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Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Rules and Regulations 553bB and 553d3 of the APA
provide for exceptions from the notice and comment and delay in effective date APA requirements; in cases in which these exceptions apply, sections 1871b2C and 1871e1Bii of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553bB of the APA
and section 1871b2C of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both sections 553d3 of the APA and section 1871e1Bii of the Act allow the agency to avoid the 30day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.
We believe that this correcting document does not constitute a rule that would be subject to the notice and comment or delayed effective date requirements. This document corrects technical and typographic errors in the preamble, addenda, payment rates, tables, and appendices included or referenced in the CY 2021 OPPS/ASC
final rule with comment period, but does not make substantive changes to the policies or payment methodologies that were adopted in the final rule with comment period. As a result, this correcting document is intended to ensure that the information in the CY
2021 OPPS/ASC final rule with comment period accurately reflects the policies adopted in that document.
In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule or delaying the effective date would be contrary to the public interest because it is in the publics interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the CY 2021 OPPS/ASC final rule accurately reflects our policies as of the date they take effect and are applicable.
Furthermore, such procedures would be unnecessary, as we are not altering our payment methodologies or policies, but rather, we are simply correctly implementing the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the CY 2021 OPPS/ASC

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final rule with comment period accurately reflects these payment methodologies and policies. For these reasons, we believe we have good cause to waive the notice and comment and effective date requirements. Moreover, even if these corrections were considered to be retroactive rulemaking, they would be authorized under section 1871e1Aii of the Act, which permits the Secretary to issue a rule for the Medicare program with retroactive effect if the failure to do so would be contrary to the public interest. As we have explained previously, we believe it would be contrary to the public interest not to implement the corrections in this correcting document because it is in the publics interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the CY 2021 OPPS/ASC final rule with comment period accurately reflects our policies.
IV. Correction of Errors In FR Doc. 202026819 of December 29, 2020 85 FR 85866, make the following corrections:
1. On page 85987, third column, after the second full paragraph ending with Addendum B is available via the internet on the CMS website. and before the section titled IV. OPPS
Payment for Devices, the following section and text are added:
31. Other Procedures/Services For CY 2021, we proposed to continue to assign CPT code 0607T to APC 5012
Clinic Visits and Related Services with status indicator V Clinic or Emergency Department Visit. Paid under OPPS; separate APC payment and a proposed payment rate of $120.88.
In addition, we proposed to continue to assign CPT code 0608T to APC 5741
Level 1 Electronic Analysis of Devices with status indicator S Procedure or Service, Not Discounted When Multiple.
Paid under OPPS; separate APC
payment and a proposed payment rate of $37.76. Below are the long descriptors for CPT codes 0607T and 0608T:
0607T: Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm e.g., ECG data, transmitted to a remote 24-hour attended surveillance center; set-up and patient education on use of equipment;
and 0608T: Remote monitoring of an external continuous pulmonary fluid monitoring system, including
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measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm e.g., ECG data, transmitted to a remote 24-hour attended surveillance center; analysis of data received and transmission of reports to the physician or other qualified health care professional.
Comment: A commenter requested that we reassign CPT codes 0607T and 0608T to non-payable OPPS status indicators because the commenter contended that the service associated with the codes is not provided to hospital outpatients during a hospital outpatient encounter. The commenter specifically requested that both codes be reassigned to either status indicator B
Codes that are not recognized by OPPS.
Not paid under OPPS or M Items and Services Not Billable to the MAC.
Not paid under OPPS for both codes.
The commenter reported that the services are prescribed by individual physicians, and are not currently provided to either hospital inpatients or outpatients, or in conjunction with any hospital service. According to the commenter, there is no hospital in the U.S. that possesses the technology to provide a remote pulmonary fluid monitoring system and further stated that ambulatory fluid monitoring system is only available through a single Independent Diagnostic Testing Facility IDTF in Pittsburgh, Pennsylvania. The commenter explained that an individual physician will prescribe the ambulatory fluid monitoring device for their patient and submit the medical order to the IDTF. Thereafter, the IDTF is ultimately responsible for the transmission, analysis, and creation of reports to the prescribing physician.
Response: Based on our review of the codes and input from our medical advisors, the services described by CPT
codes 0607T and 0608T may be provided in an HOPD setting. While the commenter has indicated that the services described by the codes are currently performed by one IDTF, we believe that the services can be performed by HOPDs. Consequently, for CY 2021, we believe that we should continue to assign these codes to APCs 5012 and 5741 so that HOPDs can be paid separately if they provide these services in the HOPD setting. Therefore, we are finalizing our proposal, without modification, to assign CPT codes 0607T and 0608T to APCs 5012 and 5741, respectively. The final CY 2021
payment rate for the codes can be found in Addendum B to this final rule with comment period which is available via the internet on the CMS website.

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