Telemedicine

Published on: January 30, 2023

Top Healthcare Law Issues in 2023

As the COVID-19 public health emergency (PHE) gets extended yet again and while the healthcare industry continues to grapple with the numerous changes and developments over the past several years, providers should gear up for an uncertain landscape in 2023. Between the massive influx of providers implementing telehealth services and the countless unprecedented changes and reforms within the healthcare industry as a whole, the PHE has continued to be a constant, underlying source of uncertainty for providers when it comes to compliance and government imposition. There are several focus areas that healthcare providers in 2023 should approach with caution and this blog will briefly discuss some of those areas.

The COVID-19 pandemic ushered in a nationwide shift in how providers deliver healthcare services, as services delivered via telehealth became more widely utilized and more readily covered by governmental and commercial payors. However, some of the fundamental regulatory flexibilities and policy waivers that made this shift possible are temporary, which creates an unpredictable environment for providers in 2023. To make matters more complex, telehealth services have been an area of increased scrutiny by enforcement agencies and appear to remain a focus of future enforcement action. Moreover, the increased prevalence of telehealth services raises data privacy concerns generally, but in particular for providers subject to HIPAA. When the PHE does inevitably come to an end, so too will some of the flexibilities that allow HIPAA-covered providers to accessibly provide telehealth services without greater data privacy controls. Providers should take the opportunity to analyze possible changes to their data privacy practices to ensure compliance following the end of the PHE.

Over the course of the past several years, providers have seen heightened levels of government enforcement activity related to alleged fraud and abuse within the healthcare industry, and it does not appear to be slowing down any time soon. In 2021 alone, the Department of Justice (DOJ) generated $5.6 billion in False Claims Act (FCA) settlements and judgments. As several of the Department’s stated priorities have not changed since February 2022, providers can expect to see continued enforcement action in areas such as opioid abuse, Medicare managed care (Part C), and audits looking for allegedly medically unnecessary services. Furthermore, a series of memoranda issued by current and past attorneys general seem to sway back and forth concerning the limitations on the uses of sub-regulatory guidance in FCA cases, adding even greater uncertainty to future fraud and abuse enforcement activity.

Published on: January 23, 2023

COVID-19 Telehealth Integrity Report Issued by Pandemic Response Accountability Committee (PRAC)

by Wachler & Associates, P.C.

In December 2022, the Pandemic Response Accountability Committee (PRAC) Health Care Subgroup released its report focusing on telehealth fraud, waste, and abuse risks associated with select healthcare programs across six federal agencies during the first year of the COVID-19 pandemic.

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) conducted this report by leading a group of OIGs from each of the six federal agencies involved. Including the HHS OIG, those six federal agencies are the Department of Defense (DoD), the Office of Personal Management (OPM), the Department of Veterans Affairs (VA), the Department of Labor (DOL), and the Department of Justice (DOJ). The report summarizes potential program integrity risks identified by the six participating OIGs. Specifically, the report aims to inform stakeholders how expanded use of telehealth during the COVID-19 pandemic helped individuals access healthcare during uncertain times, while also raising awareness about the critical importance of safeguarding expanded telehealth services against fraud, waste, and abuse.

Among the key findings across federal healthcare programs, the OIGs identified:

Published on: December 19, 2022

Medicare Telehealth Updates in 2023 Physician Fee Schedule

by Wachler & Associates, P.C.

Recently, the Centers for Medicare & Medicaid Services (CMS) published its Final Rule implementing changes to the Medicare Physician Fee Schedule for CY 2023. In addition to recent clinical laboratory updates, the Final Rule also includes certain changes regarding billing and reimbursement for telehealth services and gives providers guidance on transitioning away from the flexibilities that arose out of the COVID-19 public health emergency (PHE).

In determining whether new telehealth services may be included on the list of Medicare-covered codes, CMS assigns each potential addition to one of three defined categories. Category 1 services are those similar to professional consultation, office visits, and office psychiatry services already on the approved telehealth list. Category 2 services, which are not similar to services already on the approved telehealth list, are assessed by CMS to determine whether there is evidence of clinical benefit to patients when the service is provided via telehealth. Category 3 encompasses services added on a temporary basis during the PHE that would facilitate continued access to medically necessary services during the pandemic, but for which there is insufficient evidence to evaluate the services for permanent addition under Category 1 or Category 2 criteria.

In the Final Rule, CMS made the following changes with respect to the approved Medicare Telehealth Services List:

Published on: October 31, 2022

OIG Releases Medicare Telehealth Program Integrity Report

by Wachler & Associates, P.C.

Recently, the US Department of Health and Humans Services (HHS) Office of the Inspector General (OIG) released a data brief analyzing telehealth services covered by Medicare and related program integrity risks. OIG sought to evaluate the impacts on program integrity due to the regulatory flexibilities implemented during the COVID-19 pandemic and the corresponding spikes in utilization rates for telehealth services by Medicare beneficiaries. Of the 742,000 providers that OIG evaluated, 1,714 had “concerning billing” on at least one of the seven measures that OIG considers to be potential indicators of fraud, waste, and abuse. The data brief represents OIG’s latest effort to use data analytics to identify program integrity concerns and includes specific proposals to improve data quality to aid in program integrity efforts.

