05-24022. Medicare Program; Town Hall Meeting on the Fiscal Year 2007 Applications for New Medical Services and Technologies Add-On Payments Under the Hospital Inpatient Prospective Payment System Scheduled for February 16, 2006

AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Notice of meeting.

SUMMARY:

This notice, in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act), announces a Town Hall meeting to discuss fiscal year (FY) 2007 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their individual comments, recommendations, and data regarding whether the FY 2007 new medical services and technologies applications meet the substantial clinical improvement criteria.

DATES:

Meeting Date: The Town Hall meeting announced in this notice will be held on Thursday, February 16, 2006 at 9 a.m., and check-in will begin at 8:30 a.m. EST.

Registration Deadline for Presenters: All presenters, whether attending in person or by phone, must register and submit their agenda item(s) by February 8, 2006.

Registration Deadline for All Other Participants: All other participants must register by February 13, 2006.

Comment Deadline: Written comments for discussion at the meeting must be received by February 8, 2006. All other written comments for consideration before publication of the hospital IPPS proposed rule must be received by March 15, 2006.

ADDRESSES:

The Town Hall meeting will be held in the Auditorium in the central building of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Agenda Item(s) or Written Comments: Agenda items and written comments regarding whether a FY 2007 application meets the substantial clinical improvement criterion may be sent by mail, fax, or electronically. Agenda items must be received by February 8, 2006. We will accept written questions or other statements, not to exceed three single-spaced, typed pages that are received by March 15, 2006. Send written comments, questions, or other statements to—

Division of Acute Care, Mail stop C4-07-05, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Attention: Meredith Walz or Michael Treitel.

Fax: [phone].

Email: [e-mail].

FOR FURTHER INFORMATION CONTACT:

Meredith Walz, [phone], [e-mail]. Michael Treitel, [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

Sections 1886(d)(5)(K) and (L) of the Social Security Act (the Act) require the Secretary to establish a process of identifying and ensuring adequate payments for new medical services and technologies under Medicare.

Effective for discharges beginning on or after October 1, 2001, section 1886(d)(5)(K)(i) of the Act required the Secretary to establish (after notice and opportunity for public comment) a mechanism to recognize the costs of new services and technologies under the inpatient hospital prospective payment system (IPPS). In addition, section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered “new” if it meets criteria established by the Secretary (after notice and opportunity for public comment). (See the FY 2002 proposed rule (66 FR 22693, May 4, 2001) and the FY 2002 final rule (66 FR 46912, September 7, 2001) for a more detailed discussion.) In addition, we have further discussed our application of the newness criteria in the hospital IPPS proposed and final rules for FYs 2003, 2004, 2005, and 2006. (See 67 FR 31427, May 9, 2002; 67 FR 50009, August 1, 2002; 68 FR 27184, May 19, 2003; 68 FR 45385, August 1, 2003; 69 FR 28236, May 18, 2004; 69 FR 49000, August 11, 2004; 70 FR 23353, May 5, 2005; and 70 FR 47341, August 12, 2005 respectively).

In the September 7, 2001 final rule (66 FR 46914), we noted that we evaluate a request for special payment for a new medical service or technology against the following criteria in order to determine if the new technology meets the substantial clinical improvement requirement:

• The device offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments.
• The device offers the ability to diagnose a medical condition in a patient population where that medical condition is currently undetectable or offers the ability to diagnose a medical condition earlier in a patient population than allowed by currently available methods. There must also be evidence that use of the device to make a diagnosis affects the management of the patient.
• Use of the device significantly improves clinical outcomes for a patient population as compared to currently available treatments. Some examples of outcomes that are frequently evaluated in studies of medical devices are the following:

++ Reduced mortality rate with use of the device.

++ Reduced rate of device-related complications.

++ Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).

++ Decreased number of future hospitalizations or physician visits.

++ More rapid beneficial resolution of the disease process treatment because of the use of the device.

++ Decreased pain, bleeding, or other quantifiable symptoms.

++ Reduced recovery time.

In addition, we indicated that the requester is required to submit evidence that the technology meets one or more of these criteria.

Section 503 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pub. L. 108-173, which added section 1886(d)(5)(K)(viii) to the Act, revised the process for evaluating new medical services and technology applications by requiring the Secretary to do the following:

• Before publication of a proposed rule, provide for public input regarding whether a new service or technology represents an advance in medical technology that substantially improves the diagnosis or treatment of Medicare beneficiaries.
• Make public and periodically update a list of all the services and technologies for which an application is pending.
• Accept individual comments, recommendations, and data from the public regarding whether the service or technology represents a substantial improvement.
• Before publication of a proposed rule, provide for a meeting at which organizations representing hospitals, physicians, manufacturers, and any other interested party may present comments, recommendations, and data to the clinical staff of CMS.

