Dozens of states, some of them very large, didn’t meet Medicare’s
requirement that they survey their ambulatory surgery centers (ASCs) at
required intervals to assure they met safety protocols, such as
infection control or anesthesia administration, and many facilities went
without any state survey for at least 6 years.
That’s the finding of a recent
report from the U.S. Department of Health and Human Services’ Office of Inspector General
(OIG). The agency took some states to task for not following two rules
during fiscal years 2013-2017 — made more imperative now that Medicare
and commercial insurers reimburse ASCs for increasingly risky
procedures.
The two Medicare rules at issue apply to 3,722 of the 5,603 ASCs that
were not surveyed by a Medicare-approved “deeming” agency, such as The
Joint Commission, and must be surveyed by their state health agency.
Red ink
The first rule is that the state health agency review at least 25% of
the “non-deemed” ASCs annually. The OIG found that 15 states, including
California, New Jersey, New York, Nevada, Colorado, Rhode Island, and
Wisconsin — which the report highlighted in red ink — surveyed fewer
than 25% of its ASCs in 2017. These states had a total of 764 ASCs in
2017. California had the most at 414.
The second rule requires states to inspect all of their non-deemed
ASCs at least once every 6 years. Some 28 states failed to meet that
second requirement, although 19 states surveyed more than 95%.
Again in red ink, the report singled out four states, with a total of
291 ASCs requiring inspection, showing exceptionally low rates over
that 6-year review period: Nevada (48%), Hawaii (64%), North Carolina
(72%), and New Jersey (85%). In those states, according to the OIG, 75
ASCs went uninspected by the state for at least 6 years.
Hawaii, Nevada, and New Jersey met neither requirement by large margins, the report said.
The OIG noted that inspections are increasingly important because
ASCs are now approved for a growing number of invasive, complex
surgeries. To meet Medicare rules, the facilities must pass muster on 14
conditions of participation, such as assuring that a registered nurse
is available for emergency treatment for any patient in an ASC, and must
track patient health outcomes with quality indicators that identify
medical errors and adverse events.
State agencies “play critical roles in ensuring the health and safety
of Medicare beneficiaries who receive medical procedures, including
invasive surgeries, from ASCs,” and because “periodic surveys are an
essential tool for ensuring that ASCs meet the minimum standards for
health and safety,” the report said.
Asked for a comment, Kay Tucker of the Ambulatory Surgery Center
Association, noted that the study was part of the OIG’s routine work
plan. “It did note that, although more improvement is warranted,
significant improvement has been made over time,” she said.
The last OIG report on this topic was published in 2002.
Tucker emphasized that while these 3,722 ASCs were not inspected by a
Medicare deeming agency, some that weren’t inspected by their states at
these intervals may have been by another organization, such as the
Accreditation Association for Ambulatory Health Care. She estimated that
one-third take that route. Those that do are expected to receive 3-year
inspections from agencies other than the state.
ASCs make a decision to go with another accreditation organization
because they may “want insights from different entities … or they might
simply choose to avoid the additional expense involved in seeking deemed
status from one of the accrediting organizations,” Tucker said. It also
means they subject themselves to two inspections instead of one, since
states are still required to inspect them under Medicare rules.
More and riskier procedures
Not only are ASCs growing in number – Tucker said there are now at
least 200 more than in 2017 — surgical procedures that just a few years
ago were only performed in an inpatient hospital setting are now moving
to ASCs, where patients are discharged in 24 hours. For example,
Medicare plans to allow
total knee replacements and a half-dozen types of percutaneous cardiovascular interventions to be reimbursed in an ASC setting in 2020, although that policy could change with the agency’s final rule.
Tucker emphasized that this has been a fast-moving trend. In 2015,
2016, and 2017, she said, the Centers for Medicare and Medicaid Services
added 38 procedures to the ASC payable list, including spine, vascular,
and gynecologic procedures. She said the association wants parity for
“all procedures” that Medicare has approved for reimbursement in a
hospital outpatient department, so they are approved for payment in an
ASC as well.
Two states that responded to questions about the report denied that
they were in violation of Medicare rules. New Jersey Department of
Health spokeswoman Dawn Thomas disputed the OIG’s findings as “not
accurate,” and said that on average, Medicare certified ASCs are
inspected every 4 years in that state.
And a spokesman for the California Department of Public Health said
that a June 2018 update of the data OIG used for the current report
showed that California met all of the federal thresholds, and the report
is simply wrong.
Beth LaBouyer, executive director of the California Ambulatory
Surgery Center Association, called the report confusing and noted it did
not mention that many of California’s 414 non-deemed ASCs are inspected
every 3 years by another accreditation agency whose procedures mirror
those of a deeming accreditation organization like The Joint Commission.
“I know the deemed survey is significantly more expensive,” she said.
Serious problems found
The inspections are not merely a bureaucratic exercise: states that
did conduct them often found problems, some of which posted significant
threats to patient safety.
Just over three-fourths of the facilities inspected during 2013-2017
had at least one deficiency and 25% had serious deficiencies. The most
common one were lapses in infection control, which made up about 20% of
the deficiencies. “Serious deficiencies” are those grave enough to
indicate what the report called “pervasive noncompliance” and posing “a
serious threat to patient health and safety.”
“These findings underscore the importance of timely surveys so that
deficiencies do not go unaddressed even longer,” the report said.
Other report findings:
- During 2013-2017, complaints were filed on just 4% of ASCs, but the
share of those complaints that required an onsite survey, including
those considered an “immediate jeopardy” — those likely to cause serious
injury, harm, impairment, or death — more than tripled, from 15% to
54%.
- In general, ASCs “appear to struggle” with infection control
requirements. When states did inspect their ASCs, they found more than
half were deficient in infection control procedures, such as making sure
surgical equipment was properly sanitized.
- Of the 732 complaints that states received about ASCs during
2013-2017, nearly half were substantiated. They included a finding that
the ASC “failed to properly assess patients pre-operatively, did not
have medical records for some patients, and did not follow its own
procedures.”
- Of the ASCs inspected, roughly a third had deficiencies in observing
pharmaceutical requirements, environmental controls, or patient rights,
and some failed to meet all three.
- For those surveys done by state agencies, the mean number of
deficiencies dropped from 2013 to 2017, from 6.1 to 4.2, but that may
not mean the facilities were providing safer or higher quality care.
“These decreases could reflect improvements in ASC performance and/or
changes in how states assessed compliance,” the report said.
Assuring ASC quality is also important because of the increasing sums
Medicare pays to them, from $3.4 billion in 2011 to $4.6 billion in
2017.
https://www.medpagetoday.com/publichealthpolicy/healthpolicy/82522
