Health Law Advisor

The U.S. Supreme Court recently denied two certiorari petitions relating to the willfulness standard of the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b (AKS), an issue with profound implications for health care companies and providers defending against AKS allegations.    

On October 7, 2024, the Supreme Court denied the petition for certiorari in U.S. ex rel. Hart v. McKesson Corporation, and on October 15, 2024, denied the cert petition in Sayeed v. Stop Illinois Health Care Fraud, LLC.^[1]

“Knowingly and Willfully”

 The AKS prohibits persons from, among other things, “knowingly and willfully” soliciting or receiving “any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind—

A. in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a federal health care program, or

B. in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program[.]”

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 ...

Beginning June 21, 2023, New York State (NYS) Public Health Law (PHL) Section 2830 requires hospitals and healthcare professionals to provide written notice to patients before the patient is charged a facility fee.

Overview of Hospital Billing

Billing by hospitals and certain medical facilities typically involves a combination of a facility fee and a professional fee. Facility fees account for the overhead costs of maintaining a hospital, or other health care facility, and refer to the payments for services provided by the hospital, or other health care facility, for either ...

It is axiomatic that New York State requires every Medicaid provider to have an “effective” compliance program.  New York Social Services Law § 363-d.  In July 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) proposed extensive modifications to the regulatory requirements governing compliance programs for entities receiving “significant” Medicaid revenue (increased by these regulations from a threshold of $500,000 to $1 million).  These regulations were proposed to implement portions of the New York State 2020-2021 Budget Bill ...

New York State cannabis agencies and related individuals were served with a lawsuit from four New York veterans (Carmine Fiore, William Norgard, Steve Mejia, and Dominic Spaccio, collectively, the “Plaintiffs”) related to the cannabis market and licensing structure on August 2, 2023. The Plaintiffs are alleging that under the Conditional Adult-Use Retail Dispensary (“CAURD”) licenses, state officials have been favoring “Justice Involved” individuals over disabled veterans in the application process. Their lawsuit has thus far led to the issuance of a ...

The federal government’s announcement that the COVID-19 public health emergency (“PHE”) declaration would end on May 11, 2023 marked the end of various federal mandates and benefits. The Centers for Disease Control’s authorizations to collect certain types of public health data expired, as did the requirement that insurance providers waive costs or provide free COVID-19 tests. However, the Biden Administration announced that COVID-19 hospital admissions, deaths, emergency department visits, test positivity and results of wastewater surveillance will continue to be reported, although the sources of some of this information will change.

New York recently enacted new legislation that will amend Article 45-A of the New York Public Health Law, entitled “Disclosure of Material Transactions”.  Although the legislation, as enacted, contains no description of legislative intent, the budget bill language originally proposed referenced concerns with the “proliferation of large physician practices being managed by entities that are investor-backed” (e.g., private equity platforms) and which are otherwise unregulated by the state outside of the licensure of the individual practitioners.

Effective August 1, 2023, the new legislation requires thirty (30) days advance notice to the New York State Department of Health (“Department”) of any “material transactions” involving “health care entities” that provide administrative or management services for physician practices, provider-sponsored organizations, health insurance plans, “or any other kind of health care facility, organization, or plan providing health care services. . . .”   

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.

On August 26, 2021, the Public Health and Health Planning Council approved an emergency regulation requiring health care personnel to be fully vaccinated against COVID-19. The emergency regulation is effective immediately and will remain in effect for 90 days, subject to review and renewal.

The emergency regulation supersedes the Section 16 Order issued by the New York Department of Health (“DOH”) on August 18, 2021, which mandated the vaccine for personnel at general hospitals and nursing homes.

The emergency regulation expands the mandate to cover personnel at entities ...

2021 is set to be a landmark year for the number of jurisdictions raising wage floors across the country. According to a National Employment Law Project report, as of January 1, 2021, 20 states and 32 municipalities raised their minimum wage. By the end of 2021, the report tracks that as many as 24 states and 50 municipalities will increase wages for the lowest-paid workers.

Perhaps as a reaction to the steadily growing Fight for $15 movement or in response to the COVID-19 pandemic, 40 cities and counties will have met or exceeded a $15 minimum wage by the end of 2021. Eight states — ...

Our colleagues Susan Gross Sholinsky, Genevieve M. Murphy-Bradacs, Ann Knuckles Mahoney, and Jenna D. Russell of Epstein Becker Green have recently published an Act Now Advisory that will be of interest to our readers: "Latest New York State Department of Labor Guidance Significantly Expands COVID-19 Sick Leave Obligations".

The following is an excerpt:

On January 20, 2021, the New York State Department of Labor (“NY DOL”) issued another round of guidance (“Guidance”) on the use of COVID-19 sick leave under the New York State COVID-19 Sick Leave Law (“Law” ...

To limit exposure and reduce the spread of COVID-19, New York and New Jersey are requiring long-term care facilities to implement testing for staff.

