March 2025 The Self-Insurer

MARCH 2025

A S I P C P U B L I C AT I O N

Rx Data Reporting Stops Short of Price Transparency PBMs find a way around CMS requirement meant to prevent hidden rebates

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TABLE OF CONTENTS

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W W W. S I P C O N L I N E . N E T

F E AT U R E S 4

RX DATA REPORTING STOPS SHORT OF PRICE TRANSPARENCY PBMS FIND A WAY AROUND CMS REQUIREMENT MEANT TO PREVENT HIDDEN REBATES

By Bruce Shutan

8

GROWTH OF VALUE-BASED PURCHASING AND CONTRACTING FOR CELL & GENE THERAPIES

By Laura Carabello

ARTICLES 24

SIIA TASK FORCE RECOMMENDS BEST PRACTICES FOR ETHICAL AI USE

40

FINAL MENTAL HEALTH PARITY RULES: A PLAN SPONSOR’S IMPLEMENTATION GUIDE Written By Alston & Bird LLP Health Benefits Practice

36

IRS HAS FINAL SAY ON REGULATION OF MICRO-CAPTIVES

54

MEMBER NEWS

Written By Anthony Murrello

The Self-Insurer (ISSN 10913815) is published monthly by Self-Insurers’ Publishing Corp.

(SIPC). Postmaster: Send address changes to The Self-Insurer Editorial and Advertising Office, P.O. Box 1237, Simpsonville, SC 29681, (888) 394-5688 PUBLISHING DIRECTOR Bryan Irland, SENIOR WRITER Bruce Shutan, CONTRIBUTING EDITORS Mike Ferguson, Jennifer Ivy, PRESIDENT/CEO Erica M. Massey, CFO Grace Chen

MARCH 2025

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F E AT U R E

Rx Data Reporting Stops Short of

Price Transparency

PBMs find a way around CMS requirement meant to prevent hidden rebates

P

Written By Bruce Shutan

P

eeling back the curtain on prescription drug spending has proven to be a monumental task for selfinsured employers over the past two years since an Rx price-transparency requirement under the Consolidated Appropriations Act of 2021 (CAA) took effect.

Employer-based group health plans and health insurers must annually submit detailed information about prescription drug spending and coverage to the Centers for Medicare and Medicaid Services (CMS) by June 1. The intent is to prevent pharmacy benefit managers (PBMs) from hiding how much rebate money they’re keeping from employer customers.

However, coordinating that effort, known as RxDC, has been an enormous challenge for third-party administrators (TPAs), PBMs, brokers and health plan sponsors, explains Lauren Wells, a practice leader for Healthcare Reporting. What’s more, PBMs are exploiting a loophole that allows them to continue these unscrupulous practices, which federal regulators and lawmakers on both sides of the political aisle are trying to end.

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Rx Data/Price Transparency The reporting consists of eight data files – each containing different fields of information. Those categories, known as D1-D8, include premium and life years (D1), spending by category (D2), the top 50 frequent brand drugs (D3), top 50 most costly drugs (D4), top 50 drugs by spending increase (D5), Rx totals (D6), Rx rebates by therapeutic class (D7) and Rx rebates for the top 25 drugs (D8).

Wells explains that RxDC involves an extreme amount of coordination among the plan sponsor, TPA and PBM to complete the full filing and comply with the requirement. While many PBMs claim they’re completing D3 through D8 on behalf of their employer clients, she says “they’re not completing the pieces they don’t have the data for, which means that those groups are not in compliance with the regulations.”

DATA AGGREGATION VEIL

Another important part is the aggregation levels and restrictions that CMS has imposed in the instructions. “If you’re a large TPA that works with 50 PBMs, you have to figure out how each one is doing their filing,” she notes. In addition, there's plan sponsor information that TPAs don't track, such as employee plus dependent contributions or answers to so-called "narrative" file questions that CMS poses.

There’s a clause in the CMS regulations that forces a PBM to aggregate their files at the plan sponsor level. She provided an example of one PBM’s twofold options for a particular plan sponsor to explain how rebates are hidden. In one scenario, that PBM would charge $1,000 to create and submit to CMS on behalf of the employer D3 through D8 files in the aggregate. In another, it would charge $5,000 for those that prefer to keep their own data.

While plan sponsors would be tempted to choose the cheaper option, she explains that it’s impossible to deduce from aggregated data the amount of PBM rebates that the group should have received. Based on those examples, she says the plan sponsor should have received $46,000 in rebates but secured just $20,000. "That's going to cause them to raise a red flag," she says, "and this is why there has been such pushback in the market on this type of reporting. PBMs are trying to hide this particular column of information from employers.

The bottom line is that non-aggregated data files produced at the plan sponsor level allow for true transparency so that informed decisions can be made by their benefit partners when cost breakdowns within the D1 to D8 data files can be seen, according to Wells.

Reporting non-aggregated information that’s specifically broken down in D4 would enable a plan sponsor to justify implementing a

specialty Rx program for, say, a high infusion med that’s costing a lot of money. “That’s why the transparency of this data is so important,” Wells observes. “A lot of employers have no clue that their PBM is hiding.”

FIGHTING FOR UPDATED INSTRUCTIONS

Since PBMs have already figured out how to evade RxDC reporting on their rebate amounts, Wells has fought tooth and nail with CMS to amend the reporting instructions, which allow only the submitting party access to health plan information – and that can be the PBM. “The goal is not to allow a PBM to aggregate the data and continue to hide what they’re making,” she says.

In conversations about this issue with CMS, she says that PBMs have argued that it’s easier for them to just aggregate the data.

She’s hopeful that CMS will eventually come around. Here’s why: roughly $200 billion in pharmacy rebates are being paid out every year to PBMs and plan sponsors, but CMS is trying to figure out why there is so much medical debt when there’s so much money being paid out.

“The only way they’re going to come to a resolution on that is by updating the instructions because the regulation falls on the plan sponsor,” she explains. “It’s not the PBM that gets in trouble. It’s not the TPA that gets in trouble if they don’t file. So why wouldn’t you simplify the instructions to MARCH 2025

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Rx Data/Price Transparency say no aggregation and that you don’t get to hide your totals?”

Even though the reporting itself is already so complex, Wells says CMS also made the actual filing process extremely complicated. In the first year of the reporting, many plan sponsors couldn't create a CMS account called a Health Insurance Oversight system because they weren't approved. Personal information had to be submitted, much like getting a soft credit check done, which she described as a baffling requirement just to create an account.

When pressed for reasons why such information was required, she says CMS officials replied, "Because that is the way that it's done. That's the regulation." Consequently, she believes it resulted in many plan sponsors initially not reporting information about their prescription drug spending. There is no official penalty for non-compliance at this point outside of the standard ERISA penalty, which she adds is not to imply that it won’t happen in the future.

Whatever happens with the RxDC reporting, Wells notes that decent-sized employers need to hold their brokers, TPAs and PBMs accountable for what they’re paying them. She says they should be receiving financial reports on a regular basis so that by the end of the year, everything is in hand for reporting total pharmacy claims, administrative costs, stop-loss premiums and what employee dependents had for contributions.

“If your broker does not have an analytics system to track financial capabilities and they’re still sending reports self-created out of Excel, that’s not acceptable in this day and age,” she opines.

Bruce Shutan is a Portland, Oregon-based freelance writer who has closely covered the employee benefits industry for more than 35 years.

MARCH 2025

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F E AT U R E

Growth of Value-Based Purchasing and Contracting for

Cell & Gene Therapies Editor’s Note: This is the first of a two-part article focused on cell & gene therapy and its implications for the self-insurance marketplace. The second part of the article will appear in the April edition. Learn more about this topic at the SIIA Cell & Gene Stakeholder Forum, scheduled for May 27-28 in Minneapolis.

Details can be accessed at www.siia.org

A

Written By Laura Carabello

A

s a political power shift unfolds throughout the halls of Congress, the explosion of cell and gene therapies (CGTs) may be forcing employers to re-think coverage options and get more inventive in their approach to stop-loss coverage, policy limits and exclusions, and payment models. Innovative coverage options are emerging as employee demand accelerates for these costly but potentially lifesaving treatments.

CGTs are closely related and sometimes overlap as both aim to treat, prevent, or potentially cure diseases. They are considered "living drugs" that can heal and replace damaged tissues or diseased organs.

Jamie L. Holowka, B.S., Pharm.D., director of Clinical Strategy, Complete Captive Management Services, explains that CGTs have been called "potentially transformative" and have "great potential," according to the Centers for Medicare & Medicaid Services (CMS). They are not permitted to be described as curative by the Food & Drug Administration (FDA).

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Cell & Gene Therapies for a variety of disease states to patients and physicians,” shares "Currently, there have been forty-one (41) CGTs approved by the FDA within the United States, with seven (7) new CGTs approved in 2024.

Of these 41 approved CGTs, umbilical cord blood derivatives represent 9 of the 41 approvals to date (≈22%), with CAR-T cell therapies representing the next largest segment, composing 7 of the 41 (≈17%).

CGTs used in oncology, hemophilia, and Duchenne muscular dystrophy (DMD) are gaining traction.”

Jamie L. Holowka “Medical science is progressing based on FDA initiatives to focus on rare diseases.” she continues.

“CGTs have become a new entry to the market as a competitor to other therapies and treatments.

Most of these products are not considered first-line, first choice or the ONLY management option.”

Expanding on this concept, Andy Szczotka, Chief Pharmacy Officer, AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, adds, “CGTs have brought the hope of providing potentially curative and life-changing outcomes

Jakki Lynch

While the current CGT pipeline is very robust, there is a mounting concern among plan sponsors that there are now therapies under development that are going to treat more common disease states, like diabetic peripheral neuropathy. Greater challenges lie ahead to ensure affordability and access to these therapies for plan participants.

Jakki Lynch, CCM, CMAS, CCFA, director of Cost Containment, Carbon Stop Loss Solutions, shares this perspective, “The CGT landscape is a significant focus for our health care system as an unprecedented number of treatments for rare and devastating diseases become available for patients.

Payers face uncertainty for case volume, clinical effectiveness, and the potential extraordinary costs.”

Andy Szczotka She says payers need affordable solutions and predictable risk since numerous current therapies range in cost from $2M to $4M+, not including administration charges, pharmacy markup and potential inpatient admissions for adverse reactions.

“With the expected growth in future approvals of gene therapies, particularly for a higher number of patients and larger populations, affordability and risk reduction are strategic imperatives,” she notes.

“Additionally, payers and reinsurers may not experience the projected economic value of these therapies given the mobility risk of members changing plans or plans changing reinsurance carriers.”

