[Federal Register Volume 85, Number 66 (Monday, April 6, 2020)]
[Rules and Regulations]
[Pages 19230-19292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06990]



[[Page 19229]]

Vol. 85

Monday,

No. 66

April 6, 2020

Part II





Department of Health and Human Services





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Centers for Medicare and Medicaid





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42 CFR Parts 400, 405, 409, et al.





Medicare and Medicaid Programs; Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency; Interim Final Rule

  Federal Register / Vol. 85 , No. 66 / Monday, April 6, 2020 / Rules 
and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 400, 405, 409, 410, 412, 414, 415, 417, 418, 421, 422, 
423, 425, 440, 482, and 510

[CMS-1744-IFC]
RIN 0938-AU31


Medicare and Medicaid Programs; Policy and Regulatory Revisions 
in Response to the COVID-19 Public Health Emergency

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

ACTION: Interim final rule with comment period.

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SUMMARY: This interim final rule with comment period (IFC) gives 
individuals and entities that provide services to Medicare 
beneficiaries needed flexibilities to respond effectively to the 
serious public health threats posed by the spread of the 2019 Novel 
Coronavirus (COVID-19). Recognizing the urgency of this situation, and 
understanding that some pre-existing Medicare payment rules may inhibit 
innovative uses of technology and capacity that might otherwise be 
effective in the efforts to mitigate the impact of the pandemic on 
Medicare beneficiaries and the American public, we are changing 
Medicare payment rules during the Public Health Emergency (PHE) for the 
COVID-19 pandemic so that physicians and other practitioners, home 
health and hospice providers, inpatient rehabilitation facilities, 
rural health clinics (RHCs), and federally qualified health centers 
(FQHCs) are allowed broad flexibilities to furnish services using 
remote communications technology to avoid exposure risks to health care 
providers, patients, and the community. We are also altering the 
applicable payment policies to provide specimen collection fees for 
independent laboratories collecting specimens from beneficiaries who 
are homebound or inpatients (not in a hospital) for COVID-19 testing. 
We are also expanding, on an interim basis, the list of destinations 
for which Medicare covers ambulance transports under Medicare Part B. 
In addition, we are making programmatic changes to the Medicare 
Diabetes Prevention Program (MDPP) and the Comprehensive Care for Joint 
Replacement (CJR) Model in light of the PHE, and program-specific 
requirements for the Quality Payment Program to avoid inadvertently 
creating incentives to place cost considerations above patient safety. 
This IFC will modify the calculation of the 2021 and 2022 Part C and D 
Star Ratings to address the expected disruption to data collection and 
measure scores posed by the COVID-19 pandemic and also to avoid 
inadvertently creating incentives to place cost considerations above 
patient safety. This rule also amends the Medicaid home health 
regulations to allow other licensed practitioners to order home health 
services, for the period of this PHE for the COVID-19 pandemic in 
accordance with state scope of practice laws. We are also modifying our 
under arrangements policy during the PHE for the COVID-19 pandemic so 
that hospitals are allowed broader flexibilities to furnish inpatient 
services, including routine services outside the hospital.

DATES: 
    Effective date: These regulations are effective on March 31, 2020.
    Applicability date: These regulations are applicable beginning on 
March 1, 2020.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on June 1, 2020.

ADDRESSES: In commenting, please refer to file code CMS-1744-IFC. 
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 http://www.regulations.gov. 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-1744-IFC, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    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-1744-IFC, 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: Jamie Hermansen, (410) 786-2064, for 
general information, contact one of the following:
    [email protected], for issues related to telehealth 
services, and communication technology-based services; frequency limits 
on subsequent care services in inpatient and non-facility settings, 
critical care consultations, required ``hands-on'' visits for ESRD 
monthly capitation payments; removal of restrictions on technology, and 
supervision of interactive telecommunications technology; clinical 
laboratory fee schedule; services furnished by opioid treatment 
programs; payment under Medicare Part B for teaching physician services 
and resident moonlighting; remote physiologic monitoring; physician 
supervision flexibility for outpatient hospital services; payment for 
office/outpatient evaluation and management visits; counting of 
resident time at alternate locations; Ambulance Fee Schedule; rural 
health clinic services; federally qualified health center services; and 
inpatient hospital services furnished under arrangements outside of the 
hospital. (Note this email address has an underscore ``_'' between 
``HAPG'' and ``COVID-19''.)
    [email protected], for issues related to the Medicare 
inpatient rehabilitation facility benefits.
    [email protected], for issues related to 
national coverage determination and local coverage determination 
requirements.
    [email protected], for issues related to Medicare 
Parts C and D quality rating system.
    [email protected], for issues related to Medicaid 
home health provider flexibility.
    Hillary Loeffler, (410) 786-0456, [email protected], or 
[email protected], for issues related to the Medicare home 
health and hospice benefits.
    Megan Hyde, (410) 786-3247, and Rebecca Cole, (410) 786-1589, for 
issues related to Innovation Center Models, and alternative payment 
model treatment under the Quality Payment Program.
    Kim Spalding Bush, (410) 786-3232, and Fiona Larbi, (410) 786-7224, 
for issues related to the Medicare Shared Savings Program.
    Molly MacHarris, (410) 786-4461, for issues related to the Merit-
based Incentive Payment System (MIPS).
    Heather Holsey, (410) 786-0028, for Comprehensive Care for Joint 
Replacement model.
    Amanda Rhee, (410) 786-3888, and Elizabeth Matthews, (410) 786-
5433, for Medicare Diabetes Prevention Program expanded model.

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    Brittany LaCouture, (410) 786-0481, for Alternative Payment Model 
provisions of the Quality Payment Program.
    CAPT Scott Cooper, USPHS, (410) 786-9496, for issues related to 
special requirements for psychiatric hospitals.

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: http://regulations.gov. Follow the search instructions on that website to view 
public comments.

Table of Contents

I. Background
II. Provisions of the Interim Final Rule
    A. Payment for Medicare Telehealth Services Under Section 
1834(m) of the Act
    B. Frequency Limitations on Subsequent Care Services in 
Inpatient and Nursing Facility Settings, and Critical Care 
Consultations and Required ``Hands-on'' Visits for ESRD Monthly 
Capitation Payments
    C. Telehealth Modalities and Cost-sharing
    D. Communication Technology-Based Services (CTBS)
    E. Direct Supervision by Interactive Telecommunications 
Technology
    F. Clarification of Homebound Status Under the Medicare Home 
Health Benefit
    G. The Use of Telecommunications Technology Under the Medicare 
Home Health Benefit During the PHE for the COVID-19 Pandemic
    H. The Use of Technology Under the Medicare Hospice Benefit
    I. Telehealth and the Medicare Hospice Face-to-Face Encounter 
Requirement
    J. Modification of the Inpatient Rehabilitation Facility (IRF) 
Face-to-Face Requirement for the PHE During the COVID-19 Pandemic
    K. Removal of the IRF Post-Admission Physician Evaluation 
Requirement for the PHE for the COVID-19 Pandemic and Clarification 
Regarding the ``3-Hour'' Rule
    L. Rural Health Clinics (RHCs) and Federally Qualified Health 
Centers (FQHCs)
    M. Medicare Clinical Laboratory Fee Schedule: Payment for 
Specimen Collection for Purposes of COVID-19 Testing
    N. Requirements for Opioid Treatment Programs (OTP)
    O. Application of Teaching Physician and Moonlighting 
Regulations During the PHE for the COVID-19 pandemic During the PHE 
for COVID-19
    P. Special Requirements for Psychiatric Hospitals (Sec.  
482.61(d))
    Q. Innovation Center Models
    R. Remote Physiologic Monitoring
    S. Telephone Evaluation and Management (E/M) Services
    T. Physician Supervision Flexibility for Outpatient Hospitals--
Outpatient Hospital Therapeutic Services Assigned to the Non-
Surgical Extended Duration Therapeutic Services (NSEDTS) Level of 
Supervision
    U. Application of Certain National Coverage Determination and 
Local Coverage Determination Requirements During the PHE for the 
COVID-19 Pandemic
    V. Change to Medicare Shared Savings Program Extreme and 
Uncontrollable Circumstances Policy
    W. Level Selection for Office/Outpatient E/M Visits When 
Furnished Via Medicare Telehealth
    X. Counting of Resident Time During the PHE for the COVID-19 
Pandemic
    Y. Addressing the Impact of COVID-19 on Part C and Part D 
Quality Rating Systems
    Z. Changes to Expand Workforce Capacity for Ordering Medicaid 
Home Health Services, Medical Equipment, Supplies and Appliances and 
Physical Therapy, Occupational Therapy or Speech Pathology and 
Audiology Services
    AA. Origin and Destination Requirements Under the Ambulance Fee 
Schedule
    BB. Merit-Based Incentive Payment System Updates
    CC. Inpatient Hospital Services Furnished Under Arrangements 
Outside the Hospital During the Public Health Emergency (PHE) for 
the COVID-19 Pandemic
    DD. Advance Payments to Suppliers Furnishing Items and Services 
Under Part B
III. Waiver of Proposed Rulemaking
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
Regulations Text

Addenda Available Only Through the Internet on the CMS Website

    The Addenda along with other supporting documents and tables 
referenced in this interim final rule with comment period (IFC) are 
available through the internet on the CMS website at https://www.cms.gov/. For this IFC, refer to item CMS-1744-IFC. Readers who 
experience any problems accessing any of the Addenda or other documents 
referenced in this IFC and posted on the CMS website identified above 
should contact [email protected].

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this IFC, we use CPT codes and descriptions to refer to 
a variety of services. We note that CPT codes and descriptions are 
copyright 2019 American Medical Association. All Rights Reserved. CPT 
is a registered trademark of the American Medical Association (AMA). 
Applicable Federal Acquisition Regulations (FAR) and Defense Federal 
Acquisition Regulations (DFAR) apply.

I. Background

    The United States is responding to an outbreak of respiratory 
disease caused by a novel (new) coronavirus that was first detected in 
China and which has now been detected in more than 190 locations 
internationally, including in all 50 States and the District of 
Columbia. The virus has been named ``SARS-CoV-2'' and the disease it 
causes has been named ``coronavirus disease 2019'' (abbreviated 
``COVID-19'').
    On January 30, 2020, the International Health Regulations Emergency 
Committee of the World Health Organization (WHO) declared the outbreak 
a ``Public Health Emergency of international concern'' (PHEIC). On 
January 31, 2020, Health and Human Services Secretary, Alex M. Azar II, 
declared a PHE for the United States to aid the nation's healthcare 
community in responding to COVID-19 (hereafter referred to as the PHE 
for the COVID-19 pandemic). On March 11, 2020, the WHO publicly 
characterized COVID-19 as a pandemic. On March 13, 2020 the President 
of the United States declared the COVID-19 outbreak a national 
emergency.
    Coronaviruses are a large family of viruses that are common in 
people and many different species of animals, including camels, cattle, 
cats, and bats. Rarely, animal coronaviruses can infect people and then 
spread between people such as with MERS-CoV, SARS-CoV, and now with 
this new virus (COVID-19).
    The complete clinical picture with regard to COVID-19 is not fully 
known. Reported illnesses have ranged from very mild (including some 
with no reported symptoms) to severe, including illness resulting in 
death. While information so far suggests that most COVID-19 illness is 
mild, a report out of China suggests serious illness occurs in 16 
percent of cases. Older people and people of all ages with severe 
chronic medical conditions--like heart disease, lung disease and 
diabetes, for example--seem to be at higher risk of developing serious 
COVID-19 illness.\1\
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    \1\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html.
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    A pandemic is a global outbreak of disease. Pandemics happen when a 
new virus emerges to infect people and can spread between people 
sustainably. Because there is little to no pre-existing

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immunity against the new virus, it spreads worldwide. The virus that 
causes COVID-19 is infecting people and spreading easily from person-
to-person. This is the first pandemic known to be caused by the 
emergence of a new coronavirus.\2\
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    \2\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html.
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    People in places where ongoing community spread of the virus that 
causes COVID-19 has been reported are at elevated risk of exposure, 
with the level of risk dependent on the location. Healthcare workers 
caring for patients with COVID-19 are at elevated risk of exposure. 
Close contacts of persons with COVID-19 also are at elevated risk of 
exposure.
    Early information out of China, where COVID-19 first started, shows 
that some people are at higher risk of getting very sick from this 
illness. This includes:
     Older adults, with risk increasing by age.
     People who have serious chronic medical conditions like:
    ++ Heart disease.
    ++ Diabetes.
    ++ Lung disease.
    The Centers for Disease Control and Prevention (CDC) has developed 
guidance to help in the risk assessment and management of people with 
potential exposures to COVID-19, including recommending that health 
care professionals make every effort to interview a person under 
investigation for infection by telephone, text monitoring system, or 
video conference.\3\
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    \3\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html.
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    As the healthcare community works to implement and establish 
recommended infection prevention and control practices, regulatory 
agencies under appropriate waiver authority granted by the PHE for the 
COVID-19 pandemic declaration are also working to revise and implement 
regulations that work in concert with healthcare community infection 
prevention and treatment practices. Based on the current and projected 
increase in rate of incidence of the COVID-19 disease in the US 
population, and observed fatalities in the elderly population, who are 
particularly vulnerable due to age and co-morbidities, and 
additionally, impact on health workers that are at increased risk due 
to treating the population, we believe that certain Medicare and 
Medicaid regulations that may offer providers flexibilities in 
furnishing services to combat the COVID-19 pandemic should be reviewed 
and revised as appropriate. We are addressing some of these regulations 
in this interim final rule with comment period (IFC) to ensure that 
sufficient health care items and services are available to meet the 
needs of individuals enrolled in the programs under Title XVIII 
(Medicare) and Title XIX (Medicaid) of the Social Security Act (the 
Act).
    In this extraordinary circumstance, we recognize that public 
exposure greatly increases the overall risk to public health. We 
believe that this increased risk produces an immediate change, not only 
in the circumstances under which services can safely occur, but also 
results in an immediate change to the business relationships between 
providers, suppliers, and practitioners. By increasing access to 
services delivered using telecommunications technology, increasing 
access to testing in a patient's home, and improving infection control, 
this IFC will provide the necessary flexibility for Medicare 
beneficiaries to be able to receive medically necessary services 
without jeopardizing their health or the health of those who are 
providing those services, while minimizing the overall risk to public 
health.

II. Provisions of the Interim Final Rule

    In this IFC, we are defining the term, ``Public Health Emergency,'' 
in the regulation at 42 CFR 400.200, which contains definitions that 
apply under the entirety of chapter 400 of title 42 of the CFR. The 
definition identifies the PHE determined to exist nationwide by the 
Secretary of Health and Human services under section 319 of the Public 
Health Service Act on January 31, 2020, as a result of confirmed cases 
of COVID-19, including any subsequent renewals.

A. Payment for Medicare Telehealth Services Under Section 1834(m) of 
the Act

    Section 1834(m) of the Act specifies the payment amounts and 
circumstances under which Medicare makes payment for a discrete set of 
services, all of which must ordinarily be furnished in-person, when 
they are instead furnished using interactive, real-time 
telecommunication technology. When furnished under the telehealth 
rules, many of these specified Medicare telehealth services are still 
reported using codes that describe ``face-to-face'' services but are 
furnished using audio/video, real-time communication technology instead 
of in-person. The list of these eligible telehealth services is 
published on the CMS website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
    In contrast, Medicare pays separately for other professional 
services that are commonly furnished remotely using telecommunications 
technology, but that do not usually require the patient to be present 
in-person with the practitioner when they are furnished. These 
services, including remote physician interpretation of diagnostic 
tests, care management services and virtual check-ins among many 
others, are considered physicians' services in the same way as services 
that are furnished in-person without the use of telecommunications 
technology. They are covered and paid in the same way as services 
delivered without the use of telecommunications technology, but are not 
considered Medicare telehealth services and are not subject to the 
conditions of payment under section 1834(m) of the Act.
    On March 17, 2020, we announced the expansion of telehealth 
services on a temporary and emergency basis pursuant to waiver 
authority added under section 1135(b)(8) of the Act by the Coronavirus 
Preparedness and Response Supplemental Appropriations Act, 2020 (Pub. 
L. 116-123, March 6, 2020). Starting on March 6, 2020, Medicare can pay 
for telehealth services, including office, hospital, and other visits 
furnished by physicians and other practitioners to patients located 
anywhere in the country, including in a patient's place of residence. 
In the context of the PHE for the COVID-19 pandemic, we recognize that 
physicians and other health care professionals are faced with new 
challenges regarding potential exposure risks, for people with 
Medicare, for health care providers, and for members of the community 
at large. For example, the CDC has urged health care professionals to 
make every effort to interview persons under investigation for 
infection by telephone, text messaging system, or video conference 
instead of in-person. To facilitate the use of telecommunications 
technology as a safe substitute for in-person services, we are, on an 
interim basis, adding many services to the list of eligible Medicare 
telehealth services, eliminating frequency limitations and other 
requirements associated with particular services furnished via 
telehealth, and clarifying several payment rules that apply to other 
services that are furnished using telecommunications technologies that 
can reduce exposure risks.
    As discussed in this IFC and in prior rulemaking, several 
conditions must be met for Medicare to make payment for telehealth 
services under the Physician Fee Schedule (PFS). For further details, 
see the full discussion of the scope of

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Medicare telehealth services in the ``Medicare Program; Revisions to 
Payment Policies Under the Physician Fee Schedule and Other Revisions 
to Part B for CY 2018; Medicare Shared Savings Program Requirements; 
and Medicare Diabetes Prevention Program'' final rule (82 FR 53006, 
November 17, 2017) (hereinafter referred to as the CY 2018 PFS final 
rule) and in our regulations at 42 CFR 410.78 and 414.65.
1. Site of Service Differential for Medicare Telehealth Services
    Under the PFS, there are two payment rates for many physicians' 
services: The facility rate; and the non-facility, or office, rate. The 
PFS non-facility rate is the single amount paid to a physician or other 
practitioner for services furnished in their office. The PFS facility 
rate is the amount generally paid to a professional when a service is 
furnished in a setting of care, like a hospital, where Medicare is 
making a separate payment to an entity in addition to the payment to 
the billing physician or practitioner. This separate payment, often 
referred to as a ``facility fee'' reflects the facility's costs 
associated with the service (clinical staff, supplies and equipment) 
and is paid in addition to what is paid to the professional through the 
PFS.
    We note that, in accordance with section 1834(m)(2)(B) of the Act, 
a facility fee is, in most cases, paid to the ``originating site'' 
where the beneficiary is located at the time a telehealth service is 
furnished. The payment amount for the telehealth originating site 
facility fee is a nationally applicable flat fee, paid without 
geographic or site of service adjustments that generally apply to 
payments for different kinds of services furnished by Medicare 
providers and suppliers.
    For Medicare telehealth services, we currently make payment to the 
billing physician or practitioner at the PFS facility rate since the 
facility costs (clinical staff, supplies, and equipment) associated 
with furnishing the service would generally be incurred by the 
originating site, where the patient is located, and not by the 
practitioner at the distant site; and because the statute requires 
Medicare to pay an originating site facility fee to the site that hosts 
the patient.
    When a physician or practitioner submits a claim for their 
services, including claims for telehealth services, they include a 
place of service (POS) code that is used to determine whether a service 
is paid using the facility or non-facility rate. Currently, CMS 
requires that claims for Medicare telehealth services include the POS 
code 02, which is specific to telehealth services.
    Under the waiver authority exercised by the Secretary in response 
to the PHE for the COVID-19 pandemic, Medicare telehealth services can 
be furnished to patients wherever they are located, including in the 
patient's home. As provided by the amendments to section 1135(b)(8) of 
the Act, when telehealth services are furnished under the waiver to 
beneficiaries located in places that are not identified as permissible 
originating sites in section 1834(m)(4)(C)(ii)(I) through (IX) of the 
Act, no originating site facility fee is paid. We also recognize that 
as physician practices suddenly transition a potentially significant 
portion of their services from in-person to telehealth visits in the 
context of the PHE for the COVID-19 pandemic, the relative resource 
costs of furnishing these services via telehealth may not significantly 
differ from the resource costs involved when these services are 
furnished in person. For example, we expect that physician offices will 
continue to employ nursing staff to engage with patients during 
telehealth visits or to coordinate pre- or post-visit care, regardless 
of whether or not the visit takes place in person, as it would have 
outside of the PHE for the COVID-19 pandemic, or through telehealth in 
the context of the PHE for the COVID-19 pandemic. Consequently, the 
assumptions that have supported payment of telehealth services at the 
PFS facility rate would not apply in many circumstances for services 
furnished during the PHE for the COVID-19 pandemic. Instead, we believe 
that, as more telehealth services are furnished to patients wherever 
they are located rather than in statutory originating sites, it would 
be appropriate to assume that the relative resource costs of services 
furnished through telehealth should be reflected in the payment to the 
furnishing physician or practitioner as if they furnished the services 
in person, and to assign the payment rate that ordinarily would have 
been paid under the PFS were the services furnished in-person. For 
example, a physician practicing in an office setting who, under the PHE 
for the COVID-19 pandemic, sees patients via telehealth instead of in 
person would be paid at the non-facility, or office, rate for these 
services. Similarly, a physician who typically sees patients in an 
outpatient provider-based clinic of a hospital would be paid the 
facility rate for services newly furnished via telehealth.
    To implement this change on an interim basis, we are instructing 
physicians and practitioners who bill for Medicare telehealth services 
to report the POS code that would have been reported had the service 
been furnished in person. This will allow our systems to make 
appropriate payment for services furnished via Medicare telehealth 
which, if not for the PHE for the COVID-19 pandemic, would have been 
furnished in person, at the same rate they would have been paid if the 
services were furnished in person. Given the potential importance of 
using telehealth services as means of minimizing exposure risks for 
patients, practitioners, and the community at large, we believe this 
interim change will maintain overall relativity under the PFS for 
similar services and eliminate potential financial deterrents to the 
clinically appropriate use of telehealth. Because we currently use the 
POS code on the claim to identify Medicare telehealth services, we are 
finalizing on an interim basis the use of the CPT telehealth modifier, 
modifier 95, which should be applied to claim lines that describe 
services furnished via telehealth. We note that we are maintaining the 
facility payment rate for services billed using the general telehealth 
POS code 02, should practitioners choose, for whatever reason, to 
maintain their current billing practices for Medicare telehealth during 
the PHE for the COVID-19 pandemic.
2. Adding Services to the List of Medicare Telehealth Services
    In the ``Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule for Calendar Year 2003 and Inclusion of 
Registered Nurses in the Personnel Provision of the Critical Access 
Hospital Emergency Services Requirement for Frontier Areas and Remote 
Locations'' final rule with comment period (67 FR 79988, December 31, 
2002) (hereinafter referred to the CY 2003 PFS final rule with comment 
period), we established a process for adding services to or deleting 
services from the list of Medicare telehealth services in accordance 
with section 1834(m)(4)(F)(ii) of the Act. This process provides the 
public with an ongoing opportunity to submit requests for adding 
services, which we then review. We have also routinely reviewed 
potential services for addition to the list of telehealth services and 
sought comment on any such proposed additions. Under this process, we 
assign any potential addition to the list of telehealth services to one 
of the following two categories:

[[Page 19234]]

     Category 1: Services that are similar to professional 
consultations, office visits, and office psychiatry services that are 
currently on the list of telehealth services. In reviewing these 
requests, we look for similarities between the requested and existing 
telehealth services for the roles of, and interactions among, the 
beneficiary, the physician (or other practitioner) at the distant site 
and, if necessary, the telepresenter, a practitioner who is present 
with the beneficiary in the originating site. We also look for 
similarities in the telecommunications system used to deliver the 
service; for example, the use of interactive audio and video equipment.
     Category 2: Services that are not similar to those on the 
current list of telehealth services. Our review of these requests 
includes an assessment of whether the service is accurately described 
by the corresponding code when furnished via telehealth and whether the 
use of a telecommunications system to furnish the service produces 
demonstrated clinical benefit to the patient. Submitted evidence should 
include both a description of relevant clinical studies that 
demonstrate the service furnished by telehealth to a Medicare 
beneficiary improves the diagnosis or treatment of an illness or injury 
or improves the functioning of a malformed body part, including dates 
and findings, and a list and copies of published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits.
    Some examples of clinical benefit include the following:
     Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
     Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
     Reduced rate of complications.
     Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
     Decreased number of future hospitalizations or physician 
visits.
     More rapid beneficial resolution of the disease process 
treatment.
     Decreased pain, bleeding, or other quantifiable symptom.
     Reduced recovery time.
    The list of telehealth services, including the additions described 
later in this section, can be located on the CMS website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
    On an interim basis, we are adding the following services to the 
Medicare telehealth list on a Category 2 basis for the duration of this 
PHE for the COVID-19 pandemic, for telehealth services with dates of 
service beginning March 1, 2020 through the end of the declared PHE 
including any subsequent renewals. When we previously considered adding 
these services to the list of telehealth services, either through a 
public request or through our own internal review, we considered 
whether or not these services met the category 1 or category 2 
criteria. In many cases we reviewed requests to add these services on a 
category 1 basis but did not receive or identify information that 
allowed us to review the services on a category 2 basis. While we do 
not believe the context of this PHE for the COVID-19 pandemic changes 
the assessment of these services as category 1, we have reassessed all 
of these services on a category 2 basis in the context of the 
widespread presence of COVID-19 in the community. Given the exposure 
risks for beneficiaries, the health care work force, and the community 
at large, in-person interaction between professionals and patients 
poses an immediate potential risk that would not have been present when 
we previously reviewed these services. This new risk creates a unique 
circumstance where health care professionals need to weigh the risks 
associated with disease exposure so they can bill Medicare for the 
service. For example, certain persons, especially older adults who are 
particularly vulnerable to this specific virus, those considered at 
risk because of underlying health conditions, and those known to be 
recently exposed or diagnosed, and therefore, likely to spread the 
virus to others, are often being directed by local public health 
officials to self-isolate as much as possible. At the same time, we 
note that the risks to medical professionals treating patients is high 
and we consider it likely that medical professionals will try to treat 
patients as effectively as possible without exposing themselves or 
their patients unnecessarily. In some cases, use of telecommunication 
technology could mitigate the exposure risk, and in such cases, there 
is a clear clinical benefit of using such technology in furnishing the 
service. In other words, patients who should not be seen by a 
professional in-person due to the exposure risk are highly likely to be 
without access to clinically appropriate treatment or diagnostic 
options unless they have access to services furnished through 
interactive communication technology. Therefore, in the context of the 
PHE for the COVID-19 pandemic, we believe all of the following services 
meet the category 2 criteria to be added to the list of telehealth 
services on the basis that there is a patient population that would 
otherwise not have access to clinically appropriate treatment. We note 
that, as with other services on the Medicare telehealth list, it may 
not be clinically appropriate or possible to use telecommunications 
technology to furnish these particular services to every person or in 
every circumstance. However, in the context of the PHE for the COVID-19 
pandemic with specific regard to the exposure risks noted above, we 
recognize the clinical benefit of access to medically reasonable and 
necessary services furnished using telecommunications technology as 
opposed to the potential lack of access that could occur to mitigate 
the risk of disease exposure. In light of the PHE for the COVID-19 
pandemic, the demand for physicians in areas heavily impacted by COVID-
19 or under served by clinicians may intensify, resulting in a need for 
critical care services for patients with suspected or diagnosed COVID-
19 and those who are in acute care settings due to other conditions. 
These practitioners may be working with nurses, consulting with other 
healthcare professionals, writing orders, looking at images, 
communicating with family members for patients with a number of acute 
conditions. The CPT codes describing E/M services reflect an assumption 
that the nature of the work involved in evaluation and management 
visits varies, in part, based on the setting of care and the patient's 
status. Consequently, there are separate sets of E/M codes for 
different settings of care, such as office/outpatient codes, nursing 
facility codes, or emergency department codes. We expect physicians and 
other practitioners to use the E/M code that best describes the nature 
of the care they are providing, regardless of the physical location or 
status of the patient. Under ordinary circumstances, we would expect 
the kind of E/M code reported to generally align with the physical 
location or status of the patient. In the context of the PHE, we 
recognize that the relationship among the setting of care, patient 
status, and kind of E/M code reported may depend on the needs of local 
communities and the capacity of local health care institutions. 
Consequently, we are reiterating that practitioners should report the 
E/M code that best describes the nature of the care they are providing.

[[Page 19235]]

    We are adding the following codes to the existing list of 
telehealth services on a Category 2 basis for the PHE for the COVID-19 
pandemic:
3. Emergency Department Visits: CPT Codes
     99281 (Emergency department visit for the evaluation and 
management of a patient, which requires these 3 key components: A 
problem focused history; A problem focused examination; and 
Straightforward medical decision making. Counseling and/or coordination 
of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
presenting problem(s) are self limited or minor.)
     99282 (Emergency department visit for the evaluation and 
management of a patient, which requires these 3 key components: An 
expanded problem focused history; An expanded problem focused 
examination; and Medical decision making of low complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the presenting problem(s) are of low to moderate severity.)
     99283 (Emergency department visit for the evaluation and 
management of a patient, which requires these 3 key components: An 
expanded problem focused history; An expanded problem focused 
examination; and Medical decision making of moderate complexity. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. Usually, the presenting problem(s) are of moderate 
severity.)
     99284 (Emergency department visit for the evaluation and 
management of a patient, which requires these 3 key components: A 
detailed history; A detailed examination; and Medical decision making 
of moderate complexity. Counseling and/or coordination of care with 
other physicians, other qualified health care professionals, or 
agencies are provided consistent with the nature of the problem(s) and 
the patient's and/or family's needs. Usually, the presenting problem(s) 
are of high severity, and require urgent evaluation by the physician, 
or other qualified health care professionals but do not pose an 
immediate significant threat to life or physiologic function.)
     99285 (Emergency department visit for the evaluation and 
management of a patient, which requires these 3 key components within 
the constraints imposed by the urgency of the patient's clinical 
condition and/or mental status: A comprehensive history; A 
comprehensive examination; and Medical decision making of high 
complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the presenting problem(s) are of high 
severity and pose an immediate significant threat to life or 
physiologic function.)
4. Initial and Subsequent Observation, and Observation Discharge Day 
Management: CPT Codes
     99217 (Observation care discharge day management (This 
code is to be utilized to report all services provided to a patient on 
discharge from outpatient hospital ``observation status'' if the 
discharge is on other than the initial date of ``observation status.'' 
To report services to a patient designated as ``observation status'' or 
``inpatient status'' and discharged on the same date, use the codes for 
Observation or Inpatient Care Services [including Admission and 
Discharge Services, 99234-99236 as appropriate.])
     99218 (Initial observation care, per day, for the 
evaluation and management of a patient which requires these 3 key 
components: A detailed or comprehensive history; A detailed or 
comprehensive examination; and Medical decision making that is 
straightforward or of low complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the problem(s) 
requiring admission to outpatient hospital ``observation status'' are 
of low severity. Typically, 30 minutes are spent at the bedside and on 
the patient's hospital floor or unit.)
     99219 (Initial observation care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of moderate complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission to outpatient hospital ``observation 
status'' are of moderate severity. Typically, 50 minutes are spent at 
the bedside and on the patient's hospital floor or unit.)
     99220 (Initial observation care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of high complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission to outpatient hospital ``observation 
status'' are of high severity. Typically, 70 minutes are spent at the 
bedside and on the patient's hospital floor or unit.)
     99224 (Subsequent observation care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: Problem focused interval history; Problem 
focused examination; Medical decision making that is straightforward or 
of low complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is stable, recovering, or 
improving. Typically, 15 minutes are spent at the bedside and on the 
patient's hospital floor or unit.)
     99225 (Subsequent observation care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: An expanded problem focused interval history; 
An expanded problem focused examination; Medical decision making of 
moderate complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is responding inadequately 
to therapy or has developed a minor complication. Typically, 25 minutes 
are spent at the bedside and on the patient's hospital floor or unit.)
     99226 (Subsequent observation care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A detailed interval history; A detailed 
examination; Medical

[[Page 19236]]

decision making of high complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the patient is 
unstable or has developed a significant complication or a significant 
new problem. Typically, 35 minutes are spent at the bedside and on the 
patient's hospital floor or unit.)
     99234 (Observation or inpatient hospital care, for the 
evaluation and management of a patient including admission and 
discharge on the same date, which requires these 3 key components: A 
detailed or comprehensive history; A detailed or comprehensive 
examination; and Medical decision making that is straightforward or of 
low complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually the presenting problem(s) requiring 
admission are of low severity. Typically, 40 minutes are spent at the 
bedside and on the patient's hospital floor or unit.)
     99235 (Observation or inpatient hospital care, for the 
evaluation and management of a patient including admission and 
discharge on the same date, which requires these 3 key components: A 
comprehensive history; A comprehensive examination; and Medical 
decision making of moderate complexity. Counseling and/or coordination 
of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually the 
presenting problem(s) requiring admission are of moderate severity. 
Typically, 50 minutes are spent at the bedside and on the patient's 
hospital floor or unit.)
     99236 (Observation or inpatient hospital care, for the 
evaluation and management of a patient including admission and 
discharge on the same date, which requires these 3 key components: A 
comprehensive history; A comprehensive examination; and Medical 
decision making of high complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually the presenting 
problem(s) requiring admission are of high severity. Typically, 55 
minutes are spent at the bedside and on the patient's hospital floor or 
unit.)
5. Initial Hospital Care and Hospital Discharge Day Management: CPT 
Codes
     99221 (Initial hospital care, per day, for the evaluation 
and management of a patient, which requires these 3 key components: A 
detailed or comprehensive history; A detailed or comprehensive 
examination; and Medical decision making that is straightforward or of 
low complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the problem(s) requiring admission are 
of low severity. Typically, 30 minutes are spent at the bedside and on 
the patient's hospital floor or unit.)
     99222 (Initial hospital care, per day, for the evaluation 
and management of a patient, which requires these 3 key components: A 
comprehensive history; A comprehensive examination; and Medical 
decision making of moderate complexity. Counseling and/or coordination 
of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of moderate severity. Typically, 50 
minutes are spent at the bedside and on the patient's hospital floor or 
unit.)
     99223 (Initial hospital care, per day, for the evaluation 
and management of a patient, which requires these 3 key components: A 
comprehensive history; A comprehensive examination; and Medical 
decision making of high complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the problem(s) 
requiring admission are of high severity. Typically, 70 minutes are 
spent at the bedside and on the patient's hospital floor or unit.)
     99238 (Hospital discharge day management; 30 minutes or 
less)
     99239 (Hospital discharge day management; more than 30 
minutes)
6. Initial Nursing Facility Visits and Nursing Facility Discharge Day 
Management: CPT Codes
     99304 (Initial nursing facility care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A detailed or comprehensive history; A detailed or 
comprehensive examination; and Medical decision making that is 
straightforward or of low complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the problem(s) 
requiring admission are of low severity. Typically, 25 minutes are 
spent at the bedside and on the patient's facility floor or unit.)
     99305 (Initial nursing facility care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of moderate complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of moderate severity. Typically, 35 
minutes are spent at the bedside and on the patient's facility floor or 
unit.)
     99306 (Initial nursing facility care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of high complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of high severity. Typically, 45 
minutes are spent at the bedside and on the patient's facility floor or 
unit.)
     99315 (Nursing facility discharge day management; 30 
minutes or less)
     99316 (Nursing facility discharge day management; more 
than 30 minutes)
7. Critical Care Services: CPT Codes
     99291 (Critical care, evaluation and management of the 
critically ill or critically injured patient; first 30-74 minutes)
     99292 (Critical care, evaluation and management of the 
critically ill or critically injured patient; each additional 30 
minutes (List separately in addition to code for primary service))

[[Page 19237]]

8. Domiciliary, Rest Home, or Custodial Care Services: CPT Codes
     99327 (Domiciliary or rest home visit for the evaluation 
and management of a new patient, which requires these 3 key components: 
A comprehensive history; A comprehensive examination; and Medical 
decision making of moderate complexity. Counseling and/or coordination 
of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
presenting problem(s) are of high severity. Typically, 60 minutes are 
spent with the patient and/or family or caregiver.)
     99328 (Domiciliary or rest home visit for the evaluation 
and management of a new patient, which requires these 3 key components: 
A comprehensive history; A comprehensive examination; and Medical 
decision making of high complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the patient is 
unstable or has developed a significant new problem requiring immediate 
physician attention. Typically, 75 minutes are spent with the patient 
and/or family or caregiver.)
     99334 (Domiciliary or rest home visit for the evaluation 
and management of an established patient, which requires at least 2 of 
these 3 key components: A problem focused interval history; A problem 
focused examination; Straightforward medical decision making. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. Usually, the presenting problem(s) are self-limited or 
minor. Typically, 15 minutes are spent with the patient and/or family 
or caregiver.)
     99335 (Domiciliary or rest home visit for the evaluation 
and management of an established patient, which requires at least 2 of 
these 3 key components: An expanded problem focused interval history; 
An expanded problem focused examination; Medical decision making of low 
complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the presenting problem(s) are of low to 
moderate severity. Typically, 25 minutes are spent with the patient 
and/or family or caregiver.)
     99336 (Domiciliary or rest home visit for the evaluation 
and management of an established patient, which requires at least 2 of 
these 3 key components: A detailed interval history; A detailed 
examination; Medical decision making of moderate complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the presenting problem(s) are of moderate to high severity. 
Typically, 40 minutes are spent with the patient and/or family or 
caregiver.)
     99337 (Domiciliary or rest home visit for the evaluation 
and management of an established patient, which requires at least 2 of 
these 3 key components: A comprehensive interval history; A 
comprehensive examination; Medical decision making of moderate to high 
complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the presenting problem(s) are of 
moderate to high severity. The patient may be unstable or may have 
developed a significant new problem requiring immediate physician 
attention. Typically, 60 minutes are spent with the patient and/or 
family or caregiver.)
9. Home Visits: CPT Codes
     99341 (Home visit for the evaluation and management of a 
new patient, which requires these 3 key components: A problem focused 
history; A problem focused examination; and Straightforward medical 
decision making. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the presenting problem(s) are of low 
severity. Typically, 20 minutes are spent face-to-face with the patient 
and/or family.)
     99342 (Home visit for the evaluation and management of a 
new patient, which requires these 3 key components: An expanded problem 
focused history; An expanded problem focused examination; and Medical 
decision making of low complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the presenting 
problem(s) are of moderate severity. Typically, 30 minutes are spent 
face-to-face with the patient and/or family.)
     99343 (Home visit for the evaluation and management of a 
new patient, which requires these 3 key components: A detailed history; 
A detailed examination; and Medical decision making of moderate 
complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the presenting problem(s) are of 
moderate to high severity. Typically, 45 minutes are spent face-to-face 
with the patient and/or family.)
     99344 (Home visit for the evaluation and management of a 
new patient, which requires these 3 key components: A comprehensive 
history; A comprehensive examination; and Medical decision making of 
moderate complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the presenting problem(s) are of high 
severity. Typically, 60 minutes are spent face-to-face with the patient 
and/or family.)
     99345 (Home visit for the evaluation and management of a 
new patient, which requires these 3 key components: A comprehensive 
history; A comprehensive examination; and Medical decision making of 
high complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is unstable or has 
developed a significant new problem requiring immediate physician 
attention. Typically, 75 minutes are spent face-to-face with the 
patient and/or family.)
     99347 (Home visit for the evaluation and management of an 
established patient, which requires at least 2 of these 3 key 
components: A problem focused interval history; A problem focused 
examination; Straightforward medical decision making. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided

[[Page 19238]]

consistent with the nature of the problem(s) and the patient's and/or 
family's needs. Usually, the presenting problem(s) are self limited or 
minor. Typically, 15 minutes are spent face-to-face with the patient 
and/or family.)
     99348 (Home visit for the evaluation and management of an 
established patient, which requires at least 2 of these 3 key 
components: An expanded problem focused interval history; An expanded 
problem focused examination; Medical decision making of low complexity. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. Usually, the presenting problem(s) are of low to 
moderate severity. Typically, 25 minutes are spent face-to-face with 
the patient and/or family.)
     99349 (Home visit for the evaluation and management of an 
established patient, which requires at least 2 of these 3 key 
components: A detailed interval history; A detailed examination; 
Medical decision making of moderate complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
presenting problem(s) are moderate to high severity. Typically, 40 
minutes are spent face-to-face with the patient and/or family.)
     99350 (Home visit for the evaluation and management of an 
established patient, which requires at least 2 of these 3 key 
components: A comprehensive interval history; A comprehensive 
examination; Medical decision making of moderate to high complexity. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. Usually, the presenting problem(s) are of moderate to 
high severity. The patient may be unstable or may have developed a 
significant new problem requiring immediate physician attention. 
Typically, 60 minutes are spent face-to-face with the patient and/or 
family.)
10. Inpatient Neonatal and Pediatric Critical Care: CPT Codes
     99468 (Initial inpatient neonatal critical care, per day, 
for the evaluation and management of a critically ill neonate, 28 days 
of age or younger)
     99469 (Subsequent inpatient neonatal critical care, per 
day, for the evaluation and management of a critically ill neonate, 28 
days of age or younger)
     99471 (Initial inpatient pediatric critical care, per day, 
for the evaluation and management of a critically ill infant or young 
child, 29 days through 24 months of age)
     99472 (Subsequent inpatient pediatric critical care, per 
day, for the evaluation and management of a critically ill infant or 
young child, 29 days through 24 months of age)
     99473 (Self-measured blood pressure using a device 
validated for clinical accuracy; patient education/training and device 
calibration)
     99475 (Initial inpatient pediatric critical care, per day, 
for the evaluation and management of a critically ill infant or young 
child, 2 through 5 years of age)
     99476 (Subsequent inpatient pediatric critical care, per 
day, for the evaluation and management of a critically ill infant or 
young child, 2 through 5 years of age)
11. Initial and Continuing Intensive Care Services: CPT Codes
     99477 (Initial hospital care, per day, for the evaluation 
and management of the neonate, 28 days of age or younger, who requires 
intensive observation, frequent interventions, and other intensive care 
services)
     99478 (Subsequent intensive care, per day, for the 
evaluation and management of the recovering very low birth weight 
infant (present body weight less than 1500 grams))
     99479 (Subsequent intensive care, per day, for the 
evaluation and management of the recovering low birth weight infant 
(present body weight of 1500-2500 grams))
     99480 (Subsequent intensive care, per day, for the 
evaluation and management of the recovering infant (present body weight 
of 2501-5000 grams))
12. Care Planning for Patients With Cognitive Impairment: CPT Code
     99483 (Assessment of and care planning for a patient with 
cognitive impairment, requiring an independent historian, in the office 
or other outpatient, home or domiciliary or rest home, with all of the 
following required elements: Cognition-focused evaluation including a 
pertinent history and examination; Medical decision making of moderate 
or high complexity; Functional assessment (eg, basic and instrumental 
activities of daily living), including decision-making capacity; Use of 
standardized instruments for staging of dementia (eg, functional 
assessment staging test [FAST], clinical dementia rating [CDR]); 
Medication reconciliation and review for high-risk medications; 
Evaluation for neuropsychiatric and behavioral symptoms, including 
depression, including use of standardized screening instrument(s); 
Evaluation of safety (eg, home), including motor vehicle operation; 
Identification of caregiver(s), caregiver knowledge, caregiver needs, 
social supports, and the willingness of caregiver to take on caregiving 
tasks; Development, updating or revision, or review of an Advance Care 
Plan; Creation of a written care plan, including initial plans to 
address any neuropsychiatric symptoms, neuro-cognitive symptoms, 
functional limitations, and referral to community resources as needed 
(eg, rehabilitation services, adult day programs, support groups) 
shared with the patient and/or caregiver with initial education and 
support. Typically, 50 minutes are spent face-to-face with the patient 
and/or family or caregiver.)
13. Group Psychotherapy: CPT Code
     90853 (Group psychotherapy (other than of a multiple-
family group))
14. End-Stage Renal Disease (ESRD) Services: CPT Codes
     90952 (End-stage renal disease (ESRD) related services 
monthly, for patients younger than 2 years of age to include monitoring 
for the adequacy of nutrition, assessment of growth and development, 
and counseling of parents; with 2-3 face-to-face visits by a physician 
or other qualified health care professional per month)
     90953 (End-stage renal disease (ESRD) related services 
monthly, for patients younger than 2 years of age to include monitoring 
for the adequacy of nutrition, assessment of growth and development, 
and counseling of parents; with 1 face-to-face visit by a physician or 
other qualified health care professional per month)
     90959 (End-stage renal disease (ESRD) related services 
monthly, for patients 12-19 years of age to include monitoring for the 
adequacy of nutrition, assessment of growth and development, and 
counseling of parents; with 1 face-to-face visit by a physician or 
other qualified health care professional per month)
     90962 (End-stage renal disease (ESRD) related services 
monthly, for patients 20 years of age and older; with 1 face-to-face 
visit by a physician or other qualified health care professional per 
month)

[[Page 19239]]

