Medicare Program; Establishment of the Medicare Advantage Program, 52023-52028 [05-17280]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 169 (Thursday, September 1, 2005)]
[Rules and Regulations]
[Pages 52023-52028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17280]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 422

[CMS-4069-F3]
RIN 0938-AN06


Medicare Program; Establishment of the Medicare Advantage Program

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

ACTION: Final rule; correcting amendment; partial stay of 
effectiveness.

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SUMMARY: This document corrects technical errors that appeared in the 
final rule published in the Federal Register on January 28, 2005 
entitled ``Establishment of the Medicare Advantage Program.'' It also 
stays several amendments made in the previous rule.

EFFECTIVE DATES: This final rule is effective March 22, 2005. Sections 
422.152(a)(1) and (c), 422.156(b)(7), 422.316, and 422.527 are stayed 
from September 1, 2005 until January 1, 2006.

FOR FURTHER INFORMATION CONTACT: Christopher McClintick, (410) 786-
4682.

SUPPLEMENTARY INFORMATION: 

I. Background

    In FR Doc. 05-1322 of January 28, 2005 (70 FR 4588), there were 
several errors that we identify in the ``Summary of Errors'' section 
and correct in the ``Correction of Errors'' section below. The 
provisions in this correcting amendment are effective as if they were 
included in the final rule published January 28, 2005. Accordingly, the 
corrections are effective retroactive to March 22, 2005, the effective 
date of most of the provisions of the January 28, 2005 final rule, 
except for those provisions that are specifically designated in the 
EFFECTIVE DATES section as being stayed effective September 1, 2005 
until January 1, 2006.

II. Summary of Errors

    In the January 28, 2005 final rule, on page 4588, we inadvertently 
omitted from the list of provisions that will become effective January 
1, 2006, the following provisions relating to changes in the quality 
improvement provisions in subpart D: Sec. Sec.  422.152(a)(1) and (c), 
and 422.156(b)(7). These provisions implement changes to section 
1852(e) of the Social Security Act (the Act) that, under section 722(c) 
of the MMA, apply to contract years beginning on and after January 1, 
2006. Sections 422.152(a)(1) and (c) concern the requirement that an MA 
organization must have a chronic care improvement program for each plan 
it offers. In order to clarify that these provisions of the quality 
improvement requirements do not apply to contracts previous to contract 
periods beginning January 1, 2006, and to comply with the Act, we are 
staying the effective dates of Sec. Sec.  422.152(a)(1) and (c) until 
January 1, 2006. We are also staying Sec.  422.156(b)(7), a quality 
improvement provision concerning deemable requirements and Part D 
prescription drug programs offered by MA programs. We also 
inadvertently omitted from the list of provisions that will become 
effective January 1, 2006, the following provisions relating to 
arrangements with federally qualified health centers: Sec. Sec.  
422.316 and 422.527. Section 237(c) of the MMA provides that these 
changes apply to services provided on or after January 1, 2006, and 
contract years beginning on or after that date. In order to clarify the 
effective dates of these provisions and to bring our regulations into 
conformance with the statute, we are also staying the effective dates 
of Sec. Sec.  422.316 and 422.527 until January 1, 2006.
    On page 4676, we clarify that an MA organization and not a 
practitioner is responsible for providing a written notice to the 
beneficiary when an adverse decision is made in an office setting. In 
other words, if an enrollee requests an explanation of a practitioner's 
denial of an item or service, in whole or in part, the MA organization 
is responsible for giving the enrollee a written notice. We are making 
a corresponding change to Sec.  422.568(d) of the regulation text.
    On page 4681, we inadvertently specified 72 hours as the timeline 
for the expedited grievance process MA organizations must establish for 
complaints involving certain procedural matters in the appeals process. 
In that discussion, we were referring to 42 CFR 422.564(d), which we 
redesignated in the final rule as Sec.  422.564(f), but did not 
otherwise change. The timeline, as

[[Page 52024]]

specified in redesignated Sec.  422.564(f), is actually 24 hours. Our 
correction now specifies this.
    On page 4685, we retained language based on, and references to the 
proposed rule. As a result, we incorrectly referred to the possibility 
of public comment, and referred to a table of information collection 
requirements instead of the section of the final rule specifying such 
requirements.
    In addition to correcting errors in the preamble, in section III of 
this correcting amendment, we also correct several sections of the 
regulation text. In the summary of the regulation text corrections, we 
first discuss, in numerical order, changes that are primarily limited 
to a specific section of the regulation text. We then discuss changes 
with a broader scope.

