Medicare's proposal to expand the roster of surgical procedures that it will reimburse at independent ambulatory surgical centers (ASCs), if adopted, will have "devastating life-threatening" results for patients.
At least, that's what the hospital industry's biggest lobbying group would have you and the Centers for Medicare & Medicaid Services (CMS) believe.
In a , the American Hospital Association argued strenuously that cardiac and joint procedures at ASCs are less safe than those performed in a hospital, where patients may be observed longer than 24 hours and where rescue protocols and alert systems spring into action.
The outcome: many patients will be rushed "from ASCs to the nearby hospital ED," which could be miles away.
The AHA adds that physicians who own ASCs may have "other incentives" to refer their patients to these centers beyond whether patients' medical histories warrant hospital-based monitoring, noting that Stark self-referral laws don't apply.
AHA also charges that while allowing reimbursement for ASCs may reduce costs to Medicare, patients will shell out hundreds more in copayments; they'll pay 20% of approved charges instead of a much lower set deductible in hospital settings, the AHA contends.
Of course, not all trade groups are opposed. But the AHA filed five pages of objections to the .
Currently, knee replacement and percutaneous cardiovascular intervention (PCI) codes are reimbursed only to hospital inpatient or outpatient departments for fee-for-service enrollees, although some Medicare Advantage plans, which enroll about one-third of Medicare beneficiaries, do cover some procedures in an ASC now.
The AHA also objected to CMS plans to eliminate two requirements intended to protect patients treated at ASCs: that ASCs have a written transfer agreement with a nearby hospital and that the ASC's physicians have admitting privileges at a hospital. Taking away these safeguards would put beneficiaries at even further risk, the AHA said.
Armageddon for Hospitals?
The hospital industry's stated concerns about safety, however, are met by questions about how the move will impact hospitals' bottom lines.
The proposed expansion of these and other elective surgery payment codes to ASCs has prompted a kind of turf war between hospitals and physician groups who own ASCs, noted hospital strategy consultant Nathan Kaufman in San Diego.
In fact, he said, "it's more than a turf war" because of the huge volume of surgeries that would no longer be performed in hospital inpatient and outpatient units -- thus moving a lot of revenue out of hospitals' accounts.
"Everybody [in hospital leadership] should be nervous," Kaufman said."The vast majority of hospitals make most of their margin on outpatient services. And once Medicare says it's okay [to reimburse ASCs for a procedure], then commercial plans are really going to push that. And it's going to be a huge impact, especially for hospitals that don't have outpatient department sites. That's where I see the floodgates opening."
He pointed to a last month that predicts ASC procedures -- now about half of the outpatient surgery market -- will increase by 6%-7% annually over the next two years. By the mid 2020s, ASCs will be the setting for 33% of cardiology, 30% of spine, and 68% of orthopedic procedures, up from 4%, 7%, and 44%, respectively, in 2015.
Kaufman said, however, that for some hospitals there is no turf war because they already have or are working on collaborations with physician groups to own the facilities outright, or at least own shares. "Rather than having another entity competing against them, these organizations will be competing against themselves."
CMS apparently doesn't expect the rule will affect a large number of patients. Some Medicare Advantage plans already cover total knee arthroplasties in an ASC. But in 2016, only 800 Part C Medicare Advantage enrollees underwent that procedure in an ASC, according to CMS. The agency expects "only a small subset" of fee-for-service enrollees would end up having total knee procedures in an ASC.
The agency is adding these knee and coronary procedures under a new definition of "surgery," adopted in the 2019 rule that includes "surgery-like" procedures, and which "would not be expected to pose a significant risk to beneficiary safety when performed in an ASC, and would not be expected to require active medical monitoring and care of the beneficiary at midnight following the procedure."
CMS added that while two of the procedures involving coronary intervention "may involve blood vessels that could be considered major ... we do not believe that it is logically or clinically consistent to exclude certain cardiac procedures" from the coverage list.
Payment has been shifting for several years from hospitals to ASCs. From 2015 to 2017, CMS added 38 codes, including spine, vascular, and gynecologic procedures to those payable for services to beneficiaries to an ASC, and seeks comment on adding many more. But even that is not fast enough for ASCs.
While its advocacy group, the , which represents a growing number of some 5,800 facilities, is delighted with CMS's proposals. It wants total parity: for Medicare to reimburse ASCs for every procedure that it now covers in hospital outpatient departments (HOPDs).
In its own , the ASCA pointed out that many hospital outpatient departments, like ASCs, are miles from acute care services. The AHA's distance argument for greater safety at HOPDs is simply bogus, according to the ASCA.
"There is no credible safety argument to justify the expansive list of codes that are reimbursable in HOPDs but not ASCs," the . CMS should have two lists: one for inpatient, and one for everything else, allowing "all other surgical codes to be performed in either an HOPD or an ASC."
