At Press Time
Guidelines on Femto-phaco Charges
ASCRS and AAO advise on adding fees for Medicare patients.
By Jerry Helzner, Senior Editor
■ With Alcon’s LenSx femto-phaco system now in regular use by a small but growing number of US ophthalmology practices, critical questions have arisen as to what — if any — fees can be charged in connection with Medicare-covered cataract surgery. Patient-paid refractive lens exchange procedures are not germane to this discussion, as they are elective procedures for which charges for premium IOLs and use of the femtosecond (FS) laser can be set by market forces, subject to properly documented informed consent.
In a proactive effort to keep surgeons and practices from making errors and miscalculations that may place them in legal and financial jeopardy, ASCRS and AAO have consulted with outside legal experts to develop a single set of clear and timely guidelines designed to assist practices in assessing the overall considerations that current use of femto-phaco entails.
Since they have been published, the guidelines have generally been characterized by practices as “restrictive,” interpreting Medicare rules as permitting extra FS charges only for astigmatic keratotomy. However, the highly respected cataract surgeon David F. Chang, MD, president-elect of ASCRS and also involved in creating the guidelines, told Ophthalmology Management that, simply stated, the guidelines are intended to keep surgeons, practices and the profession of ophthalmology “out of trouble.”
“Based on questions from our membership, we realize that there is a lot of confusion as to whether it is permissible to bill Medicare patients for using the FS laser under certain scenarios, such as when a premium refractive IOL was implanted,” said Dr. Chang. “Physicians should understand that this document is meant to clarify what the current CMS regulations are — to help them understand the billing safe harbors and to avoid liability.”
Dr. Chang emphasized that the guidelines were developed to specifically address the current Medicare regulations for this technology and can only draw upon the available knowledge base regarding the outcomes achievable with femto-phaco. If CMS regulations change, then the advisory document will be updated.
“Because data from larger clinical studies will eventually emerge, we recognize that how this new technology is applied is a dynamic situation and subject to change,” he recently wrote. Thus, he envisions a time when an accumulated body of femto-phaco data might lead to different CMS regulations regarding reimbursement for use of the technology.
“The ASCRS leadership would very much like patients who so elect to have access to this promising technology,” asserted Dr. Chang. “However, under the current economic model of click fees, this would seemingly require the individual patient to share much of the additional cost. While we understand that FS laser companies are pursuing other avenues for billing Medicare patients, and don’t all agree with our document’s interpretation of safe harbors, the societies don’t create Medicare payment policy — CMS does. In this case, the societies are the messenger — not the decision maker — and the OIG enforces the regulations.”
Dr. Chang concluded that because ophthalmologists won’t all individually hire their own legal counsel for advice, the societies “have collaborated to get expert legal and regulatory guidance on behalf of members.”
Michael X. Repka, MD, AAO medical director for Governmental Affairs, noted that CMS has as yet made no specific statement on the use of the femtosecond laser in cataract surgery, leaving the ophthalmic community to provide its own interpretation of Medicare regulations.
“CMS may have to issue a clarification at some point,” said Dr. Repka. “I think, at this point, the local Medicare carriers actually might be more helpful in terms of clarifying their position on the issue.”
Dr. Repka added that practices “might want to push the envelope” and obtain opinions from their own legal counsel, but he asserts that relying on the joint guidelines is the safest course for practices to pursue.
Alcon, maker of the LenSx system, said it would have no formal comment or statement regarding the guidelines.
Achieve Efficiencies in Cataract Surgery
AAAHC releases benchmarking data for ways to improve.
By Samantha Stahl, Assistant Editor
■ New information released by the Accreditation Association for Ambulatory Health Care (AAAHC) Institute for Quality Improvement has identified key areas of pre- and postop routines that can be shortened to increase overall efficiency. Part of a national study, Cataract Extraction with Lens Insertion, data was collected from 110 organizations from July to December 2011 with information on over 3,000 cases. Naomi Kuznets, PhD, senior director and general manager of the AAAHC, analyzed benchmarking data for a wide variety of tasks.
The analyzed data included a pre-procedure time range of 30 to 157 minutes, with an average of 83 minutes. Those with the quickest preop process employed a number of strategies, including computerized charting with EHRs or simply standardized charting and routines that streamline the preop practice. Some facilities had patients administer their dilating drops at home, so they were already effective by the time patients arrived to the pre-op area.
High staff-to-patient ratio and cross training staff were also credited for trimming down preop time. Having one nurse start an IV while another takes care of charting, preop exams and interviews will help speed things along.
Discharge times were also analyzed, with a range of six to 31 minutes and an average of 24 minutes. Short wait times in this category were again attributed to delegating tasks to more than one nurse or technician. Assign a nurse to take vitals and monitor, a tech to review postop instructions and a certified paramedic to remove the IV, and have a nurse and tech begin postop care as soon as the patient leaves the OR.
The medication reconciliation form should be compiled at the patient’s preop visit, and discharge instructions should be explained so that the patient is already familiar with the protocol during the postop review. It was also recommended to give the caregiver discharge instructions while the patient is still in surgery.
Data from the survey suggests that efficiencies are best achieved using two ORs to minimize turnover time, local anesthesia and only 2 mg of midazolam. Leaving patients in street clothes and escorting them from the facility to prevent any slips and falls was also credited.
