On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy Roosevelt’s trust-busting and Franklin Roosevelt’s “supercharged antitrust enforcement”. Asserting that a “fair, open, and competitive marketplace has long been the cornerstone of the American economy,” the Executive Order sets forth 72 initiatives across over a dozen federal agencies.

Read the full post on our newly launched Proskauer in Life Sciences Blog.

Many forces have been driving the growth of telehealth over the past decade, including value-based reimbursement models, population health management trends, and technology advancements. As we have discussed in previous blog posts, the COVID-19 pandemic was the jet fuel that propelled telemedicine utilization into the stratosphere. This growth was, in large part, due to the necessity of limiting in-person contact to avoid widespread COVID-19 transmission. In fact, as COVID-19 began to spread across the United States, the Centers for Disease Control and Prevention (“CDC”) advised health care providers to offer care via telemedicine technologies wherever appropriate. However, not all of this growth in the telehealth space can be attributed to the necessity of social distancing during the pandemic; even as transmission of COVID-19 has slowed in many areas, providers continue to offer telehealth for patient care, and patients continue to utilize it. Continue Reading Where Are We Now? Trends in Telehealth Utilization

As discussed in a prior blog post, effective June 25, 2021, New York Governor Andrew Cuomo issued Executive Order 210, which officially declared the end of the New York State of Emergency caused by the COVID-19 pandemic. As a result, the New York emergency telehealth waivers have expired.  These telehealth waivers had previously allowed many digital health companies and health systems to utilize certain flexibilities related to the methods of allowable telehealth technologies and the use of out-of-state providers to expand services and to cover understaffed departments.

In response to the Governor’s announcement, the New York State Department of Health (“NYS DOH”) issued guidance extending the expansion for the ability of all Medicaid providers in all situations to use a wide variety of communication methods to deliver services remotely during the remainder of the federally-declared COVID-19 Public Health Emergency (“PHE”). Note that this guidance does not impact or provide additional flexibilities to non-Medicaid providers and, as discussed in our prior blog post, the New York State Education Department has only commented stating that given the expiration of the New York COVID-19 waivers, “professionals should exercise due diligence and good faith efforts to return to compliance with all Title VIII statutory and regulatory requirements without delay.” Continue Reading New York Medicaid Still Holding Onto Pandemic-Era Telehealth Expansions Even After COVID-19 Waivers Disappear

This post provides an update to our previous publication summarizing the federal No Surprises Act and is part two of two in a series on new interim regulations implementing certain requirements of the No Surprises Act.

In part one of this series, we discussed the recently issued interim final rule implementing the No Surprises Act and the protections afforded to patients in connection with emergency services furnished by out-of-network (OON) facilities and providers or in connection with non-emergency services performed by OON providers at certain in-network facilities.

Here, in part two of the series, we address the interim final rule’s plan coverage requirements, the methodology a health plan offering group or individual health insurance coverage must use to determine a patient’s cost-sharing responsibility, and communications between insurers and providers detailing payment amounts. Continue Reading No Surprises Act Regulations – Insurer Requirements

Cardiology procedures in the ambulatory surgery center (“ASC”) setting are growing rapidly.  According to MedPAC’s March 2021 report to Congress, there were 88 single-specialty cardiology ASCs billing Medicare in 2019 (the latest year with reportable data), which is a significant uptick from just 18 such ASCs in 2017.[1]  Despite demonstrable growth, it is important to note that this growth is occurring from a smaller base relative to other single-specialty ASCs.  For example, there were more than 1,000 gastroenterology ASCs in 2019.[2]  However, while ASCs accounted for an estimated 10% of all cardiology procedures in 2018, Bain & Company expects that they will account for 30-35% of such procedures by the mid-2020s as lower costs and favorable outcomes drive change.[3] Continue Reading Key Considerations for Cardiology Procedures in the ASC Setting

This post provides an update to our previous publication summarizing the federal No Surprises Act and is part one of two in a series on new interim regulations implementing certain requirements of the No Surprises Act.

The recently issued interim final rule governing one aspect of the No Surprises Act—the treatment of out-of-network (OON) and uninsured patients during emergencies and where services are provided at in-network facilities regardless of emergent status—largely reflects the statute but commits the adopting federal agencies (HHS, Labor and the Treasury) to expansive readings in favor of limiting patient liability where possible. Continue Reading No Surprises in Initial No Surprises Act Regulations

On June 24, 2021, New York Governor Andrew Cuomo issued Executive Order 210, which officially declared the end of the New York State of Emergency caused by the COVID-19 pandemic effective June 25, 2021. The issuance of the Executive Order marked an important milestone for life post-pandemic and a welcome result for small businesses barely treading water trying to comply with the COVID-19 restrictions. However, the abruptness of the announcement, the limited carve-outs for health care professionals and the organizations that employ or contract with them, and the lack of permanent alternative solutions will create a tumultuous few weeks for those parties. Continue Reading Abrupt End to New York State of Emergency Creates Uncertain Future for Out-of-State Licensed Health Care Professionals

This is the second of two posts discussing the June 11, 2021 updates to the PRF reporting requirements and FAQs.

As discussed in our earlier blog post, on June 11, 2021, the U.S. Department of Health and Human Services (“HHS”) released revised COVID-19 Provider Relief Fund (“PRF”) Reporting Requirements, superseding all prior versions of reporting requirements issued by HHS, along with associated revised PRF FAQs, Reporting Portal FAQs, and a Reporting Portal Registration User Guide that each make conforming changes. In addition to the new deadlines discussed in the prior post, the June 11 PRF updates offer providers more clarity into the the priority of eligible uses, required reporting elements, and instructions on how to return unused funds.

Continue Reading HHS Offers Increased Flexibility Regarding the Use of Provider Relief Fund Grant Money and Associated Data Reporting Obligations

This is the first of two posts discussing the June 11, 2021 updates to the PRF reporting requirements and FAQs.

On June 11, 2021, the U.S. Department of Health and Human Services (“HHS”) released revised COVID-19 Provider Relief Fund (“PRF”) Reporting Requirements, superseding all prior versions of reporting requirements issued by HHS, along with associated revised PRF FAQs, Reporting Portal FAQs, and a Reporting Portal Registration User Guide that each make conforming changes. The updated Reporting Requirements come just three weeks prior to when PRF recipients would have been required to expend all received funds and when reporting was scheduled to commence (July 1, 2021).

Significantly, the updates give providers a longer runway to use funds, clarify the definition of “COVID-19 patient”, and provide insight into potential upcoming PRF distributions. The updated Reporting Requirements represent the Biden Administration’s first actions to modify the PRF, which distributes federal grants to help providers offset revenue shortfalls and expenses incurred due to the COVID-19 pandemic.

Continue Reading In Significant Update to the Provider Relief Fund, HHS Sets New Deadlines for Providers to Spend PRF Grant Money and Report Uses

On June 10, 2021, the U.S. Department of Labor Occupational Safety and Health Administration (“OSHA”) announced “an emergency temporary standard to protect healthcare workers from contracting coronavirus.” The standard focuses on healthcare workers that are on the front lines of the fight against COVID-19, aiming to increase protections for those who “continue to be at high risk of contracting the [disease] . . . while they provide us with critical healthcare services.” Continue Reading OSHA Releases Emergency Temporary Standards to Protect Healthcare Workers from COVID-19 Infection