Proposed Rule2023-14768
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Proposed Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction
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Published
July 31, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed rule would revise 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 proposed 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. This proposed rule also would update and refine 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. This proposed rule would also establish payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this proposed rule would update and refine requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. We also propose to codify provisions of the Consolidated Appropriations Act, 2023, in Community Mental Health Centers Conditions of Participation (CoPs). We propose to revise the personnel qualifications of Mental Health Counselors and add personnel qualifications for Marriage and Family Therapists in the CMHC CoPs. We also seek comment on separate payment under the Inpatient Prospective Payment System (IPPS) for establishing and maintaining access to a buffer stock of essential medicines to foster a more reliable, resilient supply of these medicines. Finally, we propose to address any future revisions to the IPPS Medicare Code Editor (MCE), including any additions or deletions of claims edits, as well as the addition or deletion of ICD-10 diagnosis and procedure codes to the applicable MCE edit code lists, outside of the annual IPPS rulemakings. Additionally, we propose a technical correction to the Rural Emergency Hospital Conditions of Participation.
Full Text
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[Federal Register Volume 88, Number 145 (Monday, July 31, 2023)]
[Proposed Rules]
[Pages 49552-49921]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14768]
[[Page 49551]]
Vol. 88
Monday,
No. 145
July 31, 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 Rural Health Clinics,
Federally Qualified Health Centers, and Opioid Treatment Programs;
Hospital Price Transparency; Changes to Community Mental Health Centers
Conditions of Participation, Proposed Changes to the Inpatient
Prospective Payment System Medicare Code Editor; Rural Emergency
Hospital Conditions of Participation Technical Correction; Proposed
Rule
Federal Register / Vol. 88 , No. 145 / Monday, July 31, 2023 /
Proposed Rules
[[Page 49552]]
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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, 489
Office of the Secretary
45 CFR Part 180
[CMS-1786-P]
RIN 0938-AV09
Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems; Quality Reporting Programs;
Payment for Intensive Outpatient Services in Rural Health Clinics,
Federally Qualified Health Centers, and Opioid Treatment Programs;
Hospital Price Transparency; Changes to Community Mental Health Centers
Conditions of Participation, Proposed 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: Proposed rule.
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SUMMARY: This proposed rule would revise 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 proposed
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. This proposed rule also
would update and refine 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. This proposed rule would also establish payment for certain
intensive outpatient services under Medicare, beginning January 1,
2024. In addition, this proposed rule would update and refine
requirements for hospitals to make public their standard charge
information and enforcement of hospital price transparency. We also
propose to codify provisions of the Consolidated Appropriations Act,
2023, in Community Mental Health Centers Conditions of Participation
(CoPs). We propose to revise the personnel qualifications of Mental
Health Counselors and add personnel qualifications for Marriage and
Family Therapists in the CMHC CoPs. We also seek comment on separate
payment under the Inpatient Prospective Payment System (IPPS) for
establishing and maintaining access to a buffer stock of essential
medicines to foster a more reliable, resilient supply of these
medicines. Finally, we propose to address any future revisions to the
IPPS Medicare Code Editor (MCE), including any additions or deletions
of claims edits, as well as the addition or deletion of ICD-10
diagnosis and procedure codes to the applicable MCE edit code lists,
outside of the annual IPPS rulemakings. Additionally, we propose a
technical correction to the Rural Emergency Hospital Conditions of
Participation.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by September 11, 2023.
ADDRESSES: In commenting, please refer to file code CMS-1786-P.
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-P, P.O. Box 8010,
Baltimore, MD 21244-1810.
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-P, 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:
Elise Barringer, <a href="/cdn-cgi/l/email-protection#1b5e7772687e35597a696972757c7e695b78766835737368357c746d"><span class="__cf_email__" data-cfemail="efaa83869c8ac1ad8e9d9d8681888a9daf8c829cc187879cc1888099">[email protected]</span></a> or 410-786-9222.
Advisory Panel on Hospital Outpatient Payment (HOP Panel), contact
the HOP Panel mailbox at <a href="/cdn-cgi/l/email-protection#dc9d8c9f8cbdb2b9b09cbfb1aff2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="80c1d0c3d0e1eee5ecc0e3edf3aee8e8f3aee7eff6">[email protected]</span></a>.
Ambulatory Surgical Center (ASC) Payment System, contact Scott
Talaga via email at <a href="/cdn-cgi/l/email-protection#86d5e5e9f2f2a8d2e7eae7e1e7c6e5ebf5a8eeeef5a8e1e9f0"><span class="__cf_email__" data-cfemail="8fdcece0fbfba1dbeee3eee8eecfece2fca1e7e7fca1e8e0f9">[email protected]</span></a> or Mitali Dayal via email
at <a href="/cdn-cgi/l/email-protection#8ec3e7faefe2e7a0caeff7efe2bcceede3fda0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="84c9edf0e5e8edaac0e5fde5e8b6c4e7e9f7aaececf7aae3ebf2">[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#91d0fff8e5f0bfd3f9f0e5f8f0d1f2fce2bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="97d6f9fee3f6b9d5fff6e3fef6d7f4fae4b9ffffe4b9f0f8e1">[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#8ee3effcfde6efa0e6ebfcfaf4ecebfce9ceede3fda0e6e6fda0e9e1f8"><span class="__cf_email__" data-cfemail="97faf6e5e4fff6b9fff2e5e3edf5f2e5f0d7f4fae4b9ffffe4b9f0f8e1">[email protected]</span></a>.
Biosimilars Packaging Exception, contact Gil Ngan via email at
<a href="/cdn-cgi/l/email-protection#54333d387a3a33353a143739277a3c3c277a333b22"><span class="__cf_email__" data-cfemail="3156585d1f5f56505f71525c421f5959421f565e47">[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="9ad0f5e9f2effbb4d7f9dcffffeeffe8e9daf9f7e9b4f2f2e9b4fdf5ec">[email protected]</span></a>.
Cancer Hospital Payments, contact Scott Talaga via email at
<a href="/cdn-cgi/l/email-protection#297a4a465d5d077d4845484e48694a445a0741415a074e465f"><span class="__cf_email__" data-cfemail="4013232f34346e14212c21272100232d336e2828336e272f36">[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#1a547b6e727b74344c7f68797b6f6e7f687f745a79776934727269347d756c"><span class="__cf_email__" data-cfemail="337d52475b525d1d655641505246475641565d73505e401d5b5b401d545c45">[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#dd9eb5a8beb6f39fafbcabb8af9dbeb0aef3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="86c5eef3e5eda8c4f4e7f0e3f4c6e5ebf5a8eeeef5a8e1e9f0">[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#a3eec2d1da8df1ccd0d0cae0ccc2c9ccd6e3c0ced08dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="2a674b585304784559594369454b40455f6a49475904424259044d455c">[email protected]</span></a> or
Cara Meyer via email at <a href="/cdn-cgi/l/email-protection#3d7e5c4f5c13705844584f7d5e504e1355554e135a524b"><span class="__cf_email__" data-cfemail="5e1d3f2c3f70133b273b2c1e3d332d7036362d70393128">[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#1954706d787570375d786078752b597a746a3771716a377e766f"><span class="__cf_email__" data-cfemail="8fc2e6fbeee3e6a1cbeef6eee3bdcfece2fca1e7e7fca1e8e0f9">[email protected]</span></a>.
Comprehensive APCs (C-APCs), contact Mitali Dayal via email at
<a href="/cdn-cgi/l/email-protection#f6bb9f82979a9fd8b2978f979ac4b6959b85d89e9e85d8919980"><span class="__cf_email__" data-cfemail="7c3115081d101552381d051d104e3c1f110f5214140f521b130a">[email protected]</span></a>.
COVID-19 Final Rules, contact Elise Barringer via email at
<a href="/cdn-cgi/l/email-protection#0441686d77612a466576766d6a636176446769772a6c6c772a636b72"><span class="__cf_email__" data-cfemail="5a1f3633293f74183b282833343d3f281a39372974323229743d352c">[email protected]</span></a>.
Hospital Outpatient Quality Reporting (OQR) Program policies,
contact Kimberly Go via email <a href="/cdn-cgi/l/email-protection#9bd0f2f6f9fee9f7e2b5dcf4dbf8f6e8b5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="652e0c08070017091c4b220a250608164b0d0d164b020a13">[email protected]</span></a>.
Hospital Outpatient Quality Reporting (OQR) Program measures,
contact Janis Grady via email <a href="/cdn-cgi/l/email-protection#551f343b3c267b122734312c153638267b3d3d267b323a23"><span class="__cf_email__" data-cfemail="0e446f60677d20497c6f6a774e6d637d2066667d20696178">[email protected]</span></a>.
Hospital Outpatient Visits (Emergency Department Visits and
Critical Care Visits), contact Elise Barringer via email at
<a href="/cdn-cgi/l/email-protection#20654c4953450e62415252494e47455260434d530e4848530e474f56"><span class="__cf_email__" data-cfemail="eda881849e88c3af8c9f9f84838a889fad8e809ec385859ec38a829b">[email protected]</span></a>.
Hospital Price Transparency (HPT), contact Terri Postma via email
at <a href="/cdn-cgi/l/email-protection#6131130802043513000f12110013040f0218290e12110815000d2209001306041221020c124f0909124f060e17"><span class="__cf_email__" data-cfemail="c696b4afa5a392b4a7a8b5b6a7b4a3a8a5bf8ea9b5b6afb2a7aa85aea7b4a1a3b586a5abb5e8aeaeb5e8a1a9b0">[email protected]</span></a>.
Inpatient Only (IPO) Procedures List, contact Abigail Cesnik via
email at <a href="/cdn-cgi/l/email-protection#d899bab1bfb9b1b4f69bbdabb6b1b398bbb5abf6b0b0abf6bfb7ae"><span class="__cf_email__" data-cfemail="6f2e0d06080e0603412c0a1c0106042f0c021c4107071c41080019">[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#0a476b7863667f24427f6f4a69677924626279246d657c"><span class="__cf_email__" data-cfemail="723f13001b1e075c3a071732111f015c1a1a015c151d04">[email protected]</span></a>.
