Rule2023-24293
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction
Primary source
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Published
November 22, 2023
Effective
January 1, 2024
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 2024 based on our continuing experience with these systems. In this final rule, 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 and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REHQR) Program. In this final rule, we are also establishing a payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this final rule updates and refines requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. We are finalizing changes to the community mental health center (CMHC) Conditions of Participation (CoPs) to provide requirements for furnishing intensive outpatient (IOP) services, and we are finalizing the proposed personnel qualifications for mental health counselors (MHCs) and marriage and family therapists (MFTs). Additionally, we are finalizing the removal of discussion of the inpatient prospective payment system (IPPS) Medicare Code Editor (MCE) from the annual IPPS rulemakings, beginning with the fiscal year (FY) 2025 rulemaking. Finally, we are finalizing a technical correction to the Rural Emergency Hospital (REH) CoPs under the standard for the designation and certification of REHs.
Full Text
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[Federal Register Volume 88, Number 224 (Wednesday, November 22, 2023)]
[Rules and Regulations]
[Pages 81540-82185]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24293]
[[Page 81539]]
Vol. 88
Wednesday,
No. 224
November 22, 2023
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 416, et al.
45 CFR Part 180
Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems; Quality Reporting Programs;
Payment for Intensive Outpatient Services in Hospital Outpatient
Departments, Community Mental Health Centers, Rural Health Clinics,
Federally Qualified Health Centers, and Opioid Treatment Programs;
Hospital Price Transparency; Changes to Community Mental Health Centers
Conditions of Participation, Changes to the Inpatient Prospective
Payment System Medicare Code Editor; Rural Emergency Hospital
Conditions of Participation Technical Correction; Final Rule
Federal Register / Vol. 88 , No. 224 / Wednesday, November 22, 2023 /
Rules and Regulations
[[Page 81540]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 416, 419, 424, 485, 488, and 489
Office of the Secretary
45 CFR Part 180
[CMS-1786-FC]
RIN 0938-AV09
Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems; Quality Reporting Programs;
Payment for Intensive Outpatient Services in Hospital Outpatient
Departments, Community Mental Health Centers, Rural Health Clinics,
Federally Qualified Health Centers, and Opioid Treatment Programs;
Hospital Price Transparency; Changes to Community Mental Health Centers
Conditions of Participation, Changes to the Inpatient Prospective
Payment System Medicare Code Editor; Rural Emergency Hospital
Conditions of Participation Technical Correction
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 2024
based on our continuing experience with these systems. In this final
rule, 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 and refines the requirements for the Hospital Outpatient
Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR)
Program, and the Rural Emergency Hospital Quality Reporting (REHQR)
Program. In this final rule, we are also establishing a payment for
certain intensive outpatient services under Medicare, beginning January
1, 2024. In addition, this final rule updates and refines requirements
for hospitals to make public their standard charge information and
enforcement of hospital price transparency. We are finalizing changes
to the community mental health center (CMHC) Conditions of
Participation (CoPs) to provide requirements for furnishing intensive
outpatient (IOP) services, and we are finalizing the proposed personnel
qualifications for mental health counselors (MHCs) and marriage and
family therapists (MFTs). Additionally, we are finalizing the removal
of discussion of the inpatient prospective payment system (IPPS)
Medicare Code Editor (MCE) from the annual IPPS rulemakings, beginning
with the fiscal year (FY) 2025 rulemaking. Finally, we are finalizing a
technical correction to the Rural Emergency Hospital (REH) CoPs under
the standard for the designation and certification of REHs.
DATES:
Effective date: The provisions of this rule are effective January
1, 2024.
Comment period: To be assured consideration, comments must be
received at one of the addresses provided below, by January 1, 2024.
ADDRESSES: In commenting, please refer to file code CMS-1786-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-1786-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-1786-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:
Au'Sha Washington, <a href="/cdn-cgi/l/email-protection#acedd9dfc4cdfbcddfc4c5c2cbd8c3c2eccfc1df82c4c4df82cbc3da"><span class="__cf_email__" data-cfemail="0d4c787e656c5a6c7e6564636a7962634d6e607e2365657e236a627b">[email protected]</span></a> or 410-786-3736.
Advisory Panel on Hospital Outpatient Payment (HOP Panel), contact
the HOP Panel mailbox at <a href="/cdn-cgi/l/email-protection#cc8d9c8f9cada2a9a08cafa1bfe2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="0243524152636c676e42616f712c6a6a712c656d74">[email protected]</span></a>.
Ambulatory Surgical Center (ASC) Payment System, contact Scott
Talaga via email at <a href="/cdn-cgi/l/email-protection#90c3f3ffe4e4bec4f1fcf1f7f1d0f3fde3bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="1142727e65653f45707d70767051727c623f7979623f767e67">[email protected]</span></a> or Mitali Dayal via email
at <a href="/cdn-cgi/l/email-protection#f6bb9f82979a9fd8b2978f979ac4b6959b85d89e9e85d8919980"><span class="__cf_email__" data-cfemail="f2bf9b86939e9bdcb6938b939ec0b2919f81dc9a9a81dc959d84">[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#8fcee1e6fbeea1cde7eefbe6eecfece2fca1e7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="8dcce3e4f9eca3cfe5ecf9e4eccdeee0fea3e5e5fea3eae2fb">[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#f09d9182839891de989582848a92958297b0939d83de989883de979f86"><span class="__cf_email__" data-cfemail="c4a9a5b6b7aca5eaaca1b6b0bea6a1b6a384a7a9b7eaacacb7eaa3abb2">[email protected]</span></a>.
Biosimilars Packaging Exception, contact Gil Ngan via email at
<a href="/cdn-cgi/l/email-protection#2f4846430141484e416f4c425c0147475c01484059"><span class="__cf_email__" data-cfemail="e087898cce8e87818ea0838d93ce888893ce878f96">[email protected]</span></a>.
Blood and Blood Products, contact Josh McFeeters via email at
<a href="/cdn-cgi/l/email-protection#0842677b607d6926456b4e6d6d7c6d7a7b486b657b2660607b266f677e"><span class="__cf_email__" data-cfemail="13597c607b66723d5e705576766776616053707e603d7b7b603d747c65">[email protected]</span></a>.
Cancer Hospital Payments, contact Scott Talaga via email at
<a href="/cdn-cgi/l/email-protection#88dbebe7fcfca6dce9e4e9efe9c8ebe5fba6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="683b0b071c1c463c0904090f09280b051b4600001b460f071e">[email protected]</span></a>.
Cardiac Rehabilitation, Intensive Cardiac Rehabilitation and
Pulmonary Rehabilitation Services, contact Nate Vercauteren via email
at <a href="/cdn-cgi/l/email-protection#c789a6b3afa6a9e991a2b5a4a6b2b3a2b5a2a987a4aab4e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="eaa48b9e828b84c4bc8f98898b9f9e8f988f84aa898799c4828299c48d859c">[email protected]</span></a>.
CMS Web Posting of the OPPS and ASC Payment Files, contact Chuck
Braver via email at <a href="/cdn-cgi/l/email-protection#783b100d1b13563a0a190e1d0a381b150b5610100b561f170e"><span class="__cf_email__" data-cfemail="c586adb0a6aeeb87b7a4b3a0b785a6a8b6ebadadb6eba2aab3">[email protected]</span></a>.
Community Mental Health Centers (CMHC) Conditions of Participation,
contact Mary Rossi-Coajou via email at <a href="/cdn-cgi/l/email-protection#b7fad6c5ce99e5d8c4c4def4d8d6ddd8c2f7d4dac499dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="6f220e1d16413d001c1c062c000e05001a2f0c021c4107071c41080019">[email protected]</span></a> or
Cara Meyer via email at <a href="/cdn-cgi/l/email-protection#9cdffdeefdb2d1f9e5f9eedcfff1efb2f4f4efb2fbf3ea"><span class="__cf_email__" data-cfemail="296a485b4807644c504c5b694a445a0741415a074e465f">[email protected]</span></a>.
Composite APCs (Multiple Imaging and Mental Health), via email at
Mitali Dayal via email at <a href="/cdn-cgi/l/email-protection#c885a1bca9a4a1e68ca9b1a9a4fa88aba5bbe6a0a0bbe6afa7be"><span class="__cf_email__" data-cfemail="98d5f1ecf9f4f1b6dcf9e1f9f4aad8fbf5ebb6f0f0ebb6fff7ee">[email protected]</span></a>.
Comprehensive APCs (C-APCs), contact Mitali Dayal via email at
<a href="/cdn-cgi/l/email-protection#f9b4908d989590d7bd98809895cbb99a948ad791918ad79e968f"><span class="__cf_email__" data-cfemail="5a17332e3b3633741e3b233b36681a39372974323229743d352c">[email protected]</span></a>.
COVID-19 Final Rules, contact Au'Sha Washington via email at
<a href="/cdn-cgi/l/email-protection#632216100b024d3402100b0a0d04170c0d23000e104d0b0b104d040c15"><span class="__cf_email__" data-cfemail="6e2f1b1d060f40390f1d060700091a01002e0d031d4006061d40090118">[email protected]</span></a>.
Hospital Outpatient Quality Reporting (OQR) Program policies,
contact Kimberly Go via email <a href="/cdn-cgi/l/email-protection#a9e2c0c4cbccdbc5d087eec6e9cac4da87c1c1da87cec6df"><span class="__cf_email__" data-cfemail="f5be9c98979087998cdbb29ab5969886db9d9d86db929a83">[email protected]</span></a>.
Hospital Outpatient Quality Reporting (OQR) Program measures,
contact Janis Grady via email <a href="/cdn-cgi/l/email-protection#b0fad1ded9c39ef7c2d1d4c9f0d3ddc39ed8d8c39ed7dfc6"><span class="__cf_email__" data-cfemail="7c361d12150f523b0e1d18053c1f110f5214140f521b130a">[email protected]</span></a>.
Hospital Outpatient Visits (Emergency Department Visits and
Critical Care Visits), contact Abby Cesnik via email at <a href="/cdn-cgi/l/email-protection#85c4e7ece2e4ece9abc6e0f6ebeceec5e6e8f6abededf6abe2eaf3"><span class="__cf_email__" data-cfemail="e4a5868d83858d88caa781978a8d8fa4878997ca8c8c97ca838b92">[email protected]</span></a>.
Hospital Price Transparency (HPT), contact Terri Postma via email
at <a href="/cdn-cgi/l/email-protection#7d2d0f141e18290f1c130e0d1c0f18131e0435120e0d14091c113e151c0f1a180e3d1e100e5315150e531a120b"><span class="__cf_email__" data-cfemail="29795b404a4c7d5b48475a59485b4c474a5061465a59405d48456a41485b4e4c5a694a445a0741415a074e465f">[email protected]</span></a>.
Inpatient Only (IPO) Procedures List, contact Abigail Cesnik via
email at <a href="/cdn-cgi/l/email-protection#d998bbb0beb8b0b5f79abcaab7b0b299bab4aaf7b1b1aaf7beb6af"><span class="__cf_email__" data-cfemail="3677545f51575f5a18755345585f5d76555b45185e5e4518515940">[email protected]</span></a>.
Inpatient Prospective Payment System (IPPS) Medicare Code Editor,
contact Mady Hue via email at <a href="/cdn-cgi/l/email-protection#cd80acbfa4a1b8e385b8a88daea0bee3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="a2efc3d0cbced78cead7c7e2c1cfd18ccacad18cc5cdd4">[email protected]</span></a>.
Mental Health Services Furnished Remotely by Hospital Staff to
Beneficiaries in Their Homes, contact Emily Yoder via email at
<a href="/cdn-cgi/l/email-protection#d095bdb9bca9fe89bfb4b5a290b3bda3feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="9dd8f0f4f1e4b3c4f2f9f8efddfef0eeb3f5f5eeb3faf2eb">[email protected]</span></a>.
Method to Control Unnecessary Increases in the Volume of Clinic
Visit
[[Page 81541]]
Services Furnished in Excepted Off-Campus Provider-Based Departments
(PBDs), contact Nate Vercauteren via email at <a href="/cdn-cgi/l/email-protection#541a35203c353a7a023126373521203126313a143739277a3c3c277a333b22"><span class="__cf_email__" data-cfemail="1b557a6f737a75354d7e69787a6e6f7e697e755b78766835737368357c746d">[email protected]</span></a>.
