Mandatory Vaccination for Healthcare Workers Expanded by New Emergency Regulations

By Jessica Woodrow, Esq.
Email Jessica

On August 26, 2021, the New York State Department of Health’s Public Health and Health Planning Council in Albany voted to amend the Official Compilation of Codes, Rules and Regulations of the State of New York (NYCRR), significantly expanding the emergency Covid-19 vaccination mandate previously announced by former Governor Andrew Cuomo. Whereas the previous mandate applied only to healthcare workers at general hospitals and long-term care facilities (LTCFs), the amended regulations now require workers in nearly all categories of healthcare facilities in New York State to comply. The stated purpose of the expanded vaccine mandate is to prevent or reduce the transmission of Covid-19 by those “who engage in activities such that if they were infected with COVID-19, they could potentially expose other covered personnel, patients or residents to the disease.”

Under the newly-added NYCRR § 2.61, covered entities must “continuously require personnel to be fully vaccinated against COVID19, with the first dose for current personnel received by September 27, 2021 for general hospitals and nursing homes, and by October 7, 2021 for all other covered entities absent receipt of an [allowed] exemption.” Significantly, the new regulations go on to provide that a covered entity “may terminate personnel who are not fully vaccinated and do not have a valid medical exemption and are unable to otherwise ensure individuals are not engaged in patient/resident care or expose other covered personnel.” Upon request by the Department of Health, all covered entities are required to report and submit documentation confirming the number and percentage of personnel who have been fully vaccinated, the number and percentage of personnel who have received medical exemptions, and the total number of covered personnel. 

In addition to general hospitals and LTCFs, “covered entities” now include: diagnostic and treatment centers, including community health centers, dental clinics, birthing centers, and rehabilitation facilities; certified home health agencies, including long term home health care programs and AIDS home care programs; hospices; and adult care facilities. “Personnel” includes all individuals “employed or affiliated with a covered entity, whether paid or unpaid, including but not limited to employees, members of the medical and nursing staff, contract staff, students, and volunteers.” However, physicians and dentists in private practice are not subject to the mandate, as the New York State Department of Health has primary regulatory jurisdiction only over the health care facilities it licenses.

Shortly after the Council voted, New York State Department of Health Commissioner Howard Zucker issued a Determination on Indoor Masking which states that, pursuant to NYCRR § 2.61, effective August 27, 2021, masks shall be required: in healthcare settings for personnel and all visitors, regardless of vaccination status; in adult care facilities (ACFs) regulated by the Department for personnel and unvaccinated visitors; in P-12 school settings for all teachers, staff, students, and visitors, regardless of vaccination status; in correctional facilities and detention centers for all incarcerated/detained persons and staff when social distancing cannot be maintained, and for all visitors (facilities may impose their own policies for private visitation); in homeless shelters (including overnight emergency shelters, day shelters, and meal service providers) for all clients, visitors, staff and volunteers, regardless of vaccination status; and on public transportation conveyances and at transportation hubs, for all persons regardless of vaccination status. Any applicable restrictions apply to all persons over the age of two who are able to medically tolerate a face covering.

Notably absent from the expanded mandate is the religious exemption, which was deliberately struck before the final vote. Religious exemptions have historically been granted to individuals belonging to religious organizations whose foundational beliefs and practices discourage or reject vaccination. Under NYCRR § 2.61, only medical exemption is available, and personnel seeking such exemptions must submit supporting documentation. The nature and duration of the medical exemption must be stated, either in the personnel employment medical record or other appropriate record, and must be in accordance with generally accepted medical standards, such as the recommendations of the Advisory Committee on Immunization Practices of the U.S. Department of Health and Human Services

The Council’s decision follows on the heels of an announcement by United States Supreme Court Justice Amy Coney Barrett on August 12, 2021, denying an emergency request to block Indiana University’s mandatory vaccine policy.  By rejecting the request without referring the application to the full court or asking the university for a response, Justice Coney Barrett appears to have sent a message that the Court is unlikely to revisit, let alone overturn, the landmark ruling in Jacobson v. Massachusetts (197 U.S. 11 (1905)). The Second Circuit has also upheld Jacobson in several cases in Connecticut and New York since the start of the pandemic. Given the courts’ demonstrated reluctance to revisit longstanding public health policy, it is unlikely a challenge to these regulations will succeed, especially since the circumstances here are factually similar to the policy at issue in Jacobson.