At Custom Design Benefits, Terri Martin and Alberta Manga, Medical & Risk Management, report no increased demand for CGTs, noting, “In fact, we have only seen two cases in the past four years – requests for Car-T. We are seeing Car-T being approved for coverage in our employer’s health plans.”

MARCH 2025

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Cell & Gene Therapies But Dan Winkelman, director, Offering Design Suite, IQVIA, offers a differing perspective, “There has been strong demand for CGTs among health plan members. This can be seen in the breadth of products now available in the U.S. market (36 products) and the growth in the number of patients treated.”

For example, he points to seven CAR T-Cell products approved for Hematology cancers (Abecma,

are covering the cost of the gene therapy but administration, hospital stay, and travel expenses are not covered under these pools.”

Given the high cost of these therapies, he observes that many selffunded plan sponsors are opting to exclude gene therapies but says the narrative and pressure to cover gene therapies will continue to escalate once more prevalent disease states have a gene therapy option.

“Many gene therapies may not be cost-effective when compared to conventional or current standards of care,” continues Auten.

"Patients with Sickle Cell Disease (SCD), for example, can incur an average lifetime medical cost up to $2 million with severe cases up to $4-6 million in lifetime medical costs. Considering that current gene therapies for SCD have list prices of $2.2-3.1 million, the cost of these one-time therapies is already totaling the average lifetime medical cost of these patients.”

He continues that in the case of a patient with severe SCD, “We may get some cost savings from a gene therapy, but these patients already have significant medical costs even before being considered for this treatment.”

Jeff Auten Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta, Autolus), noting, “IQVIA U.S. patient models indicate a 30% increase in CAR T-Cell patients treated from 2022 to 2023. This growth is being driven by new indications and early lines of therapy due to the strong efficacy of these products.”

Jeff Auten, director of Clinical Consulting (PharmD) at Leaf Health, has found that selffunded plan sponsors continue to be hesitant to cover CGTs, “… even when risk pools are a viable option. Most available risk pools 10

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Health plan members are increasingly seeking out CGTs to address unmet medical needs and to explore the potential of personalized medicine, reports Jesse Roderick, senior vice president of Accident & Health Claims, QBE North America. He says some of the more requested therapies include Zolgensma (for spinal muscular atrophy), Kymriah (for acute lymphoblastic leukemia), and Luxturna (for inherited retinal disease).

“These therapies are gaining approval for coverage because they can potentially offer long-term, and in some cases, possibly curative benefits for life-threatening conditions,” he recounts. “But accessing these therapies is not always straightforward, and several barriers may be encountered, including high upfront costs, uncertain long-term efficacy, and complex regulatory and administrative hurdles. Geographic accessibility also poses a significant challenge, as it can limit access to specialized care that administers these therapies. “ Jesse Roderick

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Cell & Gene Therapies He suggests that the high cost reflects the advanced technology and potential curative benefits these therapies offer, adding, “Often intended as one-time treatments, these costs are also driven up by the small percentage of patients that need access due to the incidence rate of conditions that require such a sophisticated and complex treatment protocol.”

These costs significantly impact employer health plans, requiring more action from manufacturing through treatment to reduce the expense.

“Given the significant impact on member health and quality of life, these costs can be viewed as reasonable and justified,” he concludes.

CGTs are "living drugs" that can heal and replace damaged tissues or diseased organs.

These properties translate into curative therapies for a range of diseases that currently have no cure.

• Cell therapy: Involves transplanting cells into a patient to replace or repair damaged cells. Cells can be cultivated or modified outside the body before being injected into the patient.

• Gene therapy: Involves transferring genetic material into a carrier or vector, and then into the appropriate cells of the body. Gene therapy can silence a mistake in the gene or replace the faulty gene with a corrected version.

• CAR T-Cell Therapy: Involves a way to get immune cells called T cells (a type of white blood cell) to fight cancer by changing them in the lab so they can find and destroy cancer cells. CAR T-cell therapy is also sometimes talked about as a type of cell-based gene therapy because it involves altering the genes inside T cells to help them attack the cancer. While this type of treatment can be very helpful in treating some types of cancer, even when other treatments are no longer working, studies now support their use earlier in a patient’s disease, rather than after all other treatment options have been exhausted.

Sources: 2024 Stanford Medicine 2024 American Cancer Society

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Cell & Gene Therapies WHICH CGTS ARE GAINING TRACTION?

With this raft of CGT approvals, it is interesting to gauge some of the therapies are actually gaining adoption.

Oncology “In oncology, gene therapy aims to control the altered genes or genetic mutations of a cancer to prevent the cancer’s growth,” explains Szczotka. “Typically, oncology targeted gene therapy is not first-line therapy, but as the availability of multiple lines of oncology therapy grows and extend survival, the use of the later lines of CGTs are continuing to expand and improve survival rates.”

Advisers at Lockton observe that traditional cancer surgery, chemotherapy and radiation give patients precious moments but no long-term promise. They say cancer CGTS are changing this by harnessing the power of a patient's own immune system to destroy cancer cells without harming healthy tissue. These therapies work by adding, deleting, or changing the DNA within an individual's existing cells to give those cells a new set of instructions that can help them find and fight cancer.

The Alliance for Cancer Gene Therapy says there is an urgent need to translate the profound success of CAR T therapies for blood cancers into successful therapies for the most complex and deadly cancers – solid tumor cancers. The organization is currently funding breakthrough research to tackle pancreatic cancer, brain cancer, ovarian cancer, sarcomas, lung cancer, and more, and to advance the understanding of solid tumor biology that will lead to curative therapies.

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Cell & Gene Therapies Duchenne muscular dystrophy (DMD)

on-demand treatment of bleeds to assist with the management of the disease.”

“With the June 2024 FDA action of providing Elevidys both a traditional approval and an additional accelerated approval for use in DMD, this is one of the leading CGT agents,” explains Szczotka.

Employers see the value of Hemophilia gene therapies since they provide the potential a one-time administration of therapy to provide potential freedom from prophylactic therapies and the promise of being cost-effective if the patients no longer require prophylactic factor therapy or on-demand factor treatment -- and if they remain covered by the same payer.

The eligible population for this gene therapy is expected to soar, asserts the NEWDIGS initiative at Tufts Medical Center. DMD is a rare and serious genetic condition that worsens over time, leading to weakness and wasting away of the body's muscles. The disease occurs due to a defective gene that results in abnormalities in, or absence of, dystrophin, a protein that helps keep the body's muscle cells intact.

One advocacy group that helps patients with DMD reports while about 70% of their DMD cases involve self-insured employers, many payers exclude gene therapies. This organization has been able to get those decisions overturned.

Sickle Cell Consultants at IQVIA forecast that more than 2% or about 2,000 of the patient population with sickle cell disease in the U.S. being treated will benefit from cell-based gene therapy. They report that the reimbursement landscape improved significantly in 2024 for these treatments, with companies reporting that more than half the states have affirmed coverage through a preferred drug list of published coverage criteria, and nearly 50% of Medicaid-insured individuals with sickle cell disease live in a State that has already completed prior authorization approval for use of the therapy in at least one patient.

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Hemophilia “Three gene therapies have been approved for the treatment of hemophilia: Roctavian for hemophilia A and Hemgenix and Beqvez for hemophilia B,” continues Szczotka.

“Traditionally, hemophilia treatment consisted of frequent intravenously administered factor VIII or IX replacement therapies for prophylactic use or

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MARCH 2025

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Cell & Gene Therapies

HIGH COST OF THERAPY: KEY BARRIER TO ADOPTION

Some employers – from small-to-midsize companies -- react to the high price tags of a gene therapy as a bolt of lightning that could upend their entire healthcare spend and potentially threaten health plan financial stability. Some employers may hesitate to shoulder the heavy cost of a one-time treatment for workers who are likely to eventually switch jobs. Manufacturers argue the prices are justified because they offset a lifetime of medical costs patients would otherwise face.

Mary Ann Carlisle

Mary Ann Carlisle, chief revenue officer & COO, ELMCRx Solutions, observes, “Mid-sized PBMs and PBM alternative programs have been talking about these therapies quite a bit for the past six months. Their clients have been asking them about strategies to manage these treatments, not exclude them, but ways to include an oversight component as a way to verify that the care rendered is appropriate.”

She points out that these therapies are quite new, so understanding the course of the treatment and outcomes can be a challenge.

“Working with organizations that have experience and provider networks can bring needed expertise into the equation,” she says.

“Partnering with organizations that provide access to a network of highly specialized caregivers and medical sites seems like a prudent way to approach these treatments.”

Lynch explains, “CGT manufacturer pricing is supposed to reflect their potentially unique value—a one-time treatment that provides a durable/curable response without future clinical interventions. The belief is the therapies may yield overall plan savings by curing or improving a chronic disease and reducing the need for other ongoing costly treatments.”

She cautions that confirmed long-term data on efficacy and safety is not readily available, especially for the newer therapies with offtarget effects – such as malignancies recorded in patients treated with Lyfgenia, a one-time treatment for sickle cell disease. This also includes those therapies approved through an accelerated approval 16

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pathway. For example, Elevidys, for Duchenne muscular dystrophy patients, has prompted some payers to exclude coverage of any new FDA-approved drug approved through the accelerated approval pathway for the first 18 months.

Bloomberg recently reported that employer coverage of the treatments is “spotty at best,” due to the rarity of the diseases they target and their exorbitant price tags that can exceed $4 million.

Editors contend that many employers are dropping coverage and leaving families in a bind.

It is not surprising that the 2024 Large Employer Health Care Strategy Survey conducted by the Business Group on Health shows that 79% of employer respondents are very concerned about the patient and plan affordability of CGTs in the pipeline.

Another industry survey of 185 benefits leaders representing primarily employers, unions/TaftHartley plans as well as a swath of health plans and covering an estimated 86.6 million lives, documented that all respondents are concerned about managing these high-ticket items, with 74% of respondents citing affordability to be a moderate or major challenge.

The report shows that higher costs are hitting smaller health plans compared with large employers: 33% of respondents

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Cell & Gene Therapies overall indicate that they use stop-loss insurance to cover these therapies; 41% say they aren’t using any form of financial protection; and 17% report they are unsure what financial protections are used, indicating a need for better education.

NEWDIGS, a group at Tufts Medical Center that studies how to pay for new medicines, expresses concerns that companies are excluding gene therapies from their health plans because they worry they will be too expensive. They say that some large employers with lowwage workers are telling employees to seek coverage for high-priced medical treatments from state Medicaid programs. The researchers expect that the number of CGTS will rise to 85 by 2032, costing as much as $40 billion over the next decade. With employer healthcare costs projected to jump as much as 9% in 2025, this group – among others – lay blame on the cost of CGTs. Bob Gilkin, Senior VP, Trade and Specialty Strategy, AscellaHealth, says, “CGTs provide new treatment options for patients, but come at an extraordinarily high cost. The therapy class is responsible for the world's most expensive drugs, including six therapies that cost more than $3M. However, these treatments can potentially be a life-

Bob Gilkin changing experience for patients.

