COVID-19

March 14, 2024

Posted on by Courtney Patterson

QUESTION:
Do you have any tips for virtual meetings?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Yes, invest in Zoom!  The pandemic changed a lot of things, one of which was that many meetings became virtual.  While in-person meetings are back, virtual meetings still may be held from time-to-time, so we’ve compiled the following tips:

  • Virtual participants should be required to maintain compliance with all policies relating to confidentiality, data privacy, electronic communications and security. We recommend that all meetings begin with a reminder about confidentiality, privacy and security, and that this be reflected in the minutes.  Quorum and voting requirements apply as if at an in-person meeting.
  • The best practice is to prepare for calls by testing new cameras and microphones before the meeting. Also, minimize outside distractions, such as the dog coming in and out of the picture, hearing the neighbors fighting, or the kid next door testing out the new exhaust on his Dodge Challenger.  You can’t soundproof the walls, but do try to find a secluded, quiet space.
  • Remember that you’re in a professional setting. We’ve all heard the stories about people making dinner, brushing their teeth, etc., while on Zoom.  Avoid that and give the meeting the attention it deserves.
  • Remember that mute is your friend. Keep microphones on mute unless speaking, and always assume that the mic is hot.  Pre-pandemic, there’s the famous story about President Ronald Reagan forgetting that he had a hot mic, and saying “My fellow Americans, I’m pleased to tell you today that I’ve signed legislation that will outlaw Russia forever. We begin bombing in five minutes.”  Then there are the pandemic stories – all members of a San Francisco area school board resigned after they were heard making disparaging comments about parents at a virtual board meeting.  Always assume the mic is hot and the camera is on.
  • Set forth a process for sharing documents, taking into account: How do you control access? (passwords, secure email, etc.); Do you send emails to gmail accounts or only to hospital accounts? Are you going to blind the records?  Prohibit copies?  Which videoconferencing platform is secure for HIPAA and other privacy laws?  Create a list of approved software programs.

Finally, take everything and turn it into a policy to be used whenever a virtual meeting is held.

If you have a quick question about this, e-mail Nick at ncalabrese@hortyspringer.com.

February 29, 2024

Posted on by Courtney Patterson

QUESTION:
Since the COVID-19 waiver that paused certified registered nurse anesthetist (“CRNA”) supervision requirements expired in May 2023, our facility has been scrambling to find anesthesiologists to supervise our CRNAs.  Is there anything we can do?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
Historically, CMS has required CRNAs to be under the supervision of a practitioner when administering anesthesia.  Given the nature of their work, most facilities required CRNAs to be under the supervision of an anesthesiologist.  As recruiting providers is becoming increasingly difficult, many facilities are running into the same problem that they do not have enough anesthesiologists to adequately supervise their CRNAs.

If your state has not yet joined the 24 states that have elected to opt out of CMS’s CRNA supervision requirements, Medicare has long had flexibility built into the Medicare Conditions of Participation (“COPs”) that may help ease your burden.  The COPs allow CRNAs to provide anesthesia, if they practice in an opt‑out state or in any other state, so long as the CRNA is under the supervision of the “operating practitioner or an anesthesiologist” who is immediately available.  According to CMS Interpretive Guidelines, in the case of procedures, an operating practitioner may include the surgeon performing the procedure.

While surgeons may be an alternative to help fill your need for supervising physicians, we would not consider this an open and shut problem.  Using surgeons as supervising physicians opens the door to several key conversations that still need to take place, both with legal counsel and internally.  For instance, does state law also allow surgeons to supervise CRNAs; is there any additional liability incurred by the surgeons for supervising the CRNAs; and will the surgeons agree to act as supervising physicians?

If you have a quick question about this, e-mail Hala Mouzaffar at hmouzaffar@hortyspringer.com.

January 25, 2024

Posted on by Courtney Patterson

QUESTION:
Our hospital wants to require employees to submit documentation to Human Resources of their COVID-19 and flu vaccination status.  One employee complained that this is a HIPAA violation.  Is it?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:
No.  A hospital is acting in its role as an employer (not a covered entity/health care provider) when it asks employees to answer questions or provide documentation about their vaccination status.  Hospitals store such information in the employee’s employment record, not in the employee’s medical record.

