February 17, 2021

This year, ASCs can perform and be paid for hundreds of additional procedures.

JOINT SUPPLEMENT CMS will now pay for total hip replacements performed at ASCs.

CMS's Outpatient Prospective Payment System and Ambulatory Surgical Center final rule, which took effect on January 1, further blurs the lines between inpatient and outpatient surgical care, as well as between ASCs and HOPDs within the outpatient sphere.

The big news is the gradual elimination of the inpatient-only procedure list. This year, CMS has removed a total of 298 mostly musculoskeletal procedures from that list, and now will pay for them in HOPD settings when clinically appropriate. By 2024, the remaining 1,400 or so procedures on the inpatient-only list will be removed.

Meanwhile, ASCs gained a few more points in their quest to perform, and be paid for, procedures that are performed in HOPDs. CMS placed 267 formerly HOPD-only procedures, including total hip replacements, on the ASC list of covered procedures for 2021.

David Shapiro, MD, CHC, CHCQM, CHPRM, LHRM, CASC, an anesthesiologist based in Tallahassee, Fla., believes CMS is moving in the right direction to eliminate what he calls the "artificial distinction" between HOPD- and ASC-covered procedures. However, he says that the 2021 final rule declares that procedures on the inpatient-only list as of 2020 will be "proscribed," or forbidden, from future inclusion on the list of ASC-covered procedures. "This is puzzling, particularly in light of the positive regulatory developments that facilitate appropriate clinical decision-making by trained medical professionals," he says. "The ASC community is gathering forces now to determine the intention of this portion of the final rule."

Dr. Shapiro says the continued move of surgeries out of hospitals, and CMS's increased willingness to pay for them at HOPDs and ASCs, makes sense. "Healthcare providers and their patients should make site-of-service determinations, not payers," he says. "As surgical care evolves, physicians and patients have become increasingly aware that ASCs are able to safely perform a growing number of increasingly complex surgeries that would have been unthinkable in an ambulatory setting a decade ago.

"It shouldn't matter where a procedure is done, especially if it's done safely, but it's always mattered to CMS — until now. With the recent changes to the payment system, ASCs and HOPDs can now get paid to perform procedures that, clinically, they've been able to do safely and effectively for a long time."

Ultimately, says Dr. Shapiro, CMS is taking "a bold step away from the past and into the future," and a result, Medicare beneficiaries will be well-served, receiving quality care in any setting for years to come.

Researchers find dramatic declines in surgical volume, combined with poorer outcomes.

STENT AWAY Fearful patients and hesitant providers have resulted in a troubling decrease in a wide variety of heart procedures.

The COVID-19 pandemic has resulted in a substantial decline in overall heart surgery volume and an unexplained increase in deaths after coronary artery bypass grafting, according to research presented at the annual meeting of The Society of Thoracic Surgeons (STS) last month.

Researchers evaluated 717,103 patient results from January 2018 to June 2020 as well as The Johns Hopkins COVID-19 Dashboard from February 2020 to January 2021. They then set about comparing and correlating data from adult cardiac surgery patients and more than 20 million COVID-19 patients to determine how the pandemic affected adult cardiac surgery on national and regional levels.

The researchers found that adult cardiac surgery volume fell 53% nationwide when compared to 2019, with 65% fewer elective cases and, even worse, 40% fewer non-elective cases. The Mid-Atlantic area (New York, New Jersey, Pennsylvania) experienced a 71% decrease in overall case volume, 75% fewer elective cases and a 59% reduction in non-elective cases. The New England region showed a 63% reduction in overall case volume.

Before the pandemic, the Mid-Atlantic and New England regions had reported excellent outcomes with an observed-to-expected (O/E) ratio — the number of observed deaths divided by the number of expected deaths — of less than one, indicating a better-than-expected mortality rate. After COVID hit, however, O/E in these regions increased by 110% for all adult cardiac procedures.

"We clearly demonstrated that if you have heart surgery during COVID, you have an increased risk of morbidity and mortality," says Tom C. Nguyen, MD, of the University of California San Francisco, and one of the study's authors.