New Technology Intraocular Lenses (NTIOLs), contact Scott Talaga
via email at <a href="/cdn-cgi/l/email-protection#6f3c0c001b1b413b0e030e080e2f0c021c4107071c41080019"><span class="__cf_email__" data-cfemail="7320101c07075d27121f12141233101e005d1b1b005d141c05">[email protected]</span></a>.
No Cost/Full Credit and Partial Credit Devices, contact Scott
Talaga via email at <a href="/cdn-cgi/l/email-protection#6d3e0e02191943390c010c0a0c2d0e001e4305051e430a021b"><span class="__cf_email__" data-cfemail="8bd8e8e4ffffa5dfeae7eaeceacbe8e6f8a5e3e3f8a5ece4fd">[email protected]</span></a>.
Opioid Treatment Program (OTP) Intensive Outpatient Services (IOP)
contact Lindsey Baldwin via email at <a href="/cdn-cgi/l/email-protection#de92b7b0baadbba7f09cbfb2baa9b7b09ebdb3adf0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="8ec2e7e0eafdebf7a0ccefe2eaf9e7e0ceede3fda0e6e6fda0e9e1f8">[email protected]</span></a> and
Ariana Pitcher at <a href="/cdn-cgi/l/email-protection#fdbc8f949c939cd3ad94899e95988fbd9e908ed395958ed39a928b"><span class="__cf_email__" data-cfemail="f7b6859e969996d9a79e83949f9285b7949a84d99f9f84d9909881">[email protected]</span></a>.
OPPS Brachytherapy, contact Cory Duke via email at <a href="/cdn-cgi/l/email-protection#44072b363d6a00312f21042729376a2c2c376a232b32"><span class="__cf_email__" data-cfemail="d794b8a5aef993a2bcb297b4baa4f9bfbfa4f9b0b8a1">[email protected]</span></a> and Scott Talaga via email at <a href="/cdn-cgi/l/email-protection#99cafaf6ededb7cdf8f5f8fef8d9faf4eab7f1f1eab7fef6ef"><span class="__cf_email__" data-cfemail="6a3909051e1e443e0b060b0d0b2a09071944020219440d051c">[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#cc89bea5afa7e28fa4b9ada2ab8cafa1bfe2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="7732051e141c59341f0216191037141a04591f1f0459101801">[email protected]</span></a>, or Scott Talaga via email at <a href="/cdn-cgi/l/email-protection#c390a0acb7b7ed97a2afa2a4a283a0aeb0edababb0eda4acb5"><span class="__cf_email__" data-cfemail="3063535f44441e64515c51575170535d431e5858431e575f46">[email protected]</span></a>, or Josh McFeeters via email at <a href="/cdn-cgi/l/email-protection#eda7829e85988cc3a08eab888899889f9ead8e809ec385859ec38a829b"><span class="__cf_email__" data-cfemail="317b5e425944501f7c527754544554434271525c421f5959421f565e47">[email protected]</span></a>.
OPPS Dental Policy, contact Nicole Marcos via email at
<a href="/cdn-cgi/l/email-protection#d39dbab0bcbfb6fd9eb2a1b0bca093b0bea0fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="9ed0f7fdf1f2fbb0d3ffecfdf1eddefdf3edb0f6f6edb0f9f1e8">[email protected]</span></a>.
OPPS Drugs, Radiopharmaceuticals, Biologicals, and Biosimilar
Products, contact Josh McFeeters via email at <a href="/cdn-cgi/l/email-protection#e4ae8b978c9185caa987a2818190819697a4878997ca8c8c97ca838b92"><span class="__cf_email__" data-cfemail="a3e9ccd0cbd6c28deec0e5c6c6d7c6d1d0e3c0ced08dcbcbd08dc4ccd5">[email protected]</span></a>, Gil Ngan via email at Gil.Ngan@ cms.hhs.gov, Cory Duke via
email at <a href="/cdn-cgi/l/email-protection#d794b8a5aef993a2bcb297b4baa4f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="43002c313a6d0736282603202e306d2b2b306d242c35">[email protected]</span></a>, or Au'Sha Washington via email at
<a href="/cdn-cgi/l/email-protection#9cdde9eff4fdb2cbfdeff4f5f2fbe8f3f2dcfff1efb2f4f4efb2fbf3ea"><span class="__cf_email__" data-cfemail="f6b783859e97d8a197859e9f9891829998b6959b85d89e9e85d8919980">[email protected]</span></a>.
OPPS New Technology Procedures/Services, contact the New Technology
APC mailbox at <a href="/cdn-cgi/l/email-protection#165873614273757e5746557766667a7f7577627f79786556757b65387e7e6538717960"><span class="__cf_email__" data-cfemail="d49ab1a380b1b7bc958497b5a4a4b8bdb7b5a0bdbbbaa794b7b9a7fabcbca7fab3bba2">[email protected]</span></a>.
OPPS Packaged Items/Services, contact Mitali Dayal via email at
<a href="/cdn-cgi/l/email-protection#410c2835202d286f052038202d7301222c326f2929326f262e37"><span class="__cf_email__" data-cfemail="44092d3025282d6a00253d252876042729376a2c2c376a232b32">[email protected]</span></a> or Cory Duke via email at <a href="/cdn-cgi/l/email-protection#a7e4c8d5de89e3d2ccc2e7c4cad489cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="fcbf938e85d2b8899799bc9f918fd294948fd29b938a">[email protected]</span></a>.
OPPS Pass-Through Devices, contact the Device Pass-Through mailbox
at <a href="/cdn-cgi/l/email-protection#d397b6a5bab0b68387b2a3a3bfbab0b2a7babcbda093b0bea0fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="5014352639333500043120203c39333124393f3e2310333d237e3838237e373f26">[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#e3ae82918a8d82cda896908b8d8a918c9582a3808e90cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="8fc2eefde6e1eea1c4fafce7e1e6fde0f9eecfece2fca1e7e7fca1e8e0f9">[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#e2b2aab2b2839b8f878c96b28d8e8b819ba2818f91cc8a8a91cc858d94"><span class="__cf_email__" data-cfemail="b2e2fae2e2d3cbdfd7dcc6e2dddedbd1cbf2d1dfc19cdadac19cd5ddc4">[email protected]</span></a>.
Request for Public Comments on Potential Payment under the IPPS for
Establishing and Maintaining Access to Essential Medicines, contact
<a href="/cdn-cgi/l/email-protection#8acecbc9cae9e7f9a4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="93d7d2d0d3f0fee0bdfbfbe0bdf4fce5">[email protected]</span></a>.
Rural Emergency Hospital Conditions of Participation, contact
Kianna Banks via email <a href="/cdn-cgi/l/email-protection#6c27050d02020d422e0d02071f2c0f011f4204041f420b031a"><span class="__cf_email__" data-cfemail="8ec5e7efe0e0efa0ccefe0e5fdceede3fda0e6e6fda0e9e1f8">[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#adecc3c4d9cc83efc5ccd9c4ccedcec0de83c5c5de83cac2db"><span class="__cf_email__" data-cfemail="81c0efe8f5e0afc3e9e0f5e8e0c1e2ecf2afe9e9f2afe6eef7">[email protected]</span></a>.
Rural Emergency Hospital Quality Reporting (REHQR) Program
measures, contact Melissa Hager via email <a href="/cdn-cgi/l/email-protection#87cae2ebeef4f4e6a9cfe6e0e2f5c7e4eaf4a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="f0bd959c99838391deb891979582b0939d83de989883de979f86">[email protected]</span></a>.
Rural Health Clinic (RHC) and Federally Qualified Health Center
(FQHC) Intensive Outpatient Services (IOP), contact the RHC Payment
Policy Mailbox at <a href="/cdn-cgi/l/email-protection#f6a4beb5b6959b85d89e9e85d8919980"><span class="__cf_email__" data-cfemail="66342e2526050b15480e0e1548010910">[email protected]</span></a> or the FQHC Payment Policy Mailbox
at <a href="/cdn-cgi/l/email-protection#99dfc8d1dab4c9c9cad9faf4eab7f1f1eab7fef6ef"><span class="__cf_email__" data-cfemail="98dec9d0dbb5c8c8cbd8fbf5ebb6f0f0ebb6fff7ee">[email protected]</span></a>.
Separate Payment for High-Cost Drugs Provided by Indian Health
Service and Tribally-Owned Facilities, contact Josh McFeeters via email
at <a href="/cdn-cgi/l/email-protection#de94b1adb6abbff093bd98bbbbaabbacad9ebdb3adf0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="5c16332f34293d72113f1a393928392e2f1c3f312f7234342f723b332a">[email protected]</span></a>.
Skin Substitutes, contact Josh McFeeters via email at
<a href="/cdn-cgi/l/email-protection#c18baeb2a9b4a0ef8ca287a4a4b5a4b3b281a2acb2efa9a9b2efa6aeb7"><span class="__cf_email__" data-cfemail="92d8fde1fae7f3bcdff1d4f7f7e6f7e0e1d2f1ffe1bcfafae1bcf5fde4">[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#c08fb5b4b0a1b4a9a5aeb490909380a3adb3eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="440b31303425302d212a30141417042729376a2c2c376a232b32">[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#f6b7a5b5a6a6a5b6959b85d89e9e85d8919980"><span class="__cf_email__" data-cfemail="1d5c4e5e4d4d4e5d7e706e3375756e337a726b">[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.
