As it continues to grapple with the COVID-19 pandemic, the healthcare sector will face increased antitrust scrutiny from the Biden administration, with the Federal Trade Commission (the “FTC”) and Department of Justice, Antitrust Division (the “DOJ”) (together the “Agencies”) as the Agencies ramp up their reviews not just of “horizontal” transactions (i.e., deals between competitors), but also of “vertical” transactions (i.e., deals that combine market participants at different levels of the healthcare industry, such as payors, hospitals, and physician practices).
Continue Reading Vertical Deals in Healthcare: Key Antitrust Takeaways for Private Equity Firms

Telehealth services and providers have been in high demand as the world copes with the COVID-19 public health emergency.  Federal and state agencies have amended, and often loosened, regulations in an attempt to facilitate and expand access to telehealth.  However, the honeymoon phase of relaxed oversight may be coming to an end as the world adjusts to a new-normal.
Continue Reading The Honeymoon Phase Is Over: OIG to Audit COVID-19 Part B Telehealth Services

Will HHS’ approach for imposing penalties in the aftermath of a data breach become a little clearer in 2021? This is a distinct possibility in the wake of a Fifth Circuit decision vacating penalties against MD Anderson Cancer Center. The hospital suffered three data breaches, leading HHS to impose over $4 million in civil penalties. That fine was reversed recently by the Fifth Circuit as arbitrary, capricious, and contrary to law.
Continue Reading What Does the Fifth Circuit’s Vacating of HHS HIPAA Fines Mean for Companies This Year?

Texas Governor Wants to Make Permanent Changes to Telemedicine Access

As part of his 2021 of the State address, Texas Governor, Greg Abbott, introduced his intention to permanently expand telemedicine services that were made available during the COVID-19 public health emergency (the “Pandemic”).
Continue Reading The “State” of Telehealth: Texas

On January 13, 2021, Brad Smith, the current (and fourth) director of the Center for Medicare and Medicaid Innovation (the “Center”), published an article[1] in the New England Journal of Medicine in which he evaluates the Center’s performance over its decade-long history against the Center’s stated goals – to decrease health care spending and improve health care quality.  Smith describes an underwhelming showing from the Center and puts forward several key lessons from the Center’s past performance as a way to inform and improve future performance.
Continue Reading Evaluation of Innovation Center Models

New Hampshire Seeks to End Telehealth Parity and Audio-Only Phone Coverage

On January 13, 2021, New Hampshire lawmakers, Jess Edwards, Jason Osborne and John Hunt, introduced House Bill 602, which seeks to roll back certain provisions of the July 21, 2020 telehealth bill (“House Bill 1623”) signed into law by Governor Chris Sununu, during the height of the COVID-19 public health emergency (the “Pandemic”). House Bill 1623, amended the state’s definition of telemedicine to include new modalities, including audio-only phones, and requires Medicaid and private payers to reimburse for telehealth services on the same basis that it reimburses for in-person care. In sharp contrast, the newly proposed House Bill 602 would revise the state’s telehealth rules to eliminate payment parity and coverage for audio-only services.
Continue Reading “State” of Telehealth Series: New Hampshire

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially those in the healthcare space.  But while President Biden may have success in reversing much of his predecessor’s last minute regulatory activity, he is likely to face at least some headwinds as it relates to one of those midnight rules – the “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions” (the “Final Rule”) – that was published in the Federal Register on January 14, 2021 and became effective on January 12, 2021.
Continue Reading Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of Guidance Documents in Civil Enforcement Actions

In response to the ongoing COVID-19 public health emergency (the “PHE”) first declared on March 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued blanket Section 1135 Waivers to expand, albeit on a temporary basis during the PHE, the range of healthcare professionals who can provide Medicare-covered telehealth services to include physical therapists, occupational therapists, speech language pathologists, and other non-physician practitioners.  (See also, CMS Fact Sheet, “Medicare Telemedicine Health Care Provider Fact Sheet” (March 17, 2020) and CMS’s “COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers” (December 1, 2020)).
Continue Reading The Other Shoe Drops: OIG To Audit COVID-19 Telehealth Home Health Services

New York Telehealth Reforms – 2021 and Beyond

The Empire State continues its expansion of telehealth adoption as Governor Andrew Cuomo introduced a number of proposals as part of his 2021 State of the State agenda set to “permanently adopt COVID-19-era innovations” in telehealth.  The proposals are part of a wave of proposed legislation meant to cement the changes in telehealth regulation necessitated by the COVID-19 pandemic (the “Pandemic”). Building on New York State’s adoption of Senate Bill S8416 over the summer which had already made a permanent change in the expanded definition of telehealth to include audio-only telephone communication, if adopted the proposal would provide licensing reciprocity in certain specialties, as well as remove traditional prerequisites to the provision of telehealth.
Continue Reading “State” of Telehealth Series: New York

This week, Rep. Mike Thompson (CA-05), founder and co-chair of the Congressional Telehealth Caucus reintroduced the Protecting Access to Post-Covid-19 Telehealth Act of 2020 (the “Act”) with support from Co-Chairs Rep. Peter Welch (VT-AL), Rep. Bill Johnson (OH-06), and Rep. David Schweikert (AZ-06) and caucus member Rep. Doris Matsui (CA-06).  The Act was originally introduced in the House of Representatives on July 16, 2020. The focus of the Act is to do away with certain restrictions on providing telehealth services, and to permanently expand coverage for telehealth services both during and beyond the COVID-19 Pandemic. Among other things, the Act:
Continue Reading Re-Introducing the Protecting Access to Post-Covid-19 Telehealth Act

Over the last year, we have seen volatility in the healthcare industry overall, and Medicare Advantage (“MA”) and Medicare Part D plans (together, “Plans”) have not been immune. Particularly because of their risk adjustment payment models, and metrics by which they are measured, it was unclear how the Centers for Medicare and Medicaid Services (“CMS”) would respond.
Continue Reading CMS to the Rescue for MA and Part D Plans – Rate Announcement Includes Significant Increase in Plan Payments for 2022