The ASCA also noted that non-Medicare commercial patients now routinely get total knee surgeries at ASCs, with the advent of minimally invasive techniques, better anesthesia, and more effective post-operative pain management and rehab protocols.
On the concern that physicians may not use appropriate selection criteria in referring patients to an ASC for knee surgery, the ASCA said its facilities follow "strict protocols ... to ensure that only appropriate patients are considered." And, ASCA emphasized, an ASC setting allows patients to avoid "comingling with patients with infections ... and other inpatient conditions/treatments" usually treated in hospitals, and allows other benefits such as recovery at home.
Point by Point
The AHA listed specific objections to each of CMS's payment proposals. For knee procedures, these include total knee arthroplasty (27447) and mosaicplasty (29867).
Nearly half of all Medicare beneficiaries live with four or more chronic conditions, and one-third have conditions that require they limit their activities of daily living, which make "even simple procedures more complicated," the AHA wrote. That the majority of beneficiaries are not suitable for total knee arthroplasty in an ambulatory setting "should give CMS enough pause to act on the side of caution as it could be a patient safety risk for vulnerable Medicare beneficiaries to have these surgical procedures in ASCs."
Although CMS proposed to require any patient who undergoes a total knee procedure in an ASC to have a statement from her physician that the patient would not need active medical monitoring and care at midnight following the procedure, the AHA doubts its effectiveness.
"We question how a physician could confidently make this determination," the trade group said. "Part of our concern is that ASCs are often physician-owned and not subject to the Stark self-referral regulations. Therefore, there may be other incentives in place for physicians in making such a determination."
Unlike hospitals, ASCs generally do not have "case management infrastructure" to ensure that postoperative care plans are carried out, and the plans it does have are designed for less risky services, such as cataract removal procedures, the AHA said.
"It is not clear how ASCs, with regular business-day hours of operation, can ensure that such a plan would adequately safeguard vulnerable Medicare beneficiaries discharged less than 24 hours after such a major surgery and who are likely in significant pain, unable to walk and potentially facing serious complications."
Hospitals, the AHA letter said, will have to come to the rescue after beneficiaries' conditions deteriorate during home recovery. Additionally, pain after surgery "is controlled best in the acute care hospital setting."
The AHA also wants CMS to require ASCs and the physicians who operate within them to have minimum annual experience thresholds and performance standards for each procedure as a condition of payment.
Ironically, knee arthroplasty at an ASC will cost patients more than at hospital inpatient or outpatient departments, the AHA said. That's because the beneficiary copayment for the procedure in a hospital, paid at $11,960, is capped with a deductible of $1,364. But while the cost for the procedure in an ASC is lower, at $8,640, beneficiaries must pay 20% of that, or $1,728, plus 20% of any other ancillary services.
CMS also proposes to allow ASCs to receive payment for two percutaneous transluminal coronary angioplasty procedures (92920 and 92921) and four percutaneous transcatheter placement of intracoronary stents and drug-eluting intracoronary stent procedures (92928, 92929, C9600, and C9601) starting Jan. 1.
But the AHA said that, particularly for seniors, these interventional procedures can result in death, damage to or perforations of coronary arteries, intramural hematoma, distal embolization, stent thrombosis, or myocardial ischemia. They should only be performed in settings that can immediately rescue patients when they get into trouble.
The AHA repeated its concern that physicians doing these procedures in an ASC in which they have an ownership have a conflict in that they are not subject to Stark self-referral rules and "there may be other incentives in place in making a determination of the appropriate site of care."
Physician Groups Weigh In
Physician groups including the and the supported some aspects of the CMS proposal in their comments but also expressed concerns.
The ACC cautioned that it's important to ensure protocols for backup, such as emergency transfer, are appropriate and in place. And the AAOS said ASCs should perform joint surgeries only for "carefully selected patients who are in excellent health, with no or limited medical comorbidities and sufficient caregiver support."
The AAOS also stressed, in bold type, that CMS should make clear in its final rule that the decision on patient appropriateness should be made -- not by review contractors or other "stakeholders." It added that an "of forcing care into the outpatient setting" is when commercial payers follow CMS, and "drive patient care to specific facilities and restrict patient access to appropriate settings of care based on cost alone."
CMS also proposed to add total hip replacement procedures, now payable only for fee-for-service beneficiaries in inpatient settings, to hospital outpatient departments, part of a step process that, for many other procedures, has previously led to ASC payment. Said one spokesperson for ASCA: "First, the procedure is considered inpatient only, then it moves into the HOPD setting, and finally, it moves into the ASC setting."
But the AAOS is worried about that: "Notwithstanding our support of patient choice, the proposal to move total hip arthroplasty (THA) to an outpatient hospital setting is rash," the group wrote. "It is troubling to imagine the ways this change may be misconstrued by payers."