For example, the hemophilia gene therapies may eliminate the need for ongoing therapy in most patients and Zolgensma, for spinal muscular atrophy, has shown sustained efficacy for up to 7½ years post-dose.”

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Cell & Gene Therapies He adds that while many therapies offer potential significant clinical benefits, their cost and long-term value in demonstrating a reduction in total healthcare expenditures remains a key concern.

“In addition to conducting their own clinical and cost-effectiveness analyses, payers are looking to third-party organizations such as The Institute for Clinical and Economic Review (ICER), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the National Institute for Health Care and Excellence (NICE) and the National Comprehensive Cancer Network (NCCN) for guidance on cost impact and justification,” he continues.

ICER, for example, which began as a research program at Harvard Medical School in 2006, today stands as an independent, non-profit, research organization that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices, and health system delivery innovations. ICER engages with leading academic scholars and key stakeholders, including patient groups, clinical experts, life science companies and insurers, to inform their evidence reviews and then publishes their independent results.

Gilkin explains, “The publications provide a well-balanced, clinical, safety and economic analysis to help payers answer if the therapy is cost-justifiable based on the available evidence. Generally, their analyses on CGT therapies often recommend lower prices to meet commonly accepted cost-effectiveness thresholds than what the manufacturer is charging. As an example for CGTs, ICER stated that price benchmarks of $2.9 million for Hemgenix as compared to the actual cost of $3.5 million and a range of $1.1 to $2.1 million for Zolgensma as compared to the actual cost of $2.125 million.”

He advises that key hurdles for broader CGTs use include the proven durability of and sustained treatment effects, identifying the most appropriate patient population, elimination of concurrent and/or subsequent treatments, avoidance of long-term complications, regression of the disease state and the availability of alternative or newer therapies.

Terri Martin 20

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“As more long-term clinical data becomes available with these CGTs, these key questions will likely begin to be answered and will assist payers with addressing if these one-time therapies, with potential lifelong impacts from a clinical and quality of life perspectives, are more cost-effective than current

Alberta Manga conventional therapies,” says Gilkin.

Martin and Manga also acknowledge that plans are facing significant barriers in providing access to these therapies, adding, “The financial impact for a single hospitalization and treatment is over $1.5 million, which is a significant challenge for many health plans and employers.

Even with stop-loss insurance, there is a likelihood of placing the member being treated on a laser and receiving a higher specific deductible. The longterm outcome of cell and gene therapies remains unknown. It has not been found to be a cure.”

They concede that the costs are very high, presenting a significant financial burden on many patients and their families.

“One avenue to address the exorbitant costs would be financial assistance from the manufacturing companies for the member being treated,” they suggest. "Justifying the cost of therapy remains an unknown -only time will provide a definitive

Cell & Gene Therapies answer. The side effects of the CGTs could lead to increased debilitation and additional healthcare cost.”

Winkelman agrees that the high cost of these novel therapies, which can range from $100,000 to $3.5M (Hemgenix), is the primary barrier U.S healthcare plans are facing.

“Balancing the initial impact of the high cost of treatment is the potential to cure patients and limit, or even eliminate costly downstream care,” he explains. “Another barrier to treatment is the limited number of administration sites associated with these therapies. For example, Roctavian, which is indicated for Hemophilia A and was approved by the FDA in June 2023, is only administered in 15 locations. The funneling of patients to these specialty centers is one of the primary challenges drug manufacturers and healthcare systems face.”

Dan Winkelman

Why is gene therapy so expensive?

According to the National Organization for Rare Disorders (NORD), there are key reasons for the high cost of CGTS: •

•

•

•

•

Complex manufacturing: Producing viral vectors, which are used to deliver genetic material into cells, requires specialized equipment and highly trained personnel in cleanroom environments to prevent contamination, significantly increasing production costs.

Patient-specific treatment: Many cell therapies are autologous, meaning they are derived from the patient's own cells, requiring additional processing steps to isolate and manipulate cells before re-administration.

High research and development costs: Clinical trials for gene therapies are often lengthy and expensive due to the need to carefully monitor patients for potential long-term side effects.

Limited patient population: Many gene therapies target rare diseases, meaning the potential market size is smaller, which can inflate the cost per patient to recoup development costs.

New technology: As a relatively new field, the manufacturing techniques for cell and gene therapies are still evolving, leading to higher costs as companies invest in developing optimal production methods.

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Cell & Gene Therapies ADOPTION OF VALUE-BASED CONTRACTS

Ashley Hume, President of ETS and Chair of SIIA CGT Task Force, advises that manufacturers have stepped up to offer value-based contracts (VBCs) for cell and gene therapies (CGTs), which will be more fully explored in Part II of this series.

“These arrangements are typically made with ASOs, TPAs, PBMs, or specialty pharmacies—not directly with employers or stop-loss/ reinsurance carriers.,” she explains. "This creates a disconnect, as stoploss and reinsurers remain exposed to the high-cost risk without access to the financial protections VBCs provide. Without direct participation or alternative contracting models, stop-loss and reinsurance markets are left to manage CGT risk using traditional underwriting, limiting their ability to align costs with outcomes. Bridging this gap is critical for sustainable coverage as CGTs continue to expand."

Ashley Hume

Laura Carabello holds a degree in Journalism from the Newhouse School of Communications at Syracuse University, is a recognized expert in medical travel and is a widely published writer on healthcare issues. She is a Principal at CPR Strategic Marketing Communications. www.cpronline.com

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SIIA TASK FORCE RECOMMENDS BEST PRACTICES FOR ETHICAL AI USE Editor’s Note: SIIA’s Artificial Intelligence Task Force (now disbanded) recently produced a white paper focused on the ethical use of AI in the self-insurance industry.

That white paper is re-produced here. The white paper can also be accessed through the "resources" section of the SIIA web site at www.siia.org.

INTRODUCTION

As the self-insurance industry increasingly integrates artificial intelligence (AI) into its operations--from underwriting to claims processing--the imperative to establish robust ethical guidelines becomes ever more critical. The transformative potential of AI presents unprecedented opportunities for efficiency and innovation, yet it also introduces significant ethical challenges that must be addressed to protect consumer rights, ensure fairness, and maintain public trust.

To help address this challenge, the SIIA Artificial Intelligence Task Force has developed a collection of suggested guidelines contained in this document for companies operating in the self-insurance marketplace to consider. These guidelines establish the essential ethical principles for the development and deployment of AI technologies within the self-insurance sector, aiming to create a framework that balances technological advancement with the fundamental values of integrity, transparency, and accountability.

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AI's ability to automate tasks such as claims processing, fraud detection, and risk assessment can greatly improve operational efficiency, reduce human error, and allow for more accurate predictions. AI integration into systems can streamline customer service through virtual assistants and personalized risk models, enhancing customer experience.

However, the risks include potential biases in AI algorithms, which could lead to unfair outcomes in claims handling and underwriting, along with challenges in ensuring transparency and accountability in AI decision-making. Additionally, data privacy and security concerns arise, as AI within the healthcare sector relies heavily on personal data, requiring strict measures to protect consumer information. Balancing these benefits and risks is essential to maintaining trust and ensuring fairness in the use of AI throughout the self-insurance industry.

Please note: Nothing in this document should be considered legal advice. Companies should consult their own legal counsel and/or other business advisors as may be needed.

CORE PRINCIPLES GUIDING ETHICAL AI USE

Transparency and Accountability For AI to truly be a force for good, its workings must be understood not only by technical experts but by the broader community of stakeholders.

In addition to SIIA member companies, stakeholders affected by these developments include: •

Developers and engineers

•

Data scientists

•

Regulatory bodies and governmental agencies

•

Ethics committees and advisory boards

•

End users (employees and staff)

•

Industry associations

•

Legal experts

•

Investors and financial stakeholders

•

Medical providers

•

Health plan participants

Two foundational principles—transparency and accountability—are essential for building trust, fostering understanding, and mitigating risks associated with AI systems. By prioritizing these principles, organizations can ensure that AI systems are not only effective but also fair, compliant, and aligned with ethical standards.

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One of the foundational principles of ethical AI use in self-insurance is transparency. This can be done through many different avenues, including: •

White papers

•

Technical manuals

•

Case studies

•

Notices on emails

•

Websites

•

Any other relevant channels

Such communications should include clear explanations of how algorithms make decisions, the data utilized, and the criteria they apply. This will help demystify AI processes and allow for better scrutiny and understanding of AI behavior.

Transparency in the development, testing, deployment, validation, and monitoring of AI systems is also essential to providing insights into how and why an AI system arrives at a particular decision or recommendation. Clear communication about how AI systems comply with relevant regulations, standards, and ethical guidelines will ensure that any potential conflicts of interest, biases, or ethical considerations have been addressed. Organizations should develop and enforce guidelines and protocols for how AI

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systems will be used, including constraints on their applications and mechanisms for handling misuse, incorporating feedback from stakeholders to address their concerns about the AI system’s impact.

Alongside transparency, there is a responsibility to ensure that there are clear lines of accountability for every AI system in place. This means designating and training specific individuals or teams that are answerable for the ethical outcomes of AI operations. These people should oversee the development and deployment of AI technologies, ensuring that systems are continually reviewed for potential biases, inaccuracies, and ethical concerns.

They should conduct regular audits and reviews of AI systems and their impact to evaluate their performance, adherence to ethical standards, and compliance with regulations. When contracting with third-party vendors that offer AI capabilities, organizations should require that such services be provided in accordance with ethical standards and regulatory requirements.

Above all, AI should never be left to operate unchecked; it should always include “human-in-the-loop” mechanisms, where humans have the final say in critical decision-making processes.

DATA PROTECTION AND BIAS MITIGATION

Since AI systems rely on vast amounts of data, much of it personal and sensitive, data security and privacy are paramount. Organizations must handle this data with care, ensuring that privacy is protected at all stages. This begins with informed consent at the time of collection—people must know how their data is being used—and continues with strict controls on who can access it, how it is stored, and how it is anonymized to protect individual identities.

Regular audits, secure data transmission, and incident response plans must be part of every organization’s strategy to ensure data security. Protecting data storage systems with robust access controls and encryption can help prevent unauthorized access, breaches, and misuse of sensitive information. To ensure that AI systems meet legal requirements for data privacy and security, they must also comply with data protection regulations such as: •

The Health Insurance Portability and Accountability Act (HIPAA)

•

The European Union’s General Data Protection Regulation (GDPR)

•

The California Consumer Privacy Act (CCPA)

•

Any other relevant legal frameworks

To ensure fairness and avoid perpetuating existing biases, organizations should gather and utilize diverse and representative data sets to ensure AI systems reflect a wide range of perspectives. Algorithms should include fairness metrics to detect and assess potential biases. By following these guidelines, organizations can build AI systems that are ethical, fair, and reliable, reflecting diverse perspectives that maintain privacy and deliver accurate results:

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•

Gather and utilize data sets that include a wide range of perspectives to prevent perpetuating existing biases.

