Medicare Program; Proposal Evaluation Criteria and Standards for End Stage Renal Disease (ESRD) Network Organizations, 34047-34050 [2012-13998]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 111 / Friday, June 8, 2012 / Notices
regarding this collection contact Darlene
Anderson at 410–786–9828. For all
other issues call 410–786–1326.)
To obtain copies of the supporting
statement for the proposed paperwork
collections referenced above, access
CMS’ Web site address at https://www.
cms.hhs.gov/PaperworkReductionActof
1995, or Email your request, including
your address, phone number, OMB
number, and CMS document identifier,
to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by August 7, 2012:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier CMS–
10434, Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
Dated: June 4, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–13869 Filed 6–7–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3269–N]
Medicare Program; Proposal
Evaluation Criteria and Standards for
End Stage Renal Disease (ESRD)
Network Organizations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
This notice describes the
standards, criteria, and procedures we
will use to evaluate an End-Stage Renal
Disease (ESRD) Network Organization’s
capabilities to perform, and actual
performance of, the duties and functions
SUMMARY:
VerDate Mar<15>2010
16:23 Jun 07, 2012
Jkt 226001
under the ESRD Network Statement of
Work (SOW).
DATES: Effective Date: June 8, 2012.
FOR FURTHER INFORMATION CONTACT:
Teresa Casey, 410–786–7215. Renee
Dupee, 410–786–6747.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1881(c) of the Social Security
Act (the Act) authorized the
establishment of, among other things,
ESRD network areas and Network
Organizations under the Medicare
program to ensure the effective
administration of the ESRD program
benefits. We currently have contracts
with ESRD Network Organizations to
serve the 18 ESRD Network areas.
The existing 18 ESRD Network
contracts have been operating under the
same Statement of Work (SOW) since
2003 and have been renewed to
continue to provide service to the ESRD
population. Recent major policy and
legislative changes have modernized
Medicare payments for ESRD care. In
particular, the Medicare Improvements
for Patients and Providers Act (MIPPA)
required the Secretary of the
Department of Health and Human
Services (the Secretary) to implement an
ESRD bundled payment system under
which a single payment is made to a
provider of services or a renal dialysis
facility for renal dialysis services in lieu
of any other payment. MIPPA also
required the Secretary to establish an
ESRD Quality Incentive Program (QIP).
Additionally, a heightened focus on
quality improvement, public reporting
and value-based purchasing in
healthcare has fueled a growing need for
facility-level data collection; analysis;
monitoring; trending; evaluating and
intervening, where necessary, to
improve patient care. We have also
emphasized spreading and replicating
the best practices of high performing
providers. Therefore, a redesigned ESRD
Network SOW was drafted to
incorporate these priorities in
healthcare and changes in legislation.
The SOW will charge the ESRD Network
Organizations with establishing
relationships with patients, families and
facilities within their Network areas to
reach the objective of optimal patientcentered care.
Section 1881(c)(1)(A)(ii)(I) of the Act
provides that in order to determine
whether the Secretary should enter into,
continue, or terminate an agreement
with an ESRD Network Organization,
the Secretary shall develop and publish
in the Federal Register standards,
criteria, and procedures used to evaluate
an ESRD Network Organization’s
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
34047
capabilities to perform, and actual
performance of, the network functions
required by section 1881(c)(2) of the
Act. These functions are to:
• Encourage participation in
vocational rehabilitation programs, and
develop criteria and standards relating
to this participation.
• Evaluate the procedures used by
facilities and providers in the network
to assess patients for placement in
appropriate treatment modalities.
• Implement a procedure for
evaluating and resolving patient
grievances.
• Conduct onsite reviews of facilities
and providers as necessary (as
determined by a medical review board
or the Secretary) using standards of care
established by the ESRD Network
Organization.
• Collect, validate, and analyze data
necessary to prepare the required
annual report to the Secretary and to
ensure the maintenance of a national
ESRD registry.
• Identify facilities and providers that
are not cooperatively working toward
meeting network goals, and assist those
facilities and providers in developing
plans for correction, as well as report to
the Secretary on those facilities and
providers that are not providing
appropriate care.
• Submit an annual report to the
Secretary on July 1 of each year.
Shortly after the publication of this
Federal Register notice, we will post a
Request for Proposals (RFP) to perform
the work of the redesigned ESRD
Network SOW on the Fed Biz Opps Web
site (www.fbo.gov). The RFP will
competitively award a portion of the 18
ESRD Network contracts using a best
value process in accordance with
Federal Acquisition Regulation (FAR)
Part 15. The remaining ESRD Network
contracts will be renewed and competed
at a later date. The period of
performance for these ESRD Network
contracts will be one 12-month base
year which begins on January 1, 2013
and ends on December 31, 2013, with
two 12-month option periods. We may
exercise an option in accordance with
the FAR Part 17.2, and it may terminate
a contract for convenience or for default,
in accordance with FAR Part 49. This
notice describes the capabilities that an
applicant must demonstrate to be
awarded an ESRD Network contract and
the general criteria that will be used to
evaluate the ESRD Network
Organizations performing under the
SOW.