Mental Health Services Furnished Remotely by Hospital Staff to
[[Page 49553]]
Beneficiaries in Their Homes, contact Emily Yoder via email at
<a href="/cdn-cgi/l/email-protection#692c040005104730060d0c1b290a041a4701011a470e061f"><span class="__cf_email__" data-cfemail="6d280004011443340209081f2d0e001e4305051e430a021b">[email protected]</span></a>.
Method to Control Unnecessary Increases in the Volume of Clinic
Visit Services Furnished in Excepted Off-Campus Provider-Based
Departments (PBDs), contact Elise Barringer via email at
<a href="/cdn-cgi/l/email-protection#0b4e6762786e25496a797962656c6e794b68667825636378256c647d"><span class="__cf_email__" data-cfemail="8fcae3e6fceaa1cdeefdfde6e1e8eafdcfece2fca1e7e7fca1e8e0f9">[email protected]</span></a>.
New Technology Intraocular Lenses (NTIOLs), contact Scott Talaga
via email at <a href="/cdn-cgi/l/email-protection#7d2e1e12090953291c111c1a1c3d1e100e5315150e531a120b"><span class="__cf_email__" data-cfemail="a5f6c6cad1d18bf1c4c9c4c2c4e5c6c8d68bcdcdd68bc2cad3">[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#92c1f1fde6e6bcc6f3fef3f5f3d2f1ffe1bcfafae1bcf5fde4"><span class="__cf_email__" data-cfemail="9ecdfdf1eaeab0cafff2fff9ffdefdf3edb0f6f6edb0f9f1e8">[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#034f6a6d6770667a2d41626f67746a6d43606e702d6b6b702d646c75"><span class="__cf_email__" data-cfemail="e9a580878d9a8c90c7ab88858d9e8087a98a849ac781819ac78e869f">[email protected]</span></a> and
Ariana Pitcher at <a href="/cdn-cgi/l/email-protection#18596a717976793648716c7b707d6a587b756b3670706b367f776e"><span class="__cf_email__" data-cfemail="aaebd8c3cbc4cb84fac3dec9c2cfd8eac9c7d984c2c2d984cdc5dc">[email protected]</span></a>.
OPPS Brachytherapy, contact Scott Talaga via email at
<a href="/cdn-cgi/l/email-protection#7e2d1d110a0a502a1f121f191f3e1d130d5016160d50191108"><span class="__cf_email__" data-cfemail="edbe8e829999c3b98c818c8a8cad8e809ec385859ec38a829b">[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#3a7f485359511479524f5b545d7a59574914525249145d554c"><span class="__cf_email__" data-cfemail="6c291e050f07422f04190d020b2c0f011f4204041f420b031a">[email protected]</span></a>, or Scott Talaga via email at
<a href="/cdn-cgi/l/email-protection#1043737f64643e44717c71777150737d633e7878633e777f66"><span class="__cf_email__" data-cfemail="4615252932326812272a27212706252b35682e2e3568212930">[email protected]</span></a>, or Josh McFeeters via email at
<a href="/cdn-cgi/l/email-protection#571d38243f2236791a341132322332252417343a24793f3f2479303821"><span class="__cf_email__" data-cfemail="efa5809c879a8ec1a28ca98a8a9b8a9d9caf8c829cc187879cc1888099">[email protected]</span></a>.
OPPS Dental Policy, contact Nicole Marcos via email at
<a href="/cdn-cgi/l/email-protection#b9f7d0dad6d5dc97f4d8cbdad6caf9dad4ca97d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="632d0a000c0f064d2e0211000c1023000e104d0b0b104d040c15">[email protected]</span></a>.
OPPS Drugs, Radiopharmaceuticals, Biologicals, and Biosimilar
Products, contact Josh McFeeters via email at
<a href="/cdn-cgi/l/email-protection#470d28342f3226690a240122223322353407242a34692f2f3469202831"><span class="__cf_email__" data-cfemail="d49ebba7bca1b5fa99b792b1b1a0b1a6a794b7b9a7fabcbca7fab3bba2">[email protected]</span></a>, or Gil Ngan via email at
<a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="63240a0f4d2d04020d23000e104d0b0b104d040c15">[email protected]</a>, or Cory Duke via email at <a href="/cdn-cgi/l/email-protection#b5f6dac7cc9bf1c0ded0f5d6d8c69bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="84c7ebf6fdaac0f1efe1c4e7e9f7aaececf7aae3ebf2">[email protected]</span></a>,
or Au'Sha Washington via email at <a href="/cdn-cgi/l/email-protection#450430362d246b1224362d2c2b22312a2b052628366b2d2d366b222a33"><span class="__cf_email__" data-cfemail="347541475c551a6355475c5d5a53405b5a745759471a5c5c471a535b42">[email protected]</span></a>.
OPPS New Technology Procedures/Services, contact the New Technology
APC mailbox at <a href="/cdn-cgi/l/email-protection#b4fad1c3e0d1d7dcf5e4f7d5c4c4d8ddd7d5c0dddbdac7f4d7d9c79adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="cb85aebc9faea8a38a9b88aabbbba7a2a8aabfa2a4a5b88ba8a6b8e5a3a3b8e5aca4bd">[email protected]</span></a>.
OPPS Packaged Items/Services, contact Mitali Dayal via email at
<a href="/cdn-cgi/l/email-protection#337e5a47525f5a1d77524a525f0173505e401d5b5b401d545c45"><span class="__cf_email__" data-cfemail="a5e8ccd1c4c9cc8be1c4dcc4c997e5c6c8d68bcdcdd68bc2cad3">[email protected]</span></a> or Cory Duke via email at
<a href="/cdn-cgi/l/email-protection#cb88a4b9b2e58fbea0ae8ba8a6b8e5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="ffbc908d86d1bb8a949abf9c928cd197978cd1989089">[email protected]</span></a>.
OPPS Pass-Through Devices, contact the Device Pass-Through mailbox
at <a href="/cdn-cgi/l/email-protection#551130233c36300501342525393c3634213c3a3b26153638267b3d3d267b323a23"><span class="__cf_email__" data-cfemail="9adeffecf3f9ffcacefbeaeaf6f3f9fbeef3f5f4e9daf9f7e9b4f2f2e9b4fdf5ec">[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#125f73607b7c733c5967617a7c7b607d647352717f613c7a7a613c757d64"><span class="__cf_email__" data-cfemail="f4b995869d9a95dabf81879c9a9d869b8295b4979987da9c9c87da939b82">[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#94c4dcc4c4f5edf9f1fae0c4fbf8fdf7edd4f7f9e7bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="15455d4545746c78707b61457a797c766c557678663b7d7d663b727a63">[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#b7f3f6f4f7d4dac499dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="0246434142616f712c6a6a712c656d74">[email protected]</span></a>.
Rural Emergency Hospital Conditions of Participation, contact
Kianna Banks via email <a href="/cdn-cgi/l/email-protection#22694b434c4c430c60434c495162414f510c4a4a510c454d54"><span class="__cf_email__" data-cfemail="99d2f0f8f7f7f8b7dbf8f7f2ead9faf4eab7f1f1eab7fef6ef">[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#65240b0c11044b270d04110c04250608164b0d0d164b020a13"><span class="__cf_email__" data-cfemail="15547b7c61743b577d74617c74557678663b7d7d663b727a63">[email protected]</span></a>.
Rural Emergency Hospital Quality Reporting (REHQR) Program
measures, contact Melissa Hager via email <a href="/cdn-cgi/l/email-protection#b5f8d0d9dcc6c6d49bfdd4d2d0c7f5d6d8c69bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="450820292c3636246b0d24222037052628366b2d2d366b222a33">[email protected]</span></a>.
Rural Health Clinic (RHC) and Federally Qualified Health Center
(FQHC) Intensive Outpatient Services (IOP), contact Michele Franklin
via email at <a href="/cdn-cgi/l/email-protection#6924000a010c050c472f1b080702050007290a041a4701011a470e061f"><span class="__cf_email__" data-cfemail="1954707a717c757c375f6b787772757077597a746a3771716a377e766f">[email protected]</span></a>.
Separate Payment for High-Cost Drugs Provided by Indian Health
Service and Tribally-Owned Facilities, contact Elise Barringer via
email at <a href="/cdn-cgi/l/email-protection#81c4ede8f2e4afc3e0f3f3e8efe6e4f3c1e2ecf2afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="53163f3a20367d113221213a3d34362113303e207d3b3b207d343c25">[email protected]</span></a>.
Skin Substitutes, contact Josh McFeeters via email at
<a href="/cdn-cgi/l/email-protection#3c76534f54495d12715f7a595948594e4f7c5f514f1254544f125b534a"><span class="__cf_email__" data-cfemail="9cd6f3eff4e9fdb2d1ffdaf9f9e8f9eeefdcfff1efb2f4f4efb2fbf3ea">[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#c788b2b3b7a6b3aea2a9b397979487a4aab4e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="773802030716031e12190327272437141a04591f1f0459101801">[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#d796849487878497b4baa4f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="da9b89998a8a899ab9b7a9f4b2b2a9f4bdb5ac">[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 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/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices</a>.
The Addenda relating to the ASC payment system are available at:
<a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Regulations-and-Notices</a>.
