ESRD_Amendment_000002.pdf

(x)

CMS-2016-ESRD-NETWORKS

x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT

THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

AGG/JB2

jeannine.bohlen@cms.hhs.gov 410-786-2864 Contract Specialist Jeannine Bohlen

ASG - DQC

BALTIMORE MD 21244-1850

7500 SECURITY BLVD., MS: B3-30-03

CMS,OAGM,ASG,DQC

07/02/2015000002

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

06/23/2015

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not, is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

See attached.

Period of Performance: 12/01/2015 to 11/30/2016

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

KIMBERLY TATUM

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

NSN 7540-01-152-8070

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

RFP: CMS-2016-ESRD-NETWORKS

Amendment 000002

AMENDMENT 000002 is hereby issued, which incorporates the following:

1. Update Section L.12 as follows:

Offeror shall deliver the proposal to CMS no later than 2:00 PM, JULY 28, 2015.

2. Update Section L.13 as follows:

The Offeror’s proposal submission shall consist of Volume I Technical Proposal, Volume II Business Proposal and Volume III Conflict of Interest.

a. Volumes - The following instructions will establish the acceptable minimum requirements for the format and contents of the proposal. The proposal shall be organized (e.g. Indexed) to clearly identify the files on each Compact Disk (CD). All PDF files included on the CD shall contain bookmarks indicating each indexed section. Offerors must submit as follows:

Volume Hard Copies CDs Due Date

I – Technical Proposal One (1) Original Five (5) 11:00 am, July 28, 2015

II – Business Proposal One (1) Original Three (3) 11:00 am, July 28, 2015

III – Conflict of Interest One (1) Original Two (2) 11:00 am, July 28, 2015

Note: A separate business and technical proposal shall be prepared and submitted for each ESRD Network Area (Number), regardless of whether a contractor holds one or more ESRD contracts or proposes on multiple Network Areas.

b. Specifications for CD submissions:

i. The files on each CD shall be compatible with Microsoft (MS) Office 2010.

ii. Each file shall be printable to 8x11 paper and be readable (12 point font or larger) without requiring formatting adjustments.

iii. All PDF files shall contain bookmarks indicating each indexed section. The indexed sections shall coincide/match the hard copy sections.

iv. The Offeror is responsible for document/file version control and as such shall ensure the multiple CDs contain the exact documents that make up the official submission.

v. The Offeror shall certify that each CD has been checked using the latest version of virus detection software and is virus free. The certification shall identify the virus detection software and version used.

vi. Each electronic copy will be on an individual CD (i.e., the Technical Proposal shall include 5 CDs and the Business Proposal shall include 3 CDs. That equals 8 CDs).

3. Update L.15 as follows:

C. The Offeror shall use business proposal spreadsheets and summarize total costs for the project using Form 719, in accordance with Attachment, J.22 in addition to breaking out costs by major task listed in the SOW or major activity or set of activities as described in the project plan. The business proposal shall be submitted in an electronic version of the spreadsheet on a CD using Excel. Offerors also need to provide a PDF version of the complete business proposal. The Business Proposal is unlimited in page count. When completing Attachment J.22, please reference Attachment J.22a, Business Proposal Form Instructions.

4. Update L.16.C as follows:

C. TAB C: Compliance Program Attestation

In order to be eligible for award of a contract, the Offeror or contractor must have in place a compliance program that is acceptable to CMS. The compliance program shall submit a Compliance Program Attestation at the time of the proposal in the format specified by CMS.

Include Attachment J.19 with COI submission.

5. Update M.3.A as follows:

Staffing Plan and Personnel

• Offeror’s ability to assemble a team with the appropriate skills to meet the requirements of the SOW;

• Offeror’s proposed labor mix accurately reflects the offeror’s technical approach; and

• Offeror’s proposal presents and describes its rationale and method for staffing the contract that can be accomplished.

• Offerors shall provide resumes of all key personnel and all essential personnel for this contract.