A. Corrections to Specific Sections

    In Sec.  422.2 of the final rule, in the definition of ``Provider 
network,'' we inadvertently retained a reference to a ``network MSA 
plan'' that is no longer valid.
    Also in Sec.  422.2 of the final rule, in the definitions of 
``Prescription drug plan (PDP)'' and ``Prescription drug plan (PDP) 
sponsor,'' we incorrectly referred to the pertinent definitions section 
of the prescription drug regulations. In both instances the references 
should be to ``Sec.  423.4,'' the corresponding definitions section for 
the prescription drug benefit requirements under Part 423.
    In the heading for Sec.  422.6, we are replacing the term ``MA user 
fee'' with ``Cost-sharing in enrollment-related costs,'' as well as 
removing the first reference in Sec.  422.6(d)(2)(ii) to ``200 
million'' in order to avoid repetition and confusion.
    In Sec.  422.6(f)(1)(ii) of the final rule, in our requirements 
concerning cost-sharing of enrollment-related costs for prescription 
drug plans (PDPs), we inadvertently did not include the text 
introducing the assessment formula for PDPs.
    In Sec.  422.132, we are replacing the incorrect reference to Sec.  
422.502(g) with Sec.  422.504(g). The error came about as a result of 
our reorganization and revision of these contract-related sections of 
subpart K for the final rule.
    In Sec.  422.152(b)(3)(ii), we replace the incorrect reference to 
``Sec.  422.64(c)(10),'' a non-existent provision, with the reference, 
``Sec.  422.64.''
    In Sec.  422.208(c)(2) of the final rule, we retained a reference 
to periodic surveys that are no longer required as a result of section 
222(h) of the Medicare Prescription Drug, Improvement and Modernization 
and Improvement Act of 2003 (MMA).
    In Sec.  422.210, we inadvertently deleted paragraph (b), 
Disclosure to Medicare beneficiaries, which we intended to retain, with 
the exception of a reference to surveys no longer required.
    In Sec.  422.252, in the definition of ``MA monthly supplemental 
beneficiary premium,'' we are correcting the cross reference to Sec.  
422.266(b)(2)(i), which does not exist, and replacing it with the 
correct reference, Sec.  422.266(b)(1).
    In Sec.  422.254, paragraph (b)(1)(i), we are removing ``statutory 
non-drug bid amount'' and adding ``unadjusted MA statutory non-drug 
monthly bid amount,'' the defined term, in its place, which was our 
original intent.
    We are amending Sec.  422.314(c)(1)(i) to remove an inadvertent 
reference to Sec.  422.306. Section 422.306 concerns the capitation 
rate but not the calculated payment for deposit in the MA MSA, the 
requirement that is the subject of Sec.  422.314(c).
    We are amending Sec.  422.320(c)(1) by removing ``prescription drug 
beneficiary premium (described at Sec.  422.252)'' and replacing this 
with ``prescription drug payment described in Sec.  423.315 (if any)'' 
since Sec.  422.252 refers to the basic definition while Sec.  423.315 
describes the actual payment to which Sec.  422.320 is referring. 
Likewise, we are amending paragraph (c)(2)(ii) of Sec.  422.320 by 
removing ``beneficiary premium (if any)'' and adding ``payment 
described in Sec.  423.315 (if any).''
    We are amending Sec.  422.458 to include the correct reference to 
Sec.  422.504(d)(1)(iii), a section specifying contract provisions. 
Although we revised several sections for the final rule, we 
inadvertently referred to the previous organization of the managed care 
regulations and Sec.  422.502(d)(1)(iii) of those regulations.
    We are amending Sec.  422.504(h) to reflect the correct reference 
to the False Claims Act. In the final rule we inadvertently cited ``32 
U.S.C. 3729 et seq.,'' whereas the correct reference is ``31 U.S.C. 
3729 et seq.''
    In Sec.  422.510(a)(4), we are replacing the term ``PDP sponsor'' 
with ``MA organization'' as we inadvertently used the term ``PDP 
sponsor'' in this section.
    In Sec.  422.552(a)(3)(iii), we inadvertently did not make a 
conforming change to the cross reference and, instead of referring to 
``subpart J,'' we should have referred to ``subpart K,'' the subpart 
containing the application and contract requirements.
    In Sec.  422.553(b)(2), we inadvertently referred to ``subpart L,'' 
when intending to refer to ``subpart K,'' and the requirements for 
applications and contracts.
    In Sec. Sec.  422.562(c)(1)(ii) and 422.622(b)(1)(i), which concern 
the requirements for appeals of quality improvement organization (QIO) 
determinations, we incorrectly referenced the CFR Parts governing such 
appeals. As a result, we are amending these sections by replacing the 
incorrect references with ``Parts 476 and 478 of Chapter 42 of the 
CFR'', the correct references.

