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Supporting Statement for

Indian Health Service Medical Staff Credentials

OMB Control Number 0917-0009

A. Justification

1. Circumstances Making the Collection of Information Necessary

This is an update of a currently approved Indian Health Service (IHS) information collection titled "Indian Health Service Medical Staff Credentials and Privileges Files (OMB No. 0917-0009),” which will expire on 02/29/2020. The IHS collects and maintains this information under the following authorities: The Snyder Act (25 U.S.C. §13), Indian Health Service Transfer Act (42 U.S.C. §§ 2001-2004) and the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450 et seq.), as amended. The Indian Health Care Improvement Act (IHCIA), the cornerstone legal authority for the provision of health care to American Indians and Alaska Natives, was made permanent as part of the Patient Protection and Affordable Care Act. The authorization of appropriations for the IHCIA had expired in 2000, and while various versions of the bill were considered by Congress since then, the act now has no expiration date. The Indian Health Care Improvement Act of 1976 (25 U.S.C 1601, et seq.) and the Snyder Act of 1921 (25 U.S.C 13) comprise the basic legislative authority for the Indian Health Service. These Acts along with several other Acts give Congress appropriations for the Indian Health Service.

2. Purpose and Use of Information Collection

This collection of information is used to evaluate individual health care providers applying for medical staff privileges at IHS health care facilities. Provider credentialing and privileging in the IHS has been identified as a priority area for quality improvement to support patient safety, demonstrate quality of care, and improve provider satisfaction.

The IHS operates health care facilities that provide health care services to American Indians and Alaska Natives. To provide these services, the IHS employs (directly and under contract) several categories of health care providers including: physicians (M.D. and D.O.), dentists, psychologists, optometrists, podiatrists, audiologists, physician assistants, certified registered nurse anesthetists, nurse practitioners, and certified nurse midwives.

IHS policy specifically requires physicians and dentists to be members of the health care facility medical staff where they practice. Health care providers become medical staff members, depending on the local health care facility's capabilities and medical staff bylaws. There are three types of IHS medical staff applicants: 1.) health care providers applying for direct employment with IHS; 2.) contractors who will not seek to become IHS employees; and, 3.) employed IHS health care providers who seek to transfer between IHS health care facilities.

National health care standards developed by the Centers for Medicare and Medicaid Services, the Joint Commission, and other accrediting organizations require health care facilities to review, evaluate and verify the credentials, training and experience of medical staff applicants prior to granting medical staff privileges. In order to meet these standards, IHS health care facilities require all medical staff applicants to provide information concerning their education, training, licensure, and work experience and any adverse disciplinary actions taken against them. This information is then verified with references supplied by the applicant and may include: former employers, educational institutions, licensure and certification boards, the American Medical Association, the Federation of State Medical Boards, the National Practitioner Data Bank, and the applicants themselves.

In addition to the initial granting of medical staff membership and clinical privileges, Joint Commission standards require that a review of the medical staff be conducted not less than every two years. This review evaluates the current competence of the medical staff and verifies whether they are maintaining the licensure or certification requirements of their specialty.

The medical staff credentials and privileges records are maintained at the health care facility where the health care provider is a medical staff member. The establishment of these records at IHS health care facilities is a Joint Commission requirement. Prior to the establishment of this Joint Commission requirement, the degree to which medical staff applications were maintained at all health care facilities in the United States that are verified for completeness and accuracy varied greatly across the Nation.

The application process has been streamlined and is using information technology to make the application electronically available via the Internet. The IHS is transforming credentialing, which include granting privileges, into a centrally installed, automated, standardized, electronic/digital, measurable, portable, accessible, and efficient business process to improve the effectiveness of application and re-application to Medical Staffs, movement of practitioners within the IHS system, and recruitment/retention of high-quality practitioners. The credentialing process no longer requires paper/pdf forms for granting privileges. The electronic credentialing system incorporates privileges as part of the overall process for credentialing, eliminating the need for paper, and allows tailoring the needs to site specifications. Privileges will differ across IHS Areas and clinics, in compliance with accreditation standards.

3. Use of Improved Information Technology and Burden Reduction

The adoption of a central source IT system for medical practitioner staff credentialing/privileging data will enhance the quality, accuracy, and efficiency of the IHS credentialing/privileging process, which is expected to improve the recruitment and retention rates of medical practitioner staff at IHS. Cost savings will be obtained through the termination of disparate business processes; reduction of paperwork duplication; and eliminating systems that do not provide IHS enterprise access to credentialing/privileging information. Additionally, communicating information electronically can reduce costs and errors, promote collaboration, ensure accreditation/privileging requirements are met, and help bring practitioners on board more quickly, which will improve recruitment and retention.

Cost savings will be obtained through the termination of disparate business processes; reduction of paperwork duplication; and eliminating systems that do not provide IHS enterprise access to credentialing/privileging information.

