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.
Infection prevention is of vital concern right now, and reducing disease transmission between healthcare workers (HCWs) and patients is critical for patient safety.
One source of danger to patient safety is infection from healthcare workers who wear artificial nails or nail polish.
Appropriate policies are required to help mitigate infection risk in hospitals and other healthcare settings. HAIs are a concern not only in hospitals; infections can be acquired in any healthcare setting (e.g. physicians’ offices, clinics, dialysis facilities, nursing homes, and rehabilitation centers) when patients encounter bacteria, fungi, or viruses while receiving treatment for unrelated conditions.
When Washington Adventist Hospital of Maryland hired ECRI Institute to provide equipment planning services for their new 170-bed hospital, they were in a financial bind. Their Certificate of Need (CON) budget for patient care equipment was only $33 million. But, after we completed detailed user group meetings, it was clear that the actual cost for medical equipment would be closer to $65 million.
Our client was not alone in getting caught in the CON budget squeeze. Currently, 35 U.S. states maintain some form of CON program—including all states east of the Mississippi, except Pennsylvania and New Hampshire. CON programs give the state government the power to determine whether there is a need for a new hospital or nursing home before it is approved for construction.
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.
A 2019 JAMA viewpoint article, Is It Time for Safeguards in the Adoption of Robotic Surgery?, explores the risks associated with the increasing, uncontrolled, and indiscriminate use of robotic-assisted surgery. We could not agree more.
For more than two decades, ECRI Institute has been emphasizing these risks based on our evidence assessments and patient safety work. We do not dispute the many potential benefits of minimally invasive robotic surgery procedures. However, we are solidly grounded in the “show me the evidence” camp. Our concerns fall squarely in three areas: patient safety and surgeon experience, evidence, and cost.
The science of forecasting medical technology is lousy. We hear so many pundits predicting the next revolutionary medical technology advancement that it is literally impossible to keep track of them all. It is not news that many of these predictions never come to pass. Nonetheless, amazing technology advances do occur and change medicine forever.
Just look back 80 years when hospital wards housed dozens of monstrous-looking devices called iron lungs. These life-saving devices treated people who were unable to breathe because of paralyzed chest muscles. Today, we don’t see hospitals with huge wards filled with iron lungs anymore. Who made that technology disappear? Certainly not the iron lung manufacturers. It wasn’t even a hardware technology innovation that changed patient care. It was a biologic—the polio vaccine—that changed the future of the hospital from treating dozens of polio cases to almost none. Who could have seen that coming?
Topics: Industry Trends