•

Integrate fairness metrics into algorithms to detect and assess potential biases in AI systems.

•

Limit data collection to only what is necessary for AI functionality, reducing risks associated with excessive or irrelevant information.

THE SELF-INSURER

•

Protect individuals’ privacy by de-identifying data while ensuring it remains useful for analysis.

•

Use accurate, up-to-date, and corruption-free data to maintain AI output quality and avoid misleading results.

•

Mitigate risks of biased historical data, such as unfair premium pricing for specific demographic groups, by retraining models and updating fairness metrics regularly.

Finally, organizations should carefully manage and monitor third-party vendors or partners that handle data to ensure they comply with the same privacy and security standards and contractual obligations.

OPERATIONAL GUIDELINES FOR SELF-INSURANCE APPLICATIONS OF AI

Claims Processing: Reducing Human Error and Improving Speed In claims processing, AI can be used to automate repetitive, time-consuming tasks such as data entry, claim form validation, and eligibility verification. By using optical character recognition (OCR) technology, AI can automatically extract information from claims documents, reducing manual effort. This speeds up the process and minimizes human errors, ensuring accurate claims submission and processing. AI can also automate the adjudication process by analyzing claims data and applying business rules, policies, and coverage terms.

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AI can make real-time decisions about claim approval, denial, or escalation, while machine learning models can continuously improve based on past claims, ensuring that adjudication is both fast and accurate. AI can offer advanced decision support by analyzing claims against a range of data points, including medical records, treatment plans, and standard care guidelines. This allows adjusters to assess the appropriateness of treatments and whether they align with industry standards, reducing unnecessary claims and helping to contain costs.

FRAUD DETECTION: USING PREDICTIVE ANALYTICS TO FLAG ANOMALIES

AI-powered algorithms can be invaluable in fraud detection. By cross-referencing current claims with historical data and industry norms, AI can detect anomalies such as inflated bills, duplicate claims, or suspicious provider behaviors. AI can also identify any payment inconsistencies to help detect if there has been a change in the way claims are being submitted or paid. This allows adjusters to flag and investigate potential fraud cases early, saving both time and money.

STOP-LOSS TRIGGERS AND UNDERWRITING

AI can play a crucial role in alerting claims adjusters to potential stop-loss triggers by continuously monitoring claims data, identifying patterns, and issuing real-time alerts when costs approach certain thresholds, whether it be for a single claim in the case of a specific stop-loss, or a group’s total claims costs as they approach an aggregate stop-loss limit.

AI can also predict the likelihood that a particular claim will exceed a specific stop-loss threshold to forecast future expenses by incorporating such factors as: •

Patient diagnosis

•

Treatment types

•

Provider costs

•

Past claims patterns

For example, if a patient with a chronic illness is undergoing a costly treatment plan, AI can anticipate the total cost trajectory and alert claims adjusters before the limit is reached. Similarly, if a plan’s aggregate stop-loss limit is set at $100,000, AI could send a notification when claim costs reach 70% or 80% of that amount. These alerts give adjusters time to review the situation and explore options for managing costs.

When it comes to risk assessment and underwriting, AI can analyze historical data and spot patterns that human underwriters might miss. This allows for more accurate pricing and risk predictions. AI also can audit data sets used in underwriting to detect imbalances or biases. For example, AI might reveal that certain demographic groups are consistently charged higher premiums. By using metrics like equal opportunity and disparate impact analysis, AI can ensure that different demographic groups are treated equitably. AI can also create synthetic data to evaluate groups that are transitioning from fully insured to self-insured without adequate claims data.

CARE MANAGEMENT

AI can be highly effective in care management to identify individual health risks and tailor recommendations by analyzing vast amounts of data from various sources, including:

MARCH 2025

31

•

Medical records

•

Claims data

•

Wearable devices

•

Lifestyle surveys

•

Health apps

For example, if a person has a history of high cholesterol and a sedentary lifestyle, AI can predict an increased risk of heart disease and recommend a customized wellness program focused on heart health, including dietary changes, exercise plans, and regular health monitoring. AI can also use behavioral “nudging” techniques via wearable devices or email and text messages to encourage individuals to engage in wellness programs. For individuals already diagnosed with chronic conditions, AI can recommend ongoing medical management programs and monitor the effectiveness of these programs by tracking outcomes and suggesting adjustments as needed.

PROVIDER PERFORMANCE MEASUREMENT

Third-party claims administrators can leverage AI to assess provider performance metrics, including treatment effectiveness, patient satisfaction, and adherence to evidence-based practices. By analyzing large volumes of claims and patient outcome data, AI can identify patterns that reveal the quality of care provided, highlighting providers who consistently deliver positive outcomes while flagging those who may be underperforming. AI also can use predictive analytics to assess the likelihood of certain outcomes based on a provider’s past performance.

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THE SELF-INSURER

AI algorithms can predict the probability of hospital readmissions, complications, or higher-than-expected costs for certain treatments to prompt adjusters to work more closely with providers, offering feedback and incentivizing improvements in care quality. Additionally, AI can help adjusters benchmark providers against industry standards and peers by comparing performance across various metrics, such as treatment costs, length of hospital stays, or patient recovery rates. This allows stakeholders to negotiate more effectively with providers, ensuring that self-insured companies and their employees receive high-quality, cost-efficient care. By incorporating AI into their performance analysis processes, stakeholders can make more informed decisions that benefit both providers and patients, while also controlling healthcare costs for employers.

LEGAL AND REGULATORY COMPLIANCE

AI can assist in ensuring compliance with legal and regulatory frameworks by automating regulatory monitoring, auditing processes, and enhancing data protection. Among AI’s capabilities in compliance are: •

Automating the tracking of laws and regulations to alert compliance officers to necessary updates.

•

Automating the auditing of compliance-related activities, ensuring that policies, procedures, and documentation meet regulatory standards.

•

Generating reports for regulatory bodies, making compliance reporting more efficient and accurate.

•

Enforcing data protection rules by anonymizing and de-identifying personal data, ensuring that it is handled securely.

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•

Monitoring data access, enforcing strict access controls, and detecting potential data breaches in real time, preventing unauthorized access to sensitive information.

Organizations may consider establishing internal ethics boards to regularly review compliance with legal and regulatory frameworks and address potential ethical issues before deployment.

CUSTOMER SERVICE

Customer service also benefits from AI-powered solutions, with chatbots and virtual assistants providing 24/7 support for routine inquiries. These AI tools improve the customer experience by offering quick responses, freeing up human agents to focus on more complex issues. AI also can proactively send status updates to patients and providers.

SUMMARY: BEST PRACTICES FOR AI USE

Continuous improvement is vital to maintaining ethical AI systems. Organizations must regularly monitor AI performance, using key performance indicators (KPIs) and other metrics to identify areas for improvement and make necessary adjustments to ensure that AI systems meet desired outcomes. They also should keep up with the latest advancements in AI technology, methodologies, and best practices to continuously enhance AI capabilities. The following are some best practices for ethical AI use: •

Provide regular training sessions for employees on the use, implications, and best practices of AI technologies. This should include training on data privacy, bias mitigation, and the ethical implications of AI decisions.

•

Establish a governance framework that defines clear roles, responsibilities, and accountability for all AI initiatives. This framework should outline policies, procedures, and oversight mechanisms to ensure responsible AI use.

•

Conduct regular audits and reviews of AI systems to ensure compliance with ethical guidelines and regulatory requirements.

•

Invite regular feedback from stakeholders, including employees, customers, regulators, and providers, to evaluate the impact of AI and make necessary adjustments.

•

Support transparency, accountability, and regulatory compliance.

•

Maintain detailed documentation of all AI systems, including data sources, algorithms, decisionmaking processes, and audit trails.

•

Implement “human-in-the-loop” oversight mechanisms for critical decision-making processes.

By considering these guidelines and best practices that emphasize transparency, responsibility, fairness, and security, companies in the self-insurance industry will be better positioned to harness AI's power to enhance operational efficiency and improve customer experience. Continuous monitoring, stakeholder collaboration, and a commitment to ethical practices will ensure that AI remains a tool for positive change, benefiting both organizations and the clients they serve.

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IRS HAS ITS FINAL SAY ON REGULATION OF “MICRO-CAPTIVES” Editor’s Note: In one of the last regulatory actions taken by the outgoing Biden Administration, the IRS released final regulations on Micro-Captive Insurance arrangements, effective immediately upon its release date (January 14, 2025). This has been a multi-year legislative/regulatory process during which SIIA has played a key role in representing the interests of its members.

Written By Anthony Murrello

BACKGROUND AND SIIA’S ADVOCACY ROLE

Back in 2014, when the Senate Finance Committee was considering legislation that ultimately became the PATH Act, the Self-Insurance Institute of America, Inc. (SIIA) snapped into action and engaged Committee staff, along with Senators and members of the House of Representatives, to educate them on the merits and utility of captive insurance arrangements that are governed under Section 831(b) of the Internal Revenue Code (Code). SIIA also engaged IRS officials and scheduled a number of meetings with the Agency to discuss how 831(b) captive insurance arrangements could and should be regulated.

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Since its addition to the Code in 1986, section 831(b) has played an essential role in supporting small- and medium-sized businesses by providing a way to manage risks that may be unavailable or too costly in the commercial insurance market. Over the years, Congress has demonstrated a clear intent for Code section 831(b) to simplify and support risk management for a wide range of businesses, including farmers, auto dealers, community banks, manufacturers, trucking companies, construction firms, professional service providers, and more. During the course of SIIA’s advocacy work, we have been consistent in promoting a fair approach that would allow the IRS to combat abusive behavior, while also allowing appropriate access to captive insurance as the law provides.

PROPOSED REGULATIONS ON MICRO-CAPTIVE INSURANCE ARRANGEMENTS

In April of 2023, the IRS released proposed rule 109309-22, signaling that, in the IRS’s opinion, captive insurance arrangements that make an 831(b) election should be considered “Listed Transactions” (inherently abusive tax shelters) or “Transactions of Interest” (potentially abusive, requiring further scrutiny).

In response, SIIA submitted a formal comment letter to the IRS arguing that the proposed rule was an overreach, and we further explained that the proposed requirements would significantly restrict access to captive insurance arrangements for small and medium-sized businesses. The association's comments included:

●

Making a Code section 831(b) election does not automatically convert a captive insurance arrangement into an abusive transaction, nor are these types of captive insurance arrangements per se tax avoidance transactions.

