[Federal Register Volume 71, Number 165 (Friday, August 25, 2006)]
[Notices]
[Pages 50428-50429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-5030-N]


Frontier Extended Stay Clinic Demonstration

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

ACTION: Notice.

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SUMMARY: This notice informs interested parties of an opportunity to 
apply for the Frontier Extended Stay Clinic (FESC) demonstration, which 
is mandated by section 434 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003. A FESC is designed to 
address the needs of seriously or critically ill or injured patients 
who, due to adverse weather conditions or other reasons, cannot be 
transferred to acute care hospitals, or patients who do not need a 
hospital level of care but need monitoring and observation for limited 
periods of time.

DATES: Applications will be considered timely if we receive them no 
later than 5 p.m., Eastern Standard Time (e.s.t), on November 24, 2006.

ADDRESSES: Mail or deliver applications to the following address: 
Centers for Medicare & Medicaid Services, Attention: Sid Mazumdar, Mail 
Stop: C4-15-27, 7500 Security Boulevard, Baltimore, MD 21244, 
[email protected]. Fax: 410-786-1048. Because of staff 
and resource limitations, we cannot accept applications by facsimile 
(fax) transmission or by e-mail.

FOR FURTHER INFORMATION CONTACT: Sid Mazumdar at (410) 786-6673. 
Interested parties can obtain the complete application on the CMS Web 
site at http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS061689. Paper copies can be obtained by 
writing to Sid Mazumdar at the address listed in the ADDRESSES section 
of this notice.

SUPPLEMENTARY INFORMATION:

I. Background

    We have previously developed alternative provider types designed to 
make available basic acute care and emergency services in remote 
geographic areas. In response to Congressional mandates, in 1991 we 
piloted the Montana Medical Assistance Facility (MAF) Demonstration and 
in 1993 implemented the Essential Access Community Hospital/Rural 
Primary Care Hospital (EACH/RPCH) Program. These programs tested the 
concept of a limited service hospital, including lower required levels 
of physician and nurse staffing than full service hospitals. In the 
Balanced Budget Act of 1997, Congress mandated a nationwide program 
called ``Rural Hospital Flexibility Program'', the purpose of which is 
the provision of needed acute care services by a new type of provider 
type known as a ``critical access hospital'' (CAH). CAHs are entities 
in rural areas that generally provide limited services.
    Now under section 434 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) the Congress 
established ``The Frontier Extended Stay Clinic Demonstration 
Project,'' to test the feasibility of providing extended stay services 
to remote frontier areas under Medicare payment and regulations. In 
remote frontier areas, weather and distance can prevent patients who 
experience severe injury or illness from obtaining immediate transport 
to an acute care hospital. In some instances, when patients are unable 
to be transported, local clinics staffed by physicians or other health 
professionals may offer observation services until the patient can be 
transferred or is no longer in need of transport. This type of extended 
stay service is not currently reimbursed by Medicare, Medicaid, or most 
third-party payers. For several years, officials in the State of Alaska 
and several state offices of Rural Health, Primary Care Offices, and 
Primary Care Associations have explored the development of a new 
provider type that would enable reimbursement of these services.
    In designing the demonstration, the goal is to allow flexibility 
for these remote clinics to serve the needs of a range of patients for 
whom transportation to a full-service acute care hospital is 
problematic. In addition, this demonstration also attempts to ensure 
safety in clinics that have neither the institutional experience nor 
the level of technological sophistication of hospitals. As authorized 
by statute, we are defining requirements for providers to participate 
in the Frontier Extended Stay Clinic (FESC) demonstration.
    Specifically, section 434(a) of the MMA allows waiver of provisions 
of the Medicare program as are necessary to conduct the demonstration 
project, under which a FESC is treated as a provider of items and 
services under the Medicare program. The FESC must be located in a 
community which is-(1) at least 75 miles away from the nearest acute 
care hospital, critical access hospital, or (2) is inaccessible by 
public road. The distance requirement is in relation to the nearest 
acute care or critical access hospital, regardless of whether patients 
are generally transferred to that hospital. In addition, we are 
determining mileage as measured in terms of the shortest distance by 
road.
    We believe the FESC should be designed to address the needs of 
seriously or critically ill or injured patients who, due to adverse 
weather conditions or other reasons, cannot be transferred to acute 
care hospitals, or patients who do not meet CMS inpatient hospital 
admission criteria and who need monitoring and observation for a 
limited period of time. We believe that the FESC should provide 
extended stay services under circumstances when weather and 
transportation conditions prevent transfer, but apart from such 
circumstances when a patient's condition warrants hospitalization, he 
or she should be transported to an acute care hospital.
    According to section 434(e) of the MMA, the FESC demonstration will 
last for three years. Unless reauthorized, at the end of this period, 
the FESCs will lose their certification as Medicare providers. 
Moreover, pursuant to section 434(d)(2) of the MMA, the demonstration 
is to be budget neutral.