E:\FR\FM\08JNN1.SGM
08JNN1
34048
Federal Register / Vol. 77, No. 111 / Friday, June 8, 2012 / Notices
II. Description of the Tasks Under the
Revised ESRD Network Organization
SOW
ESRD Network Organizations are
responsible, in addition to other duties
and functions that the Secretary
prescribes, for performing the tasks
outlined in section 1881(c)(2) of the Act.
Under the revised ESRD Network
Organization SOW, ESRD Network
Organizations will complete the
requirements of the three Aims outlined
in the SOW which support the functions
required by section 1881(c)(2) of the
Act. The three Aims are as follows:
• Aim 1, is the ‘‘Better Care for the
Individual through Beneficiary and
Family Centered Care’’ Aim. This Aim
envisions ESRD Networks, facilities and
beneficiaries working together to
promote appropriateness of patient care
and processes for evaluating and
resolving patient grievances.
• Aim 2, is the ‘‘Better Health for the
ESRD Population’’ Aim. This Aim
considers the preparation and education
of beneficiaries for transplantation and
self-care settings or home dialysis.
• Aim 3, is the ‘‘Reduce Costs of
ESRD Care by Improving Care’’ Aim.
This Aim has Network Organizations
assisting dialysis facilities in meeting
the requirements of the ESRD Quality
Incentive Program (QIP), supporting
dialysis facilities in their submission of
data to designated data collection
systems and using data to provide
necessary reports to CMS and the
Secretary.
More detailed information for each Aim,
Domain, and sub-domain can be found
in sections C.2 through C.4. of the ESRD
Network SOW posted at the
www.fbo.gov Web site. Each Aim is also
described further below.
mstockstill on DSK4VPTVN1PROD with NOTICES
1. Aim 1: Better Care for the Individual
Through Beneficiary and Family
Centered Care (See Section C.4.1 of the
ESRD Network SOW)
The ‘‘Better Care for the Individual
through Beneficiary and Family
Centered Care’’ Aim strives to promote
health care that is respectful of and
responsive to individual patient
preferences, needs, and values. The
Network patient-centered domains will
achieve Aim 1. Network patientcentered domains are Patient and
Family Engagement; Patient Experience
of Care; Patient-Appropriate Access to
In-Center Dialysis Care; Vascular Access
Management; and Patient Safety:
Healthcare-Acquired Infections (HAIs).
The ESRD Network Organizations’
activities within this Aim will be
enhanced by the patient’s voice. The
ESRD Network Organization will take a
VerDate Mar<15>2010
16:23 Jun 07, 2012
Jkt 226001
two-tiered approach to incorporating the
patient’s voice in the activities of the
Network and the renal community as a
whole. The two tiers are: (1)
Engagement at the dialysis facility level
to foster patient and family
involvement; and (2) development and
implementation of a beneficiary and
family centered care focused Learning
and Action Network (LAN) to promote
patient and family involvement at the
Network level. Both tiers are essential
and work together to promote
beneficiary and family engagement to
improve quality of care.
III. Evaluation of ESRD Network
Organizations’ Capabilities To Perform,
and Evaluation of the Performance of,
the Responsibilities Under the SOW
A. Evaluation of Capabilities To Perform
the Responsibilities Under the SOW
In order to receive an ESRD Network
Contract award, an applicant must
demonstrate, through the submission of
a technical proposal, the capability to
perform the duties listed in the ESRD
Network SOW. Technical proposal
submissions must detail the applicant’s
approach to accomplish each of the
Aims of the SOW and describe how the
2. Aim 2: Better Health for the ESRD
applicant will maximize the outcome of
Population (See Section C.4.2 of the
the specific tasks within each Aim.
ESRD Network Statement of Work)
Additionally, successful applicants
must offer sound quality improvement
The ‘‘Better Health for the ESRD
approaches for the intervention
Population’’ Aim focuses on improving
strategies they are proposing to meet the
the quality of and access to ESRD care
tasks identified in the SOW. The
through a Population Health Innovation proposed interventions are expected to
Pilot Project in one of the following
be evidence-based, efficient and
areas:
effective. The proposed interventions
• Increase HBV, Influenza, and
should also be feasible in the context of
Pneumococcal Vaccination Rates;
the applicant’s ESRD Network service
• Improve Dialysis Care Coordination area, considering geography and other
relevant location-specific factors.