Since the new regulations do not include an enforcement provision, covered entities will be expected to self-enforce for the time being. The Department could impose financial penalties, but unlike the P-13 school mask mandate, which includes a $1000 fine per violation, NYCRR § 2.61 contains no penalty provision. It is unclear what consequences may result for covered entities that fail to comply and/or fail to terminate employees who refuse to be vaccinated. Although hospitals appear to be generally in favor of the new regulations, whether employers will actually terminate non-exempt employees who refuse vaccination could boil down to whether the employer will face a severe staff shortage. On the other hand, the latest Higher Education Research and Development (HERDS) survey indicates that a majority of healthcare workers are already vaccinated, with the lowest rates being reported by Dutchess and Wyoming Counties (63%). New York City is at 75% overall. Personnel who chose to be vaccinated before now will not enter into the calculus, so any turnover consequences may be limited. Covered entities may have to wait until after the initial Sept. 27 deadline passes to learn whether the Department intends to assume responsibility for enforcement.

NYCRR § 2.61 must be renewed by the Council every 90 days until emergency-basis renewal is deemed unnecessary or the Department issues a notice for proposed rule-making for permanent adoption.

Jessica Woodrow is an Associate Attorney in the litigation and administrative proceedings practice group, handling matters involving all aspects of civil litigation with a primary practice focus on healthcare law. She can be reached at jwoodrow@weisszarett.com or 516-627-7000.

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a New York law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, employment counseling and controversies, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.

New Jersey District Court Declares Cross-Plan Offsetting a Violation of ERISA

By David A. Zarett, Esq.
Email David

It has become commonplace for physicians and medical practices to face audits and payment reviews by commercial health insurers and third-party administrators (“TPAs”) under an ERISA plan. If an overpayment is identified, it is not unusual for the carrier or TPA to recoup the funds allegedly owing. One of the tactics used in recovering the alleged overpayments has become known as “cross-plan offsetting.” Simply put, cross-plan offsetting occurs when overpayment amounts allegedly due by a provider as a result of an audit under Plan A, are offset against payments otherwise owing to the provider under (a separate) Plan B. 

Very recently, a federal district court in New Jersey issued a decision, Lutz Surgical Partners PLLC, et al v. Aetna Inc., et al, Case No. 3:15-cv-02595 (BRM)(TJB) (D.N.J, June 21, 2021), holding that Aetna’s cross-plan offsetting was a violation of several sections of ERISA. (Click here to view case text).

The 52-page decision in Lutz is quite extensive, and addresses a variety of issues, including the proper parties to the lawsuit, standing, waiver and unique ERISA related legal issues, all of which are outside the scope of this Legal Alert. On the distinct issue of the legality of cross-plan offsetting, the Court reasoned that when a TPA serves in a fiduciary/trustee capacity for multiple plans, each plan is considered a separate entity and the TPA’s fiduciary obligations run separately to each. The Court continued that offsetting payments due from Plan A to a provider, in order to recoup alleged overpayments due from the provider to Plan B, violated the separate nature of the fiduciary obligations owing to each plan. Thus, the court ruled that Aetna’s cross-plan offsetting violated Section 406(b)(2) of ERISA, which prohibits plan fiduciaries from acting in “any transaction involving the plan on behalf of a party… whose interests are adverse to the interests of the plan or the interests of its participants or beneficiaries.”  In addition, the court determined that Aetna violated Section 404(a) of ERISA, which provides that ERISA fiduciaries must discharge their duties with respect to a plan “solely in the interest of the participants and beneficiaries and … for the exclusive purpose of… providing benefits to participants and their beneficiaries.”  Indeed, the Court recognized that, “failing to pay a benefit owed to a beneficiary under one plan, in order to recover money for the benefit of another plan [through cross-plan offsetting] may constitute a transfer of money from one plan to another,” all in violation of ERISA. 