HIPAA specifically excludes employment records from the definition of “Protected Health Information.”  The relevant definition states:  “Protected health information excludes individually identifiable health information…[i]n employment records held by a covered entity in its role as employer.”  45 C.F.R. § 160.103.

Thus, information that a hospital obtains when it asks an employee about vaccination status isn’t covered by HIPAA.  It follows that HIPAA isn’t violated if the hospital then discloses that information to managers and supervisors so they can enforce the hospital’s policies.

Although HIPAA doesn’t apply, the Americans with Disabilities Act (“ADA”) does govern information that a hospital holds in its role as an employer.  The regulations implementing the ADA state that information “regarding the medical condition or history of any employee shall be collected and maintained on separate forms and in separate medical files and be treated as a confidential medical record, except that:  (A) Supervisors and managers may be informed regarding necessary restrictions on the work or duties of the employee and necessary accommodations.”  29 C.F.R. § 1630.14.

It’s important to recognize that in some cases a hospital could hold information about vaccination status in its role as a covered entity/health care provider under HIPAA.  For example, a hospital might conduct a clinic by which it gives flu shots to members of the community.  HIPAA would apply to that information, because it was created by the hospital in its role as a provider of health care services.  Thus, the hospital could not disclose those vaccination records to a local third-party employer unless the individual signs a HIPAA authorization.

If you have a question about this issue, please e-mail Phil Zarone at pzarone@hortyspringer.com.

March 31, 2022

Posted on by Courtney Patterson

QUESTION:
We just heard that HRSA ran out of money for its Claims Reimbursement Program for COVID-19 Testing, Treatment, and Vaccine Administration for the Uninsured.  Does that mean we can balance bill for services to patients who would otherwise have been reimbursed under this program?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
Yes, to the extent that you have not already been reimbursed for HRSA.  HRSA recently posted the following announcement on its website:

The Uninsured Program has stopped accepting claims for testing and treatment due to lack of sufficient funds.  Confirmation of receipt of your claim submission does not mean the claim will be paid.  No claims submitted after March 22, 2022 at 11:59 pm ET for testing or treatment will be processed for adjudication/payment.

On April 5, 2022 at 11:59 pm ET, the Uninsured Program will also stop accepting vaccination claims due to a lack of sufficient funds.

The terms and conditions for the Program state in part:

The Recipient certifies that it will not engage in “balance billing” or charge any type of cost sharing for any items or services provided to Uninsured Individuals receiving a COVID-19 testing and/or testing related items, vaccination or care or treatment for a positive diagnosis of COVID-19 for which the Recipient receives a Payment from the Uninsured Program Fund.  The Recipient must not sell or seek reimbursement from an Uninsured Individual for any COVID-19 vaccine and any adjuvant, syringes, needles, or other constituent products and ancillary supplies that the federal government provides at no cost to the Recipient.  The Recipient shall consider Payment received from the Uninsured Program Fund to be payment in full for such COVID-19 testing and/or testing-related items, vaccine administration, care, or treatment.

To the extent that HRSA will no longer reimburse for these services, you can once again balance bill for these services.

November 18, 2021

Posted on by Courtney Patterson

QUESTION:
Our hospital has more than 100 employees.  Do we have to comply with both the OSHA vaccine mandate and the one issued by CMS?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
OSHA has issued two different Emergency Temporary Standards (“ETS”) that are the source of some confusion.  The first was issued on June 21, 2021.  It required that covered health care employers must develop and implement a COVID-19 plan to identify and control COVID-19 hazards in the workplace and implement requirements to reduce transmission of COVID-19 in their workplaces related to the following:  patient screening and management, standard and transmission-based precautions, personal protective equipment (facemasks, respirators), controls for aerosol-generating procedures, physical distancing of at least six feet when feasible, physical barriers, cleaning and disinfection, ventilation, health screening and medical management, training, anti-retaliation, recordkeeping, and reporting.  The June OSHA ETS encouraged but did not require vaccination by requiring employers to provide reasonable time and paid leave for employee vaccinations and any side effects.

