Employers On the Line: Personal Liability for Corporate Officers Under the CAA

Employers On the Line: Personal Liability for Corporate Officers Under the CAA

The Consolidated Appropriations Act of 2021 (CAA) is making major waves in the self-insured employer space, with a core focus on transparency and proper stewardship of employee benefit plans. However, for over a year, the CAA lay relatively dormant, with delays in enforcement and litigation — until Johnson & Johnson (J&J).

CAA Litigation Has Arrived — For Employers and Corporate Officers

The J&J lawsuit represents the first landmark in CAA litigation, with an unprecedented employee class action lawsuit against excessive prescription drug spending. Digging deeper, we find that J&J’s benefits consultant and pharmacy benefits manager (PBM) allegedly served as the primary drivers of these exorbitant pharmacy costs, preventing a fair and open RFP due to rampant conflicts of interest and hidden profits. The J&J suit is only the beginning — we’re already seeing several new lawsuits come to light as employers are now held accountable for the fiduciary non-compliance of their benefits vendors.

The story doesn’t stop there. Not only are companies as a whole on the hook for fiduciary obligations across their plans, but chief officers themselves are now personally held liable as well. CAA enforcement letters, released by the Centers for Medicare & Medicaid Services (CMS) with state-specific provisions, are now calling for thorough compliance investigations and, if necessary, enforcement action on both personal and enterprise levels.

Three Steps Employers Can Take to Root Out Non-Compliance

Recent legal action has made one thing clear: the CAA can no longer be ignored. Employers can no longer claim ignorance of CAA requirements if non-compliance is found, even among their benefits vendors and service providers. The question for many employers now is how to ensure fiduciary compliance with existing vendors, especially PBMs that coordinate drug pricing and administration between pharmacies, drug manufacturers, and health plans. Per the CAA, a plan sponsor’s fiduciary duty is to ensure the plan solely acts in the interest of its participants and beneficiaries.

How does this look in practice?

  1. Demand alignment and transparency from every vendor and service provider that touches your pharmacy plan.
  2. Certify that every vendor’s compensation is reasonable and holds no conflicts of interest that undermine the value of the plan.
  3. Gain full access to your healthcare data to maintain total oversight over service providers and responsibly manage plan assets.

By comparing prescription drug cost trends and employee cost-sharing structures against manufacturer rebates and administrative fees, employers can identify how appropriately plan assets are being managed, as well as any sources of fiduciary non-compliance.

This process, however, is time-consuming and costly, and it grows even more complex when vendors do not embed fiduciary compliance from the start. That’s why more employers are partnering with a fiduciary PBM like US-Rx Care. When you know your PBM is fully compliant you can gain peace of mind that your pharmacy benefit plan is offering the most value to your participants without opening the door to corporate and personal legal action.

Learn more about how US-Rx Care meets fiduciary standards and sharply cuts the cost of prescription drugs for plan sponsors and plan enrollees while protecting employers from fiduciary non-compliance.

How Fiduciary PBMs Are Solving Traditional Pharmacy Benefit Management Problems

How Fiduciary PBMs Are Solving Traditional Pharmacy Benefit Management Problems

For years, pharmacy benefits managers (PBMs) were left alone to oversee every part of a pharmacy benefits plan from behind the scenes. Without close oversight, PBMs manipulate pricing, contract terms, formularies, and pharmacy sourcing to their benefit. Fortunately, with recent changes to pharmacy regulation, PBMs are now under fire to answer for their many conflicts of interest and financial incentives they use to pad their bottom line. As a result, more self-insured employers and brokers are evaluating their contracts for these issues and exploring new options to protect the best interests of their plans.