While there are several other legal decisions that have touched on this issue, Lutz appears to be the first court decision to squarely hold that cross-plan offsetting violates ERISA. We doubt this will be last court opinion on the matter. 

About the Author: David A. Zarett is a founding member of Weiss Zarett Brofman Sonnenklar & Levy, P.C., and heads up the Firm’s Litigation Department. Mr. Zarett has extensive experience litigating a variety of cases in state and federal courts, which includes disputes with commercial health insurance carriers regarding plan participation and payments. If you have questions about any these issues, or other legal matters uniquely affecting healthcare providers, please reach out to David A. Zarett, Esq. at dzarett@weisszarett.com or (516) 926-3301.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.

OMIG Implements Financial Hardship Process for Providers Under Audit

By Seth A. Nadel, Esq.
Email Seth

The Office of the Medicaid Inspector General (OMIG) is the state agency within the Department of Health which is charged with investigating compliance with the requirements of the New York Medicaid program. OMIG regularly works with other state and federal government agencies such as the federal Centers for Medicare and Medicaid Services, the New York Bureau of Narcotic Enforcement, and the Medicaid Fraud Control Unit to rout out fraud and abuse in the program. OMIG also retains the power to exclude individuals from participation in the Medicaid program, a penalty which can have disastrous consequences for providers.

As part of its duties – and in a similar fashion to Medicare and third-party insurers – OMIG routinely audits the activities of healthcare providers, pharmacies, medical-equipment companies, nursing homes and other health-related businesses in its search for fraudulent or otherwise impermissible billing practices. As a result, providers which bill and collect for patient services rendered under the Medicaid program often find themselves on the receiving end of an OMIG repayment demand. Essentially, if OMIG has determined that services previously billed and collected for by a provider were not medically necessary, unsupported by medical records, or otherwise should not have been reimbursed, OMIG is entitled to recoup those funds from the provider.

Although providers are entitled to appeal rights, there remains the possibility that a provider will be left with a final determination by OMIG that it owes tens or even hundreds of thousands of dollars back to the Medicaid program after its appeal rights are exhausted, which the provider may not be in a financial position to immediately repay.

As of July 2021, however, OMIG has developed and implemented a process which allows providers to apply for relief in the event that the results of an OMIG audit pose a financial hardship to the provider. Specifically, providers who are in receipt of a final audit report may contact OMIG and request a Financial Hardship Application. Following completion of the application, OMIG will contact the provider and work with them to determine an appropriate repayment plan and hardship accommodations.

For reference a copy of a sample Financial Hardship Application may be found here. Based on the sample application, the amount of documentation providers will need to produce before OMIG will consider their request for any type of relief is extensive. Providers will not only need to produce their current financial information such as the amount of cash on hand, outstanding loans and business liquidity, but also information about whether the provider has received COVID-19 financial relief, income from bequests or legacies, and all of the provider’s business interests in other entities. Providers must also account for all assets transferred by the provider to other business interests or entities. Accordingly, providers should seriously consider whether they are willing to make these disclosures before deciding to seek hardship relief, and work with their accountants and legal counsel to ensure all disclosures are accurate and complete.

Note that OMIG has previously been amenable to allowing extended repayment of liabilities in the specific context of voluntary self-disclosures of overpayments by providers as an inducement for providers to make such disclosures. Extended repayment options are also offered by CMS in some instances with respect to recoupment of funds paid under the federal Medicare Program. 

Overall, the creation of the financial hardship process now allows for some much-needed flexibility where a provider is faced with a final audit report and accompanying repayment demand which they are either unable to fully satisfy, or where doing so would present a legitimate financial burden.

The firm has assisted numerous physicians and health-related businesses in connection with payor audits, investigations and repayment demands by government and third-party insurance payors. If you have questions about any these issues, or other legal matters uniquely affecting healthcare providers, please reach out to Seth A. Nadel, Esq. at snadel@weisszarett.com or 516-926-3308.

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.