With a Focus on Reducing Hospital
Applicants will be expected to offer
Utilization;
proposed solutions to anticipated
• Improve Transplant Coordination;
challenges with a reasonable likelihood
• Promote Appropriate Home Dialysis of success.
in Qualified Beneficiaries; or
Other factors used to determine
• Support Improvement in Quality of capability to receive an ESRD Network
Contract award include an evaluation of
Life.
the applicant’s relevant past
Under the SOW, each ESRD Network
performance, the management structure
Organization will work with low
that the applicant proposes to
performing dialysis facilities in their
successfully perform the work of the
Network to conduct one Population
contract as well as the qualified and
Health Innovation Pilot Project and
experienced staff proposed to
achieve the specified outcome or
administer the tasks of the ESRD
outcomes for the measures related to the
Network SOW.
project area. The SOW describes the
We note that the solicitation posted
outcomes the ESRD Network
on Fed Biz Opps is the official notice of
Organization should achieve for each
the ESRD Network Contract Request for
Project; however, the ESRD Network
Proposals, and in the event that any
Organizations will develop and
terms within this Federal Register
implement interventions to increase
notice conflict with those of the
performance within the participating
solicitation and the SOW, the language
dialysis facilities. Additionally, ESRD
within the solicitation and the SOW
Network Organizations must
controls.
demonstrate a reduction in one of the
B. Evaluation of Performance of the
disparity areas outlined in the SOW.
Responsibilities Under the SOW
3. Aim 3: Reduce Costs of ESRD Care by
With a focus on rapid cycle
Improving Care (See section C.4.3 of the
improvement, ESRD Network
ESRD Network Statement of Work)
Organizations’ performance of the
The ‘‘Reducing Costs of ESRD Care by responsibilities under the SOW will be
monitored and measured for
Improving Care’’ Aim focuses on
improvement on an ongoing basis using
supporting the ESRD QIP, facility
self-assessment and Contracting Officer
performance improvement on QIP
Representative (COR) review. We will
measures, and facility data submission
monitor the ESRD Network
for CROWNWeb, the National
Organization’s performance on the Aims
Healthcare Safety Network (NHSN),
and Domains against established
and/or other CMS-designated data
criteria, as specified in sections C.2
collection system(s).
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
E:\FR\FM\08JNN1.SGM
08JNN1
Federal Register / Vol. 77, No. 111 / Friday, June 8, 2012 / Notices
through C.4., on at least a quarterly
basis, and may take appropriate contract
action for low or poor performing ESRD
Network Organizations. The COR will
complete assessment and review of
qualitative and quantitative contract
evaluation objectives. Throughout the
contract cycle, monitoring and
measuring for improvement and general
performance will be conducted. In
addition, qualitative and quantitative
evaluation will be conducted at the
annual evaluation which generally
occurs in the tenth month of the one
year contract period. The annual
evaluation will be based on the most
recent data available. The performance
results of the annual evaluation will be
used, in addition to ongoing monitoring
activities, to determine the performance
on the overall contract
The qualitative evaluation of the
ESRD Network Organizations will be
based on the impact of the interventions
utilized to accomplish the tasks within
the SOW. We will evaluate the
interventions for relationship-building,
innovation, development of replicable
best practices, and sustainability. The
quantitative evaluation of the ESRD
Network Organizations will be based on
the achievement of the measureable
targets for each of the Aims, as stated in
the ESRD Network SOW (see Section
C.4).
The following Tasks will be evaluated
in accordance with the measures
provided in the SOW:
AIM—Domain
Sub-domain tasks
1—Patient and Family Engagement ...........................................
Patient Learning and Action Network Quality Improvement Activity.
Patient Learning and Action Network Campaigns ......................
Grievance Quality Improvement Activity .....................................
Patient Satisfaction with Network Grievance Process ...............
In-center Hemodialysis Consumer Assessment of Healthcare
Providers and Systems (ICH CAPHS) participation Rate.
ICH CAPHS Quality Improvement Activity .................................
Involuntary Discharge/Involuntary Transfer/Failure to Place
rate and aversion rate.
Arteriovenous Fistula (AVF) Monthly Improvement ....................
AVF Contract goal of 68% ..........................................................
Long-term Catheter (LTC) Contract goal of 2% reduction in
participating facilities.
Reporting of AVF/LTC data ........................................................
National Healthcare Safety Network (NHSN) enrollment & reporting contract goal.
NHSN Infection Quality Improvement Activity ............................
Innovation Pilot Project Disparity reduction and outcomes ........
ESRD Quality Incentive Program (QIP) and Performance Improvement on QIP Measures.
Facility Data Submission to CROWNWeb, NHSN, and/or Other
CMS–Designated Data Collection Systems(s).
1—Patient
1—Patient
1—Patient
1—Patient
and Family Engagement ...........................................
Experience of Care ....................................................
Experience of Care ....................................................
Experience of Care ....................................................
1—Patient Experience of Care ....................................................
1—Patient Appropriate Access to In-Center Dialysis Care .........
1—Vascular Access Management ..............................................
1—Vascular Access Management ..............................................
1—Vascular Access Management ..............................................
1—Vascular Access Management ..............................................
1—Patient Safety: Healthcare-Acquired Infections (HAIs) ..........
1—Patient Safety: Healthcare-Acquired Infections (HAIs) ..........
2—Population Health Innovation Pilot Project ............................
3—Reduce Costs of ESRD Care by Improving Care .................
mstockstill on DSK4VPTVN1PROD with NOTICES
3—Reduce Costs of ESRD Care by Improving Care .................
