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Notice: This CMS-approved document has been submitted to the Office of the Federal Register (OFR) for publication and has been placed on public display and is pending publication in the Federal Register. The document may vary slightly from the published document if minor editorial changes have been made during the OFR review process. Upon publication in the Federal Register, all regulations can be found at and at . The document published in the Federal Register is the official CMS-approved document.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 410, 416, and 419

[CMS-1404-FC]; [CMS-3887-F]; [CMS-3835-F-1]

RIN 0938-AP17; RIN 0938-AL80; RIN 0938-AH17

Medicare Program: Changes to the Hospital Outpatient Prospective Payment

System and CY 2009 Payment Rates; Changes to the Ambulatory Surgical Center

Payment System and CY 2009 Payment Rates; Hospital Conditions of Participation:

Requirements for Approval and Re-Approval of Transplant Centers to Perform

Organ Transplants--Clarification of Provider and Supplier Termination Policy

Medicare and Medicaid Programs: Changes to the Ambulatory Surgical Center

Conditions for Coverage

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

ACTION: Final rule with comment period; final rules.

SUMMARY: This final rule with comment period revises the Medicare hospital

outpatient prospective payment system to implement applicable statutory requirements

and changes arising from our continuing experience with this system, and to implement a

number of changes made by the Medicare Improvement for Patients and Providers Act of

2008. In this final rule with comment period, we describe the changes to the amounts and

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factors used to determine the payment rates for Medicare hospital outpatient services paid

under the prospective payment system. These changes are applicable to services

furnished on or after January 1, 2009.

In addition, this final rule with comment period updates the revised Medicare

ambulatory surgical center (ASC) payment system to implement applicable statutory

requirements and changes arising from our continuing experience with this system. In

this final rule with comment period, we set forth the applicable relative payment weights

and amounts for services furnished in ASCs, specific HCPCS codes to which these

changes apply, and other pertinent ratesetting information for the CY 2009 ASC payment

system. These changes are applicable to services furnished on or after January 1, 2009.

In this document, we are responding to public comments on a proposed rule and

finalizing updates to the ASC Conditions for Coverage to reflect current ASC practices

and new requirements in the conditions to promote and protect patient health and safety.

Further, this final rule also clarifies policy statements included in responses to

public comments set forth in the preamble of the March 30, 2007 final rule regarding the

Secretary's ability to terminate Medicare providers and suppliers (that is, transplant

centers) during an appeal of a determination that affects participation in the Medicare

program.

DATES: Effective Dates: The provisions of this rule are effective on January 1, 2009,

with one exception: Amendments to 42 CFR 416.2, 416.41 through 416.43, and 416.49

through 416.52 are effective on [Insert 180 days after the date of publication]. The

policy clarification set forth in section XVIII. of the preamble of this rule are effective

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[Insert 30 days after the date of publication].

Comment Period: We will consider comments on the payment classifications

assigned to HCPCS codes identified in Addenda B, AA, and BB to this final rule with

comment period with the "NI" comment indicator, and on other areas specified

throughout this rule, received at one of the addresses provided in the ADDRESSES

section, no later than 5 p.m. EST on [Insert 60 days after the date of display].

Application Deadline--New Class of New Technology Intraocular Lenses:

Request for review of applications for a new class of new technology intraocular lenses

must be received by 5 p.m. EST on March 2, 2009.

ADDRESSES: In commenting, please refer to file code CMS-1404-FC. Because of

staff and resource limitations, we cannot accept comments by facsimile (FAX)

transmission.

You may submit comments in one of four ways (no duplicates, please):

1. Electronically. You may submit electronic comments on this regulation to

. Follow the instructions for "Comment or Submission" and

enter the file code to find the document accepting comments.

2. By regular mail. You may mail written comments (one original and two

copies) to the following address ONLY:

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Attention: CMS-1404-FC

P.O. Box 8013,

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Baltimore, MD 21244-1850.

Please allow sufficient time for mailed comments to be received before the close

of the comment period.

3. By express or overnight mail. You may send written comments (one original

and two copies) to the following address ONLY:

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Attention: CMS-1404-FC

Mail Stop C4-26-05,

7500 Security Boulevard,

Baltimore, MD 21244-1850.

4. By hand or courier. If you prefer, you may deliver (by hand or courier) your

written comments (one original and two copies) before the close of the comment period

to one of the following addresses:

a. Room 445-G, Hubert H. Humphrey Building,

200 Independence Avenue, S.W.,

Washington, DC 20201.

(Because access to the interior of the HHH Building is not readily available to

persons without Federal Government identification, commenters are encouraged to leave

their comments in the CMS drop slots located in the main lobby of the building. A

stamp-in clock is available for persons wishing to retain a proof of filing by stamping in

and retaining an extra copy of the comments being filed.)

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b. 7500 Security Boulevard,

Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, please call the

telephone number (410) 786-9994 in advance to schedule your arrival with one of our

staff members.

Comments mailed to the addresses indicated as appropriate for hand or courier

delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the

"SUPPLEMENTARY INFORMATION" section.

Applications for a new class of new technology intraocular lenses: Requests for

review of applications for a new class of new technology intraocular lenses must be sent

by regular mail to:

ASC/NTIOL,

Division of Outpatient Care,

Mailstop C4-05-17,

Centers for Medicare & Medicaid Services,

7500 Security Boulevard,

Baltimore, MD 21244-1850.

FOR FURTHER INFORMATION CONTACT:

Alberta Dwivedi, (410) 786-0378, Hospital outpatient prospective payment

issues.

Dana Burley, (410) 786-0378, Ambulatory surgical center issues.

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