BALTIMORE — Under a proposed rule published in today's Federal Register, the circumstances under which HME providers can contact Medicare beneficiaries directly would be revised.
An Aug. 27, 2010, final rule on the DMEPOS supplier standards enlarged the scope of the direct solicitation ban beyond prohibition of unsolicited telephone contacts to include in-person contacts, email and instant messaging.
The proposed rule would modify the definition of "direct solicitation" because CMS said it is "unfeasible" as written in the final rule and "has been criticized as it covers some types of marketing activity outside the bounds of what we intended to prohibit under our regulations."
As a result, CMS would "revert to restrictions on suppliers effective before publication of the Aug. 27, 2010 final rule."
That's good new for providers, according to the American Association for Homecare, which has been working with CMS on the standards.
"The current standard prohibiting direct solicitation has proved operationally unworkable for suppliers," said the association's Walt Gorski, vice president for government affairs, in a Friday afternoon statement. "It is so broad that it seemingly prohibits communication between the supplier and the beneficiary that is essential to ensure continuity and coordination of care."
Attorney Neil Caesar of the Health Law Center, Greenville, S.C., agreed. "The changes last year to Supplier Standard 11 were a valid attempt to curb abusive solicitation practices," he said, "but CMS created a definition for 'direct solicitation' that had some large loopholes, and these loopholes both weakened the rule and created confusion."
In addition, Caesar said, "the rule was broader than the anti-solicitation statute, which still is limited to abusive telephone solicitation."
While the changes would allow suppliers greater marketing freedom, he pointed out, "CMS did not change the portion of Standard 11 dealing with physician verbal orders. The scope and implications of this rule remain unclear and troubling, and we still don't understand what sort of evidence of consent is required. I hope further clarification will be forthcoming."
In its comments on the proposal, CMS said it would continue "to actively monitor the issue of potentially unwanted and unsolicited communications between DMEPOS suppliers and beneficiaries" and would engage in further rulemaking on the issue if warranted.
The proposed rule would also modify subcontracting rules under the supplier standards.
In last year's final rule, CMS said it sought to ensure oversight of DMEPOS suppliers by adding an additional layer of oversight in the form of state law. But the absence of express state law in certain areas "has led to confusion among suppliers as to who they may contract with under our programs."
CMS said it is seeking to clarify that contracting with an individual or entity for licensed services is permissible if subcontracting is not expressly prohibited by state law. The new rule would also eliminate any distinction between contract and noncontract suppliers in their ability to subcontract for licensed services.
"By making the proposed clarification (that is, it is permissible for suppliers to contract for licensed services in the absence of an express State prohibition), we believe the requirements for contract suppliers are also clarified and that the reference to competitive bidding program contract suppliers in the existing regulation is unnecessary and redundant," CMS said in the rule.
Gorski said those proposed changes should provide greater clarity on the requirements for subcontracting "and will make these relationships easier for suppliers to administer."
Caesar also said the changes to Standard 1 "are quite welcome. CMS now says that licensure and employment questions simply must follow state law requirements, which makes sense. The prior expansion was unnecessary and overreaching, and I'm glad CMS proposes a more limited approach."
View the proposed rule, which has a 60-day comment period, in the April 4, 2011, Federal Register.