New York State’s Newly-Announced Vaccine Mandate Policy for Healthcare Entities

By Joshua D. Sussman, Esq., Beth E. Roxland, Esq., Jessica Woodrow, Esq. & Carla Hogan, Esq.
Email Joshua
Email Beth
Email Jessica
Email Carla

On August 16, Governor Cuomo announced a new vaccine mandate for New York State healthcare workers. This announcement aligns with the Department of Labor’s OSHA June emergency temporary standard, the Center for Disease Control’s July guidelines urging employers to encourage its workers to get vaccinated, and the requirements of several other U.S. states, including California and Maine, that have introduced similar vaccine mandates. 

I. Scope of Newly-Announced NYS Vaccine Mandate Policy

Not surprisingly, the announcement’s fine-print is narrower and more nuanced than the attention-grabbing headline. The announcement states that the New York State Department of Health will implement this new mandate by issuing regulations and guidance pursuant to New York State Public Health Law (PHL) Section 16, specifically requiring hospitals, long-term care facilities (LTCF), and nursing homes to develop policies requiring their employees be vaccinated by September 27, 2021. 

Despite the breadth of the Governor’s pronouncement, the new policy appears to exclude private practices, health care groups, and in-home health care workers. However, the Governor alluded to – but did not define – “other congregate care settings,” which could open the door to a broad reading of the Executive Branch’s intent.  In addition, it is important to note that the Commissioner of Health is separately imbued with the authority to issue orders, regulations, or guidance that exceeds the scope of the Governor’s announcement, as PHL Section 16 empowers the Commissioner to order a person to act or discontinue activities that are a danger to public health, so long as the Commissioner provides that person with an opportunity to be heard at a hearing and to present proof that such condition or activity does not constitute a danger to public health. In short, although the stated focus of the new vaccine mandate is on hospitals, LTCFs, and nursing homes, it is foreseeable and within the powers provided to the Commissioner of Health that the vaccine mandate could extend to private practices, health care groups, in-home health care workers, private facilities or any type of employer entity that provides care to patients.

Per the announcement and consistent with the legal requirements of Equal Employment Opportunity Commission guidelines, all healthcare institutional policies must contain limited exemptions to a vaccine mandate for employees with religious objections or medical reasons.   

II. Mandates Aimed at Employers and Entities Rather than Healthcare Workers and Other Individuals

Importantly, and similar to other recently-enunciated policies by the State, this new pronouncement mandates that healthcare employer institutions require their employees to be vaccinated, rather than directly requiring healthcare workers themselves be vaccinated. There are several potential reasons why the State’s new vaccine policy is aimed at employers rather than health care workers. 

One possible reason New York State is putting the onus on employers rather than instituting a government-level mandate directed at healthcare workers is because the currently available vaccines have not been fully approved by the federal Food & Drug Administration (“FDA”), but instead are being made available under a mechanism known as an “Emergency Use Authorization,” which is a type of conditional approval rarely relied upon except in special circumstances, such as a public health emergency. See 21 U.S.C. 360bbb-3, 360bbb-3a, and 360bbb-3b, as amended by Pub. L. 113-5. There is much debate about whether the government or other entities can or should mandate an intervention that has not yet been fully approved by the FDA, and many individuals have expressed hesitation in taking an intervention for that reason. This objection has been the basis of several of the lawsuits challenging healthcare and academic institutions’ vaccine mandates for their workers and students. To date, however, courts have found this claim without merit and insufficient to invalidate any such vaccine mandates. Moreover, the FDA has recently posited that it may grant full approval to at least one of the mRNA vaccines for adult populations in the near future, which may moot this line of reasoning.

Another potential reason why the State’s new policy may be aimed at entities rather than individuals may rest with the limitations of PHL Section 16, which requires orders to be served and opportunities to be heard for each individual personally affected by decisions made by DOH under this Section. As such, the State may need to personally serve each affected healthcare entity if the State enforces compliance with any vaccine mandates issued pursuant to PHL Section 16. While that will be a difficult task, it is far easier than serving the approximately 450,000 hospital workers, 30,000 adult care facility workers, and 145,500 nursing home workers cited in the Governor’s announcement. Additionally, as proposed, only employer health care institutions would be entitled the opportunity to be heard to contest the validity of the Orders—not their employees.

