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.