SubscribeNumerous states—including Wisconsin, Illinois, Kentucky and Oklahoma—have been busy finalizing rulemaking and legislation that create or amend professional practice standards to incorporate telehealth. What have these states been up to over the last month?
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July Trending in Telehealth
Numerous states—including Alaska, Maryland, California and Colorado—have been busy finalizing rulemaking and legislation impacting Medicaid coverage and maternal health. What have these states been up to over the last month?
Teleprescribing of Controlled Substances Temporarily Extended Beyond PHE
The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the extension is in place, the DEA indicated that it will be further evaluating its recently proposed rules for post-COVID-19 public health emergency telemedicine prescription of controlled substances.
HHS OIG Develops Toolkit to Analyze Telehealth Claims to Assess Program Integrity Risks
The US Department of Health and Human Services Office of the Inspector General (HHS OIG) recently unveiled a new toolkit that seeks to help analyze telehealth claims for federal healthcare program integrity risks. It is based on methodologies highlighted in OIG’s September 2022 data brief; the data brief identified billing practices by Medicare providers that OIG was concerned posed a high risk to program integrity. OIG intends for the toolkit to be used by public and private parties—including Medicare Advantage plan sponsors, private health plans, State Medicaid Fraud Control Units and other federal healthcare agencies—to assess program integrity risks and identify providers whose billing may warrant further scrutiny.
May Trending in Telehealth
Numerous states—including Illinois, Hawaii, Tennessee, Montana, New Hampshire and Indiana—have been busy finalizing rulemaking and legislation impacting interstate compacts, professional practice standards and COVID-19 licensure flexibilities. What have these states been up to over the last month?
April Trending in Telehealth
Numerous states—including North Dakota, Hawaii, Indiana, Texas and New Hampshire—have been busy finalizing rulemaking and legislation impacting healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate virtual care. What have these states been up to over the last month?
From Clinic to Courtroom: Legislation and Litigation Limiting Prescription Practices
On April 20, 2023, McDermott’s Alden Bianchi was a speaker at the ERISA Industry Committee’s 2023 Annual Spring Policy Conference, which was held at the National Press Club in Washington, D.C. The panel in which he participated was entitled “From Clinic to Courtroom – Legislation and Litigation Limiting Prescription Practices,” and it covered three main topics: state regulation of telehealth; the regulation of specialty pharmacy supply chains and delivery measures (“brown bagging,” “white bagging” and “clear bagging”); and state-level efforts to regulate pharmacy benefit managers (PBMs) following the US Supreme Court’s 2020 Rutledge decision, which held that an Arkansas law regulating the costs of prescription drugs was not preempted by the Employee Retirement Income Security Act of 1974 (ERISA).
Here are some of the program’s key takeaways and predictions:
- While telehealth is here to stay, the high cost of Medicare reimbursements presents an immediate barrier to widespread adoption, and the particulars of how telehealth will be regulated will be left largely to the states.
- The battle over the delivery of specialty prescription drugs is heating up as PBMs seek to capture some of the margins previously available only to providers. State laws regulating pharmacies and pharmacists will be at the center of the battle, and future legislative efforts will likely be subject to challenge.
- State legislatures have read the Rutledge decision broadly in ways that virtually guarantee a good deal of future litigation. It might take as long as a decade, and it may well take more than one trip to the Supreme Court before plans, issuers, providers, state legislators and regulators, and other stakeholders have a reliable understanding of the contours of ERISA preemption in the pharmacy context.
Accompanying this post are copies of Mr. Bianchi’s panel materials, including:
Telehealth Trends to Watch: Increased Focus on Privacy and Security
We expect to see continued focus on privacy and security at the federal and state level. For example, California, Virginia, Colorado, Utah and Connecticut have new privacy laws coming into effect in 2023. As part of our State Law Privacy Video Series, McDermott described how these laws will affect health data and healthcare entities—in particular, those entities that are regulated by HIPAA.
In addition, at the end of 2022, the US Department of Health and Human Services (HHS) proposed long-awaited changes to the regulations protecting the confidentiality of substance-use disorder patient records under Part 2 of Title 42 of the Code of Federal Regulations (42 CFR Part 2, or Part 2). Specifically, the proposed rule would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which required HHS to align Part 2 with certain provisions of HIPAA and to make certain changes to the HIPAA Notice of Privacy Practices, the form given to patients and plan members that describes patient privacy rights, covered entity duties, and the covered entity’s uses and disclosures of protected health information.
New 50-State Survey | ID Verification for Telemedicine Encounters
Verifying the identity of a patient prior to delivering telehealth services is important to prevent a range of potential risks, including the creation of fake accounts, insurance fraud and drug abuse/diversion.
A growing number of states and health plans require the verification of a patient’s identity. This verification activity has become a standard practice in the telehealth industry and is expected to continue.
Download our 50-state survey to learn which states require patient identity verification and access links to relevant state laws in one convenient place.
Telehealth and the End of the COVID-19 Emergency
The Biden administration has announced its intent to end the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) on May 11, 2023 (read our prior article for more information). In response to the COVID-19 pandemic, lawmakers and agencies made legislative and regulatory changes to expand access to telehealth services for individuals. This article explores what will happen to these temporary telehealth benefits at the end of the PHE and NE.
Current flexibilities under the Affordable Care Act (ACA) allow applicable large employers (ALEs) to offer stand-alone telehealth and remote care services to employees who were not eligible for other employer coverage during the PHE.
In addition, the Coronavirus Aid, Relief, and Economic Security Act (CARES) Act and IRS Notice 2020-29 established a temporary telehealth safe harbor, providing that a high-deductible health plan (HDHP) could cover telehealth and other remote care services on a pre-deductible basis without impacting an individual’s ability to contribute to an HSA. This relief applied to services provided on or after January 1, 2020, with respect to plan years beginning on or before December 31, 2021. Thus, for most calendar-year plans, this relief ended on December 31, 2021. The Consolidated Appropriations Act, 2022 (CAA 2022) renewed the relief under the CARES Act for months beginning after March 31, 2022, and before January 1, 2023—but it created a three-month gap in coverage from January 1, 2022, to March 31, 2022. The CAA 2022 also extended certain flexibilities related to Medicare coverage and payment for telehealth services through the end of 2024. The relief provided under the CAA 2022, however, was provided on a temporary basis and not tied to the PHE or NE.
Effective December 29, 2022, the Consolidated Appropriations Act, 2023 (CAA 2023) provided a two-year extension allowing first-dollar coverage of telehealth under an HDHP so that individuals can access services without needing to meet a deductible first. The CAA 2023 extends telehealth relief for plan years beginning after December 31, 2022, and before January 1, 2025. Most calendar year plans should therefore have coverage of pre-deductible telehealth services without affecting HSA eligibility for all of 2023 and 2024. When the PHE ends, stand-alone telehealth offerings must cease, but telehealth offerings on a pre-deductible basis can continue.
The stand-alone telehealth relief under the ACA is available until the end of the latest plan year that begins on or before the last day of the PHE. For calendar-year plans, this relief would last until December 31, 2023. When an employer ends its stand-alone telehealth benefit, it may need to provide participants a 60-day notice of a material reduction in benefits.
Employers offering telehealth coverage on a pre-deductible basis with HDHPs have been provided statutory relief through December 31, 2024, through the CAA 2023. However, employers should continue to watch for legislative updates regarding telehealth. Lawmakers have proposed multiple other bills in Congress to extend or make permanent telehealth flexibilities.
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