[Federal Register Volume 68, Number 104 (Friday, May 30, 2003)]
[Notices]
[Pages 32528-32529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2177-FN]


Medicare and Medicaid Programs; Approval of the Joint Commission 
on Accreditation of Healthcare Organizations (JCAHO) for Deeming 
Authority for Hospices

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This notice announces our decision to re-approve the Joint 
Commission on Accreditation of Healthcare Organizations (JCAHO) for 
continued recognition as a national accreditation program for hospice 
facilities seeking to participate in the Medicare or Medicaid programs.

EFFECTIVE DATE: This final notice is effective June 19, 2003 through 
June 19, 2009.

FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a hospice, provided certain requirements are met. 
Section 1861(dd)(1) of the Social Security Act (the Act) establishes 
distinct criteria for facilities seeking designation as a hospice 
program. Provider agreement regulations are located in 42 CFR part 489, 
and regulations pertaining to the survey and certification of 
facilities are located in 42 CFR part 488. The regulations at 42 CFR 
part 418 specify the conditions that a hospice facility must meet in 
order to participate in the Medicare program, the scope of covered 
services, and the conditions for Medicare payment for hospice care.
    Generally, in order to enter into an agreement, a hospice facility 
must first be certified by a State survey agency as complying with the 
conditions or requirements set forth in part 418 of our regulations. 
Then, the hospice facility 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 would ``deem'' those provider entities as having 
met the requirements. Accreditation by an accreditation organization is 
voluntary 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, 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 assurances 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 Sec.  488.4 
and Sec.  488.8(d)(3). The regulations at Sec.  488.8(d)(3) require 
accreditation organizations to reapply for continued approval of 
deeming authority every 6 years or sooner as determined by us. The 
JCAHO's term of approval as a recognized accreditation program for 
hospice facilities expires June 18, 2003.

II. Deeming Applications Approval Process

    Section 1865(b)(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 than a 30-day public 
comment period. At the end of the 210-day period we must publish a 
notice in the Federal Register of our approval or denial of the 
application.

III. Provisions of the Proposed Notice

    On January 24, 2003, we published a proposed notice in the Federal 
Register (68 FR 3532) announcing the JCAHO's request for reapproval as 
a deeming organization for hospices. In this notice, we specified in 
detail our evaluation criteria. Pursuant to section 1865(b)(2) of the 
Act and our regulations at Sec.  488.4, we conducted a review of the 
JCAHO application in accordance with the criteria specified in our 
regulation, which include, but are not limited to the following:
    [sbull] An onsite administrative review of JCAHO'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.
    [sbull] A comparison of JCAHO's hospice accreditation standards to 
our current Medicare hospice conditions for participation.
    [sbull] A documentation review of JCAHO's survey processes to:
    + Determine the composition of the survey team, surveyor 
qualifications, and the ability of JCAHO to provide continuing surveyor 
training.
    + Compare JCAHO'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 JCAHO's procedures for monitoring providers or suppliers 
found to be out of compliance with JCAHO program requirements. The 
monitoring procedures are used only when JCAHO identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at Sec.  
488.7(d).
    + Assess JCAHO's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    + Establish JCAHO's ability to provide us with electronic data in 
ASCII-comparable code and reports necessary for effective validation 
and assessment of JCAHO's survey process.
    + Determine the adequacy of staff and other resources.
    + Review JCAHO's ability to provide adequate funding for performing 
required surveys.
    + Confirm JCAHO's policies for whether surveys are announced or 
unannounced.
    + Obtain JCAHO'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(b)(3)(A) of the Act, the proposed 
notice also solicited public comments regarding whether JCAHO's

[[Page 32529]]

requirements met or exceeded the Medicare conditions of participation 
for hospices. We received no public comments in response to our 
proposed notice.

