New Therapeutic Device – maximizing the ocular penetration and discouraging the systemic absorption

Tear Duct OccluderTM is an FDA  newly approved prescription therapeutic device and has to be prescribed by a licensed eye care professional. It was designed for patients who use eyedrops requiring prolonged ocular surface contact to improve absorption and/or decrease systemic absorption of eyedrops to prevent adverse side effects (of Brimonidine and Combigan). It may reduce your patient’s reliance on additional medications at your discretion. This device also prevents dysgeusia (bitter aftertaste), which is a common complaint of patients who use certain dry-eye eyedrops (such as Xiidra), by preventing nasolacrimal duct outflow into the nasopharynx.

Tear Duct Occluder, as its name implies, is for occluding tear ducts. Unlike punctal plugs, it occludes the tear ducts via compressing the tear ducts externally. It fits the nasal aspect of the orbital rim of almost any patients of any races. The adjustment, if any, would be squeezing or widening the space between the corner of two eyes by the nose and the space across the inferior end of nose bone. The adjustments are less than 2mm and may be done by patients without any special tools.

This device should be worn for 5 minutes at a time following drops instillation. In rear occasions, patients may still experience dysgeusia which suggests that the device either does not fit correctly or the Velcro strap is not firmly fastened. Patients should perform the adjustments as stated above to minimize the dysgeusia.

See Tear Duct Occluder Labeling for more information about this device.

Clinical Study:

  • 38 patients participated the study (17 women and 19 men)
  • 34 Caucasians, 2 Africans and 2 Orientals.
  • 37 glaucoma patients and 1 dry-eye patient.

Conclusion:

  • 83% of glaucoma users lowered IOP by an average of 2.1 mmHg.
  • 10% of glaucoma users postponed surgery.
  • 97% of all users prevented dysgeusia, such as unusual taste from Xiidra.
  • 90% of users fit the device without needing adjustment.
  • Patients with serious glaucoma conditions or using Xiidra are likely to comply using Tear Duct Occluder.
  • The compliance of using Tear Duct Occluder is higher among women than men.
  • Overall, patient compliance on following eyedrop regimen was improved by using Tear Duct Occluder.

Prescribing Information

Federal law restricts this device to sale by or on the order of a licensed eye care professional (including but not limited to: ophthalmologist, optometrist, optician, rheumatologist or any doctor who takes care of patient’s eyes).

When prescribing this device for your patients, the prescription should include:

  1. Your Practice Name, address, Phone # and NPI #
  2. Your patient’s name, phone # and address
  3. Prescribed device name: Tear Duct Occluder

 

Insurance Reimbursement

Disclaimers:

Medicare policy changes frequently so the following information have been provided for your reference only and is not intended to grant rights or impose obligations. Every reasonable effort has been made to assure the accuracy of the information. However, ultimate responsibility for the correct submission of claims and response to any remittance advice lies with the provider of services.

The Medicare reimbursement for this device under Part-B coverage has not been determined, Medicare’s approval of our request for National Coverage Determination (NCD) is currently pending. In the past, Medicare approved 80% of FDA approved medical devices.

Tear Duct Occluder Labeling requires a prescription from a licensed eye care professional.  On rear occasion, fitting adjustment may be needed, that is to fit the device to the nasal aspect of the patient’s orbital rim and then performing a Simplified Dye Disappearance Test to verify the occlusion effect. If an eye examination, including “Tear Duct OccluderTM fitting”, takes longer than 25 minutes of face-to-face time with the ophthalmologist, the examination may be billed under CPT Code 99214 for established Level 4 E/M. The time spent with the patient must be documented in the chart.

When submitting E/M charges based on time spent.  The requirements are:

  1. Documentation of total time (face-to-face/floor time)
  2. Documentation describing the content of the counseling and/or coordination of care
  3. Documentation supporting greater than 50% of the total time spent involved counseling and or coordination of care, i.e. additional time spent on introducing and fitting Tear Duct Occluder to the patient.

Example

You saw a glaucoma patient and discussed the treatment of high IOP with eyedrops.  You spend a total of 25 minutes in the room with the patient discussing this issue.  To code this encounter based on time, you need to document:

Assessment/Plan:

Dx: POAG

Plan:

  1. Continue Xalatan qhs OU
  2. Start Tear Duct Occluder use prior to each drop
  3. Recheck IOP at next visit in 4 months
  4. A total of 25 minutes was spent face-to-face with the patient and over half of that time was spent on counseling and coordination of care.  We discussed the need to improve eyedrops absorption with the Tear Duct Occluder as this may decrease the need for additional medications. I fitted the device to the patient and verified nasolacrimal occlusion visually.

Technical Information

The most unique technological characteristic of the Tear Duct OccluderTM is the frame’s flexible material that is rigid enough to maintain the shape of the frame during normal use yet soft enough to be bendable by hand. This characteristic enables this device to be fully adjustable to fit individual patients. The skin contact portions are covered with silicone rubber (i.e. Latex free) to improve comfort and increase the coverage area over the nasolacrimal ducts.

The occlusive pressure is accomplished by fastening a pair of Velcro straps around the back of the head. A physician should work with the patient to fit the device in order to avoid too much pressure (a safety risk) or too little pressure (an efficacy concern). The device is designed to limit the pressure at 200 mm Hg (i.e. 3.9 psi). Even at this pressure level, it is safe to be used on normal skin for the recommended times of 5 minutes per drop (see Skin-Tolerance Chart). The physician should check the fitting with the patient as well as check the occlusion effect using a Simplified Dye Disappearance Test.

There is strong scientific proof that nasolacrimal occlusion following eyedrops instillation improves delivery of medication. Clinical studies show that punctal occlusion can lower IOP in patients with glaucoma by about 2 mm Hg. (Study A, Study B)

Simplified Dye Disappearance Test

The purpose of a simple dye disappearance test is to check whether the outflow through the nasolacrimal ducts is significantly reduced by wearing the Tear Duct OccluderTM.  A licensed eye care professional should perform the test and assess the result during a routine clinical visit for patients after initial fitting of the the Tear Duct OccluderTM. The test procedure involves having the patient wear the device and then using a wet fluorescein strip with balanced salt solution or saline to instill fluorescein into the conjunctival fornices of each eye. The licensed eye care professional should then wait 5 minutes and check the tear lake with a cobalt blue light that can be found on most direct and indirect ophthalmoscopes or as an attachment on a muscle light. Persistence of significant dye, indicates effective obstruction of the nasolacrimal ducts.