At Press Time

Tennessee Scope of Practice Fight

ODs want to perform anesthesia injections.

■ The Tennessee Academy of Ophthalmology is opposing a recently filed in both houses of the Tennessee legislature which would allow optometrists to inject local anesthesia into the delicate tissue surrounding the eye in order to perform surgery. This legislation would expand the optometrists’ scope of practice and allow ODs to perform more advanced procedures that require an injectable anesthetic. Optometrists are currently restricted to using topical anesthetic to remove what they call “lumps and bumps.”

“This legislation would create an unnecessary risk to patients and is a threat to the quality of surgical care in Tennessee,” said Ben Mahan, MD, president of the Tennessee Academy of Ophthalmology. “Anytime a needle is placed near the eye, there are serious risks to the patient that require clinical experience and expert judgment. A surgical error of a few millimeters can result in a punctured eyeball and catastrophic vision loss.

“Whether it is injections to prepare for surgery or the surgery itself, patients have a right to know that the individual performing the procedure is a qualified medical doctor and surgeon,” said Dr. Mahan. “What optometrists call ‘lumps and bumps’ are actually lesions and tumors, and they may be cancerous.”

He noted that a surgical residency is necessary to treat these problems

Dr. Mahan pointed to a statewide survey of 600 registered voters showing overwhelming support for a current state law that requires those performing eye surgeries, including laser eye correction procedures, to have a medical degree — a requirement that prohibits optometrists from performing those surgeries. The survey was conducted on behalf of the Tennessee Academy of Ophthalmology to gauge public awareness of the difference in training between ophthalmologists and optometrists, and also to test opinions on current regulations on who can perform eye surgical procedures.

Among the survey’s findings: After hearing message points on both sides of the issue, 79% of respondents said they “strongly agree” with the Tennessee requirement “that all surgeries — including laser eye surgeries — must be performed by a medical doctor.” An additional 11% said they “somewhat agree” with the statement, resulting in a 90% agreement rate. And while 76% correctly identified ophthalmologists as having medical degrees, 68% think that optometrists also are medical doctors.

HHS Expands Patient Privacy Protection

MGMA-ACMPE believes new rules could be a burden.

By Jerry Helzner, Senior Editor

■ In a controversial move that immediately drew fire from a major physician-advocate organization, HHS has strengthened the privacy and security protections for health information established under HIPAA. The final omnibus rule greatly enhances a patient’s privacy protections, provides individuals new rights to their health information and strengthens the government’s ability to enforce the law.

However, push back came from the Medical Group Management Association (MGMA) and its standard-setting division, the American College of Medical Practice Executives (ACMPE), which questioned both the short time frame for compliance and the scope of the new regulations. All entities covered by the new regulations must be in compliance by September 23, 2013.

The rationale for the new rule: “Much has changed in health care since HIPAA was enacted over 15 years ago,” HHS Secretary Kathleen Sebelius. “The new rule will help protect patient privacy and safeguard patients’ health information in an ever-expanding digital age.”

“We are strongly supportive of comprehensive privacy and security standards aimed at avoiding unauthorized use or disclosure of patient health information,” said Susan L. Turney, MD, MS, president and CEO of MGMA-ACMPE. “However, it is critical that the safeguards mandated by the government be practical, flexible and affordable for the broad spectrum of medical practices.”

MGMA-ACMPE has concerns about the short time frame for practices to make the changes associated with this final rule, including the requirement to modify and reissue notices of privacy practices and modify business associate agreements.

The HIPAA Privacy and Security Rules have previously focused on health-care providers, health plans and other entities that process health insurance claims. The new regulations expand many of the requirements to business associates of these entities that receive protected health information, such as contractors and subcontractors. HHS says some of the largest security breaches have involved business associates. Penalties are increased for noncompliance based on the level of negligence with a maximum penalty of $1.5 million per violation.

The new regulations also expand individual rights. Patients can ask for copies of their medical records in an electronic form. When individuals pay by cash they can instruct their provider not to share information about their treatment with their health plan. The final rule sets new limits on how information is used and disclosed for marketing and fund-raising purposes and prohibits the sale of an individual’s health information without their permission.

