Supporting Statement Part A
The International Classification of Diseases, 10th Revision, Procedure Coding System
(ICD-10-PCS)
(CMS-10774; OMB-0938-1409)
Under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the U.S. Department of Health and Human Services (HHS) adopted specific code sets for diagnoses and procedures used in all transactions.
On January 16, 2009, HHS released the final rule mandating that all parties covered by HIPAA implement the International Classification of Diseases, 10th Revision (ICD-10) for medical coding.
The International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) is the code set used for classifying procedures or other actions taken for diseases, injuries, and impairments on hospital inpatients reported by hospitals regarding prevention, diagnosis, treatment, and management. ICD-10-PCS is restricted to the reporting of inpatient procedures by acute care hospitals. The Centers for Medicare and Medicaid Services (CMS) has lead responsibility for the maintenance and distribution of procedure codes included in the Tabular List and Alphabetic Index for Procedures under the ICD-10-PCS classification.
The International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10- CM) is the code set used for classifying diseases, injuries, impairments, other health problems and their manifestations, and causes of injury, disease, impairment, or other health problems in all healthcare settings. The Centers for Disease Control and Prevention's (CDC) National Center for Health Statistics (NCHS) has lead responsibility for the diagnosis codes included in the Tabular List and Alphabetic Index for Diseases under the ICD-10-CM classification.
The ICD-10 Coordination and Maintenance Committee (C&M) is a Federal interdepartmental committee comprised of representatives from CMS and NCHS, charged with routine maintenance, testing, enhancement, and the expansion of the ICD-10 code sets. The committee is jointly responsible for approving coding changes, and developing errata, addenda, and other modifications to the ICD-10 coding systems to reflect newly developed procedures and technologies and newly identified diseases.
The Committee provides two meetings each year as a public forum to discuss proposed changes to ICD-10. Suggestions to CMS for ICD-10-PCS procedure code modifications come from both the public and private sectors. ICD-10-PCS modification requests can be proposals for new or revised procedure codes or requests for technical coding updates including but not limited to, enhancements to existing procedure code concepts, such as adding a new body part value or a new approach value. Requestors are asked to include a description of the procedure code or change being requested, and rationale for why the procedure code or change is needed. Supporting references and literature may also be submitted. Interested parties currently submit these ICD-10-PCS modification requests three months prior to a scheduled Spring or Fall C&M meeting via the electronic intake system, Medicare Electronic Application Request Information System™ (MEARIS™), which became active for ICD-10-PCS code request submissions on March 1, 2022. The ICD-10-PCS code request application digital platform can be accessed at:
https://mearis.cms.gov. Before March 1, 2022, interested parties submitted these modification requests via email to the following e-mail address:
ICDProcedureCodeRequest@cms.hhs.gov.
For purposes of this Paperwork Reduction Act (PRA) submission, we are requesting that the approval for public use to submit materials to CMS in support of their ICD-10-PCS request(s) using the online application system, Medicare Electronic Application Request Information System™ (MEARIS™), be extended in lieu of submitting these materials via email as described previously. We are requesting approval for an extension because we believe the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) Request application designed for MEARIS™ collects the same data elements as collected in the existing process for requesting new/revised ICD-10-PCS procedure codes as described on our webpage at: https://www.cms.gov/medicare/codingbilling/icd-10-codes/process-for-requesting-new-revised-icd-10-pcs-procedure-codes.
https://www.cms.gov/Medicare/Coding/ICD10/newrevisedcodes. We believe an extension on the approval for the online code request application has no impact on the data collection requirements or the burden associated with this collection. We also believe there is nothing new in the online code request application that a repeat requestor would not have seen in the existing process and its associated instructions.
B. Justification
The HIPAA Act of 1996 required CMS to adopt standards for coding systems that are used for reporting health care transactions. The Transactions and Code Sets final rule (65 FR 50312) published in the Federal Register on August 17, 2000 adopted the International
Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) Volumes 1 and 2 for diagnosis codes and ICD-9-CM Volume 3 for inpatient hospital services and procedures as standard code sets for use by covered entities (health plans, health care clearinghouses, and those health care providers who transmit any health information in electronic form in connection with a transaction for which the Secretary has adopted a standard). ICD-9-CM Volumes 1 and 2, and ICD-9-CM Volume 3 were already widely used in administrative transactions when we promulgated the August 17, 2000 final rule, and we decided that adopting these existing code sets would be less disruptive for covered entities than modified or new code sets.
