OASC | REGULATION

Moving Cataract Surgery into the Practice Setting

CMS INQUIRY INTO THE CONCEPT RAISES MANY QUESTIONS.

By Desiree Ifft, Contributing Editor

With its release of the 2016 Medicare Physician Fee Schedule Proposed Rule, the Centers for Medicare & Medicaid Services (CMS) included a request for information about nonfacility cataract surgery. As part of its request for comment, the agency stated that it believes it’s now possible for cataract surgery to be performed in an office-based surgical suite, especially for “routine cases,” because advances in technology have significantly reduced operating time and improved the safety of the procedure. It further stated that cataract surgery in a nonfacility setting, i.e., somewhere other than an ASC or hospital outpatient department (HOPD), could result in additional convenience for patients, greater flexibility for surgeons and lower Medicare expenditures. CMS also noted that it is seeking information from the AMA/Specialty Society Relative Value Scale Update Committee (RUC) so that it may consider developing nonfacility practice expense (PE) relative value units (RVUs) for cataract surgery.

Professional Societies Respond

The Outpatient Ophthalmic Surgery Society (OOSS) (in conjunction with the Society for Excellence in Eyecare), American Society of Cataract and Refractive Surgery (ASCRS) and American Academy of Ophthalmology (AAO) all responded to the CMS request for comment. While each responded separately, their letters shared an overriding theme: Patient safety should be the primary concern of CMS. All agreed, too, that to ensure patient safety, the same stringent regulations and standards currently applied to ASCs in vital areas, such as proper staffing and infection control, should also be applied to office-based surgery suites.

ASCRS submitted its comments to CMS based on a survey of its membership. The information it provided to the agency highlighted potential benefits of nonfacility cataract surgery, including flexibility of location for patients and convenience of scheduling procedures for providers who aren’t able to perform the surgery in an ophthalmic ASC. ASCRS also stressed that “cataract surgery is an intensive surgical procedure that should not be trivialized.”

As asserted by OOSS, “The nation’s approximately one thousand ophthalmic ASCs have demonstrated, by all measures, the ability to deliver consistently safe, quality and affordable care in the interest of patients and payers. Accordingly, and in keeping with this historical commitment, any consideration by CMS that would reimburse for and thereby encourage the furnishing of cataract surgery in the office setting should be assessed against the standards and best practices that have come to define the current ophthalmic ASC model.”

Also in its comments to CMS, the most extensive from any of the ophthalmic organizations, OOSS conveyed that it believes the agency’s consideration of creating nonfacility PE RVUs for office-based cataract surgery is premature and should be deferred until the agency:

• further considers the patient health and safety risks to cataract patients who might be treated in offices rather than ASCs or hospitals

• develops standards of care for office surgical suites that are comparable to those applied to ASCs in terms of protecting the health and safety of Medicare beneficiaries

• identifies an appropriate model for the regulation of office-based surgical facilities and the enforcement of health and safety standards

• implements a pilot or demonstration program through which quality of care, patient health and safety, and payment in the office cataract facility can be evaluated.

In addition, OOSS called into question some assumptions made by CMS, in particular that routine cases in patients with no comorbidities could be performed in a nonfacility setting, while more complicated cases could be scheduled in an ASC or HOPD. Michael Romansky, Washington counsel and vice president for corporate development with OOSS, points out two problems with that statement. “First, cataract patients with no comorbidities really don’t exist,” he says, citing a study published in the New England Journal of Medicine.¹ “Among the more than 18,000 cataract patients involved in the study, 76% had one or more of 16 recorded coexisting illnesses, and of those, 69% had two or more,” he explains. A survey OOSS sent to ASCs in August also showed the prevalence of comorbidities among cataract surgery patients. “The number of patients represented in the survey account for approximately 13% of Medicare’s annual cataract surgery volume,” Romansky says. “Ninety-four percent of them had one or more of six conditions (hypertension, cardiovascular disease, cerebrovascular disease, pulmonary disease, endocrine disease, cancer), and of those, 88% had two or more. More than 69% were taking five or more medications.” And the second problem Romansky cites with the CMS idea of “routine” is that many of the potential complications of cataract surgery, while rare, can be vision- or life-threatening, and “despite meticulous care and assessment, it usually can’t be determined prior to surgery whether a complication will occur.”