B. Corrections Affecting Multiple Sections

    In the August 3, 2004 proposed rule (69 FR 46866), we proposed to 
reorganize and revise subparts F and G due to the substantial revisions 
that the MMA made to pricing and payment rules for MA organization. In 
reorganizing and revising these subparts to reflect the new MA bidding 
and payment procedures, we reversed the order of the subparts and 
reorganized several of the provisions within the subparts. However, in 
the final rule, we made several errors as a result of this 
reorganization. Errors primarily consist of cross-references to 
subparts F and G or sections of the subparts, and other technical 
changes resulting from our reference to the previous organization of 
the subparts. Because there are several related errors involving 
subparts F and G, we address these together, below.
    As a result of reorganizing and revising subparts F and G, we 
incorrectly referred to, or identified several specific sections of 
these subparts. In the table of contents for subpart G, we incorrectly 
identified a section of the subpart. Instead of identifying the 
Announcement of annual capitation rate, benchmarks, and methodology 
changes as section Sec.  422.312, we incorrectly identified the section 
as Sec.  422.311. Other sections in which we incorrectly identified or 
referred to sections in subparts F and G include Sec. Sec.  422.60(f), 
422.66(f)(1), 422.101 (introductory text), 422.101(b)(3)(i), 422, 
100(d)(2), 422.103(d)(2), 422.109(a)(1)(ii), 422.216(b)(2), 422.322(b), 
422.500(b), and 422.504(a)(8).
    Sections in which we revise incorrect references to the subparts F 
and G themselves include Sec.  422.504(a)(9) through (a)(10), and the 
introductory text of Sec.  422.504(l), and Sec.  422.752(a)(2).
    In another general change related to revision of the payment 
provisions, we are replacing incorrect terminology and references to 
the previous payment system. The changes, which replace the ``adjusted 
community rate'' (ACR), an element of the previous payment rate for

[[Page 52025]]

