By Fred Schulte and Christina Jewett October
2, 2017
Medicare
paid at least $1.5 billion over a decade to replace seven types of defective
heart devices, a government watchdog says. The devices apparently failed for
thousands of senior patients.
The
Health and Human Services Office of Inspector General, in a report released
Monday, said officials need to do a better job tracking these costly product
failures to protect patients from harm. More detailed reporting could lead to
earlier recognition of serious problems with medical devices and faster recalls
of all types of “poorly performing” ones, the IG’s office said.
The
report marks the first effort by anyone in government to assess the losses to
taxpayers and patients 65 and older from medical gear that proves faulty.
Officials
said the $1.5 billion lost from the seven devices from 2005 through 2014 was a
“conservative estimate.” Patients also paid $140 million in out-of-pocket costs
for this care, the report noted.
The
report found that nearly 73,000 people on Medicare had one of the seven devices
replaced because of recalls, premature failures, medically necessary upgrades
or infections. It didn’t outline specific injuries patients suffered as a
result.
The
inspector general did not identify the manufacturers of the seven devices, but
officials said they included implanted cardio defibrillators and a pacemaker
that either had been recalled because of flaws or had “prematurely failed.” Pacemakers
and implantable defibrillators are small devices placed under the skin to help
treat irregular heartbeats.
How
best to identify these defects and cut Medicare spending associated with fixing
them has been under consideration at various times since 2007, according to the
report. But it remains a contentious issue.
The
inspector general recommended that hospitals and doctors be required to submit
detailed information identifying failed devices, such as serial and batch
numbers, during the billing process.
“This
could help reduce Medicare costs by identifying poorly performing devices more
quickly which could also protect beneficiaries from unnecessary costs and
improve their chances of receiving appropriate follow-up care more quickly,”
the report states.
David
Lamir, an official in the inspector general’s Boston office, said the $1.5
billion figure represented a “drop in the bucket” of the true costs to Medicare
from medical products that malfunction. He said device failures not only waste
money, but also can expose patients to a “high risk of illness,” including
needless surgeries.
The
report said medical device recalls nearly doubled from 2003 through 2012 and
noted they have likely cost Medicare billions of dollars. In the past five to
six years, more than 200 cardiac devices have been recalled, according to the
OIG. In most cases, manufacturers withdraw their products voluntarily after
reports surface of injuries or malfunctions. Device makers are required to
report problems they learn of, often from doctors and hospitals, to a database
run by the Food and Drug Administration.
Diana
Zuckerman, president of the National Center for Health Research who has
testified before Congress on device safety, said her organization supports
making hospitals report malfunctioning devices when they seek Medicare payments
to cover an implant surgery. She said the change would help officials pinpoint
faulty devices before issuing a recall for tens of thousands of products buried
in patients’ bodies.
“It
would be much more obvious much more quickly which implanted devices were
causing problems,” she said.
Zuckerman
noted that the IG report didn’t touch on many high-profile device failures,
like metal-on-metal hip implants or vaginal mesh.
Medical
device companies and some doctors have opposed tighter reporting saying it
would be costly and difficult to integrate with existing payment claim forms
and might not yield useful information.
“It
is abundantly clear that data collected in electronic health records (EHR) is a
far superior and more cost-effective method for monitoring the performance of
medical devices,” said Mark Leahey, who heads the Medical Device Manufacturers
Association. The trade group represents nearly 300 device companies.
Leahey
said that the electronic health record “captures the full clinical history of
the patient, their changing health status and detailed information on their
medical treatments,” including any surgically implanted devices.
A
Centers for Medicare & Medicaid Services spokesman said the agency had not
seen the report and would have no comment.
But
in written remarks included in the report, CMS Administrator Seema Verma said
the tighter reporting requirement is “under consideration” and that the agency
will “carefully evaluate the potential that this policy would impose a burden
on physicians unnecessarily.”
CMS
appears to have switched positions on whether to compel hospitals to report
more details about these incidents during the Obama administration.
In
a February 2015 letter to Sen. Elizabeth Warren, D-Mass., then-CMS
administrator Marilyn Tavenner argued that more reporting would “entail
significant technological challenges, costs and risks to normal claims
processing for Medicare.”
Yet
CMS and FDA supported doing so in a July 13, 2016, letter to the committee that
sets standards for electronic claim forms used for medical billing.
Andy
Slavitt, who succeeded Tavenner in the top CMS post and signed the July 2016
letter, called the inspector general’s report “important work” that “appears to
make yet another strong case” for more complete reporting of device failures.
These
policies “are important for our safety and they are clearly prudent things to
do. While it requires effort from many in health care to get there, this effort
is in our public interest,” Slavitt wrote in an email to Kaiser Health News.
Rita
Redberg, a UC-San Francisco professor and cardiologist who advises Medicare,
said unique identifiers on devices could be scanned into a patient’s medical record.
Earlier recognition of trouble-prone devices also might help Medicare recoup
some money wasted as a result.
“Medicare
is spending a lot of money on something that doesn’t seem to be their problem,”
Redberg said, adding, “Most places, if something is defective, the manufacturer
is responsible for replacing it, not the store where you bought it.”
KHN’s
coverage related to aging & improving care of older adults is supported
by The John A. Hartford Foundation.
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