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 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 2021 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 OPPS/ASC Proposed
Rule
G. Public Comments Received on the CY 2023 OPPS/ASC Final Rule
With Comment Period
II. Updates Affecting OPPS Payments
A. Recalibration of APC Relative Payment Weights
B. Conversion Factor Update
C. Proposed Wage Index Changes
D. Proposed Statewide Average Default Cost-to-Charge Ratios
(CCRs)
E. Proposed Adjustment for Rural Sole Community Hospitals (SCHs)
and Essential Access Community Hospitals (EACHs) Under Section
1833(t)(13)(B) of the Act for CY 2024
F. Proposed Payment Adjustment for Certain Cancer Hospitals for
CY 2024
G. Proposed Hospital Outpatient Outlier Payments
H. Proposed Calculation of an Adjusted Medicare Payment From the
National Unadjusted Medicare Payment
I. Proposed Beneficiary Copayments
B. Conversion Factor Update
C. Wage Index Changes
[[Page 81542]]
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 2024
F. Payment Adjustment for Certain Cancer Hospitals for CY 2024
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
C. Requirement in the Physician Fee Schedule CY 2024 Proposed
Rule for HOPDs and ASCs To Report Discarded Amounts of Certain
Single-Dose or Single-Use Package Drugs
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. Estimate of Pass-Through Spending for CY 2024
VII. OPPS Payment for Hospital Outpatient Visits and Critical Care
Services
VIII. Payment for Partial Hospitalization and Intensive Outpatient
Services
A. Partial Hospitalization
B. Intensive Outpatient Program Services
C. Coding and Billing for PHP and IOP Services Under the OPPS
D. Payment Rate Methodology for PHP and IOP
E. Outlier Policy for CMHCs
F. Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs)
G. Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs)
H. Payment Rates Under the Medicare Physician Fee Schedule for
Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus
Provider-Based Departments of a Hospital
IX. Services That Will Be Paid Only as Inpatient Services
A. Background
B. Changes to the Inpatient Only (IPO) List
C. Solicitation of Public Comments on the Services Described by
CPT Codes 43775, 43644, 43645, and 44204
X. Nonrecurring Policy Changes
A. Supervision by Nurse Practitioners, Physician Assistants, and
Clinical Nurse Specialists of Cardiac Rehabilitation, Intensive
Cardiac Rehabilitation, and Pulmonary Rehabilitation Services
Furnished to Hospital Outpatients
B. Payment for Intensive Cardiac Rehabilitation Services (ICR)
Provided by an Off-Campus, Non-Excepted Provider Based Department
(PBD) of a Hospital
C. OPPS Payment for Specimen Collection for COVID-19 Tests
D. Remote Services
E. OPPS Payment for Dental Services
F. Use of Claims and Cost Report Data for CY 2024 OPPS and ASC
Payment System Ratesetting Due to the PHE
G. Comment Solicitation on Payment for High-Cost Drugs Provided
by Indian Health Service and Tribal Facilities
H. Technical Changes to Hospital Billing for Marriage and Family
Therapist Services and Mental Health Counselor Services
XI. CY 2024 OPPS Payment Status and Comment Indicators
A. CY 2024 OPPS Payment Status Indicator Definitions
B. CY 2024 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. Comment Solicitation on Access to Non-Opioid Treatments 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. Requirements for the Hospital Outpatient Quality Reporting
(OQR) Program
A. Background
B. Hospital OQR Program Quality Measures
C. Hospital OQR Program Quality Measure Topics for Potential
Future Consideration
D. Administrative Requirements
E. Form, Manner, and Timing of Data Submitted for the Hospital
OQR Program
F. Payment Reduction for Hospitals That Fail To Meet the
Hospital OQR Program Requirements for the CY 2024 Payment
Determination
XV. Ambulatory Surgical Center Quality Reporting (ASCQR) Program
Requirements
A. Background
B. ASCQR Program Quality Measures
C. Administrative Requirements
D. Form, Manner, and Timing of Data Submitted for the ASCQR
Program
E. Payment Reduction for ASCs That Fail To Meet the ASCQR
Program Requirements
XVI. Proposed Requirements for the Rural Emergency Hospital Quality
Reporting (REHQR) Program
A. Background
B. REHQR Program Quality Measures
C. Administrative Requirements
D. Form, Manner, and Timing of Data Submitted for the REHQR
Program
XVII. Changes to Community Mental Health Center (CMHC) Conditions of
Participation (CoPs)
A. Background and Statutory Authority
B. Summary of the CMHC Proposed Provisions, Public Comments and
Responses to Comments
XVIII. Updates to Requirements for Hospitals To Make Public a List
of Their Standard Charges
A. Introduction and Overview
B. New Requirements for Making Public Hospital Standard Charges
Under 45 CFR 180.50
C. Requirements To Improve and Enhance Enforcement
D. Comments on CMS' Request for Information Related to Consumer-
Friendly Displays and Alignment With Transparency in Coverage and No
Surprises Act
XIX. Changes to the Inpatient Prospective Payment System Medicare
Code Editor
XX. Technical Edits for REH Conditions of Participation and Critical
Access Hospital (CAH) CoP Updates
XXI. Rural Emergency Hospitals (REHs): Payment for Rural Emergency
Hospitals (REHs)
A. Background on Rural Emergency Hospitals (REHs)
B. REH Payment Methodology
C. Background on the IHS Outpatient All-Inclusive Rate (AIR) for
Tribal and IHS Hospitals
D. Paying Indian Health Service (IHS) and Tribal Hospitals That
Convert to an REH Under the AIR
E. Exclusion of REHs From the OPPS
XXII. Request for Public Comments on Potential Payment Under the
IPPS and OPPS for Establishing and Maintaining Access to Essential
Medicines
A. Overview
B. Establishing and Maintaining a Buffer Stock of Essential
Medicines
C. Potential Separate Payment Under IPPS and OPPS for
Establishing and Maintaining Access to a Buffer Stock of Essential
Medicines
D. Comment Solicitation on Additional Considerations
E. Overview of Comments Received
F. Next Steps
XXIII. Files Available to the Public via the Internet
XXIV. Collection of Information Requirements
A. ICRs Related to Proposed Intensive Outpatient Physician
Certification Requirements
[[Page 81543]]
B. ICRs Related to the Hospital OQR Program
C. ICRs Related to the ASCQR Program
D. ICRs Related to the REHQR Program
E. ICRs Related to Conditions of Participation (CoPs):
Admission, Initial Evaluation, Comprehensive Assessment, and
Discharge or Transfer of the Client (Sec. 485.914)
F. ICR's Related to Conditions of Participation (CoPs):
Treatment Team, Person-Centered Active Treatment Plan, and
Coordination of Services (Sec. 485.916)
G. ICR's Related to Conditions of Participation (CoPs):
Organization, Governance, Administration of Services, Partial
Hospitalization Services (Sec. 485.918)
H. ICRs Related to Hospital Price Transparency
XXV. Response to Comments
XXVI. 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. Congressional Review
I. Summary and Background
A. Executive Summary of This Document
1. Purpose
In this final rule with comment period, 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, 2024. 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 that 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. In addition, this
final rule with comment period updates and refines the requirements for
the Hospital Outpatient Quality Reporting (OQR) Program, the ASC
Quality Reporting (ASCQR) Program, and Rural Emergency Hospital Quality
Reporting (REHQR) Program. In addition, this final rule with comment
period establishes payment for intensive outpatient services under
Medicare, beginning January 1, 2024. This final rule with comment
period also updates and refines the requirements for hospitals to make
public their standard charges and CMS enforcement of hospital price
transparency regulations. In addition, we are finalizing changes to the
CMHC CoPs to provide requirements for furnishing IOP services. In
addition, we are finalizing changes to the CMHC CoPs to provide
requirements for furnishing IOP services, as well as finalizing the
proposed personnel qualifications for MHCs and MFTs. We are also
finalizing the removal of discussion of the IPPS Medicare Code Editor
(MCE) from the annual IPPS rulemakings, beginning with the FY 2025
rulemaking. Finally, we are finalizing a technical correction to the
Rural Emergency Hospital (REH) CoPs under the standard for the
designation and certification of REHs.
2. Summary of the Major Provisions
<bullet> OPPS Update: For 2024, we are increasing the payment rates
under the OPPS by an Outpatient Department (OPD) fee schedule increase
factor of 3.1 percent. This increase factor is based on the final
inpatient hospital market basket percentage increase of 3.3 percent for
inpatient services paid under the hospital inpatient prospective
payment system (IPPS) reduced by a final productivity adjustment of 0.2
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) 2024 will be approximately $88.9 billion, an increase of
approximately $6.0 billion compared to estimated CY 2023 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> Data used in CY 2024 OPPS/ASC Ratesetting: To set OPPS and
ASC payment rates, we normally use the most updated claims and cost
report data available. The best available claims data is the most
recent set of data which would be from 2 years prior to the calendar
year that is the subject of rulemaking. Cost report data usually lags
the claims data by a year and we believe that using the most updated
cost report extract available from the Healthcare Cost Report
Information System (HCRIS) is appropriate for CY 2024 OPPS ratesetting.
Therefore, we are using our typical data process of using the most
updated cost reports and claims data available for CY 2024 OPPS
ratesetting.
<bullet> Partial Hospitalization Update: For CY 2024, we are
finalizing changes to our methodology used to calculate the Community
Mental Health Center (CMHC) and hospital-based PHP (HB PHP) geometric
mean per diem costs. We also are finalizing changes to expand PHP
payment from two APCs to four APCs.
<bullet> Medicare Payment for Intensive Outpatient Programs:
Beginning in CY 2024, we are finalizing payment for intensive
outpatient program (IOP) services under Medicare. We are finalizing the
scope of benefits, physician certification requirements, coding and
billing, and payment rates under the IOP benefit. IOP services may be
furnished in hospital outpatient departments, community mental health
centers (CMHCs), federally qualified health centers (FQHCs), and rural
health clinics (RHCs). We also are finalizing payment for intensive
outpatient services provided by opioid treatment programs (OTPs) under
the existing OTP benefit.
<bullet> Changes to the Inpatient Only (IPO) List: For 2024, we are
finalizing our proposal to not remove any services from the IPO list
for CY 2024.
<bullet> 340BAcquired Drugs: For CY 2024, we are continuing to
apply the default rate, generally average sales price (ASP) plus 6
percent, to 340B acquired drugs and biologicals in this final rule with
comment period. Therefore, drugs and biologicals acquired under the
340B program will be paid at the same payment rate as those drugs and
biologicals not acquired under the 340B program.
<bullet> Biosimilar Packaging Exception: For CY 2024, we are
finalizing our proposal to except biosimilars from the OPPS threshold
packaging policy when their reference products are separately paid.
However, we are not finalizing that all the biosimilars related to the
reference product would be similarly
[[Page 81544]]
packaged if a reference product's per-day cost falls below the
threshold packaging policy.
<bullet> Finalizing to Pay IHS and Tribal Hospitals that Convert to
a Rural Emergency Hospital (REH) Under the IHS All-Inclusive Rate
(AIR): For CY 2024, we are finalizing that IHS and tribal hospitals
that convert to an REH be paid for hospital outpatient services under
the same all-inclusive rate that would otherwise apply if these
services were performed by an IHS or tribal hospital that is not an
REH. We also are finalizing that IHS and tribal hospitals that convert
to an REH would receive the REH monthly facility payment consistent
with how this payment is applied to REHs that are not tribally or IHS
operated.
<bullet> Device Pass-Through Payment Applications: For CY 2024, we
received six applications for device pass-through payments. We sought
public comment on these applications and are approving four applicants
for device pass-through payment status in this final rule with comment
period.
<bullet> Cancer Hospital Payment Adjustment: For CY 2024, 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 public health emergency (PHE) impact on claims and cost data used
to calculate the target PCR, we have maintained the CY 2021 target PCR
of 0.89 through CYs 2022 and 2023. In this final rule with comment
period, we are finalizing 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 are finalizing a target PCR of 0.88 to
determine the CY 2024 cancer hospital payment adjustment to be paid at
cost report settlement. That is, the payment adjustments will be the
additional payments needed to result in a PCR equal to 0.88 for each
cancer hospital.
<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 PHE on healthcare
utilization, we are finalizing to extend 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 2024, we are increasing payment rates under the ASC
payment system by 3.1 percent for ASCs that meet the quality reporting
requirements under the ASCQR Program. This increase is based on a
hospital market basket percentage increase of 3.3 percent reduced by a
productivity adjustment of 0.2 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 2024 will be approximately $7.1 billion, an increase
of approximately $207 million compared to estimated CY 2023 Medicare
payments.
<bullet> Changes to the List of ASC Covered Surgical Procedures:
For CY 2024, we are adding 37 surgical procedures, including total
shoulder arthroplasty (TSA) (Healthcare Common Procedure Coding System
(HCPCS) code 23472), to the ASC covered procedures list (CPL) based
upon existing criteria at Sec. 416.166.
<bullet> Hospital Outpatient Quality Reporting (OQR) Program: We
are finalizing our proposals to: (1) modify the COVID-19 Vaccination
Coverage Among Healthcare Personnel (HCP) measure beginning with the CY
2024 reporting period/CY 2026 payment determination; (2) modify the
Cataracts: Improvement in Patient's Visual Function Within 90 Days
Following Cataract Surgery measure beginning with the voluntary CY 2024
reporting period; (3) modify the Appropriate Follow-Up Interval for
Normal Colonoscopy in Average Risk Patients measure beginning with the
CY 2024 reporting period/CY 2026 payment determination; and (4) amend
multiple codified regulations to replace references to ``QualityNet''
with ``CMS-designated information system'' or ``CMS website,'' and to
make other conforming technical edits, to accommodate recent and future
systems requirements and mitigate confusion for program participants.
We are finalizing with modification the proposal to adopt the Risk-
Standardized Patient-Reported Outcome-Based Performance Measure (PRO-
PM) Following Elective Primary Total Hip Arthroplasty (THA) and/or
Total Knee Arthroplasty (TKA) in the HOPD Setting (THA/TKA PRO-PM) with
voluntary reporting beginning with the CY 2025 reporting period through
the CY 2027 reporting period followed by mandatory reporting beginning
one year later than proposed with the CY 2028 reporting period/CY 2031
payment determination.
We are finalizing with modification the proposal to adopt the
Excessive Radiation Dose or Inadequate Image Quality for Diagnostic
Computed Tomography (CT) in Adults (Hospital Level--Outpatient) measure
with voluntary reporting beginning with the CY 2025 reporting period
and mandatory reporting beginning 1 year later than proposed with the
CY 2027 reporting period/CY 2029 payment determination.
We are not finalizing our proposal to remove the Left without Being
Seen measure. We are also not finalizing our proposal to re-adopt with
modification the Hospital Outpatient Volume Data on Selected Outpatient
Procedures measure.
We also requested public comment on: (1) patient and workforce
safety (including sepsis); (2) behavioral health (including suicide
prevention); and (3) telehealth as potential future measurement topic
areas in the Hospital OQR Program.