6. Update Attachment J.22 Business Proposal Form, attached

7. Replace entire Section H.21 with the following:

H.21 GOVERNANCE AND COMPLIANCE REQUIREMENTS

The Network (NW) shall meet certain criteria for contractor governance, including, but not limited to, Board of Directors composition, service length and compensation, and compliance plan.

A. Acceptable Compliance Program

The NW governing body shall develop and implement a compliance program. At a minimum, an acceptable compliance program should consist of the following:

1. Written code of business ethics and conduct, and written policies and procedures that articulate the organization's commitment to comply with all applicable Federal and State standards.

2. The designation of a compliance officer at a senior level, and a compliance committee.

3. Effective annual compliance training and education for the organization's employees, managers and governing body members, as well as the posting of the Office of the Inspector General or agency Fraud and Abuse Hotline Poster (FAR 52.203-14).

See https://forms.oig.hhs.gov/hotlineoperations/posters/OIG%20Hotline%20Ops %20Poster%20-%20Health%20Care%20Fraud.pdf.

4. A process to receive ethics and compliance-related complaints that permits anonymous reporting.

5. An internal monitoring and auditing function to help ensure compliance with the requirements of statutes, regulations, and the Medicare contracts.

6. An enforcement and disciplinary process to address violations of the contract provisions, code of conduct, and/or federal and state statutes and regulations.

7. Processes to conduct investigations of compliance-related complaints, and to prevent compliance-related problems from developing. Processes to vet consultants and employees who may be suspended or debarred, particularly from federal healthcare programs.

As a reference, CMS’ Compliance Program Guidance is located at http://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative- Contractors/Downloads/compliance.pdf. This Compliance Program guidance indicates it is for fee-for-service contractors but it applies to all CMS contractors.

The governing body (e.g. Board of Directors) sets overall policy and direction for the NW and retains oversight responsibility. The compliance officer handles the day-to-day operations issues that arise in the following areas: compliance, conflict of interest, ethics, program integrity and compensation and travel costs for senior executive staff and governing body members. When appropriate, the compliance officer refers issues in specific areas to the governing body. The governing body should establish a compliance committee comprised of a majority of independent members. The governing body should refer to the compliance committee for review, any concerns, issues and complaints in the above-referenced areas.

https://forms.oig.hhs.gov/hotlineoperations/posters/OIG%20Hotline%20Ops%20Poster%20-%20Health%20Care%20Fraud.pdf https://forms.oig.hhs.gov/hotlineoperations/posters/OIG%20Hotline%20Ops%20Poster%20-%20Health%20Care%20Fraud.pdf http://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/Downloads/compliance.pdf http://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/Downloads/compliance.pdf

Should the NW governing body be too small to establish a compliance committee of the board, CMS recommends that it appoint one independent member to work with the Compliance Officer to address the concerns identified in H.21.A, above.

B. Public Availability of Governing Body Information

The NW shall make publicly available on its website (at a minimum) information regarding its governing body, including:

1. Number of members;

2. Length of appointment for each;

3. Cap on Board service time;

4. When appointments are made;

5. What percentage of the governing body is typically appointed each year; and

6. Names, affiliation and compensation (unless prohibited by State law) of governing body members.

This information shall be reviewed and updated at a minimum of once per year.

C. Other Considerations

The NW shall specify the number of voting members on its governing body, but in any event the number shall not exceed 20 members except where the NW provides appropriate justification and it is approved in advance by the CO.

The NW should adopt policies ensuring governing body membership including representatives of a variety of healthcare settings and/or disciplines (e.g., hospitals, nursing homes, home health) as well as from non-healthcare backgrounds, so that the governing body is not comprised of a majority of physicians or any other type of practitioner or professional. For example, the NW shall seek to include on the governing body statisticians, epidemiologists, medical records managers, medical care/treatment planners, and other health professionals and information management disciplines, as well as experts from outside the healthcare field.

It is recognized that the governing body will include multiple provider representatives.

However, the NW shall not have more than two (2) representatives from any one provider, payor or plan on its governing body. This applies to national healthcare entities as well, regardless of whether the individual locations are franchised or otherwise partially owned by local individuals or business entities.

No family members of NW managers or of current governing body members shall be appointed to the governing body.

