Posts in Health and Human Services.
Atkinson v. NCI Nursing Corps. and MedTox Laboratories, Inc. and the West Virginia Medical Professional Liability Act

In November of 2023, the Intermediate Court of Appeals of West Virginia (“ICA”) found that urine collection during a random, employer-mandated drug screening was not “health care” under the West Virginia Medical Professional Liability Act (“MPLA”).  The ICA’s decision, albeit limited by the facts of the case, represents a slight departure in the trend of West Virginia courts broadly defining “health care” under the MPLA. It remains to be seen whether the nuances of this analysis will affect other healthcare providers facing the prospect of litigation for ...

Posted in Health Care
Laboratory Compliance in the Modern Age

It seems that clinical laboratories are under more scrutiny now than ever before.  Whether it is the testing for COVID-19 performed during the public health emergency or the urine drug screens performed as part of patient compliance monitoring for pain management and substance use disorder treatment programs or just routine panels ordered by primary care providers, an audit is going to come.  And, the burden has never been heavier on laboratory providers to establish that they have an effective corporate compliance program to ensure the provider is not engaging in practices deemed to ...

Posted in Health Care
The Cures Act, Information Blocking and Expansion of EHI Definition 

The 21st Century Cures Act Final Rule Information Blocking Provision became active on April 5, 2021.  “Information blocking” is a term used to describe a situation where a patient struggles to gain timely access to protected health information (“PHI”).  While patient rights to access PHI are established by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), patient complaints of information blocking are being addressed by – and have become a major priority of - the Office of the National Coordinator for Health Information Technology ...

The Current and Confusing Legal Status of Abortion in West Virginia

When you strip away the partisan politics and individual religious beliefs, abortion ultimately is a health care issue. And, in light of the United States Supreme Court’s recent dismantling of Roe v. Wade, there may be no health care issue that is more confusing than that of the legal status of abortion, especially in West Virginia. In today’s Health Care Law Blog, we will take a look at the current state of West Virginia’s abortion law, and we will consider how an abortion ban may affect a woman’s right to utilize prescription medications approved by the United States Food and ...

Legal Battles Rage Over CMS Vaccine Mandate While Providers Wait for Answers

Since taking office, President Joe Biden has made it a priority to increase the number of vaccinated citizens. To accomplish his goals, the Biden Administration has spearheaded several vaccine mandates, but these mandates have been met with significant political opposition, leading employers across the country – especially those operating within the realm of health care – with more questions than answers. The Centers for Medicare and Medicaid Services (“CMS”) Vaccine Mandate is expected to cover more than 17 million workers, including approximately 76,000 health ...

What Does a Potential Ban on Non-Compete Agreements Mean to West Virginia Health Care Providers?

On July 9, 2021, President Joe Biden signed a very broad Executive Order intended to promote greater competition in the U.S. economy. As part of his larger competition plan, the President called on the Federal Trade Commission (“FTC”) to ban the use of non-competition agreements. According to White House estimates, non-compete agreements are used, in some form, to restrict the work options of between 36 and 60 million American workers. As my legal practice deals solely with health care providers – both from an employer and employee perspective – I know that non-competition ...

California v. Texas and the Future of the Affordable Care Act

On November 10, 2020, the United States Supreme Court heard oral arguments in the case of California v. Texas, and in early 2021 the Court is expected to render a decision that will determine the fate of the Patient Protection and Affordable Care Act (“ACA”). The case itself, California v. Texas, was originally filed in 2018 on behalf of 20 states and two individual plaintiffs, and it sought to challenge the “minimum essential coverage provision” (also known as the “individual mandate”) contained in the ACA. Arguing the illegality of the individual mandate, these ...

Pharmaceutical Manufacturers Threaten Federal 340B Drug Pricing Program

Back in June, many of the health care providers in West Virginia (and across the country) began receiving letters from major global drug manufacturers. Some letters demanded that these organizations, who are considered “covered entities” for purposes of participating in the federal 340B drug pricing program, turn over voluminous amounts of information about patients who received discounted medications through 340B, seeming in clear violation of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Other letters just flatly announced that the ...