<bullet> Ambulatory Surgical Center Quality Reporting (ASCQR)
Program: We are finalizing our proposals to: (1) modify the COVID-19
Vaccination Coverage Among Health Care Personnel (HCP) measure
beginning with the CY 2024 Reporting Period/CY 2026 payment
determination; (2) modify the Cataracts: Improvement in Patient's
Visual Function Within 90 Days Following Cataract Surgery measure
beginning with the voluntary CY 2024 reporting period; (3) modify the
Endoscopy/Polyp Surveillance: Appropriate Follow-Up Interval for Normal
Colonoscopy in Average Risk Patients measure beginning with the CY 2024
reporting period/CY 2026 payment determination; and (4) amend multiple
codified regulations to replace references to ``QualityNet'' with
``CMS-designated information system'' or ``CMS website,'' and to make
other conforming technical edits, to accommodate recent and future
systems requirements and mitigate confusion for program participants.
We are finalizing with modification the proposal to adopt the Risk-
Standardized Patient-Reported Outcome-Based Performance Measure (PRO-
PM) Following Elective Primary Total Hip Arthroplasty (THA) and/or
Total Knee Arthroplasty (TKA) in the ASC Setting (THA/TKA PRO-PM) with
voluntary reporting beginning with the CY 2025 reporting period through
the CY 2027 reporting period followed by mandatory reporting beginning
1 year later than proposed with the CY 2028 reporting period/CY 2031
payment determination.
[[Page 81545]]
We are not finalizing our proposal to re-adopt with modification
the ASC Facility Volume Data on Selected ASC Surgical Procedures
measure.
<bullet> Rural Emergency Hospital Quality Reporting (REHQR)
Program: We are finalizing our proposals to: (1) codify the statutory
authority for the REHQR Program; (2) adopt and codify policies related
to measure retention and measure modification; (3) adopt one chart-
abstracted measure, Median Time from Emergency Department (ED) Arrival
to ED Departure for Discharged ED Patients, beginning with the CY 2024
reporting period; (4) adopt three claims-based measures, Abdomen
Computed Tomography (CT)--Use of Contrast Material, Facility 7-Day
Risk-Standardized Hospital Visit Rate After Outpatient Colonoscopy, and
Risk-Standardized Hospital Visits Within 7 Days After Hospital
Outpatient Surgery, beginning with the CY 2024 reporting period; (5)
establish related reporting requirements beginning with the CY 2024
reporting period; (6) adopt and codify policies related to public
reporting of data; (7) codify foundational requirements related to
REHQR Program participation; (8) adopt and codify policies related to
the form, manner, and timing of data submission under the REHQR
Program; (9) adopt and codify a review and corrections period for
submitted data; and (10) adopt and codify an Extraordinary
Circumstances Exception (ECE) process for data submission requirements.
We are finalizing with modification the proposal to adopt and
codify a policy related to immediate measure removal such that it is
referred to more appropriately as immediate measure suspension. In such
a case, a quality measure considered by CMS to have potential patient
safety concerns will be immediately suspended from the program and then
addressed in the next appropriate rulemaking cycle.
We also requested comment on the following potential measures and
approaches for implementing quality reporting under the REHQR Program:
(1) electronic clinical quality measures (eCQMs); (2) care coordination
measures; and (3) a tiered approach for quality measure reporting.
<bullet> Mental Health Services Furnished Remotely by Hospital
Staff to Beneficiaries in Their Homes: For CY 2024, we are finalizing
technical refinements to the existing coding for remote mental health
services to allow for multiple units to be billed daily. We also are
finalizing to create a new, untimed code to describe group
psychotherapy. Finally, we are delaying the in-person visit
requirements until January 1, 2025.
<bullet> OPPS Payment for Dental Services: For CY 2024, we are
assigning over 240 HCPCS codes describing dental services to various
clinical APCs to align with Medicare payment provisions regarding
dental services adopted in the CY 2024 Physician Fee Schedule (PFS)
final rule (87 FR 69404; November 18, 2023).
<bullet> Comment Solicitation on Payment for High-Cost Drugs
Provided by Indian Health Service and Tribal Facilities: We sought
comment on whether Medicare should pay separately for high-cost drugs
provided by IHS and tribal facilities. Commenters supported
establishing a payment methodology that would allow IHS and Tribal
healthcare facilities to receive separate payment outside of the IHS
outpatient hospital all-inclusive rate (AIR) for oncology drugs and
services whose costs exceed the AIR. Their preferred approach was to
treat the AIR payment amount as a payment threshold and to have a
separate payment for a drug if the cost of the drug was more than the
AIR. Commenters also wanted CMS to ensure the integrity of the AIR if
separate payment is established for high-cost oncology drugs and other
high-cost services. We will consider these comments for future
rulemaking.
<bullet> Supervision by Nurse Practitioners, Physician Assistants
and Clinical Nurse Specialists of Cardiac, Intensive Cardiac and
Pulmonary Rehabilitation Services Furnished to Outpatients: For CY
2024, to comply with section 51008 of the Bipartisan Budget Act of 2018
and to ensure consistency with final revisions to Sec. Sec. 410.47 and
410.49 in the CY 2024 PFS final rule, published in the Federal Register
of November 16, 2023 (FR Doc. 2023-24184), we are revising Sec.
410.27(a)(1)(iv)(B)(1) to expand the practitioners who may supervise
cardiac rehabilitation (CR), intensive cardiac rehabilitation (ICR),
and pulmonary rehabilitation (PR) services to include nurse
practitioners (NPs), physician assistants (PAs), and clinical nurse
specialists (CNSs). We also are allowing for the direct supervision
requirement for CR, ICR, and PR to include virtual presence of the
physician through audio-video real-time communications technology
(excluding audio-only) through December 31, 2024, and extend this
policy to the nonphysician practitioners, that is NPs, PAs, and CNSs,
who are eligible to supervise these services in CY 2024.
<bullet> Payment for Intensive Cardiac Rehabilitation Services
(ICR) Provided by an Off-Campus, Non-Excepted Provider Based Department
(PBD) of a Hospital: For CY 2024, to address an unintended
reimbursement disparity created by application of the off-campus, non-
excepted payment rate to intensive cardiac rehabilitation services
(ICR), we are paying for ICR services furnished by an off-campus, non-
excepted PBD of a hospital at 100 percent of the OPPS rate, which is
the amount paid for these services under the PFS.
<bullet> Final Updates to Requirements for Hospitals to Make Public
a List of Their Standard Charges: We are finalizing our proposals to
revise several of our HPT requirements in order to improve our
monitoring and enforcement capabilities by improving access to, and the
usability of, hospital standard charge information; reducing the
compliance burden on hospitals by providing CMS templates and technical
guidance for display of hospital standard charge information; aligning,
where feasible, certain HPT requirements and processes with
requirements and processes we have implemented in the Transparency in
Coverage (TIC) initiative; and making other modifications to our
monitoring and enforcement capabilities that will, among other things,
increase its transparency to the public. Together, we believe these
activities will enhance existing and future enforcement actions while
also providing the public with more meaningful standard charge
information that can be used to improve the accuracy of consumer-
friendly price estimator tools. Specifically, we are finalizing: (1)
definitions of several terms; (2) a requirement that hospitals make a
good faith effort to ensure standard charge information is true,
accurate, and complete, and to include a statement affirming this in
the machine-readable file (MRF); (3) new data elements that hospitals
must include in their MRFs, as well a requirement that hospitals encode
standard charge information in a CMS template layout; (4) phased
implementation timeline applicable to the new requirements we are
finalizing in this final rule with comment period; (5) a requirement
that hospitals to include a .txt file in the root folder that includes
a direct link to the MRF and a link in the footer on its website that
links directly to the publicly available web page that hosts the link
to the MRF; and (6) improvements to our enforcement process by updating
our methods to assess hospital compliance, requiring hospitals to
acknowledge receipt of warning notices, working with health system
officials to address noncompliance issues in one or more hospitals that
are part of a health system, and publicizing more
[[Page 81546]]
information about CMS enforcement activities related to individual
hospital compliance. Specifically, and as discussed in more detail in
section XVIII of this final rule with comment, we are finalizing that
the effective date of the changes to the hospital price transparency
regulations at 45 CFR part 180 will be January 1, 2024. However, the
regulation text will specify later dates by which hospitals must be in
compliance with some of these new requirements, and we will begin
enforcing those requirements on those specified dates. We believe this
phased implementation approach is necessary to provide hospitals time
to collect and encode the required standard charge information
completely and accurately.
<bullet> Community Mental Health Center (CMHC) Conditions of
Participation (CoPs): The Consolidated Appropriations Act (CAA), 2023
(Pub. L. 117-238) established in section 4124 coverage of intensive
outpatient (IOP) services in CMHCs. The legislation extended Medicare
coverage and payment of IOP services furnished by a CMHC beginning
January 1, 2024, adding to the existing coverage and payment for
partial hospitalization (PHP) services in CMHCs. Section 4121 of the
CAA, 2023 also established a new Medicare benefit category for services
furnished and directly billed by Mental Health Counselors (MHCs) and
Marriage and Family Therapists (MFTs). To implement these provisions of
section 4121 of the CAA, 2023, CMS is finalizing, as proposed, to
modify the requirements for CMHCs to include IOP services throughout
the CoPs. We are also finalizing our proposal to modify the CMHC CoPs
for personnel qualifications to add a definition of marriage and family
therapists and revise the current definition of mental health
counselors. In addition, we are adding MFTs and MHCs to the list of
practitioners who can lead interdisciplinary team meetings when deemed
necessary.
<bullet> Changes to the Inpatient Prospective Payment System
Medicare Code Editor: Consistent with the process that is used for
updates to the Integrated Outpatient Code Editor (I/OCE) and other
Medicare claims editing systems, we are finalizing our proposal to
remove discussion of the IPPS Medicare Code Editor (MCE) from the
annual IPPS rulemakings, beginning with the FY 2025 rulemaking, and to
generally address future changes or updates to the MCE through
instruction to the MACs.
<bullet<ls-thn-eq> Request for Public Comments on Potential Payment
under the IPPS and OPPS for Establishing and Maintaining Access to
Essential Medicines: We sought comment on potential separate payment
under the IPPS for establishing and maintaining access to a buffer
stock of essential medicines.
<bullet> Rural Emergency Hospital (REH) Conditions of Participation
(CoPs): On November 23, 2022, we published a final rule for the REH
health and safety standards, which was included in the ``Medicare
Program: Hospital Outpatient Prospective Payment and Ambulatory
Surgical Center Payment Systems and Quality Reporting Programs; Organ
Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of
Participation, Provider Enrollment, Physician Self-Referral; New
Service Category for Hospital Outpatient Department Prior Authorization
Process; Overall Hospital Quality Star Rating; COVID-19'' final rule
with comment period (87 FR 71748). We are finalizing as proposed a
technical correction to the REH CoPs under the standard for the
designation and certification of REHs.
3. Summary of Costs and Benefits
In section XXVI of this final rule with comment period, we set
forth a detailed analysis of the regulatory and federalism impacts that
the changes will have on affected entities and beneficiaries. Key
estimated impacts are described below.
a. Impacts of All OPPS Changes
Table 168 in section XXVI.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 2024 compared to all estimated
OPPS payments in CY 2023. We estimate that the final policies in this
final rule would result in a 3.2 percent overall increase in OPPS
payments to providers. We estimate that total OPPS payments for CY
2024, including beneficiary cost-sharing, to the approximately 3,600
facilities paid under the OPPS (including general acute care hospitals,
children's hospitals, cancer hospitals, and CMHCs) will increase by
approximately $2.2 billion compared to CY 2023 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 in CY 2024, they
will also be paid for new 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 9.2 percent increase in CY 2024
payments to CMHCs relative to their CY 2023 payments.
b. Impacts of the Updated Wage Indexes
We estimate that our update of the wage indexes based on the fiscal
year (FY) 2024 IPPS final rule wage indexes will result in a 0.0
percent increase for urban hospitals under the OPPS and a 1.2 percent
increase for rural hospitals. These wage indexes include the continued
implementation of the Office of Management and Budget (OMB) labor
market area delineations based on 2010 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
We are implementing the reduction to the cancer hospital payment
adjustment for CY 2024 required by section 1833(t)(18)(C) of the Act,
as added by section 16002(b) of the 21st Century Cures Act, and the
final target payment-to-cost ratio (PCR) for CY 2024 cancer hospital
adjustment of 0.89. However, as section 16002 requires that we reduce
the target PCR by 0.01, that brings the final target PCR to 0.88
instead. This is 0.01 less than the target PCR of 0.89 from CY 2021
through CY 2023, which was previously held at the pre-PHE target.
d. Impacts of the OPD Fee Schedule Increase Factor
For the CY 2024 OPPS/ASC, we are establishing an OPD fee schedule
increase factor of 3.1 percent and applying that increase factor to the
conversion factor for CY 2024. 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 4.2 percent. Classifying hospitals by teaching
status, we estimate non-teaching hospitals will experience an increase
in payments of 3.9 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 2.4 percent. We also classified
hospitals by the type of ownership. We estimate that hospitals with
voluntary ownership will experience an increase of 3.2 percent in
payments, while hospitals with government ownership will experience an
increase of 2.8 percent in payments. We estimate that hospitals with
proprietary ownership will experience an increase of 4.6 percent in
payments.
