On Monday, the Department of Health and Human Services announced it would stop requiring doctors to have a “need to know” before they prescribe a drug or procedure, and would allow doctors to “provide” the information they need for their patients to receive a drug without needing a prescription.
While there are many reasons for the move, the administration also announced it was suspending the mandatory MRI testing for Medicare beneficiaries in the next two years, a move the Department claimed would save $7 billion.
On Thursday, the FDA said it will not renew the Medicare drug-immunity exemption for MRIs, even though it’s not clear when that exemption will expire.
In a letter to Congress, the agency noted that it is concerned that Medicare has a large backlog of MRIs and that the current exemption will leave the system vulnerable to counterfeit drugs and biologics, which will then spread to Medicare beneficiaries.
But it also said that it’s working with the Department’s Office of Drug Enforcement to address this issue and that it will ensure that it does not become a problem.
“FDA’s continued efforts to address the importation of counterfeit medications, including by removing and de-emphasizing the Medicare-enforced requirement to obtain an MRI, are designed to ensure the protection of the integrity of Medicare, and its beneficiaries, without compromising the safety and efficacy of Medicare’s drug programs,” FDA wrote.
“As a result, the Federal Government has not required Medicare to provide an MRI to a patient who does not require it.
“The proposed policy changes will further protect Medicare by reducing the number of MRI claims for Medicare by about 25%, thereby reducing the likelihood of fraud and counterfeiting.”
The administration also said it would no longer allow Medicare beneficiaries to “do more than the bare minimum” in order to receive their medications, and it was not clear if this meant they would be required to undergo an MRI before receiving the prescription.
Under the current policy, a patient can receive a blood test before being placed on a ventilator, but the administration said it was only able to determine whether the test had been given.””
Physicians are free to determine if a person is unable to consent to a resuscitation, if the patient does not have a pulse, and if the person is not in cardiac arrest,” the agency wrote.
Under the current policy, a patient can receive a blood test before being placed on a ventilator, but the administration said it was only able to determine whether the test had been given.
“While a blood sample can be collected from a patient and sent to a laboratory for testing, the laboratory will not conduct an MRI,” the letter said.
“A patient can request a test in writing, and the patient must be present and have a blood drawn.
The patient must receive the blood sample at the time of the test.
The administration said that if a patient is unable or unwilling to provide a blood specimen, the patient can be given a prescription for a blood draw.
To prevent fraud, the Medicare payment program is required to track MRIs through the Department, and for the first five years of coverage, the program will have to track all MRIs from every Medicare beneficiary.
However, it did not say how the payment program will enforce the requirement.
Earlier this week, the Senate passed a bill that would prevent Medicare from using the drug-impairment exemption to provide reimbursement for the cost of an MRI.
(H/T: New York Times)”
This decision will prevent Medicare’s use of the exemption to cover the cost for MRI’s that are not covered by Medicare,” the FDA wrote, adding that “fraudulently obtained and counterfeit MRIs” are “the most common cause of preventable hospitalizations and deaths.”
(H/T: New York Times)