Executive Summary: Tracking Telehealth Changes State-by-State In Response To COVID-19 – Healthcare – United States – Mondaq

H.R. 207: Advanced Safe Testing at Residence Telehealth Act of
2023

Introduced January 9, 2023

• This bill would amend Title XVII of the Social Security act to
  provide payment for cover certain tests (e.g., serology tests for
  COVID-19, diagnostic tests or screenings for certain types of
  cancer, Haptoglobin genetic tests, prediabetes and diabetes
  screenings, etc.) and assistive telehealth consultations (e.g., an
  evaluation and management service; the ordering of a diagnostic
  test or screening; an assessment of an individual succeeding the
  delivery of a diagnostic test or screening; etc.) under state
  programs.

H.R. 2617: Consolidated Appropriations Act, 2023

Passed December 29, 2022

• This bill will, among other provisions, extend the following
  COVID-19 PHE flexibilities for Medicare beneficiaries to December
  31, 2024:
  • Removing specific telehealth geographic requirements and
    expanding originating sites;
  • Expanding practitioners allowed to practice telehealth;
  • Telehealth service provision by FQHCs;
  • Delaying in-person requirements for mental health
    services;
  • Allowing audio-only telehealth service provision; and,
  • Allowing the use of telehealth to conduct face-to-face
    encounters prior to recertification of eligibility for hospice
    care.

Delaware

• Delaware passed House
  Bill No. 334 which:
  • Establishes a pathway and sets forth requirements for an
    out-of-state provider to obtain an “interstate telehealth
    registration” from the Division of Professional Regulation in
    order to provide telehealth and telemedicine services outlined in
    the legislation; and,
  • Allows providers to establish a relationship with a patient
    either in-person or through telehealth and telemedicine if certain
    conditions are met.

CMMI Report on Value-Based Care Strategic Vision

Released November 7, 2022

• The Center for Medicare and Medicaid Innovation (CMMI) at CMS
  released a report on its updated strategic vision for “high
  quality, affordable, person-centered care”. The report focuses
  on several strategies, including enhancing care coordination
  between primary care doctors and specialists, noting that the
  Innovation center could consider expanding tools to promote data
  exchange between providers, such as e-consults.

Final CY 2023 Medicare Physician Fee Schedule

Released November 2, 2022

• The Center for Medicare & Medicaid Services (CMS) released
  its final rule, updating the Medicare Physician Fee Schedule for CY
  2023. Changes in the fee schedule to telehealth services include:
  • Extending some “Category 3” telehealth service
    coverage;
  • Adding permanent coverage for prolonged services in some
    settings;
  • Adding permanent coverage for chronic pain therapy and
    management; and,
  • Ending coverage for some temporarily-covered telehealth
    services after 151 days after the end of the COVID-19 public health
    emergency (PHE).

For more information on the Final Rule for the CY 2023
Physician Fee Schedule, please see our 
November 10 newsletter

HRSA Draft Telehealth Policy Guidance

Released September 15, 2022

• The Health Resources & Services Administration released a
  Draft Policy Information Notice (PIN) that established policy
  guidance for health centers that receive federal award funds
  through the Health Center Program project (authorized Section 330
  of the Public Health Services Act), and outlines key considerations
  and criteria that health centers must meet when providing
  telehealth services to patients within the Health Center program
  project.
  • Key considerations that health centers are responsible for
    addressing include:
    • Ensuring that patients who receive telehealth also have access
      to other services;
    • Delineating responsibilities of staff as related to telehealth
      provision;
    • Providing ways to bill directly for services provided through
      telehealth; and,
    • Ensuring compliance with federal, state, and local requirements
      and standards relating to licensure, scope of practice, and
      delivery of services.
  • Criteria that health centers must meet when delivering service
    via telehealth include:
    • Individuals receiving services via telehealth undergo an intake
      process;
    • Individuals receiving services via telehealth receive an “in-scope required or additional health service”;
    • Individuals receiving services via telehealth are located
      within the health center’s service area;
    • Providers deliver in-scope services on behalf of the health
      center (but do not have to be located at the health center);
      and,
    • The health center keeps a patient record for the services
      delivered via telehealth.
  • The PIN also addresses health center eligibility for other
    federal programs.

NIH to Fund Four Telehealth Cancer Centers of
Excellence

Announced August 18, 2022

• The National Cancer Institute (NCI) of the National Institute
  of Health (NIH) announced it will award $23 million to establish
  telehealth cancer centers of excellence at NYU Grossman School of
  Medicine, Northwestern University, University of Pennsylvania, and
  Memorial Sloan Kettering Cancer Center as part of its Telehealth
  Research Centers of Excellence (TRACE) Initiative.
• These centers will research how telehealth affects the delivery
  of cancer-related care and explore innovations in service
  delivery.

Proposed Medicare Physician Fee Schedule for CY
2023

Released July 7, 2022

• The proposed rule updating the Medicare Physician Fee Schedule
  (MPFS) for calendar year (CY) 2023 proposes:
  • Changes to implement telehealth provisions included within the
    Consolidated Appropriations Act, 2022;
  • Extending coverage through the end of CY 2023 for some
    telehealth services that have been enabled during the PHE;
    and,
  • Adding four new codes to address concerns about access to
    remote therapeutic monitoring services and supervisory
    requirements.

Guidance on How the HIPAA Rules Permit Covered
Health Care Providers and Health Plans to Use Remote Communication
Technologies for Audio-Only Telehealth

Issued June 13, 2022

• HHS Office for Civil Rights (OCR) has created new guidance for
  providers and health plans regarding the provision of audio-only
  telehealth and HIPAA compliance.
• The guidance, in FAQ format, outlines steps that covered
  entities can take to ensure that audio-only telehealth services are
  delivered in a HIPAA compliant manner after the end of the
  PHE.

HHS Announces $16.3 Million to Expand Telehealth
Care in the Title X Family Planning Program

Announced May 10, 2022

• On May 10, 2022, the United States Department of Health and
  Human Services announced that the Department will leverage American
  Rescue Plan Act funding to award $16.3 million in grants to support
  31 Title X family planning grantees in efforts to expand telehealth
  infrastructure and capacity. Funds will be available for a 12-month
  project period, starting on May 15, 2022.

Omnibus FY 2022 Spending Bill

• Temporarily extends the following Medicare telehealth
  flexibilities, which are central to enabling Medicare beneficiaries
  to access a broad range of services via telehealth from any
  location, for 151 days beginning on the first day after the end of
  the public health emergency (PHE) period:
  • Any site in the United States, including a patient’s home,
    will be considered an eligible originating site for the delivery of
    telehealth services.
  • Facility fees will not be paid to newly covered originating
    sites (e.g., patient’s home).
  • Eligible telehealth practitioners will continue to include
    qualified occupational therapists, physical therapists,
    speech-language therapists, and audiologists.
  • Federally qualified health centers and rural health clinics may
    serve as originating or distant sites for the delivery of
    telehealth services.
  • Providers will not be required to meet in-person visit
    requirements in order to deliver mental health services via video
    or audio-only visit. This applies to all sites of care, including
    Federally Qualified Health Centers and Rural Health Clinics (except
    in the case of hospice patients).
  • Coverage of telehealth services delivered via audio-only format
    will continue for specific service codes identified by Medicare as
    being eligible for delivery via audio only.
  • Practitioners will be able to use telehealth to conduct
    face-to-face encounters prior to recertification of eligibility for
    hospice care.
• Allows health savings account-eligible plans to provide
  pre-deductible coverage for telehealth services through the end of
  2022. 
• Establishes telehealth reporting requirements for the Medicare
  Payment Advisory Commission (MedPAC) and the HHS related to
  telehealth utilization under the Medicare program.

In January 2022, CMS released “CARES Act Telehealth
Expansion: Trends in Post-Discharge Follow-Up and Association with
30-Day Readmissions for Hospital Readmissions

• This report assessed the impact of telehealth on post-discharge
  follow-up and hospital readmission rates among Medicare
  beneficiaries based on claims data from April 1, 2019 –
  September 30, 2020.
• The report found that:
  • Telehealth utilization varied based on beneficiaries’
    socioeconomic characteristics, with higher utilization for
    post-discharge telehealth visits among dually eligible
    beneficiaries or those living in areas with greater social
    deprivation.
• Use of telehealth for post-discharge follow-up contributed to
  lower 30-day readmissions when compared to beneficiaries who had no
  post-discharge follow-up visit, but slightly higher readmission
  rates relative to those who had an in-person follow-up visit.

