Rule2024-25521
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 27, 2024
Effective
January 1, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2025 based on our continuing experience with these systems. We describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule updates the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, and Hospital Inpatient Quality Reporting Program. We also summarize information received in response to a Request for Information on potential modifications to the Safety of Care measure group in the Overall Hospital Quality Star Rating methodology. In this final rule, we are also finalizing our proposal to narrow the description of "custody" in the Medicare payment exclusion rule and to revise the special enrollment period criteria for formerly incarcerated individuals. We are also finalizing our Medicaid and Children's Health Insurance Program (CHIP) continuous eligibility provisions. We are also finalizing the proposal to reduce the review timeframe for standard prior authorization requests for certain covered outpatient department services paid under the OPPS from 10-business days to 7-calendar days. Further, this rule finalizes updates to the Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) in an effort to advance the health and safety of pregnant, birthing, and postpartum women. This rule also finalizes our proposed policy to separately pay Indian Health Service (IHS) and Tribal hospitals for high-cost drugs furnished in hospital outpatient departments through an add-on payment in addition to the all-inclusive rate (AIR) under the authorities used to calculate the AIR starting January 1, 2025. Finally, we are finalizing exceptions to the Medicaid clinic services four walls requirement for IHS and Tribal clinics, and, at state option, for behavioral health clinics and clinics located in rural areas.
Full Text
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<title>Federal Register, Volume 89 Issue 229 (Wednesday, November 27, 2024)</title>
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[Federal Register Volume 89, Number 229 (Wednesday, November 27, 2024)]
[Rules and Regulations]
[Pages 93912-94594]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-25521]
[[Page 93911]]
Vol. 89
Wednesday,
No. 229
November 27, 2024
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 406, 407, 410, et al.
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; Final Rule
Federal Register / Vol. 89 , No. 229 / Wednesday, November 27, 2024 /
Rules and Regulations
[[Page 93912]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 406, 407, 410, 411, 416, 419, 435, 440, 457, 482, and
485
[CMS-1809-FC]
RIN 0938-AV35
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
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Final rule with comment period.
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SUMMARY: This final rule with comment period revises the Medicare
Hospital Outpatient Prospective Payment System (OPPS) and the Medicare
Ambulatory Surgical Center (ASC) payment system for calendar year 2025
based on our continuing experience with these systems. We describe the
changes to the amounts and factors used to determine the payment rates
for Medicare services paid under the OPPS and those paid under the ASC
payment system. Also, this final rule updates the requirements for the
Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital
Quality Reporting Program, Ambulatory Surgical Center Quality Reporting
Program, and Hospital Inpatient Quality Reporting Program. We also
summarize information received in response to a Request for Information
on potential modifications to the Safety of Care measure group in the
Overall Hospital Quality Star Rating methodology. In this final rule,
we are also finalizing our proposal to narrow the description of
``custody'' in the Medicare payment exclusion rule and to revise the
special enrollment period criteria for formerly incarcerated
individuals. We are also finalizing our Medicaid and Children's Health
Insurance Program (CHIP) continuous eligibility provisions. We are also
finalizing the proposal to reduce the review timeframe for standard
prior authorization requests for certain covered outpatient department
services paid under the OPPS from 10-business days to 7-calendar days.
Further, this rule finalizes updates to the Conditions of Participation
(CoPs) for hospitals and critical access hospitals (CAHs) in an effort
to advance the health and safety of pregnant, birthing, and postpartum
women. This rule also finalizes our proposed policy to separately pay
Indian Health Service (IHS) and Tribal hospitals for high-cost drugs
furnished in hospital outpatient departments through an add-on payment
in addition to the all-inclusive rate (AIR) under the authorities used
to calculate the AIR starting January 1, 2025. Finally, we are
finalizing exceptions to the Medicaid clinic services four walls
requirement for IHS and Tribal clinics, and, at state option, for
behavioral health clinics and clinics located in rural areas.
DATES:
Effective date: The provisions of this rule are effective January
1, 2025.
Implementation date: Except as set forth in this section, the
regulations at Sec. Sec. 482.43(c), 482.55(c), and 485.618(e) must be
implemented by July 1, 2025; the regulations at Sec. Sec. 482.59(a)
and (b) and 485.649(a) and (b) must be implemented by January 1, 2026;
and the regulations at Sec. Sec. 482.21(b)(4) and (e), 482.59(c),
485.641(d)(4) and (e)(2), and 485.649(c) must be implemented by January
1, 2027.
Comment period: To be assured consideration, comments must be
received at one of the addresses provided below, by December 31, 2024.
ADDRESSES: In commenting, please refer to file code CMS-1809-FC.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1809-FC, P.O. Box 8010,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1809-FC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Regulation coordination questions at
<a href="/cdn-cgi/l/email-protection#1a554a4a49375b495937486f767f777b7173747d5a79776934727269347d756c"><span class="__cf_email__" data-cfemail="f5baa5a5a6d8b4a6b6d8a780999098949e9c9b92b5969886db9d9d86db929a83">[email protected]</span></a> or Elise Barringer (410) 786, 9222.
Advisory Panel on Hospital Outpatient Payment (HOP Panel), contact
the HOP Panel mailbox at <a href="/cdn-cgi/l/email-protection#d697869586b7b8b3ba96b5bba5f8bebea5f8b1b9a0"><span class="__cf_email__" data-cfemail="5312031003323d363f13303e207d3b3b207d343c25">[email protected]</span></a>.
Ambulatory Surgical Center Quality Reporting (ASCQR) Program
policies, contact Anita Bhatia via email at <a href="/cdn-cgi/l/email-protection#ecad8285988dc2ae848d98858dac8f819fc284849fc28b839a"><span class="__cf_email__" data-cfemail="1d5c7374697c335f757c69747c5d7e706e3375756e337a726b">[email protected]</span></a>.
Ambulatory Surgical Center Quality Reporting (ASCQR) Program
measures, contact Marsha Hertzberg via email at
<a href="/cdn-cgi/l/email-protection#165b7764657e77385e7364626c7473647156757b65387e7e6538717960"><span class="__cf_email__" data-cfemail="87cae6f5f4efe6a9cfe2f5f3fde5e2f5e0c7e4eaf4a9efeff4a9e0e8f1">[email protected]</span></a>.
All-Inclusive Rate (AIR) Add-On Payment for High-Cost Drugs
Provided by Indian Health Service (IHS) and Tribal Facilities, contact
Nate Vercauteren via email at <a href="/cdn-cgi/l/email-protection#2d634c59454c43037b485f4e4c5859485f48436d4e405e0345455e034a425b"><span class="__cf_email__" data-cfemail="4c022d38242d22621a293e2f2d3938293e29220c2f213f6224243f622b233a">[email protected]</span></a>.
Blood and Blood Products, contact Au'Sha Washington via email at
<a href="/cdn-cgi/l/email-protection#9fdeeaccf7fec8feecf7f6f1f8ebf0f1dffcf2ecb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="59182c0a31380e382a3130373e2d3637193a342a7731312a773e362f">[email protected]</span></a> or Nicole Marcos via email at
<a href="/cdn-cgi/l/email-protection#d799beb4b8bbb2f99ab6a5b4b8a497b4baa4f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="bef0d7ddd1d2db90f3dfccddd1cdfeddd3cd90d6d6cd90d9d1c8">[email protected]</span></a>.
Cancer Hospital Payments, contact Scott Talaga via email at
<a href="/cdn-cgi/l/email-protection#3261515d46461c66535e53555372515f411c5a5a411c555d44"><span class="__cf_email__" data-cfemail="edbe8e829999c3b98c818c8a8cad8e809ec385859ec38a829b">[email protected]</span></a>.
CMS Web Posting of the OPPS and ASC Payment Files, contact Gil Ngan
via email at <a href="/cdn-cgi/l/email-protection#480f212466062f2926082b253b6620203b662f273e"><span class="__cf_email__" data-cfemail="7f3816135131181e113f1c120c5117170c51181009">[email protected]</span></a>.
Medicaid Clinic Services Four Walls Exceptions, contact Sheri
Gaskins via email at <a href="/cdn-cgi/l/email-protection#80d3e8e5f2e9aec7e1f3ebe9eef3c0e3edf3aee8e8f3aee7eff6"><span class="__cf_email__" data-cfemail="d586bdb0a7bcfb92b4a6bebcbba695b6b8a6fbbdbda6fbb2baa3">[email protected]</span></a> or Ryan Tisdale via
email at <a href="/cdn-cgi/l/email-protection#8ad8f3ebe4a4dee3f9eeebe6efcae9e7f9a4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="0a58736b64245e63796e6b666f4a69677924626279246d657c">[email protected]</span></a>.
Composite APCs (Multiple Imaging and Mental Health) and
Comprehensive APCs (C-APCs), via email at Elise Barringer via email at
<a href="/cdn-cgi/l/email-protection#6f2a03061c0a412d0e1d1d0601080a1d2f0c021c4107071c41080019"><span class="__cf_email__" data-cfemail="87c2ebeef4e2a9c5e6f5f5eee9e0e2f5c7e4eaf4a9efeff4a9e0e8f1">[email protected]</span></a>.
Device-Intensive Status and No Cost/Full Credit and Partial Credit
Devices, contact Scott Talaga via email at <a href="/cdn-cgi/l/email-protection#97c4f4f8e3e3b9c3f6fbf6f0f6d7f4fae4b9ffffe4b9f0f8e1"><span class="__cf_email__" data-cfemail="7e2d1d110a0a502a1f121f191f3e1d130d5016160d50191108">[email protected]</span></a>.
Domestic Personal Protection Equipment RFI, contact Jesse Hawkins
via email at <a href="/cdn-cgi/l/email-protection#b5dfd0c6c6d09bddd4c2dedcdbc6f5ddddc69bd2dac3"><span class="__cf_email__" data-cfemail="ef858a9c9c8ac1878e988486819caf87879cc1888099">[email protected]</span></a>
Health and Safety Standards for Obstetrical Services in Hospitals
and Critical Access Hospitals, contact The Clinical Standards Group,
<a href="/cdn-cgi/l/email-protection#cb83aeaaa7bfa3aaa5af98aaadaebfb282a5babea2b9a2aeb88ba8a6b8e5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="c38ba6a2afb7aba2ada790a2a5a6b7ba8aadb2b6aab1aaa6b083a0aeb0edababb0eda4acb5">[email protected]</span></a>
Hospital Inpatient Quality Reporting (IQR) Program policies,
contact Julia Venanzi via email at <a href="/cdn-cgi/l/email-protection#2d475841444c035b48434c4357446d4e405e0345455e034a425b"><span class="__cf_email__" data-cfemail="462c332a2f276830232827283c2f06252b35682e2e3568212930">[email protected]</span></a>.
[[Page 93913]]
Hospital Inpatient Quality Reporting (IQR) Program measures,
contact Melissa Hager via email at <a href="/cdn-cgi/l/email-protection#335e565f5a4040521d5b5254564173505e401d5b5b401d545c45"><span class="__cf_email__" data-cfemail="d5b8b0b9bca6a6b4fbbdb4b2b0a795b6b8a6fbbdbda6fbb2baa3">[email protected]</span></a> or Ngozi
Uzokwe via email at <a href="/cdn-cgi/l/email-protection#305e575f4a591e454a5f5b475570535d431e5858431e575f46"><span class="__cf_email__" data-cfemail="076960687d6e29727d686c706247646a74296f6f7429606871">[email protected]</span></a>.
Hospital Outpatient Quality Reporting (OQR) Program policies,
contact Kimberly Go via email at <a href="/cdn-cgi/l/email-protection#e5ae8c88878097899ccba28aa5868896cb8d8d96cb828a93"><span class="__cf_email__" data-cfemail="1a517377787f687663345d755a79776934727269347d756c">[email protected]</span></a>.
Hospital Outpatient Quality Reporting (OQR) Program measures,
contact Janis Grady via email at <a href="/cdn-cgi/l/email-protection#bdf7dcd3d4ce93facfdcd9c4fdded0ce93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="4a002b242339640d382b2e330a29273964222239642d253c">[email protected]</span></a>.
Hospital Outpatient Visits (Emergency Department Visits and
Critical Care Visits), contact Elise Barringer via email at
<a href="/cdn-cgi/l/email-protection#67220b0e140249250615150e0900021527040a14490f0f1449000811"><span class="__cf_email__" data-cfemail="7f3a13160c1a513d1e0d0d1611181a0d3f1c120c5117170c51181009">[email protected]</span></a>.
IHS Outpatient Encounter Rate available to all American Indian and
Alaska Native (AI/AN) Outpatient Programs Request for Information,
contact Lisa Parker via email at <a href="/cdn-cgi/l/email-protection#9ad6f3e9fbb4cafbe8f1ffe8abdaf9f7e9b4f2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="c38faab0a2ed93a2b1a8a6b1f283a0aeb0edababb0eda4acb5">[email protected]</span></a>.
Inpatient Only (IPO) Procedures List, contact Abigail Cesnik via
email at <a href="/cdn-cgi/l/email-protection#d495b6bdb3b5bdb8fa97b1a7babdbf94b7b9a7fabcbca7fab3bba2"><span class="__cf_email__" data-cfemail="99d8fbf0fef8f0f5b7dafceaf7f0f2d9faf4eab7f1f1eab7fef6ef">[email protected]</span></a>.
Medicaid and CHIP Continuous Eligibility Policy, contact Cassie
Lagorio via email at <a href="/cdn-cgi/l/email-protection#4a092b39392b242e382b64062b2d253823250a29273964222239642d253c"><span class="__cf_email__" data-cfemail="9ad9fbe9e9fbf4fee8fbb4d6fbfdf5e8f3f5daf9f7e9b4f2f2e9b4fdf5ec">[email protected]</span></a>.
New Technology Intraocular Lenses (NTIOLs), contact Scott Talaga
via email at <a href="/cdn-cgi/l/email-protection#bdeeded2c9c993e9dcd1dcdadcfdded0ce93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="b2e1d1ddc6c69ce6d3ded3d5d3f2d1dfc19cdadac19cd5ddc4">[email protected]</span></a>.
No Legal Obligation to Pay Payment Exclusion, contact Frederick
Grabau via email at <a href="/cdn-cgi/l/email-protection#7137031415140318121a5f36031013100431121c025f1919025f161e07"><span class="__cf_email__" data-cfemail="e8ae9a8d8c8d9a818b83c6af9a898a899da88b859bc680809bc68f879e">[email protected]</span></a>.
Non-Opioid Policy or Implementation of Section 4135 of the
Consolidated Appropriations Act (CAA), 2023, contact Cory Duke via
email at <a href="/cdn-cgi/l/email-protection#571438252e7913223c3217343a24793f3f2479303821"><span class="__cf_email__" data-cfemail="edae829f94c3a9988688ad8e809ec385859ec38a829b">[email protected]</span></a>.
OPPS Brachytherapy, contact Cory Duke via email at
<a href="/cdn-cgi/l/email-protection#e8ab879a91c6ac9d838da88b859bc680809bc68f879e"><span class="__cf_email__" data-cfemail="783b170a01563c0d131d381b150b5610100b561f170e">[email protected]</span></a> and Scott Talaga via email at
<a href="/cdn-cgi/l/email-protection#bae9d9d5cece94eedbd6dbdddbfad9d7c994d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="abf8c8c4dfdf85ffcac7cacccaebc8c6d885c3c3d885ccc4dd">[email protected]</span></a>.
OPPS Data (APC Weights, Conversion Factor, Copayments, Cost-to-
Charge Ratios (CCRs), Data Claims, Geometric Mean Calculation, Outlier
Payments, and Wage Index), contact Erick Chuang via email at
<a href="/cdn-cgi/l/email-protection#c085b2a9a3abee83a8b5a1aea780a3adb3eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="8ecbfce7ede5a0cde6fbefe0e9ceede3fda0e6e6fda0e9e1f8">[email protected]</span></a> or Scott Talaga via email at
<a href="/cdn-cgi/l/email-protection#f2a1919d8686dca6939e939593b2919f81dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="80d3e3eff4f4aed4e1ece1e7e1c0e3edf3aee8e8f3aee7eff6">[email protected]</span></a>.
OPPS Dental Policy, contact Nicole Marcos via email at
<a href="/cdn-cgi/l/email-protection#2866414b47444d0665495a4b475b684b455b0640405b064f475e"><span class="__cf_email__" data-cfemail="b0fed9d3dfdcd59efdd1c2d3dfc3f0d3ddc39ed8d8c39ed7dfc6">[email protected]</span></a>.
OPPS Drugs, Radiopharmaceuticals, Biologicals, and Biosimilar
Products, contact Gil Ngan via email at <a href="/cdn-cgi/l/email-protection#b8ffd1d496f6dfd9d6f8dbd5cb96d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="12557b7e3c5c75737c52717f613c7a7a613c757d64">[email protected]</span></a>, Cory Duke
via email at <a href="/cdn-cgi/l/email-protection#03406c717a2d4776686643606e702d6b6b702d646c75"><span class="__cf_email__" data-cfemail="1a59756863345e6f717f5a79776934727269347d756c">[email protected]</span></a>, or Tonya Gierke via email at
<a href="/cdn-cgi/l/email-protection#3a6e5554435b147d535f48515f7a59574914525249145d554c"><span class="__cf_email__" data-cfemail="8edae1e0f7efa0c9e7ebfce5ebceede3fda0e6e6fda0e9e1f8">[email protected]</span></a>.
OPPS New Technology Procedures/Services, contact the New Technology
APC mailbox at <a href="/cdn-cgi/l/email-protection#fdb3988aa9989e95bcadbe9c8d8d91949e9c899492938ebd9e908ed395958ed39a928b"><span class="__cf_email__" data-cfemail="f6b89381a293959eb7a6b59786869a9f9597829f999885b6959b85d89e9e85d8919980">[email protected]</span></a>.
OPPS Packaged Items/Services, contact Cory Duke via email at
<a href="/cdn-cgi/l/email-protection#22614d505b0c6657494762414f510c4a4a510c454d54"><span class="__cf_email__" data-cfemail="6f2c001d16412b1a040a2f0c021c4107071c41080019">[email protected]</span></a>.
OPPS Pass-Through Devices, contact the Device Pass-Through mailbox
at <a href="/cdn-cgi/l/email-protection#723617041b111722261302021e1b1113061b1d1c0132111f015c1a1a015c151d04"><span class="__cf_email__" data-cfemail="377352415e545267635647475b5e5456435e58594477545a44195f5f4419505841">[email protected]</span></a>.
OPPS Status Indicators (SI) and Comment Indicators (CI), contact
Marina Kushnirova via email at <a href="/cdn-cgi/l/email-protection#baf7dbc8d3d4db94f1cfc9d2d4d3c8d5ccdbfad9d7c994d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="81cce0f3e8efe0afcaf4f2e9efe8f3eef7e0c1e2ecf2afe9e9f2afe6eef7">[email protected]</span></a>.
Outpatient Department Prior Authorization Process, contact Kelly
Wojciechowski via email at <a href="/cdn-cgi/l/email-protection#95def0f9f9ecbbc2fafff6fcf0f6fdfae2e6fefcd5f6f8e6bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="377c525b5b4e1960585d545e52545f5840445c5e77545a44195f5f4419505841">[email protected]</span></a>.
Overall Hospital Quality Star Rating Request for Information,
contact Tyson Nakashima Sr. via email at <a href="/cdn-cgi/l/email-protection#fda9848e9293d3b39c969c8e9594909cbd9e908ed395958ed39a928b"><span class="__cf_email__" data-cfemail="e6b29f958988c8a8878d87958e8f8b87a6858b95c88e8e95c8818990">[email protected]</span></a>.
Partial Hospitalization Program (PHP), Intensive Outpatient (IOP),
and Community Mental Health Center (CMHC) Issues, contact the PHP
Payment Policy Mailbox at <a href="/cdn-cgi/l/email-protection#59091109093820343c372d093635303a20193a342a7731312a773e362f"><span class="__cf_email__" data-cfemail="b9e9f1e9e9d8c0d4dcd7cde9d6d5d0dac0f9dad4ca97d1d1ca97ded6cf">[email protected]</span></a>.
Payment Policy for Devices in Category B Investigational Device
Exemption Clinical Trials Policy and Drugs with a Medicare Coverage
with Evidence Development (CED) Designation, contact Cory Duke via
email at <a href="/cdn-cgi/l/email-protection#e3a08c919acda7968886a3808e90cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="470428353e6903322c2207242a34692f2f3469202831">[email protected]</span></a> and Nicole Marcos via email at
<a href="/cdn-cgi/l/email-protection#521c3b313d3e377c1f3320313d2112313f217c3a3a217c353d24"><span class="__cf_email__" data-cfemail="5f11363c30333a71123e2d3c302c1f3c322c7137372c71383029">[email protected]</span></a>.