In early November, OSHA issued a second emergency temporary standard requiring worker vaccinations for any employers (not just health care employers) with 100 or more employees or weekly testing for those who remain unvaccinated without an eligible exemption.  This ETS that was enjoined by the 5th Circuit Court of Appeals this past Friday, and the 5th Circuit  ordered that OSHA take no steps to implement or enforce the ETS until further court order.  CMS said it worked closely with OSHA to ensure that the November regulations of both agencies were complementary.

The FAQs issued with the CMS rule on November 5 contained the following guidance:

Q. Which rule is a given health care facility expected to follow – the CMS Omnibus Staff Vaccination Rule, the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, the OSHA COVID-19 Healthcare Emergency Temporary Standard, or the upcoming (or new) OSHA Emergency Temporary Standard?

A.  If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s Omnibus Staff Vaccination Rule, it should look to those requirements first. Health care facilities are generally subject to new federal vaccination requirements based on primacy.  If facilities participate in and are certified under the Medicare and Medicaid programs and are regulated by the CMS health and safety standards known as the Conditions of Participation 11 (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation, then they are expected to abide by the requirements established in the CMS Omnibus Staff Vaccination Rule.  This rule takes priority above other federal vaccination requirements.  CMS’s oversight and enforcement will exclusively monitor and address compliance for the provisions outlined in the CMS Omnibus Staff Vaccination Rule, while also continuing to monitor for proper infection control procedures as established under previous regulations.  The OSHA COVID-19 Employer Emergency Temporary Standard (for facilities with greater than 100 employees) applies to employers that are not subject to the preceding two regulations.  Facilities should review the inclusion criterion for these regulations and comply with all applicable requirements.

Hospitals that participate in Medicare subject to the CMS’s Omnibus Staff Vaccination Rule which amended the Conditions of participation, so per this FAQ guidance hospitals are NOT subject to the November ETS which requires weekly testing for those who remain unvaccinated without an eligible exemption.  Therefore, testing is not an alternative for staff who have not been exempted from the CMS vax requirement to comply with the rule.

On the other hand, while testing is not a substitute for vaccinations under the CMS rule, hospitals are allowed to require testing of unvaccinated/exempt workforce members as a mitigation measure.  The CMS FAQs say:  “In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID19 to at-risk individuals, in keeping with their obligation to protect the health and safety of patients” but this does not require testing.

CMS explained in the preamble to the regulation:  “we considered requiring daily or weekly testing of unvaccinated individuals.  We have reviewed scientific evidence on testing and found that vaccination is a more effective infection control measure.  As such, we chose not to require such testing for now but welcome comment.  Of course, nothing prevents a provider from exercising testing precautions voluntarily in addition to vaccination.”  86 Fed. Reg. 61614.

However, the September 2020 CMS emergency rule that established new requirements for Long Term Care facilities (nursing homes) to test facility residents and staff for COVID-19 is still in effect.  The new FAQs say:  “CMS expects continued compliance with this requirement.”

If you have a quick question about this, e-mail Dan Mulholland at dmulholland@hortyspringer.com

Also, listen to HortySpringer’s latest podcast on the CMS vaccine mandate here.

November 11, 2021

Posted on by Courtney Patterson

QUESTION:
Last month, our hospital announced a policy requiring individuals who are physically present on the premises to be fully vaccinated with the COVID-19 vaccine.  We understand that this policy applies to advanced practice professionals and members of the Medical Staff, but we are not sure how to enforce it.  Any suggestions would be appreciated.

ANSWER:
The Medical Staff Bylaws and Credentials Policy (“Medical Staff Governance Documents”) probably require members “to abide by the medical staff documents and the policies of the Hospital.”  That’s a start, but you may want more.  Here are some ideas.

We recommend that the Medical Staff Governance Documents include a threshold criterion that requires individuals to “document compliance with immunization and health screening requirements (e.g., TB testing, mandatory vaccines, and infectious agent exposures).”  We also recommend that your documents expressly state: “Failure of an individual to continuously satisfy any of the threshold eligibility criteria will result in the administrative relinquishment of appointment and clinical privileges, unless a waiver is granted.”

