Quick Hits
CMS takes aim at ‘recalcitrant providers’
Habitual overchargers face fines and expulsion.
By René Luthe, Senior Associate Editor
Physicians whom the CMS deems to have a pattern of billing for medically unnecessary services and charging excessive fees — even after extensive training to remedy such behaviors — will find themselves targeted for civil fines and possible expulsion from Medicare as part of a new initiative to combat Medicare abuse.
In a CMS directive issued in January, the agency offered a new means of policing what it terms “recalcitrant providers” suspected of abusive billing practices. Medicare administrative contractors are to report such providers to CMS, which would turn them over to the Office of the Inspector General (OIG) in the Department of Health and Human Services (HHS). The OIG would have the power to fine these providers, exclude them from Medicare or do both.
CMS defines “recalcitrant providers” eligible for targeting as those who “abuse” Medicare despite remedial education; the agency cites two particular kinds of abuse federal law addresses. One is submitting claims for a pattern of services or items that the provider “knows or should know are not medically necessary.” In the other, CMS referred to a part of federal law stating that HHS may exclude providers from Medicare for submitting claims for excessive fees or unnecessary services, or for not furnishing necessary services.
In a recent OIG report, the office recommended CMS focus on physicians with the highest Medicare billings for improper payments. According to the OIG, 303 physicians received more than $3 million each in 2009. Ophthalmologists, along with radiation oncologists and internists, comprise the majority of the highest-billing doctors.
Meanwhile, the Obama administration announced it would consider releasing data showing the amounts individual doctors receive in Medicare payments each year in response to Freedom of Information Act requests.
Scheduled to go into effect March 18, the policy allows Medicare officials to “weigh the balance between the privacy interest of individual physicians and the public interest in disclosure of such information.”
Ophthalmology Hall of Fame inductees: Drs. Vladimir Filatov and Theo Seiler
Two new inductees to the Ophthalmology Hall of Fame will be formally announced at next month’s ASCRS meeting. They are the late Russian ophthalmologist Vladimir Filatov (1875-1956), who was the first in the world to perform corneal transplantation on a living patient with cadaver eyes, and Prof. Theo Seiler of the University of Zurich, a pioneer in laser refractive surgery.
Prof. Seiler was the first in the world to perform PRK in 1987 and is acknowledged as the inventor of corneal collagen crosslinking. He is credited with being the first to treat a human eye using an excimer laser. Dr. Seiler continues to lecture and has received numerous awards.
CMS schedules additional testing of ICD-10 codes
But physician advocates want a more robust format and wider participation.
After continued urging from such organizations as the American Medical Association, the Medical Group Management Association (MGMA) and the Workgroup for Electronic Data Interchange, CMS has scheduled “end-to-end” testing of submitted medical claims using the new ICD-10 codes due to be implemented in October.
The testing is scheduled for this summer. CMS has made few details available except to say that the testing, though limited in scope, would involve a “broad cross section” of different types of providers, claims and submitters.
The CMS action marks a major turnaround from its initial position to not test the ICD-10 codes before the October 1 start date. The first softening of the CMS position came when the federal agency scheduled a week of front-end testing from March 3 to 7. However, MGMA called the March front-end testing “insufficient” because it would only demonstrate whether a provider transmitted a claim and if the Medicare contractor on the other end received it. The testing did not determine whether a claim had been approved.
CMS has said little about who can participate in the new round of testing. MGMA has urged CMS to expand the scope of the testing so that any provider who wishes to may participate. MGMA also has requested that CMS quickly disseminate test results.
“This more robust testing is imperative to identify potential operational problems similar to what was experienced during the rollout of healthcare.gov,” said Susan Turney, MD, president and CEO of MGMA.
ELEVEN BIOTHERAPEUTICS BEGINS PIVOTAL PHASE 3 DRY EYE TRIAL
Eleven Biotherapeutics (Cambridge, Mass.), a clinical-stage biopharmaceutical company developing protein therapeutics to treat diseases of the eye, said patient dosing is under way in the company’s pivotal phase 3 clinical trial of EBI-005 for moderate to severe dry eye disease, known as the OASIS study.
The trial is a multicenter, double-masked, randomized, controlled, efficacy and safety study of EBI-005 5 mg/ml. The company says EBI-005 reflects a new approach to the treatment of dry eye disease and is the first IL-1 signaling inhibitor designed for topical ocular administration.
The phase 3 trial follows a positive six-week phase 1b/2a study of EBI-005 in patients with dry eye disease. The company reported that EBI-005 demonstrated statistically significant improvements in signs and symptoms of dry eye vs. baseline. EBI-005 also met the predefined efficacy criteria of the study and showed a differential effect between subjects who received EBI-005 and those who received only the vehicle. Data showed that EBI-005 was generally safe and well tolerated.