15. Psychological and Neuropsychological Testing: CPT Codes
     96130 (Psychological testing evaluation services by 
physician or other qualified health care professional, including 
integration of patient data, interpretation of standardized test 
results and clinical data, clinical decision making, treatment planning 
and report, and interactive feedback to the patient, family member(s) 
or caregiver(s), when performed; first hour)
     96131 (Psychological testing evaluation services by 
physician or other qualified health care professional, including 
integration of patient data, interpretation of standardized test 
results and clinical data, clinical decision making, treatment planning 
and report, and interactive feedback to the patient, family member(s) 
or caregiver(s), when performed; each additional hour (List separately 
in addition to code for primary procedure))
     96132 (Neuropsychological testing evaluation services by 
physician or other qualified health care professional, including 
integration of patient data, interpretation of standardized test 
results and clinical data, clinical decision making, treatment planning 
and report, and interactive feedback to the patient, family member(s) 
or caregiver(s), when performed; first hour)
     96133 (Neuropsychological testing evaluation services by 
physician or other qualified health care professional, including 
integration of patient data, interpretation of standardized test 
results and clinical data, clinical decision making, treatment planning 
and report, and interactive feedback to the patient, family member(s) 
or caregiver(s), when performed; each additional hour (List separately 
in addition to code for primary procedure))
     96136 (Psychological or neuropsychological test 
administration and scoring by physician or other qualified health care 
professional, two or more tests, any method; first 30 minutes)
     96137 (Psychological or neuropsychological test 
administration and scoring by physician or other qualified health care 
professional, two or more tests, any method; each additional 30 minutes 
(List separately in addition to code for primary procedure))
     96138 (Psychological or neuropsychological test 
administration and scoring by technician, two or more tests, any 
method; first 30 minutes)
     96139 (Psychological or neuropsychological test 
administration and scoring by technician, two or more tests, any 
method; each additional 30 minutes (List separately in addition to code 
for primary procedure))
16. Therapy Services
    We have received a number of requests, most recently for CY 2018 
PFS rulemaking, that we add therapy services to the Medicare telehealth 
list. In the CY 2018 PFS final rule, we noted that section 
1834(m)(4)(E) of the Act specifies the types of practitioners who may 
furnish and bill for Medicare telehealth services as those 
practitioners under section 1842(b)(18)(C) of the Act. Physical 
therapists, occupational therapists and speech-language pathologists 
are not among the practitioners identified in section 1842(b)(18)(C) of 
the Act. We stated in the Medicare Program; Revisions to Payment 
Policies under the Physician Fee Schedule and Other Revisions to Part B 
for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare 
Advantage and Part D Medical Loss Ratio Data Release; Medicare 
Advantage Provider Network Requirements; Expansion of Medicare Diabetes 
Prevention Program Model; Medicare Shared Savings Program 
Requirements'' final rule (81 FR 80198, November 15, 2016) (hereinafter 
referred to as the CY 2017 PFS final rule) that because these services 
are predominantly furnished by physical therapists, occupational 
therapists and speech-language pathologists, we did not believe it 
would be appropriate to add them to the list of telehealth services at 
this time. In a subsequent request to consider adding these services 
for 2018, the original requester suggested that we might propose these 
services to be added to the list so that they can be furnished via 
telehealth when furnished by eligible distant site practitioners. Since 
the majority of the codes are furnished over 90 percent of the time by 
therapy professionals, who are not included on the statutory list of 
eligible distant site practitioners, we stated that we believed that 
adding therapy services to the telehealth list could result in 
confusion about who is authorized to furnish and bill for these 
services when furnished via telehealth.
    In light of the PHE for the COVID-19 pandemic, we believe that the 
risks associated with confusion are outweighed by the potential 
benefits for circumstances when these services might be furnished via 
telehealth by eligible distant site practitioners. We believe this is 
sufficient clinical evidence to support the addition of therapy 
services to the Medicare telehealth list on a category 2 basis. 
However, we note that the statutory definition of distant site 
practitioners under section 1834(m) of the Act does not include 
physical therapists, occupational therapists, or speech-language 
pathologists, meaning that it does not provide for payment for these 
services as Medicare telehealth services when furnished by physical 
therapists, occupational therapists, or speech-language pathologists.
    CPT codes:
     97161 (Physical therapy evaluation: low complexity, 
requiring these components: A history with no personal factors and/or 
comorbidities that impact the plan of care; An examination of body 
system(s) using standardized tests and measures addressing 1-2 elements 
from any of the following: body structures and functions, activity 
limitations, and/or participation restrictions; A clinical presentation 
with stable and/or uncomplicated characteristics; and Clinical decision 
making of low complexity using standardized patient assessment 
instrument and/or measurable assessment of functional outcome. 
Typically, 20 minutes are spent face-to-face with the patient and/or 
family.)
     97162 (Physical therapy evaluation: moderate complexity, 
requiring these components: A history of present problem with 1-2 
personal factors and/or comorbidities that impact the plan of care; An 
examination of body systems using standardized tests and measures in 
addressing a total of 3 or more elements from any of the following: 
body structures and functions, activity limitations, and/or 
participation restrictions; An evolving clinical presentation with 
changing characteristics; and Clinical decision making of moderate 
complexity using standardized patient assessment instrument and/or 
measurable assessment of functional outcome. Typically, 30 minutes are 
spent face-to-face with the patient and/or family.)
     97163 (Physical therapy evaluation: high complexity, 
requiring these components: A history of present problem with 3 or more 
personal factors and/or comorbidities that impact the plan of care; An 
examination of body systems using standardized tests and measures 
addressing a total of 4 or more elements from any of the following: 
body structures and functions, activity limitations, and/or 
participation restrictions; A clinical presentation with unstable and 
unpredictable characteristics; and Clinical decision making of high 
complexity using standardized patient assessment instrument and/or 
measurable assessment of functional outcome. Typically, 45 minutes are 
spent face-to-face with the patient and/or family.)
     97164 (Re-evaluation of physical therapy established plan 
of care,

[[Page 19240]]

requiring these components: An examination including a review of 
history and use of standardized tests and measures is required; and 
Revised plan of care using a standardized patient assessment instrument 
and/or measurable assessment of functional outcome. Typically, 20 
minutes are spent face-to-face with the patient and/or family.)
     97165 (Occupational therapy evaluation, low complexity, 
requiring these components: An occupational profile and medical and 
therapy history, which includes a brief history including review of 
medical and/or therapy records relating to the presenting problem; An 
assessment(s) that identifies 1-3 performance deficits (ie, relating to 
physical, cognitive, or psychosocial skills) that result in activity 
limitations and/or participation restrictions; and Clinical decision 
making of low complexity, which includes an analysis of the 
occupational profile, analysis of data from problem-focused 
assessment(s), and consideration of a limited number of treatment 
options. Patient presents with no comorbidities that affect 
occupational performance. Modification of tasks or assistance (eg, 
physical or verbal) with assessment(s) is not necessary to enable 
completion of evaluation component. Typically, 30 minutes are spent 
face-to-face with the patient and/or family.)
     97166 (Occupational therapy evaluation, moderate 
complexity, requiring these components: An occupational profile and 
medical and therapy history, which includes an expanded review of 
medical and/or therapy records and additional review of physical, 
cognitive, or psychosocial history related to current functional 
performance; An assessment(s) that identifies 3-5 performance deficits 
(ie, relating to physical, cognitive, or psychosocial skills) that 
result in activity limitations and/or participation restrictions; and 
Clinical decision making of moderate analytic complexity, which 
includes an analysis of the occupational profile, analysis of data from 
detailed assessment(s), and consideration of several treatment options. 
Patient may present with comorbidities that affect occupational 
performance. Minimal to moderate modification of tasks or assistance 
(eg, physical or verbal) with assessment(s) is necessary to enable 
patient to complete evaluation component. Typically, 45 minutes are 
spent face-to-face with the patient and/or family.)
     97167 (Occupational therapy evaluation, high complexity, 
requiring these components: An occupational profile and medical and 
therapy history, which includes review of medical and/or therapy 
records and extensive additional review of physical, cognitive, or 
psychosocial history related to current functional performance; An 
assessment(s) that identifies 5 or more performance deficits (ie, 
relating to physical, cognitive, or psychosocial skills) that result in 
activity limitations and/or participation restrictions; and Clinical 
decision making of high analytic complexity, which includes an analysis 
of the patient profile, analysis of data from comprehensive 
assessment(s), and consideration of multiple treatment options. Patient 
presents with comorbidities that affect occupational performance. 
Significant modification of tasks or assistance (eg, physical or 
verbal) with assessment(s) is necessary to enable patient to complete 
evaluation component. Typically, 60 minutes are spent face-to-face with 
the patient and/or family.)
     97168 (Re-evaluation of occupational therapy established 
plan of care, requiring these components: An assessment of changes in 
patient functional or medical status with revised plan of care; An 
update to the initial occupational profile to reflect changes in 
condition or environment that affect future interventions and/or goals; 
and A revised plan of care. A formal reevaluation is performed when 
there is a documented change in functional status or a significant 
change to the plan of care is required. Typically, 30 minutes are spent 
face-to-face with the patient and/or family.)
     97110 (Therapeutic procedure, 1 or more areas, each 15 
minutes; therapeutic exercises to develop strength and endurance, range 
of motion and flexibility)
     97112 (Therapeutic procedure, 1 or more areas, each 15 
minutes; neuromuscular reeducation of movement, balance, coordination, 
kinesthetic sense, posture, and/or proprioception for sitting and/or 
standing activities)
     97116 (Therapeutic procedure, 1 or more areas, each 15 
minutes; gait training (includes stair climbing)
     97535 (Self-care/home management training (eg, activities 
of daily living (ADL) and compensatory training, meal preparation, 
safety procedures, and instructions in use of assistive technology 
devices/adaptive equipment) direct one-on-one contact, each 15 minutes)
     97750 (Physical performance test or measurement (eg, 
musculoskeletal, functional capacity), with written report, each 15 
minutes)
     97755 (Assistive technology assessment (e.g., to restore, 
augment or compensate for existing function, optimize functional tasks 
and/or maximize environmental accessibility), direct one-on-one 
contact, with written report, each 15 minutes)
     97760 (Orthotic(s) management and training (including 
assessment and fitting when not otherwise reported), upper 
extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s) 
encounter, each 15 minutes)
     97761 (Prosthetic(s) training, upper and/or lower 
extremity(ies), initial prosthetic(s) encounter, each 15 minutes)
     92521 (Evaluation of speech fluency (eg, stuttering, 
cluttering)
     92522 (Evaluation of speech sound production (eg, 
articulation, phonological process, apraxia, dysarthria)
     92523 (Evaluation of speech sound production (eg, 
articulation, phonological process, apraxia, dysarthria); with 
evaluation of language comprehension and expression (eg, receptive and 
expressive language)
     92524 (Behavioral and qualitative analysis of voice and 
resonance)
     92507 (Treatment of speech, language, voice, 
communication, and/or auditory processing disorder; individual)
17. Radiation Treatment Management Services
    The code used to report radiation treatment management services 
includes several components, including reviewing the radiation dose and 
various treatment parameters, as well as weekly face-to-face visits 
with the patient to assess the patient's response to treatment and 
manage any symptoms the patient may be experiencing. We believe that in 
the context of the PHE for the COVID-19 pandemic, the weekly face-to-
face visit component of this service could be conducted via telehealth 
when the billing practitioner weighs the exposure risks against the 
value of in-person assessment on a case-by-case basis. Therefore, we 
are adding CPT code 77427 (Radiation treatment management, 5 
treatments) to the telehealth list so that the required face-to-face 
visit can be furnished via telehealth.
    We believe that allowing the services listed above to be furnished 
as Medicare telehealth services will significantly increase the ability 
of Medicare physicians and practitioners to work without increasing 
exposure risk to themselves, their patients, and the broader community. 
Given widespread concerns regarding the health and safety

[[Page 19241]]

of our beneficiaries and health care providers during the PHE for the 
COVID-19 pandemic, we seek input on whether there are other services 
where the use of telecommunications technology could mitigate the 
exposure risk, and where there is clear clinical benefit to using such 
technology in furnishing the service.
    We note that the inclusion of this code on the telehealth list to 
ensure that the included visits can be furnished via telehealth is 
similar to the inclusion of the transitional care management codes on 
the telehealth list. In both of these cases, the non-face-to-face 
portions of the service are not considered telehealth services that are 
subject to any of the payment provisions specific to telehealth 
services under section 1834(m) of the Act.
     CPT code 77427 (Radiation treatment management, 5 
treatments)
    As we noted above, we have previously considered adding many of 
these services to the Medicare telehealth list in prior rulemaking and 
declined, in many cases citing concerns over patient acuity and the 
feasibility of fulfilling all of the required elements of a service via 
communication technology. However, in the context of the PHE for the 
COVID-19 pandemic with specific regard to the exposure risks noted 
above, we recognize the clinical benefit of access to medically 
reasonable and necessary services furnished using telecommunications 
technology as opposed to the potential lack of access that could occur 
to mitigate the risk of disease exposure. We are also interested in 
learning of any potential negative consequences of adding these CPT 
codes to the list of telehealth services on an interim basis.

B. Frequency Limitations on Subsequent Care Services in Inpatient and 
Nursing Facility Settings, and Critical Care Consultations and Required 
``Hands-On'' Visits for ESRD Monthly Capitation Payments

    In adding some services to the Medicare telehealth list, we have 
done so while including certain restrictions on how frequently a 
service may be furnished via Medicare telehealth to ensure that the 
services met the category 1 or 2 criteria. For example, in the CY 2011 
PFS final rule (75 FR 73317 through 73318), we added the subsequent 
hospital care services to the Medicare telehealth list. We stated that, 
because of our concerns regarding the potential acuity of hospital 
inpatients, we would limit the provision of subsequent hospital care 
services through telehealth to once every 3 days. Similarly, when we 
added subsequent nursing facility visits to the Medicare telehealth 
list, we stated our concerns regarding the potential acuity and 
complexity of nursing facility (NF) patients, we would limit the 
provision of subsequent nursing facility care services furnished 
through telehealth to once every 30 days.
    Given our assessment that under the PHE for the COVID-19 pandemic, 
there is a patient population that would otherwise not have access to 
clinically appropriate in-person treatment, we do not believe these 
frequency limitations are appropriate or necessary. In our prior 
analysis, for example, we were concerned that patients might not 
receive the necessary in-person services for nursing facility or 
hospital inpatient services. Since in the context of this PHE, 
telehealth visits mitigate exposure risk, fewer in-person visits may 
reflect the most appropriate care, depending on the needs of individual 
patients. Consequently, on an interim basis, we are removing the 
frequency restrictions for each of the following listed codes for 
subsequent inpatient visits and subsequent NF visits furnished via 
Medicare telehealth for the duration of the PHE for the COVID-19 
pandemic. Similarly, we note that we previously limited critical care 
consultations through telehealth to only once per day, given the 
patient acuity involved in critical care. However, we also understand 
that critical care patients have significant exposure risks such that 
more frequent services furnished via telehealth may reflect the best 
available care in the context and for the duration of the PHE for the 
COVID-19 pandemic. For this reason, we are also removing the 
restriction that critical care consultation codes may only be furnished 
to a Medicare beneficiary once per day. These restrictions were 
established through rulemaking and implemented through systems edits.
1. Subsequent Inpatient Visits: CPT Codes
     99231 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A problem focused interval history; A problem 
focused examination; Medical decision making that is straightforward or 
of low complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is stable, recovering or 
improving. Typically, 15 minutes are spent at the bedside and on the 
patient's hospital floor or unit.)
     99232 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: An expanded problem focused interval history; 
An expanded problem focused examination; Medical decision making of 
moderate complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is responding inadequately 
to therapy or has developed a minor complication. Typically, 25 minutes 
are spent at the bedside and on the patient's hospital floor or unit.)
     99233 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A detailed interval history; A detailed 
examination; Medical decision making of high complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the patient is unstable or has developed a significant 
complication or a significant new problem. Typically, 35 minutes are 
spent at the bedside and on the patient's hospital floor or unit.)
2. Subsequent Nursing Facility Visits: CPT Codes
     99307 (Subsequent nursing facility care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A problem focused interval history; A problem 
focused examination; Straightforward medical decision making. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. Usually, the patient is stable, recovering, or 
improving. Typically, 10 minutes are spent at the bedside and on the 
patient's facility floor or unit.)
     99308 (Subsequent nursing facility care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: An expanded problem focused interval history; 
An expanded problem focused examination; Medical decision making of low 
complexity.

[[Page 19242]]

Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. Usually, the patient is responding inadequately to 
therapy or has developed a minor complication. Typically, 15 minutes 
are spent at the bedside and on the patient's facility floor or unit.)
     99309 (Subsequent nursing facility care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A detailed interval history; A detailed 
examination; Medical decision making of moderate complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the patient has developed a significant complication or a 
significant new problem. Typically, 25 minutes are spent at the bedside 
and on the patient's facility floor or unit.)
     99310 (Subsequent nursing facility care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A comprehensive interval history; A 
comprehensive examination; Medical decision making of high complexity. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. The patient may be unstable or may have developed a 
significant new problem requiring immediate physician attention. 
Typically, 35 minutes are spent at the bedside and on the patient's 
facility floor or unit.)
3. Critical Care Consultation Services: HCPCS Codes
     G0508 (Telehealth consultation, critical care, initial, 
physicians typically spend 60 minutes communicating with the patient 
and providers via telehealth.)
     G0509 (Telehealth consultation, critical care, subsequent, 
physicians typically spend 50 minutes communicating with the patient 
and providers via telehealth.)
    We are seeking information on how these services are furnished via 
telecommunications technology to ensure that patients are safe and 
receiving adequate care.
4. Required ``Hands-On'' Visits for ESRD Monthly Capitation Payments
    In the ``Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule for Calendar Year 2005'' final rule with comment 
period (69 FR 66236, November 15, 2004) (hereinafter referred to the CY 
2005 PFS final rule with comment period), we added ESRD related 
services to the Medicare telehealth list; however, we specified that 
the required clinical examination of the vascular access site must be 
furnished face-to-face ``hands on'' (without the use of an interactive 
telecommunications system) by physician, clinical nurse specialist 
(CNS), nurse practitioner (NP), or physician assistant (PA) (69 FR 
66278). On an interim basis in light of the PHE for the COVID-19 
pandemic, we are instead permitting the required clinical examination 
to be furnished as a Medicare telehealth service during the PHE for the 
COVID-19 pandemic. We note that sections 1881(b)(3) and 1834(m) of the 
Act allow an individual determined to have ESRD receiving home dialysis 
to choose to receive certain monthly ESRD-related clinical assessments 
via telehealth on or after January 1, 2019. The Bipartisan Budget Act 
of 2018 (Pub. L. 115-123, enacted on February 9, 2018) (BBA of 2018) 
amended section 1881(b)(3)(B) of the Act to require that such an 
individual must receive a face-to-face visit, without the use of 
telehealth, at least monthly in the case of the initial 3 months of 
home dialysis and at least once every 3 consecutive months after the 
initial 3 months. Due to the conditions presented by the PHE, we are 
also exercising enforcement discretion on an interim basis to relax 
enforcement in connection with the requirements under section 
1881(b)(3)(B) of the Act that certain visits be furnished without the 
use of telehealth for services furnished during the PHE. Specifically, 
CMS will not conduct review to consider whether those visits were 
conducted face-to-face, without the use of telehealth. The following 
CPT codes, when furnished via Medicare telehealth, are impacted by 
these policies:
     90951 (End-stage renal disease (ESRD) related services 
monthly, for patients younger than 2 years of age to include monitoring 
for the adequacy of nutrition, assessment of growth and development, 
and counseling of parents; with 4 or more face-to-face visits by a 
physician or other qualified health care professional per month)
     90952 (End-stage renal disease (ESRD) related services 
monthly, for patients younger than 2 years of age to include monitoring 
for the adequacy of nutrition, assessment of growth and development, 
and counseling of parents; with 2-3 face-to-face visits by a physician 
or other qualified health care professional per month)
     90953 (End-stage renal disease (ESRD) related services 
monthly, for patients younger than 2 years of age to include monitoring 
for the adequacy of nutrition, assessment of growth and development, 
and counseling of parents; with 1 face-to-face visit by a physician or 
other qualified health care professional per month)
     90954 (End-stage renal disease (ESRD) related services 
monthly, for patients 2-11 years of age to include monitoring for the 
adequacy of nutrition, assessment of growth and development, and 
counseling of parents; with 4 or more face-to-face visits by a 
physician or other qualified health care professional per month)
     90955 (End-stage renal disease (ESRD) related services 
monthly, for patients 2-11 years of age to include monitoring for the 
adequacy of nutrition, assessment of growth and development, and 
counseling of parents; with 2-3 face-to-face visits by a physician or 
other qualified health care professional per month)
     90957 (End-stage renal disease (ESRD) related services 
monthly, for patients 12-19 years of age to include monitoring for the 
adequacy of nutrition, assessment of growth and development, and 
counseling of parents; with 4 or more face-to-face visits by a 
physician or other qualified health care professional per month)
     90958 (End-stage renal disease (ESRD) related services 
monthly, for patients 12-19 years of age to include monitoring for the 
adequacy of nutrition, assessment of growth and development, and 
counseling of parents; with 2-3 face-to-face visits by a physician or 
other qualified health care professional per month)
     90959 (End-stage renal disease (ESRD) related services 
monthly, for patients 12-19 years of age to include monitoring for the 
adequacy of nutrition, assessment of growth and development, and 
counseling of parents; with 1 face-to-face visit by a physician or 
other qualified health care professional per month)
     90960 (End-stage renal disease (ESRD) related services 
monthly, for patients 20 years of age and older; with 4 or more face-
to-face visits by a physician or other qualified health care 
professional per month)
     90961 (End-stage renal disease (ESRD) related services 
monthly, for patients 20 years of age and older; with

[[Page 19243]]

2-3 face-to-face visits by a physician or other qualified health care 
professional per month)
     90962 (End-stage renal disease (ESRD) related services 
monthly, for patients 20 years of age and older; with 1 face-to-face 
visit by a physician or other qualified health care professional per 
month)
     90963 (End-stage renal disease (ESRD) related services for 
home dialysis per full month, for patients younger than 2 years of age 
to include monitoring for the adequacy of nutrition, assessment of 
growth and development, and counseling of parents)
     90964 (End-stage renal disease (ESRD) related services for 
home dialysis per full month, for patients 2-11 years of age to include 
monitoring for the adequacy of nutrition, assessment of growth and 
development, and counseling of parents)
     90965 (End-stage renal disease (ESRD) related services for 
home dialysis per full month, for patients 12-19 years of age to 
include monitoring for the adequacy of nutrition, assessment of growth 
and development, and counseling of parents)
     90966 (End-stage renal disease (ESRD) related services for 
home dialysis per full month, for patients 20 years of age and older)
     90967 (End-stage renal disease (ESRD) related services for 
dialysis less than a full month of service, per day; for patients 
younger than 2 years of age)
     90968 (End-stage renal disease (ESRD) related services for 
dialysis less than a full month of service, per day; for patients 2-11 
years of age)
     90969 (End-stage renal disease (ESRD) related services for 
dialysis less than a full month of service, per day; for patients 12-19 
years of age)
     90970 (End-stage renal disease (ESRD) related services for 
dialysis less than a full month of service, per day; for patients 20 
years of age and older)

C. Telehealth Modalities and Cost-Sharing

1. Clarifying Telehealth Technology Requirements
    Our regulation at Sec.  410.78(a)(3) states that telephones, 
facsimile machines, and electronic mail systems do not meet the 
definition of an interactive telecommunications systems for purposes of 
Medicare telehealth services. As we interpret it, this regulation does 
not apply to mobile computing devices that include audio and video 
real-time interactive capabilities, even though such devices are now 
referred to colloquially as ``phones'' since they can also be used for 
audio-only telecommunications. In light of the PHE for the COVID-19 
pandemic, we believe it is important to avoid the potential perception 
that this language might prohibit use of any device that could 
otherwise meet the interactive requirements for Medicare telehealth, 
especially given that leveraging use of such readily available 
technology may be of critical importance.
    Therefore, we are revising Sec.  410.78(a)(3) to add an exception 
to this language on an interim basis for the duration of the PHE for 
the COVID-19 pandemic providing that for the duration of the public 
health emergency as defined in Sec.  400.200, ``interactive 
telecommunications system'' means multimedia communications equipment 
that includes, at a minimum, audio and video equipment permitting two-
way, real-time interactive communication between the patient and 
distant site physician or practitioner.
    In addition, the HHS Office for Civil Rights (OCR) is exercising 
enforcement discretion and waiving penalties for HIPAA \4\ violations 
against health care providers that serve patients in good faith through 
everyday communications technologies, such as FaceTime or Skype, during 
the PHE for the COVID-19 pandemic. For more information, see https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/index.html. While OCR is not imposing penalties for 
noncompliance with the regulatory requirements under HIPAA against 
covered providers in connection with the good faith provision of 
telehealth during the PHE for the COVID-19 pandemic, HHS, OIG, and DOJ 
continue to actively monitor for any healthcare fraud and abuse, 
including potential Medicare coronavirus scams.
---------------------------------------------------------------------------

    \4\ Health Insurance Portability and Accountability Act of 1996 
(Pub. L. 104-191, enacted August 21, 1996).
---------------------------------------------------------------------------

2. Beneficiary Cost-Sharing

    In response to the unique circumstances resulting from the outbreak 
of COVID-19 and the Secretary's January 31, 2020 determination under 
section 319 of the Public Health Service Act that a PHE exists and has 
existed since January 27, 2020 (COVID-19 Declaration), the Office of 
Inspector General (OIG) issued a Policy Statement \5\ to notify 
physicians and other practitioners that they will not be subject to 
administrative sanctions for reducing or waiving any cost-sharing 
obligations Federal health care program beneficiaries may owe for 
telehealth services furnished consistent with the then applicable 
coverage and payment rules. OIG's Policy Statement is not limited to 
the services governed by Sec.  410.78 but applies to a broad category 
of non-face-to-face services furnished through various modalities, 
including telehealth visits, virtual check-in services, e-visits, 
monthly remote care management, and monthly remote patient monitoring. 
The Policy Statement applies to a physician or other practitioner 
billing for services provided remotely through information or 
communication technology or a hospital or other eligible individual or 
entity billing on behalf of the physician or practitioner for such 
services when the physician or other practitioner has reassigned his or 
her right to receive payments to such individual or entity.
---------------------------------------------------------------------------

    \5\ https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/policy-telehealth-2020.pdf.
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D. Communication Technology-Based Services (CTBS)

    In the ``Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2019; 
Medicare Shared Savings Program Requirements; Quality Payment Program; 
Medicaid Promoting Interoperability Program; Quality Payment Program-
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS 
Payment Year; Provisions From the Medicare Shared Savings Program-
Accountable Care Organizations-Pathways to Success; and Expanding the 
Use of Telehealth Services for the Treatment of Opioid Use Disorder 
Under the Substance Use-Disorder Prevention That Promotes Opioid 
Recovery and Treatment (SUPPORT) for Patients and Communities Act'' 
final rule (83 FR 59452 through 60303) (hereinafter referred to as the 
CY 2019 PFS final rule), we noted that under current PFS payment rules, 
Medicare routinely pays for many kinds of services that are furnished 
via telecommunications technology (83 FR 59482), but are not considered 
Medicare telehealth services. These communication technology-based 
services (CTBS) include, for example, certain kinds of remote patient 
monitoring (either as separate services or as parts of bundled 
services), and interpretations of diagnostic tests when furnished 
remotely. These services are different than the kinds of services 
specified in section 1834(m) of the Act, in that they are not the kind 
of services that are ordinarily furnished in person but are routinely 
furnished using a telecommunications system.
    In the CY 2019 PFS final rule, we finalized separate payment for a 
number

[[Page 19244]]

of services that could be furnished via telecommunications technology, 
but that are not Medicare telehealth services. Specifically, we 
finalized Healthcare Common Procedure Coding System (HCPCS) code G2010 
(Remote evaluation of recorded video and/or images submitted by an 
established patient (e.g., store and forward), including interpretation 
with follow-up with the patient within 24 business hours, not 
originating from a related E/M service provided within the previous 7 
days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment), and HCPCS code G2012 (Brief 
communication technology-based service, e.g. virtual check-in, by a 
physician or other qualified health care professional who can report 
evaluation and management services, provided to an established patient, 
not originating from a related E/M service provided within the previous 
7 days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 5-10 minutes of medical 
discussion). We finalized these codes as part of the set of codes that 
is only reportable by the physicians and practitioners who can furnish 
evaluation and management (E/M) services. We stated that we believed 
this was appropriate since the service describes a check-in directly 
with the billing practitioner to assess whether an office visit is 
needed. However, we did note that similar check-ins provided by nurses 
and other clinical staff can be important aspects of coordinated 
patient care (83 FR 59486).
    We also finalized that these services be limited to established 
patients, and that beneficiary consent must be documented in the 
patient's medical record for each service (83 FR 59487). This latter 
provision was amended in the CY PFS 2020 final rule to allow for a 
single beneficiary consent to be obtained annually (84 FR 62699). These 
requirements also apply to monthly care management and remote patient 
monitoring services.
    In the context of the PHE for the COVID-19 pandemic, when brief 
communications with practitioners and other non-face-to-face services 
might mitigate the need for an in-person visit that could represent an 
exposure risk for vulnerable patients, we believe that these services 
should be available to as large a population of Medicare beneficiaries 
as possible. In some cases, use of telecommunication technology could 
mitigate the exposure risk, and in such cases, the clinical benefit of 
using technology to furnish the service is self-apparent. This would be 
especially true should a significant increase in the number of people 
or health care professionals needing treatment or isolation occur in a 
way that would limit access to brief communications with established 
providers. Therefore, on an interim basis, during the PHE for the 
COVID-19 pandemic, we are finalizing that these services, which may 
only be reported if they do not result in a visit, including a 
telehealth visit, can be furnished to both new and established 
patients. We are also making clear that the consent to receive these 
services can be documented by auxiliary staff under general 
supervision. While we continue to believe that beneficiary consent is 
necessary so that the beneficiary is notified of any applicable cost 
sharing, we do not believe that the timing or manner in which 
beneficiary consent is acquired should interfere with the provision of 
one of these services. Therefore, we are finalizing on an interim basis 
during the PHE for the COVID-19 pandemic that, while consent to receive 
these services must be obtained annually, it may be obtained at the 
same time that a service is furnished. We are also re-emphasizing that 
this consent may be obtained by auxiliary staff under general 
supervision, as well as by the billing practitioner. We are retaining 
the requirement that in instances when the brief communication 
technology-based service originates from a related E/M service 
(including one furnished as a telehealth service) provided within the 
previous 7 days by the same physician or other qualified health care 
professional, that this service would be considered bundled into that 
previous E/M service and would not be separately billable.
    In the ``Medicare Program; CY 2020 Revisions to Payment Policies 
Under the Physician Fee Schedule and Other Changes to Part B Payment 
Policies; Medicare Shared Savings Program Requirements; Medicaid 
Promoting Interoperability Program Requirements for Eligible 
Professionals; Establishment of an Ambulance Data Collection System; 
Updates to the Quality Payment Program; Medicare Enrollment of Opioid 
Treatment Programs and Enhancements to Provider Enrollment Regulations 
Concerning Improper Prescribing and Patient Harm; and Amendments to 
Physician Self-Referral Law Advisory Opinion Regulations Final Rule'' 
(84 FR 62568, November 15, 2019) (hereinafter referred to as the CY 
2020 PFS final rule), we finalized separate payment for CPT codes 99421 
(Online digital evaluation and management service, for an established 
patient, for up to 7 days, cumulative time during the 7 days; 5-10 
minutes), 99422 (Online digital evaluation and management service, for 
an established patient, for up to 7 days, cumulative time during the 7 
days; 11-20 minutes), and 99423 (Online digital evaluation and 
management service, for an established patient, for up to 7 days, 
cumulative time during the 7 days; 21 or more minutes). We also 
finalized separate payment for HCPCS codes G2061 (Qualified 
nonphysician healthcare professional online assessment and management, 
for an established patient, for up to seven days, cumulative time 
during the 7 days; 5-10 minutes), G2062 (Qualified nonphysician 
healthcare professional online assessment and management service, for 
an established patient, for up to seven days, cumulative time during 
the 7 days; 11-20 minutes), and G2063 (Qualified nonphysician qualified 
healthcare professional assessment and management service, for an 
established patient, for up to seven days, cumulative time during the 7 
days; 21 or more minutes) (84 FR 62796).
    In the context of the PHE for the COVID-19 pandemic, where 
communications with practitioners might mitigate the need for an in-
person visit that could represent an exposure risk for vulnerable 
patients, we do not believe the limitation of these services to 
established patients is warranted. While some of the code descriptors 
refer to ``established patient,'' during the PHE, we are exercising 
enforcement discretion on an interim basis to relax enforcement of this 
aspect of the code descriptors. Specifically, we will not conduct 
review to consider whether those services were furnished to established 
patients.
    Additionally, in the CY 2020 PFS final rule (84 FR 62796), we 
stated that HCPCS codes G2061-G2063, specific to practitioners who do 
not report E/M codes, may describe services outside the scope of 
current Medicare benefit categories and as such, may not be eligible 
for Medicare payment. We have received a number of questions regarding 
which benefit categories HCPCS codes G2061-G2063 fall under. In 
response to these requests, we are clarifying here that there are 
several types of practitioners who could bill for these service. For 
example, the services described by these codes could be furnished as 
licensed clinical social worker services, clinical psychologist 
services, physical therapist services, occupational therapist services, 
or speech language pathologist services, so practitioners that report 
services in

[[Page 19245]]

those benefit categories could also report these online assessment and 
management services.
    On an interim basis, during the PHE for the COVID-19 pandemic, we 
are also broadening the availability of HCPCS codes G2010 and G2012 
that describe remote evaluation of patient images/video and virtual 
check-ins. We recognize that in the context of the PHE for the COVID-19 
pandemic, practitioners such as licensed clinical social workers, 
clinical psychologists, physical therapists, occupational therapists, 
and speech-language pathologists might also utilize virtual check-ins 
and remote evaluations instead of other, in-person services within the 
relevant Medicare benefit to facilitate the best available appropriate 
care while mitigating exposure risks. We note that this is not an 
exhaustive list and we are seeking input on other kinds of 
practitioners who might be furnishing these kinds of services as part 
of the Medicare services they furnish in the context of the PHE for the 
COVID-19 pandemic.
    Further, to facilitate billing of the CTBS services by therapists 
for the reasons described above, we are designating HCPCS codes G2010, 
G2012, G2061, G2062, or G2063 as CTBS ``sometimes therapy'' services 
that would require the private practice occupational therapist, 
physical therapist, and speech-language pathologist to include the 
corresponding GO, GP, or GN therapy modifier on claims for these 
services. CTBS therapy services include those furnished to a new or 
established patients that the occupational therapist, physical 
therapist, and speech-language pathologist practitioner is currently 
treating under a plan of care.

E. Direct Supervision by Interactive Telecommunications Technology

    Many services paid under the PFS can be paid when provided under a 
level of physician or nonphysician practitioner (NPP) supervision 
rather than personal performance. In many cases, the supervision 
requirements in physician office settings necessitate the presence of 
the physician or NPP in a particular location, usually in the same 
location as the beneficiary when the service is provided. For example, 
as described at Sec.  410.26, services incident to a physicians' 
service usually require the direct supervision of a physician. As 
currently defined in Sec.  410.32(b)(3)(ii), direct supervision means 
that the physician must be present in the office suite and immediately 
available to furnish assistance and direction throughout the 
performance of the procedure. It does not mean that the physician must 
be present in the room when the procedure is performed.
    Given the circumstances of the PHE for the COVID-19 pandemic, we 
recognize that in some cases, the physical proximity of the physician 
or practitioner might present additional exposure risks, especially for 
high risk patients isolated for their own protection or cases where the 
practitioner has been exposed to the virus but could otherwise safely 
supervise from another location using telecommunications technology. In 
these cases, we believe that the current requirement would necessarily 
limit access to procedures and tests that could be appropriately 
supervised by a physician isolated for purposes of limiting exposure to 
COVID-19. For example, we consider the possibility that patients 
routinely receiving medically necessary physician-administered drugs at 
the office of a physician may lose access to the provision of that drug 
should the physician who regularly supervises the provision of that 
drug be isolated for purposes of minimizing exposure risks. Likewise, 
should that same patient need to be isolated for purposes of exposure 
risk based on presumed or confirmed COVID-19 infection, administering 
such a drug in the patient's home would require the billing 
professional to accompany the clinical staff to the patient's home, 
presumably with the necessary personal protective equipment (PPE) 
available to both the physician and the clinical staff.
    In some cases, depending upon the unique circumstances of 
individual patients and billing physicians, we believe that 
telecommunications technology could be used in a manner that would 
facilitate the physician's immediate availability to furnish assistance 
and direction without necessarily requiring the physician's physical 
presence in the location where the service is being furnished, such as 
the office suite or the patient's home. For example, we believe that 
use of real-time, audio and video telecommunications technology allows 
for a billing practitioner to observe the patient interacting with or 
responding to the in-person clinical staff through virtual means, and 
thus, their availability to furnish assistance and direction could be 
met without requiring the physician's physical presence in that 
location. We note that to be covered under Part B, drugs furnished 
``incident to'' are typically injectable drugs that are bought by the 
physician, in ordinary circumstances are administered in the 
physician's office, and then billed by the physician to the Medicare 
Administrative Contractor (MAC). By definition, ``incident to a 
physician's professional service'' requires the item or service to be 
billed by the physician. We also note that the supervision requirements 
that apply to both services incident to a physicians' service and 
diagnostic tests do not necessarily reflect the appropriate level of 
supervision for particular patients, services, and health care workers. 
Instead, we view these levels as the minimum possible requirement for 
provision of the service for purposes of Medicare payment. Likewise, 
even in the context of the PHE for the COVID-19 pandemic and the 
inherent exposure risks for Medicare beneficiaries, physicians and 
other health care providers, we believe that in many cases furnishing 
services without the physical presence of the physician in the same 
location would not be appropriate. However, we recognize that in some 
cases, technology would allow appropriate supervision without the 
physical presence of a physician. In the context of the PHE for the 
COVID-19 pandemic, given the risks of exposure, the immediate potential 
risk to needed medical care, the increased demand for health care 
professionals in the context of the PHE for the COVID-19 pandemic, and 
the widespread use of telecommunications technology, we believe that 
individual practitioners are in the best position to make decisions 
based on their clinical judgement in particular circumstances. 
Consequently, we are revising the definition of direct supervision to 
allow, for the duration of the PHE for the COVID-19 pandemic, direct 
supervision to be provided using real-time interactive audio and video 
technology. We are seeking information from commenters as to whether 
there should be any guardrails and what kind of risk might this policy 
introduce for beneficiaries while reducing risk of COVID-19 spread. We 
note that this change is limited to only the manner in which the 
supervision requirement can be met, and does not change the underlying 
payment or coverage policies related to the scope of Medicare benefits, 
including Part B drugs. We also note that any and all applicable rules 
regarding safe transportation and proper waste disposal continue to 
apply.
    We note that in specifying that direct supervision includes virtual 
presence through audio/video real-time communications technology during 
the PHE for the COVID-19 pandemic, this can include instances where the 
physician enters into a contractual arrangement for auxiliary personnel 
as

[[Page 19246]]

defined in Sec.  410.26(a)(1), to leverage additional staff and 
technology necessary to provide care that would ordinarily be provided 
incident to a physicians' service (including services that are allowed 
to be performed via telehealth). For example, physicians may enter into 
contractual arrangements with a home health agency (defined under 
section 1861(o) of the Act), a qualified infusion therapy supplier 
(defined under section 1861(iii)(3)(D) of the Act), or entities that 
furnish ambulance services in order to utilize their nurses or other 
clinical staff as auxiliary personnel under leased employment (Sec.  
410.26(a)(5)). In such instances, the provider/supplier would seek 
payment for any services they provided from the billing practitioner 
and would not submit claims to Medicare for such services. For 
telehealth services that need to be personally provided by a physician, 
such as an E/M visit, the physician would need to personally perform 
the E/M visit and report that service as a Medicare telehealth service. 
However, we acknowledge that there may be instances where the physician 
may want to use auxiliary personnel to be present in the home with the 
patient during the telehealth service, though this is not required for 
telehealth services under section 1834(m) of the Act. Other services, 
including both face-to-face and non-face-to-face services, could be 
provided incident to a physicians' service by a nurse or other 
auxiliary personnel, as long as the billing practitioner is providing 
appropriate supervision through audio/video real-time communications 
technology (or in person), when needed. We would not expect that 
services furnished at a patient's home incident to a physician service 
would usually occur during the same period as a home health episode of 
care, and we will be monitoring claims to ensure that services are not 
being inappropriately unbundled from payments under the home health 
PPS.
    For the reasons discussed above, on an interim basis for the 
duration of the PHE for the COVID-19 pandemic, we are altering the 
definition of direct supervision at Sec.  410.32(b)(3)(ii), to state 
that necessary presence of the physician for direct supervision 
includes virtual presence through audio/video real-time communications 
technology when use of such technology is indicated to reduce exposure 
risks for the beneficiary or health care provider. We are revising 
Sec.  410.32(b)(3)(ii) to include, during a PHE, as defined in Sec.  
400.200 of this chapter, the presence of the physician includes virtual 
presence through audio/video real-time communications technology when 
use of such technology is indicated to reduce exposure risks for the 
beneficiary or health care provider.
1. Supervision Changes for Certain Hospital and CAH Diagnostic and 
Therapeutic Services
    For all of the same reasons described above, we are adopting 
similar changes in the regulations at Sec.  410.28(e)(1) with respect 
to the supervision of diagnostic services furnished directly or under 
arrangement in the hospital or in an on-campus or off-campus outpatient 
department of the hospital, as defined in Sec.  413.65. We note that 
under current Medicare rules, most therapeutic services in the hospital 
require only general supervision and the supervision requirements for 
diagnostic services generally conform to the service-level supervision 
levels required for payment under the PFS. Because we have every reason 
to believe that potential exposure risks and limits on the availability 
of medical professionals could equally apply to hospital services, we 
are amending the definition of direct supervision for hospital services 
for the duration of the PHE for the COVID-19 pandemic so it continues 
to conform with the applicable definitions for services paid under the 
PFS. As stated above, we believe this change is necessary due to the 
circumstances of the PHE for the COVID-19 pandemic. Specifically, we 
recognize that in some cases, the physical proximity of the physician 
or practitioner might present additional exposure risks, especially for 
high risk patients isolated for their own protection or cases where the 
practitioner has been exposed to the virus but could otherwise safely 
supervise from another location using telecommunications technology. In 
these cases, we believe that the current definition would necessarily 
limit access to diagnostic procedures and tests that could be 
appropriately supervised by a physician, including one who is isolated 
for purposes of limiting exposure to COVID-19.
    In addition, with respect to pulmonary rehabilitation, cardiac 
rehabilitation, and intensive cardiac rehabilitation services described 
in the regulations at Sec. Sec.  410.47 and 410.49, respectively, we 
are adopting a similar change under Sec.  410.27(a)(1)(iv)(D), for the 
duration of the PHE for the COVID-19 pandemic, for all the reasons 
described above, to specify that direct supervision for these services 
includes virtual presence through audio/video real-time communications 
technology when use of such technology is indicated to reduce exposure 
risks for the beneficiary or health care provider.

