Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities; Correcting Amendment

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 406, 407, 410, 411, 416, 419, 435, 440, 457, 482, and 485</CFR> <DEPDOC>[CMS-1809-F2]</DEPDOC> <RIN>RIN 0938-AV35</RIN> <SUBJECT>Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, Including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities; Correcting Amendment</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), HHS. <HD SOURCE="HED">ACTION:</HD> Final rule with comment period; correcting amendment. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This document corrects technical and typographical errors in the final rule with comment period that appeared in the November 27, 2024 <E T="04">Federal Register</E> titled “Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities”. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This correcting amendment is effective January 8, 2025, and is applicable beginning January 1, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> For OPPS/ASC related questions, contact Elise Barringer via email at <E T="03">Elise.Barringer@cms.hhs.gov</E> or at (410) 786-9222. For OPPS Addenda questions, contact Marina Kushnirova via email at <E T="03">Marina.Kushnirova@cms.hhs.gov.</E> For ASC Addenda questions, contact Scott Talaga via email at <E T="03">Scott.Talaga@cms.hhs.gov.</E> For Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals questions, contact the Clinical Standards Group via email at <E T="03">HealthandSafetyInquiries@cms.hhs.gov.</E> For Hospital Outpatient Quality Reporting Program policies, contact Kimberly Go via email at <E T="03">Kimberly.Go@cms.hhs.gov</E> or Janis Grady via email at <E T="03">Janis.Grady@cms.hhs.gov.</E> For Medicaid Clinic Services Four Walls Exceptions related questions, contact Sheri Gaskins via email at <E T="03">Sheri.Gaskins@cms.hhs.gov</E> or Ryan Tisdale via email at <E T="03">Ryan.Tisdale@cms.hhs.gov.</E> For Medicaid and CHIP Continuous Eligibility questions, contact Cassie Lagorio via email at <E T="03">Cassandra.Lagorio@cms.hhs.gov.</E> For New Technology APC questions, contact Nicole Marcos via email at <E T="03">Nicole.Marcos@cms.hhs.gov.</E> For Outpatient Department Prior Authorization Process, contact Kelly Wojciechowski via email at <E T="03">Kelly.Wojciechowski@cms.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> In the FR Doc. 2024-25521 of November 27, 2024 (89 FR 93912), there were a number of technical and typographical errors that are identified and corrected in this correcting document. The corrections in this correcting document are effective as if they had been included in the document that appeared in the November 27, 2024 <E T="04">Federal Register</E> . Accordingly, the corrections are effective January 1, 2025. <HD SOURCE="HD1">II. Summary of Errors</HD> <HD SOURCE="HD2">A. Summary of Errors in For Further Information Contact</HD> In the <E T="02">FOR FURTHER INFORMATION CONTACT</E> section, the email address for Kelly Wojciechowski is incorrect. <HD SOURCE="HD2">B. Summary of Errors in the Preamble</HD> <HD SOURCE="HD3">1. Hospital Outpatient Prospective Payment System (OPPS) Corrections</HD> On pages 94054 and 94055, we are correcting typographical errors. Specifically, we are correcting CPT code “0899T” to “0889T”. On pages 94111 and 94114, we referred to an incorrect APC assignment for CPT code 15013. We inadvertently failed to account for the impact on the amount of payment for the skin cell suspension autograft procedure described by CPT code 15013 ( <E T="03">Preparation of skin cell suspension autograft, requiring enzymatic processing, manual mechanical disaggregation of skin cells, and filtration; first 25 sq cm or less of harvested skin</E> ) of the assignment of this code to status indicator “T” (Procedure or Service, Multiple Procedure Reduction Applies; Paid under OPPS, separate APC payment) when we assigned CPT code 15013 to APC 1567 New Technology—Level 30 ($6,001-$6,500), which has a payment rate of $6,250.50 and status indicator “T”. In the final rule with comment period, we stated that when the full service (skin cell suspension autograft described by CPT codes 15011 through 15018) is performed, meaning