While great strides have been made for increasing OR efficiency over the years, fine-tuning everything that happens before and after a patient is on the operating table can make a great impact on a surgery center’s flow. “Over the years that the AAAHC Institute has conducted this study, we have seen very large improvements in facility times through adoption of some or all of these strategies,” said Dr. Kuznets.
Bascom Palmer Celebrates 50 Years
Institute marks anniversary with major research symposium.
■ Bascom Palmer Eye Institute began its golden anniversary year by hosting a global scientific meeting in Miami. With more than 600 prominent ophthalmologists attending, many of them alumni, the early February meeting shared new research projects in such areas as macular degeneration, glaucoma, gene therapy and cellular regeneration using stem cells.
“We brought together the best and brightest in ophthalmology,” said the Institute’s Chairman Eduardo C. Alfonso, MD. “This meeting is certain to create great momentum within the field and we look forward to sharing the results with our colleagues around the world.”
Dr. Alfonso also said that in the next few years Bascom Palmer will expand its facilities and human capital, increasing access to the latest clinical trials and finding fresh solutions to preserve vision and meet the needs of an aging population.
In the area of ophthalmic research, Bascom Palmer Eye Institute is currently conducting clinical trials of a treatment to stop progression of the dry form of AMD and studies to discover ways to regenerate optic nerves.
“Working collaboratively with our colleagues at the University of Miami, Bascom Palmer now has the most robust genetics research program in the nation,” added Dr. Alfonso. “That talent has already enabled us to identify specific genes involved in glaucoma and retinal degenerative diseases.”
On a global scale, in addition to its long-established collaboration with key research centers in Europe, the Institute is building relationships in emerging areas of the world. Specific partnerships include those with King Saud University in Saudi Arabia and LV Prasad Eye Institute in India, as well as several others in South America, the Caribbean and China.
Dr. Alfonso said Bascom Palmer’s expansion plans over the next few years will include doubling clinical space at its Plantation location, creating a freestanding retina center on Bascom Palmer Eye Institute’s Palm Beach Gardens campus, expanding space at the Institute’s Naples facility to enhance clinical care and research capability, and developing a long-term master plan for a 500,000-square-foot patient care, research and education facility in Miami.
To be funded through private donations, the complex will be built on land purchased by Bascom Palmer decades ago near its current location. The complex will be twice the size of the Institute’s current space, serving as an exceptional venue for training future ophthalmologists and conducting revolutionary vision research.
In the News |
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■ ICD-10 codes implementation delayed. HHS Secretary Kathleen Sebelius said that the department will initiate a process to postpone the date by which healthcare entities have to comply with International Classification of Diseases, 10th Edition diagnosis and procedure codes (ICD-10). The final rule adopting ICD-10 as a standard was published in January 2009 and had set a compliance date of October 1, 2013. HHS will announce a new compliance date moving forward. “ICD-10 codes are important to many positive improvements in our healthcare system,” said Ms. Sebelius. “We have heard from many in the provider community who have concerns about the administrative burdens they face in the years ahead. We are committing to work with the provider community to reexamine the pace at which HHS and the nation implement these important improvements to our health care system.” The ICD-10 codes provide more specific data and are intended to help improve patient care and to enable the exchange of healthcare data with that of the rest of the world that has long been using ICD-10. Entities covered under HIPAA will be required to use the ICD-10 diagnostic and procedure codes. ■ Dr. Ruth Williams is new AAO president. Illinois glaucoma specialist Ruth D. Williams, MD, began her term as the president of the American Academy of Ophthalmology in January. Dr. Williams also serves as president of the Wheaton Eye Clinic, located in Chicago’s western suburbs. Dr. Williams served on the Academy’s Board of Trustees for the past year as president-elect, as secretary for member services from 2005-10, and as trustee-at-large from 2000-04. She also led the Academy’s young ophthalmologist program. ■ FDA approves new Merck prostaglandin. Merck said the FDA has approved Zioptan (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution. Zioptan is approved for reducing elevated IOP in patients with open-angle glaucoma or ocular hypertension. ■ Correlating structural and functional loss in glaucoma. One of the long-running issues in diagnosing glaucoma progression is how to determine when retinal nerve fiber layer (RNFL) thinning begins to affect functional vision. Leading glaucoma specialists from the University of Pittsburgh and Tufts University conducted a study to determine the RNFL thickness at which visual field (VF) damage becomes detectable and associated with structural loss. They reported their findings in the January 2012 issue of the British Journal of Ophthalmology. In this prospective cross-sectional study, 72 healthy and 40 glaucoma subjects (one eye per subject) had multiple VF examinations and SD-OCT optic disc cube scans (Humphrey field analyzer and Cirrus HD-OCT, respectively). The mean RNFL thickness threshold for VF loss was 75.3 µm, reflecting a 17.3% RNFL thickness loss from age-matched normative value. The researchers concluded that substantial structural loss (~17%) appears to be necessary for functional loss to be detectable using the current testing methods. ■ Kit form of mitomycin-C approved. Mobius Therapeutics has received FDA approval to manufacture and market Mitosol, a kit form of mitomycin-C for use in three indications: glaucoma surgery, prevention of corneal haze following surface ablation and pterygium removal. Mitosol had been granted orphan drug designation for the three indications by the FDA. The kit contains vials of liquids that can be mixed by a nurse shortly before surgery. “The approval of Mitosol is an important event on multiple levels,” said Henry D. Jampel, MD, professor of ophthalmology at the Wilmer Eye Institute. “Surgeons, patients and operating room staff will benefit from improved precision, convenience, quality assurance and safety.” OM |