Interim Final Rule Issued for 21st Century Cures Act

Last week, on October 29, 2020, the Office of the National Coordinator for Health Information Technology (“ONC”) released an interim final rule that delays compliance dates for information blocking and other health information technology (“HIT”) requirements set forth in the 21st Century Cures Act (“Cures Act”). The ONC’s stated reason for this delay is the COVID-19 Public Health Emergency, as the ONC previously had implemented the requirements in a final rule issued on May 1, 2020 (“Final Rule”).

Developers of certified HIT, health care providers, health ...

DOL Issues Revised Guidance on FFCRA Leave Rules

On September 11, 2020, the U.S. Department of Labor’s Wage and Hour Division (“DOL”) announced it would be releasing its revisions to previously released regulations governing paid sick leave and the expanded family and medical leave act (“eFMLA”) under the Families First Coronavirus Response Act (“FFCRA”). These revised rules come in response to the recent decision of the U.S. District Court for the Southern District of New York (“Court”), which invalidated four aspects of the original FFCRA regulations. The revised regulations, which become effective ...

The Government's Response to COVID-19 and its Impact on the Health Care Industry

The past few weeks have been a busy time for those interested in the legal side of the federal government's response to the novel coronavirus (COVID-19).  It has been just as busy at the state level, with press conferences, Executive Orders and other recommended procedures and guidelines issued to address the pandemic in West Virginia.  Here are just a few of the recent highlights related specifically to the health care industry.

Additional COVID-19 Relief for Hospitals

On April 24, President Donald Trump signed into law the Paycheck Protection Program and Health Care Enhancement Act

COVID-19 Workforce Reductions and the WARN Act

Over the last couple of weeks, the Bowles Rice CARES Act/COVID-19 Team has fielded a lot of questions from companies trying to understand their legal duties under the Families First Coronavirus Response Act and whether permanent layoffs, reductions of hours or temporary furloughs are appropriate for their business under these unique circumstances.  While no one wants to let valued employees go during this time of so much uncertainty, companies must do what is necessary to ensure that their employees have work to return to once this pandemic is over.

Recognizing this necessity for so ...

New Measures Released to Address the Impacts of COVID-19 on Health Care Entities

Last week was a very busy one for those following the legal side of the novel coronavirus (“COVID-19”), as lots of new measures are being released to address the impacts of the virus on health care entities and other businesses across the country.  Here are just a few of the healthcare-related highlights.

Guidance on the Definition of Health Care Provider

Late on Friday afternoon (March 27), the U.S. Department of Labor (“DOL”) issued additions to its guidance related to the Families First Coronavirus Response Act ("FFCRA"), explaining its paid sick leave and expanded Family ...

Coronavirus Q & A – Part 2: Health Care Law Issues

Since the first case of the Novel Coronavirus (COVID-19) was reported on January 21, 2020, people across the country have been faced with more questions than answers. With no known vaccine or treatment for the virus, and with other countries seeing COVID-19 spread at an alarming rate, it is not surprising that some degree of panic has begun to develop. While there are no known cases in West Virginia at the time of this posting, government agencies and health care providers across the state are working to prepare for the inevitable spread of COVID-19 into the Mountain State.

Meanwhile, the ...

Coronavirus Q & A – Part 1: Employment Law Issues

Since the first case of the Novel Coronavirus (COVID-19) was reported on January 21, 2020, people across the country have been faced with more questions than answers. With no known vaccine or treatment for the virus, and with other countries seeing COVID-19 spread at an alarming rate, it is not surprising that some degree of panic has begun to develop. While there are no known cases in West Virginia at the time of this posting, government agencies and health care providers across the state are working to prepare for the inevitable spread of COVID-19 into the Mountain State.

Meanwhile, the ...

Posted in Health Care
Rural Hospital Closures Are on the Rise

As the leader of the Bowles Rice Health Care Practice Group, I have the privilege of working with many of the fine rural hospitals serving underserved populations throughout West Virginia. But I am becoming increasingly worried about these important safety net providers.

Last week, it was announced that Fairmont Regional Medical Center would be closing its doors in just 60 days. Understandably, local residents were shocked, saddened and scared. But those working within the industry were not all that surprised, as rural hospital closures are on the rise – not just in West Virginia ...

