JAMA Internal Medicine recently published an article finding that the number of homebound adults aged 70 or older more than doubled during the last decade. In 2011, approximately 5% of adults aged 70 or older were homebound compared with 13% in the same age group in 2020. The authors indicate the steep incline in 2020 was likely due to social distancing restrictions and other health precautions taken over the course of the COVID-19 pandemic. But the high number of homebound adults aged 70 and older will likely continue throughout 2021 and have potential lasting effects on the overall health of the individuals and their health care delivery.

While telehealth has become a staple in the lives of many post-pandemic (as discussed in a prior blog post), it may not be reaching this vulnerable population. The JAMA article indicated that, of the survey respondents, 27.8% did not have a cell phone, 50.8% did not have a computer, and more than 50% did not email, text or go online in the last month. This means those in this population that need assistance with health care services may need to rely on in-person home care. Continue Reading Home Is Where the Health Care Is: New Study Shows Increase in Number of Homebound Older Adults While CMS Expands Home Health Reimbursement Model

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

As discussed in a prior post, the Hospital Price Transparency Rule at 45 C.F.R. § 180.10 et. seq. (the “Rule”), requires all hospitals to provide clear, accessible pricing information about the items and services they provide by publicizing (1) the prices for 300 of their most “shoppable services” or services that can be scheduled by a consumer in advance; and (2) total charges, payor-specific negotiated rates, and discounted cash prices for individuals paying out-of-pocket. Continue Reading Proposal to Increase Penalties for a Hospital’s Failure to Comply with Price Transparency Rule

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

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