An NTIOL is defined as an IOL that CMS determines that the FDA approved for labeling and advertising claims of specific clinical advantages and superiority over existing IOLs. These may include reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages.
In its final notice published in the Federal Register, CMS stated, "CMS approves AMO's claims of clinical advantages and superiority of the Tecnis IOL for ocular spherical aberrations and simulated night driving. We find the AMO Tecnis lenses models Z9000, Z9001, and ZA9003 meet the NTIOL definition and are to be given the new NTIOL classification of Reduced Spherical Aberration."
"Today's announcement of coverage with additional payment for an innovative type of intraocular lens reflects Medicare's attention to improved clinical benefits," said CMS Administrator, Mark McClellan, MD, PhD. "For these lenses, there is clear evidence of improved functional vision and contrast acuity."
CMS has implemented an annual process under which interested parties may request a particular intraocular lens be designated with "new technology" status and become eligible for an additional $50 payment when provided to a Medicare beneficiary in an ambulatory surgical center.
This payment adjustment is valid for a five-year period, beginning when CMS recognizes an IOL as the first IOL of a new class providing specific clinical advantages and superiority over existing IOLs.
Since the NTIOL process began in 1999, two NTIOL classes have been approved. These NTIOL classes—multifocal corrective IOLs and toric—were created in 2000 and expired in 2005. The additional $50 NTIOL payment for these NTIOL classes stopped in May 2005.
The Tecnis IOL is the only lens approved for NTIOL reimbursement status, which provides for additional Medicare reimbursement of $50 per lens for ambulatory surgical centers, which perform more than half of all cataract surgeries in the United States.
"This designation by CMS demonstrates the fact that not all aspheric lenses are created equal," said AMO President and CEO Jim Mazzo. "AMO's Tecnis IOL is the only aspheric lens that demonstrates improved functional vision with claims approved by the FDA and NTIOL approval from CMS. These approvals underscore the unique benefits of this superior technology and validate AMO's commitment to provide truly differentiating technologies that help doctors deliver the best possible visual performance to their patients. From an industry perspective, it emphasizes the value of developing technologies that improve the quality of people's lives."
ANCHOR Results: Improved Vision With Lucentis
Genentech announced positive one-year results from its second pivotal Phase III study of the investigational drug Lucentis (ranibizumab) in patients with wet age-related macular degeneration.
Data from the ANCHOR study comparing Lucentis to verteporfin (Visudyne) photodynamic therapy showed a difference in mean change in visual acuity of 18 letters for patients treated with 0.3 mg of Lucentis and 21 letters for patients treated with 0.5 mg of Lucentis from study entry compared to those treated with PDT at 12 months. In the first year of this two-year study, patients treated with Lucentis gained an average of 8.5 letters in the 0.3-mg dose group and 11 letters in the 0.5-mg dose group compared to patients treated with PDT, who lost an average of 9.5 letters. In November 2005, Genentech announced that the Phase III ANCHOR study met its primary efficacy endpoint of maintaining vision (defined as a loss of less than 15 letters in visual acuity) in patients with wet AMD.
"Lucentis is the first investigational therapy that has shown improved vision, not just a slowing of vision loss, in patients with all types of wet AMD," said Peter K. Kaiser, MD, director of the Clinical Research Center at the Cleveland Clinic Cole Eye Institute, who presented the data. "As a result, physicians may be one step closer to being able to set a new expectation for the future treatment of this condition."
An analysis of the one-year data showed that adverse events were similar to those seen in earlier trials of Lucentis. Common ocular adverse side effects that occurred more frequently in the Lucentis arms than in the control group were mild to moderate and included conjunctival hemorrhage, increased intraocular pressure, eye pain and vitreous floaters. Serious ocular adverse events that occurred more frequently in the Lucentis-treated arms were uncommon and included endophthalmitis and intraocular inflammation (each reported in less than 1 percent of patients per group). Among non-ocular serious adverse events, the frequency of cerebral vascular events was less than 1 percent of patients per group. The frequency of myocardial infarctions was slightly higher in patients treated with 0.5 mg of Lucentis (2.1 percent) than in the other two arms (0.7 percent).
Additional key clinically meaningful study findings include:
• 94 percent of patients (132/140) treated with 0.3-mg of Lucentis and 96 percent (134/139) of those treated with 0.5-mg of Lucentis lost fewer than 15 letters compared to baseline, the primary efficacy endpoint of the study, compared with 64 percent (92/143) of those treated with PDT [p <0.0001].
• Nearly 36 percent of patients (50/140) treated with 0.3 mg of Lucentis and 40 percent of patients (56/139) treated with 0.5 mg of Lucentis improved vision by a gain of 15 letters or more compared with approximately 6 percent of patients (8/143) treated with PDT.