Posted in Health Care, HIPAA
How Does HIPAA Apply to Employers?

Overview

Many employers wonder if they need to comply with HIPAA.  Of course, there is never an easy answer, and a fact intensive analysis should be performed to determine if HIPAA applies.  This article is intended to discuss the common situations in which HIPAA applies to employers.

General Principals of HIPAA

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was adopted by Congress in 1996. HIPAA's purpose is “to improve portability and continuity of health insurance coverage in the group and individual markets, to combat waste, fraud, and abuse in health ...

HIPAA and Cybersecurity - Part Two / Breach Response

As mentioned in Part One of this two-part discussion on the Health Insurance Portability and Accountability Act (HIPAA), HIPAA has become a pervasive force within the practice of medicine.  All health care providers should be conducting some form of meaningful annual training with their employees.  In Part One, we discussed hacking and criminal behaviors targeted at health care companies, and those will always be very difficult to anticipate and prevent.  By contrast, health care providers can do a great deal to avoid the kinds of internal HIPAA violations – usually committed by ...

HHS Issues Regulations Protecting Against Religious Discrimination in Health Care

On May 2, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued new guidelines expanding the provider conscience rule for health care workers and entities participating in federally funded programs. The "conscience rule" allows individuals and entities to refuse to perform, accommodate, or assist with certain health care services, such as birth control, abortions, or sterilization procedures, on religious or moral grounds.

The new protections, effective 60 days following pending publication in the federal register, apply to ...

Posted in Cybersecurity, HIPAA
HIPAA and Cybersecurity - Part One

Since its passage by Congress in 1996, the Health Insurance Portability and Accountability Act (HIPAA) has become a pervasive force in the health care industry.  While most, even within the medical field, do not know exactly how HIPAA works or how far it reaches, almost everyone, especially within the medical field, has been taught to be afraid of it.  This post is part one of a two-part discussion on HIPAA, the issues to be aware of when considering patient confidentiality, and how to deal with any confidentiality breaches or HIPAA violations.

As “covered entities” under HIPAA ...

Posted in Subpoenas
What Providers are Supposed to Do When Subpoenaed

Having worked imbedded within the medical field for more than a decade before joining the health group at Bowles Rice, I can tell you that most medical practices do not know what to do when they receive a subpoena from a lawyer’s office.  Most of the time, the initial reaction will be to quickly comply in order to avoid initiating a confrontational situation with the lawyer.  However, there are many occasions in which simply answering the subpoena is the wrong answer, and it can get the health care provider in a lot of trouble.  As such, it is important that the health care provider, when served ...

Labor and Employment Pains: Navigating the Relationship Between West Virginia's Safer Workplace Act and Medical Cannabis Act

One of the more interesting legal landscapes to monitor within West Virginia will develop over the next few months as the Mountain State approaches its July 1 kickoff of the Medical Cannabis Act (which is discussed in more detail here).  The West Virginia Medical Cannabis Act comes at a particularly fascinating time for employment lawyers, as it arrives almost two years to the day after the effective date of the West Virginia Safer Workplace Act on July 7, 2017.  The Safer Workplace Act was heralded by Governor Jim Justice for its dramatic (and, from an employer’s perspective, largely ...

Smoke Signals – What’s On the Horizon for Medical Cannabis in West Virginia?

As most of us in West Virginia look forward to the arrival of summer, employers throughout the Mountain State may be feeling a little bit of trepidation.  After more than two years in the waiting, the West Virginia Department of Health and Human Resources (DHHR) Bureau for Public Health can begin issuing the patient and caregiver identification cards necessary to obtain medical cannabis on July 1, 2019. 

Posted in Medicaid
The Attempt to Employ Medicaid Work Requirements in West Virginia

As February came to an end, a bill that sought to impose work or other work-like requirements on Medicaid recipients died in the West Virginia House of Delegates.  President Donald Trump has been vocal in his support of states tying the receipt of Medicaid benefits to work, and our own GOP-led House of Delegates had hoped to implement new work requirements in the Mountain State this session.