F. Clarification of Homebound Status Under the Medicare Home Health 
Benefit

    Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act state that 
payment for home health services is made when a physician certifies 
that such services are or were required because the individual is or 
was confined to his home and needs or needed skilled nursing care 
(other than solely venipuncture for the purpose of obtaining a blood 
sample) on an intermittent basis or physical or speech therapy or, in 
the case of an individual who has been furnished home health services 
based on such a need and who no longer has such a need for such care or 
therapy, continues or continued to need occupational therapy. In 
addition, the physician must certify that a plan for furnishing such 
services to such individual has been established and is periodically 
reviewed by the physician and that such services are or were furnished 
while the individual was under the care of a physician. Also, in the 
case of a certification made by a physician after January 1, 2010, 
prior to making such certification the physician must document that the 
physician himself or herself, or an NP or clinical nurse specialist 
(CNS) (as those terms are defined in section 1861(aa)(5) of the Act) 
who is working in collaboration with the physician in accordance with 
State law, or a certified nurse-midwife (as defined in section 1861(gg) 
of the Act) as authorized by State law, or a PA (as defined in section 
1861(aa)(5) of the Act) under the supervision of the physician, has had 
a face-to-face encounter (including through use of telehealth, subject 
to the requirements in section 1834(m) of the Act, and other than for 
encounters that are incident to services involved, as described in 
section II.E. of this IFC) with the individual within a reasonable 
timeframe as determined by the Secretary.
    Most recently, we have been asked by stakeholders to provide more 
clarity on whether patients who are instructed to remain in their homes 
or are under ``self-quarantine'' are considered ``confined to the 
home'' or ``homebound'' for purposes of the Medicare home health 
benefit in the context of the PHE for the COVID-19 pandemic. Per 
sections 1814(a) and 1835(a) of the Act, an individual shall be 
considered to be ``confined to his home'' if the individual has a 
condition, due to an illness or injury, that restricts the ability of 
the individual to leave his

[[Page 19247]]

or her home except with the assistance of another individual or the aid 
of a supportive device (such as crutches, a cane, a wheelchair, or a 
walker), or if the individual has a condition such that leaving his or 
her home is medically contraindicated. While an individual does not 
have to be bedridden to be considered ``confined to his home'', the 
condition of the individual should be such that there exists a normal 
inability to leave home and, that leaving home requires a considerable 
and taxing effort by the individual.
    The definition of ``confined to the home'' (that is, ``homebound'') 
allows patients to be considered ``homebound'' if it is medically 
contraindicated for the patient to leave the home. As an example for 
the PHE for COVID-19 pandemic, this would apply for those patients: (1) 
Where a physician has determined that it is medically contraindicated 
for a beneficiary to leave the home because he or she has a confirmed 
or suspected diagnosis of COVID-19; or (2) where a physician has 
determined that it is medically contraindicated for a beneficiary to 
leave the home because the patient has a condition that may make the 
patient more susceptible to contracting COVID-19. A patient who is 
exercising ``self-quarantine'' for one's own safety would not be 
considered ``confined to the home'' unless a physician certifies that 
it is medically contraindicated for the patient to leave the home. For 
the PHE for the COVID-19 pandemic, the CDC is currently advising that 
older adults and individuals with serious underlying health conditions 
stay home (CDC's guidance is interim and is expected to continue to be 
updated as warranted).\6\ As such, we expect that many Medicare 
beneficiaries could be considered ``confined to the home''. However, 
determinations of whether home health services are reasonable and 
necessary, including whether the patient is homebound and needs skilled 
services, must be based on an assessment of each beneficiary's 
individual condition and care needs.
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    \6\ https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html.
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    In cases where it is medically contraindicated for the patient to 
leave the home, the medical record documentation for the patient must 
include information as to why the individual condition of the patient 
is such that leaving the home is medically contraindicated. With 
regards to a pandemic outbreak of an infectious disease, this can 
include reviewing and applying any guidance on risk assessment and 
public health management issued by the CDC. For example, the CDC 
interim guidance ``Preventing the Spread of Coronavirus Disease 2019 in 
Homes and Residential Communities'' applies for both confirmed or 
suspected COVID-19 states that patients who are medically stable enough 
to receive care in the home must isolate at home during their 
illness.\7\ Additionally, these guidelines state that patients should 
restrict activities outside the home, except for getting medical care. 
These restrictions include that the individual not go to work, school, 
or public areas, as well as avoiding use of public transportation, 
ride-sharing, or taxis; making it such that there exists a normal 
inability for an individual to leave home and leaving home would 
require a considerable and taxing effort.
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    In regards to those circumstances in which the patient does not 
have confirmed or suspected diagnosis of an infectious disease, such as 
COVID-19, but the patient's physician states that it is medically 
contraindicated for the patient to leave the home because the patient's 
condition may make the patient more susceptible to contracting a 
pandemic disease, the patient would be considered ``confined to the 
home'' or ``homebound'' for purposes of this eligibility requirement. 
For example, if a patient is having an exacerbation of chronic 
obstructive pulmonary disease (COPD) and the physician certifies that 
it is medically contraindicated to leave the home because the patient's 
compromised respiratory system makes him or her more likely to contract 
an infectious disease, such as COVID-19, the patient would be 
considered ``confined to the home'' in alignment with Medicare home 
health eligibility criteria. Another example of this type of scenario 
would be a cancer patient receiving chemotherapy treatment and where 
the physician states that it is medically contraindicated for the 
patient to leave the home because the patient may be more at risk of 
contracting an infectious disease because of the patient's 
immunocompromised state. In both examples, the medical contraindication 
makes it such that there exists a normal inability for an individual to 
leave home and leaving home safely would require a considerable and 
taxing effort.
    In addition to being considered ``confined to the home'' or 
``homebound'', the patient must meet the other Medicare home health 
eligibility requirements to receive Medicare home health services. That 
is, the beneficiary must be under the care of a physician; receiving 
services under a plan of care established and periodically reviewed by 
a physician; be in need of skilled nursing care on an intermittent 
basis or physical therapy or speech-language pathology; or have a 
continuing need for occupational therapy. Even if the patient is 
confined to the home because of a suspected diagnosis of an infectious 
disease as part of a pandemic event, a home health visit solely to 
obtain a nasal or throat culture would not be considered a skilled 
service because it would not require the skills of a nurse to obtain 
the culture as the specimen could be obtained by an appropriately-
trained medical assistant or laboratory technician. However, a home 
health nurse, during an otherwise covered skilled visit, could obtain 
the nasal or throat culture to send to the laboratory for testing. 
Please see section II.M. of this IFC for further discussion about how a 
Medicare patient without a skilled need who is under self-quarantine 
may be tested at home.
    We believe this clarification is not limited to the PHE for the 
COVID-19 pandemic, but would also apply for other outbreaks of an 
infectious disease and instances where the condition of a patient is 
such that it is medically contraindicated for the patient to leave his 
or her home. We solicit comments on this clarification.

G. The Use of Technology Under the Medicare Home Health Benefit During 
the PHE for the COVID-19 Pandemic

    Section 1895 of the Act outlines the statutory parameters of the 
home health prospective payment system (HH PPS) that was implemented on 
October 1, 2000. The HH PPS provides payment for all services furnished 
under the Medicare home health benefit as outlined in section 1861(m) 
of the Act in the form of a ``bundled'' 30-day unit of payment that is 
adjusted for case-mix and area wage differences in accordance with 
section 1895(b) of the Act. Section 1895(e)(1)(A) of the Act states 
that nothing under section 1895 of the Act prevents a home health 
agency (HHA) from furnishing services via a telecommunications system, 
as long as such services do not: (1) Substitute for in-person home 
health services ordered as part of a plan of care certified by a 
physician; and (2) are not considered a home health visit for purposes 
of eligibility or payment. In the CY 2019 HH PPS proposed rule (83 FR 
32425), we stated that ``remote patient monitoring'' is one type of 
service that can be furnished via a telecommunications system to 
augment a home health plan of care without

[[Page 19248]]

substituting for an in-person visit. In the CY 2019 HH PPS final rule 
with comment (83 FR 56527), for purposes of the Medicare home health 
benefit, we finalized the definition of ``remote patient monitoring'' 
in regulation at 42 CFR 409.46(e) as the collection of physiologic data 
(for example, ECG, blood pressure, glucose monitoring) digitally stored 
and/or transmitted by the patient and/or caregiver to the HHA. We also 
included in regulation at Sec.  409.46(e) that the costs of remote 
patient monitoring are considered allowable administrative costs 
(operating expenses) if remote patient monitoring is used by the HHA to 
augment the care planning process (83 FR 56527).
    We received positive feedback from the policy changes finalized in 
the CY 2019 HH PPS final rule with comment period. Commenters 
encouraged us to even go further in adopting and promoting technology 
use in home health. Recently, we have been asked by stakeholders to 
provide more clarity on how HHAs can leverage technology to keep home 
health clinicians and patients safe during outbreaks of an infectious 
disease, such as the PHE for the COVID-19 pandemic. While we remain 
statutorily-prohibited from paying for home health services furnished 
via a telecommunications system if such services substitute for in-
person home health services ordered as part of a plan of care and for 
paying directly for such services under the home health benefit, for 
the duration of the PHE for the COVID-19 pandemic, we are amending the 
regulations at Sec.  409.43(a) on an interim basis to provide HHAs with 
the flexibility, in addition to remote patient monitoring, to use 
various types of telecommunications systems (that is, technology) in 
conjunction with the provision of in-person visits. Specifically, we 
are amending the regulations at Sec.  409.43(a) on an interim basis to 
state that the use of technology must be related to the skilled 
services being furnished by the nurse/therapist/therapy assistant to 
optimize the services furnished during the home visit or when there is 
a home visit. We are also amending the regulations at Sec.  409.43(a) 
on an interim basis to state that the use of technology must be 
included on the home health plan of care along with a description of 
how the use of such technology will help to achieve the goals outlined 
on the plan of care without substituting for an in-person visit as 
ordered on the plan of care. As a reminder, the plan of care must be 
signed prior to submitting a final claim to Medicare for payment (Sec.  
409.43(c)(2)); therefore, HHAs have flexibility on the timing in which 
they obtain physician signatures for changes to the plan of care when 
incorporating the use of technology into the patient's plan of care. In 
addition, HHAs may also provide services based on verbal orders in 
accordance with the regulations at Sec. Sec.  484.60(b) and 409.43(d). 
Finally, on an interim basis HHAs can report the costs of 
telecommunications technology as allowable administrative and general 
(A&G) costs by identifying the costs using a subscript between line 
5.01 through line 5.19.
    We reiterate that by law the use of technology may not substitute 
for an in-person home visit ordered as part of the plan of care and 
services furnished via a telecommunications system cannot be considered 
a home health visit for purposes of eligibility or payment. However, we 
acknowledge that the use of such technology may result in changes to 
the frequency or types of visits outlined on the plan of care, 
especially to combat the PHE for the COVID-19 pandemic. For example, a 
patient recently discharged from the hospital after coronary bypass 
surgery was receiving home health skilled nursing visits three times a 
week for medication management, teaching and assessment. The patient 
developed a fever, cough, sore throat and moderate shortness of breath 
and now has a confirmed COVID-19 diagnosis, which the doctor has 
determined can be safely managed at home with home health services. The 
patient has been prescribed new medications for symptom management and 
oxygen therapy to support the patient's respiratory status. The 
patient's home health plan of care was updated to include an in-person 
skilled nursing visit once a week to assess the patient and to monitor 
for worsening symptoms. The plan of care was updated also to include a 
video consultation twice a week between the skilled nurse and the 
patient for medication management, teaching and assessment, as well as 
to obtain oxygen saturation readings that the patient relays to the 
nurse during the consultation.
    With regards to payment under the HH PPS, if the primary reason for 
home health care is to provide care to manage the symptoms resulting 
from COVID-19, this 30-day period of care would be grouped into the 
Medication, Management, Teaching and Assessment (MMTA)--Respiratory 
clinical group, and it would be an early 30-day period of care with an 
institutional admission source. Assuming a medium functional impairment 
level with ``low'' comorbidities, the low-utilization payment 
adjustment (LUPA) threshold would be 4 visits. Regardless if the 
patient continued to receive the original 3 in-person skilled nursing 
visits per week (12 visits total in the 30-day period) rather than the 
once per-week in-person skilled nursing visits (4 visits total in the 
30-day period) the HHA would still receive the full 30-day payment 
amount (rather than paying per visit if the total number of visits was 
below the LUPA threshold). In this example, the use of technology is 
not a substitute for the provision of in-person visits as ordered on 
the plan of care, as the plan of care was updated to reflect a change 
in the frequency of the in-person visits and to include ``virtual 
visits'' as part of the management of the home health patient.
    As discussed previously in section II.E ``Direct Supervision by 
Interactive Telecommunications Technology'' in this IFC, there may be 
instances during the PHE for the COVID-19 pandemic where physicians can 
enter into a contractual arrangement, that meets the definition of 
auxiliary personnel at Sec.  410.26, with another provider/supplier 
type. For example, physicians may enter into contractual arrangements 
with a HHA, a qualified infusion therapy supplier, or other entity to 
leverage auxiliary personnel under leased employment (Sec.  
410.26(a)(5)), including nurses or other clinical staff, to provide 
virtual visits for patients in their homes. These virtual visits are 
considered provided incident to a physician's service, as long as the 
billing practitioner is providing appropriate supervision through 
audio/video real-time communications technology, when needed. Payment 
for such services would be made to the billing practitioner who would 
then make the appropriate payment to the contracted entity (for 
example, the HHA). This payment would be made in accordance with the 
PFS and would not be considered a home health service under the 
Medicare home health benefit. This particular flexibility can enable 
more patients to receive services at home via telehealth for instances 
in which there are no in-person visits that would trigger payment under 
the Medicare HH PPS. As such, we would not expect that services 
furnished at a patient's home incident to a physician service will 
usually occur during the same period as a home health episode of care, 
and we will be monitoring claims that practitioners are billing under 
arrangement to ensure appropriate

[[Page 19249]]

services are being billed by the practitioner and not being 
inappropriately unbundled from payments under the HH PPS.
    The remainder of this section includes information on examples of 
technology that can be leveraged in providing care in the home setting, 
such as telemedicine, interactive clinician ``consulting'' and other 
patient-facing technologies; and provides a summary of the regulations 
text we are amending in this IFC.
    In general, technology has become an integral part of medicine 
across the entire spectrum of healthcare. Telemedicine, in particular 
has the potential to play a large role in enhancing the delivery of 
healthcare in the home for Medicare beneficiaries, including the 
provision of information, education, and services provided via 
telecommunications systems. One of the biggest benefits of 
telemedicine, separate from its potential to minimize risk to 
clinicians and patients during an outbreak of an infectious disease, is 
to increase access to healthcare to geographically disadvantaged and 
medically underserved populations, providing an improved quality of 
care.\8\ Telemedicine and remote monitoring can also be used to 
encourage patient involvement and autonomy, and to increase the tools 
available for the home health provider.
---------------------------------------------------------------------------

    \8\ Int J Environ Res Public Health. 2013 Dec; 10(12): 6472-
6484. Published online 2013 Nov 28. doi: 10.3390/ijerph10126472.
---------------------------------------------------------------------------

    Recent CMS site visits with HHAs, as well as meetings with industry 
associations detailed the extent to which HHAs are researching and 
integrating technology into their care. These organizations provided 
examples of technology they have tested and/or are currently using, 
ranging from patient facing apps on cell phones to robotics. 
Additionally, they provided examples of patients with specific home 
health needs that they believe would benefit most from leveraging 
technology in home health care. They indicated a wide variety of uses 
for technology in home health including medication management and 
teaching, behavioral/crisis or social work counseling, post-transplant 
monitoring, dietary counseling, and even functional training through 
remote occupational or physical therapy. In particular, they 
highlighted certain diagnoses and conditions for which they are already 
utilizing telecommunications systems. For diagnoses/conditions such as 
COPD, congestive heart failure (CHF), sepsis, and wounds, technology 
can offer an efficient way of monitoring chronic respiratory and 
cardiovascular diseases that represent an increasingly high burden on 
healthcare systems.\9\ We referenced some of the benefits of remote 
patient monitoring of chronic diseases in the CY 2019 HH PPS proposed 
rule (83 FR 32425), including readmission prevention and improved 
patient involvement and accountability.
---------------------------------------------------------------------------

    \9\ Breathe (Sheff). 2016 Dec; 12(4): 350-356. doi: 10.1183/
20734735.014616.
---------------------------------------------------------------------------

    Certain HHAs and industry groups have implemented technology that 
goes beyond remote patient monitoring for the treatment of chronic 
diseases. One such HHA utilizes two-way, interactive ``consulting'' 
between the nurse furnishing the home visit and a specialty clinician 
at the agency. The nurse furnishing the home visit can use a tablet to 
visually connect the patient with the specialty clinician or advanced 
practice nurse at the agency to assess swelling, breathing, or to 
review and reconcile medications. These specialty clinicians are also 
beneficial in treating acute conditions, such as wounds, or monitoring 
for the prevention of sepsis. Wound, Ostomy, and Continence Nurses 
(WOCNs) are being utilized for their specialized skills as consultants 
for the nurse in the home. The nurse furnishing the home visit can use 
a tablet to connect visually with the WOCN at the agency to consult on 
the management of the wound. If necessary, the WOCN can contact the 
physician or surgeon to relay progress or request a change in 
treatment. Specialized software can even be utilized to assess the 
wound with precision and accuracy, including measuring surface area and 
depth, to improve consistency of care.\10\ Additionally, incorporating 
technology into home health may be beneficial in attracting these 
specialty clinicians, such as cardiac nurses and WOCNs, to homecare, 
which promotes the provision of a more advanced level of care; a 
benefit that will become imperative if the home health patient 
population, as a whole, exhibits more characteristics of an acute care 
population. Allowing advanced practice clinicians to consult virtually 
with the RN in the home may minimize transportation and labor costs and 
potentially improve patient access to specialty care.
---------------------------------------------------------------------------

    \10\ https://parablehealth.com/post-acute-inpatient.
---------------------------------------------------------------------------

    Telecommunications systems are also playing a valuable role in 
managing patients at risk for sepsis after a hospitalization. Sepsis 
continues to be a top diagnosis for hospital 30-day readmission rates 
amongst Medicare patients.\11\ Utilizing individualized software 
platforms to monitor appetite, mental changes, biometrics, etc., which 
alert care providers of any changes that may indicate a problem, can be 
helpful in treating the patient in the home prior to the patient 
requiring hospitalization. These patient-facing devices (tablets or 
apps) can be programmed to require the patient to perform a virtual 
daily ``check-in'' to monitor for potential issues. If the ``check-in'' 
goes beyond specified individualized parameters, an alert will signal 
the HHA to follow-up with the critical care team following the patient 
to accelerate treatment. The software can also be programmed to deliver 
specific care instructions and reminders regarding hygiene or 
medications. In addition to disease-specific monitoring, patient-facing 
technologies can also be integral in promoting patient involvement and 
compliance. Certain scheduling and communication platforms allow HHAs 
to interface with patients in more ways than in-person visits or 
telephone calls. Some devices can ``talk'' to the patient, even 
utilizing multiple languages. Others can provide medication reminders, 
daily health tips, and assist in arranging for community or caregiver 
support.
---------------------------------------------------------------------------

    \11\ https://www.hcup-us.ahrq.gov/reports/statbriefs/sb225-Inpatient-US-Stays-Trends.pdf.
---------------------------------------------------------------------------

    Overall, we have seen how technology can expand the reach of 
healthcare into the home, through consultation with specialized 
clinicians and critical care teams, as well as through the integration 
of devices designed to increase patient involvement and compliance. As 
outlined above, incorporating these various forms of technology, in 
addition to remote patient monitoring as defined under the home health 
benefit (Sec.  409.46(e)), can be appropriate in furnishing home health 
services when used in conjunction with the provision of in-person 
visits. In addition, technology can be used to minimize the risk of 
exposure to clinicians, patients, and the public during an outbreak of 
an infectious disease, such as the PHE for the COVID-19 pandemic. 
Although HHAs have the flexibility, in addition to remote patient 
monitoring, to use various types of technology, payment for home health 
services remains contingent on the furnishing of a visit. Therefore, 
the use of technology must be related to the skilled services being 
furnished by the nurse or therapist or therapy assistant to optimize 
the services furnished during the home visit or when there is a home 
visit. To be eligible for the home health benefit, beneficiaries must 
need intermittent

[[Page 19250]]

skilled nursing or therapy services and must be considered homebound. 
Covered home health services include skilled nursing, home health aide, 
physical therapy, speech-language pathology, occupational therapy, 
medical social services, and medical supplies, provided on a visiting 
basis in a place of residence such as the individual's home (section 
1861(m) of the Act). A visit is defined at Sec.  409.48(c) as an 
episode of personal contact with the beneficiary by staff of the HHA or 
others under arrangements with the HHA, for the purpose of providing a 
covered service. Generally, one visit may be covered each time an HHA 
employee or someone providing home health services under arrangement 
with the HHA enters the beneficiary's home and provides a covered 
service to a beneficiary.
    To appropriately recognize the role of technology in furnishing 
services under the Medicare home health benefit, the use of such 
technology must be included on the plan of care. The inclusion of 
technology on the plan of care must continue to meet the requirements 
at Sec.  484.60, and must be tied to the patient-specific needs as 
identified in the comprehensive assessment and the measurable outcomes 
that the HHA anticipates will occur as a result of implementing the 
plan of care. For example, if a physician orders an in-person skilled 
nursing visit once a week to assess the patient and to monitor for 
worsening symptoms and a video consultation twice a week between the 
skilled nurse and the patient for medication management, teaching and 
assessment, as well as to obtain oxygen saturation readings that the 
patient relays to the nurse during the consult; the plan of care could 
specify that the goal of the video consultation is to increase patient 
adherence with medication regimen and oxygen use with no worsening 
respiratory symptoms.
    In summary, we are amending the plan of care requirements at Sec.  
409.43(a) on an interim basis, for the purposes of Medicare payment, to 
state that the plan of care must include any provision of remote 
patient monitoring or other services furnished via a telecommunications 
system, and that these services cannot substitute for a home visit 
ordered as part of the plan of care and cannot be considered a home 
visit for the purposes of patient eligibility or payment. The plan of 
care must include a description of how the use of such technology will 
help to achieve the goals outlined on the plan of care. We believe that 
this change will help to increase access to technologies, such as 
telemedicine and remote patient monitoring, that enable the necessary 
flexibility for Medicare beneficiaries to be able to receive medically 
necessary services without jeopardizing their health or the health of 
those who are providing such services, while minimizing the overall 
risk to public health during the PHE for the COVID-19 pandemic. As we 
stated above, HHAs can report the costs of telecommunications 
technology as allowable A&G costs on an interim basis by identifying 
the costs using a subscript between line 5.01 through line 5.19. We 
invite feedback on our interim changes to the plan of care requirements 
at Sec.  409.43(a).

H. The Use of Telecommunications Technology Under the Medicare Hospice 
Benefit

    As outlined in section II.G. of this IFC, The Use of Technology 
Under the Medicare Home Health Benefit, technology has become an 
integral part of medicine across the entire spectrum of healthcare. 
Telemedicine, in particular has the potential to play a large role in 
enhancing the delivery of healthcare in the home, including the 
provision of information, education, and services provided via 
telecommunications systems. One of the benefits of telemedicine is its 
potential to minimize risk to clinicians and patients during an 
outbreak of an infectious disease, such as the PHE for the COVID-19 
pandemic. Recently, we have been asked by stakeholders to provide more 
clarity on how hospices can leverage technology to keep clinicians and 
patients safe during the PHE for the COVID-19 pandemic.
    For the duration of the PHE for the COVID-19 pandemic, we are 
amending the hospice regulations at 42 CFR 418.204 on an interim basis 
to specify that when a patient is receiving routine home care, hospices 
may provide services via a telecommunications system if it is feasible 
and appropriate to do so to ensure that Medicare patients can continue 
receiving services that are reasonable and necessary for the palliation 
and management of a patients' terminal illness and related conditions 
without jeopardizing the patients' health or the health of those who 
are providing such services during the PHE for the COVID-19 pandemic. 
To appropriately recognize the role of technology in furnishing 
services under the hospice benefit, the use of such technology must be 
included on the plan of care. The inclusion of technology on the plan 
of care must continue to meet the requirements at Sec.  418.56, and 
must be tied to the patient-specific needs as identified in the 
comprehensive assessment and the measurable outcomes that the hospice 
anticipates will occur as a result of implementing the plan of care. 
The following is an example of where it could be appropriate to furnish 
hospice services via a telecommunications system during the PHE for the 
COVID-19 pandemic:

    A terminally ill 85-year-old male with heart failure has been 
receiving hospice services and recently developed a fever, sore 
throat and cough. The patient has been diagnosed with suspected 
COVID-19 and his hospice plan of care now includes medications for 
symptom management. He is mildly short of breath but does not 
require supportive oxygen therapy. The patient's wife is concerned 
about potential for worsening cardiac and respiratory symptoms as a 
result of the patient's risk for increased complications due to 
COVID-19. The hospice plan of care has been updated to include 
remote patient monitoring with a telecommunications system to assess 
the patient's daily weight and oxygen saturation levels. The plan of 
care identifies the measurable goal that the patient will maintain 
an oxygen level above 92 percent and the patient will not gain more 
than 2 pounds in a 24-hour period. The plan of care identifies 
interventions if either of these goals are not met. The remote 
patient monitoring allows for more expedited modifications to the 
plan of care in response to the patient's changing needs.

    We believe that this clarification in the regulations at Sec.  
418.204 will help to increase access to technologies, such as 
telemedicine and remote patient monitoring, that enable the necessary 
flexibility for patients to be able to receive necessary services 
without jeopardizing their health or the health of those who are 
providing those services, while minimizing the overall risk to public 
health during the PHE for the COVID-19 pandemic. Hospices are paid a 
per diem payment amount based on the level of care for each day that a 
patient is under a hospice election (Sec.  418.302). There is no 
payment beyond the per diem amount for the use of technology in 
providing services under the hospice benefit. For the purposes of the 
hospice claim submission, only in-person visits (with the exception of 
social work telephone calls) should be reported on the claim. However, 
hospices can report the costs of telecommunications technology used to 
furnish services under the routine home care level of care during the 
PHE for the COVID-19 pandemic as ``other patient care services'' using 
Worksheet A, cost center line 46, or a subscript of line 46 through 
46.19, cost center code 4600 through 4619, and identifying this cost 
center as ``PHE for COVID-19''. We invite feedback on our changes to 
the

[[Page 19251]]

special requirements for coverage at Sec.  418.204.

I. Telehealth and the Medicare Hospice Face-to-Face Encounter 
Requirement

    To receive hospice services under the Medicare hospice benefit, a 
beneficiary must be certified as terminally ill with a medical 
prognosis of a life expectancy of 6 months or less if the illness runs 
its normal course, in accordance with section 1814(a)(7) of the Act and 
as codified in Sec.  418.22. A written certification is required at the 
beginning of the first 90-day period of hospice care, a subsequent 90-
day period and each 60-day period thereafter. The hospice must obtain 
written certification of terminal illness for each benefit period, even 
if a single election continues in effect. In accordance with section 
1814(a)(7)(D)(i) of the Act, a hospice physician or hospice NP must 
have a face-to-face encounter with each Medicare hospice patient whose 
total stay across all hospices is anticipated to reach the 3rd benefit 
period. The face-to-face encounter must occur prior to, but no more 
than 30 calendar days prior to, the 3rd benefit period recertification, 
and every benefit period recertification thereafter, to gather clinical 
findings to determine continued eligibility for hospice care.
    The Medicare hospice face-to-face encounter is an administrative 
requirement related to certifying the terminal illness as required in 
section 1814(a)(7)(D)(i) of the Act. By itself, it is not billable, as 
it is considered administrative (see Pub. 100-04, Medicare Claims 
Processing Manual, chapter 11, section 40.1.1). However, if a hospice 
physician, or a hospice NP who is also the patient's designated 
attending physician, provides reasonable and necessary non-
administrative patient care during the face-to-face visit, that portion 
of the visit would be billable under the Medicare rules. There are 
additional requirements for billing physician services provided by NPs 
(see Pub. 100-04, chapter 11, section 40.1.3.2). Therefore, if a 
hospice physician or the hospice NP acting as the patient's designated 
attending physician provides direct patient care during the course of 
the face-to-face encounter, the physician or NP may bill for such 
direct care services for Medicare beneficiaries under the PFS. As a 
reminder, the hospice benefit defines an ``attending physician'' as a 
doctor of medicine or osteopathy, an NP, or a PA designated by the 
individual at the time he or she elects to receive hospice care as 
having the most significant role in the determination and delivery of 
the individual's medical care (Sec.  418.3). However, we note that PAs 
are not authorized to perform the required face-to-face encounter under 
section 1814(a)(7)(D)(i) of the Act. In the event of a pandemic 
outbreak of an infectious disease, such as COVID-19, an example of 
direct patient care during the course of an in-person face-to-face 
visit for recertification for Medicare beneficiaries could be as 
follows:

    An 85-year-old male with a primary diagnosis of end stage heart 
failure with diabetes, peripheral vascular disease, and hypertension 
is being seen by the hospice physician for hospice recertification 
and has developed a fever, cough and mild shortness of breath over 
the last 24 hours. After discussion with his caregiver, the hospice 
physician discovers that the patient had a visit from his niece who 
was found to be COVID-19 positive. The physician washes his hands, 
puts on gloves and then places a mask on himself, the patient and 
caregiver. After examining the patient, the physician discusses with 
the patient and caregiver if he would like to be tested for COVID-19 
and if he would like to continue to be treated at home. The patient 
decides that he would like to be treated at home and that he would 
like to be tested. The nasopharyngeal and oropharyngeal swabs are 
performed. The hospice physician discusses with the patient's 
caregiver infection control techniques, symptomatic treatment, and 
provides them with gloves and disposable masks. During the course of 
this recertification visit, the hospice physician provided direct 
patient care, and therefore, can bill for such services.

    While we do not believe that direct patient care for Medicare 
hospice patients will typically be furnished via telehealth, we note 
that nothing in statute or regulation precludes a hospice designated 
attending physician from furnishing services via telehealth in 
accordance with section 1834(m) of the Act. In response to the PHE for 
the COVID-19 pandemic, The Coronavirus Preparedness and Response 
Supplemental Appropriations Act, 2020 was signed into law on March 6, 
2020. Section 102 of the Coronavirus Preparedness and Response 
Supplemental Appropriations Act, 2020 gives the Secretary the authority 
to waive: (1) The telehealth originating site requirements under 
section 1834(m)(4)(C) of the Act (both geographic and site of service) 
for telehealth services furnished in an emergency area; and (2) the 
restriction on use of a telephone for furnishing telehealth services 
(in Sec.  410.78(a)(3)), but only if the telephone has audio and video 
capabilities that are used for two-way, real-time interactive 
communication. The originating site facility fee would be paid to 
originating sites on the current list of permissible sites (except for 
the patient's home) in any geographic location. The provision 
established a definition of ``qualified providers'' that specifies the 
practitioners eligible for furnishing distant site services under the 
waiver. Specifically, the practitioners currently permitted to furnish 
distant site telehealth services under section 1834(m) of the Act--
physicians (as defined in section 1861(r) of the Act) and NPPs (as 
defined in section 1842(b)(18)(C) of the Act)--would be eligible to 
furnish telehealth services under the waiver to patients with an 
established relationship with the practitioner or a practitioner in the 
same practice (defined by tax identification number (TIN)). This would 
be determined based on a patient for whom Medicare payment was made for 
an item or service furnished by the practitioner (or another 
practitioner within the same practice) within the previous 3 years.\12\ 
The telehealth waiver is in effect and is limited to the PHE for the 
COVID-19 pandemic.
---------------------------------------------------------------------------

    \12\ We note that HHS will not conduct audits to ensure that 
such prior relationship existed for claims submitted during this 
PHE. Also, effective immediately, the HHS Office for Civil Rights 
(OCR) will exercise enforcement discretion and waive penalties for 
HIPAA violations against health care providers that serve patients 
in good faith through everyday communications technologies, such as 
FaceTime or Skype, during the COVID-19 nationwide PHE.
---------------------------------------------------------------------------

    The statute is silent as to whether a face-to-face encounter solely 
for the purpose of Medicare hospice recertification (meaning there is 
no direct patient care) could be conducted via telecommunications 
technology by the hospice physician or NP. Given that a face-to-face 
visit solely for the purpose of recertification for Medicare hospice 
services is considered an administrative requirement related to 
certifying the terminal illness as required in section 1814(a)(7)(D)(i) 
of the Act, we believe that such visit could be performed via 
telecommunications technology as a result of the PHE for the COVID-19 
pandemic. We recognize that public exposure during a pandemic event of 
an infectious disease greatly increases the overall risk to public 
health and terminally ill patients are exceptionally vulnerable to 
complications associated with COVID-19. Therefore, we are amending the 
regulations at Sec.  418.22(a)(4) on an interim basis to allow the use 
of telecommunications technology by the hospice physician or NP for the 
face-to-face visit when such visit is solely for the purpose of 
recertifying a patient for hospice services during the PHE for the 
COVID-19 pandemic. By telecommunications

[[Page 19252]]

technology, we mean the use of multimedia communications equipment that 
includes, at a minimum, audio and video equipment permitting two-way, 
real-time interactive communication between the patient (from home, or 
any other site permissible for receiving services under the hospice 
benefit) and distant site hospice physician or hospice NP.\13\ Such 
encounters solely for the purpose of recertification would not be a 
separately billed service, but rather considered an administrative 
expense. We request feedback on the amendments to the face-to-face 
visit requirement for hospice recertification during the PHE for the 
COVID-19 pandemic.
---------------------------------------------------------------------------

    \13\ Section 410.78(a)(2) defines a ``distant site'' as the site 
at which the physician or practitioner delivering the service is 
located at the time the service is provided via a telecommunications 
system.
---------------------------------------------------------------------------

J. Modification of the Inpatient Rehabilitation Facility (IRF) Face-to-
Face Requirement for the PHE During the COVID-19 Pandemic

    Under 42 CFR 412.622(a)(3)(iv), for an inpatient rehabilitation 
facility (IRF) claim to be considered reasonable and necessary under 
section 1862(a)(1) of the Act, there must be a reasonable expectation 
at the time of the patient's admission to the IRF that the patient 
requires physician supervision by a rehabilitation physician, defined 
as a licensed physician with specialized training and experience in 
inpatient rehabilitation. The requirement for medical supervision means 
that the rehabilitation physician must conduct face-to-face visits with 
the patient at least 3 days per week throughout the patient's stay in 
the IRF to assess the patient both medically and functionally, as well 
as modify the course of treatment as needed to maximize the patient's 
capacity to benefit from the rehabilitation process.
    The purpose of the physician supervision requirement is to ensure 
that the patient's medical and functional statuses are being 
continuously monitored as the patient's overall plan of care is being 
carried out.
    We continue to believe it is in the patient's best interest to be 
seen in person by a rehabilitation physician to assess their medical 
and functional statuses while at the IRF, and we encourage 
rehabilitation physicians to continue to visit IRF patients in person 
as long as all necessary precautions, including the use of PPE, are 
taken to ensure the health and safety of the patient and the physician. 
However, during the PHE for the COVID-19 pandemic, we believe that it 
is essential to temporarily allow the face-to-face visit requirements 
at Sec. Sec.  412.622(a)(3)(iv) and 412.29(e) to be conducted via 
telehealth to safeguard the health and safety of Medicare beneficiaries 
and the rehabilitation physicians treating them. This allows 
rehabilitation physicians to use telehealth services as defined in 
section 1834(m)(4)(F) of the Act, to conduct the required 3 physician 
visits per week during the PHE for the COVID-19 pandemic. By increasing 
access to telehealth, this IFC will provide the necessary flexibility 
for Medicare beneficiaries to be able to receive medically necessary 
services without jeopardizing their health or the health of those who 
are providing those services, while minimizing the overall risk to 
public health.
    To effectuate these changes, on an interim basis we are finalizing 
revisions to the regulations at Sec. Sec.  412.622(a)(3)(iv) and 
412.29(e) during the PHE for the COVID-19 pandemic.
    In Sec.  412.622(a)(3)(iv), we are revising this paragraph to state 
that physician supervision by a rehabilitation physician is required, 
except that during the PHE, as defined in Sec.  400.200, such visits 
may be conducted using telehealth services (as defined in section 
1834(m)(4)(F) of the Act). The requirement for medical supervision 
means that the rehabilitation physician must conduct face-to-face 
visits with the patient at least 3 days per week throughout the 
patient's stay in the IRF to assess the patient both medically and 
functionally, as well as to modify the course of treatment as needed to 
maximize the patient's capacity to benefit from the rehabilitation 
process. The post-admission physician evaluation described in paragraph 
(a)(4)(ii) may count as one of the face-to-face visits.
    In Sec.  412.29(e), we are revising this paragraph to state that a 
procedure must be in effect to ensure that patients receive close 
medical supervision, as evidenced by at least 3 face-to-face visits per 
week by a licensed physician with specialized training and experience 
in inpatient rehabilitation to assess the patient both medically and 
functionally, as well as to modify the course of treatment as needed to 
maximize the patient's capacity to benefit from the rehabilitation 
process, except that during the PHE, as defined in Sec.  400.200, such 
visits may be conducted using telehealth services (as defined in 
section 1834(m)(4)(F) of the Act).
    We welcome feedback on these revisions to the regulations at 
Sec. Sec.  412.622(a)(3)(iv) and 412.29(e) for the duration of the PHE.

K. Removal of the IRF Post-Admission Physician Evaluation Requirement 
for the PHE for the COVID-19 Pandemic and Clarification Regarding the 
``3-Hour'' Rule

    IRF care is only considered by Medicare to be reasonable and 
necessary under section 1862(a)(1) of the Act if the patient meets all 
of the IRF coverage requirements outlined in Sec.  412.622(a)(3), (4), 
and (5). Failure to meet the IRF coverage criteria in a particular case 
results in denial of the IRF claim. Under Sec.  412.622(a)(4)(ii), to 
document that each patient for whom the IRF seeks payment is reasonably 
expected to meet all of the requirements in Sec.  412.622(a)(3) at the 
time of admission, the patient's medical record at the IRF must contain 
a post-admission physician evaluation that meets ALL of the following 
requirements:
     It is completed by the rehabilitation physician within 24 
hours of the patient's admission to the IRF.
     It documents the patient's status on admission to the IRF, 
includes a comparison with the information noted in the preadmission 
screening documentation, and serves as the basis for the development of 
the overall individualized plan of care.
     It is retained in the patient's medical record at the IRF.
    In an effort to provide rehabilitation physicians with as much 
flexibility as possible, we are removing the post-admission physician 
evaluation requirement at Sec.  412.622(a)(4)(ii) for all IRFs during 
the PHE for the COVID-19 pandemic. We believe that removal of this 
requirement will greatly reduce the amount of time rehabilitation 
physicians in IRFs spend on completing paperwork requirements when a 
patient is admitted to the IRF, and will free up their time to focus 
instead on caring for patients and helping where they may be needed 
with the PHE for the COVID-19 pandemic. Accordingly, we are amending 
Sec.  412.622(a)(4)(ii) to note that the post-admission physician 
evaluation is not required during the PHE for the COVID-19 pandemic. To 
effectuate this change, on an interim basis, we are revising Sec.  
412.622(a)(4)(ii) to specify that the post-admission physician 
evaluation is not required during the PHE for the COVID-19 pandemic.
    We note that this does not preclude an IRF patient from being 
evaluated by a rehabilitation physician within the first 24 hours of 
admission if the IRF believes that the patient's condition warrants 
such an evaluation.
    We invite feedback on our removal of the post-admission physician 
evaluation

[[Page 19253]]

documentation requirement at Sec.  412.622(a)(4)(ii) for all IRFs 
during the PHE for the COVID-19 pandemic.
    In addition, we are providing clarity for all IRFs during the PHE 
for the COVID-19 pandemic with regard to the intensive rehabilitation 
therapy requirements for IRF coverage at Sec.  412.622(a)(3)(ii), 
commonly known as the ``3-hour'' rule. Section 412.622(a)(3)(ii) 
generally requires that a beneficiary be reasonably expected to 
actively participate in, and benefit from, an intensive rehabilitation 
therapy program on admission to the IRF. Under current industry 
standards, this intensive rehabilitation therapy program generally 
consists of at least 3 hours of therapy (physical therapy, occupational 
therapy, speech-language pathology, or prosthetics/orthotics therapy) 
per day at least 5 days per week. In certain well-documented cases, 
this intensive rehabilitation therapy program might instead consist of 
at least 15 hours of intensive rehabilitation therapy within a 7-
consecutive day period, beginning with the date of admission to the 
IRF. Benefit from this intensive rehabilitation therapy program is 
demonstrated by measurable improvement that will be of practical value 
to the patient in improving the patient's functional capacity or 
adaptation to impairments. The required therapy treatments must begin 
within 36 hours from midnight of the day of admission to the IRF.
    We recognize that IRFs may have difficulties in meeting these 
requirements because normal staffing shifts may be disrupted as staff 
who would conduct the therapy program may have COVID-19, be self-
isolated, or be unavailable for other reasons related to the PHE. As 
such, while these requirements remain in place, we are clarifying that 
in cases where an IRF's intensive rehabilitation therapy program is 
impacted by the PHE for the COVID-19 pandemic (for example, due to 
staffing disruptions resulting from self-isolation, infection, or other 
circumstances related to the PHE), the IRF should not feel obligated to 
meet the industry standards referenced in Sec.  412.622(a)(3)(ii), but 
should instead make a note to this effect in the medical record.

L. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)

1. Expansion of Virtual Communication Services Furnished by RHCs and 
FQHCs
a. Background
    RHC and FQHC visits are face-to-face (in-person) encounters between 
a patient and an RHC or FQHC practitioner during which time one or more 
RHC or FQHC qualifying services are furnished. RHC and FQHC 
practitioners are physicians, NPs, PAs, certified nurse midwives, 
clinical psychologists, and clinical social workers, and under certain 
conditions, a registered nurse (RN) or licensed practical nurse 
furnishing care to a homebound RHC or FQHC patient. A Transitional Care 
Management service can also be an RHC or FQHC visit. A Diabetes Self-
Management Training (DSMT) service or a Medical Nutrition Therapy (MNT) 
service furnished by a certified DSMT or MNT provider may also be an 
FQHC visit.
    RHCs are paid an all-inclusive rate (AIR) for medically-necessary, 
face-to-face visits with an RHC practitioner. The rate is subject to a 
payment limit, except for those RHCs that have an exception to the 
payment limit for being ``provider-based'' (see Sec.  413.65). FQHCs 
are paid the lesser of their actual charges or the FQHC PPS rate for 
medically-necessary, face-to-face visits with an FQHC practitioner. 
Only medically-necessary medical, mental health, or qualified 
preventive health services that require the skill level of an RHC or 
FQHC practitioner can be RHC or FQHC billable visits.
    The RHC and FQHC payment rates reflect the cost of all services and 
supplies that an RHC or FQHC furnishes to a patient in a single day, 
and are not adjusted for the complexity of the patient health care 
needs, the length of the visit, or the number or type of practitioners 
involved in the patient's care. Services furnished by auxiliary 
personnel (such as nurses, medical assistants, or other clinical 
personnel acting under the supervision of the RHC or FQHC practitioner) 
are considered to be incident to the visit and are included in the per-
visit payment. This may include services furnished prior to or after 
the billable visit that occur within a medically appropriate time 
period, which is usually 30 days or less.
    RHCs and FQHCs are also paid for care management services, 
including chronic care management services, general behavioral health 
integration services, and psychiatric Collaborative Care Model 
services. These are typically non-face-to-face services that do not 
require the skill level of an RHC or FQHC practitioner and are not 
included in the RHC or FQHC payment methodologies.
    In the CY 2019 PFS proposed rule (83 FR 35863), we proposed 
separate payments to RHCs and FQHCs for certain CTBS referred to as 
``Brief Communication Technology-Based Services'' for a ``virtual 
check-in'' and separate payment for remote evaluation of recorded video 
and/or images. ``Virtual check-ins'' are brief (5 to 10 minutes), non-
face-to-face check ins with a patient via communication technology to 
assess whether the patient's condition necessitates an office visit. 
This service could be billed only in situations where the medical 
discussion was for a condition not related to an RHC or FQHC visit 
furnished within the previous 7 days, and does not lead to an RHC or 
FQHC visit within the next 24 hours or at the soonest available 
appointment. We also proposed payment for remote evaluation of patient-
transmitted information conducted via pre-recorded ``store and 
forward'' video or image technology, including interpretation with 
verbal follow-up with the patient within 24 business hours. We had 
proposed that payment would be made if the remote evaluation did not 
originate from a related RHC or FQHC visit furnished within the 
previous 7 days, or lead to an RHC or FQHC visit within the next 24 
hours or soonest available appointment.
    In the CY 2019 PFS final rule (83 FR 59683), we finalized 
requirements and payment for RHCs and FQHCs furnishing Virtual 
Communication Services. Effective January 1, 2019, RHCs and FQHCs are 
paid for Virtual Communication Services HCPCS code G0071 (Payment for 
communication technology-based services for 5 minutes or more of a 
virtual (non-face-to-face) communication between an RHC or FQHC 
practitioner and RHC or FQHC patient, or 5 minutes or more of remote 
evaluation of recorded video and/or images by an RHC or FQHC 
practitioner, occurring in lieu of an office visit; RHC or FQHC only). 
HCPCS code G0071 is on an RHC or FQHC claim, either alone or with other 
payable services, and at least 5 minutes of communication technology-
based or remote evaluation services are furnished by an RHC or FQHC 
practitioner to a patient who has had an RHC or FQHC billable visit 
within the previous year, and the medical discussion or remote 
evaluation is for a condition not related to an RHC or FQHC service 
provided within the previous 7 days, and does not lead to an RHC or 
FQHC visit within the next 24 hours or at the soonest available 
appointment. We added a new paragraph (e) to 42 CFR 405.2464 to reflect 
this payment.
    HCPCS code G0071 is set at the average of the national non-facility 
PFS payment rates for HCPCS code G2012 (communication technology-based 
services) and HCPCS code G2010

[[Page 19254]]

(remote evaluation services) and is updated annually based on the PFS 
national non-facility payment rate for these codes. RHC and FQHC face-
to-face requirements are waived when these services are furnished to an 
RHC or FQHC patient. Coinsurance and deductibles apply to RHC claims 
for HCPCS code G0071 and coinsurance applies to FQHC claims for HCPCS 
code G0071.
b. Improving Access to Care Management and Virtual Communication 
Services Furnished by RHCs and FQHCs
    RHCs and FQHCs furnish services in rural and urban areas that have 
been determined to be medically underserved areas or health 
professional shortage areas. They are an integral component of the 
Nation's health care safety net, and we want to ensure that Medicare 
patients who are served by RHCs and FQHCs are able to communicate with 
their RHC or FQHC practitioner in a manner that enhances access to 
care, consistent with evolving medical care.
    Particularly in rural areas where transportation is limited and 
distances may be far, we believe the use of CTBS may help some patients 
to determine if they need to schedule a visit at the RHC or FQHC. If it 
is determined that a visit is not necessary, the RHC or FQHC 
practitioner would be available for other patients who need their care.
    In the CY 2019 PFS final rule (83 FR 59452), we finalized payment 
for new online digital assessment services, also referred to as ``E-
Visits,'' for practitioners billing under the PFS. These are non-face-
to face, patient-initiated communications using online patient portals. 
An online patient portal is a secure online website that gives patients 
24-hour access to personal health information from anywhere with an 
internet connection by using a secure username and password. These 
digital assessment services are for established patients who require a 
clinical decision that otherwise typically would have been provided in 
the office. To minimize risks associated with exposure to COVID-19, and 
to provide the best care possible during the PHE for the COVID-19 
pandemic, we believe that RHCs and FQHC practitioners, like many other 
health care providers, should explore the use of interactive 
communications technology in the place of services that would have 
otherwise been furnished in person and reported and paid under the 
established methodologies.
    To facilitate the ability of RHCs and FQHCs to take such measures 
when appropriate, on an interim basis, we are expanding the services 
that can be included in the payment for HCPCS code G0071, and update 
the payment rate to reflect the addition of these services. 
Specifically, we are adding the following three CPT codes:
     99421 (Online digital evaluation and management service, 
for an established patient, for up to 7 days, cumulative time during 
the 7 days; 5-10 minutes)
     99422 (Online digital evaluation and management service, 
for an established patient, for up to 7 days, cumulative time during 
the 7 days; 11-20 minutes)
     99423 (Online digital evaluation and management service, 
for an established patient, for up to 7 days, cumulative time during 
the 7 days; 21 or more minutes)
    We are revising the payment rate for HCPCS code G0071 to include 
the national non-facility payment rates for these three new codes. 
Effective for services furnished on or after March 1, 2020 and 
throughout the PHE for the COVID pandemic, the payment rate for HCPCS 
code G0071 will be the average of the PFS national non-facility payment 
rate for HCPCS code G2012 (communication technology-based services), 
HCPCS code G2010 (remote evaluation services), CPT code 99421, CPT code 
99422, and CPT code 99423. The RHC and FQHC face-to-face requirements 
are be waived for these services. Section 405.2464(e) establishes 
payment for communication technology-based and remote evaluation 
services, and no regulatory changes are required.
    The services that are payable using HCPCS code G0071 require that 
the beneficiary has been seen by an RHC or FQHC practitioner during the 
previous 12 months. Under the current PHE for the COVID-19 pandemic, we 
believe that it is necessary to make these services available to 
beneficiaries who would otherwise not have access to clinically 
appropriate in-person treatment. Therefore, during the PHE for the 
COVID-19 pandemic, we are finalizing that all virtual communication 
services that are billable using HCPCS code G0071 will also be 
available to new patients that have not been seen in the RHC or FQHC 
within the previous 12 months. Also, in situations where obtaining 
prior beneficiary consent would interfere with the timely provision of 
these services, or the timely provision of the monthly care management 
services, during the PHE for the COVID-19 pandemic consent can obtained 
when the services are furnished instead of prior to the service being 
furnished, but must be obtained before the services are billed. We will 
also allow patient consent to be acquired by staff under the general 
supervision of the RHC or FQHC practitioner for the virtual 
communication and monthly care management codes during the PHE for the 
COVID-19 pandemic. These changes are consistent with the flexibilities 
were are establishing for similar services paid under the PFS as 
described in section II.D. of this IFC.
2. Revision of Home Health Agency Shortage Area Requirements for 
Furnishing Visiting Nursing Services
a. Background
    Sections 1861(aa)(1)(A) and (B) of the Act describes RHC and FQHC 
services as services and supplies furnished by a physician, PA, NP, 
clinical psychologist clinical social worker; and items and services 
furnished incident to these services, and specifies requirements for 
these practitioners and services.
    In the case of an RHC or FQHC that is located in an area in which 
there exists a shortage of HHAs, part-time or intermittent nursing care 
and related medical supplies (other than drugs and biologicals) are 
authorized under section 1861(aa)(1)(C) of the Act. These services can 
be furnished by a registered professional nurse or licensed practical 
nurse to a homebound individual under a written plan of treatment that 
is established and periodically reviewed by an RHC or FQHC physician, 
or established by a NP or PA and periodically reviewed and approved by 
the RHC or FQHC physician.
    In Sec.  405.2416, we specify that visiting nurse services are 
covered if all of the following are met:
     The RHC or FQHC is located in an area in which the 
Secretary has determined that there is a shortage of HHAs;
     The services are rendered to a homebound individual;
     The services are furnished by a registered professional 
nurse or licensed practical nurse that is employed by, or receives 
compensation for the services from the RHC or FQHC;
     The services are furnished under a written plan of 
treatment that is established and reviewed at least every 60 days by a 
supervising physician of the RHC or FQHC; or established by an NP, PA 
or certified nurse midwife (CNM); and reviewed at least every 60 days 
by a supervising physician. The written plan of treatment must be 
signed by the supervising physician, NP, PA or CNM of the RHC or FQHC.
    Nursing care that is covered by this section includes services that 
must be

[[Page 19255]]

performed by a registered professional nurse or licensed practical 
nurse if the safety of the patient is to be assured and the medically 
desired results achieved; and personal care services, to the extent 
covered under Medicare as home health services. These services include 
helping the patient to bathe, to get in and out of bed, to exercise and 
to take medications. Household and housekeeping services or other 
services that would constitute custodial care are not covered.
    Section 405.2416 also defines ``homebound'' as an individual who is 
permanently or temporarily confined to his or her place of residence 
because of a medical or health condition, or if the individual leaves 
the place of residence infrequently. It does not include a hospital or 
long term care facility.
    In Pub. 100-02, Medicare Benefit Policy Manual, Chapter 13, section 
190, we further describe RHC and FQHC visiting nursing services as 
skilled nursing services that require the skills of a nurse based on 
the complexity of the service (for example, intravenous and 
intramuscular injections or insertion of catheters), the condition of 
the patient (for example, a non-skilled service that, because of the 
patient's condition, can only be safely and effectively provided by a 
nurse), and accepted standards of medical and nursing practice. All 
services must be reasonable and necessary to the diagnosis and 
treatment of the patient's illness or injury within the context of the 
patient's unique medical condition, and a service that can be safely 
and effectively self-administered or performed by a nonmedical person 
without the direct supervision of a nurse, is not considered a skilled 
nursing service, even if provided by a nurse. A service which, by its 
nature, requires the skills of a nurse to be provided safely and 
effectively continues to be a skilled service even if it is taught to 
the patient, the patient's family, or other caregivers. If a patient 
needs skilled nursing care and there is no one trained or able and 
willing to provide it, the services of a nurse would be reasonable and 
necessary to the treatment of the illness or injury. We also specify 
that the determination of whether visiting nurse services are 
reasonable and necessary is made by the physician based on the 
condition of the patient when the services were ordered and what is 
reasonably expected to be appropriate treatment for the illness or 
injury throughout the certification period.
    The requirements for furnishing visiting nursing services include 
that the patient is considered to be ``confined to the home'' as 
defined in section 1835(a) of the Act and that the RHC or FQHC is 
located in an area that has a shortage of HHAs. The services and 
supplies must be provided under a written plan of treatment; are 
furnished on a part-time or intermittent basis only; and drugs and 
biological products are not provided.
    Chapter 13 of the Medicare Benefit Policy Manual, section 190, 
specifies the requirements for HHA shortage areas for purposes of 
visiting nursing services furnished by RHCs and FQHCs. The RHC or FQHC 
must be currently located in a county, parish or similar geographic 
area in which the Secretary has determined that there is no 
participating HHA under Medicare; or adequate home health services are 
not available to RHC or FQHC patients even though a participating HHA 
is in the area; or, there are patients whose homes are not within the 
area serviced by a participating HHA; or considering the area's climate 
and terrain, whose homes are not within a reasonable traveling distance 
to a participating HHA. RHCs and FQHCs that are located in an area that 
has not been determined to have a current HHA shortage and are seeking 
to provide visiting nurse services must make a written request to the 
appropriate CMS Regional Office along with written justification that 
the area it serves meets the required conditions.
b. Revision of Home Health Agency Shortage Area Requirements for 
Furnishing Visiting Nursing Services
    To address the PHE for the COVID-19 pandemic and its impact on 
underserved rural and urban communities, we are implementing, on an 
interim basis, changes to the requirements for visiting nursing 
services furnished in the home by RHCs and FQHCs.
    Section 405.2416(a)(1) states that visiting nurse services are 
covered if the RHC or FQHC is located in an area in which the Secretary 
has determined that there is a shortage of HHAs, and Sec.  405.2417 
provides additional requirements for an area to be determined to have a 
shortage of HHAs. During the PHE for the COVID-19 pandemic, we believe 
the need for visiting nursing services furnished by RHCs or FQHCs may 
increase. Therefore, for the duration of the PHE for the COVID-19 
pandemic, we are determining that any area typically served by the RHC, 
and any area that is included in the FQHCs service area plan, is 
determined to have a shortage of HHAs, and no request for this 
determination is required.
    We believe this flexibility is important for patient access to 
nursing services in the home and the potential for HHAs to be 
overwhelmed during PHE for the COVID-19 pandemic. However, RHCs and 
FQHCs should check the HIPAA Eligibility Transaction System (HETS) 
before providing visiting nurse services to ensure that the patient is 
not already under a home health plan of care. If a patient is under a 
home health plan of care, the HHA must provide optimal care to achieve 
the goals and outcomes identified in the patient's plan of care, for 
each patient's medical, nursing, and rehabilitative needs (Sec.  
484.105). Therefore, RHC/FQHC visiting nurse services would not be 
covered by Medicare if such services are found to overlap with a 30-day 
period of home health care. We note that an RHC/FQHC visiting nurse 
service solely to obtain a nasal or throat culture would not be 
considered a nursing service because it would not require the skills of 
a nurse to obtain the culture as the specimen could be obtained by an 
appropriately-trained medical assistant or laboratory technician. 
However, during an otherwise covered RHC/FQHC visiting nurse service, 
the nurse could obtain the nasal or throat culture to send to the 
laboratory for testing.
    Section 405.2416(a)(2) states that visiting nursing services are 
rendered to a homebound individual, and Sec.  405.2416(d) states that 
homebound means an individual who is permanently or temporarily 
confined to his or her place of residence because of a medical or 
health condition, and that the individual may be considered homebound 
if he or she leaves the place of residence infrequently. We refer the 
reader to the definition of ``homebound'' as it pertains the PHE for 
the COVID-19 pandemic in section II.F. of this IFC, Clarification of 
Homebound Status under the Medicare Home Health Benefit.
c. Regulatory Changes
    To make available additional visiting nursing services during the 
PHE for the COVID-19 pandemic in areas served by RHCs and FQHCs, we are 
revising, on an interim basis, Sec.  405.2416 to add paragraph (a)(5), 
to state that during the PHE for the COVID-19 pandemic, an area 
typically served by the RHC, and an area that is included in the FQHC's 
service area plan, is determined to have a shortage of HHAs, and no 
request for this determination is required.

[[Page 19256]]

M. Medicare Clinical Laboratory Fee Schedule: Payment for Specimen 
Collection for Purposes of COVID-19 Testing

    In response to the PHE for the COVID-19 pandemic and in an effort 
to be as expansive as possible within the current authorities to have 
testing available to Medicare beneficiaries who need it, we are 
changing Medicare payment policies during the PHE for the COVID-19 
pandemic to provide payment to independent laboratories for specimen 
collection for COVID-19 testing under certain circumstances.
    In general, section 1833(h)(3) of the Act requires the Secretary to 
provide for and establish a nominal fee for specimen collection for 
laboratory testing and a fee to cover transportation and personnel 
expenses for trained personnel to collect specimens from homebound 
patients and inpatients (not in a hospital), in addition to the amounts 
provided under the Medicare Clinical Laboratory Fee Schedule (CLFS). 
Section 1833(h)(3)(A) of the Act provides that the Secretary must 
establish a nominal fee to cover the appropriate costs in collecting 
the sample on which a clinical diagnostic laboratory test was performed 
and for which payment is made under Medicare Part B, except that not 
more than one such fee may be provided with respect to samples 
collected in the same encounter. The HCPCS codes for the nominal 
specimen fees currently listed on the CLFS (HCPCS codes 36415, P9612, 
and P9615) have a payment rate of $3. Section 216(a) of the Protecting 
Access to Medicare Act of 2014 (Pub. L. 113-93, enacted April 1, 2014) 
added section 1834A(b)(5) to the Act which increases by $2 the nominal 
fee that would otherwise apply under section 1833(h)(3)(A) of the Act 
for a sample collected from an individual in a skilled nursing facility 
(SNF) or by a laboratory on behalf of an HHA. Therefore, effective 
April 1, 2014, the nominal fee that would otherwise apply for a sample 
collected from an individual in a SNF or by a laboratory on behalf of a 
HHA is $5 (see Sec.  414.507(f)), and the relevant HCPCS code is G0471.
    In addition, section 1833(h)(3)(B) of the Act requires the 
Secretary to provide for and establish a fee to cover the 
transportation and personnel expenses for trained personnel to travel 
to the location of an individual to collect the sample, except that 
such a fee may be provided only with respect to an individual who is 
homebound or an inpatient in an inpatient facility (other than a 
hospital). In accordance with this provision, Medicare established a 
travel allowance for a laboratory technician to draw a specimen from 
homebound patients and non-hospital inpatients. Under current guidance, 
the travel allowance is intended to cover the estimated travel costs of 
collecting a specimen from a Medicare beneficiary and to reflect the 
technician's salary and travel costs. It is paid only when the nominal 
specimen collection is also payable and is not available if the 
technician is merely performing a messenger service to pick a specimen 
drawn by a physician or nursing home personnel. The methodology for 
determining the travel allowance varies depending on the round trip 
mileage to patients' homes. For instance, a per mile travel allowance 
methodology applies when the round trip to patients' homes is greater 
than 20 miles and a flat rate travel allowance methodology applies when 
the round trip to patients' homes is less than 20 miles. Medicare Part 
B MACs calculate the travel allowance for each claim. We have heard 
from stakeholders that in some cases the MAC requires them to maintain 
paper logs of miles traveled to receive the travel allowance.
    CMS' current policies for payment of the nominal specimen 
collection fee and the fee to cover transportation and expenses for 
trained personnel to collect specimens from homebound patients and non-
hospital inpatients are set forth in Pub. 100-04, Medicare Claims 
Processing Manual, chapter 16, section 60. We also implemented the 
increased nominal specimen collection fee under section 1834A(b)(5) of 
the Act in our regulations at Sec.  414.507(f). The manual instructions 
regarding payment of these fees are available on the CMS website at 
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c16.pdf. Neither the annual cash deductible nor the 20 
percent coinsurance for Medicare apply to the specimen collection fees 
or travel allowance for laboratory tests.
    This IFC is establishing the following changes to the specimen 
collection fee policy for the duration of the PHE for the COVID-19 
pandemic. We will provide for Medicare payment of a nominal specimen 
collection fee and associated travel allowance to independent 
laboratories for collection of specimens related to COVID-19 clinical 
diagnostic laboratory testing for homebound and non-hospital 
inpatients. Stakeholders have informed us that access to COVID-19 
testing in facilities especially is limited due to the resource costs 
associated with acquiring the samples in a manner that prevents 
exposure for patients and health care workers. With patients confined 
to their homes for their own safety or the safety of others, there is 
an additional need to have patients tested in their homes and minimize 
exposure to others. We believe that providing a specimen collection fee 
for COVID-19 testing during the PHE will provide independent 
laboratories with additional resources to provide this testing and at 
the same time help with efforts to limit patients' exposure to the 
general population and alleviate patients' unease with leaving the 
home.
    Under this policy, the nominal specimen collection fee for COVID-19 
testing for homebound and non-hospital inpatients generally will be 
$23.46 and for individuals in a SNF or individuals whose samples will 
be collected by laboratory on behalf of an HHA will be $25.46. 
Medicare-enrolled independent laboratories can bill Medicare for the 
specimen collection fee using one of two new HCPCS codes for specimen 
collection for COVID-19 testing and bill for the travel allowance with 
the current HCPCS codes set forth in section 60.2 of the Medicare 
Claims Processing Manual (P9603 and P9604). Our policy will also 
incorporate the clarification in the definition of homebound as 
discussed in section II.F. of this IFC, relating to the clarification 
of homebound status under the Medicare home health benefit.
    In establishing a nominal fee for COVID-19 specimen collection, we 
considered the type of trained laboratory personnel required to collect 
the specimen and the resources this type of collection could require. 
As noted previously, the current specimen collection fee HCPCS codes on 
the CLFS for homebound and non-hospital inpatients are $3 and $5, but 
we recognize that these fees are not intended to address additional 
resources needed during the PHE for the COVID-19 pandemic. Absent 
concrete information regarding the costs associated with independent 
laboratories collecting such specimens for COVID-19 tests in the 
context of the PHE, we looked to similar services in other settings of 
care as a potential benchmark. In looking at other Medicare payment 
systems, we believe the PFS is the best source for a potential payment 
amount since physicians and other practitioners often bill for services 
that involve specimen collection by trained, non-institutional staff.
    Under the PFS, a Level 1 office visit (CPT code 99211) typically 
does not require the presence of a physician or other qualified health 
care professional and the usual presenting problem(s) are minimal. This 
code is what is typically reported by physician practices when the 
patient only sees clinical office staff

[[Page 19257]]

for services like acquiring a routine specimen sample. CPT code 99211, 
describes an:
    Office visit for E/M of an established patient that may be 
performed by clinical staff under supervision (may not require a 
physician's presence). Usually the presenting problem(s) are minimal 
and typically 5 minutes are spent supervising or performing the 
service.
    The CY 2020 national PFS payment amount for Level 1 established 
patient office visits is $23.46 on the PFS. We also considered 
establishing a higher payment amount that considered the Level 1 E/M 
visit plus the payment amount for CPT code 89220, Sputum obtaining 
specimen aerosol induced technique, for a specimen collection fee of 
$40.06, but we believe there is likely overlapping costs in staff time 
for these two services and the Level 1 office visit payment rate is 
adequate.
    For initial diagnostic testing for COVID-19, the CDC issued interim 
guidelines that recommend collecting and testing for the virus using an 
upper respiratory nasopharyngeal swab (NP). The CDC guidance also 
states that collection of oropharyngeal swabs (OP) is a lower priority 
and if collected should be combined in the same tube as the NP. The CDC 
guidance advises that collection of sputum should only be done for 
those patients with productive coughs. See https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html. Similar 
collection method types, that is, NP or OP swabs are also used in other 
laboratory developed tests for COVID-19.
    Section 1833(h)(3) of the Act does not specifically describe the 
types of specimen collection methods that are eligible for the nominal 
fee and transportation and personnel expenses. However, section 
1833(h)(3)(B) of the Act does refer to ``trained personnel'' that would 
collect the sample from homebound individuals and inpatients in non-
hospital inpatient facilities. This suggests that to be medically 
necessary and for payment to be made for sample collection, the method 
of sample collection must require some training or skill on the part of 
the laboratory technician and cannot be conducted by the beneficiary, 
the beneficiary's caregiver, or facility staff if the facility does not 
have a laboratory, and therefore, is using an outside laboratory to 
perform its testing of patients. The Medicare Claims Processing Manual 
provides additional guidance on the medical necessity requirements for 
specimen collection. Specifically, the manual states that ``Medicare 
allows payment for a specimen collection fee when it is medically 
necessary for a laboratory technician to draw a specimen from either a 
nursing home patient or homebound patient'' and that ``the technician 
must personally draw the specimen.'' It also states that ``[t]his fee 
will not be paid to anyone who has not extracted the specimen'' and 
lists ``venipuncture or urine sample by catheterization'' as examples 
of a technician personally drawing the specimen. The manual further 
clarifies what it means for a specimen collection to be medically 
necessary stating that ``. . .where the specimen is a type that would 
require only the services of a messenger and would not require the 
skills of a laboratory technician, for example, urine or sputum, a 
specimen pickup service would not be considered medically necessary.''
    We note that venipuncture and urine sample by catheterization are 
currently provided in the Medicare Claims Processing Manual as examples 
of a technician personally drawing a specimen, however, they are not an 
exhaustive list of all possible scenarios that require trained 
personnel to collect a specimen. In the case of collecting a specimen 
for COVID-19 testing, we believe that in the context of and for the 
duration of the PHE for the COVID-19 pandemic, collecting specimens 
using NP or OP swabs or collection of sputum will require a trained 
laboratory professional, as well as additional precautions that must be 
taken to minimize exposure risks in handling specimens that are 
suspected or confirmed for COVID-19. Thus, we believe that collecting a 
specimen for COVID-19 testing will incur higher costs than similar 
specimen collection services which require a trained laboratory 
professional but not additional precautions, to minimize exposure 
risks. The CDC advises that specimen collection must be performed 
correctly the first time the specimen is collected. A focus of the 
response to the PHE for the COVID-19 pandemic is to quickly identify 
individuals who are infected so that appropriate treatment for the 
patients being tested is provided in a timely manner. At the same time, 
another goal is to appropriately isolate those patients and quarantine 
those exposed to the patients to prevent further spread of the virus. 
We believe laboratory personnel will need to be trained on how to 
handle the specimen to maximize accurate test results for COVID-19. 
Laboratory personnel also will need to be trained on how to minimize 
risks for spreading the virus to themselves and/or others in the chain 
of handling the specimen before it arrives at the laboratory for 
analysis. The CDC guidance states that specimens should be collected as 
soon as possible once a person under investigation (PUI) is identified, 
regardless of the time of symptom onset, and that proper infection 
control must be maintained when collecting specimens. We believe that 
specimens for COVID-19 testing using NP, OP, or sputum must be 
collected by trained laboratory personnel, and the specimens are a type 
that would not require only the services of a messenger or specimen 
pick up service. The manual currently lists collection of sputum as a 
type that would require only the services of a messenger, and 
therefore, is not considered medically necessary. However, for the PHE 
for the COVID-19 pandemic only, we believe a specimen collection fee 
for sputum collection would be warranted and medically necessary due to 
the reasons discussed previously. If in the future other types of 
COVID-19 tests are available, such as serological tests or point of 
care tests, we note that the specimen collection fee would apply if the 
specimen collection method must be performed by trained laboratory 
personnel. However, COVID-19 tests that allow patients to collect the 
specimen themselves would not be eligible for the specimen collection 
fee.
    To identify specimen collection for COVID-19 testing, we are 
establishing two new level II HCPCS codes. Independent laboratories 
must use one of these HCPCS codes when billing Medicare for the nominal 
specimen collection fee for COVID-19 testing for the duration of the 
PHE for the COVID-19 pandemic. These new HCPCS codes are:
     G2023, specimen collection for severe acute respiratory 
syndrome coronavirus [hairsp]2 (SARS-CoV-2) (Coronavirus disease 
[COVID-19]), any specimen source.
     G2024, specimen collection for severe acute respiratory 
syndrome coronavirus [hairsp]2 (SARS-CoV-2) (Coronavirus disease 
[COVID-19]), from an individual in a SNF or by a laboratory on behalf 
of a HHA, any specimen source.
    We created the second Level II HCPCS code, G2024, because section 
1834A(b)(5) of the Act and our regulations at Sec.  414.507(f) require 
a higher fee for collecting a specimen from an individual in a SNF or 
by a laboratory on behalf of an HHA, as described previously in this 
section of the IFC. We will issue guidance when the PHE for the COVID-
19 pandemic is over and when these codes are no longer valid and 
terminated in the HCPCS file and/or the CLFS as appropriate.

[[Page 19258]]

    In addition, Medicare payment for transportation and expenses for 
trained personnel to collect specimens from homebound patients (as 
discussed in section II.F. of this IFC, relating to the clarification 
of homebound status under the Medicare home health benefit) and 
inpatients (not in a hospital) for purposes of COVID-19 testing will be 
made in accordance with existing instructions found in the Medicare 
Claims Processing Manual. Independent laboratories must use the 
existing level II HCPCS codes when billing for the travel allowance, 
that is, the per mile travel allowance as described by HCPCS code P9603 
and the flat rate travel allowance as described by HCPCS code P9604. 
Additionally, we are clarifying that paper documentation of miles 
traveled is not required and laboratories can maintain electronic logs 
with that information. However, laboratories will need to be able to 
produce these electronic logs in a form and manner that can be shared 
with MACs. As stated previously, we have heard from stakeholders that 
maintaining paper logs of miles is burdensome, especially with the 
development of GPS systems and various applications for cellular phones 
in recent years that can track miles traveled. Thus, we are clarifying 
that there is no requirement that laboratories maintain logs on paper 
to document travel, and that laboratories may use digital documentation 
of this information if preferred. The MACs may provide more information 
on acceptable formats.
    In defining an individual who is homebound for purposes of the 
specimen collection fee and the travel allowance under section 
1833(h)(3) of the Act, the manual refers to Chapters 7 and 15 of Pub. 
100-02, the Medicare Benefit Policy Manual. The definition of 
``homebound'' in Chapters 7 and 15 of Pub. 100-02 originate from the 
statutory definition of ``confined to the home'' (that is, 
``homebound'') under sections 1814(a) and 1835(a) of the Act. As 
discussed in section II.F. of this IFC, relating to the clarification 
of homebound status under the Medicare home health benefit patients are 
considered ``confined to the home'' (that is, ``homebound'') if it is 
medically contraindicated for the patient to leave the home. When it is 
medically contraindicated for a patient to leave the home, there exists 
a normal inability for an individual to leave home and leaving home 
safely would require a considerable and taxing effort.
    As an example for the PHE for COVID-19 pandemic, this would apply 
for those patients: (1) Where a physician has determined that it is 
medically contraindicated for a beneficiary to leave the home because 
he or she has a confirmed or suspected diagnosis of COVID-19; or (2) 
where a physician has determined that it is medically contraindicated 
for a beneficiary to leave the home because the patient has a condition 
that may make the patient more susceptible to contracting COVID-19. A 
patient who is exercising ``self-quarantine'' for his or her own 
safety, would not be considered ``homebound'' unless it is also 
medically contraindicated for the patient to leave the home. 
Determinations of whether the patient is homebound must be based on an 
assessment of each beneficiary's individual condition. For the PHE for 
the COVID-19 pandemic, the CDC is currently advising that older adults 
and individuals with serious underlying health conditions stay home 
(CDC's guidance is interim and is expected to continue to be updated as 
warranted).\14\ As such, during the PHE for the COVID-19 pandemic, we 
expect that many Medicare beneficiaries could be considered 
``homebound''. In light of this clarification regarding the definition 
of homebound, we are noting this clarification pertains to the specimen 
collection fee and travel allowance in the PHE for COVID-19 pandemic 
testing for homebound patients; that is, a patient is considered 
homebound for purposes of the fees under sections 1833(h)(3) and 
1834A(b)(5) of the Act if it is medically contraindicated for the 
patient to leave home.
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    \14\ https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html.
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    In summary, to address the PHE for the COVID-19 pandemic, we are 
using this IFC as a vehicle to provide additional payment during the 
PHE in the form of a specimen collection fee of $23.46 generally, and 
$25.46 for an individual in a SNF or by a laboratory on behalf of a 
HHA, for COVID-19 testing and to provide a travel allowance for a 
laboratory technician to collect a specimen for COVID-19 testing from a 
non-hospital inpatients or homebound patients under section 1833(h)(3) 
of the Act.

N. Requirements for Opioid Treatment Programs (OTP)

    In the CY 2020 PFS final rule (84 FR 62645 and 62646), we finalized 
allowing the use of interactive two-way audio/video communication 
technology to furnish the counseling and therapy portions of the weekly 
bundle of services furnished by OTPs. In light of the PHE for the 
COVID-19 pandemic, during which the public has been instructed to 
practice self-isolation or social distancing, and because interactive 
audio-video communication technology may not be available to all 
beneficiaries, we are revising Sec.  410.67(b)(3) and (4) to allow the 
therapy and counseling portions of the weekly bundles, as well as the 
add-on code for additional counseling or therapy, to be furnished using 
audio-only telephone calls rather than via two-way interactive audio-
video communication technology during the PHE for the COVID-19 pandemic 
if beneficiaries do not have access to two-way audio/video 
communications technology, provided all other applicable requirements 
are met. We believe this change is necessary to ensure that 
beneficiaries with opioid use disorders are able to continue to receive 
these important services during the current PHE.

O. Application of Teaching Physician and Moonlighting Regulations 
During the PHE for the COVID-19 Pandemic

a. Background
    In context of the PHE for the COVID-19 pandemic, we have been asked 
by stakeholders to relax supervision requirements related to the 
provision of teaching physician services under the PFS. For teaching 
physicians, section 1842(b) of the Act specifies that in the case of 
physicians' services furnished to a patient in a hospital with a 
teaching program, the Secretary shall not provide payment for such 
services unless the physician renders sufficient personal and 
identifiable physicians' services to the patient to exercise full, 
personal control over the management of the portion of the case for 
which payment is sought. We have also been asked to allow residents to 
independently furnish services in their capacity as fully licensed 
physicians outside of the scope of their approved GME residency in the 
inpatient setting of the hospital at which they provide services.
b. Revisions to Teaching Physician Regulations During a PHE for the 
COVID-19 Pandemic
    Regulations regarding PFS payment for teaching physician services 
and moonlighting are codified in 42 CFR part 415. Under Sec.  415.172, 
if a resident participates in a service furnished in a teaching 
setting, PFS payment is made only if the teaching physician is present 
during the key portion of any service or procedure for which payment is 
sought. The provisions in Sec.  415.174 exempt certain office/
outpatient E/M services provided in the outpatient department of a 
hospital or another ambulatory care

[[Page 19259]]

entity (that is, primary care centers) from the physical presence 
requirement for the key portion of the service, pending all provisions 
of the regulation are met. The regulations in Sec.  415.180 state that 
for the interpretation of diagnostic radiology and other diagnostic 
tests, PFS payment is made if the interpretation is performed or 
reviewed by a physician other than a resident. For Sec.  415.184, the 
requirement for the presence of the teaching physician during 
psychiatric services in which a resident is involved may be met by 
observation of the service by use of a one-way mirror, video equipment, 
or similar device.
    In context of the PHE for the COVID-19 pandemic, teaching hospitals 
have expressed a need to increase their capacity to respond to the PHE 
for the COVID-19 pandemic because there has been increased demand for 
physicians to respond to patient needs. For example, we have been asked 
by stakeholders to allow Medicare to make payment under the PFS for 
services billed by teaching physicians when residents have furnished 
the entirety of a service in the inpatient setting in the area of their 
approved GME program and have a teaching physician review and sign off 
on the service, rather than requiring the teaching physician be 
physically present for the key portion of the service.
    Given the circumstances of the PHE for the COVID-19 pandemic, we 
believe that the requirements for the physical presence of the teaching 
physician during the key portion of the service would necessarily limit 
access to services paid under the PFS. We recognize that in some cases, 
the physical proximity of the physician might present additional 
exposure risks, especially for high risk patients isolated for their 
own protection or in cases where the teaching physician and/or the 
resident has been exposed to the virus and must be under quarantine, or 
who may be at home caring for family members or providing childcare. If 
the teaching physician and/or the resident is under quarantine or at 
home, it could unintentionally limit the number of licensed 
practitioners available to furnish services to Medicare patients and 
could have the unintended consequence of limiting access to services 
paid under the PFS.
    To increase the capacity of teaching settings to respond to the PHE 
for the COVID-19 pandemic as more practitioners are increasingly being 
asked to assist with the COVID-19 response, on an interim basis, for 
the duration of the PHE for the COVID-19 pandemic, we are amending the 
teaching physician regulations to allow that as a general rule under 
Sec.  415.172, the requirement for the presence of a teaching physician 
can be met, at a minimum, through direct supervision by interactive 
telecommunications technology, as described in section II.E. of this 
IFC. In other words, the teaching physician must provide supervision 
either with physical presence or be present through interactive 
telecommunications technology during the key portion of the service. 
Specifically, we believe that when use of such real-time, audio and 
video telecommunications technology allows for the teaching physician 
to interact with the resident through virtual means, their ability to 
furnish assistance and direction could be met without requiring the 
teaching physician's physical presence for the key portion of the 
service.
    Currently, under the primary care exception in Sec.  415.174, 
certain lower and mid-level office/outpatient E/M services provided in 
primary care centers are exempt from the physical presence requirement 
for the key portion of the service. The teaching physician must direct 
the care from such proximity as to constitute immediate availability 
(that is, provide direct supervision). In context of the PHE for the 
COVID-19 pandemic, the teaching physician may be under quarantine or 
otherwise at home, or the physical proximity of the teaching physician 
might present additional exposure risks. Additionally, during the PHE 
for the COVID-19 pandemic, more patients may present with more complex 
needs, such as an underlying condition that places them at high risk 
for COVID-19 and that necessitate a high level office/outpatient E/M 
service (that is, level 4 or 5 visit). Consequently, on an interim 
basis, for the duration of the PHE for the COVID-19 pandemic, we are 
amending Sec.  415.174 to allow that all levels of an office/outpatient 
E/M service provided in primary care centers may be provided under 
direct supervision of the teaching physician by interactive 
telecommunications technology. We believe use of real-time, audio and 
video telecommunications technology allows for the teaching physician 
to interact with the resident through virtual means, and thus would 
meet the requirement for teaching physician presence for office/
outpatient E/M services furnished in primary care centers. For Sec.  
415.180, for the duration of the PHE for the COVID-19 pandemic, we will 
allow PFS payment to be made for the interpretation of diagnostic 
radiology and other diagnostic tests when the interpretation is 
performed by a resident under direct supervision of the teaching 
physician by interactive telecommunications technology. The teaching 
physician must still review the resident's interpretation. For Sec.  
415.184, for the duration of the PHE for the COVID-19 pandemic, the 
requirement for the presence of the teaching physician during the 
psychiatric service in which a resident is involved may be met by the 
teaching physician's direct supervision by interactive 
telecommunications technology. For both Sec. Sec.  415.180 and 415.184, 
allowing residents to furnish these services under direct supervision 
of the teaching physician by interactive telecommunications technology 
would allow for the presence requirement to be met. These diagnostic 
radiology, diagnostic tests, and psychiatry services could continue to 
be provided to patients that need them in the event the teaching 
physician is in quarantine or otherwise at home, or where the physical 
proximity of the teaching physical might present additional exposure 
risk.
    The regulations describing PFS payment for teaching physician 
services do have additional exceptions for specific policies. For 
example, as described in Sec.  415.172, in the case of surgical, high-
risk, or other complex procedures, the teaching physician must be 
present during all critical portions of the procedure and immediately 
available to furnish services during the entire service or procedure. 
In the case of procedures performed through an endoscope, the teaching 
physician must be present during the entire viewing. As described in 
Sec.  415.178 for anesthesia services, the teaching anesthesiologist 
must be present during all critical or key portions of the anesthesia 
service or procedure involved and the teaching anesthesiologist must be 
immediately available to furnish anesthesia services during the entire 
procedure. Given the complex nature of these procedures and the 
potential danger to the patient, even in the context of the PHE for the 
COVID-19 pandemic and the inherent exposure risks for patients and 
physicians, we believe that the requirements for physical presence for 
either the entire procedure or the key portions of the service, 
whichever are applicable, are necessary for patient safety. Thus, the 
PHE for the COVID-19 pandemic exceptions previously described will not 
apply in the case of surgical, high risk, interventional, or other 
complex procedures, services performed through an endoscope, and 
anesthesia services. We seek comment

[[Page 19260]]

on whether other procedures should also be exempt from this policy 
given the complex nature or potential danger to the patient.
    Collectively, the flexibilities described for Sec. Sec.  415.172, 
415.174, 415.180, and 415.184 are intended to ensure there are as many 
qualified practitioners as possible. They are also intended to minimize 
the number of people coming into contact with one another by removing 
the need for in-person direct supervision. We view direct supervision 
by interactive telecommunications technology as the minimum requirement 
for provision of the service for purposes of Medicare payment. However, 
teaching physicians may continue to exercise their clinical judgment to 
decide whether it is appropriate to utilize these flexibilities in 
furnishing their services involving residents. We also seek comment on 
our belief that direct supervision by interactive telecommunications 
technology is appropriate in the context of this PHE, as well as 
whether any guardrails should be included, and how it balances risks 
that might be introduced for beneficiaries with reducing exposure risk 
and the increased spread of the disease, in the context of this PHE.
c. Application of the Expansion of Telehealth Services to Teaching 
Physician Services
    On March 17, 2020, we announced the expansion of telehealth 
services on a temporary and emergency basis pursuant to waiver 
authority added under section 1135(b)(8) by the Coronavirus 
Preparedness and Response Supplemental Appropriations Act.\15\ Starting 
on March 1, 2020, Medicare can pay for telehealth services, including 
office, hospital, and other visits furnished by physicians and other 
practitioners to patients located anywhere across the country including 
in a patient's place of residence. We have been asked by stakeholders 
to clarify whether this expansion applies to teaching physician 
services, including those furnished under the primary care exception. 
We believe that allowing Medicare payment for services billed by the 
teaching physician when the resident is furnishing services, including 
office/outpatient E/M services provided in primary care centers, via 
telehealth under direct supervision by interactive telecommunications 
technology would allow residents to furnish services remotely to 
patients who may need to be isolated for purposes of exposure risk 
based on presumed or confirmed COVID-19 infection, and as a result, 
would increase access to services for patients. To increase the 
capacity of teaching settings to respond to the PHE for the COVID-19 
pandemic as more practitioners are increasingly being asked to assist 
with the COVID-19 response, we believe that, for telehealth services 
involving residents, the requirement that a teaching physician be 
present for key portions of the service can be met through virtual 
means. We also believe same is true for telehealth services furnished 
by the resident in primary care centers. The use of real-time, audio 
and video telecommunications technology allows for the teaching 
physician to interact with the resident through virtual means while the 
resident is furnishing services via telecommunications technology, and 
thus, in the circumstances of the PHE, would meet the requirement for 
teaching physician presence for office/outpatient E/M services 
furnished in primary care centers. Consequently, on an interim basis 
for the duration of the PHE for the COVID-19 pandemic, we are revising 
our regulations to specify that Medicare may make payment under the PFS 
for teaching physician services when a resident furnishes telehealth 
services to beneficiaries under direct supervision of the teaching 
physician which is provided by interactive telecommunications 
technology. Additionally, on an interim basis, for the duration of the 
PHE for the COVID-19 pandemic, Medicare may make payment under the PFS 
for services billed under the primary care exception by the teaching 
physician when a resident furnishes telehealth services to 
beneficiaries under the direct supervision of the teaching physician by 
interactive telecommunications technology. We also seek comment on our 
belief that direct supervision by interactive telecommunications 
technology is appropriate in the context of this PHE, as well as 
whether and how it balances risks that might be introduced for 
beneficiaries with reducing exposure risk and the increased spread of 
the disease, in the context of this PHE.
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    \15\ https://www.cms.gov/newsroom/press-releases/president-trump-expands-telehealth-benefits-medicare-beneficiaries-during-covid-19-outbreak.
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d. Payment Under the PFS for Teaching Physician Services When Resident 
Under Quarantine
    There also may be circumstances in which the resident may need to 
furnish services while under quarantine (for example, while at home). 
We have been asked by stakeholders if residents who have been exposed 
to COVID-19 and are under quarantine, and otherwise well and able to 
work, are able to furnish services that do not require face-to-face 
patient care, such as reading the results of tests and other imaging 
studies. Because current regulations require the physical presence of 
the teaching physician during the key portion of the service, residents 
would not be able to furnish services from quarantine, which could 
limit the number of licensed practitioners available to furnish 
services to Medicare patients and could have the unintended consequence 
of limiting access to services paid under the PFS. Because we are 
amending the teaching physician regulations to allow that as a general 
rule under Sec.  415.172, the requirement for the presence of a 
teaching physician can be met through direct supervision by interactive 
telecommunications technology, on an interim basis, for the duration of 
the PHE for the COVID-19 pandemic, Medicare may also make payment under 
the PFS for teaching physician services when the resident is furnishing 
these services while in quarantine under direct supervision of the 
teaching physician by interactive telecommunications technology. We 
believe this policy will limit exposure to COVID-19 and to allow for 
the continued access to physicians' services of residents while in 
quarantine.
e. Revisions to Moonlighting Regulations During a PHE for the COVID-19 
Pandemic
    A licensed resident physician is considered to be ``moonlighting'' 
when they furnish physicians' services to outpatients outside the scope 
of an approved graduate medical education (GME) program. Under current 
regulations, the services of residents in hospitals in which the 
residents have their approved GME program are not considered separately 
billable as physicians' services and instead are payable under 
Sec. Sec.  413.75 through 413.83 regarding direct GME payments, whether 
or not the services are related to the approved GME training program. 
When a resident furnishes services that are not related to their 
approved GME programs in an outpatient department or emergency 
department of a hospital in which they have their training program, 
those services can be billed separately as physicians' services and 
payable under the PFS if they meet the criteria described in our 
regulation at Sec.  415.208(b)(2).
    In light of the PHE for the COVID-19 pandemic, teaching hospitals 
need to secure as much physician coverage as possible because there has 
been increased demand for physicians to

[[Page 19261]]

respond to patient needs, such as furnishing services to patients in 
inpatient settings who have either a presumed or confirmed COVID-19 
infection. Stakeholders have requested that residents be able to 
furnish physicians' services to patients in the inpatient setting 
outside of the scope of their approved GME programs in the hospital 
where they have their training.
    We believe that our regulation at Sec.  415.208(b), which limits 
the scope of services that can be separately billable by moonlighting 
residents when furnished outside their approved GME programs to 
patients in an outpatient department or emergency department of a 
hospital in which they have their training program, does not adequately 
meet the needs of teaching hospitals to ensure there are as many 
qualified practitioners available as possible given the circumstances 
of the PHE for the COVID-19 pandemic. Under current policy, for 
example, a resident in a hospital's approved GME program for anesthesia 
who typically furnishes only anesthesia-related services in an 
operating room would not be able to provide separately billable 
physicians' services when treating inpatients in the intensive care 
unit for COVID-19 infection, even if these services were not part of 
the resident's approved GME program. As a result, this regulation could 
unintentionally limit the number of licensed practitioners available to 
furnish services to Medicare patients and could have the unintended 
consequence of limiting access to critically needed care. Consequently, 
on an interim basis, for the duration of the PHE for the COVID-19 
pandemic, we are amending our regulation in Sec.  415.208 to state that 
the services of residents that are not related to their approved GME 
programs and are performed in the inpatient setting of a hospital in 
which they have their training program are separately billable 
physicians' services for which payment can be made under the PFS 
provided that the services are identifiable physicians' services and 
meet the conditions of payment for physicians' services to 
beneficiaries in providers in Sec.  415.102(a), the resident is fully 
licensed to practice medicine, osteopathy, dentistry, or podiatry by 
the State in which the services are performed, and the services are not 
performed as part of the approved GME program.
P. Special Requirements for Psychiatric Hospitals (Sec.  482.61(d))
    In the June 16, 2016 Federal Register, we published the ``Medicare 
and Medicaid Programs; Hospital and Critical Access Hospital (CAH) 
Changes To Promote Innovation, Flexibility, and Improvement in Patient 
Care'' proposed rule (81 FR 39447), which outlined a number of proposed 
hospital and CAH Condition of Participation (CoP) requirements, 
including those focused on infection control, antibiotic use, and scope 
of practice for NPPs (that is, advanced practice providers (APPs) such 
as PAs, NPs, psychologists, and CNSs, as well as other qualified, 
licensed practitioners to whom this revision might also be applicable).
    Subsequently, in the September 30, 2019 Federal Register, we 
published the ``Medicare and Medicaid Programs; Hospital and Critical 
Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and 
Improvement in Patient Care'' final rule (84 FR 51775) that finalized 
several of these proposed changes to modernize the hospital and CAH 
requirements, improve quality of care, and support HHS and CMS 
priorities. In that final rule, we deleted the modifying term 
``independent'' from the Patient's Rights CoP at 42 CFR 482.13(e)(5) 
and (e)(8)(ii) regarding which practitioners may order the use of 
restraints and seclusion. These revisions to the regulatory text were 
intended to finally make the language of the hospital CoPs consistent 
with the language of the Children's Health Act of 2000 (CHA) (Pub. L. 
106-310, enacted October 17, 2000) regarding restraint and seclusion 
orders and licensed practitioners, and upon which the CoP language was 
originally intended to be based. Additionally, and to remain consistent 
throughout this CoP, we revised Sec.  482.13(e)(10) and (11), 
(e)(12)(i)(A), (e)(14), and (g)(4)(ii) that contained the term 
``licensed independent practitioner'' by changing the term from 
``licensed independent practitioner'' to simply ``licensed 
practitioner.''
    In the final rule, we stated that the revision reflected our goal 
to have health professionals operate within the scope of practice 
allowed by state law, and that it also recognized the need to fully 
utilize the healthcare workforce. We also stated that we believe that 
this change will reduce unnecessary burden for hospitals and remove 
obstacles APPs face when ordering seclusion and restraints. However, we 
stated that we disagreed with the commenters who stated that the 
removal of the term ``independent'' will cause confusion over the 
applicability of this requirement. Our removal of the term 
``independent'' is consistent with the language used in the CHA, which 
utilizes the term ``other licensed practitioner,'' without the 
independent modifying term. In addition, the order of restraint or 
seclusion must be ordered by a licensed practitioner who is authorized 
by hospital policy in accordance with State law to do so.
    In the September 30, 2019 final rule, we made additional revisions 
to address other areas of the hospital CoPs that we viewed as being 
either conflicting with, or more stringent than, existing state scope-
of-practice laws and licensing requirements, and which, if 
appropriately revised, would give APPs greater flexibility to practice 
more broadly in the current healthcare system while still being in 
accordance with respective state scope-of-practice laws.
    Therefore, in our review of the Hospital CoPs for the proposed 
rule, we discovered that there were several provisions that incorrectly 
reference Sec.  482.12(c)(1), which lists the types of physicians and 
applies only to patients who are Medicare beneficiaries. Section 
482.12(c) states that the governing body of the hospital must ensure 
that every Medicare patient is under the care of one of the following 
practitioners:
     A doctor of medicine or osteopathy;
     A doctor of dental surgery or dental medicine who is 
legally authorized to practice dentistry by the State and who is acting 
within the scope of his or her license;
     A doctor of podiatric medicine, but only with respect to 
functions which he or she is legally authorized by the State to 
perform;
     A doctor of optometry who is legally authorized to 
practice optometry by the State in which he or she practices;
     A chiropractor who is licensed by the State or legally 
authorized to perform the services of a chiropractor, but only with 
respect to treatment by means of manual manipulation of the spine to 
correct a subluxation demonstrated by X-ray to exist; and
     A clinical psychologist as defined in Sec.  410.71, but 
only for a clinical psychologist services as defined in Sec.  410.71 
and only to the extent permitted by State law.
    The reference of this ``Medicare beneficiary-only'' requirement in 
certain other provisions of the hospital CoPs (which we have listed 
below) inappropriately links it to all patients and not Medicare 
beneficiaries exclusively. In fact, per section 1861(e)(4) of the Act, 
every patient with respect to whom payment may be made under this title 
must be under the care of a physician except that a patient receiving 
qualified psychologist services (as defined in subsection (ii)) may be 
under the care of a clinical psychologist with respect to such services 
to the extent permitted under State law. In

[[Page 19262]]

accordance with that provision, we have chosen to apply Sec.  482.12(c) 
to Medicare patients. With the exception of a few provisions in the 
CoPs such as those directly related to Sec.  482.12(c) described here, 
the remainder of the CoPs apply to all patients, regardless of payment 
source, and not just Medicare beneficiaries. For example, the Nursing 
Services CoP, at Sec.  482.23(c)(1), requires that all drugs and 
biologicals must be prepared and administered in accordance with 
Federal and State laws, the orders of the practitioner or practitioners 
responsible for the patient's care as specified under Sec.  482.12(c), 
and accepted standards of practice. Since the CoPs clearly allow 
hospitals to determine which categories of practitioners would be 
responsible for the care of other patients, outside the narrow Medicare 
beneficiary restrictions of Sec.  482.12(c), this reference is 
inappropriate and unnecessarily restrictive of hospitals and their 
medical staffs to make these determinations based on State law and 
practitioner scope of practice.
    To clarify that these provisions apply to all patients and not only 
Medicare beneficiaries, we deleted any inappropriate references to 
Sec.  482.12(c) in the final rule. Therefore, we deleted references to 
Sec.  482.12(c) found in the following provisions: Sec.  482.13(e)(5), 
(e)(8)(ii), (e)(14), and (g)(4)(ii) in the Patients' Rights CoP; and 
Sec.  482.23(c)(1) and (3) in the Nursing Services CoP. We note here 
that we did not receive any comments on these changes as they proposed 
in the June 2016 proposed rule, and therefore, we finalized them 
without change.
    In performing our most recent review of the hospital CoPs, 
including the Requirements for Specialty Hospitals at subpart E of 42 
CFR part 482, we discovered that we inadvertently failed to propose to 
delete another inappropriate reference to Sec.  482.12(c), which is 
contained in the current provision at Sec.  482.61(d) in the Special 
Medical Record Requirements for Psychiatric Hospitals CoP (pertaining 
to which hospital personnel may complete progress notes for patients). 
The current provision also contains the term ``licensed independent 
practitioner.'' Therefore, in the interests of consistency with the 
other recent revisions we have noted here, we are now deleting the 
reference to Sec.  482.12(c) along with the modifier ``independent'' in 
this IFC.
    We believe that as currently written and implemented, this 
requirement requires some clarification for the reasons that we have 
discussed. As we have already stated and made clear through our recent 
revisions to the hospital CoPs, we believe that APPs, including PAs, 
NPs, psychologists, and CNSs (as well as other qualified, licensed 
practitioners to whom this revision might also be applicable), when 
acting in accordance with State law, their scope of practice, and 
hospital policy, should have the authority to practice more broadly and 
to the highest level of their education, training, and qualifications 
as allowed under their respective state requirements and laws in this 
area.
    We believe that NPPs practicing in the psychiatric hospital setting 
should be able to record progress notes of psychiatric patients for 
whom they are responsible. Therefore, we will allow the use of NPPs, or 
APPs, to document progress notes of patients receiving services in 
psychiatric hospitals, in addition to MDs/DOs as is currently allowed.
    Given the changes made to the requirements under Sec.  482.13 
regarding the removal of the word ``independent'' from the phrase 
``licensed independent practitioner'' when referencing NPPs that we 
have previously discussed, we are making the same change for this 
provision. We believe that the regulatory language should be as 
consistent as possible throughout the hospital CoPs and, in addition, 
as was the case with the requirement under Sec.  482.13, using the term 
``licensed independent practitioner'' may inadvertently exacerbate 
workforce shortage concerns, might unnecessarily impose regulatory 
burden on hospitals by restricting a hospital's ability to allow APPs 
and other NPPs to operate within the scope of practice allowed by state 
law, and does not recognize the benefits to patient care that might be 
derived from fully utilizing APPs and their clinical skills to the 
highest levels of their training, education, and experience as allowed 
by hospital policy in accordance with state law. We believe that this 
change permits a greater scope of practice for these professionals in 
the psychiatric hospital context.

