On May 11, 2021, the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health & Human Services published an interim final rule/guidance to establish COVID-19 vaccination requirements for Long-Term Care (LTC) facilities. The requirements are applicable to both residents and staff. LTC facilities have already been managing COVID-19 vaccination requirements both at the federal and state levels. CMS’ interim final rule, however, adds new requirements for educating residents (or resident representatives) and staff regarding the benefits and potential side effects associated with the COVID-19 vaccine, offering the vaccine, and reporting COVID-19 vaccine and therapeutics treatment information to the Center for Disease Control’s (CDC’s) National Healthcare Safety Network (NHSN)

An important definition in the guidance is of the term “staff.” This includes individuals who work in the facility on a regular (that is, at least once a week) basis, including individuals who may not be physically in the LTC facility for a period of time due to illness, disability, or scheduled time off, but who are expected to return to work. The term also includes individuals under contract or arrangement, including hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals, or volunteers, who are in the facility on a regular basis, as the vaccine is available.

The chart below provides an outline of the requirements in the interim final rule.

Residents/Staff

Education Education should be provided in a manner that is easily understood and in advance of each vaccination dose, which should include (i) FDA EUA Fact Sheet, (ii) benefits and side effects (e.g., fever, aches, rare reactions) for each dose needed.
Vaccination

LTC facilities must have policies and procedures to oversee that vaccines are offered when supplies are available (unless contraindicated or already immunized). Facilities also need to be screening for prior immunization, and medical precautions, contraindications necessary to determine eligibility.

Residents and staff must have opportunity to accept or decline the vaccine, and change their decisions. Note, residents may decline vaccines and LTC facilities may not take any adverse action, including social isolation, denied visitation, and involuntary discharge. However, staff may not be able to decline vaccination, as LTC facilities will need to review state law and organizational policies.

If a resident or staff member requested vaccination and missed prior opportunity for any reason, the LTC facility must offer vaccine as soon as possible.

Vaccinations must be conducted in accordance with CDC, ACIP, FDA, and manufacturer guidelines. All facilities must adhere to current infection prevention and control recommendations when preparing and administering vaccines, including monitoring for adverse reactions. This includes monitoring of indications and contraindications for COVID-19 vaccination, including new or revised guidelines issued by the CDC, FDA, vaccine manufacturers, or other expert stakeholders.

If the vaccine is unavailable, LTC facilities should provide information on obtaining vaccination opportunities (e.g., health department or local pharmacy)

Vaccine education and offer requirements do not apply to individuals entering the LTC facility for a specific purpose, or limited amount of time – e.g., delivery, repair persons, volunteers, entering facility less than once per week.

 

Residents

Staff

Documentation

Residents’ medical record must document:

o   that resident or resident representative was provided education regarding the benefits and potential risks associated with COVID-19 vaccine;

o   each dose of vaccine administered, or that the resident did not receive the COVID-19 vaccine due to refusal or medical contraindications;

o   date education and offer of vaccine took place;

o   name of representative that received education and accepted/refused vaccine, if applicable; and

o   Samples of educational materials used.

LTC facilities need to document vaccine status of residents, including total numbers of residents, numbers of residents vaccinated, numbers of each dose of COVID19 vaccine received, vaccination adverse events, and therapeutics administered for treatment of COVID-19.

Documentation concerning staff includes:

o   that staff was provided education regarding the benefits and potential risks associated with COVID-19 vaccine;

o   that staff were offered the vaccine or information on obtaining-19 vaccine, unless contraindicated or already vaccinated; and

o   vaccine status of staff and related information as indicated by NHSN.

LTC facilities need to document vaccine status, including total numbers of staff, number of staff vaccinated, numbers of each dose of COVID19 vaccine received, and any vaccination adverse events.

This could be accomplished with a staff roster noting education (e.g., sign-in sheets), date of education, samples of educational materials. Additionally, for staff that have already been vaccinated or received the vaccination outside the LTC facility, the facility should request staff to substantiate their vaccination.

 

LTC facilities must be able to provide evidence, upon request, of efforts made to make the vaccine available.

If there is manufacturing delay, LTC facility must be able to provide evidence of the delay, and efforts to acquire subsequent doses as necessary.

Reporting

Adverse reactions must be reported to the Vaccine Adverse Event Reporting System (VAERS)

Through the National Healthcare Safety Network (NHSN) LTC facilities are required to report, on a weekly basis, the COVID-19 vaccination status of residents and staff, total numbers of residents and staff vaccinated, each dose of vaccine received, COVID-19 vaccination adverse events, and therapeutics administered to residents for treatment of COVID-19.

These new requirements will raise additional data privacy and security requirements for LTC facilities involving the collection, storage, transmission, and potential recordkeeping of resident and employee health information. LTC facilities should review their policies and procedures and how they will be applied these new requirements.

CMS will begin reviewing for compliance with the new vaccination reporting requirements beginning Monday, June 14, 2021.

