Supporting Statement for
Indian Health Service Medical Staff Credentials and Privileges
Records
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 Application (OMB No. 0917-0009),” which will expire on August 31, 2023. The IHS collects and maintains this information under the following authorities: The Snyder Act (25 U.S.C. §13) and the Indian Health Service Transfer Act (42 U.S.C. §§ 2001-2004). The Indian Health Care Improvement Act (IHCIA), the cornerstone legal authority for the provision of health care to American Indians and Alaska Natives (AI/AN), 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 IHCIA 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 IHS. These Acts along with several other Acts give Congress appropriations for the IHS.
2. Purpose and Use of Information Collection
This collection of information is used to evaluate IHS medical and health care professionals to include: licensed practitioners (LP) applying for medical staff membership, credentialing and privileges at IHS health care facilities. Practitioner 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 practitioner satisfaction.
Indian Health Service policy specifically requires all LP (i.e. Federal employees, contractors, and/or volunteers) who intend to provide health care services at IHS facilities to be credentialed and privileged prior to providing such care. When a practitioner applies to provide health care services at an IHS clinic or hospital, that application contains two parts. The first is for membership in the medical staff. Criteria for such membership may include type of licensure, education, training, and experience. The second part is for privileges, which define the scope of clinical care that a practitioner can administer and matches the practitioner’s current clinical competency. There are certain criteria that practitioners must meet in order to exercise particular privileges in the facilities. These criteria may overlap with criteria for membership on the medical staff, but those for privileges are more specific and must be facility specific to meet the facility’s requirements.
The IHS operates health care facilities that provide health care services to AI/AN patients. To provide these services, the IHS employs (direct-hire and direct-contract) several categories of fully licensed, registered, or certified individuals permitted by law to independently provide patient care services within the scope of the individuals license, registration, or certification, and in accordance with individually granted clinical privileges when the individual is a credentialed member of the IHS medical staff. Licensed Practitioners who are eligible may become medical staff members, depending on the local health care facility's capabilities and medical staff bylaws.
All LP who provide care at IHS facilities must maintain full, active, unrestricted and current licensure and credentials, and be proficient in their granted privileges in accordance with the facility’s medical staff bylaws, accreditation standards, privilege criteria, agency and local policies, and applicable law and guidelines.
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 prime source verify credentials of medical staff applicants prior to granting medical staff privileges. Medical credentials specifically include the primary source verified and documented evidence of competence, character, judgment, education, and training. In order to meet these standards, IHS health care facilities require all medical staff applicants to provide verifiable information concerning their education, training, licensure, work experience, health status, and current professional conduct and competence and any adverse disciplinary actions taken against them. This information is collected through the agency’s current commercial off the shelf credentialing software to make the following application packets electronically available via the Internet. The Application packets are: 1) Pre-Application; 2) Initial Application for Membership & Privileges; 3) Reappointment Application for Membership and Privileges; and 4) Credentialing by Proxy (CBP) Intake Form. The first three application packets include an IHS Conditions of Application and Release and Health Attestation Statement for the LP to sign; Item 4, the CBP Intake Form, only includes an IHS Conditions of Application and Release.
Privileges vary across all IHS Areas and clinics, as services and procedures provided and equipment utilized varies across facilities and can change often. Privilege forms are required to be current and modified to reflect only services and procedures provided by that specific facility in order to be in compliance with accreditation standards. The electronic credentialing system allows tailoring the privileging needs to site specifications.
Information collected in the application packets are prime source verified by IHS staff using standard IHS forms (Affiliation, Peer Reference, Insurance, and Education) with the original source of the credential. The credentials review includes, but is not limited to, verifying information from the state medical boards, the Drug Enforcement Administration, Excluded Parties List System/System for Awards Management, National Practitioner Data Bank, Office of Inspector General, colleges or universities, residency programs, peer references, insurance companies, etc.
Once the LP application packet is approved, agency policy requires licensure, registration, and certification requirements and clinical competency be continuously verified on an ongoing basis until the time of the next reappointment. At the time of reappointment the health care practitioner will go through a similar reappointment process to renew their membership and privilege status. This review evaluates the current competence of the health care providers and verifies whether they are maintaining the licensure or certification requirements of their specialty.
The medical staff credentials and privileges records are stored in two ways: records stored in file folders are stored at the IHS facilities or the Federal Record Center, and computer‑based or electronic records are located at the IHS Albuquerque Data Center in Albuquerque, New Mexico.
The IHS is continuing to standardize, transform, and optimize the medical staff credentialing and privileging process into a centrally automated, standardized, electronic/digital, measurable, portable, accessible, and efficient business process to improve the effectiveness of application and re-application to medical staff, movement of practitioners within the IHS system, and recruitment/retention of high-quality LP.
