Health Law Advisor

While we wait for long-anticipated federal regulations from the Occupational Safety and Health Administration (OSHA) addressing the issue of workplace violence in health care, activity continues at the state level.

California and North Carolina are among those currently filling the gaps—with the latter bringing law enforcement officers into hospital emergency departments to address the problem, and the former legislating to keep weapons out (through screening devices).

These laws are the latest developments in the national landscape of initiatives designed to address workplace violence in health care facilities. Though a federal OSHA standard is slated to issue by year-end, it remains to be seen whether that will happen and what effect, if any, the 2024 presidential election might have on those plans.

Global hospital budgets, where hospitals receive a fixed amount of revenue for the upcoming year for a specific patient population (e.g., Medicare and/or Medicaid), are the opposite of fee for service reimbursement.

The Center for Medicare and Medicaid Services (CMS) and state Medicaid programs have taken interest in global hospital budgets and hospitals in impacted states will need to prepare.  This article summarizes two of these programs: the federal Advancing All-Payer Health Equity Approaches and Development (AHEAD) model and New York’s Health Equity Reform 1115 Medicaid Waiver.

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform important surgical tasks or sensitive or invasive procedures or examinations (“Guidance”). The Guidance aims to address increasing concerns over patient privacy, in particular the performance of sensitive examinations and invasive procedures on anesthetized patients.

The Guidance both revises the Hospital Interpretive Guidelines regarding ...

On December 6, 2023, Senate Budget Committee Ranking Member Chuck Grassley (R-Iowa) and Chair Sheldon Whitehouse (D.-R.I.) announced a new bipartisan investigation into private equity ownership in hospitals—just ahead of a new plan by the Biden-Harris Administration to crack down on anticompetitive practices in health care.

Under the Biden plan, announced December 7, the Department of Justice (DOJ), the Federal Trade Commission (FTC), and Department of Health and Human Services (HHS) will seek input on how private equity is affecting the health care of Americans and the ...

New York Governor, Kathy Hochul, recently announced proposed cybersecurity rules for New York hospitals, which are due to be imminently published in the State Register on December 6, 2023, subject to approval by the Public Health and Health Planning Council.  The Governor’s press release indicates the proposed regulations, if enacted, will require New York hospitals to meet at least the following requirements: 

• Establish a cybersecurity program and take proven steps to assess internal and external cybersecurity risks;
• Develop a response plan for potential cybersecurity ...

Introduction

Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is obvious. But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI?

As health care entities around the country face staffing shortages, hospitals have started to turn to apps to fill nursing shifts. New apps allow hospitals to engage nurses as independent contractors to fill open shifts, allowing nurses to bid on shifts and select hours that match their schedule. Apps allow nurses to work as independent contractors and engage directly with the hospital as opposed to employees of the hospital or a nursing staffing agency that then engages on their behalf to staff the hospital. The Wall Street Journal recently reported on these apps, crediting their rise to nurses retiring or leaving the field after burn out from the COVID-19 pandemic, from which hospitals are still struggling to recover. But, these apps have existed for several years, and employment issues such as correct calculation of wages and tracking work time are something Epstein Becker Green has previously spotted.

In September of this year, New York City Councilwoman Julie Menin announced her plan to introduce a series of bills that would create further price transparency requirements for hospitals, with noncompliance resulting in high financial penalties.

The bill package would create an office of hospital accountability that would inform the public as to how much hospitals are charging for various services via a price transparency information portal, where hospitals would be required to provide certain key pricing information to the public. Currently, such pricing data is not typically available for public access, and patients typically have little knowledge regarding how much they will be charged for services.

On February 4, 2022, the Centers for Medicare and Medicaid Services (CMS) issued important updated guidance in a memo (QSO-21-08-NLTC) regarding how acute and continuing care facilities—including hospitals, ambulatory surgical centers, end-stage renal disease facilities, home health agencies, and hospices—manage infection control procedures in light of the COVID-19 public health emergency.

On September 30, 2021, the federal Departments of Treasury, Labor, and Health and Human Services issued “Requirements Related to Surprise Billing; Part II,” the second in a series of interim final regulations (the “Second NSA Rules”) implementing the No Surprises Act (“NSA”). This new federal law became effective for services on or after January 1, 2022.