MA organizations, with language reflecting the new bidding process, 
affect several sections of the regulation. As we do in our discussion 
of the cross references to subparts F and G, we are discussing these 
payment language corrections together.
    Sections in which we replace the term ``ACR'' with ``bid'' to 
reflect the new process include Sec. Sec.  422.206(b)(2)(i) and Sec.  
422.503(d)(1). Several of the contract requirements specified in 
subpart K are also affected. Thus, in Sec.  422.504 we make corrections 
to reflect the correct payment language in paragraphs (d)(1)(i), 
(d)(1)(iv), (d)(1)(v) and (l)(4). The changes to remove references to 
ACR are consistent with Sec.  422.2 of the final rule, where we 
correctly deleted the definition of ACR.
    In another correction affecting several sections of the 
regulations, we replace incorrect references referring to ``encounter 
data.'' Just as we changed the term ``ACR'' to ``bid'' in order to be 
consistent with the statute, we are also changing the term ``encounter 
data'' to ``data.'' Sections affected include Sec.  422.504(a)(8), 
(l)(2) through (l)(3), and Sec.  422.510(a)(7). In both the proposed 
and final rules we discussed that we were no longer requiring encounter 
data and, instead, are requiring other data, to include risk adjustment 
data. Although we discussed this change in the preamble (see 70 FR 
4661), we inadvertently did not revise the regulation text to reflect 
this.
    In our final rule, we stated that MA organizations, like PDP 
sponsors, are required to maintain data for the current contract period 
and 10 prior periods. We discussed this requirement in the comments 
section of the preamble of the final rule and correctly stated the 
requirement in the published regulation text. Several other sections of 
the regulation text should have been amended to reflect the data 
retention requirement. In this correcting amendment we are making 
conforming change to those sections (see Sec.  422.504(d), (e)(1)(iii), 
and (i)(2)(ii)).

III. Waiver of Proposed Rulemaking

    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 take effect in accordance with section 553(b) of 
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we 
can waive this notice and comment procedure if the Secretary finds, for 
good cause, that the notice and comment process is impracticable, 
unnecessary, or contrary to the public interest, and incorporate a 
statement of the finding and the reasons therefore in the notice.
    Section 553(d) of the Administrative Procedure Act ordinarily 
requires a 30-day delay in effective date of final rules after the date 
of their publication in the Federal Register. This 30-day delay in 
effective date can be waived, however, if an agency finds for good 
cause that the delay is impracticable, unnecessary, or contrary to the 
public interest, and the agency incorporates a statement of the 
findings and its reasons in the rule issued. In addition, section 
1871(e)(1)(B) of the Act, as amended by section 903(b) of Pub. L. 108-
173, provides that substantive changes may take effect before the end 
of the 30-day period that begins on the date that the Secretary has 
issued the substantive change only if the waiver of the 30-day period 
is necessary to comply with statutory requirements or the application 
of the 30-day delay is contrary to the public interest.
    Most of the revisions contained in this rule concern conforming 
changes, cross references, and typographical errors, and therefore, are 
not substantive. Because they are not substantive, we find that public 
comment on these revisions is not necessary. The revisions do not 
represent changes to our policy, and the public interest would, as a 
result, be best served by timely correction of these technical errors. 
A delay in the applicability of the non-substantive changes would be 
contrary to public interest in that such corrections are necessary for, 
especially, plans transitioning to the new Medicare Advantage program.
    Several of the changes, however, are corrections that could be 
viewed as substantive. We are staying the effectiveness of certain 
quality improvement requirements to clarify that MA plans need not meet 
them until January 1, 2006. Similarly, we are staying the effectiveness 
of the provisions pertaining to Federally Qualified Health Centers 
(FQHC) payments. In the case of these substantive corrections, we find 
that public comment is unnecessary because the corrections are being 
made to bring the regulations into conformity with the statutory 
requirements, which themselves do not apply until January 1, 2006. We 
also find that the 30-day delay ordinarily called for under the APA and 
section 1871(e)(1)(B) of the Act is contrary to the public interest 
because there is no statutory authority for these regulatory provisions 
until January 1, 2006, the effective date of the statutory provisions.
    Section 1871(e)(1)(A) of the Act, as amended by section 903(a) of 
Pub. L. 108-173, provides that a substantive change in regulations 
shall not be applied retroactively to items and services furnished 
before the effective date of the change, unless the Secretary finds 
that such retroactive application is necessary to comply with statutory 
requirements or failure to apply the change retroactively would be 
contrary to the public interest.
    The provisions of this correcting amendment that apply 
retroactively make no substantive changes, but merely correct minor 
technical errors. Failure to make these changes retroactive to March 
22, 2005, is contrary to the public interest because of the confusion 
that could result from the technical errors identified above. It is in 
the public interest to make the corrections retroactive in that it will 
help prevent confusion among plans that must now follow these 
requirements for plans offered in January 1, 2006, the year the new MA 
program requirements are implemented.

