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Durable Medical Equipment, Prosthetics and Orthotics

Accreditation

In July 2008, the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) stated that accreditation standards should not be applied to health professionals unless CMS has specific guidelines for them. The act also gave CMS the authority to further exempt professionals from the accreditation.

Enrollment

DMEPOS Suppliers must enroll in the Medicare program using the Medicare enrollment application (Form CMS-855S) in order to be eligible to receive Medicare payments for covered services provided to Medicare beneficiaries.

Implications to Stark (self-referral) regulations

Practices must pay special attention to items classified as DME under the DMEPOS fee schedule, because groups generally cannot provide such items under the in-office ancillary services exception. It's important to note that not every item referred to as "DME" in typical usage will be classified as DME under the DMEPOS fee schedule. Many items referred to as DME in common usage are classified as prosthetic devices and not DME under the DMEPOS fee schedule, and are not subject to the service restrictions.


Durable medical equipment that may be provided through group practices:
The Stark law states that, with the exception of certain infusion pumps, group practices many not provide DME via the in-office ancillary services exception. However, CMS elected to make specific, limited exceptions to this general exclusion to further patient care and convenience, so practices may provide a limited list of DME via the in-office ancillary services exception. The identification of items classified as DME is made on the DMEPOS fee schedule published quarterly by CMS.

CMS elected to allow medical practices to provide certain additional items of DME under the in-office ancillary services exception. Those items are canes, crutches, walkers, folding manual wheelchairs and blood glucose monitors. CMS allows these exceptions due to concerns about patient care and convenience, but each comes with significant additional requirements.

The final rule requires that canes, crutches, walkers and folding manual wheelchairs provided through a physician's office must be essential to the patient to ambulate. Orthopedic and other medical practices can provide necessary items of DME to assist their patients, but they cannot function more generally as DME supply houses.

Under certain circumstances, medical practices can also provide patients with blood glucose monitors (including one starter set of test strips and lancets of no more than 100 each). A practice can only provide such monitors, however, when they are furnished by a physician or employee of the physician who also provides the patient with outpatient diabetes self-management training.

Special requirements for providing DME
Medical practices must meet five additional requirements to provide the limited types of DME allowed by the in-office ancillary services exception.
These requirements likely originate in concerns expressed by the U.S. Department of Health and Human Services' Office of Inspector General (OIG) regarding the use of DME consignment closets and similar arrangements involving physicians, groups and DME suppliers. The OIG is concerned that many such arrangements risk violations of the federal antikickback statute. These concerns likely serve as the source of the final rule's requirements related to who furnishes the DME, how the items are billed and the requirement that the arrangement not violate the antikickback statute.
  1. The DME must be furnished in the same building where treatment of the particular patient-physician encounter led to the furnishing of DME. Medical practices may not use a central repository to furnish DME in a different building from where the patient is seen. This also means that the DME may not be provided in a centralized building that is not the same building in which the medical practice physicians provide other physician services. So, a medical practice may not send a patient to a building across the street to pick up crutches or a wheelchair, nor may it send the patient to another location to receive a blood glucose monitor.
  2. The DME must be furnished personally by the physician who ordered it, by another physician in the group practice or by an employee of the physician or group. For purposes of this requirement, employees of other organizations such as a DME supply company cannot furnish the DME even under the direction of a physician if the group intends to charge for this item. A DME supply company can furnish the DME and bill for it separately, but a group may generally not provide DME through the group.
  3. The physician or the group furnishing the DME must meet all DME supplier standards under the Medicare program.
  4. The arrangement must not violate the antikickback law or any billing or claims requirement.
  5. The furnishing of the DME must meet all other requirements of the in-office ancillary services exception.

See the full list of Stark Regulations
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