• 31 percent of patients (44/140) treated with 0.3-mg of Lucentis and nearly 39 percent of patients (54/140) treated with 0.5-mg of Lucentis achieved visual acuity of 20/40 or better at 12 months compared with approximately 3 percent (4/143) of those treated with PDT.
In December 2005, Genentech announced that it had submitted a Biologics License Application to the FDA for the use of Lucentis in the treatment of neovascular wet AMD. The BLA submission, which included a request for priority (six-month) review, is based on one-year clinical data on the efficacy and safety of Lucentis from two pivotal Phase III trials, ANCHOR and MARINA, as well as one-year clinical data from the Phase I/II FOCUS trial.
AAO Sets 2006 Advocacy Agenda
The American Academy of Ophthalmology's targets for its 2006 advocacy efforts center on Medicare reimbursement issues, but also include an effort to develop a new emphasis on children's vision screening.
The AAO's Secretariat for Federal Affairs defined the agenda during its annual meeting in Washington, D.C. "This year we are faced with a number of reimbursement challenges, many of which could affect the viability of our practices and the quality of patient care, including the SGR [Sustainable Growth Rate], pay for performance, practice expense and the Five Year Review of work values," said Michael X. Repka, MD, secretary of Federal Affairs.
Key reimbursement issues include:
• The development of a "value-based purchasing" system. "The reality is that Medicare payment tied to quality measures is no longer the question and physician leadership on this will be key to positive payment reform discussions with policy makers, particularly Congress and the [Bush] administration," said William Rich, MD, the AAO's medical director of health policy. "The Academy must be at the table when these issues are discussed in order to protect ophthalmology's interests as we move forward on Medicare's use of quality measures for physicians."
The AAO previously developed measures for ophthalmology based on its Preferred Practice Patterns. The measures were not included in the list to be used by CMS in its new Physician Voluntary Reporting Program, but the AAO is working with CMS to ensure that ophthalmology may participate in the program should financial incentives be included in 2007 or 2008.
• Fixing the Sustainable Growth Rate. Medicare reduces payments to physicians and other practitioners whenever program expenditures for their services exceed a set target, or SGR. The SGR cuts payments if growth in Medicare patients' use of services exceeds Gross Domestic Product growth. The AAO says that fixing the SGR is now a greater challenge because of the growing price tag for a fix and the increasing federal deficit.
• CMS's policy on Medicare physician practice expenses (PE). The AAO persuaded CMS to halt a disastrous proposal for the calculation of PE last year, but CMS will revisit the issue this year. The Academy will work to ensure that the new PE policy is fair to ophthalmology and that any PE calculation proposals are based on appropriate survey data.
The AAO elevated children's vision screening to a priority in response to an aggressive campaign by optometry and the eyeglass frame manufacturers to discredit screening of pre-Kindergarten and school age children in favor of complete eye examinations for all. The AAO will work with pediatric ophthalmology, pediatricians and family physicians to bring about regular screening intervals and referrals for children identified in 18 states with no children's vision requirements.
Finally, the quality of patient care in federal health-care facilities continues to be a critical issue for the AAO since its efforts to ensure surgery by surgeons in Veterans Affairs facilities. The disproportionately high rate of serious, often debilitating, eye injury and vision impairment suffered by veterans of Iraq and Afghanistan makes this priority all the more important to ophthalmology.
Glaucoma Sibs at Increased Risk
Siblings of glaucoma patients have an increased risk of developing the disease that increases with age to as much as 20 percent by age 70, according to a study in Nottingham, England, reported in the January British Journal of Ophthalmology. An effective and repeated screening program should be considered for this high-risk group.
Between 1994 and 2003, a group of 271 siblings (mean age 63.6 years; female to male ratio 1:2) of 156 OAG probands underwent both initial and follow-up standardized ophthalmic examinations as part of the Nottingham Family Glaucoma Screening Study. Siblings were classified as "definite glaucoma" (primary OAG and normal tension glaucoma), "glaucoma suspects" (NTG suspects or ocular hypertension), and normal. The prevalence and cumulative incidence of OAG over the follow-up interval were calculated.
Thirty two (11.8 percent) were classified as definite glaucoma and 15 (5.5 percent) as suspects. In the follow-up study, 157 of the 224 "normal" siblings from the initial study were examined (mean interval from initial study 7.0 (SD 1.0) years). Eleven (7 percent) were classified as definite glaucoma and 30 (19.1 percent) as suspects. There were significant trends of increasing prevalence and incidence of OAG with age and a lifetime risk estimated at approximately 20 percent by age 70. The authors recommend repeated screening for this high-risk group.
