Is insurance coverage available for Risk Evaluation and Mitigation Strategy (REMS) related bone density tests or treatments?

Insurance Coverage for REMS-Related Bone Density Testing

Insurance may cover bone mineral density testing related to REMS programs, but coverage varies significantly among insurance providers and often requires a letter of medical necessity from your healthcare provider to justify the test.

Understanding REMS and Bone Density Testing

Risk Evaluation and Mitigation Strategy (REMS) programs are FDA-mandated safety protocols for certain medications with significant risks. Some REMS programs require monitoring of bone mineral density (BMD), particularly for medications that may affect bone health.

Insurance Coverage Challenges

• Insurance coverage for bone density testing varies widely among providers 1
• Many patients face high deductibles and co-pays even when testing is approved 1
• Some insurance companies have specific policies limiting or denying coverage for certain tests 1
• The cost of bone density scans may be significant if not covered by insurance 1

Strategies to Obtain Insurance Coverage

Letter of Medical Necessity

A healthcare provider can write a letter of medical necessity to improve chances of coverage:

• Should explain that you are at increased risk of bone density loss 1
• Should detail why you would benefit from bone density testing 1
• Should include references to peer-reviewed literature on clinical validity and utility 1

Documentation Requirements

To maximize likelihood of coverage:

1. Ensure proper documentation of risk factors
2. Verify that the testing follows established clinical guidelines
3. Use appropriate diagnostic codes that align with medical necessity
4. Document that the testing is part of a required REMS program

When Insurance Coverage Is Most Likely

Insurance coverage is more likely in these scenarios:

• High-Risk Populations: Patients who received radiotherapy to brain or spinal cord, total body irradiation, or corticosteroids 1
• Recommended Timeframes: Testing at entry into long-term follow-up (2+ years after therapy completion) and at age 25 1
• Established Diagnosis: Patients with previously diagnosed osteopenia or osteoporosis requiring monitoring 2
• REMS Requirement: When bone density testing is explicitly required as part of a medication's REMS program 1

Common Coverage Pitfalls

• Insurance may approve less appropriate but covered tests instead of more appropriate bone density tests 1
• Limited access to clinical genetics services can restrict assistance with insurance approval 1
• Lack of standardized coverage policies creates inconsistent access 1
• Some insurers may consider certain testing methods experimental or investigational 1

Advocating for Coverage

If coverage is denied:

1. Request a detailed explanation of the denial
2. Appeal with additional documentation of medical necessity
3. Consider involving your healthcare provider in the appeals process
4. Explore patient assistance programs if available

Future Outlook

Professional medical organizations are working with insurance providers to improve coverage policies:

• The American Society of Human Genetics (ASHG), American College of Medical Geneticists (ACMG), and other professional bodies are advocating for improved access 1
• Publication of practice guidelines by these professional bodies should help standardize coverage 1

Remember that while insurance coverage for bone density testing can be challenging to navigate, your healthcare provider can help advocate for appropriate coverage when the testing is medically necessary, especially when required as part of a REMS program.