[[Page 81547]]
e. Impacts of the Final 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 2024 payment
rates, compared to estimated CY 2023 payment rates, generally ranges
between a decrease of 11 percent and an increase of 8 percent,
depending on the service, with some exceptions. We estimate the impact
of applying the final inpatient hospital market basket update to ASC
payment rates will increase payments by $207 million under the ASC
payment system in CY 2024. We note that an increase based on the
Consumer Price Index for all urban consumers (CPI-U) update would be
2.5 percent and would increase payments by $174 million under the ASC
payment system in CY 2024. This increase would have been based on a
projected CPI-U update of 2.9 percent minus a multifactor productivity
adjustment required by the Affordable Care Act of 0.4 percentage point.
f. Impacts of Hospital Price Transparency
The policies we are finalizing to enhance automated access to
hospital MRFs and aggregation and use of MRF data are estimated to
increase burden on hospitals, including a one-time mean of $2,787 per
hospital, and a total national cost of $19,784,539 ($2,787 x 7,098
hospitals). The cost estimate reflects estimated costs ranging from
$1,274 and $4,181 per hospital, and a total national cost ranging from
$9,040,620 to $29,676,809. As discussed in detail in section XXVI of
this final rule with comment period, we believe that the benefits to
the public (and to hospitals themselves) outweigh the burden imposed on
hospitals.
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 (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 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.
[[Page 81548]]
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 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; and
<bullet> Indian Health Service (IHS) hospitals.
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
[[Page 81549]]
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 21, 2023. 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
2018, we published a Federal Register notice requesting nominations to
fill vacancies on the Panel (83 FR 3715). 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 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 2024 OPPS/ASC Proposed Rule
We received approximately 3,777 timely pieces of correspondence on
the CY 2024 OPPS/ASC proposed rule that appeared in the Federal
Register on July 31, 2023 (88 FR 49552 through 49921), from
individuals, elected officials, providers and suppliers, practitioners,
manufacturers 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 2024 OPPS/ASC proposed rule. Out-of-scope-public comments are
not addressed in this CY 2024 OPPS/ASC final rule with comment period.
G. Public Comments Received on the CY 2023 OPPS/ASC Final Rule With
Comment Period
We received approximately 12 timely pieces of correspondence on the
CY 2023 OPPS/ASC final rule with comment period that appeared in the
Federal Register on November 23, 2022 (87 FR 71748).
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 2024 OPPS, we proposed to recalibrate the APC relative
payment weights for services furnished on or after January 1, 2024, and
before January 1, 2025 (CY 2024), using the same basic methodology that
we described in the CY 2023 OPPS/ASC final rule with comment period (86
FR 63466), using CY 2022 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 2024, we began with approximately 180 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, 2022, and before January 1, 2023, before applying our
exclusionary criteria and other methodological adjustments. After the
application of those data processing changes, we used approximately 93
million final action claims to develop the proposed CY 2024 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
2024 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 2024 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>) included the proposed list of bypass codes for CY
2024. The proposed list of bypass codes contains codes that are
reported on claims for services in CY 2022 and, therefore, includes
codes that were in effect in CY 2022 and used for billing. We retained
these deleted bypass codes on the proposed CY 2024 bypass list because
these codes existed in CY 2022 and were covered OPD services in that
period, and CY 2022 claims data were used to calculate proposed CY 2024
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 2024 OPPS/ASC
proposed rule. HCPCS codes that we proposed to add for CY 2024 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
[[Page 81550]]
proposed bypass code process. We are finalizing as proposed the
``pseudo'' single claims process and the final CY 2024 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 2024, we used
approximately 103 million final actions 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, 2022, and before
January 1, 2023. 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 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 2024, 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 2024 APC payment rates are based, we calculated hospital-
specific departmental CCRs for each hospital for which we had CY 2022
claims data by comparing these claims data to the most recently
available hospital cost reports, which, in most cases, are from CY
2021. For the proposed CY 2024 OPPS payment rates, we used the set of
claims processed during CY 2022. 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 2022 (the year
of claims data we used to calculate the proposed CY 2024 OPPS payment
rates) and updates to the National Uniform Billing Committee (NUBC)
2022 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 the CY 2023 OPPS/ASC final rule with comment period, a few
commenters recommended that we revise our revenue code-to-cost center
crosswalk to provide consistency with the NUBC definitions and to
improve the accuracy of cost data for OPPS ratesetting with respect to
chimeric antigen receptor therapy (CAR-T) administration services (87
FR 71758). In that final rule with comment period, we stated that we
intend to explore the implications of this recommendation further and
may consider such changes in future rulemaking. In the CY 2024 OPPS/ASC
proposed rule, we explored the impacts of the commenters'
recommendation from the CY 2023 OPPS/ASC final rule with comment period
that we assign primary cost centers to certain CAR-T-related revenue
codes that were not previously assigned cost centers. Specifically, in
the CY 2024 OPPS/ASC proposed rule, we explored the commenter's
recommendations regarding changes to the revenue code-to-cost center
crosswalk, which included:
<bullet> Revising revenue codes 0870 (Cell/Gene Therapy General
Classification) and 0871 (Cell Collection) to be mapped to a primary
cost center of 9000 (Clinic);
<bullet> Revising revenue codes 0872 (Specialized Biologic
Processing and Storage--Prior to Transport) and 0873 (Storage and
Processing After Receipt of Cells from Manufacturer) to be mapped to a
primary cost center of 3350 (Hematology);
<bullet> Revising revenue codes 0874 (Infusion of Modified Cells)
and 0875 (Injection of Modified Cells) to be mapped to a primary cost
center of 6400 (Intravenous Therapy); and
<bullet> Revising revenue codes 0891 (Special Processed Drugs--FDA
Approved Cell Therapy) and 0892 (Special Processed Drugs--FDA Approved
Gene Therapy) to be mapped to a primary cost center of 7300 (Drugs
Charged to Patients).
After reviewing the impact of these crosswalk revisions on our
proposed CY 2024 OPPS APC geometric mean costs, we only observed an
increase in the geometric mean cost of CPT code 0540T (Chimeric antigen
receptor t-cell (car-t) therapy; car-t cell administration,
autologous)--from $148.31 to $294.17 for the CY 2024 OPPS/ASC proposed
rule--as a result of the revenue code for CPT code 0540T being assigned
to a new cost center and the new corresponding cost-to-charge ratio. We
did not observe any significant impact on APC geometric mean costs or
payment as a result of these revisions. We stated that we believe these
revisions would provide greater consistency with the NUBC definitions
(which already adopted these revenue code revisions) and more
accurately account for the costs of CAR-T administration services under
the OPPS. Therefore, for CY 2024 and subsequent years, we proposed to
adopt the aforementioned revisions to revenue codes 0870, 0871 0872,
0873, 0874, 0875, 0891, and 0892 in our revenue code-to-cost center
crosswalk.
We solicited comment on our proposed changes to the revenue code-
to-cost center crosswalk for CY 2024.
In accordance with our longstanding policy, similar to our
finalized policy for CY 2023 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 2024, we proposed not
to include the nonstandard cost centers reported in this way in the
OPPS ratesetting database construction.
Comment: Two commenters supported our proposed revenue code-to-cost
center crosswalk changes associated with CAR-T.
Response: We appreciate the commenters' support for our proposal.
Comment: A few commenters listed a number of concerns regarding the
revenue code-to-cost center crosswalk mappings associated with revenue
codes 0815 and 0819. They noted that the 2552-96 revenue code-to-cost
center crosswalk does not show the cost center used for ratesetting.
They also noted that the current 2552-10 revenue code-to-cost center
crosswalk includes a primary cost center mapping to 112.50 and no
secondary or tertiary cost centers listed.
A commenter requested more detail around the cost reporting and
billing patterns related to revenue codes 0815 and cost centers 112.50
and 7700. A commenter believed that the mapping
[[Page 81551]]
for revenue code 0819 to cost center 8600 was incongruent with CMS
instructions for cost reporting periods after 2017 to no longer include
donor costs in cost center 8600. They believed that this mapping should
not apply.
Commenters stated that cost center 7700 represented a logical
alternative mapping for revenue code 0815 but noted that it did not
represent all donor search and cell acquisition costs because those
costs were only recently calculated through Worksheet D-6 of the
Medicare cost report and that data would not be available for
ratesetting for several years. They also suggested that CMS review the
use of the hospital overall ancillary CCR until more accurate
information could be obtained in both cost center 7700 and Worksheet D-
6. A commenter also requested that CMS ensure that the Worksheet D-6 is
available for all cost reporting periods beginning on or after October
1, 2020.
Response: As discussed in this section and briefly in the claims
accounting narrative available online, the revenue code-to-cost center
crosswalk is a hierarchy that attempts to apply departmental cost
center CCRs to estimate costs from charges. Where no specific CCR is
available, the provider's overall ancillary CCR will be applied. There
may be significant differences in the cost reports used in our
ratesetting process, based on providers' charging structures as well as
cost reporting periods. As a result, the revenue code-to-cost center
crosswalk is designed to accommodate that flexibility by selecting what
we believe to be the most accurate CCRs available.
The Medicare cost report form 2552-10 was implemented for cost
reporting periods on or after May 1, 2010. Providers have familiarity
with cost reporting using this form. While there may be a range in the
cost reporting periods available, all cost report data used in
ratesetting for the CY 2024 OPPS final rule with comment period are
based on the Medicare cost report form 2552-10. The 2552-96 crosswalk
is largely provided for historical reference purposes and not because
it is actively used in our ratesetting process. However, we can
consider removing those worksheets from the form if they no longer
serve a purpose for hospitals.
With regard to the primary mapping of revenue code 0815 to cost
center 112.50 (Stem Cell Acquisition) indicated in the display version
of the revenue code-to-cost center crosswalk, the cost center was
inadvertently listed as a primary mapping. The primary and sole mapping
for revenue code 0815 in our current ratesetting process is to cost
center 7700 (Allogeneic Stem Cell Acquisition). In cases where that
cost center CCR is not available in a provider's cost report but
services are billed using revenue code 0815, the overall ancillary CCR
would instead be applied to reduce charges to estimated cost. We note
that there are no cost reports we are including in the CY 2024 OPPS
ratesetting process that report cost and charges under 112.50, and
there are no revenue code-to-cost center crosswalk mappings to that
cost center.
As discussed earlier, the cost reports used in OPPS ratesetting can
have varying cost reporting periods and varying cost reporting
structures. Therefore, the cost center CCR mappings included in the
revenue code-to-cost center crosswalk are designed to accommodate this
variability. For revenue code 0815 (Allogeneic Stem Cell Acquisition
Services), most of the providers billing using this revenue code are
also cost reporting with cost center 7700. Within our ratesetting
process, the CCRs for cost center 7700 are significantly higher than
those for the overall ancillary CCR; and we continue to believe that
the preference should be to use the cost center 7700 CCR unless it is
not otherwise available. We note that billing using revenue code 0819
(Organ Acquisition: Other donor) is extremely limited, with only a
single line observed within our data. We believe that having the
flexibility to use its cost center 8600 mapping where this revenue code
is billed is more reflective than the overall ancillary CCR. However,
we will monitor the data to determine if this cost center CCR mapping
continues to remain appropriate in the future.
