FDA Approves Hulio for Rheumatoid Arthritis and More

The FDA has approved Hulio (adalimumab-fkjp) subcutaneous injections for the treatment of the following indications:

  • Rheumatoid arthritis (RA)
  • Juvenile idiopathic arthritis (JIA)
  • Psoriatic arthritis (PsA)
  • Ankylosing spondylitis (AS)
  • Adult Crohn’s Disease (CD)
  • Ulcerative colitis
  • Plaque psoriasis (Ps)

In various industries, workers may develop certain forms of arthritis due to cumulative or acute trauma, or they may aggravate pre-existing forms of arthritis. This has led to an increase in specialty arthritis drugs making their way into workers’ comp, which makes this a potential drug of interest in workers’ comp.

Hulio is a tumor necrosis factor (TNF) blocker and a biologic. Dosing guidelines vary depending on indication, and the injections are available in three different dosage forms and strengths.

Hulio comes with an increased risk of serious infection, including tuberculosis, which can lead to hospitalization or death. Treatment should not be started in patients during an active infection, and treatment should be discontinued if a patient develops a serious infection or sepsis.

For further information, read the FDA-approved drug label


Tags: Hulio, adalimumab-fkjp, FDA, drug approval


A New Routine: The Growth of Complex Claims and How to Manage Them

Industry stakeholders in all areas of workers’ comp – from employers to insurance brokers, claims adjusters to executive leaders – are concerned about increasing claims complexity with over 65% citing it as a top challenge in our recent survey.1

Although the overall number of claims continues to decrease nationwide, more routine claims are escalating and taking longer to close at higher costs. According to the National Council on Compensation Insurance (NCCI), from 2014 – 2018 lost-time claim severity increased by 3.4% and medical claim severity increased by 2.9%.2

CAUSES AND CONSEQUENCES

The reasons that claims are becoming more difficult to process and conclude are somewhat complicated in themselves. Poor worker health and chronic conditions, such as obesity, hypertension, and diabetes, along with psychosocial factors, such as anxiety and depression, troubled home life, and inability to cope with the challenges of an injury, can significantly affect an injured worker’s recovery. And the impact of comorbidities has been well documented, including findings that claims with comorbidities have medical costs that are double those of similar claims without a comorbidity diagnosis.3

Comorbidities and psychosocial issues are not new, of course, but their prevalence in workers’ comp has grown, largely due to the changing workforce population. The U.S. workforce is getting older. By 2024, nearly 25% of workers will be over 55,4 accounting for the largest segment of the workforce, and approximately 80% of those are likely to have at least one chronic condition.5

At the same time, millennials (aged 23-38) currently make up the largest segment of the workforce and they are more likely to experience anxiety and depression.6 Add to those demographic shifts the combination of widespread legislation mandating coverage for mental health exposures, a range of social and economic ills, from the opioid crisis to inadequate group health insurance, and changing medical trends, including a shift to other potentially risky drugs for pain relief, such as NSAIDs and anticonvulsants, and the result is a higher percentage of complex claims.

This article explores just how exactly claims are growing more complex, along with strategies to anticipate and mitigate some of those risks. Read the article in full at RxInformer.


Tags: complex claims, complexity, RxInformer, comorbidity, psychosocial


American Medical Association Asks CDC to Revise Opioid Guidelines

With four years having passed since the Centers for Disease Control and Prevention (CDC) published their Guideline for Prescribing Opioids for Chronic Pain, the CDC recently opened up a comment period to allow a broad range of stakeholders to provide their perspectives on public health challenges tied to pain, opioids, diversion, overdose, the CDC guidelines, and more.

The American Medical Association (AMA) submitted their comments in a 17-page letter, stating their belief that the U.S. no longer has a prescription opioid-driven epidemic, but rather an overdose epidemic driven by heroin and illicit synthetic opioids.

Citing prescription opioid decreases, the increased utilization of prescription drug monitoring programs (PDMPs), increased provider education requirements, a higher number of physicians now certified to treat opioid use disorder, and increased naloxone prescribing, the AMA is asking the CDC to remove certain limits and restrictions placed on opioid prescribing.

Suggesting that various entities have used the CDC guidelines to create excessive restriction across the board for opioids, the AMA believes these limits and restrictions create a stigma around pain management, resulting in the denial of care. Furthermore, the AMA takes the position that the CDC Guideline has harmed patients because various organizations have adopted the guidelines as hard policies, when certain patients may benefit from opioid prescriptions that exceed CDC thresholds.

The AMA suggests that the following policies currently serve as barriers to evidence-based care:

  • Prior authorization
  • Step therapy
  • Quantity limits
  • High cost-sharing
  • Coverage limitations on medications for treating opioid use disorder
  • Coverage limitations on opioid and non-opioid medications
  • Coverage limitations for non-pharmaceutical therapies for managing pain

Furthermore, the AMA states that while opioid supplies have decreased in volume and strength, there has not been a concomitant increase in access to or affordability of evidence-based non-opioid alternatives.

Within their letter, the AMA suggest 13 recommended changes to improve the CDC guideline, all of which fall under the following three tenets:

  • Many patients experience pain that is not well controlled, substantially impairs their quality of life and/or functional status, stigmatizes them, and could be managed with more compassionate patient care
  • The revised CDC guideline should be used as part of a coordinated federal strategy to help ensure patients with pain receive comprehensive care delivered in a patient-centric approach
  • Policymakers, payers, and other stakeholders should suspend use of the CDC Guideline as a hard policy for limiting, discontinuing, or tapering a patient’s opioid therapy

For more information, read the AMA’s letter in full.


