Author: WorkCompAcademy

Reuters reports that U.S. FDA rules that ensure prescription medicines are not misused have been manipulated by brand-name drug companies to fight off generic competitors, costing consumers billions of dollars, according to a report recently released.

Called “risk evaluation and mitigation strategies” (REMS), these U.S. Food and Drug Administration rules are meant to secure the safe distribution of dangerous medicines. However, the report from the Generic Pharmaceutical Association said REMS have been used to prevent generic drugmakers from getting branded medicine to test their own versions, which is required to win FDA approval. This has delayed the arrival of 40 potential generic drugs, costing consumers some $5.4 billion a year, according to the report by Matrix Global Advisors and released by the generic drug trade group.

Senator Richard Blumenthal, a Democrat from Connecticut, said the issue was worrisome. “This study raises serious concerns about whether safety protocols are being inappropriately used to inhibit access to cheaper alternatives,” he said in an emailed statement. “The potential savings that this study suggests must be considered as we in Congress continue to work to slow health care spending.”

The U.S. Federal Trade Commission, which works with the Justice Department to enforce antitrust law, has also voiced concern. In a 2013 amicus brief filed in a case brought by Actelion Ltd against companies that wanted access to its Tracleer and Zavesca drugs, the FTC said it had investigated allegations of abuse, but had not filed any complaints. Tracleer is a treatment for hypertension and Zavesca treats Gaucher disease, a rare metabolic disorder.

Generic Pharmaceutical Association members include Impax Laboratories Inc, Perrigo Co Plc, Ranbaxy Laboratories Ltd, Sandoz Inc; Teva Americas, a unit of Teva Pharmaceutical Industries Ltd and Apotex Corp, among others.

AB 1746 which was signed into law by Governor Brown this week, requires the Administrative Director of the Division of Workers Compensation (DWC) to include injured workers who are or were employed by an illegally uninsured employer on the priority conference calendar when the issues in dispute are employment or injury arising out of employment or in the course of employment. The bill amends Section 5502 of the Labor Code to add the language shown in bold below.

“The administrative director shall establish a priority conference calendar for cases in which the employee is represented by an attorney or is or was employed by an illegally uninsured employer and the issues in dispute are employment or injury arising out of employment or in the course of employment. The conference shall be conducted by a workers’ compensation administrative law judge within 30 days after the declaration of readiness to proceed. If the dispute cannot be resolved at the conference, a trial shall be set as expeditiously as possible, unless good cause is shown why discovery is not complete, in which case status conferences shall be held at regular intervals. The case shall be set for trial when discovery is complete, or when the workers’ compensation administrative law judge determines that the parties have had sufficient time in which to complete reasonable discovery. A determination as to the rights of the parties shall be made and filed within 30 days after the trial.”

The law passed the state Assembly in May and the Senate on July 3 with no opposition by any legislator. Prior to the vote, the supporters of the bill were AFSCME, AFL-CIO, Association of California Healthcare Districts, California Chamber of Commerce, California Coalition on Workers’ Compensation, California Labor Federation, AFL-CIO, California Professional Firefighters, Pacific Compensation Insurance Company, Rural County Representatives of California, Salud Para La Gente, The California Applicant Attorneys Association, Watsonville Law Center and Worksafe. There was no opposition voiced by any industry stakeholder group.

The argument in support of the law stated “that this bill is a necessary reform that will help some of the most vulnerable injured workers and assist California in its fight against the underground economy. Specifically, proponents argue that injured workers who work for illegally uninsured employers do not have the same access to medical care, as insurers are required by law to provide medical benefits in a timely manner with a significant pool of medical providers. As injured workers who work or worked for an illegally uninsured employer have none of these protections, this bill ensures that they receive an expedited hearing so that they can quickly receive the medical care they need. Additionally, proponents note that this bill allows for the rapid identification of illegally uninsured employers, giving California another important tool in the fight against the underground economy.”

Sierra Chemical Co. manufactures, packages, and distributes chemicals for treating water, including water in swimming pools. As the weather gets warmer in spring and summer, consumer demand for its products increases, while in fall and winter demand decreases, which in turn results in seasonal layoffs of many production line employees. Those laid-off workers generally are recalled to work when consumer demand rises.

In April 2003, Vicente Salas applied for a job with Sierra, providing a Social Security number and a resident alien card. He completed and signed, under penalty of perjury, federal Immigration and Naturalization form I-9, in which he listed the same Social Security number he had given to Sierra, and he attached to the form a copy of a Social Security card with that number. He also signed an employee’s Internal Revenue Service withholding form W-4, which had the same Social Security number he had given. In May 2003, Salas began working on Sierra’s production line.

In March 2006, Salas injured his back while stacking crates on Sierra’s production line. On August 16, 2006, he again injured his back while stacking crates and was taken to the hospital. Thereafter, he filed a workers’ compensation claim for his workplace back injury. He still came to work, performing modified duties, until December 15, 2006, when he was laid off during seasonal reduction of workers. In either late January or early February of 2007, Salas started working for another company. On May 1, Sierra sent Salas a letter stating that it was recalling laid-off employees and informing him to call or come to the office to make arrangements to return to work. The letter also told him to bring “a copy of your doctor’s release stating that you have been released to return to full duty.” Salas did not reported for work as he had not yet been released by his physician. But the employer indicated he would hold the job open until he was able to get a release.