Current Procedural Terminology (CPT) Copyright Notice
Throughout this proposed rule, 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. Executive Summary of This Document
II. Proposed 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
III. Proposed OPPS Ambulatory Payment Classification (APC) Group
Policies
A. Proposed OPPS Treatment of New and Revised HCPCS Codes
B. Proposed OPPS Changes--Variations Within APCs
C. Proposed New Technology APCs
D. Universal Low Volume APC Policy for Clinical and
Brachytherapy APCs
E. Proposed APC-Specific Policies
IV. Proposed OPPS Payment for Devices
A. Proposed Pass-Through Payment for Devices
B. Proposed Device-Intensive Procedures
[[Page 49554]]
V. Proposed OPPS Payment for Drugs, Biologicals, and
Radiopharmaceuticals
A. Proposed OPPS Transitional Pass-Through Payment for
Additional Costs of Drugs, Biologicals, and Radiopharmaceuticals
B. Proposed 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. Proposed 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. Proposed Estimate of Pass-Through Spending for CY 2024
VII. Proposed 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. Proposed Payment Rate Methodology for PHP and IOP
E. Proposed 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. Proposed 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 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 Tribally-Owned Facilities
XI. Proposed CY 2024 OPPS Payment Status and Comment Indicators
A. Proposed CY 2024 OPPS Payment Status Indicator Definitions
B. Proposed CY 2024 Comment Indicator Definitions
XII. MedPAC Recommendations
A. OPPS Payment Rates Update
B. Medicare Safety Net Index
C. ASC Cost Data
XIII. Proposed Updates to the Ambulatory Surgical Center (ASC)
Payment System
A. Background, Legislative History, Statutory Authority, and
Prior Rulemaking for the ASC Payment System
B. Proposed ASC Treatment of New and Revised Codes
C. Payment Policies Under the ASC Payment System
D. Proposed 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. Proposed New Technology Intraocular Lenses (NTIOLs)
H. Proposed Calculation of the ASC Payment Rates and the ASC
Conversion Factor
XIV. Hospital Outpatient Quality Reporting (OQR) Program
Requirements, Proposals, and Requests for Comment
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. Requirements for the Ambulatory Surgical Center Quality
Reporting (ASCQR) Program
A. Background
B. ASCQR Program Quality Measure
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. Provisions of the Proposed Rule
XVIII. Proposed Updates to Requirements for Hospitals To Make Public
a List of Their Standard Charges
A. Introduction and Overview
B. Proposal To Modify the Requirements for Making Public
Hospital Standard Charges at 45 CFR 180.50
C. Proposals To Improve and Enhance Enforcement
D. Seeking Comment on Consumer-Friendly Displays and Alignment
With Transparency in Coverage and No Surprises Act
XIX. Proposed Changes to the Inpatient Prospective Payment System
Medicare Code Editor
XX. Proposed Technical Edits for REH Conditions of Participation
XXI. Rural Emergency Hospitals (REHs): Proposal Regarding Payment
For Rural Emergency Hospitals (REHs)
A. Background on Rural Emergency Hospitals
B. REH Payment Methodology
C. Background on the IHS Outpatient All-Inclusive Rate (AIR) for
Tribal and IHS Hospitals
D. Proposal To Pay 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 Essential
Medicines
D. Comment Solicitation on Additional Considerations
XXIII. Files Available to the Public via the internet
XXIV. Collection of Information Requirements
A. ICRs Related to Proposed Intensive Outpatient Physician
Certification Requirements
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 Proposed Rule
C. Detailed Economic Analyses
D. Regulatory Review Cost Estimation
E. Regulatory Flexibility Act (RFA) Analysis
[[Page 49555]]
F. Unfunded Mandates Reform Act Analysis
G. Federalism
H. Conclusion
I. Summary and Background
A. Executive Summary of This Document
1. Purpose
In this proposed rule, we propose to update 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 proposed rule
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 proposed rule.
In addition, this proposed rule would update and refine 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 proposed
rule would establish payment for intensive outpatient services under
Medicare, beginning January 1, 2024. This proposed rule would also
update and refine the requirements for hospitals to make public their
standard charges and CMS enforcement of hospital price transparency
regulations. In addition, this proposed rulemaking would also update
the Community Mental Health Center (CMHC) Conditions of Participation
(CoPs). We propose to revise the personnel qualifications of Mental
Health Counselor's (MHCs) and add personnel qualifications for Marriage
and Family Therapists (MFTs) in the CMHC CoP. Finally, we propose to
remove discussion of the IPPS Medicare Code Editor (MCE) from the
annual IPPS rulemakings, beginning with the FY 2025 rulemaking.
Additionally, we propose 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 propose to increase the payment
rates under the OPPS by an Outpatient Department (OPD) fee schedule
increase factor of 2.8 percent. This proposed increase factor is based
on the proposed inpatient hospital market basket percentage increase of
3.0 percent for inpatient services paid under the hospital inpatient
prospective payment system (IPPS) reduced by a proposed 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 would be approximately $88.6 billion, an
increase of approximately $6.0 billion compared to estimated CY 2023
OPPS payments.
We propose to continue 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 0.9805 to the OPPS payments and copayments for all
applicable services.
<bullet> Data used in Proposed CY 2024 OPPS/ASC Ratesetting: To set
proposed 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 propose to resume 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 propose
changes to our methodology used to calculate the Community Mental
Health Center (CMHC) and hospital-based PHP (HB PHP) geometric mean per
diem costs, as well as proposing changes to expand PHP payment from two
APCs to four APCs.
<bullet> Proposed Medicare Payment for Intensive Outpatient
Programs: Beginning in CY 2024, we propose to establish payment for
intensive outpatient programs (IOPs) under Medicare. We propose 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 (FQHC), and rural
health clinics (RHC). We also propose to establish 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
not proposing to remove any services from the IPO list.
<bullet> 340B-Acquired Drugs: For CY 2024, we propose to continue
to apply the default rate, generally average sales price (ASP) plus 6
percent, to 340B acquired drugs and biologicals. Therefore, drugs and
biologicals acquired under the 340B program would 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 propose to
except biosimilars from the OPPS threshold packaging policy when their
reference biologicals are separately paid. In addition, if a reference
product's per-day cost falls below the threshold packaging policy, we
propose that all the biosimilars related to the reference product would
be similarly packaged.
<bullet> Proposal 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 propose 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
propose 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 6 applications for device pass-through payments. We solicit
public comment on these applications and will make final determinations
on these applications in the CY 2024 OPPS/ASC final rule with comment
period.
[[Page 49556]]
<bullet> Cancer Hospital Payment Adjustment: For CY 2024, we
propose to continue providing 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 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 proposed rule, we propose 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 propose to use 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 propose to extend our policy to update the ASC payment
system using the hospital market basket update an additional two
years--through CYs 2024 and 2025. Using the hospital market basket
methodology, for CY 2024, we propose to increase payment rates under
the ASC payment system by 2.8 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 3.0 percent reduced
by a productivity adjustment of 0.2 percentage point. Based on this
proposed 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 $6.0
billion, an increase of approximately $170 million compared to
estimated CY 2023 Medicare payments.
<bullet> Changes to the List of ASC Covered Surgical Procedures:
For CY 2024, we propose to add 26 dental surgical procedures to the ASC
covered procedures list (CPL) based upon existing criteria at Sec.
416.166.
<bullet> Hospital Outpatient Quality Reporting (OQR) Program: For
the Hospital OQR Program measure set, we propose to: (1) remove the
Left Without Being Seen measure beginning with the CY 2024 reporting
period/2026 payment determination; (2) modify the COVID-19 Vaccination
Coverage Among Healthcare Personnel (HCP) measure beginning with the CY
2024 reporting period/CY 2026 payment determination; (3) modify the
Cataracts: Improvement in Patient's Visual Function Within 90 Days
Following Cataract Surgery measure beginning with the voluntary CY 2024
reporting period; (4) 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; (5) re-adopt
with modification the Hospital Outpatient Volume Data on Selected
Outpatient Procedures measure beginning with the voluntary CY 2025
reporting period and mandatory reporting beginning with the CY 2026
reporting period/CY 2028 payment determination; (6) 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)
beginning with the voluntary CYs 2025 and 2026 reporting periods, and
mandatory reporting beginning with the CY 2027 reporting period/CY 2030
payment determination; (7) adopt the Excessive Radiation Dose or
Inadequate Image Quality for Diagnostic Computed Tomography (CT) in
Adults (Hospital Level--Outpatient) measure, beginning with the
voluntary CY 2025 reporting period and mandatory reporting beginning
with the CY 2026 reporting period/CY 2028 payment determination; and
(8) 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 also requesting 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: For the ASCQR Program measure set, we propose 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; (4) re-adopt with
modification the ASC Facility Volume Data on Selected ASC Surgical
Procedures measure beginning with the voluntary CY 2025 reporting
period and mandatory reporting beginning with the CY 2026 reporting
period/CY 2028 payment determination; (5) 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) beginning with
the voluntary CYs 2025 and 2026 reporting periods, and mandatory
reporting beginning with the CY 2027 reporting period/CY 2030 payment
determination; and (6) 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.
<bullet> Rural Emergency Hospital Quality Reporting (REHQR)
Program: For the REHQR Program, we propose to: (1) codify the statutory
authority for the REHQR Program; (2) adopt and codify policies related
to measure retention, measure removal, and measure modification; (3)
adopt one chart-abstracted measure and three claims-based measures for
the REHQR Program measure set and establish related reporting
requirements beginning with the CY 2024 reporting period; (4) adopt and
codify policies related to public reporting of data; (5) codify
foundational requirements related to REHQR Program participation; (6)
adopt and codify policies related to the form, manner, and timing of
data submission under the REHQR Program; (7) adopt and codify a review
and corrections period for submitted data; and (8) adopt and codify an
Extraordinary Circumstances Exception (ECE) process for data submission
requirements. We are also requesting 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
[[Page 49557]]
measures; and (3) a tiered quality measure approach.
<bullet> Mental Health Services Furnished Remotely by Hospital
Staff to Beneficiaries in Their Homes: For CY 2024, we propose
technical refinements to the existing coding for remote mental health
services to allow for multiple units to be billed daily. We also
propose to create a new, untimed code to describe group psychotherapy.
Finally, we propose to delay any in-person visit requirements until the
end of CY 2024.
Proposed OPPS Payment for Dental Services: For CY 2024, we propose
to assign 229 HCPCS codes describing dental services to various
clinical APCs to align with Medicare payment provisions regarding
dental services in the CY 2023 PFS final rule.
Comment Solicitation on Payment for High-Cost Drugs Provided by
Indian Health Service and Tribally-Owned Facilities: We are seeking
comment on whether Medicare should pay separately for high-cost drugs
provided by IHS and tribally-owned facilities.
<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 proposed revisions to Sec. 410.47 and
Sec. 410.49 in the CY 2024 PFS proposed rule, we propose to revise
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 propose to allow 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. 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 propose to pay 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> Proposed Updates to Requirements for Hospitals to Make
Public a List of Their Standard Charges: We propose to amend several of
our hospital price transparency (HPT) requirements in order to improve
our monitoring and enforcement capabilities by way of improving access
to, and the usability of, hospital standard charge information; reduce
the compliance burden on hospitals by providing CMS templates and
technical guidance for display of hospital standard charge information;
align, where feasible, certain hospital price transparency requirements
and processes with requirements and processes we have implemented in
the Transparency in Coverage (TIC) initiative; and make other
modifications to our monitoring and enforcement capabilities that will,
among other things, increase its transparency to the public.