IV. Correction of Errors

    Make the following corrections to the January 28, 2005 final rule 
(70 FR 4588):
    1. On page 4676 in column 3, at the end of the first full paragraph 
add the following: ``Thus, we are making a conforming change to Sec.  
422.568(d) to provide that if an enrollee requests an MA organization 
to provide an explanation of a practitioner's denial of an item or 
service, in whole or in part, the MA organization must give the 
enrollee a written notice. This change eliminates the practitioner's 
requirement to deliver a general notice to an enrollee whenever an 
adverse decision is made in an office setting. An enrollee retains the 
right to obtain a detailed notice from an MA organization upon an 
enrollee's request for an explanation of a practitioner's denial.''
    2. On page 4681, column 1, line 7, delete ``72-hour'' and add ``24-
hour'' in its place.
    3. On page 4685, column 2--
    A. In line 8, remove the word ``proposed.''
    B. In line 13, remove the word ``Table'' and add the word 
``section'' in its place.
    C. Remove the paragraph beginning line 15.

List of Subjects in 42 CFR Part 422

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Medicare, Penalties, Privacy, 
Reporting and recordkeeping requirements.


0
Accordingly, 42 CFR chapter IV is corrected by making the following 
correcting amendments to part 422:

[[Page 52026]]

PART 422--MEDICARE ADVANTAGE PROGRAM

0
1. The authority citation for part 422 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


0
2. Amend Sec.  422.2 as follows:
0
A. Revise the definition for ``Provider network''.
0
B. In the definition for ``Prescription drug plan (PDP)'' remove the 
reference to ``Sec.  423.272'' and add ``Sec.  423.4'' in its place.
0
C. In the definition for ``Prescription drug plan (PDP) sponsor'' 
remove the reference to ``Sec.  423.2'' and add ``Sec.  423.4'' in its 
place.
    The revisions read as follows:


Sec.  422.2  Definitions.

* * * * *
    Provider network means the providers with which an MA organization 
contracts or makes arrangements to furnish covered health care services 
to Medicare enrollees under an MA coordinated care plan.
* * * * *


Sec.  422.4  [Corrected]

0
3. In Sec.  422.4, amend paragraph (a)(1)(iii) by removing the 
parenthetical phrase ``(except MSA and PFFS plans)'' and adding in its 
place ``(except PFFS plans).''

0
4. In Sec.  422.6--
0
A. Revise the section heading to read as set forth below.
0
B. Revise paragraph (d)(2)(ii) to read as set forth below.
0
C. In paragraph (e), remove the phrase ``for those PDP sponsors PDP 
sponsors'' and add ``for those PDP sponsors'' in its place.
0
D. Revise paragraph (f)(1)(ii) to read as set forth below.
    The revisions read as follows:


Sec.  422.6  Cost-sharing in enrollment-related costs.

* * * * *
    (d) * * *
    (2) * * *
    (ii) For fiscal year 2006 and each succeeding year, the applicable 
portion (as defined in paragraph (e) of this section) of $200 
million.''
* * * * *
    (f) * * *
    (1) * * *
    (ii) The assessment formula for PDPs: C divided by A times B 
where--A is the total estimated January payments to all PDP sponsors 
subject to the assessment; B is the 9-month (January through September) 
assessment period; and C is the total fiscal year PDP sponsor's user 
fee assessment amount determined in accordance with paragraph (d)(2) of 
this section.
* * * * *


Sec.  422.50  [Corrected]

0
5. In Sec.  422.50, amend paragraph (a)(4) by removing the reference to 
``Sec.  422.12'' and adding in its place ``Sec.  422.112.''