The opinions and alternatives provided during this meeting will assist us as we evaluate the new medical services and technology applications for FY 2007. In addition, they will help us to evaluate our policy on the hospital IPPS new technology add-on payment process before the publication of the FY 2007 hospital IPPS proposed rule.

II. Meeting Format

This meeting will allow for a discussion of the substantial clinical improvement criteria to each of the FY 2007 new medical services and technology add-on payment applications. Information regarding the applications can be found on our Web site at http://www.cms.hhs.gov/​providers/​hipps/​newtech.asp. In addition, we are interested in individual public comments on our application of the concept of “substantial similarity”. See the FY 2006 final rule (70 FR 47350-47352, August 12, 2005), for a detailed discussion of this issue. Although we do not expect to have a general discussion of this topic during the timeframe of the town hall meeting, we are inviting individual comments as part of this town hall meeting notice. We will accept comments on our application of the concept of “substantially similar” by the deadline stated above so they may be considered in our proposed rule. We will also solicit comments during the rulemaking process.

The majority of the meeting will be reserved for individual comments, recommendations, and data from registered presenters. The time for each presenter's comments will be approximately 10 to 15 minutes and will be based on the number of registered presenters. Presenters will be scheduled to speak in the order in which they register and grouped by new technology applicant. Therefore, individuals who want to be presenters must register and submit their agenda item(s) by Wednesday, February 8, 2006. Once the agenda is completed, it will be posted on the hospital IPPS Web site at http://www.cms.hhs.gov/​providers/​hipps/​newtech.asp. Comments from participants will be heard (time permitting) after the completion of the presentations.

For presenters or participants who cannot come to CMS for the meeting, an open toll-free phone line, [phone], has been made available. If you are calling in, you will be prompted to enter the conference identification number, 9386196, or the name of the meeting. In addition, written comments will also be accepted and presented at the meeting if they are received by February 8, 2006. Written comments may also be submitted after the meeting. If the comments are to be considered before the publication of the proposed rule, the comments must be received by March 15, 2006.

III. Registration Instructions

The Division of Acute Care in CMS is coordinating the meeting registration. While there is no registration fee, individuals must register to attend. Individuals may present their comments either in person or by phone at the town hall meeting. These individuals must register and submit their agenda item(s) by February 8, 2006. All other participants must register by February 13, 2006. All registrants will receive confirmation with instructions for arrival at the CMS complex (persons who register on-line will receive this confirmation upon completion of the registration process and should print the confirmation and bring it with them to the meeting). Because of limited meeting space and our desire to maintain an accurate count of registrants who plan to come to CMS, we prefer that these persons register on-line. In addition, we would prefer that registrants who plan to participate by phone register by phone or fax.

On-line Registration: Registration may be completed on-line at the following Web address: http://www.cms.hhs.gov/​events/​default.asp. Select the link “Register to Attend the New Technology Town Hall Meeting” and then select “New Technology Town Hall Meeting” from the drop down menu and follow the instructions. After completing the registration, on-line registrants should print the confirmation page and bring it with them to the meeting.

Registration by Phone or Fax: Registration may be completed by contacting Meredith Walz at [phone] or Michael Treitel at [phone]. Registration may also be completed by fax to the attention of Meredith Walz or Michael Treitel at [phone]. If registration is completed by phone or fax, please provide your name, address, telephone number, and, if available, e-mail address and fax number.

IV. Security Information

Since this meeting will be held in a Federal government building, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. In order to gain access to the building and grounds, participants must bring a government-issued photo identification and a copy of their confirmation of registration for the meeting. Access may be denied to persons without proper identification. For security reasons, no additional meeting registrations will be accepted after the close of the registration period.

Security measures also include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all persons entering the building must pass through a metal detector. All items brought to CMS, whether personal or for the purpose of demonstration or to support a presentation, are subject to inspection. Laptops and other computer equipment must be registered with the security desk upon entry. CMS cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a presentation. Participants should e-mail presentations to CMS staff listed above prior to the meeting to ensure that CMS has a back-up copy in the event of computer problems or lack of software or memory card compatibility. Please note that CMS headquarters is a smoke-free facility.

Authority: Section 503 of Public Law 108-173.

(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: December 1, 2005.

Mark B. McClellan,

Administrator, Centers for Medicare & Medicaid Services.