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Specialists oppose plan to deny coverage for dry eye testing in Pennsylvania
ASCRS Cornea Clinical Committee urges Medicare carrier to continue coverage of tear osmolarity and MMP-9 testing.
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Cornea subspecialists are urging a Medicare carrier to reconsider a proposed determination to end reimbursement for point-of-service dry eye testing in Pennsylvania.
In January, Novitas Solutions, the regional Medicare carrier in Pennsylvania, issued a draft local coverage determination (LCD) that would deny reimbursement for tear osmolarity and MMP-9 testing for dry eye.
The draft LCD cites “lack of supporting data to demonstrate patient benefit from microfluidic analysis (tear osmolarity) or immunoassay analysis of tears relative to treatment choice and planning, disease outcome or evolution,” and further says such testing is not medically reasonable or necessary.
Novitas invited commentary on the LCD. OSN Cornea/External Disease Board Member Terry Kim, MD, as chairman of the American Society of Cataract and Refractive Surgery’s Cornea Clinical Committee, sent a letter to Novitas asking that the company reconsider its proposal.
“It is pertinent that the two defining conditions of dry eye, tear film osmolarity and inflammation, are precisely the tear tests that your draft LCD deems ‘not medically necessary,’” the letter said, citing the findings of a 2007 report of the International Dry Eye WorkShop (DEWS). “ASCRS supports the appropriate use of tear testing by eye care professionals for the diagnosis and management of dry eye. Most importantly, we believe that denial of this coverage will have an adverse outcome on the quality of care of our patients with dry eye disease.”
Tear osmolarity is critical to disease surveillance and staged treatment, the letter said.
“Measuring tear film osmolarity has been shown to be an effective way to stage and monitor the impact of dry eye treatments,” the letter said. “This staged approach to therapy is not effective without a method to track efficacy.”
In addition, the “specificity and sensitivity of MMP-9 is clinically useful in dry eye management,” the letter said.
Eric D. Donnenfeld
According to Eric D. Donnenfeld, MD, OSN Cornea/External Disease Board Member, the LCD was based on a Preferred Practice Pattern document issued by the American Academy of Ophthalmology that questioned the value of tear osmolarity testing.
“When they published these findings, it was at the very best controversial. Most corneal specialists disagree with the findings of this paper,” Donnenfeld told Ocular Surgery News.
Donnenfeld expressed concern that the ruling, limited to Pennsylvania, might inspire other regional Medicare carriers to make similar determinations.
“This opens up a Pandora’s box of problems going forward. I think it is a very significant problem for ophthalmology — one that I think we have to pay very careful attention to and one that I think that ASCRS is working very strongly to help resolve,” Donnenfeld said.
ASCRS committee defends testing
The letter to Novitas stated, “We strongly feel that your draft LCD denying coverage will result in the elimination of a valuable diagnostic modality for dry eye disease, which represents one of the most common conditions encountered by eye care practitioners. … This denial could have a significantly negative impact on research and technology in this field, which will undoubtedly hinder further developments on diagnostic devices (and potentially therapeutic agents) for dry eye and other conditions where tear testing may apply.”
ASCRS considers tear testing “one of the few in vitro diagnostic modalities pertinent to dry eye disease, as an essential tool for successful patient management,” the letter said. “Very few eye care providers would make a final diagnosis and execute a treatment plan that spans 3-6 months, such as that for dry eye disease, without the benefit of laboratory assessment to guide their decision.”
The letter noted that CPT code 83861 is used specifically for tear osmolarity testing: “Because 83861 is specific to the testing of tears, we expect the majority of tests reported with CPT code 83861 will be performed appropriately by eye care practitioners within the medical necessity of diagnosing or managing dry eye.”
However, there is no specific CPT code for MMP-9. The code 83516, “immunoassay for analyte other than infectious agent antibody or infectious agent antigen: qualitative or semiqualitative, multiple step method,” is used.
According to the ASCRS committee, ophthalmologists should be able to use the code for MMP-9 testing: “Consistent with the code’s non-specific descriptor, a broad range of diagnosis codes — including many that are not related to dry eye disease or another ocular condition — may be reported in Medicare fee-for-service claims for 83516. Because this code may be used to report testing in several non-tear specimen types, we expect that a broad range of practitioners will report 83516. However, utilization of 83516 by ophthalmologists would be considered consistent with the clinical utility of the test … and appropriate within medical necessity of diagnosing or managing dry eye.”
Defining conditions of dry eye
The letter quoted a 2007 report in which the DEWS declared that tear osmolarity and inflammation of the ocular surface are the defining conditions of dry eye disease.
The DEWS report said there is clinical utility in using tear testing for osmolarity and immunoassay tear testing for ocular surface inflammation.
“An important conclusion of the DEWS guidelines is that tear hyperosmolarity is the central cause of damage to the ocular surface in both aqueous deficient dry eye and evaporative dry eye, and tear hyperosmolarity is identified as both the core mechanism of dry eye and its essential signature,” the letter stated. “Measuring tear film osmolarity has been shown to be an effective way to stage and monitor the impact of dry eye treatments.”
In addition, MMP-9 testing is clinically useful in identifying inflammatory markers in dry eye disease.
The ASCRS Cornea Clinical Committee is expected to publish an evidence-based guidance document on tear testing for dry eye disease later this year. – by Matt Hasson
For more information:
Eric D. Donnenfeld, MD, can be reached at Ophthalmic Consultants of Long Island, 2000 North Village Ave., Rockville Centre, NY 11570; email: ericdonnenfeld@gmail.com.Disclosure: Donnenfeld reports he serves on the Executive Committee of the American Society of Cataract and Refractive Surgery and is a consultant for TearLab.