Sec.  422.60  [Corrected]

0
6. In Sec.  422.60, amend paragraph (f) introductory text by removing 
the reference to ``Sec.  422.250(b)'' and adding ``Sec.  
422.308(f)(2)'' in its place.


Sec.  422.66  [Corrected]

0
7. In Sec.  422.66 amend paragraph (f)(1) by removing the reference to 
``Sec.  422.250(b)'' and adding ``Sec.  422.308 (f)(2)'' in its place.


Sec.  422.100  [Amended]

0
8. In Sec.  422.100 amend paragraph (d)(2) by removing the reference to 
``Sec.  422.304(b)(2)'' and adding ``Sec.  422.262(c)(2)'' in its 
place.


Sec.  422.101  [Corrected]

0
9. In Sec.  422.101--
0
A. Amend the introductory text by removing the references to ``Sec.  
422.264'' and ``Sec.  422.266'' and adding in their place ``Sec.  
422.318'' and ``Sec.  422.320'', respectively.
0
B. Amend paragraph (b)(3)(i) by removing the reference to ``Sec.  
422.306(a)'' and adding in its place ``Sec.  422.254(a)(1),'' and by 
removing the phrase ``adjusted community rate proposals'' and adding 
``bid amounts'' in its place.
0
C. Amend paragraph (d)(1) by removing the phrase ``are only permitted'' 
and adding in its place ``are permitted.''


Sec.  422.103  [Corrected]

0
10. In Sec.  422.103, amend paragraph (d)(2) by removing the reference 
to ``Sec.  422.252(b)'' and adding in its place ``Sec.  
422.306(a)(2).''


Sec.  422.109  [Corrected]

0
11. In Sec.  422.109, amend paragraph (a)(1)(ii) by removing the 
reference to ``Sec.  422.254(b)'' and adding in its place ``Sec.  
422.308(a).''


Sec.  422.111  [Corrected]

0
12. In Sec.  422.111, amend paragraph (b)(2) by removing the reference 
to ``MD-PD'' and adding ``MA-PD'' in its place.


Sec.  422.132  [Amended]

0
13. In Sec.  422.132 remove the reference to ``Sec.  422.502(g)'' and 
add ``Sec.  422.504(g)'' in its place.


Sec.  422.152  [Stayed in part]

0
14. Section 422.152(a)(1) and (c) is stayed effective September 1, 2005 
until January 1, 2006.


Sec.  422.152  [Corrected]

0
14a. In Sec.  422.152, amend paragraph (b)(3)(ii) by removing the 
reference to ``Sec.  422.64(c)(10)'' and adding in its place, ``Sec.  
422.64.''


Sec.  422.156  [Stayed in part]

0
15. Section 422.156(b)(7) is stayed effective September 1, 2005 until 
January 1, 2006.


Sec.  422.206  [Amended]

0
16. In Sec.  422.206, amend paragraph (b)(2)(i) by removing the phrase 
``ACR'' and adding in its place ``bid''.


Sec.  422.208  [Corrected]

0
17. In Sec.  422.208, amend paragraph (c)(2) by removing the phrase 
``and conduct periodic surveys in accordance with paragraph (h) of this 
section''.

0
18. Revise Sec.  422.210 to read as follows.


Sec.  422.210  Assurances to CMS.

    (a) Assurances to CMS. Each organization will provide assurance 
satisfactory to the Secretary that the requirements of Sec.  422.208 
are met.
    (b) Disclosure to Medicare Beneficiaries. Each MA organization must 
provide the following information to any Medicare beneficiary who 
requests it:
    (1) Whether the MA organization uses a physician incentive plan 
that affects the use of referral services.
    (2) The type of incentive arrangement.
    (3) Whether stop-loss protection is provided.


Sec.  422.216  [Amended]

0
19. In Sec.  422.216, amend paragraph (b)(2) by removing the reference 
to ``Sec.  422.308(b)'' and adding in its place ``Sec.  
422.256(b)(3).''