On December 13, 2021, the Supreme Court of the United States rejected the petition of New York health care workers seeking to stop the State from enforcing regulations requiring covered personnel of hospitals, nursing homes, public health centers, and other health care entities to be fully vaccinated against COVID-19 as a condition of continued employment, subject to narrow exceptions. The Supreme Court’s unsigned order allows the continuing enforcement of the regulations, as litigation of the multiple lawsuits challenging the statewide vaccine mandate for health care workers issued last August continues.

From our Thought Leaders in Health Law video series:  Is your organization ready for the No Surprises Act (NSA)? The law goes into effect January 1, 2022, and contains a new federal ban on surprise billing as well as new disclosure requirements.

The NSA applies to certain payors, providers, facilities, and ancillary service entities that support patients who receive emergency services or other non-emergency services at certain facilities, such as hospitals, hospital outpatient departments, and ambulatory surgical centers.

In this episode of the Diagnosing Health Care Podcast:  We’re beginning to see how mergers and acquisitions in the hospital industry are being impacted by President Biden’s executive order promoting competition in the American economy. The Federal Trade Commission recently announced policy changes, and the Department of Justice has been asked to consider policy changes, that boards of directors and C-suite officers must take into account when weighing transactions.

Special guest Dr. Subramaniam (Subbu) Ramanarayanan, Managing Director at NERA Economic Consulting ...

On March 11, 2020, the World Health Organization declared that the 2019 novel coronavirus (known as “COVID-19”) is now a pandemic. The effects continue to be felt in the United States, which currently has well over 1,000 cases of COVID-19. As of March 12, 2020, 19 states have declared a state of emergency to ensure there are resources to address the coronavirus, and President Trump has announced a ban on travel to and from Europe for 30 days starting on Friday, March 13, 2020, which was extended to the United Kingdom and Ireland on March 15^th. Additionally, on March 13, 2020 President ...

Health care providers and custodial agencies operating in Illinois are now subject to new obligations under the Health Care Violence Prevention Act (210 ILCS 160/1 et seq.)(“HCVPA”), which went into effect on January 1, 2019. The HCVPA, which was enacted in response to two 2017 incidents involving inmates who assaulted hospital nurses, seeks to reduce the growing rates of violence against health care workers.

The HCVPA establishes both preventive and curative measures to protect health care workers. Health care providers are required to create an OSHA-compliant workplace ...

Our colleagues David J. Clark and Erica R. McKinney at Epstein Becker Green has a post on the Trade Secrets & Employee Mobility blog that will be of interest to our readers in the health care industry: “Mile High Non-Compete Law: Colorado Court of Appeals Determines Enforceability of Liquidated Damages Clause in Physician Non-Compete Agreement.”

Following is an excerpt:

The Colorado Court of Appeals, in Crocker v. Greater Colorado Anesthesia, P.C., recently examined several unique enforceability considerations with respect to a physician non-compete agreement.  Of ...

In the last couple of months, ballot initiatives have significantly affected health policy and the health industry as a whole. Constituents are becoming more involved in policy matters that have traditionally been left to elected officials in state legislatures. On January 25, 2018, Oregon held a special election for a ballot initiative that asked whether Oregonians would support funding the state Medicaid program by taxing health plans and hospitals. The ballot initiative passed with a margin of 62 percent of voters supporting the measure. The measure proposed a 1.5 percent ...

There has been a growing trend of strategic joint ventures throughout the healthcare industry with the goal of enhancing expertise, accessing financial resources, gaining efficiencies, and improving performance in the changing environment. This includes, for example, hospital-hospital joint ventures, hospital-payor joint ventures, and hospital joint ventures with various ancillary providers (e.g., ambulatory surgery, imaging, home health, physical therapy, behavioral health, etc.). Extra precautions need to be taken in joint ventures between tax-exempt entities ...

Perspectives on Health Care and Life Sciences advisory by Bob Atlas, President of EBG Advisors, Inc. 

Following is an excerpt:

The U.S. Senate and House of Representatives have both passed their tax reform bills and will now confer toward creating a unified bill that both chambers can support, and that President Trump will sign. The two bills differ in some key respects, but their implications for health care are already rather clear. Some aspects of the legislation explicitly touch health care, while other effects would be indirect. Overall, it appears that most of the changes would ...

