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.
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?
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?
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:
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.
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.
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.
A key feature of the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) was the government’s ability to provide access and coverage of COVID-19 tests. This resulted in overlapping legislation targeted at providing tests to benefit plan participants for free.
With the end of the NE and PHE set for May 11, 2023, there is confusion about what will happen to COVID-19 testing.
Starting on March 18, 2020, the Families First Coronavirus Response Act (FFCRA) required all public and private insurance coverage, including self-funded plans, to cover COVID-19 tests and costs associated with diagnostic testing with no cost-sharing for the duration of the PHE. The Coronavirus Aid, Relief, and Economic Security (CARES) Act enacted shortly after expanded this requirement to cover out-of-network tests during the PHE. The Consolidated Appropriations Act of 2021 (CAA) then took a new approach and applied the requirement to over-the-counter (OTC) COVID-19 tests and added additional obligations. Under guidance issued by the US Departments of Labor, Health and Human Services, and Treasury, effective January 15, 2022, health plans were required to cover up to eight free OTC at-home tests per covered individual per month. Health plans could limit the reimbursement of these tests to the lesser of the actual or negotiated price or $12 per test. Health plans could also provide tests through participating network providers, such as pharmacies or retailers.
When the PHE ends, health plans will no longer be required to cover COVID-19 tests, either diagnostic or OTC, or testing-related services with no cost-sharing.
Employers should consider whether they want to continue to cover COVID-19 tests as required by a doctor or OTC without cost sharing. There is no requirement to stop doing this after the PHE but doing so may have some implications on group health plans. Importantly, if an employer decides to continue covering testing at no cost, they should consider how this affects any employer-sponsored high-deductible health plan (HDHP). IRS Notice 2020-15 permitted HDHP coverage of COVID-19 testing with no cost-sharing without conflicting with HSA eligibility (see our article here). This relief continues until further guidance is issued. Though COVID-19 testing could be considered preventative care under Section 223 of the Internal Revenue Code, the US Department of Treasury will need to provide further clarification. Employers should also consider whether they want to continue to apply a $12 reimbursement cap on COVID-19 or some other limitation.
After the PHE, employers who choose to continue to cover COVID-19 tests at no cost or apply a reimbursement cap may need to amend their plans or summary plan descriptions for these practices. They will also need to coordinate with any insurer or third-party administrator of the employer’s group health plan to ensure proper administration. Depending on the timing of these amendments, they may also need to provide a summary of material modifications to participants. Employers who decide not to continue coverage of COVID-19 tests or apply a reimbursement cap may need to amend their plans, depending on whether [...]
On January 30, 2023, the Biden administration announced its intention to make final extensions of both the COVID-19 National Emergency (NE) and the COVID-19 Public Health Emergency (PHE) through May 11, 2023, at which point both will end. These emergency declarations have been in place for nearly three years and have enabled the government to modify certain coverage requirements by Medicare, Medicaid and private insurance plans, as well as benefits administration rules. The end of the PHE and NE may mean added costs for benefits plans and new questions regarding compliance. This series will explore the implications of the PHE and NE and what their impending end may mean for benefit plan sponsors with articles released periodically before May 11.
There are several important benefit coverage and administration requirements connected to the PHE and/or NE that may remain the same, remain for a temporary period or may need to be discontinued upon the end of these federal emergencies. Over the course of the upcoming weeks, we will cover the key topics that may be triggered by the end of the PHE and/or NE, including:
High Deductible Health Plans, Health Savings Accounts and Employee Assistance Plans (Part 6 of 10)
Deadline Tolling Applied to Each of:
COBRA (Part 7 of 10)
Claims and Appeals + External Review (Part 8 of 10)
HIPAA Special Enrollment (Part 9 of 10)
Other Plan-Related Notices (Part 10 of 10)
Note that the items covered above are not an exhaustive list of all legislative and regulatory changes that could affect employee benefit plans. This series is meant to keep employers informed about some of the most important upcoming changes and the impending decisions and disclosures that need to be made.
For any questions regarding the end of the PHE and/or NE, please contact your regular McDermott lawyer or one of the authors.
On December 1, 2022, the Pandemic Response Accountability Committee (PRAC) Health Care Subgroup issued its report on fraud, waste and abuse risks that arose as a result of the dramatic increase in telehealth services provided during the COVID-19 pandemic. The PRAC was created under the CARES Act to oversee the historic spending that was part of the federal government’s response to the COVID-19 pandemic. The PRAC Health Care Subgroup comprises the offices of the inspector general (OIGs) for six federal agencies:
The US Department of Health and Human Services (HHS)
The US Department of Defense (DoD)
The Office of Personnel Management (OPM)
The US Department of Veterans Affairs (VA)
The US Department of Labor (DOL)
The US Department of Justice (DOJ).
Each OIG oversees an agency that administers a federal program connected to using or paying for telehealth services.
The report highlights the increased access to services that telehealth facilitated during the pandemic and notes key focus areas with respect to program integrity and preventing fraud and abuse. The report is a resource intended to be used by stakeholders across the healthcare industry, including congressional lawmakers, federal and state agencies, and healthcare organizations. The report aims to raise awareness of the importance of safeguarding expanded telehealth services against fraud, waste and abuse.
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