In August 2007, Salas sued Sierra. The first cause of action alleged Sierra failed to provide reasonable accommodations for his disability, in violation of California’s FEHA. The second cause of action alleged a violation of the public policy expressed in the FEHA, by retaliating against him for filing a workers’ compensation claim and for being disabled.

Salas advised the court that he would testify at trial and assert his privilege against self-incrimination under the Fifth Amendment to the United States Constitution if asked about his immigration status. This information led the employer to investigate the authenticity of the employment documents that were given to Sierra which were discovered to be fraudulent. The employer moved for summary judgment based upon this information which was granted after appeal to the Court of Appeal. The Court of Appeal reasoned that the doctrine of after-acquired evidence barred Salas’ causes of action because he had misrepresented his eligibility under federal law to work in the United States. It also held that his claims were subject to the doctrine of unclean hands because he had falsely used another person’s Social Security number in seeking employment with defendant, he was disqualified under federal law from working in the United States, and his conduct exposed the employer to penalties under federal law.

The California Supreme Court reversed in the case of Salas v Sierra Chemical Company. It concluded that (1) Senate Bill No. 1818, which extends state law employee protections and remedies to all workers “regardless of immigration status,” is not preempted by federal immigration law except to the extent it authorizes an award of lost pay damages for any period after the employer’s discovery of an employee’s ineligibility to work in the United States; and (2) contrary to the Court of Appeal’s holdings, the doctrines of after-acquired evidence and unclean hands are not complete defenses to a worker’s claims under California’s FEHA, although they do affect the availability of remedies.

The California Legislature enacted Senate Bill No. 1818 in 2002 in response to the United States Supreme Court’s decision earlier the same year in Hoffman Plastic Compounds, Inc. v. NLRB (2002) 535 U.S. 137 (Hoffman). It said that the NLRB could not “award backpay to an illegal alien for years of work not performed, for wages that could not lawfully have been earned, and for a job obtained in the first instance by a criminal fraud.” (Id. at p. 149.) “[A]warding backpay to illegal aliens,” the high court held, “runs counter to policies underlying” the Immigration Reform and Control Act of 1986.

However, Hoffman, did not decide any issue regarding federal preemption of state law but instead addressed federal immigration law’s impact on a federal agency’s authority. A distinction is made between pre-discovery and post-discovery. remedies. Federal law preempts state Senate Bill No. 1818 to the extent that it makes a California FEHA lost pay award available to an unauthorized alien worker for the post-discovery period. In allowing lost wages for the pre-discovery period, state labor laws does not directly conflict with the federal Immigration Reform and Control Act of 1986, because compliance with both federal and state laws is not impossible. Federal law does not prohibit an employer from paying, or an employee from receiving, wages earned during employment wrongfully obtained by false documents, so long as the employer remains unaware of the employee’s unauthorized status.

More than half of heart patients in a new study made mistakes taking their medications or misunderstood instructions given to them after being discharged from the hospital. Those with the lowest “health literacy” were among the most likely to make the risky errors, highlighting the importance of healthcare professionals making sure their instructions are clear and of patients being sure they understand what they need to do after they get home, the study authors say. “Some errors have the potential to be harmful to patients,” said lead author Dr. Amanda Mixon, a hospitalist with the VA Tennessee Valley Healthcare System in Nashville. “Thousands of patients are discharged home with medications every day. Knowing which patients are at risk of medication errors after patients go home can help inpatient providers counsel patients about their medications before they go home,” added Mixon, who is also affiliated with Vanderbilt University.

According to the story in Reuters Health, past research suggests that an individual’s health literacy, the ability to interpret and act on health information, is a strong predictor of whether they will correctly follow instructions for their own care. Overall, 20 to 30 percent of prescriptions are never filled, and 50 percent are not continued as prescribed, according to the U.S. Centers for Disease Control and Prevention.

To assess what factors might influence whether heart patients will follow their care instructions correctly after leaving the hospital, Mixon’s team recruited 471 people hospitalized for heart failure, heart attacks and related conditions, then discharged from the hospital. The participants’ average age was 59 and just under half were women. Every participant took a seven-minute health literacy test to gauge their understanding of health information as well as a short numeracy test to measure basic math skills.

The researchers contacted the patients by telephone two to three days after they left the hospital and compared the medications on the discharge list from their doctors to what the patients said they were taking. When someone said they were taking a medication not on the list, or forgot to mention one that was on the list, it was counted as an error. If a patient didn’t know the purpose, dose or frequency of a medication, it was classified as a misunderstanding. Failure to refill a prescription, discontinuing use of a medication against a healthcare professional’s orders or not being aware of a medication were also counted as errors.