Surveyors will engage in efforts to ensure compliance. Surveyors will be looking for a facility representative to provide information on how residents and staff are educated about and offered the COVID-19 vaccine. They will want to see educational materials. Surveyors will request a list of residents and staff and their COVID-19 vaccination status, further review their records and even conduct interviews to confirm residents and staff were educated on and offered the COVID-19 vaccine, in accordance with the new requirements.

According to the guidance, failure to meet reporting requirements will result in a Civil Monetary Penalty (CMP) starting at $1,000 for the first occurrence. For each subsequent week that the facility fails to submit the required report, noncompliance will result in an additional CMP imposed at an amount increased by $500 and added to the previously imposed CMP amount for each subsequent occurrence.

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Photo of Joseph J. Lazzarotti Joseph J. Lazzarotti

Joseph J. Lazzarotti is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. He founded and currently leads the firm’s Privacy, e-Communication and Data Security Practice, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP) with…

Joseph J. Lazzarotti is a Principal in the Morristown, New Jersey, office of Jackson Lewis P.C. He founded and currently leads the firm’s Privacy, e-Communication and Data Security Practice, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP) with the International Association of Privacy Professionals. Trained as an employee benefits lawyer, focused on compliance, Mr. Lazzarotti also is a member of the firm’s Employee Benefits Practice Group.

In short, his practice focuses on the matrix of laws governing the privacy, security, and management of data, as well as the impact and regulation of social media. He also counsels companies on compliance, fiduciary, taxation, and administrative matters with respect to employee benefit plans.

Privacy and cybersecurity experience – Mr. Lazzarotti counsels multinational, national and regional companies in all industries on the broad array of laws, regulations, best practices, and preventive safeguards. The following are examples of areas of focus in his practice:

  • Advising health care providers, business associates, and group health plan sponsors concerning HIPAA/HITECH compliance, including risk assessments, policies and procedures, incident response plan development, vendor assessment and management programs, and training.
  • Coached hundreds of companies through the investigation, remediation, notification, and overall response to data breaches of all kinds – PHI, PII, payment card, etc.
  • Helping organizations address questions about the application, implementation, and overall compliance with European Union’s General Data Protection Regulation (GDPR) and, in particular, its implications in the U.S., together with preparing for the California Consumer Privacy Act.
  • Working with organizations to develop and implement video, audio, and data-driven monitoring and surveillance programs. For instance, in the transportation and related industries, Joe has worked with numerous clients on fleet management programs involving the use of telematics, dash-cams, event data recorders (EDR), and related technologies. He also has advised many clients in the use of biometrics including with regard to consent, data security, and retention issues under BIPA and other laws.
  • Assisting clients with growing state data security mandates to safeguard personal information, including steering clients through detailed risk assessments and converting those assessments into practical “best practice” risk management solutions, including written information security programs (WISPs). Related work includes compliance advice concerning FTC Act, Regulation S-P, GLBA, and New York Reg. 500.
  • Advising clients about best practices for electronic communications, including in social media, as well as when communicating under a “bring your own device” (BYOD) or “company owned personally enabled device” (COPE) environment.
  • Conducting various levels of privacy and data security training for executives and employees
  • Supports organizations through mergers, acquisitions, and reorganizations with regard to the handling of employee and customer data, and the safeguarding of that data during the transaction.
  • Representing organizations in matters involving inquiries into privacy and data security compliance before federal and state agencies including the HHS Office of Civil Rights, Federal Trade Commission, and various state Attorneys General.

Benefits counseling experience – Mr. Lazzarotti’s work in the benefits counseling area covers many areas of employee benefits law. Below are some examples of that work:

  • As part of the Firm’s Health Care Reform Team, he advises employers and plan sponsors regarding the establishment, administration and operation of fully insured and self-funded health and welfare plans to comply with ERISA, IRC, ACA/PPACA, HIPAA, COBRA, ADA, GINA, and other related laws.
  • Guiding clients through the selection of plan service providers, along with negotiating service agreements with vendors to address plan compliance and operations, while leveraging data security experience to ensure plan data is safeguarded.
  • Counsels plan sponsors on day-to-day compliance and administrative issues affecting plans.
  • Assists in the design and drafting of benefit plan documents, including severance and fringe benefit plans.
  • Advises plan sponsors concerning employee benefit plan operation, administration and correcting errors in operation.

Mr. Lazzarotti speaks and writes regularly on current employee benefits and data privacy and cybersecurity topics and his work has been published in leading business and legal journals and media outlets, such as The Washington Post, Inside Counsel, Bloomberg, The National Law Journal, Financial Times, Business Insurance, HR Magazine and NPR, as well as the ABA Journal, The American Lawyer, Law360, Bender’s Labor and Employment Bulletin, the Australian Privacy Law Bulletin and the Privacy, and Data Security Law Journal.

Mr. Lazzarotti served as a judicial law clerk for the Honorable Laura Denvir Stith on the Missouri Court of Appeals.