The bill, titled the Accelerating Innovations in Medicine Act, was sponsored by Sens. Rob Portman (R-Ohio), Michael Bennet (D-Colo.), John Thune (R-S.D.), and Martin Heinrich (D-N.M.). Authors of the bill hope it will speed up the process for self-pay patients and promote faster development and adoption of new devices.
Currently, if a Medicare patient wishes to self-pay for a device that is not covered, their doctors must submit a claim to Medicare, wait for a response and then receive an Advanced Beneficiary Notice, advising them that the particular treatment option will not be covered, according to a press release from the AIM Act Alliance.
The patient must then provide written acknowledgement and another claim must be submitted. Failure to adhere to this process can expose physicians to civil monetary penalties, according to the AIM Act Alliance.
“The current medical device process is cumbersome and limits access to innovative devices and procedures for seniors who are willing to pay out of pocket. Our bill simply allows seniors to take government out of the equation by purchasing these devices themselves rather than through Medicare. Ultimately, it will help to ensure patients and physicians have access to the most innovative medical technologies,” Sen. Portman said in a press release.
The new bill operates by creating an category of FDA-approved medical devices, called the AIM list, which receive a 3-year exemption from Medicare consideration during which Medicare patients may pay out-of-pocket for the devices.
“The bipartisan AIM Act opens the door to innovation by making it easier for seniors to access new, safe, and effective technology in health care on a self-pay basis. Allowing for more patient choice is good for both the patient and his or her health care provider,” Sen. Thune said.
As a condition for being registered on the AIM list, manufacturers must provide published or publicly available data on clinical studies completed for the device at the end of the previous 3-year listing period. If manufacturers fail to provide the data, their devices could not get renewed or be removed entirely, according to the bill.
“This bill helps ensure doctors and patients have access to the latest innovative medical technologies. Streamlining the process for patients to purchase FDA-approved medical devices enhances treatment options in the short term, and has the potential to improve health outcomes, yielding long-term benefits for seniors,” Sen. Heinrich said.
The AIM Act Alliance argues that having the 3-year exemption “will facilitate the collection of safety, efficacy, and patient outcome data – equating to privately-funded cost effectiveness data. With manufacturers and self-pay patients funding more research, Medicare patients and the entire health care system benefit in the long run.”
The group claims the bill will save $1.5 billion annually by 2024, with $7.5 billion in cumulative savings over the next 10 years.
“Many seniors rely on innovative medical devices to help manage their health, but the Medicare claims process can hold up their timely access to these tools. This bill gives patients new payment options to help make the best decisions with their doctors to manage their care,” Sen. Bennet said.