If you don’t have that language now, the Medical Executive Committee may be able to add it to your Medical Staff Governance Documents, but you’ll have to check the notice requirements and the amendment process.

Another alternative is to rely on language in your Medical Staff Governance Documents that requires individuals to provide information when it is requested by a medical staff leader.  Specifically, we recommend the following language:  “Failure of an individual to provide information pertaining to an individual’s qualifications for appointment or clinical privileges in response to a written request from any medical staff leader or any other authorized committee will result in the administrative relinquishment of appointment and clinical privileges until the information is provided to the satisfaction of the requesting party.”  Since the hospital policy requires proof of vaccination, we are comfortable using this language to help enforce the hospital policy.

Remember, a relinquishment is administrative in nature and is not considered an adverse professional review action.  Therefore, the individual is not entitled to a hearing and the hospital is not required to report the individual to the National Practitioner Data Bank or the State Board.

June 17, 2021

Posted on by Courtney Patterson

QUESTION:   “We have a mandatory COVID-19 vaccination program for our employees.  If an employee has an adverse reaction to the vaccination, are we required to record it in our Occupational Safety and Health Administration (“OSHA”) 300 log?”

ANSWER:      No, not at this time, but here’s the background.  On April 20, 2021, in its FAQs, OSHA stated that an adverse reaction would be recordable if the injury or illness was work-related (OSHA’s position was that if the vaccine was mandated by employers, it was work-related), it was a new case, and the illness met one of the recording criteria (days off of work, restricted work, medical treatment beyond first aid, etc.).  However, OSHA has since updated its guidance and has stated that at this time it will no longer require employers to record those events since it might disincentivize employers’ vaccination efforts.  OSHA stated that it won’t enforce the rule until May 2022.

June 10, 2021

Posted on by Courtney Patterson

QUESTION:   “Can our hospital impose a requirement that all Medical Staff members get a COVID-19 vaccine?”

ANSWER:      While we are aware of some hospitals that are considering making COVID-19 vaccination mandatory for their Medical Staffs, most have not yet implemented such a policy.  We should also note that at least one health system is subject to a class action lawsuit filed by 117 of its employees because of its policy requiring employees to be vaccinated against COVID-19. Read about it here.

While the COVID-19 vaccination is proving to be remarkably effective in controlling the spread of the virus, one of the things that is holding some hospitals and health systems back is that the vaccine is currently under emergency use authorization, rather than the full vaccine authorization normally granted by the FDA.  However, at least two pharmaceutical companies are seeking full authorization from the FDA.  On May 7, 2021, Pfizer requested full approval for their COVID-19 vaccine from the FDA.  Moderna followed suit on June 1, 2021.

As noted above in Your Government at Work, the EEOC, in its updated guidance, emphasized that the federal employment equal opportunity laws do not prevent employers from requiring COVID-19 vaccinations, subject to reasonable accommodation provisions and other equal employment considerations.  But, the EEOC also notes that it is beyond its jurisdiction “to discuss the legal implications of [emergency use authorization] or the FDA approach.”

The section of the federal Food, Drug, and Cosmetic Act allowing emergency use authorization requires that individuals to whom a product subject to emergency use authorization is administered are informed of “the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”  A reasonable interpretation of this statute would give any individual the right to refuse a vaccine that has only been given emergency use authorization and thus preclude mandates.  A counter-interpretation is that an individual must be informed of the consequences of refusal to accept an emergency use authorization vaccination, such as, for example, automatic relinquishment of clinical privileges.

Nonetheless, if you do decide to move forward with a COVID-19 vaccination requirement, you want to make sure that it is consistent with your Medical Staff Governance Documents and Hospital policies.  There should not be anything to keep you from proceeding, but you will want to confirm this.  You will also want to check if your documents permit you to mandate any vaccines.  If they do, this could set the groundwork for a COVID-19 vaccine requirement.  For example, Medical Staff Bylaws often already require influenza vaccination.  Further, many Bylaws include a threshold eligibility criterion for appointment and privileges stating that an individual must complete all required health screenings and vaccinations prior to providing any patient care at the hospital and any appointment/privileges granted by the Board are conditioned on the individual’s compliance with those requirements.  If you have this threshold eligibility criterion language, it should be broad enough to include a COVID-19 vaccination requirement in a separate policy.

