Clarity on light therapy terminology needed to improve regulations, access to new treatments

BUFFALO, N.Y. – Light therapy is gaining mainstream acceptance in health care, but government and insurance regulations of the treatment continue to lag behind, says University at Buffalo light therapy expert Praveen Arany.

Policies and credentialing are particularly vague for photobiomodulation therapy, a form of low-dose light therapy that has the ability to relieve pain and promote healing, says Arany. The result: limited patient access due to confusion over best clinical use and hard to obtain insurance reimbursements for treatment.

Clarity is also needed in the wake of several proposals for light therapy in response to the COVID-19 pandemic that involve the use of harmful forms of ultraviolet light or high levels of exposure, increasing risk for skin cancer, says Arany.

“The use of light as a therapeutic procedure is often met with some skepticism, despite its all-pervasive nature in our daily lives – from sunlight promoting vitamin D metabolism to light enabling our vision,” says Arany, DDS, PhD, assistant professor of oral biology in the UB School of Dental Medicine.

“A lack of unified terminology is leading to much confusion, in spite of the highest level of clinical evidence for safety and efficacy of several of these treatments that can benefit patients right now,” he says. “Better categorization of these treatments will enable both regulatory and reimbursement policies to be implemented effectively.”

In a commentary published on June 29 in Photobiomodulation, Photomedicine, and Laser Surgery, Arany proposes dividing phototherapy (light therapy) into three distinct categories that are each regulated differently: photobiomodulation, photodynamic therapy and photothermal phototherapy (laser surgery).

The review also explores the overlapping effect of all light treatments on the immune system, particularly in the ongoing quest for new treatments in the COVID-19 pandemic, says Arany.

Laser surgery, the most commonly known of the three forms of light therapy, uses high heat to cut or destroy tissue. The majority of light therapy regulations pertain to laser surgery, including the American National Standards Institute (ANSI) Z136 consensus standards, he says.

Photodynamic therapy and photobiomodulation, on the other hand, are non-thermal treatments. The difference between the two is that photodynamic therapy is used to destroy biological targets such as tumor cells. The treatment is frequently used for cancer therapy, disinfection and to treat skin diseases as well. Photobiomodulation stimulates or inhibits biological responses, but is never destructive.

Although photobiomodulation and photodynamic therapy are used effectively in treatments, unclear device regulation and mislabeling of clinical use prevent medical insurance reimbursement, says Arany.

Training and certification to provide photobiomodulation therapy is also non-standardized, he says, with most clinicians and scientists being personally mentored on its use. The therapy’s growth in popularity has increased the need for formal training and certification on its use for clinical care, says Arany.

Without reimbursement, access to new and effective treatments is limited, he says. Photobiomodulation for the prevention and management of oral mucositis – a side effect of cancer therapy – is not yet medically reimbursed, even though the treatment was accepted as a standard of care last year by the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology.

“Far from being a mere cerebral exercise, the proposed new nomenclature based on biological responses can have a profound impact on the regulatory, policy and clinical decision-making processes,” says Arany.

About Praveen Arany

Arany is an advocate for wider use of photobiomodulation treatments in the United States.

He is president of the World Association for Photobiomodulation Therapy (WALT), which promotes research, education and clinical application of laser photostimulation world-wide. And he is chair of the mechanisms of photobiomodulation conference for the Society of Engineers for Optics and Photonics (SPIE).