Vickers Consulting

This does not even include the significant number of illegal FDA-unapproved prescription drugs dispensed through retail and through mail order. https://lnkd.in/eJWzimvb

State Employee Health Plan - 1 year - 0.87% of claims are FDA-unapproved medications, with a total ingredient cost of $659,136.85. Why does this specific PBM formulary include many FDA-unapproved medications, when this PBM has stated that their Pharmacy & Therapeutics Committee reviews all medications for FDA approval? This PBM's mail order facility resides in a state that prohibits the dispensing of FDA-unapproved medications, and as per the State Board of Pharmacy regarding this issue, "The Board has authority to deny, condition, restrict, suspend, place on probation, or revoke a registration. They can also impose a fine of up to $5,000 per violation." We do not charge for our pharmacy compliance assessment to identify unapproved medications. #PBM #pharmacy #pharmacybenefits #employeebenefits #humanresources #compliance

7,000+ National Drug Codes for illegal FDA-unapproved medications charged by PBMs and carriers every day to plans of all types throughout the country, including employers, health plans, and state Medicaid plans. We provide complimentary pharmacy compliance reviews, and we have confirmed findings in 100% of the hundreds of assessments that we have provided. This is about patient safety, plan compliance, fiduciary responsibility, and wasteful dollars spent on these drugs. PBMs, MCOs, carriers, and TPAs cannot stop this so everyone should be aware that they are being charged for illegal medications. We want to help every plan sponsor eliminate their risk and avoid the next massive whistleblower lawsuit. #pharmacy #PBM #pharmacybenefits #employeebenefits #humanresources #compliance #ERISA #Medicaid

Language below from the "Code of Conduct" from a large MCO/PBM that administers prescription benefits for millions of Medicaid members. This language directly conflicts with our pharmacy compliance assessment findings for several state Medicaid programs that utilize this MCO/PBM: STATE 1 - $120 million billed for illegal FDA-unapproved medications, including $79 million billed for one unapproved prenatal vitamin ($3,400 PER PRESCRIPTION) and $24 million billed for one unapproved topical (For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation - $5,900 PER PRESCRIPTION) STATE 2 - $15 million billed for illegal FDA-unapproved medications, including $3.5 million billed for one unapproved topical (For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation - $2,845 PER PRESCRIPTION) and $3.1 million billed for one unapproved topical (combination of two generic topicals - $2,535 PER PRESCRIPTION) STATE 3 - $25.6 million billed for illegal FDA-unapproved medications, including $522,000 billed for one unapproved topical ($3,900 PER PRESCRIPTION), $122,000 billed for one unapproved topical (combination of two generic topicals - $2,400 PER PRESCRIPTION), $930,000 billed for one unapproved dietary supplement ($1,900 PER PRESCRIPTION), $2 million billed for one unapproved dietary supplement ($915 PER PRESCRIPTION). [MCO/PBM] is subject to both federal and state laws designed to prevent fraud and abuse in government programs (such as Medicare, Medicaid, Federal Procurement and other programs) and private insurance. These laws are commonly referred to as fraud and abuse laws. [MCO/PBM] has corporate policies and procedures in place to address fraud, waste, and abuse. The policies regarding fraud, waste, and abuse include the Federal Compliance Program; Medicaid: Compliance Program and Medicaid: Program Integrity and Compliance Program. The Federal False Claims Act is a federal statute that covers claim fraud involving any federally funded contract or program, including the Medicare and Medicaid programs. The Act establishes liability for any person who knowingly presents or causes to be presented a false or fraudulent claim to the U.S. Government for payment.?As part of [MCO/PBM's] compliance program for the prevention of fraud and abuse, [MCO/PBM] complies with all state and federal billing requirements for government-sponsored programs, and other payers. [MCO/PBM] will not tolerate false claims to a government agency or other payer. [MCO/PBM] is committed to complying with the letter and spirit of these laws and regulations. [MCO/PBM} will uphold our legal obligations:? comply with all applicable laws and regulations and honor contractual obligations. #pharmacy #pharmacybenefits #PBM #Medicaid #managedcare #compliance #fraud

NP Thyroid is an illegal FDA-unapproved drug that we have identified in nearly every one of our hundreds of provided pharmacy compliance assessments. Why is this drug listed in so many PBM formularies, health plan formularies, and State Medicaid formularies? Unfortunately, there are thousands more FDA-unapproved drugs billed to plan sponsors by PBMs and health plans, many with FDA warning letters sent to their manufacturers, recalls, and multiple lawsuits. Ask your broker or consultant how much your plan is being charged for illegal FDA-unapproved medications, creating significant patient safety risk and plan fiduciary responsibility risk, and then tell them to contact us since we are the only firm in the country that can provide this figure. #pharmacy #pharmacybenefits #pbm #employeebenefits #humanresources #compliance #ERISA #Medicaid https://lnkd.in/ec-tRYWp

Here are some interesting items from the defense motion to dismiss in the Johnson & Johnson case. ESI includes FDA-unapproved medications on their formularies, so a significant disconnect exists. "Under the Plan, participants are eligible to obtain virtually any prescription drug approved for use in the United States." Additional language in the?Summary Plan Description:?Prescription Drug Coverage Details Supplement "Therefore, since the FDA does?not confirm their quality, safety and effectiveness, compound medications are not covered?under the prescription drug plan for non-Medicare-eligible individuals." "Medications that are non-FDA approved or that offer no therapeutic improvement including compounding kits, pain patches or topical creams/ointments or gels are not covered under the plan." "Your doctor will need to provide Express Scripts with detailed information to?ensure it is being utilized based on FDA-approved prescribing and safety information, clinical?guidelines and uses that are considered reasonable, safe and effective."