In January 2022, CMS released “Changes in Access to
Medication Treatment during COVID-19 Telehealth Expansion and
Disparities in Telehealth Use for Medicare Beneficiaries with
Opioid Use Disorder”

• This data highlight provided information on access to
  medication treatment for Medicare beneficiaries with opioid use
  disorder (OUD) as a result of COVID-19 telehealth
  expansions. 
• Data suggests that telehealth expansions improved access to
  medication treatment and contributed to lower use of inpatient
  and/or emergency department visits among beneficiaries with
  OUD.
• The study found that the majority of Medicare beneficiaries
  with OUD who used outpatient telehealth services were 65 years
  old and disabled, non-Hispanic White, dually-eligible for Medicare
  and Medicaid, and lived in urban areas.

CY2022 Telehealth Update Medicare Physician Fee
Schedule

Released on Jan. 14, 2022

• This update to the Medicare Physician Fee Schedule primarily
  covers recent expansions to mental health treatment via telehealth,
  which will activate at the end of the federal public health
  emergency (PHE) when temporary PHE waivers expire.

On December 6, CMS released updates to the State Medicaid
& CHIP Telehealth Toolkit: Policy Considerations for States
Expanding Use of Telehealth, COVID-19 Version.

• Funding will support clinical effectiveness research (CER)
  studies that explore the effectiveness of telehealth for a wide
  range of conditions and situations, such as: the effectiveness of
  mHealth technology in smoking cessation, managing chronic pain
  through online classes, and treating depression through remote yoga
  classes

On December 3, the Patient-Centered Outcomes Research Institute
(PCORI) Board of Governors approved $23.5 million to focus on
telehealth and mobile health strategies.

• Funding will support clinical effectiveness research (CER)
  studies that explore the effectiveness of telehealth for a wide
  range of conditions and situations, such as: the effectiveness of
  mHealth technology in smoking cessation, managing chronic pain
  through online classes, and treating depression through remote yoga
  classes

On November 23, HHS announced $35 million in funding for
telehealth in the Title X Family Planning Program.

• $35 million of American Rescue Plan funding will be used to
  enhance and expand the telehealth infrastructure and capacity of
  Title X family planning providers
• HHS will award 60 one-time grants to active Title X
  grantees

On November 12, CMS released a Preliminary Medicaid &
CHIP Data Snapshot.

• Includes information on services delivered from the beginning
  of the PHE through May 31, 2021, including a snapshot of services
  delivered via telehealth among Medicaid and CHIP
  beneficiaries.

On November 11, CMS finalized the Physician Fee Schedule
Rule.

• The Medicare Physician Fee Schedule (MPFS) finalizes the
  extension of coverage of certain Medicare telehealth services
  through calendar year (CY) 2023, permanently extends coverage of
  tele-behavioral health services delivered to patients in their
  homes and via audio-only technology, and finalizes changes that
  would allow for rural health centers (RHCs) and federally qualified
  health centers (FQHCs) to deliver mental health visits
  virtually.
• For more information regarding the Final CY2023 Physician
  Fee Schedule, please see our Manatt Insights  summary.

On November 9, the FCC approved 75 new projects funded under the
COVID-19 Telehealth Program.

• FCC approved 75 projects totaling $42.1 million for Round 2 of
  the COVID-19 Telehealth Program. The funding will be used to
  provide reimbursement for telecommunication services, information
  services, and connected devices necessary to enable
  telehealth.

On October 15, HHS announced the renewal of the Public
Health Emergency (PHE).

• The COVID-19 PHE will be renewed for another 90 days. It is now
  extended, through January 15, 2022.
• This update enumerates the key regulatory flexibilities and
  funding sources that are linked to the PHE, as well as key
  emergency measures with independent timelines that are not directly
  affected by the PHE renewal.

On August 26th, the FCC approved 62 new projects funded under the
COVID-19 Telehealth Program.

The projects total $41.98 million for Round 2 of the COVID-19
Telehealth Program. The funding will be used to provide
reimbursement for telecommunication services, information services,
and connected devices necessary to enable telehealth.

On August 18, the Biden Administration invested over $19M to expand telehealth
for rural and underserved communities.

The Biden Administration announced a series of key investments
— totaling $19 million — that will strengthen telehealth services
in rural and underserved communities and expand telehealth
innovation and quality nationwide. The Health Resources and
Services Administration (HRSA) will invest in the following
programs:

• Telehealth Technology-Enabled Learning Program
  (TTELP): ~$4.28M will be awarded to 9 organizations to
  develop sustainable tele-mentoring programs and networks in rural
  and medically underserved communities. This program will
  utilize to help academic medical centers train and support
  providers in rural areas treat patients with complex
  conditions.
• Telehealth Resource Centers (TRCs): $4.55M
  will be awarded to 12 regional and 2 national telehealth resource
  centers that provide information, assistance and education on
  telehealth to providers seeking to deliver care via
  telehealth.
• Evidence-Based Direct to Consumer Telehealth Network
  Program (EB TNP): ~$3.85M will be awarded to 11
  organizations to help health networks improve access to telehealth
  services and assess its effectiveness.

Telehealth Centers of Excellence (COE) Program:
$6.5M will be awarded to 2 organizations to evaluate telehealth
strategies and services to improve care for rural medically
underserved communities with high rates of chronic disease and
poverty.

On July 23rd, the Centers for Medicare and Medicaid Services
(CMS) released the proposed CY 2022 Physician
Fee Schedule proposing to extend telehealth benefits.

CMS is proposing to:

• Extend coverage of certain Medicare telehealth services through
  calendar year (CY) 2023,
• Permanently extend coverage of tele-behavioral services
  delivered to patients in their homes and via audio-only technology,
  and
• Make changes that would allow for rural health centers (RHCs)
  and federally qualified health centers (FQHCs) to deliver mental
  health visits virtually.

For more information regarding the Final CY2022 Physician
Fee Schedule, please see our Manatt Insights  summary.

On July 19th, HHS announced the renewal of the Public
Health Emergency (PHE).

The COVID-19 PHE will be renewed for another 90 days, beginning
on July 20 (the date the PHE was previously scheduled to expire)
and extending through October 18, 2021.

This update enumerates the key regulatory flexibilities and
funding sources that are linked to the PHE, as well as key
emergency measures with independent timelines that are not directly
affected by the PHE renewal.

On June 17th, the Federal Communications Commission (FCC)
Commission issued updated guidance on the Connected
Care Pilot Program.

• The FCC released further guidance on eligible services,
  competitive bidding, invoicing, and data reporting for selected
  participants, which will enable applicants selected for the Pilot
  Program to begin their projects.
• The $100 million program will support Connect Care Services
  focusing on low-income and veteran patients over a three-year
  period.
• The FCC approved 36 additional pilot projects for a total of
  over $31 million in funding.

On May 26th, the Department of Justice (DOJ) announced several criminal charges for
fraudulently using COVID-19 flexibilities, including those related
to telehealth.

• The charges are against 14 defendants for their alleged
  participation in various health care fraud schemes that exploited
  the COVID-19 pandemic and resulted in $143 million in false
  billings.
• The Center for Program Integrity, Centers for Medicare &
  Medicaid Services (CPI/CMS) separately announced it took adverse
  administrative action against over 50 medical providers for their
  involvement in health care fraud schemes relating to COVID-19.

On May 11th, the U.S. Department of Health & Human Services
(HHS) awarded funding to the Maternal, Infant,
and Early Childhood Home Visiting (MIECHV) Program.

• Appropriated by the American Rescue Plan, the $40 million in
  emergency home visiting funds awarded to states and territories
  will support the delivery of evidence-based home visiting services
  to children and families living in communities at risk for poor
  maternal and child health outcomes.
• Families unable to access home visiting services will be
  provided technology to participate in virtual home visiting.
• Funds will also be used to train home visitors on how to safely
  conduct virtual intimate partner violence screenings.

On May 6th, the Centers for Medicare & Medicaid Services
(CMS) updated the Risk Adjustment Telehealth and
Telephone Services During COVID-19 FAQs.

• The updated FAQs clarify which telehealth services and
  telephone services are valid for data submissions for the
  HHS-operated risk adjustment program.
• HHS also clarifies which telehealth service codes will be valid
  for inclusion for the 2021 benefit year HHS-operated risk
  adjustment program.

On May 20th, the U.S. Department of Health & Human Services
(HHS) announced the expansion of Pediatric
Mental Health Care Access Programs.

• Appropriated by the American Rescue Plan, the $14.2 million
  will expand pediatric mental health access by integrating
  telehealth services into pediatric primary care.
• The funds will expand the projects into new states and tribal
  areas to provide teleconsultations, training, technical assistance,
  and care coordination for pediatric primary care providers to treat
  and refer children and youth with mental health conditions and
  substance use disorder.
• Applications are due by July 6, 2021.