The NW Medical Review Board is not subject to these requirements. However, Section 1881(c)(1)(A) of the Social Security Act requires a minimum of at least one (1) consumer representative on the NW Medical Review Board body. CMS encourages greater diversity in consumer representation, which will help the NWs to maintain a focus on the consumer as a customer. Any Medical Review Board body with more than ten (10) members should have at least two (2) consumer representatives. The second consumer representative, being a contractual requirement rather than a legislative one, need not be a Medicare beneficiary.

The NW’s governing body shall adopt policy ensuring that at least two-thirds (2/3) of the members are independent of the relevant NW and have not been compensated by the NW within the last year for non-governing body services. The Executive Director (ED), CFO, CMO and COO shall not receive additional compensation for governing body membership. Officers of the NW and/or its parent entity should not comprise more than 20% of the governing body. The NW shall adopt a cap on consecutive governing body member service time of six (6) years in order to ensure new and different perspectives.

Governing bodies with 1-5 members may exempt one (1) member from the six (6) year term limit, those with 6-10 members may exempt two (2) members from the six (6) year term limit and those with eleven (11) or more may exempt three (3) members from the six (6) year term limit. Notwithstanding these exemptions , no board member may exceed nine (9) consecutive years of board service. This requirement excludes ex-officio members of the board. There shall be a quorum rule of the governing body that states that no business of the governing body can be conducted unless a majority of the present and available membership consists of independent governing body members who are eligible to vote.

The duties of governing body members shall be delineated in corporate by-laws that are reviewed annually and updated as necessary, and should include: attendance and participation in a minimum of fifty percent (50%) of governing body meetings;

participation in an ongoing training plan (development plan) for governing body members that would include training in ethics, compliance, conflict of interest, cultural awareness and other relevant topics, and participation in sub-committees as appropriate.

The NW shall develop and implement annual performance evaluations for the governing body members, including the ED, COO, CMO and CFO, as well as an annual governing body self-assessment and an overall performance improvement plan.

CMS, through the CO, reserves the right to waive or authorize any deviation from the Governance and Compliance Requirements on a case-by-case basis provided the waiver or deviation is in the best interest of the Government.

8. Pre-Proposal Conference Registrant List is below.

1. Business Integra, Inc. (BI)

2. Lamer Ventures LLC

3. HealthCare Dynamics International

4. Lumetra Healthcare Solutions

5. Colston Consultants LLC

6. CGI Federal

7. Qualidigm

8. Mid-Atlantic Renal Coalition

9. Telligen

10. DeFco Networks

11. Konquered Healthcare Solutions LLC

12. Quality Insights Renal Network 3

13. C-HIT

14. Livanta, LLC

15. Avaya Government Solutions

16. OFMQ

17. IST2-Integrated Systems Technology & Telecom Inc.

18. HYBRiD Health IT, Inc.

19. GloNet, Inc.

20. NYSA LLC

21. Softek International, Inc

22. SONA Networks, LLC

23. Synergy ECP, LLC

24. Health Services Advisory Group (HSAG)

25. The Renal Network (ESRD Networks 9/10)

26. National Government Services

27. Heartland Kidney Network

28. G2Xchange, LLC.

29. IPRO

30. Alliant Quality

31. HighPoint Global

32. HealthInsight ESRD Alliance

33. Quality Insights

34. Network 8, Inc

35. Arch Systems, LLC

36. Southeastern Kidney Council, Inc.

37. TMF Health Quality Institute

38. Renal Network of the Upper Midwest, Inc.

39. Qsource

40. InnovTech Inc

41. SoftDev Incorporated

42. Carson Solutions, LLC

43. Booz Allen Hamilton

44. AQAF

45. 3G Federal Solutions LLC

9. Pre-Proposal Conference Questions and Answers are below.

# Participant’s Question CMS Response SOW Location

1 Can staff (other the full time RN with nephrology experience and the full time MSW) be shared over more than one network?

Yes, as long as the bidder’s staffing will successfully meet the requirements of the SOW.