IV. Provisions of the Final Notice

A. Differences Between JCAHO and Medicare's Conditions and Survey 
Requirements

    We compared the standards contained in JCAHO's ``Comprehensive 
Accreditation Manual for Home Care'' (CAMHC) and its survey process in 
the ``Request for Continued Deeming for Hospice Handbook'' with the 
Medicare hospice conditions for participation and our State and 
Regional Operations Manual. Our review and evaluation of JCAHO's 
deeming application, which were conducted as described in section III 
of this notice yielded the following:
    [sbull] In order to meet the requirements of Sec.  488.4(a)(4)(v), 
JCAHO provided a copy of their Conflict of Interest and Financial 
Integrity policy that is required to be signed by all JCAHO surveyors.
    [sbull] JCAHO provided a list of all full and partial hospice 
accreditation surveys scheduled to be performed by the organization in 
2002 and 2003 to satisfy our requirements at Sec.  488.4(a)(10).
    [sbull] To satisfy the requirements of Sec.  488.4(b)(3)(v), JCAHO 
provided documentation that allows its surveyors to serve as witnesses 
if we take an adverse action based on accreditation findings.
    [sbull] In order to comply with Sec.  418.100(k)(2)(i), JCAHO 
agreed to add to its ``intent'' statement that Medicare certified 
hospice, facilities require that a physician must order all medications 
for the patient.
    [sbull] To comply with Sec.  418.22(b), JCAHO agreed to add to 
their ``intent'' statement that in a Medicare certified hospice 
``terminally ill'' means that the individual has a medical prognosis 
that his or her life expectancy is 6 months or less if the terminal 
illness runs its normal course.

B. Term of Approval

    Based on the review and observations described in section IV of 
this final notice, we have determined that JCAHO's requirements for 
hospices meet or exceed our requirements. Therefore, we recognize the 
JCAHO as a national accreditation organization for hospices that 
request participation in the Medicare program, effective June 19, 2003 
through June 19, 2009.

V. Collection of Information Requirements

    This final notice does not impose any information collection and 
record keeping requirements subject to the Paperwork Reduction Act 
(PRA). Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB) under the authority of the PRA. The 
requirements associated with granting and withdrawal of deeming 
authority to national accreditation organizations, specified in 42 CFR 
part 488, ``Survey, Certification, and Enforcement Procedures,'' are 
currently approved by OMB under OMB approval number 0938-0690.

VI. Regulatory Impact Statement

    We have examined the impact of this notice as required by Executive 
Order 12866 and the Regulatory Flexibility Act (RFA) (Pub. L. 98-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety effects; 
distributive impacts; and equity). The RFA requires agencies to analyze 
options for regulatory relief for small businesses. For purposes of the 
RFA, States and individuals are not considered small entities.
    Also, section 1102(b) of the Act requires the Secretary to prepare 
a regulatory impact analysis for any notice that may have a significant 
impact on the operations of a substantial number of small rural 
hospitals. Such an analysis must conform to the provisions of section 
604 of the RFA. For purposes of section 1102(b) of the Act, we consider 
a small rural hospital as a hospital that is located outside of a 
Metropolitan Statistical Area and has fewer than 100 beds.
    This final notice recognizes JCAHO as a national accreditation 
organization for hospices that request participation in the Medicare 
and Medicaid programs. There are neither significant costs nor savings 
for the program and administrative budgets of Medicare. Therefore, this 
notice is not a major rule as defined in Title 5, United States Code, 
section 804(2) and is not an economically significant rule under 
Executive Order 12866. We have determined, and the Secretary certifies, 
that this notice will not result in a significant impact on a 
substantial number of small entities and will not have a significant 
effect on the operations of a substantial number of small rural 
hospitals. Therefore, we are not preparing analyses for either the RFA 
or section 1102(b) of the Act.
    In an effort to better assure the health, safety, and services of 
beneficiaries in hospices already certified as well as provide relief 
to State budgets in this time of tight fiscal restraints, we deem 
hospices accredited by JCAHO as meeting our Medicare requirements. 
Thus, we continue our focus on assuring the health and safety of 
services by providers and suppliers already certified for participation 
in a cost-effective manner.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget. In 
accordance with Executive Order 13132, we have determined that this 
notice will not significantly affect the rights of States, local, or 
tribal governments.

    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; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplemental Medical Insurance Program)

    Dated: April 18, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 03-13471 Filed 5-29-03; 8:45 am]
BILLING CODE 4163-18-P