The contract evaluation will
determine if the ESRD Network
Organization has met the performance
evaluation criteria as specified in C.4 of
this Statement of Work. We will
evaluate whether a Network
Organization has achieved each of the
Aims and Domains on an individual
basis. In general, evaluation of each Aim
will relate only to that area, however in
the event of failure in multiple Aims,
we reserve the right to take appropriate
contract action by, for example,
providing warning of the need for
adjustment, instituting a formal
correction plan, terminating an activity,
or recommending early termination of a
contract.
An ESRD Network Organization will
pass an Aim or Domain if it meets the
evaluation criteria specified for that
Aim or Domain. An ESRD Network
Organization will fail an Aim or Domain
if it does not meet the evaluation criteria
specified for that Aim or Domain. Any
failure for any Aim or Domain may
result in that ESRD Network
Organization receiving an adverse
performance evaluation. Further, failure
VerDate Mar<15>2010
16:23 Jun 07, 2012
Jkt 226001
may impact the ESRD Network
Organization’s ability to continue
similar work in, or eligibility for, award
of the next contract cycle of the ESRD
Network contract.
We may revise measures, adjust the
expected minimum thresholds for
satisfactory performance, remove
criteria from an Aim and/or Domain
evaluation for any of the following
reasons, including, but not limited to:
Data gathered on Aim and/or Domain;
the level of improvement achieved
during the contract cycle or in pilot
projects currently in progress;
information gathered through evaluation
of the ESRD Network Program overall;
or any unforeseen or other
circumstances. Further, in accordance
with standard contract procedures, we
reserve the right at any time to
discontinue an Aim and/or Domain or
any other part of this contract regardless
of the Network’s performance on the
Aim and/or Domain. In accordance with
section 1881(c)(1)(A)(ii)(I) of the Act,
when we make changes to the
standards, criteria, and procedures used
to evaluate an ESRD Network
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
34049
ESRD SOW
reference
C.4.1A
C.4.1A
C.4.1.B.1
C.4.1.B.1
C.4.1.B.2
C.4.1.B.2
C.4.1.C.1–
C.4.1.C.2
C.4.1.D
C.4.1.D
C.4.1.D
C.4.1.D
C.4.1.E
C.4.1.E
C.4.2.A.
C.4.3.A
C.4.3.B
Organization’s capabilities to perform
and/or actual performance of the duties
and functions under the ESRD Network
SOW, we will publish an updated
notice in the Federal Register.
If we choose, we may notify the ESRD
Network Organization of our intention
not to renew the ESRD Network
Organization contract. We reserve our
termination rights under FAR Part 49.
IV. 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
Budget under the authority of the
Paperwork Reduction Act of 1995.
V. Regulatory Impact Statement
In accordance with the provisions of
Executive Order 12866, this regulation
was not reviewed by the Office of
Management and Budget.
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
E:\FR\FM\08JNN1.SGM
08JNN1
34050
Federal Register / Vol. 77, No. 111 / Friday, June 8, 2012 / Notices
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: June 5, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–13998 Filed 6–7–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–8051–N]
Medicare Program; Meeting of the
Medicare Economic Index Technical
Advisory Panel—June 25, 2012
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces that a
public meeting of the Medicare
Economic Index Technical Advisory
Panel (‘‘the Panel’’) will be held on
Monday, June 25, 2012. The purpose of
the Panel is to review all aspects of the
Medicare Economic Index (MEI). This
second meeting will focus on MEI pricemeasurement proxies and the index’s
productivity adjustment. This meeting
is open to the public in accordance with
the Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)).
DATES: Meeting Date: The public
meeting will be held on Monday, June
25, 2012 from 8:30 a.m. until 5 p.m.,
Eastern Daylight Time (EDT).
Deadline for Submission of Written
Comments: Written comments must be
received at the mailing or email address
specified in the section of this notice
entitled, FOR FURTHER INFORMATION
CONTACT, by 5 p.m. EDT, Monday, June
18, 2012. Once submitted, all comments
are considered to be final.
Deadlines for Speaker Registration
and Presentation Materials: The
deadline to register to be a speaker and
to submit PowerPoint presentation
materials and any other written
materials that will be used in support of
an oral presentation is 5 p.m. EDT,
Monday, June 18, 2012. Speakers may
register by contacting Toya Via, HCD
International, by phone at (301) 552–
8803 or via email at MEITAP@hcdi.com.
Materials that will be used in support of
an oral presentation must be received at
the mailing or email address specified
in the FOR FURTHER INFORMATION
CONTACT section of this notice, by 5 p.m.
EDT, Monday, June 18, 2012.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:23 Jun 07, 2012
Jkt 226001
Deadline for All Other Attendees
Registration: Individuals may register
online at https://www.hcdi.com/mei/ or
by phone by contacting Toya Via, HCD
International, at (301) 552–8803 by 5
p.m. EDT, Monday, June 18, 2012.