OIG identified seven measures that it views as posing high risk for fraud, waste, and abuse. It is worth noting that these integrity measures are related to, but different from, the seven measures OIG identified in a special fraud alert issued in July 2022 with respect to provider arrangements with telehealth companies. The seven measures that OIG identified in the data brief are as follows:

Billing for both a telehealth service and a facility fee for most visits

Published on: August 17, 2022

HHS and DOJ Release Guidance Regarding Accessibility of Telemedicine Services

by Wachler & Associates, P.C.

The use of telemedicine has exploded over the last few years. The COVID-19 pandemic spurred a shift from in-person services to services provided by telemedicine. As healthcare providers and patients experience the added convenience of telemedicine in some circumstances, some of the large-scale shifts to telemedicine will likely become permanent. However, with increased use comes increased scrutiny from regulators. The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) and the Department of Justice (DOJ) recently released guidance regarding the provision of telehealth services to individuals with disabilities or with limited English proficiency.

Collectively, several federal laws generally prohibit discrimination on the basis of disability, race, color, and national origin, among other bases. Federal regulations also generally require covered health programs or activities provided by covered entities through electronic or information technology to be accessible to individuals with disabilities unless doing so would result in undue financial and administrative burdens or fundamental alteration of the health program. According to the joint guidance, “A health care provider’s failure to take appropriate action to ensure that care provided through telehealth is accessible can result in unlawful discrimination.”

HHS and DOJ’s guidance generally directs providers to make exceptions to their telemedicine policies or to make special accommodations to individuals with disabilities or limited English proficiency, such as allowing extra time for familiarization with the telemedicine platform or for communication with the provider, allowing caregivers or others to be present during a telemedicine visit, adding additional capabilities or support for functions like real-time captioning or screen reader software, and use of language assistance services. A provider’s obligation to accommodate disabilities over telemedicine is generally the same as when providing in-person services.

Published on: May 2, 2022

Providing Cross-State Telehealth Services

by Wachler & Associates, P.C.

As telemedicine becomes an increasingly popular method for connecting patients with healthcare providers, many providers are becoming interested in expanding the reach of their telehealth practices across state lines. Although technological advancements have helped providers communicate with patients remotely, state and federal regulations add additional considerations for practicing across multiple states.

Generally, healthcare providers will provide telehealth services to patients located within their own state. Most states allow for telehealth services and will allow state-licensed providers to provide telehealth services within the state in which they are licensed. State licensure requirements become more complex when an out-of-state provider wishes to provide telehealth services to a patient located in another state.

Telehealth services are generally considered to be performed at the patient’s physical location, which usually means that the provider must be licensed in the patient’s home state. Although the COVID-19 pandemic caused several states to temporarily waive some licensing requirements for cross-state telehealth services, many of those waivers has since expired.

Published on: April 21, 2022

Consolidated Appropriations Act Extends Post-PHE Telehealth Coverage

by Wachler & Associates, P.C.

On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, otherwise known as the “Omnibus Bill.” Included in the many provisions introduced by the Omnibus Bill is an extension of Medicare coverage of professional consultations, office visits, and office psychiatry services conducted via telemedicine for 151 days following the termination of the COVID-19 public health emergency (PHE).

As part of the government’s response to the COVID-19 pandemic in March 2020, administrative and legislative changes waived the traditional location and technology requirements necessary to qualify for Medicare coverage for the duration of the PHE. In addition to extending these waivers, the Omnibus Bill expands the types of practitioners eligible to provide telehealth services to patients. Prior to the PHE, Medicare covered telehealth services only if offered by physicians, physician assistants, nurse practitioners, clinical nurse specialists, nurse-midwives, clinical psychologists, clinical social workers, registered dieticians, or certified registered nurse anesthetics. The Omnibus Bill adds to the list of qualifying practitioners occupational therapists, physical therapists, speech-language pathologists, and audiologists. Other changes under the Bill include delaying in-person requirements for the provision of mental health services and extending coverage of telehealth services rendered by federally qualified health centers to provide telehealth services for the same 151-day post-PHE time period.

While these changes may be welcomed by many healthcare providers as supplying necessary resources for both telehealth patients and providers, it remains to be seen whether coverage flexibilities established during the PHE will become permanent moving forward. The Omnibus Bill requires the Medicare Payment Advisory Commission to provide Congress with a report by June 15, 2023 on the expansion of telehealth services as a result of the PHE. The Department of Health and Human Services (HHS) Office of Inspector General (OIG) is similarly required to provide Congress with a report by June 15, 2023 on program integrity risks associated with Medicare telehealth services. Additionally, HHS must post quarterly data, beginning on July 1, 2022, on Medicare claims for telemedicine services. Healthcare providers should be cognizant of these developments and take steps to ensure compliance is maintained as these and other legislative and regulatory changes unfold.

Published on: October 19, 2021

State Relaxes Licensing Requirements to Address Healthcare Worker Shortage

by Wachler & Associates, P.C.