New York

On May 11, 2020, New York Governor Andrew Cuomo issued Executive Order 202.30 requiring nursing homes and adult care facilities, including all adult homes, enriched housing programs and assisted living residences (“facilities”), to test all staff for COVID-19 twice per week.  Staff who refuse to be tested will be deemed to have incomplete health assessment and will be prohibited from providing services until the test has ...

Failing a drug test may not kill the buzz for medical marijuana patients in the Empire State.  In contrast to courts in California and other jurisdictions, a New York state court has held that medical marijuana users are entitled to reasonable accommodations, even if they only obtain certification after testing positive for marijuana.

In Gordon v. Consolidated Edison, Inc., Kathleen Gordon failed a random drug test by her employer, Consolidated Edison, Inc. (“CEI”).  After testing positive, but before her termination, Gordon became a certified medical marijuana patient to ...

Following an effort in the state legislature to legalize recreational marijuana, on July 29, 2019, Governor Andrew Cuomo signed S.6579A/A.8420 (the “Law”), a law decriminalizing marijuana possession in New York State. The Law will take effect on August 28, 2019. The Law expunges many past convictions for marijuana use and reduces the penalty for possession of small amounts (less than two ounces) of the drug from a misdemeanor to a violation.

Importantly, the Law does not legalize marijuana, and – relevant to this blog – therefore provides no employment protections for ...

This Employment Law This Week^® Monthly Rundown discusses the most important developments for employers in August 2019.

This episode includes:

• Increased Employee Protections for Cannabis Users
• First Opinion Letters Released Under New Wage and Hour Leadership
• New Jersey and Illinois Enact Salary History Inquiry Bans
• Deadline for New York State Anti-Harassment Training Approaches
• Tip of the Week

See below to watch the full episode – click here for story details and video.

We invite you to view Employment Law This Week^® – tracking the latest developments that could ...

In an announcement about New York’s budget for fiscal year 2020, New York Governor Andrew Cuomo highlighted, among other things, an amendment to Section 3-110 of New York’s Election Law mandating three hours of paid time off for all New Yorkers to vote on election day.

Under the amendment, which is effective immediately, all New York employees who are registered to vote may request up to three hours of paid time off to vote, regardless of their work schedules, as long as the request is made at least two working days before the election.  New York employers may designate that any ...

Consumer privacy protection continues to be top of mind for regulators given a climate where technology companies face scrutiny for lax data governance and poor data stewardship.  Less than a year ago, California passed the California Consumer Privacy Act (CCPA) of 2018, to strengthen its privacy laws.  In many regards, the CCPA served as a watershed moment in privacy due to its breadth and similarities to the E.U. sweeping General Data Protection Regulation (GDPR) law.

Yet, California continues to push the envelope further.  Recently, California State Senator Jackson and Attorney ...

Did you know that your zip code is a better predictor of your health than your genetic code? Public health experts – and your health insurance provider – have long known that the air you breath, the education you receive, your net worth, and even the music that you listen to are strong indicators of your overall health – and the possibility that you might need expensive medical procedures in the future. By some measures, up to 50% of your overall health is determined by social, economic, and environmental factors. As the movement to value-based payment continues in health care, there ...

Last month, the New York State Court of Appeals invalidated a state Department of Health (DOH) regulation that restricted certain health care providers contracting with the state from paying executives more than $199,000 annually, regardless of whether the funds came from the state or not. However, the Court upheld two other DOH regulations; one that limits providers from using public tax-payer money directly to pay executives in excess of $199,000 annually, and another that limits the amount of public funds used for administrative costs.

In January 2012, Governor Andrew Cuomo ...

At this point, it's not really ground-breaking news that America has a problem with opioid drugs. By way of anecdote, when I became a federal prosecutor in 2011, the last heroin case that had been prosecuted in the Nashville U.S. Attorney's office was in the early-1990s; although, to be fair, there were then lots of what we called "pill" cases involving opioids. When I left the office in 2017, at least half of the office's major investigations were directly related to opioids--some pills, but mostly outright heroin or fentanyl/carfentanyl . In Nashville, Tennessee, OxyContin (which ...

Our colleagues Susan Gross Sholinsky, Nancy Gunzenhauser Popper, and Judah L. Rosenblatt, at Epstein Becker Green, have a post on the Retail Labor and Employment Law blog that will be of interest to many of our readers in the health care industry: “Proposed Federal Bill Would Pre-Empt State and Local Paid Sick Leave Laws.”

Following is an excerpt:

On November 2, 2017, three Republican Representatives, Mimi Walters (R-CA), Elise Stefanik (R-NY), and Cathy McMorris Rodgers (R-WA), introduced a federal paid leave bill that would give employers the option of providing their ...

As we have previously reported, there has been an uptick of new employment decisions finding in favor of registered medical marijuana users.  In keeping with these decisions, an administrative law judge (“ALJ”) at New York City’s Office of Administrative Trials & Hearings (“OATH”) also issued a report and recommendation, subsequently adopted by the relevant City commissioner, to dismiss a petition against a taxi driver that would have stripped him of his driver license because of his lawful medical marijuana use.

