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: §§ 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 §§ 422.152(a)(1) and (c) until January 1, 2006. We are also staying § 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: §§ 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 §§ 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 § 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 § 422.564(f), but did not otherwise change. The timeline, as ( printed page 52024) specified in redesignated § 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 § 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 § 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 “§ 423.4,” the corresponding definitions section for the prescription drug benefit requirements under Part 423.

In the heading for § 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 § 422.6(d)(2)(ii) to “200 million” in order to avoid repetition and confusion.

In § 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 § 422.132, we are replacing the incorrect reference to § 422.502(g) with § 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 § 422.152(b)(3)(ii), we replace the incorrect reference to “§ 422.64(c)(10),” a non-existent provision, with the reference, “§ 422.64.”

In § 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 § 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 § 422.252, in the definition of “MA monthly supplemental beneficiary premium,” we are correcting the cross reference to § 422.266(b)(2)(i), which does not exist, and replacing it with the correct reference, § 422.266(b)(1).

In § 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 § 422.314(c)(1)(i) to remove an inadvertent reference to § 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 § 422.314(c).

We are amending § 422.320(c)(1) by removing “prescription drug beneficiary premium (described at § 422.252)” and replacing this with “prescription drug payment described in § 423.315 (if any)” since § 422.252 refers to the basic definition while § 423.315 describes the actual payment to which § 422.320 is referring. Likewise, we are amending paragraph (c)(2)(ii) of § 422.320 by removing “beneficiary premium (if any)” and adding “payment described in § 423.315 (if any).”

We are amending § 422.458 to include the correct reference to § 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 § 422.502(d)(1)(iii) of those regulations.

We are amending § 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 § 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 § 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 § 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 §§ 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 § 422.312, we incorrectly identified the section as § 422.311. Other sections in which we incorrectly identified or referred to sections in subparts F and G include §§ 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 § 422.504(a)(9) through (a)(10), and the introductory text of § 422.504(l), and § 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 ( printed 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 §§ 422.206(b)(2)(i) and § 422.503(d)(1). Several of the contract requirements specified in subpart K are also affected. Thus, in § 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 § 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 § 422.504(a)(8), (l)(2) through (l)(3), and § 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 § 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 § 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.

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

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).

2. Amend § 422.2 as follows:

A. Revise the definition for “Provider network”.

B. In the definition for “Prescription drug plan (PDP)” remove the reference to “§ 423.272” and add “§ 423.4” in its place.

C. In the definition for “Prescription drug plan (PDP) sponsor” remove the reference to “§ 423.2” and add “§ 423.4” in its place.

The revisions read as follows:

3. In § 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).”

4. In § 422.6—

A. Revise the section heading to read as set forth below.

B. Revise paragraph (d)(2)(ii) to read as set forth below.

C. In paragraph (e), remove the phrase “for those PDP sponsors PDP sponsors” and add “for those PDP sponsors” in its place.

D. Revise paragraph (f)(1)(ii) to read as set forth below.

The revisions read as follows:

5. In § 422.50, amend paragraph (a)(4) by removing the reference to “§ 422.12” and adding in its place “§ 422.112.”

6. In § 422.60, amend paragraph (f) introductory text by removing the reference to “§ 422.250(b)” and adding “§ 422.308(f)(2)” in its place.

7. In § 422.66 amend paragraph (f)(1) by removing the reference to “§ 422.250(b)” and adding “§ 422.308 (f)(2)” in its place.

8. In § 422.100 amend paragraph (d)(2) by removing the reference to “§ 422.304(b)(2)” and adding “§ 422.262(c)(2)” in its place.

9. In § 422.101—

A. Amend the introductory text by removing the references to “§ 422.264” and “§ 422.266” and adding in their place “§ 422.318” and “§ 422.320”, respectively.

B. Amend paragraph (b)(3)(i) by removing the reference to “§ 422.306(a)” and adding in its place “§ 422.254(a)(1),” and by removing the phrase “adjusted community rate proposals” and adding “bid amounts” in its place.

C. Amend paragraph (d)(1) by removing the phrase “are only permitted” and adding in its place “are permitted.”

10. In § 422.103, amend paragraph (d)(2) by removing the reference to “§ 422.252(b)” and adding in its place “§ 422.306(a)(2).”