III. Legality of Vaccine Mandate Policies

In addition to the long-standing Supreme Court precedent Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), which upheld the legality of vaccine mandates, the legality of vaccine mandates set by private institutions for healthcare workers, university students, and others, has been the subject of several recent litigations – all of which have upheld such mandates. Notably, on June 16, 2021, a federal district court dismissed a challenge by 117 workers at Houston Methodist Hospital who refused to abide by the institution’s vaccine mandate. See Bridges, et al. v. Houston Methodist Hospital, et al., 21 CV 1774 (S.D. Tex. June 12, 2021). 

More recently, on August 12, 2021, the United States Supreme Court denied students’ challenge of the University of Indiana’s vaccine mandate, following the 7th Circuit’s refusal to issue an injunction pending appeal of the University’s vaccine mandate to students returning to campus. See Klaassen v. Trustees of Indiana University, No. 21-cv-2326 (7th Cir. Aug. 2, 2021). These decisions may be persuasive authority in denying other challenges to similar vaccine mandates. 

IV. Application of Government Mandates to Unionized Workers

Although courts have upheld vaccination mandates, it is unclear whether management in collectively bargained environments can unilaterally force union members to be vaccinated. That issue is currently being litigated in Illinois. Each collective bargaining agreement challenge is different, but employers should not unilaterally implement policies without first bargaining in good faith on certain issues related to such policies, such as: (i) implementation, including who is subject to vaccination unless specified, (ii) pay for time spent being vaccinated, (iii) timing of the vaccination, and (iv) consequences for an employee’s refusal to submit to vaccination.  

V. Penalties for Non-Compliance 

Thus far is it unclear how the State intends to enforce any Section 16 orders that issue, but the Department of Health already reviews vaccine policies related to grade schools and universities and delegates enforcement of those vaccine policies to local health departments. A transition to reviewing and enforcing these new policies may be seamless. Additionally, the Public Health Law contains powerful statutory enforcement tools, including imposition of a $2,000 penalty for each violation pursuant to PHL Section 12, and also authorizes the Attorney General to seek an injunction against any person who violates, disobeys or disregards such orders. 

As neither the Commissioner nor the Department of Health has issued regulations or guidance on the new vaccine mandate, however, it is unclear how or to what extent any noncompliance will be penalized. 

The healthcare and regulatory attorneys at Weiss Zarett will continue to provide updates about the issues presented by this new State vaccine mandate affecting healthcare workers, as well as by other Federal and State rules, regulations and policies developing in response to the quickly-evolving landscape of the Covid pandemic.

If you need guidance on compliance with the new vaccine policy, on other issues surrounding re-opening or operating your business, or on developing strategies in response to the Covid pandemic, please contact Joshua D. SussmanBeth E. Roxland, Carla Hogan or Jessica Woodrow at (516) 627-7000.

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.

How to Prepare for OPMC Investigations: A Legal Perspective

In the state of New York, there is an office within the Department of Health that serves to investigate claims of medical misconduct, known as the Office of Professional Medical Conduct or “OPMC.”

While the scope of OPMC’s jurisdiction is not unlimited, they play a heavy hand and are the primary governmental enforcement agency responsible for monitoring physician conduct, addressing complaints against doctors and adjudicating remedial and disciplinary actions that can leave a lasting stain on a physician’s career.

Luckily, there are key steps you can take to ensure legal protection, should you find yourself in the midst of an OPMC investigation. With the help of the right team of healthcare attorneys, you can protect yourself, your practice and your professional reputation.

For this reason, it is imperative that you know how to properly respond in the event an OPMC investigation does occur. For more information on the legal perspective of these events, keep reading below.

What Is an OPMC Investigation?

“OPMC” is the Office of Professional Medical Conduct. This office sits within the New York State Department of Health.