On May 19th the Government Accountability Office (GAO) released Medicare and Medicaid COVID-19
Program Flexibilities and Considerations for their
Continuation.

• The report includes preliminary observations from ongoing work
  related to telehealth in the Medicaid and Medicare program.
• The GAO’s preliminary analysis indicated Medicare
  fee-for-service telehealth waivers increased utilization and
  access, but full effects of the waivers are not yet known.
• Temporary state Medicaid flexibilities effects are not yet
  fully known.

On April 15th the Federal Communications Commission
(FCC) announced the second round of the
COVID-19 Telehealth funding will open April 29th.

Appropriated by the Consolidated Appropriations Act, the $250
million reimbursement program will support projects aimed at
boosting access to connected health services through better
broadband resources.

In an effort to promote transparency on how the funds are
distributed, the FCC is seeking comment on changes to the Program,
including the metrics used to evaluate applications for funding,
and how to treat applications filed in Round 1 of the program.

On April 12th the FDA lifted restrictions on telehealth
abortions during the PHE.

Healthcare providers will be allowed to prescribe
abortion-inducing medication via telehealth, without the usual
required in-person examination until the end of the PHE.

On April 12th, HHS announced the Rural Maternity and
Obstetrics Management Strategies (RMOMS) program.

The $12 million program will fund three projects over four years
to allow awardees to test models to address unmet needs for
underserved populations in rural America.

One of the focus areas for the program includes telehealth and
specialty care.

On April 5th, the U.S. Department of Agriculture (USDA)
began accepting applications for the USDA
Distance Learning & Telemedicine Grant Program (DLT).

The program makes $44.5 million available to helps rural
communities acquire the technology and training needed to connect
medical professionals with patients in rural areas.

Awards can range from $50,000 to $1 million.

Applications must be received by June 4, 2021.

On March 30th, the Centers for Medicare & Medicaid Services
(CMS) expanded Medicare coverage for certain
services delivered via telehealth.

CMS added several audiology and speech-language pathology
related services to the list of authorized telehealth services to
Medicare Part B beneficiaries during the PHE. The PHE is expected
to last through at least the end of 2021.

On February 26th, HHS Office of the Inspector General (OIG)
released a statement clarifying “telefraud” schemes
and telehealth fraud.

OIG clarified in a letter the difference between ‘telefraud’ and ‘telehealth fraud’. Nothing that
much of its focus has been in the former which generally combine
sham phone calls to fraudulently prescribe durable medical
equipment or high-cost diagnostic tests. OIG noted that it is
continuing work to ensure telehealth delivers quality, convenient
care for patients and is not compromised by fraud.

On February 25th, the USDA announced it is investing $42.3 million
in distance learning and telemedicine infrastructure.

USDA announced an investment of $42.3 million ($24 million
provided through the CARES Act) to help rural residents gain access
to health care. The funding is expected to benefit five million
rural residents.

On February 25th, the FCC approved the Emergency Broadband Benefit.

The FCC approved a new program which will provide discounts of
up to $50 per month towards broadband service for low-income
households, and up to $75 per month for households on Tribal lands.
There will also be a one-time discount of up to $100 on a computer,
laptop, or tablet.

The start date for the program has not yet been established.

On January 19th, HHS’ OIG released an updated list of its Active Work Plan
Items.

HHS OIG announced it is conducting the Audit of Home Health
Services Provided as Telehealth During the COVID-19 Public Health
Emergency and the Audits of Medicare Part B Telehealth Services
During the COVID-19 Public Health Emergency.

On January 15th, the FCC announced the first round of grants for
the Connected Care Pilot Program.

The FCC has awarded a total of $26.6 million to 15 pilot
projects with over 150 treatment sites in 11 states. The Pilot aims
to award $100 million over three years to improve broadband
connectivity in underserved parts of the country where access is
limited.

On January 15th, CMS released a Preliminary Medicaid & CHIP Data
Snapshot.

It includes information on services delivered from the beginning
of the PHE through July 31, 2020, including a snapshot of services
delivered via telehealth among Medicaid and CHIP beneficiaries.

On January 12th, HHS invested $8 million in a new Telehealth
Broadband Pilot Program.

$6.5 million was awarded to the National Telehealth Technology
Assessment Resource Center and $1.5 million was awarded to the
Telehealth-Focused Rural Health Research Center.

The program is aimed at expanding broadband connectivity in
rural parts of Alaska, Michigan, Texas, and West Virginia where
lack of resources is a major barrier to telehealth adoption.

On December 29th, the Department of Labor’s Wage and Hour
Division issued guidance for Telemedicine and Serious Health Conditions under
the Family and Medical Leave Act (FMLA).

Employees can permanently use telehealth to establish a serious
health condition that would qualify them for taking time off from
work under the FMLA.

The Wage and Hour Division (WHD) will consider telemedicine an “in-person” visit.

On December 3rd, HHS issued an amendment to the Public Readiness and Preparedness (PREP)
Act.

• The fourth amendment makes two important changes, the first of
  which implements another nationwide change regarding licensure: any
  licensed healthcare provider who is permitted to order and
  administer a Covered Countermeasure in any one state may now order
  and administer that Covered Countermeasure in any other state via
  telehealth, even if the provider is not licensed in the other state
  (subject to compliance with any rules established by the
  practitioner’s state of licensure). A provider may now provide
  qualifying COVID-19-related telehealth services to patients in
  multiple states without needing to confirm each state’s laws
  regarding practice across state lines (some of which may require
  out-of-state practitioners to register or otherwise seek
  authorization from the state).

  Second, the fourth amendment broadens the scope of protection
  afforded to all “covered persons” who manufacture, test,
  develop, distribute, administer, or use Covered Countermeasures
  (including those who provide telehealth services).

On December 1st, CMS finalized the Physician Fee Schedule Rule (previously
proposed on August 4th) which make certain Medicare telehealth
flexibilities permanent and extend others for the remainder of the
year in which the public health emergency (PHE) ends.

Note: On January 19th, CMS published clarifications to its 2021 Physician fee
schedule.

Initial Rule: CMS finalized several changes to
the Medicare telehealth covered services list.
First, CMS is adding permanent coverage for a range of services,
including group psychotherapy, low-intensity home visits, and
psychological and neuropsychological testing, among others. Second,
CMS has finalized temporary coverage for certain services through
the end of the calendar year in which the COVID-19 PHE ends,
including high-intensity home visits, emergency department visits,
specialized therapy visits, and nursing facility discharge day
management, among others. Finally, CMS is indicating which services
that have been covered on a temporary basis during the PHE it will
not to cover on a permanent basis once the PHE ends. This includes
services such as telephonic evaluation and management services,
initial nursing facility visits, radiation treatment management
services, and new patient home visits, among others. Notably, after
significant public comment supporting the addition of more services
to the list of services covered through the calendar year in which
the PHE ends, CMS included extended coverage for several additional
services that it had proposed ending coverage for at the end of the
PHE.

Prior to the PHE, given statutory restrictions that telehealth
services must be delivered via a “telecommunications
system,” which CMS has long-interpreted to preclude audio-only
technology, CMS only covered certain audio-only services defined as
communication technology-based services (CTBS), which are not
considered Medicare telehealth services. During the PHE,
recognizing that in-person visits posed a high risk of infection
exposure and that not all providers and patients had access to
video technology, CMS established temporary coverage for audio-only
telephone (E/M) visits (CPT codes 99441-3). CMS is finalizing that
at the end of the PHE, coverage for these audio-only telephone
(E/M) visits will end given the statutory restrictions on “telecommunications systems.” However, recognizing that
audio-only visits could still be beneficial, for CY 2021, CMS is
establishing on an interim basis a HCPCS code, G2252, for CTBS
audio-only services of 11-20 minutes of medical discussion. This
code supplements existing code G2012 which is a CTBS audio-only
service of 5-10 minutes of medical discussion.

In addition to the changes to the telehealth covered services
list, CMS is finalizing that the 30-day frequency limit for
subsequent nursing facility visits provided via telehealth be
revised to a 14-day frequency limit. CMS is also finalizing that
additional types of providers—including licensed clinical
social workers, clinical psychologists, physical therapists,
occupational therapists, and speech-language pathologists—be
permitted to bill for brief online assessment and management
services, virtual check-ins, and remote evaluations and has added
new codes for these services.

On a temporary basis, CMS finalized a policy to allow for
virtual supervision using “interactive audio/visual real-time
communications technology” (i.e. two-way live video), by
revising the definition of “direct supervision” to
include virtual presence. This will allow “incident to”
services to be provided if furnished under the supervision of a
virtually present physician or nonphysician practitioner in order
to reduce infection exposure risk. CMS will continue allowing
virtual supervision through the later of the end of the calendar
year in which the PHE ends or December 31, 2021.

