Since we published an update on the expiring telehealth flexibilities last week, the government has entered the third week of shutdown with no signs of an imminent resolution. As uncertainty around the treatment and future of these flexibilities continues to grow, both industry and CMS have weighed in:Continue Reading The Telehealth Cliff Has Arrived: What’s Changing and What to Watch
On October 1st, certain key telehealth flexibilities created during the COVID-19 public health emergency (“PHE”) expired as the government shutdown began. The Centers for Medicare & Medicaid Services (“CMS”) issued a number of telehealth waivers during the PHE, some of which were extended through September 30, 2025 by the Full-Year Continuing Appropriations Act, 2025 (“CAA”). The flexibilities expired as legislative efforts to once again extend the flexibilities, including through the House Committee’s stop-gap government funding Continuing Resolution, failed to pass.Continue Reading The Telehealth Cliff Has Arrived: What’s Changing and What to Watch
I. Overview of Telehealth and Tele-Prescribing Landscape
Since the end of the Public Health Emergency (“PHE”) exceptions in 2023, states have continued to re-evaluate the broad telehealth and tele-prescribing flexibilities granted during the pandemic. Over the past year, many jurisdictions, including New York, California, Delaware, Florida, New Hampshire, and Texas, have either enacted or proposed legislation codifying, modifying, or rolling back pandemic-era waivers related to remote patient care. These regulatory changes touch on several key areas of remote care, including the use of telehealth modalities for the initial “in-person” visit requirement for prescribing controlled substances remotely and remote visitation protocols in institutional specialty care. Concurrently, the federal government has also extended certain temporary flexibilities through the end of 2025. During this period, the federal government is developing a longer-term regulatory framework around the use of telehealth and tele-prescribing for controlled substances. Healthcare providers, digital health startups, and their respective regulatory counsel must remain diligent in navigating the complex legal landscape shaped by overlapping federal rules and increasingly divergent state laws.Continue Reading Telehealth and “In-Person Visits”: Tracking Federal and State Updates to Pandemic Era Telehealth Exceptions
With only two weeks remaining in the year, Congress is considering a government funding deal (the “Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025” or the “Bill”) that includes a welcome holiday gift for health care providers and patients – an expansive health care package that would extend certain telehealth flexibilities promulgated during the COVID-19 public health emergency (“PHE”) for an additional two years. The extended telehealth flexibilities are currently set to expire on December 31, 2024. This extension would generally allow providers to continue to serve Medicare patients via telehealth consistent with the current practices.Continue Reading Congress Extends Telehealth Flexibilities for Two More Years
On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable by Medicare. Although the majority of telehealth waivers enacted during the COVID-19 public health emergency (the “PHE”) are set to expire at the end of 2024 in the absence of legislative action, CMS has proposed to leave certain key flexibilities in place, including the allowance for physicians and other practitioners to furnish remote “direct supervision” through their immediate availability via audio-video technology.Continue Reading Key Telehealth Updates in the CY 2025 Physician Fee Schedule Proposed Rule
On May 16, 2024, the Subcommittee on Health of the House Committee on Energy and Commerce (the “Subcommittee”) announced that it advanced the Telehealth Modernization Act of 2024 (H.R. 7623) as amended (the “Bill”) during a markup session. The Bill is meant to extend a number of telehealth flexibilities under Medicare through 2026. This corresponded with 22 other bills advanced by the Subcommittee to strengthen access to healthcare.Continue Reading Congress Seeks to Extend COVID-19 Telehealth Flexibilities Through 2026 and Expand Reimbursement
The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting continued enforcement and recovery actions under the Health Care Fraud and Abuse Control Program (HCFAC). During fiscal year 2022 (FY 2022), over $1.7 billion was returned through HCFAC’s enforcement actions.Continue Reading HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment Centers, Among Other Initiatives
This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers of the Ryan Haight Act (“RHA”) promulgated during the COVID-19 Public Health Emergency (“PHE”) from November 11, 2023 until December 31, 2024. Under the Second Temporary Rule, practitioners may continue to prescribe schedule II-V controlled medications via telemedicine for new and existing patients without conducting a prior in-person medical evaluation through 2024. Continue Reading Tele-Prescribing Flexibilities Extended Again in Second Temporary Rule
This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan Haight Act (“RHA”) promulgated during the COVID-19 Public Health Emergency (“PHE”). This is notable as access to care, including mental health and substance abuse treatment, remains a crucial industry focus, especially as the transition to the post-PHE has begun.Continue Reading DEA and SAMHSA Extend Tele-Prescribing Flexibilities
This blog is the third installment of our Digital Health Trends Series, see previous blog posts here and here.
On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008 (“RHA”) after the COVID-19 Public Health Emergency (“PHE”) terminates on May 11, 2023. The proposed rule extends certain flexibilities beyond the PHE and proposes to make permanent certain scenarios, in which a practitioner may prescribe controlled substances without a prior in-person medical evaluation.Continue Reading DEA Proposes Rule for Post-PHE Telemedicine
The once-novel medium of telehealth surged onto the stage as a common sense solution to the COVID-19 pandemic. This surge was facilitated, in part, by certain flexibilities authorized by the Centers for Medicare & Medicaid Services in its response to the public health emergency (“PHE”) declared in March of 2020 and which was repeatedly renewed until now. On January 30, 2023, President Joe Biden announced that the PHE would end on May 11, 2023. As the curtains are drawn on the PHE, there can be no doubt that telehealth is here to stay. In light of that reality, it is essential that participants in the telehealth space understand what flexibilities will remain in play.Continue Reading Telehealth in a Post-PHE World