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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services 

          - [CMS-2899-FN] 

# AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS. 

# ACTION:

Final notice. 

# SUMMARY:

This notice announces our decision to approve the Accreditation Commission for Health Care, Incorporated (ACHC) for continued recognition as a national accreditation program for home health agencies (HHAs) seeking to participate in the Medicare or Medicaid programs. 

# DATES:

*Effective Date:*                         This final notice is effective February 24, 2009 through February 24, 2015.                     

# FOR FURTHER INFORMATION CONTACT:

Lillian Williams, (410) 786-8636. Patricia Chmielewski, (410) 786-6899. 

# SUPPLEMENTARY INFORMATION:

## I. Background 

Under the Medicare program, eligible beneficiaries may receive selected covered services from a home health agency (HHA) provided certain requirements are met. Sections 1861(m) and (o), 1891, and 1895 of the Social Security Act (the Act) authorize the Secretary to establish distinct criteria for facilities seeking designation as an HHA. Under this authority, the minimum requirements that an HHA must meet to participate in Medicare are set forth in regulations at 42 CFR part 484 and 42 CFR part 409, which determine the basis and scope of HHA-covered services, and the conditions for Medicare payment for home health care. 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, to enter into an agreement, an HHA must first be certified by a State survey agency as complying with conditions or requirements set forth in part 484 of our regulations. Then, the HHA is subject to regular surveys by a State survey agency to determine whether it continues to meet those requirements. There is an alternative, however, to surveys by State agencies. 

                    Section 1865(a)(1) of the Act (as redesignated under section 125 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) 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 may “deem” those provider entities as having met Medicare requirements. (We note that section 125 of MIPPA redesignated subsections (b) through (e) of subsection 1865 of the Act as (a) through (d) respectively.) Accreditation by an accreditation organization is voluntary                           ( print page 4204)                        and is not required for Medicare participation.                 

If an accreditation organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, a provider entity accredited by the national accrediting body's approved program may 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 conditions. Our regulations concerning reapproval of accrediting organizations are set forth at § 488.4 and § 488.8(d)(3). The regulations at § 488.8(d)(3) require accreditation organizations to reapply for continued approval of deeming authority every 6 years, or sooner as we determine. The Accreditation Commission for Health Care, Incorporated's (ACHC) term of approval as a recognized accreditation program for HHAs expires February 24, 2009. 

## II. Deeming Applications Approval Process 

                    Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of deeming applications is conducted in a timely manner. The Act provides us with 210 calendar days after the date of receipt of an application to complete our survey activities and application review process. Within 60 days of receiving a completed application, we must publish a notice in the                     **Federal Register**                     that identifies the national accreditation body making the request, describes the request, and provides no less that a 30-day public comment period. At the end of the 210-day period, we must publish an approval or denial of the application.                 

## III. Provisions of the Proposed Notice 

                    In the August 22, 2008                     **Federal Register**                     (73 FR 49681), we published a proposed notice announcing the ACHC's request for reapproval as a deeming organization for HHAs. In the proposed notice, we detailed our evaluation criteria. Under section 1865(a)(2) of the Act and our regulations at § 488.4 (Application and reapplication procedures for accreditation organizations), we conducted a review of the ACHC application in accordance with the criteria specified by our regulation, which include, but are not limited to the following:                 
    - An onsite administrative review of ACHC's (1) Corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring, and evaluation of its surveyors; (4) ability to investigate and respond appropriately to complaints against accredited facilities; and (5) survey review and decision-making process for accreditation.
    - A comparison of ACHC's HHA accreditation standards to our current Medicare HHA conditions of participation (COPs).
    - A documentation review of ACHC's survey processes to—

++ Determine the composition of the survey team, surveyor qualifications, and the ability of ACHC to provide continuing surveyor training; 

++ Compare ACHC's processes to those of State survey agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities; 

++ Evaluate ACHC's procedures for monitoring providers or suppliers found to be out of compliance with ACHC program requirements. The monitoring procedures are used only when ACHC identifies noncompliance. If noncompliance is identified through validation reviews, the State survey agency monitors corrections as specified at § 488.7(d); 

++ Assess ACHC's ability to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner; 

++ Establish ACHC's ability to provide us with electronic data and reports necessary for effective validation and assessment of ACHC's survey process; 

++ Determine the adequacy of staff and other resources; 

++ Review ACHC's ability to provide adequate funding for performing required surveys; 

++ Confirm ACHC's policies with respect to whether surveys are announced or unannounced; and, 

++ Obtain ACHC's agreement to provide us with a copy of the most current accreditation survey together with any other information related to the survey as we may require, including corrective action plans. 

In accordance with section 1865(a)(3)(A) of the Act, the August 22, 2008 proposed notice (73 FR 49681) solicited public comments regarding whether ACHC's requirements met or exceeded the Medicare conditions of coverage for HHAs. We received no public comments in response to our proposed notice. 

## IV. Provisions of the Final Notice 

### A. Differences Between the ACHC's Standards and Requirements for Accreditation and Medicare's Conditions and Survey Requirements 

We compared the standards contained in ACHC's accreditation requirements for HHAs and its survey process in ACHC's application for renewal of deeming authority for HHAs with the Medicare HHA conditions for participation and our State Operations Manual (SOM). Our review and evaluation of ACHC's deeming application, which were conducted as described in section III. of this final notice, yielded the following: 
    - To meet the requirements at § 488.4(a)(3)(iii), ACHC revised their record retention policy to require all survey documentation be kept for a minimum of 3 years.
    - To meet the requirements at § 484.4(a)(4), ACHC revised its surveyor training and evaluation policy to include a process for addressing unsatisfactory performance.
    - To comply with the requirement at § 488.4(b)(3)(i), ACHC developed an action plan to resolve issues related to timely data submissions.
    - ACHC modified its policies regarding timeframe for sending and receiving a plan of correction (PoC) to comply with the requirements of section 2728 of the SOM.
    - To meet the Medicare requirements related to a plan of correction (PoC), ACHC amended its policies to ensure approved PoCs contain all the required elements specified in section 2728 of the SOM.
    - ACHC revised its accreditation decision letters to ensure they are accurate and contain all the required elements necessary for the CMS Regional Office to render a decision regarding deemed status of a provider.

### B. Term of Approval 

Based on the review and observations described in section III. of this final notice, we have determined that the ACHC requirements for HHA meet or exceed our requirements. Therefore, we approve ACHC as a national accreditation organization for HHAs that request participation in the Medicare program, effective February 24, 2009 through February 24, 2015. 

## V. Collection of Information Requirements 

                    This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and                           ( print page 4205)                        Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).                 

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; Program No. 93.774, Medicare—Supplementary Medical Insurance Programs)

Dated: November 21, 2008. 

Kerry Weems, 

Acting Administrator, Centers for Medicare & Medicaid Services.

[FR Doc. E9-684 Filed 1-22-09; 8:45 am] 

BILLING CODE 4120-01-P