that the harvesting (described by CPT code 15011), preparation (described by CPT code 15013), and application (described by CPT codes 15015 or 15017) steps are performed, the total cost for the service for CY 2025 would be approximately $10,000. However, because of the effect of the multiple procedure reduction, the total payment for the skin cell suspension autograft furnished using the RECELL System would have been approximately $8,000, contrary to the intended target of $10,000 as stated in the CY 2025 OPPS/ASC final rule with comment period. To correct this error, we are assigning CPT code 15013 to APC 1532 New Technology—Level 32 ($7,001-$7,500), which has a payment rate of $7,250.50 and status indicator “S” (Procedure or Service, Not Discounted When Multiple, Paid under OPPS; separate APC payment.). On page 94120, we stated “We note that we will replace HCPCS code C9734 with CPT code 5X008 (55882) effective January 1, 2025, as well as assign the underlying claims associated with HCPCS code C9734 to CPT code 5X008 (55882).” While we intended to crosswalk the claims data for HCPCS code C9734 to CPT code 5X008 (55882) to determine the APC assignment for CPT code 5X008 (55882) for CY 2025, we did not intend to retire HCPCS code C9734 because, based on its descriptor, C9734 can be used for services other than those described by CPT code 5X008 (55882). We are correcting this reference to indicate that we are using C9734 claims data to set the payment rate for CPT code 5X008 (55882) and removing the reference to replacing HCPCS code C9734. HCPCS code C9734 will remain assigned to APC 5115 (Level 5 Musculoskeletal Procedures).” <HD SOURCE="HD3">2. The Hospital Outpatient Quality Reporting (OQR), Rural Emergency Hospital Quality Reporting (REHQR), and Ambulatory Surgical Center Quality Reporting (ASCQR) Programs Corrections</HD> On pages 94368 and 94380, we are correcting URL links in footnotes 270 and 316 (respectively) for accuracy. On page 94407, we are making a technical edit and removing language for accuracy. On pages 94411 and 94412, we are correcting URL links in footnotes 446 and 461 (respectively) for accuracy. On pages 94416 and 94417, we are correcting section references for accuracy. On page 94417, we are correcting final rule references for accuracy. On page 94522, we are correcting the number of web-based measures that are being finalized in the rule for the Hospital OQR program. On pages 94561 through 94563, we are correcting section references for accuracy. <HD SOURCE="HD3">3. Medicaid Clinic Services Four Walls Exceptions Corrections</HD> On pages 94442, 94446, 94448, 94452, and 94561, we made typographical errors. Specifically, on page 94442 we inadvertently included a dollar symbol ($), on page 94446 we inadvertently repeated the word “that,” on page 94448 we inadvertently repeated the phrase “rely upon,” on page 94452 we inadvertently omitted the word “system” from the phrase “mistrusted the health care system at higher rates,” and on page 94561 we inadvertently included the phrase “Four Walls:” at the beginning of the title for Table 207. On page 94455, we incorrectly stated in footnote 586 that as of November 27, 2024, the Health Resources and Services Administration (HRSA) had not finalized their proposed changes to the Federal Office of Rural Health Policy's (FORHP) definition of rural. However, HRSA finalized changes to FORHP's definition of rural in a final notice published in the <E T="04">Federal Register</E> on November 21, 2024 (89 FR 92131), which post-dated CMS's development of the final rule. We are making corrections to state that, as of the development of the OPPS final rule, HRSA had not finalized changes to FORHP's definition of rural. <HD SOURCE="HD3">4. Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals</HD> On pages 94481, 94483, 94542, 94569, 94571, 94572, and 94573 we are replacing the word “biannual” and/or “biannually” with the word “biennial” and/or “biennially”, to clarify that staff training is required every other year, not twice a year. <HD SOURCE="HD2">C. Summary of Errors in the Regulations Text</HD> On page 94586, ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 37k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━