Spotting the Gaps in Traditional PBM Models

Traditional PBMs, including the “Big Three”, have long been criticized for severely inflating the costs of prescription drugs and embedding conflicts of interest throughout the entire benefit. Boiling it down, these are the top three challenges we see in the traditional model:

  1. Opaque pricing and rebates. Despite negotiating rebates and discounts with manufacturers, PBMs often pass little to none of these savings to the plan. Complex rebate structures and a lack of transparency about rebate distribution ultimately lead to consistent price hikes for needed prescription drugs, leaving plan sponsors unaware if their rebates are being used to lower pharmacy spend or funneled into PBM profits.
  2. Spread pricing. The traditional PBM model often generates gaps in what the PBM charges the plan for a certain medication and how it reimburses the pharmacy — with the PBM extracting profits from the difference, or spread, between those two numbers. This hidden source of revenue can skyrocket drug costs and degrade plan value.
  3. Lack of transparency. PBMs are notorious for a lack of transparency in how they manage a plan’s pharmacy benefit. This includes limited access to data around drug pricing, rebate distribution, and the fees included in the PBM contract. By keeping this data behind closed doors, traditional PBMs are not held accountable for how they manage pharmacy costs.

How a Fiduciary Partner Closes the Gaps

Standing in direct opposition to a traditional PBM is a fiduciary partner — a different type of PBM that is now a requirement for self-insured employers, per the Consolidated Appropriations Act of 2021.1 The fiduciary PBM model represents a fundamental shift in pharmacy benefits administration, shifting the focus from maximizing PBM profits to optimizing client outcomes, both clinically and financially, by:

  1. Prioritizing plan interests. By definition, a fiduciary must hold a deep commitment to promoting the best interests of the plan only. Unlike traditional PBMs, fiduciaries align their solutions with the goals of each employer, eliminating conflicting incentives due to rebates, spread pricing, and other sources of hidden revenue. A fiduciary’s formulary management strategies are solely based on clinical efficacy and cost-effectiveness, ensuring that the best interests of the plan sponsor and enrollees are always top of mind.
  2. Ensuring cost transparency. Instead of keeping employers away from their utilization data, fiduciaries disclose all costs associated with managing the entire pharmacy benefit. Employers receive regular, detailed information about what the plan paid for each medication, including how manufacturer rebates and PBM fees were used. By providing 100% transparency, fiduciary PBMs help plan sponsors understand exactly how plan assets are utilized, helping employers budget accurately and make informed decisions to enhance plan value.
  3. Delivering equitable benefits. Prioritizing the best interests of the plan with complete transparency naturally provides equitable benefits to each enrollee. By focusing on how to best meet clinical needs with cost-effective practices, fiduciary PBMs help plan sponsors make needed medical therapies affordable and accessible to their enrollees, driving better outcomes at a lower cost. This patient-centric approach not only enhances quality of care but also drives consistent, measurable reductions in pharmacy spend.

With a fiduciary partner like US-Rx Care, you can deliver the best of both worlds: richer benefit value at a lower cost. Learn more about how US-Rx Care’s fiduciary PBM solutions can safeguard your organization against predatory PBM practices to reduce pharmacy spend up to 50% or more in the first 12 months.


Sources

  1. Consolidated Appropriations Act, 2021 (CAA). (2024, January 26). U.S. Centers for Medicare & Medicaid Services. https://www.cms.gov/marketplace/about/oversight/other-insurance-protections/consolidated-appropriations-act-2021-caa
US-Rx Care Partners With GoodRx to Complement Its National Pharmacy Network

US-Rx Care Partners With GoodRx to Complement Its National Pharmacy Network

Fiduciary pharmacy benefits organization US-Rx Care is proud to announce the addition of GoodRx to its national pharmacy network. GoodRx is one of the nation’s most recognizable providers of “cash discount” prices on prescription medications, used by millions of individuals throughout the U.S. annually. This relationship augments US-Rx Care’s own network pharmacy contracts to access GoodRx discounts in the event that the GoodRx price is better for a given drug on a given day at a particular pharmacy. This helps self-insured employers strengthen overall benefit value and provides the best possible care to their enrollees.

This unique savings opportunity automatically checks the GoodRx “cash price” discounts at the point of dispensing. Instead of searching on their own for additional savings through GoodRx, plan members can simply present their US-Rx Care health benefits card to the pharmacy, which will compare the US-Rx Care network rate with the GoodRx cash price. The member will always pay the lower amount and earn credit towards their deductibles and out-of-pocket maximums with no paperwork or reimbursement forms to submit. Through this integrated approach, US-Rx Care and GoodRx are working side-by-side to deliver the savings and quality of care that employers and enrollees both expect and deserve.