3. Use of Improved Information Technology and Burden Reduction
In response to Sections 1104 and 10109 of the Affordable Care Act and to reduce administrative burdens, the National Committee on Vital Health Statistics (NCVHS) developed recommendations to digitize and standardize the practitioner credentialing process. The NCVHS cited redundant forms, the lack of automation, and the unique process that each facility requires as the critical obstacle to simplifying and streamlining the practitioner credentialing process. The adoption of a central source credentialing software system for LP staff credentialing/privileging data continues to enhance and improve the quality, accuracy, and efficiency of the IHS credentialing/privileging process. A byproduct seen of this credentialing software is the reduction of turnaround time, one IHS Area recorded a 34 percent reduction in turnaround time for processing initial and reappointments. In addition, the affiliation module of the software reduces the administrative burden to responding to ongoing request for affiliation verifications by four hours a week. The same IHS Area tracked the cost savings of the termination of paperwork and eliminating duplicative processes and recorded a $90,720 cost savings on paper alone.
The time that medical service professionals must devote to processing redundant credentialing forms alone is approximately 20 hours per provider each year. A New England Journal of Medicine in 2012 projected that a standardized credentialing system could save the U.S. health care system close to $1 billion each year.
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.
4. Efforts to Identify Duplication and Use of Similar Information
There is little if any duplication of efforts with the new system. The IHS facilities can use current provider information within the agency credentialing software that meets agency policy and the verifying organizations terms of use for evaluating and verifying the applications of medical staff applicants and approve medical staff membership and privileges in IHS health care facilities. The IHS cannot reuse any information from other departments or Agencies. Information from the Division of Commissioned Personnel and Office of Personnel Management 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 the IHS.
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, staff 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 credentialing information must be collected and verified at the time that the individual is initially applying for membership and privileges on the IHS medical staff (either as a direct or contract provider) and reappointment cycle thereafter according to IHS policy and/or accreditation standards. Less frequent information collection could jeopardize patient quality care and safety and the accreditation status of the facility.
The burden of information collection is reduced by the electronic credentialing software system which enables 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 (FR) notice was published in the FR (88 FR 30317) on May 11, 2023, 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 IHS received one public comment.
A current 30-day FR Notice was published in the FR on July 28, 2023 (88 FR 48896).
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9. Explanation of any Payment/ Gift to Respondents
The respondents will not receive any payments or gifts for providing the information.
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 medical staff credentials and privileges process, as well as the handling and storage of this information, will be in compliance with the Privacy Act. To the extent the records are protected by 25 U.S.C. § 1675, the records may only be disclosed in accordance with the exceptions in 25 U.S.C. § 1675(d), (e)(2).
The system shall keep Personally Identifiable Information (PII) data secure per the National Institute of Standards and Technology (NIST) 800‑53 and the HHS Policy for Information Security and Privacy Protection (HHS OCIO-OIS-2021‑11-006). The system shall comply with the Federal Information Security Modernization Act 2014 including the NIST Special Publication (SP) 800 Series and associated Federal Information Processing Standard Publications standards to meet security control baselines supporting data in accordance with FIPS 199, Privacy Act of 1974, 42 CFR Part 2, the Computer Matching and Privacy Protection Act of 1988, and 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, the Credentials Committee, the Medical Executive Committee of the Medical Staff, Quality Managers, Area Directors, and members of the Governing Board. Elements of the information may be collected and updated by the assigned IHS staff, IHS Area Office staff, or a non-Federal credential verification service under contract. All applicants sign a release authorizing the 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 Privacy Act Considerations. The IHS SORN was updated for the new system and published on May 25, 2023.
Justification for Sensitive Questions
Applicants for medical staff membership and privileges provide information of a sensitive
nature including PII and other information concerning their professional experience with medical liability or adverse actions, as well as their health status, any criminal activity, and any alcohol or drug dependency. This information is collected, evaluated and verified to ensure that members of IHS medical staff are fully qualified, competent, and capable of delivering quality and safe 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 in Section 12A 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 the IHS. Instruments are completed by health care providers and there are no costs to the respondents.
12A. Estimated Annualized Burden Hours
Applicant Documents:
Pre-Application Package to identify eligibility of potential applicants to receive a full application for medical staff and/or privileges. The forms included in this package are:
Indian Health Service Pre-Application
Indian Health Service Conditions of Application and Release
Initial Application Package for medical staff and/or privileges. The forms included in this package are:
Indian Health Service Medical Staff Initial Application and/or Privileges, OMB No. 0917-0009
Indian Health Service Statement of Health
Indian Health Service Conditions of Application and Release
Reappointment Application Package for medical staff. The forms included in this package are:
Indian Health Service Medical Staff Reappointment Application and Privileges
Indian Health Service Statement of Health
Indian Health Service Conditions of Application and Release
Credentialing by Proxy Intake Form for medical staff. The forms included in this package are:
Indian Health Service CBP Intake Form
Indian Health Service Conditions of Application and Release
Verification Request Documents:
Affiliation Verification
Education Verification
Malpractice Verification
Peer Reference
For ease of understanding:
* Average Burden Hour Per Response are provided in actual minutes.