Remote Services, contact Elise Barringer via email at
<a href="/cdn-cgi/l/email-protection#e4a1888d9781caa68596968d8a838196a4878997ca8c8c97ca838b92"><span class="__cf_email__" data-cfemail="8acfe6e3f9efa4c8ebf8f8e3e4edeff8cae9e7f9a4e2e2f9a4ede5fc">[email protected]</span></a> or Nate Vercauteren via email at
<a href="/cdn-cgi/l/email-protection#95dbf4e1fdf4fbbbc3f0e7f6f4e0e1f0e7f0fbd5f6f8e6bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="b2fcd3c6dad3dc9ce4d7c0d1d3c7c6d7c0d7dcf2d1dfc19cdadac19cd5ddc4">[email protected]</span></a>.
Rural Emergency Hospital Quality Reporting (REHQR) Program
policies, contact Anita Bhatia via email at <a href="/cdn-cgi/l/email-protection#d091beb9a4b1fe92b8b1a4b9b190b3bda3feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="4a0b24233e2b6408222b3e232b0a29273964222239642d253c">[email protected]</span></a>.
Rural Emergency Hospital Quality Reporting (REHQR) Program
measures, contact Melissa Hager via email at <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="5d103831342e2e3c73153c3a382f1d3e302e7335352e733a322b">[email protected]</a>.
Special Enrollment Period for Formerly Incarcerated Individuals,
contact Steve Manning via email at <a href="/cdn-cgi/l/email-protection#267552435043086b4748484f484166454b55084e4e5508414950"><span class="__cf_email__" data-cfemail="0e5d7a6b786b20436f60606760694e6d637d2066667d20696178">[email protected]</span></a>.
All Other Issues Related to Hospital Outpatient Payments Not
Previously Identified, contact the OPPS mailbox at
<a href="/cdn-cgi/l/email-protection#7f300a0b0f1e0b161a110b2f2f2c3f1c120c5117170c51181009"><span class="__cf_email__" data-cfemail="a9e6dcddd9c8ddc0ccc7ddf9f9fae9cac4da87c1c1da87cec6df">[email protected]</span></a>.
All Other Issues Related to the Ambulatory Surgical Center Payments
Not Previously Identified, contact the ASC mailbox at
<a href="/cdn-cgi/l/email-protection#1b5a48584b4b485b78766835737368357c746d"><span class="__cf_email__" data-cfemail="85c4d6c6d5d5d6c5e6e8f6abededf6abe2eaf3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
plain language summary of this rule may be found at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
Severability of Provisions: We are clarifying and emphasizing our
intent that if any provision of this final rule is held to be invalid
or unenforceable by its terms, or as applied to any person or
circumstance, or stayed pending further action, it shall be severable
from other parts of this final rule, and from rules and regulations
currently in effect, and not affect the remainder thereof or the
application of the provision to other persons not similarly situated or
to other, dissimilar circumstances. If any provision is held to be
invalid or unenforceable, the remaining provisions which could function
independently should take effect and be given the maximum effect
permitted by law. Through this rule, we adopt provisions that are
intended to and will operate independently of each other, even if each
serves the same general purpose or policy goal. Where a provision is
necessarily dependent on another, the context generally makes that
clear.
Addenda Available Only Through the Internet on the CMS Website
In the past, a majority of the Addenda referred to in our OPPS/ASC
proposed and final rules were published in the Federal Register as part
of the annual rulemakings. However, beginning with the calendar year
(CY) 2012 OPPS/ASC proposed rule, all of the Addenda no longer appear
in the Federal Register as part of the annual OPPS/ASC proposed and
final rules to decrease administrative burden and reduce costs
associated with publishing lengthy tables. Instead, these Addenda are
published and available only on the CMS website. The Addenda relating
to the OPPS are available at: <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices</a>.
The Addenda relating to the ASC payment
[[Page 93914]]
system are available at: <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/ambulatory-surgical-center-asc/asc-regulations-and-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/ambulatory-surgical-center-asc/asc-regulations-and-notices</a>.
Current Procedural Terminology (CPT) Copyright Notice
Throughout this final rule with comment period, we use CPT codes
and descriptions to refer to a variety of services. We note that CPT
codes and descriptions are copyright 2024 American Medical Association
(AMA). All Rights Reserved. CPT is a registered trademark of the AMA.
Applicable Federal Acquisition Regulations and Defense Federal
Acquisition Regulations apply.
Table of Contents
I. Summary and Background
A. Executive Summary of This Document
B. Legislative and Regulatory Authority for the Hospital OPPS
C. Excluded OPPS Services and Hospitals
D. Prior Rulemaking
E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel
or the Panel)
F. Public Comments Received on the CY 2024 Proposed Rule
G. Public Comments Received on the CY 2024 OPPS/ASC Final Rule
With Comment Period
II. Updates Affecting OPPS Payments
A. Recalibration of APC Relative Payment Weights
B. Conversion Factor Update
C. Wage Index Changes
D. Statewide Average Default Cost-to-Charge Ratios (CCRs)
E. Adjustment for Rural Sole Community Hospitals (SCHs) and
Essential Access Community Hospitals (EACHs) Under Section
1833(t)(13)(B) of the Act for CY 2025
F. Payment Adjustment for Certain Cancer Hospitals for CY 2025
G. Hospital Outpatient Outlier Payments
H. Calculation of an Adjusted Medicare Payment From the National
Unadjusted
Medicare Payment
I. Beneficiary Copayments
III. OPPS Ambulatory Payment Classification (APC) Group Policies
A. OPPS Treatment of New and Revised HCPCS Codes
B. OPPS Changes--Variations Within APCs
C. New Technology APCs
D. Universal Low Volume APC Policy for Clinical and
Brachytherapy APCs
E. APC-Specific Policies
IV. OPPS Payment for Devices
A. Pass-Through Payment for Devices
B. Device-Intensive Procedures
V. OPPS Payment for Drugs, Biologicals, and Radiopharmaceuticals
A. OPPS Transitional Pass-Through Payment for Additional Costs
of Drugs, Biologicals, and Radiopharmaceuticals
B. OPPS Payment for Drugs, Biologicals, and Radiopharmaceuticals
Without Pass-Through Payment Status
VI. Estimate of OPPS Transitional Pass-Through Spending for Drugs,
Biologicals, Radiopharmaceuticals, and Devices
A. Amount of Additional Payment and Limit on Aggregate Annual
Adjustment
B. Final Estimate of Pass-Through Spending for CY 2025
VII. OPPS Payment for Hospital Outpatient Visits and Critical Care
Services
VIII. Payment for Partial Hospitalization and Intensive Outpatient
Services
A. Background
B. Coding and Billing for PHP and IOP Services Under the OPPS
C. CY 2025 Payment Rates for PHP and IOP
D. Outlier Policy for CMHCs
IX. Services That Will Be Paid Only as Inpatient Services
A. Background
B. Changes to the Inpatient Only (IPO) List
X. Nonrecurring Policy Changes
A. Remote Services
B. Virtual Direct Supervision of Cardiac Rehabilitation (CR),
Intensive Cardiac Rehabilitation (ICR), Pulmonary Rehabilitation
(PR) Services and Diagnostic Services Furnished to Hospital
Outpatients
C. All-Inclusive Rate (AIR) Add-On Payment for High-Cost Drugs
Provided by Indian Health Service and Tribal Facilities
D. Coverage Changes for Colorectal Cancer (CRC) Screening
Services
E. Request for Comment on Payment Adjustments under the IPPS and
OPPS for Domestic Personal Protective Equipment
F. Payment for HIV Pre-Exposure Prophylaxis (PrEP) in Hospital
Outpatient Departments
G. Payment Policy for Devices in Category B Investigational
Device Exemption (IDE) Clinical Trials Policy and Drugs/Devices With
a Medicare Coverage With Evidence Development (CED) Designation
XI. CY 2025 OPPS Payment Status and Comment Indicators
A. CY 2025 OPPS Payment Status Indicator Definitions
B. CY 2025 Comment Indicator Definitions
XII. MedPAC Recommendations
A. OPPS Payment Rates Update
B. Medicare Safety Net Index
C. ASC Cost Data
XIII. Updates to the Ambulatory Surgical Center (ASC) Payment System
A. Background, Legislative History, Statutory Authority, and
Prior Rulemaking for the ASC Payment System
B. ASC Treatment of New and Revised Codes
C. Payment Policies Under the ASC Payment System
D. Additions to ASC Covered Surgical Procedures and Covered
Ancillary Services Lists
E. ASC Payment Policy for Non-Opioid Post-Surgery Pain
Management Drugs, Biologicals, and Devices
F. Final CY 2025 Non-Opioid Policy for Pain Relief Under the
OPPS and ASC Payment System
G. New Technology Intraocular Lenses (NTIOLs)
H. Calculation of the ASC Payment Rates and the ASC Conversion
Factor
XIV. Cross-Program Measures for the Hospital Outpatient Quality
Reporting (OQR), Rural Emergency Hospital Quality Reporting (REHQR),
and Ambulatory Surgical Center Quality Reporting (ASCQR) Programs
A. Background
B. CMS Commitment To Advancing Health Equity Using Quality
Measurement
C. Modification of the Immediate Measure Removal Policy for the
Hospital Outpatient Quality Reporting (OQR) and Ambulatory Surgical
Center Quality Reporting (ASCQR) Programs Beginning With CY 2025
XV. Hospital Outpatient Quality Reporting (OQR) Program
A. Background and Statutory Authority
B. Program Measure Set Policies
C. Program Measure Updates
D. Administrative Requirements
E. Form, Manner, and Timing of Data Submission
F. Public Reporting of Measure Data
G. Payment Reduction for Hospitals That Fail To Meet the
Hospital OQR Program Requirements for the CY 2025 Payment
Determination
XVI. Rural Emergency Hospital Quality Reporting (REHQR) Program
A. Background and Statutory Authority
B. Program Measure Set Policies
C. Program Measure Updates
D. Administrative Requirements
E. Form, Manner, and Timing of Data Submission
F. Public Reporting of Measure Data
XVII. Ambulatory Surgical Center Quality Reporting (ASCQR) Program
A. Background and Statutory Authority
B. Program Measure Set Policies
C. Program Measure Updates
D. Administrative Requirements
E. Form, Manner, and Timing of Data Submission
F. Public Reporting of Measure Data
G. Request for Information (RFI)--Development of Frameworks for
Specialty Focused Reporting and Minimum Case Number for Required
Reporting
H. Payment Reduction for ASCs That Fail To Meet the ASCQR
Program Requirements
XVIII. Medicaid Clinic Services Four Walls Exceptions
A. Background
B. Summary of the Medicaid Clinic Services Four Walls Exceptions
Proposed Provisions, Public Comments and Responses to Comments
XIX. Changes to the Review Timeframes for the Hospital Outpatient
Department (OPD) Prior Authorization Process
XX. Provisions Related to Medicaid and the Children's Health
Insurance Program (CHIP)
A. Continuous Eligibility in Medicaid and CHIP (42 CFR 435.926
and 457.342)
B. Summary of the Proposed Provisions, Public Comments and
Responses to Comments on Medicaid and CHIP Continuous Eligibility
[[Page 93915]]
XXI. Health and Safety Standards for Obstetrical Services in
Hospitals and Critical Access Hospitals
A. Background and Statutory Authority
B. The U.S. Maternal Health Crisis
C. Summary of the Proposed Provisions, Public Comments and
Responses to Comments on Health and Safety Standards for Obstetrical
Services in Hospitals and Critical Access Hospitals
XXII. Hospital-Wide All-Cause Risk Standardized Mortality Measures
in the Hospital Inpatient Quality Reporting Program
A. Background
B. Updates to the Form, Time, and Manner Requirements for the
Hybrid Hospital-Wide All-Cause Readmission (HWR) and Hybrid
Hospital-Wide All-Cause Risk Standardized Mortality (HWM) Measures
for the FY 2026 and the FY 2027 Payment Determinations
XXIII. Individuals Currently or Formerly in the Custody of Penal
Authorities
A. Medicare FFS No Legal Obligation to Pay Payment Exclusion and
Incarceration (revisions to 42 CFR 411.4)
B. Revision to Medicare Special Enrollment Period for Formerly
Incarcerated Individuals
XXIV. Overall Hospital Quality Star Rating Modification To Emphasize
the Safety of Care Measure Group: Request for Information (RFI)
A. Summary
B. Background
C. Current Overall Hospital Quality Star Rating Methodology
D. Safety of Care in Star Ratings
E. Potential Future Options To Greater Emphasize Patient Safety
in the Overall Hospital Quality Star Rating
F. Solicitation of Public Comment
XXV. Files Available to the Public via the Internet
XXVI. Collection of Information Requirements
A. ICRs for the Hospital Outpatient Quality Reporting (OQR)
Program
B. ICRs for the Rural Emergency Hospitals Quality Reporting
(REHQR) Program
C. ICRs for the Ambulatory Surgical Center Quality Reporting
(ASCQR) Program
D. ICRs Related to Medicaid Clinic Services Four Walls
Exceptions
E. ICRs for Changes to the Review Timeframes for Hospital
Outpatient Department (OPD) Prior Authorization Process
F. ICRs for the Hospital Inpatient Quality Reporting (IQR)
Program
G. ICRs for Continuous Eligibility (42 CFR 435.926 and 457.342)
H. ICRs Regarding Organization, Staffing and Delivery of
Services for Hospitals (Sec. 482.59(a) and (b)) and CAHs (Sec.
485.649(a) and (b))
I. ICRs Regarding OB Staff Training for Hospitals (Sec.
482.59(c) and CAHs (Sec. 485.649(c))
J. ICRs Regarding Revisions to QAPI (Sec. 482.21) Standards for
OB Services
K. ICRS Regarding Emergency Services Readiness in Emergency
Services (Sec. 482.55) for Hospitals
L. Transfer Protocols in Discharge Planning (Sec. 482.43) for
Hospitals
M. Total Costs for all ICRs Related to Maternal Health
XXVII. Response to Comments
XXVIII. Economic Analyses
A. Statement of Need
B. Overall Impact of Provisions of This Final Rule With Comment
Period
C. Detailed Economic Analyses
D. Regulatory Review Cost Estimation
E. Regulatory Flexibility Act (RFA) Analysis
F. Unfunded Mandates Reform Act Analysis
G. Federalism
H. Conclusion
I. Waiver Fiscal Responsibility Act Requirements
I. Summary and Background
A. Executive Summary of This Document
1. Purpose
We are updating the payment policies and payment rates for services
furnished to Medicare beneficiaries in hospital outpatient departments
(HOPDs) and ambulatory surgical centers (ASCs), beginning January 1,
2025. Section 1833(t) of the Social Security Act (the Act) requires us
to annually review and update the payment rates for services payable
under the Hospital Outpatient Prospective Payment System (OPPS).
Specifically, section 1833(t)(9)(A) of the Act requires the Secretary
of the Department of Health and Human Services (the Secretary) to
review certain components of the OPPS not less often than annually, and
to revise the groups, the relative payment weights, and the wage and
other adjustments to take into account changes in medical practice,
changes in technology, and the addition of new services, new cost data,
and other relevant information and factors. In addition, under section
1833(i)(D)(v) of the Act, we annually review and update the ASC payment
rates. This final rule with comment period also includes additional
policy changes made in accordance with our experience with the OPPS and
the ASC payment system and recent changes in our statutory authority.
We describe these and various other statutory authorities in the
relevant sections of this final rule with comment period. Also, this
final rule with comment period updates the requirements for the
Hospital Outpatient Quality Reporting (OQR) Program, the Rural
Emergency Hospital Quality Reporting (REHQR) Program, the Ambulatory
Surgical Center Quality Reporting (ASCQR) Program, and the Hospital
Inpatient Quality Reporting (IQR) Program. We summarize information
received in response to a Request for Information on potential
modifications of the Safety of Care measure group in the Overall
Hospital Quality Star Rating methodology. Given that the maternal
health crisis in the United States is among the highest in high-income
countries and also disproportionately impacts racial and ethnic
minorities, we are finalizing updates to the CoPs for hospitals and
CAHs in an effort to advance the health and safety of pregnant,
birthing, and post-partum women. We are also finalizing an
implementation approach in phases that allows additional time for
hospitals and CAHs to comply with the requirements of the rule. In
addition, we are narrowing the description of ``custody'' for the
purposes of Medicare's no legal obligation to pay payment exclusion at
Sec. 411.4(b), providing an illustrative list of individuals who are
not considered to be in custody, adding a definition of ``penal
authority,'' reorganizing the regulation, and making certain technical
edits. This rule also revises the eligibility requirements in the
special enrollment period (SEP) for formerly incarcerated individuals
at Sec. Sec. 406.27(d) (Premium Part A) and 407.23(d) (Part B) to tie
the eligibility for this SEP to the determination made by the Social
Security Administration (SSA) that they are no longer incarcerated for
releases beginning on January 1, 2025, and limit the current
eligibility criteria for the SEP, with reference to ``custody''
associated with Sec. 411.4(b) to releases between January 1, 2023, and
December 31, 2024. Additionally, we are finalizing our proposed
revisions to Medicaid and CHIP regulations to codify the requirement
within the CAA, 2023 to require States to provide 12 months of
continuous eligibility to children under the age of 19 in Medicaid and
CHIP, with limited exceptions.
Finally, we are finalizing our proposed exceptions to the Medicaid
clinic services benefit four walls requirement, to authorize Medicaid
payment for clinic services provided outside the four walls of the
clinic for IHS/Tribal clinics, and at State option, behavioral health
clinics and clinics located in rural areas. Our current regulation at
42 CFR 440.90(b) includes an exception to the four walls requirement
under the Medicaid clinic services benefit only for clinic services
furnished to individuals who are unhoused. We believe finalizing these
additional exceptions will help maintain and improve access for the
populations served by IHS/Tribal clinics, behavioral health clinics,
and clinics located in rural areas.
[[Page 93916]]
2. Summary of the Major Provisions
<bullet> OPPS Update: For CY 2025, we are increasing the payment
rates under the OPPS by an Outpatient Department (OPD) fee schedule
increase factor of 2.9 percent. This increase factor is based on the
final inpatient hospital market basket percentage increase of 3.4
percent for inpatient services paid under the hospital inpatient
prospective payment system (IPPS) reduced by a final productivity
adjustment of 0.5 percentage point. Based on this update, we estimate
that total payments to OPPS providers (including beneficiary cost
sharing and estimated changes in enrollment, utilization, and case mix)
for calendar year (CY) 2025 will be approximately $87.7 billion, an
increase of approximately $4.7 billion compared to estimated CY 2024
OPPS payments. We are continuing to implement the statutory 2.0
percentage point reduction in payments for hospitals that fail to meet
the hospital outpatient quality reporting requirements by applying a
reporting factor of 0.9806 to the OPPS payments and copayments for all
applicable services.
<bullet> ASC Payment Update: For CYs 2019 through 2023, we adopted
a policy to update the ASC payment system using the hospital market
basket update. In light of the impact of the COVID-19 public health
emergency (PHE) on healthcare utilization, we extended our policy to
update the ASC payment system using the hospital market basket update
an additional 2 years--through CYs 2024 and 2025. Using the hospital
market basket methodology, for CY 2025, we increased payment rates
under the ASC payment system by 2.9 percent for ASCs that meet the
quality reporting requirements under the ASCQR Program. This increase
is based on a final hospital market basket percentage increase of 3.4
percent reduced by a productivity adjustment of 0.5 percentage point.
Based on this final update, we estimate that total payments to ASCs
(including beneficiary cost sharing and estimated changes in
enrollment, utilization, and case-mix) for CY 2025 will be
approximately $7.4 billion, an increase of approximately $308 million
compared to estimated CY 2024 Medicare payments.
<bullet> Device Pass-Through Payment Applications: For CY 2025, we
received 14 complete applications for device pass-through payments. We
sought public comment on these applications and make final
determinations on these applications in this final rule with comment
period.
<bullet> Changes to the List of ASC Covered Surgical Procedures and
Ancillary Services Lists: For CY 2025, we are adding 21 medical and
dental procedures to the ASC covered procedures list (CPL) and
ancillary services lists, based upon existing criteria at Sec.
416.166.
<bullet> Changes to the Inpatient Only (IPO) List: For CY 2025, we
are finalizing adding three liver allograft services for which codes
were newly created by the AMA CPT Editorial Panel for CY 2025 to the
IPO list. Additionally, we are finalizing removing a pelvic fixation
code (CPT code 22848) from the IPO list for CY 2025.
<bullet> Remote Services: For CY 2025, we are clarifying our
policies for remotely furnished outpatient therapy services, Diabetes
Self-Management Training and Medical Nutrition Therapy services and
mental health services furnished remotely to beneficiaries in their
homes by hospital staff to maintain alignment across payment systems.
