FDA & Medicare

Medical Professional with Clipboard

Approve and Certified

The Heart Hugger is a Medicare Approved U.S. FDA Class I Medical Device. In compliance with FDA Classification and Medicare approval, Heart Hugger has been approved on all fronts. It is tested and proven to be a safe and effective tool for thoracic surgery recovery.

Heart Hugger was approved by the Department of Health and Human Services and Food and Drug Administration on September 20, 1988. It was recognized by Medicare and Medicaid when prescribed by a physician on January 13, 1989.

Reimbursement

Heart Hugger is U.S. FDA classified and Medicare approved. Medicare and 3rd party Insurance billing is highly specialized requiring detailed knowledge of forms, codes, and procedures.

A prescription or standing order is necessary for reimbursement and includes custom fit by a Nursing Personnel. Typical reimbursement ranges from $115 to $155, depending upon region. Heart Hugger can be included on the hospital UB92 FORM The Part A Revenue code is 27x subcategory 4 (Prosthetic/Orthotic Devices). The Part B HCPCS Code is L0450 TLSO (Thoracic-Lumbar-Sacral-Orthosis).

PER REGION IX OF THE CENTER FOR MEDICARE

and Medicaid Services (CMS), “the support harness is a Medicare-covered device when prescribed by a physician or furnished incident to a physician’s service.” It is covered under section 2133 of the Medicare Carriers Manual (HCFA Publication 14-3) within the definition of a brace . . . “a brace includes either a rigid or semi-rigid device, used for supporting a weak or deformed body member and restricts or eliminates motion in a diseased or injured part of the body.”

THE MEDICARE BENEFIT POLICY MANUAL

states in Chapter 1 - Inpatient Hospital Services Covered Under Part A, Section 40 (Supplies, Appliances & Equipment) “Under certain circumstances, supplies, appliances, and equipment used during the beneficiary's inpatient stay are covered under Part A even though the supplies, appliances, and equipment leave the hospital with the patient upon discharge. These are circumstances in which it would be unreasonable or impossible from a medical standpoint to limit the patient's use of the item to the periods during which the individual is an inpatient,” and Section 50.1 (Therapeutic Items) “Therapeutic items, which are covered when ordinarily furnished by the hospital to its’ inpatients, or when ordinarily furnished to hospital inpatients by others under arrangements with them made by the hospital, include but are not limited to the following: Surgical dressings, and splints, casts, and other devices used for the reduction of fractures and dislocations . . .

A PRESCRIPTION OR STANDING ORDER IS NECESSARY FOR REIMBURSEMENT

The prescription or standing orders must include a statement: “Includes custom fit by Nursing Personnel.” Typical reimbursement ranges from $115 to $155, depending upon region.

HEART HUGGER ™ CAN BE INCLUDED ON THE HOSPITAL UB92 FORM The Part A Revenue code is 27x subcategory 4 (Prosthetic/Orthotic Devices). The Part B HCPCS Code is L0450 TLSO (Thoracic-Lumbar-Sacral-Orthosis).


To discuss sternal support options,