February 12, 1999
Contact: HCFA Press Office
(202) 690-6145


Expanding treatment options for Medicare beneficiaries with prostate cancer, the Health Care Financing Administration today announced a national decision to cover cryosurgery for patients with localized prostate cancer.After reviewing new medical evidence of cryosurgery's effectiveness in treating localized prostate cancer, HCFA rescinded an October 1996 national decision denying coverage of cryosurgery. The earlier non-coverage decision reflected a lack of conclusive scientific evidence at the time regarding cryosurgery for prostate cancer. "As new scientific evidence becomes available, we will reconsider national coverage issues," HCFA Administrator Nancy-Ann DeParle said. "This decision demonstrates how HCFA, the medical community, patient advocacy groups and the industry can work together to make sure beneficiaries have access to safe and effective treatments that are medically necessary."

HCFA's national decision covers cryosurgery as primary treatment for localized prostate cancer. Under the national coverage policy, however, cryosurgery as a treatment of last resort continues to be a non-covered Medicare service.

"Our decision today means beneficiaries will have greater access to cutting-edge technology to combat prostate cancer," said Grant Bagley, M.D., director of HCFA's Coverage and Analysis Group within the Office of Clinical Standards and Quality. "Medicare beneficiaries will now have another option to discuss with their doctors to help determine what course of treatment is best for them."

While most Medicare coverage decisions are made locally by HCFA contractors -- the private companies that by law process and pay Medicare claims -- HCFA makes national coverage decisions that apply nationwide and supersede local policies. HCFA will next issue a coverage instruction, including coding and billing information, to all of its carriers which will also specify an effective date when payment will be available.

Comment by Dr. Richard Ablin:

A Comment on Medicare's Recent Decision to Cover Cryosurgery for Localized Prostate Cancer

In further reference to national Medicare coverage for cryosurgery, we welcome this long over due decision by the Health Care Finance Administration (HCFA). However, in making and commenting on this announcement, I take a rather dim view of the technically correct, but glib, statements by Grant Bagley, M.D., Director of HCFA's Coverage and Analysis Group.

As reported in Oncology News International (page 18, April, 1999), Doctor Bagley stated "Our decision means beneficiaries will have greater access to cutting-edge technology to combat prostate cancer" and "Medicare beneficiaries will now have another option to discuss with their doctors to help determine their treatment". In spite of HCFA's earlier persistance of a non-coverage policy for cryosurgery, it has been known for sometime that a representative segment of the medical community, including physicians, hospitals and insurers (other than Medicare) accepted that cryosurgery, shortly following its re-introduction with improved technological modifications for the treatment of prostate cancer, has been safe and effective.

Furthermore, many patients with co-existing medical conditions, for whom the less traumatic and less stressful effects of cryosurgery (which was one of the initial purposes for which it was intended) vs. radical surgery was unequivocally indicated, were, due to personal financial constraints, denied access to cryosurgery, and suffered the possible consequences.

It has been unfortunate that it took HCFA so long to recognize the clear advantages of cryosurgery for the treatment of prostate cancer, when similar or lesser benefits, with associated increased morbidity, were still well accepted for other forms of treatment. In this regard, neither of the presently highly thought of forms of early treatment, i.e., radical prostatectomy and external beam radiation, are definitive. In the case of radical prostatectomy, data show that upwards of 50% of prostate cancer patients presurgically thought to have organ-confined disease have extracapsular disease. And perhaps most revealing, attention drawn by Coley et al. (Ann. Intern. Med., 126:468, 1997) to analysis of data from national Medicare claims (Lu-Yao et al. J. Nat'l. Cancer Inst., 88:116, 1996), indicates that approximately 25% of patients reported to have pathologically localized disease at the time of radical prostatectomy require additional treatment within 5 years. External beam radiation, not to mention the side effects, shows a local recurrence of prostate cancer which approaches 80% by 7 years. And, up to 40% of patients receiving conformal radiotherapy will have a positive biopsy.

By comparison, long-term survival data from previous studies demonstrated that cryosurgery was equivalent to radical prostatectomy and radiation (Bonney et al., Urology, 19:37, 1982). Clinical experience with current percutaneous transperineal ultrasound-guided cryosurgery at several centers evaluated by the percent negative biopsies from 1000+ patients followed-uo to 4 years ranged from 71-96% (Bahn et al. Personal Communication; Schmidt et al. CA- A Cancer J Clin, 48:239, 1998). It must be noted that the percent negative biopsies included patients who underwent cryosurgery of the prostate after failure of radiation therapy, i.e., salvage cryotherapy. Presented earlier this year by Dr. John Long (New England Medical Center, Boston, MA), the results of an 800 patient multi-site retrospective comparative study of brachytherapy and cryosurgery showed that while the results were about equal among low-risk prostate cancer patients, cryosurgery outperformed brachytherapy among patients considered high-risk (9th International Prostate Cancer Update, Beaver Creek, CO, 24 January, 1999).

Is not being told you have cancer bad enough, only then to be told next, particularly with possible knowledge of the less than definitive treatments available, that you do not have access to perhaps the best therapy for you! Every patient should have the chance to make a choice, including Doctor Bagley.

Richard J. Ablin, Ph.D. President



Copyright 2000 Mark Haythorn