In the HIPAA Administrative Simplification: Modifications to Medical Data Code Set
Standards to Adopt ICD-10-CM and ICD-10-PCS Final Rule published in the Federal Register on January 16, 2009 (74 FR 3328 through 3362) §162.1002 was amended to adopt ICD-10-CM and ICD-10-PCS as medical data code sets under HIPAA, replacing ICD-9-CM, Volumes 1 and 2, and ICD-9-CM Volume 3, and mandated that all parties covered by HIPAA implement ICD-10 for transactions conducted on or after October 1, 2013 as described.
However, the Secretary of HHS issued a final rule (77 FR 54664) that delayed the compliance date for ICD-10 from October 1, 2013, to October 1, 2014. On April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) was enacted, which specified that the Secretary may not adopt ICD-10 prior to October 1, 2015.
Accordingly, HHS released a final rule in the Federal Register on August 4, 2014 (79 FR 45128 through 45134) that established October 1, 2015 as the compliance date for ICD-10.
The ICD-10-PCS code set has been maintained, enhanced, and expanded as a direct result of recommendations for updates (e.g., adding new codes, deleting codes, and editing descriptive material related to existing codes) received from interested parties from both the public and private sectors. Thus, information collected in the application is significant to code set maintenance. The ICD-10-PCS code set maintenance is an ongoing process, as changes are implemented and updated; therefore, the process requires continual collection of information from requestors on a bi-annual basis. As new technology evolves and new complex medical procedures are developed, requests are submitted to CMS requesting modifications to the ICD-10-PCS code set. Requests have been received prior to HIPAA implementation and must continue to be collected to facilitate quality decision-making.
When a request is submitted in MEARIS™, the Diagnosis Related Groups (DRGs) and Coding Team in the Division of Coding and DRGs (DCDRG) have instant access to the request and accompanying materials to facilitate a more timely review of the proposed updates or changes. Upon receipt of a procedure code request, CMS immediately acknowledges receipt of the request and communicates to the requestor that additional follow up will occur once an analyst has been assigned. In addition, CMS provides information via email communication in a letter to each requestor outlining the meeting process. CMS holds standard pre-meeting conference calls with requestors to discuss their procedure code topic request in more detail in advance of the ICD-10 C&M Committee Meetings. Also, prior to the committee meeting, we make the procedure code topic meeting materials publicly available, commonly referred to as the “Agenda packet” on our website at:
https://www.cms.gov/medicare/coding-billing/icd-10-codes/icd-10-coordination-
maintenance-committee-materials. Lastly, once the meeting has concluded, CMS sends a follow-up letter to the requestor informing them of next steps in the process so they can anticipate what to expect.
The ICD-10 C&M Committee's role is advisory. No decisions are made during the public ICD-10 C&M Committee Meetings. Instead, representatives of recognized organizations in the coding field, such as the American Health Information Management Association (AHIMA), the American Hospital Association (AHA), and various physician specialty groups, as well as individual physicians, health information management professionals, and other members of the public, as well as the requestor, are provided an opportunity to contribute ideas on the coding matters presented. Comments are encouraged both during the meetings and in writing. After carefully reviewing and considering the opinions expressed during the public meetings and in writing following the meeting, the Committee formulates recommendations, which then must be approved by the agencies. All final decisions are made by the Director of NCHS and the Administrator of CMS.
Requests are submitted in the International Classification of Diseases, 10th Revision,
Procedure Coding System (ICD-10-PCS) Request application, via the Medicare Electronic
Application Request Information System™ (MEARIS™), on a designated website through CMS.gov. The electronic version of the ICD-10-PCS code request application collects the same information as described on our webpage at: https://www.cms.gov/medicare/codingbilling/icd-10-codes/process-for-requesting-new-revised-icd-10-pcs-procedure-codes. This secure online code request platform maintained by CMS enables requestors to submit their responses to our code request application questions directly to CMS as opposed to sending the requested information via email. We have not made any changes in MEARIS™ that have an impact on the process associated with collecting this data, and MEARIS™ continues to provide a more convenient way for our requestors to submit ICD-10-PCS code request applications. Requests that are received by the established deadline will be considered for the upcoming cycle; and requests that are received after the deadline for any coding cycle, will be considered for inclusion in the next cycle.