Specifically, we propose to: (1) add definitions for ``CMS template'',
``consumer-friendly expected allowed charges'', ``encode'', and
``machine-readable file'' (MRF); (2) require hospitals to affirm the
accuracy and completeness of data in their MRF; (3) revise and expand
the data elements hospitals must include in the MRF; (4) require
hospitals to conform to a CMS template layout and other technical
specifications for encoding standard charge information in the MRF; (5)
require hospitals to establish and maintain a txt file and footer as
specified by CMS; and (6) revise 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 information about CMS
enforcement activities related to individual hospital compliance.
Additionally, we are seeking comment on additional considerations for
improving compliance and aligning consumer-friendly policies and
requirements with other federal price transparency initiatives.
<bullet> Community Mental Health Center (CMHC) Conditions of
Participation (CoPs): We propose to update the CMHC CoPs to implement
the provisions of the Consolidated Appropriations Act (CAA), 2023 (Pub.
L. 117-238) by establishing coverage of intensive outpatient services
(IOP) in CMHCs. 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). We propose
to revise the personnel qualifications of MHCs and add personnel
qualifications for MFTs in the CMHC CoPs.
<bullet> Proposed 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 propose 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> Request for Public Comments on Potential Payment under the
IPPS and OPPS for Establishing and Maintaining Access to Essential
Medicines: We are seeking comment on, and may consider finalizing based
on the review of comments received, as early as for cost reporting
periods beginning on or after January 1, 2024, separate payment under
IPPS, for establishing and maintaining access to a buffer stock of
essential medicines to foster a more reliable, resilient supply of
these medicines. An adjustment under OPPS could be considered for
future years.
<bullet> Rural Emergency Hospital (REH) Conditions of Participation
(CoPs): We propose 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 proposed rule, we set forth a detailed
analysis of the regulatory and federalism impacts that the changes
would have on affected entities and beneficiaries. Key estimated
impacts are described below.
a. Impacts of all OPPS Changes
Table 100 in section XXVI.C of this proposed rule 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 proposed policies in this proposed
rule would result in a 2.9 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) would increase by approximately
$1.9 billion compared to CY 2023 payments, excluding our estimated
changes in enrollment, utilization, and case-mix. We estimated the
isolated impact of our
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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 5.8 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 proposed rule wage indexes would result in no
change for urban hospitals under the OPPS and a 1.4 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 proposed rule.
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
proposed 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 proposed 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 propose an OPD fee schedule increase
factor of 2.8 percent and applying that proposed 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 would experience an increase in payments of
approximately 2.8 percent and that rural hospitals would experience an
increase in payments of 4.4 percent. Classifying hospitals by teaching
status, we estimate non-teaching hospitals would experience an increase
in payments of 3.5 percent, minor teaching hospitals would experience
an increase in payments of 3.0 percent, and major teaching hospitals
would 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 would experience an increase of 3.0
percent in payments, while hospitals with government ownership would
experience an increase of 2.8 percent in payments. We estimate that
hospitals with proprietary ownership would experience an increase of
3.4 percent in payments.
e. Impacts of the Proposed 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 6 percent and an increase of 7 percent, depending
on the service, with some exceptions. We estimate the impact of
applying the proposed inpatient hospital market basket update to ASC
payment rates would increase payments by $170 million under the ASC
payment system in CY 2024.
f. Impacts of Hospital Price Transparency
We propose 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 proposed
rule, 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-
[[Page 49559]]
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 proposed rule. Section
1833(t)(1)(B) of the Act provides for payment under the OPPS for
hospital outpatient services designated by the Secretary (which
includes partial hospitalization services furnished by CMHCs), and
certain inpatient hospital services that are paid under Medicare Part
B.
The OPPS rate is an unadjusted national payment amount that
includes the Medicare payment and the beneficiary copayment. This rate
is divided into a labor-related amount and a nonlabor-related amount.
The labor-related amount is adjusted for area wage differences using
the hospital inpatient wage index value for the locality in which the
hospital or CMHC is located.
All services and items within an APC group are comparable
clinically and with respect to resource use, as required by section
1833(t)(2)(B) of the Act. In accordance with section 1833(t)(2)(B) of
the Act, subject to certain exceptions, items and services within an
APC group cannot be considered comparable with respect to the use of
resources if the highest median cost (or mean cost, if elected by the
Secretary) for an item or service in the APC group is more than 2 times
greater than the lowest median cost (or mean cost, if elected by the
Secretary) for an item or service within the same APC group (referred
to as the ``2 times rule''). In implementing this provision, we
generally use the cost of the item or service assigned to an APC group.
For new technology items and services, special payments under the
OPPS may be made in one of two ways. Section 1833(t)(6) of the Act
provides for temporary additional payments, which we refer to as
``transitional pass-through payments,'' for at least 2 but not more
than 3 years for certain drugs, biological agents, brachytherapy
devices used for the treatment of cancer, and categories of other
medical devices. For new technology services that are not eligible for
transitional pass-through payments, and for which we lack sufficient
clinical information and cost data to appropriately assign them to a
clinical APC group, we have established special APC groups based on
costs, which we refer to as New Technology APCs. These New Technology
APCs are designated by cost bands which allow us to provide appropriate
and consistent payment for designated new procedures that are not yet
reflected in our claims data. Similar to pass-through payments, an
assignment to a New Technology APC is temporary; that is, we retain a
service within a New Technology APC until we acquire sufficient data to
assign it to a clinically appropriate APC group.
C. Excluded OPPS Services and Hospitals
Section 1833(t)(1)(B)(i) of the Act authorizes the Secretary to
designate the hospital outpatient services that are paid under the
OPPS. While most hospital outpatient services are payable under the
OPPS, section 1833(t)(1)(B)(iv) of the Act excludes payment for
ambulance, physical and occupational therapy, and speech-language
pathology services, for which payment is made under a fee schedule. It
also excludes screening mammography, diagnostic mammography, and
effective January 1, 2011, an annual wellness visit providing
personalized prevention plan services. The Secretary exercises the
authority granted under the statute to also exclude from the OPPS
certain services that are 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/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices</a>.html.
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
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advise the Secretary concerning) the clinical integrity of the payment
groups and their weights under the OPPS. In CY 2000, based on section
1833(t)(9)(A) of the Act, the Secretary established the Advisory Panel
on Ambulatory Payment Classification Groups (APC Panel) to fulfill this
requirement. In CY 2011, based on section 222 of the Public Health
Service Act (the PHS Act), which gives discretionary authority to the
Secretary to convene advisory councils and committees, the Secretary
expanded the panel's scope to include the supervision of hospital
outpatient therapeutic services in addition to the APC groups and
weights. To reflect this new role of the panel, the Secretary changed
the panel's name to the Advisory Panel on Hospital Outpatient Payment
(the HOP Panel). The HOP Panel is not restricted to using data compiled
by CMS, and in conducting its review, it may use data collected or
developed by organizations outside the Department.
2. Establishment of the Panel
On November 21, 2000, the Secretary signed the initial charter
establishing the Panel, and, at that time, named the APC Panel. This
expert panel is composed of appropriate representatives of providers
(currently employed full-time, not as consultants, in their respective
areas of expertise) who review clinical data and advise CMS about the
clinical integrity of the APC groups and their payment weights. Since
CY 2012, the Panel also is charged with advising the Secretary on the
appropriate level of supervision for individual hospital outpatient
therapeutic services. The Panel is technical in nature, and it is
governed by the provisions of the Federal Advisory Committee Act
(FACA). The current charter specifies, among other requirements, that
the Panel--
<bullet> May advise on the clinical integrity of Ambulatory Payment
Classification (APC) groups and their associated weights;
<bullet> May advise on the appropriate supervision level for
hospital outpatient services;
<bullet> May advise on OPPS APC rates for ASC covered surgical
procedures;
<bullet> Continues to be technical in nature;
<bullet> Is governed by the provisions of the FACA;
<bullet> Has a Designated Federal Official (DFO); and
<bullet> Is chaired by a Federal Official designated by the
Secretary.
The Panel's charter was amended on November 15, 2011, renaming the
Panel and expanding the Panel's authority to include supervision of
hospital outpatient therapeutic services and to add critical access
hospital (CAH) representation to its membership. The Panel's charter
was also amended on November 6, 2014 (80 FR 23009), and the number of
members was revised from up to 19 to up to 15 members. The Panel's
current charter was approved on November 21, 2022, for a 2-year period.
The current Panel membership and other information pertaining to
the Panel, including its charter, Federal Register notices, membership,
meeting dates, agenda topics, and meeting reports, can be viewed on the
CMS website at: <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html">https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html</a>.
3. Panel Meetings and Organizational Structure
The Panel has held many meetings, with the last meeting taking
place on August 22, 2022. 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 22, 2022, 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 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 4, 2022 (87 FR 71748). In-scope comments
related to the interim APC assignments and/or status indicators of new
or replacement Level II HCPCS codes (identified with comment indicator
``NI'' in OPPS Addendum B, ASC Addendum AA, and ASC Addendum BB to that
final rule).
II. Proposed 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 propose 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 propose 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
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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 this proposed rule on the CMS website at:
<a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html</a>.
Addendum N to this proposed rule (which is available via the
internet on the CMS website at: <a href="http://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html">http://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html</a>) includes 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
propose to retain 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
proposed rule. HCPCS codes that we propose to add for CY 2024 are
identified by asterisks (*) in the fourth column of Addendum N.
b. Proposed Calculation and Use of Cost-to-Charge Ratios (CCRs)
For CY 2024, we propose 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/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index</a>.html.
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. For this 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, for
this 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 this 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 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 propose 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 solicit 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 propose 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 propose not
to include the nonstandard cost centers
[[Page 49562]]
reported in this way in the OPPS ratesetting database construction.
2. Proposed Data Development and Calculation of Costs Used for
Ratesetting
In this section of this proposed rule, 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 proposed rule is posted (<a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index</a>.html) provides an accounting of claims used
in the development of the proposed payment rates. That accounting
provides additional detail regarding the number of claims derived at
each stage of the process. In addition, later in this section we
discuss the file of claims that comprises the data set that is
available upon payment of an administrative fee under a CMS data use
agreement. The CMS website, <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index</a>.html, 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 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 proposed payment rates for this proposed
rule.