CMS finalized as proposed several changes to coverage
of remote physiologic monitoring (RPM)
services. CMS finalized that at the conclusion of the PHE,
it will once again require that practitioners have an established
patient relationship in order to initiate RPM services and that 16
days of data for each 30 days must be collected in order to meet
the requirements of CPT codes 99453 and 99454. CMS also finalized
that practitioners may furnish RPM services to beneficiaries with
acute conditions—previously coverage had been limited to
beneficiaries with chronic conditions. In addition, CMS finalized
that consent may be obtained at the time the RPM service is
furnished; that auxiliary personnel (including contracted
employees) may furnish certain RPM device setup and supply
services; that data from the RPM device must be automatically
collected and transmitted rather than self-reported; and that for
the purposes of discussing RPM results, “interactive
communication” includes real-time synchronous, two-way
interaction such as video or telephone.

In addition, Medicare Diabetes and Prevention Program (MDPP)
providers who use telehealth will continue to be reimbursed through
Medicare during the remainder of the COVID-19 PHE and any future
applicable 1135 waiver event when in-person care delivery is
disrupted. Coverage for virtual-only DPPs will not continue after
the PHE.

January 2021 Update: Clarifies that the
20-minutes of intra-service work associated with CPT codes 99457
and 99458 includes a practitioner’s time engaged in “interactive communication” and time engaged in
non-face-to-face care management services during a calendar
month.

Additionally, only one practitioner can bill CPT codes 99453 and
99454 during a 30-day period and only when at least 16 days of data
have been collected on at least one medical device.

For more information regarding the Final CY2021 Physician
Fee Schedule, please see our Manatt Insights summary.

On November 20th, HHS published two rules that finalize reforms to the
regulatory framework that governs fraud and abuse in Medicare and
Medicaid programs.

HHS’s newly finalized regulations remove historical barriers
to collaboration between providers and health tech companies on
digital health initiatives, including those that promote care
coordination and drive value-based efficiencies.

Specifically, the regulations include several new and modified “safe harbor” arrangements that would allow providers and
health IT companies to collaborate on initiatives that would
previously have created risks under the Anti-Kickback Statute.
Critically, these safe harbors allow parties to exchange health IT
technology and other in-kind benefits at less than fair market
value, as long as certain requirements are met. Depending on the
circumstances, the recipient may be able to receive the benefit for
free, or may be required to contribute at least 15% of the total
cost.

If a given arrangement meets all the criteria for a safe harbor,
then the parties are shielded from liability even if they are
exchanging “remuneration” within the meaning of the
Anti-Kickback Statute. Because violations of the Anti-Kickback
Statute can result in substantial civil and criminal penalties,
providers often avoid arrangements that do not fit squarely within
a safe harbor.

In early November, CMS published a new final rule that enables health home
agencies (HHAs) to use telecommunications technology or audio-only
services.

Services provided to patients must be included in the plan of
care and not substituted for or considered a home visit for
eligibility or payment purposes.

On October 14, CMS expanded the list of telehealth services Medicare
Fee-For-Service will pay for during the PHE.

CMS added 11 new services to the Medicare telehealth service
list, adding to the over 80 additional eligible telehealth services
outlined in the May 1 COVID-19 IFC. The new telehealth services include
certain neurostimulator analysis and programming services, and
cardiac and pulmonary rehabilitation services.

On October 14, CMS released a Preliminary Medicaid and CHIP Data Snapshot to
provide information on telehealth utilization during the PHE.

This data shows more than 34.5 million services were delivered
to Medicaid and CHIP beneficiaries via telehealth between March and
June of this year—an increase of 2,600% when compared to the
same period in 2019. Additionally, CMS updated its State Medicaid & CHIP Telehealth Toolkit:
Policy Considerations for States Expanding Use of Telehealth,
COVID-19 Version to help providers and other stakeholders
understand which policies are temporary or permanent, and to
communicate telehealth access and utilization strategies to
providers.

On August 4th, CMS released a proposed Physician Fee Schedule Rule which would
make certain Medicare telehealth flexibilities permanent and extend
others for the remainder of the year in which the public health
emergency (PHE) ends.

For CY 2021, CMS is proposing several changes to the Medicare
telehealth covered services list. First, CMS is proposing to add
permanent coverage for a range of services, including group
psychotherapy, low-intensity home visits, and psychological and
neuropsychological testing, among others. Second, CMS is proposing
to add extended temporary coverage for certain services through the
end of the calendar year in which the COVID-19 PHE ends, including
high intensity home visits, low-intensity emergency department
visits, and nursing facility discharge day management, among
others. Finally, CMS is indicating which services that have been
covered on a temporary basis during the PHE it does not propose to
cover on a permanent basis once the PHE ends. This includes a wide
range of more than 70 services such as telephonic evaluation and
management services, nursing facility visits, specialized therapy
services, critical care services, end stage renal disease
dialysis-related services, and radiation management services, among
others.

For a summary of the proposed Physician Fee schedule Rule,
please see the August 7 Manatt Insights
summary.

On May 1, CMS released a second IFR with comment period (IFC), “Medicare and Medicaid Programs, Basic Health Program, and
Exchanges; Additional Policy and Regulatory Revisions in Response
to the COVID-19 Public Health Emergency and Delay of Certain
Reporting Requirements for the Skilled Nursing Facility Quality
Reporting Program,” outlining further flexibilities in
Medicare, Medicaid, and health insurance markets as a result of
COVID-19.

• Section D. Opioid Treatment Programs
  (OTPs) – Furnishing Periodic Assessments via Communication
  Technology (42 CFR 410.67(b)(3) and (4)): Temporary change to allow
  periodic assessments of individuals treated at OTPs to occur during
  the PHE by two-way interactive audio-video or audio-only
  communication
• Section N. Payment for Audio-Only
  Telephone Evaluation and Management Services: Temporary increase in
  the reimbursement rates for telephonic care
• Section AA. Updating the Medicare
  Telehealth List (42 CFR 410.78(f)): Temporary change to remove
  Medicare regulations that require amendments to the list of covered
  telehealth services be made through the physician fee schedule
  (PFS) rulemaking process and allow changes to be made to the list
  of covered telehealth services through subregulatory guidance
  only

For a summary of the second IFR, please see the 
May 5 Manatt Insights
summary.

On April 17, CMS released Frequently Asked Questions (FAQs) on Medicare
Fee-for-Service Billing and highlighted several changes to
RHC and FQHC requirements and payments.

New Payment for Telehealth Services (real-time, audio
visual):

• Section 3704 of the Coronavirus Aid, Relief, and Economic
  Security (CARES) Act authorizes RHCs and FQHCs to provide distant
  site telehealth services to Medicare beneficiaries. Services can be
  provided by any health practitioner working for the RHC or the FQHC
  as long as the service is within their scope; there is no
  restriction on locations where the provider may be to furnish
  telehealth services.
• FQHCs and RHCs are paid a flat fee of $92 when they serve as
  the distant site provider for a telehealth visit.
• CMS will pay for all reasonable costs for any service related
  to COVID-19 testing, including relevant telehealth services. RHCs
  and FQHCs must waive the collection of co-insurance for COVID-19
  testing-related services.

Expansion of Virtual Communication Services (telephone, online
patient communication):

• Virtual communication services now include online digital
  evaluation and management services. CPT codes 99421–23 have
  been added for non-face-to-face, patient-initiated, digital
  communications using a secure patient portal.

For more information on Expanded Telehealth Reimbursement
for FQHCs and RHCs, see our  June 9 Manatt
newsletter.

On April 2, CMS issued an informational bulletin regarding Medicaid
coverage of telehealth services to treat substance use disorders
(SUDs)—one of many guidance documents required by the October
2018-enacted Substance Use Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities (SUPPORT)
Act.

This guidance provides states options for federal reimbursement
for “services and treatment for SUD under Medicaid delivered
via telehealth, including assessment, medication-assisted
treatment, counseling, medication management, and medication
adherence with prescribed medication regimes.”

For a summary of this bulletin, please see the  April 6 Manatt Insights
summary.

On March 30, CMS released an interim final rule (IFR) outlining new
flexibilities to preexisting Medicare and Medicaid payment policies
in the midst of the COVID-19 public health emergency (also,
PHE).

These provisions include adding over 80 additional eligible
telehealth services, giving providers flexibility in waiving
copays, expanding the list of eligible types of providers who can
deliver telehealth services, introducing new coverage for remote
patient monitoring services, reducing frequency limitations on
telehealth utilization, and allowing telephonic and secure
messaging services to be delivered to both new and established
patients. The provisions listed in this rule are effective March
31, with applicability beginning on March 1.

