FDA Approves Posimir for Post-Surgical Pain Relief

The FDA has approved Posimir® (bupivacaine solution) for infiltration use for post-surgical analgesia for the subacromial space under direct arthroscopic visualization (the space above the shoulder’s ball-and-socket joint).

Posimir is an amide local anesthetic that can provide pain relief for up to 72 hours following arthroscopic subacromial decompression (a procedure designed to release tight ligaments in the shoulder).

Posimir is a novel formulation of bupivacaine, a common numbing anesthetic, administered directly to surgical site for single administration only. Posimir should not be diluted or mixed with local anesthetics or other drugs or diluents.

Patients who receive Posimir should avoid additional local anesthetics for 168 hours (seven days) following administration.

Adverse reactions include dizziness, dysgeusia (altered taste), dysuria (discomfort when urinating), headache, hypoesthesia (numbness), paresthesia (tingling), tinnitus, diarrhea, bruising, fever, somnolence, surgical site bleeding, and vomiting.

Tags: Posimir, bupivacaine, FDA, drug approval, approval, shoulder pain, pain, surgery, post-surgery

Powering People with Technology to Close Gaps Across the Life of a Claim

The U.S healthcare system is comprised of many independent silos – primary care physicians, specialists, hospitals, pharmacies, labs, and more.

Add to the mix the variable regulations and requirements of workers’ comp insurance, and this complex environment makes it challenging to maintain an efficient flow of communication. Important pieces of information can be lost in the gaps between silos, causing delays, misdirected treatment, unnecessary costs, and compromised care.

Risk & Insurance® sat down with thought leaders across Healthesystems to discuss failed connections that can create obstacles to timely and effective care for injured workers, as well as the latest solutions to address and prevent information and communication gaps by driving for a more thoughtful synergy between people and technology.

Within this article, the following leaders speak to the topics described below.

Mike Theis, Director of Enterprise Analytics, discusses using technologies like Natural Language Processing (NLP) to better leverage unstructured data into analytics systems that drive claims management.

Silvia Sacalis, BS, PharmD, VP of Clinical Services, speaks to the importance of recognizing and flagging risk indicators and addressing them as soon as possible within a claim, using technology to detect those risk indicators, and to start the conversation quickly.

Stephanie Arkelian, Director of Product Management, explains why centralizing information maximizes efficiency for the adjusters managing injured worker claims, helping them to make the best care decisions possible for their patients.

Read the article in full at Risk & Insurance® and to dive deeper into these topics.

Tags: Healthesystems, Mike Theis, Silvia Sacalis, Stephanie Arkelian, Risk & Insurance, technology, claims management, NLP, natural language processing

Xeljanz Could Increase the Risk of Heart Problems and Cancer

The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with Xeljanz and Xeljanz XR (tofacitinib).

Xeljanz® and Xeljanz XR® are used for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Workers may develop various forms of arthritis due to cumulative or acute trauma, or an occupational injury could aggravate pre-existing inflammatory joint disease that may have been previously mild. For these reasons, Xeljanz and Xeljanz XR could appear in workers’ comp claims.

While the final results of the safety trial are not yet available, tofacitinib is a tumor necrosis factor (TNF) inhibitor that works by decreasing activity of the immune system, as an overactive immune system contributes to these conditions. However, decreasing the activity of the immune system can come with negative side effects, which is why the safety trial was initially launched.

When the FDA first approved tofacitinib in 2017, they required the manufacturer to conduct the safety clinical trial in patients with rheumatoid arthritis who were taking methotrexate to evaluate the risk of serious heart-related events, cancer, and infections.

The trial studied two doses of tofacitinib, 5 mg twice daily and a higher 10 mg twice daily dosage, in comparison to another TNF inhibitor. Patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor.

After reviewing preliminary results in 2019, the FDA previously warned healthcare professionals twice that year that Xeljanz and Xeljanz XR can increase the risk of blood clots and death with higher than 10mg twice daily dosages, resulting in a new boxed warning.

The extent of these new heart-disease and cancer risks is not fully known, and the FDA will continue to evaluate the clinical trial results and work with the drug manufacturer to obtain further information.

Patients should not stop taking these medications without first consulting with their provider. Providers should consider the benefits and risks of a patient using Xeljanz or Xeljanz XR before deciding to continue or discontinue use.