Furthermore, communicating information electronically can reduce costs and errors, promote collaboration, ensure accreditation/privileging requirements are met, and help bring practitioners on board more quickly, which will improve recruitment and retention.

In the currently approved collection, an electronic version of the “Indian Health Service Application for Medical Staff Appointment and /or Privileges” form allowed individual providers to download the form and related information electronically, and is posted on the following IHS.gov Website addresses:

http://www.ihs.gov/IHM/index.cfm?module=dsp_ihm_pc_p3c1.

http://www.ihs.gov/RiskManagement/index.cfm?module=dsp_rm_resources

The electronic version will remain on the IHS web site until all IHS areas have converted to the new system.

4. Efforts to Identify Duplication and Use of Similar Information

There is no duplication of efforts with the new system. IHS cannot reuse any information from other departments or Agencies. Information from the Division of Commissioned Personnel (DCP) and Office of Personnel Management (OPM) may be related, but is not sufficient to be used for medical credentials and privileges. Additionally, the medical peer review cannot be conducted by any another departments or agencies for IHS. There is no specifically similar information available which could be used or modified to evaluate and verify the applications of medical staff applicants and approve medical staff membership and privileges in IHS health care facilities.

5. Impact on Small Businesses or Other Small Entities

This collection of information, in general, does not involve small businesses or other small entities but rather individual health professionals, staffs of health care provider organizations, colleges or universities, and state licensing boards. Rural hospitals may be considered small entities; however, the information requested of them (i.e., verification of employment and work history) should not impose an undue reporting burden since such information should be routinely contained in the rural hospital's personnel or medical staff records.

6. Consequences of Collecting the Information and Less Frequent Collection

The information must be collected at the time that the individual is initially applying for membership on the IHS medical staff (either as a direct or contract provider) and every one or two years thereafter, and at the time an IHS medical staff member's credentials and privileges are re-evaluated and re-certified. Less frequent information collection could jeopardize patient quality care and safety and the accreditation status of the facility.

The burden of information collection will be reduced by the electronic credentialing software system which will enable automated, electronic updates of credentials from primary sources (e.g. licensing boards) via online (secure, encrypted) query.

7. Special Circumstances Relating to the Guidelines of 5 C.F.R. § 1320.5

This information collection is consistent with the guidelines in 5 C.F.R. § 1320.5(d) (2).

8. Comments in Response to the Federal Register Notice/Outside Consultation

The 60 Day Federal Register notice was published in the Federal Register (84 FR 70197) on December 20, 2019, to solicit public comments on the information collection prior to submission to OMB, as required by 44 U.S.C. § 3506(c) (2) (A). The 30 day Federal Register Notice (85 FR 10705) published on February 25, 2020. IHS received no outside comments.

9. Explanation of any Payment/ Gift to Respondents

The respondents will not receive any payments or gifts for providing the information, but it is required for employment.

10. Assurance of Confidentiality Provided to Respondents

The records contained in this information collection activity are subject to the Privacy Act system of records notice (SORN) titled "Indian Health Service Medical Staff Credentials and Privileges Records" (SORN 09-17-0003). Information collected in the IHS credentials and privileges process, as well as the handling and storage of this information, will be in compliance with the Privacy Act and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The system shall keep Personally Identifiable Information (PII) data secure per NIST 800-53 and HHS Information System Security and Privacy Policy (HHS OCIO-2014- 0001). The system shall comply with the Federal Information Security Management Act (FISMA) 2002 including the National Institute of Standards and Technology (NIST) Special Publication (SP) 800 Series and associated Federal Information Processing Standard Publications (FIPSPUB) standards to meet security control baselines supporting data in accordance with FIPS 199, Privacy Act of 1996 and Public Law (P.L.) 100-503, the Computer Matching and Privacy Protection Act of 1988, E-Government Act of 2002.

If any physical file folders are used, they are secured in locked cabinets and access to them is restricted to staff directly involved with the credentialing/privileging process. The latter may include the medical staff coordinator, the Clinical Director, and the Credentials Committee. Elements of the information may be collected and updated by the assigned IHS or tribal facility staff, IHS Area Office staff, or a non-federal credential verification service under contract. Applicants sign a release authorizing IHS to verify the information submitted in their applications, and they are provided a Privacy Act notification statement which describes the authority for collecting the information, the purposes for which it is collected, and the routine use disclosures.

The Indian Health Manual chapter on medical credentialing and privileging addresses the HIPAA compliance requirements. The IHS Privacy Act System of Records Notice, “09-17-0003 IHS Medical Staff Credentials and Privileges Records,” was amended to add a new “purpose” and “routine use” in order to disclose data to the Health Integrity and Protection Data Bank (HIPDB) pursuant to HIPAA. The Report of an Altered System of Records Medical Staff Credentials and Privileges Records was published in the Federal Register (Volume 74, Number 173), on September 9, 2009. The SORN will be updated for the new system.

