State-by-State Changes 2021

• Passed House Bill No. 6470, which requires the CT medical assistance program to provide coverage for audio-only telehealth and requires the Commissioner to provide Medicaid reimbursement for services delivered via telehealth at parity.

• Passed Senate Bill No. 970, which authorizes the establishment of a physician-patient relationships via a telehealth interaction if the physician is licensed to practice in the state.

• Passed Senate Bill No. 5, which includes the delivery of telehealth services through audio-only interactions; allows providers to establish a patient relationship through telehealth; requires the state to establish a data dashboard that allows analysis of data relating to access to telehealth ; and requires a third-party payer who is not an industrial insurer to cover services provided through telehealth, except for services provided through audio-only interaction.

• Passed Senate Bill No. 40, which allows health professionals to provide telehealth services and allows licensed dyslexia therapists to provide telehealth services in educational centers.

• 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.

• 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.

• 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.

• 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.

• 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.

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.

For more information regarding PHE renewal, please see our Manatt Insights summary.

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.

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

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

Applications must be received by June 4, 2021.

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

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.

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

• 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).

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

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.

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.

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

• 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.

• 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.

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

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

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

• 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.