While we do not have any specific changes at this time associated
with the data from Worksheet D-6 of the Medicare cost report form, we
will review the data as they become available. Based on that review, we
will consider inclusion of that data and integration into the cost
estimation process, if appropriate. We appreciate commenter input as we
consider possible changes in the OPPS ratesetting process we use to
estimate service costs. We also note that the cost reporting software
has already been updated to allow for submission of data regarding
these acquisition costs for cost reporting periods on or after October
1, 2020.
After consideration of the public comments we received, we are
finalizing the proposed crosswalk, including the proposed changes
associated with CAR-T. In addition, we are making the change to our
display copy of the revenue code-to-cost center crosswalk to assign
cost center 77 as the primary cost center CCR mapping for revenue code
0815.
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 2024. 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 final 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 2022 claims that
are used to calculate the final payment rates for this final rule with
comment period.
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 final relative payment weights used in
calculating the OPPS payment rates for CY 2024 shown in Addenda A and B
to this final rule with comment period (which are available via the
internet on
[[Page 81552]]
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 2024 OPPS, we
proposed to continue to remove claim lines with modifier ``PN'' from
the ratesetting process.
For details of the claims accounting process used in 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>.
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.
a. Calculation of Single Procedure APC Criteria-Based Costs
(1) Blood and Blood Products
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 2024 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 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 proposed 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 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, 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 2024 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: Two commenters discussed our payment policies for blood
and blood products. One commenter expressed concerns about lower
payment rates for some blood products in CY 2024 as compared to CY 2023
and encouraged CMS to work with interested parties in the blood
products and blood services community to address this issue. The other
commenter expressed their support for separate payment for blood and
blood products in the OPPS for most services.
Response: We appreciate the input from the commenters, and we will
keep these issues in mind in future rulemaking.
After consideration of the public comments we received, we are
adopting as final our proposals for blood and blood products using our
blood-specific CCR methodology without modification. Refer to Addendum
B to this final rule with comment period (which is available via the
internet on the CMS website) for the final CY 2024 payment rates for
blood and blood products.
(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
[[Page 81553]]
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 2024, except where otherwise indicated, we proposed to use
the costs derived from CY 2022 claims data to set the proposed CY 2024
payment rates for brachytherapy sources because CY 2022 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 2024 OPPS. We
proposed this methodology for CY 2024 and subsequent years. 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 2024 OPPS/ASC proposed rule (88 FR 49563),
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 2024 OPPS/ASC
proposed rule (88 FR 49563). We also proposed for CY 2024 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 60537). For CY 2024
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 2024 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 2024 payment rates for brachytherapy sources are included on
Addendum B to the CY 2024 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, p-
103). 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, and CY 2023 OPPS/ASC final rules
with comment period (85 FR 85879 and 85880 and 86 FR 63469 and 87 FR
71760 and 71761), 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 CY
2021, for CY 2022, and for CY 2023.
We reviewed CY 2022 claims data available for the CY 2024 OPPS/ASC
proposed rule, and we observed three claims that reported HCPCS code
C2645. Each claim reported one unit of HCPCS code C2645 and the
geometric mean unit cost from these three claims was $168.67. We stated
we were unable to use these claims for ratesetting purposes given the
reporting of only one unit per claim and the high geometric mean cost.
Therefore, we proposed to use our equitable adjustment authority under
section 1833(t)(2)(E) of the Act to maintain the CY 2023 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 2024.
For this final rule with comment period, we once again reviewed CY
2022 claims data available; and we observed the same three claims that
reported HCPCS code C2645.
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 2024, we proposed to designate five brachytherapy APCs as
Low Volume APCs as these APCs meet
[[Page 81554]]
our criteria to be designated as a Low Volume APC. For more information
on the brachytherapy APCs we proposed to designate as Low Volume APCs,
see section III.D of the CY 2024 OPPS/ASC proposed rule (88 FR 49628)
and section III.D of this final rule with comment period.
We invited interested parties to submit recommendations for new
codes to describe new brachytherapy sources. We will continue to add
new brachytherapy source codes and descriptors to our systems for
payment on a quarterly basis.
We did not receive any public comments on either proposal
described. We are finalizing, without modification, to use our
equitable adjustment authority under section 1833(t)(2)(E) of the Act
to maintain the CY 2023 payment rate of $4.69 per mm\2\ for HCPCS code
C2645, which is assigned to APC 2648 (Brachytx planar, p-103), for CY
2024.
Similarly, for CY 2024 and subsequent years we are finalizing,
without modification, our proposal to continue to set the payment rates
for other brachytherapy sources that are not otherwise assigned to
designated Low Volume APCs for CY 2024 using our established
prospective payment methodology. The final CY 2024 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 outpatientpps@ cms.hhs.gov 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 2024
(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 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; and
87 FR 71769).
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 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>). 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,'' \1\
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.
---------------------------------------------------------------------------
\1\ Status indicator ``J1'' denotes Hospital Part B Services
Paid Through a Comprehensive APC. Further information can be found
in CY 2024 Addendum D1.
---------------------------------------------------------------------------
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.'' \2\ Specifically, we make a payment through C-
APC 8011 for a claim that:
---------------------------------------------------------------------------
\2\ Status indicator ``J2'' denotes Hospital Part B Services
That May Be Paid Through a Comprehensive APC. Further information
can be found in CY 2024 Addendum D1.
---------------------------------------------------------------------------
[[Page 81555]]
<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 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.\3\
---------------------------------------------------------------------------
\3\ <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>.
---------------------------------------------------------------------------
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
[[Page 81556]]
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 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 2024, 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 2024, 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 final 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 2024 are listed in Table 1 below.
BILLING CODE 4150-28-P
[[Page 81557]]
[GRAPHIC] [TIFF OMITTED] TR22NO23.000
[[Page 81558]]
[GRAPHIC] [TIFF OMITTED] TR22NO23.001
[[Page 81559]]
[GRAPHIC] [TIFF OMITTED] TR22NO23.002
[[Page 81560]]
[GRAPHIC] [TIFF OMITTED] TR22NO23.003
BILLING CODE 4150-28-C
Response: We reviewed each of the requested code combinations
suggested by commenters, listed in Table 1, against our complexity
adjustment criteria. The code combination for primary HCPCS code 43270
with secondary HCPCS code 43252 meets our cost and frequency criteria,
qualifying for a complexity adjustment for CY 2024. All the remaining
code combinations listed failed to meet our cost or frequency criteria
and do not qualify for complexity adjustments for CY 2024.
Additionally, the code combinations for primary HCPCS codes, C9600,
92928, 92943, and 92920 with secondary HCPCS code C1761 would not
qualify for complexity adjustments for CY 2024 as the Coronary IVL
device, described by C1761, is still on transitional pass-through
status through June 2024. 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. Other commenter suggestions
included considering an amount halfway between the standard APC and the
complexity-adjusted APC as a cost threshold, as well as a implementing
a sliding scale approach for procedures with high frequency that do not
meet the cost criteria.
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 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.
In addition, commenters requested that CMS expand its review of
procedure combinations to include ``J1'' and expiring transitional
pass-through codes to allow facilities to continue to provide these
services after pass-through expiration.
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 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.
As we explained in the CY 2019 OPPS/ASC final rule with comment
period (83 FR 58843), we do not believe that it is necessary to adjust
the complexity adjustment criteria to allow claims that include more
than two ``J1'' procedures, add-on codes, or procedures that are not
assigned to C-APCs to qualify for a complexity adjustment. As
previously mentioned, we believe the current criteria are adequate to
determine if a combination of procedures represents a complex, costly
subset of the primary service. We will continue to monitor the
application of the complexity adjustment criteria for future
rulemaking.
After consideration of the public comments we received, we are
finalizing the C-APC complexity adjustment policy for CY 2024 as
proposed. We are also finalizing the proposed complexity adjustments,
with the addition of one new code combination suggested by commenters,
that meet 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
[[Page 81561]]
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. 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 2024 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'' of the CY 2024 OPPS/ASC proposed rule 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) Additional C-APCs for CY 2024
For CY 2024 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 2024, but we did propose to
create two new APCs that will both be C-APCs. Thus, we
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proposed that the number of C-APCs for CY 2024 would be 72 C-APCs.
We proposed to split the Level 2 Intraocular APC (APC 5492) into
two and assign the higher cost procedures previously within this APC to
a new Level 3 Intraocular APC (APC 5493). The previous Level 3, Level
4, and Level 5 Intraocular APCs (APCs 5493, 5494, and 5495) would be
renamed the Level 4, Level 5, and Level 6 Intraocular APC (APCs 5494,
5495, and 5496), respectively. We refer readers to section III.E of the
CY 2024 OPPS/ASC proposed rule (88 FR 49552) for more information
regarding the proposal.
We also proposed to add a new Level 2 Abdominal/Peritoneal/Biliary
and Related Procedures APC (APC 5342) to improve clinical and resource
homogeneity in the Level 1 Abdominal/Peritoneal/Biliary and Related
Procedures APC (APC 5341).
Comment: Commenters supported the creation of the two new proposed
C-APCs, C-APCs 5342 (Level 2 Abdominal/Peritoneal/Biliary and Related
Procedures APC) and 5496 (Level 6 Intraocular APC) for CY 2024, based
on resource cost and clinical characteristics.
Response: We appreciate commenters' support.
Comment: Several commenters expressed concerns with the C-APC
methodology for surgical insertion codes for brachytherapy treatment,
noting 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, implementing a modified C-APC
methodology to allow separate payment for specified preparation and
planning codes, or moving brachytherapy for cervical cancer treatment
to C-APC 5416 (Level 6 Gynecologic Procedures).
Response: We appreciate the comments on the C-APC methodology.
However, we believe that the current C-APC methodology is appropriately
applied to these surgical 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. This
methodology also enables hospitals to manage their resources with
maximum flexibility by monitoring and adjusting the volume and
efficiency of services themselves.
We reviewed the request by commenters to move brachytherapy
procedures, CPT code 57155 and CPT code 58346, to a higher paying C-
APC. For CPT code 57155, the claims data in the two times rule
evaluation show that this code is being paid at the appropriate level
in C-APC 5415 (Level 5 Gynecologic Procedures). For CPT code 53846,
given that this code has fewer than 100 claims, it does not meet the
significance threshold for the two times rule evaluation, and we do not
believe the few claims available provide an accurate reflection of the
service's cost sufficient to move this procedure to a higher C-APC. We
will continue to examine these concerns and will determine if any
modifications to this policy are warranted in future rulemaking.
Comment: Several commenters requested that CMS unpackage and pay
separately for all status indicator ``K'' drugs from C-APCs due to
certain instances of high-cost drugs and biologics, such as CAR-T,
being paid through C-APC 8011 and potentially impacting beneficiary
access to high-cost therapies.
Response: We thank the commenters for their comments. We will take
the issue of C-APCs and payments for high-cost drugs into consideration
for future rulemaking.
After consideration of the public comments we received, we are
finalizing as proposed C-APCs 5342 (Level 2 Abdominal/Peritoneal/
Biliary and Related Procedures APC) and 5496 (Level 6 Intraocular APC)
for CY 2024. Table 2 lists the final C-APCs for CY 2024. All C-APCs are
displayed in Addendum J to this CY 2024 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 the data related to the C-APC payment policy methodology,
including the list of complexity adjustments and other information for
CY 2024.
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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 2024, 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, 33581, 59246, and 59247, respectively), 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 that will be paid for APC 5863, which is the maximum partial
hospitalization per diem payment rate for a hospital, and finalized a
policy that the hospital will continue to be paid the payment rate for
composite APC 8010. Under this policy, the Integrated OCE (I/OCE) will
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 5863 for all the specified mental health
services furnished by the hospital on that single date of service. We
continue to believe 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 proposed 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
3 partial hospitalization services provided in a
[[Page 81566]]
day by a hospital, those specified mental health services would be paid
through composite APC 8010 for CY 2024. In addition, we proposed to set
the payment rate for composite APC 8010 at the same payment rate that
we proposed for APC 5863, which is a partial hospitalization per diem
payment rate for 3 partial hospitalization services furnished in a day
by a hospital, and that the hospital continue to be paid the proposed
payment rate for composite APC 8010. We explained that while APC 5863
is no longer the maximum partial hospitalization per diem payment rate
for a hospital, due to proposed APC 5864, which is 4 or more hospital-
based PHP services per day, discussed in section VIII.B of this CY 2024
OPPS/ASC proposed rule, we believed it was still appropriate to apply
the APC 5863 per diem payment amount as the upper limit on payment per
day for individual OPPS mental health services. This is because the
daily mental health cap would not be expected to reach a level of
intensity beyond 3 services per day, as described by APC 5863. The PHP
is meant to be the most intensive mental health services program,
requiring inpatient care if PHP is not received. We would not
anticipate more than three services per patient on a given day, as
patients needing additional services in 1 day would potentially require
an inpatient admission, as described by APC 5863. Thus, setting the
mental health cap at APC 5863, rather than the 4 service per day APC
5864, is more consistent with our longstanding policy, which has been
for the 3 service per day APC. We note that the proposed CY 2024
payment amount for APC 5863 would be comparable to the CY 2023 payment
amount for APC 5863, which is the PHP APC used to set the daily mental
health cap for CY 2023.