Previously, the OPPS established the scaled relative weights on
which payments are based using APC median costs, a process described in
the CY 2012 OPPS/ASC final rule with comment period (76 FR 74188).
However, as discussed in more detail in section II.A.2.f of the CY 2013
OPPS/ASC final rule with comment period (77 FR 68259 through 68271), we
finalized the use of geometric mean costs to calculate the relative
weights on which the CY 2013 OPPS payment rates were based. While this
policy changed the cost metric on which the relative payments are
based, the data process in general remained the same under the
methodologies that we used to obtain appropriate claims data and
accurate cost information in determining estimated service cost.
We used the methodology described in sections II.A.2.a through
II.A.2.c of this proposed rule to calculate the costs we used to
establish the proposed relative payment weights used in calculating the
OPPS payment rates for CY 2024 shown in Addenda A and B to this
proposed rule (which are available via the internet on the CMS website
at: <a href="https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html">https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html</a>). We refer readers to section II.A.4 of this proposed rule
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
propose to continue to remove claim lines with modifier ``PN'' from the
ratesetting process.
For details of the claims accounting process used in this CY 2024
OPPS/ASC proposed rule, we refer readers to the claims accounting
narrative under supporting documentation for this proposed rule on the
CMS website at: <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index</a>.html.
a. Proposed 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.
We propose to continue to establish payment rates for blood and
blood products using our blood-specific CCR methodology, 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
propose to calculate the costs upon which the proposed payment rates
for blood and blood products are based using the actual blood-specific
CCR for hospitals that reported costs and charges for a blood cost
center and a hospital-specific, simulated, blood-specific CCR for
hospitals that did not report costs and charges for a blood cost
center.
Because this proposed 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 proposed rule (which is
available via the internet on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices</a>) for the proposed 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 through 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
[[Page 49563]]
<bullet> the CY 2015 OPPS/ASC final rule with comment period (79 FR
66795 through 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. We propose to continue
to establish payment rates for blood and blood products using our
blood-specific CCR methodology.
(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 through 68241). As we have
stated in prior OPPS updates, we believe that adopting the general OPPS
prospective payment methodology for brachytherapy sources is
appropriate for a number of reasons (77 FR 68240). The general OPPS
methodology uses costs based on claims data to set the relative payment
weights for hospital outpatient services. This payment methodology
results in more consistent, predictable, and equitable payment amounts
per source across hospitals by averaging the extremely high and low
values, in contrast to payment based on hospitals' charges adjusted to
costs. We believe that the OPPS methodology, as opposed to payment
based on hospitals' charges adjusted to cost, also would provide
hospitals with incentives for efficiency in the provision of
brachytherapy services to Medicare beneficiaries. Moreover, this
approach is consistent with our payment methodology for the vast
majority of items and services paid under the OPPS. We refer readers to
the CY 2016 OPPS/ASC final rule with comment period (80 FR 70323
through 70325) for further discussion of the history of OPPS payment
for brachytherapy sources.
For CY 2024, except where otherwise indicated, we propose 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 propose 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 this proposed rule, we propose to base the payment
rates for brachytherapy sources on the geometric mean unit costs for
each source, consistent with the methodology that we propose for other
items and services paid under the OPPS, as discussed in section II.A.2
of this proposed rule. We also propose 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 propose 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 propose 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 this 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 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 through 85880, 86 FR 63469, and 87 FR 71760 through
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.
After reviewing CY 2022 claims data available for this proposed
rule, 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 yielded $168.67. We are 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 propose
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.
[[Page 49564]]
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 propose to designate five brachytherapy APCs as Low
Volume APCs as these APCs meet our criteria to be designated as a Low
Volume APC. For more information on the brachytherapy APCs we propose
to designate as Low Volume APCs, see section III.D of this proposed
rule.
We invite interested parties to submit recommendations for new
codes to describe new brachytherapy sources. Such recommendations
should be directed via email to <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="d8b7adaca8b9acb1bdb6aca8a8ab98bbb5abf6b0b0abf6bfb7ae">[email protected]</a> or by mail to
the Division of Outpatient Care, Mail Stop C4-01-26, Centers for
Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD
21244. We will continue to add new brachytherapy source codes and
descriptors to our systems for payment on a quarterly basis.
b. Comprehensive APCs (C-APCs) for CY 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 through 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 70 (80 FR 70332; 81 FR 79584 through 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 through 66801). A list of services excluded
from the C-APC policy is included in Addendum J to this proposed rule
(which is available via the internet on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-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.
---------------------------------------------------------------------------
<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
[[Page 49565]]
(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 through 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 of the items and services included in the C-APC
service payment bundle.) Charges for services that would otherwise be
separately payable are added to the charges for the primary service.
This process differs from our traditional cost accounting methodology
only in that all such services on the claim are packaged (except
certain services as described above). We apply our standard data trims,
which exclude claims with extremely high primary units or extreme
costs.
The comprehensive geometric mean costs are used to establish
resource similarity and, along with clinical similarity, dictate the
assignment of the primary services to the C-APCs. We establish a
ranking of each primary service (single unit only) to be assigned to
status indicator ``J1'' according to its comprehensive geometric mean
costs. For the minority of claims reporting more than one primary
service assigned to status indicator ``J1'' or units thereof, we
identify one ``J1'' service as the primary service for the claim based
on our cost-based ranking of primary services. We then assign these
multiple ``J1'' procedure claims to the C-APC to which the service
designated as the primary service is assigned. If the reported ``J1''
services on a claim map to different C-APCs, we designate the ``J1''
service assigned to the C-APC with the highest comprehensive geometric
mean cost as the primary service for that claim. If the reported
multiple ``J1'' services on a claim map to the same C-APC, we designate
the most costly service (at the HCPCS code level) as the primary
service for that claim. This process results in initial assignments of
claims for the primary services assigned
[[Page 49566]]
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 proposed rule, 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 of the
other proposed complexity adjustments, in Addendum J to this proposed
rule (which is available via the internet on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices</a>).
Addendum J to this proposed rule 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 proposed rule also contains summary cost statistics for each of
the paired code combinations that describe a complex code combination
that would qualify for a complexity adjustment and be reassigned to the
next higher cost C-APC within the clinical family. The combined
statistics for all proposed reassigned complex code combinations are
represented by an alphanumeric code with the first four digits of the
designated primary service followed by a letter. For example, the
proposed geometric mean cost listed in Addendum J for the code
combination described by complexity adjustment assignment 3320R, which
is assigned to C-APC 5224 (Level 4 Pacemaker and Similar Procedures),
includes all paired code combinations that will be reassigned to C-APC
5224 when CPT code 33208 is the primary code. Providing the information
contained in Addendum J to this proposed rule 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.
(2) Exclusion of Procedures Assigned to New Technology APCs From the C-
APC Policy
Services that are assigned to New Technology APCs are typically new
procedures that do not have sufficient claims history to establish an
accurate payment for them. Beginning in CY 2002, we retain services
within New Technology APC groups until we gather sufficient claims data
to enable us to assign the service to an appropriate clinical APC. This
policy allows us to move a service from a New Technology APC in less
than 2 years if sufficient data are available. It also allows us to
retain a service in a New Technology APC for more than 2 years if
sufficient data upon which to base a decision for reassignment have not
been collected (82 FR 59277).
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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 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 has 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 has been 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 have 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. Please see Addendum J for the CY 2024
comprehensive APC payment policy exclusions.
In the CY 2023 OPPS/ASC final rule with comment period, we
finalized the proposal in section XI ``CY 2023 OPPS Payment Status and
Comment Indicators'' to add a new definition to status indicator ``A''
to include unclassified drugs and biologicals that are reportable with
HCPCS code C9399 (87 FR 72051). The definition, found in Addendum D1,
would ensure the MAC prices claims for drugs, biologicals or
radiopharmaceuticals billed with HCPCS code C9399 at 95 percent of the
drug or biological's AWP and pays separately for the drug, biological,
or radiopharmaceutical under the OPPS when it appears on the same claim
as a primary C-APC service.
(4) Additional C-APCs for CY 2024
For CY 2024 and subsequent years, we propose 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 are not proposing to convert any
standard APCs to C-APCs in CY 2024, but we are creating two new APCs
that will both be C-APCs. Thus, we propose that the number of C-APCs
for CY 2024 would be 72 C-APCs.
For this proposed rule, we propose to split the Level 2 Intraocular
APC (APC 5492) into two and assign the higher cost procedures
previously within this
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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) will
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 this proposed rule for more information regarding this proposal.
We also propose 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).
Table 1 lists the proposed C-APCs for CY 2024. All C-APCs are
displayed in Addendum J to this proposed rule (which is available via
the internet on the CMS website). Addendum J to this proposed rule 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
through 59242 and 59246 through 52950) for more recent background.
(1) Mental Health Services Composite APC
We propose 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. 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 through 33581 and 59246 through 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 of 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 propose 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 day by a hospital,
those specified mental health services would be paid
[[Page 49572]]
through composite APC 8010 for CY 2024. In addition, we propose to set
the payment rate for composite APC 8010 at the same payment rate that
we propose 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. 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 proposed rule, we
believe it is 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 one 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 are also soliciting 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.
(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 2 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.
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 propose 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 propose 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)
are based on proposed geometric mean costs calculated from CY 2022
claims available for this 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 have used the same
methodology that we use 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), are identified by asterisks in Addendum N to this
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 this proposed
rule.
For CY 2024, we were able to identify approximately 0.95 million
``single session'' claims out of an estimated 2.0 million potential
claims for payment through composite APCs from our ratesetting claims
data, which represents approximately 47.5 percent of all eligible
claims, to calculate the proposed CY 2024 geometric mean costs for the
multiple imaging composite APCs. Table 2 of this proposed rule lists
the proposed HCPCS codes that would be subject to the multiple imaging
composite APC policy and their respective families and approximate
composite APC proposed geometric mean costs for CY 2024.
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3. Proposed 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 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. Proposal 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 do not propose any changes to the overall packaging
policy previously discussed. We propose 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 do not propose any changes to the overall packaging policy
above, we solicit comments on potential modifications to our packaging
policy as described in the following sections.