<bullet> Payment for High-Cost Drugs Provided by Indian Health
Service and Tribal Hospitals: For CY 2025, we are finalizing our policy
to separately pay IHS and tribal hospitals for high-cost drugs
furnished in hospital outpatient departments through an add-on payment
in addition to the AIR under the authorities used to calculate the AIR.
<bullet> Clinical Trials Coding and Payment: We are finalizing a
clarification to our Category B clinical trials coding and payment
policy for devices and procedures to specify that our policy applies
only to IDE studies with a control arm and where a payment adjustment
is necessary to preserve the scientific validity of such a study. We
are not finalizing our proposal to extend our coding and payment policy
to drugs and devices that are being studied in clinical trials under a
Coverage with Evidence Development (CED) National Coverage
Determination (NCD),\1\ for which the trial includes a treatment and
control arm for CY 2025. We are taking additional time to consider the
broad implications of a payment methodology for clinical trials for CED
drugs and devices.
---------------------------------------------------------------------------
\1\ <a href="https://www.cms.gov/medicare/coverage/evidence">https://www.cms.gov/medicare/coverage/evidence</a>.
---------------------------------------------------------------------------
<bullet> Payment for HIV Pre-Exposure Prophylaxis (PrEP) in
Hospital Outpatient Departments: For CY 2025, we are finalizing paying
for HIV PrEP drugs covered as an additional preventive service and
related services under the OPPS. We are finalizing a site neutral
policy where products are generally paid similar rates under the OPPS
and Physician Fee Schedule.
<bullet> Diagnostic Radiopharmaceuticals Separate Payment: We are
finalizing a policy to pay separately for diagnostic
radiopharmaceuticals with per day costs above a threshold of $630,
which is approximately two times the volume weighted average cost
amount currently associated with diagnostic radiopharmaceuticals in the
Nuclear Medicine APCs. We also are finalizing updating the $630
threshold in CY 2026 and subsequent years by the Producer Price Index
(PPI) for Pharmaceutical Preparations. Finally, we are finalizing
payment for separately payable diagnostic radiopharmaceuticals based on
their Mean Unit Cost (MUC) derived from OPPS claims for CY 2025.
<bullet> Exclusion of Cell and Gene Therapies from Comprehensive
Ambulatory Payment Classification (C-APC) Packaging: We are finalizing
a policy to exclude qualifying cell and gene therapies from C-APC
packaging.
<bullet> Add-on Payment for Radiopharmaceutical Technetium-99m (Tc-
99m) Derived from Domestically Produced Mo-99: For CY 2025, an add-on
payment applies to radiopharmaceuticals that use Tc-99m produced
without use of highly enriched uranium (HEU). For CY 2026, we are
finalizing replacing the add-on payment for radiopharmaceuticals
produced without the use of Tc-99m derived from non-HEU sources with an
add-on payment for radiopharmaceuticals that use Tc-99m derived from
domestically produced Mo-99.
<bullet> Changes to the Review Timeframes for the Hospital
Outpatient Department (OPD) Prior Authorization Process: We are
changing the current review timeframe for prior authorization requests
for OPD services from 10-business days to 7-calendar days for standard
reviews.
<bullet> Health Equity Measures for the Hospital Outpatient Quality
Reporting (OQR), Rural Emergency Hospital Quality Reporting (REHQR),
and Ambulatory Surgical Center Quality Reporting (ASCQR) Programs: We
are finalizing: (1) adoption of the Hospital Commitment to Health
Equity (HCHE) measure in the Hospital OQR and the REHQR Programs, and
adoption of the Facility Commitment to Health Equity (FCHE) measure in
the ASCQR Program, beginning with the CY 2025 reporting period/CY 2027
payment or program determinations; (2) adoption of the Screening for
Social Drivers of Health (SDOH) measure in all three programs beginning
with voluntary reporting for the CY 2025 reporting period followed by
mandatory reporting beginning with the CY 2026 reporting period/CY 2028
[[Page 93917]]
payment or program determinations; and (3) adoption of the Screen
Positive Rate for SDOH measure in all three programs beginning with
voluntary reporting for the CY 2025 reporting period followed by
mandatory reporting beginning with the CY 2026 reporting period/CY 2028
payment or program determinations.
<bullet> Modification of the Immediate Measure Removal Policy for
the Hospital OQR and ASCQR Programs: We are finalizing modification of
the immediate measure removal policy to an immediate measure suspension
policy to increase transparency regarding the process for removing
adopted measures in the Hospital OQR and ASCQR Programs beginning with
CY 2025.
<bullet> Hospital Outpatient Quality Reporting (OQR) Program: In
addition to the cross-program measures and policies, we are finalizing:
(1) adoption of the Patient Understanding of Key Information Related to
Recovery After a Facility-Based Outpatient Procedure or Surgery,
Patient Reported Outcome-Based Performance Measure (Information
Transfer PRO-PM) beginning with voluntary reporting for the CY 2026
reporting period followed by mandatory reporting beginning with the CY
2027 reporting period/CY 2029 payment determination; (2) removal of the
MRI Lumbar Spine for Low Back Pain measure beginning with the CY 2025
reporting period/CY 2027 payment determination; (3) removal of the
Cardiac Imaging for Preoperative Risk Assessment for Non-Cardiac, Low-
Risk Surgery measure beginning with the CY 2025 reporting period/CY
2027 payment determination; (4) the requirement that electronic health
record (EHR) technology be certified to all electronic clinical quality
measures (eCQMs) available to report beginning with the CY 2025
reporting period/CY 2027 payment determination; and (5) public
reporting of the Median Time from Emergency Department (ED) Arrival to
ED Departure for Discharged ED Patients measure--Psychiatric/Mental
Health Patients stratification on Care Compare beginning with CY 2025.
<bullet> Rural Emergency Hospital Quality Reporting (REHQR)
Program: In addition to the cross-program measures, we are finalizing:
(1) extension of the reporting period for the Risk-Standardized
Hospital Visits Within 7 Days After Hospital Outpatient Surgery measure
from 1 year to 2 years beginning with the CY 2027 program
determination; and (2) when, after status conversion, REHs are required
to report data under the REHQR Program.
<bullet> Ambulatory Surgical Center Quality Reporting (ASCQR)
Program: In addition to finalizing the cross-program measures and
policies, we summarize comments received on the potential development
of frameworks for specialty focused reporting and minimum case number
for required reporting under the ASCQR Program.
<bullet> Hospital Inpatient Quality Reporting (IQR) Program: We are
finalizing the voluntary reporting of the core clinical data elements
(CCDEs) and linking variables for both the Hybrid Hospital-Wide
Readmission (HWR) and Hybrid Hospital-Wide Standardized Mortality (HWM)
measures, for the performance period of July 1, 2023, through June 30,
2024, impacting the FY 2026 payment determination for the Hospital IQR
Program. Additionally, we are extending voluntary reporting of CCDEs
and linking variables for an additional year for the performance period
of July 1, 2024, through June 30, 2025, impacting the FY 2027 payment
determination for the Hospital IQR Program.
<bullet> Overall Hospital Quality Star Rating: We summarize
comments received on potential modifications to the Safety of Care
measure group in the Overall Hospital Quality Star Rating methodology.
<bullet> Medicare FFS No Legal Obligation to Pay Payment Exclusion
and Incarceration: We are narrowing the description of ``custody'' for
purposes of Medicare's no legal obligation to pay payment exclusion at
Sec. 411.4(b), stating explicitly in regulatory text that individuals
who are released to the community pending trial (including those in
pretrial community supervision and those released pursuant to cash
bail), on parole, probation, or home detention, or required to reside
in halfway houses are not considered to be in ``custody'' for purposes
of the payment exclusion, adding a definition of ``penal authority,''
reorganizing the regulation, and making certain technical edits.
<bullet> Revision to Medicare Special Enrollment Period for
Formerly Incarcerated Individuals: We are finalizing the eligibility
requirements in the special enrollment period (SEP) for formerly
incarcerated individuals at Sec. Sec. 406.27(d) and 407.23(d) to
remove the reference to ``custody'' associated with Sec. 411.4(b) and
instead tie the eligibility for this SEP to the determination made by
SSA that they are no longer incarcerated. We are also expanding the SEP
eligibility criteria to include individuals released from confinement
to residency in halfway houses.
<bullet> Continuous Eligibility in Medicaid and CHIP: We are
finalizing our proposed revisions to Medicaid and CHIP regulations to
codify the requirement within the CAA, 2023 for States to provide 12
months of continuous eligibility to children under the age of 19 in
Medicaid and CHIP, with limited exceptions. Specifically, we are
finalizing the removal of the option to provide continuous eligibility
to a subgroup of Medicaid and CHIP enrollees and for a time period of
less than 12 months. For CHIP, we are finalizing the removal of the
option to disenroll children from CHIP during a continuous eligibility
period for failure to pay premiums.
<bullet> Medicaid Clinic Services Four Walls Exceptions: We are
finalizing three exceptions to the Medicaid clinic services benefit
four walls requirement at 42 CFR 440.90. Our current regulation at 42
CFR 440.90(b) allows for Medicaid payment for clinic services furnished
outside of the four walls of the clinic only to individuals who are
unhoused. Our final rule adds a mandatory exception to the four walls
requirement for IHS/Tribal clinics at 42 CFR 440.90(c) and optional
exceptions for behavioral health clinics and clinics located in rural
areas at 42 CFR 440.90(d) and (e), respectively.
<bullet> Health and Safety Standards for Obstetrical Services in
Hospitals and Critical Access Hospitals: We are finalizing new
Conditions of Participation (CoPs) for hospitals and CAHs for
obstetrical services, including new requirements for maternal quality
assessment and performance improvement (QAPI), as well as baseline
standards for the organization, staffing, and delivery of care within
obstetrical units, and staff training on evidence-based best practices
every 2 years. We are finalizing revisions to the emergency services
CoP related to emergency readiness for hospitals and CAHs that provide
emergency services. In addition, we are finalizing revisions to the
Discharge Planning CoP for all hospitals related to transfer protocols.
Further, we are finalizing a phased-in implementation to provide
hospitals and CAHs with additional time to come into compliance with
the requirements. Lastly, we sought comments in the proposed rule on
whether these requirements should also apply to rural emergency
hospitals (REHs), which we discuss below.
3. Summary of Costs and Benefits
In section XXVIII of this final rule with comment period, we set
forth a detailed analysis of the regulatory and federalism impacts that
the proposed
[[Page 93918]]
changes would have on affected entities and beneficiaries. Key
estimated impacts are described below.
a. Impacts of All OPPS Changes
Table 201 in section XXVIII.C of this final rule with comment
period displays the distributional impact of all the OPPS changes on
various groups of hospitals and CMHCs for CY 2025 compared to all
estimated OPPS payments in CY 2024. We estimate that the final policies
in this final rule with comment period would result in a 3.0 percent
overall increase in OPPS payments to providers. We estimate that total
OPPS payments for CY 2025, including beneficiary cost-sharing, to the
approximately 3,500 facilities paid under the OPPS (including general
acute care hospitals, children's hospitals, cancer hospitals, and
CMHCs) would increase by approximately $1.98 billion compared to CY
2024 payments, excluding our estimated changes in enrollment,
utilization, and case-mix.
We estimated the isolated impact of our OPPS policies on CMHCs
because CMHCs have historically only been paid for partial
hospitalization services under the OPPS. Beginning CY 2024, they are
also paid for intensive outpatient program (IOP) services under the
OPPS. Continuing the provider-specific structure we adopted beginning
in CY 2011, and basing payment fully on the type of provider furnishing
the service, we estimate a 11.9 percent increase in CY 2025 payments to
CMHCs relative to their CY 2024 payments.
b. Impacts of the Updated Wage Indexes
We estimate that our update of the wage indexes based on the fiscal
year (FY) 2025 IPPS final rule wage indexes will result in a 0.1
percent increase for urban hospitals under the OPPS and a 0.9 percent
increase for rural hospitals. These wage indexes include continued
implementation of the Office of Management and Budget (OMB) labor
market area delineations based on 2020 Decennial Census data, with
updates, as discussed in section II.C of this final rule with comment
period.
c. Impacts of the Rural Adjustment and the Cancer Hospital Payment
Adjustment
For CY 2025, we are continuing to provide additional payments to
cancer hospitals so that a cancer hospital's payment-to-cost ratio
(PCR) after the additional payments is equal to the weighted average
PCR for the other OPPS hospitals using the most recently submitted or
settled cost report data. Section 16002(b) of the 21st Century Cures
Act requires that this weighted average PCR be reduced by 1.0
percentage point. In light of the COVID-19 PHE impact on claims and
cost data used to calculate the target PCR, we had maintained the CY
2021 target PCR of 0.89 through CYs 2022 and 2023. However, in CY 2024,
we finalized a policy to reduce the target PCR by 1.0 percentage point
each calendar year until the target PCR equals the PCR of non-cancer
hospitals using the most recently submitted or settled cost report
data. For CY 2024, we finalized a target PCR of 0.88. For CY 2025, we
are finalizing a target PCR of 0.87 to determine the CY 2025 cancer
hospital payment adjustment to be paid at cost report settlement. That
is, the payment adjustments would be the additional payments needed to
result in a PCR equal to 0.87 for each cancer hospital.
d. Impacts of the OPD Fee Schedule Increase Factor
For the CY 2025 OPPS/ASC, we are establishing an OPD fee schedule
increase factor of 2.9 percent and applying that increase factor to the
conversion factor for CY 2025. As a result of the OPD fee schedule
increase factor and other budget neutrality adjustments, we estimate
that urban hospitals will experience an increase in payments of
approximately 3.2 percent and that rural hospitals will experience an
increase in payments of 3.2 percent. Classifying hospitals by teaching
status, we estimate non-teaching hospitals will experience an increase
in payments of 3.3 percent, minor teaching hospitals will experience an
increase in payments of 3.5 percent, and major teaching hospitals will
experience an increase in payments of 2.7 percent. We also classified
hospitals by the type of ownership. We estimate that hospitals with
voluntary ownership will experience an increase of 3.1 percent in
payments, while hospitals with government ownership will experience an
increase of 2.6 percent in payments. We estimate that hospitals with
proprietary ownership will experience an increase of 4.9 percent in
payments.
e. Impacts of the ASC Payment Update
For impact purposes, the surgical procedures on the ASC covered
surgical procedure list are aggregated into surgical specialty groups
using CPT and HCPCS code range definitions. The percentage change in
estimated total payments by specialty groups under the CY 2025 payment
rates, compared to estimated CY 2024 payment rates, generally ranges
between an increase of 3 percent and an increase of 4 percent,
depending on the service, with some exceptions. We estimate the impact
of applying the inpatient hospital market basket update to ASC payment
rates will increase payments by $193 million under the ASC payment
system in CY 2025.
f. Impacts of Medicaid Clinic Services Four Walls Exceptions
We estimate that the finalized exceptions to the four walls
requirement under the Medicaid clinic services benefit for IHS/Tribal
clinics, behavioral health clinics, and clinics located in rural areas
will increase total expenditures by $1.18 billion from FY 2025 through
2029. Our estimate includes a Federal impact of $1.15 billion and
impact to States of $30 million. These estimates are discussed in more
detail in section XXVIII of this final rule.
g. Impacts of Health and Safety Standards for Obstetrical Services in
Hospitals and Critical Access Hospitals
We are finalizing maternal health focused revisions to the CoPs for
hospitals and CAHs, which are estimated to increase burden on hospitals
and CAHs by $423 million annually with total costs estimated at $4.23
billion over 10 years. We expect an average annual cost of $67,103 per
hospital and CAH. As discussed in detail in section XXVIII of this
final rule with comment period, we expect the benefits of these
policies to include reduced maternal morbidity and mortality, leading
to financial benefits for patients, their families, and payors. We also
expect that the policies are likely to reduce inequality in maternal
health outcomes among pregnant and postpartum women from different
groups and lead to overall improvements in patient care.
h. Impacts of the Medicaid and CHIP Continuous Eligibility Requirements
We are finalizing our proposed revisions to Medicaid and CHIP
regulations to codify the requirement within the CAA, 2023 for States
to provide 12 months of continuous eligibility to children under the
age of 19 in Medicaid and CHIP, with limited exceptions. For CHIP, we
are finalizing the removal of the option to disenroll children from
CHIP during a continuous eligibility period for failure to pay
premiums. Requiring 12months of continuous eligibility in Medicaid and
CHIP is estimated to increase annual average enrollment in Medicaid and
CHIP by approximately 124,000 by 2028 (75,000 in Medicaid and 49,000 in
CHIP). The total estimated impact of this requirement over 5 years is
$2,466 million, including Federal impact of
[[Page 93919]]
$1,592 million and State impact of $874 million.
B. Legislative and Regulatory Authority for the Hospital OPPS
When Title XVIII of the Act was enacted, Medicare payment for
hospital outpatient services was based on hospital-specific costs. In
an effort to ensure that Medicare and its beneficiaries pay
appropriately for services and to encourage more efficient delivery of
care, the Congress mandated replacement of the reasonable cost-based
payment methodology with a prospective payment system (PPS). The
Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) added section
1833(t) to the Act, authorizing implementation of a PPS for hospital
outpatient services. The OPPS was first implemented for services
furnished on or after August 1, 2000. Implementing regulations for the
OPPS are located at 42 CFR parts 410 and 419.
The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
1999 (BBRA) (Pub. L. 106-113) made major changes in the hospital OPPS.
The following Acts made additional changes to the OPPS: the Medicare,
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000
(BIPA) (Pub. L. 106-554); the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (MMA) (Pub. L. 108-173); the Deficit
Reduction Act of 2005 (DRA) (Pub. L. 109-171), enacted on February 8,
2006; the Medicare Improvements and Extension Act under Division B of
Title I of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA)
(Pub. L. 109-432), enacted on December 20, 2006; the Medicare,
Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173),
enacted on December 29, 2007; the Medicare Improvements for Patients
and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), enacted on July
15, 2008; the Patient Protection and Affordable Care Act (Pub. L. 111-
148), enacted on March 23, 2010, as amended by the Health Care and
Education Reconciliation Act of 2010 (HCERA, Pub. L. 111-152), enacted
on March 30, 2010 (these two public laws are collectively known as the
Affordable Care Act); the Medicare and Medicaid Extenders Act of 2010
(MMEA, Pub. L. 111-309); the Temporary Payroll Tax Cut Continuation Act
of 2011 (TPTCCA, Pub. L. 112-78), enacted on December 23, 2011; the
Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA, Pub. L.
112-96), enacted on February 22, 2012; the American Taxpayer Relief Act
of 2012 (Pub. L. 112-240), enacted January 2, 2013; the Pathway for SGR
Reform Act of 2013 (Pub. L. 113-67) enacted on December 26, 2013; the
Protecting Access to Medicare Act of 2014 (PAMA, Pub. L. 113-93),
enacted on March 27, 2014; the Medicare Access and CHIP Reauthorization
Act (MACRA) of 2015 (Pub. L. 114-10), enacted April 16, 2015; the
Bipartisan Budget Act of 2015 (Pub. L. 114-74), enacted November 2,
2015; the Consolidated Appropriations Act, 2016 (Pub. L. 114-113),
enacted on December 18, 2015, the 21st Century Cures Act (Pub. L. 114-
255), enacted on December 13, 2016; the Consolidated Appropriations
Act, 2018 (Pub. L. 115-141), enacted on March 23, 2018; the Substance
Use Disorder--Prevention that Promotes Opioid Recovery and Treatment
for Patients and Communities Act (Pub. L. 115-271), enacted on October
24, 2018; the Further Consolidated Appropriations Act, 2020 (Pub. L.
116-94), enacted on December 20, 2019; the Coronavirus Aid, Relief, and
Economic Security Act (Pub. L. 116-136), enacted on March 27, 2020; the
Consolidated Appropriations Act, 2021 (Pub. L. 116-260), enacted on
December 27, 2020; the Inflation Reduction Act, 2022 (Pub. L. 117-169),
enacted on August 16, 2022; and the Consolidated Appropriations Act
(CAA), 2023 (Pub. L. 117-238), enacted December 29, 2022.
Under the OPPS, we generally pay for hospital Part B services on a
rate-per-service basis that varies according to the APC group to which
the service is assigned. We use the Healthcare Common Procedure Coding
System (HCPCS) (which includes certain Current Procedural Terminology
(CPT) codes) to identify and group the services within each APC. The
OPPS includes payment for most hospital outpatient services, except
those identified in section I.C of this final rule with comment period.
Section 1833(t)(1)(B) of the Act provides for payment under the OPPS
for hospital outpatient services designated by the Secretary (which
includes partial hospitalization services furnished by CMHCs), and
certain inpatient hospital services that are paid under Medicare Part
B.
