U00001_Q-A.pdf

Phoenix Area Indian Health Service Two Renaissance Square 40 North Central Avenue Phoenix, Arizona 85004

Clarification Response Form

Post Type: _____________________

Post Identifier: _____________________

Project Title: _____________________________________________

Response Date: ________________

Posting Close Date: __________________

Vendor Questions:

Government Response:

Government Response Continued:

2. What are the essential features the software must have to facilitate the utilization review process?

3. What type of reports should the software be able to generate for utilization review?

4. How should the software handle retrospective evaluations of risk management and quality care delivery?

5. What CMS Conditions of Participation (CoPs) must the software comply with?

6. What standards of care and evidence-based criteria should the software incorporate?

7. How will the software ensure compliance with Section 508 of the Rehabilitation Act regarding accessibility?

8. What type of training and support will the contractor provide for end-users and administrators?

9. What is the process for ensuring ongoing software updates and training?

10. How will the contractor provide technical IT support during the life of the contract?

11. How will the contractor ensure the security of the software, especially concerning PHI and PII?

12. What measures will be taken to prevent unauthorized access to sensitive information?

13. What qualifications must the contractor possess to be considered for this project?

14. How will the performance and quality of the contractor’s software be evaluated during the contract period?

15. What is the timeline for the implementation of the software at PIMC and WRSU?

16. How will the software integrate with existing systems at the healthcare facilities?

Text5: 1. The software should allow users to evaluate clinical criteria for the following:

1. Images/procedures

2. Observation services

3. Inpatient admissions

4. Continued inpatient stays

5. Evaluation of discharge planning

6. Evaluate ambulatory surgical services for appropriateness of setting

7. Determine appropriate transition of care to rehabilitation care services, sub-acute services, and skilled nursing services.

8. Evaluate substance use disorders and appropriate transition of care.

9. Evaluate transition of care needs utilizing CMS Durable Medical Equipment.

10. Retrospective evaluation of risk management and quality care delivery evaluation.

2. The criteria must utilize evidence-based clinical criteria as the foundation of establishing “medical necessity”, must include the source documentation in the criteria, and must incorporate standards of care in the recommended treatment modalities. The contractor shall provide comprehensive, clinical evidence-based notations that summarize the standard of care for a specific diagnosis, thus supporting a comprehensive approach to diagnosis and treatment. The notations shall provide an objective source that medical professionals can reference to support their care recommendations for individual patient treatment.

3. The software shall produce various utilization review reports to include:

• Variance days

• Medical necessity met

• Observation

• Others consistent with UR conditions of participation (length of stay application)

4. The contractor shall provide a non-transferable (evidence-based clinical criteria) software license for no less than twelve (12) simultaneous users to use in the process of utilization review. This will be used to determine the medical necessity of inpatient admissions, continued inpatient stays, evaluation (including retrospective evaluation) of the discharge plan, to determine observation status and to evaluate the appropriateness of ambulatory surgical procedures through standard report options, not custom queries.

5. Contractor Site-Hosted evidenced-based clinical criteria shall comply with the State Operations Manual, Regulations and Interpretive Guidelines for Hospitals, 482.30 Condition of Participation: Utilization Review and be in alignment with Centers for Medicare and Medicaid Services (CMS) and the Health Services Advisory Group (HSAG) for determining “Medical Necessity” and “Quality of Care”.

6. The Standards of care and evidence-based criteria shall incorporate and comply with State Operations Manual, Regulations and Interpretive Guidelines for Hospitals, 482.30 Condition of Participation: Utilization Review and be in alignment with Centers for Medicare and Medicaid Services (CMS) and the Health Services Advisory Group (HSAG) for determining “Medical Necessity” and “Quality of Care”.

Text6: 7. Section 508 Compliance Standards:

The contractor shall ensure compliance with the requirements herein as it pertains to Section 508 compliance.

HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice. (Dec 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document - in detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://www.hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

352.239-74 Electronic and Information Technology Accessibility (DEC 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS Web site: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

8. The contractor shall provide initial onsite training and other additional training courses that are designed to familiarize end-users with the use of the criteria. These training modules shall be self-paced to accommodate the end-users' schedules. Training courses will be aligned with this scope of work.

Quality Assurance: The contractor shall provide software updates to keep current with any changes to standards of care in their evidenced-based clinical criteria for the diagnosis and treatment of diseases as appropriate. The contractor shall provide training or training resources for a minimum of 12 IHS employees and training and support for the application administrator with a focus on report production. Any additional web based training shall be included in the cost proposal.

9. The contractor will provide technical IT support services as necessary during the life of the contract (The contractor shall provide software updates to keep current with any changes to standards of care in their evidenced-based clinical criteria for the diagnosis and treatment of diseases as appropriate). A point of contact shall be designated to ensure ad-hoc maintenance and support services are provided for the proper functioning of the site-hosted software license.

10. The contractor will provide technical IT support services as necessary during the life of the contract. A point of contact shall be designated to ensure ad-hoc maintenance and support services are provided for the proper functioning of the site-hosted software license.

11. The contractor will not access, manage or control Protected Health Information (PHI) or other Personally Identifiable Information (PII). The contractor Site-Hosted evidenced-based clinical criteria shall comply with and be in alignment with Centers for Medicare and Medicaid Services (CMS) including the national standards of Health Insurance Portability and Accountability Act of 1996 (HIPAA) for managing or controlling Protected Health Information (PHI) or other Personally Identifiable Information (PII).

12. The Site-Hosted evidenced-based clinical criteria shall comply with and be in alignment with Centers for Medicare and Medicaid Services (CMS) including the national standards of Health Insurance Portability and Accountability Act of 1996 (HIPAA) for managing or controlling Protected Health Information (PHI) or other Personally Identifiable Information (PII).

13. PIMC requires the services of a contractor able to provide a Site-Hosted, evidence-based clinical criteria software and license for use in a hospital utilization review process. The software should be easy to use and allow for expedited workflow.

The contractor shall provide software that will allow for searches of relevant criteria by keywords, CPT codes, and ICD-10 codes. This will act as a guide for establishing defensible admissions and continuing to stay positions of PIMC’s utilization review process, thereby enhancing third-party billing collections. This will be accomplished by decreasing denials and allowing for cost controls. Case management staff, third-party staff, and medical professionals shall have access through a web-hosted program.

The contractor shall provide a Site-Hosted software license for evidence-based clinical criteria for the following areas:

1) Inpatient adult

2) Obstetrical

3) Newborn

4) Continued inpatient stays

5) Evaluation of discharge planning

6) Evaluation of ambulatory surgical procedures

7) Imaging

14. Government officials agencies are instructed to use the Contractor Performance Assessment Reporting System (CPARS) to create and measure the quality and timely reporting of performance information.

15. TBD.

16. The contractor shall provide a non-transferable software license for no less than twelve (12) simultaneous users to use in the process of utilization review. The contractor shall provide PIMC a site-hosted, interactive software that provides access to criteria and helps automate/streamline the utilization review process. The contractor shall provide software that will allow for searches of relevant criteria by keywords, CPT codes, and ICD-10 codes. This will act as a guide for establishing defensible admissions and continuing to stay positions of PIMC’s utilization review process, thereby enhancing third-party billing collections. This will be accomplished by decreasing denials and allowing for cost controls. Case management staff, third-party staff, and medical professionals shall have access through a web-hosted program. The contractor shall ensure PIMC is provided with the most current and up-to-date evidence-based clinical criteria software as it becomes available throughout the life of the contract.