The new leadership at Medicare is reviewing its support for a possible change in hospital billing forms. That single change—adding a number about 14 digits long to identify medical devices — could reap enormous benefits in greater patient safety and save billions in taxpayer money. Previously, Medicare stated that this change could improve the identification of safety problems with medical devices and also support the financial integrity of the program. So to borrow a phrase from President Ronald Reagan, Medicare should stay the course.
The news comes in the wake of an independent audit showing that taxpayers paid an astonishing $1.5 billion to treat Medicare patients who were harmed by just seven models of faulty cardiac implants. The analysis by the office of the inspector general at the U.S. Department of Health and Human Service (HHS) shows the urgent need for more and better data about medical devices throughout the health care system.
The audit required painstaking forensic accounting over months, as auditors plowed through thousands of Medicare records and hospital files. But adding that one number to the Medicare claims form, a unique identifying code for each implanted device, would have made that job much simpler.
Such a move would not only help Medicare track cardiac implants, but also the make and model of millions of medical implants on the market from cataract lenses to hip and knee replacements — especially since joint implantations are the most common hospital procedures performed under Medicare.
The vast majority of medical devices in this country are safe and effective, but when they fail, the consequences can be dire. Some years ago, malfunctioning defibrillator wires gave patients unnecessary, ferocious shocks to the heart. In another incident, metal-on-metal hip joints sent tiny, toxic shards into patients’ bloodstreams. Procedures to replace flawed implants often expose patients to further surgical risks and the danger of infection.
For example, as the huge baby-boom population ages, the need for devices that save lives and preserve the independence and quality of life for the elderly, from cardiac stents to replacement knee joints, will only increase. The device code data could track millions of devices over years of use, allowing researchers to tease out trends that could lead to better designs for devices and help doctors and their patients choose the best course of treatment for each individual.
The problem is that although manufacturers began to assign codes to medical implant packages in 2015, there is still no place in the Medicare claims form to record them — an omission that could, and should, be corrected soon.
Prescription drugs are already identified in claims forms, which help researchers analyze the safety of medications. If device identifiers were recorded, those digital records could be found in the insurance databases. Problem devices could be identified and recalled much more quickly to prevent additional harm.
The agency that runs Medicare endorsed adding device identifiers to the claims form more than a year ago, as have an influential board of Medicare advisers and the Food and Drug Administration, the federal agency responsible for ensuring medical device safety. Health plans, hospitals, physicians, and public health advocates also support adding the information.
Meanwhile, the public-private committee that recommends revisions to the Medicare claims form is taking comments on its recommendation to add a field for device codes. Once the committee acts, and Medicare adopts the change, it can be put in place.
This could be the last chance to take action for a decade or more. The Medicare form is rarely changed, and it takes years to implement revisions. While the American Medical Association has voiced concerns that recording the device codes might place an undue burden on doctors, several organizations that represent doctors who implant devices favor the change, including the American College of Cardiology and the Society of Thoracic Surgeons. And, as the audit demonstrates, the gains in patient safety and the enormous amount of money that can be saved over time make it a wise investment for our health care system.
With support for the move in both the House of Representatives and the Senate, now is the time to act. Medicare should continue its support for changing the claims form to safeguard patient health — and save untold billions in taxpayer dollars.
Dr. Josh Rising is the director of health care programs at The Pew Charitable Trusts, and Ben Moscovitch manages Pew’s health information technology project.
This article was originally published in The Hill on November 3, 2017.