EBI-005 is the company’s most advanced product candidate generated using its AMP-Rx platform. It is a novel, topically administered Interleukin-1 (IL-1) receptor blocker for the treatment of dry eye disease and allergic conjunctivitis. EBI-005 was designed to bind and block the IL-1 receptor to prevent transmission of biological signals responsible for many signs and symptoms of ocular surface diseases.
This pivotal phase 3 trial will include approximately 650 subjects in the United States, who will be randomized to receive EBI-005 or a vehicle-control. The study endpoints are change in corneal fluorescein staining score and improvement in pain and discomfort.
Ophthalmology losing hours in med schools
New survey shows a continuing decline in ophthalmic instruction.
By René Luthe, Senior Associate Editor
An alarming survey into the state of ophthalmic education in standard medical school curriculum has found the specialty continues to decline in its share of attention.1 The survey of 135 member medical schools of the Association of University Professors of Ophthalmology (AUPO), plus 30 osteopathic and 40 non-AUPO-affiliated allopathic medical schools in the United States and Canada, conducted over 2012-2013, shows that ophthalmology lost ground both in required hours and in clinical rotations.
Specifically, the investigators reported that while preclinical ophthalmology education remains “nearly universal” among the 109 AUPO institutions that responded, in the form of lectures and basic examination skills during the first two years of medical school, clinical exposure to ophthalmology patients “was more variable.” Twenty-one percent of schools offered no additional ophthalmic teaching, 24% offered an additional one to two hours, 35% offered another three to seven hours and 20% offered another eight or more hours of ophthalmic instruction.
Only 18% of the AUPO respondents required a clinical rotation in ophthalmology. In surveys conducted in 2000 and 2004, 68% and 30% of members respectively required a clinical rotation in the specialty. All of the respondents offered an elective rotation in ophthalmology.
Evan Waxman, MD, PhD, of the department of ophthalmology at University of Pittsburgh School of Medicine, and senior study author, says the results point to a need for medical schools to do better of ophthalmic education.
“Patients with eye complaints present to their primary-care doctors because they have a reasonable expectation that their doctors will know something about their eyes,” he says. “Now we know the majority of physicians can graduate from medical school without adequate ophthalmology training.”
Dr. Waxman attributes the decline in ophthalmic education to the trend of academic ophthalmology departments separating from their medical schools over the last decade or so.
That means ophthalmology is less likely to recruit the best and brightest from medical schools. “But more importantly, when we separate from our medical schools our colleagues in primary care and other fields don’t know who we are and what we do,” he says. “They are less likely to understand the role of the ophthalmologist in the health of our patients.”
REFERENCE
Shah M, Knoch D, Waxman E. The state of ophthalmology medical student education in the United States and Canada, 2012-2013. Ophthalmology. E-pub Feb. 10, 2014.
Get involved in clinical trials |
tip of the month |
Participation in clinical trials is one area that some — especially smaller — ophthalmology practices tend to overlook. Here, Michael Korenfeld, MD, ACOS, of Comprehensive Eye Care Ltd. in Washington, Mo., explains why your practice and your patients can benefit from your involvement in clinical trials.
1. Participation in in studies identifies you as an alert, cutting-edge practice seeking to offer your patients the newest and best treatments.
2. When you choose patients from your practice to be in a trial, they gain the benefits of comprehensive monitoring, free medications and a per-visit stipend to offset the time and travel the study requires.
3. As far as finding studies that need investigators, start by contacting study sponsors. All FDA-approved studies are published at clinicaltrials.gov. so I recommend checking this site. Many sponsors will ask you to participate in subsequent studies if you and your staff do a good job on the first one; and you should do just that.
PhotoMedex to acquire LCA-Vision
PhotoMedex Inc., a company focusing on the dermatologic and aesthetic sector, and LCA-Vision, which was a pioneer in providing laser refractive surgery in multiple branded centers nationwide, have signed a definitive agreement in which PhotoMedex will acquire LCA-Vision for $5.37 per share in cash, or approximately $106.4 million. LCA-Vision has operated under the LasikPlus brand.
PhotoMedex is a global skin health company that provides integrated disease management and aesthetic solutions to dermatologists, professional aestheticians and consumers. The company said it believes owning the LasikPlus centers will give it a national footprint and also provide opportunities to introduce its laser skin care procedures for psoriasis and vitiligo into the LasikPlus centers.
Study challenges use of aspirating speculums
They may irritate dry eyes in cataract surgery.
