New Coverage Further Validates Laparoscopic Radiofrequency Ablation (Lap-RFA) as a Standard of Care for Uterine Fibroids

Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that Cigna, one of the largest global health insurance service companies, has updated its medical policy to cover the Acessa® Laparoscopic Radiofrequency Ablation (Lap-RFA) procedure (CPT code 58674) as medically necessary.

In less than eight months, the number of people covered for the Acessa procedure has grown by 18 million, resulting in more than 75 million commercially insured people covered to-date with significantly expanded coverage in almost every state.

“For too long, limited insurance coverage of less invasive fibroid treatment options has caused women to settle for interventions that may not align with their treatment goals,” said Essex Mitchell, division president, GYN Surgical Solutions, Hologic. “Cigna’s decision to cover the Acessa procedure grants providers the opportunity to offer more women a treatment option that can best support their desired health outcomes.”

For the estimated three in four women in the U.S. who are affected by fibroids, access to the full spectrum of treatment options has been limited in large part due to a lack of insurance coverage for procedures beyond hysterectomy.¹ Cigna’s coverage decision will go a long way toward removing barriers to evidence-based, minimally invasive treatment options for uterine fibroids.

“Cigna’s new policy to reimburse Acessa Lap-RFA as a medically necessary procedure will enable millions of women suffering from fibroids to get the care they deserve,” says Dr. Jay Berman, professor and vice chair OBGYN Dept. Wayne State University Medical School, DMC Harper/Hutzel Chief of Gynecology Services. “Coming on the heels of the updated ACOG PB228 guidance, this policy is yet another step in the right direction to ensuring women have a choice in their fibroid treatment that is not limited by what their insurance will or will not cover.”

The Acessa procedure can provide significant improvements to the symptoms caused by fibroids while preserving the uterus and is therefore an important treatment option for women who would otherwise require more invasive interventions.² This outpatient procedure results in less recovery time than more invasive interventions and allows patients to return to work within four to five days.² For more information about the benefits and risks of the Acessa procedure, visit www.AcessaProcedure.com.

About Hologic, Inc.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Acessa product. There can be no assurance this product will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the product can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that this product will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions, or circumstances on which any such statements are based.

Hologic, Acessa, and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

References

¹ Al-Hendy A, Myers ER, Stewart E. Uterine Fibroids: Burden and Unmet Medical Need. Semin Reprod Med. 2017;35(6):473-480. doi:10.1055/s-0037-1607264

² SG Chudnoff, et al. Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas. Obstetrics and Gynecology, 2013;121(5):1075-82.

SOURCE: Hologic, Inc.

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Cigna Updates Medical Policy to Cover Hologic’s Acessa® Procedure, Expanding Access to Millions of Women Across the Country