Sec.  422.252  [Corrected]

0
20. In Sec.  422.252, amend the entry, ``MA monthly supplemental 
beneficiary premium'' by removing the reference to ``Sec.  
422.266(b)(2)(i)'' and adding in its place ``Sec.  422.266(b)(1).''


Sec.  422.254  [Corrected]

0
21. In Sec.  422.254 amend paragraph (b)(1)(i) by removing the phrase 
``statutory non-drug bid amount'' and adding ``unadjusted MA statutory 
non-drug monthly bid amount'' in its place.

[[Page 52027]]

Sec.  422.256  [Corrected]

0
22. Amend paragraph (c) by removing the reference to ``Sec.  
422.258(b)'' and adding ``Sec.  422.258(c)'' in its place.


Sec.  422.314  [Corrected]

0
23. In Sec.  422.314, amend paragraph (c)(1)(i) by removing the phrase 
``determined under Sec.  422.306''.


Sec.  422. 316  [Stayed]

0
23a. Section 422.316 is stayed effective September 1, 2005 until 
January 1, 2006.


Sec.  422.320  [Corrected]

0
24. In Sec.  422.320--
0
A. Amend paragraph (c)(1) by removing the phrase ``prescription drug 
beneficiary premium (described at Sec.  422.252)'' and adding 
``prescription drug payment described in Sec.  423.315 (if any)'' in 
its place.
0
B. Amend paragraph (c)(2)(ii) by removing the phrase ``beneficiary 
premium (if any)'' and adding ``payment described in Sec.  423.315 (if 
any)'' in its place.


Sec.  422.322  [Corrected]

0
25. In Sec.  422.322--
0
A. Amend paragraph (b) by removing the reference to ``Sec.  422.264'' 
and adding ``Sec.  422.316'' in its place; by removing the reference to 
``Sec.  422.266'' and adding ``Sec.  422.320'' in its place.
0
B. Amend paragraph (c) by adding the reference ``Sec.  422.316,'' 
immediately following the reference to ``Sec.  422.314''.

0
26. In Sec.  422.458, revise paragraph (d)(2) to read as follows:


Sec.  422.458  Risk sharing with regional MA organizations for 2006 and 
2007.

* * * * *
    (d) * * *
    (2) According to Sec.  422.504(d)(1)(iii), CMS has the right to 
inspect and audit any books and records of the organization that 
pertain to the information regarding costs provided to CMS under 
paragraph (b)(2) of this section.
* * * * *


Sec.  422.500  [Corrected]

0
27. In Sec.  422.500(b), amend paragraph (1) of the definition of 
``Clean claim'' by removing the reference to ``Sec.  422.257(d)'' and 
adding ``Sec.  422.310(d)'' in its place.


Sec.  422.503  [Corrected]

0
28. In Sec.  422.503--
0
A. Amend paragraph (b)(4)(vi)(H) by removing the phrase ``MA-PDPs'' and 
adding ``MA-PDs'' in its place.
0
B. Amend paragraph (d)(1) by removing the phrase ``ACR'' and adding 
``bid'' in its place.


Sec.  422.504  [Corrected]

