In a FAQ published on August 20, 2021, the Departments of Labor, Health and Human Services, and the Treasury (collectively, the “Departments”) significantly delayed implementation of statutory requirements on surprise billing and price transparency, which we had previously summarized in a series of blog posts throughout this past year:

Specifically, the FAQs focus on the implementation of certain provisions of the Affordable Care Act’s (the “ACA’s”) Transparency in Coverage Final Rules (the “TiC Final Rules”) and certain provisions of title I (the No Surprises Act) and title II (Transparency) of Division BB of the Consolidated Appropriations Act, 2021 (the “CAA”).
Continue Reading The Surprises Continue: The Biden Administration Delays Implementation of Certain Provisions of the No Surprises Act and Transparency in Coverage Final Rules Applicable to Providers and Insurers

As demand, coverage and investment are all on the rise and transactions proliferate, we explore certain attributes of the fertility services industry.

Driving Factors

In 2019, there were 58.3 births for every 1,000 women ages 15 to 44 in the U.S., down from 59.1 in 2018.[1]  This marked the fifth consecutive year in which the fertility rate declined.  Many factors may be driving down the rate, including the lingering effects of the Great Recession, delays in marriage and an emphasis on career and educational objectives prior to having children. As women wait longer to have children, there is increasing interest in assisted reproductive technology (ART), including in vitro fertilization (IVF). Other demands for fertility services are driven by LGBTQ couples as well as people who wish to better understand their genetic makeup.
Continue Reading The State of the Fertility Industry

Given the current political dynamic within Congress, the chances of the Biden Administration enacting significant, substantive health care legislation appear slim in the short-term. Thus, the Biden Administration has sought alternative routes to advance its policy priorities, mainly through budget reconciliation (see here for a comprehensive explainer from the Congressional Research Service) and agency regulation. For example, we have previously written here and here about the “No Surprises Act”, enacted through the legislative short-cut of budget reconciliation as part of the 2021 Consolidated Appropriations Act, and the Biden Administration’s new regulations implementing consumer protections against surprise medical bills. In this mold, President Biden’s July 9 Executive Order on Promoting Competition in the American Economy (the “Order”) appears to lay out an aspirational, yet somewhat more practical agenda to implementing reforms in the health care sector, as compared to relying on new legislation coming through Congress.

The Order tasks federal agencies across the “whole-of-government” to “protect competition in the American economy” by acting on 72 regulatory initiatives, to be coordinated by a newly established “White House Competition Council” with representatives from key federal agencies. While the “whole-of-government” is involved and the entirety of the U.S. economy is targeted, there is a distinct focus among these initiatives on “improving health care” by addressing “overconcentration, monopolization, and unfair competition” in the sector. The Order specifically cites four areas in the health care sector ripe for renewed enforcement and regulatory attention with the goal of lowering prices, promoting competition, and benefiting consumers.
Continue Reading Pass Go and Collect Regulatory Scrutiny: The Biden Administration Takes Aim at Consolidation & Anti-Competitive Business Practices in Health Care

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

Many of us have been waiting to hear the final word about what’s next from CMS for the Next Generation ACO Model. On May 21, 2021, CMS’s Innovation Center (“CMMI”) confirmed that the Next Generation ACO Model would not be extended and will conclude at the end of this year as planned. The Next Generation ACO Model has been the most advanced value-based contracting model offered by CMS with participating risk-bearing entities taking between 80%-100% upside and downside risk.  However, according to reports, the model didn’t achieve sufficient savings to justify making it a permanent CMMI program.
Continue Reading CMS to Discontinue Next Generation ACO Model as Expected but Allows Program Participants to Apply For Direct Contracting