In response to the mounting nationwide shortage of healthcare workers, one state will allow certain healthcare workers to practice solely on out-of-state licenses. This move may signal similar actions by other states and could have wide-ranging implications for the delivery of healthcare services.

During the height of the COVID-19 pandemic, many states waived requirements that healthcare providers, including in some cases physicians and nurses, be licensed in a particular state to provide services in that state. Often, states allowed a provider licensed and in good standing in any state to providers services to patients within the state based on the provider’s out-of-state licenses. This regulatory flexibility allowed more efficient delivery of care during the pandemic. The greatest efficiency was likely added to the delivery of telemedicine. Quite simply, there is often no technical or practice-related reason why a provider seeing patients via telemedicine must be licensed in the same state as their patient. By waiving regulatory obstacles, providers could practice across state lines by telemedicine and help deliver care to where it was needed most.

However, most of these regulatory flexibilities were only temporary and have since ended, meaning that physicians and providers again must often be licensed in a state to provide services to patients within that state. However, while these flexibilities have largely ended, the shortage of physicians and other healthcare workers, which pre-dates the pandemic, have only grown more acute during the pandemic. In response to these shortages, Nebraska will allow some healthcare workers, including PT, OT, and SLP therapists, to practice in Nebraska without a Nebraska license if the provider is licensed in another state. This move is currently only temporary and does not extend to physicians or nurses.

Published on: July 26, 2021

CMS Proposes to Keep Medicare Coverage for Some Audio-Only Services

by Wachler & Associates, P.C.

During the COVID-19 public health emergency, the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) waived many of the restrictions that limited Medicare coverage for healthcare services for telemedicine and allowed for much greater use of these services. Among these was the introduction of Medicare coverage for several audio-only services, whereas Medicare coverage had previously only extended to telemedicine services provided by interactive two-way audio/video communication. However, these actions were only temporary and will end when the declaration of a public health emergency ends.

Due to the tremendous value that audio-only telemedicine has provided to the healthcare system, providers, and Medicare beneficiaries, there have been calls for the temporary expansion of telemedicine to be made permanent. While CMS has asserted that large-scale changes to the Medicare program must come from Congress, CMS recently released the proposed 2022 Physician Fee Schedule which, among many other proposals, would retain Medicare coverage for some audio-only services.

Specifically, CMS would permit the use of audio-only communications technology for mental health telehealth services under certain conditions when the services are provided to beneficiaries located in their home. Under the CMS proposal, coverage would be limited to the diagnosis, evaluation, or treatment of mental health disorders in established patients where the originating site is the patient’s home. CMS would retain the requirement that an in-person item or service must be furnished within six months of such a mental health telehealth service. Further, CMS would require that the provider has the technical capability at the time of the service to use an interactive telecommunications system that includes video, but conducts the visit via audio-only because the beneficiary is unable to use, does not wish to use, or does not have access to two-way, audio/video technology. CMS states its goal is to allow audio-only services only where no service would otherwise occur.

Published on: July 15, 2021

CMS Proposes to Keep Some Medicare Telehealth Access in 2022 Physician Fee Schedule

by Wachler & Associates, P.C.

Many of the Medicare requirements surrounding telemedicine have been greatly relaxed or waived entirely during the COVID-19 public health emergency. Providers and patients wondered if these changes would end or if some might become permanent. In May 2021, Congress introduced H.R.3447, a bill to amend the Social Security Act to expand accessibility to certain telehealth services under the Medicare program, which was an encouraging sign that at least some of the telemedicine waivers may become permanent. Now, the Centers for Medicaid and Medicare Services (CMS) seeks to preserve telehealth access with the proposed 2022 Medicare Physician Fee Schedule (MPFS). If finalized, the rule would codify some of the recent flexibilities CMS has granted regarding telehealth use for the diagnosis, evaluation, and treatment of mental health disorders.

CMS plans to allow Medicare providers to continue offering certain telehealth services until the end of 2023 while the agency decides whether to add those services to the telehealth list permanently. CMS will permit all Medicare patients to access telehealth services from their homes, as called for in the Consolidated Appropriations Act Congress passed in December 2020. Additionally, the agency seeks to enable Medicare to pay for mental health visits via telehealth services provided through community health centers. CMS plans to allow providers to deliver audio-only behavioral and mental health services, including opioid addiction treatment. The proposed rule would also pay physicians for mental health visits, via interactive telecommunications technology, furnished to rural and vulnerable populations in rural health clinics and federal qualified health centers.

The rule also proposes notable changes to the Quality Payment Program (QPP), including the Merit-based Incentive Payment System (MIPS). Specifically, the agency seeks to make it more difficult for clinicians to earn bonuses under its QPP by raising the eligibility threshold. Furthermore, CMS unveiled its first seven MIPS Value Pathways, including: rheumatology; stroke care and prevention; heart disease; chronic disease management; emergency medicine; anesthesia; and lower-extremity joint repairs. CMS, as part of these initiatives, would evaluate clinicians using measures that are meaningful to their practices and their specialties or are relevant to public health priorities. The proposed fee schedule is open for public comment until September 13, 2021.