In September 2020, the Centers for Medicare and Medicaid Services proposed a rule that would establish a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). After the final rule is effective, the Medicare Coverage of Innovative Technology (MCIT) pathway would begin national Medicare coverage on the date of FDA market authorization and would continue for 4 years. Following is an excerpt of ECRI’s submitted public comment.
After heart disease and cancer, medical errors are the third leading cause of death in the United States and include misdiagnoses, incorrect anesthesia, delayed treatment, and patient misidentification.
Patient identification has been on the minds of healthcare leaders and policy makers for more than two decades. When the Health Insurance Portability and Accountability Act (HIPAA) was signed into law in 1996, it called for developing a national patient identifier that would solve patient misidentification by assigning a unique, permanent number to every individual in the United States. The idea was to implement a uniform approach for accessing a patient’s medical history across the healthcare system. After HIPAA became law, Congress blocked this effort over privacy concerns, and the issue gradually faded from public attention.