For more information on the IFR, see our April 9 Manatt newsletter.

On March 18, the HHS and the Office for Civil Rights (OCR)
issued a public notice stating that OCR will not
impose penalties for noncompliance with regulatory requirements
under the HIPAA rules “against covered health care providers
in connection with the good faith provision of telehealth during
the COVID-19 nationwide public health emergency.”

This will allow providers to communicate with patients through
telehealth services and remote communications technologies during
the COVID-19 national emergency. Providers may use any
non-public-facing remote communication product that is available to
communicate to patients; these applications can include Apple
FaceTime, Facebook Messenger video chat, Google Hangouts video,
Zoom, and Skype.

For more information on our HIPAA summary, see our April 23 Manatt newsletter.

On March 10, CMS introduced significant new
flexibilities for Medicare Advantage (MA) and Part D plans
to waive cost-sharing for testing and treatment of COVID-19,
including emergency room and telehealth visits during the
crisis.

MA plans are required to:

• Cover Medicare Parts A and B services and supplemental Part C
  plan benefits furnished at noncontracted facilities; this means
  that facilities that furnish covered A/B benefits must have
  participation agreements with Medicare.
• Waive, in full, requirements for gatekeeper referrals where
  applicable.
• Provide the same cost-sharing for the enrollee as if the
  service or benefit had been furnished at a plan-contracted
  facility.
• Make changes that benefit the enrollee effective immediately
  without the 30-day notification requirement at 42 §
  422.111(d)(3). Such changes could include reductions in
  cost-sharing and waiving of prior authorizations.

For more information on Medicare changes, see our 
March 17 Manatt
newsletter.

In March 2021, MedPAC issued a report entitled “Medicare
Payment Policy.”

The report included a chapter that proposes how Medicare may
cover telehealth services for a limited duration of time after the
end of the COVID-19 PHE; the commission noted that more time and
data are needed prior to recommending permanent coverage and
reimbursement changes. Specifically, MedPAC proposes temporarily
continuing the following flexibilities for a limited duration of
time after the end of the PHE:

• Providing reimbursement for specific telehealth services to all
  beneficiaries, regardless of their location;
• Covering certain telehealth services (in addition to those
  covered prior to the PHS), if there is potential clinical benefit;
  and,
• Covering certain telehealth services delivered via audio-only
  modalities if there is potential clinical benefit.

After the PHE ends, MedPAC proposes: 1) returning to the fee
schedule’s facility rate for telehealth services and collecting
data on the cost to deliver telehealth services; and, 2)
reintroducing cost sharing for telehealth services. In addition,
MedPAC suggests implementing the following safeguards to prevent
unnecessary spending and fraud:

• Requiring clinicians to have an in-person visits with a patient
  prior to ordering high-cost durable medical equipment or laboratory
  tests;
• Monitoring outlier clinicians who bill more telehealth services
  per beneficiary relative to other clinicians; and,
• Prohibiting “incident to” billing for telehealth
  services provided by any clinician who can bill Medicare
  directly.

Notably, the path forward proposed by MedPAC in this report does
not ensure long-term permanent coverage for telehealth for all
Medicare members regardless of where they are located (e.g.,
patients in non-rural areas, patients located in their home), or
for telehealth services delivered via audio-only modalities.

On March 5th, the House Energy & Commerce Health
Subcommittee held a hearing, The Future of Telehealth: How
COVID-19 is Changing the Delivery of Virtual Care to discuss the
future of telehealth in Medicare.

Members of the sub-committee were not aligned on a timeline for
adopting permanent telehealth reimbursement policies in Medicare,
but generally voiced support for continuing many of the
flexibilities that have been implemented during the public health
emergency. While acknowledging the value that telehealth has
demonstrated during the pandemic, many members continue to express
long-standing concerns about the potential for increased fraud and
abuse of telehealth services.

On January 14th, MedPAC hosted a meeting to discuss whether and
how to permanently expand telehealth in fee-for-service
Medicare.

The Commissioners largely supported the policy options outlined
by MedPAC staff to maintain on a permanent basis some of the
temporary policy changes made during the PHE. Several commissioners
noted that given the pace of change with respect to telehealth
adoption during the COVID-19 pandemic and the lack of concrete
evidence to support permanent expansion of certain policies, they
would be more comfortable supporting expansion on a more
time-limited basis (e.g. 1-2 years) than permanently. In addition,
the Commissioners identified several areas that will require
continued discussion in order to balance access, cost and quality
imperatives.

The policy options will be incorporated into MedPAC’s
upcoming report to Congress expected in March 2021.

For more information regarding the MedPAC meeting, please
see our Manatt Insights  Newsletter.

On November 9, MedPac issued a report on the expansion of
telehealth in Medicare.

The presentation highlights permanent (post-PHE) policy options
that CMS may consider when expanding Medicare telehealth
coverage.

For more information, please see our Manatt  Newsletter.

S. 4965: A bill to amend title XCIII of the Social Security Act
to remove in-person requirements under Medicare for mental health
services furnished through telehealth and telecommunications
technology.

Introduced September 27, 2022

• This bill would permanently remove in-person requirements for
  mental health services delivered via telehealth to Medicare
  beneficiaries after the end of the COVID-19 public health
  emergency.

H.R. 8976: Protecting Reproductive Freedom Act

Introduced September 22, 2022

• This bill would prevent states from placing restrictions on the
  prescription of mifepristone and misoprostol, two abortifacient
  medications, via telehealth.

S. 4747: Investing in Kids’ Mental
Health Now Act of 2022

Introduced August 2, 2022

• This bill would direct the Secretary of Health and Human
  Services to provide states with guidance to improve the
  availability of mental, emotional, and behavioral telehealth
  services covered by Medicaid State Plans.

HR.R. 8650 / S. 4723: Let Doctors Provide Reproductive
Health Care Act

Introduced August 2, 2022

• This bill would prevent states and other entities from placing
  restrictions on the provision of reproductive health care services,
  including abortion services, through telehealth.

H.R. 8588: Fair Care Act of 2022

Introduced July 28, 2022

• This bill would:
  • Expand Medicare coverage to include remote patient monitoring
    and additional telehealth services;
  • Allow the Secretary of Health and Human Services to waive
    Medicare telehealth requirements, including those related to
    originating sites, technology, and allowed services, to reduce
    spending or improve access to services in high-needs areas;
  • Remove Medicare restrictions on originating sites for mental
    health services and emergency medical care provided through
    telehealth;
  • Remove Medicare restrictions on originating/distant sites for
    federally qualified health centers, rural health clinics, and
    facilities operated by the Indian Health Service;
  • Allow under Medicare the use of telehealth to conduct
    face-to-face encounters prior to recertification of eligibility for
    hospice care;
  • Direct MedPAC to conduct a study on the use of telehealth in
    the home by Medicare beneficiaries; and,
  • Allow the Secretary of Health and Human Services to test models
    of telehealth use and delivery under Medicare.

H.R. 4040: Advancing Telehealth Beyond
COVID-19 Act of 2022

Engrossed July 27, 2022

• This legislation seeks to extend many of the key Medicare
  telehealth flexibilities associated with the COVID-19 public health
  emergency (PHE) included in the Consolidated Appropriations Act,
  2022 (CAA), enacted in March (for more on the CAA, see the Manatt
  on Health analysis). The House-passed legislation would further
  extend the following flexibilities through December 31, 2024:
  • Removing geographic requirements and expanding originating
    sites for telehealth services to enable beneficiaries in both rural
    and non-rural communities to receive telehealth services from their
    home or any other location;
  • Expanding the list of telehealth eligible providers include
    qualified occupational therapists, physical therapists,
    speech-language therapists, and audiologists.
  • Delaying in-person visit requirements for the delivery of
    mental health services via telehealth, including those furnished by
    rural health clinics and federally qualified health clinics;
  • Including audio-only as a covered telehealth modality;
    and,
  • Allowing the use of telehealth to conduct a face-to-face
    encounter prior to recertification of eligibility for hospice
    care.

H.R. 8489: Greater Access to Telehealth
Act

Introduced July 26, 2022

• This bill would:
  • Remove geographic requirements and expand originating sites for
    telehealth services;
  • Expand practitioners eligibility to furnish telehealth services
    through December 31, 2026;
  • Extend telehealth services for federally qualified Health
    Centers and Rural Health Clinics to end before December 31,
    2026;
  • Delay the in-person requirements under Medicare for mental
    health services furnished through telehealth and telecommunications
    technology;
  • Allow for the furnishing of Audio-Only telehealth services
    through December 31, 2026; and,
  • Allow the use of telehealth to conduct face-to-face encounter
    prior to recertification of eligibility for hospice care during the
    emergency period through December 31, 2026.

