Articles Posted in Telemedicine

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Earlier this month, the Department of Health and Human Services (HHS) released a concept paper that outlines the Department’s cybersecurity strategy for the healthcare sector. The concept paper builds on the Biden Administration’s National Cybersecurity Strategy, specifically focusing on strengthening resilience for hospitals, patients, and communities threatened by cyber-attacks. The paper arrives at a crucial time for healthcare providers since, according to the HHS Office for Civil Rights (OCR), large breach cyber incidents in the healthcare sector have increased 93% from 2018-2022, with a 278% increase in large breaches involving ransomware.

The HHS healthcare cybersecurity strategy is comprised of four concurrent components, with the overarching goal of strengthening cyber resiliency in the healthcare sector. The four components established by HHS are:

  • Establish voluntary cybersecurity performance goals for the healthcare sector;
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The Centers for Medicare & Medicaid Services (CMS) recently issued the final rule for the physician fee schedule (PFS) for calendar year (CY) 2024, which implements new evaluation and management (E/M) policies and solidifies certain existing telehealth policies.

In the final rule, CMS reduced overall payment rates under the PFS by 1.25% in CY 2024 compared to CY 2023. The final CY 2024 PFS conversion factor is $32.74, which is a decrease of $1.15 (or 3.4%) from the current CY 2023 conversion factor of $33.89, representing a decrease in overall pay to physicians.

CMS has also finalized a new payment code to reflect changes in policies regarding evaluation and management (E/M) services. Beginning January 1, 2024, a separate add-on payment for healthcare common procedure coding system (HCPCS) code G2211 is being implemented for billing split (or shared) visits. Split (or shared) E/M visits refer to visits provided in part by physicians and in part by other non-physician practitioners in hospitals and other institutional settings. The new code reflects the resource costs associated with E/M visits for primary care and longitudinal care. Generally, it will be applicable for outpatient and office visits as an additional payment, recognizing the inherent costs involved when clinicians are the continuing focal point for all needed services, or are part of ongoing care related to a patient’s single, serious condition or a complex condition.

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On July 13, 2023, the Centers for Medicare & Medicaid Service (CMS) released the Calendar Year 2024 Physician Fee Schedule Proposed Rule, proposing to extend remote supervision. The proposed rule continues to define “direct supervision” by allowing supervising physicians and practitioners the ability to continue “direct supervision” through real-time audio and visual interactive telecommunications through December 21, 2024.

Typically, to be payable under Medicare Part B, specific types of services must be provided under certain levels of “direct supervision” by a practitioner or physician. These services often include many diagnostic tests and other services furnished by auxiliary personnel incident to the services of the billing physician. “Direct supervision” usually requires the “immediate availability” of a supervising professional — both in-person and physical availability. However, during the COVID-19 Public Health Emergency (PHE), CMS allowed flexibility in what constituted “direct supervision” by allowing “immediate availability” to include virtual presence using two-way, real-time audio or video technology, instead of requiring physical presence. This policy allowing remote direct supervision was originally set to expire at the end of 2023.

However, due to the increased reliance on virtual direct supervision by physicians and beneficiaries alike, CMS expressed several concerns regarding the expiration of the policy. In its proposed rule, CMS noted that, despite the new patterns of virtual direct supervision that were established and often maintained during the PHE, evidence showing that patient safety is compromised by virtual direct representation is entirely absent. Moreover, telehealth services have overall allowed individuals in rural and undeserved areas to have improved access to care. Expiration of this policy could create substantial barriers to access of many healthcare services, including those furnished incident-to a physician’s service.

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The Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) recently released a toolkit regarding analysis of telehealth claims to assess program integrity risks. Use of telehealth services exploded during the pandemic, with Medicare beneficiaries in particular using 88 times more telehealth services in the first year of the pandemic than in the year prior. In the toolkit, OIG outlined its approach to analyzing telehealth claims, ostensibly in an effort to help Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units, and other Federal health care agencies analyze telehealth claims data. Therefore, healthcare providers may see this type of analysis in other contexts or use this type of analysis for their own compliance purposes.

Specifically, OIG is performing data analysis on Medicare and Medicare Advantage claims for telehealth services and has identified seven measures that OIG believes may indicate fraud, waste, or abuse, as well as thresholds where OIG believes these measures signify “high risk.”

• Billing telehealth services at the highest, most expensive level for a high proportion of services, including E/M services. OIG considers providers to be high risk if they billed 100 percent of their telehealth services at the highest level.

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The Michigan Department of Health and Human Services (MDHHS) recently announced that it will implement an Electronic Visit Verification (EVV) system to validate in-home visits for Medicaid recipients. MDHHS plans to begin the transition to the EVV system in early 2024.

Michigan’s transition to an EVV system was precipitated by the 21st Century Cures Act, which requires states to implement an EVV system for all Medicaid personal care services and home health services that require in-home visits by a provider.

MDHHS awarded a five-year contract to IT firm HHAeXchange to build out and manage an EVV system that MDHHS will provide free of charge. However, MDHHS will be using an “Open Vendor Model,” which allows providers and managed care organizations to use either the state-provided EVV system, or their own EEV system software that directly integrates with the state’s system. To comply with the Act, The EEV system will collect information about the services provided, including the type of service provided, the provider who provided the service, the name of the patient who received the service, the start and end times of the service provided, the date when the service was provided, and the location where the services were provided.

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The U.S. Department of Health and Human Services (HHS) has announced the coming end of the COVID-19 Public Health Emergency (PHE) and has provided guidance on the phase-out of PHE 1135 Waivers. HHS announced that the PHE will expire on May 11, 2023, which will trigger the planned transition and phase-out of PHE 1135 Waivers.

During the COVID-19 PHE, HHS and its constituent agencies, such as the Centers for Medicare & Medicaid Services (CMS), waived many regulatory requirements to create additional flexibility for providers to help ensure that beneficiaries’ needs for healthcare items and services continued to be met during the pandemic. Under the 1135 Waivers, a provider’s noncompliance with certain requirements would generally not result in sanctions so long as the goods or services were provided in good faith and absent of fraud and abuse. As the pandemic winds down and the PHE ends, HHS has provided guidance on the phasing out of the 1135 Waivers and has provided insight on which items and services will and will not be affected moving forward.

According to HHS, the federal government will stop providing free COVID-19 vaccines and treatments, primarily because Congress has not authorized additional funds to purchase more vaccines and treatments. Instead, these items will be transitioned to traditional health insurance carriers. HHS has indicated that this transition will be accomplished in a “thoughtful, well-coordinated manner” and that carriers would cover COVID-19 vaccines and treatments without co-pays, but HHS has not released details or addressed how this transition will impact providers. COVID-19 testing will similarly be affected. While Congress required insurance carriers to cover certain COVID-19 tests during the PHE, when the PHE ends, this requirement will also end and coverage for COVID-19 testing will be determined solely by the individual carrier’s coverage policies.

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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.

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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:

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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:

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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
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