The OPPS rate is an unadjusted national payment amount that
includes the Medicare payment and the beneficiary copayment. This rate
is divided into a labor-related amount and a nonlabor-related amount.
The labor-related amount is adjusted for area wage differences using
the hospital inpatient wage index value for the locality in which the
hospital or CMHC is located.
All services and items within an APC group are comparable
clinically and with respect to resource use, as required by section
1833(t)(2)(B) of the Act. In accordance with section 1833(t)(2)(B) of
the Act, subject to certain exceptions, items and services within an
APC group cannot be considered comparable with respect to the use of
resources if the highest median cost (or mean cost, if elected by the
Secretary) for an item or service in the APC group is more than 2 times
greater than the lowest median cost (or mean cost, if elected by the
Secretary) for an item or service within the same APC group (referred
to as the ``2 times rule''). In implementing this provision, we
generally use the cost of the item or service assigned to an APC group.
For new technology items and services, special payments under the
OPPS may be made in one of two ways. Section 1833(t)(6) of the Act
provides for temporary additional payments, which we refer to as
``transitional pass-through payments,'' for at least 2 but not more
than 3 years for certain drugs, biological agents, brachytherapy
devices used for the treatment of cancer, and categories of other
medical devices. For new technology services that are not eligible for
transitional pass-through payments, and for which we lack sufficient
clinical information and cost data to appropriately assign them to a
clinical APC group, we have established special APC groups based on
costs, which we refer to as New Technology APCs. These New Technology
APCs are designated by cost bands which allow us to provide appropriate
and consistent payment for designated new procedures that are not yet
reflected in our claims data. Similar to pass-through payments, an
assignment to a New Technology APC is temporary; that is, we retain a
service within a New Technology APC until we acquire sufficient data to
assign it to a clinically appropriate APC group.
C. Excluded OPPS Services and Hospitals
Section 1833(t)(1)(B)(i) of the Act authorizes the Secretary to
designate the hospital outpatient services that are paid under the
OPPS. While most hospital outpatient services are payable under the
OPPS, section 1833(t)(1)(B)(iv) of the Act excludes payment for
ambulance, physical and occupational therapy, and speech-language
pathology services, for which payment is made under a fee schedule. It
also excludes screening mammography, diagnostic mammography, and
effective January 1, 2011, an annual wellness visit providing
personalized prevention plan services. The Secretary exercises the
authority granted under the statute to also exclude from the OPPS
certain services that are
[[Page 93920]]
paid under fee schedules or other payment systems. Such excluded
services include, for example, the professional services of physicians
and nonphysician practitioners paid under the Medicare Physician Fee
Schedule (MPFS); certain laboratory services paid under the Clinical
Laboratory Fee Schedule (CLFS); services for beneficiaries with end-
stage renal disease (ESRD) that are paid under the ESRD prospective
payment system; and services and procedures that require an inpatient
stay that are paid under the hospital IPPS. In addition, section
1833(t)(1)(B)(v) of the Act does not include applicable items and
services (as defined in subparagraph (A) of paragraph (21)) that are
furnished on or after January 1, 2017, by an off-campus outpatient
department of a provider (as defined in subparagraph (B) of paragraph
(21)). We set forth the services that are excluded from payment under
the OPPS in regulations at 42 CFR 419.22.
Under Sec. 419.20(b) of the regulations, we specify the types of
hospitals that are excluded from payment under the OPPS. These excluded
hospitals are:
<bullet> Critical access hospitals (CAHs);
<bullet> Hospitals located in Maryland and paid under Maryland's
All-Payer or Total Cost of Care Model;
<bullet> Hospitals located outside of the 50 States, the District
of Columbia, and Puerto Rico;
<bullet> Indian Health Service (IHS) hospitals; and
<bullet> Rural emergency hospitals (REH).
D. Prior Rulemaking
On April 7, 2000, we published in the Federal Register a final rule
with comment period (65 FR 18434) to implement a prospective payment
system for hospital outpatient services. The hospital OPPS was first
implemented for services furnished on or after August 1, 2000. Section
1833(t)(9)(A) of the Act requires the Secretary to review certain
components of the OPPS, not less often than annually, and to revise the
groups, the relative payment weights, and the wage and other
adjustments to take into account changes in medical practices, changes
in technology, the addition of new services, new cost data, and other
relevant information and factors.
Since initially implementing the OPPS, we have published final
rules in the Federal Register annually to implement statutory
requirements and changes arising from our continuing experience with
this system. These rules can be viewed on the CMS website at: <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices</a>.
E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel or the
Panel)
1. Authority of the Panel
Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of
Public Law 106-113, and redesignated by section 202(a)(2) of Public Law
106-113, requires that we consult with an expert outside advisory panel
composed of an appropriate selection of representatives of providers to
annually review (and advise the Secretary concerning) the clinical
integrity of the payment groups and their weights under the OPPS. In CY
2000, based on section 1833(t)(9)(A) of the Act, the Secretary
established the Advisory Panel on Ambulatory Payment Classification
Groups (APC Panel) to fulfill this requirement. In CY 2011, based on
section 222 of the Public Health Service Act (the PHS Act), which gives
discretionary authority to the Secretary to convene advisory councils
and committees, the Secretary expanded the panel's scope to include the
supervision of hospital outpatient therapeutic services in addition to
the APC groups and weights. To reflect this new role of the panel, the
Secretary changed the panel's name to the Advisory Panel on Hospital
Outpatient Payment (the HOP Panel). The HOP Panel is not restricted to
using data compiled by CMS, and in conducting its review, it may use
data collected or developed by organizations outside the Department.
2. Establishment of the Panel
On November 21, 2000, the Secretary signed the initial charter
establishing the Panel, and, at that time, named the APC Panel. This
expert panel is composed of appropriate representatives of providers
(currently employed full-time, not as consultants, in their respective
areas of expertise) who review clinical data and advise CMS about the
clinical integrity of the APC groups and their payment weights. Since
CY 2012, the Panel also is charged with advising the Secretary on the
appropriate level of supervision for individual hospital outpatient
therapeutic services. The Panel is technical in nature, and it is
governed by the provisions of the Federal Advisory Committee Act
(FACA). The current charter specifies, among other requirements, that
the Panel--
<bullet> May advise on the clinical integrity of Ambulatory Payment
Classification (APC) groups and their associated weights;
<bullet> May advise on the appropriate supervision level for
hospital outpatient services;
<bullet> May advise on OPPS APC rates for ASC covered surgical
procedures;
<bullet> Continues to be technical in nature;
<bullet> Is governed by the provisions of the FACA;
<bullet> Has a Designated Federal Official (DFO); and
<bullet> Is chaired by a Federal Official designated by the
Secretary.
The Panel's charter was amended on November 15, 2011, renaming the
Panel and expanding the Panel's authority to include supervision of
hospital outpatient therapeutic services and to add critical access
hospital (CAH) representation to its membership. The Panel's charter
was also amended on November 6, 2014 (80 FR 23009), and the number of
members was revised from up to 19 to up to 15 members. The Panel's
current charter was approved on November 21, 2022, for a 2-year period.
The current Panel membership and other information pertaining to
the Panel, including its charter, Federal Register notices, membership,
meeting dates, agenda topics, and meeting reports, can be viewed on the
CMS website at: <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html</a>.
3. Panel Meetings and Organizational Structure
The Panel has held many meetings, with the last meeting taking
place on August 26, 2024. The recommendations of the Panel for the most
recent meeting are available on the CMS website at: <a href="https://www.cms.gov/medicare/regulations-guidance/advisory-committees/hospital-outpatient-payment">https://www.cms.gov/medicare/regulations-guidance/advisory-committees/hospital-outpatient-payment</a>. Prior to each meeting, we publish a notice in the
Federal Register to announce the meeting, new members, and any other
changes of which the public should be aware. Beginning in CY 2017, we
have transitioned to one meeting per year (81 FR 31941). In CY 2022, we
published a Federal Register notice requesting nominations to fill
vacancies on the Panel (87 FR 68499). CMS is currently accepting
nominations at: <a href="https://mearis.cms.gov">https://mearis.cms.gov</a>.
In addition, the Panel has established an administrative structure
that, in part, currently includes the use of three subcommittee
workgroups to provide preparatory meeting and subject support to the
larger panel. The three current subcommittees include the following:
<bullet> APC Groups and Status Indicator Assignments Subcommittee,
which advises and provides recommendations to the Panel on the
appropriate status
[[Page 93921]]
indicators to be assigned to HCPCS codes, including but not limited to
whether a HCPCS code or a category of codes should be packaged or
separately paid, as well as the appropriate APC assignment of HCPCS
codes regarding services for which separate payment is made;
<bullet> Data Subcommittee, which is responsible for studying the
data issues confronting the Panel and for recommending options for
resolving them; and
<bullet> Visits and Observation Subcommittee, which reviews and
makes recommendations to the Panel on all technical issues pertaining
to observation services and hospital outpatient visits paid under the
OPPS.
Each of these workgroup subcommittees was established by a majority
vote from the full Panel during a scheduled Panel meeting, and the
Panel recommended at the August 21, 2023, meeting that the
subcommittees continue. We accepted this recommendation.
For discussions of earlier Panel meetings and recommendations, we
refer readers to previously published OPPS/ASC proposed and final
rules, the CMS website mentioned earlier in this section, and the FACA
database at <a href="https://facadatabase.gov">https://facadatabase.gov</a>.
F. Public Comments Received on the CY 2025 Proposed Rule
We received approximately 3,500 timely pieces of correspondence on
the CY 2025 OPPS/ASC proposed rule that appeared in the Federal
Register on July 22, 2024 (89 FR 59186). We received comments from
elected officials, providers and suppliers, practitioners, and advocacy
groups. We provide summaries of the public comments, and our responses
are set forth in the various sections of this final rule with comment
period under the appropriate headings. We note that we received some
public comments that were outside the scope of the CY 2025 OPPS/ASC
proposed rule. Out-of-scope-public comments are not addressed in this
CY 2025 OPPS/ASC final rule with comment period.
G. Public Comments Received on the CY 2024 OPPS/ASC Final Rule With
Comment Period
We received approximately 180 timely pieces of correspondence on
the CY 2024 OPPS/ASC final rule with comment period that appeared in
the Federal Register on November 22, 2023 (88 FR 81540).
II. Updates Affecting OPPS Payments
A. Recalibration of APC Relative Payment Weights
1. Database Construction
a. Database Source and Methodology
Section 1833(t)(9)(A) of the Act requires that the Secretary review
not less often than annually and revise the relative payment weights
for Ambulatory Payment Classifications (APCs). In the April 7, 2000,
OPPS final rule with comment period (65 FR 18482), we explained in
detail how we calculated the relative payment weights that were
implemented on August 1, 2000, for each APC group.
For the CY 2025 OPPS, we proposed to recalibrate the APC relative
payment weights for services furnished on or after January 1, 2025, and
before January 1, 2026 (CY 2025), using the same basic methodology that
we described in the CY 2024 OPPS/ASC final rule with comment period (88
FR 81549 through 81552), using CY 2023 claims data. That is, we
proposed to recalibrate the relative payment weights for each APC based
on claims and cost report data for hospital outpatient department
(HOPD) services to construct a database for calculating APC group
weights.
For the purpose of recalibrating the proposed APC relative payment
weights for CY 2025, we began with approximately 145 million final
action claims (claims for which all disputes and adjustments have been
resolved and payment has been made) for HOPD services furnished on or
after January 1, 2023, and before January 1, 2024, before applying our
exclusionary criteria and other methodological adjustments. After the
application of those data processing changes, we used approximately 73
million final action claims to develop the proposed CY 2025 OPPS
payment weights. For exact numbers of claims used and additional
details on the claims accounting process, we refer readers to the
claims accounting narrative under supporting documentation for the CY
2025 OPPS/ASC proposed rule on the CMS website at: <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient</a>.
Addendum N to the CY 2025 OPPS/ASC proposed rule (which is
available via the internet on the CMS website at: <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices</a>) includes the proposed list of bypass codes for CY
2025. The proposed list of bypass codes contains codes that are
reported on claims for services in CY 2023 and, therefore, includes
codes that were in effect in CY 2023 and used for billing. We proposed
to retain these deleted bypass codes on the proposed CY 2025 bypass
list because these codes existed in CY 2023 and were covered OPD
services in that period, and CY 2023 claims data were used to calculate
proposed CY 2025 payment rates. Keeping these deleted bypass codes on
the bypass list potentially allows us to create more ``pseudo'' single
procedure claims for ratesetting purposes. ``Overlap bypass codes''
that are members of the proposed multiple imaging composite APCs are
identified by asterisks (*) in the third column of Addendum N to the CY
2025 OPPS/ASC proposed rule. HCPCS codes that we proposed to add for CY
2025 are identified by asterisks (*) in the fourth column of Addendum
N.
We did not receive any public comments on our general proposal to
recalibrate the relative payment weights for each APC based on claims
and cost report data for HOPD services or on our proposed bypass code
process. We are finalizing as proposed the ``pseudo'' single claims
process and the final CY 2025 list of bypass codes, as displayed in
Addendum N to this final rule with comment period (which is available
via the internet on the CMS website). For this final rule with comment
period, for the purpose of recalibrating the final APC relative payment
weights for CY 2025, we used approximately 78 million final action
claims (claims for which all disputes and adjustments have been
resolved and payment has been made) for HOPD services furnished on or
after January 1, 2023, and before January 1, 2024. For the exact
numbers of claims used and additional details on the claims accounting
process, we refer readers to the claims accounting narrative under
supporting documentation for this final rule with comment period on the
CMS website at: <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient</a>.
b. Calculation and Use of Cost-to-Charge Ratios (CCRs)
For CY 2025, we proposed to continue to use the hospital-specific
overall ancillary and departmental cost-to-charge ratios (CCRs) to
convert charges to estimated costs through application of a revenue
code-to-cost center crosswalk. To calculate the APC costs on which the
proposed CY 2025 APC payment rates are based, we calculated hospital-
specific departmental CCRs for each hospital for which we had CY 2023
claims data by comparing these claims data to the most recently
available hospital cost reports, which, in most
[[Page 93922]]
cases, are from CY 2022. For the proposed CY 2025 OPPS payment rates,
we used the set of claims processed during CY 2023. We applied the
hospital-specific CCR to the hospital's charges at the most detailed
level possible, based on a revenue code-to-cost center crosswalk that
contains a hierarchy of CCRs used to estimate costs from charges for
each revenue code. To ensure the completeness of the revenue code-to-
cost center crosswalk, we reviewed changes to the list of revenue codes
for CY 2023 (the year of claims data we used to calculate the proposed
CY 2025 OPPS payment rates) and updates to the National Uniform Billing
Committee (NUBC) 2023 Data specifications Manual. That crosswalk is
available for review and continuous comment on the CMS website at
<a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient</a>.
In accordance with our longstanding policy, similar to our
finalized policy for CY 2024 OPPS ratesetting, we proposed to calculate
CCRs for the standard cost centers--cost centers with a predefined
label--and nonstandard cost centers--cost centers defined by a
hospital--accepted by the electronic cost report database. In general,
the most detailed level at which we calculate CCRs is the hospital-
specific departmental level.
While we generally view the use of additional cost data as
improving our OPPS ratesetting process, we have historically not
included cost report lines for certain nonstandard cost centers in the
OPPS ratesetting database construction when hospitals have reported
these nonstandard cost centers on cost report lines that do not
correspond to the cost center number. We believe it is important to
further investigate the accuracy of these cost report data before
including such data in the ratesetting process. Further, we believe it
is appropriate to gather additional information from the public as well
before including them in OPPS ratesetting. For CY 2025, we proposed not
to include the nonstandard cost centers reported in this way in the
OPPS ratesetting database construction.
We did not receive any public comments on the general CCR process
and therefore, we are finalizing our proposal for CY 2025 to use the
hospital-specific overall ancillary and departmental CRs to convert
charges to estimated costs through application of a revenue code-to-
cost center crosswalk and the proposed methodology.
2. Final Data Development and Calculation of Costs Used for Ratesetting
In this section of this final rule with comment period, we discuss
the use of claims to calculate the OPPS payment rates for CY 2025. The
Hospital OPPS page on the CMS website on which this final rule with
comment period is posted (<a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient</a>) provides an accounting
of claims used in the development of the proposed payment rates. That
accounting provides additional detail regarding the number of claims
derived at each stage of the process. In addition, later in this
section we discuss the file of claims that comprises the data set that
is available upon payment of an administrative fee under a CMS data use
agreement. The CMS website, <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient</a>, includes information
about obtaining the ``OPPS Limited Data Set,'' which now includes the
additional variables previously available only in the OPPS Identifiable
Data Set, including International Classification of Diseases, Tenth
Revision, Clinical Modification (ICD-10-CM) diagnosis codes and revenue
code payment amounts. This file is derived from the CY 2023 claims that
are used to calculate the proposed payment rates for the CY 2025 OPPS/
ASC proposed rule.
Previously, the OPPS established the scaled relative weights on
which payments are based using APC median costs, a process described in
the CY 2012 OPPS/ASC final rule with comment period (76 FR 74188).
However, as discussed in more detail in section II.A.2.f of the CY 2013
OPPS/ASC final rule with comment period (77 FR 68259 through 68271), we
finalized the use of geometric mean costs to calculate the relative
weights on which the CY 2013 OPPS payment rates were based. While this
policy changed the cost metric on which the relative payments are
based, the data process in general remained the same under the
methodologies that we used to obtain appropriate claims data and
accurate cost information in determining estimated service cost.
We used the methodology described in sections II.A.2.a through
II.A.2.c of this final rule with comment period to calculate the costs
we used to establish the proposed relative payment weights used in
calculating the OPPS payment rates for CY 2025 shown in Addenda A and B
to this final rule with comment period (which are available via the
internet on the CMS website at: <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices</a>).
We refer readers to section II.A.4 of this final rule with comment
period for a discussion of the conversion of APC costs to scaled
payment weights.
We note that under the OPPS, CY 2019 was the first year in which
the claims data used for setting payment rates (CY 2017 data) contained
lines with the modifier ``PN,'' which indicates nonexcepted items and
services furnished and billed by off-campus provider-based departments
(PBDs) of hospitals. Because nonexcepted items and services are not
paid under the OPPS, in the CY 2019 OPPS/ASC final rule with comment
period (83 FR 58832), we finalized a policy to remove those claim lines
reported with modifier ``PN'' from the claims data used in ratesetting
for the CY 2019 OPPS and subsequent years. For the CY 2025 OPPS, we
proposed to continue to remove claim lines with modifier ``PN'' from
the ratesetting process.
We did not receive any public comments on our proposal and are
finalizing our proposal to continue to remove claim lines reported with
modifier ``PN'' from the ratesetting process.
For details of the claims accounting process used in this CY 2025
OPPS/ASC final rule with comment period, we refer readers to the claims
accounting narrative under supporting documentation for this final rule
with comment period on the CMS website at: <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient</a>.
a. Calculation of Single Procedure APC Criteria-Based Costs
(1) Blood and Blood Products
(a) Methodology
Since the implementation of the OPPS in August 2000, we have made
separate payments for blood and blood products through APCs rather than
packaging payment for them into payments for the procedures with which
they are administered. Hospital payments for the costs of blood and
blood products, as well as for the costs of collecting, processing, and
storing blood and blood products, are made through the OPPS payments
for specific blood product APCs.
In the CY 2025 OPPS/ASC proposed rule, we proposed to continue to
establish payment rates for blood and blood products using our blood-
specific CCR methodology (88 FR 49562), which utilizes actual or
simulated CCRs from
[[Page 93923]]
the most recently available hospital cost reports to convert hospital
charges for blood and blood products to costs. This methodology has
been our standard ratesetting methodology for blood and blood products
since CY 2005. It was developed in response to data analysis indicating
that there was a significant difference in CCRs for those hospitals
with and without blood-specific cost centers and past public comments
indicating that the former OPPS policy of defaulting to the overall
hospital CCR for hospitals not reporting a blood-specific cost center
often resulted in an underestimation of the true hospital costs for
blood and blood products. To address the differences in CCRs and to
better reflect hospitals' costs, our methodology simulates blood CCRs
for each hospital that does not report a blood cost center by
calculating the ratio of the blood-specific CCRs to hospitals' overall
CCRs for those hospitals that do report costs and charges for blood
cost centers and applies this mean ratio to the overall CCRs of
hospitals not reporting costs and charges for blood cost centers on
their cost reports. We propose to calculate the costs upon which the
proposed payment rates for blood and blood products are based using the
actual blood-specific CCR for hospitals that reported costs and charges
for a blood cost center and a hospital-specific, simulated, blood-
specific CCR for hospitals that did not report costs and charges for a
blood cost center.
