[Federal Register Volume 77, Number 111 (Friday, June 8, 2012)]
[Notices]
[Pages 34047-34050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13998]


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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.

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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
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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

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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