November 5, 2020

Posted on by hortyspringer

QUESTION:        I know that the Centers for Medicare and Medicaid Services (“CMS”) have made certain regulatory flexibilities available in response to the public health emergency.  Where is the best place to learn more about these changes?

 

ANSWER:           CMS has made available a large amount of material relating to COVID-19 on its website, but it isn’t always easy to find a specific piece of information (or to know when something’s been recently updated).  Speaking generally, the best starting point for research is the agency’s “Current Emergencies” page, which you can find here.  It’s a bit overwhelming at first, but I would first suggest that you focus on the link that says:  “Get waiver & flexibility information.”  This will take you to a new page that lists “Waivers & flexibilities for health care providers.”  You can skim that list to look for items that may be relevant to your question.  I often scroll down to the “provider-specific fact sheets” when I am beginning my research.

Be careful of relying too heavily on any one document, unless it is crystal clear.  These guidance pages are being updated regularly, and we have encountered numerous situations where the information provided can be misleading or seriously incomplete.  Although it’s not always possible, it’s good if you can locate relevant material from a regulation.

If you have a question about a recent change to a policy, be aware that the agency may not yet have an answer for you.  Under these circumstances, it may be helpful to check this list of CMS podcast transcripts to look for recent updates.  The “CMS Office Hours” calls will often have transcripts that you can search.  (If you have the time, you can also call into one of the agency’s “Office Hours” calls directly.  Agency representatives make themselves available to answer questions related to the Medicare program.)

These online resources can be a helpful way to answer run-of-the-mill questions, but we would encourage you not to rely on them for more important matters.  In those cases, it’s best to seek legal counsel.

September 10, 2020

Posted on by hortyspringer

QUESTION:        I heard that the Centers for Medicare & Medicaid Services (“CMS”) recently announced a new payment model, referred to as the “Community Health Access and Rural Transformation (“CHART”) Model.”  Can you provide a brief overview of this?  Is participation mandatory or voluntary?

 

ANSWER:          CHART is a voluntary payment model intended to improve health care quality in participating rural communities.  Participating rural communities have the option to choose between one of two different “tracks.”  The first is labeled the Community Transformation Track, which builds upon certain lessons learned from the Maryland Total Cost of Care Model and the Pennsylvania Rural Health Model.  To participate, communities must identify a Lead Organization (such as a local public health department or health system).  In exchange for spearheading efforts to implement health care redesign in the targeted community, the Lead Organization is eligible to receive up to $5 million in funding.  This track is scheduled to begin in July of 2021.

The second is the ACO Transformation Track.  This enables rural accountable care organizations (“ACOs”) to receive advance shared savings payments.  CMS hopes that these advance payments will encourage rural ACOs to advance more quickly into models that involve downside risk (i.e., two-sided risk models).  This track is scheduled to begin in January of 2022.

It is important to keep in mind that the CMS Innovation Center is designed to test and experiment with various payment and service delivery models, which means that its initiatives often involve significant risk and uncertainty.  CHART is no different.  Although the agency hopes that this will result in improved health care quality at reduced cost, there are key obstacles that the agency (and the participants) will need to overcome.  For example, what sorts of entities are well-qualified to serve as a community’s Lead Organization (responsible for developing a strategy to redesign the community’s health care delivery system)?  How effective will the participants be in redesigning their health care delivery systems while simultaneously juggling the demands of the COVID-19 pandemic?  Assuming that rural ACOs do choose to accept downside risk, how resilient will they be if obstacles or mistakes cause them to fall short of their goals?

If participants are able to navigate through and ultimately overcome these obstacles, it will be a promising sign for the future of large-scale efforts to promote value-based payment systems nationwide.