Additionally, this is an evaluation factor for contract award. This could be included in the possible efficiencies that we mentioned with regards to staffing that Networks may incorporate into their staffing plans and proposals.

C.3.3.F pg

2 Can one Executive Director serve two networks?

Yes, as long as the bidder’s staffing will successfully meet the requirements of the SOW.

Additionally, this is an evaluation factor for contract award. This could be included in the possible efficiencies that we mentioned with regards to staffing that Networks may incorporate into their staffing plans and proposals.

3 Can one Executive Director be shared among more than one network?

Yes, as long as the bidder’s staffing will successfully meet the requirements of the SOW.

Additionally, this is an evaluation factor for contract award. This could be included in the possible efficiencies that we mentioned with regards to staffing that Networks may incorporate into their staffing plans and proposals.

4 With regard to the Governance requirements, may a multi-network contractor have one Board of Directors representing its networks while maintaining separate Medical Review Boards and Network Councils in each Network region?

Yes, as long as the communities of providers, patients and facilities are being addressed, and are in evident representation and integration of these group deliberations, then different configurations of geographic representation could be considered in planning to meet their functions, as expected in the SOW. Also, the criteria in H.21 need to be met.

5 On the J-22 business proposal forms (685-G), the period of performance (last column header) indicates 60 Months Plus Transition Total. If December 1- 31 is the transition period, and Option 4 ends November 30, 2020, wouldn't this be 60 months including transition period? The answer may impact the

This should read 59 months plus transition subsequent pages (685-A), where there's a separate Table (Appendix A) for Network Transition, and then defined years (i.e., Year 1 12-1-15 to 11-30-16).

6 Incumbent contracts do not expire until December 31, 2015. If the incumbent is successful in retaining its contract, what happens during the contract overlap period in December 2015?

Incumbent will be subject to their current contract and will begin performing the duties of the new contract on January 1 at the conclusion of the prior period of performance.

7 On the J-22 business proposal forms (685-G), the period of performance (last column header) indicates 60 Months Plus Transition Total.

This should read 59 months plus transition

8 Do bidders that do not currently hold ESRD contracts propose transition costs beginning December 1, but incumbents propose as if they begin the full scope of work on December 1?

Bidders who do not currently hold ESRD contracts propose transition costs beginning December 1.

Incumbents will continue their current contract and propose costs to begin the scope on January 1 at the conclusion of the prior period of performance.

9 Section H.18 of the incumbent's contract states that prior to commencement of transition CMS will request a transition plan. What does CMS expect Offerors to price under B.4.A, Base Year Transition Period (December 1, 2015 through December 31, 2015)?

Bidders who do not currently hold ESRD contracts propose transition costs beginning December 1.

Incumbents should have transition plans in place in accordance with their current contract.

10 Which applicants are required to submit a transition plan as referenced in L-14 in the RFP?

Bidders who do not currently hold ESRD contracts should propose transition costs for the period of December 1 – December 31.

11 Is the ESRD Style Guide provided in the J-2 attachment applicable for ESRD proposal submission?

Proposals should be submitted in accordance with Sections L and M of the RFP

12 Please clarify a “reduction in funding”. The scope of work is ambitious with 8 QIAs and expanded Patient Engagement. A reduction in the requirement of MRB/BOD meetings is a minimal expense decrease as most are done by teleconference. Are there other areas in the SOW that are streamlined?

While the SOW may seem ambitious we expect bidders to propose innovative efficiencies. The QIAs have been streamlined with many of the process measures from previous contract cycles refined. The current contract cycle was initially proposed with 10 QIAs.

13 Does having Network staff residing and working in a Network meet the requirement for a physical location?

Local presence includes the ability to interact with and have quick access to a participating community and the providers in that community. The NW should have knowledge of the culture, practices, and improvement needs of a community in which it is working and apply that knowledge to its case review and quality improvement projects. Local presence does not necessarily require a brick-and-mortar presence. The NW should be located in the geographic location(s) in which it can best meet the needs of its populations and communities and establish the necessary strong relationships within the states and at the facility and practice level necessary to accomplish the goals of the contract.

