Telemedicine

Published on: November 15, 2024

CMS Extends Direct Supervision by Telemedicine, Hints at Future Plans

Telemedicine has become an increasingly important part of the healthcare delivery landscape. Since the early stages of the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (“CMS”) have repeatedly issued regulatory flexibilities to allow Medicare to cover certain services provided in whole or in part by telemedicine. One of the most important of these regulatory flexibilities is the expansion of the definition of “direct supervision” to include direct supervision by telemedicine. CMS recently extended the effective period of this expansion through the end of 2025 and hinted at how it may handle direct supervision after that.

CMS has created three levels of supervision: personal, direct, and general supervision. Various services may require one of these levels of supervision in order to be covered by Medicare. Direct supervision is particularly important because it applies to several circumstances, including services provided and billed “incident to” a physician’s service. Click here for an explanation of “incident to” billing. Historically, direct supervision in the office setting has meant that the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.

However, during the COVID-19 public health emergency (“PHE”), CMS expanded this definition of direct supervision to provide that the presence of the physician (or other practitioner) includes virtual presence through audio/video real-time communications technology. Audio-only communication is not included. This expansion was intended to be temporary and expires at the end of the PHE. However, it has proved so useful and integral to the delivery of services to Medicare beneficiaries that it has been repeatedly extended, including past the official end of the PHE.

Published on: July 8, 2024

Major Indictment of Telemedicine Company

by Wachler & Associates, P.C.

The US Department of Justice (DOJ) recently filed its first criminal drug distribution prosecutions related to telemedicine prescribing through a digital health company. The indictments accused Done Global, Inc., its founder and CEO, its clinical president, and several other persons associated with the company of participating in a scheme to distribute Adderall over the internet, conspire to commit health care fraud in connection with the submission of false and fraudulent claims for reimbursement for Adderall and other stimulants, and obstruct justice. This case is highly instructive for those seeking to structure both telemedicine arrangements and payment arrangements with healthcare providers.

Specifically, DOJ alleged that Done operated a business model wherein it charged monthly subscription fees to patients and facilitated telemedicine visits with prescribers for the treatment of ADHD, including prescribing Adderall. DOJ alleged that the business model limited the information available to prescribers, instructed Done prescribers to prescribe Adderall and other stimulants even if the patient did not qualify, mandated that initial encounters would be under 30 minutes, included an auto-refill function that allowed patients to automatically request a refill each month, did not compensate prescribers for follow-up visits or consults after the initial consults, and compensated prescribers solely based on the number of patients who received prescriptions. DOJ alleged that these practices led to false and fraudulent claims for medically unnecessary services being submitted to Medicare, Medicaid, and commercial insurers.

In addition to allegations regarding the business model, DOJ also alleged that the company had been made aware that material was posted on online social networks about how to use Done to obtain easy access to Adderall and other stimulants, but that Done allegedly sought to conceal this information and made fraudulent statements to the media regarding it. The indictments of the individual officers of the corporation are also consistent with federal law enforcement’s emphasis on holding individuals, rather than just the corporation, responsible for alleged healthcare fraud.

Published on: March 19, 2024

Michigan Medicaid Releases New Telemedicine Policy

by Wachler & Associates, P.C.

The use of telemedicine for patient care exploded during the COVID-19 pandemic. While telemedicine services were generally a limited and niche practice prior to the pandemic, social distancing measures, lock-downs, and fear of spreading the disease combined with a desire for widespread testing for the disease created a tremendous need for the use of telemedicine for the delivery of many kinds of healthcare services.

Government programs, like Medicare and Medicaid, and commercial insurance carriers, which had all long restricted the use of telemedicine, scrambled to change their rules to allow telemedicine services in the face of this need. Many of these changes were made in a temporary manner, to expire at the end of the pandemic, with permanent changes to be determined later. Throughout the pandemic, telemedicine services proved to be safe, effective, and convenient. Therefore, healthcare providers and patients generally concurred that permanent changes to telemedicine policies should allow more widespread use.

The Michigan Medicaid program recently released an important update clarifying its permanent, post-pandemic policies regarding which providers are authorized to render services via telemedicine under the Michigan Medicaid program. First, as a general rule, a healthcare provider must be licensed or otherwise authorized to practice in the state where the patient is located. Usually, this will include a Medicaid patient in Michigan and a provider located outside of Michigan. In this situation, the provider must be licensed in Michigan in order for the services to be reimbursed under Michigan Medicaid. Although not a condition of Michigan Medicaid, the provider should also be mindful of the licensing requirements of the state in which they are located, which may require that the provider be licensed there as well. Under limited circumstances, Michigan Medicaid may also cover telemedicine services provided by providers who are licensed in another state to Michigan Medicaid patients if the patient is in the state where the provider is licensed. In either case, the provider must be enrolled in Michigan Medicaid and also have the ability to refer the patient to another provider of the same type or specialty who can see the patient in-person when necessary.

Published on: December 27, 2023

HHS Issues Healthcare Cybersecurity Concept Paper

by Wachler & Associates, P.C.

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;

Published on: December 18, 2023

CMS Finalizes CY 2024 Medicare Physician Fee Schedule

by Wachler & Associates, P.C.

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.

Published on: August 7, 2023

CMS Proposes Extension of Virtual Direct Supervision

by Wachler & Associates, P.C.

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.

Published on: April 26, 2023

OIG Continues Scrutiny of Telehealth Services

by Wachler & Associates, P.C.

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.

Published on: April 5, 2023

MDHHS Launching Electronic Visit Verification System

by Wachler & Associates, P.C.

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 21^st 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.

Published on: March 13, 2023

HHS Addresses End of Public Health Emergency and PHE Waivers

by Wachler & Associates, P.C.

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.

Published on: January 30, 2023

Top Healthcare Law Issues in 2023

by Wachler & Associates, P.C.

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.