Health Care

Early on November 4, 2021, the federal Occupational Safety and Health Administration (“OSHA”) filed its Emergency Temporary Standard (the “Standard”) requiring employers with 100 or more employees to implement mandatory COVID-19 vaccine policies no later than January 4, 2022.  These rules are added to OSHA’s existing Emergency Temporary Standard for Health Care providers and similar rules adopted by the Safer Federal Workforce Task Force with respect to contracts amended on or after October 15, 2021, or newly awarded on or after November 14, 2021.

Under the new guidance, by January 4, 2022, employers (other than healthcare providers and federal contractors
Continue Reading OSHA mandates new vaccination rules for large employers

As efforts at the federal and individual states level evolve every day at almost a breakneck pace to address challenges and needs related to the COVID-19 outbreak, here is a updated running list of some of the top actions taken at the federal level that we thought would be helpful to the healthcare industry (Caveat, this is not an exhaustive list): 
Continue Reading Summary List Update of COVID19-related Federal Actions Relevant to Healthcare

On May 1, modifications to the Medicare Conditions of Participation (“CoPs”) went into effect, requiring certain electronic event notifications for admissions, discharges and transfers (“ADTs”) to and from hospitals, critical access hospitals and psychiatric hospitals. To provide guidance to hospitals and state surveyors, CMS released several FAQs as well as interpretive guidance last week to be published in the State Operations Manual.

Hospitals are required to make a “reasonable effort” to ensure that notifications are sent to post-acute care services providers and suppliers, and other practitioners and entities, which need such notifications for treatment, care coordination or quality improvement. Under
Continue Reading CMS Releases Hospital COP Event Notification FAQs; Interpretive Guidance

Labor and Employment
BlogCOVID-19’s Implications for OSHA and the NLRAMay 7, 2021
Recent news regarding the COVID-19 pandemic brings long-awaited optimism as signs of improvement begin to show. According to recent statistics from the Center for Disease Control and Prevention (CDC), 40.7% of the Arizona population has received at least one dose of the COVID-19 vaccine, with 28.9% being fully vaccinated. The number of confirmed cases and deaths related to COVID-19 continues to decline as well. As conditions seem to improve, businesses are eager to re-open their doors and bring back their workforce in an effort to return to “normal.”
Continue Reading COVID-19’s Implications for OSHA and the NLRA

Under the Information Blocking Rule (IBR), a health information network (HIN) or health information exchange (HIE) type actor is one that “determines,” “controls,” or has the “discretion to administer” access, exchange or use of EHI between two or more unaffiliated entities. ONC has said that a separate entity is not necessary to trigger the IBR HIN/HIE definition of an Actor. Additionally, ONC has specifically pointed out that a health care system, for example, could wear two IBR actor hats: (1) as a health care provider, and (2) as a HIN/HIE.
Continue Reading When Does a Health Care Provider Wear an HIE/HIN Hat for Purposes of the Info Blocking Rule?

Well folks, the Information Blocking Rule (IBR) April 5th compliance deadline is behind us at this point.  However, I know that many of you are continuing to work through your top IBR challenges and questions one at a time.  At this point, I have worked through many thorny IBR issues with numerous health care providers and health information exchanges (HIE), so I thought it might be interesting for me to share what is the main topic that I see Actors are focused on. And the winner is …..
Continue Reading What Information Must be Made Available on Patient Portals?

The deadline for compliance with the Information Blocking Rule is just 12 days away!  I am certain that all the Actors are working feverishly and diligently to come into compliance with these new requirements by this fast-approaching date.  On the bright side, I suppose that we can all be relieved that ONC did not stick with its original deadline date of November 2, 2020.  However, even with the extra time Actors may still be scrambling to get all of their ducks in a row by April 5, 2021. So, what are the actual consequences if everything is not “buttoned-up” in time?
Continue Reading Information Blocking Compliance — So What Happens on April 5th?

On and after April 5, 2021, any actor’s agreements, arrangements, or contracts are subject to and may implicate the Information Blocking Rule. The Communications Condition of Certification (CCOC) requirements must be revised to remove or void the contractual provision that contravenes the CCOC requirements whenever the contract is next modified for any reason. A Business Associate Agreement should generally not prohibit or limit the access, exchange, or use of the EHI for treatment.
Continue Reading NEW ONC FAQ: Prior Agreements or Contracts CAN Implicate Information Blocking as of April 5th!

