[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8475-8477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 410

[CMS-1717-F3]
RIN-0938-AT74


Medicare Program: Changes to Hospital Outpatient Prospective 
Payment and Ambulatory Surgical Center Payment Systems and Quality 
Reporting Programs; Revisions of Organ Procurement Organizations 
Conditions of Coverage; Prior Authorization Process and Requirements 
for Certain Covered Outpatient Department Services; Potential Changes 
to the Laboratory Date of Service Policy; Changes to Grandfathered 
Children's Hospitals-Within-Hospitals; Notice of Closure of Two 
Teaching Hospitals and Opportunity To Apply for Available Slots; 
Correcting Amendment

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Correcting amendment.

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SUMMARY: In the November 12, 2019 issue of the Federal Register, we 
published a final rule with comment period that made changes to the 
conditions for therapeutic outpatient hospital or CAH services and 
supplies incident to a physician's or nonphysician practitioner's 
service. This correcting amendment corrects a technical error in the 
regulations resulting from an error in that final rule with comment 
period.

DATES: This correcting amendment is effective February 14, 2020 and is 
applicable beginning January 1, 2020.

FOR FURTHER INFORMATION CONTACT:  Supervision of Outpatient Therapeutic 
Services in Hospitals and CAHs, contact Josh McFeeters via email at 
[email protected] or at (410) 786-9732.

SUPPLEMENTARY INFORMATION: 

I. Background

    In FR Doc. 2019-24138 of November 12, 2019 (84 FR 61142), 
``Medicare Program: Changes to Hospital Outpatient Prospective Payment 
and Ambulatory Surgical Center Payment Systems and Quality Reporting 
Programs; Revisions of Organ Procurement Organizations Conditions of 
Coverage; Prior Authorization Process and Requirements for Certain 
Covered Outpatient Department Services; Potential Changes to the 
Laboratory Date

[[Page 8476]]

of Service Policy; Changes to Grandfathered Children's Hospitals-
Within-Hospitals; Notice of Closure of Two Teaching Hospitals and 
Opportunity to Apply for Available Slots'' (hereinafter referred to as 
the CY 2020 OPPS/ASC final rule with comment period), there was a 
technical error in the regulations text that is identified and 
corrected in this correcting amendment. The provisions of this 
correcting amendment are treated as if the technical error in the 
regulations text at Sec.  410.27 that resulted from the error in the 
document published November 12, 2019 had not occurred. Accordingly, the 
corrections are applicable beginning January 1, 2020.

II. Summary of Error in the Regulations Text

    On page 61490 of the CY 2020 OPPS/ASC final rule with comment 
period, we made a technical error in an amendatory instruction which 
resulted in the unintended removal of paragraphs (a)(1)(iv)(C), (D), 
and (E) from Sec.  410.27 of the CFR. Accordingly, we are amending 
Sec.  410.27 to accurately reflect the intent as described in the 
preamble language included in the CY 2020 OPPS/ASC final rule with 
comment period (84 FR 61359 through 61363), but which was not properly 
reflected in the regulatory text portion of the rule. In the amendatory 
instruction, we stated that ``Sec.  410.27 is amended by revising 
paragraph (a)(1)(iv).'' The amendatory instruction should have read 
``Sec.  410.27 is amended by revising paragraphs (a)(1)(iv) 
introductory text, (a)(1)(iv)(A), and (B). This error in the amendatory 
instruction resulted in Sec.  410.27(a)(1)(iv)(C) through (E) being 
erroneously removed. Therefore, this correcting amendment corrects this 
error by adding paragraphs (a)(1)(iv)(C), (D), and (E).

III. Waiver of Proposed Rulemaking and Delay in Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rule in the 
Federal Register before the provisions of a rule take effect. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide for notice of the proposed rule in the Federal Register and 
provide a period of not less than 60 days for public comment. In 
addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) 
mandate a 30-day delay in effective date after issuance or publication 
of a rule. Sections 553(b)(B) and 553(d)(3) 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 
1871(b)(2)(C) and 1871(e)(1)(B)(ii) 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 553(b)(B) of the APA and 
section 1871(b)(2)(C) 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 
section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act 
allow the agency to avoid the 30-day 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 amendment does not constitute a 
rulemaking that would be subject to these requirements. This correcting 
amendment corrects a technical error in the regulations text included 
in the CY 2020 OPPS/ASC final rule with comment period but does not 
make substantive changes to the policies that were adopted in the final 
rule with comment period. As a result, the corrections made through 
this correcting amendment are intended to ensure that the information 
in the CY 2020 OPPS/ASC final rule with comment period accurately 
reflects the policies adopted.
    In addition, even if this were a rulemaking 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 with comment period or delaying the 
effective date would be contrary to the public interest because it is 
in the public's interest to ensure that the CY 2020 OPPS/ASC final rule 
with comment period 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 policies, but rather, we are simply correctly implementing 
the policies that we previously proposed, received comment on, and 
subsequently finalized. This correcting amendment is intended solely to 
ensure that the CY 2020 OPPS/ASC final rule with comment period 
accurately reflects these policies. For these reasons, we believe we 
have good cause to waive the notice and comment and effective date 
requirements.

List of Subjects in 42 CFR Part 410

    Diseases, Health facilities, Health professions, Laboratories, 
Medicare, Reporting and recordkeeping requirements, Rural areas, X-
rays.

    Accordingly, 42 CFR chapter IV is corrected by making the following 
correcting amendment:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
1. The authority citation for part 410 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.


0
2. Section 410.27 is amended by adding paragraphs (a)(1)(iv)(C), (D), 
and (E) to read as follows:


Sec.  410.27  Therapeutic outpatient hospital or CAH services and 
supplies incident to a physician's or nonphysician practitioner's 
service: Conditions.

* * * * *
    (a) * * *
    (1) * * *
    (iv) * * *
    (C) Nonphysician practitioners may provide the required supervision 
of services that they may personally furnish in accordance with State 
law and all additional requirements, including those specified in 
Sec. Sec.  410.71, 410.73, 410.74, 410.75, 410.76, and 410.77;
    (D) For pulmonary rehabilitation, cardiac rehabilitation, and 
intensive cardiac rehabilitation services, direct supervision must be 
furnished by a doctor of medicine or a doctor of osteopathy, as 
specified in Sec. Sec.  410.47 and 410.49, respectively; and
    (E) For nonsurgical extended duration therapeutic services 
(extended duration services), which are hospital or CAH outpatient 
therapeutic services that can last a significant period of time, have a 
substantial monitoring component that is typically performed by 
auxiliary personnel, have a low risk of requiring the physician's or 
appropriate nonphysician practitioner's immediate availability after 
the initiation of the service, and are not primarily surgical in 
nature, Medicare requires a minimum of direct supervision during the 
initiation of the service which may be followed by general supervision 
at the discretion of the supervising physician or the appropriate 
nonphysician practitioner. Initiation means the beginning portion of 
the nonsurgical extended duration therapeutic service which ends when 
the patient is stable and the supervising physician or the appropriate 
nonphysician practitioner determines

[[Page 8477]]

that the remainder of the service can be delivered safely under general 
supervision; and
* * * * *

    Dated: February 6, 2020.
Ann C. Agnew,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2020-02847 Filed 2-13-20; 8:45 am]
 BILLING CODE 4120-01-P