On March 9, 2012, CMS released a final rule revising certain Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier safeguards. The rule, which adopts without change the agency’s April 4, 2011 proposed rule, includes the following policies:

• The rule removes the definition of and modifies requirements regarding the prohibition on “direct solicitation” of Medicare beneficiaries that were included in a August 27, 2010 final supplier standard rule. Prior to the 2010 rule, CMS regulations required suppliers to agree not to contact a beneficiary by telephone when supplying a Medicare-covered item unless certain exceptions applies (such as the individual gave written permission for such contact, the supplier is coordinating delivery of an item, or the supplier has furnished at least one covered item to the individual during the preceding 15-month period). The 2010 rule expanded the scope of this prohibition to include in-person contacts, e-mail, and instant messaging. CMS subsequently determined this expansion was “unfeasible”; CMS therefore is removing all references to “direct solicitation,” and clarifying that the prohibition is limited to telephonic contact. Note that CMS has posted frequently asked questions about its telemarketing policy.
• The rule allows DMEPOS suppliers, including DMEPOS competitive bidding program contract suppliers, to contract with licensed agents to provide DMEPOS supplies unless expressly prohibited by state law (CMS notes that the absence of express state law has led to confusion about contracting rules).
• The rule removes the requirement that DMEPOS suppliers comply with local zoning as part of the supplier standards. While suppliers still must comply with all applicable local zoning requirements, CMS leaves it to local municipalities to enforce zoning requirements.
• The rule modifies certain state licensing requirement exceptions to allow prosthetic and orthotic professionals to qualify for the minimum square footage exception if the state does not offer a licensure option. If a state does offer licensure for such professionals, however, the professionals would be required to obtain licensure in order to qualify for the exception to the minimum square footage requirement. CMS also clarifies that certain physical and occupational therapists are exempt from the minimum hours of operation requirement.

The official version of the rule will be published March 14, 2012. The rule is effective April 13,
2012.