“As a fiduciary PBM, US-Rx Care puts the best interest of employers and their plan enrollees ahead of anything else,” said Renzo Luzzatti, US-Rx Care Founder and President. “By partnering with GoodRx, we continue to deliver on our fiduciary responsibilities by making it simple for employers to avoid conflicts of interest in their pharmacy plans and drive greater value for their plan enrollees.”

US-Rx Care maintains full contractual adherence to fiduciary duties, ensuring employers with self-sponsored health plans reduce wasteful spending and provide needed medical therapies to their plan members at the most affordable cost. Together, US-Rx Care and GoodRx are committed to enhancing price transparency and increasing flexibility for employer-sponsored pharmacy benefits. By eliminating hidden profits and deconflicting the complex processes within pharmacy benefits management, these two organizations now offer a more cost-effective, clinically responsible, and high-value pharmacy benefits solution.

About US-Rx Care

US-Rx Care is a fiduciary pharmacy benefits organization. We grew up in the health plan environment, working for and consulting to multiple Medicare, Medicaid, and commercial health insurers for over thirty years. At US-Rx Care, clients have access to proven pharmacy risk management programs and solutions that have consistently delivered 30%-50% reductions or more in pharmacy benefit spend for at-risk health plan sponsors. We have also assisted multiple plans achieve dramatic increases in HEDIS / Stars quality scores despite ever increasing thresholds to achieve a 5 star rating.

Full PBM Model or Utilization Management Only? Choosing the Best Pharmacy Benefits Option

Full PBM Model or Utilization Management Only? Choosing the Best Pharmacy Benefits Option

Building a high-value benefits plan is crucial for self-insured employers to control costs while improving employee satisfaction. However, this is easier said than done on the pharmacy side of healthcare benefits, as prescription drug costs continue to rise in response to a myriad of factors, including inflationary pressures, utilization, and, most notably, the conflicted PBM relationship characterized by hidden profits at the expense of plan sponsors and enrollees.1

Employers who self-sponsor their health plans take a front seat in their pharmacy benefit plan decisions, but selecting the right solution can be challenging due to binding contract terms and a lack of transparency from PBMs. That’s why clinical pharmacy organizations like US-Rx Care provide more than one option, allowing employers to choose the solution that best fits their needs while providing the highest value possible — whether it’s full pharmacy benefits management or behind-the-scenes utilization management.

Piece-Meal or Full-Service: Evaluating Pharmacy Benefits Solutions

Selecting the right pharmacy benefits solution depends on a number of factors, including existing vendor relationships, financial considerations, and overall goals for your pharmacy plan. Self-insured employers can select one of these two solutions:

  • Pharmacy benefits management. The full PBM model encompasses every service that touches the pharmacy benefit, including formulary management, claims processing, pharmacy network management, medication management, and specialty pharmacy services. This comprehensive approach provides an all-in-one solution to help employers streamline pharmacy benefits administration by keeping all prescription drug information in one place.
  • Utilization management. Instead of an all-inclusive solution, employers can leverage utilization management to establish a stronger clinical backbone within their existing PBM relationship. This solution focuses entirely on reviewing prescription drug claims through a clinical lens, with a team of healthcare professionals working to ensure members receive the best possible medication at the lowest available price. By targeting utilization patterns and promoting cost-effective prescribing practices, this solution aims to control pharmacy costs while ensuring appropriate medication utilization.

Maximize Savings and Satisfaction With a Fiduciary Partner

Despite best appearances, a PBM or utilization management organization will fail to provide optimal savings if they do not contractually adhere to fiduciary responsibilities — the same standards that self-insured employers are required to follow. A fiduciary partner like US-Rx Care can fundamentally transform an employer’s pharmacy benefit plan, leveraging a PBM or utilization management solution to unlock higher value and deliver maximum savings for both the plan and its enrollees.