0
29. In Sec.  422.504--
0
A. Amend paragraph (a)(8) by removing the cross reference to ``Sec.  
422.257'' and adding ``Sec.  422.310'' in its place, and by removing 
``encounter data'' and adding ``data'' in its place.
0
B. Amend paragraph (a)(9) by removing the cross reference to ``subpart 
F'' and adding ``subpart G'' in its place.
0
C. Amend paragraph (a)(10) by removing the phrase ``ACR'' and adding 
``bid'' in its place; by removing the phrase ``May 1'' and adding ``not 
later than the first Monday in June'' in its place; and by removing the 
phrase ``subpart G'' and adding ``subpart F'' in its place.
0
D. Amend paragraph (d), introductory text, by removing the phrase ``6 
years'' and adding ``10 years'' in its place.
0
E. Amend paragraphs (d)(1)(i), (d)(1)(iv) and (d)(1)(v) by removing the 
phrase ``ACR'' and adding ``bid'' in its place wherever it occurs.
0
F. Amend paragraphs (d)(2)(ii) and (d)(2)(iii) by removing the phrase 
``six prior periods'' and adding ``10 prior periods'' in its place 
wherever it occurs.
0
G. Amend paragraph (e)(1)(iii) by removing the phrase ``six prior 
periods'' and adding ``10 prior periods'' in its place.
0
H. Amend paragraph (h)(1) by removing the reference to ``32 U.S.C. 3729 
et seq.'' and adding ``31 U.S.C. 3729 et seq.'' in its place.
0
I. Amend paragraph (i)(2)(ii) by removing the phrase ``6 years'' and 
adding ``10 years'' in its place.
0
J. Amend the introductory text of paragraph (l) by removing the cross 
reference to ``subpart F'' and adding ``subpart G'' in its place, and 
by removing the phrase ``encounter data.''
0
K. Amend paragraph (l)(2) by removing the phrase ``encounter data'' and 
adding ``data'' in its place, and by removing the cross reference to 
``Sec.  422.257'' and adding ``Sec.  422.310'' in its place.
0
L. Amend paragraph (l)(3) by removing the phrase ``encounter data'' and 
adding ``data'' in its place.''
0
M. Amend paragraph (l)(4) by removing the phrase ``ACR'' and adding 
``bid'' in its place and by removing the cross reference to ``Sec.  
422.310'' and adding ``Sec.  422.254'' in its place.


Sec.  422.510  [Corrected]

0
30. In Sec.  422.510--
0
A. Amend paragraph (a)(4) by removing the phrase ``PDP sponsor'' and 
adding ``MA organization'' in its place.
0
B. Amend paragraph (a)(7) by removing the phrase ``encounter data'' and 
adding ``data'' in its place, and by removing the reference to ``Sec.  
422.257'' and adding ``Sec.  422.310'' in its place.


Sec.  422.527  [Stayed]

0
30a. Section 422.527 is stayed effective September 1, 2005 until 
January 1, 2006.


Sec.  422.552  [Amended]

0
31. In Sec.  422.552--
0
A. Amend paragraph (a) by removing the phrase ``HCFA'' and adding 
``CMS'' in its place.
0
B. Amend paragraph (a)(3)(iii) by removing the reference to ``subpart 
J'' and adding ``subpart K'' in its place.


Sec.  422.553  [Amended]

0
32. In Sec.  422.553, amend paragraph (b)(2) by removing the reference 
to ``subpart L'' and adding ``subpart K'' in its place.


Sec.  422.562  [Corrected]

0
33. In Sec.  422.562, amend paragraph (c)(1)(ii) by removing the phrase 
``in part 478 of this chapter'' and adding in its place ``in parts 476 
and 478 of this chapter.''

0
34. In Sec.  422.568 revise paragraph (d) to read as follows:


Sec.  422.568  Standard timeframes and notice requirements for 
organization determinations.

* * * * *
    (d) Written notice for MA Organization denials. If an enrollee 
requests an MA organization to provide an explanation of a 
practitioner's denial of an item or service, in whole or in part, the 
MA organization must give the enrollee a written notice.
* * * * *

0
35. In Sec.  422.622 revise paragraph (b)(1)(i) to read as follows:


Sec.  422.622  Requesting immediate QIO review of noncoverage of 
inpatient hospital care.

* * * * *
    (b) * * *
    (1) * * *
    (i) To the QIO that has an agreement with the hospital under parts 
476 and 478 of this chapter.
* * * * *


Sec.  422.752  [Corrected]

0
36. In Sec.  422.752, amend paragraph (a)(2) by removing the reference 
to ``subpart G,'' and adding in its place ``subpart F.''

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital

[[Page 52028]]

Insurance; and Program No. 93.774, Medicare--Supplementary Medical 
Insurance Program)


    Dated: August 16, 2005.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. 05-17280 Filed 8-26-05; 10:10 am]
BILLING CODE 4120-01-P