By Linda Rouse O’Neill, VP Govt Affairs, HIDA
Competitive bidding delay garners bipartisan support
The effort to delay Medicare’s competitive bidding program for DMEPOS received a significant boost for the supply chain when 39 senators signed on to a bipartisan letter to Centers for Medicare and Medicaid Services (CMS) Administrator Marilyn Tavenner urging she delay further expansion of the program until the Office of Inspector General (OIG) finishes its examination of the program’s second round. HIDA’s grassroots efforts were instrumental in securing signatures from both sides of the political aisle, sending a strong signal of congressional interest in this issue.
The letter urges CMS to allow the OIG to complete its investigation on competitive bidding licensure problems and verification of Round Two single payment amounts and give Congress time to review the results before implementing the program nationwide in 2016. This letter is a very positive sign for distributors, as it marks the first time the Senate has weighed in on the controversial issue of competitive bidding since Round Two commenced.
FDA nears final guidance for pedigree
If you’re still trying to sift through the Food and Drug Administration’s (FDA’s) pedigree requirements for the Drug Quality and Security Act, you’re not alone. HIDA recently participated in a public workshop conducted by the agency on the interoperable data exchange and compliance strategies for distributors, manufacturers, and providers affected by the law.
Manufacturers and distributors are awaiting final guidance on transaction history, transaction information, and transaction statements requirements for the supply chain. HIDA and other industry stakeholders have submitted recommendations to the FDA during the current comment period, which the agency will review prior to drafting its final guidance.
HIDA’s recommendation to the FDA: recognize that multiple standards are necessary given the aggressive timeline proposed and various capabilities that exist among trading partners, including providers. HIDA also recommends that the eventual guidance provide flexibility so that both paper and electronic practices currently used by supply chain partners can continue to meet new requirements.
Gift disclosure comes under the microscope
The Physician Payments Sunshine Act has been in effect for several months now, and it is time for distributors and manufacturers to take note as the law enters its second phase. The Sunshine Act seeks to make public all “transfers of value” reported by vendors starting September 30, but a multi-step process must take place before that happens.
In June, applicable manufacturers began reporting payments and/or gifts to physicians and teaching hospitals for the August 2013 to December 2013 time period. Providers must first register under CMS’s Enterprise Portal before any review of gift disclosure information submitted by manufacturers and group purchasing organizations takes place. The CMS Open Payments system officially opens in July for final provider review before any data goes public in September.
HIDA’s Government Affairs team will continue to keep you informed of gift disclosure developments, as well as other regulatory issues affecting the supply chain. For more information, visit us at www.HIDA.org or contact us at HIDAGovAffairs@hida.org.
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