Source: https://www.federalregister.gov/documents/2006/01/27/06-748/medicare-and-medicaid-programs-application-by-the-tu
Timestamp: 2018-08-21 12:33:04
Document Index: 283265085

Matched Legal Cases: ['art 482', 'art 489', 'art 488', 'art 482', 'art 488', '§\u2009488', '§\u2009488', '§\u2009488']

Federal Register :: Medicare and Medicaid Programs; Application by the TU
Medicare and Medicaid Programs; Application by the TU
4584-4586 (3 pages)
CMS-2228-PN
V. Response to Public Comments and Notice Upon Completion of Evaluation
https://www.federalregister.gov/d/06-748 https://www.federalregister.gov/d/06-748
This proposed notice acknowledges the receipt of an application from the TUV Healthcare Start Printed Page 4585Specialists for deeming authority for hospitals that wish to participate in the Medicare and Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
We will consider comments if we receive them at the appropriate address, as provided below, no later than 5 p.m. on February 27, 2006.
In commenting, please refer to file code CMS-2228-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
1. Electronically. You may submit electronic comments on specific issues in this regulation to http://www.cms.hhs.gov/​regulations/​eRulemaking. Click on the link “Submit electronic comments on CMS regulations with an open comment period.) (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2228-PN, P.O. Box 8018, Baltimore, MD 21244-8018.
3. By express or overnight mail. You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2228-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Amber Wolfe, (410) 786-6773.
Submitting Comments: We welcome comments from the public on all issues set forth in this proposed notice to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-2228-PN.
Under the Medicare program, eligible beneficiaries may receive covered services in a hospital provided certain requirements are met. The regulations specifying the Medicare conditions of participation (CoPs) for hospitals are located in 42 CFR part 482. These conditions implement section 1861(e) of the Social Security Act (the Act), which specifies services covered as hospital care and the requirements that a hospital must meet in order to participate in the Medicare program. Regulations concerning provider agreements are at 42 CFR part 489, and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488.
Generally, in order to enter into an agreement with CMS, a hospital must first be certified by a State survey agency as complying with the CoPs set forth in part 482 of our regulations. Thereafter, the hospital is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements. There is an alternative, however, to surveys by State agencies.
Section 1865(b)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accreditation organization that all applicable Medicare conditions are met or exceeded, we will “deem” those provider entities as having met the requirements.
If an accreditation organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accreditation organization applying for approval of deeming authority under part 488, subpart A must provide us with reasonable assurance that the accreditation organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare CoPs. Accreditation by an accreditation organization is voluntary and is not required for Medicare participation.
Section 1865(b)(2) of the Act and our regulations at § 488.8(a) require that our findings concerning review and approval of a national accrediting organization's requirements consider, among other factors, the applying accreditation organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or Start Printed Page 4586requirements; and ability to provide us with the necessary data for validation.
The purpose of this proposed notice is to inform the public of our consideration of the TÜV Healthcare Specialists' (TÜVHS') request to become a national accreditation organization for hospitals. This notice also solicits public comment on the ability of TÜVHS requirements to meet or exceed the Medicare CoPs for hospitals.
On December 2, 2005, the TÜV Healthcare Specialists (TÜVHS) submitted all the necessary materials to enable us to make a determination concerning its request for approval as a deeming organization for hospitals. Under section 1865(b)(2) of the Act and our regulations at § 488.8 (Federal review of accreditation organizations), our review and evaluation of TÜVHS will be conducted in accordance with, but not necessarily limited to, the following factors:
The equivalency of TÜVHS' standards for hospitals as compared with our comparable hospital CoPs.
—The comparability of TÜVHS' processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
—TÜVHS' processes and procedures for monitoring providers or suppliers found out of compliance with TÜVHS' program requirements. These monitoring procedures are used only when TÜVHS identifies noncompliance. If noncompliance is identified through validation reviews, the survey agency monitors corrections as specified at § 488.7(d).
—TÜVHS' capacity to provide us with electronic data in ASCII comparable code, and reports necessary for effective validation and assessment of the organization's survey process.
—TÜVHS' agreement to provide us with a copy of the most current ac creditation survey together with any other information related to the survey as we may require (including corrective action plans).
Because of the large number of comments we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this proposed notice.
Upon completion of our evaluation, including evaluation of comments received as a result of this proposed notice, we will publish a final notice in the Federal Register responding to the public comments and announcing the result of our evaluation.
[FR Doc. 06-748 Filed 1-26-06; 8:45 am]