The main purpose of this office is to investigate complaints lodged against medical practitioners who are governed by the Orders of the State Board for Professional Medical Conduct. This includes:

  • Physicians
  • Physician assistants

The board itself is mostly comprised of physicians, with the remaining one-third of personnel made up of physician assistants and laypersons.

What Happens When an OPMC Complaint Is Filed?

An OPMC complaint may be filed by a patient, or from a patient’s family or friends. These issues can also be lodged by hospitals and government sources. Additionally, healthcare facilities must also report internal disciplinary action for misconduct matters.

Examples of qualifying misconduct include:

  • Negligence
  • Incompetence
  • Impairment from alcohol or drugs
  • Refusing to provide care based on race, color, national origin, etc.
  • Ordering excessive tests or treatments
  • Billing fraud
  • Moral Unfitness

These are just a handful of the potential violations that OPMC would investigate. Others might include: failing to maintain or transfer medical records, privacy violations, or sexual harassment or abusive conduct towards a patient. 

Once an investigation is launched, physicians are expected to fully cooperate. This includes providing any requested documentation, such as medical records and billing materials. Physicians are also given the right to participate in an informal interview with OPMC representatives, but are not obligated to do so. 

From there, the board will make a determination to either dismiss the investigation, or proceed to phase 2 of the process that involves formal charges of misconduct and a multi-step administrative hearing and appeal process. If found guilty, OPMC can impose a variety of disciplinary or remedial actions including: 

  • Revocation of medical license
  • Suspension or limitation of medical license
  • Probation
  • Monitoring
  • Censure
  • Reprimand
  • Fines
  • Community service

With such potentially serious consequences on the line, it is imperative every medical professional who may be subject to these rules take these matters seriously, and do what s/he can to minimize risk and outcome. Since the vast bulk of investigations are closed before proceeding to the phase 2 charges, it is strongly recommended that all efforts be taken to “nip the matter in the bud” and try to get the complaint dismissed as soon as possible. 

It is extremely important to reiterate that during these interviews—and any other stage of the investigation—physicians are authorized to bring in legal counsel.

What Are OPD Investigations?

Similar to OPMC, OPD is another New York State office that handles these types of investigations. OPD stands for the Office of Professional Discipline and sits within the New York State Department of Education

The Department of Education oversees the licensing process for other (non-medical) professionals practicing in New York. This covers a wide span of professionals, including:

  • Dentists
  • Mental health professionals besides psychiatrists
  • Nurses
  • Pharmacists
  • Veterinarians
  • Athletic trainers
  • Chiropractors

These are just a handful of categories that the New York OPD oversees. As with OPMC cases, OPD inquiries typically begin with a claim that is then investigated.

Like OPMC, an OPD investigation can result in drastic remedial or disciplinary action. 

How Can I Prepare for an OPMC or OPD Investigation?

In the event you do find yourself under an OPMC or OPD investigation, one of the most important steps you can take is to secure legal representation. With the help of a trusted team of healthcare lawyers, you can ensure you properly understand all rules and regulations and how they apply to you. Experienced counsel have been down the OPMC/OPD road many times before, and have acquired practical experience in dealing with this very important matter in a professional’s career.

More often than not, physicians fare better during OPMC investigations when they are honest and forthcoming with information. But with that said, it is important to understand your rights under the law throughout the process.

This is where trusted attorneys  in this area of law can help keep compliant with these procedures while avoiding unnecessary instances of self-incrimination.

Turn to the Lawyers at Weiss Zarett Brofman Sonnenklar & Levy, P.C.

With this information, you can gain a greater understanding of OPMC and its investigations. It is imperative that all medical professionals understand this information and the potentially serious consequences on the line.

Should you find yourself on the wrong side of an OPMC investigation, the best thing you can do for yourself and your professional reputation is to immediately seek proper counsel.

With the help of a qualified team of healthcare attorneys that are well-versed in this area of law, you can rest assured that your rights remain protected throughout.

In New York, there is a qualified team of dedicated lawyers standing by to help. Contact an attorney today to learn more, and to ensure you are putting your best foot forward heading into an OPMC investigation.