We stated in the CY 2025 OPPS/ASC proposed rule that we continue to
believe that the hospital-specific, simulated, blood-specific CCR
methodology takes into account the unique charging and cost accounting
structure of each hospital, as it better responds to the absence of a
blood-specific CCR for a hospital than alternative methodologies, such
as defaulting to the overall hospital CCR or applying an average blood-
specific CCR across hospitals. This methodology also yields more
accurate estimated costs for these products and results in payment
rates for blood and blood products that appropriately reflect the
relative estimated costs of these products for hospitals without blood
cost centers and for these blood products in general.
We refer readers to Addendum B to this final rule with comment
period (which is available via the internet on the CMS website at
<a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices</a>) for the final CY 2025 payment
rates for blood and blood products (which are generally identified with
status indicator ``R'').
For a more detailed discussion of payments for blood and blood
products through APCs, we refer readers to:
<bullet> the CY 2005 OPPS proposed rule (69 FR 50524 and 50525) for
a more comprehensive discussion of the blood-specific CCR methodology;
<bullet> the CY 2008 OPPS/ASC final rule with comment period (72 FR
66807 through 66810) for a detailed history of the OPPS payment for
blood and blood products; and
<bullet> the CY 2015 OPPS/ASC final rule with comment period (79 FR
66795 and 66796) for additional discussion of our policy not to make
separate payments for blood and blood products when they appear on the
same claims as services assigned to a C-APC.
Comment: We received one comment regarding the cost calculations
for blood and blood products. The commenter stated that current payment
rates do not always cover the cost to process, store, and transport the
unit of blood. The commenter recommended that CMS utilize the average
wholesale price (AWP) as the payment rate for blood products, in
addition to basing payment rates on the hospital CCRs, as they believed
using AWP would help eliminate outliers and produce more accurate
payment calculations. The commenter explained that cost reporting
methodologies may vary among hospitals. For example, some cost centers
may combine blood products with blood bank testing which could skew the
CCRs for that cost center, which would then impact the payment rates.
Response: We thank the commenter for their input and will keep it
in mind for future rulemaking. However, we note that reflecting the
range and variation of billing patterns across hospitals, as reflected
in their claims, is part of establishing prospective payment rates.
Additionally, we do not believe at this time that using AWP to set the
payment rate for blood products would necessarily result in more
accurate payment calculations, because AWP does not factor in volume
discounts or rebates and, therefore, may not reflect the true cost of
the product.
Comment: One commenter supported our proposal to continue to pay
separately for blood and blood products.
Response: We thank the commenter for their support.
After consideration of the public comments we received, we are
finalizing our proposals for blood and blood products using our blood-
specific CCR methodology without modification. Please refer to Addendum
B to this final rule with comment period, which is available on the CMS
website, for the final CY 2025 payment rates for blood and blood
products.
(b) New HCPCS Code for Red Blood Cell Product (HCPCS Code P9027)
Effective October 1, 2024, the HCPCS workgroup created HCPCS code
P9027 (Red blood cells, leukocytes reduced, oxygen/carbon dioxide
reduced, each unit). HCPCS code P9027 may be used to bill for a blood
product that utilizes a two-stage process to remove oxygen and maintain
a deoxygenated state throughout its storage period, thereby preventing
oxidative damage to red blood cells. We note that because HCPCS code
P9027 was created after the CY 2025 OPPS/ASC proposed rule was issued,
we did not include a proposal regarding the APC assignment for HCPCS
code P9027 in the CY 2025 OPPS/ASC proposed rule. Due to its effective
date, we assigned HCPCS code P9027 to APC 9541 with an SI = R (Blood
and Blood Products) in Change Request 13784. The payment rate for HCPCS
code P9027, effective October 1, 2024, is $252.48.
While we usually calculate payment rates for blood and blood
products using our blood-specific CCR methodology, when there is no
claims data on the charges and costs for blood products upon which to
apply our blood-specific CCR methodology, we establish a payment rate
for the new blood product based on a crosswalk to an existing blood
product HCPCS code that we believe provides the best proxy for the
costs of the new blood product. Because we did not have any claims data
on HCPCS code P9027 ahead of its October 1, 2024, effective date, we
used a crosswalk code to assign a payment rate for HCPCS code P9027.
Specifically, we found that HCPCS code P9040 (Red blood cells,
leukocytes reduced, irradiated, each unit) with a CY 2024 payment rate
of $252.48 was sufficiently similar to P9027 to serve as a crosswalk
for purposes of a payment rate assignment.
Comment: We received a comment from the manufacturer of the blood
product described by P9027. HCPCS code P9027 may be used to bill for
the blood product involving the Hemanext ONE System. The commenter
provided estimated cost information regarding the blood product,
including an expected average per-unit anticipated hospital cost of
$510. The manufacturer provided the estimated costs based on total
blood establishment manufacturing costs, including the costs to
manufacture a single unit of the starting materials, the sales price
for the Hemanext ONE System, and the blood establishment labor,
overhead,
[[Page 93924]]
administrative, and shipping costs. The commenter noted that they
believe their red blood cell product is potentially transformative and
would provide improved health outcomes. The commenter stated that they
believe the product whose CY 2024 Medicare payment rate reasonably
approximates the projected average hospital acquisition cost for HCPCS
P9027 is HCPCS code P9057 (Red blood cells, frozen/deglycerolized/
washed/leukocytes reduced, irradiated, each unit), with a CY 2024
payment rate of $493.21 per unit. As such, the commenter recommends
that CMS crosswalk the payment rate for HCPCS P9057 to HCPCS P9027. The
commenter believes that a crosswalk to any other red blood cell product
will result in a payment rate that does not cover the acquisition cost
for HCPCS P9027 and creates patient access barriers.
Response: We thank the commenter for their comment. Based on the
additional cost information provided by the manufacturer, we believe
that HCPCS code P9040 is not the best proxy for the costs of the blood
product described by HCPCS code P9027. However, we disagree with the
commenter that HCPCS code P9057 is the most appropriate crosswalk for
new HCPCS code P9027 because the payment rate for HCPCS code P9057
reflects additional processes that are not reflected in the code
descriptor for HCPCS code P9027. Given this difference in process, and
the associated differences in estimated costs, we believe HCPCS code
P9035 is a more appropriate proxy for the costs associated with HCPCS
code P9027. Therefore, we are establishing an interim payment rate for
HCPCS code P9027 based on a crosswalk to existing blood product HCPCS
code P9035. Table 1 lists the new HCPCS code P9027 and its payment
crosswalk.
[GRAPHIC] [TIFF OMITTED] TR27NO24.000
The interim payment rate for HCPCS code P9027 is open for public
comment in this CY 2025 final rule with comment period. Specifically,
HCPCS code P9027 is flagged with comment indicator ``NI'' in Addendum B
to this final rule with comment period to indicate that we have
assigned the codes an interim OPPS payment status for CY 2025 and are
seeking public comments on the APC and status indicator assignments.
Once we have claims data for this new HCPCS P-code, we will calculate a
payment rate using the claims data that should be available for these
new codes beginning in CY 2027, which is our practice for other blood
products for which claims data have been available for 2 years.
(2) Brachytherapy Sources
Section 1833(t)(2)(H) of the Act mandates the creation of
additional groups of covered OPD services that classify devices of
brachytherapy--cancer treatment through solid source radioactive
implants--consisting of a seed or seeds (or radioactive source)
(``brachytherapy sources'') separately from other services or groups of
services. The statute provides certain criteria for the additional
groups. For the history of OPPS payment for brachytherapy sources, we
refer readers to prior OPPS final rules, such as the CY 2012 OPPS/ASC
final rule with comment period (77 FR 68240 and 68241). As we have
stated in prior OPPS updates, we believe that adopting the general OPPS
prospective payment methodology for brachytherapy sources is
appropriate for a number of reasons (77 FR 68240). The general OPPS
methodology uses costs based on claims data to set the relative payment
weights for hospital outpatient services. This payment methodology
results in more consistent, predictable, and equitable payment amounts
per source across hospitals by averaging the extremely high and low
values, in contrast to payment based on hospitals' charges adjusted to
costs. We believe that the OPPS methodology, as opposed to payment
based on hospitals' charges adjusted to cost, also would provide
hospitals with incentives for efficiency in the provision of
brachytherapy services to Medicare beneficiaries. Moreover, this
approach is consistent with our payment methodology for the vast
majority of items and services paid under the OPPS. We refer readers to
the CY 2016 OPPS/ASC final rule with comment period (80 FR 70323
through 70325) for further discussion of the history of OPPS payment
for brachytherapy sources.
For CY 2025, except where otherwise indicated, we proposed to
continue our policy and use the costs derived from CY 2023 claims data
to set the proposed CY 2025 payment rates for brachytherapy sources
because CY 2023 is the year of data we proposed to use to set the
proposed payment rates for most other items and services that would be
paid under the CY 2025 OPPS. With the exception of the proposed payment
rate for brachytherapy source C2645 (Brachytherapy planar source,
palladium-103, per square millimeter) and the proposed payment rates
for low-volume brachytherapy APCs discussed in section III.D of the CY
2025 OPPS/ASC proposed rule, we proposed to base the payment rates for
brachytherapy sources on the geometric mean unit costs for each source,
consistent with the methodology that we proposed for other items and
services paid under the OPPS, as discussed in section II.A.2 of the CY
2025 OPPS/ASC proposed rule. We also proposed for CY 2025 and
subsequent years to continue the other payment policies for
brachytherapy sources that we finalized and first implemented in the CY
2010 OPPS/ASC final rule with comment period (74 FR
[[Page 93925]]
60537). For CY 2025 and subsequent years, we proposed to pay for the
stranded and nonstranded not otherwise specified (NOS) codes, HCPCS
codes C2698 (Brachytherapy source, stranded, not otherwise specified,
per source) and C2699 (Brachytherapy source, non-stranded, not
otherwise specified, per source), at a rate equal to the lowest
stranded or nonstranded prospective payment rate for such sources,
respectively, on a per-source basis (as opposed to, for example, per
mCi), which is based on the policy we established in the CY 2008 OPPS/
ASC final rule with comment period (72 FR 66785). For CY 2025 and
subsequent years, we also proposed to continue the policy we first
implemented in the CY 2010 OPPS/ASC final rule with comment period (74
FR 60537) regarding payment for new brachytherapy sources for which we
have no claims data, based on the same reasons we discussed in the CY
2008 OPPS/ASC final rule with comment period (72 FR 66786; which was
delayed until January 1, 2010, by section 142 of Pub. L. 110-275).
Specifically, this policy is intended to enable us to assign new HCPCS
codes for new brachytherapy sources to their own APCs, with prospective
payment rates set based on our consideration of external data and other
relevant information regarding the expected costs of the sources to
hospitals. The proposed CY 2025 payment rates for brachytherapy sources
are included on Addendum B to the CY 2025 OPPS/ASC proposed rule (which
is available via the internet on the CMS website) and identified with
status indicator ``U.''
For CY 2018, we assigned status indicator ``U'' (Brachytherapy
Sources, Paid under OPPS; separate APC payment) to HCPCS code C2645
(Brachytherapy planar source, palladium-103, per square millimeter) in
the absence of claims data and established a payment rate using
external data (invoice price) at $4.69 per mm\2\ for the brachytherapy
source's APC-APC 2648 (Brachytx planar, p-103). For CY 2019, in the
absence of sufficient claims data, we continued to establish a payment
rate for C2645 at $4.69 per mm\2\ for APC 2648 (Brachytx planar, p103).
Our CY 2018 claims data available for the CY 2020 OPPS/ASC final rule
with comment period (84 FR 61142) included two claims with a geometric
mean cost for HCPCS code C2645 of $1.02 per mm\2\. In response to
comments from interested parties, we agreed that, given the limited
claims data available and a new outpatient indication for C2645, a
payment rate for HCPCS code C2645 based on the geometric mean cost of
$1.02 per mm\2\ may not adequately reflect the cost of HCPCS code
C2645. In the CY 2020 OPPS/ASC final rule with comment period, we
finalized our policy to use our equitable adjustment authority under
section 1833(t)(2)(E) of the Act, which states that the Secretary shall
establish, in a budget neutral manner, other adjustments as determined
to be necessary to ensure equitable payments, to maintain the CY 2019
payment rate of $4.69 per mm\2\ for HCPCS code C2645 for CY 2020.
Similarly, in the absence of sufficient claims data to establish an APC
payment rate, in the CY 2021, CY 2022, CY 2023, and CY 2024 OPPS/ASC
final rules with comment period (85 FR 85879 through 85880, 86 FR
63469, 87 FR 71760-71761, and 88 FR 81553), we finalized our policy to
use our equitable adjustment authority under section 1833(t)(2)(E) of
the Act to maintain the CY 2019 payment rate of $4.69 per mm\2\ for
HCPCS code C2645 for CYs 2021 through 2024.
There were no CY 2023 claims available that reported HCPCS code
C2645 for the CY 2025 OPPS/ASC proposed rule. Therefore, in the absence
of claims data, we proposed to continue to use our equitable adjustment
authority under section 1833(t)(2)(E) of the Act to maintain the CY
2024 payment rate of $4.69 per mm\2\ for HCPCS code C2645, which we
proposed to be assigned to APC 2648 (Brachytx planar, p-103), for CY
2025.
Additionally, for CY 2022 and subsequent calendar years, we adopted
a Universal Low Volume APC policy for clinical and brachytherapy APCs.
As discussed in further detail in section X.C of the CY 2022 OPPS/ASC
final rule with comment period (86 FR 63743 through 63747), we adopted
this policy to mitigate wide variation in payment rates that occur from
year to year for APCs with low utilization. Such volatility in payment
rates from year to year can result in even lower utilization and
potential barriers to access. Brachytherapy APCs that have fewer than
100 single claims used for ratesetting purposes are designated as Low
Volume APCs unless an alternative payment rate is applied, such as the
use of our equitable adjustment authority under section 1833(t)(2)(E)
of the Act in the case of APC 2648 (Brachytx planar, p-103), for which
HCPCS code C2645 (Brachytherapy planar source, palladium-103, per
square millimeter) is the only code assigned as discussed previously in
this section.
For CY 2025, we proposed to designate six brachytherapy APCs as Low
Volume APCs as these APCs meet our criteria to be designated as Low
Volume APCs. For more information on the brachytherapy APCs we proposed
to designate as Low Volume APCs, see section III.D of the CY 2025 OPPS/
ASC proposed rule.
Comment: We received support from commenters for our proposal to
use our equitable adjustment authority under section 1833(t)(2)(E) of
the Act to maintain the CY 2024 payment rate of $4.69 per mm\2\ for
HCPCS code C2645, which we proposed to assign to APC 2648 (Brachytx
planar, p-103) for CY 2025.
Response: We thank the commenters for their support.
After consideration of the public comment we received, we are
finalizing, without modification, that we will use our equitable
adjustment authority under section 1833(t)(2)(E) of the Act to maintain
the CY 2024 payment rate of $4.69 per mm\2\ for HCPCS code C2645, which
we are assigning to APC 2648 (Brachytx planar, p-103), for CY 2025.
The final CY 2025 payment rates for brachytherapy sources are
included in Addendum B to this final rule with comment period (which is
available via the internet on the CMS website) and are identified with
status indicator ``U.'' We continue to invite interested parties to
submit recommendations for new codes to describe new brachytherapy
sources. Such recommendations should be directed via email to
<a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="abc4dedfdbcadfc2cec5dfdbdbd8ebc8c6d885c3c3d885ccc4dd">[email protected]</a> or by mail to the Division of Outpatient
Care, Mail Stop C4-01-26, Centers for Medicare and Medicaid Services,
7500 Security Boulevard, Baltimore, MD 21244. We will continue to add
new brachytherapy source codes and descriptors to our systems for
payment on a quarterly basis.
b. Comprehensive APCs (C-APCs) for CY 2025
(1) Background
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 74861
through 74910), we finalized a comprehensive payment policy that
packages payment for adjunctive and secondary items, services, and
procedures into the most costly primary procedure under the OPPS at the
claim level. The policy was finalized in CY 2014, but the effective
date was delayed until January 1, 2015, to allow additional time for
further analysis, opportunity for public comment, and systems
preparation. The comprehensive APC (C-APC) policy was implemented
effective January 1, 2015, with modifications and clarifications in
response to public
[[Page 93926]]
comments received regarding specific provisions of the C-APC policy (79
FR 66798 through 66810).
A C-APC is defined as a classification for the provision of a
primary service and all adjunctive services provided to support the
delivery of the primary service. We established C-APCs as a category
broadly for OPPS payment and implemented 25 C-APCs beginning in CY 2015
(79 FR 66809 and 66810). We have gradually added new C-APCs since the
policy was implemented beginning in CY 2015, with the number of C-APCs
now totaling 72 (80 FR 70332; 81 FR 79584 and 79585; 83 FR 58844
through 58846; 84 FR 61158 through 61166; 85 FR 85885; 86 FR 63474; 87
FR 71769; and 88 FR 81562).
Under our C-APC policy, we designate a service described by a HCPCS
code assigned to a C-APC as the primary service when the service is
identified by OPPS status indicator ``J1.'' When such a primary service
is reported on a hospital outpatient claim, taking into consideration
the few exceptions that are discussed below, we make payment for all
other items and services reported on the hospital outpatient claim as
being integral, ancillary, supportive, dependent, and adjunctive to the
primary service (hereinafter collectively referred to as ``adjunctive
services'') and representing components of a complete comprehensive
service (78 FR 74865 and 79 FR 66799). Payments for adjunctive services
are packaged into the payments for the primary services. This results
in a single prospective payment for each of the primary, comprehensive
services based on the costs of all reported services at the claim
level. One example of a primary service would be a partial mastectomy
and an example of a secondary service packaged into that primary
service would be a radiation therapy procedure.
Services excluded from the C-APC policy under the OPPS include
services that are not covered OPD services, services that cannot by
statute be paid for under the OPPS, and services that are required by
statute to be separately paid. This includes certain mammography and
ambulance services that are not covered OPD services in accordance with
section 1833(t)(1)(B)(iv) of the Act; brachytherapy seeds, which also
are required by statute to receive separate payment under section
1833(t)(2)(H) of the Act; pass-through payment drugs and devices, which
also require separate payment under section 1833(t)(6) of the Act;
self-administered drugs (SADs) that are not otherwise packaged as
supplies because they are not covered under Medicare Part B under
section 1861(s)(2)(B) of the Act; and certain preventive services (78
FR 74865 and 79 FR 66800 and 66801). A list of services excluded from
the C-APC policy is included in Addendum J to this final rule (which is
available via the internet on the CMS website at <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices</a>). If a service does not appear on this list of
excluded services, payment for it will be packaged into the payment for
the primary C-APC service when it appears on an outpatient claim with a
primary C-APC service.
The C-APC policy payment methodology set forth in the CY 2014 OPPS/
ASC final rule with comment period and modified and implemented
beginning in CY 2015 is summarized as follows (78 FR 74887 and 79 FR
66800):
Basic Methodology. As stated in the CY 2015 OPPS/ASC final rule
with comment period, we define the C-APC payment policy as including
all covered OPD services on a hospital outpatient claim reporting a
primary service that is assigned to status indicator ``J1,'' \2\
excluding services that are not covered OPD services or that cannot by
statute be paid for under the OPPS. Services and procedures described
by HCPCS codes assigned to status indicator ``J1'' are assigned to C-
APCs based on our usual APC assignment methodology by evaluating the
geometric mean costs of the primary service claims to establish
resource similarity and the clinical characteristics of each procedure
to establish clinical similarity within each APC.
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\2\ Status indicator ``J1'' denotes Hospital Part B Services
Paid Through a Comprehensive APC. Further information can be found
in CY 2025 Addendum D1.
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In the CY 2016 OPPS/ASC final rule with comment period, we expanded
the C-APC payment methodology to qualifying extended assessment and
management encounters through the ``Comprehensive Observation
Services'' C-APC (C-APC 8011). Services within this APC are assigned
status indicator ``J2.'' \3\ Specifically, we make a payment through C-
APC 8011 for a claim that:
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\3\ Status indicator ``J2'' denotes Hospital Part B Services
That May Be Paid Through a Comprehensive APC. Further information
can be found in CY 2025 Addendum D1.