More than half – 242 of the 471 patients – had at least one discrepancy between the medications they reported taking, and the ones on their discharge list. Over a quarter left out one or more medications on their list and more than a third were taking something that was not on the list. And 59 percent of patients had a misunderstanding of the purpose, dose or frequency of their medications.

Participants who scored highest on the math skills test were about 23 percent less likely than those who scored lowest to add or omit medications, the researchers report in Mayo Clinic Proceedings. People with the highest health literacy scores were about 16 percent less likely to make an error compared to those who scored lowest. And women were about 40 percent less likely than men to make a mistake. Single people were almost 70 percent more likely than people who were married to make errors. Older age and worse cognitive function also predicted higher odds of having an error.

“It’s a powerful study in that it helps to define some of the things we assume, but haven’t been able to fully understand,” said Dr. Benjamin Brooke, a surgeon and professor at the University of Utah School of Medicine in Salt Lake City, who was not involved in the study. “I think this says that we need to do a better job of understanding a patient at the time of discharge, what are their risks of having a post discharge adverse event,” he told Reuters Health.

This study should help workers’ compensation case managers focus on a strategy that should help better post surgical outcomes.

The Department of Industrial Relations and its Division of Workers’ Compensation posted a progress report on the department’s implementation of Senate Bill 863, the 2012 law which makes wide-ranging changes to California’s workers’ compensation system.

The report, “SB 863: Assessment of Workers’ Compensation Reforms,” describes improvements made as well as the challenges remaining to fulfill the law’s intent to improve benefits to injured employees while containing costs. SB 863 became law on Jan.1, 2013, but not all provisions were effective immediately, and some aspects are still going through the rulemaking process.

:DIR took a balanced approach to putting SB 863’s reforms into practice,” said DIR Director Christine Baker. “The priority was to increase the benefits in 2013, reduce frictional costs and implement the cost savings efficiencies through regulations, a process that started as soon as the law was signed. We have laid the groundwork for the next stage of improvements and expect more gains in the years ahead.” Key findings of the report include:

1)  Although SB 863 successfully trimmed three percentage points off the rate increase, employers still had to endure an increase of more than 10% in their workers’ compensation costs. Insurance prices had already begun to rise in 2012. After SB 863 was passed, the Department of Insurance adopted a minimum pure premium rate for Jan. 1, 2013, which was up 11.3% from the rate one year earlier. If SB 863 had not been enacted, indications are that the rates would have increased by 14.3%.
2)  Permanent disability benefits increases are now in effect. It is too soon to determine the net effects, primarily because it takes up to two years or more for permanent disability to be determined.
3)  SB 863 strengthened California’s self-insurance marketplace, thanks to the greater oversight authority provided to DIR’s Office of Self Insurance Plans over self-insured employers. The reforms lowered the rate of defaults thereby reducing costs to all remaining self-insurers. To date, no defaults have occurred in self-insured entities since SB 863 regulatory changes went into effect.
4)  SB 863 reduced ambulatory surgery center (ASC) facility fees from 120% to 80% of Medicare’s hospital outpatient fee schedule. The average amount paid per ASC episode in the first six months after the change in fee schedules was 26% lower than in the year before the change took effect.
5)  SB 863 amended the inpatient fee schedule by repealing the separate reimbursement for spinal hardware. The average amount paid per episode of the spinal surgery involving implantable hardware declined by 56% after the separate reimbursement (duplicate payment) for spinal hardware was repealed.
6)  The lien filing fee halved the number of new liens being filed. In the first year the filing fee was in effect, 213,092 liens were filed, down from 469,190 in 2011, a greater than 50% reduction. This represents a cost savings of an estimated $270 million per year in litigation costs to California employers and insurers.
7)  Medical costs appear to be down: Preliminary data from WCIRB indicate that the estimated ultimate medical loss per lost-time claim is down 1.3% from calendar year 2012 to 2013. However, because the estimate is based on historical trends and adjusters’ predictions of what their cases will cost over the lifetime of the case, it is a weak performance indicator of the workers’ compensation system after the extensive reforms brought about by SB 863.
8)  The Independent Medical Review (IMR) process is heavily used: approximately 185,000 IMR applications have been filed to date. The qualified medical evaluator (QME) process that IMR replaces costs on average $1,653 per QME request, at least three times higher than the administrative cost of an IMR. An IMR costs $420 to process, down from $560 initially, and the cost will go down further starting in 2015.
9)  Ten sets of cost-saving regulations have been enacted, and additional regulations are in process.
10)  More than 80 percent of IMR determinations uphold the utilization review (UR) finding that the treatment requested is not medically necessary. Pharmaceuticals are the most common IMR request, and narcotics are the most common type of pharmaceutical requested.

“One of the key improvements of the reforms was to improve the delivery of appropriate medical care to injured workers through an independent medical review process that is transparent and consistent and uses evidence-based medicine,” said Dr. Rupali Das, DWC Medical Director. It is still too early to gauge the overall effect of SB 863 reforms. Revisions to the lien filing procedures, as well as the conflict of interest statute and the fee schedule changes, are expected to help reduce fraudulent behavior in the workers’ comp system.

The progress report is posted on the DIR website.