The term also does not mean that the NW must allocate its resources equally within each state of its area but CMS does expect local activity and resources dedicated to each state served. The ability of a NW to meet the needs of its entire area is paramount. CMS will monitor to ensure that each NW service area is improving in the established goals based on the terms of the contract.

14 Vaccination information on patients in not currently in NHSN. The current planned update includes staff vaccinations but not patients. Will there be an update to this?

The Network shall use the CROWNWeb data provided by CMS to establish the baseline for the base contract year, as well as for measurement throughout the project. Facilities may be kept within the project until they achieve at least 60% vaccination rates for each measure, at which time they are to be replaced by different facilities in the lowest quintile for the subsequent year. For example, Facility X starts the baseline with Hepatitis-B and pneumococcal pneumonia vaccination (PPV) rates of 17% and 20%, respectively. In Option Year 1, Facility X obtains rates of 52% and 63%, respectively. In Option Year 2, the facility obtains respective rates of 62% and 75%. In this example, the facility would be replaced with Facility Y for Option Year 3; the facility would not be replaced in OY1, because it had not achieved the greater than 60% vaccination threshold for both measures.

C.4.1.D.4 (2nd Paragraph ) Page: 48

15 Asks the Networks to use CrownWeb to identify root causes for hospitalizations. CrownWeb currently only has admit date, discharge date and hospital. This is not enough data to allow for a RCA. What updates are expected? Can we use other data

CW will be the primary data source for measurement and evaluation. However, other data may be collected by the Networks to complete the project.

sources and if so which?

16 6.29 AIM 3

Role of the Network: Does this mean CMS plans to maintain www.dialysisreports.org (with DFR and DFC) as a separate site and not bring it into the QIMS/QARM portal and account management.

The CROWN memo 15-0896-GN released on June 25, 2015 states “The Centers for Medicare & Medicaid Services (CMS) is informing the End- Stage Renal Disease (ESRD) Network Organizations (Networks) that CMS will provide training for a new user system for the ESRD Quality Incentive Program (QIP) and related programs. This system, which will be known as “ESRD QIP 1.0.0,” replaces the DialysisReports.org ESRD QIP interface that was discontinued earlier this year.”

17 6.29 AIM 3

The QIP QIA requires the Network to select 10 or more facilities. What if there are not 10 facilities below the ESRD QIP penalty threshold?

On page 60, under Section C.4.3.A., the RFP states “The Network shall select 10 or more facilities in its service area that achieved the poorest performance on the QIA-eligible measure(s).” This criterion does not require any of the 10 facilities to be below the QIP penalty threshold. It directs the Network to work with the 10 lowest performers.

18 Can costs be included for ESRD NW staff to attend national educational meetings (i.e. NKF, ANNA, AAKP) in the business proposal?

Yes if Networks believe that these costs are essential to meeting the requirements of the SOW

19 Is the PAC prohibited from meeting face-to-face or is it an allowable cost that can be included in the business proposal?

The PAC may meet face-to-face but the RFP is not imposing a requirement of a face to face meeting

20 Only the ED is listed as Key Personnel. Does this mean only the ED has to submit COI information under Section H.11.b (page 109)? Section H.1.C.3.

(page 89) states "respondent (officers, board of director members, other directors (including medical directors) and managers)..." Section L.16.C.7 (page 174) requires that COI questionnaires be completed by employees, managers, officers and Board members.

No. Please follow section H.1 and L.16 for proposal purposes. This provision lists all information required for the OCI review. Section H.11.b is specific to the post-award reviews by the compliance officer if there is a key personnel change. The review would be performed by the compliance officer and not CMS.

21 Should any of the COI disclosures be submitted with identifiers or can they be blinded?

Identifiers is preferred; however, it is the expectation that the compliance officer will review the personal COI information.

22 Has the requirement for a patient learning and action network been removed or replaced by the

Networks are expected to provide patients for the national NCC Learning and Action Network (LAN) activities. Additionally, Networks must use Patient http://www.dialysisreports.org/ requirement for a patient advisory council?

SMEs in specified QIA work of the SOW and are encouraged to incorporate Patient SMEs throughout the work of the SOW