E7-18470. Medicare and Medicaid Programs; Application by the Indian Health Service (IHS) for Continued Recognition as a National Accreditation Organization for Accrediting American Indian and Alaska Native Entities To Furnish Outpatient Diabetes ...

AGENCY:

Centers for Medicare and Medicaid Services, HHS.

ACTION:

Proposed notice.

SUMMARY:

This proposed notice announces the receipt of an application from the Indian Health Service for continued recognition as a national accreditation organization for accrediting American Indian and Alaska Native entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries. This notice also announces a 30-day public comment period.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. October 29, 2007.

ADDRESSES:

In commenting, please refer to file code CMS-3186-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (no duplicates, please):

1. Electronically. You may submit electronic comments on specific issues in this regulation to http://www.cms.hhs.gov/​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-3186-PN, P.O. Box 3014, Baltimore, MD 21244-1850.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

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-3186-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number [phone] in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850.

(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Eva Fung, [phone].

SUPPLEMENTARY INFORMATION:

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-3186-PN 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. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.cms.hhs.gov/​eRulemaking. Click on the link “Electronic Comments on CMS Regulations” on that Web site to view public comments.

Comments received timely will also 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 [phone].

I. Background

Under the Medicare program, eligible beneficiaries may receive outpatient diabetes self-management training when ordered by the physician or qualified nonphysician practitioner treating the beneficiary's diabetes, provided certain requirements are met. We sometimes use national accreditation organizations to determine whether a provider entity meets the Medicare requirements that are necessary in order for an entity to provide a service covered by Medicare.

Section 1865(b)(1) of the Social Security Act (the Act), provides that a national accreditation organization must have an agreement in effect with the Secretary and meet the standards and requirements as specified in 42 CFR part 410, subpart H. The regulations pertaining to application procedures for national accreditation organizations for diabetes self-management training services are specified in § 410.142 (CMS process for approving national accreditation organizations).

A national accreditation organization applying for deeming authority must provide us with reasonable assurance that it requires accredited entities to meet requirements that are at least as stringent as those set forth by CMS. Nonprofit or not-for-profit organizations with demonstrated experience in representing the interests of individuals with diabetes are eligible to request recognition as a national accreditation organization. The national accreditation organization, after being approved and recognized by CMS, evaluates the entity to determine if it meets one of the sets of quality standards as specified in § 410.144 (Quality standards for deemed entities). If the national accreditation organization finds that the entity meets or exceeds applicable requirements, the Secretary shall deem the entity as meeting the Medicare requirements.

Section 1865(b)(2) of the Act requires that the Secretary's findings relative to approving a national accreditation organization as a deeming authority consider the organization's requirements for accreditation, its survey procedures, its ability to provide adequate resources for conducting required surveys and its ability to supply information for use in enforcement activities, its monitoring procedures for entities found out of compliance with the conditions or requirements, and its ability to provide the Secretary with necessary data for validation. The Secretary evaluates the national accreditation organization's accreditation requirements to determine if they meet or exceed the Medicare conditions as we would have applied them.

Section 1865(b)(3)(A) of the Act requires that the Secretary publish within 60 days of receipt of a completed application, a notice identifying the national accreditation body making the request, describing the nature of the request, and providing at least a 30-day public comment period. In addition, the Secretary has 210 days from receipt of the request to publish a finding of approval or denial of the application. If the Secretary recognizes an accreditation organization in this manner, once an entity that furnishes diabetes training is accredited by a national accreditation organization, it can be “deemed” to meet the Medicare conditions of coverage for diabetes self-management training.

II. Provisions of the Proposed Notice

[If you choose to comment on issues in this section, please include the caption “PROVISIONS OF THE PROPOSED NOTICE” at the beginning of your comments.]

The purpose of this notice is to notify the public of the Indian Health Service's (IHS's) request for the approval for continued recognition as a national accrediting organization for accreditation of American Indian and Alaska Native entities to furnish outpatient diabetes self-management training services. The IHS proposes to continue to adopt the National Standards for Diabetes Self-Management Education as its quality standards. This notice also solicits public comments on the ability of the IHS to develop and apply its standards to entities furnishing outpatient diabetes self-management training services.

Outpatient Diabetes Self-Management Training Services

The regulations specifying the Medicare conditions for coverage for outpatient diabetes self-management training services are specified in 42 CFR parts 410, subpart H. These conditions implement section 1861(qq) of the Act, which provides for Medicare Part B coverage of outpatient diabetes self-management training services specified by the Secretary.

Under section 1865(b)(2) of the Act and our regulations at § 410.142 (CMS process for approving national accreditation organizations) and § 410.143 (Requirements for approved accreditation organizations), we review and evaluate a national accreditation organization based on (but not necessarily limited to) the criteria specified in § 410.142(b), and we review the ongoing responsibilities of an approved accreditation organization.

We may visit the prospective organization's offices to verify information in the organization's reapplication package, including, but not limited to, review of documents, and interviews with the organization's staff. We may conduct onsite inspection of a national accreditation organization's operations and office to verify information and assess the organization's compliance with its own policies and procedures. The onsite inspection may include, but is not limited to, reviewing documents, auditing documentation from meetings concerning the accreditation process, evaluating accreditation results or the accreditation status decision making process, and interviewing the organization's staff.

Notice Upon Completion of Evaluation

Upon completion of our evaluation, including consideration of public comments received as a result of this notice, we will publish a final notice in the Federal Register announcing the result of our evaluation.

III. Response to Comments

Because of the large number of public comments we normally receive on Federal Register documents, 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 preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

In accordance with the provisions of Executive Order 12866, the Office of Management and Budget did not review this notice.

Authority: Section 1865 of the Social Security Act (42 U.S.C. 1395bb).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program)

Dated: September 6, 2007.

Kerry Weems,

Acting Administrator, Centers for Medicare & Medicare Services.