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 Social Security Act,
respectively, to provide for temporary additional payments for non-
opioid treatments for pain relief (as that term is defined in section
1833(t)(16)(G)(i) of the Act). In particular, section 1833(t)(16)(G) 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 will include our proposals to implement
the CAA, 2023 section 4135 amendments in the CY 2025 OPPS/ASC proposed
rule. We discuss section 4135 of CAA, 2023 at length in section XIII.F
of this proposed rule, where we solicit comment on numerous aspects of
this future policy. While we expect this policy to operate similarly in
the ASC and HOPD settings, we welcome 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.
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 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
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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 through
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 through 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 through 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 through 71963) for the most recent
discussion of this subject.
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 are seeking public comments on
potential modifications to our packaging policy for diagnostic
radiopharmaceuticals in order to ensure equitable payment and continued
beneficiary access.
Depending on the comments we receive in response to this comment
solicitation, we may adopt as final alternative payment mechanisms for
radiopharmaceuticals for CY 2024 in the CY 2024 OPPS/ASC final rule
with comment period.
(ii) Comment Solicitation on Potential Issues Caused by Current Payment
of Diagnostic Radiopharmaceuticals Under the OPPS
We are soliciting 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 seek
information on specific cost-prohibitive diagnostic
radiopharmaceuticals that commenters believe are superior to
alternative diagnostic modalities. We are 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 are seeking information or evidence that these
high-cost diagnostic radiopharmaceuticals have unique clinical value,
and access has been negatively impacted by our packaging policy. We are
also seeking 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.
We are 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 are soliciting comment on the following potential
approaches that would enhance beneficiary access, while also
maintaining the principles of the outpatient prospective payment
system. These approaches include: (1) paying separately for diagnostic
radiopharmaceuticals with per-day costs
[[Page 49579]]
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 solicit
comments, we are specifically seeking 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 this 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
seek additional information from interested parties on this approach.
Regarding the second listed option, we seek 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 are 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 seek
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 are 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 are
requesting comment as to whether CMS should consider creating payment
policies for diagnostic radiopharmaceuticals used in clinical trials.
Specifically, we are 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 are seeking 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 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 seek 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 welcome
comment regarding ideas discussed in this section, discussed in prior
rulemaking, or new ideas for payment for diagnostic
radiopharmaceuticals in OPPS.
Finally, we are 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 that of
a prospective payment system rather than a fee schedule. 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.
We note that depending on the comments received, we may adopt as
final one or more alternative payment mechanisms for
radiopharmaceuticals for CY 2024.
4. Calculation of OPPS Scaled Payment Weights
We established a policy in the CY 2013 OPPS/ASC final rule with
comment period (77 FR 68283) of using geometric mean-based APC costs to
[[Page 49580]]
calculate relative payment weights under the OPPS. In the CY 2023 OPPS/
ASC final rule with comment period (87 FR 71778 through 71780), we
applied this policy and calculated the relative payment weights for
each APC for CY 2023 that were shown in Addenda A and B of the CY 2023
OPPS/ASC final rule with comment period (which were made available via
the internet on the CMS website) using the APC costs discussed in
sections II.A.1 and II.A.2 of the CY 2023 OPPS/ASC final rule with
comment period (87 FR 71757 through 71777). For CY 2024, as we did for
CY 2023, we propose to continue to apply the policy established in CY
2013 and calculate relative payment weights for each APC for CY 2024
using geometric mean-based APC costs.
For CY 2012 and CY 2013, outpatient clinic visits were assigned to
one of five levels of clinic visit APCs, with APC 0606 representing a
mid-level clinic visit. In the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75036 through 75043), we finalized a policy that created
alphanumeric HCPCS code G0463 (Hospital outpatient clinic visit for
assessment and management of a patient), representing any and all
clinic visits under the OPPS. HCPCS code G0463 was assigned to APC 0634
(Hospital Clinic Visits). We also finalized a policy to use CY 2012
claims data to develop the CY 2014 OPPS payment rates for HCPCS code
G0463 based on the total geometric mean cost of the levels one through
five CPT Evaluation or Assessment and Management (E/M) codes for clinic
visits previously recognized under the OPPS (CPT codes 99201 through
99205 and 99211 through 99215). In addition, we finalized a policy to
no longer recognize a distinction between new and established patient
clinic visits.
For CY 2016, we deleted APC 0634 and reassigned the outpatient
clinic visit HCPCS code G0463 to APC 5012 (Level 2 Examinations and
Related Services) (80 FR 70372). For CY 2024, as we did for CY 2023, we
propose to continue to standardize all of the relative payment weights
to APC 5012. We believe that standardizing relative payment weights to
the geometric mean of the APC to which HCPCS code G0463 is assigned
maintains consistency in calculating unscaled weights that represent
the cost of some of the most frequently provided OPPS services. For CY
2024, as we did for CY 2023, we propose to assign APC 5012 a relative
payment weight of 1.00 and to divide the geometric mean cost of each
APC by the geometric mean cost for APC 5012 to derive the unscaled
relative payment weight for each APC. The choice of the APC on which to
standardize the relative payment weights does not affect payments made
under the OPPS because we scale the weights for budget neutrality.
Section 1833(t)(9)(B) of the Act requires that APC reclassification
and recalibration changes, wage index changes, and other adjustments be
made in a budget neutral manner. Budget neutrality ensures that the
estimated aggregate weight under the OPPS for CY 2024 is neither
greater than nor less than the estimated aggregate weight that would
have been calculated without the changes. To comply with this
requirement concerning the APC changes, we propose to compare the
estimated aggregate weight using the CY 2023 scaled relative payment
weights to the estimated aggregate weight using the proposed CY 2024
unscaled relative payment weights.
For CY 2023, we multiplied the CY 2023 scaled APC relative payment
weight applicable to a service paid under the OPPS by the volume of
that service from CY 2022 claims to calculate the total relative
payment weight for each service. We then added together the total
relative payment weight for each of these services in order to
calculate an estimated aggregate weight for the year. For CY 2024, we
propose to apply the same process using the estimated CY 2024 unscaled
relative payment weights rather than scaled relative payment weights.
We propose to calculate the weight scalar by dividing the CY 2023
estimated aggregate weight by the unscaled CY 2024 estimated aggregate
weight.
For a detailed discussion of the weight scalar calculation, we
refer readers to the OPPS claims accounting document available on the
CMS website at: <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index</a>.html. Click on the link labeled
``CY 2024 OPPS/ASC Notice of Proposed Rulemaking'', which can be found
under the heading ``Hospital Outpatient Prospective Payment System
Rulemaking'' and open the claims accounting document link at the bottom
of the page, which is labeled ``2024 NPRM OPPS Claims Accounting
(PDF)''.
We propose to compare the estimated unscaled relative payment
weights in CY 2024 to the estimated total relative payment weights in
CY 2023 using CY 2022 claims data, holding all other components of the
payment system constant to isolate changes in total weight. Based on
this comparison, we propose to adjust the calculated CY 2024 unscaled
relative payment weights for purposes of budget neutrality. We propose
to adjust the estimated CY 2024 unscaled relative payment weights by
multiplying them by a proposed weight scalar of 1.4529 to ensure that
the proposed CY 2024 relative payment weights are scaled to be budget
neutral. The proposed CY 2024 relative payment weights listed in
Addenda A and B to this proposed rule (which are available via the
internet on the CMS website) are scaled and incorporate the
recalibration adjustments discussed in sections II.A.1 and II.A.2 of
this proposed rule.
Section 1833(t)(14) of the Act provides the payment rates for
certain specified covered outpatient drugs (SCODs). Section
1833(t)(14)(H) of the Act provides that additional expenditures
resulting from this paragraph shall not be taken into account in
establishing the conversion factor, weighting, and other adjustment
factors for 2004 and 2005 under paragraph (9) but shall be taken into
account for subsequent years. Therefore, the cost of those SCODs (as
discussed in section V.B.2 of this proposed rule) is included in the
budget neutrality calculations for the CY 2024 OPPS.
B. Proposed Conversion Factor Update
Section 1833(t)(3)(C)(ii) of the Act requires the Secretary to
update the conversion factor used to determine the payment rates under
the OPPS on an annual basis by applying the OPD rate increase factor.
For purposes of section 1833(t)(3)(C)(iv) of the Act, subject to
sections 1833(t)(17) and 1833(t)(3)(F) of the Act, the OPD rate
increase factor is equal to the hospital inpatient market basket
percentage increase applicable to hospital discharges under section
1886(b)(3)(B)(iii) of the Act. In the FY 2024 IPPS/Long Term Care
Hospital (LTCH) PPS proposed rule (88 FR 27004 through 27005),
consistent with current law, based on IHS Global, Inc.'s fourth quarter
2022 forecast, the proposed FY 2024 IPPS market basket percentage
increase was 3.0 percent. We note that under our regular process for
the CY 2024 OPPS/ASC final rule, we would use the market basket update
for the FY 2024 IPPS/LTCH PPS final rule, which would be based on IHS
Global, Inc.'s second quarter 2023 forecast of the FY 2024 IPPS market
basket percentage increase. If that forecast is different than the IPPS
market basket percentage increase used for this proposed rule, the CY
2024 OPPS/ASC final rule OPD rate increase factor would reflect that
updated forecast of the market basket percentage increase.