By Bill Kekevian, Senior Associate Editor
Using an aspirating speculum for cataract procedures may aggravate dry eyes, according to research from South Korea.1 The prospective study evaluated the short-term influence of aspirating speculums on dry eye following cataract surgery. The study, published in the journal Cornea, found elevated dry eye parameters during the early postoperative period.
The dry eye parameters the researchers, from Gachon University Gil Hospital in Incheon, measured included conjunctival staining, tear film break-up time, conjunctivochalasis grades and ocular surface disease index evaluated.
The researchers studied 58 eyes undergoing cataract surgery. Half were treated using an aspirating speculum and half were treated with a nonaspirating speculum. While the nonaspirating speculum group showed aggravation by tear film break-up time and conjunctivochalasis grades on day one postoperativly, the aspirating speculum group showed the same aggravation by tear film break-up time and conjunctivochalasis grades up to seven days postoperatively, the authors reported. The parameters for both groups returned to preoperative values one month after surgery.
Surgeons’ comment on study
David R. Hardten, MD, of Minnesota Eye Consultants, says trauma at the time of surgery can impact dry eye symptoms. Although this is a small study and only looks at one factor, he says, “there may be some intuitive basis of this study. The active air pulling across the conjunctiva may temporarily irritate the goblet cells or epithelium of the conjunctiva. There is still much to learn about factors involved in dry eye around the time of surgery.”
Dr. Hardten recommends ophthalmologists identify dry eye and meibomian gland dysfunction preoperatively.
However, Bradley Black, MD, of Dr. Black’s Eye Associates in Jeffersonville, Ind., does not think the study findings will have a wide impact. He points to several metrics the authors have not taken into account, including postoperative drop regimen, patient medications and environmental factors, among others.
More importantly, though, Dr. Black wonders if temporary corneal dryness isn’t a fair trade off for other benefits of aspirating speculums. “Although I do not use an aspirating speculum during cataract surgery, they offer some potential benefits such as visibility and removal of pooled fluid that could be a reservoir for bacteria from the lids or lashes, all of which might outweigh the temporary concern of corneal dryness,” he says. Dryness issues “could easily be handled by recommending artificial tears and/or aggressive ocular surface disease treatment preoperatively,” he adds.
REFERENCE
1. Moon H, Yoon JH, Hyun SH, Kim KH., Short-Term Influence of Aspirating Speculum Use on Dry Eye After Cataract Surgery: A Prospective Study. Cornea. 2014 Jan 30. [Epub ahead of print]
IN THE NEWS
Dr. Skuta is new AAO president
Oklahoma glaucoma specialist Gregory L. Skuta, MD, has begun his term as the 117th president of the American Academy of Ophthalmology. Dr. Skuta, who was elected by the Academy’s 32,000 eye physician and surgeon members, will hold the office for one year.
Dr. Skuta is president and CEO of the Dean McGee Eye Institute and serves as the Edward L. Gaylord professor and chair of the University of Oklahoma College of Medicine’s department of ophthalmology. In his role as Academy president, Dr. Skuta will represent the profession within the broader field of medicine and serve as ophthalmology’s advocate-in-chief to federal, state, local and global officials and organizations.
Ellex acquires canaloplasty business
Ellex Medical Lasers Ltd. (Adelaide, Australia) has acquired the canaloplasty catheter and suture surgical technology developed by iScience International (Menlo Park, Calif.) to treat mild-to-moderate glaucoma. Ellex sees canaloplasty as complementary to its own line of SLT lasers that treat early-stage glaucoma.
The canaloplasty business will trade as Ellex iScience Inc., while production of the device will continue from the existing FDA-approved facility at Menlo Park. Ellex said expansion of the canaloplasty clinical training team will begin immediately to better support existing and new customers.
Lumenis goes public at $12 a share
Following a recent trend of several ophthalmic companies selling stock to the public, Lumenis Ltd. (Yokneam, Israel), a supplier of ophthalmic and other medical lasers, recently sold $100 million in common stock at an offering price of $12 a share. Lumenis ophthalmic lasers are used for glaucoma, secondary cataract and retina procedures. Underwriters for the offering included Credit Suisse, Goldman Sachs Jefferies and Wells Fargo. Lumenis has listed its common shares on the Nasdaq Global Market under the ticker symbol “LMNS.”
Envisia funds sustained-release glaucoma drug
Envisia Therapeutics, a new biotechnology company formed by Liquidia Technologies, has received $25 million in Series A financing to focus on addressing unmet medical needs in various areas of ophthalmology. Envisia’s lead product, ENV515, is an extended-release formulation of a prostaglandin analogue. The company says ENV515 has the potential to offer glaucoma patients an innovative product that can provide a sustained reduction in IOP over many months after single administration. OM