●

The proposed criteria for determining whether an 831(b) captive insurance arrangement should be considered a Listed Transaction, or a Transaction of Interest are overly broad, casting too wide of net and capturing arrangements that are established for risk-mitigation purposes and not tax avoidance.

●

A 65% Loss Ratio for an 831(b) captive is too high, and the IRS does not have the authority under the Code to establish such an arbitrary Loss Ratio for determining whether a captive arrangement is an insurance company for Federal income tax purposes.

FINAL REGULATIONS ON MICRO-CAPTIVE INSURANCE ARRANGEMENTS

The IRS effectively finalized the proposed requirements, confirming that a captive insurance arrangement could be considered a Listed Transaction or a Transaction of Interest, requiring participants of the arrangement to file Form 8886 and material advisors to the arrangement to file Form 8918.

However, the IRS did take into account SIIA’s comment on the proposed 65% Loss Ratio. More specifically, the IRS agreed that the 65% Loss Ratio factor was too high and would capture captive arrangements established in good faith for risk-mitigation purposes. As a result, the IRS agreed to lower the Loss Ratio to 30%.

A notable concern in the final regulations involves loan-back arrangements. According to the IRS, such practices conflict with the core principle of risk transfer, which is essential to legitimate insurance MARCH 2025

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operations. Although commenters sought clearer guidance and examples of loan-back arrangements, the IRS maintained that loanback practices strongly suggest abusive behavior and should be scrutinized individually based on their specific circumstances.

According to the IRS, taxpayers involved in arrangements classified as Listed Transactions or Transactions of Interest bear the burden of proving that the arrangement serves a genuine insurance purpose and adheres to sound practices. In an effort to provide transition relief, the IRS will provide limited relief from additional disclosures for taxpayers choosing to (1) resolve disputes or (2) revoke their 831(b) elections before 2026.

Captive owners and their advisors are encouraged to consult with their own legal counsel regarding compliance questions going forward.

Anthony Murrello serves as SIIA Government Relations Manager. He can be reached at amurrello@siia.org

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This example is illustrative only and not indicative of actual past or future results. Stop Loss is underwritten by Berkley Life and Health Insurance Company, a member company of W. R. Berkley Corporation and rated A+ (Superior) by A.M. Best, and involves the formation of a group captive insurance program that involves other employers and requires other legal entities. Berkley and its affiliates do not provide tax, legal, or regulatory advice concerning EmCap. You should seek appropriate tax, legal, regulatory, or other counsel regarding the EmCap program, including, but not limited to, counsel in the areas of ERISA, multiple employer welfare arrangements (MEWAs), taxation, and captives. EmCap is not available to all employers or in all states.

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FINAL MENTAL HEALTH PARITY RULES: A PLAN SPONSOR’S IMPLEMENTATION GUIDE Written By Alston & Bird LLP Health Benefits Practice

PART I: HIGH-LEVEL OVERVIEW OF THE NQTL REQUIREMENTS AND COMPARATIVE ANALYSIS

In September 2024, the U.S. Departments of Labor, Treasury, and Health and Human Services (the “Departments”) issued a Final Rule under the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). The Final Rule, which codifies prior guidance, has a general effective date of the first day of the plan year beginning on or after January 1, 2025. Additional new requirements are effective within the first plan year starting on/after January 1, 2026.

This article is the first in a three-part series designed to inform plan sponsors of self-insured plans about the key components of the Final Rule and compliance steps for satisfying regulatory requirements. In this Part I, we provide a high-level overview of the essential elements of the Final Rule, focusing on the two-part test for nonquantitative treatment limitations (NQTLs) and the requirement to perform an NQTL comparative analysis.

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The Departments summarize the Final Rule in the preamble by way of providing a statement that the purpose of the Final Rule is to: •

Make clear that MHPAEA requires that individuals will not face greater restrictions on access to mental health or substance use disorder (MH/SUD) benefits as compared to medical or surgical (Med/Surg) benefits.

•

Reinforce that plans cannot use NQTLs for MH/SUD benefits that are more restrictive than the predominant NQTL applied to Med/Surg benefits in the same classification, including: o

Medical management techniques (such as prior authorization).

o

Standards related to network composition.

o

Methodologies to determine out-of-network reimbursement rates.

•

Require plans to collect and evaluate data and take reasonable action to address material differences in access to MH/SUD benefits as compared to Med/Surg benefits.

•

Codify the NQTL comparative analysis requirement that was first mandated by the Consolidated Appropriations Act, 2021 (CAA).

•

Prohibit plans from using discriminatory information, evidence, sources, or standards that systematically disfavor or are specifically designed to disfavor access to MH/SUD benefits when designing NQTLs.

NQTL REQUIREMENTS

MHPAEA prohibits a plan from applying NQTLs on MH/SUD benefits that are more restrictive than the limitations applicable to Med/Surg benefits. To determine whether NQTLs are more restrictive, the Departments describe a two-part test in the Final Rule that includes (1) design and application requirements and (2) relevant data evaluation requirements.

1. Design and Application Requirements

The first part of the test looks to how NQTLS are designed and applied. An NQTL cannot be imposed “under the terms of the plan, as written and in operation” unless “any processes, strategies, evidentiary standards, or other factors used in designing and applying the [NQTL] to [MH/SUD] benefits in the classification are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in designing and applying the limitation with respect to [Med/Surg] benefits in the classification.” Definitions for processes, strategies, evidentiary standards, and factors are also included in the Final Rule. This provision is effective for plans beginning on or after January 1, 2025.

The Final Rule adds specific provisions prohibiting the use of “discriminatory” or biased information in the design and application of NQTLs. Information, evidence, sources, or standards, including historical plan data or other historical information from a time when the plan was not subject to or not in compliance with MHPAEA, are considered to be biased or not objective if, based "on all relevant facts and circumstances," they "systematically disfavor access or are specifically designed to disfavor access to [MH/SUD] benefits as compared to [Med/Surg] benefits." A plan can still use such data but must provide steps to correct, cure, or supplement any information, sources, or standards that would otherwise be biased or not objective when identifying and defining factors used to design or apply the NQTL. This prohibition on the use of discriminatory or biased information is effective for plan years beginning on or after January 1, 2026.

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2. Relevant Data Evaluation Requirements

The second part of the test, which becomes effective for plan years beginning on or after January 1, 2026, looks to outcomes based on relevant data evaluations. For each NQTL, a plan must collect, evaluate, and consider the impact of relevant data on access to MH/SUD benefits relative to access to Med/Surg benefits. If the analysis reveals “material differences” in access to MH/SUD benefits as compared to Med/Surg benefits, then the Final Rule states that this is a “strong indicator” that the NQTL violates the MHPAEA, and the plan must take reasonable corrective action, which must be described in the comparative analysis. The Departments do not define "material differences"; instead, they provide guidance on making a "facts and circumstances" determination of what data may be relevant to suggest that the NQTL contributes to a material difference. The Final Rule includes provisions that address situations in which no data exists for either a new or existing NQTL, and such provisions require that the plan provide information and explanations about the lack of data in the comparative analysis.

On data collection for relevant data generally, the Final Rule refers only to: •

The number and percentage of claims denials in a classification of benefits.

•

Other data relevant to the NQTL required by state law or private accreditation standards.

For data collection on NQTLs related to network composition, the Final Rule states that relevant data could include: •

In-network and out-of-network utilization rates (including data related to provider claim submissions).

•

Network adequacy metrics (including time and distance data, and data on providers accepting new patients).

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•

Provider reimbursement rates (for comparable services and as benchmarked to a reference standard).

The Departments provide some additional suggested relevant data in the preamble for the majority of NQTLs for each MHPAEA classification but decline to provide a list of all relevant outcomes data required to be collected and reviewed in this Final Rule. Instead, the Departments promise to issue in further guidance the type, form, and manner of collection and evaluation for the data required and the lists of examples of data that are relevant across the majority of NQTLs, as well as additional relevant data for NQTLs related to network composition. This guidance will also include an update of the MHPAEA SelfCompliance Tool to provide a “robust framework and roadmap” for plans to determine which data to collect and evaluate.

Under the Final Rule, relevant data are considered to suggest that the NQTL contributes to material differences in access to MH/SUD benefits as compared to Med/Surg benefits if, based on facts and circumstances (and taking other considerations outlined in the Rule), the difference in the data suggests that the NQTL is likely to have a negative impact on access to MH/SUD benefits in comparison with Med/ Surg benefits. Relevant facts and circumstances may include: •

The terms of the NQTL;

•

The quality or limitations of the data;

•

Causal explanations and analyses;

•

Evidence as to the recurring or nonrecurring nature of the results and

•

The magnitude of any disparities.

Plans may consider other relevant factors that are not specifically listed in the Final Rule, including that a difference in access to MH/SUD benefits is attributable to independent professional medical or clinical standards or fraud and abuse measures.

THE NQTL COMPARATIVE ANALYSIS PROCESS

The Final Rule reshapes the content of the NQTL comparative analysis by incorporating the data collection requirements. Other organizational and substantive changes are made as well. The Departments acknowledge that for self-funded plans, third-party administrators play a critical role in developing a comparative analysis and stated that ERISA-governed plans should contact the Department of Labor if any service provider refuses to provide information needed to perform a comparative analysis.

The Final Rule contains six separate requirements for a comparative analysis, with multiple subparts under each requirement. In next month's article, we will take a deeper dive into each of these. Generally, the six broad requirements are:

44

•

Description of the NQTLs.

•

Identification and definition of the factors used to design or apply the NQTL.

•

Description of how the factors are used in the design and application of the NQTL.

•

Determination of comparability and stringency as written.

•

Determination of comparability and stringency in operation.

•

Finding and conclusions.

THE SELF-INSURER

Companies are increasingly looking to self-funding and Medical Stop Loss (MSL) group captives to control costs. But when it comes to captives, one size does not fit all. That’s why Captive Resources supports several different captive programs to meet the unique needs of employers.

Program Control: Group captives allow members to take control of their insurance programs and self-fund in a stable environment as part of a group of best-in-class, engaged employers.

Cost Containment: Captives afford members the necessary transparency and flexibility to identify cost drivers and implement targeted cost containment solutions.

Profit Potential: Members can further bend the trend on total costs with the ability to earn dividends for better-than-projected loss performance.

Captive Resources currently advises 48 Casualty and MSL captives comprised of 6,850 member-companies and nearly $5 billion in annual premium.