11. In § 422.109, amend paragraph (a)(1)(ii) by removing the reference to “§ 422.254(b)” and adding in its place “§ 422.308(a).”

12. In § 422.111, amend paragraph (b)(2) by removing the reference to “MD-PD” and adding “MA-PD” in its place.

13. In § 422.132 remove the reference to “§ 422.502(g)” and add “§ 422.504(g)” in its place.

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

14a. In § 422.152, amend paragraph (b)(3)(ii) by removing the reference to “§ 422.64(c)(10)” and adding in its place, “§ 422.64.”

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

16. In § 422.206, amend paragraph (b)(2)(i) by removing the phrase “ACR” and adding in its place “bid”.

17. In § 422.208, amend paragraph (c)(2) by removing the phrase “and conduct periodic surveys in accordance with paragraph (h) of this section”.

18. Revise § 422.210 to read as follows.

19. In § 422.216, amend paragraph (b)(2) by removing the reference to “§ 422.308(b)” and adding in its place “§ 422.256(b)(3).”

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

21. In § 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.

22. Amend paragraph (c) by removing the reference to “§ 422.258(b)” and adding “§ 422.258(c)” in its place.

23. In § 422.314, amend paragraph (c)(1)(i) by removing the phrase “determined under § 422.306”.

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

24. In § 422.320—

A. Amend paragraph (c)(1) by removing the phrase “prescription drug beneficiary premium (described at § 422.252)” and adding “prescription drug payment described in § 423.315 (if any)” in its place.

B. Amend paragraph (c)(2)(ii) by removing the phrase “beneficiary premium (if any)” and adding “payment described in § 423.315 (if any)” in its place.

25. In § 422.322—

A. Amend paragraph (b) by removing the reference to “§ 422.264” and adding “§ 422.316” in its place; by removing the reference to “§ 422.266” and adding “§ 422.320” in its place.

B. Amend paragraph (c) by adding the reference “§ 422.316,” immediately following the reference to “§ 422.314”.

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

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

28. In § 422.503—

A. Amend paragraph (b)(4)(vi)(H) by removing the phrase “MA-PDPs” and adding “MA-PDs” in its place.

B. Amend paragraph (d)(1) by removing the phrase “ACR” and adding “bid” in its place.

29. In § 422.504—

A. Amend paragraph (a)(8) by removing the cross reference to “§ 422.257” and adding “§ 422.310” in its place, and by removing “encounter data” and adding “data” in its place.

B. Amend paragraph (a)(9) by removing the cross reference to “subpart F” and adding “subpart G” in its place.

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.

D. Amend paragraph (d), introductory text, by removing the phrase “6 years” and adding “10 years” in its place.

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.

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.

G. Amend paragraph (e)(1)(iii) by removing the phrase “six prior periods” and adding “10 prior periods” in its place.

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.

I. Amend paragraph (i)(2)(ii) by removing the phrase “6 years” and adding “10 years” in its place.

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.”

K. Amend paragraph (l)(2) by removing the phrase “encounter data” and adding “data” in its place, and by removing the cross reference to “§ 422.257” and adding “§ 422.310” in its place.

L. Amend paragraph (l)(3) by removing the phrase “encounter data” and adding “data” in its place.”

M. Amend paragraph (l)(4) by removing the phrase “ACR” and adding “bid” in its place and by removing the cross reference to “§ 422.310” and adding “§ 422.254” in its place.

30. In § 422.510—

A. Amend paragraph (a)(4) by removing the phrase “PDP sponsor” and adding “MA organization” in its place.

B. Amend paragraph (a)(7) by removing the phrase “encounter data” and adding “data” in its place, and by removing the reference to “§ 422.257” and adding “§ 422.310” in its place.

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

31. In § 422.552—

A. Amend paragraph (a) by removing the phrase “HCFA” and adding “CMS” in its place.

B. Amend paragraph (a)(3)(iii) by removing the reference to “subpart J” and adding “subpart K” in its place.

32. In § 422.553, amend paragraph (b)(2) by removing the reference to “subpart L” and adding “subpart K” in its place.

33. In § 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.”

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

(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.

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

(b) * * *

(1) * * *

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

36. In § 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 ( printed page 52028) Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program)