However, it should be noted that reporting of fraud by Federal providers is an extremely uncommon event because Federal employees do not collect fees for their professional services, but rather are salaried by the Federal employer. Violations requiring reporting would most likely involve default of health professions loans and scholarship obligations or would be reported by prior employers. Virtually all of the data needed for HIPDB reporting would be accessible in other administrative records such as the Official Personnel Folder or Federal scholarship record.

11. Justification for Sensitive Questions

Applicants for medical staff membership and privileges provide information of a sensitive

nature including personally identifiable information (PII) and other information concerning their professional experience with medical liability or adverse actions, as well as their health status and any alcohol or drug dependency. This information is collected, evaluated and verified to ensure that members of IHS medical staffs are fully qualified, competent and capable of delivering quality health services to patients without any impairment. By formally applying for IHS medical staff membership and privileges, signing the release statement and receiving the IHS Privacy Act notification statement described in item 10, applicants are informed and provide IHS informed consent to obtain this information and to use this information as described in the Privacy Act notification statement.

12. Estimates of Annualized Hour and Cost Burden

The table below describes: Types of data collection instruments, estimated number of respondents, number of responses per respondent, average burden hour per response, and total annual burden hours. The number of respondents corresponds directly with approximate number of credentialed providers currently working directly for IHS. Instruments are completed by health care providers and there are no costs to the respondents.

12A. Estimated Annualized Burden Hours

Data Collection Instrument(s)	Estimated Number of Respondents	Responses per Respondent	Average Burden Hour per Response*	Total Annual Burden (current)
Initial Application to Medical Staff and Signature Documents	1900	1	.75	1425
Reappointment Application to Medical Staff	700	1	0.333 (20 min)	233
Total	2600	-	-	1658

*For ease of understanding, burden hours are provided in actual minutes.

Annual number of respondents were factored based on total IHS providers credentialed and privileged on the indicated cycles in the paragraphs above.

11. Estimated Annualized Cost to Respondents

There are no capital costs, operating costs and/or maintenance costs to respondents.

13. Estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories

Except for their time to complete the necessary application process, there is no annual cost burden to respondents for this information collection activity. This information collection places no additional computer or record keeping requirements upon the respondents. It will not require any capital equipment or create any start-up costs, and will not create additional costs associated with generating, maintaining, and disclosing or providing the information.

14. Annualized Cost to Federal Government

The estimated annual cost to the Federal Government for this information collection activity is $2.36 million.

The initial purchase and implementation of a Credentialing/Provisioning IT solution will be supported by Non-Recurring Emergency Funding (NEF). Funding is included for hardware, software, training, security, risk management, and Enterprise Performance Life Cycle (EPLC).

Planning and development are included in the current fiscal year and total $100,000 for government personnel costs and $1 million for IHS Contract Funds. Operations and Maintenance cost are as follows:

• $2 million per year for the next four fiscal years

• $300,000 in FY 2018 for IHS Contract Funds

• $250,000 each year for FY 2019 to 2021 for IHS Contract Costs

The total lifecycle cost for the project is $10.15 million and includes:

• Software maintenance and license renewals

• Vendor technical support

• Management of infrastructure within IHS

• Federal program oversight and management support

Clinician and support staff time, which includes an estimate of credential committee person-hours, is based on the following:

A. Cost associated with new applicants to the medical staff (non-employees):

Collect and analyze data* $ 15,000

Total $ 15,000 for new applicants

*50.00/hr x 0.5 hours per applicant x 600 new applicants: $15,000.

B. Cost associated with reappointments to the medical staff and requests for renewal of clinical privileges (most are employees)

Collect and analyze data* $ 7,500

Total $ 7,500 for re-applicants/renewals

*50.00/hr x 0.5 hours per applicant x 300 reappointments applicants: $7,500.

15. Explanation for Program Changes or Adjustments

The annual burden hours for this information collection request decreased 1059 hours from previous approved 1784 hours to the current 725 hours. The total annual cost burden for use of the system by applicants reduces from the previous methods by $79,425 (59% reduction). The total annual cost burden for use of the system by credentialing specialists/ officers is $22,500 (89% reduction).

The adjustment (decrease) in burden for data collection is due to adjustment in the new COTS system which simplifies the process for IHS staff involved in credentialing, by allowing them to conduct electronic queries for primary and secondary source information required including but not limited to NPDB, license and training information. IHS received no comments to the current 60 and 30 day Federal Register Notices.

16. Plans for Tabulation and Publication and Project Time Schedule

The results of the proposed collection of information will not be published for statistical use.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

The OMB approval number and expiration date will be appropriately displayed in the new system and on all the information collection forms.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

No exceptions are being requested.

B. Collection of Information Employing Statistical Methods

This information collection will not employ statistical methods.