The dire results should not discourage symptomatic patients from seeking care, according to Robbin G. Cohen, MD, MMM, of the Keck School of Medicine of the University of Southern California in Los Angeles. He was not directly involved with the study, but says, "If anything, they are a warning to get into the system as soon as possible."

On the horizon are substantial savings in the next decade for surgeries performed in an ASC.

Currently, there are close to 6,000 ASCs in the United States with more than 40% located in just five states: California, Florida, Texas, Maryland and New Jersey. Of these facilities, 65% represent single-specialty ambulatory surgery centers (ASCs). Cataract surgery, with an intraocular lens implant, represents nearly 19% of all procedures performed in an ASC.

Other common procedures include upper GI endoscopy and biopsy (7.9%); colonoscopy and biopsy (6.9%); and lesion removal colonoscopy (6.2%). Spinal-related injections for pain management represent 10.7% of all procedures. Orthopedics, ophthalmology and pain management head the list of ASC specialties, followed closely by endoscopy, plastic surgery, podiatry, ENT and OB/GYN. Each of these specialty procedures are performed in 21% to 36% of all facilities.

A recent KNG Health analysis of Medicare payment data from 2011 to 2018 shows that the Centers for Medicare and Medicaid Services saved $28.7 billion from surgeries performed in ASCs instead of hospital outpatient departments.¹ These savings are expected to increase to $73.4 billion from 2019 to 2028, with $12 billion saved in 2028 alone.

According to this report, while most of the savings from 2011 to 2018 are attributed to a stable group of high-volume procedures, especially cataract surgeries and colonoscopies, projected savings for 2019 to 2028 are expected to be driven by growing specialties such as endocrine, cardiovascular and orthopedic surgery. Four specialty areas – eye and ocular adnexa, cardiovascular, nervous system and digestive system surgery – each accounted for more than $3 billion in total savings from 2011 to 2018. By 2028, five specialty areas – eye and ocular adnexa, cardiovascular, nervous system, digestive system and musculoskeletal surgery – are each projected to save Medicare more than $1 billion per year.

Like their hospital OR counterparts, ASCs were adversely affected this past year by the restrictions imposed on elective procedures in many states in response to the COVID-19 crisis. Revenue decreases of 30% to 50% have not been uncommon, despite the fact that the federal government implemented a "Hospital Without Walls" policy in late March 2020. This policy was designed to ensure that local health systems had the capacity to handle any dramatic influx of COVID-19 patients, allowing institutions to provide hospital services in ASCs, and other approved sites, for the duration of the public health emergency. The policy served to boost needed revenues for hospitals and ASCs alike.

A majority of ASCs expect to move forward with strategic plans formulated prior to the pandemic, with a smaller percentage considering joining an ASC chain or bringing on a private equity partner.

Experts recommend following strict protocols to qualify them for elective surgeries.

For the past year, surgical facilities have focused on keeping patients with COVID-19 infections out of operating rooms unless absolutely necessary. But what about those who have already had the virus and are recovering from it?

Researchers at Oregon Health and Science University (OHSU) last month published a protocol for preoperatively evaluating previously COVID-19-positive patients for elective surgeries that establishes a strict timeline and extensive screening.

Because of the many recovering patients experiencing extended post-COVID syndrome, also referred to as "long haulers," the guidelines screen for symptoms such as fatigue, respiratory problems, joint and chest pain, cognitive and sleep issues, and loss of taste and/or smell to better determine risk.

Here's how it works: Patients scheduled for elective surgeries under general anesthesia who have had a positive COVID-19 test undergo a comprehensive history and physical examination preoperatively. These patients must display a complete resolution of COVID-19 symptoms, with a minimum recovery time of four weeks for asymptomatic patients and six to eight weeks for symptomatic patients. The provider and the patient discuss the individual's personal course with the disease, while the provider logs signs and symptoms of potential subclinical coronavirus-related complications and determines whether the patient has returned to a pre-COVID-19 baseline of health. Functional capacity is assessed, and oxygen saturation is measured. Patients older than 65 years and those previously hospitalized for COVID-19 also undergo an Edmonton Frail Scale assessment.