---------------------------------------------------------------------------
<bullet> Does not contain a procedure described by a HCPCS code to
which we have assigned status indicator ``T;''
<bullet> Contains 8 or more units of services described by HCPCS
code G0378 (Hospital observation services, per hour);
<bullet> Contains services provided on the same date of service or
one day before the date of service for HCPCS code G0378 that are
described by one of the following codes: HCPCS code G0379 (Direct
admission of patient for hospital observation care) on the same date of
service as HCPCS code G0378; CPT code 99281 (Emergency department visit
for the evaluation and management of a patient (Level 1)); CPT code
99282 (Emergency department visit for the evaluation and management of
a patient (Level 2)); CPT code 99283 (Emergency department visit for
the evaluation and management of a patient (Level 3)); CPT code 99284
(Emergency department visit for the evaluation and management of a
patient (Level 4)); CPT code 99285 (Emergency department visit for the
evaluation and management of a patient (Level 5)) or HCPCS code G0380
(Type B emergency department visit (Level 1)); HCPCS code G0381 (Type B
emergency department visit (Level 2)); HCPCS code G0382 (Type B
emergency department visit (Level 3)); HCPCS code G0383 (Type B
emergency department visit (Level 4)); HCPCS code G0384 (Type B
emergency department visit (Level 5)); CPT code 99291 (Critical care,
evaluation and management of the critically ill or critically injured
patient; first 30-74 minutes); or HCPCS code G0463 (Hospital outpatient
clinic visit for assessment and management of a patient); and
<bullet> Does not contain services described by a HCPCS code to
which we have assigned status indicator ``J1.''
The assignment of status indicator ``J2'' to a specific set of
services performed in combination with each other allows for all other
OPPS payable services and items reported on the claim (excluding
services that are not covered OPD services or that cannot by statute be
paid for under the OPPS) to be deemed adjunctive services representing
components of a comprehensive service and resulting in a single
prospective payment for the comprehensive service based on the costs of
all reported services on the claim (80 FR 70333 through 70336).
Services included under the C-APC payment packaging policy, that
is, services that are typically adjunctive to the primary service and
provided during the delivery of the comprehensive service, include
diagnostic procedures, laboratory tests, and other diagnostic tests and
treatments that assist in the delivery of the primary procedure; visits
and evaluations performed in association with the procedure; uncoded
services and supplies used during the service; durable medical
equipment as well as prosthetic and
[[Page 93927]]
orthotic items and supplies when provided as part of the outpatient
service; and any other components reported by HCPCS codes that
represent services that are provided during the complete comprehensive
service (78 FR 74865 and 79 FR 66800).
In addition, payment for hospital outpatient department services
that are similar to therapy services, such as speech language
pathology, and delivered either by therapists or nontherapists is
included as part of the payment for the packaged complete comprehensive
service. These services that are provided during the perioperative
period are adjunctive services and are deemed not to be therapy
services as described in section 1834(k) of the Act, regardless of
whether the services are delivered by therapists or other nontherapist
health care workers. We have previously noted that therapy services are
those provided by therapists under a plan of care in accordance with
section 1835(a)(2)(C) and section 1835(a)(2)(D) of the Act and are paid
for under section 1834(k) of the Act, subject to annual therapy caps as
applicable (78 FR 74867 and 79 FR 66800). However, certain other
services similar to therapy services are considered and paid for as
hospital outpatient department services. Payment for these nontherapy
outpatient department services that are reported with therapy codes and
provided with a comprehensive service is included in the payment for
the packaged complete comprehensive service. We note that these
services, even though they are reported with therapy codes, are
hospital outpatient department services and not therapy services. We
refer readers to the July 2016 OPPS Change Request 9658 (Transmittal
3523) for further instructions on reporting these services in the
context of a C-APC service.
Items included in the packaged payment provided in conjunction with
the primary service also include all drugs, biologicals, and
radiopharmaceuticals, regardless of cost, except those drugs with pass-
through payment status and SADs, unless they function as packaged
supplies (78 FR 74868, 74869, and 74909 and 79 FR 66800). We refer
readers to Section 50.2M, Chapter 15, of the Medicare Benefit Policy
Manual for a description of our policy on SADs treated as hospital
outpatient supplies, including lists of SADs that function as supplies
and those that do not function as supplies.\4\
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\4\ <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf</a>.
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We define each hospital outpatient claim reporting a single unit of
a single primary service assigned to status indicator ``J1'' as a
single ``J1'' unit procedure claim (78 FR 74871 and 79 FR 66801). Line-
item charges for services included on the C-APC claim are converted to
line-item costs, which are then summed to develop the estimated APC
costs. These claims are then assigned one unit of the service with
status indicator ``J1'' and later used to develop the geometric mean
costs for the C-APC relative payment weights. (We note that we use the
term ``comprehensive'' to describe the geometric mean cost of a claim
reporting ``J1'' service(s) or the geometric mean cost of a C-APC,
inclusive of all the items and services included in the C-APC service
payment bundle.) Charges for services that would otherwise be
separately payable are added to the charges for the primary service.
This process differs from our traditional cost accounting methodology
only in that all such services on the claim are packaged (except
certain services as described above). We apply our standard data trims,
which exclude claims with extremely high primary units or extreme
costs.
The comprehensive geometric mean costs are used to establish
resource similarity and, along with clinical similarity, dictate the
assignment of the primary services to the C-APCs. We establish a
ranking of each primary service (single unit only) to be assigned to
status indicator ``J1'' according to its comprehensive geometric mean
costs. For the minority of claims reporting more than one primary
service assigned to status indicator ``J1'' or units thereof, we
identify one ``J1'' service as the primary service for the claim based
on our cost-based ranking of primary services. We then assign these
multiple ``J1'' procedure claims to the C-APC to which the service
designated as the primary service is assigned. If the reported ``J1''
services on a claim map to different C-APCs, we designate the ``J1''
service assigned to the C-APC with the highest comprehensive geometric
mean cost as the primary service for that claim. If the reported
multiple ``J1'' services on a claim map to the same C-APC, we designate
the most costly service (at the HCPCS code level) as the primary
service for that claim. This process results in initial assignments of
claims for the primary services assigned to status indicator ``J1'' to
the most appropriate C-APCs based on both single and multiple procedure
claims reporting these services and clinical and resource homogeneity.
Complexity Adjustments. We use complexity adjustments to provide
increased payment for certain comprehensive services. We apply a
complexity adjustment by promoting qualifying paired ``J1'' service
code combinations or paired code combinations of ``J1'' services and
certain add-on codes (as described further below) from the originating
C-APC (the C-APC to which the designated primary service is first
assigned) to the next higher paying C-APC in the same clinical family
of C-APCs. We apply this type of complexity adjustment when the paired
code combination represents a complex, costly form or version of the
primary service according to the following criteria:
<bullet> Frequency of 25 or more claims reporting the code
combination (frequency threshold); and
<bullet> Violation of the 2 times rule, as stated in section
1833(t)(2) of the Act and section III.B.2 of this final rule with
comment period, in the originating C-APC (cost threshold).
These criteria identify paired code combinations that occur
commonly and exhibit materially greater resource requirements than the
primary service. The CY 2017 OPPS/ASC final rule with comment period
(81 FR 79582) included a revision to the complexity adjustment
eligibility criteria. Specifically, we finalized a policy to
discontinue the requirement that a code combination (that qualifies for
a complexity adjustment by satisfying the frequency and cost criteria
thresholds described above) also not create a 2 times rule violation in
the higher level or receiving APC.
After designating a single primary service for a claim, we evaluate
that service in combination with each of the other procedure codes
reported on the claim assigned to status indicator ``J1'' (or certain
add-on codes) to determine if there are paired code combinations that
meet the complexity adjustment criteria. For a new HCPCS code, we
determine initial C-APC assignment and qualification for a complexity
adjustment using the best available information, crosswalking the new
HCPCS code to a predecessor code(s) when appropriate.
Once we have determined that a particular code combination of
``J1'' services (or combinations of ``J1'' services reported in
conjunction with certain add-on codes) represents a
[[Page 93928]]
complex version of the primary service because it is sufficiently
costly, frequent, and a subset of the primary comprehensive service
overall according to the criteria described above, we promote the claim
including the complex version of the primary service as described by
the code combination to the next higher cost C-APC within the clinical
family, unless the primary service is already assigned to the highest
cost APC within the C-APC clinical family or assigned to the only C-APC
in a clinical family. We do not create new APCs with a comprehensive
geometric mean cost that is higher than the highest geometric mean cost
(or only) C-APC in a clinical family just to accommodate potential
complexity adjustments. Therefore, the highest payment for any claim
including a code combination for services assigned to a C-APC would be
the highest paying C-APC in the clinical family (79 FR 66802).
We package payment for all add-on codes into the payment for the C-
APC. However, certain primary service add-on combinations may qualify
for a complexity adjustment. As noted in the CY 2016 OPPS/ASC final
rule with comment period (80 FR 70331), all add-on codes that can be
appropriately reported in combination with a base code that describes a
primary ``J1'' service are evaluated for a complexity adjustment.
To determine which combinations of primary service codes reported
in conjunction with an add-on code may qualify for a complexity
adjustment for CY 2025, we apply the frequency and cost criteria
thresholds discussed above, testing claims reporting one unit of a
single primary service assigned to status indicator ``J1'' and any
number of units of a single add-on code for the primary ``J1'' service.
If the frequency and cost criteria thresholds for a complexity
adjustment are met and reassignment to the next higher cost APC in the
clinical family is appropriate (based on meeting the criteria outlined
above), we make a complexity adjustment for the code combination; that
is, we reassign the primary service code reported in conjunction with
the add-on code to the next higher cost C-APC within the same clinical
family of C-APCs. As previously stated, we package payment for add-on
codes into the C-APC payment rate. If any add-on code reported in
conjunction with the ``J1'' primary service code does not qualify for a
complexity adjustment, payment for the add-on service continues to be
packaged into the payment for the primary service and is not reassigned
to the next higher cost C-APC. We list the complexity adjustments for
``J1'' and add-on code combinations for CY 2025, along with all the
other final complexity adjustments, in Addendum J to this final rule
with comment period (which is available via the internet on the CMS
website at <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices</a>).
Addendum J to this final rule with comment period includes the cost
statistics for each code combination that would qualify for a
complexity adjustment (including primary code and add-on code
combinations). Addendum J to this final rule with comment period also
contains summary cost statistics for each of the paired code
combinations that describe a complex code combination that would
qualify for a complexity adjustment and be reassigned to the next
higher cost C-APC within the clinical family. The combined statistics
for all proposed reassigned complex code combinations are represented
by an alphanumeric code with the first four digits of the designated
primary service followed by a letter. For example, the proposed
geometric mean cost listed in Addendum J for the code combination
described by complexity adjustment assignment 3320R, which is assigned
to C-APC 5224 (Level 4 Pacemaker and Similar Procedures), includes all
paired code combinations that will be reassigned to C-APC 5224 when CPT
code 33208 is the primary code. Providing the information contained in
Addendum J to this final rule with comment period allows interested
parties the opportunity to better assess the impact associated with the
assignment of claims with each of the paired code combinations eligible
for a complexity adjustment.
Comment: We received support from commenters for a variety of
existing and proposed complexity adjustments.
Response: We thank the commenters for their support.
Comment: Multiple commenters requested that CMS apply a complexity
adjustment to additional code combinations. The specific C-APC
complexity adjustment code combinations requested by the commenters for
CY 2025 are listed in Table 2.
BILLING CODE 4120-01-P
[[Page 93929]]
[GRAPHIC] [TIFF OMITTED] TR27NO24.001
[[Page 93930]]
[GRAPHIC] [TIFF OMITTED] TR27NO24.002
BILLING CODE 4120-01-C
Response: We reviewed each of the requested code combinations
suggested by commenters, listed in Table 2, against our complexity
adjustment
[[Page 93931]]
criteria. The code combination for primary HCPCS code 28296 with
secondary HCPCS code 28270 meets our cost and frequency criteria,
qualifying for a complexity adjustment for CY 2025. All the remaining
code combinations listed failed to meet our cost or frequency criteria
and do not qualify for complexity adjustments for CY 2025. Addendum J
to this final rule with comment period includes the cost statistics for
each code combination that was evaluated for a complexity adjustment.
Comment: Commenters requested that CMS modify, waive, or eliminate
the established C-APC complexity adjustment eligibility criteria of 25
or more claims reporting the code combination (frequency) and a
violation of the 2 times rule in the originating C-APC (cost) to allow
additional code combinations to qualify for complexity adjustments.
These commenters were concerned that C-APC packaging and a lack of
complexity adjustment would limit access to procedures. Specifically,
some commenters expressed concern that CMS's methodology for
determining complexity adjustments is unnecessarily restrictive,
particularly the 25-claim threshold, and suggested that CMS eliminate
the 25-claim threshold and implement a complexity adjustment whenever a
code pair exceeds the cost threshold.
Some commenters were concerned that when multiple ``J1'' primary
services are reported on a claim, along with an add-on service, the
add-on service is not evaluated for a complexity adjustment. Commenters
cited examples where significant claims volume from add-on services may
not be incorporated into the complexity adjustment evaluation.
Commenters also reiterated requests to broaden the complexity
adjustment policy and allow clusters of procedures, consisting of a
``J1'' code pair and multiple other associated add-on codes used in
combination with that ``J1'' code pair, to qualify for complexity
adjustments. Commenters stated that there are certain complex
procedures that include numerous add-on codes and this approach would
allow more accurate reflection of the cost of medical practice when
multiple procedures are performed together. They noted that lack of
additional payment for these code combinations can present a financial
challenge for the providers who perform these more resource intensive
services.
Response: We appreciate these comments. At this time, we do not
believe changes to the C-APC complexity adjustment criteria are
necessary or that we should make exceptions to the criteria to allow
claims with the code combinations suggested by the commenters to
receive complexity adjustments. As we stated in the CY 2017 OPPS/ASC
final rule (81 FR 79582), we believe that the complexity adjustment
criteria, which require a frequency of 25 or more claims reporting a
code combination and a violation of the 2 times rule in the originating
C-APC, are appropriate to determine if a combination of procedures
represents a complex, costly subset of the primary service that should
qualify for the adjustment and be paid at the next higher paying C-APC
in the clinical family. As we also previously stated in the CY 2020
OPPS/ASC final rule with comment period (84 FR 61161), a minimum of 25
claims is already a very low threshold for a national payment system.
Lowering the minimum of 25 claims further could lead to unnecessary
complexity adjustments for service combinations that are rarely
performed.
Comment: A few commenters suggested that to help maintain better
stability and predictability of payments associated with complex
procedures, CMS should revise the complexity adjustment policy by
allowing qualifying codes to maintain the complexity adjusted payment
for three calendar years before they are required to go through the
eligibility review. For codes that do not qualify in a given year, they
could be evaluated in the next calendar year. Commenters asserted that
the updated cadence would allow more time for providers and coders to
be educated on new code pairs that qualify for complexity adjustments
and it would help promote payment stability and predictability for
these complex procedures.
Response: For the OPPS ratesetting process, our goal is to use the
best available data for ratesetting to accurately estimate the costs
associated with furnishing outpatient services and to set appropriate
payment rates. We evaluate code combinations each year against our
complexity adjustment criteria using the latest available data.
Potentially maintaining complexity adjustments that are not supported
by the latest data could undermine our goals for the ratesetting
process.
Comment: A few commenters requested that CMS provide additional
information on the rationale for not counting claims that reflect code
combinations of services that would otherwise meet the frequency
criteria needed to receive a complexity adjustment. Commenters
conducted their own data modeling using data reflecting all code
combinations that met the frequency criteria needed to receive a
complexity adjustment. Commenters asked for greater transparency on the
methodology CMS used to evaluate the complexity adjustment frequency
criteria for code combinations.
Response: We refer commenters to the claims accounting narrative
under supporting documentation for this CY 2025 OPPS/ASC final rule on
the CMS website at: <a href="https://www.cms.gov/files/document/2025-nprm-opps-claims-accounting.pdf">https://www.cms.gov/files/document/2025-nprm-opps-claims-accounting.pdf</a>. The claims accounting narrative provides a
detailed overview of how CMS processes the CY 2023 claims data to
produce the proposed prospective CY 2025 OPPS payment rates. We are
updating the section on Comprehensive APCs in order to provide
additional clarity on the claims accounting process used for
determining complexity adjustments.
After consideration of the public comments we received, we are
finalizing the C-APC complexity adjustment policy for CY 2025 as
proposed. We are also finalizing the proposed complexity adjustments,
with the addition of one new code combination (i.e., primary HCPCS code
28296 with secondary HCPCS code 28270) suggested by commenters that
meets our complexity adjustment criteria.
(2) Exclusion of Procedures Assigned to New Technology APCs From the C-
APC Policy
Services that are assigned to New Technology APCs are typically new
procedures that do not have sufficient claims history to establish an
accurate payment for them. Beginning in CY 2002, we retain services
within New Technology APC groups until we gather sufficient claims data
to enable us to assign the service to an appropriate clinical APC. This
policy allows us to move a service from a New Technology APC in less
than 2 years if sufficient data are available. It also allows us to
retain a service in a New Technology APC for more than 2 years if
sufficient data upon which to base a decision for reassignment have not
been collected (82 FR 59277).
The C-APC payment policy packages payment for adjunctive and
secondary items, services, and procedures into the most costly primary
procedure under the OPPS at the claim level. Prior to CY 2019, when a
procedure assigned to a New Technology APC was included on the claim
with a primary procedure, identified by OPPS status indicator ``J1,''
payment for the new technology service was typically packaged into the
payment for the primary procedure.
[[Page 93932]]
Because the new technology service was not separately paid in this
scenario, the overall number of single claims available to determine an
appropriate clinical APC for the new service was reduced. This was
contrary to the objective of the New Technology APC payment policy,
which is to gather sufficient claims data to enable us to assign the
service to an appropriate clinical APC.
To address this issue and ensure that there are sufficient claims
data for services assigned to New Technology APCs, in the CY 2019 OPPS/
ASC final rule with comment period (83 FR 58847), we finalized
excluding payment for any procedure that is assigned to a New
Technology APC (APCs 1491 through 1599 and APCs 1901 through 1908) from
being packaged when included on a claim with a ``J1'' service assigned
to a C-APC. In the CY 2020 OPPS/ASC final rule with comment period, we
finalized that beginning in CY 2020, payment for services assigned to a
New Technology APC would be excluded from being packaged into the
payment for comprehensive observation services assigned status
indicator ``J2'' when they are included on a claim with a ``J2''
service (84 FR 61167).
(3) Exclusion of Drugs and Biologicals Described by HCPCS Code C9399
(Unclassified Drugs or Biologicals) From the C-APC Policy
Section 1833(t)(15) of the Act, as added by section 621(a)(1) of
the Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (Pub. L. 108-173), provides for payment under the OPPS for new
drugs and biologicals until HCPCS codes are assigned. Under this
provision, we are required to make payment for a covered outpatient
drug or biological that is furnished as part of covered outpatient
department services but for which a HCPCS code has not yet been
assigned in an amount equal to 95 percent of average wholesale price
(AWP) for the drug or biological.
In the CY 2005 OPPS/ASC final rule with comment period (69 FR
65805), we implemented section 1833(t)(15) of the Act by instructing
hospitals to bill for a drug or biological that is newly approved by
the Food and Drug Administration (FDA) and that does not yet have a
HCPCS code by reporting the National Drug Code (NDC) for the product
along with the newly created HCPCS code C9399 (Unclassified drugs or
biologicals). We explained that when HCPCS code C9399 appears on a
claim, the Outpatient Code Editor (OCE) suspends the claim for manual
pricing by the Medicare Administrative Contractor (MAC). The MAC prices
the claim at 95 percent of the drug or biological's AWP, using Red Book
or an equivalent recognized compendium, and processes the claim for
payment. We emphasized that this approach enables hospitals to bill and
receive payment for a new drug or biological concurrent with its
approval by the FDA. The hospital does not have to wait for the next
quarterly release or for approval of a product specific HCPCS code to
receive payment for a newly approved drug or biological or to resubmit
claims for adjustment. We instructed that hospitals would discontinue
billing HCPCS code C9399 and the NDC upon implementation of a product
specific HCPCS code, status indicator, and appropriate payment amount
with the next quarterly update. We also note that HCPCS code C9399 is
paid in a similar manner in the ASC setting, as 42 CFR 416.171(b)
outlines that certain drugs and biologicals for which separate payment
is allowed under the OPPS are considered covered ancillary services for
which the OPPS payment rate, which is 95 percent of AWP for HCPCS code
C9399, applies. Since the implementation of the C-APC policy in 2015,
payment for drugs and biologicals described by HCPCS code C9399 had
been included in the C-APC payment when these products appear on a
claim with a primary C-APC service. Packaging payment for these drugs
and biologicals that appear on a hospital outpatient claim with a
primary C-APC service is consistent with our C-APC packaging policy
under which we make payment for all items and services, including all
non-pass-through drugs, reported on the hospital outpatient claim as
being integral, ancillary, supportive, dependent, and adjunctive to the
primary service and representing components of a complete comprehensive
service, with certain limited exceptions (78 FR 74869). It was our
position that the total payment for the C-APC with which payment for a
drug or biological described by HCPCS code C9399 is packaged includes
payment for the drug or biological at 95 percent of its AWP.