However, 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, we also solicited comment on whether the
next higher-level APC, proposed APC 5864, which is for four hospital-
based PHP services per day, would be appropriate to use as the daily
mental health cap.
Comment: One commenter supported CMS's alternative proposal to use
APC 5864 as the basis for setting the daily mental health cap for APC
8010. They stated that as CMS is introducing APC 5864 to capture four
or more hospital-based PHP services per day, as opposed to three
services in APC 5863, the mental health cap should be increased to
match this new code.
Response: We thank the commenter for their comment. Although
setting the daily mental health cap at APC 5863 would be comparable to
the CY 2023 payment for APC 5863, we recognize that raising the cap
allows hospitals increased flexibility to determine the level of care
necessary for their patient. Additionally, setting the mental health
cap at APC 5864 aligns with 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. Based upon the comment we received as well as the fact that
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, we are finalizing APC 5864, which is for four hospital-based
PHP services per day, as the daily mental health cap.
Comment: Several commenters 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 on the same date or increase the payment
rate for the primary testing procedure code. 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, as packaging
multiple testing services performed on a single date of service creates
incentives for hospitals to provide these services in the most cost-
efficient manner. 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 partial hospitalization
services provided by a hospital, those specified mental health services
would be paid through composite APC 8010 for CY 2024. In addition, we
are finalizing setting the payment rate for composite APC 8010 for CY
2024 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 3 below.
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.
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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 2024, 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.
For CY 2024, except where otherwise indicated, we proposed to use
the costs derived from CY 2022 claims data to set the proposed CY 2024
payment rates. Therefore, for CY 2024, the payment rates for the five
multiple imaging composite APCs (APCs 8004, 8005, 8006, 8007, and 8008)
were based on proposed geometric mean costs calculated from CY 2022
claims available for the CY 2024 OPPS/ASC proposed rule that qualify
for composite payment under the current policy (that is, those claims
reporting more than one procedure within the same family on a single
date of service). To calculate the proposed geometric mean costs, we
used the same methodology that we used to calculate the geometric mean
costs for these composite APCs since CY 2014, as described in the CY
2014 OPPS/ASC final rule with comment period (78 FR 74918). The imaging
HCPCS codes referred to as ``overlap bypass codes'' that we removed
from the bypass list for purposes of calculating the proposed multiple
imaging composite APC geometric mean costs, in accordance with our
established methodology as stated in the CY 2014 OPPS/ASC final rule
with comment period (78 FR 74918), were identified by asterisks in
Addendum N to the CY 2024 OPPS/ASC proposed rule (which is available
via the internet on the CMS website) and are discussed in more detail
in section II.A.1.b of the CY 2024 OPPS/ASC proposed rule (88 FR
49561).
For this CY 2024 OPPS/ASC final rule, we were able to identify
approximately 0.99 million ``single session'' claims out of an
estimated 2.2 million potential claims for payment through composite
APCs from our ratesetting claims data, which represents approximately
45.0 percent of all eligible claims, to calculate the final CY 2024
geometric mean costs for the multiple imaging composite APCs. Table 2
of this CY 2024 OPPS/ASC final rule lists the final HCPCS codes that
would be subject to the multiple imaging composite APC policy and their
respective families and approximate composite APC final geometric mean
costs for CY 2024.
We did not receive any public comments on this policy. We are
finalizing our proposal to continue the use of multiple imaging
composite APCs to pay for services providing more than one imaging
procedure from the same family on the same date without modification.
Table 3 below lists the HCPCS codes that will be subject to the
multiple imaging composite APC policy and their respective families and
approximate composite APC final geometric mean costs for CY 2024.
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3. Changes to Packaged Items and Services
a. Background and Rationale for Packaging in the OPPS
Like other prospective payment systems, the OPPS relies on the
concept of averaging to establish a payment rate for services. The
payment may be more or less than the estimated cost of providing a
specific service or a bundle of specific services for a particular
beneficiary. The OPPS packages payments for multiple interrelated items
and services into a single payment to create incentives for hospitals
to furnish services most efficiently and to manage their resources with
maximum flexibility. Our packaging policies support our strategic goal
of using larger payment bundles in the OPPS to maximize hospitals'
incentives to provide care in the most efficient manner. For example,
where there are a variety of devices, drugs, items, and supplies that
could be used to furnish a service, some of which are more costly than
others, packaging encourages hospitals to use the most cost-efficient
item that meets the patient's needs, rather than to routinely use a
more expensive item, which may occur if separate payment is provided
for the item.
Packaging also encourages hospitals to effectively negotiate with
manufacturers and suppliers to reduce the purchase price of items and
services or to explore alternative group purchasing arrangements,
thereby encouraging the most economical health care delivery.
Similarly, packaging encourages hospitals to establish protocols that
ensure that necessary services are furnished, while scrutinizing the
services ordered by practitioners to maximize the efficient use of
hospital resources. Packaging payments into larger payment bundles
promotes the predictability and accuracy of payment for services over
time. Finally, packaging may reduce the
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importance of refining service-specific payment because packaged
payments include costs associated with higher cost cases requiring many
ancillary items and services and lower cost cases requiring fewer
ancillary items and services. Because packaging encourages efficiency
and is an essential component of a prospective payment system,
packaging payments for items and services that are typically integral,
ancillary, supportive, dependent, or adjunctive to a primary service
has been a fundamental part of the OPPS since its implementation in
August 2000. As we continue to develop larger payment groups that more
broadly reflect services provided in an encounter or episode of care,
we have expanded the OPPS packaging policies. Most, but not necessarily
all, categories of items and services currently packaged in the OPPS
are listed in 42 CFR 419.2(b). Our overarching goal is to make payments
for all services under the OPPS more consistent with those of a
prospective payment system and less like those of a per-service fee
schedule, which pays separately for each coded item. As a part of this
effort, we have continued to examine the payment for items and services
provided under the OPPS to determine which OPPS services can be
packaged to further achieve the objective of advancing the OPPS toward
a more prospective payment system.
b. Policy and Comment Solicitation on Packaged Items and Services
For CY 2024, we examined the items and services currently provided
under the OPPS, reviewing categories of integral, ancillary,
supportive, dependent, or adjunctive items and services for which we
believe payment would be appropriately packaged into payment for the
primary service that they support. Specifically, we examined the HCPCS
code definitions (including CPT code descriptors) and hospital
outpatient department billing patterns to determine whether there were
categories of codes for which packaging would be appropriate according
to existing OPPS packaging policies or a logical expansion of those
existing OPPS packaging policies.
For CY 2024, we did not propose any changes to the overall
packaging policy discussed above. We proposed to continue to
conditionally package the costs of selected newly identified ancillary
services into payment for a primary service where we believe that the
packaged item or service is integral, ancillary, supportive, dependent,
or adjunctive to the provision of care that was reported by the primary
service HCPCS code.
While we did not propose any changes to the overall packaging
policy, we solicited comments on potential modifications to our
packaging policy as described in the following sections.
Comment: Several commenters expressed concerns that packaging
policies may create access barriers and incentives for stinting on
care. They urged CMS to do a comprehensive evaluation and study all
OPPS packaging policies to determine whether they reduce patients'
access to appropriate therapies and quality of care. They also
requested CMS provide continued opportunity for interested parties to
weigh in to help advance patient access to new innovations.
One commenter suggested that packaging can only create the types of
efficiency incentives CMS intends when there are certain principles in
place, recommending CMS only package items/services that truly have
substitutes, take cost and volume into consideration when determining
whether to package an item/service, and package the charges for
packaged items and/or services in a more logical and deliberate manner.
Another commenter clarified that potential access issues cannot always
be identified by a decline in volume of packaged services; access
issues also occur when patients do not receive the most clinically
appropriate drug, biological, or service because of how packaging
policies prioritize minimizing costs. Commenters felt that these issues
are increasingly important as health care moves toward more
personalized medicine and new innovations.
Commenters stated that, when CMS defines a packaging threshold,
manufacturers may select a price to ensure that the costs exceed the
packaging threshold to market the fact that separate CMS payment is
available. Commenter felt this conflicted with CMS' goal to provide
hospitals with incentives to choose the most clinically viable and
cost-effective option for their patients.
Response: We appreciate the comments on this issue, and we will
take these suggestions into consideration for future rulemaking.
After consideration of the public comments we received, we are
finalizing our overall OPPS packing policy, as proposed, for CY 2024.
c. Comment Solicitation on Access to Non-Opioid Treatments for Pain
Relief
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 sections 1833(t)(16) and 1833(i) of the 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) of
the Act provides that with respect to a non-opioid treatment for pain
relief furnished on or after January 1, 2025, 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, respectively. Because the additional payments are required
to begin on January 1, 2025, we previously stated that we will include
our proposals to implement the CAA, 2023, section 4135 amendments in
the CY 2025 OPPS/ASC proposed rule. We discussed section 4135 of CAA,
2023, at length in section XIII.F of the CY 2024 OPPS/ASC proposed rule
(88 FR 49767), and we solicited comment on numerous aspects of this
future policy. While we expect this policy to operate similarly in the
ASC and HOPD settings, we welcomed comment on whether there are any
HOPD-specific payment issues we should take into consideration as we
plan to implement section 1833(t)(16)(G) of the Act for CY 2025.
We thank commenters for their detailed comments regarding the
implementation of section 4135 of the CAA, 2023. We received a range of
comments regarding potential qualifying drugs, biologicals, devices,
and services, as well as evidence requirements for medical devices,
payment amounts, and payment limitations. See section XIII.F of this
final rule with comment period for a brief summary of the comments
received. We intend to take these comments into consideration as we
develop our proposals for the CY 2025 OPPS/ASC proposed rule.
d. Comment Solicitation on OPPS Packaging Policy for Diagnostic
Radiopharmaceuticals
(i) Background on OPPS Packaging Policy for Diagnostic
Radiopharmaceuticals
Under the OPPS, we package several categories of nonpass-through
drugs, biologicals, and radiopharmaceuticals, regardless of the cost of
the products. As the products are packaged according to
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the policies in Sec. 419.2(b), we refer to these packaged drugs,
biologicals, and radiopharmaceuticals as ``policy-packaged'' drugs,
biologicals, and radiopharmaceuticals. In particular, under Sec.
419.2(b)(15), payment for drugs, biologicals, and radiopharmaceuticals
that function as supplies when used in a diagnostic test or procedure
is packaged with the payment for the related procedure or service.
Packaging costs into a single aggregate payment for a service,
encounter, or episode of care is a fundamental principle that
distinguishes a prospective payment system from a fee schedule. In
general, packaging the costs of supportive items and services into the
payment for the primary procedure or service with which they are
associated encourages hospital efficiencies and enables hospitals to
manage their resources with maximum flexibility.
Diagnostic radiopharmaceuticals, which include contrast agents,
stress agents, and other products, are one specific type of product
that is policy packaged under the category described by Sec.
419.2(b)(15). Since we implemented this policy in CY 2008, interested
parties have raised concerns regarding policy packaging of diagnostic
radiopharmaceuticals. In previous rulemaking (87 FR 71962 and 71963),
commenters recommended that CMS always pay separately for diagnostic
radiopharmaceuticals paid under the OPPS, not just when the products
have pass-through payment status. Many of these commenters mentioned
that pass-through payment status helps the diffusion of new diagnostic
radiopharmaceuticals into the market. However, commenters believe the
packaged payment rate is often inadequate after pass-through status
expires, especially in cases where the diagnostic radiopharmaceutical
is high-cost and has low utilization.