224.293.6276

As part of the findings and conclusions of the NQTL comparative analysis, one or more named plan fiduciaries must confirm such fiduciary’s engagement in a prudent process to select one or more qualified service providers to perform and document a comparative analysis as well as satisfaction of the duty to monitor those service providers. In the preamble, DOL stated it does expect that a plan fiduciary will, at a minimum, review the comparative analysis, ask questions about the analysis, and discuss it with service providers, as necessary, to understand the findings and conclusions. According to the

preamble, the fiduciary should also have the service provider make an assurance that, to the best of its ability, the comparative analysis complies with the requirements of the MHPAEA and the Final Rule.

For ERISA-covered plans, the Final Rule provides that the comparative analysis is an instrument under which a plan is established or operated under §104(b)(4) of ERISA and must be provided to participants and beneficiaries within 30 days of a written request.

The plan administrator could face a penalty of up to $110 per day for not providing that comparative analysis. The Final Rule also includes timeframes when responding to a request for the comparative analysis from the Department of Labor (DOL) (ten business days for an initial request), as well as notice requirements for plans that the DOL determines to be out of compliance. We cover those details later in this series of articles.

MEANINGFUL BENEFITS STANDARD/CORE TREATMENTS REQUIREMENT

The Final Rule confirms that the classifications and subclassifications for quantitative treatment limitations (QTLs) are equally applicable to NQTLs and states that a plan does not provide meaningful benefits

We provide innovative, tailored solutions and unmatched support.

You retain clients.

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THE SELF-INSURER

U N I V E RS I TY

unless it also provides benefits for a core treatment for an MH/SUD condition or disorder in each classification in which the plan provides benefits for a core treatment for one or more Med/Surg conditions or procedures. “Core treatment” is defined as “a standard treatment or course of treatment, therapy, service, or intervention indicated by generally recognized independent standards of current medical practice.” The preamble to the Final Rule notes that except for this broad definition, there is no specific requirement on what constitutes a core treatment, and it might not necessarily be a single item or service but could be a “suite” of services. If there is no core treatment available for an MH/SUD condition, then a plan is not required to provide a core treatment, but it still must provide benefits for the condition in every classification when Med/Surg benefits are provided.

EFFECTIVE DATE

The Final Rule has a general effective date of the first day of the plan year beginning on or after January 1, 2025. The elements highlighted in this article have an effective date of the first day of the plan year beginning on or after January 1, 2026: •

The prohibition on discriminatory information used in the design and application requirements.

•

The relevant data evaluation requirements.

•

The meaningful benefits standard, which includes the new “core treatments” requirement.

Any aspect of the comparative analysis that requires disclosure or analysis of these provisions is also not applicable until the first day of the plan year beginning on or after January 1, 2026. All other provisions regarding the comparative analysis are effective January 1, 2025, and, as mentioned above, the deadline for completion of a comparative analysis in the first instance was February 10, 2021.

POSSIBLE CHALLENGES TO THE FINAL RULE

Regulatory Freeze: As of January 20, 2025, any federal regulation published in the Federal Register that is not yet in effect is part of a 60-day regulatory freeze as the incoming administration conducts its own reviews. The memorandum explains that the regulatory freeze applies to rules as defined by United States Code “that have been issued in any manner but have not taken effect” and “any agency statement of general applicability and future effect that sets forth a policy on a statutory, regulatory, or technical issue or an interpretation of a statutory or regulatory issue.”

The Final Rule has an effective date of November 23, 2024, although the compliance date—the date when the regulated entity needs to come into compliance with the Final Rule—applies to plan years beginning on or after January 1, 2025, or 2026, depending on the provision. Based on the outcome in prior litigation, the Final Rule appears to be outside the scope of this regulatory freeze because the effective date and compliance dates are distinguishable under applicable law (see Becerra v. United States DOI, 276 F. Supp.

3d 953, 955, 2017 U.S. Dist. LEXIS 150458).

Congressional Review Act (CRA): Under the CRA, Congress can negate certain administration actions taken close to the start of a new Congress. A CRA disapproval resolution to eliminate a rule requires a simple majority of the House and Senate and must be signed by the President. The CRA "lookback" period includes the period reaching back 60 "session days" in the Senate or 60 "legislative days" in the House before adjournment sine die. The Senate and House Parliamentarians are the sole definitive arbiters of the operation of the CRA mechanism, including its associated time periods, and should be consulted if a formal opinion is desired.

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THE SELF-INSURER

Depend on Sun Life to help you manage risk and help your employees live healthier lives By supporting people in the moments that matter, we can improve health outcomes and help employers manage costs.

For over 40 years, self-funded employers have trusted Sun Life to help them manage financial risk. But we know that behind every claim is a person facing a health challenge and we are ready to do more to help people navigate complicated healthcare decisions and achieve better health outcomes. Sun Life now offers care navigation and health advocacy services through Health Navigator, to help your employees and their families get the right care at the right time – and help you save money. Let us support you with innovative health and risk solutions for your business. It is time to rethink what you expect from your stop-loss partner.

Ask your Sun Life Stop-Loss Specialist about what is new at Sun Life.

For current financial ratings of underwriting companies by independent rating agencies, visit our corporate website at www.sunlife.com. For more information about Sun Life products, visit www.sunlife.com/us. Group stop-loss insurance policies are underwritten by Sun Life Assurance Company of Canada (Wellesley Hills, MA) in all states, except New York, under Policy Form Series 07-SL REV 7-12 and 22-SL. In New York, Group stop-loss insurance policies are underwritten by Sun Life and Health Insurance Company (U.S.) (Lansing, MI) under Policy Form Series 07-NYSL REV 7-12 and 22-NYSL. Policy offerings may not be available in all states and may vary due to state laws and regulations. Not approved for use in New Mexico. © 2024 Sun Life Assurance Company of Canada, Wellesley Hills, MA 02481. All rights reserved. The Sun Life name and logo are registered trademarks of Sun Life Assurance Company of Canada. Visit us at www.sunlife.com/us.

BRAD-6503-z #1293927791 02/24 (exp. 02/26)

On August 21, 2024, the Congressional Review Service estimated that Biden Administration rules submitted to the House or Senate on or after August 1, 2024, until the end of the second session of the 118th Congress, were likely to be subject to the CRA lookback provisions and will qualify for additional periods of CRA review in the first 60 session days of the 119th Congress (2025). The MPHAEA Final Rule, issued September 9, 2024, falls within the estimated lookback period, and may be subject to a CRA disapproval resolution.

Litigation: On January 17, 2025, a complaint was filed in the United States District Court for the District of Columbia by the ERISA Industry Committee (ERIC), an association representing the employee benefits interests of large employers, alleging that the Final Rule is impermissibly vague and violates the Administrative Procedures Act (APA). The plaintiffs challenged several provisions in the Final Rule on various grounds. Challenged provisions include the comparative analysis requirements, meaningful benefits standard, the material differences in access provision, and the fiduciary certification requirement.

[See ERISA Industry Committee v. Department of Health and Human Services et al., D.D.C., No. 1:25-cv00136.]

The new presidential administration will inevitably have new goals and priorities that will require action by health and welfare plans and their vendors. We expect that there will be more challenges to the Final Rule, especially the relevant data evaluation requirement and the meaningful benefits standard. It is also possible that the 119th Congress may seek to revoke the Final Rule under the APA or CRA. We will continue to monitor developments and provide insights on what to expect with regard to implementation.

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THE SELF-INSURER

STOP LOSS INSURANCE

WE’LL HELP MANAGE THE RISK. YOU’LL KEEP YOUR PROMISES. Prudential’s Stop Loss insurance helps reduce unpredictable risks from self-funded medical plans.

This way you can focus on giving your employees the coverage they deserve, while helping to reduce your worries about the increased frequency of catastrophic claims.

Get Stop Loss insurance from a partner you can rely on: • A highly rated, experienced carrier recognized for nearly 150 years for strength, stability, and innovation • Efficient, responsive service with streamlined processes across quoting, onboarding, and reimbursements • A dedicated distribution team that works hand-in-hand with your existing relationships • Flexible policy options so we can build a coverage plan that meets the unique needs of your organization Did you know, 1% of people account for a quarter of healthcare spending in the U.S.* See how Prudential can help you manage the risk from your self-funded medical plan.

For more information, contact us at stoploss@prudential.com or visit our website: www.prudential.com/stoploss

*KFF Analysis of Medical Expenditure Panel Survey data, January 2024.

Prudential Stop Loss is not available in all states. Contact your Prudential representative for more information.

Group Insurance coverage is issued by The Prudential Insurance Company of America, a Prudential Financial company, Newark, NJ. The Booklet-Certificate contains all details, including any policy exclusions, limitations, and restrictions, which may apply. Contract Series: 113830 © 2024 Prudential Financial, Inc. and its related entities. Prudential, the Prudential logo, and the Rock symbol are service marks of Prudential Financial, Inc., and its related entities, registered in many jurisdictions worldwide.

1081937-00001-00 NOT11_DG_GI1739_01

CONCLUSION

In this article, we provided a general overview of the MPHAEA Final Rule and highlighted the requirements for self-insured plans under its future effective provisions. In the next two installments, we intend to cover compliance steps in more detail and prospective compliance tools to help plan sponsors prepare for heightened regulatory scrutiny in plan years beginning on or after January 1, 2026.

Attorneys John Hickman, Ashley Gillihan, Steven Mindy, Amy Heppner, Laurie Kirkwood, and Bria Smith provide the answers in this column. John is partner in charge of the Health Benefits Practice with Alston & Bird, LLP, an Atlanta, New York, Los Angeles, Charlotte, Dallas and Washington, D.C. law firm. Ashley and Steven are partners in the practice; Amy and Laurie are senior members in the Health Benefits Practice; Bria Smith is an associate in the Employee Benefits Practice. Answers are provided as general guidance on the subjects covered in the question and are not provided as legal advice to the questioner’s situation. Any legal issues should be reviewed by your legal counsel to apply the law to the particular facts of your situation.

Readers are encouraged to send questions by E-MAIL to John at john.hickman@alston.com.

Expect More FROM YOUR PARTNERS

Premier Broker Support

Scan to learn more. ©2023 BenefitMall. All Rights Reserved.

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THE SELF-INSURER

Stop-Loss Management Services.

Claim Risk Management Solutions.

You look out for them, we look out for you.

Our team is here to help navigate and protect self-funded plans through even the most complex situations. With nearly 50 years’ experience in the stop loss business, we earn the trust of our partners and customers by following through on our promises and supporting every plan with professional, informative and responsive service.

Learn how Symetra Stop Loss can help protect your self-funded plan. Visit us at symetra.com.

NEWS

NEWS FROM SIIA MEMBERS 2025 MARCH MEMBER NEWS Provided below are news highlights from these upgraded members. News items should be submitted to membernews@siia.org.

