From the Editor

When “But” Becomes the Elephant in the Room

WILLIAM J. FISHKIND, MD, FACS
CHIEF MEDICAL EDITOR

Our surgical group recently completed construction of a new ASC in Tucson, Ariz., designed to meet CMS conditions for coverage, Life Safety regulations, OSHA rules and HIPPA conditions. We were required to meet all the regulations applicable for a 10-room, multispecialty ASC, even though our facility is a two-room, single-specialty, single-purpose ASC. We were required to install a $30,000 wall-suction system, and a $100,000 HVAC system with laminar flow to prevent infection and maintain room temperatures between 68 and 72 degrees. Among other things, we also are required to use single-use packaged medication only for single use.

These regulations apply to all ophthalmic ambulatory surgery centers — no matter the size or the number and complexity of procedures performed. Yes, we chafe at some of the regulations. And yes, these regulations do add to the cost of surgical procedures and pose challenges for our highly efficient business model.

However, for more than 30 years, ophthalmic ASCs have been working with CMS to develop reasonable regulations that protect the health and safety of patients. It has always been our position that patient health and safety must come first.

Now, in an utterly perplexing about-face, CMS is considering a proposal to pay for cataract surgery in the relatively unregulated office settings of ophthalmology.

Why Would CMS Do This?

For one thing, CMS might save money and physicians might be paid less. But — and this is a very big “but” — cataract patients will have fewer protections and will be exposed to greater risk.

OOSS has taken the unequivocal position that cataract surgery should be performed only in a facility, such as an ASC or hospital, that “meets rigorous and well-established patient health and safety standards” — and I agree wholeheartedly.

Rather than considering the nominal savings and substantial risks associated with paying for cataract surgeries in a minimally regulated office environment, the ultimate objectives of CMS would be better served by working collaboratively with the ASC community to address overreaching regulations that contribute nothing to patient safety but do, in fact, add cost.

What are the real consequences? The current state of cataract surgery — an effective, benign, established, and life-changing ocular surgical procedure — could become blemished by an increase in complications, resulting in less certain outcomes. With more complications and less certain outcomes most certainly comes additional risk to patients and consequential costs to the healthcare system.

I’m most certainly not in favor over-regulation, but reasonable regulation that is focused on safety first is absolutely critical. The surgical theater should meet reasonable and verifiable requirements for airflow, cleanliness, sterilization, and all matters of patient and staff safety. It’s an obligation we all share … a mission to which we can all agree.

We know the overwhelming majority of our cataract patients in the United States are elderly, and most have at least one or more complicating health conditions. These patients require appropriate anesthesia and monitoring, and effective pre- and post-op care. At ophthalmic ASCs, we have the facilities, medical equipment, skilled staff — and yes, regulations — in place to provide maximum safety for our patients.

Let’s endeavor to work together to achieve and appropriately apply measured regulation that serves to enhance patient safety and quality of care, without adding unnecessary cost to surgical procedures. ■

William J. Fishkind, MD, FACS, is Chief Medical Editor of The Ophthalmic ASC and past President of OOSS. He is Director of the Fishkind, Bakewell & Maltzman Eye Care and Surgery Center in Tucson, Ariz.