The core difference between traditional and fiduciary PBMs is the ultimate goal of their efforts. Where traditional PBMs notoriously seek opportunities for profit, a fiduciary only works in the plan’s best interest, operating with full price transparency and eliminating every conflict of interest. By removing hidden profits from the equation, fiduciaries can negotiate lower prices, optimize formularies to only include the appropriate medications, and implement cost-saving strategies tailored to each employer’s plan needs.

Choose the PBM That Works For, Not Against, Your Plan

As a leader in the fiduciary PBM space, US-Rx Care has the clinical and pharmacy benefit administration expertise necessary to sharply cut the costs of needed prescription drugs. Our full PBM solution is proven to save up to 50% on pharmacy benefit costs in just 12 months for self-insured employers. Alternatively, employers who wish to keep their PBMs can carve out utilization management and prior authorization functions to our clinically-based Right Rx program. By advocating strictly for your enrollee’s best interest, Right Rx saves an average of $15-$25 per enrollee per month with over 30% or greater out-of-pocket savings for non-specialty, specialty, and J-code prescription drugs. Whether your organization is looking for partial or full pharmacy optimization, US-Rx Care has the tools and cost-saving frameworks in place to deliver the savings and plan value your enrollees deserve.

Learn more about US-Rx Care’s pharmacy benefit services to discover which solution is best for your plan.


Sources

  1. Wager, E., Telesford, I., Cox, C., Amin, K. (2023, September 15). What are the recent and forecasted trends in prescription drug spending? Peterson-KFF Health System Tracker. https://www.healthsystemtracker.org/chart-collection/recent-forecasted-trends-prescription-drug-spending/#Annual%20change%20in%20per%20capita%20retail%20prescription%20drug%20spending,%201970%20-%202021;%20projected%202022%20-%202031%C2%A0
The Diabetes Dilemma: Balancing Effective Treatment with Cost Efficiency in Healthcare

The Diabetes Dilemma: Balancing Effective Treatment with Cost Efficiency in Healthcare

Diabetes remains a leading chronic condition impacting over 38 million people in the United States — over 11% of the population.1 Due to a myriad of lifestyle, environmental, and genetic factors, the prevalence rate is expected to continue its upward spiral, with more than one million new cases per year through 2030. As the healthcare spotlight continues to shine on diabetes management, self-insured employers will grow increasingly responsible for bearing the financial burden of this complex, chronic, and costly condition.

A Widespread and Growing Concern for Self-insured Employers

While the current prevalence rate is substantial, we can expect numbers to skyrocket in coming years, as one in three Americans are prediabetic and likely to develop type 2 diabetes, in conjunction with other life-threatening diseases such as heart disease and stroke.2 Only 1.7 million out of the 38 million diabetics have type 1, signaling the primary role of obesity in the onset of diabetes.1 Looking at current statistics for obesity, we can predict a corresponding increase in the number of diabetes cases if obesity is left untreated:

  • Nearly 42% of adults and 20% of children and adolescents are obese.3,4
  • From 1999-2000 to 2017-2020, the adult obesity rate increased by 37%.5
  • From 1999-2000 to 2017-2020, youth obesity increased by 42%.5

With the growing number of individuals who need medical management for diabetes, new treatments have quickly emerged to manage blood sugar more effectively and help patients achieve an improved state of health — with the added benefit of significant weight loss.

Emerging Treatments for a Complex Condition

Insulin is the long-standing treatment for an estimated 27% of diabetics, most of whom have type 1.6 However, type 2 diabetics often need additional or alternative treatment. The standard medication therapy typically starts with Metformin, along with diet and exercise modifications. If Metformin alone at optimal dosing is ineffective, Sulfonylureas (Glipizide) or Thiazolidinedione (Pioglitazone) may be added to the treatment protocol. The goal is to reduce Hemoglobin A1c (HbA1c) levels, a standardized metric for blood sugar levels, to below the diabetic range (6.4% and above).

