UR Nation End of Month Regulatory News Summary

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Alabama Case that Briefly Struck Down Workers’ Comp Act Settled

As you may recall, Alabama Jefferson County Circuit Court Judge Pat Ballard declared the entire Alabama workers’ comp system unconstitutional. Judge Ballard heard the case of Clower v. CVS Caremark Corporation. He took offense to the attorney’s fees cap and permanent partial disability benefits provision. He said that the law was “arbitrary, capricious, irrational” and “a clear violation of equal protection of the laws” under the U.S. Constitution. However, Judge Ballard also stayed enforcement of his order for 120 days. This was to give lawmakers a chance to cure the “deficiencies he identified.” Later, Judge Ballard made the stay permanent.

The good news is that the case has now settled. That means that the constitutional threat to the Alabama workers’ comp system, brought by this case, is over. That’s good news for workers’ compensation system participants doing business in the Alabama system.

CMS Backing Off Bundled Payments Program

The Centers for Medicare and Medicaid Services (CMS) has a pilot program underway. The program is commonly called “bundling” and applies to hip and knee replacements.  Essentially, CMS pays for a 90-day “episode of care.” The idea is that CMS gets more bang for the buck, as hospitals are required to provide the episode of care for a flat fee. But now CMS is scaling back the program.

Specifically, CMS has slashed the number of metropolitan areas where hospitals must participate in the program from 67 to 34. Hospitals in the eliminated areas would still be able to participate in the program on a voluntary basis. Part of the reason CMS is scaling back may be provider complaints. For example, the American Academy of Orthopaedic Surgeons said that all participation should be voluntary. This is because some surgeons and facilities don’t have the experience and resources to successfully participate in the program.

Another issue is the program’s unclear application to workers’ comp. Matt High, vice president of bill review operations for Coventry Workers’ Comp Services, said “In workers’ comp the volume of injured workers with particular medical conditions might not be large enough to make bundling worthwhile for providers.” It is also unclear how each state would adapt to bundling as each state has its own workers’ comp system.

Dr. Alexandra Page, with the American Association of Orthpaedic Surgeons, said that there’s been little action in workers’ comp. “Nobody is willing to take the first step.” Dr. Page said reluctance is likely a combination of payers waiting to see what others do, as well as uncertainty on how to mesh the bundled payment model with fee-for-services based workers’ compensation systems.

FDA Grants Marketing of Nerve Stimulation Device that Relieves Opioid Withdrawal Symptoms

The FDA has granted authorization for Innovative Health Solutions Inc. to market its NSS-2 electronic nerve stimulator. The device is a small nerve stimulator that is placed behind the ear. It emits an electrical pulse to stimulate branches of certain cranial nerves. According to an FDA reviewed clinical study of 73 patients who used the device as part of an opioid withdrawal program, those using the device experienced an average of 31 percent reduced opioid withdrawal symptoms (including pulse rate, perspiration levels, pupil size, tremors and anxiety). The 31 percent reduced opioid withdrawal symptoms occurred in the first 30 minutes of use.

FDA Commissioner Scott Gottlieb said “While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy. The FDA is committed to supporting the development of novel treatments, both drugs and devices, that can be used to address opioid dependence or addiction, as well as new, non-addictive treatments for pain that can serve as alternatives to opioids.”

New JAMA Study Suggests Non Opioids Provide Equal Pain Relief as Opioids

An new Journal of the American Medical Association (JAMA) study shows that a combination of non-opioid drugs was statistically as effective for treating arm and leg pain as opioids in emergency room patients. Dr. Andrew Chang of Albany Medical College authored the new study.

Specifically, the study included 441 patients who visited Montefiore Medical Center in New York in 2015 and 2016. One group of patients took ibuprofen and acetaminophen (think Tylenol), while the other patients took opioids oxycodone, hydrocodone and codeine. All patients in the study rated their pain on the pain scale. The average score of all patients before taking any drugs was 8.7.

Two hours after taking the drugs, pain relief was statistically the same between the non-opioid users and the opioid users. The non-opioid users reported a decrease in pain of 4.3, while the opioid users reported a decrease of 4.4. Dr. Gary Franklin, medical director of the Washington State Dept. of Labor, called the study “highly relevant” to workers’ compensation. Dr. Franklin said this begged the question, “Why even get started (with opioids) if there are good alternatives?”