We will be broadcasting the meeting
live via webinar and conference call (for
audio purposes). Webinar details will be
sent to registered attendees.
Deadline for Submitting a Request for
Special Accommodations: Persons
attending the meeting who are hearing
or visually impaired, or have a
condition that requires special
assistance or accommodations, are
asked to contact the Designated Federal
Officer as specified in the FOR FURTHER
INFORMATION CONTACT section of this
notice, by 5 p.m. EDT, Monday, June 18,
2012.
ADDRESSES: Meeting Location: The
meeting will be held in the Media
Center of the Centers for Medicare &
Medicaid Services (CMS), 7500 Security
Boulevard, Baltimore, MD 21244.
FOR FURTHER INFORMATION CONTACT: John
Poisal, Designated Federal Officer,
Centers for Medicare & Medicaid
Services, Office of the Actuary, Mail
stop N3–02–02, 7500 Security
Boulevard, Baltimore, MD 21244 or
contact Mr. Poisal by phone at (410)
786–6397 or via email at
John.Poisal@cms.hhs.gov. Press
inquiries are handled through the CMS
Press Office at (202) 690–6145.
SUPPLEMENTARY INFORMATION:
I. Background
The Medicare Economic Index
Technical Advisory Panel (‘‘the Panel’’)
was established by the Secretary to
conduct a technical review of the
Medicare Economic Index (MEI). The
review will include the inputs, input
weights, price-measurement proxies,
and productivity adjustment. For more
information on the Panel, see the
October 7, 2011 Federal Register (76 FR
62415). You may view and obtain a
copy of the Secretary’s charter for the
Panel at https://www.cms.gov/
Regulations-and-Guidance/Guidance/
FACA/MEITAP.html. The members of
the Panel are: Dr. Ernst Berndt, Dr.
Robert Berenson, Dr. Zachary Dyckman,
Dr. Kurt Gillis, and Ms. Kathryn Kobe.
This notice announces the Monday,
June 25, 2012 public meeting of the
Panel. This meeting will focus on MEI
price-measurement proxies and the
index’s productivity adjustment.
II. Meeting Format
This meeting is open to the public.
There will be up to 45 minutes allotted
at this meeting for the Panel to hear oral
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
presentations from the public. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
we will conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by 5
p.m. EDT, Wednesday, June 20, 2012.
Any presentations that are not selected
based on the lottery will be forwarded
to the panel for consideration. For this
meeting, public comments should focus
on MEI price-measurement proxies and
the index’s productivity adjustment. We
require that you declare at the meeting
whether you have any financial
involvement with manufacturers (or
their competitors) of any items or
services being discussed.
The Panel will deliberate openly on
the topics under consideration.
Interested persons may observe the
deliberations, but the Panel will not
hear further comments during this time
except at the request of the chairperson.
The Panel will also allow up to 15
minutes for an unscheduled open public
session for any attendee to address
issues specific to the topics under
consideration.
III. Registration Instructions
HCD International is coordinating
meeting registration. While there is no
registration fee, individuals must
register to attend. You may register
online at https://www.hcdi.com/mei/ or
by phone by contacting Toya Via, HCD
International, at (301) 552–8803, by the
date specified in the DATES section of
this notice. Please provide your full
name (as it appears on your
government-issued photographic
identification), address, organization,
telephone, and email address. At the
time of registration, you will be asked to
designate if you plan to attend in person
or via webinar. You will receive a
registration confirmation with
instructions for your arrival at the CMS
complex or you will be notified that the
seating capacity has been reached.
IV. Security, Building, and Parking
Guidelines
This meeting will be held in a Federal
Government building; therefore, Federal
security measures are applicable. We
recommend that confirmed registrants
arrive reasonably early, but no earlier
than 45 minutes prior to the start of the
meeting, to allow additional time to
clear security. Security measures
include the following:
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 77, Number 111 (Friday, June 8, 2012)]
[Notices]
[Pages 34047-34050]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13998]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3269-N]
Medicare Program; Proposal Evaluation Criteria and Standards for
End Stage Renal Disease (ESRD) Network Organizations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice describes the standards, criteria, and procedures
we will use to evaluate an End-Stage Renal Disease (ESRD) Network
Organization's capabilities to perform, and actual performance of, the
duties and functions under the ESRD Network Statement of Work (SOW).
DATES: Effective Date: June 8, 2012.
FOR FURTHER INFORMATION CONTACT: Teresa Casey, 410-786-7215. Renee
Dupee, 410-786-6747.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1881(c) of the Social Security Act (the Act) authorized the
establishment of, among other things, ESRD network areas and Network
Organizations under the Medicare program to ensure the effective
administration of the ESRD program benefits. We currently have
contracts with ESRD Network Organizations to serve the 18 ESRD Network
areas.
