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Texas Consent Requirements Effective 2020

The Texas Medical Disclosure Panel (TMDP) revised the Disclosure and Consent for Medical Care and Surgical Procedures Rules and Regulations: Texas HHS Rules and Regulations.

Effective January 1, 2020, Texas physicians should use the new informed consent form for patients undergoing 9 ophthalmic procedures (see List A below).

The Texas specific consent form should be used in combination with the OMIC procedure specific consent form.

The new Texas consent forms can be downloaded from the Texas HHS website (link above).

List A: 9 eye treatments and procedures that require specific risks listed on Texas specific consent form listed below or go to the following link: Direct Link to List A

(f) Eye treatments 

(1) Eye muscle surgery.

(A) Additional treatment and/or surgery.

(B) Double vision.

(C) Partial or total blindness.

(2) Surgery for cataract with or without implantation of intraocular lens.

(A) Complications requiring additional treatment and/or surgery.

(B) Need for glasses or contact lenses.

(C) Complications requiring the removal of implanted lens.

(D) Partial or total blindness.

(3) Retinal or vitreous surgery.

(A) Complications requiring additional treatment and/or surgery.

(B) Recurrence or spread of disease.

(C) Partial or total blindness.

(4) Reconstructive and/or plastic surgical procedures of the eye and eye region, such as blepharoplasty, tumor, fracture, lacrimal surgery, foreign body, abscess, or trauma.

(A) Blindness.

(B) Nerve damage with loss of use and/or feeling to eye or other areas of face.

(C) Painful or unattractive scarring.

(D) Worsening or unsatisfactory appearance.

(E) Dry eye.

(5) Photocoagulation and/or cryotherapy.

(A) Complications requiring additional treatment and/or surgery.

(B) Pain.

(C) Partial or total blindness.

(6) Corneal surgery, such as corneal transplant, refractive surgery and pterygium.

(A) Complications requiring additional treatment and/or surgery.

(B) Pain.

(C) Need for glasses or contact lenses.

(D) Partial or total blindness.

(7) Glaucoma surgery by any method.

(A) Complications requiring additional treatment and/or surgery.

(B) Worsening of the glaucoma.

(C) Pain.

(D) Partial or total blindness.

(8) Removal of the eye or its contents (enucleation or evisceration).

(A) Complications requiring additional treatment and/or surgery.

(B) Worsening or unsatisfactory appearance.

(C) Recurrence or spread of disease.

(9) Surgery for penetrating ocular injury, including intraocular foreign body.

(A) Complications requiring additional treatment and/or surgery.

(B) Possible removal of eye.

(C) Pain.

(D) Partial or total blindness.

List B: 3 eye treatments and procedures that do not require a Texas specific consent form listed below or go to the following link: Direct Link to List B

(f) Eye procedures that do not require a TX specific consent form

(1) Administration of topical, parenteral (such as IV), or oral drugs or pharmaceuticals, including, but not limited to, fluorescein angiography, orbital injection or periocular injections.

(2) Removal of extraocular foreign bodies.

(3) Chalazion excision.

BEOVU

There are two BEOVU forms

Use BEOVU for all adult patients receiving BEOVU. This form was updated on 3/13/20 to add retinal arterial occlusion to the list of complications.

Ask women of child-bearing age to sign Beovu.Possible risk for the fetus about the possible risk to the fetus. The BEOVU prescribing label states that there is a possible risk to the fetus from this and other anti-VEGF drugs. It should only be used in women of childbearing age if the possible benefit for the woman is greater than the potential risk to the fetus.

Review our risk management recommendations on the use of anti-VEGF drugs in adults.

AntiVEFG drugs for adults addresses on- and off-label use, preventing endophthalmitis, informed consent issues, and documentation. It incorporates key guidelines on intravitreal injection published by a panel of experts. It also addresses the FDA warning about Avastin in more detail.

Conduct a time out before each intravitreal injection.

OMIC has received reports of “wrong” events associated with intravitreal injections. These include wrong patient, wrong eye, wrong condition, wrong drug, and wrong dose.

To ensure that the correct drug and dose are injected into the correct eye every time, the ophthalmologist needs to lead a time out.  Time-out before intravitreal injections/ provides the opportunity to confirm that the patient, medical record, and ophthalmologist are in agreement.

Comanagement consent form

Obtain informed consent for comanaged surgical care

Patients need to know which care will be delegated to a comanaging optometrist. They must be informed that they may contact the ophthalmologist and return to him for care at any time. OMIC advises ophthalmologists who comanage with community optometrists to ask patients to sign  Consent for comanagement of surgical patients. Ophthalmologists who comanage with optometrists in their own practice should obtain oral consent and document the patient’s agreement in the medical record. Ophthalmologists in Florida should use the FL comanagement consent form to meet the requirements of state law.

 

LipiFlow Consent Form

Download:  Lipiflow 2016

LipiFlow® Treatment Of Dry Eye

Dry eye condition can cause eye discomfort and blurred vision. Healthy eyes make a tear film that protects the eyes. The tear film has a water layer, a mucus layer, and an oily layer. Sometimes, the gland that makes the oily layer becomes blocked. Gland blockage is one cause of dry eye condition.

The LipiFlow® System is a medical device that treats dry eye. Your ophthalmologist (eye surgeon) will put numbing drops into your eyes to make your eyes more comfortable. The eye surgeon will then place the device around and behind the eye lids. It rests on the eye like a contact lens to warm and massage the eyelids. This help the oils from the blocked eyelid glands flow into the tear film.

The goal of a LipiFlow treatment is to make your eye more comfortable. Your eye may not feel better the first few weeks. Your eye may not feel completely better if you have some diseases, have had dry eye a long time, or have an eye gland disease. The LipiFlow treatment will help for 9 to 15 months. You may need to have a treatment once a year. Talk to your ophthalmologist about how well LipiFlow will work for you and how often you will need a treatment.

It is your choice to have a LipiFlow treatment. Here are some other options.

  • Dry eye can damage the surface of the eye if it is not treated, but your eyes may not bother you enough to have treatment.
  • There are other treatments for dry eye such as eyelid scrub with warm compresses, eye drops, punctal plugs that keep tears in the eye, or surgery to open the tear ducts. 

As with all surgery, there are risks (problems that can happen) with LipiFlow. While the eye surgeon cannot tell you about all risks, here are some of the most common or serious:

  • Eye injury or burn
  • Eye infection
  • Eye or eyelid pain
  • Eyelid irritation (redness, burning, tearing, itching, discharge, foreign body sensation)
  • Changes in your vision
  • Sensitivity to light
  • Stye (a red, sore lump near the edge of the eyelid)
  • Swelling of the eyelid glands
  • Scratch on the front of the eye
  • Swelling of the lining of the eye

Consent. By signing below, you consent (agree) that:

  • You read this informed consent form, or someone read it to you.
  • You understand the information in this informed consent form.
  • The eye surgeon or staff offered you a copy of this informed consent form.
  • The eye surgeon or staff answered all your questions about LipiFlow.

I consent to have LipiFlow treatment for:

Right eye:_________

Left eye:__________

Both eyes:________

 

 

                                                                                                                                               

Patient (or person authorized to sign for patient)          Date:

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Six reasons OMIC is the best choice for ophthalmologists in America.

Supporting your specialty.

OMIC was founded by members of the American Academy of Ophthalmology nearly a quarter century ago and is the only carrier sponsored and endorsed by AAO. OMIC is also endorsed by 54 other ophthalmic societies. The OMIC partnerships with state and subspecialty societies qualifies their members for an exclusive 10% premium credit. Contact your state society for details.

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