National Coverage Analysis (NCA) Tracking Sheet

Prolotherapy for Chronic Low Back Pain

CAG-00045N

Issue

Prolotherapy, also known as sclerotherapy or proliferant therapy, is a collagen-strengthening injection technique that targets the soft tissues of the lower back by injecting solutions at the interface between bone and tendon, ligament or fascia to provoke an inflammatory response resulting in collagen proliferation. The Coverage Issues Manual (CIM) §35-13, "Prolotherapy, Joint Sclerotherapy, and Ligamentous Injections with Sclerosing Agents Not Covered," states that the medical effectiveness of these therapies has not been verified by scientifically controlled studies, and therefore, cannot be covered by the Social Security Act, §1862(a)(1), as a "reasonable and necessary" treatment. HCFA must evaluate whether the current scientific data supports modification or revision of CIM §35-13.

Benefit Category

Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Irwin Abraham, MD, New York N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/29/1999
Expected NCA Completion Date
09/27/1999
Public Comment Period
07/29/1999 - 08/27/1999
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
09/27/1999

Contacts

Lead Analysts
Poppy S. Kendall
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

June 1, 1999

Application received.

June 29, 1999

Formal request accepted for review.

August 3, 1999

Letter sent accepting formal request.

September 27, 1999

Decision retaining national non-coverage policy issued.

October 5, 1999

Letter sent informing requestor of decision retaining a national non-coverage policy.