So why do PBMs, carriers, and health plans include these medications on their formularies, and why do they charge plan sponsors for them, since they are not legal? "Thousands of prescription drugs are marketed without approval, which is approximately 2% of the prescriptions filled in the U.S. annually. Why Are unapproved drugs a public health problem? 1. Unapproved drugs may be unsafe - the absence of proof of a problem is not proof of the absence of a problem. 2. Unapproved drugs may be ineffective. 3. The product labeling for unapproved drugs is not FDA-approved. 4. Concerns regarding the manufacturing processes for unapproved drugs and changes in the formulations of these products - the potential for drug quality deficiencies exists. 5. No opportunity for FDA to review and approve trade names to minimize potential safety issues caused by name confusion between marketed drugs. 6. Challenge the integrity of the drug approval system. 7. Limited post-market surveillance - no periodic reporting. 8. There is a common misconception amongst healthcare practitioners and consumers that all marketed drugs are FDA-approved, and therefore are assumed to be safe and effective." - Division of New Drugs and Labeling Compliance, Office of Compliance, Center of Drug Evaluation and Research, Food and Drug Administration #pharmacy #pharmacybenefits #PBM #employeebenefits #humanresources #medicaid #ERISA #compliance

As per a prominent Blue Cross Blue Shield plan from their 2024 formulary guide: "The medications listed have been approved by the Food and Drug Administration (FDA) as safe and effective and were selected in consultation with a team of health care professionals because they meet our criteria for safety, quality and value. Generic drugs treat your illness or condition with the same effectiveness and safety as their brand-name equivalents because they have to meet the same rigorous FDA requirements as brand-name drugs." The problem is that within the formulary composition are many illegal FDA-unapproved medications, including several whose manufacturers have received warning letters directly from the FDA confirming that approval was not granted. Several of these manufacturers have also been involved in multiple lawsuits filed by, amongst others, Attorneys General offices. #pharmacy #pharmacybenefits #PBM #employeebenefits #humanresources #ERISA #compliance #fraud

As per a state Medicaid program: Pharmacy drug coverage policies take into consideration all U.S. Food and Drug Administration-approved covered outpatient drugs, as defined by the Centers for Medicare & Medicaid Services. Program also consults with the Drug Advisory Committee as required by state law. As per the MCO administering their Medicaid program: - MCO is subject to both federal and state laws designed to prevent fraud and abuse in government programs (such as Medicare, Medicaid, Federal Procurement and other programs) and private insurance. - MCO is committed to conducting business honestly, ethically and in accordance with all applicable laws and regulations.? - The Federal False Claims Act is a federal statute that covers claim fraud involving any federally funded contract or program, including the Medicare and Medicaid programs. The Act establishes liability for any person who knowingly presents or causes to be presented a false or fraudulent claim to the U.S. government for payment. Violation of the federal False Claims Act is punishable by a civil penalty of between $11,181 to $22,363 per false claim, plus three times the amount of damages incurred by the government. - As part of MCO’s compliance program for the prevention of fraud and abuse, MCO complies with all state and federal billing requirements for government-sponsored programs, and other payers. MCO will not tolerate false claims to a government agency or other payer. Considering all of the above information, in 18 months, why did this MCO bill this state Medicaid program $79.3 MILLION ($3,397 PER SCRIPT) for an illegal FDA-unapproved dietary supplement, and bill this state Medicaid program $24.4 MILLION ($5,923 PER SCRIPT) for an illegal FDA-unapproved topical? ("For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.") The Federal Medical Assistance Percentage (FMAP) for this state is 50%, which means half of this $103.7 million was a federal payment and half was a state payment. This is a major issue for every state Medicaid program in the country, regardless of population or vendor administering the pharmacy benefit program. This MCO's stated "compliance program for the prevention of fraud and abuse" clearly does not exist or is seriously flawed, resulting in more than $100 million paid for two illegal medications. #medicaid #pharmacy #pharmacybenefits #PBM #healthcare #compliance #fraud

“While a patient or prescriber may believe that a drug is safe or effective because of individual experience, such subjective experiences can be misleading and insufficient to establish safety and effectiveness. Instead, FDA relies on carefully designed clinical trials that weigh the risks and benefits of taking a drug compared with the risks and benefits of taking placebo or another accepted therapy. Carefully designed clinical trials have repeatedly demonstrated that the safety and effectiveness of drugs cannot be adequately established from anecdotal evidence or consumer or prescriber preferences." - Janet Woodcock, MD FDA Principal Deputy Commissioner #pharmacy #pharmacybenefits #PBM #employeebenefits #humanresources #compliance