A Test for Avellino Corneal Dystrophy

Screening of refractive surgery patients can prevent vision loss.

By Jerry Helzner, Senior Editor

■ Avellino Lab USA, developer of the first genetic test for Avellino corneal dystrophy (ACD), has announced the availability of the Avellino-Gene Detection System (AGDS) test in the United States. There is no cure for ACD (also known as granular corneal dystrophy Type II), a disease characterized by slowly developing cloudiness and vision loss in the center of the cornea. However, the test can detect the genetic mutation and enable patients to make an informed decision on whether it is safe to undergo laser vision correction surgery.

Avellino Lab says that carriers of ACD — about one in every 870 individuals tested — are at an extreme risk of experiencing eventual blindness should they undergo vision correction surgery. A positive AGDS Test allows the patient to take precautionary steps to potentially postpone the progression of the condition. Specifically, the company says patients and their physicians can make an informed decision on whether to proceed with vision correction surgery.

“Since 2008, more than 330,000 individuals have been tested with the AGDS Test outside the United States, as the standard of care in Korea and Japan, identifying 301 people as positive for the genetic mutation that causes ACD, protecting them from blindness,” said Scott Korney, chief operating officer of Avellino Lab USA. “The non-invasive AGDS test involves a simple mouth swab from the patient’s cheek. The sample is sent to Avellino Lab USA and in 24 to 48 hours, the results are provided to the ophthalmologist, with reported 100% accuracy. Based on a negative result, patients are able to proceed with the planned LASIK procedure with increased confidence.”

Brianne Cannon, spokesperson for Avellino Lab, says the AGDS test is currently not covered by insurance, but she suggests that ophthalmologists screen all of their refractive surgery patients for ACD and include what she terms the “affordable” cost of the test in the overall cost of the surgery. Patients may use their flexible spending accounts to pay for the test.

The Blind Read With Retinal Prosthesis

Highly encouraging long-term results with Argus II.

■ Second Sight Medical Products, developers of the Argus II Retinal Prosthesis System, has reported the results of an internal study, which found that the majority of blind subjects fitted with the Argus II consistently identified letters and words using the retinal implant. The data was presented in a paper published in a recent online edition of the British Journal of Ophthalmology.

Second Sight says the encouraging results, in combination with stable, long-term functioning of the device, represent significant progress in the evolution of artificial sight. Some of the participants in the study have been using the Argus II for six years.

The prospective, internally controlled study was completed across 10 centers worldwide. Thirty subjects with bare light perception vision were implanted with the Argus II. Controlled, closed-group, forced-choice letter identification, and, open-choice two-, three- and four-letter word identification tests were carried out on a subset of these individuals. Study results showed that the percentage correct letter identification for 21 subjects tested was: 72.3% with system on and 17.7% with system off.

A subgroup of six subjects was able to consistently read letters of reduced size, the smallest measuring 0.9 cm (1.7°) at 30 cm. A further group of four subjects correctly read two-, three- and four-letter words with 75% accuracy of two-letter words and 58% accuracy of four-letter words. Control data confirmed that subjects could not achieve these results if the system was disabled, or if the spatial information provided by the device was artificially scrambled. Second Sight says this data shows that reading is possible for the best performers using Argus II. Average use duration was 19.9 months at the time of this study.

“The fact that we are seeing many of our patients being able to recognize large letters, locate the position of objects and more, is truly encouraging and beyond initial expectations,” noted lead study author Lyndon da Cruz, MD, ophthalmologist at Royal College of Ophthalmology, London.

Argus II is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals with severe retinitis pigmentosa, and has the capacity to offer functional visual capabilities to those currently unable to see anything except, at best, extremely bright lights. The device received its CE mark in February 2011 and US FDA approval, most recently, in February 2013. It remains the only approved retinal prosthesis anywhere in the world.

Reference

Br J Ophthalmol, doi: 10. 1136. Published online February 20, 2013.