Tags: American Medical Association, AMA, CDC, opioid, opioid guideline, guideline


States Pass COVID-19 Liability Limitations

In the last month, two states have passed measures to limit civil liabilities tied to COVID-19, and other states are considering similar policies, which could foreshadow a legislative movement across the country

First, Arkansas Governor Asa Hutchinson signed two executive orders on this topic.

Executive Order 20-33 protects businesses that open or remain open during the pandemic from civil liability for damages or injuries caused by or resulting from exposure of an individual to COVID-19 on business premises. This immunity does not apply to willful, reckless, or intentional misconduct resulting in injury or damages. However, this immunity does not extend to workers’ comp benefits.

Executive Order 20-34 authorizes all licensed and certified healthcare providers to provide services in their normal course of business operations for the purpose of diagnosis, treating, or mitigating COVID-19, while also providing immunity from liability for any death, injury, or property damage alleged to have been sustained as a result of or omission by such healthcare providers.

Shortly thereafter, Louisiana Governor John Bel Edwards recently signed two new bills into law, limiting liability around COVID-19 exposure.

House Bill 826 establishes that no person, state or local government, or political subdivision thereof shall be liable for any civil damages for injury or death resulting from or related to actual or alleged exposure to COVID-19 in the course of business operations. However, this clause does not apply when a party failed to substantially comply with applicable COVID-19 procedures established by the federal, state, or local agency which governs business operations. Furthermore, the presence of gross negligence or wanton or reckless misconduct nullifies this rule.

In addition, employees who contract COVID-19 due to workplace exposure are entitled to workers’ comp, but they shall have no remedy based in tort, unless exposure was intentional. Interestingly, this bill creates similar liability protections for parties that handle large gatherings, including business event strategists, association meeting planners, independent tradeshow organizers, and other hosting entities.

House Bill 59 passes similar protections from liability to public and private schools, as well as their districts, governing authorities, charter school governing authorities, and the officers, employees, and agents thereof. This bill also applies the same rules to public and private postsecondary education systems, their institutions, education management boards, officers, employees, and agents thereof.

At this time, New York is considering similar legislation, having introduced Senate Bill 8800, which would apply to individuals, businesses, trusts, legal representatives, corporations, companies, associations, firms, partnerships, societies, joint stock companies, universities, schools, non-profit organizations, religious organizations, and more. This bill is still undergoing discussion.

Furthermore, while information is constantly changing, at this time discussions surrounding another federal coronavirus relief bill from the U.S. Senate include the utilization of similar liability protections for schools and businesses that reopen.


Tags: Liability, COVID-19, exposure, Arkansas, Louisiana


WCRI Reports on Interstate Variation Trends in Drug Payments

The Workers’ Compensation Research Institute (WCRI) published a new Flash Report on interstate variation and trends in workers’ comp drug payments from Q1 of 2016 to Q1 of 2019.

This report presents data from 28 states on quarterly payments of prescription drug groups including:

  • Dermatological agents
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Anticonvulsants
  • Musculoskeletal therapy agents
  • Opioids
  • Compounds

At 22 pages, this report contains various insights, but key among them were insights related to dermatological agents, which have seen increased utilization.

In most states, dermatological agents and NSAIDs have become more important than other drug groups as a share of total prescription payments. In the median of the 28 study states, both dermatological agents and NSAIDs accounted for 18% of total prescription payments in Q1 of 2019, with payment shares varying widely between states.

Dermatological agents saw substantial interstate variation in per-claim payment, ranging from $7 per claim in Iowa to $192 per claim in Illinois in Q1 of 2019. Payment shares increased by more than 3% in 20 states and more than 10% in nine states. Furthermore, a rapid increase in average payment per claim with a prescription for dermatological agents was seen in six states, with a 28-state median averaging an increase of 22%.

This increase was greatest in Texas at 44%, while in Connecticut, the per-claim payment of a claim with dermatological agents was three times higher in Q1 of 2019 than in Q1 of 2016. A doubling of per-claim payments across the same period was seen in five other states; Kansa, Louisiana, Massachusetts, South Carolina, and Virginia.

At 22 pages, more insights are contained throughout the report. Of note, opioid prescribing continued to decline in all 28 study states, with per-claim payments decreasing by 58% in the typical state. Rate of reduction ranged from 33% in Louisiana to 85% in California.

It is possible that a decrease in opioid utilization has led to an increase in the prescribing of other pain medication alternatives. Healthesystems recently published Growing Pains: The Shift from Opioids to Other Pain Therapies which explores how the utilization of other pain therapies has increased, while also examining concerns related to those opioid alternatives.

Other miscellaneous findings of the WCRI report include:

  • Quarterly payments per claim for NSAIDs varied widely, from $18 to $89 per claim, with a median of $40 per claim in Q1 of 2019. However, NSAID payment shares remained fairly stable over time
  • Anticonvulsants and musculoskeletal therapy agents saw stable trends in payments, with a handful of exceptions in certain states

Tags: WCRI, interstate variation, drug price, drug, price, payment, dermatological