The FDA has released a draft guidance addressing the dissemination of patient-specific information to the patient, a document that on the surface seems at least in part driven by a January guidance from HHS on patient data disclosure. The FDA draft would require disclosure of device malfunctions and failures, and invokes the possibility that labeling regulations would be activated in such disclosures, presenting device makers with what might constitute a minefield of regulatory and/or legal liability.

The guidance from the Department of Health and Human Services made note of two exclusions from the general principle of personal health information a patient has a right to access, including psychotherapy notes and any information gathered for use or in anticipation of use in a legal action or an administrative proceeding. The party holding the information must take "reasonable steps" to verify the identity of the requestor, and there are limits as to the fees the sender can charge for providing such information, even if the transmission is to a third party, such as a physician.

Myriad Genetics Inc., of Salt Lake City, recently ran afoul of the HHS guidance in a complaint filed by four patients and the American Civil Liberties Union, which blew into public view when the ACLU held a press briefing on the situation recently. Myriad had received requests from several individuals for the entirety of their genomic information in February, providing the first test of the limits of the HHS guidance. The company ultimately provided the sought-after information, but maintained it had done so voluntarily. (Medical Device Daily, May 20, 2016.)

The FDA draft guidance defined patient-specific information as any information that is specific to the patient and their treatment, but which may include health care provider inputs and records of device malfunctions or failures. The agency stated that a device maker may share such information with a patient or the patient's provider at the patient's request "without obtaining additional premarket review before doing so," but noted that "any labeling, as the term is defined" in section 201(m) of the Food, Drug and Cosmetic Act that is provided with the patient's information "is subject to the applicable requirements" of the statute and the regulations.

The draft stated that a manufacturer should "take certain considerations into account" when providing information, including any steps needed to ensure usability by the patient, and should avoid disclosure of information that may prove "confusing or unclear," or information which could be "misinterpreted" by the patient. The FDA cited other considerations as well, such as the context in which the patient might use the information, and the need for follow-up information after the initial disclosure.

The question of labeling arises in a discussion of the provision of supplementary materials in the follow-up phase of disclosure, in which case the device maker would be on the hook for compliance with labeling regulations should the provision of that supplemental information seem to entail provision of labeling, the definition of which some in industry would argue has expanded considerably in recent years.

The information which the agency suggests a manufacturer might provide would include physiological parameters, the meaning of which may be obscure to a patient. In this instance, the FDA recommends the manufacturer provide information on how the parameter was measured and recorded, and the circumstances in which a measured parameter might provoke a programmed response by the device, such as when a pacemaker stimulates the heart in response to electrophysiological abnormalities.

The comment period for the draft formally opens June 10 and runs 60 days, or through Aug. 9 at docket number FDA-2016-D-1264.

FDA SAYS NASOLACRIMAL DEVICES ARE CLASS I

The FDA announced in the Federal Register that nasolacrimal devices are henceforth deemed class I devices, exempting them from premarket notification requirements under the 510(k) program. The agency stated that Innovatex, Inc., of Weston, Mass., had petitioned the agency for the reclassification of its tear duct occluder, adding that this is the initial regulatory classification for this device and others like it, which will appear in the regulations at 21 CFR 886.5838.

The agency said the generic name of the nasolacrimal compression device will carry the intended use of applying pressure to the orbital rim of the eye at the nasal aspect in order to stanch outflow through the nasolacrimal ducts. The order is effective immediately.

AETNA: MORE COVERAGE OF BONE GROWTH STIMULATION

Hartford, Conn.-based Aetna reported in a recent update to its clinical policy for ultrasonic osteogenesis stimulators that the procedure is covered for patients diagnosed with a Colles fracture for fresh fractures, delayed unions, and fusions. However, the payer indicated it is holding on to a non-coverage stance in the case of preoperative use for fractures that require internal or external fixation or surgical intervention. Aetna noted that the treatment for Colles fracture applies when the condition requires closed reduction and immobilization with a cast.

Other conditions that are now covered include non-unions, failed arthrodesis, and congenital pseudarthrosis of the arms, legs, hands, feet, hips and shoulder girdle, assuming that X-rays have demonstrated no evidence of additional healing for at least three months under standard fracture care. However, Aetna stipulated that treatment with stimulation can only be covered in this scenario when the bone is not infected, and when the bone is stable on both ends via a cast or some method of fixation. The fracture must also be less than one centimeter in width.

Aetna also revised its coverage stance for imaging of the optic nerves and retina to cover such procedures for macular edema and age-related macular degeneration. The previous substantive update to this policy came in 2013 when the insurer announced coverage of imaging of these organs for monitoring patients using the anti-seizure medication Potiga (ezogabine). Aetna said it will revisit coverage in March 2017.