Congress works to ease Medicare DME restrictions

WASHINGTON —A new move is afoot in Congress to eliminate barriers to the sale of Medicare Part B durable medical equipment, prosthetics, orthotics and supplies by retail pharmacies.

In a bipartisan gesture on behalf of the pharmacy industry, two U.S. senators have introduced legislation that would exempt pharmacies from federal requirements that they post $50,000 surety bonds in order to participate in the Medicare Part B market for DMEPOS. The legislation, sponsored by Sen. Jon Tester, D-Mont., and Sen. Pat Roberts, R-Kan., serves as a companion bill to a similar measure in the House of Representatives, known as H.R. 1970, or the Preserve Patents Access to Reputable DMEPOS Providers Act of 2009.

The National Community Pharmacists Association welcomed the move. “This legislation is important to maintaining patient access to essential medical supplies, such as diabetes testing strips,” said NCPA EVP and CEO Bruce Roberts in a statement issued May 4. “It allows patients to continue relying on their trusted local pharmacies as a one-stop shop where prescription drugs, medical advice and supplies are available, and health outcomes are maximized. We deeply appreciate the leadership of Sens. Jon Tester and Pat Roberts and their continued efforts to help pharmacists continue to play a vital role in the healthcare chain.”

For roughly three years, chain and independent pharmacies have fought to head off new and more stringent rules from the Centers for Medicare and Medicaid Services governing the sale of DMEPOS to Medicare beneficiaries. As originally proposed by CMS in 2006, those rules would require retail pharmacies to bid competitively with other outlets for the right to sell and distribute supplies under Medicare Part B, even including diabetes-testing strips. The new rules also called for pharmacists to be certified for the sale of DMEPOS and for the establishment of a surety bond requirement for anyone engaged in the sale of the products.

Since those regulations first were proposed, Congress has acted to ease the requirements somewhat by passing the Medicare Improvements for Patients and Providers Act, which excludes diabetes-testing supplies from the new competitive bidding requirements. CMS, however, has responded with interim final rules that effectively could expand competitive bidding to again include diabetes supplies sold at retail, and also has proposed including diabetic supplies in a Medicare mail-order program.

In addition, CMS has issued a DMEPOS final rule that requires pharmacies to obtain a surety bond to continue selling DMEPOS by Oct. 2.

In response, both the NCPA and the National Association of Chain Drug Stores have raised new alarms and renewed pleas to Congress to set aside the new requirements. “The bond requirement should not apply to pharmacists, who are already subject to state regulations and are not associated with violation,” Roberts said.

“Fourteen other medical providers are already exempted from this time-consuming and expensive requirement, and this bill would add pharmacists to that list. NCPA encourages the Senate and House to move these bills in an expeditious fashion. This will ensure patient access to medical supplies is not endangered,” Roberts added.

NACDS also has lobbied Congress for relief from the new rules. In testimony earlier this year to the House Committee on Small Business’ Subcommittee on Rural Development, Entrepreneurship and Trade, NACDS warned that “expansion of the competitive bidding program to include diabetic supplies sold at retail pharmacies or CMS’ plan to include diabetic supplies in the national mail-order program could limit participation by pharmacies and reduce diabetic patients’ access to life-saving supplies and services.”

In addition, noted NACDS, “as CMS moves forward with the first round of competitive bidding, it is critical that contract suppliers’ marketing practices be subject to strict oversight by CMS, and any communication to diabetic patients contain information about the continued availability of diabetic supplies at retail pharmacies.”

“We urge Congress to consider the competitive bidding program within the context of a broader set of difficulties pharmacies and patients face in the DMEPOS program,” added the organization in a letter to the subcommittee. “CMS’ recent initiatives, such as the requirement for pharmacies to obtain accreditation and a surety bond in the amount of $50,000 per location, create significant administrative and financial burdens for pharmacies, resulting in the likelihood of beneficiary access difficulties.”