4. Duplication of Efforts
This information collection does not duplicate other efforts.
There is minimal impact on small businesses as this process has been in place for years; and there is ample time allotted from the beginning of the cycle to the deadline to read, complete and submit a request. Timelines and upcoming key future dates are published in the meeting materials from each ICD-10 C&M meeting. Reminder messages are also sent to all subscribers of the ICD-10 Coordination and Maintenance Committee Meetings GovDelivery Subscriber List.
This information is collected one time, and a coding action is rendered. However, the requestor can choose to submit another code request in a subsequent coding cycle.
The information collected in the code request application is significant to ICD-10-PCS code set maintenance. If this information were not to be collected, CMS would not have a mechanism to receive recommendations from interested parties from both the public and private sectors to alert us that a need exists to enhance, expand or otherwise maintain the only mechanism hospitals have to classify the procedures or other actions taken for diseases, injuries, and impairments on hospital inpatients.
There are no special circumstances that would require an information collection to be conducted in a manner that requires respondents to:
Report information to the agency more often than quarterly;
Prepare a written response to a collection of information in fewer than 30 days after
receipt of it;
Submit more than an original and two copies of any document;
Retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;
Collect data in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study,
Use a statistical data classification that has not been reviewed and approved by
OMB;
Include a pledge of confidentiality that is not supported by authority established in statute or regulation that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
Submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
8. Federal Register / Outside Consultation
The 60-day Federal Register notice published on 3/25/2024 (89 FR 20658).
No comments were received.
The 30-day Federal Register notice published on 6/10/2024 (89 FR 48900).
There are no payments/gifts to respondents. ICD-10-PCS codes are reported on a claim when hospitals have a claims processing need to identify inpatient hospital services. The existence of a code does not guarantee Medicare payment. CMS maintains the ICD-10PCS code set, as designated by the Secretary, HHS; for use by all government and nongovernment insurers in identifying inpatient procedures on electronic medical claims forms, as designated under HIPAA. The ICD-10-PCS code set is in the public domain and may be freely downloaded, used, and distributed.
“CMS pledges privacy to the extent provided by law.” The MEARIS™ application is covered under the CMS.gov Privacy Policy which can be found at:
https://www.cms.gov/about-cms/web-policies-important-links/web-policies/privacy. Any personally identifiable information (PII), as defined by the Office of Management and Budget (OMB), submitted by applicants is safeguarded according to the Privacy Act of 1974, as amended (5 U.S.C. Section 552a).
11. Sensitive Questions
There are no sensitive questions.
We estimate the average response time to be 10 hours. The time estimate for preparation of the ICD-10-PCS code request is based upon the professional judgment of staff members at the Centers for Medicare and Medicaid Services and includes the time and effort involved with completing administrative requirements.
Based on our recent experience, in the next several years we continue to estimate receiving approximately 80 requests annually for ICD-10-PCS classification modifications. We have chosen the average of 80 requests on a yearly basis for purposes of this PRA extension request. It is estimated that there are 80 requests filed annually at an average response time of 10 hours per filing.
Therefore, we have calculated the burden as follows: 80 requests x 10 hours per request = 800 burden hours (annual). We believe that we will continue to receive this average number of ICD-10-PCS code requests, our estimate of the number of requests is realistic, and using the average of 80 requests for the purposes of this PRA extension is reasonable.
The estimated maximum number of requests for modification to the ICD-10-PCS classification is 80 per cycle year. The estimated time to read, execute, and submit this form is 10 hours.
Time to fill out application (Electronic version):
15 minutes - to read application instructions and questions
2 hours. - to gather information in response to questions
2 hours. - to gather performance data, study data and research current coding
hour. - to gather product information and FDA documentation
hours. 45 min. - to copy/paste and/or type in responses 2 hours. - to proof and edit Total - 10 hours.
The requestors are no longer required to email CMS as the code request process is now completely online.