However, we determined that in certain instances, drugs and
biologicals described by HCPCS code C9399 are not being paid at 95
percent of their AWPs when payment for them is packaged with payment
for a primary C-APC service. In order to ensure payment for new drugs,
biologicals, and radiopharmaceuticals described by HCPCS code C9399 at
95 percent of their AWP, for CY 2023 and subsequent years, we finalized
our proposal to exclude any drug, biological, or radiopharmaceutical
described by HCPCS code C9399 from packaging when the drug, biological,
or radiopharmaceutical is included on a claim with a ``J1'' service,
which is the status indicator assigned to a C-APC, and a claim with a
``J2'' service, which is the status indicator assigned to comprehensive
observation services. See Addendum J for the CY 2025 C-APC payment
policy exclusions.
In the CY 2023 OPPS/ASC final rule with comment period, we
finalized the proposal in section XI ``CY 2023 OPPS Payment Status and
Comment Indicators'' to add a new definition to status indicator ``A''
to include unclassified drugs and biologicals that are reportable with
HCPCS code C9399 (87 FR 72051). The definition, found in Addendum D1,
would ensure the MAC prices claims for drugs, biologicals, or
radiopharmaceuticals billed with HCPCS code C9399 at 95 percent of the
drug or biological's AWP and pays separately for the drug, biological,
or radiopharmaceutical under the OPPS when it appears on the same claim
as a primary C-APC service.
(4) Exclusion of Cell and Gene Therapies From the C-APC Policy
As previously discussed in this section, and in the CY 2014 OPPS/
ASC final rule with comment period (78 FR 74865), the C-APC policy
packages payment for items and services that are typically integral,
ancillary, supportive, dependent, or adjunctive to the primary service
and provided during the delivery of the comprehensive service,
including diagnostic procedures, laboratory tests and other diagnostic
tests and treatments that assist in the delivery of the primary
procedure. In the CY 2014 OPPS/ASC final rule (78 FR 74861), we
finalized defining a comprehensive APC as a classification for the
provision of a primary service and all adjunctive services provided to
support the delivery of the primary service. Because a comprehensive
APC treats all individually reported codes as representing components
of the comprehensive service, we make a single prospective payment
based on the cost of all individually reported codes that represent the
provision of a primary service and all adjunctive services provided to
support that delivery of the primary service.
As discussed in the CY 2025 OPPS/ASC proposed rule (89 FR 59201
through 59204), we generally treat all items and services reported on a
C-APC claim as integral, ancillary, supportive, dependent, and
adjunctive to the primary service and representing
[[Page 93933]]
components of a comprehensive service. Historically, items packaged for
payment provided in conjunction with the primary C-APC service also
include all drugs, biologicals, and radiopharmaceuticals, regardless of
cost, except those drugs with pass-through payment status and those
drugs that are usually self-administered (SADs), unless they function
as supplies (78 FR 74868 through 74869 and 74909).
Our intent has been to make a single prospective payment based on
the cost of all individually reported codes that appear on a claim with
the primary C-APC service, which we believe represent the provision of
a primary service and all adjunctive services provided to support that
delivery of the primary service. We discussed in the CY 2025 OPPS/ASC
proposed rule (89 FR 59201 through 59204), there are rare instances
where the cell and gene therapies listed in Table 3, which are usually
separately payable under the OPPS, appear on the same claim as a
primary C-APC service and therefore, have their payment packaged with
payment for the primary C-APC service. The therapies in Table 3 are
usually separately paid and priced using the ASP methodology when not
on a C-APC claim. Given the unique nature of these therapies, we do not
believe they function as integral, ancillary, supportive, dependent, or
adjunctive to any of the current C-APCs primary services. The cell
therapies described in Table 3 are primarily for the treatment of
specific cancers and are administered through an intravenous infusion.
The gene therapies listed in Table 3 are generally for the treatment of
certain rare ocular or spinal conditions caused by specific genetic
mutations and are also either intravenously infused or administered
through a subretinal injection. When these products are administered,
they are the primary treatment being administered to a patient and
thus, are not integral, ancillary, supportive, dependent, or adjunctive
to any primary C-APC services. Additionally, the current primary C-APC
services describe common surgical procedures, such as breast/lymphatic
surgery and musculoskeletal procedures. The cell and gene therapies
listed in Table 3 are intended to treat a specific condition and would
not be used to support the outcome of any primary C-APC procedure. For
example, HCPCS code J3399 (Injection, onasemnogene abeparvovec-xioi,
per treatment, up to 5x10[caret]15 vector genomes) may be used to
describe the gene therapy Zolgensma. This product is FDA-approved as an
adeno-associated virus (AAV) vector-based gene therapy indicated for
the treatment of pediatric patients less than 2 years of age with
spinal muscular atrophy (SMA) with bi-allelic mutations in the survival
motor neuron 1 (SMN1) gene. The specified mechanism of onasemnogene
abeparvovec is a recombinant AAV9-based gene therapy designed to
deliver a copy of the gene encoding the human SMN protein.\5\ The
function of a product such as Zolgensma, is not intended to be
integral, ancillary, supportive, dependent, and adjunctive to any C-APC
as the gene therapy itself is an independent treatment.
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\5\ Zolgensma. FDA Package Insert. October 2023. <a href="https://www.fda.gov/media/126109/download?attachment">https://www.fda.gov/media/126109/download?attachment</a>.
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Yescarta (HCPCS code Q2041) is an example of a cell therapy that
functions as an independent treatment. Based on its FDA-approved
indication,\6\ this product's intended clinical use would not be
integral, ancillary, supportive, dependent, or adjunctive to any
current C-APC primary service. Yescarta is indicated as a CD19-directed
genetically modified autologous T cell immunotherapy for the treatment
of Adult patients with large B-cell lymphoma that is refractory to
first-line chemoimmunotherapy or that relapses within 12 months of
first-line chemoimmunotherapy and adult patients with relapsed or
refractory large B-cell lymphoma after two or more lines of systemic
therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise
specified, primary mediastinal large B-cell lymphoma, high grade B-cell
lymphoma, and DLBCL arising from follicular lymphoma. Yescarta is the
primary treatment being performed when administered for these FDA-
approved indications and should not be packaged as supportive of any C-
APC primary service even if the two services appear on the same claim.
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\6\ FDA Package Insert. Yescarta. April 2024. <a href="https://www.fda.gov/media/108377/download?attachment">https://www.fda.gov/media/108377/download?attachment</a>.
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We explained in the CY 2014 OPPS/ASC final rule with comment period
(78 FR 74868) that intravenous drugs, for example, are OPPS services
that are considered adjunctive to the primary procedure because the
correct administration of the drug either promotes a beneficial
outcome, such as the use of intravenous pain medications, or prevents
possible complications, such as the use of intravenous blood pressure
medications to temporarily replace oral blood pressure medications and
reduce the risk of a sudden rise in blood pressure when a normal daily
medication is stopped. In the case of the cell and gene therapies
described in Table 3, however, we do not believe the therapies
``promote a beneficial outcome'' or ``prevent possible complications''
of any of the procedures currently designated as primary C-APC
services. While the cell and gene therapies in Table 3 may ``promote a
beneficial outcome'' for the patient in general, we do not believe the
provision of cell and gene therapies are ``promoting a beneficial
outcome'' for any of the primary C-APC services themselves, as the cell
and gene therapies are serving as independent therapies. These are
distinguishable from the previous examples of intravenous pain
medications that are directly related to the primary C-APC service and
promote a beneficial outcome for that procedure. Further, in the CY
2014 OPPS/ASC final rule with comment period (78 FR 74865), we stated
that we proposed to package into C-APCs all of these integral,
ancillary, supportive, dependent, and adjunctive services, hereinafter
collectively referred to as ``adjunctive services,'' provided during
the delivery of the comprehensive service. This includes the diagnostic
procedures, laboratory tests and other diagnostic tests, and treatments
that assist in the delivery of the primary procedure. In the CY 2025
OPPS/ASC proposed rule (89 FR 59201 through 59204), we stated we did
not believe that the cell and gene therapies listed in Table 3 are
assisting in the delivery of any primary procedure currently assigned
to a C-APC.
Therefore, for CY 2025 only, we proposed not to package payment for
the cell and gene therapies listed in Table 3 into the payment for the
primary C-APC service when they appear on the same claim as primary C-
APCs services. We proposed this policy for one year only in order to
gather more information from interested parties as to whether the
proposed policy appropriately captures all of the unique therapies,
such as the cell and gene therapies listed in Table 3, that function as
primary treatments and do not support C-APC primary services. As
discussed later in this section, we welcomed comments from readers on
the proposal and the potential need for a different, modified,
expanded, or supplemental policy for future rulemaking. We stated we
will assess whether to continue this policy, or a modified version of
this policy, beyond one year in future rulemaking, taking into
consideration the comments received.
We did not propose to include therapies that are on drug pass-
through status for all of CY 2025 in Table 3
[[Page 93934]]
because pass-through drugs are already excluded from C-APC packaging.
We proposed that products for which pass-through status is expiring in
CY 2025 would be excluded from C-APC packaging after their pass-through
status expires. For example, the product described by HCPCS code Q2056
has pass-through status expiring June 30, 2025. Until its pass-through
status expires, the product will be excluded from C-APC packaging due
to the pass-through C-APC exclusion policy, but after its pass-through
status expires, we propose that the therapy would continue to be
excluded from C-APC packaging under our proposed exclusion for cell and
gene therapies. For more information on drug pass-through status,
including expiring and continuing pass-through status, please see
section V.A of this final rule with comment period.
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We proposed to exclude the therapies listed in Table 3 from C-APC
packaging. We invited comment on the proposal, and we invited comment
on whether there are any additional cell and gene therapies that may be
appropriate to exclude from C-APC packaging for CY 2025. We asked
commenters to explain why any additional cell and gene therapies that
they believe should be excluded from C-APC packaging were not integral,
ancillary, supportive, dependent, or adjunctive to any C-APC primary
service. We invited comment on whether the proposal should be extended
beyond 1 year or if a different, expanded, or supplemental policy
approach may be warranted in future rulemaking. For example, we were
interested in comments on whether there are other classes of drugs,
biologicals, or other products that are not clearly integral,
ancillary, adjunctive, or supportive of a primary C-APC service but
could appear on the same claim as the C-APC for that primary service
and for which payment would be packaged into the C-APC payment under
our current policy. We stated that we would expect clinical evidence
supporting commenters' assertion that other identified classes of
drugs, biologicals, medical devices, or other products are not clearly
supportive of a primary C-APC service but may nonetheless appear on the
same claim as a primary C-APC procedure. Similarly, we invited comment
on whether interested parties believe it is appropriate for these other
classes of drugs, biologicals, or medical devices to be excluded from
packaging with all C-APCs or only specific C-APCs, such as the
Comprehensive Observation Services C-APC (SI = ``J2'').
Finally, we invited comment on the following:
<bullet> Because the cell and gene therapies listed in Table 3 are
not integral, ancillary, supportive, dependent, or adjunctive to any
current C-APC procedure, how could CMS structure a new C-APC, or
similar packaged payment policy, for the service to administer cell or
gene therapies, such by creating as a Chimeric Antigen Receptor (CAR)
T-cell therapy administration C-APC, with which the CAR-T or gene
therapy would be integral, ancillary, supportive, dependent, or
adjunctive to the primary C-APC service? What integral, ancillary,
supportive, dependent, or adjunctive items and services are routinely
provided as part of the administration of cell and gene therapies or in
conjunction with cell and gene therapies generally?
We recognized that currently, for CY 2024, the following HCPCS
codes are associated with CAR-T therapy: HCPCS code 0537T (Chimeric
antigen receptor t-cell (car-t) therapy; harvesting of blood-derived t
lymphocytes for development of genetically modified autologous car-t
cells, per day), 0538T (Chimeric antigen receptor t-cell (car-t)
therapy; preparation of blood-derived t lymphocytes for transportation
(eg, cryopreservation, storage)), 0539T (Chimeric antigen receptor t-
cell (car-t) therapy; receipt and preparation of car-t cells for
administration), and 0540T (Chimeric antigen receptor t-cell (car-t)
therapy; car-t cell administration, autologous) as discussed in
previous OPPS rulemaking, including the CY 2022 OPPS/ASC final rule
with comment period (86 FR 63550 through 63552).
Separately, we also invited comment on whether policy revisions to
the C-APC policy may be appropriate in future rulemaking, such as a
modified outlier payment policy specific to C-APCs to address related
situations in the future. We listed all proposed C-APC exclusion
categories for CY 2025 in Addendum J to the CY 2025 OPPS/ASC proposed
rule (which is available via the internet on the CMS website at <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices</a>).
Comment: Commenters were generally very supportive of the proposal
and thought this agency action was a positive step forward to ensure
access to these new classes of drugs. They agreed with CMS's assessment
that the cell and gene therapies listed in the CY 2025 OPPS/ASC
proposed rule did not function as integral, ancillary, supportive,
dependent, or adjunctive to any of the current C-APCs primary services.
Commenters noted that they agreed that these treatments acted as
independent therapies and were the reason for a Medicare beneficiary's
visit to a hospital outpatient department. Additionally, commenters
believed that this policy was necessary and important given the large
number of cell and gene therapy products currently being researched
that may ultimately be approved and available to Medicare beneficiaries
in the coming years.
Response: We thank commenters for their support of our proposal and
rationale.
Comment: Many commenters recommended CMS make this policy permanent
as soon as possible. They noted that they agreed with CMS's assessment
that it would be inappropriate to package cell and gene therapies into
C-APCs for CY 2025 only, but that the same reasons that C-APC packaging
would be inappropriate for CY 2025 would also apply to subsequent
years. Other commenters recommended that CMS make this policy effective
for an extended period of time, such as three years, in order to better
understand how the policy is working.
Response: We thank commenters for their feedback. Based on the
comments received, we are persuaded that the reasoning for excluding
these cell and gene therapy products from C-APC packaging in CY 2025
would also apply to subsequent years. As such, we will be finalizing
our proposal as later discussed in this section for CY 2025 and
subsequent years.
Comment: One commenter recommended that its cell therapy be added
to the list of qualifying exceptions to C-APC packaging as their
product received FDA approval on August 1, 2024, during the public
comment period. A few commenters recommended CMS apply this packaging
exception to other categories of drugs that they believed fell into a
similar clinical category as cell and gene therapies. For example, one
commenter suggested that its drug product is one of a growing number of
innovative drugs that are administered using surgical procedures that
are mapped to a C-APC, resulting in packaging of that product. The
commenter stated that the product was the primary treatment being
delivered to the patient, and not the C-APC procedure. Another
commenter stated they have a product in the pipeline that, according to
guidance from a specialty society, requires a procedure corresponding
to CPT code 51720 (bladder instillation of anticarcinogenic agent),
which is assigned to C-APC 5372, in order to insert the investigational
product into the bladder. This commenter believed their product is the
primary treatment being administered to a patient and is not supportive
to any primary C-APC services. Therefore, they requested this product
not be packaged into a C-APC and believed C-APC packaging would be
inappropriate. This commenter also requested that in order to prevent
C-APC packaging, one option would be for CMS to reassign the code used
to describe the administration of its product to a drug administration
APC rather than a C-APC. Specifically, they recommended CMS reassign
CPT code 51720, which corresponds to the procedure used to administer
the investigational product, to a non C-APC, such as a drug
administration APC.
[[Page 93936]]
Some commenters recommended that CMS extend the proposed policy to
cell and gene therapies assigned to status indicator ``G'', which
correlates to pass-through status. Similarly, commenters recommend CMS
exclude a variety of products from C-APC packaging, such as Casgevy,
Lyfgenia, Amtagvi, Omisurge, Zynteglo, Obe-cel, Hemgenix, Beqvez,
Roctavian, Spinraza and Elevidys. A few commenters suggested CMS should
review and identify any other products that may be administered as
independent therapies in the hospital outpatient setting and stated
that such products should be separately paid.
Response: We greatly thank commenters for their detailed comments.
For new cell and gene therapy products that are not integral,
ancillary, supportive, dependent, or adjunctive to any C-APC primary
service that were approved during CY 2024 and that continue to be
approved, CMS will add their product specific HCPCS codes, when
created, to the C-APC exclusion list. For example, HCPCS code J3392
(Injection, exagamglogene autotemcel, per treatment) effective October
1, 2024, which may be used to describe the product Casgevy, was added
to the list of qualifying products. We also thank commenters for their
suggestions to add additional drugs and classes of drugs to this C-APC
exclusion policy as well as those drugs that are administered during a
C-APC procedure. Additionally, we thank the commenter for its
suggestion to move some codes that describe the administration of a
product from a C-APC to a drug administration APC. We will take this
feedback into consideration for future rulemaking. As we stated in the
proposed rule, we welcomed comments from readers on the proposal and
the potential need for a different, modified, expanded, or supplemental
policy for future rulemaking. We believe that cell and gene therapies
are a unique class of products, but we believe we need additional
evidence and engagement from interested parties concerning whether
other identified classes of drugs, biologicals, medical devices, or
other products are not supportive of a primary C-APC service but may
nonetheless appear on the same claim as a primary C-APC procedure. We
strongly believe in the principles of our prospective payment system
and the C-APC policy; therefore, we want to ensure than any potential
future changes to our C-APC packaging policy maintain these principles.
Commenters suggested that we exclude several additional products
from C-APC packaging, such as Lyfgenia, Zynteglo, Hemgenix, Beqvez,
Roctavian, and Elevidys. We note that these products are currently on
OPPS pass-through status for the duration of CY 2025, and therefore
will be excluded from C-APC packaging under that policy. Similarly, in
response to commenters suggestion that we apply this policy to cell and
gene therapy products assigned to status indicator ``G'', we note that
we specifically did not propose to include therapies that are on drug
pass-through status, represented by status indicator ``G'' for all of
CY 2025 because pass-through drugs are already excluded from C-APC
packaging. Please see section V.A of this final rule with comment
period for additional information on OPPS drug pass-through status.
Comment: Several commenters recommended that CMS unpackage all
status indicator ``K'' drugs from C-APC packaging, which aligned with
the 2024 Advisory Panel on Hospital Outpatient Payment recommendation
to no longer package drugs with a status indicator of ``K'' into any C-
APC and, instead, they recommended CMS provide separate payment for all
drugs and biologicals above the drug packaging threshold. Commenters
said these status indicator ``K'' drugs should be paid based on 1847A
of the Social Security Act and reimbursed at Average Sales Price plus 6
percent rather than packaged. Similarly, a commenter suggested that
since drugs on pass-through status are paid separately when billed with
a C-APC, that CMS should continue that separately payable status after
passthrough status expiration and the transition of that code's status
indicator from ``G'' to ``K.''
Commenters suggested that the proportion of status indicator ``K''
drug charges relative to all other charges appearing on C-APCs claims
was less than 2.5 percent across all C-APCs. Meaning, in commenters'
views, that C-APCs do not inherently involve the provision of status
indicator ``K'' drugs. Another commenter recommended that CMS exclude
high-cost primary therapy drugs across drug classes and not only to
cell and gene therapies, apply the C-APC exclusion to primary therapy
drugs that clinically align to C-APCs, and they included specific
examples they researched that serve as the primary therapy drugs
similar to cell and gene therapies.
Response: We appreciate the information submitted by commenters,
but respectfully disagree with their conclusions. The C-APC policy aims
to package payment for items and services that are typically integral,
ancillary, supportive, dependent, or adjunctive to the primary service
and provided during the delivery of the comprehensive service,
including diagnostic procedures, laboratory tests and other diagnostic
tests and treatments that assist in the delivery of the primary
procedure. We believe it is appropriate for most drugs and biologicals
to be packaged into C-APCs as we believe they function to ``promote a
beneficial outcome'' or ``prevent possible complications'' of C-APC
services. We explained in the CY 2014 OPPS/ASC final rule with comment
period (78 FR 74868) that intravenous drugs, for example, are OPPS
services that are considered adjunctive to the primary procedure
because the correct administration of the drug either promotes a
beneficial outcome, such as the use of intravenous pain medications, or
prevents possible complications, such as the use of intravenous blood
pressure medications to temporarily replace oral blood pressure
medications and reduce the risk of a sudden rise in blood pressure when
a normal daily medication is stopped. We are therefore not excluding
all status indicator ``K'' drugs above the drug packaging threshold
from C-APC packaging. Our packaging policies are a fundamental
component of the OPPS and they support our strategic goal of using
larger payment bundles in the OPPS to maximize hospitals' incentives to
provide care in the most efficient manner. Additionally, we do not
believe at this time that cost alone is a reason to exclude a product
from packaging.
Comment: Many commenters responded to several of our requests for
comment associated with the proposal. Commenters recommended no
significant overall changes to the general methodology CMS proposed to
exclude products from all C-APC packaging and pay separately based on
the individual product's average sales price plus 6 percent.