All submissions are subject to editing for brevity. Information about upgraded memberships can be accessed online at www.siia.org.

If you would like to learn more about the benefits of SIIA’s premium memberships, please contact Jennifer Ivy at jivy@siia.org.

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NEWS

SIIA boasts a very active and dynamic membership. Here are some of the latest developments from the companies powering the self-insurance industry.

NATIONWIDE TO ACQUIRE ALLSTATE’S STOP-LOSS BUSINESS

Nationwide announced that it has entered into a definitive agreement to purchase The Allstate Corporation’s employer stop loss segment for $1.25 billion. The transaction is expected to close in the second half of 2025, subject to customary closing conditions.

"As Nationwide continues to focus on our mission to protect people, businesses and futures with extraordinary care, this acquisition is a strong fit," said Nationwide CEO Kirt Walker. "We are extending our protection solutions to meet the needs of business owners today and into the future."

"Acquiring Allstate's employer stop loss segment will broaden Nationwide Financial’s portfolio, meeting the needs of small businesses, allowing us to serve more customers and positioning us as a leading provider in the stop loss industry,” said John Carter, President and Chief Operating Officer of Nationwide Financial.

“This represents a significant investment in the stop loss market, adding experienced talent with proven business results, protecting over 13,000 small businesses and complementing our existing offerings in the market while accelerating our opportunity for growth.”

MORE THAN JUST “OFF-THE-SHELF” OPTIONS When it comes to Excess of Loss, one size doesn’t fit all. That’s why our team of experts is dedicated to delivering customized solutions that are as unique as your business. At StarLine, we pride ourselves on being concierge underwriters, offering tailored, flexible coverage options to meet your specific needs.

Visit starlinegroup.com or call (508) 809-3179 to discuss how we can get started for you.

STOP LOSS | CAPTIVE | PAYOR | PROVIDER | GROUP ACCIDENT

MARCH 2025

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NEWS UNDERWRITING MANAGEMENT EXPERTS BECOMES SIIA DIAMOND MEMBER

SIIA has announced that Underwriting Management Experts (UME) has become a Diamond member company.

Diamond membership signifies the highest level of support for SIIA and demonstrates a company’s leadership position within the self-insurance marketplace.

advocacy. Becoming a Diamond member reinforces our commitment to supporting these efforts and deepening our involvement in the industry.” – Anne Marie Chapman, CEO of Underwriting Management Experts.

H.H.C. STRENGTHENS INDEPENDENT REVIEW ORGANIZATION ACCREDITATION

H.H.C. Group (H.H.C.) announced that it successfully completed its latest URAC Monitoring Validation Review as an Independent Review Organization (IRO). H.H.C. has been a URAC-accredited IRO since 2004. URAC is the independent leader in promoting healthcare quality by setting high standards for clinical practice, consumer protections, performance measurement, operations infrastructure, and risk “UME has long appreciated SIIA’s management. By achieving this status, H.H.C. reports that it has role in shaping the self-insurance/ demonstrated its commitment to quality care, enhanced processes, patient safety, and improved outcomes. captive space and values the organization’s dedication to fostering connections, delivering industry-leading educational content, and driving impactful

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 Comprehensive and Customizable Solutions

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THE SELF-INSURER

Give Your Clients The Power of True Independence At Pinnacle Claims Management, we answer only to you and your clients, not investors.

As an independent TPA, we’re free from conflicts of interest and short-term pressures, giving you the flexibility to offer unmatched health benefits solutions that others can’t. With transparency and a focus on long-term service, we’re the partner who always puts your clients first.

Discover how PCMI’s independence can elevate your client relationships. Partner with us today.

Discover Excellence. pinnacletpa.com/excellence

NEWS JOHN BLANEY PROMOTED AT THE PHIA GROUP

The Phia Group announced the promotion of John Blaney to Executive Vice President of Transformation and Recovery Services.

In his new role, Mr. Blaney will spearhead all recovery functions, including subrogation, overpayment, and other cost containment opportunities. Mr. Blaney will leverage his decades of experience serving as an executive in the healthcare field toward streamlining operations as well as automating department-wide processes, all of which will help optimize services offered to Phia’s clients. The Phia Group’s successful growth initiatives and major investments in technology have enabled us to identify more recovery opportunities and deliver higher recoveries to our clients than any other recovery vendor in the market.

John Blaney The Phia Group

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THE SELF-INSURER

"In the short time that John has been at Phia, he has automated more processes and identified more opportunities for driving forward innovation than we previously had,” remarked Phia CEO Adam V. Russo. “He is a true partner in Phia’s mission to lower the overall cost of healthcare.”

You want unparalleled customer service. Employers need the right stop loss coverage.

At Swiss Re Corporate Solutions, we deliver both. We combine cutting-edge risk knowledge with tech-driven solutions and a commitment to put our customers first. We make it easy to do business with us and relentlessly go above and beyond to make stop loss simpler, smarter, faster and better. We’re addressing industry inefficiencies and customer pain points, moving the industry forward – rethinking employer stop loss coverage with you in mind. corporatesolutions.swissre.com/esl

Employer Stop Loss: Limit Health Care Exposure.

Advancing Self-funding Together.

Insurance products underwritten by Swiss Re Corporate Solutions America Insurance Corporation. © Swiss Re 2022. All rights reserved.

NEWS HEATHER UNDERHILL TO LEAD CUSTOMER CARE AT PARETOHEALTH

ParetoHealth announces Heather Underhill as its new Chief Customer Officer. According to a company statement, Underhill joins ParetoHealth at a pivotal moment of growth marked by increased investment in customer success and expansion of our partner ecosystem.

Previously, Underhill was Senior Vice President of Client Experience and Operations at Teladoc Health, where she supported a $1B portfolio with over 10,000 customers and transformed telehealth operations.

"At ParetoHealth, we're not just talking about change-we're leading it," said Maeve O'Meara, President of ParetoHealth.

"Heather's arrival and the continued expansion of our ecosystem are investments in making health insurance work for midsize employers and giving consultants the tools they need to win."

Heather Underhill ParetoHealth

We are your trusted advisor EMPOWERING YOUR BUSINESS WITH FIRST CL ASS PARTNERSHIPS

Tatum RE is an insurance and reinsurance intermediary that works with clients, producers, insurers, and reinsurers to design, structure and place insurance and reinsurance programs in the self-funded and broader Accident and Health market.

Tatum RE SIIA Diamond Member tatumreinsurance.com

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THE SELF-INSURER

Combined with our London UK sister company, Secan & Partners, we also access the international (re)insurance markets for our clients.

EMPOWERING SAVINGS, ELIMINATING WASTE RECLAIM 20-30% OF YOUR ANNUAL HEALTH PLAN COSTS

HCIQ’s SaaS platform helps self-insured entities to gain access to critical insights: 

Uncover high-cost medical and Rx claims, encounters, and utilization patterns



Track past, current, and future member and group risk status



Identify claims payment irregularities, fraud, abuse, and costly inefficiencies

The cornerstone of effective health plan management is a data-driven approach. Armed with the tools and data insights available through HCIQ, organizations can engage in evidence-based decision-making.

It’s time to proactively pinpoint waste in your health plan and eliminate unnecessary spending.

healthcostiq.com

Schedule a product demo with us today: healthcostiq.com

| (800) 526-3540 | info@healthcostiq.com |

NEWS ANSLEY FACILITATES SALES OF VITORI HEALTH

Ansley Capital Group represented Vitori Health in its recent sale to Global Excel Management. Vitori Health’s innovative approach to plan administration aligns perfectly with Global Excel’s global leadership in healthcare risk management.

"We're proud to have played a role in bringing these two exceptional organizations together. Congratulations to the teams at Vitori Health and Global Excel!" commented Ansley Managing Director Russ Burks.

CRUM & FORSTER EXPAND BUSINESS DEVELOPMENT TEAM

Crum & Forster’s A&H Division has announced the hiring of Michael Vaccaro as Vice President, Business Development.

In this new role, Vaccaro will be responsible for sourcing and managing all new business development efforts across both the Medical Business Unit (MBU) and the Strategic Business Unit (SBU). An industry veteran.

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THE SELF-INSURER

Michael Vaccaro Crum & Forster’s A&H Division

FLEXIBLE COMPLIANT DYNAMIC PBM Solutions To address the ever-changing pharmacy benefit complexities, PharmPix offers scalable and user-friendly solutions. OneArk™ Suite, our wholly-owned adjudication platform, backed by our clinical support team, is the business intelligence you have been looking for.

Beginning January 2027, PharmPix is proud to release our newest platform, MedArk™, intuitively built to support Medicare Part D Plans with the most recent regulations in mind.

OneArk™ and MedArk™ both offer white-label capabilities and the ultimate flexibility to create compliant and dynamic solutions. Our innovative platforms are the ideal PBM solutions you have been searching for to actively manage your Pharmacy Benefit Programs.

Manage Specialty Costs Targeted strategies maximize co-pay assistance programs and discounts that reduce up to 40% of specialty drug spend.

Proactive Technology Real-time review of claim adjudication results in savings of 5% to 25%.

Best-In-Class Network Powerful network contracting ensures members have access to care through 65,000 retail pharmacies across the U.S.

Why PharmPix? White-label capabilities Flexibility to setup any plan regardless of complexity Lowest net cost strategies Member and Prescriber Portals for easy digital access Call center built for first level resolution Clinical Programs for the best outcomes, including: Drug Utilization Review Drug Management Program Drug Reject Monitoring Clinical Edits Review

Make an Impact.

Sales@PharmPix.com

NEWS IMAGINE 360 PURCHASES HEALTHFIRST AND AFFILIATED COMPANIES

Imagine360 has announced its acquisition of Ardent Health's third-party administrator (TPA), HealthFirst.

As part of the deal, Imagine360 will also acquire two related companies—Medical Management Solutions and Risk Funding Alternatives. The medical management division will be folded into Imagine360’s team.

HealthFirst was the TPA partner of UT Health East Texas, a health system jointly owned by the University of Texas and Ardent Health, for nearly 30 years. The health system has more than 2,300 providers and covers more than 14,000 patients.

"That was attractive to us," said Imagine360 President and CEO Jeff Bak in an interview with Fierce Healthcare. “What we saw in our review was a really good claims administrative system.”

CHRISTINA CARLSON JOINS SYMETRA

Symetra Life Insurance Company, announced the appointment of Christine Carlson as Vice President, Stop-Loss Claims.

Christine Carlson Symetra

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THE SELF-INSURER

Ms. Carlson joins Symetra from Tokio Marine HCC, where, as Senior Vice President, Claims Operations & Innovation, she managed a $2 billion portfolio. She previously held senior claims positions at Blue Cross and Blue Shield of Minnesota.

Strong relationships.