H.R. 8506: To amend title XVIII of the
Social Security Act to extend telehealth services for federally
qualified health centers and rural health clinics.

Introduced July 26, 2022

• This bill would permanently extend Medicare coverage for
  telehealth services provided by federally qualified health centers
  and rural health clinics beyond the end of the COVID-19 public
  health emergency.

H.R. 8505: To amend title XVIII of the
Social Security Act to permit the use of telehealth for purposes of
recertification of eligibility for hospice care.

Introduced July 26, 2022

• This bill would allow under Medicare the use of telehealth to
  conduct face-to-face encounters prior to recertification of
  eligibility for hospice care.

H.R. 8515: To amend title XVIII of the
Social Security Act to allow for the furnishing of audio-only
telehealth services.

Introduced July 26, 2022

• This bill would permanently extend Medicare coverage of
  audio-only telehealth services beyond the end of the COVID-19
  public health emergency.

H.R. 8493: To amend title XVIII of the
Social Security Act to remove geographic requirements and expand
originating sites for telehealth services.

Introduced July 26, 2022

• This bill would permanently expand Medicare flexibilities
  regarding originating sites and geographic requirements beyond the
  end of the COVID-19 public health emergency.

H.R. 8491:To amend title XVIII of the Social
Security Act to expand eligible practitioners to furnish telehealth
services.

Introduced July 26, 2022

• This bill would permanently allow occupational therapists,
  physical therapists, speech-language pathologists, and audiologists
  to practice via telehealth beyond the end of the COVID-19 public
  health emergency.

H.R. 8497: To amend title XVIII of the
Social Security Act to remove in-person requirements under Medicare
for mental health services furnished through telehealth and
telecommunications technology.

Introduced July 26, 2022

• This bill would permanently remove in-person requirements for
  telehealth services provided to Medicare beneficiaries beyond the
  end of the COVID-19 public health emergency.

H.R. 8405 / S. 4467: Protecting Access to Medication
Abortion Act

H.R. 8405 Introduced July 18, 2022

S.4467 Introduced June 23, 2022

• This bill would protect access to medication abortion via
  telehealth and certified pharmacies, including mail-order
  pharmacies, by codifying current the current FDA mifepristone Risk
  Evaluation and Mitigation Strategy (REMS).

H.R. 8296: Women’s Health Protection
Act of 2022

Engrossed July 15, 2022

• This bill would limit government restrictions on the provision
  of abortion services, including medication abortion services
  delivered via telehealth.

H.R.7900: National Defense Authorization
Act for Fiscal Year 2023

Engrossed July 14, 2022

• This bill will expand access to behavioral health care under
  the military health system using telehealth.
• This bill will also introduce the Telehealth Pilot Program on
  Sexual Health, which would:
  • Direct the Defense Health Agency to carry out a five-year
    telehealth pilot program for sexual health for members of the
    uniformed services on active duty enrolled in TRICARE Prime;
    and,
  • Extend telehealth screenings and assessment of the
    participant’s sexual health, comprehensive counseling on a full
    range of methods of contraception, diagnostic services,
    prescription medications as appropriate, laboratory diagnostic
    services, and follow up remote appointments.

S. 2938: Bipartisan Safer Communities
Act

Passed June 25, 2022

• This bill would direct the Secretary of Health and Human
  Services to publish guidance for states to improve telehealth
  accessibility under Medicaid and CHIP.

S. 4498: Kids’ Mental Health
Improvement Act

Introduced June 23, 2022

• This bill would direct the Secretary of Health and Human
  Services to publish guidance for states to improve the availability
  of telehealth services covered by Medicaid State Plans.

S. 4486: Health Equity and Accountability Act
of 2022

Introduced June 23, 2022

• This bill would direct the Secretary of Health and Human
  Services to:
  • Work with state representatives, physician and non-physician
    health care practitioners, and advocates to promote telehealth
    provisions that allow practitioners to provide services across
    state lines; and,
  • Publish guidance for states to improve telehealth accessibility
    under Medicaid and CHIP.
• This bill would also:
  • Direct the Comptroller General to report to Congress on the use
    of telehealth by State Medicaid programs to improve maternity care
    access;
  • Direct the Secretary of Veterans Affairs to develop pilot
    projects to evaluate the cost-effectiveness of telehealth and how
    it impacts health outcomes in rural areas and those with medically
    underserved populations; and,
• Amend the Social Security Act to remove restrictions on and
  allow the home and other locations to be considered geographic
  originating sites for telehealth.

H.R. 8169: Rural Telehealth Access Task
Force Act

Introduced June 22, 2022

• This bill would create a Rural Telehealth Access Task Force for
  the purpose of improving access to broadband internet and the use
  of telehealth services in rural areas.

H.R. 8180: Undertaking Needed Investments
in Therapy, Education, and De-Escalation Act of 2022

Introduced June 22, 2022

• This bill would extend authorized emergency telehealth services
  two years following the end of the COVID-19 emergency.

H.R. 7878: Kidney Health Connect Act of 2022

Introduced May 24, 2022

• This bill would allow for renal dialysis facilities to serve as
  originating sites for telehealth services under the Medicare
  program.

H.R.7876: Connecting Rural Telehealth to the Future
Act

Introduced May 24, 2022

• This bill would extend Medicare telehealth flexibilities
  implemented during the COVID-19 Public Health Emergency and would:
  • Extend all temporary telehealth provisions included in the
    FY2022 omnibus through December 31, 2024
  • Permanently allow the use of audio-only telehealth
    flexibilities for two years
• Permanently allow audio-only technologies when providers are
  evaluating or managing patient health or providing behavioral
  health services

H.R. 7666: Restoring Hope for Mental
Health and Well-Being Act of 2022

Introduced May 6, 2022

• This bill would provide grant support to schools and emergency
  departments to establish or expand existing pediatric mental health
  care telehealth access programs.

H.R. 7585: Health Equity and
Accountability Act of 2022

Introduced April 26, 2022

• This bill would direct the Secretary of Health and Human
  Services to:
  • Work with state representatives, physician and non-physician
    health care practitioners, and advocates to promote telehealth
    provisions that allow practitioners to provide services across
    state lines; and,
  • Publish guidance for states to improve telehealth accessibility
    under Medicaid and CHIP.
• This bill would also:
  • Direct the Comptroller General to report to Congress on the use
    of telehealth by State Medicaid programs to improve maternity care
    access;
  • Direct the Secretary of Veterans Affairs to develop pilot
    projects to evaluate the cost-effectiveness of telehealth and how
    it impacts health outcomes in rural areas and those with medically
    underserved populations; and,
  • Amend the Social Security Act to remove restrictions on and
    allow the home and other locations to be considered geographic
    originating sites for telehealth.

H.R. 7573: Telehealth Extension and
Evaluation Act

Introduced April 26, 2022

• This bill aims to extend certain telehealth flexibilities
  enabled by Medicare for two years following the COVID-19 pandemic.
  It would allow:
  • Limitation on payment for high-cost medical equipment via
    telehealth
  • Limitation on payment for high-cost laboratory tests via
    telehealth
  • A telehealth service provided by a Federally Qualified Health
    Center or Rural Clinic to be reimbursed as an outpatient
    service
  • Telehealth flexibilities at critical access hospitals,
    including payment for telehealth services that are furnished via a
    telecommunications system
  • The use of telehealth for the dispensing of controlled
    substances by means of the internet
• This act would also fund a study on the effects of changes to
  telehealth under the Medicare and Medicaid programs during the
  COVID–19 emergency.

S. 4132: Women’s Health Protection
Act of 2022

Introduced May 4, 2022

(Note: Failed to pass the Senate on May 11, 2022)

• This bill would protect a provider’s ability to perform and
  a patients ability to receive abortion services, including via
  telehealth.

H.R. 7097: Telehealth Treatment and Technology
Act of 2022

Introduced on March 16, 2022

• This bill would enable appropriately licensed health care
  professionals to practice within the scope of their license,
  certification, or authorization via telehealth in any State, the
  District of Columbia, or any territory or possession of the United
  States regardless of where they obtained their license or where
  they are located.
• Under this bill, health care professionals would:
  • Be able to deliver telehealth services to any patient
    regardless of whether they have a prior treatment relationship with
    the patient, as long as a new relationship may be established only
    via a written acknowledgment or synchronous technology.
  • Be required to complete the following steps before initiating
    services via telehealth:
    • Verify the patient’s identity;
    • Obtain oral or written acknowledgement from the patient (or
      patient’s legal representative to perform telehealth services;
      and,

• Obtain or confirm an alternative method of connecting with the
  patient if the telehealth technology connection fails.

