Healthcare Providers: Beware New Information Blocking Rule

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By Kim Stanger

Healthcare providers focusing on COVID-19 may have missed the final Interoperability and Information Blocking Rule that was published May 1, 2020 and takes effect November 3, 2020. (45 C.F.R. Part 171). The Rule implements the 21st Century Cures Act and furthers the government’s efforts to enable the exchange of electronic health information (“EHI”) to facilitate better outcomes, lower costs, and greater patient access to information. In general, the Rule prohibits covered actors from blocking the flow of EHI; violations may result in significant civil penalties as discussed below.

Application to Healthcare Providers. The Rule applies to healthcare providers, health IT developers of certified health IT,1 health information exchanges, and health information networks (collectively referred to as “actors”). “Healthcare provider” is defined to include nearly any entity rendering healthcare, including physicians, practitioners, group practices, hospitals, long term care facilities, clinics, ambulatory surgery centers, and other entities determined appropriate by HHS.2

Prohibited Information Blocking. The Rule generally prohibits “information blocking,” i.e., a practice that the healthcare provider “knows3…. is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information”4 unless (i) the practice is required by law, or (ii) the practice fits within one of the exceptions listed below. (45 C.F.R. § 171.103(a)). Information blocking may occur, for example, when a healthcare provider refuses, ignores, delays, or imposes unreasonable conditions in response to requests to share EHI, including requests from patients, other providers, or payors. (See 85 FR 25811). It may occur when contracts, business associate agreements, license terms, or organizational policies unnecessarily restrict data sharing, or when technology is implemented, configured, or disabled so as to limit system interoperability. (85 FR 82511-12). The Rule generally prohibits any practices that increase the cost, complexity or burdens associated with accessing, exchanging or using EHI, or that limit the utility, efficacy or value of EHI such as diminishing the integrity, quality, completeness, or timeliness of the data. (85 FR 25809). Ultimately, “[a]ny analysis of whether an actor’s practices constitute information blocking will depend on the particular facts and circumstances of the case,” including whether the action rises to the level of an impermissible interference, whether the actor acted with the requisite intent, and whether the actor had control over the EHI or interoperability elements necessary to access, exchange or use the EHI in question. (85 FR 25811 and 25820).5 Read more

Idaho COVID-Related Civil Liability Immunity – Special Session Legislation

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By William Myers III

When Gov. Little called the Legislature into Special Session on August 24th, he did so with a proclamation that attached draft legislation establishing immunity from liability when a person or company makes “good faith efforts” to undertake activities safely during the coronavirus emergency.

The draft legislation must be introduced and passed in the House and Senate and that has not happened as of this writing. However, a review of the draft bill attached to the Governor’s proclamation gives an idea where the legislation may go. Read more

Use of CARES Act Provider Relief Funds

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By Kim Stanger

Healthcare providers who received or receive payments from the CARES Act Provider Relief Fund (“PRF”) may only use the payment for permissible purposes, must document and report the proper use, and return any excess funds to HHS. This alert summarizes the most recent guidance we have concerning these important issues.

Permissible Uses. The PRF includes both General Distributions (to all eligible providers) and Targeted Distributions (to specific provider segments, such as certain rural hospitals, hospitals in high impact areas, and skilled nursing facilities). Under the PRF Terms and Conditions applicable to each,1 Recipients of the PRF Payments must certify “that the Payment will only be used to prevent, prepare for, and respond to coronavirus, and that the Payment shall reimburse the Recipient only for health care related expenses or lost revenues that are attributable to coronavirus.” (See, e.g., https://www.hhs.gov/sites/default/files/terms-and-conditions-provider-relief-20-b.pdf, emphasis added). Read more

Update to Provider Relief Fund

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By Kim Stanger

Beginning April 10, 2020, HHS began issuing payments to providers eligible to receive a portion of the $30 billion reserved for the Provider Relief Fund. There have been two important developments this week:

First, HHS has now opened the portal to allow providers to certify their eligibility; it may be accessed at https://covid19.linkhealth.com/#/step/1.

Second, HHS has updated the terms and conditions associated with the Provider Relief Fund payments. (See https://www.hhs.gov/sites/default/files/relief-fund-payment-terms-and-conditions-04132020.pdf. The revised terms and conditions appear to broaden provider eligibility for the funds. Read more

DOL Finalizes FFCRA Regulations

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By Bradley Cave

After days of uncertainty and looming deadlines created by the Families First Coronavirus Response Act (FFCRA), the DOL has finally issued some definitive regulatory guidance, as well as twenty new Q&As to its list of non-regulatory guidance. You can read the Q&As and access the final regulations at the DOL’s website. But, if you have had enough of the daily changes, we offer the following summary of the new Q&As and the regulations:

Stay-at-Home Orders. A “Federal, state or local quarantine or isolation order” as used in the definitions of qualifying reasons for leave under the Paid Sick Leave Act, includes shelter-in-place or stay-at-home orders that cause an employee to be unable to work, and employees can take paid sick leave for this reason if the employer has work for the employee to do. The supplementary information DOL published with the final rules explains that quarantine and isolation orders include “a broad range of governmental orders.” The regulations also state a bright line rule that paid sick leave can be used only if the employee would have been able to perform work at the worksite or by teleworking but for the quarantine or isolation order. If the employer does not have work for the employee to do regardless of the shelter-in-place or stay-at-home order, the employee is not eligible for paid sick leave. Read more