Q. Innovation Center Models

1. Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency 
Policy
    Through this IFC, we are amending the Medicare Diabetes Prevention 
Program (MDPP) expanded model to modify certain MDPP policies during 
the PHE. Specifically, this IFC will permit certain beneficiaries to 
obtain the set of MDPP services more than once per lifetime, increase 
the number of virtual make-up sessions, and allow certain MDPP 
suppliers to deliver virtual MDPP sessions on a temporary basis. These 
changes are in response to COVID-19, which resulted in an interruption 
to expanded model services delivered by MDPP suppliers and/or prevented 
MDPP beneficiaries from attending sessions. Throughout the rulemaking 
for the MDPP expanded model, we sought to ensure that the MDPP set of 
services would be delivered in-person, in a classroom based setting, 
within an established timeline. At the time, the priority was placed on 
establishing a structured service that, when delivered within the 
confines of the rule, would create the least risk of fraud and abuse, 
increase the likelihood of success, and maintain the integrity of the 
data collected for evaluation purposes. However, the COVID-19 pandemic 
has led to suspension of in-person class sessions and guidance from CDC 
that Medicare-age beneficiaries stay home. In response, we will 
implement provisions that allow for temporary flexibilities that 
prioritize availability and continuity of services for MDPP suppliers 
and MDPP beneficiaries impacted by extreme and uncontrollable 
circumstances during the COVID-19 PHE. The changes in this IFC are 
applicable to MDPP suppliers, as defined in Sec.  410.79(b), that are 
enrolled in MDPP as March 1, 2020, and MDPP beneficiaries as defined in 
Sec.  410.79(b) who were receiving MDPP set of services as of March 1, 
2020. Under these temporary flexibilities, the requirement for in-
person attendance at the first core-session will remain in effect. As a 
result, if beneficiaries are prohibited from attending the first core 
session in person, suppliers will be unable to start any new cohorts 
with MDPP beneficiaries. All flexibilities described in this IFC will 
cease to be available at the conclusion of the PHE. The CDC issued 
guidance to all National Diabetes Prevention Program suppliers on or 
about March 12, 2020, providing alternative delivery options during the 
COVID-19 national emergency, including encouraging organizations to use 
virtual make-up sessions as necessary, regardless of usual delivery 
mode; if virtual make-up sessions are not possible, organizations may 
pause offering classes. When classes resume, the CDC is allowing 
suppliers to pick up where they left off, or to restart the expanded 
model program from week one. It is our intent to conform with the CDC 
guidance where feasible, with the overall intent to minimize disruption 
of services for MDPP suppliers and MDPP beneficiaries; by allowing MDPP 
beneficiaries to maintain their

[[Page 19263]]

eligibility. We are amending the MDPP regulations to provide for 
certain changes, including allowing MDPP suppliers to either deliver 
MDPP services virtually or suspend in-person services and resume 
services at a later date. The limit to the number of virtual make-up 
sessions is waived for MDPP suppliers with existing capabilities to 
provide services virtually, so long as the virtual services are 
furnished in a manner that is consistent with the CDC Diabetes 
Prevention Recognition Program (DPRP) standards for virtual sessions, 
follow the CDC-approved DPP curriculum requirements, and are provided 
upon the individual MDPP beneficiary's request. In addition, the MDPP 
supplier may only furnish to the MDPP beneficiary a maximum of one 
session on the same day as a regularly scheduled session and a maximum 
of one virtual make-up session per week. Virtual make-up sessions may 
only be furnished to achieve attendance goals and may not be furnished 
to achieve weight-loss goals. An MDPP supplier may offer to an MDPP 
beneficiary no more than: 15 virtual make-up sessions offered weekly 
during the core session period; 6 virtual make-up sessions offered 
monthly during the core maintenance session interval periods; and 12 
virtual make-up sessions offered monthly during the ongoing maintenance 
session interval periods.
    In addition, these changes permit certain MDPP beneficiaries to 
obtain the set of MDPP services more than once per lifetime, for the 
limited purposes of allowing a pause in service and to provide the 
flexibilities that will allow MDPP beneficiaries to maintain 
eligibility for MDPP services despite a break in service, attendance, 
or weight loss achievement.
    We are amending our provisions at Sec.  410.79 by adding paragraph 
(e).
2. Changes to the Comprehensive Care for Joint Replacement (CJR) Model 
To Extend the Length of Performance Year 5 by Three Additional Months 
and To Change the Extreme and Uncontrollable Circumstances Policy To 
Account for the COVID-19 Pandemic
    Through this IFC, we are implementing two changes to the 
Comprehensive Care for Joint Replacement (CJR) model to support the 
continuity of model operations and to ensure that CJR participants do 
not unfairly suffer financial consequences from the impact of COVID-19 
due to their participation in CJR. Specifically, we are implementing a 
3-month extension to CJR performance year (PY) 5 such that the model 
will now end on March 31, 2021, rather than ending on December 31, 
2020. On February 24, 2020, we published a proposed rule titled 
``Medicare Program: Comprehensive Care for Joint Replacement Model 
Three-Year Extension and Changes to Episode Definition and Pricing'' 
(85 FR 10516; CMS-5529-P). We wish to ensure continuity of CJR model 
operations in participant hospitals during this PHE for the COVID-19 
pandemic so that we do not create any additional disruptions to the 
standard care procedures hospitals have in place during this 
challenging time. Therefore, we are implementing a 3-month extension of 
CJR PY 5 and amending the provisions at 42 CFR 510.2 and 510.200(a) to 
reflect that extension.
    Further, recognizing that the current CJR model policy for extreme 
and uncontrollable circumstances policy is not applicable to the PHE 
for the COVID-19 pandemic, we also are implementing a change to that 
policy in this IFC such that it will be applicable to episodes impacted 
by the COVID-19 pandemic. Currently, the CJR extreme and uncontrollable 
circumstances policy, which is codified at Sec.  510.305(k), applies 
only during major disaster declarations where a participant hospital 
and its beneficiaries are affected by natural disasters, such as, 
hurricanes, earthquakes, wildfires.\16\ Although the COVID-19 outbreak 
in the United States was declared as a national emergency on March 13, 
2020,\17\ the current CJR extreme and uncontrollable circumstances 
policy does not apply to this national emergency. Although we do not 
expect many new CJR episodes to initiate as we have recently issued 
guidance \18\ stressing the need to avoid elective surgeries in light 
of the COVID-19 virus, we recognize that a number of beneficiaries are 
in active CJR episodes that initiated prior to March 2020. Further, we 
acknowledge that CJR hip fracture episodes, which generally result from 
emergent accidents and are not necessarily avoidable, will continue to 
occur. Given the challenges to the health care delivery system in 
responding to COVID-19 cases and the expenses associated with treating 
this highly contagious virus, we want to avoid inadvertently creating 
incentives to place cost considerations above patient safety within the 
CJR model during this COVID-19 pandemic. Therefore, to enable the CJR 
model to adjust for the effect of COVID-19, we are broadening the 
extreme and uncontrollable circumstances policy by applying certain 
financial safeguards to participant hospitals that have a CCN primary 
address that is located in an emergency area for episodes that overlap 
with the emergency period, as those terms are defined in section 
1135(g) of the Act, for which the Secretary issued a waiver or 
modification of requirements under section 1135 of the Act on March 13, 
2020, which applies nationwide.\19\ Accordingly, all participant 
hospitals are located in the emergency area and qualify for applicable 
financial safeguards during the emergency period.
---------------------------------------------------------------------------

    \16\ 82 FR 57066.
    \17\ See: https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
    \18\ See: https://www.cms.gov/files/document/31820-cms-adult-elective-surgery-and-procedures-recommendations.pdf.
    \19\ See https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
---------------------------------------------------------------------------

    Amending the extreme and uncontrollable circumstances policy to 
account for all participant hospitals affected by the COVID-19 pandemic 
allows participant hospitals to concentrate on patient care and ensures 
that participant hospitals are not held financially liable for episode 
costs that escalate due to effects from the COVID-19 pandemic. While 
this amendment greatly broadens the extreme and uncontrollable 
circumstances policy, the significant impact the health care delivery 
system faces in responding to COVID-19 cases and the expenses 
associated with treating this highly-contagious virus justifies 
modifying the extreme and uncontrollable circumstances policy and 
increasing the financial safeguards. Specifically, we are stating that 
for a fracture or non-fracture episode with a date of admission to the 
anchor hospitalization that is on or within 30 days before the date 
that the emergency period (as defined in section 1135(g) of the Act) 
begins or that occurs through the termination of the emergency period 
(as described in section 1135(e) of the Act), actual episode payments 
are capped at the target price determined for that episode under Sec.  
[thinsp]510.300. Though different financial safeguards apply for 
fracture and non-fracture episodes when a major disaster declaration is 
declared, we believe applying equal financial safeguards for both 
episodes during the COVID-19 pandemic is more appropriate due to its 
nationwide impact on hospitals and post-acute care facilities ability 
to provide care for beneficiaries during this PHE.
    We are codifying these provisions at Sec.  510.305 (k)(3) and (4).

[[Page 19264]]

3. Alternative Payment Model Treatment Under the Quality Payment 
Program
    As has been described previously in this IFC, we are seeking to 
give entities and individuals that provide services to Medicare 
beneficiaries needed flexibilities to respond effectively to the 
serious public health threats posed by the spread of the COVID-19, and 
to address the needs of health care providers specific to this declared 
national emergency. We further recognize that flexibilities may be 
necessary and appropriate in the context of Alternative Payment Models 
(APMs), including applicable model tests conducted under section 1115A 
of the Act by the CMS Center for Medicare and Medicaid Innovation 
(Innovation Center), as well as the Medicare Shared Savings Program. We 
note that aspects of APM policies under the Quality Payment Program are 
designed to follow on from the specific designs, policies, and 
operations of individual APMs. We recognize that our current 
regulations may be insufficient for purposes of adequately responding 
to the still-emerging COVID-19 national emergency and that additional 
action may be necessary and appropriate to prevent APM participants 
from facing undue burden in or negative consequences through the 
Quality Payment Program.
    We acknowledge that possible changes might be needed to address 
issues that may arise for APM participants in light of the current 
emergency. We will consider undertaking additional rulemaking, 
including possibly another interim final rule, to amend or suspend APM 
QPP policies as necessary to ensure accurate and appropriate 
application of Quality Payment Program policies in light of the PHE due 
to COVID-19.

R. Remote Physiologic Monitoring

    In recent years, we have finalized payment for seven CPT codes in 
the Remote Physiologic Monitoring (RPM) code family. We finalized 
payment in the CY 2018 PFS final rule for CPT code 99091 (Collection 
and interpretation of physiologic data digitally stored and/or 
transmitted by the patient and/or caregiver to the physician or other 
qualified health care professional, qualified by education, training, 
licensure/regulation requiring a minimum of 30 minutes of time). The 
following year, we finalized payment for CPT codes 99453 (Remote 
monitoring of physiologic parameter(s)(e.g., weight, blood pressure, 
pulse oximetry, respiratory flow rate), initial; set-up and patient 
education on use of equipment), 99454 (Remote monitoring of physiologic 
parameter(s)(e.g., weight, blood pressure, pulse oximetry, respiratory 
flow rate), initial; device(s) supply with daily recording(s) or 
programmed alert(s) transmission, each 30 days), and 99457 (Remote 
physiologic monitoring treatment management services, clinical staff/
physician/other qualified health care professional time in a calendar 
month requiring interactive communication with the patient/caregiver 
during the month; first 20 minutes)). Most recently, for the CY 2020 
PFS final rule (84 FR 62645 and 62646), we finalized a treatment 
management add-on code CPT code 99458 (Remote physiologic monitoring 
treatment management services, clinical staff/physician/other qualified 
health care professional time in a calendar month requiring interactive 
communication with the patient/caregiver during the month; each 
additional 20 minutes) and two self-measured blood pressure monitoring 
codes, CPT code 99473 (Self-measured blood pressure using a device 
validated for clinical accuracy; patient education/training and device 
calibration) and CPT code 99474 (Separate self-measurements of two 
readings one minute apart, twice daily over a 30-day period (minimum of 
12 readings), collection of data reported by the patient and/or 
caregiver to the physician or other qualified health care professional, 
with report of average systolic and diastolic pressures and subsequent 
communication of a treatment plan to the patient).
    We are concerned that under the PHE for the COVID-19 pandemic, 
physicians and other health care professionals are faced with 
challenges regarding potential exposure risks for themselves and their 
patients. In response, the CDC has urged health care professionals to 
make every effort to interview patients by telephone, text monitoring, 
or video conferencing instead of in-person. We believe that RPM 
services support the CDC's goal of reducing human exposure to the novel 
coronavirus while also increasing access to care and improving patient 
outcomes.
    RPM services are considered to be CTBS and, as such, would be 
billable only for established patients. Our goal during the PHE for the 
COVID-19 pandemic is to reduce exposure risks to the novel coronavirus 
for practitioners and patients and to increase access to services by 
eliminating as many obstacles as possible to delivering necessary 
services. Allowing RPM services to be furnished only to established 
patients could be an obstacle to delivery of reasonable and necessary 
care particularly during current conditions. Thus, in response to the 
PHE for the COVID-19 pandemic, we are finalizing on an interim basis, 
that RPM services can be furnished to new patients, as well as to 
established patients.
    In addition to current policy that there be an established patient-
practitioner relationship, we require for CTBS at least verbal consent 
from a Medicare beneficiary to receive the services. We finalized this 
requirement to avoid scenarios where beneficiaries are unexpectedly 
responsible for copays for services that do not involve the typical in-
person, face-to-face service that a patient receives during an office 
visit. We continue to believe that patient consent is important. 
However, we also believe that acquiring patient consent should not 
interfere with the provision of RPM services during the PHE for the 
COVID-19 pandemic. Therefore, we are finalizing on an interim basis 
that consent to receive RPM services can be obtained once annually, 
including at the time services are furnished, during the duration of 
the PHE for the COVID-19 pandemic. However, to enhance beneficiary 
protection, for both new and established patients, we suggest that the 
physician or other health care practitioner review consent information 
with a beneficiary, obtain the beneficiary's verbal consent, and 
document in the medical record that consent was obtained.
    Finally, we are clarifying that RPM codes can be used for 
physiologic monitoring of patients with acute and/or chronic 
conditions. The typical patient needing RPM services may have a chronic 
condition (for example, high blood pressure, diabetes, COPD). However, 
RPM can be used for other conditions. For example, RPM services allow a 
patient with an acute respiratory virus to monitor pulse and oxygen 
saturation levels using pulse oximetry. Nurses, working with 
physicians, can check-in with the patient and then using patient data, 
determine whether home treatment is safe, all the while reducing 
exposure risk and eliminating potentially unnecessary emergency 
department and hospital visits.

S. Telephone Evaluation and Management (E/M) Services

    For CY 2008, the CPT Editorial Panel created CPT codes to describe 
E/M services furnished by a physician or qualified healthcare 
professional via telephone or online, including CPT codes 98966 
(Telephone assessment and management service provided by a qualified 
nonphysician health care professional to an established patient,

[[Page 19265]]

parent, or guardian not originating from a related assessment and 
management service provided within the previous 7 days nor leading to 
an assessment and management service or procedure within the next 24 
hours or soonest available appointment; 5-10 minutes of medical 
discussion), 98967 (Telephone assessment and management service 
provided by a qualified nonphysician health care professional to an 
established patient, parent, or guardian not originating from a related 
assessment and management service provided within the previous 7 days 
nor leading to an assessment and management service or procedure within 
the next 24 hours or soonest available appointment; 11-20 minutes of 
medical discussion), 98968 (Telephone assessment and management service 
provided by a qualified nonphysician health care professional to an 
established patient, parent, or guardian not originating from a related 
assessment and management service provided within the previous 7 days 
nor leading to an assessment and management service or procedure within 
the next 24 hours or soonest available appointment; 21-30 minutes of 
medical discussion), 99441 (Telephone evaluation and management service 
by a physician or other qualified health care professional who may 
report evaluation and management services provided to an established 
patient, parent, or guardian not originating from a related E/M service 
provided within the previous 7 days nor leading to an E/M service or 
procedure within the next 24 hours or soonest available appointment; 5-
10 minutes of medical discussion), 99442 (Telephone evaluation and 
management service by a physician or other qualified health care 
professional who may report evaluation and management services provided 
to an established patient, parent, or guardian not originating from a 
related E/M service provided within the previous 7 days nor leading to 
an E/M service or procedure within the next 24 hours or soonest 
available appointment; 11-20 minutes of medical discussion), and 99443 
(Telephone evaluation and management service by a physician or other 
qualified health care professional who may report evaluation and 
management services provided to an established patient, parent, or 
guardian not originating from a related E/M service provided within the 
previous 7 days nor leading to an E/M service or procedure within the 
next 24 hours or soonest available appointment; 21-30 minutes of 
medical discussion). We assigned a status indicator of ``N'' 
(Noncovered) to these services because: (1) These services are non-
face-to-face; and (2) the code descriptors include language that 
recognizes the provision of services to parties other than the 
beneficiary for whom Medicare does not provide coverage (for example, a 
guardian).
    We do not believe that we should continue to consider these to be 
categorically non-covered services. In PFS rulemaking subsequent to CY 
2008, we established separate payment for numerous non-face-to-face 
services, including care management services and prolonged non-face-to-
face E/M services. We have also noted, for example in CY 2017, that we 
recognize that in current medical practice, practitioner interaction 
with caregivers is an integral part of treatment for some patients. 
Accordingly, the descriptions for several payable codes under the PFS 
include direct interactions between practitioners and caregivers (81 FR 
80331).
    When we established separate payment for services like virtual 
check-ins and e-visits, we recognized that non-face-to-face services 
had become an important part of overall physician care of Medicare 
beneficiaries, especially relative to care for chronic conditions. The 
current Medicare policy regarding the CPT codes that describe telephone 
E/M services predated our ongoing recognition of the need to pay 
separately for these kinds of services. Despite the fact that these are 
classified as E/M services in the coding, we do not believe that these 
codes describe full E/M services, but rather are closely analogous to 
the virtual check-in services. Although we assigned a ``Noncovered'' 
status indicator for the telephone E/M codes, we still established the 
American Medical Association's RUC-recommended RVUs for them. To 
establish the payment rate for the virtual check-in service, we used 
the RUC-recommended valuation for the lowest level telephone E/M code. 
However, the telephone E/M codes provide additional stratification by 
time for circumstances when a practitioner spends more than a brief 
amount of time in direct communication with the patient. We believe 
that under ordinary circumstances outside of the PHE, if the needs of 
the patient are significant enough to require the amount of time and 
attention from the practitioner specified in the codes for higher level 
telephone evaluations or assessments, either an in-person visit or a 
telehealth visit would be required. Alternatively, if the needs of the 
patient are less acute and lengthy, a virtual check-in would suffice. 
However, in the context of the goal of reducing exposure risks 
associated with the PHE for the COVID-19 pandemic, especially in the 
case that two-way, audio and video technology required to furnish a 
Medicare telehealth service might not be available, we believe there 
are many circumstances where prolonged, audio-only communication 
between the practitioner and the patient could be clinically 
appropriate yet not fully replace a face-to-face visit. We believe that 
the existing telephone E/M codes, in both description and valuation, 
are the best way to recognize the relative resource costs of these 
kinds of services. Therefore, we are finalizing, on an interim basis 
for the duration of the PHE for the COVID-19 pandemic, separate payment 
for CPT codes 98966-98968 and CPT codes 99441-99443. For these codes, 
we are finalizing on an interim basis for the duration of the PHE for 
the COVID-19 pandemic, work RVUs as recommended by the AMA Health Care 
Professionals Advisory Committee (HCPAC) for CY PFS 2008 rulemaking as 
discussed in the CY 2008 PFS final rule (72 CFR 66371) of 0.25 for CPT 
code 98966, 0.50 work RVUs for CPT code 98967, and 0.75 for CPT code 
98968, and work RVUs as recommended by the AMA Relative Value Scale 
Update Committee (RUC) of 0.25 for CPT code 99441, 0.50 for CPT code 
99442, and 0.75 for CPT code 99443. We are finalizing the HCPAC and 
RUC-recommended direct PE inputs which consist of 3 minutes of post-
service RN/LPN/MTA clinical labor time for each code.
    Similar to the CTBS described in section II.D. of this IFC, we 
believe it is important during the PHE to extend these services to both 
new and established patients. While some of the code descriptors refer 
to ``established patient,'' during the PHE we are exercising 
enforcement discretion on an interim basis to relax enforcement of this 
aspect of the code descriptors. Specifically, we will not conduct 
review to consider whether those services were furnished to established 
patients. CPT codes 98966-98968 described assessment and management 
services performed by practitioners who cannot separately bill for E/
Ms. We are noting that these services may be furnished by, among 
others, LCSWs, clinical psychologists, and physical therapists, 
occupational therapists, and speech language pathologists when the 
visit pertains to a service that falls within the benefit category of 
those practitioners.
    To facilitate billing of these services by therapists, we are 
designating CPT codes 98966-98968 as CTBS ``sometimes therapy'' 
services that

[[Page 19266]]

would require the private practice occupational therapist, physical 
therapist, and speech-language pathologist to include the corresponding 
GO, GP, or GN therapy modifier on claims for these services.

T. Physician Supervision Flexibility for Outpatient Hospitals--
Outpatient Hospital Therapeutic Services Assigned to the Non-Surgical 
Extended Duration Therapeutic Services (NSEDTS) Level of Supervision

    Non-surgical extended duration therapeutic services (NSEDTS) 
describe services that have a significant monitoring component that can 
extend for a sizable period of time, that are not surgical, and that 
typically have a low risk of complications after the assessment at the 
beginning of the service. The minimum default supervision level of 
NSEDTS was established in the CY 2011 OPPS/ASC final rule with comment 
period (75 FR 72003 through 72013) as being 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 NPP (Sec.  410.27(a)(1)(iv)(E)). In this case, initiation 
means the beginning portion of the NSEDTS which ends when the patient 
is stable and the supervising physician or the appropriate NPP 
determines that the remainder of the service can be delivered safely 
under general supervision. We established general supervision as the 
appropriate level of supervision after the initiation of the service 
because it is challenging for hospitals to ensure direct supervision 
for services with an extended duration and a significant monitoring 
component, particularly for CAHs and small rural hospitals.
    In the CY 2020 OPPS/ASC final rule with comment period (84 FR 61359 
through 61363), we changed the generally applicable minimum required 
level of supervision for most hospital outpatient therapeutic services 
from direct supervision to general supervision for hospitals and CAHs. 
Given the circumstances of the PHE for the COVID-19 pandemic, we 
believe it is critical that hospitals have the most flexibility as 
possible to provide the services Medicare beneficiaries need during 
this challenging time. Changing the minimum default level of 
supervision to general supervision for NSEDTS during the initiation of 
the service will give providers additional flexibility they will need 
to handle the burdens created by the PHE for the COVID-19 pandemic.
    Therefore, we are assigning, on an interim basis, all outpatient 
hospital therapeutic services that fall under Sec.  
410.27(a)(1)(iv)(E), a minimum level of general supervision to be 
consistent with the minimum default level of general supervision that 
applies for most outpatient hospital therapeutic services, and we are 
revising Sec.  410.27(a)(1)(iv)(E) to reflect this change in the 
minimum level of supervision. General supervision, as defined in our 
regulation at Sec.  410.32(b)(3)(i) means that the procedure is 
furnished under the physician's overall direction and control, but that 
the physician's presence is not required during the performance of the 
procedure.

U. Application of Certain National Coverage Determination and Local 
Coverage Determination Requirements During the PHE for the COVID-19 
Pandemic

    National Coverage Determinations (NCDs) are determinations by the 
Secretary with respect to whether or not a particular item or service 
is covered nationally under Title XVIII. Local Coverage Determinations 
(LCDs) are determinations by a Medicare Administrative Contractor (MAC) 
with respect to whether or not a particular item or service is covered 
under section 1862(a)(1)(A) of the Act in the particular MAC's 
geographical areas. Articles are often published alongside LCDs and 
contain coding or other guidelines that complement an LCD. NCDs and 
LCDs contain clinical conditions a patient must meet to qualify for 
coverage of the item or service. Some NCDs and LCDs may also contain 
requirements for face-to-face, timely evaluations or re-evaluations for 
a patient to initially qualify for coverage or to qualify for 
continuing coverage of the item or service. These requirements are more 
often present in NCDs and LCDs for durable medical equipment than for 
other items and services.
1. Face-to-Face and In-Person Requirements
    For the duration of this PHE for the COVID-19 pandemic, it is in 
the best interest of patients, health care professionals and suppliers 
to limit face-to-face encounters and avoid exposure of vulnerable 
Medicare beneficiaries to COVID-19. Therefore, on an interim basis, we 
are finalizing that to the extent an NCD or LCD (including articles) 
would otherwise require a face-to-face or in-person encounter for 
evaluations, assessments, certifications or other implied face-to-face 
services, those requirements would not apply during the PHE for the 
COVID-19 pandemic.
    We note that some face-to-face encounter requirements for DMEPOS 
Power Mobility Devices (PMDs) are mandated by statute for program 
integrity purposes. This IFC does not apply to those statutory 
requirements. For example, PMD face-to-face encounter requirements are 
found in section 1834(a)(1)(E)(iv) of the Act, as codified in Sec.  
410.38, and our regulation already permits the use of telehealth in 
accordance with Medicare guidelines. We have extended flexibilities to 
permit a broader use of telehealth services during the PHE for the 
COVID-19 pandemic. It should be noted that this does not confer changes 
to the clinical indications of coverage for any LCD or NCD unless 
specifically indicated below.
2. Clinical Indications for Certain Respiratory, Home Anticoagulation 
Management and Infusion Pump Policies
    During the PHE for the COVID-19 pandemic, it is possible that 
patients receiving services for respiratory related indications will be 
required to receive care in unexpected settings, including the home. 
This may be necessary as COVID-19 and other patients are shifted across 
healthcare settings to accommodate an increase in patient volume.
    Therefore, we are finalizing on an interim basis that we will not 
enforce the clinical indications for coverage across respiratory, home 
anticoagulation management and infusion pump NCDs and LCDs (including 
articles) allowing for maximum flexibility for practitioners to care 
for their patients. This enforcement discretion will only apply during 
the PHE for the COVID-19 pandemic. These policies include, but are not 
limited to:
     NCD 240.2 Home Oxygen.
     NCD 240.4 Continuous Positive Airway Pressure for 
Obstructive Sleep Apnea.
     LCD L33800 Respiratory Assist Devices (ventilators for 
home use).
     NCD 240.5 Intrapulmonary Percussive Ventilator.
     LCD L33797 Oxygen and Oxygen Equipment (for home use).
     NCD 190.11 Home Prothrombin Time/International Normalized 
Ratio (PT/INR) Monitoring for Anticoagulation Management.
     NCD 280.14 Infusion Pumps.
     LCD L33794 External Infusion Pumps.
    At the conclusion of the PHE for the COVID-19 pandemic, we will 
return to enforcement of these clinical indications for coverage.

[[Page 19267]]

3. Requirements for Consultations or Services Furnished by or With the 
Supervision of a Particular Medical Practitioner or Specialist
    Staffing is being adjusted in both facility and non-facility 
settings to accommodate for the needs of patients during the PHE for 
the COVID-19 pandemic. These staffing decisions may impact the 
availability of physicians and physician specialists to furnish 
evaluations, consultations and procedures or to supervise others. To 
the extent NCDs and LCDs require a specific practitioner type or 
physician specialty to furnish a service, procedure or any portion 
thereof, we are finalizing on an interim basis the chief medical 
officer or equivalent of the facility can authorize another physician 
specialty or other practitioner type to meet those requirements during 
the PHE for the COVID-19 pandemic. Additionally, to the extent NCDs and 
LCDs require a physician or physician specialty to supervise other 
practitioners, professionals or qualified personnel, the chief medical 
officer of the facility can authorize that such supervision 
requirements do not apply during the PHE for the COVID-19 pandemic.

V. Change to Medicare Shared Savings Program Extreme and Uncontrollable 
Circumstances Policy

    In December 2017, we issued an interim final rule with comment 
period, titled ``Medicare Shared Savings Program: Extreme and 
Uncontrollable Circumstances Policies for Performance Year 2017'' 
(hereinafter referred to as the ``December 2017 interim final rule with 
comment period''), which appeared in the Federal Register on December 
26, 2017 (82 FR 60912 through 60919). The December 2017 interim final 
rule with comment period established a policy for determining quality 
performance scores for accountable care organizations (ACOs) 
participating in the Medicare Shared Savings Program (Shared Savings 
Program), when the ACO, its participating ACO providers and suppliers, 
and assigned beneficiaries were located in geographic areas that were 
impacted by extreme and uncontrollable circumstances, such as 
hurricanes, wildfires, or other triggering events, during performance 
year (PY) 2017, including the applicable quality data reporting period 
for the performance year if the quality reporting period was not 
extended. In the CY 2019 PFS final rule we extended the extreme and 
uncontrollable circumstances policy finalized for PY 2017 to PY 2018 
and subsequent performance years. Under the policy adopted in that 
final rule, for a given performance year, including the applicable 
quality data reporting period for the performance year if the quality 
reporting period is not extended, we will use an alternative approach 
to calculating the quality score for ACOs affected by extreme and 
uncontrollable circumstances (42 CFR 425.502(f)).
    Under this current policy at Sec.  425.502(f), the Shared Savings 
Program extreme and uncontrollable circumstances policy does not apply 
for a performance year if an extreme and uncontrollable circumstance 
occurs during the quality reporting period for that performance year 
and the quality reporting period is extended. For all performance years 
starting in 2019, the original quality reporting period was January 2, 
2020, through March 31, 2020. In response to the PHE for the COVID-19 
pandemic, we have determined that the 2019 MIPS data submission 
deadline will be extended by 30 days until April 30, 2020, to give 
eligible clinicians more time to report quality and other data for 
purposes of MIPS. This extended timeline also applies to Shared Savings 
Program ACOs because they are required to report quality data via the 
CMS Web Interface and we align the Shared Savings Program data 
submission timeline with the timeline for MIPS data submission. While 
the extended timeframe for data submission is intended to give eligible 
clinicians sufficient time to complete all the elements of MIPS 
reporting during the PHE for the COVID-19 pandemic, we realize that 
this extension alone may not be sufficient to ease the burden of 
reporting given the increased burden of providing care to all patients 
during this time. For this reason, under the Quality Payment Program, 
we have determined that the MIPS automatic extreme and uncontrollable 
circumstances policy will apply to MIPS eligible clinicians, who do not 
submit their MIPS data by the extended timeline. Under this automatic 
extreme and uncontrollable circumstances policy, MIPS eligible 
clinicians, who are not participants in APMs, who do not submit any 
MIPS data will have all performance categories reweighted to zero 
percent, resulting in a score equal to the performance threshold, and a 
neutral MIPS payment adjustment. However, under the policy, if a MIPS 
eligible clinician submits data on two or more MIPS performance 
categories, they will be scored and receive a 2021 MIPS payment 
adjustment based on their final score.
    The automatic extreme and uncontrollable circumstances policy 
described above does not apply to MIPS eligible clinicians who are 
subject to the APM scoring standard (82 FR 53899), such as MIPS 
eligible clinicians participating in Shared Savings Program ACOs. 
Instead, these MIPS eligible clinicians will continue to be scored 
under the existing APM scoring standard. Generally, if no MIPS eligible 
clinicians in an APM Entity submit data by the extended deadline for 
the Quality and Promoting Interoperability performance categories due 
to extreme and uncontrollable circumstances, the APM scoring standard 
would apply as follows. The Cost performance category will be weighted 
at zero percent, as usual. The Improvement Activities performance 
category will be scored as usual. The Quality performance category will 
be reweighted to zero percent where the APM has waived quality 
reporting for purposes of the APM as in these circumstances CMS 
determines that there are not sufficient measures or activities 
applicable and available to MIPS eligible clinicians, consistent with 
Sec.  414.1370(h). Finally, if all MIPS eligible clinicians in an APM 
Entity have been excepted from reporting the Promoting Interoperability 
performance category, then the Promoting Interoperability performance 
category weight will be reweighted to zero for the APM Entity for that 
MIPS performance period (Sec.  414.1370(g)(4)(iii)(A)). As a result, in 
these circumstances, the Quality, Cost, and Promoting Interoperability 
categories would all be weighted at zero percent. And as only one 
performance category will be scored, the Improvement Activities 
performance category, such MIPS eligible clinicians would receive a 
neutral MIPS payment adjustment.
    For MIPS eligible clinicians participating in Shared Savings 
Program ACOs that do not report quality and obtain a neutral payment 
adjustment under MIPS, according to the existing APM scoring standard 
described above, the Shared Savings Program must determine that the 
ACOs are impacted by an extreme and uncontrollable circumstance and 
waive the quality reporting requirement under the Shared Savings 
Program. As currently written, the Shared Savings Program extreme and 
uncontrollable circumstances policy does not allow for the 
determination that an ACO has been impacted by an extreme and 
uncontrollable circumstance that occurs during the quality reporting 
period if quality reporting period is extended, as

[[Page 19268]]

it has been for performance years starting in 2019.
    In addition, under the Shared Savings Program, if an ACO fails to 
report quality data by the submission deadline, the ACO will not have 
met the quality performance standard and will receive a quality score 
of zero, unless the extreme and uncontrollable circumstances policy 
under Sec.  425.502(f) applies. In the event an ACO receives a quality 
performance score of zero, the ACO would be ineligible to share in 
savings, if earned and would owe maximum losses if participating under 
Track 2 or the ENHANCED track. The current Medicare Shared Savings 
Program extreme and uncontrollable circumstances policy for purposes of 
determining an ACO's quality score for use in determining shared 
savings or losses applies if twenty percent or more of an ACO's 
assigned beneficiaries or its legal business entity are located in an 
area identified under the Quality Payment Program as being affected by 
an extreme and uncontrollable circumstance for the performance year, 
including the quality reporting period if the quality reporting period 
is not extended.
    The effect of the MIPS quality reporting period extension is that 
the current Shared Savings Program extreme and uncontrollable 
circumstance policy does not apply, because the current extreme and 
uncontrollable circumstances policy is only available for extreme and 
uncontrollable circumstances that occur during the quality reporting 
period, such as the current PHE for the COVID-19 pandemic, if the 
quality reporting period is not extended. The inability to apply the 
extreme and uncontrollable circumstances policy to waive the quality 
reporting requirements under the Shared Savings Program during the PHE 
may adversely impact ACOs and their participating ACO providers and 
suppliers, because the extended timeline to submit data alone may not 
be sufficient to support ACOs and their participating ACO providers and 
suppliers, who are focused on care delivery during the national 
emergency.
    The intent of the Shared Savings Program extreme and uncontrollable 
circumstance policy is to mitigate any impact on quality performance 
and the resultant effect on financial reconciliation due to emergency 
circumstances outside of the ACO's control. Accordingly, we believe it 
is necessary to revise the policies governing the availability of the 
Shared Savings Program extreme and uncontrollable circumstances 
policies to extend the protection to ACOs that may not be able to 
completely and accurately report their quality data for 2019, despite 
the extension of the quality reporting period. To provide relief to all 
ACOs participating in the Shared Savings Program during 2019, we need 
to modify the extreme and uncontrollable circumstances policy as it 
applies to disasters that occur during the reporting period to 
eliminate the restriction that the extreme and uncontrollable 
circumstances policy applies only if the reporting period is not 
extended.
    As explained above, the PHE for the COVID-19 pandemic was declared 
during the quality reporting period for performance years starting in 
2019. The PHE for the COVID-19 pandemic applies to all counties in the 
United States, and we believe it is appropriate to offer relief under 
the Shared Savings Program extreme and uncontrollable circumstances 
policy to all Shared Savings Program ACOs that are unable to completely 
and accurately report quality for 2019 by the extended deadline due to 
the PHE for the COVID-19 pandemic. Due to the PHE for the COVID-19 
pandemic and our desire to provide relief for Shared Savings ACOs who 
need to focus resources on patient care at this time, we believe that 
this policy must be effective starting with the quality reporting 
period for performance years starting in 2019. Further, as illustrated 
by the current PHE for the COVID-19 pandemic, there may be 
unanticipated situations in the future, during which extension of a 
quality reporting window alone would not provide sufficient relief from 
reporting burden at a time when ACOs and their ACO providers and 
suppliers need to focus on patient care. Accordingly, in this IFC, we 
are revising the regulation at Sec.  425.502(f) to remove the 
restriction which prevents the application of the Shared Savings 
Program extreme and uncontrollable circumstances policy for disasters 
that occur during the quality reporting period if the reporting period 
is extended, to offer relief under the Shared Savings Program to all 
ACOs that may be unable to completely and accurately report quality 
data for 2019 due to the PHE for the COVID-19 pandemic. Specifically, 
we are amending the regulation at Sec.  425.502(f) to remove the phrase 
``if the quality reporting period is not extended,'' effective with 
quality reporting for PY 2019.
    We are considering whether the current policy, which assigns an ACO 
the higher of the mean quality score across all ACOs and the ACO's own 
quality score, in the event the ACO is determined to be impacted by an 
extreme and uncontrollable circumstances, will continue to be 
appropriate for PY 2020 and beyond. Any change to that current policy 
would be made through future notice and comment rulemaking.
    Regarding Shared Savings Program financial reconciliations for 
performance years starting in 2019, we note that because the PHE for 
the COVID-19 pandemic was declared during the reporting period for 
those performance years, the provisions that allow for an adjustment to 
the amount of shared losses for ACOs found to be affected by an extreme 
and uncontrollable circumstance during a performance year would not 
apply for performance years starting in 2019. However, for PY 2020 
financial reconciliation, we will reduce the amount of an ACO's shared 
losses by an amount determined by multiplying the shared losses by the 
percentage of the total months in the performance year affected by an 
extreme and uncontrollable circumstance, and the percentage of the 
ACO's assigned beneficiaries who reside in an area affected by an 
extreme and uncontrollable circumstance. At this time, the PHE for the 
COVID-19 pandemic applies to all counties in the country; therefore, 
100 percent of assigned beneficiaries for all Shared Savings Program 
ACOs reside in an affected area and the total months affected by an 
extreme and uncontrollable circumstance will begin with March and 
continue through the end of the current PHE, as defined in Sec.  
400.200.
    Additionally, the Medicare Shared Savings Program financial 
methodology includes updating each ACO's benchmark at the end of each 
performance year based on the performance year expenditure trend. The 
factors used to update ACOs' benchmarks will reflect the national and 
regional trends related to spending and utilization changes during 
2020, including any changes arising from the PHE for the COVID-19 
pandemic.

W. Level Selection for Office/Outpatient E/M Visits When Furnished Via 
Medicare Telehealth

    In the CY 2020 PFS final rule (84 FR 62847 and 62848), we finalized 
a number of changes to the framework of the office/outpatient E/M 
requirements for CY 2021. Beginning January 1, 2021 for office/
outpatient E/M visits, the code level will be selected based on either 
the level of MDM or the total time personally spent by the reporting 
practitioner on the day of the visit

[[Page 19269]]

(including face-to-face and non-face-to-face time). We noted that there 
was broad support for these changes from the AMA and other specialty 
societies. Currently, telehealth office/outpatient E/Ms can be 
furnished to beneficiaries in their homes only when they are for 
individuals with a substance use disorder (SUD) diagnosis for purposes 
of treatment of such disorder or co-occurring mental health disorder. 
For these services, the primary factor in selecting the appropriate 
level of E/M service to bill would be time spent counseling the 
patient. Under the waiver issued by the Secretary pursuant to section 
1135(b)(8) of the Act, telehealth office/outpatient E/Ms can be 
furnished to any patient in their home regardless of their diagnosis or 
medical condition. However, the current E/M coding guidelines would 
preclude the billing practitioner from selecting the office/outpatient 
E/M code level based on time in circumstances where the practitioner is 
not engaged in counseling and/or care coordination.
    On an interim basis, we are revising our policy to specify that the 
office/outpatient E/M level selection for these services when furnished 
via telehealth can be based on MDM or time, with time defined as all of 
the time associated with the E/M on the day of the encounter; and to 
remove any requirements regarding documentation of history and/or 
physical exam in the medical record. This policy is similar to the 
policy that will apply to all office/outpatient E/Ms beginning in 2021 
under policies finalized in the CY 2020 PFS final rule. It remains our 
expectation that practitioners will document E/M visits as necessary to 
ensure quality and continuity of care. To reduce the potential for 
confusion, we are maintaining the current definition of MDM. We note 
that currently there are typical times associated with the office/
outpatient E/Ms, and we are finalizing those times as what should be 
met for purposes of level selection. The typical times associated with 
the office/outpatient E/Ms are available as a public use file at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1715-F. This 
policy only applies to office/outpatient visits furnished via Medicare 
telehealth, and only during the PHE for the COVID-19 pandemic.

