Pharmacy Law CE Column

By Laura Carpenter, RPh, JD, attorney and pharmacist, founder Carpenter Law Firm PC

Accreditation requirements for pharmacies billing Medicare Part B for DMEPOS

Pharmacies have been granted another three-month reprieve before having to obtain durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) accreditation for Medicare Part B. On Oct. 13, 2009, President Barak Obama signed HR 3663¹ and extended the deadline for pharmacy DMEPOS accreditation from Oct. 2, 2009, to Jan. 1, 2010, for pharmacies that do not qualify for bidding in a competitive acquisition area.² However, this new law, titled "The DMEPOS Accreditation Extension Bill," did NOT extend the deadline for pharmacies to comply with the surety bond requirement. As a result, pharmacies must fulfill the surety bond requirement in order to bill Part B for DMEPOS. Depending on what happens with healthcare reform legislation, the entire provision could be replaced with new requirements.

Under the current law, in order for a pharmacy to obtain DMEPOS accreditation, it must contract with 1-of-10 accreditation agencies that the Centers for Medicare and Medicaid Services has approved.³ The agency then will complete three steps. First, it must ensure that the pharmacy and staff hold all required licenses and that such licenses are in good standing. Second, the agency will review the pharmacy's policies and procedures to ensure that they align with CMS' quality standards and other requirements for personnel, the pharmacy, record-keeping and patient services. Finally, the agency will complete an unannounced on-site survey at some of the company's pharmacies.

Because the surety bond deadline was not extended for pharmacies, if a pharmacy did not secure a surety bond, it may not bill Medicare for DMEPOS, and it is barred from re-enrolling in Medicare for at least one year. For those pharmacies that have obtained a surety bond, the following is a summary of whether the pharmacy may bill Part B for services provided before Jan. 1, 2010:

Accredited pharmacies: If a pharmacy already obtained accreditation (and a surety bond), it can continue to bill for Medicare Part B-covered drugs and DMEPOS. YES: May bill Part B for drugs and DMEPOS

Pending approval: If a pharmacy's accreditation is still pending (or if CMS has not yet confirmed that it has approved the accreditation and changed the pharmacy's status), it can continue to bill for DMEPOS as long as a surety bond is in place. YES: May bill Part B for drugs and DMEPOS

Opted out of DMEPOS: If a pharmacy: 1) did not seek DMEPOS accreditation; 2) will provide only Part B drugs; 3) has voluntarily removed itself as a DMEPOS supplier; and 4) already has received confirmation from CMS of its status change, the pharmacy may not bill for DMEPOS unless it re-enrolls. NO: May only bill Part B for drugs

Because Congress is continuing to negotiate a final law related to the nation's healthcare coverage, it is possible that pharmacy's DMEPOS billing requirements may change. It is important to keep informed of new developments. Pharmacy Practice will do a follow-up law column on this topic if the DMEPOS billing requirements change.

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1. "SECTION 1. EXTENSION OF MEDICARE DME ACCREDITATION DEADLINE FOR CERTAIN PHARMACIES.

(a) IN GENERAL.-Section 1834(a)(20)(F)(i) of the Social Security Act (42 U.S.C. 1395m(a)(20)(F)(i)) is amended by inserting before the semicolon the following: ", except that the Secretary shall not require under this clause pharmacies to obtain such accreditation before January 1, 2010."

(b) CONSTRUCTION.-Nothing in subsection (a) shall be construed as affecting the application of an accreditation requirement for pharmacies to qualify for bidding in a competitive acquisition area under section 1847 of the Social Security Act (42 U.S.C. 1395w-3)." A copy of the DMEPOS Accreditation Extension Bill may be found at: http://thomas.loc.gov/cgi-bin/bdquery/z?d111:HR3663:/.

2. The House of Representatives had passed a 90-day extension of the deadline for pharmacies to obtain DMEPOS accreditation so that they can be reimbursed for these supplies, but the Senate failed to act before the Oct. 2 deadline passed. That placed some pharmacies in jeopardy for having their Medicare Part B billing privileges for DMEPOS suspended by CMS. However, CMS delayed its enforcement actions in anticipation of congressional action on this temporary delay.

3. The CMS-approved accreditation agencies include JCAHO; National Association of Boards of Pharmacy; Board for Orthotist/Prosthetist Certification; The Compliance Team, Inc.; American Board for Certification in Orthotics & Prosthetics, Inc.; The National Board of Accreditation for Orthotic Suppliers; Commission on Accreditation of Rehabilitation Facilities; Community Health Accreditation Program; HealthCare Quality Association on Accreditation; and Accreditation Commission for Health Care, Inc. Further information is available from CMS at: http://www.cms.hhs.gov/DMEPOSCompetitiveBid/downloads/DMEPOS_Accreditation_Organizations.pdf.