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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 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

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 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

Among the numerous consequences of the Covid-19 Pandemic is a well-documented emphasis on the home.  Work at home.  Exercise at home.  See your doctor or other health provider at home.  Home-based health care beyond the traditional nursing care is yet another change wrought by the pandemic that will not likely be eliminated as we come to define the new normal.…
Continue Reading A New Era for Home-Based Patient Care

The U.S. Department of Justice (the “DOJ”) recently settled whistleblower False Claims Act (“FCA”) allegations against The University of Miami (“UMiami”) for $22 million, which resolves claims from three separate lawsuits related to billing practices at UMiami’s off-campus hospital-based facilities (“Off-Campus Hospital Facilities”) and fraudulent claims for laboratory services.…
Continue Reading The University of Miami to Pay $22 Million to Settle Medicare False Claims Act Allegations

In a prior blog post, we discussed CMS’ Hospital Price Transparency Rule at 45 C.F.R. § 180.10 et. seq., effective January 1, 2021 (the “Rule”), which requires hospitals to make public “a machine-readable file containing a list of all standard charges for all items and services.” Specifically, the Rule requires hospitals to post (1) a description of each item or service provided by the hospital; (2) the gross charge that applies to each individual item or service; (3) payer-specific negotiated rates that apply to each item or service for which a payer negotiated rate has been established. Each payer negotiated price must be clearly associated with the name of the applicable third-party payer and plan; (4) de-identified minimum negotiated rates that apply to each item or service; (5) de-identified maximum negotiated rates that apply to each item or service; (6) discounted cash prices that apply to each item or service; and (7) CPT, HCPCS, or other billing codes used by the hospital for purposes of accounting or billing for the item or service.

In a study published on March 16, 2021, Health Affairs found that out of the largest 100 hospitals in the U.S. (by certified bed count), 65 were “unambiguously noncompliant.” 12 of these 65 (18%) did not post any files or provided links to searchable databases that were not downloadable and 53 (82%) either did not include the payer-specific negotiated rates with the name of payer and plan clearly associated with the charges or were in some other way noncompliant. The data informing this study was pulled from late January 2021 to early February 2021.…
Continue Reading Recent Study Shows Lack of Compliance With CMS’ Hospital Price Transparency Rule