The existing 18 ESRD Network contracts have been operating under
the same Statement of Work (SOW) since 2003 and have been renewed to
continue to provide service to the ESRD population. Recent major policy
and legislative changes have modernized Medicare payments for ESRD
care. In particular, the Medicare Improvements for Patients and
Providers Act (MIPPA) required the Secretary of the Department of
Health and Human Services (the Secretary) to implement an ESRD bundled
payment system under which a single payment is made to a provider of
services or a renal dialysis facility for renal dialysis services in
lieu of any other payment. MIPPA also required the Secretary to
establish an ESRD Quality Incentive Program (QIP).
Additionally, a heightened focus on quality improvement, public
reporting and value-based purchasing in healthcare has fueled a growing
need for facility-level data collection; analysis; monitoring;
trending; evaluating and intervening, where necessary, to improve
patient care. We have also emphasized spreading and replicating the
best practices of high performing providers. Therefore, a redesigned
ESRD Network SOW was drafted to incorporate these priorities in
healthcare and changes in legislation. The SOW will charge the ESRD
Network Organizations with establishing relationships with patients,
families and facilities within their Network areas to reach the
objective of optimal patient-centered care.
Section 1881(c)(1)(A)(ii)(I) of the Act provides that in order to
determine whether the Secretary should enter into, continue, or
terminate an agreement with an ESRD Network Organization, the Secretary
shall develop and publish in the Federal Register standards, criteria,
and procedures used to evaluate an ESRD Network Organization's
capabilities to perform, and actual performance of, the network
functions required by section 1881(c)(2) of the Act. These functions
are to:
Encourage participation in vocational rehabilitation
programs, and develop criteria and standards relating to this
participation.
Evaluate the procedures used by facilities and providers
in the network to assess patients for placement in appropriate
treatment modalities.
Implement a procedure for evaluating and resolving patient
grievances.
Conduct onsite reviews of facilities and providers as
necessary (as determined by a medical review board or the Secretary)
using standards of care established by the ESRD Network Organization.
Collect, validate, and analyze data necessary to prepare
the required annual report to the Secretary and to ensure the
maintenance of a national ESRD registry.
Identify facilities and providers that are not
cooperatively working toward meeting network goals, and assist those
facilities and providers in developing plans for correction, as well as
report to the Secretary on those facilities and providers that are not
providing appropriate care.
Submit an annual report to the Secretary on July 1 of each
year.
Shortly after the publication of this Federal Register notice, we
will post a Request for Proposals (RFP) to perform the work of the
redesigned ESRD Network SOW on the Fed Biz Opps Web site (www.fbo.gov).
The RFP will competitively award a portion of the 18 ESRD Network
contracts using a best value process in accordance with Federal
Acquisition Regulation (FAR) Part 15. The remaining ESRD Network
contracts will be renewed and competed at a later date. The period of
performance for these ESRD Network contracts will be one 12-month base
year which begins on January 1, 2013 and ends on December 31, 2013,
with two 12-month option periods. We may exercise an option in
accordance with the FAR Part 17.2, and it may terminate a contract for
convenience or for default, in accordance with FAR Part 49. This notice
describes the capabilities that an applicant must demonstrate to be
awarded an ESRD Network contract and the general criteria that will be
used to evaluate the ESRD Network Organizations performing under the
SOW.
[[Page 34048]]
II. Description of the Tasks Under the Revised ESRD Network
Organization SOW
ESRD Network Organizations are responsible, in addition to other
duties and functions that the Secretary prescribes, for performing the
tasks outlined in section 1881(c)(2) of the Act.
Under the revised ESRD Network Organization SOW, ESRD Network
Organizations will complete the requirements of the three Aims outlined
in the SOW which support the functions required by section 1881(c)(2)
of the Act. The three Aims are as follows:
Aim 1, is the ``Better Care for the Individual through
Beneficiary and Family Centered Care'' Aim. This Aim envisions ESRD
Networks, facilities and beneficiaries working together to promote
appropriateness of patient care and processes for evaluating and
resolving patient grievances.
Aim 2, is the ``Better Health for the ESRD Population''
Aim. This Aim considers the preparation and education of beneficiaries
for transplantation and self-care settings or home dialysis.
Aim 3, is the ``Reduce Costs of ESRD Care by Improving
Care'' Aim. This Aim has Network Organizations assisting dialysis
facilities in meeting the requirements of the ESRD Quality Incentive
Program (QIP), supporting dialysis facilities in their submission of
data to designated data collection systems and using data to provide
necessary reports to CMS and the Secretary.
More detailed information for each Aim, Domain, and sub-domain can be
found in sections C.2 through C.4. of the ESRD Network SOW posted at
the www.fbo.gov Web site. Each Aim is also described further below.
1. Aim 1: Better Care for the Individual Through Beneficiary and Family
Centered Care (See Section C.4.1 of the ESRD Network SOW)
The ``Better Care for the Individual through Beneficiary and Family
Centered Care'' Aim strives to promote health care that is respectful
of and responsive to individual patient preferences, needs, and values.
The Network patient-centered domains will achieve Aim 1. Network
patient-centered domains are Patient and Family Engagement; Patient
Experience of Care; Patient-Appropriate Access to In-Center Dialysis
Care; Vascular Access Management; and Patient Safety: Healthcare-
Acquired Infections (HAIs).
