Source: https://www.federalregister.gov/documents/2004/12/30/04-28155/medicare-program-modifications-to-managed-care-rules
Timestamp: 2018-08-15 21:40:04
Document Index: 711774920

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This interim final rule with comment period is effective January 31, 2005.
CMS-4041-IFC
https://www.federalregister.gov/d/04-28155 https://www.federalregister.gov/d/04-28155
Start Preamble Start Printed Page 78336
This interim final rule with comment period corrects a technical error made in the August 22, 2003 final rule “Modifications to Medicare Rules” (68 FR 50840).
Comment date: To ensure consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on February 28, 2005.
In commenting, please refer to file code CMS-4041-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
2. By 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-4041-IFC, P.O. Box 8010, Baltimore, MD 21244-1850.
Submitting Comments: We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-4041-IFC and the specific “issue identifier” that precedes the section on which you choose to comment.
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. After the close of the comment period, CMS posts all electronic comments received before the close of the comment period on its public website. Comments received timely will 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 (410) 786-7197.
On August 22, 2003, we published a final rule titled, “Modifications to Managed Care Rules” (68 FR 50840), which implemented the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), which included certain changes to the intermediate sanctions regulations at 42 CFR 422.758.
In that final rule, we made limited organizational changes to the intermediate sanctions regulations (68 FR 50841); however, when making those organizational changes, we made technical errors in § 422.752 and § 422.758. Specifically, the $25,000 Civil Money Penalty (CMP) that had been described at § 422.758(a) was inadvertently omitted in the revised version of the intermediate sanctions regulation. We note that these CMPs are set forth at section 1857(g)(3)(A) of the Social Security Act (Act) and provide authority for the Secretary to apply up to a $25,000 penalty for each determination under section 1857(c)(2) that a deficiency not otherwise described in section 1857(g)(1) of the Act exists and has directly and adversely affected (or has the substantial likelihood of adversely affecting) one or more Medicare Advantage (MA) enrollees.
The omission of the $25,000 CMP from § 422.758(a) occurred because we included language in § 422.758(a) that was intended to replace the first two sentences of § 422.752(a). This language clarifies that CMS does not have CMP authority in the case of the violations set forth in § 422.752(a). The OIG has CMP authority in the case of these violations. In the preamble to our August 22, 2003 final rule, we noted that we were changing § 422.752(a) for this purpose (68 FR 50851). However, the regulatory text was inadvertently placed at § 422.758(a).
We also have determined that the reference to § 422.756(f)(3) in existing § 422.758(b) more appropriately belongs in the introductory text of § 422.758 because our authority to impose CMPs in the amounts set forth in all of § 422.758 is described in § 422.756(f)(3). Section § 422.758(b) also contains a redundant reference to § 422.752(b), which we are eliminating, in this interim final rule with comment period, to avoid confusion.
Section 902 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and requires the Secretary, in consultation with the Director of the Office of Management and Budget, to establish and publish timelines for the publication of Medicare final regulations based on the previous publication of a Medicare proposed or interim final regulation. Section 902 of the MMA also states that the timelines for these regulations may vary but shall not exceed 3 years after publication of the preceding proposed or interim final Start Printed Page 78337regulation except under exceptional circumstances.
This interim final rule finalizes provisions set forth in the August 22, 2003 final rule. We will publish the final rule within the 3-year time limit imposed by section 902 of the MMA. Therefore, we believe that the interim final rule is in accordance with the Congress' intent to ensure timely publication of final regulations.
To ensure that the Medicare regulations are an accurate reflection of our current statutory authority to impose CMPs, in this interim final rule with comment period, we are correcting § 422.758 to state that if we make a determination under § 422.752(b), based on any determination under § 422.510(a) except a determination under § 422.510(a)(4), we may impose civil money penalties, pursuant to § 422.756(f)(3), in the following amounts:
If the deficiency on which the determination is based has directly adversely affected (or has the substantial likelihood of adversely affecting) one or more MA enrollees—up to $25,000 for each determination.
For each week that a deficiency remains uncorrected after the week in which the MA organization receives CMS' notice of the determination—up to $10,000.
If we make a determination, based on a determination under § 422.510(a)(1), that an MA organization has terminated its contract with us in a manner other than as described under § 422.512—$250 per Medicare enrollee from the terminated MA plan or plans at the time the MA organization terminated its contract, or $100,000, whichever is greater.
In addition, we are correcting § 422.752(a) to incorporate the changes that we intended to make in the August 22, 2003 final rule (and which currently appear at § 422.758(a)) to provide that for the violations listed in § 422.752(a), we may impose the sanctions specified in § 422.750(a)(2), (a)(3), or (a)(4) on any MA organization that has a contract in effect. The MA organization may also be subject to other applicable remedies available under law.
We find for good cause that it is unnecessary to undertake notice and comment procedures because this correcting amendment does not make any substantive policy changes. This correcting amendment sets forth self-implementing provisions of the Act (as described above) with respect to the imposition of CMPs. Because the rule directly conforms to the statute and does not articulate new requirements, we believe that pursuing notice and comment is unnecessary. Moreover, because that process could introduce confusion regarding our current authority to impose CMPs, we find that pursuing that process would be both impracticable and contrary to the public interest. Therefore, for good cause, we waive notice and comment procedures under 5 U.S.C. 553(b)(B).
With respect to the requirement of a 60-day delay in the effective date of any final rule under the Congressional Review Act (CRA) (see U.S.C. section 801), the CRA provides that the 60-day delayed effective date shall not apply to any rule “which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” (See 5 U.S.C. section 808(2).) For the reasons set forth above, we believe that additional notice and comment rulemaking on this subject would be impracticable, unnecessary, or contrary to the public interest. Therefore, we do not believe that the CRA requires a 60-day delay in the effective date of this final rule.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 for final rules of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 Start Printed Page 78338beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This interim final rule with comment period does not have any costs associated with this requirement and will not approach the Unfunded Mandates Reform Act threshold.
2. Section 422.752(a) introductory text is revised to read as follows:
Basis for imposing sanctions.
(a) All intermediate sanctions. For the violations listed in this paragraph (a), we may impose the sanctions specified in § 422.750(a)(2), (a)(3), or (a)(4) on any MA organization that has a contract in effect. The MA organization may also be subject to other applicable remedies available under law.
3. Section 422.758 is revised to read as follows:
If CMS makes a determination under § 422.752(b), based on any determination under § 422.510(a) except a determination under § 422.510(a)(4), CMS may impose civil money penalties, pursuant to § 422.756(f)(3), in the following amounts:
(a) If the deficiency on which the determination is based has directly adversely affected (or has the substantial likelihood of adversely affecting) one or more Medicare Advantage enrollees—up to $25,000 for each determination.
(b) For each week that a deficiency remains uncorrected after the week in which the Medicare Advantage organization receives CMS' notice of the determination—up to $10,000.
(c) If CMS makes a determination, based on a determination under § 422.510(a)(1) that a Medicare Advantage organization has terminated its contract with CMS in a manner other than as described under § 422.512—$250 per Medicare enrollee from the terminated Medicare Advantage plan or plans at the time the Medicare Advantage organization terminated its contract, or $100,000, whichever is greater.
[FR Doc. 04-28155 Filed 12-29-04; 8:45 am]