[Federal Register: September 1, 2005 (Volume 70, Number 169)]
[Rules and Regulations]
[Page 52023-52028]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se05-13]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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