If these initial therapies are in place for at least three months and fail to lower HbA1c below 6.4%, patients can begin taking glucagon-like peptide-1 receptor (GLP-1) agonists, such as Ozempic, Wegovy, or Mounjaro. GLP-1s are used to treat both type 2 diabetes and obesity by slowing the movement of food from the stomach to the small intestine, which reduces appetite and feelings of hunger. GLP-1s can be used with the maximum dose of Metformin when a patient is obese with type 2 diabetes. However, despite its proven efficacy in treating diabetes and obesity, not all GLP-1s are as effective as others and can cause serious side effects, including gastric stasis, pancreatitis, and, in rare cases, thyroid cancer.7

The Role of Financial Incentives in GLP-1 Treatment Trends

Despite the potentially dangerous side effects, GLP-1s have exploded in utilization in recent years, beginning with off-label use for weight loss and now through the FDA-approved Wegovy dosage designed for treating obesity. However, because generic versions of GLP-1s have yet to be approved, manufacturers and pharmacy benefit managers (PBMs) are taking full advantage of the opportunity to boost their margins for these popular brand-name medications.

GLP-1 manufacturers typically offer “Class of Trade” financial incentives, instead of rebates, to PBMs to ensure placement on the PBM’s formulary and to incent the dispensing of GLP-1s from the PBM’s mail-order pharmacy. These class of trade incentives have resulted in minimal clinical oversight required by the PBMs to approve the use of GLP-1s. In most cases, PBMs will give their stamp of approval if there is evidence of past or current treatment with Metformin — without investigating whether HbA1c levels indicate the existence of type 2 diabetes.

PBMs have struck gold with GLP-1s, as the combination of class of trade financial incentives with the highly sought-after weight loss effects has exponentially increased utilization and sales, with projections of over $71 billion by 2032, according to J.P. Morgan.8 However, by placing profit over outcomes, PBMs are to blame for the continual escalation of GLP-1 utilization and prices — without close consideration of if/how these medications will truly impact clinical outcomes.

Containing Costs With Fiduciary Utilization Management

Working in direct opposition to traditional PBMs, a fiduciary utilization management partner operates only in the best interests of the plan sponsor and its enrollees. By focusing on medical necessity and clinical rigor, a fiduciary clinical services program like US-Rx Care’s Right Rx service can generate substantial cost savings without compromising patient outcomes. Compared to the current “open floodgate” PBM model, proper GLP-1 utilization management should lead to a 50% cost reduction that enhances the value and integrity of self-insured pharmacy benefit plans.

Learn more about how US-Rx Care can help your self-insured plan optimize GLP-1 utilization management by eliminating financial incentives.

Sources

  1. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States. (2023, November 29). CDC. https://www.cdc.gov/diabetes/data/statistics-report/index.html
  2. Prediabetes. (2022, December 30). CDC. https://www.cdc.gov/diabetes/basics/prediabetes.html
  3. Adult Obesity Facts. (2022, May 17). CDC. https://www.cdc.gov/obesity/data/adult.html
  4. Childhood Obesity Facts. (2022, May 17). CDC. https://www.cdc.gov/obesity/data/childhood.html
  5. The State of Obesity: Better Policies for a Healthier America. (September 2022). Trust for America’s Health. https://www.tfah.org/wp-content/uploads/2022/09/2022ObesityReport_FINAL3923.pdf
  6. Weinger, K., & Beverly, E. A. (2010). Barriers to achieving glycemic targets: who omits insulin and why?. Diabetes care, 33(2), 450–452.
  7. Lisco, G., De Tullio, A., Disoteo, O., Piazzolla, G., Guastamacchia, E., Sabbà, C., De Geronimo, V., Papini, E., & Triggiani, V. (2023). Glucagon-like peptide 1 receptor agonists and thyroid cancer: is it the time to be concerned?. Endocrine connections, 12(11), e230257.
  8. Dunleavy, K. (2023, September 11). Novo, Lilly set to dominate $71B GLP-1 drug market by 2032: J.P. Morgan. Fierce Pharma. https://www.fiercepharma.com/pharma/after-promising-heart-data-novo-nordisks-wegovy-jp-morgan-doubles-2032-market-projection-71b