Phil Walls, chief clinical officer at myMatrixx, said the findings in the report did not come as a surprise. “For years, I’ve been telling people ibuprofen is equally effective to opioids in treating pain.” But Walls added that doctors “can’t go backwards” after a patient starts taking opioids. As Walls describes it, this is because non-opioids like ibuprofen and Tylenol lack the “feel good” opiate component.

North Carolina Task Force Releases Draft Opioid Guidelines

To address their opioid crisis, North Carolina formed the Opioid Task Force about nine months ago. Since that time the Task Force has been working to come up with a new set of opioid guidelines. The good news is that the Task Force has just released its new Draft Opioid Guidelines.

The proposed effective date for the new guidelines is May 1, 2018. The guidelines contain many new provisions that most system participants view as positive. The guidelines are unique in that they break down appropriate medication usage at the various stages of pain, including first and subsequent opioid, and other pain medication prescriptions during the acute and chronic pain stages. Some of the proposed rules are as follows:

  • Would require prescribers to document that non-opioid treatment is insufficient, and urges the shortest duration possible, with short-acting opioids only.
  • Would limit daily dosages for acute paint to 50 morphine equivalent dose (MED).
  • Would cap initial prescriptions for non-surgical patients to a 5-day supply.
  • Would cap subsequent prescriptions at 30 days at 50 MED. Anything more would require specific documented medical justification.
  • The new rules would not apply to claims were the injured worker takes opioids for more than 12 weeks preceding the May 1, 2018 effective date.
  • Under certain circumstances a prescriber must prescribe the opioid antagonist naloxone hydrochloride, such as when prescribing more than 50 MED or where a patient has mental health issues.
  • No fentanyl, benzodiazepines or carisoprodol (think muscle relaxants like Soma) can be prescribed for acute pain.

Mark Pew, senior vice president for Prium, said “They have specifically targeted fentanyl, benzos and carisoprodol. And I appreciate the fact that they broke it down to the stage of pain. It’s a very unique approach compared to what other states have done… I think this is a quantum leap forward.”

The new proposed guidelines are subject to a public comment period, after which we may see more changes.

TX DWC Disciplines 7 out of 10 Compound Providers

Workers’ Compensation Commissioner Ryan Brannon spoke at the Insurance Council of Texas’ annual conference in early November. Commissioner Brannon said that TX DWC audited the top 10 compounding prescribers and fined 7 out of them. The fines ranged from $5,000 to $25,000 for prescribing compounds that were not medically necessary. Interestingly, all 7 of the prescribers have signed consent orders agreeing to pay the fines.

TX DWC is also still in the process of closing the loophole that allows compounded drugs as long as they contain “Y” ingredients from the Texas ODG formulary. In June, the division posted an informal rule that would require preauthorization for all compounded drugs, regardless of whether the ingredients are listed as “Y” drugs on the formulary. Plans are still in place to begin the rule-making process before the end of this year.

TX TDI Planning Audit Targeting Heavy Ordering of Lumbar Spine MRIs

Texas Department of Insurance Division of Workers’ Comp gave notice that they are planning an audit to evaluate the appropriateness of a doctor’s decision to order lumbar spine MRIs before one month of conservative therapy. ODG does not recommend MRIs for uncomplicated low back pain until at least one month of conservative therapy unless symptoms of a severe or progressive neurologic deficit are present. The agency plans to audit 10 practitioners who ordered the highest number of lumbar spine MRIs within 30 days of the date of injury. The data set will be culled from July 2015 to June 2017.

DWC medical advisor Dr. Patrick Palmer approved the audit as part of the 2017 Medical Quality Annual Audit Plan.

Tom Swiatek

Tom Swiatek

As Assistant Vice President of Regulatory Services, General Counsel, and Editor in Chief of UR Nation, Tom Swiatek draws on his experience as an insurance attorney on both the general liability side, as well as on workers’ compensation matters. As a California Workers’ Compensation Section Member, Tom is leading the discussion with respect to the regulatory challenges and opportunities facing the workers’ compensation system.