug Administration which analyzed national survey data on drug use from 2002 to 2013.

The report found that nearly all people (96 percent) who use heroin also use multiple other substances, and that the strongest risk factor for heroin abuse is prescription opiate abuse. In recent years people in nearly every demographic group are using the drug more: For example, heroin use has doubled among women.

According to the report, individuals who abuse prescription opiates have a 40 times greater risk of abusing heroin. The increased use has fueled sharp increases in overdose deaths.

Frieden said reversing the trend will require an “all-society response” to improve opioid prescribing practices and expand access to effective treatment, increasing the use of drugs such as naloxone to reverse drug overdoses and working with law enforcement partners such as the Drug Enforcement Administration to disrupt the supply of heroin.

He said doctors are prescribing “way too much of these medications, and the result of it is large numbers of people who are addicted.”

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So Much for Evidence Based Medicine – Drug Makers Fake the Evidence

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You don’t have to look very far to get head-bangingly upset about the current state of medical and scientific research. Pfizer (maybe) hid evidence that Zoloft use by pregnant women caused heart defects in babies. GlaxoSmithKlein paid $3 billion in fines for a) generating a fake journal article saying Paxil was safe for kids b) paying doctors lavish speaker fees and using sham advisory boards to promote Wellbutrin for off-label use and c) failing to report that Avandia, a diabetes drug, could potentially cause heart problems. Merck, for its part, is currently being accused of lying about the efficacy of its mumps vaccine in order to maintain its market monopoly on the drug.

And you can’t necessarily just go straight to the source and trust an article in a “peer reviewed” journal either. Who can you trust? Well, the truth is out there. Here’s where to start.

Part of the delight of the public interest website Retraction Watch is that it exposes the many weird things that scientists study. Outer space dentistry? Check. Rabbit hepatitis? Check. The nutritional value of mushrooms? Yep. So that’s pretty fun, but then the less fun part is why are those guys lying about this stuff?.

It is generally believed that retractions help maintain the purity of science, help with the integrity of individual scientific journals and the whole of the scientific literature, and, when properly enforced, help keep scientists from bending the rules regarding scientific misconduct and publication. Yet several articles have appeared in the library literature concerning the fate of retracted articles. When researchers in one study tracked the fate of retracted, invalid articles they found that, after retraction, completely retracted articles were cited a total of 733 times.

Research misconduct became a public issue in the United States in 1981 when then Representative Albert Gore, Jr., chairman of the Investigations and Oversight Subcommittee of the House Science and Technology Committee, held the first hearing on the emerging problem. The hearing was prompted by the public disclosure of research misconduct cases at four major research centers in 1980. Some twelve cases of research misconduct were disclosed in this country between 1974-1981. Congressional attention to research misconduct was maintained throughout the 1980s by additional allegations of research misconduct and reports that the National Institutes of Health (NIH), universities, and other research institutions were inadequately responding to those allegations.

Congress took action in 1985 by passing the Health Research Extension Act. The Act, in part, added Section 493 to the Public Health Service (PHS) Act. Section 493 required the Secretary of Health and Human Services to issue a regulation requiring applicant or awardee institutions to establish “an administrative process to review reports of scientific fraud” and “report to the Secretary any investigation of alleged scientific fraud which appears substantial.”

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