X. Counting of Resident Time During the PHE for the COVID-19 Pandemic

    In section II.O. of this IFC, ``Application of the Teaching 
Physician Regulations During the PHE for the COVID-19 pandemic,'' we 
state that the teaching supervision requirement can be met in certain 
circumstances through direct supervision using interactive 
telecommunications technology, including when a medical resident is 
quarantined at home. Regarding claiming of the residents for indirect 
medical education (IME) and Direct graduate medical education (DGME) 
purposes, under current regulations, if a resident is training in a 
hospital, that hospital claims the resident for IME and DGME (per Sec.  
413.78(a)), and if a resident is training in a nonprovider site such as 
a doctor's office or clinic, the hospital or hospitals that pays the 
resident's salaries and fringe benefits claims the resident for IME and 
DGME (per Sec.  413.78(g)). Currently, there is no provision in the 
regulations for a hospital to claim a resident for IME or DGME if the 
resident is performing patient care activities within the scope of his 
or her approved program in his or her own home, or in a patient's home. 
For the duration of this emergency situation, we are permitting the 
hospital that is paying the resident's salary and fringe benefits for 
the time that the resident is at home or in the home of a patient that 
is already a patient of the physician or hospital, but performing 
patient care duties within the scope of the approved residency program 
(and meets appropriate physician supervision requirements as stated in 
section II.O. of this IFC) to claim that resident for IME and DGME 
purposes.

Y. Addressing the Impact of COVID-19 on Part C and Part D Quality 
Rating Systems

1. Background
a. Legislative Authority for Star Ratings
    Based on its authority to disseminate comparative information, 
including about quality, to beneficiaries under sections 1851(d) and 
1860D-1(c) of the Act and authority to collect various types of quality 
data under section 1852(e) of the Act, CMS develops and publicly posts 
a 5-star ratings system for MA and Part D plans. That system is also 
the basis for determining quality bonus payment (QBP) status for MA 
plans under section 1853(o) of the Act. Section 1876 cost plans are 
also included in the MA and Part D Star Rating system as codified at 42 
CFR 417.472(k) and are also required by Sec.  417.472(j) to make CAHPS 
survey data available to CMS. In a final rule, ``Medicare Program; 
Contract Year 2019 Policy and Technical Changes to the Medicare 
Advantage, Medicare Cost Plans, Medicare Fee-for-Service, the Medicare 
Prescription Drug Benefit Programs, and the PACE Program,'' published 
on April 16, 2018 (83 FR 16519 through 16589), we adopted regulations 
to govern this quality rating system for cost MA and Part D plans, 
which are generally rated at the contract level. In a final rule, 
``Medicare and Medicaid Program; Policy and Technical Changes to the 
Medicare Advantage, Medicare Prescription Drug Benefit, Programs of 
All-Inclusive Care for the Elderly (PACE), Medicaid Fee-for-Service, 
and Medicaid Managed Care Programs for Years 2020 and 2021,'' published 
April 16, 2019 (84 FR 15830 and 15831), we amended the regulations 
governing the quality rating program for MA and Part D plans. Those 
final rules contain a more detailed discussion of CMS' authority in 
this area and we encourage readers to refer to those final rules.
    In the CY 2020 Final Call Letter and the CY 2020 final rule, 
published in the Federal Register on April 16, 2019 (84 FR 15830 and 
15831), we finalized a set of rules for adjusting the calculation of 
Star Ratings for the cost and Parts C and D organizations that are 
impacted by extreme and uncontrollable circumstances. We provided in 
the 2021 Advance Notice that the same policy as used for adjustments to 
2020 Star Ratings based on extreme and uncontrollable circumstances 
would be continued for CY 2021 Star Ratings. We did not envision the 
unprecedented circumstances surrounding the PHE for the COVID-19 
pandemic when we developed the adjustments for extreme and 
uncontrollable circumstances for the Part C and D Star Ratings program; 
as they exist currently, they are not sufficient in the case of the PHE 
for the COVID-19 pandemic.
b. Overview of Star Ratings
    The Star Ratings are generally based on measures of performance 
during a period that is 2 calendar years before the year for which the 
Star Ratings are issued; 2021 Star Ratings will generally be based on 
performance during 2019 and the 2022 Star Ratings will similarly be 
based on performance in 2020. We use multiple data sources to measure 
quality and performance of contracts. Various regulations require plans 
to report on quality improvement and quality assurance and to provide 
data which we can use to help beneficiaries compare plans (for example, 
Sec. Sec.  417.472(j) and (k), 422.152(b), 423.153(c), and 423.156). In 
addition, we may require plans to report statistics and other 
information in specific categories (Sec. Sec.  422.516 and 423.514). 
Data from these sources and other sources are used to calculate 
measures

[[Page 19270]]

of plan sponsor performance each year, as provided in Sec. Sec.  
422.162 and 423.182. The Star Ratings serve an important purpose in 
providing comparative information to enrollees and are also used to 
identify whether an MA plan is eligible for a QBP under section 1853(o) 
of the Act. The Patient Protection and Affordable Care Act (Pub. L. 
111-148), as amended by the Healthcare and Education Reconciliation Act 
(Pub. L. 111-152), provides for quality ratings, based on a 5-star 
rating system and the information collected under section 1852(e) of 
the Act, to be used in calculating payment to MA organizations 
beginning in 2012. Specifically, sections 1853(o) and 1854(b)(1)(c) of 
the Act were added and amended to provide, respectively, for an 
increase in the benchmark against which MA organizations bid and in the 
portion of the savings between the bid and the benchmark available to 
the MA organization to use as a rebate. We assign both low and high 
performing icons that are displayed on www.Medicare.gov to help 
Medicare beneficiaries make plan decisions based on either consistently 
low performance for 3 or more years or receiving 5 stars for the 
highest rating, respectively. Additionally, plans that demonstrate 
exceptional performance due to achieving a 5 Star Rating for their 
highest rating can market year round and beneficiaries receive a 
special election period that allows the eligible beneficiary to enroll 
in a 5-star plan during the contract year. We also have the authority 
to terminate plans that have below a 3-star rating for 3 or more years. 
The Star Ratings therefore serve a number of important purposes for 
cost, MA and Part D plans; we believe that plans engage in behavior 
during the performance measurement period to improve their Star Ratings 
and to achieve higher Star Ratings.
    Healthcare Effectiveness Data and Information Set (HEDIS) and 
Consumer Assessment of Healthcare Providers and Systems (CAHPS) data 
are the basis for the calculation of the majority of measures for both 
the Part C and Part D Star Ratings. HEDIS measures include clinical 
measures assessing the effectiveness of care, access/availability 
measures, and service use measures and are calculated by CMS through a 
contract with the National Committee for Quality Assurance (NCQA). Many 
of the HEDIS measures require plans to perform reviews of patients' 
medical records or to obtain information directly from physician 
offices, which is a time-intensive activity.
    CAHPS refers to a comprehensive family of surveys that ask 
consumers and patients to evaluate experiences of care. Cost plans, 
Part C plans, and Part D plans are all required by regulation 
(Sec. Sec.  417.472, 422.152, and 423.156, respectively) to contract 
with approved Medicare CAHPS survey vendors to conduct the Medicare 
CAHPS satisfaction survey of Medicare plan enrollees in accordance with 
CMS specifications and submit the survey data to CMS. The Star Ratings 
system uses measures from HEDIS and CAHPS extensively, and there are 
negative consequences for a plan's Star Ratings (overall and on 
specific measures) if the necessary data for the HEDIS and CAHPS 
measures are not reported or validated. Although the 2021 Star Ratings 
reflect performance in 2019 for most of the measures, data collection 
for HEDIS and CAHPS is conducted in the first half of CY 2020 to feed 
into the 2021 Star Ratings that are finalized by October 2020. 
Similarly, the Health Outcomes Survey will occur in 2020 to collect 
data used for the 2022 Star Ratings and the same concerns about survey 
activities apply to that survey.
2. Impact of COVID-19 on Star Ratings Data Collection
    The World Health Organization (WHO) has characterized COVID-19 as a 
pandemic, and there are alarming levels of spread and severity of 
COVID-19 across the United States. The CDC and medical professionals 
recommend that the best way to prevent the spread of the virus is to 
avoid contact with infected individuals. Social distancing is a method 
that public health officials use to curb the transmission and spread of 
infectious illnesses like COVID-19. Prior research has shown that these 
measures help mitigate the spread of contagious viruses in the absence 
of vaccines (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3372334/), as 
is the case with COVID-19.
    To help curb the spread of COVID-19, governors around the country 
are putting in place actions to protect public health and safety and 
help mitigate the spread of the virus, including school closures, 
limiting the size of gatherings and events, and restaurant closures. 
Employers are moving to mandatory telework when feasible. The intent of 
these actions is to save lives, keep people safe, and slow the rate of 
infection. As of March 28, 2020, all 50 states were under a State of 
Emergency. Additionally, areas of the country are being put under 
shelter-in-place orders to further curtail the spread of the virus. CDC 
has provided guidance to health care facilities (for example, https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/guidance-hcf.html) that range from rescheduling non-urgent outpatient visits and 
elective surgeries, promoting telehealth visits, and managing mildly 
ill COVID-19 patients at home. Also, on March 16, 2020, CDC issued 
interim guidance (https://www.cdc.gov/coronavirus/2019-ncov/community/large-events/index.html) advising the public against holding gatherings 
of more than 10 individuals. On March 18, 2020, we released 
recommendations related to delaying adult elective surgeries, non-
essential medical, surgical, and dental procedures during the COVID-19 
outbreak to be able to focus health care professionals on those most in 
need of healthcare (https://www.cms.gov/newsroom/press-releases/cms-releases-recommendations-adult-elective-surgeries-non-essential-medical-surgical-and-dental).
    On March 13, 2020, President Trump declared a national emergency as 
a result of the COVID-19 pandemic. The declaration of the PHE for the 
COVID-19 pandemic allows certain Medicare requirements and conditions 
of participation to be waived under section 1135 of the Act providing 
more flexibility to providers in furnishing medically necessary health 
care to beneficiaries.
    Currently, data collection for HEDIS measures is ongoing for 
services and performance during the 2019 measurement period. MA 
contracts are required to submit their HEDIS summary-level data to the 
NCQA by June 15, 2020, as well as to submit their HEDIS patient-level 
data to CMS the same day. Currently, data collection activities are 
underway to meet the June deadlines. Some of the HEDIS measures require 
medical record review or obtaining information directly from physician 
offices. We recognize that obtaining medical records from physician 
offices and the necessary documentation from physician offices needed 
for the plan to meet HEDIS requirements, and requiring plans to 
participate in HEDIS audits will put a strain on the limited resources 
available to these health care providers. Some of these activities are 
generally done in person so compliance with social distancing efforts, 
travel bans and quarantines raise additional challenges, as well as 
risks to staff. CMS' top priority is to ensure public health and 
safety, including that of beneficiaries, health and drug plan staff, 
and providers, and to allow health and drug plans, providers, and 
physician offices to focus on what is most important at this time: The 
provision of care.
    Under Sec. Sec.  417.472(i) and (j), 422.152(b)(5), and 423.156, 
all

[[Page 19271]]

coordinated care MA plans, section 1876 contracts, and Part D sponsors, 
respectively, are required to contract with a CMS-approved CAHPS survey 
vendor to conduct the Medicare CAHPS satisfaction survey in accordance 
CMS specifications and to submit the data to CMS. The administration of 
the surveys and data collection are currently ongoing until the end of 
May 2020 for the CAHPS survey data that would be used for the 2021 Star 
Ratings. We are concerned that the COVID-19 pandemic will pose 
significant challenges and safety concerns in successfully completing 
the current CAHPS data collection. Most of the survey administration 
protocols cannot be completed remotely, requiring staff to work in mail 
facilities and call centers where telephone interviewers assemble in 
close quarters to perform the telephone administration of the survey. 
We are concerned that cost plans, MA organizations, and Part D plan 
sponsors will not be able to complete this year's data collection 
without jeopardizing the health and safety of survey vendor staff. We 
have similar concerns about the Health Outcomes Survey (HOS) data 
collection scheduled for later in 2020.
    This IFC amends, as necessary, the calculations for the 2021 and 
2022 Part C and D Star Ratings to incorporate changes to address the 
expected impact of the PHE for the COVID-19 pandemic on data collection 
and performance. Plans urgently need to know these changes so as not to 
further exacerbate the PHE for the COVID-19 pandemic by continuing 
efforts to complete the HEDIS and CAHPS data collection activities. The 
HEDIS data collection diverts physicians' offices and health plans from 
handling the day-to-day emergencies as a result of the PHE for the 
COVID-19 pandemic. Additionally, we are concerned it is not possible to 
safely continue the HEDIS and CAHPS data collection activities while 
complying with the CDC recommendation for social distancing.
    Under normal circumstances, if Part C and section 1876 plans do not 
fully complete their HEDIS data collection activities and successfully 
meet NCQA's HEDIS audit requirements, we assign each of the HEDIS Star 
Ratings measures 1 star. Similarly, if the CAHPS data cannot be 
completed and submitted on time by Part C, section 1876 cost, and Part 
D plans, we historically have assigned each of the CAHPS Star Ratings 
measures 1 star. Furthermore, unreliable CAHPS measure scores are 
excluded from the Part C and D Star Ratings calculations. Without 
knowing the changes made by this IFC to the methodology for calculating 
the 2021 and 2022 Star Rating, plans could have conflicting incentives, 
needing physician offices and plan staff to focus on caring for those 
impacted by COVID-19 and keeping Medicare beneficiaries and those 
involved in data collection activities safe, while at the same time 
wanting to ensure that future Star Ratings and QBP ratings are not 
impacted by the PHE for the COVID-19 pandemic which could negatively 
impact future benefits offered by MA organizations. The changes to the 
calculations for 2021 and 2022 Star Ratings are designed to avoid 
inadvertently creating incentives for plans to place cost and Star 
Rating considerations above efforts to address the COVID-19 pandemic.
3. Provisions of IFC
    This IFC is modifying the calculation of the 2021 and 2022 Part C 
and D Star Ratings to address the expected disruption to data 
collection posed by the PHE for the COVID-19 pandemic. Specifically, 
this IFC: (1) Replaces the 2021 Star Ratings measures calculated based 
on HEDIS and Medicare CAHPS data collections with earlier values from 
the 2020 Star Ratings (which are not affected by the public health 
threats posed by COVID-19); (2) establishes how we will calculate or 
assign Star Ratings for 2021 in the event that CMS' functions become 
focused on only continued performance of essential Agency functions and 
the Agency and/or its contractors do not have the ability to calculate 
the 2021 Star Ratings; (3) modifies the current rules for the 2021 Star 
Ratings to replace any measure that has a data quality issue for all 
plans due to the COVID-19 outbreak with the measure-level Star Ratings 
and scores from the 2020 Star Ratings; (4) in the event that we are 
unable to complete HOS data collection in 2020 (for the 2022 Star 
Ratings), replaces the measures calculated based on HOS data 
collections with earlier values that are not affected by the public 
health threats posed by COVID-19 for the 2022 Star Ratings; (5) removes 
guardrails for the 2022 Star Ratings; and (6) expands the existing hold 
harmless provision for the Part C and D Improvement measures to include 
all contracts for the 2022 Star Ratings.
a. HEDIS, CAHPS, and HOS Data Collection and Submission for 2021 Star 
Ratings and 2022 Star Ratings
    We issued a Health Plan Management System (HPMS) memo, entitled 
``Reporting Requirements for 2020 HEDIS[supreg], HOS, and CAHPS[supreg] 
Measures,'' on September 9, 2019 to establish the due date for the 2019 
measurement year for HEDIS. In light of the public safety issues in 
continuing to require the submission of HEDIS data for the 2019 
measurement year, we are eliminating the HEDIS 2020 submission 
requirement that covers the 2019 measurement year and we are requesting 
that Medicare health plans, including MA and section 1876 
organizations, curtail HEDIS data collection work immediately. This 
will allow health plans, providers, and physician offices to focus on 
caring for Medicare beneficiaries during this PHE for the COVID-19 
pandemic and will minimize risk of the spread of infection by 
eliminating travel and in-person work for the collection of HEDIS data. 
Our goal is to ensure that offices of health care providers remain 
focused on patients needing care. Medicare health plans can use any 
HEDIS data that they have collected for their internal quality 
improvement efforts.
    We are also amending the regulations requiring the submission of 
the CAHPS survey data to CMS for Medicare health and drug plans to 
relieve them of the requirement as it applies to the 2020 survey data 
collection to ensure the safety of survey vendor staff and align with 
the CDC's social distancing guidance. Both Part C and D plans can use 
any CAHPS survey data already collected for their internal quality 
improvement efforts. Accordingly, we are modifying regulations in parts 
417, 422, and 423 to eliminate requirements for the collection of HEDIS 
and CAHPS data that would otherwise occur in 2020. Specifically, we are 
revising the Part C regulation at Sec.  422.152 by adding a new 
paragraph (b)(6), which provides that MA organizations are not required 
to submit HEDIS and CAHPS data that would otherwise be required for the 
calculation of the 2021 Star Ratings. In addition, we are revising the 
cost plan regulation at Sec.  417.472(i) and (j) in two ways: In 
paragraph (i), to add a requirement for cost plans to comply with Sec.  
422.152(b)(6) and in paragraph (j), to make the obligation for cost 
plans to conduct CAHPS surveys subject to paragraph (i). Finally, we 
are revising the Part D regulations at Sec. Sec.  423.156 and 423.182. 
We are revising Sec.  423.156 to not require Part D sponsors to submit 
CAHPS data that would otherwise be required for the calculation of the 
2021 Star Ratings. We are also adding Sec.  423.182(c)(3) so that for 
2021 Star Ratings only, Part D sponsors are not required to submit 
CAHPS data that would otherwise be required for the calculation of the 
2021 Star Ratings. While our revisions do not outright prohibit cost 
plans, MA plans, and Part D plans from continuing efforts to

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collect HEDIS data or conduct CAHPS surveys during 2020, such as to use 
that data about plan performance in 2019 for the plan's own internal 
quality initiatives, we do not expect plans to do so. An additional 
component of the HEDIS data collection is the HOS that NCQA administers 
in partnership with CMS. This year's HOS survey administration was 
scheduled to be from April through July 2020. Given the significant 
safety concerns, similar to the ones related to the administration of 
the CAHPS survey, we are moving the HOS survey administration to late 
summer and will provide MA plans more information in the upcoming 
months. We will continue to monitor the situation to see if any further 
adjustments are needed. To prepare for the possibility that the PHE for 
the COVID-19 pandemic continues and the HOS survey data cannot be 
collected starting in late summer for the 2022 Star Ratings, we are 
amending the regulations for the Part C 2022 Star Ratings (by adding 
new Sec.  422.166(j)(2)) to allow us to use the Star Ratings and 
measure scores for the 2021 Star Ratings for any measures that come 
from the HOS survey; this will address any gaps in the necessary HOS 
data if the HOS survey cannot be administered in 2020. The measures 
from the HOS survey include the following: Improving or Maintaining 
Physical Health; Improving or Maintaining Mental Health; Reducing the 
Risk of Falling; Improving Bladder Control; and Monitoring Physical 
Activity.
b. Adjustments to the 2021 Star Ratings Methodology Due To Lack of 
HEDIS and CAHPS Data
    In response to the PHE for the COVID-19 pandemic and its impact on 
health care delivery and data collection, we are making a series of 
adjustments to the Star Ratings methodology to protect the health and 
safety of individuals who would collect the HEDIS and CAHPS data; to 
allow health and drug plans and their providers to focus on caring for 
Medicare beneficiaries during the PHE for the COVID-19 pandemic; and to 
address the unusual, unexpected, and uncontrollable changes that this 
pandemic is likely to have on the Part C and D Star Ratings. Because of 
the short time frame during which information is collected, analyzed, 
and used in the calculation of the Star Ratings published in October 
each year, immediate action is necessary to amend the methodology as a 
result of the extraordinary circumstances created by the PHE for the 
COVID-19 pandemic. Data collection is currently underway for both the 
HEDIS and CAHPS data, and the data are due to CMS in June 2020. A 
series of adjustments to the 2021 Star Ratings are being made to 
account for eliminating the need to collect and submit HEDIS and CAHPS 
data for the 2021 Star Ratings.
    The April 2018 final rule (83 FR 16538 through 16546) included the 
measures finalized for the 2021 Star Ratings. Included in those 
measures are many that use HEDIS or CAHPS as the data source. In the 
2020 Star Ratings, 14 measures had HEDIS as their data source, and nine 
measures had CAHPS as their data source. The measurement period for 
most of the Star Ratings measures is 2019; for many of those measures, 
we (or the plans) already have the data necessary to calculate a 
measure score and assign a 2021 measure-level rating but validation and 
analysis of those data remain to be done. For the HEDIS data source, 
the measurement period finalized in the April 2018 final rule is the 
calendar year 2 years prior to the Star Ratings year so for the 2021 
Star Ratings, the HEDIS measurement period is the 2019 measurement 
year. However, those data are collected in 2020.
    Similarly, for the CAHPS data source, the measurement period 
finalized for the 2021 Star Ratings is the most recent data submitted 
for the survey of enrollees. In general, the most recent data would be 
the survey conducted from March through the end of May each year, which 
for the 2021 Star Ratings would have corresponded to March through May 
2020 data collection. However, these data will not be available for 
HEDIS and CAHPS measures. CMS considered if we could remove all of the 
HEDIS and CAHPS measures from the 2021 Star Ratings. If we removed 
these measures from the Star Ratings, we would not have enough measures 
to rate plans and to have a complete picture of performance given 
approximately half of the Star Ratings measures come from HEDIS and 
CAHPS. Removing all of these measures would severely compromise the 
integrity of the Part C and D Star Ratings and would have significant 
impact on payment for MA organizations. Given measure scores and stars 
do not fluctuate significantly year to year, we believe using the 2020 
measure-level stars and scores for the missing HEDIS and CAHPS data 
provides the best approximation of performance in 2019. This 
substitution addresses the lack of HEDIS and CAHPS data that would 
otherwise be used for 2021 Star Ratings while permitting us to 
calculate and use reliable Star Ratings for 2021 enrollment and 2022 
QBP status determinations. Given the issues related to PHE for the 
COVID-19 pandemic associated with completing the HEDIS data collection 
for the 2019 measurement year, we will use the HEDIS measure scores and 
Star Ratings based on the 2018 measurement year (that is, the data used 
for the 2020 Star Ratings) for the 2021 Star Ratings. For the 2021 Star 
Ratings, given the safety concerns related to completing the CAHPS 
surveys and data collection and the inability of survey vendors to 
fully complete data collection for 2020, we will use the CAHPS data 
submitted to CMS in June 2019. To accomplish this, we are revising 
Sec. Sec.  422.166 and 423.186 to add new regulation text that the 
measures calculated based on HEDIS data are calculated based on data 
for the 2018 performance period and the measures calculated based on 
CAHPS data are calculated based on survey data collected from March 
through May 2019. Specifically, we are adding a new paragraph (j) to 
each of these regulations and are codifying these specific rules about 
HEDIS and CAHPS data at Sec. Sec.  422.166(j)(1)(i) and (ii) and 
423.186(j)(1)(i).
    The measurement period for all other measures will not change from 
what was finalized in the April 2018 final rule. For both HEDIS and 
CAHPS measures, we will use 2020 measure-level Star Ratings (and 
associated measure-level scores) in all the Star Ratings calculations 
codified at Sec. Sec.  422.160, 422.162, 422.164, 422.166, 423.180, 
423.182, 423.184, and 423.186 in calculating the 2021 Star Ratings. For 
the 2021 Star Ratings, there will be no changes from the prior year in 
the measure-level cut points for any of the HEDIS and CAHPS measures. 
We had previously announced in the April 2019 final rule that the Plan 
All-Cause Readmissions measure would be moved to display for the 2021 
Star Ratings due to the substantive specification change. We will 
continue to exclude this measure for the 2021 Star Ratings as provided 
in that final rule, so the data associated with it for the 2018 
performance period (collected in spring 2019) will be posted on the 
display page for 2021 ratings.
    Since we will be using the 2020 Star Ratings data for the HEDIS and 
CAHPS measures, we will carry forward the measure-level improvement 
change score as described at Sec. Sec.  422.164(f)(4)(i) and 
423.184(f)(4)(i) from the 2020 Star Ratings for all HEDIS or CAHPS 
measures for the 2021 Star Ratings Part C and D improvement measure 
calculations. We are codifying this at Sec. Sec.  422.166(j)(1)(iii) 
and 423.186(j)(1)(ii).
    Under Sec. Sec.  422.164(g)(1) and (2) and 423.184(g)(2), we reduce 
HEDIS and CAHPS measures to 1 star when either

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HEDIS measures used to populate the Star Ratings are not reported or 
for failure to adhere to CAHPS reporting requirements. For the 2021 
Star Ratings, we will not reduce these measures to 1 star for failure 
to report the 2020 HEDIS or CAHPS data and is codifying that approach 
at Sec. Sec.  422.166(j)(1)(iv) and 423.186(j)(1)(iii). We are amending 
Sec. Sec.  422.166 and 423.186 by adding paragraph (j) to codify these 
various special rules for the 2021 Star Ratings.
c. Use of 2020 Star Ratings To Substitute for 2021 Star Ratings in the 
Event of Extraordinarily Compromised CMS Capabilities or Systemic Data 
Issues
    There is great uncertainty about how the COVID-19 pandemic will 
evolve over the next 6 to 9 months, and the impact on the American 
population and institutions resulting from the pandemic. We have 
considered the normal activities required to prepare, calculate, and 
publish the Star Ratings, as well as finalize the ratings to be used as 
the basis for MA QBPs in the event that CMS' functions to calculate the 
2021 Star Ratings are significantly impacted. The operational timelines 
for calculating the Star Ratings each year are extremely tight. For 
example, when we receive all of the measure-level data in early August, 
we have approximately 1 month to: Review the Star Ratings measure data 
for accuracy; prepare data and supportive material to provide plans 
with a preview period so they can review their numeric measure scores 
and raise issues to CMS; work with contractors to calculate the Star 
Ratings; prepare for a second preview period for plans to see their 
preliminary measure level and overall star ratings. This work must be 
completed in the months of August and September so that the Star 
Ratings are ready for public display on Medicare Plan Finder in early 
October for the Annual Enrollment Period. If the COVID-19 pandemic or 
actions necessary in connection with the PHE impact the ability of CMS 
and its contractors to complete these steps to calculate the 2021 Star 
Ratings, it would be impracticable and contrary to the public interest 
to begin rulemaking in August to adopt a policy for how to address such 
an unprecedented situation. The normal notice and comment rulemaking 
process would also prevent CMS from providing quality ratings to 
Medicare beneficiaries choosing a 2021 plan during the Annual 
Enrollment Period beginning in October and conflict with CMS providing 
MA organizations the opportunity to appeal their QBP ratings for 2022 
payment in time for 2022 bid submissions. There would be insufficient 
time to engage in notice and comment rulemaking to make changes to the 
2021 Star Ratings methodology in time to issue the Star Ratings on 
Medicare Plan Finder.
    Star Ratings are used to identify which MA plans are eligible for a 
QBP and for a greater percentage of the amount by which the benchmark 
for the plan's service area exceeds the plan's bid for covering Part A 
and Part B benefits; the quality bonus results in an increase to the 
benchmark for an MA plan's service area and the percentage that 
determines the amount of the beneficiary rebate. See Sec. Sec.  
422.258(d)(7) and 422.260. Together, these financial consequences for a 
high Star Rating, can result in higher beneficiary rebates, which are 
used to pay for supplemental benefits and reductions in the Part B or 
Part D premium for enrollees in the plan. Given the impact the Star 
Ratings have on payment and the benefits offered to Medicare 
beneficiaries, it is critical that MA organizations have certainty in 
terms of how the ratings would be calculated if this situation should 
occur.
    Adopting a provision to address such extraordinary circumstances 
before they come to pass in connection with the COVID-19 pandemic will 
ensure that Medicare health and drug plans and Medicare beneficiaries 
are aware of the steps CMS will take before those actions become 
necessary. This advance notice will alleviate uncertainty and provide 
stability for cost plans, MA organizations, and Part D sponsors so they 
can focus on continuing to ensure Medicare beneficiaries have access to 
needed medical care. In case the PHE for the COVID-19 pandemic gets to 
a point that CMS' functions become focused on only continued 
performance of essential agency functions or the agency and its 
contractors do not have the ability to calculate the 2021 Star Ratings, 
as part of this IFC, we are establishing rules for this circumstance. 
These rules would only be implemented for the 2021 Star Ratings if the 
impact of the PHE for the COVID-19 pandemic reaches a point where CMS 
and its contractors are compromised to the point the 2021 Star Ratings 
cannot be calculated using the methodology set forth in the April 2018 
final rule and this IFC. Calculating the Star Ratings requires a full 
team of staff and contractors with specialized skill sets. If the PHE 
for the COVID-19 pandemic escalates, we will need to devote more 
resources to activities to address essential Agency functions so that 
adding staff or resources to calculate the Star Ratings would not be 
appropriate.
    If CMS' resources become extraordinarily compromised, we will use 
the 2020 Star Ratings as the 2021 Star Ratings. This authority is 
codified at Sec. Sec.  422.166(j)(1)(v) and 423.186(j)(1)(iv) and 
limited specifically to the COVID-19 pandemic.
    We are also concerned, given the uncertainties ahead, whether CMS 
and plans will be able to safeguard against data quality issues for 
non-CAHPS and non-HEDIS measures for which CMS does not already have 
data for the 2021 Star Ratings. As an example, sponsors report Special 
Needs Plan (SNP) Care Management and Medication Therapy Management 
(MTM) data to CMS by March 2020, and these data undergo independent 
data validation beginning in April. While validation activities can be 
conducted remotely between the plans' staff and data validation 
reviewers, there may be other difficulties in completing the work this 
year on time and consistent with CMS requirements due to the 
significant impact of the PHE for the COVID-19 pandemic. Normally, as 
codified at Sec. Sec.  422.164(b) and 423.184(b), we review the quality 
of the data before making a final determination about inclusion of the 
measures in each year's Star Ratings. Given the potential for multiple 
measures to have data quality issues across many plans as a result of 
COVID-19, we are addressing this possibility by adopting a rule to 
permit replacing the 2021 Star Ratings measure scores and stars with 
the 2020 Star Ratings measures scores and stars for the impacted 
measures for all plans rather than excluding multiple measures from the 
2021 Star Ratings calculations. Removing multiple measures from the 
Star Ratings can cause unanticipated changes in the ratings which would 
create more instability for Medicare health and drug plan sponsors and 
could have significant impacts on MA QBPs at a time where MA 
organizations need stability in the ratings when they need to focus on 
caring for those impacted by COVID-19.
    To be prepared if we have data quality issues for any non-HEDIS or 
non-CAHPS 2021 Star Ratings measures, we are adopting a specific rule 
limited to the PHE for the COVID-19 pandemic. At Sec. Sec.  422.164(i) 
and 423.184(i), we are adopting authority for CMS to substitute the 
score and star for the measure used in the 2020 Star Ratings in the 
calculation of the 2021 Star Ratings when there is a systemic data 
quality issue for all plans as a result of the PHE for the COVID-19 
pandemic. Therefore, in the above example, we would use sponsors' SNP 
Care Management and MTM Program Completion Rate for Comprehensive 
Medication Review measures' scores and stars from the

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2020 Star Ratings as the sponsors' 2021 Star Ratings on those measures.
    We are making these adjustments to the Star Ratings methodology 
since our inability to make calculations at a late stage in the annual 
Star Ratings publication process would severely jeopardize our ability 
to calculate 2022 MA payments accurately and consistent with the 
statutory QBP provision particularly since our ability to change other 
deadlines based on availability of the Star Ratings (for example, the 
bid deadline, Annual Election Period, and the start of the new plan 
benefit year) is limited but the Star Ratings are an integral part of 
those other activities. In extreme situations like the ones described 
above, the solicitation and consideration of public comments to 
establish how CMS should proceed would be impracticable since the 
process could not be completed in time to issue new Star Ratings that 
could be used to inform beneficiary choice during the Annual Election 
Period. The MA statute, at section 1851(d) of the Act, requires that 
information about plan quality and performance indicators be provided 
to Medicare beneficiaries to help them make informed plan choices. In 
addition, MA plans need to know their eligibility for QBPs in advance 
of the bid deadline to develop their bids; the bid deadline is also set 
by the statute, as the first Monday in the June prior to the coverage 
year. The 2021 Star Ratings will be the basis for 2022 QBPs so 
definitive Star Ratings need to be available to plans in advance of 
June 2021, to accommodate bid planning and to ensure that plans have 
the ability to appeal their QBP status if necessary. We understand that 
MA organizations begin developing and pricing their plan benefit 
packages well before the June bid deadline and depend on the release of 
Star Ratings in the preceding October as a critical milestone in their 
planning for an upcoming plan year. Adopting the new rule at Sec. Sec.  
422.164(i) and 423.184(i) to address measure-level substitutions of 
2020 scores for data quality issues that impact the availability, 
accuracy, reliability and validity of the measure-level data that would 
otherwise be used for 2021 ratings will provide stability and certainty 
for the program. This approach will allow CMS and MA organizations to 
move seamlessly to a new basis for calculating QBPs in the event that 
the original one (that is, using the data about 2019 performance) is 
unavailable. It will also allow MA organizations to incorporate into 
their planning the possibility that they will be required to use the 
2020 Star Ratings for some or all measures in developing their 2022 
bids.
    To codify these provisions, we are amending Sec. Sec.  422.164 and 
423.184 by adding a new paragraph (i) to each section, as well as by 
amending Sec.  422.166 by adding a new paragraph (j)(1)(v) and amending 
Sec.  423.186 by adding a new paragraph (j)(1)(iv).
d. 2022 Star Ratings
    For the 2022 Star Ratings, we expect plans to submit HEDIS data in 
June 2021 and to administer the CAHPS survey in 2021 as usual. The 
majority of measures for the 2022 Star Ratings are based on the 2020 
measurement year, which is ongoing during the PHE for the COVID-19 
pandemic. We are using the IFC to make immediate changes to the 
methodology for the 2022 Star Ratings so as not to inappropriately 
incentivize actions by plans and healthcare providers that are not 
directly related to the PHE for the COVID-19 pandemic. By adopting 
these changes immediately, Medicare health and drug plans will be 
assured as quickly as possible about how performance changes driven or 
caused by the COVID-19 pandemic will be addressed in the Star Ratings 
that use this performance period. Except as addressed in this IFC, we 
anticipate that the 2022 Star Ratings will be implemented as codified 
at Sec. Sec.  422.160, 422.162, 422.164, 422.166, 423.180, 423.182, 
423.184, and 423.186.
i. Guardrails
    We recognize that health and drug plans and their providers are 
needing to adapt their current care practices in light of the PHE for 
the COVID-19 pandemic and the need to care for the most vulnerable 
patients, such as the elderly and those with chronic health conditions; 
these changes in how plans and providers care for Medicare 
beneficiaries as a result of COVID-19 will impact performance for the 
2020 measurement period which feeds into the 2022 Star Ratings. On 
March 18, 2020, we issued guidance (available on the CMS website at 
https://www.cms.gov/files/document/31820-cms-adult-elective-surgery-and-procedures-recommendations.pdf) to delay all non-essential planned 
surgeries and procedures, including dental, until further notice. 
Healthcare providers are being asked to encourage patients to remain at 
home, except for emergencies, to help curb the spread of COVID-19 and 
to help limit the exposure to the virus. Plans and their providers are 
focused primarily on providing urgent care to Medicare beneficiaries 
who may be infected by COVID-19. We realize that this will impact the 
data collected during the 2020 measurement year which will impact the 
2022 Part C and D Star Ratings. Thus, as part of this IFC, we are 
making some adjustments to account for the potential decreases in 
measure-level scores so health plans can have some degree of certainty 
knowing that the Star Ratings will be adjusted and can focus right now 
on patients who are most in need.
    To increase the predictability of the cut points used for measure-
level ratings, we previously finalized that, starting with the 2022 
Star Ratings, guardrails would be implemented for measures that have 
been in the program for more than 3 years. As specified at Sec. Sec.  
422.166(a)(2)(i) and 423.186(a)(2)(i), the guardrails ensure that the 
measure-threshold-specific cut points for non-CAHPS measures do not 
increase or decrease more than 5 percentage points from one year to the 
next. As noted in the April 2019 final rule, the trade-off for the 
predictability provided by the bi-directional cap is the inability to 
fully keep pace with changes in performance across the industry. While 
cut points that change less than the cap would be unbiased and keep 
pace with changes in the measure score trends, changes in the overall 
performance that are greater than the cap would not be reflected in the 
new cut points. The performance that will be used for the 2022 Star 
Ratings is performance in 2020, that is, during the PHE for the COVID-
19 pandemic. We anticipate that most, if not all, plans could have 
performance changes on certain measures as they deal with the demands 
the PHE for the COVID-19 pandemic will place on the health care system 
in the United States. Guardrails that prevent the cut points for 
measures from lowering, even when performance scores are lower across 
the board, will result in plans having similar low measure-level 
ratings even if their performance is relatively distinguishable.
    Since the Star Ratings are used to calculate the payment to MA 
organizations by providing an increase in the benchmark against which 
MA organizations bid and in the portion of the savings between the bid 
and benchmark available to MA organizations to use as rebates, 
unanticipated significant declines in the Star Ratings would create 
significant uncertainty in the program and potential beneficiary access 
issues if ratings significantly decline across the cost plan, MA and 
Part D programs. Given the enormity of this situation we believe it is 
important for plans to be able to focus on patients that are in the 
most need during the outbreak, and our

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guardrails, as currently constructed, could have unintended incentives 
to the contrary. In addition, adopting this policy as soon as possible 
will minimize incentives for plans and providers to focus on non-urgent 
care or administrative efforts, even if those issues are tied to 
existing Star Ratings measures, and focus their attention on urgent 
care issues. As such, in response to the PHE for the COVID-19 pandemic, 
we are delaying implementation of the guardrails so that cut points can 
change by more than 5 percentage points if national performance 
declines as a result of the PHE for the COVID-19 pandemic. We are 
modifying Sec. Sec.  422.166(a)(2)(i) and 423.186(a)(2)(i) to delay the 
application of the guardrails beginning with the 2023 Star Ratings 
produced in October 2022. No other aspect of the guardrails policies 
finalized in the April 2019 final rule is changing with this 
modification.
ii. Improvement Measure
    The existing Star Ratings system and regulations include a well-
developed improvement measure and methodology for calculating and using 
it. However, because we anticipate that performance during the 2020 
measurement period may decline for plans across the nation, we believe 
that it is appropriate to adopt a provision to minimize the negative 
effect of the improvement measure and improvement scores. As with the 
guardrails policy, this amendment to the existing regulations is 
designed to minimize or eliminate incentives in the Star Ratings that 
might be inconsistent with the steps necessary to address the COVID-19 
pandemic. We are revising the methodology for the Part C and D 
improvement measure for the 2022 Star Ratings to expand the hold 
harmless rule to include all contracts at the overall and summary 
rating levels recognizing that the PHE for the COVID-19 pandemic may 
result in a decline in industry performance. Currently, for MA-PD 
contracts with an overall rating of 4 or more stars, if the inclusion 
of the improvement measure(s) reduces a contract's overall Star Rating, 
the Part C and D improvement measures are excluded from the overall 
Star Ratings calculations for that contract. Similarly, for MA-only 
contracts with 4 or more stars, if the inclusion of the Part C 
improvement measure reduces the Part C summary Star Rating, it is 
excluded from the calculations for that contract. Our revision will 
expand the current hold harmless rule and how it works to all contracts 
regardless of their ratings and also apply it to the Part C and D 
summary ratings for the 2022 Star Ratings only.
    We are codifying a new paragraph (g)(3) at Sec. Sec.  422.166 and 
423.186 and adding text at the end of the existing text in Sec. Sec.  
422.166(f)(1)(i) and 423.186(f)(1)(i) to implement this new hold 
harmless provision for the 2022 Star Ratings only.
iii. Categorical Adjustment Index
    Beginning with the 2017 Star Ratings, we implemented the 
Categorical Adjustment Index (CAI) that adjusts for the average within-
contract disparity in performance associated with the percentages of 
enrollees who receive a low-income subsidy and/or are dual eligible 
(LIS/DE) and/or have disability status. For the 2022 Star Ratings, we 
will calculate the CAI as codified at Sec. Sec.  422.166(f)(2) and 
423.186(f)(2). The CAI values will be calculated based on the 2021 Star 
Ratings data which will use the older HEDIS and CAHPS data from the 
2020 Star Ratings. For each measure, adjusted measure scores which are 
used to construct the CAI values will be calculated using the 
enrollment year associated with the year of data being used for that 
measure (that is, 2018 enrollment year data for HEDIS and CAHPS 
measures, 2019 enrollment year data for all other measures). Given we 
are following the rules codified in regulation, there are no changes to 
the regulatory text. We are providing this explanation to avoid 
uncertainty on this point for Medicare health and drugs plans.
iv. QBP Calculations for New Contracts
    Under Sec.  422.252, a new MA plan means an MA contract offered by 
a parent organization that has not had another MA contract in the 
previous 3 years. For just the 2022 QBP ratings that are based on 2021 
Star Ratings, we are modifying this definition to treat an MA plan as a 
new MA plan if it is offered by a parent organization that has not had 
another MA contract for the previous 4 years. This change would account 
for how new plans that started in 2019 would have reported HEDIS and 
CAHPS data to CMS for the first time in 2020 for the 2021 Star Ratings; 
because of our elimination of the HEDIS and CAHPS data submissions to 
CMS, these plans will not have enough measures to calculate the 2021 
Star Ratings and, consequently, the 2022 QBP rating. A new contract 
with an effective date of January 1, 2019 would normally be treated as 
new for purposes of QBPs for 2019, 2020, and 2021. The 2022 QBP rating 
would be based on the 2021 Star Ratings which these contracts will not 
have due to the elimination of HEDIS and CAHPS data.

Z. Changes To Expand Workforce Capacity for Ordering Medicaid Home 
Health Nursing and Aide Services, Medical Equipment, Supplies and 
Appliances and Physical Therapy, Occupational Therapy or Speech 
Pathology and Audiology Services

    Title XIX of the Act requires that, to receive Federal Medicaid 
matching funds, a State must offer certain basic services to the 
categorically needy populations specified in the Act. Home health 
services for Medicaid-eligible individuals who are entitled to nursing 
facility services is one of these mandatory services. Individuals 
``entitled to'' nursing facility services include the basic 
categorically needy populations that receive the standard Medicaid 
benefit package, and can include medically needy populations if nursing 
facility services are offered to the medically needy within a State. 
Home health services include part-time or intermittent nursing, home 
health aide services, medical supplies, equipment, and appliances, and 
may include therapeutic services. Current Medicaid regulations require 
an individual's physician to order home health services as part of a 
written plan of care. The plan of care must be reviewed every 60 days, 
except for medical supplies, equipment and appliances which must be 
reviewed by a physician annually.
    We recognize that increased demand on the direct care services 
provided by physicians during the PHE for the COVID-19 pandemic could 
cause a delay in the availability of physicians to order home health 
services in the normal timeframe. In recognition of the critical need 
to expand workforce capacity, we are amending 42 CFR 440.70 to allow 
licensed practitioners practicing within their scope of practice, such 
as, but not limited to, NPs and PAs, to order Medicaid home health 
services during the existence of the PHE for the COVID-19 pandemic.
    This change to Sec.  440.70 will expand the workforce and is also a 
continuation of CMS' efforts to align with Medicare on who can order 
medical supplies, equipment, and appliances, and allowing smoother 
access to services for Medicaid beneficiaries, including those who are 
dually eligible. This alignment will also eliminate administrative 
burden to states and providers when dealing with inconsistencies in the 
practitioners who may order these items between the Medicare and 
Medicaid programs.

[[Page 19276]]

    This change applies to who can order Medicaid home health nursing 
and aide services, medical supplies, equipment and appliances and 
physical therapy, occupational therapy or speech pathology and 
audiology services covered under Sec.  440.70(b)(1), (2), (3), and (4).
    This change does not expand the benefit categories where these 
items can be covered. States must continue to cover and claim home 
health nursing and aide services, medical supplies, equipment and 
appliances, and physical therapy, occupational therapy or speech 
pathology and audiology services (that are covered under the home 
health benefit) under the home health benefit, unless otherwise allowed 
by federal regulations.