CMS has previously heard from interested parties regarding
alternative payment methodologies, such as subjecting diagnostic
radiopharmaceuticals to the drug packaging threshold and creating
separate APC payments for diagnostic radiopharmaceuticals with a per-
day cost greater than $500. Interested parties have also recommended
that we analyze our nuclear medicine APC structure and consider
establishing additional nuclear medicine APCs to more accurately
reflect the costs of diagnostic radiopharmaceuticals. Historically,
commenters opposed incorporating the cost of diagnostic
radiopharmaceuticals into the associated nuclear medicine APC as the
nuclear medicine APCs are sometimes paid at a lower rate than the
payment rate for the diagnostic radiopharmaceutical itself when it has
pass-through payment status (87 FR 71962 and 71963).
Importantly, commenters historically have also been concerned that
packaging payment for precision diagnostic radiopharmaceuticals in the
outpatient setting creates barriers to beneficiary access for safety
net hospitals serving a high proportion of Medicare beneficiaries and
hospitals serving underserved communities (87 FR 71962 and 71963).
Commenters specified that certain populations, such as those with
Alzheimer's disease, depend on the use of certain high-cost diagnostic
radiopharmaceuticals. Commenters discussed difficulties enrolling
hospitals in clinical studies due to OPPS packaging policies.
Commenters also suggested that CMS pay separately under the OPPS
specifically for radiopharmaceuticals that are used for Alzheimer's
disease. Additionally, commenters have recommended that CMS continue to
apply radiolabeled product edits to the nuclear medicine procedures to
ensure that all packaged costs are included on nuclear medicine claims
in order to establish appropriate payment rates in the future. Many of
these comments and our responses have been discussed in rulemaking
since the policy to package diagnostic radiopharmaceuticals was
adopted. We refer readers to the CY 2023 OPPS/ASC final rule with
comment period (87 FR 71962 and 71963) for the most recent discussion
of this subject.
As stated in the CY 2024 OPPS/ASC proposed rule (88 FR 49577), we
continue to believe that diagnostic radiopharmaceuticals are an
integral component of many nuclear medicine and imaging procedures and
charges associated with them should be reported on hospital claims to
the extent they are used. Accordingly, the payment for the
radiopharmaceuticals should be reflected within the payment for the
primary procedure. We note that ratesetting uses the geometric mean of
reported procedure costs based on data submitted to CMS from all
hospitals paid under the OPPS to set the payment rate for the service.
The costs that are calculated by Medicare reflect the average costs of
items and services that are packaged into a primary procedure and will
not necessarily equal the sum of the cost of the primary procedure and
the average sales price of the specific items and services used in the
procedure in each case. Furthermore, the costs are based on the
reported costs submitted to Medicare by the hospitals and not the list
price established by the manufacturer. Claims data that include the
radiopharmaceutical packaged with the associated procedure reflect the
combined cost of the procedure and the radiopharmaceutical used in the
procedure.
As CMS has reiterated over the years, we believe these packaging
policies are inherent principles of the OPPS and are essential to a
prospective payment system. We are also committed to ensuring
beneficiary access to diagnostic radiopharmaceuticals while also
ensuring the availability of new and innovative diagnostic tools for
Medicare beneficiaries. Therefore, we sought public comments on
potential modifications to our packaging policy for diagnostic
radiopharmaceuticals in order to ensure equitable payment and continued
beneficiary access.
Below we include the comment solicitation described in the CY 2024
OPPS/ASC proposed rule (88 FR 49578) followed by a brief summary of the
public comments we received.
(ii) Comment Solicitation on Potential Issues Caused by Current Payment
of Diagnostic Radiopharmaceuticals Under the OPPS
As described in the CY 2024 OPPS/ASC proposed rule (88 FR 49578),
we solicited comment on how the OPPS packaging policy for diagnostic
radiopharmaceuticals has impacted beneficiary access, including whether
there are specific patient populations or clinical disease states for
whom this issue is especially critical. We sought information on
specific cost-prohibitive diagnostic radiopharmaceuticals that
commenters believe are superior to alternative diagnostic modalities.
We were interested to learn the specific clinical scenarios that exist
for which it is only clinically appropriate to use the more expensive
diagnostic radiopharmaceutical, rather than a lower cost alternative,
as well as what clinical scenarios exist in which the only diagnostic
modality is a high-cost radiopharmaceutical. We sought information or
evidence that these high-cost diagnostic radiopharmaceuticals have
unique clinical value, and access has been negatively impacted by our
packaging policy. We also sought information about whether commenters
believe these high-cost and low-utilization diagnostic
radiopharmaceuticals are being appropriately utilized according to
their clinical treatment algorithm, meaning the stepwise procedures
generally accepted by the medical community for diagnosis, or clinical
practice guidelines.
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We were also interested in learning more about whether there is a
difference in outcomes for patients, or patient quality of care, based
on the radiopharmaceutical used as well as whether there is a
difference for hospitals, such as in terms of financial outcomes, based
on the radiopharmaceutical that used.
(iii) Comment Solicitation on New Approaches To Payment of Diagnostic
Radiopharmaceuticals Under the OPPS
In addition, we solicited comment on the following potential
approaches that would enhance beneficiary access, while also
maintaining the principles of the outpatient prospective payment
system. These approaches included: (1) paying separately for diagnostic
radiopharmaceuticals with per-day costs above the OPPS drug packaging
threshold of $140; (2) establishing a specific per-day cost threshold
that may be greater or less than the OPPS drug packaging threshold; (3)
restructuring APCs, including by adding nuclear medicine APCs for
services that utilize high-cost diagnostic radiopharmaceuticals; (4)
creating specific payment policies for diagnostic radiopharmaceuticals
used in clinical trials; and (5) adopting codes that incorporate the
disease state being diagnosed or a diagnostic indication of a
particular class of diagnostic radiopharmaceuticals.
To expand upon the first listed option on which we solicited
comments, we specifically sought comments about whether we should use
our statutory authority for separately payable drugs, biologicals, and
radiopharmaceuticals under 1833(t)(14)(A)(iii)(II) of the Act in order
to pay separately for diagnostic radiopharmaceuticals and subject those
diagnostic radiopharmaceuticals to the longstanding OPPS drug packaging
threshold policy, proposed to be $140 for CY 2023. Or said another way,
payment for diagnostic radiopharmaceuticals with per-day costs greater
than $140 would not be packaged and would be paid separately based on
available average sales price (ASP), wholesale acquisition cost (WAC),
or average wholesale price (AWP) data with the applicable add-on. This
would be similar to payment for therapeutic radiopharmaceuticals and
other drugs and biologicals as discussed in section V.B. of the CY 2024
OPPS/ASC proposed rule. We believe this could be a reasonable first
step as this threshold is well understood and known to commenters as
therapeutic drugs, biologicals, and radiopharmaceuticals are currently
paid separately if they have a calculated per-day cost above this
threshold and are not policy-packaged. However, it is also our
longstanding belief that diagnostic radiopharmaceuticals should have
their payment packaged as they function as supplies during a diagnostic
test or procedure and enable the provision of an independent service
and are not themselves the primary therapeutic modality. We sought
additional information from interested parties on this approach. We
note, for CY 2024, the OPPS drug packaging threshold was proposed to be
$140. However, based on updated data, we are finalizing a threshold of
$135 for CY 2024. For more information on the drug packaging threshold,
see section V.B.1.a of this final rule with comment period.
Regarding the second listed option, we sought comment on whether to
pay separately for a diagnostic radiopharmaceutical with a specific
per-day cost threshold that may be greater or less than the OPPS drug
packaging threshold. Specifically, we were interested to learn why
interested parties believe a threshold-based policy is important as
well as interested parties' rationale for creating a threshold that
would be different from the OPPS drug packaging threshold.
Regarding the third listed option, we have heard from some
interested parties that they believe APC restructuring, including
adding additional nuclear medicine APCs for services utilizing high-
cost diagnostic radiopharmaceuticals, would be appropriate. We sought
comment as to how these interested parties specifically envision
operationalizing this approach and what advantage this approach would
have for beneficiaries, hospitals, and CMS over other options.
For the fourth listed option, we recently became aware that some
interested parties believe that CMS packaging policies could influence
participation of beneficiaries and testing sites in clinical trials,
particularly those studying Alzheimer's disease, and were interested to
learn more about these concerns. While we believe there could be a
multitude of reasons for difficulty in recruiting study sites and
beneficiaries for clinical trials, including the COVID-19 PHE, we
requested comment as to whether CMS should consider creating payment
policies for diagnostic radiopharmaceuticals used in clinical trials.
Specifically, we were interested to learn what commenters believe an
appropriate payment mechanism would be for these diagnostic
radiopharmaceuticals, whether there are certain disease states or
categories of trials for which we should target our payment policies,
ways in which this policy could help promote equitable recruitment and
diverse participation, and the method by which CMS should determine
which clinical trial diagnostic radiopharmaceuticals should be subject
to this policy.
Finally, for approach five, we sought comment on new codes that CMS
could adopt that may incorporate the disease state being diagnosed or a
diagnostic indication of a particular class of diagnostic
radiopharmaceuticals. CMS could create indication-specific coding to
reflect the imaging procedure and the target of the imaging procedure.
For example, CMS could create a code to represent a positron emission
tomography (PET) scan that detects a specific protein. If multiple
diagnostic radiopharmaceuticals are available to use during this PET
scan to detect this specific protein, then their payment would be
packaged into the payment for this newly created code and reflected in
the payment for this code. Therefore, if there is a specific clinical
indication for which only very costly diagnostic radiopharmaceuticals
are available, our data would appropriately reflect their utilization.
Alternatively, if there is a specific clinical indication in which a
wide variety of diagnostic radiopharmaceuticals can be used, all with
varying costs, then our data would reflect this and our payment rates
would not incentivize a higher-cost diagnostic radiopharmaceutical when
there is a lower-cost, but clinically similar, diagnostic
radiopharmaceutical alternative. This coding approach could be coupled
with the restructuring of the nuclear medicine APC family. We believe
this approach of more granular coding could allow for more specific
data to be reported and thus more targeted and appropriate payment
rates to be developed. This approach would also help to maintain the
principles of a prospective payment system by maintaining current
packaging policies as payment for the diagnostic radiopharmaceutical
would continue to be packaged into the payment for the procedure in
which the diagnostic radiopharmaceutical is used.
We also sought additional explanation from interested parties as to
why they believe their suggested approach is the best policy approach
to ensure beneficiary access to diagnostic radiopharmaceuticals and
equitable payment for innovative and effective technologies. We
welcomed comment regarding ideas discussed in this section, discussed
in prior rulemaking, or new ideas for payment for diagnostic
radiopharmaceuticals in the OPPS.
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Finally, we were interested in hearing from stakeholders how the
discussed policy modifications might impact our overarching goal of
utilizing packaging policies to better align OPPS policies with those
of a prospective payment system rather than a fee schedule. We stated
we would also like to know if making any of the policy changes
discussed previously could have negative consequences for
beneficiaries, such as unintentionally influencing clinical practice
decisions, increasing beneficiary cost-sharing obligations, or
inadvertently encouraging the use of higher-cost diagnostic
radiopharmaceuticals over lower cost, but equally effective, diagnostic
options.
In the CY 2024 OPPS/ASC proposed rule (88 FR 49578), we noted that
depending on the comments received, we may adopt as final one or more
alternative payment mechanisms for radiopharmaceuticals for CY 2024.
Comment: We received a significant number of comments in response
to the comment solicitation on potential issues caused by our current
payment policy for diagnostic radiopharmaceuticals under the OPPS and
on new approaches to payment for these products. Overall, commenters
described clinical scenarios in which they believed CMS' payment
policies created the most significant access issues, and accordingly,
commenters urged CMS to reform payment policy for diagnostic
radiopharmaceuticals to address these concerns. However, there was not
a general consensus among commenters as to the most effective way for
CMS to reform its OPPS diagnostic radiopharmaceutical payment policy.
Commenters expressed concerns regarding the CMS policy to package
diagnostic radiopharmaceuticals and the financial burden it has on
facilities. These commenters believed radiopharmaceuticals are not
supp
[…truncated; see source link]Indexed from Federal Register on November 22, 2023.
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