Section 1833(t)(3)(F)(i) of the Act requires that, for 2012 and
subsequent years, the OPD fee schedule increase factor under
subparagraph (C)(iv) be
[[Page 49581]]
reduced by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act. Section 1886(b)(3)(B)(xi)(II) of the
Act defines the productivity adjustment as equal to the 10-year moving
average of changes in annual economy-wide, private nonfarm business
multifactor productivity (MFP) (as projected by the Secretary for the
10-year period ending with the applicable fiscal year, year, cost
reporting period, or other annual period) (the ``productivity
adjustment''). In the FY 2012 IPPS/LTCH PPS final rule (76 FR 51689
through 51692), we finalized our methodology for calculating and
applying the productivity adjustment, and then revised this
methodology, as discussed in the FY 2016 IPPS/LTCH PPS final rule (80
FR 49509). The U.S. Department of Labor's Bureau of Labor Statistics
(BLS) publishes the official measures of private nonfarm business
productivity for the U.S. economy. We note that previously the
productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the
Act was published by BLS as private nonfarm business multifactor
productivity. Beginning with the November 18, 2021 release of
productivity data, BLS replaced the term multifactor productivity (MFP)
with total factor productivity (TFP). BLS noted that this is a change
in terminology only and will not affect the data or methodology. As a
result of the BLS name change, the productivity measure referenced in
section 1886(b)(3)(B)(xi)(II) of the Act is now published by BLS as
private nonfarm business total factor productivity. However, as
mentioned, the data and methods are unchanged. Please see <a href="http://www.bls.gov">www.bls.gov</a>
for the BLS historical published TFP data. A complete description of
IGI's TFP projection methodology is available on the CMS website at
<a href="https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/">https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/</a> MarketBasketResearch. In
addition, we note that beginning with the FY 2022 IPPS/LTCH PPS final
rule, we refer to this adjustment as the productivity adjustment rather
than the MFP adjustment to more closely track the statutory language in
section 1886(b)(3)(B)(xi)(II) of the Act. We note that the adjustment
continues to rely on the same underlying data and methodology. In the
FY 2024 IPPS/LTCH PPS proposed rule (88 FR 27005), the proposed
productivity adjustment for FY 2024 was 0.2 percentage point.
Therefore, we propose that the productivity adjustment for the CY
2024 OPPS would be 0.2 percentage point. We also propose that if more
recent data subsequently become available after the publication of this
proposed rule (for example, a more recent estimate of the market basket
percentage increase and/or the productivity adjustment), we would use
such updated data, if appropriate, to determine the CY 2024 market
basket update and the productivity adjustment, which are components in
calculating the OPD fee schedule increase factor under sections
1833(t)(3)(C)(iv) and 1833(t)(3)(F) of the Act.
We note that section 1833(t)(3)(F) of the Act provides that
application of this subparagraph may result in the OPD fee schedule
increase factor under section 1833(t)(3)(C)(iv) of the Act being less
than 0.0 percent for a year, and may result in OPPS payment rates being
less than rates for the preceding year. As described in further detail
below, we propose for CY 2024 an OPD fee schedule increase factor of
2.8 percent for the CY 2024 OPPS (which is the proposed estimate of the
hospital inpatient market basket percentage increase of 3.0 percent,
less the proposed 0.2 percentage point productivity adjustment).
We propose that hospitals that fail to meet the Hospital OQR
Program reporting requirements would be subject to an additional
reduction of 2.0 percentage points from the OPD fee schedule increase
factor adjustment to the conversion factor that would be used to
calculate the OPPS payment rates for their services, as required by
section 1833(t)(17) of the Act. For further discussion of the Hospital
OQR Program, we refer readers to section XIV of this proposed rule.
To set the OPPS conversion factor for 2024, we propose to increase
the CY 2023 conversion factor of $85.585 by 2.8 percent reflecting the
proposed IPPS hospital market basket update. In accordance with section
1833(t)(9)(B) of the Act, we propose further to adjust the conversion
factor for CY 2024 to ensure that any revisions made to the wage index
and rural adjustment are made on a budget neutral basis. We propose to
calculate an overall budget neutrality factor of 0.9974 for wage index
changes by comparing proposed total estimated payments from our
simulation model using the proposed FY 2024 IPPS wage indexes to those
payments using the FY 2023 IPPS wage indexes, as adopted on a calendar
year basis for the OPPS. We further propose to calculate an additional
budget neutrality factor of 0.9975 to account for our proposed policy
to cap wage index reductions for hospitals at 5 percent on an annual
basis.
For the CY 2024 OPPS, we propose to maintain the current rural
adjustment policy, as discussed in section II.E of this proposed rule.
Therefore, the proposed budget neutrality factor for the rural
adjustment is 1.0000.
We propose to calculate a CY 2024 budget neutrality adjustment
factor for the cancer hospital payment adjustment by transitioning from
the target PCR of 0.89 we finalized for CYs 2020 through 2023 (which
included the 1.0 percentage point reduction as required by section
16002(b) of the 21st Century Cures Act) and incrementally reducing the
target PCR by an additional 1.0 percentage point for each calendar
year, beginning with CY 2024, until the target PCR equals the PCR of
non-cancer hospitals calculated using the most recent data minus 1.0
percentage point as required by section 16002(b) of the 21st Century
Cures Act. Therefore, we propose to apply a budget neutrality
adjustment factor of 1.0005 to the conversion factor for the cancer
hospital payment adjustment. In accordance with section 1833(t)(18)(C)
of the Act, as added by section 16002(b) of the 21st Century Cures Act
(Pub. L. 114-255), requires that we reduce the target PCR by 0.01,
which brings the proposed target PCR to 0.88. This is 0.01 less than
the target PCR of 0.89 from CY 2021 through CY 2023, which was held at
the pre-PHE target.
For this proposed rule, we estimated that proposed pass-through
spending for drugs, biologicals, and devices for CY 2024 would equal
approximately $234.1 million, which represents 0.26 percent of total
projected CY 2024 OPPS spending. Therefore, the proposed conversion
factor would be adjusted by the difference between the 0.16 percent
estimate of pass-through spending for CY 2023 and the 0.26 percent
estimate of proposed pass-through spending for CY 2024, resulting in a
proposed decrease to the conversion factor for CY 2024 of 0.1 percent.
Proposed estimated payments for outliers would remain at 1.0
percent of total OPPS payments for CY 2024. We estimated for this
proposed rule that outlier payments would be approximately 0.78 percent
of total OPPS payments in CY 2023; the 1.00 percent for proposed
outlier payments in CY 2024 would constitute a 0.22 percent increase in
payment in CY 2024 relative to CY 2023.
For CY 2024, we also propose that hospitals that fail to meet the
reporting requirements of the Hospital OQR Program would continue to be
subject to a further reduction of 2.0 percentage points to the OPD fee
schedule increase factor. For hospitals that fail to meet the
[[Page 49582]]
requirements of the Hospital OQR Program, we propose to make all other
adjustments discussed above, but use a reduced OPD fee schedule update
factor of 0.8 percent (that is, the proposed OPD fee schedule increase
factor of 2.8 percent further reduced by 2.0 percentage points). This
would result in a proposed reduced conversion factor for CY 2024 of
$85.782 for hospitals that fail to meet the Hospital OQR Program
requirements (a difference of -1.706 in the conversion factor relative
to hospitals that met the requirements).
In summary, for 2024, we propose to use a reduced conversion factor
of $85.782 in the calculation of payments for hospitals that fail to
meet the Hospital OQR Program requirements (a difference of -1.706 in
the conversion factor relative to hospitals that met the requirements).
For 2024, we propose to use a conversion factor of $87.488 in the
calculation of the national unadjusted payment rates for those items
and services for which payment rates are calculated using geometric
mean costs; that is, the proposed OPD fee schedule increase factor of
2.8 percent for CY 2024, the required proposed wage index budget
neutrality adjustment of approximately 0.9974, the proposed 5 percent
annual cap for individual hospital wage index reductions adjustment of
approximately 0.9975, the proposed cancer hospital payment adjustment
of 1.0005, and the proposed adjustment of an decrease of 0.1 percentage
point of projected OPPS spending for the difference in pass-through
spending, which results in a proposed conversion factor for CY 2024 of
$87.488. The calculations we performed to determine the CY 2024
proposed conversion factor are shown in Table 3.
BILLING CODE 4120-01-P
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[GRAPHIC] [TIFF OMITTED] TP31JY23.007
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[GRAPHIC] [TIFF OMITTED] TP31JY23.008
BILLING CODE 4120-01-C
C. Proposed Wage Index Changes
Section 1833(t)(2)(D) of the Act requires the Secretary to
determine a wage adjustment factor to adjust the portion of payment and
coinsurance attributable to labor-related costs for relative
differences in labor and labor-related costs across geographic regions
in a budget neutral manner (codified at 42 CFR 419.43(a)). This portion
of the OPPS payment rate is called the OPPS labor-related share. Budget
neutrality is discussed in section II.B of this proposed rule.
The OPPS labor-related share is 60 percent of the national OPPS
payment. This labor-related share is based on a regression analysis
that determined that, for all hospitals, approximately 60 percent of
the costs of services paid under the OPPS were attributable to wage
costs. We confirmed that this labor-related share for outpatient
services is appropriate during our regression analysis for the payment
adjustment for rural hospitals in the CY 2006 OPPS final rule with
comment period (70 FR 68553). We propose to continue this policy for
the CY 2024 OPPS. We refer readers to section II.H of this proposed
rule for a description and an example of how the wage index for a
particular hospital is used to determine payment for the hospital.
As discussed in the claims accounting narrative included with the
supporting documentation for this proposed rule (which is available via
the internet on the CMS website (<a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices</a>)), for estimating APC costs, we would
standardize 60 percent of estimated claims costs for geographic area
wage variation using the same FY 2024 pre-reclassified wage index that
we use under the IPPS to standardize costs. This standardization
process removes the effects of differences in area wage levels from the
determination of a national unadjusted OPPS payment rate and copayment
amount.
Under 42 CFR 419.41(c)(1) and 419.43(c) (published in the OPPS
April 7, 2000 final rule with comment period (65 FR 18495 and 18545)),
the OPPS adopted the final fiscal year IPPS post-reclassified wage
index as the calendar year wage index for adjusting the OPPS standard
payment amounts for labor market differences. Therefore, the wage index
that applies to a particular acute care, short-stay hospital under the
IPPS also applies to that hospital under the OPPS. As initially
explained in the September 8, 1998 OPPS proposed rule (63 FR 47576), we
believe that using the IPPS wage index as the source of an adjustment
factor for the OPPS is reasonable and logical, given the inseparable,
subordinate status of the HOPD within the hospital overall. In
accordance with section 1886(d)(3)(E) of the Act, the IPPS wage index
is updated annually.