II. Provisions of the Notice

A. Eligible Organizations

    Potentially qualifying applicants are currently operational primary 
care clinics, including clinics operated by the Indian Health Service 
or tribal authorities. Other clinics may be eligible

[[Page 50429]]

if they propose plans to adopt the features of a FESC. To be eligible 
for the Frontier Extended Stay Clinic demonstration, a clinic must be 
located in a community which is at least 75 miles from the nearest 
acute care hospital or critical access hospital, or which is 
inaccessible by public road. Mileage is measured in terms of the 
shortest distance by road.

B. Conditions of Participation

    This notice solicits applications for demonstration projects to 
enable participating remote clinics to provide services to seriously or 
critically ill or injured patients who, due to adverse weather 
conditions, or other reasons, cannot be transferred quickly to an acute 
care hospital, and to patients who do not meet hospital admission 
criteria but who need monitoring and observation for a limited period 
of time.
    FESCs may vary as far as their architectural design and original 
type of clinic. At a minimum, an interested clinic must be able to 
provide primary care, ambulatory care, and extended stay services, but 
there are no requirements that an interested clinic be of any 
particular type. For example, Rural Health Clinics (RHCs) and federally 
qualified health centers (FQHCs), which are separately certified under 
Medicare, are especially appropriate for the FESC model. We will 
require each such clinic to explain how its staff and equipment will 
meet the needs of emergency and overnight patients.
    Given the wide variety of clinical conditions that a clinic will 
face, it is vital that each FESC maintain stable, effective transfer 
relationships with acute care hospitals. All clinics participating in 
the FESC demonstration will be required to keep all billable items 
under the demonstration separate from those of the existing outpatient 
clinic. The FESC portion of a clinic participating in the demonstration 
will be able to share staff and resources with its non-FESC portion as 
long as billing for staff and resources is kept distinct during 
discrete blocks of time. An applicant must also describe its transfer 
agreements with acute care hospitals.
    In addition, we expect all participants in the demonstration to 
have a physically separate area dedicated to extended stay FESC 
patients. A more specific listing of the FESC requirements are found in 
the application package at Web address identified above.

C. Evaluation Process and Criteria

    If the application meets the basic eligibility requirements and 
responds to all components of the application, it will be referred to a 
technical review panel for evaluation and scoring for an independent 
review. The comments and evaluations of the panelists will be 
transcribed into a summary statement that will serve as the basis for 
award decisions. The evaluations of the panelists will contain 
numerical ratings based on the rating criteria specified in this 
section, the ranking of all applications, and a written assessment of 
each application. In addition, we will conduct a financial analysis of 
the recommended proposals and evaluate the proposed projects to ensure 
that they are budget neutral. CMS will make the final selection.
    The evaluation criteria and weights are detailed in the complete 
application package. These criteria will be used to evaluate the 
applications for the FESC demonstration. Applications will be scored on 
an absolute basis. The application package, as well as the Medicare 
Waiver Demonstration Application, are available on the CMS Web site.

III. Requirements for Submission of Applications

    Individual clinics or consortia that represent several clinics may 
submit applications. Each applicant organization is to submit one 
application, regardless of the number of proposed demonstration sites. 
The application is to be coordinated and submitted by an organizational 
component that has the authority to determine the financial and 
clinical service policy of an applicant body. If applicable, variations 
related to proposed sites should be outlined in the application text or 
supplemental materials. Applications should be a maximum of 40 
typewritten pages, excluding appendices. The complete application 
package is at the CMS Web site at http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS061689. Hard copies 
can be obtained by calling Sid Mazumdar (410) 786-6673 or by e-mail at 
[email protected].
    In order to be considered for review by the technical review panel, 
applicants must complete, sign, date and return the Medicare Waiver 
Demonstration Applicant Data Sheet found on this Web page. The Medicare 
Waiver Demonstration Application, on the Web page, serves as the 
required outline for submitting information in the application. The 
required narrative portion is to consist of responses to the questions 
under ``Evaluation Process and Criteria.'' Queries for the narrative 
portion of the application may be submitted in writing by mail, fax, or 
e-mail. (Please see the ADDRESSES section of this notice for necessary 
information.)

IV. Collection of Information Requirements

    This information collection requirement is subject to the Paperwork 
Reduction Act of 1995 (PRA); however, the collection is currently 
approved under OMB control number 0938-0880 entitled ``Medicare 
Demonstration Waiver Application'' with a current expiration date of 
July 31, 2006.

    Authority : Section 434 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 Pub. L. 108-173.

    Dated: May 18, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
 [FR Doc. E6-14176 Filed 8-24-06; 8:45 am]
BILLING CODE 4120-01-P