New Senate Bill Cuts Red Tape For Medicare Patients Who Want To Self-Pay
A new bill proposed in the Senate seeks to eliminate the red tape that currently exists between Medicare patients and life-saving, innovative treatments. The Accelerating Innovation in Medicine (AIM) Act, drafted by a bipartisan group of U.S. senators, would streamline access to FDA-approved medical devices for patients wishing to self-pay, accelerating the collection of clinical data to be used in future Medicare coverage decisions.
According to a statement released by the AIM Act Alliance (AAA), the current process requires doctors to submit a claim to Medicare — even if a patient wishes to self-pay — and then advise the patient that coverage for a particular treatment option would not be covered by Medicare. The patient then must submit a written acknowledgement to Medicare, and the doctor must submit the claim again, noting their understanding of the non-covered status. Physicians and patients who do not adhere to this process are subject to civil penalties.
According to lawmakers, the process is needlessly tedious. Sen. Rob Portman (R-Ohio), one of the bill’s co-sponsors, said in a press release, “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.”
The bill, which was introduced by Portman, Martin Heinrich (D-N.M.), John Thune (R- S.D.) and Michael Bennet (D- Colo.), works by creating a new category of FDA-approved medical devices, an AIM list, which will exempt a device from Medicare consideration for a period of three years. During those three years, Medicare patients may pay out of pocket for the device, without any bureaucratic hold-up.
Sponsors of the bill believe that it will benefit patients, physicians, device manufacturers, and Medicare in equal measure. Patients will have broader access to therapy, and data collected from their use of the technology will work toward securing Medicare coverage down the road. Meanwhile, physicians will be able to offer the highest standards of care.
In the AAA statement, authors said, “Currently, the speed at which new products and procedures make their way to patients is slowed by uncertainty over whether the new innovation will receive Medicare coverage after it has received FDA approval.”
The AAA estimates that the new act will encourage the introduction of 1,000 new devices and more than 5,000 high-paying jobs by 2024. In addition, the act will save Medicare $1.5 billion annually through 2024.
“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,” said Heinrich in the press release.
“Ultimately, it will help to ensure patients and physicians have access to the most innovative medical technologies,” Portman added.