In November 2006, the Centers for Medicare & Medicaid Services (CMS) approved 10 national accreditation organizations that will accredit suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) as meeting new quality standards under Medicare Part B.
In order to enroll or maintain Medicare billing privileges, all DMEPOS suppliers (except for exempted professionals and other persons as specified by the Medicare Improvement for Patients and Providers Act of 2008) must comply with the Medicare program's supplier standards (found at 42 CFR §424.57 (c)) and quality standards to become accredited. The accreditation requirement applies to suppliers of durable medical equipment, medical supplies, home dialysis supplies and equipment, therapeutic shoes, parenteral/enteral nutrition, transfusion medicine and prosthetic devices, and prosthetics and orthotics.
On March 23, 2010, the President signed HR 3590 into Public Law no: 111-148, which amends title XVII of the Social Security Act to exempt a pharmacy from accreditation if it meets all of the following criteria:
- the total billings by the pharmacy for DMEPOS are less than 5 percent of total pharmacy sales;
- the pharmacy has been enrolled as a supplier of durable medical equipment, prosthetics, orthotics and suppliers, as has been issued a provider number for at least 5 years;
- no final adverse action has been imposed on the pharmacy in the past 5 years;
- the pharmacy submits an attestation, as determined by CMS, that the pharmacy meets the first three criteria;
- the pharmacy agrees to submit materials as requested during the course of an audit conducted on a random sample of pharmacies selected annually.
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