The ESRD Network Organizations' activities within this Aim will be
enhanced by the patient's voice. The ESRD Network Organization will
take a two-tiered approach to incorporating the patient's voice in the
activities of the Network and the renal community as a whole. The two
tiers are: (1) Engagement at the dialysis facility level to foster
patient and family involvement; and (2) development and implementation
of a beneficiary and family centered care focused Learning and Action
Network (LAN) to promote patient and family involvement at the Network
level. Both tiers are essential and work together to promote
beneficiary and family engagement to improve quality of care.
2. Aim 2: Better Health for the ESRD Population (See Section C.4.2 of
the ESRD Network Statement of Work)
The ``Better Health for the ESRD Population'' Aim focuses on
improving the quality of and access to ESRD care through a Population
Health Innovation Pilot Project in one of the following areas:
Increase HBV, Influenza, and Pneumococcal Vaccination
Rates;
Improve Dialysis Care Coordination With a Focus on
Reducing Hospital Utilization;
Improve Transplant Coordination;
Promote Appropriate Home Dialysis in Qualified
Beneficiaries; or
Support Improvement in Quality of Life.
Under the SOW, each ESRD Network Organization will work with low
performing dialysis facilities in their Network to conduct one
Population Health Innovation Pilot Project and achieve the specified
outcome or outcomes for the measures related to the project area. The
SOW describes the outcomes the ESRD Network Organization should achieve
for each Project; however, the ESRD Network Organizations will develop
and implement interventions to increase performance within the
participating dialysis facilities. Additionally, ESRD Network
Organizations must demonstrate a reduction in one of the disparity
areas outlined in the SOW.
3. Aim 3: Reduce Costs of ESRD Care by Improving Care (See section
C.4.3 of the ESRD Network Statement of Work)
The ``Reducing Costs of ESRD Care by Improving Care'' Aim focuses
on supporting the ESRD QIP, facility performance improvement on QIP
measures, and facility data submission for CROWNWeb, the National
Healthcare Safety Network (NHSN), and/or other CMS-designated data
collection system(s).
III. Evaluation of ESRD Network Organizations' Capabilities To Perform,
and Evaluation of the Performance of, the Responsibilities Under the
SOW
A. Evaluation of Capabilities To Perform the Responsibilities Under the
SOW
In order to receive an ESRD Network Contract award, an applicant
must demonstrate, through the submission of a technical proposal, the
capability to perform the duties listed in the ESRD Network SOW.
Technical proposal submissions must detail the applicant's approach to
accomplish each of the Aims of the SOW and describe how the applicant
will maximize the outcome of the specific tasks within each Aim.
Additionally, successful applicants must offer sound quality
improvement approaches for the intervention strategies they are
proposing to meet the tasks identified in the SOW. The proposed
interventions are expected to be evidence-based, efficient and
effective. The proposed interventions should also be feasible in the
context of the applicant's ESRD Network service area, considering
geography and other relevant location-specific factors. Applicants will
be expected to offer proposed solutions to anticipated challenges with
a reasonable likelihood of success.
Other factors used to determine capability to receive an ESRD
Network Contract award include an evaluation of the applicant's
relevant past performance, the management structure that the applicant
proposes to successfully perform the work of the contract as well as
the qualified and experienced staff proposed to administer the tasks of
the ESRD Network SOW.
We note that the solicitation posted on Fed Biz Opps is the
official notice of the ESRD Network Contract Request for Proposals, and
in the event that any terms within this Federal Register notice
conflict with those of the solicitation and the SOW, the language
within the solicitation and the SOW controls.
B. Evaluation of Performance of the Responsibilities Under the SOW
With a focus on rapid cycle improvement, ESRD Network
Organizations' performance of the responsibilities under the SOW will
be monitored and measured for improvement on an ongoing basis using
self-assessment and Contracting Officer Representative (COR) review. We
will monitor the ESRD Network Organization's performance on the Aims
and Domains against established criteria, as specified in sections C.2
[[Page 34049]]
through C.4., on at least a quarterly basis, and may take appropriate
contract action for low or poor performing ESRD Network Organizations.
The COR will complete assessment and review of qualitative and
quantitative contract evaluation objectives. Throughout the contract
cycle, monitoring and measuring for improvement and general performance
will be conducted. In addition, qualitative and quantitative evaluation
will be conducted at the annual evaluation which generally occurs in
the tenth month of the one year contract period. The annual evaluation
will be based on the most recent data available. The performance
results of the annual evaluation will be used, in addition to ongoing
monitoring activities, to determine the performance on the overall
contract
The qualitative evaluation of the ESRD Network Organizations will
be based on the impact of the interventions utilized to accomplish the
tasks within the SOW. We will evaluate the interventions for
relationship-building, innovation, development of replicable best
practices, and sustainability. The quantitative evaluation of the ESRD
Network Organizations will be based on the achievement of the
measureable targets for each of the Aims, as stated in the ESRD Network
SOW (see Section C.4).