Tags: FDA, warning, Xeljanz, tofacitinib, rheumatoid arthritis, arthritis, ulcerative colitis, cancer, heart problems

Wisconsin Announces Plan to Lower Prescription Drug Costs

Wisconsin Governor Tony Evers announced that his 2021-2023 biennial budget proposal will include a number of critical provisions to lower prescription drug prices.

This is the latest state-led initiative to counteract rising prescription drug costs. Across the nation, several other states continue to introduce proposals and new measures created to lower prescription drug costs, all to varying levels of success.

Components of this Wisconsin plan include:

  • Creating a Prescription Drug Importation Program
  • Giving the state authority to develop a State Prescription Drug Purchasing Entity
  • Improving the Wisconsin Drug Repository Program
  • Under certain circumstances, requiring insurers to apply discounts and coupons utilized by consumers
  • And more

Governor Evers’ budget must be accepted before these plans can go into motion, and if approved they would take time to come to fruition. However, the initiatives proposed have been discussed significantly in other states.

Just last year, California issued a proposal for the state to establish its own generic drug label, while in 2019 a total of 44 different state Attorney Generals sued 20 generic drug manufacturers for supposedly inflating generic drug costs.

In 2018, Oregon passed a pricing transparency law requiring drug manufacturers to report every drug that has a wholesale acquisition cost (WAC) of more than $100 for a one-month-or-less supply that experienced a 10% increase in price, along with additional data.

While the COVID-19 pandemic greatly shifted regulatory priorities, this move by Governor Evers could be a sign that the drug price debate could soon come back into the spotlight, potentially resulting in more initiatives that target this concern.

Tags: Wisconsin, drug price, prescription, importation, purchasing, cost

IAIABC Names Sandy Shtab Vice Chair of Associate Member Council

The International Association of Industrial Accident Boards and Commissions (IAIABC) announced their 2021 IAIABC council and committee leadership, and Sandy Shtab, Healthesystems AVP of Advocacy & Compliance, was named Vice Chair of the Associate Member Council.

The IAIABC is an association of government agencies that administer and regulate their jurisdiction’s workers' compensation acts. The Associate Member Council assists the IAIABC Board of Directors by providing private sector advice and guidance on the regulatory impacts associated with new and developed workers’ comp rules, statutory laws, and administrative practices.

Furthermore, the Associate Member Council also encourages continuous improvement of the IAIABC’s policies, procedures, and practices to foster enhanced and positive working relationships between the IAIABC and various entities.

Such affiliations maintain effective channels of communication between state regulators and the IAIABC, keeping parties aware of industry trends, market indicators, and issues that impact workers’ comp adjudication and reimbursement.

Healthesystems congratulates Sandy Shtab and her fellow appointees.

Tags: Sandy Shtab, IAIABC, Healthesystems, Associate Member Council

A Disruptive Year for Workers’ Comp: Insights from the 2020 Industry Survey

The National Workers’ Compensation and Disability Conference (NWCDC) continues to offer digital content throughout the year. Healthesystems will take part in an upcoming panel presentation on March 10th.

Healthesystems and Risk & Insurance® Magazine surveyed over 600 workers’ comp industry stakeholders about disruptions and barriers encountered in 2020, as well as predictions and priorities for going forward.

A Disruptive Year for Workers’ Comp: Insights from the 2020 Industry Survey will cover key findings of the survey, including:

  • How the COVID-19 pandemic has affected workers’ comp
  • Key industry concerns in 2020 and how they differed from previous years
  • Which technical innovations will be most important for our industry
  • How priorities differ between – and within – organizations
  • What to expect in the short- and long-term

Healthesystems’ User Researcher and chief architect of the survey, Brittany Derenoncourt, PhD, will present key findings from the survey and moderate the discussion. Dr. Derenoncourt will be joined by Healthe’s AVP of Advocacy & Compliance, Sandy Shtab, and Lynn Cavalcanti, Senior Vice President of Acclamation Insurance Management Services (AIMS).

The presentation will take place at 2:00 PM EST on March 10, 2021.

Register now for the digital presentation.

Tags: Healthesystems, Brittany Derenoncourt, Sandy Shtab, NWCDC, industry survey, Risk & Insurance®, survey, disruptor