Specifically, commenters strongly conveyed that they did not see an
appropriate reason for CMS to structure a new C-APC, or similar
packaged payment policy, for the service to administer cell or gene
therapies, such as by creating a CAR T-cell therapy administration C-
APC. Commenters believed that there is no accurate way to create a
bundled payment for a whole group of cell and gene therapies as the
costs and resources required are unique and novel between each of the
therapies, which also makes it difficult to determine appropriate items
and services associated with each therapy for inclusion in C-APC
packaging. Commenters broadly believed no
[[Page 93937]]
different or supplemental policy was warranted given the numerous
challenges providers face related to cell and gene therapies currently.
They saw any additional change to move towards a packaged payment
policy as an additional challenge for the hospitals providing the
therapies.
Similarly, commenters cautioned CMS against creating C-APCs for
cell and gene therapies as this may cause inadequate Medicare
reimbursement to hospitals, which, in their view, has the potential to
jeopardize beneficiary access to CAR T-cell therapy and other high-cost
therapies as commenters communicated that institutions weigh
reimbursement challenges with their ability to provide this costly
care. Commenters were concerned that creating a new packaged payment
policy could lead to a financial loss and decrease the number of
facilities offering high-cost cell and gene therapies in the hospital
outpatient department.
Commenters emphasized that these therapies involve highly
specialized procedures, intensive monitoring, and multidisciplinary
care teams, all of which contribute to their substantial costs.
Commenters were concerned by the fact that the administration of cell
and gene therapies are multi-step processes that can take weeks if not
months and entail multiple services that would not appear on the same
claim. Additional commenters reiterated that all of the various and
distinct clinical services for CAR T-cell therapy are furnished over
multiple encounters on different dates--making CAR T-cell therapy
inappropriate for C-APCs, which are typically specific to a single
encounter in their view. Commenters believed a CAR T-cell therapy C-
APC, or similar packaged payment policy, would be unprecedented and a
huge policy departure for CMS and recommended CMS not pursue the idea
any further.
Many commenters believed that separate payment based on average
sales price plus 6 percent is the most appropriate payment methodology
for cell and gene therapies due to its transparency, uniformity and
predictability. A few commenters pointed out that current hospital cost
data is lower than ASP for CAR T-cell therapy products, potentially
leaving products underpaid if paid based on C-APC principles.
Commenters similarly took the position that there is no appropriate
method in which CMS could modify its outlier payment policy with
respect to C-APCs to better pay for these types of products.
Response: We appreciate the insights provided by commenters and
will take them into consideration for future rulemaking. At this time,
we are not considering the creation of a new C-APC, similar packaged
payment policy, or modified outlier policy, for services to administer
cell or gene therapies.
After consideration of the public comments we received, we are
finalizing our policy proposal with a modification with respect to how
long this policy will apply. For CY 2025 and subsequent years, we are
finalizing a policy not to package payment for cell and gene therapies
into C-APCs, when those cell and gene therapies are not functioning as
integral, ancillary, supportive, dependent, or adjunctive to the
primary C-APC service. For new cell and gene therapy products that are
not integral, ancillary, supportive, dependent, or adjunctive to any C-
APC primary service, we will continue to add their product specific
HCPCS codes, when created, to the C-APC exclusion list. The current
list of qualifying products can be found in Table 4. We are not adding
any additional drug classes to this policy exclusion at this time, and
we are not currently considering any additional modifications to our
policy, but will continue to consider additional refinements for future
rulemaking.
We list all final C-APC exclusion categories for CY 2025 in
Addendum J to this final rule (which is available via the internet on
the CMS website at <a href="https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices">https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices</a>).
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(5) Exclusion of Non-Opioid Products for Pain Relief Under Section 4135
of the Consolidated Appropriations Act, 2023 From the C-APC Policy
The Consolidated Appropriations Act (CAA), 2023 (Pub. L. 117-328),
was signed into law on December 29, 2022. Section 4135(a) and (b) of
the CAA, 2023, titled ``Access to Non-Opioid Treatments for Pain
Relief,'' amended section 1833(t)(16) and section 1833(i) of the Social
Security Act, respectively, to provide for temporary additional
payments for non-opioid treatments for pain relief (as that term is
defined in section 1833(t)(16)(G)(i) of the Act). In particular,
section 1833(t)(16)(G) provides that with respect to a non-opioid
treatment for pain relief furnished on or after January 1, 2025,
[[Page 93939]]
and before January 1, 2028, the Secretary shall not package payment for
the non-opioid treatment for pain relief into payment for a covered OPD
service (or group of services) and shall make an additional payment for
the non-opioid treatment for pain relief as specified in clause (ii) of
that section. Clauses (ii) and (iii) of section 1833(t)(16)(G) of the
Act provide for the amount of additional payment and set a limitation
on that amount. As stated earlier in this section, our current policy
is to exclude from the packaged C-APC payment those items and services
that are required by statute to be separately paid.
Accordingly, we proposed to exclude the non-opioid treatments for
pain relief identified as satisfying the required criteria for payment
under section 4135 of the CAA, 2023 from the C-APC policy to ensure
payment is not packaged into any C-APC and that separate payment is
made in accordance with the statute.
Comment: Commenters were generally supportive of our proposal not
to package payment and to pay separately for qualifying drugs,
biologicals, and medical devices that met the criteria for payment
under section 4135 of the CAA, 2023. A commenter mentioned its support
of CMS packaging policies, and noted reservations about paying
separately, and not packaging, non-opioid treatments for pain relief;
however, they ultimately conceded that CMS must implement section 4135
of the CAA, 2023, which requires separately payable status, and
supported CMS's implementation methodology.
Response: We thank commenters for their support.
After consideration of the public comments we received, we are
finalizing our policy as proposed, and will exclude the non-opioid
treatments for pain relief identified as satisfying the required
criteria for payment under section 4135 of the CAA, 2023 from the C-APC
policy to ensure payment is not packaged into any C-APC and that
separate payment is made in accordance with the statute. Please see
section XIII.F of this final rule with comment period for a list of the
products that we are finalizing would qualify for payment under the new
payment policy for non-opioid drugs, biologicals, and devices for pain
relief.
(6) C-APCs for CY 2025
For CY 2025 and subsequent years, we proposed to continue to apply
the C-APC payment policy methodology. We refer readers to the CY 2017
OPPS/ASC final rule with comment period (81 FR 79583) for a discussion
of the C-APC payment policy methodology and revisions.
Each year, in accordance with section 1833(t)(9)(A) of the Act, we
review and revise the services within each APC group and the APC
assignments under the OPPS. As a result of our annual review of the
services and the APC assignments under the OPPS, we did not propose to
convert any standard APCs to C-APCs in CY 2025; thus, we proposed that
the number of C-APCs for CY 2025 would be the same as the number for CY
2024, which is 72 C-APCs.
Comment: A few commenters requested that CMS reconsider our
packaging policies for C-APC 8011 (Comprehensive Observation Services).
They requested that CMS remove the rule that the presence of a SI ``T''
procedure on a claim excludes payment of C-APC 8011 and instead package
the payment of the SI ``T'' procedure into C-APC 8011, as is already
done with SI ``Q'' procedures. Commenters stated that this requirement
violates the basic tenet of the packaging concept in that when
observation services are ordered and furnished, the observation
services become the primary service provided to such patients and the
SI ``T'' procedure is provided ancillary to that primary service.
Commenters cited scenarios in which hospitals provide significant,
resource-intensive services to a patient but are paid significantly
less than if a SI ``T'' procedure was not done.
Response: We thank the commenters for bringing this to our
attention. In the CY 2016 OPPS/ASC final rule with comment period (80
FR 70334-70336), in response to commenters' concerns regarding
packaging payment for potentially high-cost surgical procedures into
the payment for an observation C-APC, we finalized a policy that claims
reporting procedures assigned status indicator ``T'' do not qualify for
payment through C-APC 8011, regardless of whether the procedure
assigned status indicator ``T'' was furnished before or after
observation services (described by HCPCS code G0378) were provided. In
the CY 2017 OPPS/ASC final rule with comment period (81 FR 79562), we
stated that services that would otherwise qualify for C-APC 8011 are
not considered to be observation services when they are associated with
a surgical procedure (assigned to status indicator ``T''). Instead,
they are considered to be perioperative recovery, which is always
packaged in with the surgical procedure. We will continue to review the
impacts of this issue and may revisit it in future rulemaking.
Comment: Two commenters expressed concerns with the C-APC
methodology for surgical insertion codes for brachytherapy treatment,
stating that these concerns impact beneficiary access to brachytherapy
in the HOPD setting. These commenters stated that the C-APC methodology
lacks the appropriate charge capture mechanisms to accurately reflect
the services associated with the C-APC, that there are significant
variations in the clinical practice and billing patterns in the
hospital claims data used for ratesetting, and that the C-APC rates do
not accurately or fully reflect the services and costs associated with
the primary procedure. Commenters urged the agency to explore
alternatives, including that CMS discontinue the C-APC policy for all
brachytherapy insertion codes. Alternatively, one commenter suggested
that CMS could continue to pay for ``J1'' brachytherapy insertion codes
under the C-APC payment methodology but exclude and make separate
payment for designated preparation and planning services in addition to
the C-APC payment. Another commenter called for education on whether
services, like brachytherapy, that are assigned to a J1 indicators and
delivered over multiple patient encounters may be reported per
encounter.
Response: We appreciate the comments on the C-APC methodology.
However, we believe that the current C-APC methodology is appropriately
applied to surgical insertion for brachytherapy treatment procedures
and is accurately capturing costs, particularly as the brachytherapy
sources used for these procedures are excluded from C-APC packaging and
are separately payable. We will evaluate if provider education may be
appropriate in this circumstance. We will continue to examine these
concerns and will determine if any modifications on this policy are
warranted in future rulemaking.
After consideration of the public comments we received, we are
finalizing the C-APCs as proposed. Table 5 lists the final C-APCs for
CY 2025. All C-APCs are displayed in Addendum J to this CY 2025 OPPS/
ASC final rule with comment period (which is available via the internet
on the CMS website). Addendum J to this final rule with comment period
also contains all of the data related to the C-APC payment policy
methodology, including the list of complexity adjustments and other
information for CY 2025.
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[GRAPHIC] [TIFF OMITTED] TR27NO24.006
BILLING CODE 4120-01-C
C-APC Clinical Family Descriptor Key:
AENDO = Airway Endoscopy
AICDP = Automatic Implantable Cardiac Defibrillators, Pacemakers,
and Related Devices.
BREAS = Breast Surgery
COCHL = Cochlear Implant
EBIDX = Excision/Biopsy/Incision and Drainage
ENTXX = ENT Procedures
EPHYS = Cardiac Electrophysiology/
EVASC = Endovascular Procedures
EXEYE = Extraocular Ophthalmic Surgery
GIXXX = Gastrointestinal Procedures
GYNXX = Gynecologic Procedures
INEYE = Intraocular Surgery
LAPXX = Laparoscopic Procedures
NERVE = Nerve Procedures
NSTIM = Neurostimulators
ORTHO = Orthopedic Surgery
PUMPS = Implantable Drug Delivery Systems
RADTX = Radiation Oncology
SCTXX = Stem Cell Transplant
[[Page 93942]]
UROXX = Urologic Procedures
VASCX = Vascular Procedures
WPMXX = Wireless PA Pressure Monitor
c. Calculation of Composite APC Criteria-Based Costs
As discussed in the CY 2008 OPPS/ASC final rule with comment period
(72 FR 66613), we believe it is important that the OPPS enhance
incentives for hospitals to provide necessary, high-quality care as
efficiently as possible. For CY 2008, we developed composite APCs to
provide a single payment for groups of services that are typically
performed together during a single clinical encounter and that result
in the provision of a complete service. Combining payment for multiple,
independent services into a single OPPS payment in this way enables
hospitals to manage their resources with maximum flexibility by
monitoring and adjusting the volume and efficiency of services
themselves. An additional advantage to the composite APC model is that
we can use data from correctly coded multiple procedure claims to
calculate payment rates for the specified combinations of services,
rather than relying upon single procedure claims which may be low in
volume and/or incorrectly coded. Under the OPPS, we currently have
composite policies for mental health services and multiple imaging
services. We refer readers to the CY 2008 OPPS/ASC final rule with
comment period (72 FR 66611 through 66614 and 66650 through 66652) for
a full discussion of the development of the composite APC methodology,
and the CY 2012 OPPS/ASC final rule with comment period (76 FR 74163)
and the CY 2018 OPPS/ASC final rule with comment period (82 FR 59241,
59242, and 59246 through 52950) for more recent background.
(1) Mental Health Services Composite APC
For CY 2025, we proposed to continue our longstanding policy of
limiting the aggregate payment for specified less resource-intensive
mental health services furnished on the same date to the payment for a
day of partial hospitalization services provided by a hospital, which
we consider to be the most resource-intensive of all outpatient mental
health services (88 FR 49572). We refer readers to the April 7, 2000,
OPPS final rule with comment period (65 FR 18452 through 18455) for the
initial discussion of this longstanding policy and the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74168) for more recent
background.
In the CY 2018 OPPS/ASC proposed rule and final rule with comment
period (82 FR 33580 and 33581 and 82 FR 59246 and 59247), we proposed
and finalized the policy for CY 2018 and subsequent years that, when
the aggregate payment for specified mental health services provided by
one hospital to a single beneficiary on a single date of service, based
on the payment rates associated with the APCs for the individual
services, exceeds the maximum per diem payment rate for partial
hospitalization services provided by a hospital, those specified mental
health services will be paid through composite APC 8010 (Mental Health
Services Composite). In addition, we set the payment rate for composite
APC 8010 for CY 2018 at the same payment rate for APC 5863, which was
the maximum partial hospitalization per diem payment rate for a
hospital, and finalized a policy that the hospital would continue to be
paid the payment rate for composite APC 8010. This policy applied in
CYs 2018 through 2023.
In the CY 2024 OPPS/ASC proposed rule, we stated that APC 5863 was
no longer the maximum partial hospitalization per diem payment rate for
a hospital due to the creation of APC 5864, which is four or more
hospital-based PHP services per day (88 FR 49572). We solicited comment
on whether APC 5864 would be appropriate to use as the daily mental
health cap, as we have historically set the daily mental health cap for
composite APC 8010 at the maximum partial hospitalization per diem
payment rate for a hospital (88 FR 49572). Based on public comments
received and our longstanding policy, in CY 2024 OPPS/ASC final rule,
we finalized APC 5864, four hospital-based PHP services per day, as the
daily mental health cap (88 FR 81566).
We continue to believe that the costs associated with administering
a partial hospitalization program represent the most resource intensive
of all outpatient mental health services. For CY 2025 and subsequent
years, we proposed to continue this policy that when the aggregate
payment for specified mental health services provided by one hospital
to a single beneficiary on a single date of service, based on the
payment rates associated with the APCs for the individual services,
exceeds the per diem payment rate for 4 partial hospitalization
services provided in a day by a hospital (the payment amount for APC
5864), those specified mental health services would be paid through
composite APC 8010. In addition, we proposed to continue to set the
payment rate for composite APC 8010 at the same payment rate that we
propose for APC 5864, which is a partial hospitalization per diem
payment rate for 4 partial hospitalization services furnished in a day
by a hospital.
Under the proposed policy, the Integrated OCE (I/OCE) would
continue to determine whether to pay for these specified mental health
services individually, or to make a single payment at the same payment
rate established for APC 5864 for all the specified mental health
services furnished by the hospital on that single date of service by
paying for the services through composite APC 5863.
Comment: One commenter recommended that CMS change the status
indicator for two neuropsychological testing codes (HCPCS codes 96133
and 96137) from SI = N to SI = Q3 to allow separate payment for
additional hours of testing or increase the payment rate for the
primary testing procedure codes. Noting the multiple day structure of
neuropsychological testing, they requested a daily payment for each
date of service. The commenters noted that the payment rate for
Composite APC 8010, which is capped at the maximum per diem partial
hospitalization rate, is lower than the individual HCPCS code APC
payment rates and does not provide sufficient payment for these
procedures.
Response: After reviewing this issue, we believe the Composite APC
methodology is being appropriately applied in this case. Composite APCs
provide a single payment for groups of services that are typically
performed together during a single clinical encounter and that result
in the provision of a complete service.
The words ``list separately in addition to code for primary
procedure'' are included in the long descriptors for HCPCS codes 96133
and 96137 to indicate that that the codes are considered ``add-ons'' to
another primary code that cannot be reported independently.
Specifically, add-on codes must always be reported with another primary
code on the same day. The AMA states in the CPT 2024 Professional
Edition (page xviii) that ``add-on codes are always performed in
addition to the primary service or procedure and must never be reported
as a stand-alone code.'' In most cases, add-on codes are typically
ancillary and supportive to a primary diagnostic or therapeutic
modality and are an integral part of the primary service they support.
As specified under 42 CFR 419.2(b)(18), certain services described by
add-on codes are generally packaged under the OPPS, and payments for
the codes are bundled with the primary codes.
[[Page 93943]]
Consequently, HCPCS codes 96133 and 96137 are not paid separately under
the OPPS, but instead, their payment is packaged into the primary code.
In the CY 2018 OPPS/ASC final rule with comment period (82 FR 59246
through 59247), we stated that the costs associated with administering
a partial hospitalization program at a hospital represent the most
resource intensive of all outpatient mental health services. We
continue to believe that the Composite APC methodology, which limits
the aggregate payment for specified mental health services provided by
one hospital to a single beneficiary on a single date of service, based
on the payment rates associated with the APCs for the individual
services, to the per diem payment rate for four partial hospitalization
services provided in a day by a hospital (the payment amount for APC
5864), is appropriate.
We will continue to examine these concerns and will determine if
any modifications to this policy are warranted in future rulemaking.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, that when the aggregate
payment for specified mental health services provided by one hospital
to a single beneficiary on a single date of service, based on the
payment rates associated with the APCs for the individual services,
exceeds the maximum per diem payment rate for four partial
hospitalization services provided in a day by a hospital (the payment
amount for APC 5864), those specified mental health services would be
paid through composite APC 8010 for CY 2025. In addition, we are
finalizing setting the payment rate for composite APC 8010 for CY 2025
at the same payment rate that we set for APC 5864, which is the maximum
partial hospitalization per diem payment rate for a hospital.
(2) Multiple Imaging Composite APCs (APCs 8004, 8005, 8006, 8007, and
8008)
Effective January 1, 2009, we provide a single payment each time a
hospital submits a claim for more than one imaging procedure within an
imaging family on the same date of service, to reflect and promote the
efficiencies hospitals can achieve when performing multiple imaging
procedures during a single session (73 FR 41448 through 41450). We
utilize three imaging families based on imaging modality for purposes
of this methodology: (1) ultrasound; (2) computed tomography (CT) and
computed tomographic angiography (CTA); and (3) magnetic resonance
imaging (MRI) and magnetic resonance angiography (MRA). The HCPCS codes
subject to the multiple imaging composite policy and their respective
families are listed in Table 6.
While there are three imaging families, there are five multiple
imaging composite APCs due to the statutory requirement under section
1833(t)(2)(G) of the Act that we differentiate payment for OPPS imaging
services provided with and without contrast. While the ultrasound
procedures included under the policy do not involve contrast, both CT/
CTA and MRI/MRA scans can be provided either with or without contrast.
The five multiple imaging composite APCs established in CY 2009 are:
<bullet> APC 8004 (Ultrasound Composite);
<bullet> APC 8005 (CT and CTA without Contrast Composite);
<bullet> APC 8006 (CT and CTA with Contrast Composite);
<bullet> APC 8007 (MRI and MRA without Contrast Composite); and
<bullet> APC 8008 (MRI and MRA with Contrast Composite).
We define the single imaging session for the ``with contrast''
composite APCs as having at least one or more imaging procedures from
the same family performed with contrast on the same date of service.
For example, if the hospital performs an MRI without contrast during
the same session as at least one other MRI with contrast, the hospital
will receive payment based on the payment rate for APC 8008, the ``with
contrast'' composite APC.
We make a single payment for those imaging procedures that qualify
for payment based on the composite APC payment rate, which includes any
packaged services furnished on the same date of service. The standard
(noncomposite) APC assignments continue to apply for single imaging
procedures and multiple imaging procedures performed across families.
For a full discussion of the development of the multiple imaging
composite APC methodology, we refer readers to the CY 2009 OPPS/ASC
final rule with comment period (73 FR 68559 through 68569).
For CY 2025, we proposed to continue to pay for all multiple
imaging procedures within an imaging family performed on the same date
of service using the multiple imaging composite APC payment
methodology. We continue to believe that this policy would reflect and
promote the efficiencies hospitals can achieve when performing multiple
imaging procedures during a single session.
[…truncated; see source link]Indexed from Federal Register on November 27, 2024.
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