The following Tasks will be evaluated in accordance with the
measures provided in the SOW:
------------------------------------------------------------------------
ESRD SOW
AIM--Domain Sub-domain tasks reference
------------------------------------------------------------------------
1--Patient and Family Patient Learning and C.4.1A
Engagement. Action Network
Quality Improvement
Activity.
1--Patient and Family Patient Learning and C.4.1A
Engagement. Action Network
Campaigns.
1--Patient Experience of Care. Grievance Quality C.4.1.B.1
Improvement Activity.
1--Patient Experience of Care. Patient Satisfaction C.4.1.B.1
with Network
Grievance Process.
1--Patient Experience of Care. In-center C.4.1.B.2
Hemodialysis
Consumer Assessment
of Healthcare
Providers and
Systems (ICH CAPHS)
participation Rate.
1--Patient Experience of Care. ICH CAPHS Quality C.4.1.B.2
Improvement Activity.
1--Patient Appropriate Access Involuntary Discharge/ C.4.1.C.1-C.4.1.C
to In-Center Dialysis Care. Involuntary Transfer/ .2
Failure to Place
rate and aversion
rate.
1--Vascular Access Management. Arteriovenous Fistula C.4.1.D
(AVF) Monthly
Improvement.
1--Vascular Access Management. AVF Contract goal of C.4.1.D
68%.
1--Vascular Access Management. Long-term Catheter C.4.1.D
(LTC) Contract goal
of 2% reduction in
participating
facilities.
1--Vascular Access Management. Reporting of AVF/LTC C.4.1.D
data.
1--Patient Safety: Healthcare- National Healthcare C.4.1.E
Acquired Infections (HAIs). Safety Network
(NHSN) enrollment &
reporting contract
goal.
1--Patient Safety: Healthcare- NHSN Infection C.4.1.E
Acquired Infections (HAIs). Quality Improvement
Activity.
2--Population Health Innovation Pilot C.4.2.A.
Innovation Pilot Project. Project Disparity
reduction and
outcomes.
3--Reduce Costs of ESRD Care ESRD Quality C.4.3.A
by Improving Care. Incentive Program
(QIP) and
Performance
Improvement on QIP
Measures.
3--Reduce Costs of ESRD Care Facility Data C.4.3.B
by Improving Care. Submission to
CROWNWeb, NHSN, and/
or Other CMS-
Designated Data
Collection
Systems(s).
------------------------------------------------------------------------
The contract evaluation will determine if the ESRD Network
Organization has met the performance evaluation criteria as specified
in C.4 of this Statement of Work. We will evaluate whether a Network
Organization has achieved each of the Aims and Domains on an individual
basis. In general, evaluation of each Aim will relate only to that
area, however in the event of failure in multiple Aims, we reserve the
right to take appropriate contract action by, for example, providing
warning of the need for adjustment, instituting a formal correction
plan, terminating an activity, or recommending early termination of a
contract.
An ESRD Network Organization will pass an Aim or Domain if it meets
the evaluation criteria specified for that Aim or Domain. An ESRD
Network Organization will fail an Aim or Domain if it does not meet the
evaluation criteria specified for that Aim or Domain. Any failure for
any Aim or Domain may result in that ESRD Network Organization
receiving an adverse performance evaluation. Further, failure may
impact the ESRD Network Organization's ability to continue similar work
in, or eligibility for, award of the next contract cycle of the ESRD
Network contract.
We may revise measures, adjust the expected minimum thresholds for
satisfactory performance, remove criteria from an Aim and/or Domain
evaluation for any of the following reasons, including, but not limited
to: Data gathered on Aim and/or Domain; the level of improvement
achieved during the contract cycle or in pilot projects currently in
progress; information gathered through evaluation of the ESRD Network
Program overall; or any unforeseen or other circumstances. Further, in
accordance with standard contract procedures, we reserve the right at
any time to discontinue an Aim and/or Domain or any other part of this
contract regardless of the Network's performance on the Aim and/or
Domain. In accordance with section 1881(c)(1)(A)(ii)(I) of the Act,
when we make changes to the standards, criteria, and procedures used to
evaluate an ESRD Network Organization's capabilities to perform and/or
actual performance of the duties and functions under the ESRD Network
SOW, we will publish an updated notice in the Federal Register.
If we choose, we may notify the ESRD Network Organization of our
intention not to renew the ESRD Network Organization contract. We
reserve our termination rights under FAR Part 49.
IV. 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 Budget under the authority of the
Paperwork Reduction Act of 1995.
V. Regulatory Impact Statement
In accordance with the provisions of Executive Order 12866, this
regulation was not reviewed by the Office of Management and Budget.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital
[[Page 34050]]
Insurance Program; and No. 93.774, Medicare--Supplementary Medical
Insurance Program)
Dated: June 5, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-13998 Filed 6-7-12; 8:45 am]
BILLING CODE 4120-01-P