Romansky continues, “CMS also suggested that frequent use of local anesthesia mitigates the risks associated with cataract surgery, but the common anesthesia protocol is a combination of intravenous, oral and/or topical agents, which, combined with the extent of comorbidities among cataract surgery patients, makes the presence of a qualified anesthesia provider even more important.”

OOSS ended its official feedback to CMS by listing the ASC Conditions for Coverage it believes should be essential requirements for office-based facilities that want to provide cataract surgery — including those that pertain to surgical environment, life safety code, infection control, governing body and management, staffing and/or nursing services, patient admission and/or assessment, administration and oversight of drugs, quality assessment and/or performance improvement, medical records, and patient charting — noting that “It is beyond comprehension that a senior patient with multiple comorbidities should be afforded these protections in one surgical facility and not another.”

Would Surgeons Embrace Office-based Surgery?

Romansky declines to predict whether CMS will ultimately add payment for office-based cataract surgery to the Physician Fee Schedule, saying it would be a guess. But he notes, “I’d like to think that given the concerns OOSS raised, they wouldn’t move forward unless they met the four prerequisites outlined in our comments. Otherwise, the risk to patients is on a different scale than with in-office procedures performed in other medical specialties. With more than 3 million cataracts removed every year, a problem with just 1% or 2% of facilities would impact tens of thousands of patients.”

If CMS proceeds with paying for office-based surgery without creating an accompanying regulatory structure, the quality of care patients receive in an office setting could hinge on what each state might decide to regulate, Romansky says. He doubts states would change what they do in this regard based on what CMS decides. As it stands now, according to Michael X. Repka, MD, the AAO’s medical director of Government Affairs, the Academy performed a cursory review and found that “only 27 states require accreditation of office-based surgery practices, and only 28 states have any guidelines or regulations pertaining to office-based facilities.”

It’s worth noting, says Bruce Maller, president and CEO of BSM Consulting, that “CMS has never regulated procedures performed inside the four walls of a doctor’s office.” To what extent the agency might decide to do that for cataract surgery and what it would reimburse the doctor/practice will be key factors in whether or not surgeons embrace the idea, Maller adds. “Surgeons who have already made multimillion-dollar investments in building, licensing, certifying, and maintaining ASCs will likely question why they would ever perform surgery in-office,” he continues. “On the other hand, surgeons who don’t own ASCs, such as those in states where certificate of need (CON) requirements make it difficult to open an ophthalmic ASC, and who deem the in-office setting to be safe, might be interested. They may be able to work with third-party payers looking for a lower reimbursement level as well. Health plans may endorse this idea, especially those that don’t have a full appreciation of what’s involved in cataract surgery.”

The AAO’s Dr. Repka thinks some cataract surgeries would migrate to the office setting, if the reimbursement were sufficient to support the cases. The Academy noted in its comments to CMS that an accurate enumeration of the significant direct and indirect practice expenses required to operate a safe surgical facility would need to be done and funded to make office-based cataract surgery feasible. Dr. Repka thinks a CMS policy change would also likely cause further erosion of cases from the HOPD to the ASC and/or office setting. “If ophthalmologists start to perform cataract surgery in the office after determining it is safe, patients may increasingly favor that setting or an ASC for a number of reasons,” he says. “Convenience might be one. Perhaps more powerful might be the lower co-payment that already exists in the ASC compared with the HOPD, which might be mirrored for office surgery. The 21st Century Cures bill that passed the House and is pending in the Senate requires CMS to publish the patient co-payments for surgeries done in the HOPD and ASC. Once those figures are published, patients will be able to easily understand potential savings to them depending on their choice of setting.” From a different point of view, he wonders what impact the emergence of in-office cataract surgery might have on the Medicare pool of funds for ophthalmology.

Maller adds that if a substantial percentage of surgeries shift to office-based settings, the current payment rate for cataract surgery in the ASC could be affected. “There is an interesting provision in the CMS regulations,” he explains, “whereby if a procedure is performed more than 50% of the time in-office, Medicare gets to pay the lesser of the in-office rate or the ASC rate.”

What’s Next?

For now, all parties with an interest in whether CMS ultimately decides to pay for office-based cataract surgery are players in a waiting game. OOSS, ASCRS, and the AAO will be monitoring the CMS’ next moves and have indicated their willingness to be engaged in further discussion of the issue. ■

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