Patients are also objectively tested based on the severity of symptoms they had during their COVID-19 infection, the complexity of the surgical procedure and the need for general anesthesia. These tests evaluate patients' cardiopulmonary function, coagulation status, markers of inflammation and nutritional status, which have been shown to be disturbed by COVID-19. Abnormal values, the researchers say, may indicate incomplete resolution of the disease, which could lead to increased risk of complications during and after surgery.

Patients with normal results can proceed to surgery after the minimum wait period, while those who display any significant abnormalities trigger multidisciplinary discussion and consultation with other specialties as appropriate. "In the case of non-elective time-sensitive surgeries, the protocol will be completed as thoroughly as possible," say the researchers. The patient is then provided detailed risk-benefit counseling and goals of care discussions before proceeding to surgery.

OHSU reports that the protocol, which was approved and introduced to the institution last August, has worked effectively on several dozen patients with illnesses ranging from asymptomatic to severe infection. The protocol is expected to be expanded to patients presenting for minor procedures performed under moderate sedation. The protocol could also prove extremely handy for asymptomatic patients who test positive during their preoperative screening. OHSU says the number of these patients continues to grow.

"We know that patients who undergo surgery with active COVID-19 infection fare significantly worse, but the timeline for recovery remains nebulous," say the OHSU researchers. "The onus is on us to view contracting and recovering from COVID-19 as we do any other serious medical event, with appropriate presurgical evaluation to prepare and optimize these patients for elective surgery."

Addressing airborne pathogens further reduces the risk of transmitting the virus.

The COVID-19 pandemic has generated a lot of talk about hand hygiene, PPE and surface disinfection, but what about the air in which the aerosolized virus travels before it lands on surfaces? You need that to be clean, too.

Air cleanliness is all about risk mitigation, and it's something you should constantly monitor. Stephanie Taylor, MD, M. Arch., CIC, the CEO of Taylor Healthcare Commissioning, says you should focus on these factors:

• Relative humidity. This is by far the most important aspect of helping to prevent COVID-19 spread, as well as surgical site infections, says Dr. Taylor, who recommends your entire building stay within 40% to 60%. "In terms of human health, we do best in that range," she explains. "Pathogens are least infectious in that humidity zone." A corresponding benefit is that cells around surgical incisions are less likely to become damaged in air that isn't too dry. Also, says Dr. Taylor, you're supporting everyone's respiratory immunity, keeping mucus in airways hydrated, ensuring cilia can function and facilitating production of the protective protein interferon.
• Air filtration. Dr. Taylor recommends MERV 13 middle-efficiency filtration throughout the building, with higher-efficiency HEPA filters in ORs. This can address concerns that COVID-19, a ribonucleic acid (RNA) virus, could travel through your HVAC system. "Viral RNA has been recovered from HVAC systems, but the jury remains out on how infectious it might be," says Dr. Taylor. "We still need more testing and study."
• Air exchanges. Current recommendations suggest performing 15 to 22 room air changes per hour in your ORs, says Dr. Taylor. However, this must be done in coordination with keeping relative humidity in the 40% to 60% sweet spot. "If the air is really dry and you have 30 air changes an hour, you'll actually have more particles in the air than if you have proper humidity and a lower air change rate," explains Dr. Taylor. "At 40% to 60% relative humidity, you can reduce your room air change rates and save energy, too."
• Supplemental technology. Hydrogen peroxide vapor, aerosolized hydrogen peroxide and ultraviolet light (UVC) can bolster your clean-air efforts. Although UVC is often thought of in terms of portable robots, Dr. Taylor believes it also could be effective as a fixed presence in ductwork, such as around cooling coils where biofilm could form. One caveat: "We're beginning to see viruses and bacteria that have developed resistance to ultraviolet light," she says.

By employing all of these air cleanliness tools in concert, you can best mitigate risk of COVID-19 spread and make your environment as safe as possible, says Dr. Taylor.