In an Advisory Opinion dated October 20, 2017, to Crouse Health Hospital ("Crouse Hospital"), the Federal Trade Commission ("FTC") agreed that the Non-Profit Institutions Act ("NPIA") would protect the sale of discounted drugs from Crouse Hospital to the employees, retirees, and their dependents of an affiliated medical practice (Crouse Medical Practice, PLLC) ("Medical Practice") from antitrust liability under the Robinson-Patman Act.  Significantly, the FTC provided this advice despite the fact that the Medical Practice is a for-profit entity, and is not owned by Crouse ...

On November 1, 2017, the Centers for Medicare & Medicaid Service ("CMS") released the Medicare Hospital Outpatient Prospective Payment System ("OPPS") final rule ("Final Rule"), finalizing a Medicare payment reduction from Average Sales Price ("ASP") + 6% to ASP - 22.5%, for 340B discounted drugs in the hospital outpatient setting, as was proposed in the OPPS proposed rule earlier this year. This payment reduction is effective January 1, 2018, and would primarily impact disproportionate share hospitals, rural referral centers, and non-rural sole community hospitals.

340B ...

Recently, the Federal Trade Commission ("FTC") faced major losses in challenging hospital mergers.  However, it is clear that the FTC is not backing down, especially given its tendency to conclude that proposed efficiencies do not outweigh the chance of lessening competition.

In July of this year, the FTC abandoned a challenge to the proposed merger of St. Mary's Medical Center and Cabell Huntington Hospital in West Virginia after state authorities had changed West Virginia law and approved the merger despite the FTC's objections. This year as well, the FTC failed to enjoin the Penn ...

On March 24, 2015, the House of Representatives Energy and Commerce Health Subcommittee^[1] (the "Subcommittee") held a 340B Program hearing with testimony from the Deputy Administrator of Health Resources and Services Administration ("HRSA"), the Director of the Office of Pharmacy Affairs ("OPA") of HRSA,[2] the Director of Health Care of the Government Accountability Office ("GAO"), and Assistant Inspector General of the Office of Evaluation and Inspection of the U.S. Department of Health and Human Services ("HHS") Office of Inspector General ("OIG").

The purpose of the ...

On Epstein Becker Green's OSHA Law Update blog, Eric Conn reviews an article about OSHA's web-based "Worker Safety in Hospitals" guidance.  The article is entitled "Hospitals' Heavy Lifting: Understanding OSHA's New Hospital Worker and Patient Safety Guidance" and is co-authored by our colleagues Eric Conn, James Frank, and Serra Schlanger.

Following is an excerpt from the blog post:

The article, published in AHLA's Spring 2014 Labor & Employment publication, summarizes OSHA's new web-based "Worker Safety in Hospitals" guidance, explains how the guidance relates to ...

Our colleagues' OSHA Law Update blog has a post we think will be of interest: "OSHA Launches Ergonomics Campaign in Healthcare Industries," by Eric J. Conn, Head of Epstein Becker Green’s OSHA Practice Group.

Following is an excerpt:

OSHA recently announced a campaign to raise awareness about the hazards likely to cause musculoskeletal disorders (MSDs) among health care workers responsible for patient care.  Common MSDs suffered in the patient care industry include sprains, strains, soft tissue and back injuries.  These injuries are due in large part to over exertion related to ...

My earlier post explored various real estate strategies frequently used in hospital M&A transactions.  Each of those different approaches – using real estate assets to secure acquisition financing, increasing existing lines of credit, or monetizing the real estate assets through divestiture – reflect different objectives and opportunities.  But, real estate is more than "location, location, location" and "strategy, strategy, strategy"—there must also be "value, value, value".  The real estate market itself is the lynchpin to establishing the value of individual ...

Please join the attorneys of EpsteinBeckerGreen on June 7, 2011, at the National Press Club, as we present eight panels covering labor and employment topics that have increasingly impacted employers in the health care industry.

Our first panel, entitled Significant Labor and Employment Issues that Affect Health Entities, will include representatives from the health care industry, such as a hospitals, skilled nursing facilities, and emergency medical services. These executive panelists will discuss the critical labor and employment issues they are currently experiencing ...