More solutions.

Partner with Nationwide® to simplify Medical Stop Loss for you and your clients.

Save time and effort with easy access to experienced underwriters who offer a broad range of solutions. Our flexible plans are tailored to fit your clients’ needs and reduce future risk. Plus, claims are backed by a carrier with A+ financial ratings.* As a leader in Medical Stop Loss coverage for 20 years, and in the health business for more than 80 years, you can trust Nationwide to take care of you and your clients.

To learn why top Medical Stop Loss producers and underwriters choose Nationwide, email stoploss@nationwide.com or visit nationwidefinancial.com/stoploss. *A+ ranking from AM Best received 10/17/02, affirmed 12/7/23, and A+ ranking from Standard & Poor’s received 12/22/08, affirmed 5/16/23.

Plans are underwritten by Nationwide Life Insurance Company, Columbus, OH 43215. CA COA #7032. In Hawaii, Louisiana and Oregon, plans are underwritten by Nationwide Mutual Insurance Company, Columbus, OH 43215.

Nationwide, the Nationwide N and Eagle, and Nationwide is on your side are service marks of Nationwide Mutual Insurance Company. © 2024 Nationwide NSV-0122AO (01/24)

MARCH 2025

65

NEWS "We are delighted to welcome Christine as our new VP of Stop-Loss Claims," said Jeremy Freestone, Senior Vice President, Stop-Loss Business Strategy. "Our stop loss unit is a critical component of the solutions-driven product suite we offer employers looking to effectively manage their healthcare costs.

Christine's extensive claims management experience, her passion for optimizing processes, leading cost containment initiatives, driving innovation, and building strong partnerships will be invaluable assets as we continue to deliver on our reputation for superior claims experience."

ALLIANT INSURANCE BENEFITS EXPANDS PRESENCE IN SOUTHEAST WITH NEW HIRE

Justin Davis has joined Alliant Insurance Services as a Producer within its Employee Benefits Group. Based in Virginia and focusing on the Southeast region, Davis will provide tailored benefits solutions to a wide-ranging portfolio of small, midsized, and large national clients.

Davis has extensive expertise in self-funded healthcare solutions, alternative funding arrangements, ancillary benefits, and employee education. His background serving on both the carrier and consulting sides of the business has provided him with a depth of experience in health, life, disability, dental, vision, supplemental coverage, and Medicare.

Justin Davis Alliant Insurance Services

“Justin takes a proactive approach to the benefits consulting process, working diligently to find the most creative solutions to meet the needs of the client and their employees,” said Kevin Overbey, President of Alliant Employee Benefits. “His ability to combine service, problem-solving, and market knowledge provides a powerful advantage for his diverse client base.”

NOVA EARNS URAC ACCREDITATION

Nova Healthcare Administrators, Inc. (Nova) announced it has earned URAC accreditation for Case Management. URAC is the independent leader in promoting healthcare quality by setting high standards for clinical practice, consumer protections, performance measurement, operations infrastructure, and risk management.

Coupled with URAC accreditation in Health Utilization Management, receiving re-accreditation for Case Management reflects Nova’s adherence to rigorous clinical and operational standards, including excellence in care coordination, improved patient engagement, service access and utilization and transitions of care. N “We are honored to receive URAC accreditation in case management,” said Lorene Barulich, Manager, Clinical Programs & Strategy at Nova. “This recognition underscores our commitment to delivering exceptional care coordination and support to members. By adhering to URAC’s rigorous standards, we ensure that our case management programs continue to provide meaningful, personalized assistance that improves health outcomes and enhances the overall member experience.”

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Considering RBP? Go with the MVP Reign in healthcare costs and take better care of employees with a health plan from the experts at Imagine360.

Your health plan can do better.

We promise.

imagine360.com

NEWS BOON-CHAPMAN ADDS STOP-LOSS SPECIALIST TO MANAGEMENT TEAM

BOON-CHAPMAN ANNOUNCED THE APPOINTMENT OF TIMOTHY BRACCO AS VICE PRESIDENT, STOP-LOSS

Bracco brings over 25 years of industry experience, having held leadership roles in stop-loss claims management, audit operations, and innovative product development. His career spans large insurance carriers, MGUs, and TPAs, where he specialized in driving operational efficiency and integrating advanced technologies, such as AI-based underwriting systems.

"Stop loss insurance is the unsung hero of self-insured health plans. Tim's extensive background, operational savvy, and adept understanding of the nuances within stop-loss coverage will advance our Stop Loss operations and empower our clients to make informed financial decisions that align with their long-term health plan objectives," said Kari L. Niblack, President of BoonChapman.

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Timothy Bracco Boon-Chapman

Zero in on catastrophic claims risks.

Curv® can isolate risk above a specified individual stop-loss threshold, giving finely tuned insight into potential high-cost claims. Depend on Curv’s predictive analytics for more accurate pricing across your spectrum of underwritten groups. rxhistories.com/curv/group-health

Milliman IntelliScript

Prior to joining Boon-Chapman, Bracco was the Vice President of Accident and Health Audit Solutions at a leading insurance services company and previously served as the Director of Stop Loss Operations at a carrier with an in-house TPA, where he led claims processing system development and financial process optimization. His strategic insights have consistently helped organizations adapt to the evolving insurance landscape.

LOU FISCELLA JOINS H.H.C. GROUP

H.H.C. Group has hired Lou Fiscella as Vice President of Sales.

Fiscella brings over 20 years of experience in healthcare sales, strategy and client relationship management, most recently serving in leadership roles at CVS Health/Aetna.

"Lou brings a combination of proven sales acumen and client service expertise, attributes that will further enhance the delivery of our cost-containment services," says Bruce Roffé, President and CEO, H.H.C. “His industry experience, particularly in marketing healthcare solutions to providers, TPAs and self-funded employers, will help expand our reach and effectively communicate the value of H.H.C.’s services to a broader range of healthcare payors.”

Lou Fiscella H.H.C. Group

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Changing the way healthcare is Financed, Disclosed and Delivered 70

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Better outcomes.

Long-term cost savings.

Mayo Clinic Complex Care Program

52% experienced a change in diagnosis

85%

experienced a change in treatment plan

23%

avoided a locally recommended surgery

Discover how a customizable center of excellence program can help minimize healthcare costs while offering high-cost, high-risk members exactly the care they need.

The Mayo Clinic Complex Care Program is for a small subset of a population with serious, complex or rare conditions who need subspecialized expertise that may not be available locally.

Learn more by calling 507-422-6103 or visit us online at mayoclinic.org/complex-care-program

© 2024 Mayo Clinic

Based on medical record review of 516 patients, from multiple employers, referred into the Mayo Clinic Complex Care Program in 2023.

2025 SELF-INSURANCE INSTITUTE OF AMERICA BOARD OF DIRECTORS

CHAIRMAN OF THE BOARD*

DIRECTOR

Matt Kirk President The Benecon Group

Matthew Smith Managing Director Risk Strategies

CHAIRPERSON ELECT,

DIRECTOR

TREASURER AND CORPORATE SECRETARY*

Amy Gasbarro President ELMCRx Solutions DIRECTOR

Mark Combs CEO/President Self-Insured Reporting DIRECTOR

Orlo “Spike” Dietrich Operating Partner Ansley Capital Group DIRECTOR

Beth Turbitt Managing Director Aon Re, Inc.

VOLUNTEER COMMITTEE CHAIRS

Captive Insurance Committee George M. Belokas, FCAS, MAAA President Beyond Risk Future Leaders Committee Erin Duffy Director of Business Development Imagine360

Jeffrey L. Fitzgerald Managing Director SRS Benefit Partners Strategic Risk Solutions, Inc.

Price Transparency Committee Christine Cooper CEO aequum LLC

DIRECTOR

Cell and Gene Task Force Ashley Hume President Emerging Therapy Solutions®

Mark Lawrence President HM Insurance Group

* Also serves as Director

72

THE SELF-INSURER

2025 BOARD OF DIRECTORS

SIEF CHAIRMAN

Nigel Wallbank President New Horizons Insurance Solutions Wellington, FL SIEF PRESIDENT

Dani Kimlinger, PhD, MHA, SPHR, SHRM-SCP Chief Executive Officer MINES & Associates, Inc Littleton, CO

Do you aspire to be a published author?

We would like to invite you to share your insight and submit an article to The Self-Insurer! SIIA’s official magazine is distributed in a digital and print format to reach 10,000 readers all over the world.

DIRECTORS

The Self-Insurer has been delivering information to top-level executives in the self-insurance industry since 1984.

Matt Hayward Office President Ryan Specialty Benefits Greenwood Village, CO

Articles or guideline inquires can be submitted to Editor at Editor@sipconline.net

Les Boughner Chairman Advantage Insurance Management (USA) LLC Charleston, SC

Elizabeth Midtlien Vice President, Emerging Markets AmeriHealth Administrators, Inc. Bloomington, MN

The Self-Insurer also has advertising opportunties available. Please contact Shane Byars at sbyars@ sipconline.net for advertising information.

Jonathan Socko Senior Vice President East Coast Underwriters, LLC Spartanburg, SC

MARCH 2025

73

SIIA NEW MEMBERS MARCH 2025

REGUL AR CORPORATE MEMBERS Ali Panjwani Founder & CEO Merit Medicine Austin, TX Amil Patel Co-Founder & CEO Meeko Health San Francisco, CA Ben Dewar SVP Business Development Strategic Benefit Resources Atlanta, GA Dalton Poole Director of Sales HeadsUp Healthcare Tampa, FL Erica Armstrong MD Root Functional Medicine Grand Rapids, MI

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THE SELF-INSURER

James LeRoy President JKL Enterprises St. George, UT June Castle CFO Nascentia Health Syracuse, NY Peter Parent President Innovative Stop Loss Solutions Portland, ME Rachel Benton Director, Payer Product & Operations Promise Health Plan Greenville, SC Richard Phillips President & CUO Reinsurance Program Managers, LLC Whitehouse Station, NJ Shannon Elizabeth Director or Customer Success Quantify Specialty Care Dublin, OH

SILVER MEMBERS Jeff Bloom Chief Revenue Officer Healthcare2U Austin, TX

EMPLOYER MEMBERS Lauren Haddox Director of Risk & Benefits Mgmt.

The School Board of Osceola County Florida Kissimmee, FL Natasha Andrews Assistant Director of Employee Medical Health Plan Suffolk County Department of Civil Service Hauppauge, NY

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*

Cost estimate based on HM Insurance Group historical Stop Loss data and additional industry observations, May 2024.

Underwritten or reinsured by HM Life Insurance Company, Pittsburgh, PA; HM Life Insurance Company of New York, New York, NY; or Bridge City Insurance Company, Pittsburgh, PA.