As advances in surgery continue, more and more procedures are destined for the outpatient arena.
This year saw dramatic changes for ambulatory surgery centers (ASCs), with the release of the 2020 Outpatient Prospective Payment System (OPPS) Proposed Rule (CMS-1717-P) and the release of the final Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction Rule (CMS-3346-F).
The use of ASCs has been growing, as medical technology has made otherwise previously invasive surgeries with long in-hospital recovery times more amenable to rapid recovery with early discharge. Care coordination efforts, including preparing the patient pre-operatively for discharge home, have led to changing patient expectations – and realizations that, often, the best place to recover is in one’s own home. The controlled environment and schedule of an ASC are also appealing to surgeons when compared to the hectic hospital environment that often produces unexpected delays due to emergencies. Of course, it would be naïve to ignore the fact that surgeon ownership in ASCs allows them to share in the profits. This may attract surgeons who see downward pressure on their professional fees from most payers.
New Procedures Present New Opportunities
But to fully understand the changes ahead, one needs to go back a year. In the 2019 OPPS Final Rule, the Centers for Medicare & Medicaid Services (CMS) modified the definition of surgery to include “surgery like procedures.” This change allowed for the addition of diagnostic cardiac procedures to the list of surgeries permitted to be performed at ASCs as of Jan. 1, 2019. The adoption of these procedures in ASCs was slow, likely due to the added capital expenditures required to perform the procedures and the relatively low reimbursement for diagnostic procedures.
In the 2020 OPPS Proposed Rule, CMS proposed to also allow therapeutic cardiac procedures in ASCs. Commonly called stenting, or percutaneous cardiac intervention (PCI), these procedures have a much higher approved payment rate for both the facility and the performing physician. It is widely believed that CMS will adopt this proposal, as such procedures are already being performed safely on non-Medicare patients in ASCs. Patients who have PCI in the hospital are now commonly discharged the same day. With this increase in potential patient volume, many ASCs may reassess whether adding this service line and recruiting cardiologists makes sense.
CMS has also proposed to allow total knee arthroplasty to be performed in ASCs. As with PCI, improved procedural methods now allow many of these patients to be discharged on the day of surgery. In the commentary in the proposed rule, CMS noted that in 2016, over 800 Medicare Advantage beneficiaries had total knee arthroplasty in an ASC, supporting the contention that proper patient selection can result in the successful performance of this surgery in an ASC.
More Independence, Less Administrative Burden
Along with this expansion of the types of surgeries that can be performed in ASCs, CMS also made several moves to lessen the administrative burden on ASCs. Their first change is that ASCs are no longer required to have a transfer agreement with a hospital, with CMS noting that in the event of an emergency, the patient would be transferred to the nearest hospital, and treatment there would be mandated by Emergency Medical Treatment and Labor Act (EMTALA) regulations. CMS is requiring ASCs to periodically provide nearby hospitals with their hours of operation and a list of procedures performed at the ASCs, so the hospitals can alert their on-call physicians and let them know that they may be asked to care for these patients in the event of an emergency. There is no requirement that the surgeons who operate at ASCs have hospital privileges. This could be perceived as a potential burden for ASC on-call physicians, since they may not be able to care for patients who require hospital care.
Discretion on H&Ps Allowed, but Set Guidelines Absent
CMS is also allowing ASCs (and hospitals) to modify their rules and designate specific surgeries that do not require a comprehensive history and physical examination (H&P) to be performed within 30 days of the surgery. As an internist who has performed countless pre-operative H&Ps, many on perfectly healthy people, simply to meet this requirement, this change makes sense. If the patient has a cataract that meets the standard for extraction and the patient is stable, without an acutely decompensated medical condition, they may undergo surgery. As I told my patients, if they have a cataract and their heart is beating, they can withstand the surgery.
Unfortunately, it won’t be that easy for ASCs to modify their requirements for H&Ps within 30 days prior to surgery. The Final Rule addresses the policy change for ASCs, stating that “the ASC policy must be based on any applicable nationally recognized standards of practice and guidelines, and any applicable state and local health and safety laws.” However, earlier in the commentary, CMS states that it is “allowing ASCs flexibility to establish patient policies, and encouraging the use of clinician judgment, as appropriate, to assure patient health and safety while also reducing the burden on patients and providers…”
Herein lies the difficulty. Requiring the “guideline” to be based on nationally recognized standards of practice and guidelines, while at the same time allowing for clinician judgment, can be like threading a needle with vision impaired by a cataract. There is abundant literature supporting the lack of utility of pre-operative testing, including EKGs, chest X-rays, and laboratory tests. But those studies aim to address the wide variation in test requirements set by hospitals for patients undergoing surgery and do not address the H&P itself.
On the other hand, every hospital and every ASC in the United States requires a comprehensive H&P prior to every surgery, because one is required by CMS and every accreditation organization. Because of this disparity, it would be impossible to conduct a trial wherein patients were randomized to either having a comprehensive H&P or proceeding to surgery without an H&P. True guidelines cannot be produced, nor standards of care developed if there is no clinical trial that provides consistent data and results.
Without controlled trials being performed and reviewed by expert panels, it’s impossible for an ASC to find guidelines that a comprehensive H&P is not required if they were surveyed and asked for decision-making documentation while developing their policy. There is one opinion piece written by Dr. Peter Pronovost, a nationally recognized patient safety expert, appropriately titled A Preoperative Medical History and Physical Should Not Be a Requirement for All Cataract Patients. However, an opinion piece does not constitute a guideline or standard of care.
It should also be noted that CMS is granting the same discretion to hospitals to develop policies not requiring pre-operative H&P for selected surgeries. But in that case, the rule commentary sets the standard by stating, “[w]e expect that this decision will be based on the clinical judgment and recommendations of the medical staff, which must be supported by nationally recognized evidence and guidelines for best practices in this area,” creating an even higher standard (requiring evidence) and not simply constituting standards and guidelines.
Current Progress Still Means Uncertainty for Future
As the popularity of ASCs grows, CMS continues to reduce provider burden and offer more patient choice. While solid progress has been made, there will still be challenges in the future, when it comes to fully understand the actual requirements and how they will impact ASCs in the years to come.