[Federal Register: February 19, 2009 (Volume 74, Number 32)]
[Rules and Regulations]
[Page 7653-7654]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe09-9]
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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