CNBC Investigations: U.S. health plans tap prescriptions that feds say are illegal

Here's a summary of the provided YouTube video transcript:

Key Concepts

• Alternative Funding Programs (AFPs): Companies contracted by employer-sponsored insurance plans to source expensive specialty medications from overseas at a lower cost.
• Specialty Medications: High-cost drugs used for serious illnesses like cancer and multiple sclerosis.
• FDA Approval: The process by which the U.S. Food and Drug Administration ensures the safety, efficacy, and quality of medications.
• Counterfeit Drugs: Medications that are fake, contain incorrect ingredients, or lack the proper dosage.
• Trans-shipping: The practice of routing goods through multiple countries to obscure their origin.
• Personal Importation Policy: A policy that allows individuals to bring a 90-day supply of drugs into the U.S. for personal use.

Risky RX: The High Cost of Prescription Drugs and Insurance Schemes

The transcript discusses the pressing issue of high prescription drug costs in the U.S., where prices are nearly three times higher than in other countries. This has led employers and families to seek solutions, creating a market for insurance schemes that promise significant savings.

The Problem of Skyrocketing Drug Prices

• Magnitude of the Issue: Specialty medications can cost tens or hundreds of thousands of dollars annually.
• Desperation: Patients and employers are in a desperate situation, fearing they might not be able to access necessary medications.

Alternative Funding Programs (AFPs) as a Solution

• Mechanism: Employer-sponsored insurance plans contract with AFPs to reduce costs for expensive specialty medicines.
• AFP's Role: AFPs source these medications from overseas, offering them to patients at little to no cost in exchange for a fee or a percentage of the savings.
• Targeted Medications: These programs typically cover drugs for serious conditions such as cancer and multiple sclerosis.

The Major Catch: Safety and Legality Concerns

• Illegality: The FDA states that importing drugs that are available and sold in the United States is illegal.
• Lack of FDA Oversight: Medications sourced by AFPs are often not FDA-approved and do not come from FDA-managed or overseen sites. This means there is no guarantee of quality, safety, or efficacy.
• Risk of Counterfeit or Ineffective Drugs:
  • Packaging can be identical to legitimate drugs, but the contents may be counterfeit.
  • Mishandling during transit (e.g., lack of refrigeration for temperature-sensitive drugs) can render them ineffective.
  • The drugs may be expired or not contain the correct formula, leading to a lack of treatment for serious illnesses.
• FDA Warning Letters: The FDA has issued warning letters to some AFPs for potentially importing counterfeit or mislabeled drugs.

Case Study: Merrion Health

• Example: One AFP, Merrion Health (an Aetna company, owned by CVS), sourced an HIV PrEP medication from Turkey.
• Packaging Issues: The medication arrived with packaging and instructions entirely in Turkish, raising concerns about its origin and suitability for U.S. patients.

Navigating the System and Employee Protection

• Employee Awareness: Employees may not be aware that their employers are making deals with insurance companies for these programs.
• How to Protect Yourself:
  • Review your employee handbook for information on specialty medicine coverage.
  • Inquire about where your medications are sourced from.
  • Be cautious of AFPs that claim to source drugs from countries like the UK or Canada, as these drugs may be trans-shipped through other regions, including Turkey or even the U.S., to obscure their true origin.

The Legal Argument and FDA's Stance

• AFP's Defense: AFPs often argue they are operating legally under the personal importation policy, which allows individuals to import a 90-day supply of drugs for personal use. They claim to be facilitating this for patients.
• FDA's Rebuttal: The FDA has explicitly stated that this business practice is illegal and not permitted for FDA-approved drugs that are commercially available in the U.S.

Conclusion

While the high cost of prescription drugs is a critical issue, the use of Alternative Funding Programs that source medications from overseas presents significant risks to patient safety and legality. The lack of FDA oversight on these imported drugs means patients may receive counterfeit, ineffective, or mishandled medications, potentially endangering their lives. The FDA maintains that such importation is illegal, despite the arguments made by AFPs. Employees are advised to be vigilant and inquire about the sourcing of their specialty medications to protect themselves from these risky schemes.