The Affordable Care Act contained several provisions affecting the
wage index. These provisions were discussed in the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74191). Section 10324 of the
Affordable Care Act added section 1886(d)(3)(E)(iii)(II) to the Act,
which defines a frontier State and amended section 1833(t) of the Act
to add paragraph (19), which requires a frontier State wage index floor
of 1.00 in certain cases, and states that the frontier State floor
shall not be applied in a budget neutral manner. We codified these
requirements at Sec. 419.43(c)(2) and (3) of our regulations. For
2024, we propose to implement this provision in the same manner as we
have since CY 2011. Under this policy, the frontier State hospitals
would receive a wage index of 1.00 if the otherwise applicable wage
index (including reclassification, the rural floor, and rural floor
budget neutrality) is less than 1.00. Because the HOPD receives a wage
index based on the geographic location of the specific inpatient
hospital with which it is associated, the frontier State wage index
adjustment applicable for the inpatient hospital also would apply for
any
[[Page 49585]]
associated HOPD. We refer readers to the FY 2011 through FY 2023 IPPS/
LTCH PPS final rules for discussions regarding this provision,
including our methodology for identifying which areas meet the
definition of ``frontier States'' as provided for in section
1886(d)(3)(E)(iii)(II) of the Act: for FY 2011, 75 FR 50160 through
50161; for FY 2012, 76 FR 51793, 51795, and 51825; for FY 2013, 77 FR
53369 through 53370; for FY 2014, 78 FR 50590 through 50591; for FY
2015, 79 FR 49971; for FY 2016, 80 FR 49498; for FY 2017, 81 FR 56922;
for FY 2018, 82 FR 38142; for FY 2019, 83 FR 41380; for FY 2020, 84 FR
42312; for FY 2021, 85 FR 58765; for FY 2022, 86 FR 45178; and for FY
2023, 87 FR 49006.
In addition to the changes required by the Affordable Care Act, we
note that the proposed FY 2024 IPPS wage indexes continue to reflect a
number of adjustments implemented in past years, including, but not
limited to, reclassification of hospitals to different geographic
areas, the rural floor provisions, the imputed floor wage index
adjustment in all-urban states, an adjustment for occupational mix, an
adjustment to the wage index based on commuting patterns of employees
(the out-migration adjustment), and the permanent 5-percent cap on any
decrease to a hospital's wage index from its wage index in a prior FY.
Beginning with FY 2024, we proposed to include hospitals with Sec.
412.103 reclassification along with geographically rural hospitals in
all rural wage index calculations, and to exclude ``dual reclass''
hospitals (hospitals with simultaneous Sec. 412.103 and Medicare
Geographic Classification Review Board (MGCRB) reclassifications)
implicated by the hold harmless provision at section 1886(d)(8)(C)(ii)
of the Act (88 FR 26973 through 26974). We also propose to continue the
low wage index hospital policy, under which we increase the wage index
for hospitals with a wage index value below the 25th percentile wage
index value for a fiscal year by half the difference between the
otherwise applicable final wage index value for a year for that
hospital and the 25th percentile wage index value for that year across
all hospitals. We refer readers to the FY 2024 IPPS/LTCH PPS proposed
rule (88 FR 26963 through 26986) for a detailed discussion of all
proposed changes to the FY 2024 IPPS wage indexes.
We note that in the FY 2023 IPPS/LTCH PPS final rule (87 FR 49018
through 49021), we finalized a permanent approach to smooth year-to-
year decreases in hospitals' wage indexes. Specifically, for FY 2023
and subsequent years, we apply a 5-percent cap on any decrease to a
hospital's wage index from its wage index in the prior FY, regardless
of the circumstances causing the decline. That is, a hospital's wage
index for FY 2024 would not be less than 95 percent of its final wage
index for FY 2023, and that for subsequent years, a hospital's wage
index would not be less than 95 percent of its final wage index for the
prior FY. We stated that we believe this policy would increase the
predictability of IPPS payments for hospitals and mitigate instability
and significant negative impacts to hospitals resulting from changes to
the wage index. It would also eliminate the need for temporary and
potentially uncertain transition adjustments to the wage index in the
future due to specific policy changes or circumstances outside
hospitals' control. Except for newly opened hospitals, we will apply
the cap for a fiscal year using the final wage index applicable to the
hospital on the last day of the prior fiscal year. A newly opened
hospital would be paid the wage index for the area in which it is
geographically located for its first full or partial fiscal year, and
it would not receive a cap for that first year because it would not
have been assigned a wage index in the prior year (in accordance with
42 CFR 419.41(c)(1) and 419.43(c), as noted above).
Core Based Statistical Areas (CBSAs) are made up of one or more
constituent counties. Each CBSA and constituent county has its own
unique identifying codes. The FY 2018 IPPS/LTCH PPS final rule (82 FR
38130) discussed the two different lists of codes to identify counties:
Social Security Administration (SSA) codes and Federal Information
Processing Standard (FIPS) codes. Historically, CMS listed and used SSA
and FIPS county codes to identify and crosswalk counties to CBSA codes
for purposes of the IPPS and OPPS wage indexes. However, the SSA county
codes are no longer being maintained and updated, although the FIPS
codes continue to be maintained by the U.S. Census Bureau. The Census
Bureau's most current statistical area information is derived from
ongoing census data received since 2010; the most recent data are from
2015. The Census Bureau maintains a complete list of changes to
counties or county equivalent entities on the website at: <a href="https://www.census.gov/geo/reference/county-changes.html">https://www.census.gov/geo/reference/county-changes.html</a> (which, as of May 6,
2019, migrated to: <a href="https://www.census.gov/programs-surveys/geography.html">https://www.census.gov/programs-surveys/geography.html</a>). In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38130),
for purposes of crosswalking counties to CBSAs for the IPPS wage index,
we finalized our proposal to discontinue the use of the SSA county
codes and begin using only the FIPS county codes. Similarly, for the
purposes of crosswalking counties to CBSAs for the OPPS wage index, in
the CY 2018 OPPS/ASC final rule with comment period (82 FR 59260), we
finalized our proposal to discontinue the use of SSA county codes and
begin using only the FIPS county codes. For CY 2024, under the OPPS, we
are continuing to use only the FIPS county codes for purposes of
crosswalking counties to CBSAs.
We propose to use the FY 2024 IPPS post-reclassified wage index for
urban and rural areas as the wage index for the OPPS to determine the
wage adjustments for both the OPPS payment rate and the copayment rate
for CY 2024. Therefore, any policies and adjustments for the FY 2024
IPPS post-reclassified wage index would be reflected in the final CY
2024 OPPS wage index beginning on January 1, 2024. We refer readers to
the FY 2024 IPPS/LTCH PPS proposed rule (88 FR 26963 through 26986) and
the proposed FY 2024 hospital wage index files posted on the CMS
website at <a href="https://www.cms.gov/medicare/acute-inpatient-pps/fy-2024-ipps-proposed-rule-home-page">https://www.cms.gov/medicare/acute-inpatient-pps/fy-2024-ipps-proposed-rule-home-page</a>. With regard to budget neutrality for the
CY 2024 OPPS wage index, we refer readers to section II.B of this
proposed rule. We continue to believe that using the IPPS post-
reclassified wage index as the source of an adjustment factor for the
OPPS is reasonable and logical, given the inseparable, subordinate
status of the HOPD within the hospital overall.
Hospitals that are paid under the OPPS, but not under the IPPS, do
not have an assigned hospital wage index under the IPPS. Therefore, for
non-IPPS hospitals paid under the OPPS, it is our longstanding policy
to assign the wage index that would be applicable if the hospital was
paid under the IPPS, based on its geographic location and any
applicable wage index policies and adjustments. We propose to continue
this policy for CY 2024. We refer readers to the FY 2024 IPPS/LTCH PPS
proposed rule (88 FR 26963 through 26986) for a detailed discussion of
the proposed changes to the FY 2024 IPPS wage indexes.
It has been our longstanding policy to allow non-IPPS hospitals
paid under the OPPS to qualify for the out-migration adjustment if they
are located in a section 505 out-migration county (section 505 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)).
[[Page 49586]]
Applying this adjustment is consistent with our policy of adopting IPPS
wage index policies for hospitals paid under the OPPS. We note that,
because non-IPPS hospitals cannot reclassify, they are eligible for the
out-migration wage index adjustment if they are located in a section
505 out-migration county. This is the same out-migration adjustment
policy that would apply if the hospital were paid under the IPPS. For
CY 2024, we propose to continue our policy of allowing non-IPPS
hospitals paid under the OPPS to qualify for the outmigration
adjustment if they are located in a section 505 out-migration county
(section 505 of the MMA). Furthermore, we propose that the wage index
that would apply for CY 2024 to non-IPPS hospitals paid under the OPPS
would continue to include the rural floor adjustment and any policies
and adjustments applied to the IPPS wage index to address wage index
disparities. In addition, the wage index that would apply to non-IPPS
hospitals paid under the OPPS would include the 5-percent cap on wage
index decreases.
For CMHCs, for CY 2024, we propose to continue to calculate the
wage index by using the post-reclassification IPPS wage index based on
the CBSA where the CMHC is located. Furthermore, we propose that the
wage index that would apply to a CMHC for CY 2024 would continue to
include the rural floor adjustment and any policies and adjustments
applied to the IPPS wage index to address wage index disparities. In
addition, the wage index that would apply to CMHCs would include the 5-
percent cap on wage index decreases. Also, we propose that the wage
index that would apply to CMHCs would not include the outmigration
adjustment because that adjustment only applies to hospitals.
Table 4A associated with the FY 2024 IPPS/LTCH PPS proposed rule
(available via the internet on the CMS website at: <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index</a>)
identifies counties that would be eligible for the out-migration
adjustment. Table 2 associated with the FY 2024 IPPS/LTCH PPS proposed
rule (available for download via the website above) identifies IPPS
hospitals that would receive the out-migration adjustment for FY 2024.
We are including the outmigration adjustment information from Table 2
associated with the FY 2024 IPPS/LTCH PPS proposed rule as Addendum L
to this proposed rule, with the addition of non-IPPS hospitals that
would receive the section 505 outmigration adjustment under this
proposed rule. Addendum L is available via the internet on the CMS
website. We refer readers to the CMS website for the OPPS at: <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index</a>. At this link, readers will find a link to
the proposed FY 2024 IPPS wage index tables and Addendum L.
D. Proposed Statewide Average Default Cost-to-Charge Ratios (CCRs)
In addition to using CCRs to estimate costs from charges on claims
for ratesetting, we use overall hospital-specific CCRs calculated from
the hospital's most recent cost report (OMB NO: 0938-0050 for Form CMS-
2552-10) to determine outlier payments, payments for pass-through
devices, and monthly interim transi
[…truncated; see source link]Indexed from Federal Register on July 31, 2023.
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