** Total Annual Burden (Current) are provided in hours.
Annual number of respondents and average burden hour were factored based on total IHS providers credentialed and privileged Calendar Year (CY) 2022, accreditation requirements with estimates of verification per applicant and respondent estimate time of completion in the paragraphs above.
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 $2.8 million based on fiscal year 2023.
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).
The cost are as follows:
|
Fiscal Year 2023 |
Fiscal Year 2024 |
Fiscal Year 2025 |
Fiscal Year 2026 |
Fiscal Year 2027 |
Total |
Operations and Maintenance |
$1,097,715 |
$1,103,371 |
$1,176,174 |
$1,254,871 |
$1,340,007 |
$5,972,138 |
Contract Cost (FEDRAMP, Contract, Contract Training) |
$1,705,705 |
$1,020,856 |
$1,055,749 |
$1,092,387 |
$1,130,856 |
$6,005,553 |
|
$2,803,420 |
$2,124,227 |
$2,231,923 |
$2,347,258 |
$2,470,863 |
$11,977,691 |
The total lifecycle cost for the project (first 5 years) is $11.98 million and includes:
Software maintenance and license renewals;
Vendor technical support;
Guided FEDRAMP process;
Management of infrastructure within the IHS; and
Federal program oversight and management support
Clinician leaders and support staff time, which includes an estimate of credential committee person-hours and which is included in operation and maintenance costs, is based on the following:
A. Cost associated with pre- applicants to the medical staff (non-employees):
Collect and analyze data* $ 25,000
Total $ 25,000 for pre-applicants
*50.00/hr x 1 hours per applicant x 500 new applicants: $25,000.
B. Cost associated with new applicants to the medical staff (non-employees):
Collect and analyze data* $ 263,400
Total $ 263,400 for new applicants
*50.00/hr x 6 hours per applicant x 878 new applicants: $263,400.
C. Cost associated with reappointments to the medical staff and requests for renewal of clinical privileges (most are employees)
Collect and analyze data* $ 348,900
Total $ 348,900 for re-applicants/renewals
*50.00/hr x 3 hours per applicant x 2326 reappointments applicants: $348,900.
D. Cost associated with CBP to the medical staff (non-employees):
Collect and analyze data* $ 187,500
Total $ 187,500 for CBP applicants
*50.00/hr x 30 minutes per applicant x 250 new applicants: $187,500.
15. Explanation for Program Changes or Adjustments
The Agency will be adding privileges back into the collection and title change. This update is to be consistent with the SORN and be inclusive that the health care providers are required to request.
The annual total burden hours for this information collection request increased 4954 hours from previous approved 1,400 hours to the current 6,354 hours (354 percent increase) because a pre-application and a CBP Intake Form are being added and four additional forms were included that were missed on the previous submission. The total estimated number of respondents for initial applications reduced from the previous 1200 to 878 (322 decrease, a 26.8 percent reduction) and the total estimated number of respondents for reappointment applications increased from the previous 1,500 to 2,212 by 826 (712 increase, a 47.4 percent increase).
The differences reflected in the number of respondents for initial and reappointment is due to actual CY 2022 number or respondents being used and not estimating respondents. However, since the pre-application and the CBP Intake Form are new forms and processes for IHS, estimates are being used for this statement, until actual use numbers can be identified. The use of this Commercial Off The Shelf system has greatly increased agency wide and more accurate reports can now be generated. The total annual cost burden for use of the system by applicants decreased from the previous methods by $79,425 to $0.00 (100 percent reduction) because this information collection places no additional computer or record keeping requirements upon the respondents.
The annualized cost to Federal Government increased 1.69 percent from $2.36 million to $2.4 million. The Operations and Maintenance cost, including the costs of contracts increased, as did the total lifecycle cost for the project increased 18 percent from $10.15 million to $11.98 million. All the annualized costs increases were due to having actual costs associated from Acquisitions and not estimating.
The total annual cost burden for use of the system by clinician/credentialing specialists for initial and reappointment application increased based on industry estimates of credentialing specialist time to work an initial and/or reappointment application. The cost per hour remained the same as we could not locate any industry estimates that combines the time of clinicians (very high pay) and support staff time (much lower pay), including an estimate of credential committee person-hours. The number of initial and reappointments are based on actual CY 2022 numbers, as previously mentioned.
The total annual cost burden for use of the system by applicants decreased from the previous method, as it was erroneously reported previously that respondents had an annual cost. As noted in Items 12 and 13, there are no capital costs, operating costs, and/or maintenance costs to respondents, except for their time to complete the necessary application process.
The current credentialing system continues to be optimized, standardized, and systemized across the agency to increase quality collection and use of medical staff credentialing information to assist in meeting Federal laws and regulations, accrediting body standards, facility governance documents, and agency policies; as well as support agency oversight, reports, safe, and quality patient care.
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.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Lance Hodahkwen |
| File Modified | 0000-00-00 |
| File Created | 2023-08-02 |