2021 CONG US S 3593

Introduced Feb. 8 2022

• This bill would extend certain telehealth services covered by
  Medicare for an additional two years after the last day of the
  public health emergency period, and initiate a study to evaluate
  the impact of telehealth services on Medicare beneficiaries.

Telehealth Extension and Evaluation Act

Introduced on Feb. 7, 2022

• This bill would allow Centers for Medicare and Medicaid
  Services (CMS) to extend Medicare payments for a variety of
  telehealth services, and commission a study on the impact of the
  pandemic telehealth flexibilities.

S. 150: Ensuring Parity in MA for Audio-Only
Telehealth Act of 2021

Reintroduced Feb. 2, 2021

• Requires Medicare to factor certain qualifying diagnosis
  obtained through telehealth during the PHE when setting risk
  adjustment payments in Medicare Advantage plans in future
  years
• Requires any payment made for a telehealth service during the
  PHE under the new risk adjust to be the same as the in-person
  rate

S. 155: Equal Access to Care Act

Reintroduced Feb. 2, 2021

• Allows licensed health care providers to provide health care
  services in a secondary state under the rules and regulations that
  govern them in their primary state
• If passed, the bill would remain in effect for up to 180 days
  after the PHE ends

S. 340: Telehealth Response for E-prescribing
Addiction Therapy Services (TREATS) Act

Reintroduced Feb. 22, 2021

• Extends ability to prescribe Medication Assisted Therapies
  (MAT) and other necessary drugs without needing a prior in-person
  visit
• Enables Medicare to cover audio-only telehealth services for
  substance use disorder services in a case where a provider has
  already conducted an in-person or telehealth evaluation

S. 368: Telehealth Modernization Act

Reintroduced Feb. 23, 2021

• Remove geographic barriers for originating site
• Require telehealth services to be covered by Medicare at FQHCs
  and RHCs
• Direct HHS to permanently expand the telehealth services
  covered by Medicare during the PHE
• Require Medicare to cover additional telehealth services for
  hospice and home dialysis care

S. 445: Mainstreaming Addiction Treatment Act
of 2021

Reintroduced Feb. 25, 2021

• Allows community health practitioners to dispense narcotic
  drugs in schedule III, IV, or V, to an individual for maintenance
  treatment or detoxification through the practice of
  telemedicine

S. 620: KEEP Telehealth Options Act of
2021

Reintroduced Mar. 9, 2021

• Directs the HHS Secretary and the Comptroller General of the
  United States to conduct studies and report to Congress on actions
  taken to expand access to telehealth services under the Medicare,
  Medicaid, and Children’s Health Insurance programs during the
  COVID-19 emergency

S. 660: Tele-Mental Health Improvement Act

Introduced March 10, 2021

• A bill to require parity in the coverage of mental health and
  substance use disorder services provided to enrollees in private
  insurance plans, whether such services are provided in-person or
  through telehealth.

S. 801: Connected MOM Act

Introduced Mar. 17, 2021

• Requires Health and Human Services to identify and address
  barriers to coverage of remote physiologic devices under State
  Medicaid programs to improve maternal and child health outcomes for
  pregnant and postpartum women

S. 1309: Home Health Emergency Access to
Telehealth (HEAT) Act

Introduced Apr. 28, 2021

• Gives the Centers for Medicare & Medicaid Services (CMS)
  the authority to issues waivers to allow payments for home health
  services furnished via visual or audio telecommunication systems
  during an emergency period

S. 1704/H.R.5981: Telehealth Expansion Act

S. 1704 introduced May 19, 2021

H.R. 5981 introduced November 15, 2021

• Permanently allows first-dollar coverage of virtual care under
  high-deductible health plans (HDHPs)
• Allows access to a wider variety of telehealth services without
  first meeting a deductible

S. 2061: Telemental Healthcare Access Act of
2021

Introduced June 15, 2021

• Expands access to telemental health services by removing
  statutory requirement that Medicare beneficiaries be seen in-person
  within six months of being treated for mental health services
  through telehealth

S. 2097: Telehealth Health Savings Account
(HSA) Act

Introduced June 17, 2021

• Allow employers to offer high-deductible health plans that
  include telehealth services without limiting employees’ ability
  to use health savings accounts.

S. 2110: Increasing Rural Telehealth Access
Act of 2021

Introduced June 17, 2021

• Expands access to health care by improving remote patient
  monitoring technology for individuals in rural areas

S. 2111: Audio-Only Telehealth for Emergencies
Act

Introduced June 17, 2021

• Allow physicians delivering care during a public health
  emergency or a major disaster declaration to receive the same
  compensation for audio-only telehealth visits as they would receive
  for in-person appointments

S. 2173: Promoting Responsible and Effective
Virtual Experiences through Novel Technology to Deliver Improved
Access and Better Engagement with Tested and Evidence-based
Strategies (PREVENT DIABETES) Act

Reintroduced June 22, 2021

• Enables Medicare coverage of connected health services in the
  MDPP (Medicare Diabetes Prevention Program)

S. 2197: Rural and Fronteir Telehealth
Expansion Act

Introduced June 23, 2021

• Amends title XIX of the Social Security Act to increase the
  Federal medical assistance percentage for States that provide
  Medicaid coverage for telehealth services.

H.R. 318: Safe Testing at Residence Telehealth
Act of 2021

Reintroduced Jan. 13, 2021

• Provides Medicare payment of telehealth assessments provided in
  relation to COVID-19
• Requires Medicare payment of COVID-19 blood tests ordered via
  telehealth during the PHE
• Requires practitioners to report demographic data with respects
  to tests and services ordered via telehealth

H.R. 341: Ensuring Telehealth Expansion Act of
2021

Reintroduced Jan. 15, 2021

• Extend telehealth provisions in the CARES Act through December
  31, 2025
• Require payment parity for telehealth services furnished at
  FQHCs and RHCs
• Allows the use of telehealth to conduct a face-to-face
  encounters for recertification of eligibility for hospice care

H.R. 366: Protecting Access to Post-COVID-19
Telehealth Act of 2021

Reintroduced Jan. 19, 2021

• Eliminate most geographic and originating site restrictions in
  Medicare and establish the patient’s home as an eligible
  distant site
• Authorize CMS to continue reimbursement for telehealth for 90
  days beyond the end of the PHE
• Allow HHS to expand telehealth in Medicare during all future
  emergencies
• Require a study on the use of telehealth during COVID-19

H.R. 596: The Advancing Connectivity During
the Coronavirus to Ensure Support for Seniors (ACCESS) Act

Reintroduced Jan. 28, 2021

• Allows HHS Telehealth Resource Center to allocate $50 million
  to expand Medicare and Medicaid coverage of telehealth services in
  nursing facilities
• Creates a grant for nursing homes to offer virtual visits

H.R. 708: Temporary Reciprocity to Ensure
Access to Treatment Act (TREAT)

Reintroduced Jan. 19, 2021

• Note: H.R. 708 is nearly identical in scope to the Equal Access
  to Care Act (see S.155 above), with the exception that H.R. 708
  would grant HHS authority to unilaterally create similar temporary
  licensure regulations in the event of future public health or other
  emergencies

H.R. 726: COVID–19 Testing, Reaching,
And Contacting Everyone (TRACE) Act

Introduced Feb. 2, 2021

• Authorizes the Secretary of Health and Human Services to award
  grants to eligible entities to conduct diagnostic testing for
  COVID-19, and related activities

H.R. 937: Tech To Save Moms Act

Introduced Feb. 8, 2021

• Amends title XI of the Social Security Act to integrate
  telehealth models in maternity care services, and for other
  purposes

H.R. 1149: Creating Opportunities Now for
Necessary and Effective Care Technologies (CONNECT) for Health Act
of 2021
Reintroduced for fourth time on Apr. 29, 2021 with overwhelming
support (sponsored by 50 bi-partisan senators)

• Permanently removes the Medicare geographic restrictions and
  allow the home to be an originating site for mental telehealth
  services
• Remove the geographic and distant site restrictions for
  federally qualified health centers (FQHCs) and rural health clinics
  (RHCs)
• Allows the HHS secretary to waive telehealth restrictions
• Encourages CMS Innovation Center to test more payment models
  that include telehealth

H.R. 1406: COVID-19 Emergency Telehealth
Impact Reporting Act

Reintroduced Feb. 26, 2021

• Require HHS to study telehealth use during the pandemic and
  impact on care delivery

H.R. 1397: Telehealth Improvement for Kids’
Essential Services (TIKES) Act 

Reintroduced Feb. 26, 2021

• Provide states with guidance and strategies to increase
  telehealth access for Medicaid and Children’s Health Insurance
  Program (CHIP) populations. Guidance and strategies will include:
  • Delivery of covered telehealth services
  • Recommended voluntary billing codes, modifiers, and
    place-of-service designations
  • Simplifications or alignment of provider licensing,
    credentialing, and enrollment
  • Existing strategies States can use to integrate telehealth into
    value-based health care models
  • Examples of States that have used waivers under the Medicaid
    program to test expanded access to telehealth
• Require a Medicaid and CHIP Payment and Access Commission
  (MACPAC) study examining data and information on the impact of
  telehealth on the Medicaid population
• Require a Government Accountability Office (GAO) study
  reviewing coordination among federal agency telehealth policies and
  examine opportunities for better collaboration, as well as
  opportunities for telehealth expansion into early care and
  education settings

H.R. 2166: Ensuring Parity in MA and PACE for
Audio-Only Telehealth Act

Bill text not yet available at the time of publication.
Introduced Mar. 23, 2021

• Requires the inclusion of certain audio-only diagnoses in the
  determination of risk adjustment for Medicare Advantage plans and
  PACE programs, and for other purposes.