AA. Origin and Destination Requirements Under the Ambulance Fee 
Schedule

    Section 1861(s)(7) of the Act establishes an ambulance service as a 
Medicare Part B service where the use of other methods of 
transportation is contraindicated by the individual's condition, but 
only to the extent provided in regulations. We have established 
regulations at Sec.  410.40 that govern Medicare coverage of ambulance 
services. Under Sec.  410.40(e)(1), Medicare Part B covers ground (land 
and water) and air ambulance transport services only if they are 
furnished to a Medicare beneficiary whose medical condition is such 
that other means of transportation are contraindicated. The 
beneficiary's condition must require both the ambulance transportation 
itself and the level of service provided for the billed services to be 
considered medically necessary.
    Under Sec.  410.40(e)(1), nonemergency transportation by ambulance 
is appropriate if either the beneficiary is bed-confined, and it is 
documented that the beneficiary's condition is such that other methods 
of transportation are contraindicated; or, if his or her medical 
condition, regardless of bed confinement, is such that transportation 
by ambulance is medically required. That section further provides that 
bed confinement is not the sole criterion in determining the medical 
necessity of ambulance transportation but is one factor that is 
considered in medical necessity determinations. For a beneficiary to be 
considered bed-confined, Sec.  410.40 (e)(1) states that all of the 
following criteria must be met: (1) The beneficiary is unable to get up 
from bed without assistance, (2) the beneficiary is unable to ambulate, 
and (3) the beneficiary is unable to sit in a chair or wheelchair.
    The origin and destination requirements for coverage of ambulance 
services are addressed in our regulations at Sec.  410.40(f). As 
provided in that section, Medicare covers the following ambulance 
transportation:
     From any point of origin to the nearest hospital, critical 
access hospital (CAH), or skilled nursing facility (SNF) that is 
capable of furnishing the required level and type of care for the 
beneficiary's illness or injury. The hospital or CAH must have 
available the type of physician or physician specialist needed to treat 
the beneficiary's condition;
     From a hospital, CAH, or SNF to the beneficiary's home;
     From a SNF to the nearest supplier of medically necessary 
services not available at the SNF where the beneficiary is a resident, 
including the return trip; and
     For a beneficiary who is receiving renal dialysis for 
treatment of ESRD, from the beneficiary's home to the nearest facility 
that furnishes renal dialysis, including the return trip.
    We continue to believe that our current regulatory requirements 
governing coverage of ambulance services are appropriate under normal 
circumstances. However, in the context of the PHE for the COVID-19 
pandemic, we recognize that providers and suppliers furnishing ground 
ambulance services and other health care professionals are faced with 
new challenges regarding potential exposure risks, for Medicare 
beneficiaries and for members of the community at large.
    Therefore, on an interim basis, we will expand the list of 
destinations at Sec.  410.40(f) for which Medicare covers ambulance 
transportation to include all destinations, from any point of origin, 
that are equipped to treat the condition of the patient consistent with 
Emergency Medical Services (EMS) protocols established by state and/or 
local laws where the services will be furnished. The EMS protocols are 
recognized operating procedures that all emergency service 
professionals such as emergency medical technicians (EMTs) and 
paramedics must follow for patient assessment, treatment, 
transportation and delivery to definitive care. These protocols are 
designed by national, state and/or local medical authorities and 
institutions. Based on these protocols, a patient suspected of having 
COVID-19 that requires a medically necessary transport may be 
transported to a testing facility to get tested for COVID-19 instead of 
a hospital in an effort to prevent possible exposure to other patients 
and medical staff.
    These destinations may include, but are not limited to: Any 
location that is an alternative site determined to be part of a 
hospital, CAH or SNF, community mental health centers, FQHCs, RHCs, 
physicians' offices, urgent care facilities, ambulatory surgery centers 
(ASCs), any location furnishing dialysis services outside of an ESRD 
facility when an ESRD facility is not available, and the beneficiary's 
home. This expanded list of destinations will apply to medically 
necessary emergency and non-emergency ground ambulance transports of 
beneficiaries during the PHE for the COVID-19 pandemic. Consistent with 
section 1861(s)(7) of the Act, there must be a medically necessary 
ground ambulance transport of a patient in order for an ambulance 
service to be covered.
    We are revising, on an interim basis, Sec.  410.40 to add a new 
paragraph (f)(5), to state that during the PHE for the COVID-19 
pandemic only, a covered destination includes a ground ambulance 
transport from any point of origin to a destination that is equipped to 
treat the condition of the patient consistent with state and local EMS 
protocols where the services will be furnished. These destinations 
include, but are not limited to, any location that is an alternative 
site determined to be part of a hospital, CAH or SNF, community mental 
health centers, FQHCs, RHCs, physician offices, urgent care facilities, 
ASCs, any location furnishing dialysis services outside of an ESRD 
facility when an ESRD facility is not available, and the beneficiary's 
home. Home may be an appropriate destination for a COVID-19 patient who 
is discharged from the hospital to home to be under quarantine (as 
noted above, there must be a medically necessary ground ambulance 
transport of a patient in order for an ambulance service to be 
covered).

BB. Merit-Based Incentive Payment System (MIPS) Updates

1. MIPS Improvement Activities Inventory Update
    The CY 2018 Quality Payment Program final rule (82 FR 53660) 
finalized that we would add new improvement activities or make 
modifications to existing improvement activities in the Improvement 
Activities Inventory through notice-and-comment rulemaking. An 
improvement activity means an activity that relevant MIPS eligible 
clinician, organizations and other relevant stakeholders identify as 
improving clinical practice or care delivery and that the Secretary 
determines, when effectively executed,

[[Page 19277]]

is likely to result in improved outcomes. We refer readers to Table H 
in the Appendix of the CY 2017 Quality Payment Program final rule (81 
FR 77177 through 77199), Tables F and G in the Appendix of the CY 2018 
Quality Payment Program final rule (82 FR 54175 through 54229), Tables 
A and B in the Appendix 2 of the CY 2019 PFS final rule (83 FR 60286 
through 60303), and Tables A, B, and C in the Appendix 2 of the CY 2020 
PFS final rule (84 FR 63514 through 63538) for our previously finalized 
Improvement Activities Inventory. We also refer readers to the Quality 
Payment Program website at https://qpp.cms.gov/ for a complete list of 
the most current list of improvement activities.
    The COVID-19 pandemic has been deemed a PHE by the Secretary of the 
Department of Health and Human Services. Information regarding the PHE 
for the COVID-19 pandemic may be found at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. In this IFC, we 
are adding one new improvement activity to the Improvement Activities 
Inventory for the CY 2020 performance period in response to this PHE. 
We refer readers to Table 1 for a full description which includes the 
type of action that would qualify for this improvement activity. This 
improvement activity promotes clinician participation in a COVID-19 
clinical trial utilizing a drug or biological product to treat a 
patient with a COVID-19 infection.\20\ To receive credit for this 
clinical improvement, clinicians must report their findings through an 
open source clinical data repository or clinical data registry. When 
utilizing the term ``open source'' we mean making available to the 
public the results of research, including publications and scientific 
data, which enables reuse, increases transparency, and facilitates 
reproductibility of research results.\21\
---------------------------------------------------------------------------

    \20\ For more information on the COVID-19 clinical trials we 
refer readers to the U.S. National Library of Medicine website at 
https://clinicaltrials.gov/ct2/results?cond=COVID-19.
    \21\ More information on open source is available at https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html; https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
---------------------------------------------------------------------------

    We believe that participation in this activity is likely to result 
in improved outcomes by improving the collection of data clinicians use 
for the care of their patients as they monitor and manage COVID-19 and 
drive care improvements. We believe that encouraging clinicians to 
utilize an open source clinical data repository or clinical data 
registry for data reporting will bring the results of their research to 
the forefront of healthcare far quicker than if it goes through the 
cycle of peer review and publishing. In addition, we believe that this 
could improve clinical practice and care delivery, a relevant 
stakeholder donated a database for the pandemic so that health 
officials/clinicians/the public could track patients and drugs that 
work to better improve outcomes of COVID-19 patients.
    In the CY 2019 PFS (83 FR 59778 through 59782), we provided details 
regarding the Annual Call for Activities and how stakeholders submit 
potential improvement activities. In general, to nominate a new 
activity or request a modification to an existing improvement activity, 
a stakeholder must submit a nomination form available at 
www.qpp.cms.gov during the Annual Call for Activities. For this new 
improvement activity, we are making a one-time exception from our 
established Annual Call for Activities timeframe and processes due to 
this PHE.
    New improvement activities should meet one or more criteria to be 
included in the Improvement Activities Inventory (82 FR 53660). We 
believe that this activity meets the improvement activities submission 
criteria of a ``public health emergency as determined by the 
Secretary,'' which was finalized in the 2019 PFS final rule (83 FR 
59779). As noted in the CY 2017 Quality Payment Program final rule, we 
use the criteria for nominating new improvement activities in selecting 
improvement activities for inclusion in the program (82 FR 53659). We 
also clarified that those criteria are but one factor in determining 
which improvement activities we ultimately proposed (83 FR 59780). For 
MIPS eligible clinicians who wish to submit this new improvement 
activity, we refer readers to the CY 2019 PFS final rule (83 FR 59778 
through 59782) for our previously finalized improvement activities 
submission requirements. Table 1 displays the new improvement activity.

   Table 1--New Improvement Activity for the MIPS CY 2020 Performance
                                 Period
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                          Improvement activity
------------------------------------------------------------------------
Activity ID:......................  IA_ERP_XX.
Subcategory:......................  Emergency Response And Preparedness.
Activity Title:...................  COVID-19 Clinical Trials.
Activity Description:.............  To receive credit for this activity,
                                     a MIPS-eligible clinician must
                                     participate in a COVID-19 clinical
                                     trial utilizing a drug or
                                     biological product to treat a
                                     patient with a COVID-19 infection
                                     and report their findings through a
                                     clinical data repository or
                                     clinical data registry for the
                                     duration of their study. For more
                                     information on the COVID-19
                                     clinical trials we refer readers to
                                     the U.S. National Library of
                                     Medicine website at https://clinicaltrials.gov/ct2/results?cond=COVID-19.
Weighting:........................  High.
------------------------------------------------------------------------

2. MIPS Applications for Reweighting Based on Extreme and 
Uncontrollable Circumstances
    As a result of the PHE for the COVID-19 pandemic, we are applying 
the MIPS automatic extreme and uncontrollable circumstances policy at 
Sec.  414.1380(c)(2)(i)(A)(8) and (c)(2)(i)(C)(3) to MIPS eligible 
clinicians for the 2019 MIPS performance period/2021 MIPS payment year. 
We believe that this application of the policy is appropriate given the 
impact COVID-19 will likely have on the ability of many MIPS eligible 
clinicians to complete data submission for the MIPS program for the 
2019 MIPS performance period because most of those submissions will 
occur during CY 2020.
    Due to the timing of the PHE, we realize that there may be 
scenarios where MIPS-eligible clinicians are not covered by the 
automatic extreme and uncontrollable circumstances policy. For example, 
as we stated in the CY 2019 PFS final rule, the automatic extreme and 
uncontrollable circumstances policy does not apply to groups or virtual 
groups (83 FR 59874

[[Page 19278]]

and 59875); however, under Sec.  414.1380(c)(2)(i), individual 
clinicians, groups and virtual groups could submit an application for 
reweighting the performance categories based on extreme and 
uncontrollable circumstances. To provide additional relief to 
individual clinicians, groups, and virtual groups for whom sufficient 
MIPS measures and activities may not be available for the 2019 MIPS 
performance period due to the PHE for the COVID-19 pandemic, we are 
extending the deadline to submit an application for reweighting the 
quality, cost, and improvement activities performance categories based 
on extreme and uncontrollable circumstances (Sec.  
414.1380(c)(2)(i)(A)(6)) and the Promoting Interoperability performance 
category based on extreme and uncontrollable circumstances (Sec.  
414.1380(c)(2)(i)(C)(2)) from December 31, 2019 to April 30, 2020, or a 
later date that we may specify. This extended deadline of April 30, 
2020 mirrors the MIPS data submission deadline extension. The extended 
deadline is available only for applications that demonstrate the 
clinician has been adversely affected by the PHE for the COVID-19 
pandemic.
    We are also modifying our existing policy for the 2019 performance 
period/2021 MIPS payment year so that if a MIPS eligible clinician, 
group, or virtual group submits an application for reweighting based on 
the PHE for the COVID-19 pandemic by the extended deadline, any MIPS 
data they have submitted or will submit would not effectively void 
their application. Under Sec.  414.1380(c)(2)(i)(A)(6) and 
(c)(2)(i)(C), if an application for reweighting the performance 
categories based on extreme and uncontrollable circumstances is 
submitted, but data on measures or activities for a performance 
category are also submitted, a MIPS eligible clinician will be scored 
on the submitted data, and the performance categories for which data 
are submitted will not be reweighted. However, for the 2019 performance 
period we believe it is appropriate to modify this policy, because we 
believe it is possible that a MIPS eligible clinician, group, or 
virtual group could have submitted some MIPS data prior to the PHE for 
the COVID-19 pandemic, but due to circumstances related to the PHE for 
the COVID-19 pandemic, are not able to complete their submission such 
that the data they submitted may not reflect their actual performance 
on the measures and activities. As a result, we are modifying the 
policy at Sec.  414.1380(c)(2)(i)(A)(6) to create an exception for the 
2019 performance period/2021 MIPS payment year only, such that if a 
MIPS eligible clinician demonstrates through an application submitted 
to CMS that they have been adversely affected by the PHE for the COVID-
19 pandemic, but also submits data for the quality, cost, or 
improvement activities performance categories, the performance 
categories for which data are submitted would still be reweighted 
(subject to CMS' approval of the application), and the data submission 
would not effectively void the application for reweighting. We are also 
modifying the policy at Sec.  414.1380(c)(2)(i)(C) to create a similar 
exception for the Promoting Interoperability performance category for 
the 2019 performance period/2021 MIPS payment year only.

CC. Inpatient Hospital Services Furnished Under Arrangements Outside 
the Hospital During the Public Health Emergency (PHE) for the COVID-19 
Pandemic

1. Overview for Inpatient Hospital Services
    For purposes of Medicare payment, section 1861(b) of the Act 
defines inpatient hospital services in part as the following items and 
services furnished to an inpatient of a hospital and (except as 
provided in paragraph (3)) by the hospital: (1) Bed and board; (2) such 
nursing services and other related services, such use of hospital 
facilities, and such medical social services as are ordinarily 
furnished by the hospital for the care and treatment of inpatients, and 
(3) such other diagnostic or therapeutic items or services, furnished 
by the hospital or by others under arrangements with them made by the 
hospital, as are ordinarily furnished to inpatients either by such 
hospital or by others under such arrangements.
    Routine services in the hospital setting are those described in 
sections 1861(b)(1) and (b)(2) of the Act. Under our current policy for 
hospital services furnished under arrangements that we adopted in the 
FY 2012 IPPS/LTCH PPS rulemaking (76 FR 51714), routine services cannot 
be provided under arrangement outside the hospital. Only the 
therapeutic and diagnostic services described in section 1886(b)(3) of 
the Act can be provided under arrangement outside the hospital.
    We continue to believe that our current policy prohibiting routine 
services from being provided under arrangement outside the hospital is 
consistent with the statute and appropriate for the reasons discussed 
in the FY 2012 IPPS/LTCH PPS rulemaking. However, we wish to give 
hospitals that provide services to Medicare beneficiaries flexibility 
to respond effectively to the serious public health threats posed by 
COVID-19. Recognizing the urgency of this situation, and understanding 
that our current policy may inhibit use of capacity in settings that 
might otherwise be effective in the efforts to mitigate the impact of 
the pandemic on Medicare beneficiaries and the American public, we are 
changing our under arrangements policy during the PHE for the COVID-19 
pandemic so that hospitals are allowed broader flexibilities to furnish 
inpatient services, including routine services outside the hospital.
2. Prior Rulemaking
    In the FY 2012 IPPS/LTCH PPS rulemaking (76 FR 51711), we noted 
that the statute specifies that ``routine services,'' for example, bed, 
board, nursing and other related services, except those specified at 
paragraph (3) of section 1861(b) of the Act are to be provided by ``the 
hospital,'' and not just ``a hospital.'' Similarly, we noted that our 
implementing regulations at Sec.  409.12 indicate that Medicare pays 
for nursing and related services, use of hospital facilities, and 
medical social services as inpatient hospital services or inpatient CAH 
services only if those services are ordinarily furnished by the 
hospital or CAH. We pointed out that, consistent with section 
1861(b)(3) of the Act, only with regard to other diagnostic or 
therapeutic services do the regulations at Sec.  409.16 state that 
Medicare will also pay for these services if furnished ``by others 
under arrangements made by the hospital or CAH.''
    Under our current policy adopted in the FY 2012 IPPS/LTCH PPS 
rulemaking, if routine services, that is, services described in 
sections 1861(b)(1) and (b)(2) of the Act, are provided in the 
hospital, they are considered as being provided ``by the hospital.'' We 
stated that we believe this policy is consistent with the statute 
because the statutory language specifying that the routine services 
described in sections 1861(b)(1) and (b)(2) of the Act be provided ``by 
the hospital'' suggests that the hospital is required to exercise 
professional responsibility over the services, including quality 
controls. In situations in which certain routine services are provided 
through arrangement ``in the hospital,'' for example, contracted 
nursing services, we stated that we believe the arrangement generally 
results in the hospital exercising the same level of control over those 
services as the hospital does in situations in

[[Page 19279]]

which the services are provided by the hospital's salaried employees.
    Therefore, if routine services are provided in the hospital to its 
inpatients, we consider the service as being provided by the hospital. 
However, if these services are provided to its patients outside the 
hospital, the services are considered as being provided under 
arrangement, and not by the hospital. Therefore, consistent with the 
statute, we stated that only therapeutic and diagnostic services can be 
provided under arrangement outside the hospital.
    Some commenters during the FY 2012 IPPS/LTCH PPS rulemaking stated 
that our policy to limit the services a hospital may provide under 
arrangements is not required by the statute or regulations. Some 
commenters also believed that CMS' proposed reading of the statutory 
definition of inpatient hospital services is only one possible 
interpretation of the statute.
    In our response to these comments, we noted that we focused on 
section 1861(b) of the Act because it provides the statutory basis for 
our policy to limit the services that may be furnished under 
arrangement. As we noted in that rulemaking, the reference to 
diagnostic or therapeutic items or services in section 1861(b)(3) of 
the Act is to services furnished by the hospital or by others under 
arrangements. Therefore, we stated that we believe it is consistent 
with the statutory language to limit the services that may be furnished 
outside of a hospital under arrangement to only diagnostic and 
therapeutic services.
    We noted that our policy does not alter the definition of inpatient 
hospital services, but instead limits the services a hospital may 
provide under arrangements outside the hospital. If a patient of 
Hospital A is in Hospital B receiving routine services, the patient 
will still be an ``inpatient,'' but the services will not be considered 
``inpatient hospital services'' furnished by the hospital for purposes 
of payment for services defined under section 1861(b) of the Act. If 
the patient is admitted to Hospital B, then the patient would be an 
``inpatient'' of Hospital B and the routine services furnished to that 
individual would meet the definition of ``inpatient routine services'' 
under section 1861(b) of the Act.
    We also discussed in the FY 2012 IPPS/LTCH PPS rulemaking the 
policy considerations supporting this change. We stated that we became 
aware that some hospitals were furnishing certain routine services, 
including ICU services, under arrangement. For example, under certain 
arrangements, if an inpatient of an IPPS-excluded hospital (``hospital 
A'') required ICU services, and the IPPS-excluded hospital could not 
provide these services, the patient was moved to an IPPS hospital 
(``hospital B'') that could furnish the ICU services. In these 
situations, the patient was not transferred to hospital B but was moved 
from an inpatient bed of hospital A to an inpatient bed of hospital B. 
However, the IPPS-excluded hospital treated these services as being 
provided under arrangement and included the cost of those services on 
its cost report. We found it problematic that the patient was, at all 
times, considered an inpatient of hospital A even though the patient 
occupied an inpatient bed at hospital B.
    Because the two hospitals in the example above are under two 
different payment systems, we stated that we believe this arrangement 
can result in inappropriate and potentially excessive Medicare 
payments. The IPPS-excluded hospital, hospital A, is paid on a 
reasonable cost basis, subject to a ceiling. In most cases, this 
payment is greater than if the hospital were paid under the IPPS for 
the same patient. Furthermore, although there is a ceiling on the 
amount of Medicare payment for hospital A, there are also provisions 
that allow hospital A to receive adjustments to its ceiling in certain 
circumstances, which in the absence of our policy could allow payment 
to hospital A above those allowed by its ceiling. Therefore, in the 
absence of our policy these arrangements could allow hospital A to 
request an adjustment to its ceiling because its ICU costs had 
increased beyond what is allowed. In that case, hospital A would 
receive additional payments beyond its ceiling. We stated that we 
believe that by limiting the furnishing of routine services under 
arrangements to situations in which the services are furnished in 
hospital A, we reduce the opportunity for gaming. In these more limited 
situations, hospital A exercises sufficient control over the use of 
hospital resources when furnishing these services such that the 
services are appropriately included in hospital A's cost report.
    Under our current policy adopted in that rulemaking, if hospital A 
did not have the resources to treat a patient, it would transfer the 
patient to hospital B for ICU services, and hospital B would bill 
Medicare consistent with the IPPS provisions. Hospital A would be paid 
for an inpatient discharge.
3. Inpatient Hospital Services Furnished Under Arrangements Outside the 
Hospital During the PHE for the COVID-19 Pandemic
    As noted earlier in this section, we continue to believe that our 
current policy is consistent with the statute and appropriate for the 
reasons discussed in the FY 2012 IPPS/LTCH PPS rulemaking. However, we 
wish to give hospitals that provide services to Medicare beneficiaries 
additional flexibilities to respond effectively to the serious public 
health threats posed by the spread of COVID-19. Recognizing the urgency 
of this situation, and understanding that some pre-existing Medicare 
payment rules may inhibit use of capacity that might otherwise be 
effective in the efforts to mitigate the impact of the pandemic on 
Medicare beneficiaries and the American public, we are changing our 
under arrangements policy during the PHE for the COVID-19 pandemic 
beginning March 1, 2020, so that hospitals are allowed broader 
flexibilities to furnish inpatient services, including routine services 
outside the hospital.
    We believe that our concerns articulated in the FY 2012 rulemaking 
regarding gaming of routine services provided outside the hospital for 
payment reasons are significantly mitigated by the existence of the 
PHE. Hospitals would be treating patients in locations outside the 
hospital for a variety of reasons, including limited beds and/or 
limited specialized equipment such as ventilators, and for a limited 
time period. We do not expect that during the PHE for the COVID-19 
pandemic hospitals would be treating patients outside the hospital for 
gaming reasons.
    As noted, we continue to believe that our current policy of 
limiting the services that may be provided under arrangements outside 
of the hospital to therapeutic and diagnostic items and services is 
consistent with the statute and supported by the policy considerations 
discussed in the FY 2012 IPPS/LTCH PPS final rule. However, we do not 
believe that the statute would preclude this change in policy to allow 
routine services to also be provided under arrangements outside the 
hospital, in light of the compelling circumstances and the need for 
additional, short-term flexibility during the current PHE for the 
COVID-19 pandemic. Consistent with this, and as previously summarized 
in section II.BB.2 of this IFC, we note that we received comments 
during the FY 2012 rulemaking that our policy to limit the services a 
hospital may provide under

[[Page 19280]]

arrangements is not required by the statute and that CMS' reading of 
the statutory definition of inpatient hospital services is only one 
possible interpretation of the statute.
    While we are changing our under arrangements policy during the PHE 
for the COVID-19 pandemic to allow hospitals broader flexibilities in 
furnishing inpatient services, we emphasize that we are not changing 
our policy that a hospital needs to exercise sufficient control and 
responsibility over the use of hospital resources in treating patients, 
as discussed in the FY 2012 IPPS/LTCH PPS final rule and Section 10.3 
of Chapter 5 of the Medicare General Information, Eligibility, and 
Entitlement Manual (Pub. 100-01). Nothing in the current PHE for the 
COVID-19 pandemic has changed our policy or thinking with respect to 
this issue and we are making no modifications to this aspect of the 
policy. Hospitals need to continue to exercise sufficient control and 
responsibility over the use of hospital resources in treating patients 
regardless of whether that treatment occurs in the hospital or outside 
the hospital under arrangements. If a hospital cannot exercise 
sufficient control and responsibility over the use of hospital 
resources in treating patients outside the hospital under arrangements, 
the hospital should not provide those services outside the hospital 
under arrangements.
    For the reasons set forth above, effective for services provided 
for discharges for patients admitted to the hospital during the PHE for 
COVID-19 beginning March 1, 2020, if routine services are provided 
under arrangements outside the hospital to its inpatients, these 
services are considered as being provided by the hospital.

DD. Advance Payments to Suppliers Furnishing Items and Services Under 
Part B

    In an effort to be able to be more responsive to situations in 
which Part B suppliers could request advance payments from CMS, we are 
making modifications to existing advance payments rules found in 42 CFR 
421.214. Currently, Sec.  421.214 limits CMS' ability to make advance 
payments in situations where a CMS contractor is unable to process 
claims within established time limits. In light of the PHE Declaration 
related to COVID-19 and the inability to project the impact it may have 
in the future on CMS' abilities to ensure timely payment and the 
potential challenges for suppliers to prepare and submit claims to CMS 
contractors, we are revising the definition of advance payment in Sec.  
421.214(b). Currently, paragraph (b) defines advance payment as a 
conditional partial payment made by the carrier in response to a claim 
that it is unable to process within established time limits. We are 
revising this definition to state that the conditional partial payment 
will be made by the ``contractor'' (not the carrier) except as provided 
in paragraph (j). We are also adding language to permit payments under 
an exception at Sec.  421.214(c). In addition, we are also adding 
paragraph (j) to specifically address emergency situations in which it 
will be able to make advance payments. Additionally, existing rules 
limit CMS to no more than 80 percent of the anticipated payment for 
that claim based upon the historical assigned claims payment data for 
claims paid to the supplier. Under exceptional circumstances as 
outlined in paragraph (j), we are increasing this limit to 100 percent 
of the anticipated payment for that claim based upon the historical 
assigned claims payment data for claims paid to the supplier in 
paragraph (f)(1)(i). We are also adding a criterion to Sec.  421.214 
that suppliers in bankruptcy would not be eligible to receive advance 
payments to ensure that, with such expanded authority, CMS is able to 
appropriately pay and recover advance payments made to Part B 
suppliers.

III. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule before 
the provisions of the rule take effect, in accordance with 5 U.S.C. 
553(b) of the Administrative Procedure Act (APA) and section 1871 of 
the Act. Specifically, section 553(b) of the APA requires the agency to 
publish a notice of the proposed rule in the Federal Register that 
includes a reference to the legal authority under which the rule is 
proposed, and the terms and substance of the proposed rule or a 
description of the subjects and issues involved. Section 553(c) of the 
APA further requires the agency to give interested parties the 
opportunity to participate in the rulemaking through public comment 
before the provisions of the 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 a period of not less than 
60 days for public comment. Section 553(b)(3)(B) of the APA and section 
1871(b)(2)(C) of the Act authorize the agency to waive these 
procedures, however, if the agency finds good cause that notice and 
comment procedures are impracticable, unnecessary, or contrary to the 
public interest and incorporates a statement of the finding and its 
reasons in the rule issued.
    Section 553(d) of the APA ordinarily requires a 30-day delay in the 
effective date of a final rule from the date of its publication in the 
Federal Register. This 30-day delay in effective date can be waived, 
however, if an agency finds good cause to support an earlier effective 
date. Section 1871(e)(1)(B)(i) of the Act also prohibits a substantive 
rule from taking effect before the end of the 30-day period beginning 
on the date the rule is issued or published. Section 1871(e)(1)(B)(ii) 
of the Act permits a substantive rule to take effect before 30 days if 
the Secretary finds that a waiver of the 30-day period is necessary to 
comply with statutory requirements or that the 30-day delay would be 
contrary to the public interest. Furthermore, section 1871(e)(1)(A)(ii) 
of the Act permits a substantive change in regulations, manual 
instructions, interpretive rules, statements of policy, or guidelines 
of general applicability under Title XVIII of the Act to be applied 
retroactively to items and services furnished before the effective date 
of the change if the failure to apply the change retroactively would be 
contrary to the public interest.
    The nation is experiencing an emergency of unprecedented magnitude. 
Ensuring the health and safety of Medicare beneficiaries, Medicaid 
recipients, and healthcare workers is of primary importance. As this 
IFC directly supports that goal by offering healthcare professionals 
flexibilities in furnishing services while combatting the COVID-19 
pandemic and ensuring that sufficient health care items and services 
are available to meet the needs of individuals enrolled in the Medicare 
and Medicaid programs, it is critically important that we implement 
this IFC as quickly as possible. As we are in the midst of a PHE, we 
find good cause to waive notice and comment rulemaking as we believe it 
would be contrary to the public interest for us to undertake normal 
notice and comment rulemaking procedures. For the same reasons, because 
we cannot afford any delay in effectuating this IFC, we find good cause 
to waive the 30-day delay in the effective date and, moreover, to make 
this IFC effective as of March 1, 2020--the date the President of the 
United States declared to be the beginning of the national emergency 
concerning the COVID-19 outbreak.
    On January 30, 2020, the International Health Regulations Emergency 
Committee of the World Health

[[Page 19281]]

Organization (WHO) declared the outbreak of the 2019 Novel Coronavirus 
(COVID-19) to be a Public Health Emergency of International 
Concern.\22\ On January 31, 2020, Health and Human Services Secretary 
Alex M. Azar II declared a Public Health Emergency (PHE) \23\ under 
section 319 of the Public Health Service Act (42 U.S.C. 247d), in 
response to COVID-19. On March 11, 2020, the WHO publicly declared 
COVID-19 to be a pandemic.\24\ On March 13, 2020, the President 
declared that the COVD-19 outbreak in the United States constitutes a 
national emergency,\25\ beginning March 1, 2020. This declaration, 
along with the Secretary's January 30, 2020 declaration of a PHE, 
conferred on the Secretary certain waiver authorities under section 
1135 of the Act. On March 13, 2020, the Secretary authorized waivers 
under section 1135 of the Act, effective March 1, 2020.\26\
---------------------------------------------------------------------------

    \22\ https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-
(2005)-emergency-committee-regarding-the-outbreak-of-novel-
coronavirus-(2019-ncov).
    \23\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
    \24\ https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.
    \25\ https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
    \26\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
---------------------------------------------------------------------------

    In support of the imperative to contain and combat the virus in the 
United States, this IFC will give health care workers and hospitals 
additional flexibility to respond to the virus and continue caring for 
patients while minimizing exposure. CDC guidelines are clear that 
public exposure greatly increases the overall risk to public health and 
they stress the importance of containment and mitigation strategies to 
minimize public exposure and the spread of COVID-19. As of March 29th, 
the CDC reports 122,653 cases of COVID-19 in the United Sates and 2,112 
deaths.\27\ Individuals such as healthcare workers who come in close 
contact with those infected with COVID-19 are at an elevated risk of 
contracting the disease. To minimize these risks, the CDC has urged 
healthcare professionals to make every effort to distance themselves 
from those who are potentially sick with COVID-19 by using modalities 
such as telephonic interviews, text monitoring systems, or video 
conference.\28\ As the healthcare community works to establish and 
implement infection prevention and control practices, CMS is also 
working to revise and implement regulations that function in concert 
with those healthcare community infection prevention and treatment 
practices.
---------------------------------------------------------------------------

    \27\ https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.
    \28\ https://www.cdc.gov/coronavirus/2019-ncov/php/guidance-evaluating-pui.html.
---------------------------------------------------------------------------

    This IFC offers flexibilities in certain Medicare and Medicaid 
regulations that support measures to combat the COVID-19 pandemic and 
safeguard all interests by protecting healthcare providers and 
vulnerable beneficiaries. The provisions of this IFC better enable and 
facilitate physicians and other clinicians, to focus on caring for 
these beneficiaries during this PHE for the COVID-19 pandemic and 
minimize their own risks to COVID-19 exposure. For example, by 
increasing access to telehealth and testing in a patient's home, and 
improving infection control, this IFC will provide flexibilities for 
Medicare beneficiaries to be able to receive medically necessary 
services without jeopardizing their health or the health of those who 
are providing those services, in turn minimizing public exposure and 
the overall risk to public health. Moreover, changes to Medicare 
payment rules will confer on practitioners and other healthcare 
providers the broadest flexibility to use remote communications 
technology to avoid exposure risks to themselves, their patients, and 
communities. These changes include greater flexibilities to use 
communications technology to interact with patients directly and to 
supervise care directly provided by other clinicians. This IFC alters 
the applicable payment rules to provide specimen collection fees for 
independent laboratories collecting specimens from beneficiaries who 
are homebound or inpatients (not in a hospital) for COVID-19 testing. 
Additionally, certain new model-specific requirements for Innovation 
Center Models and program-specific requirements for the Quality Payment 
Program will reduce or prevent practices that might inappropriately 
incentivize cost considerations over patient safety. Changes to the 
calculation of the 2021 and 2022 Part C and D Star Ratings will address 
the expected disruption to data collection and measure scores posed by 
the COVID-19 pandemic, and amendments to the Medicaid home health 
regulations will enable other licensed practitioners to order services, 
equipment, and therapy they otherwise could not.
    We believe it would be contrary to the public interest for us to 
undertake normal notice and comment procedures and to delay the 
effective date of this IFC. We find good cause to waive notice of 
proposed rulemaking under section 553(b)(3)(B) of the APA and section 
1871(b)(2)(C) of the Act, and, for the reasons stated, we find that it 
would be contrary to the public interest to delay the effective date of 
this IFC, under section 553(d) of the APA and section 1871(e)(1)(B)(i) 
of the Act.
    Furthermore, the President declared that the COVID-19 outbreak in 
the United States constituted a national emergency beginning March 1, 
2020. To ensure the consistent availability throughout the national 
emergency period of measures we are taking to address the COVID-19 
pandemic, we believe it is vital that the effective date of this IFC 
align with the first day of the national emergency. It is also 
important to ensure the health care providers that acted expeditiously 
to implement appropriate physical and operational changes to their 
practices to adapt to emergency conditions, even in the absence of 
changes in our policies to address them, are not disadvantaged relative 
to other health care providers, and will not be discouraged from taking 
similar appropriate actions in the future. March 1, 2020 precedes the 
date of publication of this IFC in the Federal Register, which means 
this rule has a retroactive effect. However, section 1872(e)(1)(A)(ii) 
of the Act permits the Secretary to issue a rule with retroactive 
effect if the failure to do so would be contrary to the public 
interest. As we have explained above, we believe it would be contrary 
to the public interest not to implement this IFC as soon as we are 
authorized to do so under the authority of section 1871(e)(1)(A)(ii) of 
the Act, that is, retroactively to March 1, 2020. We are providing a 
60-day public comment period for this IFC as specified in the DATES 
section of this document.

IV. Collection of Information Requirements

    For IFC changes to the MA and Part D Star Ratings program, the 
elimination of the requirement to collect and submit data for OMB 
control numbers 0938-1028 (HEDIS) and 0938-0732 (CAHPS) will reduce 
some burden. Those collections are approved for 164,200 hours and 
123,375 hours annually, respectively. Due to the ongoing nature of 
these information collections, it is difficult to determine the extent 
of the burden. However, the burden estimates for the HEDIS and CAHPS 
information collection requests are approved

[[Page 19282]]

through November 30, 2020 and April 30, 2021, respectively. Upon 
resubmission for OMB approval, we will revise both information 
collections to more accurately account for the burden decreases.

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VI. Regulatory Impact Analysis

    Executive Order 12866 and other laws and Executive orders require 
economic analysis of the effects of proposed and final (including 
interim final) rules.\29\ The Office of Management and Budget has 
designated this rulemaking as ``economically significant'' under E.O. 
12866 and also major under the Congressional Review Act. This IFC's 
designation under Executive Order 13771, titled ``Reducing Regulation 
and Controlling Regulatory Costs'' (82 FR 9339), which was issued on 
January 30, 2017, will be informed by public comments received.
---------------------------------------------------------------------------

    \29\ Section 202 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-04, enacted on March 22, 1995) also requires 
that agencies assess anticipated costs and benefits before issuing 
any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2020, 
that amount is approximately $156 million. This IFC does not 
mandate, on an unfunded basis, any requirements for State, local, or 
tribal governments, or for the private sector.
---------------------------------------------------------------------------

A. Statement of Need

    Throughout this IFC, we discuss several changes to payment and 
coverage policies intended to allow health care providers maximum 
flexibility to minimize the spread of COVID-19 among Medicare and 
Medicaid beneficiaries, health care personnel, and the community at 
large and increase capacity to address the needs of their patients. The 
flexibilities and changes contained within this IFC are responsive to 
this developing pandemic emergency. Given the potentially catastrophic 
impact to public health, it is difficult to estimate the economic 
impact of the spread of COVID-19 under current payment rules compared 
to the rules issued in this IFC.
    We believe that the needs of Medicare patients will likely test the 
capacity of the health care system over the coming months. Our policies 
during the PHE for the COVID-19 Pandemic will allow home health 
agencies and hospices more flexibility to furnish services via 
telecommunications technologies to minimize exposure risks to patients, 
clinicians and the general public; and there would be no change in 
Medicare payment rates or change in the types of patients treated under 
these policies compared to the absence of these policy changes.
    Our additions to the list of Medicare telehealth services will 
allow more physicians' services to be furnished in a manner that 
reduces the exposure risk to patients and physicians. To the extent 
that physicians utilize these new flexibilities for patients that would 
have been treated in more traditional offices or hospital settings 
without this policy change, given the competing demand for physicians' 
services during the pandemic this additional flexibility would not 
result in any significant change in aggregate Medicare payments for 
physicians' services.
    Still, it is possible that the flexibilities and changes contained 
within this IFC would increase aggregate Medicare payments. For 
example, if its protections against exposure risk are effective, 
providers may maintain their own health and thus be available to 
provide more medical treatment overall. Improvements in both provider 
and/or patient health are intended benefits of this IFC.
    We anticipate that the change in the site of service payment amount 
for telehealth services under the PHE along with the changes that allow 
for broader flexibilities in supervision will allow physicians and 
other practitioners to better maintain overall level of needed care to 
Medicare beneficiaries in the face of exposure risks and competing 
demands for health care providers.
    Finally, the changes to Medicaid's regulations to expand the scope 
of certain providers are anticipated to eliminate some burdens on 
providers and beneficiaries.
    The modifications to the calculations for the 2021 and 2022 Part C 
and D Star Ratings to address the expected disruption to data 
collection and measure scores posed by the PHE for the COVID-19 
pandemic should not have a significant impact on the distribution of 
ratings across Part C and D sponsors. Consequently, there should be 
negligible impacts on payments for MA organizations from these 
modifications.

B. Special Requirements for Psychiatric Hospitals

    In section II.P. of this final rule, we note that existing 
requirements for psychiatric hospitals specify that progress notes must 
be recorded by the physician(s), psychologists, or other licensed 
independent practitioner(s) responsible for the care of the patient. We 
believe that this provision requires clarification and revision since 
the regulatory language is inconsistent with other recent changes 
finalized throughout the hospital CoPs as this provision applies to 
APPs, including PAs, NPs, psychologists, and CNSs.
    Continued use of this outdated term may inadvertently exacerbate 
workforce shortage concerns, might unnecessarily impose regulatory 
burden on hospitals, especially psychiatric hospitals, by restricting a 
hospital's ability to allow APPs to operate within the scope of 
practice allowed by state law. We believe that the existing regulation 
fails to recognize the benefits to patient care that might be derived 
from fully utilizing APPs and their clinical skills to the highest 
levels of their training, education, and experience as allowed by 
hospital policy in accordance with state law.
    Therefore, we are removing the term ``licensed independent 
practitioner(s)'' from the regulations. We believe that this revision 
is non-controversial, and that the public interest will be served by 
permitting a greater scope of practice for professionals in the 
psychiatric hospital context and further believe that these trained and 
qualified practitioners, when acting in accordance with State law, 
their scope of practice, and hospital policy, should have the authority 
to record progress notes of psychiatric patients for whose care they 
are responsible.
    At Sec.  482.61(d), we are allowing NPPs, or APPs, to document 
progress notes in accordance with State laws and scope-of-practice 
requirements. We believe that clarification of the intent of the 
regulation is necessary and will result in NPPs (specifically PAs, NPs, 
and CNSs) documenting in the progress notes for patients receiving 
services in psychiatric hospitals.
    We estimate that MDs/DOs currently spend approximately 30 minutes 
documenting progress notes in psychiatric hospitals, and that 33 
percent of this time would be covered by NPPs. Of the 4,823 Medicare 
participating hospitals, approximately 620 (or 13 percent) are 
psychiatric hospitals. According to AHA, there were 36,510,207 
inpatient hospital stays in 2017, and therefore, an estimated 13 
percent of these stays were at psychiatric hospitals. The change will 
result in a savings of $153.5 million (4,746,327 psychiatric hospital 
stays x 2 progress notes per stay x 0.5 hours of physician/psychiatrist 
time x $98 per

[[Page 19283]]

hourly wage difference between physicians/psychiatrists ($198) and NPPs 
($100, the average wage between NPs and PAs) x 33 percent of physician 
time spent writing progress notes covered by NPPs, or APPs).

C. Anticipated Effects of Changes to the MDPP Expanded Model

1. Effects on Beneficiaries
    In section II.Q. of this IFC, we are amending the MDPP expanded 
model to modify certain requirements of the model in an emergency area 
during an emergency period, as those terms are defined in section 
1135(g) of the Act, for which the Secretary has issued a waiver under 
section 1135 of the Act. Specifically, as the Secretary has issued a 
waiver under section 1135 of the Act, certain MDPP beneficiaries will 
be permitted to obtain the set of MDPP services more than once per 
lifetime, the number of virtual make-up sessions is increased, and 
certain MDPP suppliers will be permitted to deliver time limited 
virtual MDPP sessions. These changes apply only to MDPP beneficiaries 
(as defined in Sec.  410.79(b)) who were receiving the MDPP set of 
services during the emergency period, as defined under section 1135(g) 
of the Act.
    We believe that during this COVID-19 pandemic, Medicare 
beneficiaries will not be able to attend in-person classes. Because we 
do not want to disrupt their progress and we want to promote both MDPP 
beneficiary and MDPP supplier retention, we have modified how the set 
of services can be delivered to make the program accessible to 
currently enrolled MDPP beneficiaries during this national emergency. 
Our policies during the PHE for the COVID-19 Pandemic will allow 
enrolled MDPP suppliers with active MDPP cohorts more flexibility to 
furnish virtual sessions, as described by the CDC's DPRP Standards.
    With the exception of the requirement for in-person attendance and 
the in-person body weight measurement at the first core-session, the 
in-person attendance requirements are waived. MDPP suppliers shall not 
start any new cohorts with MDPP beneficiaries throughout the COVID-19 
PHE period in the geographic area, as defined under section 1135(g) of 
the Act, given that most beneficiaries cannot receive in-person 
services right now.
    During the emergency period, the number of virtual make-up sessions 
is waived for MDPP suppliers, with an MDPP supplier offering MDPP 
beneficiaries no more than 15 weekly virtual make-up sessions during 
the core session period, no more than 6 monthly virtual make-up 
sessions during the core maintenance session interval period, no more 
than 12 monthly virtual make-up sessions during the ongoing maintenance 
session interval periods. All flexibilities described in this IFC will 
cease to be available as of the effective end date of the PHE. When in-
person classes resume, the CDC is allowing suppliers to pick up where 
they left off, or to restart the program from week one. It is our 
intent to conform with the CDC guidance where feasible, with the 
overall intent to minimize disruption of services for MDPP suppliers 
and MDPP beneficiaries; by allowing MDPP beneficiaries to maintain 
their eligibility. In this IFC, we are amending the MDPP regulations to 
provide for changes as described in section II.Q.1 of this IFC, 
including allowing MDPP suppliers to either deliver MDPP services 
virtually or suspend delivery and resume services at a later date, in 
an emergency area and during this COVID-19 PHE period, as those terms 
are defined in section 1135(g) of the Act, for which the Secretary has 
authorized a waiver under section 1135 of the Act and the Secretary has 
declared a PHE. In addition, these changes permit certain MDPP 
beneficiaries to obtain the set of MDPP services more than once per 
lifetime, for the limited purposes of allowing a pause in service and 
allow MDPP beneficiaries to maintain eligibility for MDPP services 
despite a break in service, attendance, or weight loss achievement. 
These changes will have a positive impact on affected MDPP 
beneficiaries, as it will allow them to maintain eligibility for the 
expanded model, and request virtual make-up sessions if needed for 
successful completion of attendance and weight loss milestones.
2. Effects on the Market
    Currently, more than 196 organizations nationally are enrolled as 
MDPP suppliers. There are approximately 798 locations. We anticipate 
that of the 1,818 beneficiaries identified through our monitoring data 
and the CDC's Diabetes Prevention Recognition Program (DPRP) data, 
1,358 beneficiaries may be impacted by allowing both the once-per-
lifetime benefit and the minimum weight loss requirement to be waived 
for those beneficiaries in the first 12 months of MDPP.

