[Federal Register Volume 74, Number 32 (Thursday, February 19, 2009)]
[Rules and Regulations]
[Pages 7653-7654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3491]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

[CMS-1561-IFC2]
RIN 0938-AP59


Medicare Program; Changes to the Competitive Acquisition of 
Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies 
(DMEPOS) by Certain Provisions of the Medicare Improvements for 
Patients and Providers Act of 2008 (MIPPA)

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

ACTION: Delay of effective date.

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SUMMARY: In accordance with the memorandum of January 20, 2009, from 
the Assistant to the President and Chief of Staff, entitled 
``Regulatory Review Plan,'' this action temporarily delays for 60 days 
the effective date of the final rule entitled ``Medicare Program; 
Changes to the Competitive Acquisition of Certain Durable Medical 
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain 
Provisions of the Medicare Improvements for Patients and Providers Act 
of 2008 (MIPPA)'' published in the January 16, 2009 Federal Register 
(74 FR 2873). The temporary 60-day delay in effective date is necessary 
to give Department officials the opportunity for further review of the 
issues of law and policy raised by this rule. In addition, this action 
solicits additional comments on the delay of the effective date.

DATES: Effective Date. The effective date of the rule amending 42 CFR 
part 414 published in the January 16, 2009 Federal Register (74 FR 
2873) is delayed 60 days until April 18, 2009.
    Comment Period. To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on March 23, 2009.

ADDRESSES: In commenting, please refer to file code CMS-1561-IFC2. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the instructions for 
``Comment or Submission'' and enter the filecode 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-1561-IFC2, P.O. Box 8020, Baltimore, MD 21244-8020.
    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-1561-IFC2, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-8020.
    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 either of the following addresses:
    a. Room 445-G, Hubert H. Humphrey Building, 200 Independence 
Avenue, SW., 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.)
    b. 7500 Security Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call 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.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

FOR FURTHER INFORMATION CONTACT: Sabrina Teferi, (410) 786-6884. Barry 
Brook, (410) 786-5889.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 16, 2009, we published an interim final rule with 
comment period entitled ``Medicare Program; Changes to the Competitive 
Acquisition of Certain Durable Medical Equipment, Prosthetics, 
Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare 
Improvements for Patients and Providers Act of 2008 (MIPPA)'' in the 
Federal Register that implements certain provisions of section 154 of 
the Medicare Improvements for Patients and Providers Act of 2008 
(MIPPA) (Pub. L. 110-275) related to the durable medical equipment, 
prosthetics, orthotics, and supplies (DMEPOS) Competitive Acquisition 
Program. Specifically, the January 16, 2009 interim final rule with 
comment: implements certain MIPPA provisions that delay implementation 
of Round 1 of the competitive bidding program; requires CMS to conduct 
a second Round 1 competition (the ``Round 1 rebid'') in 2009; and 
mandates certain changes for both the Round 1 rebid and subsequent 
rounds of the program, including a process for providing feedback to 
suppliers regarding missing financial documentation and requiring 
contractors to disclose to CMS information regarding subcontracting 
relationships.
    In addition, in the February 10, 2009 Federal Register, we 
published a notice with comment entitled, ``Medicare Program; Changes 
to the Competitive Acquisition of Certain Durable Medical Equipment, 
Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of 
the Medicare Improvements for Patients and Providers Act of 2008 
(MIPPA)'', (74 FR 6557). That notice solicited public comments on the 
contemplated 60-day delay in the effective date of the January 16, 2009 
interim final rule with comment.

II. Provisions of This Action

    This action delays the effective date of the January 16, 2009 
interim final rule with comment period. The effective date of the 
January 16, 2009 interim final

[[Page 7654]]

rule with comment period, which would have been February 17, 2009, is 
now April 18, 2009. The 60-day delay in the effective date is necessary 
to give Department officials the opportunity for further review of the 
issues of law and policy raised by the rule. We are also seeking 
additional comments on this action to delay the effective date.

III. Response to Comments

    In response to the February 10, 2009 notice with comment period, we 
received approximately 550 public comments in favor of delaying the 
effective date of the January 16, 2009 interim final rule with comment 
period. The following discussion includes a summary of the public 
comments that we received and our response to those comments.
    Comment: Virtually all comments were in favor of delaying the 
effective date of the January 16, 2009 interim final rule with comment 
period. Commenters offered various reasons for supporting the delay. 
For example, some commenters believe that CMS should spend additional 
time evaluating the overall impact and structure of the DMEPOS 
competitive bidding program, determining improvements that need to be 
made to the processes used to implement the program, and/or considering 
additional public comment. In addition, other commenters offered 
comments on the DMEPOS competitive bidding program that were beyond the 
scope of the proposed 60-day effective date delay or were on DMEPOS 
topics unrelated to the DMEPOS competitive bidding program.
    Response: We appreciate the commenters' concerns. We have decided 
to proceed with the delay to allow Department officials the opportunity 
for further review of the issues of law and policy raised by the rule. 
We note that the original comment period on the rule remains unchanged; 
the public has until March 17, 2009 to submit comments on the 
substantive policy issues discussed in the rule. We will address such 
comments in future rulemaking. We also thank commenters for sharing 
concerns about issues that were outside the scope of the notice; as 
these comments were not pertinent to the delay, we will not address the 
specific issues in this response.

IV. Waiver of Proposed Rulemaking and Delay in Effective Date

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register to provide a period for public comment before the 
provisions of a rule such as this take effect, in accordance with 
section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 
553(b)). We also ordinarily provide a 30-day delay in the effective 
date of the provisions of a rule in accordance with section 553(d) of 
the APA (5 U.S.C. 553(d)). However, we can waive both the notice and 
comment procedure and the 30-day delay in the effective date if the 
Secretary finds, for good cause, that it is impracticable, unnecessary 
or contrary to the public interest to follow the notice and comment 
procedure or to comply with the 30-day delay in the effective date, and 
incorporates a statement of the finding and the reasons in the rule.
    This action delays the effective date of the January 16, 2009 
interim final rule with comment period. A delay in effective date is 
necessary to give Department officials the opportunity for further 
review of the issues of law and policies raised by the rule before the 
interim final rule with comment period becomes effective. Moreover, we 
believe it would be contrary to the public interest for the January 16, 
2009 interim final rule with comment period to become effective until 
we are certain that all public comments are reviewed. To do otherwise, 
could potentially result in uncertainty and confusion as to the 
finality of the interim final rule with comment period. For the reasons 
stated above, we find that both notice and comment and the 30-day delay 
in effective date for this action are unnecessary and contrary to the 
public interest. Therefore, we find there is good cause to waive notice 
and comment procedures and the 30-day delay in effective date for this 
rule.

(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: February 13, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Approved: February 13, 2009.
Charles E. Johnson,
Acting Secretary.
[FR Doc. E9-3491 Filed 2-13-09; 4:15 pm]
BILLING CODE 4120-01-P