H.R. 2168: Expanded Telehealth Access Act

Bill text not yet available at the time of publication.
Introduced Mar. 23, 2021

• Allows on a permanent basis the HHS Secretary to expand the
  list of healthcare providers who would be able to use the connected
  health program including: physical and occupational therapists,
  audiologists, and speech and language pathologists

H.R. 2228: Rural Behavioral Health Access
Act

Bill text not yet available at the time of
publication.
Introduced Mar. 26, 2021

• Allows for payment of outpatient critical access hospital
  services furnished through telehealth under the Medicare program,
  including behavioral health services such as psychotherapy

H.R. 2903: CONNECT for Health Act

Introduced Apr. 28, 2021

• Amends title XVIII of the Social Security Act to expand access
  to telehealth services

H.R. 3371: Home Health Emergency Access to
Telehealth (HEAT) Act

Reintroduced May 20, 2021

• Gives the Centers for Medicare & Medicaid Services (CMS)
  the authority to issues waivers to allow payments for home health
  services furnished via visual or audio telecommunication systems
  during an emergency period

H.R. 3447: Permanency for Audio-Only
Telehealth Act

Introduced May 20, 2021

• Allows Medicare coverage of audio-only telehealth services
  after the COVID-19 public health emergency

H.R. 3755: Women’s Health Protection Act
of 2021

Reintroduced June 8, 2021

• Allows health care providers to provide abortion services via
  telemedicine

H.R. 4012: Expanding Access to Mental Health
Services Act
Introduced June 17, 2021

Bill text not yet available at the time of
publication.

• Permanently broadens mental health options, including intake
  examinations and therapy, via telehealth for Medicare members.

H.R. 4040: Advancing Telehealth Beyond
COVID-19 Act of 2021

Reintroduced June 22, 2021

• Permanently removes the originating site and geographical
  limitations within Medicare.
• Makes permanent the telehealth coverage at Federally Qualified
  Health Centers (FQHC) and Rural Health Clinics (RHC)
• Removes restrictions that limit health care providers’
  ability to provide access to smart devices and innovative digital
  technology to their patients.

H.R. 4036/
S.2112: Enhance Access to Support Essential Behavioral Health
Services (EASE) Act
S. 2112 introduced June 17, 2021

H.R. 4036 Introduced June 22, 2021

• Permanently allows Medicare and Medicaid to reimburse for all
  behavioral health services for children, seniors and those on
  disability.

H.R. 4058 S.2061:
Telemental Health Care Access Act of 2021
S. 2061 introduced June 15, 2021

H.R. 4058 introduced June 22, 2021

• Expands access to telemental health services by removing
  statutory requirement that Medicare members be seen in-person
  within six months of being treated for mental health services
  through telehealth.

H.R. 4437: HEALTH Act of 2021

Introduced July 16, 2021

• Amends title XVIII of the Social Security Act to permanently
  provide reimbursement to Federally qualified health centers (FQHCs)
  and rural health clinics (RHCs) under the Medicare program for
  services delivered via telehealth.

H.R. 4480

Introduced July 16, 2021

• Requires group health plans and health insurance issuers
  offering group or individual health insurance coverage to provide
  coverage for services furnished via telehealth if such services
  would be covered if furnished in-person.

H.R. 4670: Advanced Safe Testing at
Residence Telehealth Act (A-START)

Introduced July 22, 2021

• Enables individuals who receive care through Medicare
  Advantage, Medicaid, and the Veterans Affairs to receive
  FDA-approved at-home tests at home in conjunction with an assistive
  telehealth consultations

H.R. 4770: Evaluating Disparities and Outcomes
of Telehealth (EDOT) During the COVID-19 Emergency Act of 2021

Introduced July 28, 2021

Requires the Secretary of HHS to conduct a study evaluating the
effects of changes to telehealth under Medicare and Medicaid during
the COVID-19 emergency.

H.R. 4918: Rural Telehealth Expansion
Act

Introduced Aug. 3, 2021

Amends the Social Security Act to include store-and- forward
technologies as telecommunications systems through which telehealth
services may be furnished for payment under the Medicare
program.

H.R. 5248: Temporary Responders for
Immediate Aid in Grave Emergencies Act of 2021

Introduced Sept. 14, 2021

Authorizes the HRSA Provider Bridge Program to:

• Streamline the process for mobilizing health care professionals
  during the COVID-19 pandemic and future public health emergencies,
  including by utilization communications pathways and new
  technologies; and,
• Connect health care professionals with state agencies and
  health care entities to quickly increase access to care for
  patients via telehealth.

H.R. 5425: Protecting Rural Telehealth Access
Act

Introduced Sept. 29, 2021

• Amends title XVIII of the Social Security Act to protect access
  to telehealth services under the Medicare program
• Eliminates geographic requirements for originating sites
• Requires reimbursement for telehealth services provided in a
  critical access hospital
• Requires a telehealth payment rate for telehealth services
  furnished by a FQHC or RHC

Allows the use of audio-only technology for certain telehealth
services including: E/M services, behavioral health counseling and
education services, and other services determined appropriate by
the secretary.

H.R. 6074: Coronavirus Preparedness and
Response Supplemental Appropriations Act

• Allows CMS to extend coverage of telehealth services to
  beneficiaries regardless of where they are located
• Allows CMS to extend coverage to telehealth services provided
  by “telephone” but only those with “audio and video
  capabilities that are used for two-way, real-time interactive
  communication” (e.g., smartphones)

For more information on Medicare changes, see our 
March 17 Manatt
newsletter.

H.R. 748: Coronavirus Aid, Relief, and
Economic Security (CARES) Act

• Telehealth Provisions include:
  • Telehealth Network and Telehealth Resource Centers Grant
    Programs
  • Exemption for Telehealth Services
  • Increasing Medicare Telehealth Flexibilities During
    Emergency
  • Enhancing Medicare Telehealth Services for Federally Qualified
    Health Centers and Rural Health Clinics During Emergency
    Periods
  • Temporary Waiver of Requirement for Face-to-Face Visits Between
    Home Dialysis Patients and Physicians
  • Use of Telehealth to Conduct Face-to-Face Encounter Prior to
    Recertification of Eligibility for Hospice Care During Emergency
    Period
  • Encouraging Use of Telecommunications Systems for Home Health
    Services Furnished During Emergency Period

For more information on the CARES Act, see our  March 27 Manatt
newsletter.

H.R. 133: Consolidated Appropriations Act,
2021

• Telehealth provisions include:
  • Expanding Access to Mental Health Services Furnished through
    Telehealth
  • Funding for Telehealth and Broadband Programs including:
    • An additional $250M to the FCC COVID-19 Telehealth Program
    • $285M for a pilot program to award grants to Historically Black
      Colleges or Universities, tribal colleges and universities, and
      other minority-serving institutions
    • $3.2B to establish an Emergency Broadband Benefit program at
      the FCC
    • $1B at the NTIA support broadband connectivity on tribal lands
      to be used for broadband development, telehealth, distance
      learning, affordability and digital inclusion
    • $300M for broadband development program targeted towards rural
      areas to support broadband infrastructure development

For more information on the Consolidated Appropriations Act,
see our December 23 Manatt newsletter.

H.R. 1319: American Rescue Plan Act of
2021

• Includes funding for the following opportunities that would
  expand access to telehealth, including:
  • Emergency Grants to help Rural Health Care facilities increase
    telehealth capabilities
  • Funding to support information technology infrastructure for
    telehealth at Indian Health Services Centers
  • Funding to support behavioral and mental health professionals
    who utilize telehealth to deliver care via telehealth
  • Support and training for home care visiting entities that
    conduct virtual home visits 
• Assistance for rape crisis centers transitioning to virtual
  services