We believe Medical and Health Service managers are primarily responding to the information collection requirements. Based on the most recent Bureau of Labor and Statistics Occupational and Employment Data (May 2022 http://www.bls.gov/oes/current/oes_md.htm) for Category 11-9111 (Medical and Health Services Managers), the median hourly wage for a Medical and Health Services Manager is $61.25. We have added 100% of the median hourly wage to account for fringe and overhead benefits, which calculates to $122.50 ($61.25 + $61.25). We estimate the total annual cost to be $98,000 (800 hours x $122.50/hour).
The International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) Request application is available online on a designated website through CMS.gov. Requestors need a computer with internet access, which is publicly available. We do not anticipate any change in the capital costs to the requestors.
The cost to evaluate ICD-10-PCS code requests is estimated as follows based on review by analysts, contractors, medical officers, and supervisory staff. This review includes analyses of the submission, required coding research, database inputs, preparation of background papers for the agenda packet, review of draft coding options for appropriateness based on the request and the conventions of the ICD-10-PCS classification, pre-C&M meeting conferences with requestors and their representatives and the preparation of materials for internal clearance. This review also includes the drafting of both pre-C&M meeting and post-C&M meeting template letters to requestors, the review and feedback of presentation slides for content and 508 compliance, the preparation and posting of meeting materials related to the requests for either the Spring or Fall ICD-10 C&M Committee Meeting and the receipt and summarization of public comments to finalize a decision. We estimate the total time to process, evaluate, present the request to the public and reach a decision is 40 to 80 hours per request. We use the midpoint of this range (60 hours) to derive the following estimated labor cost for government employees.
$42.73/hour (average salary GS 12, 13, 14)0 X 60 hours per request X 80 requests (potential/projected number of requests) = $205,104.
There are no anticipated changes to the intent and substance of the electronic International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) Request application form as described on our webpage at:
https://www.cms.gov/Medicare/Coding/ICD10/newrevisedcodes, as the request application form collects the same data elements as solicited in the previous process for requesting new/revised ICD-10-PCS procedure codes.
The change in the total annual cost can be attributed to the increase in the median hourly wage for Medical and Health Services Managers since the approval of the existing PRA package. Similarly, the change in the estimated labor cost for government employees can be attributed to the increase in the average salary for GS 12, 13, and 14 employees since the approval of the existing PRA package.
The International Classification of Diseases, 10th Revision, Procedure Coding System (ICD10-PCS) Request application is made available online on a designated website through CMS.gov. The dates and deadlines are changed bi-annually to reflect the upcoming coding cycles. Content of the material remains the same; however, questions may need to be revised periodically for clarity so that the requestor will know how to respond correctly.
The information collected in the application is not made public for review. Upon receipt of a procedure code request, CMS immediately acknowledges receipt of the request and communicates to the requestor that additional follow up will occur once an analyst has been assigned. After initial analyst review, CMS informs the requestor if CMS will proceed with the topic and provides information via email communication in a letter to each requestor outlining the details of the meeting process. We make the procedure code topic meeting materials associated with the requests that have been accepted for discussion at a Spring or Fall ICD-10 C&M Committee Meetings publicly available in our “Agenda packet” which is published on our website at: https://www.cms.gov/medicare/coding-billing/icd-10codes/icd-10-coordination-maintenance-committee-materials.
Codes discussed at the Fall meeting and subsequently finalized (or approved) are made available in Table 6B- New Procedure Codes of the following fiscal year’s (FY) Inpatient Prospective Payment System (IPPS)/Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule and are generally implemented on April 1 of the current fiscal year or October 1 of the following fiscal year. Codes discussed at the Spring meeting are not finalized in time to include in the proposed rule therefore, if approved they appear in the following FY Addenda posted to the CMS ICD-10 web page in June of each year.
The existing PRA package will expire on January 31, 2025. The OMB approval expiration date is made available on the welcome page of the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) Request application in MEARIS™ at https://mearis.cms.gov/secure/icd-10-pcs/introduction.
18. Certification Statement
There are no exceptions to the certification statement.
No statistical methods are employed.
0 Office of Personnel Management. 2024 General Schedule (Base). Retrieved on March 4, 2024 from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2024/general-schedule/.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Supporting Statement for CMS Real-Time Eligibility Agreement |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2024-07-22 |