In Taxi & Limousine Comm’n v. W.R., OATH Index. No ...

When: Thursday, September 14, 2017 8:00 a.m. – 4:30 p.m.

Where: New York Hilton Midtown, 1335 Avenue of the Americas, New York, NY 10019

Epstein Becker Green’s Annual Workforce Management Briefing will focus on the latest developments in labor and employment law, including:

• Immigration
• Global Executive Compensation
• Artificial Intelligence
• Internal Cyber Threats
• Pay Equity
• People Analytics in Hiring
• Gig Economy
• Wage and Hour
• Paid and Unpaid Leave
• Trade Secret Misappropriation
• Ethics

We will start the day with two morning Plenary Sessions. The first session is kicked off ...

Our colleagues Patrick G. Brady and Julie Saker Schlegel, at Epstein Becker Green, have a post on the Retail Labor and Employment Law blog that will be of interest to many of our readers in the health care industry: “Beyond Joint Employment: Do Companies Aid and Abet Discrimination by Conducting Background Checks on Independent Contractors?”

Following is an excerpt:

Ever since the National Labor Relations Board (“NLRB”) issued its August 2015 decision in Browning-Ferris Industries of California, Inc., holding two entities may be joint employers if one exercises either ...

On February 1, the New York State Department of Labor (“NYSDOL”) adopted regulations (“Regulations”) clarifying the pay transparency provisions of Section 194(4) of the New York Labor Law. The pay transparency section was added to Section 194 as part of a broader amendment to New York State’s equal pay law in January 2016. This pay transparency section provides that employers may not prohibit employees from “inquiring about, discussing, or disclosing” the wages of that employee or another employee, and explains what any company policy on the topic can and cannot ...

Our colleagues Judah L. Rosenblatt, Jeffrey H. Ruzal, and Susan Gross Sholinsky, at Epstein Becker Green, have a post on the Hospitality Labor and Employment Law Blog that will be of interest to many of our readers in the health care industry: “Where Federal Expectations Are Low Governor Cuomo Introduces Employee Protective Mandates in New York.”

Following is an excerpt:

Earlier this week New York Governor Andrew D. Cuomo (D) signed two executive orders and announced a series of legislative proposals specifically aimed at eliminating the wage gap in gender, among other ...

With flu season quickly approaching, health care employers may be considering mandatory influenza vaccinations for their workforce. Mandatory vaccination policies may dramatically increase patient safety, but they may also cause friction within the workforce when employees object on religious grounds to being vaccinated.

While no federal and few state statutes address the legality of enforcing mandatory vaccination policies, the EEOC and private litigants recently have moved this issue forward in the courts. Under Title VII of the Civil Rights Act of 1964 (“Title ...

On November 4, 2016, the Western District of Pennsylvania held that the “because of sex” provision in Title VII of the Civil Rights Act prohibits discrimination on the basis of sexual orientation. In doing so, the court broke from the recent trend of federal courts that have felt compelled by prior precedent to dismiss sexual orientation discrimination claims.

In EEOC v. Scott Medical Health Center, P.C., the plaintiff (a gay male) alleged that he was subjected to repeated and unwelcome offensive comments regarding his sexual orientation and his relationship with a male ...

When: Tuesday, October 18, 2016 8:00 a.m. – 4:00 p.m.

Where: New York Hilton Midtown, 1335 Avenue of the Americas, New York, NY 10019

Epstein Becker Green’s Annual Workforce Management Briefing will focus on the latest developments in labor and employment law, including:

• Latest Developments from the NLRB
• Attracting and Retaining a Diverse Workforce
• ADA Website Compliance
• Trade Secrets and Non-Competes
• Managing and Administering Leave Policies
• New Overtime Rules
• Workplace Violence and Active-Shooter Situations
• Recordings in the Workplace
• Instilling Corporate Ethics

We recently wrote about the many failures of health insurance co-ops created under the Affordable Care Act ("ACA"), and the impact of those failures on providers and other creditors, consumers, and taxpayers.

As we described, nonprofit co-op insurers were intended to increase competition and provide less expensive coverage to consumers; however, low prices, lack of adequate government funding, restrictions on the use of federal loans for marketing, and low risk corridor payments from the Centers for Medicare & Medicaid Services created financial challenges for these ...

by Joseph J. Kempf, Jr., and Jane L. Kuesel

On April 12, 2012, Governor Andrew Cuomo issued an Executive Order requiring the State of New York to establish an American Health Benefit Exchange and Small Business Health Options Program in New York (together, the “Health Benefit Exchange”). The Governor’s action was taken in response to the mandate contained in Section 1311 of the Patient Protection and Affordable Care Act, and the New York Legislature’s failure to enact legislation to begin development of the Health Benefit Exchange. Although the Health Benefit Exchange is ...