Recent news regarding COVID-19 vaccines seems to be overwhelmingly positive.  Johnson & Johnson has developed a single-dose COVID-19 vaccine which will soon enter manufacturing and distribution stages to eventually become widely available in the United States, along with the currently available Pfizer and Moderna vaccines which are now being administered to anyone 55 years or older in Arizona and essential workers, depending on state protocols.  With these positive developments, however, employers are now faced with the decision of what role vaccinations play in returning to the workplace.  In particular, employers must decide whether they want to require employees to receive
Continue Reading Employer considerations for COVID-19 vaccines

When an Actor wants to potentially deny access of EHI to a person who is suspected of some type of abuse of the individual (the “Abuser”) whose EHI is being sought, the natural inclination is want to look to the Information Blocking (IB) Rule’s Preventing Harm Exception to justify such denial.  However, the IB Rule’s Privacy Exception offers additional options and, in certain ways, more flexibility for the Actor to deny a suspected Abuser’s request for EHI.  
Continue Reading How to Use the Privacy Exception to Deny an Abuser Access to EHI

Over the last few weeks, I have come across a number of health care provider organizations that are under the incorrect assumption or belief that their EMR vendor is “taking care of” all that needs to be done in order for the provider to comply with Information Blocking. This is false. There are operational decisions and other process issues that must be addressed and can only be implemented by the Actor. Every health health care provider that meets the definition of an “Actor” should be taking active steps towards getting their organization positioned to comply with Information Blocking by April
Continue Reading Checklist for Info Blocking Compliance

How can an Actor/covered entity provider comply with both the Information Blocking Rule & HIPAA when access to EHI/PHI needs to be denied based on harm that arises from corrupted data?

  • Delay access to EHI/PHI instead of denying access completely.
  • Have a licensed health care professional confirm the denial of access due to data issues.
  • Adopt a standing policy “signed off” by a licensed health care professional permitting denials of access in pre-identified scenarios involving data issues.

The Information Blocking (IB) Rule is intended to work in sync with HIPAA, including the “right of access” granted to patients with regard
Continue Reading Threading the HIPAA needle through information blocking to block patient access when data is corrupted

I believe that the “Preventing Harm Exception” under the Information Blocking Rule is the most challenging exception to decipher and apply. This is particularly so because some of the standards do not precisely track HIPAA, and yet other standards appear to be inconsistent in how they are applied. In this post, I will attempt to distill the Preventing Harm Exception down to its basic elements, as well as point out issues to be aware of as Actors work to implement these new requirements into their compliance processes.

The Preventing Harm Exception can be found at 45 C.F.R. §171.201. Under
Continue Reading How the ‘Preventing Harm Exception’ changes HIPAA

Bankruptcy, Restructuring, and Creditors’ Rights

Restaurants Continue to Face Uncertain Times Due to the Impact of COVID-19February 4, 2021
Before the impact of COVID-19, restaurants were already facing various developments that collectively impacted historical dine-in trends. Whether it was the increase in patrons utilizing delivery services such as UberEats, DoorDash, GrubHub, or the fairly new market of prepackaged, ready-to-cook meals such as Blue Apron. Each have impacted the restaurant industry in different ways.  The decline in dine-in patrons was exponentially increased with COVID-19 restrictions.  Leaving the questions of how, can, and will restaurants adjust to remain open. . .
Continue Reading Restaurants Continue to Face Uncertain Times Due to the Impact of COVID-19

Written by Catriona Coffey.

The new year has much in store for electronic health information exchange compliance!  Today’s post provides an overview of anticipated changes to the health information regulatory landscape in 2021, including increased interoperability efforts and telehealth expansion due to the coronavirus pandemic. It is not surprising that many of the topics discussed below are a direct result of the interoperability requirements created by the 21st Century Cures Act (“Cures Act”) enacted in December 2016.

Information Blocking

Section 4004 of the Cures Act prohibits “information blocking,” or any practice by a health IT developer of
Continue Reading 2021 changes ahead for health insurance compliance