                                 Table 2
------------------------------------------------------------------------
                   Recommended waivers                      Cost impact
------------------------------------------------------------------------
Adjust the limit to the # Virtual Make-up sessions......             $--
Waive the once per lifetime requirement.................      279,748.00
Waive the minimum weight loss requirement for OM........       53,301.50
Waive the MDPP services time periods and intervals......              --
Average Y1 MDPP Payments (Y1) with no COVID action......      177,898.00
                                                         ---------------
    Total cost of COVID-19 response.....................      333,049.50
------------------------------------------------------------------------
Assumptions:
--Average MDPP payments in Year 1: $412, assuming that beneficiaries
  attended 9 sessions, and reached the 5 percent weight loss during
  interval 1 of the core maintenance session
--Average MDPP payments in Year 1 with no COVID-19 action: $131,
  assuming beneficiaries attended 2 ongoing maintenance sessions

D. Modification to the Extreme and Uncontrollable Circumstances Policy 
Under the Shared Savings Program

    In section II.V. of this IFC, we discuss a modification to the 
extreme and uncontrollable circumstances policy under the Shared 
Savings Program. The current Medicare Shared Savings Program extreme 
and uncontrollable circumstances policy for purposes of determining an 
ACO's quality score for use in determining shared savings or shared 
losses applies if twenty percent or more of an ACO's assigned 
beneficiaries or its legal business entity are located in an area 
identified under the Quality Payment Program as being affected by an 
extreme and uncontrollable circumstance, during the performance year, 
including the applicable quality data reporting period for the 
performance year if, the quality reporting period is not extended. In 
response to the National Emergency for

[[Page 19284]]

the COVID-19 pandemic declared on March 13, 2020, we have determined 
that the 2019 MIPS data submission deadline will be extended by 30 days 
until April 30, 2020, to give eligible clinicians more time to report 
quality and other data for purposes of MIPS. This extended timeline 
also applies to Shared Savings Program ACOs because they are required 
to report quality data via the CMS Web Interface and we align the 
Shared Savings Program data submission timeline with the timeline for 
MIPS data submission. As currently written, our extreme and 
uncontrollable circumstances policy cannot be applied to waive the 
quality reporting requirements under the Shared Savings Program because 
the quality data submission period has been extended.
    The PHE for the COVID-19 pandemic applies to all counties in the 
United States, and we think it is appropriate to offer relief under the 
Shared Savings Program extreme and uncontrollable circumstances policy 
to all Shared Savings Program ACOs that are unable to completely and 
accurately report quality for 2019 by the extended deadline. 
Accordingly, in this IFC, we are revising the regulation at Sec.  
425.502(f) to remove the restriction which prevents the application of 
the Shared Savings Program extreme and uncontrollable circumstances 
policy for disasters that occur during the quality period if the 
reporting period is extended, to offer relief under the Shared Savings 
Program to all ACOs that may be unable to completely and accurately 
report quality for 2019 due to the PHE for the COVID-19. As currently 
written, our extreme and uncontrollable circumstances policy cannot be 
applied to waive the quality reporting requirements under the Shared 
Savings Program because the quality data submission period has been 
extended.
    The PHE for the COVID-19 pandemic applies to all counties in the 
United States, and we think it is appropriate to offer relief under the 
Shared Savings Program extreme and uncontrollable circumstances policy 
to all Shared Savings Program ACOs that are unable to completely and 
accurately report quality for 2019 by the extended deadline, 
Accordingly, in this interim final rule, we are revising the regulation 
at Sec.  425.502(f) to remove the restriction which prevents the 
application of the Shared Savings Program extreme and uncontrollable 
circumstances policy for disasters that occur during the quality period 
if the reporting period is extended, in order to offer relief under the 
Shared Savings Program to all ACOs that may be unable to completely and 
accurately report quality for 2019 due to the PHE for the COVID-19 
pandemic.
    We estimate based on patterns evident in the financial 
reconciliation for performance year 2018 that this change would allow 
roughly 100 ACOs that achieve savings either to qualify to receive 
shared savings or to receive a higher effective sharing rate. We 
estimate the average resulting benefit to such ACOs ranging from 
$150,000 to $200,000 per ACO. The total impact of extending the extreme 
and uncontrollable circumstances policy despite the extension of the 
quality reporting period for 2019 is therefore estimated to be $20 
million with a range of uncertainty in such estimate spanning $15 
million to $25 million.

E. Anticipated Effects of Changes to the Quality Payment Program

    Since it is not possible to comprehensively predict the impact of 
the evolving PHE for the COVID-19 pandemic at this time, the Office of 
the Actuary was unable to calculate a discrete impact estimate for the 
effect of extending CJR PY 5 an additional 3 months. However, given the 
previous estimate for PY 5 in the ``Comprehensive Care for Joint 
Replacement Model Three-Year Extension and Changes to Episode 
Definition and Pricing'' proposed rule (CMS-5529-P), we anticipate the 
impact of the additional 3 months could range between $0 and $1.2 
million. We will continue to refine this analysis and will provide a 
more detailed estimate in the final rule if available. Table 3 
summarizes the financial impact of extending PY 5 an additional 3 
months. Table 3 includes the full amount of FFS episode payments and 
also includes any reconciliation payments related to the model. Table 3 
also shows costs/savings (costs are represented as positive amounts and 
savings as negative amounts) imposed on non-federal entities (that is, 
participating medical facilities), as well as net transfers of federal 
funds (that is, increases in Medicare program expenditures are 
indicated as positive amounts and decreases in Medicare program 
expenditures are indicated as negative amounts).

   Table 3--Financial Impact of Extending PY 5 an Additional 3 Months
------------------------------------------------------------------------
                                                            Transfers
                Scenario                 Costs/benefits     (millions)
------------------------------------------------------------------------
Net financial impact of extending CJR    ..............             1.2
 model PY 5 by 3 additional months.....
------------------------------------------------------------------------

F. Overall Impact

    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. The great majority of hospitals and most 
other health care providers and suppliers are small entities, either by 
being nonprofit organizations or by meeting the SBA definition of a 
small business (having revenues of less than $8.0 million to $41.5 
million in any one year). Individuals and states are not included in 
the definition of a small entity. As its measure of significant 
economic impact on a substantial number of small entities, HHS uses an 
adverse change in revenue of more than 3 to 5 percent. We do not 
believe that this threshold will be reached by the provisions in this 
IFC.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a metropolitan 
statistical area and has fewer than 100 beds. This IFC will not have a 
significant impact on the operations of a substantial number of small 
rural hospitals.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule that imposes 
substantial direct requirement costs on state and local governments, 
preempts state law, or otherwise has federalism implications. This IFC 
does not have a substantial direct cost impact on state or local 
governments, preempt state law, or otherwise have federalism 
implications.
    Under the Congressional Review Act (5 U.S.C. 801 et seq.), the 
Office of Information and Regulatory Affairs designated this rule as a 
major rule, as

[[Page 19285]]

defined by 5 U.S.C. 804(2). As such, this rule has been transmitted to 
the Congress and the Comptroller General for review.

List of Subjects

42 CFR Part 400

    Grant programs--health, Health facilities, Health maintenance 
organizations (HMO), Medicaid, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 405

    Administrative practice and procedure, Diseases, Health facilities, 
Health insurance, Health professions, Medical devices, Medicare, 
Reporting and recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 410

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

42 CFR Part 412

    Administrative practice and procedure, Health facilities, Medicare, 
Puerto Rico, Reporting and recordkeeping requirements.

42 CFR Part 414

    Administrative practice and procedure, Biologics, Diseases, Drugs, 
Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 415

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 417

    Administrative practice and procedure, Grant programs--health, 
Health care, Health insurance, Health maintenance organizations (HMO), 
Loan programs--health, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 421

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 422

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Medicare, Penalties, Privacy, 
Reporting and recordkeeping requirements.

42 CFR Part 423

    Administrative practice and procedure, Emergency medical services, 
Health facilities, Health maintenance organizations (HMO), Health 
professionals, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

42 CFR Part 425

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 440

    Grant programs--health, Medicaid.

42 CFR Part 482

    Grant programs--health, Hospitals, Medicaid, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 510

    Administrative practice and procedure, Health facilities.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 400--INTRODUCTION; DEFINITIONS

0
1. The authority citation part 400 is revised to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh, and 44 U.S.C. Chapter 35.


0
2. Section 400.200 is amended by adding the definition of ``Public 
Health Emergency'' in alphabetical order to read as follows:


Sec.  400.200  General definitions.

* * * * *
    Public Health Emergency (PHE) means the Public Health Emergency 
determined to exist nationwide as of January 27, 2020, by the Secretary 
pursuant to section 319 of the Public Health Security Act on January 
31, 2020, as a result of confirmed cases of COVID-19, including any 
subsequent renewals.
* * * * *

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
3. The authority citation part 405 continues to read as follows:

    Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 
1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).


0
4. Section 405.2416 is amended by adding paragraph (a)(5) to read as 
follows:


Sec.  405.2416  Visiting nurse services.

    (a) * * *
    (5) During a PHE, as defined in Sec.  400.200 of this chapter, an 
area typically served by the RHC, and an area that is included in the 
FQHC's service area plan, is determined to have a shortage of home 
health agencies, and no request for this determination is required.
* * * * *

PART 409--HOSPITAL INSURANCE BENEFITS

0
5. The authority citation for part 409 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.


0
6. Section 409.43 is amended by revising paragraph (a)(3) to read as 
follows:


Sec.  409.43  Plan of care requirements.

    (a) * * *
    (3) The plan of care must include the identification of the 
responsible discipline(s) and the frequency and duration of all visits, 
as well as those items listed in Sec.  484.60(a) of this chapter that 
establish the need for such services. All care provided must be in 
accordance with the plan of care. During a PHE, as defined in Sec.  
400.200 of this chapter, the plan of care must include any provision of 
remote patient monitoring or other services furnished via a 
telecommunications system and such services must be tied to the 
patient-specific needs as identified in the comprehensive assessment, 
cannot substitute for a home visit ordered as part of the plan of care, 
and cannot be considered a home visit for the purposes of patient 
eligibility or payment. The plan of care must include a description of 
how the use of such technology will help to achieve the goals outlined 
on the plan of care.
* * * * *

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

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

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


0
8. Section 410.27 is amended by revising paragraphs (a)(1)(iv)(D) and 
(E) to read as follows:

[[Page 19286]]

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) * * *
    (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. For purposes 
of this section, direct supervision means that the physician or 
nonphysician practitioner must be immediately available to furnish 
assistance and direction throughout the performance of the procedure. 
It does not mean that the physician or nonphysician practitioner must 
be present in the room when the procedure is performed. During a Public 
Health Emergency, as defined in Sec.  400.200 of this chapter, the 
presence of the physician includes virtual presence through audio/video 
real-time communications technology when use of such technology is 
indicated to reduce exposure risks for the beneficiary or health care 
provider; 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 that the remainder of the service 
can be delivered safely under general supervision. During a Public 
Health Emergency, as defined in Sec.  400.200 of this chapter, Medicare 
requires a minimum level of general supervision for the entire service; 
and
* * * * *

0
9. Section 410.28 is amended by revising paragraph (e)(1) to read as 
follows:


Sec.  410.28  Hospital or CAH diagnostic services furnished to 
outpatients: Conditions.

* * * * *
    (e) * * *
    (1) For services furnished directly or under arrangement in the 
hospital or in an on-campus or off-campus outpatient department of the 
hospital, as defined in Sec.  413.65 of this chapter, ``direct 
supervision'' means that the physician must be immediately available to 
furnish assistance and direction throughout the performance of the 
procedure. It does not mean that the physician must be present in the 
room where the procedure is performed. During a Public Health 
Emergency, as defined in Sec.  400.200 of this chapter, the presence of 
the physician includes virtual presence through audio/video real-time 
communications technology when use of such technology is indicated to 
reduce exposure risks for the beneficiary or health care provider.
* * * * *

0
10. Section 410.32 is amended by revising paragraph (b)(3)(ii) to read 
as follows:


Sec.  410.32  Diagnostic x-ray tests, diagnostic laboratory tests, and 
other diagnostic tests: Conditions.

* * * * *
    (b) * * *
    (3) * * *
    (ii) Direct supervision in the office setting means the physician 
must be present in the office suite and immediately available to 
furnish assistance and direction throughout the performance of the 
procedure. It does not mean that the physician must be present in the 
room when the procedure is performed. During a PHE, as defined in Sec.  
400.200 of this chapter, the presence of the physician includes virtual 
presence through audio/video real-time communications technology when 
use of such technology is indicated to reduce exposure risks for the 
beneficiary or health care provider.
* * * * *

0
11. Section 410.40 is amended by adding paragraph (f)(5) to read as 
follows:


Sec.  410.40   Coverage of ambulance services.

* * * * *
    (f) * * *
    (5) During a Public Health Emergency, as defined in Sec.  400.200 
of this chapter, a ground ambulance transport from any point of origin 
to a destination that is equipped to treat the condition of the patient 
consistent with any applicable state or local Emergency Medical 
Services protocol that governs the destination location. Such 
destinations include, but are not limited to, alternative sites 
determined to be part of a hospital, critical access hospital or 
skilled nursing facility, community mental health centers, federally 
qualified health centers, rural health clinics, physician offices, 
urgent care facilities, ambulatory surgical centers, any location 
furnishing dialysis services outside of an ESRD facility when an ESRD 
facility is not available, and the beneficiary's home.
* * * * *

0
12. Section 410.67(b) is amended in paragraphs (3) and (4) of the 
definition of ``Opioid use disorder treatment service'' by adding a 
sentence at the end of each paragraph to read as follows:


Sec.  410.67  Medicare coverage and payment of Opioid use disorder 
treatment services furnished by Opioid treatment programs.

* * * * *
    (b) * * *
    Opioid use disorder treatment service * * *
    (3) * * * During a Public Health Emergency, as defined in Sec.  
400.200 of this chapter, where audio/video communication technology is 
not available to the beneficiary, the counseling services may be 
furnished using audio-only telephone calls if all other applicable 
requirements are met.
    (4) * * * During a Public Health Emergency, as defined in Sec.  
400.200 of this chapter, where audio/video communication technology is 
not available to the beneficiary, the therapy services may be furnished 
using audio-only telephone calls if all other applicable requirements 
are met.
* * * * *

0
13. Section 410.78 is amended by--
0
a. Adding paragraph (a)(3)(i) and reserved paragraph (a)(3)(ii); and
0
b. Revising paragraph (b) introductory text.
    The additions and revision read as follows:


Sec.  410.78  Telehealth services.

    (a) * * *
    (3) * * *
    (i) Exception. For the duration of the Public Health Emergency as 
defined in Sec.  400.200 of this chapter, Interactive 
telecommunications system means multimedia communications equipment 
that includes, at a minimum, audio and video equipment permitting two-
way, real-time interactive communication between the patient and 
distant site physician or practitioner.
    (ii) [Reserved]
* * * * *
    (b) General rule. Medicare Part B pays for covered telehealth 
services included

[[Page 19287]]

on the telehealth list when furnished by an interactive 
telecommunications system if the following conditions are met, except 
that for the duration of the Public Health Emergency as defined in 
Sec.  400.200 of this chapter, Medicare Part B pays for office and 
other outpatient visits, professional consultation, psychiatric 
diagnostic interview examination, individual psychotherapy, 
pharmacologic management and end stage renal disease related services 
included in the monthly capitation payment furnished by an interactive 
telecommunications system if the following conditions are met:
* * * * *

0
14. Section 410.79 is amended by adding paragraph (e) to read as 
follows:


Sec.  410.79   Medicare Diabetes Prevention Program expanded model: 
Conditions of coverage.

* * * * *
    (e) MDPP expanded model emergency policy. (1) Notwithstanding 
paragraphs (a) through (d) of this section, the policies described in 
this paragraph (e) apply during the Public Health Emergency (PHE), as 
defined in Sec.  400.200 of this chapter.
    (2) MDPP requirement changes described in paragraph (e)(1) of this 
section are applicable to:
    (i) Organizations that are enrolled as an MDPP supplier as defined 
in paragraph (b) of this section, as of March 1, 2020; and
    (ii) MDPP beneficiaries as defined in paragraph (b) of this 
section, who are receiving the MDPP set of services as of March 1, 
2020.
    (3) The following changes apply under this paragraph (e):
    (i) The in-person attendance requirements of paragraphs 
(c)(1)(ii)(A), (c)(1)(iii)(A), and (c)(3)(ii) of this section are 
waived. MDPP suppliers shall not start new cohorts with MDPP 
beneficiaries who are unable to attend the first core session in-
person;
    (ii) The limit described in paragraphs (d)(2) and (d)(3)(i) and 
(ii) of this section to the number of virtual make-up sessions is 
waived for MDPP suppliers with capabilities to provide services 
virtually so long as the provision of virtual services complies with 
the following:
    (A) The curriculum furnished during the virtual make-up session 
must address the same CDC-approved DPP curriculum topic as the 
regularly scheduled session;
    (B) The MDPP supplier furnishes to the MDPP beneficiary a maximum 
of one session on the same day as a regularly scheduled session;
    (C) The MDPP supplier furnishes to the MDPP beneficiary a maximum 
of one virtual make-up session per week;
    (D) Virtual make-up sessions must be furnished in a manner 
consistent with the DPRP standards for virtual sessions;
    (E) Virtual make-up sessions can only be furnished to achieve 
attendance goals and cannot be furnished to achieve weight-loss goals;
    (F) An MDPP supplier can only offer virtual make-up sessions upon 
an individual MDPP beneficiary's request; and
    (G) An MDPP supplier can offer to an MDPP beneficiary:
    (1) No more than 15 virtual make-up sessions offered weekly during 
the core session period, months 1 through 6 of the MDPP services 
period;
    (2) No more than 6 virtual make-up sessions offered monthly during 
the core maintenance session interval periods, months 7 through 12 of 
the MDPP services period; and
    (3) No more than 12 virtual make-up sessions offered monthly during 
the ongoing maintenance session interval periods, months 13 through 24;
    (iii) The once per lifetime requirement as described in paragraph 
(c)(1)(i)(B) of this section is waived to permit MDPP beneficiaries 
whose sessions were paused or cancelled due to the PHE to obtain the 
set of MDPP services more than once per lifetime by electing to restart 
the MDPP set of services or resume with the most recent attendance 
session of record;
    (iv) The minimum weight loss requirements for beneficiary 
eligibility in the ongoing maintenance session intervals described in 
paragraphs (c)(1)(ii)(B) and (c)(1)(iii)(B) of this section are waived; 
and
    (v) MDPP suppliers may pause or delay the delivery of the MDPP set 
of services and subsequently resume services on a delayed schedule. The 
time periods and intervals must be consistent with the MDPP 
requirements as described in paragraphs (c)(1)(i)(B), (c)(1)(ii)(A), 
(c)(1)(iii)(A), (c)(2)(i)(A) and (B), and (c)(3)(i) and (ii) of this 
section.

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL 
SERVICES

0
15. The authority citation for part 412 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
16. Section 412.29 is amended by revising paragraph (e) to read as 
follows:


Sec.  412.29   Classification criteria for payment under the inpatient 
rehabilitation facility prospective payment system.

* * * * *
    (e) Have in effect a procedure to ensure that patients receive 
close medical supervision, as evidenced by at least 3 face-to-face 
visits per week by a licensed physician with specialized training and 
experience in inpatient rehabilitation to assess the patient both 
medically and functionally, as well as to modify the course of 
treatment as needed to maximize the patient's capacity to benefit from 
the rehabilitation process, except that during a Public Health 
Emergency, as defined in Sec.  400.200 of this chapter, such visits may 
be conducted using telehealth services (as defined in section 
1834(m)(4)(F) of the Act).
* * * * *

0
17. Section 412.622 is amended by revising paragraphs (a)(3)(iv) and 
(a)(4)(ii) introductory text to read as follows:


Sec.  412.622  Basis of payment.

    (a) * * *
    (3) * * *
    (iv) Requires physician supervision by a rehabilitation physician. 
The requirement for medical supervision means that the rehabilitation 
physician must conduct face-to-face visits with the patient at least 3 
days per week throughout the patient's stay in the IRF to assess the 
patient both medically and functionally, as well as to modify the 
course of treatment as needed to maximize the patient's capacity to 
benefit from the rehabilitation process, except that during a Public 
Health Emergency, as defined in Sec.  400.200 of this chapter, such 
visits may be conducted using telehealth services (as defined in 
section 1834(m)(4)(F) of the Act). The post-admission physician 
evaluation described in paragraph (a)(4)(ii) of this section may count 
as one of the face-to-face visits.
    (4) * * *
    (ii) A post-admission physician evaluation that meets all of the 
following requirements, except for the duration of the Public Health 
Emergency, as defined in Sec.  400.200 of this chapter--
* * * * *

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
18. The authority citation for part 414 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).


0
19. Section 414.1380 is amended by--
0
a. Revising paragraphs (c)(2)(i)(A)(6) and (c)(2)(i)(C) introductory 
text; and
0
b. Adding paragraph (c)(2)(i)(C)(11).

[[Page 19288]]

    The revisions and addition read as follows:


Sec.  414.1380  Scoring.

* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (A) * * *
    (6) Beginning with the 2020 MIPS payment year, for the quality, 
cost, and improvement activities performance categories, the MIPS 
eligible clinician demonstrates through an application submitted to CMS 
that they were subject to extreme and uncontrollable circumstances that 
prevented the clinician from collecting information that the clinician 
would submit for a performance category or submitting information that 
would be used to score a performance category for an extended period of 
time. Beginning with the 2021 MIPS payment year, in the event that a 
MIPS eligible clinician submits data for the quality, cost, or 
improvement activities performance categories, the scoring weight 
specified in paragraph (c)(1) of this section will be applied and its 
weight will not be redistributed, unless an exception applies. 
Exception: for the 2021 MIPS payment year only, if a MIPS eligible 
clinician demonstrates through an application submitted to CMS that 
they have been adversely affected by the Public Health Emergency for 
the COVID-19 pandemic and also submits data for the quality, cost, or 
improvement activities performance categories, the preceding sentence 
will not apply.
* * * * *
    (C) Under section 1848(o)(2)(D) of the Act, a significant hardship 
exception or other type of exception is granted to a MIPS eligible 
clinician based on the following circumstances for the Promoting 
Interoperability performance category. Except as provided in paragraphs 
(c)(2)(i)(C)(10) and (11) of this section, in the event that a MIPS 
eligible clinician submits data for the Promoting Interoperability 
performance category, the scoring weight specified in paragraph (c)(1) 
of this section will be applied and its weight will not be 
redistributed.
* * * * *
    (11) For the 2021 MIPS payment year only, the MIPS eligible 
clinician demonstrates through an application submitted to CMS that 
they have been adversely affected by the Public Health Emergency for 
the COVID-19 pandemic.
* * * * *

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, 
SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN 
CERTAIN SETTINGS

0
20. The authority citation for part 415 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
21. Section 415.172 is amended by revising paragraphs (a) introductory 
text, (a)(2), and (b) to read as follows:


Sec.  415.172   Physician fee schedule payment for services of teaching 
physicians.

    (a) General rule. If a resident participates in a service furnished 
in a teaching setting, physician fee schedule payment is made only if a 
teaching physician is present during the key portion of any service or 
procedure for which payment is sought. During the Public Health 
Emergency, as defined in Sec.  400.200 of this chapter, if a resident 
participates in a service furnished in a teaching setting, physician 
fee schedule payment is made if a teaching physician is present during 
the key portion of the service using interactive telecommunications 
technology for any service or procedure for which payment is sought.
* * * * *
    (2) In the case of evaluation and management services, the teaching 
physician must be present during the portion of the service that 
determines the level of service billed. (However, in the case of 
evaluation and management services furnished in hospital outpatient 
departments and certain other ambulatory settings, the requirements of 
Sec.  415.174 apply.) During a Public Health Emergency, as defined in 
Sec.  400.200 of this chapter, the teaching physician may be present 
during the portion of the service that determines the level of service 
billed using interactive telecommunications technology. (However, in 
the case of evaluation and management services furnished in hospital 
outpatient departments and certain other ambulatory settings, the 
requirements of Sec.  415.174 apply.)
    (b) Documentation. Except for services furnished as set forth in 
Sec. Sec.  415.174 (concerning an exception for services furnished in 
hospital outpatient and certain other ambulatory settings), 415.176 
(concerning renal dialysis services), and 415.184 (concerning 
psychiatric services), the medical records must document the teaching 
physician was present at the time the service is furnished. The 
presence of the teaching physician during procedures and evaluation and 
management services may be demonstrated by the notes in the medical 
records made by the physician or as provided in Sec.  410.20(e) of this 
chapter. During a Public Health Emergency, as defined in Sec.  400.200 
of this chapter, except for services furnished as set forth in 
Sec. Sec.  415.174 (concerning an exception for services furnished in 
hospital outpatient and certain other ambulatory settings), 415.176 
(concerning renal dialysis services), and 415.184 (concerning 
psychiatric services), the medical records must document if the 
teaching physician was physically present or if the teaching physician 
was present through interactive telecommunications technology at the 
time the service is furnished. The presence of the teaching physician 
during procedures and evaluation and management services may be 
demonstrated by the notes in the medical records made by the physician 
or as provided in Sec.  410.20(e) of this chapter.
* * * * *

0
22. Section 415.174 is amended by adding paragraph (b) to read as 
follows:


Sec.  415.174   Exception: Evaluation and management services furnished 
in certain centers.

* * * * *
    (b) During a Public Health Emergency, as defined in Sec.  400.200 
of this chapter, carriers may make physician fee schedule payment for a 
service furnished by a resident if the teaching physician is present 
through interactive telecommunications technology.

0
23. Section 415.180 is revised to read as follows:


Sec.  415.180   Teaching setting requirements for the interpretation of 
diagnostic radiology and other diagnostic tests.

    (a) General rule. Physician fee schedule payment is made for the 
interpretation of diagnostic radiology and other diagnostic tests if 
the interpretation is performed or reviewed by a physician other than a 
resident. During a Public Health Emergency, as defined in Sec.  400.200 
of this chapter, physician fee schedule payment may also be made for 
the interpretation of diagnostic radiology and other diagnostic tests 
if the interpretation is performed by a resident when the teaching 
physician is present through interactive telecommunications technology.
    (b) [Reserved]

0
24. Section 415.184 is revised to read as follows:


Sec.  415.184   Psychiatric services.

    To qualify for physician fee schedule payment for psychiatric 
services furnished under an approved GME

[[Page 19289]]

program, the physician must meet the requirements of Sec. Sec.  415.170 
and 415.172, including documentation, except that the requirement for 
the presence of the teaching physician during the service in which a 
resident is involved may be met by observation of the service by use of 
a one-way mirror, video equipment, or similar device. During a Public 
Health Emergency, as defined in Sec.  400.200 of this chapter, the 
requirement for the presence of the teaching physician during the 
service in which a resident is involved may be met by direct 
supervision by interactive telecommunications technology.

0
25. Section 415.208 is amended by revising paragraph (b)(2) 
introductory text to read as follows:


Sec.  415.208   Services of moonlighting residents.

* * * * *
    (b) * * *
    (2) Services of residents that are not related to their approved 
GME programs and are performed in an outpatient department or emergency 
department of a hospital in which they have their training program are 
covered as physician services and payable under the physician fee 
schedule if criteria in paragraphs (b)(2)(i) through (iii) of this 
section are met. During a Public Health Emergency, as defined in Sec.  
400.200 of this chapter, the services of residents that are not related 
to their approved GME programs and are furnished to inpatients of a 
hospital in which they have their training program are covered as 
physician services and payable under the physician fee schedule if 
criteria in paragraphs (b)(2)(i) through (iii) of this section are met.
* * * * *

PART 417--HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL 
PLANS, AND HEALTH CARE PREPAYMENT PLANS

0
26. The authority citation for part 417 is revised to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh, and 300e, 300e-5, and 
300e-9, and 31 U.S.C. 9701.


0
27. Section 417.472 is amended by revising paragraphs (i) and (j) to 
read as follows:


Sec.  417.472   Basic contract requirements.

* * * * *
    (i) HMOs and CMPs. The HMO or CMP must comply with the requirements 
at Sec.  422.152(b)(5) and (6) of this chapter.
    (j) Coordinated care and cost contracts. Subject to paragraph (i) 
of this section, all coordinated care contracts (including local and 
regional PPOs, contracts with exclusively SNP benefit packages, private 
fee-for-service contracts, and MSA contracts), and all cost contracts 
under section 1876 of the Act, with 600 or more enrollees in July of 
the prior year, must contract with approved Medicare Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) survey vendors 
to conduct the Medicare CAHPS satisfaction survey of Medicare plan 
enrollees in accordance with CMS specifications and submit the survey 
data to CMS.
* * * * *

PART 418--HOSPICE CARE

0
28. The authority citation for part 418 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
29. Section 418.22 is amended by--
0
a. Redesignating the text of paragraph (a)(4) as paragraph (a)(4)(i); 
and
0
b. Adding paragraph (a)(4)(ii).
    The addition reads as follows:


Sec.  418.22   Certification of terminal illness.

    (a) * * *
    (4) * * *
    (ii) During a Public Health Emergency, as defined in Sec.  400.200 
of this chapter, if the face-to-face encounter conducted by a hospice 
physician or hospice nurse practitioner is for the sole purpose of 
hospice recertification, such encounter may occur via a 
telecommunications technology and is considered an administrative 
expense. Telecommunications technology means the use of interactive 
multimedia communications equipment that includes, at a minimum, the 
use of audio and video equipment permitting two-way, real-time 
interactive communication between the patient and the distant site 
hospice physician or hospice nurse practitioner.
* * * * *

0
30. Section 418.204 is amended by adding paragraph (d) to read as 
follows:


Sec.  418.204   Special coverage requirements.

* * * * *
    (d) Use of technology in furnishing services during a Public Health 
Emergency. When a patient is receiving routine home care, during a 
Public Health Emergency as defined in Sec.  400.200 of this chapter, 
hospices may provide services via a telecommunications system if it is 
feasible and appropriate to do so to ensure that Medicare patients can 
continue receiving services that are reasonable and necessary for the 
palliation and management of a patients' terminal illness and related 
conditions. The use of such technology in furnishing services must be 
included on the plan of care, meet the requirements at Sec.  418.56, 
and must be tied to the patient-specific needs as identified in the 
comprehensive assessment and the plan of care must include a 
description of how the use of such technology will help to achieve the 
goals outlined on the plan of care.

PART 421--MEDICARE CONTRACTING

0
31. The authority citation for part 421 is revised to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
32. Section 421.214 is amended by--
0
a. Revising paragraphs (b) and (c) introductory text;
0
b. Adding paragraph (d)(5);
0
c. Revising paragraph (f)(1)(i); and
0
d. Adding paragraph (j).
    The revisions and additions read as follows:


Sec.  421.214   Advance payments to suppliers furnishing items and 
services under Part B.

* * * * *
    (b) Definition. As used in this section, advance payment means a 
conditional partial payment made by the contractor in response to a 
claim that it is unable to process within established time limits 
except as provided in paragraph (j) of this section.
    (c) When advance payments may be made. Unless otherwise qualified 
under paragraph (j) of this section, an advance payment may be made if 
all of the following conditions are met:
* * * * *
    (d) * * *
    (5) Is in bankruptcy.
* * * * *
    (f) * * *
    (1) * * *
    (i) Unless otherwise qualified under paragraph (j) of this section, 
a contractor must calculate an advance payment for a particular claim 
at no more than 80 percent of the anticipated payment for that claim 
based upon the historical assigned claims payment data as defined in 
paragraph (f)(1)(ii) of this section for claims paid to the supplier. 
For suppliers qualifying and approved for advance payments under 
paragraph (j) of this section, a contractor may calculate an advance 
payment for a particular claim at up to 100 percent of the anticipated 
payment for that claim based upon the historical assigned claims 
payment data as defined in paragraph (f)(1)(ii) of this section for 
claims paid to the supplier.
* * * * *

[[Page 19290]]

    (j) Advanced payments in exceptional circumstances. CMS may 
approve, in writing to the contractor, the making of advance payments 
during the period of a Public Health Emergency, as defined in Sec.  
400.200 of this chapter, or during the period under a Presidential 
Disaster Declaration, under the following exceptional conditions:
    (1) The contractor is unable to process the claim timely, or is at 
risk of being untimely in processing the claim; or
    (2) When the supplier has experienced a temporary delay in 
preparing and submitting bills to the contractor beyond its normal 
billing cycle.

PART 422--MEDICARE ADVANTAGE PROGRAM

0
33. The authority citation for part 422 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
34. Section 422.152 is amended by adding paragraph (b)(6) to read as 
follows:


Sec.  422.152   Quality improvement program.

* * * * *
    (b) * * *
    (6) For 2021 Star Ratings only, MA organizations are not required 
to submit HEDIS and CAHPS data that would otherwise be required for the 
calculation of the 2021 Star Ratings.
* * * * *

0
35. Section 422.164 is amended by adding paragraph (i) to read as 
follows:


Sec.  422.164   Adding, updating, and removing measures.

* * * * *
    (i) Special rule for 2021 Star Ratings only. In the event that the 
threat to health and safety posed by the COVID-19 pandemic compromises 
the quality of the data, or ability to validate such data for all plans 
used to calculate a particular measure, CMS will substitute and use the 
2021 Star Ratings measure score and Star Rating with the 2020 Star 
Ratings measure score and Star Rating.

0
36. Section 422.166 is amended--
0
a. By revising paragraph (a)(2)(i);
0
b. In paragraph (f)(1)(i), by adding a sentence to the end of the 
paragraph; and
0
c. By adding paragraphs (g)(3) and (j).
    The revision and additions read as follows:


Sec.  422.166   Calculation of Star Ratings.

    (a) * * *
    (2) * * *
    (i) The method maximizes differences across the star categories and 
minimizes the differences within star categories using mean resampling 
with the hierarchal clustering of the current year's data. Effective 
for the Star Ratings issued in October 2022 and subsequent years, CMS 
will add a guardrail so that the measure-threshold-specific cut points 
for non-CAHPS measures do not increase or decrease more than the value 
of the cap from one year to the next. The cap is equal to 5 percentage 
points for measures having a 0 to 100 scale (absolute percentage cap) 
or 5 percent of the restricted range for measures not having a 0 to 100 
scale (restricted range cap). New measures that have been in the Part C 
and Part D Star Rating program for 3 years or less use the hierarchal 
clustering methodology with mean resampling with no guardrail for the 
first 3 years in the program.
* * * * *
    (f) * * *
    (1) * * *
    (i) * * * For the 2022 Star Ratings only, since all contracts may 
have the improvement measure(s) excluded in the determination of their 
highest rating and summary rating(s), each contract's weighted variance 
and weighted mean are calculated both with and without the improvement 
measures.
* * * * *
    (g) * * *
    (3) For 2022 Star Ratings only, CMS runs the calculations twice for 
the highest rating for each contract-type (overall rating for MA-PD 
contracts and Part C summary rating for MA-only contracts) and Part C 
summary rating for MA-PDs with all applicable adjustments (CAI and the 
reward factor), once including the improvement measure(s) and once 
without including the improvement measure(s). In deciding whether to 
include the improvement measures in a contract's highest and summary 
rating(s), CMS applies the following rules:
    (i) For MA-PDs and MA-only contracts, a comparison of the highest 
rating with and without the improvement measure is done. The higher 
rating is used for the highest rating.
    (ii) For MA-PDs, a comparison of the Part C summary rating with and 
without the improvement measure is done. The higher rating is used for 
the summary rating.
* * * * *
    (j) Special rules for 2021 and 2022 Star Ratings only. (1) For the 
2021 Star Ratings:
    (i) The measures calculated based on HEDIS data are calculated 
based on data from the 2018 performance period.
    (ii) The measures calculated based on CAHPS data are calculated 
based on survey data collected from March through May 2019.
    (iii) The measure-level change score calculation described at Sec.  
422.164(f)(4)(i) is not applied for HEDIS and CAHPS measures and the 
measure-level change score used for the 2020 Star Ratings is applied in 
its place for all HEDIS and CAHPS-based measures.
    (iv) The provisions of Sec.  422.164(g)(1) and (2) are not applied 
for the failure to submit HEDIS and CAHPS-based measures.
    (v) In the event that there are extraordinary circumstances 
resulting from the COVID-19 pandemic that compromise CMS resources to 
the extent that CMS cannot calculate or issue 2021 Star Ratings by 
October 2020, CMS will adopt the 2020 Star Ratings as the 2021 Star 
Ratings.
    (2) For the 2022 Star Ratings:
    (i) In the event that the threat to health and safety posed by the 
COVID-19 pandemic compromises the ability to collect the Health 
Outcomes Survey in 2020, CMS will adopt the 2021 Star Ratings and 
measure scores for the measures that come from the Health Outcomes 
Survey as the 2022 Star Ratings and measures scores for the measures 
that come from the Health Outcomes Survey.
    (ii) [Reserved]

0
37. Section 422.252 is amended by revising the definition of ``New MA 
plan'' to read as follows:


Sec.  422.252   Terminology.

* * * * *
    New MA plan means a MA contract offered by a parent organization 
that has not had another MA contract in the previous 3 years. For 
purposes of 2022 quality bonus payments based on 2021 Star Ratings 
only, new MA plan means an MA contract offered by a parent organization 
that has not had another MA contract in the previous 4 years.
* * * * *

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
38. The authority for part 423 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395w-101 through 1395w-152, and 
1395hh.


0
39. Section 423.156 is amended by adding a sentence at the end of the 
paragraph to read as follows:


Sec.  423.156   Consumer satisfaction surveys.

    * * * Part D sponsors are not required to submit CAHPS data that 
would otherwise be required for the calculation of the 2021 Star 
Ratings.

[[Page 19291]]


0
40. Section 423.182 is amended by adding paragraph (c)(3) to read as 
follows:


Sec.  423.182   Part D Prescription Drug Plan Quality Rating System.

* * * * *
    (c) * * *
    (3) For 2021 Star Ratings only, Part D sponsors are not required to 
submit CAHPS data that would otherwise be required for the calculation 
of the 2021 Star Ratings.

0
41. Section 423.184 is amended by adding paragraph (i) to read as 
follows:


Sec.  423.184  Adding, updating, and removing measures.

* * * * *
    (i) Special rule for 2021 Star Ratings only. In the event that the 
threat to health and safety posed by the COVID-19 pandemic compromises 
the quality of the data, or ability to validate such data, for all 
plans, used to calculate a particular measure, CMS will substitute and 
use the 2021 Star Ratings measure score and Star Ratings with the 2020 
Star Ratings measure score and Star Rating.

0
42. Section 423.186 is amended--
0
a. By revising paragraph (a)(2)(i);
0
b. In paragraph (f)(1)(i), by adding a sentence to the end of the 
paragraph; and
0
c. By adding paragraphs (g)(3) and (j).
    The revision and additions read as follows:


Sec.  423.186  Calculation of Star Ratings.

    (a) * * *
    (2) * * *
    (i) The method maximizes differences across the star categories and 
minimizes the differences within star categories using mean resampling 
with the hierarchal clustering of the current year's data. Effective 
for the Star Ratings issued in October 2022 and subsequent years, CMS 
will add a guardrail so that the measure-threshold-specific cut points 
for non-CAHPS measures do not increase or decrease more than the value 
of the cap from one year to the next. The cap is equal to 5 percentage 
points for measures having a 0 to 100 scale (absolute percentage cap) 
or 5 percent of the restricted range for measures not having a 0 to 100 
scale (restricted range cap). New measures that have been in the Part C 
and D Star Rating program for 3 years or less use the hierarchal 
clustering methodology with mean resampling with no guardrail for the 
first 3 years of the program.
* * * * *
    (f) * * *
    (1) * * *
    (i) * * * For the 2022 Star Ratings only, since all contracts may 
have the improvement measure(s) excluded in the determination of their 
highest rating and summary rating(s), each contract's weighted variance 
and weighted mean are calculated both with and without the improvement 
measures.
* * * * *
    (g) * * *
    (3) For 2022 Star Ratings only, CMS runs the calculations twice for 
the highest rating for each contract-type (overall rating for MA-PD 
contracts and Part D summary rating for PDPs) and Part D summary rating 
for MA-PDs with all applicable adjustments (CAI and the reward factor), 
once including the improvement measure(s) and once without including 
the improvement measure(s). In deciding whether to include the 
improvement measures in a contract's highest and summary rating(s), CMS 
applies the following rules:
    (i) For MA-PDs and PDPs, a comparison of the highest rating with 
and without the improvement measure is done. The higher rating is used 
for the highest rating.
    (ii) For MA-PDs, a comparison of the Part D summary rating with and 
without the improvement measure is done. The higher rating is used for 
the summary rating.
* * * * *
    (j) Special rules for 2021 Star Ratings only. (1) For the 2021 Star 
Ratings:
    (i) The measures calculated based on CAHPS data are calculated 
based on survey data collected from March through May 2019.
    (ii) The measure-level change score calculation described at Sec.  
423.184(f)(4)(i) is not applied for CAHPS measures and the measure-
level change score used for the 2020 Star Ratings is applied in its 
place for all CAHPS-based measures.
    (iii) The provisions of Sec.  423.184(g)(2) are not applied for 
failure to submit CAHPS-based measures.
    (iv) In the event that there are extraordinary circumstances 
resulting from the COVID-19 pandemic that compromise CMS resources to 
the extent that CMS cannot calculate or issue 2021 Star Ratings by 
October 2020, CMS will adopt the 2020 Star Ratings as the 2021 Star 
Ratings.
    (2) [Reserved]

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
43. The authority citation for part 425 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.


Sec.  425.502  [Amended]

0
44. Section 425.502 is amended in paragraph (f) introductory text by 
removing the phrase ``if the quality reporting period is not 
extended''.

PART 440--SERVICES: GENERAL PROVISIONS

0
45. The authority citation for part 440 is revised to read as follows:

    Authority:  42 U.S.C. 1302.


0
46. Section 440.70 is amended by revising paragraphs (a)(2), 
(b)(1)(ii), and (b)(3)(iii) and (iv) to read as follows:


Sec.  440.70  Home health services.

    (a) * * *
    (2) On his or her physician's orders as part of a written plan of 
care that the physician reviews every 60 days for services described in 
paragraphs (b)(1), (2), and (4) of this section, or, for the period of 
the Public Health Emergency, as defined in Sec.  400.200 of this 
chapter, orders written by an other licensed practitioner of the 
healing arts acting within the scope of practice authorized under State 
law, as part of a written plan of care that the ordering practitioner 
reviews every 60 days for services described in paragraphs (b)(1), (2), 
and (4) of this section.
    (b) * * *
    (1) * * *
    (ii) Receives written orders from the patient's physician or, for 
the period of the Public Health Emergency, as defined in Sec.  400.200 
of this chapter, other licensed practitioner of the healing arts acting 
within the scope of practice authorized under State law;
* * * * *
    (3) * * *
    (iii) A beneficiary's need for medical supplies, equipment, and 
appliances must be reviewed by a physician or, for the period of the 
Public Health Emergency, as defined in Sec.  400.200 of this chapter, 
an other licensed practitioner of the healing arts acting within the 
scope of practice authorized under State law, annually.
    (iv) Frequency of further physician or, for the period of the 
Public Health Emergency, as defined in Sec.  400.200 of this chapter, 
an other licensed practitioner review of a beneficiary's continuing 
need for the items is determined on a case-by-case basis based on the 
nature of the item prescribed.
* * * * *

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
47. The authority citation for part 482 continues to read as follows:


[[Page 19292]]


    Authority:  42 U.S.C. 1302, 1395hh, 1395rr, and 1395lll unless 
otherwise noted.


0
48. Section 482.61 is amended by revising paragraph (d) to read as 
follows:


Sec.  482.61  Condition of participation: Special medical record 
requirements for psychiatric hospitals.

* * * * *
    (d) Standard: Recording progress. Progress notes for the patient 
must be documented, in accordance with applicable State scope-of-
practice laws and hospital policies, by the following qualified 
practitioners: Doctor(s) of medicine or osteopathy, or other licensed 
practitioner(s), who is responsible for the care of the patient; 
nurse(s) and social worker(s) (or social service staff) involved in the 
care of the patient; and, when appropriate, others significantly 
involved in the patient's active treatment modalities.
    The frequency of progress notes is determined by the condition of 
the patient but must be recorded at least weekly for the first 2 months 
and at least once a month thereafter and must contain recommendations 
for revisions in the treatment plan as indicated, as well as precise 
assessment of the patient's progress in accordance with the original or 
revised treatment plan.
* * * * *

PART 510--COMPREHENSIVE CARE FOR JOINT REPLACEMENT MODEL

0
49. The authority citation of part 510 is revised to read as follows:

    Authority:  42 U.S.C. 1302, 1315a, and 1395hh.


0
50. Section 510.2 is amended by revising the definition of 
``Performance year'' to read as follows:


Sec.  510.2  Definitions.

* * * * *
    Performance year means one of the years in which the CJR model is 
being tested. Performance years for the model correlate to calendar 
years with the exceptions of performance year 1, which is April 1, 2016 
through December 31, 2016 and performance year 5, which is January 1, 
2020 through March 31, 2021.
* * * * *


Sec.  510.200  [Amended]

0
51. Section 510.200 is amended in paragraph (a) by removing the phrase 
``before December 31, 2020'' and adding in its place the phrase 
``before March 31, 2021''.

0
52. Section 510.305 is amended by adding paragraphs (k)(3) and (4) to 
read as follows:


Sec.  510.305  Determination of the NPRA and reconciliation process.

* * * * *
    (k) * * *
    (3) The following is an extreme and uncontrollable circumstances 
adjustment for 2019 Novel Coronavirus (previously referred to as 2019-
nCoV, now as COVID-19):
    (i) The episode spending adjustments specified in paragraph (k)(4) 
of this section apply for a participant hospital that has a CCN primary 
address that is located in an emergency area during an emergency 
period, as those terms are defined in section 1135(g) of the Act, for 
which the Secretary issued a waiver or modification of requirements 
under section 1135 of the Act on March 13, 2020.
    (ii) [Reserved]
    (4) For a fracture or non-fracture episode with a date of admission 
to the anchor hospitalization that is on or within 30 days before the 
date that the emergency period (as defined in section 1135(g) of the 
Act) begins or that occurs through the termination of the emergency 
period (as described in section 1135(e) of the Act), actual episode 
payments are capped at the target price determined for that episode 
under Sec.  510.300.

    Dated: March 24, 2020.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: March 26, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

[FR Doc. 2020-06990 Filed 3-31-20; 4:15 pm]
 BILLING CODE 4120-01-P