Dear Ms. DeParle:
Recently, I met with representatives of the medical device industry regarding implementation of the hospital outpatient prospective payment system. We discussed a variety of questions they have raised about the process for new devices being approved for transitional pass-through payments. I recognize the complexity of issues involved with developing the approval process, and I do not encourage undertaking any steps that would delay implementation or further complicate transitional issues for contractors or providers. However, I am also concerned about ensuring beneficiary access to new and innovative technologies without interruption.
For that reason, I am seeking to resolve the difficulty we share regarding those devices currently listed by the Agency as deferrals or denials, pending additional interaction with the applicants. I appreciate that these devices could be approved in the next quarter, but that is at odds with my goal of providing services to beneficiaries without disruption. With some brand-specific devices approved for the transitional payments and comparable devices still pending on the deferred list, it is likely that hospitals will alter their contracts to acquire and utilize the items approved, thus disrupting patient access to technologies.
Therefore, I am writing to inquire whether the Administration has the authority to issue a Program Memorandum conditionally approving those devices which meet the statutory criteria of being a new device in order to receive the transitional payments, but which are still pending before the Agency. Such conditional approvals would be subject to completion of your final review and decision, and would be in effect only during this interim period beginning with the initial implementation date of August 1 and ending on the date of the first quarterly update.
Please advise me of your willingness to take the suggested step, or difficulties you foresee with this option. I thank you for your continued collaboration and cooperation in resolving issues to strengthen the options available to beneficiaries and look forward to continuing to work together on issues of mutual concern.
Sincerely,
William V. Roth, Jr.
Chairman
Source: Ranking Member’s News
